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Xenetic Biosciences, Inc.NOVELION THERAPEUTICS INC. FORM 10-K (Annual Report) Filed 03/30/17 for the Period Ending 12/31/16 Telephone CIK 6047077000 0000827809 Symbol NVLN SIC Code Industry 2834 - Pharmaceutical Preparations Biotechnology & Medical Research Sector Healthcare Fiscal Year 12/31 http://www.edgar-online.com © Copyright 2017, EDGAR Online, Inc. All Rights Reserved. Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use. U.S. SECURITIES AND EXCHANGE COMMISSIONWASHINGTON, DC 20549 FORM 10-K (Mark One)☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscal year ended December 31, 2016◻ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period from to Commission file Number: 000-17082 Novelion Therapeutics Inc. (Formerly QLT Inc.)(Exact Name of Registrant as Specified in Its Charter) British Columbia, CanadaN/A(State or Other Jurisdiction of Incorporation or Organization)(IRS Employer Identification Number) 887 Great Northern Way, Suite 250,Vancouver, B.C., CanadaV5T 4T5(Address of principal executive offices)(Zip Code)Registrant’s telephone number, including area code: (604) 707-7000 SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT:Title of className of each exchange on which registeredCommon Shares, without par valueThe NASDAQ Global Select MarketSECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ◻ No ☒ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ◻ No ☒ Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during thepreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for thepast 90 days. Yes ☒ No ◻ Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to besubmitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submitand post such files). Yes ☒ No ◻ Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best ofregistrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☒ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. Seedefinitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.Large accelerated filer◻Accelerated filer☒Non-accelerated filer◻ (Do not check if a smaller reporting company)Smaller reporting company◻ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ◻ No ☒ The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant as of June 30, 2016 was approximately$46,106,522, based upon the closing price on the NASDAQ Global Select Market reported for such date. As of March 16, 2017, 18,558,072 shares of theregistrant’s common shares were outstanding.DOCUMENTS INCORPORATED BY REFERENCEPortions of the registrant’s definitive Proxy Statement for its 2017 Annual General Meeting of Shareholders are incorporated by reference into Part III of thisAnnual Report on Form 10-K (Annual Report). The information to be included in Part III of this Annual Report will be provided in accordance with instructionG(3) to Form 10-K no later than May 1, 2017.FORM 10-KTABLE OF CONTENTS PART I Item 1.Business4Item 1A. Risk Factors46Item 1B. Unresolved Staff Comments89Item 2. Properties89Item 3. Legal Proceedings89Item 4. Mine Safety Disclosures91 PART II Item 5. Market for Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities92Item 6. Selected Financial Data95Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations97Item 7A. Quantitative and Qualitative Disclosures About Market Risk119Item 8. Consolidated Financial Statements and Supplementary Data121Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure158Item 9A. Controls and Procedures158Item 9B. Other Information159 PART III Item 10. Directors, Executive Officers and Corporate Governance161Item 11. Executive Compensation161Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters161Item 13. Certain Relationships and Related Transactions, and Director Independence161Item 14. Principal Accountant Fees and Services161 PART IV Item 15. Exhibits and Financial Statement Schedules 162Item 16.Summary163 SIGNATURES 163 Explanatory Note On November 29, 2016, Novelion Therapeutics Inc. (Novelion) (formerly known as QLT Inc.) completed its acquisition of Aegerion Pharmaceuticals, Inc.(Aegerion), through the merger (the Merger) of its indirect, wholly-owned subsidiary Isotope Acquisition Corp. (MergerCo) with and into Aegerion, pursuant to anAgreement and Plan of Merger (as amended, the Merger Agreement), dated as of June 14, 2016, among Novelion, Aegerion and MergerCo. As a result of theMerger, Aegerion became an indirect wholly-owned subsidiary of Novelion. The former stockholders of Aegerion received shares of Novelion as consideration inconnection with the Merger.1The Merger has been accounted for as a business combination in which Novelion was considered the acquirer of Aegerion. As such, the Consolidated FinancialStatements of Novelion are treated as the historical financial statements of the combined companies, with the results of Aegerion being included from November29, 2016.All references in this Annual Report to “we,” “us,” “our” and the “Company” refer to Novelion and its consolidated subsidiaries. For periods following the closingof the Merger, such references include Aegerion.As described more fully in this Annual Report, following the Merger, Novelion continues to conduct research and development related to zuretinol and Aegerioncontinues to develop and commercialize lomitapide and metreleptin, and each maintains its respective ownership of or licenses covering intellectual propertyrelated to such products and remains as party to the regulatory filings and approvals for such products. Certain portions of this Annual Report may contain information that may no longer be material to our business related to Aegerion’s historical operations. Anycomparison of pre-Merger Aegerion revenues and operations with ours may not be helpful to an understanding of our results for the fiscal year endedDecember 31, 2016 or future periods.On December 16, 2016, we completed a one-for-five (1:5) consolidation of all of our issued and outstanding common shares, without par value, for shareholders ofrecord as of December 16, 2016 (the Consolidation). All share and per-share data presented in the Company's Consolidated Financial Statements and notes havebeen retrospectively restated to reflect the Consolidation unless otherwise noted.Forward-Looking StatementsAll statements included or incorporated by reference into this Annual Report, other than statements or characterizations of historical fact, are “forward-lookingstatements” under applicable laws, regulations and other legal principles and constitute “forward-looking information” within the meaning of applicable Canadiansecurities laws. Forward-looking statements and information are often identified by words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,”“believes,” “seeks,” “estimates,” “forecasts,” “may,” “will,” “should,” “would,” “could,” “potential,” “guidance,” “continue,” “ongoing” and similar expressions,and variations or negatives of these words. Examples of forward-looking statements and information contained in this Annual Report include our statementsregarding: the commercial potential for, and market acceptance of, our products; our estimates as to the potential number of patients with the diseases for whichour products are approved or for which our product candidates are being developed; our expectations with respect to reimbursement of our products in the UnitedStates (U.S.) and elsewhere; our expectations with respect to named patient sales of our products in Brazil and in other countries where such sales are permitted;the potential for and possible timing of approval of our products in countries where we have not yet obtained approval; our plans for further clinical developmentof our products; the potential for zuretinol to obtain a rare pediatric disease designation and/or priority review voucher, if approved; our expectations regardingfuture regulatory filings for our products, including planned marketing approval applications with respect to metreleptin to expand the indication for metreleptin inthe U.S., subject to discussions with the FDA; our plans for commercial marketing, sales, manufacturing and distribution of our products; our expectations withrespect to the impact of competition on our future operations and results; our beliefs with respect to our intellectual property portfolio for our products and theextent to which it allows us to exclusively develop and commercialize our products and product candidates; our expectations regarding the availability of data andmarketing exclusivity for our products in the U.S., the European Union (EU), Japan and other countries; our view of potential outcomes of Aegerion’s ongoingDepartment of Justice (DOJ) and Securities and Exchange Commission (SEC) investigations and shareholder litigation, including the terms of the agreements inprinciple with respect to the investigations and the memorandum of understanding with respect to the settlement of Aegerion’s shareholder litigation, andinvestigations in Brazil, and the possible impact and additional consequences of each on our business; our expectations regarding the impact on U.S. sales andpatient attrition of JUXTAPID ® as a result of the implementation of the modified JUXTAPID Risk Evaluation and Mitigation Strategy program; our expectationsregarding our global consolidated tax structure and planning, our ability to achieve tax savings or utilize net operating loss carryforwards and other tax and taxplanning activities, including whether we are characterized as a U.S. domestic corporation or passive foreign investment company for U.S. federal income taxpurposes; our forecasts regarding sales of our products, our future expenses, our cash position and the timing of any future need for additional capital to fundoperations; our ability to successfully integrate the businesses of Aegerion and Novelion; and our ability to manufacture and supply sufficient amounts of ourproducts to meet demand.The forward-looking statements contained in this Annual Report and in the documents incorporated into this Annual Report by reference are based on our currentbeliefs and assumptions with respect to future events, all of which are subject to change. Forward-looking statements are based on estimates and assumptionsregarding, for example, our financial position and execution of our business strategy, post-merger integration and synergies, resolution of litigation andinvestigations, future competitive conditions and market acceptance of products, the possibility and timing of future regulatory approvals, expectations regardingour core capabilities, and the availability of sufficient liquidity, each made in light of current conditions and expected future developments,2as well as other factors that we believe are appropriate in the circumstances. Forward-looking statements are not guarantees of future performance, and are subjectto risks, uncertainties and assumptions that are difficult to predict, including those discussed in the “Risk Factors” section of this Annual Report. It is not possiblefor us to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors may impact ouroperations or results. New risks may emerge from time to time. Past financial or operating performance is not necessarily a reliable indicator of futureperformance. Given these risks and uncertainties, we can give no assurances that any of the events anticipated by the forward-looking statements will occur or, ifany of them does occur, what impact such event will have on our results of operations and financial condition. Our actual results could differ materially andadversely from those expressed in any forward-looking statement in this Annual Report or in our other filings with the SEC.This Annual Report also contains “forward-looking information” that constitutes “financial outlooks” within the meaning of applicable Canadian securities laws.This information is provided to give investors general guidance on management’s current expectations of certain factors affecting our business, including ourfinancial results. Given the uncertainties, assumptions and risk factors associated with this type of information, including those described above, investors arecautioned that the information may not be appropriate for other purposes. See the “ Management’s Discussion and Analysis of Financial Condition and Results ofOperations ” section of this Annual Report .Except as required by law, we undertake no obligation to revise our forward-looking statements to reflect events or circumstances that arise after the date of thisAnnual Report or the respective dates of documents incorporated into this Annual Report by reference that include forward-looking statements. Therefore, youshould not assume that our silence over time means that actual events are bearing out as expressed or implied in these forward-looking statements.TrademarksNovelion ™ , Aegerion ® , JUXTAPID, LOJUXTA ® , MYALEPT ® and MYALEPTA ® are registered trademarks of Novelion or its subsidiary, Aegerion. All othertrademarks referenced in this Annual Report are the property of their respective owners.3PART IItem 1.Business.OverviewOn November 29, 2016, QLT Inc. (QLT) acquired Aegerion Pharmaceuticals, Inc. (Aegerion) (the Merger) and, changed its name to Novelion Therapeutics Inc.(Novelion). Novelion is a biopharmaceutical company dedicated to developing new standards of care for individuals living with rare diseases.We have a diversified commercial portfolio through Aegerion, our indirect wholly-owned subsidiary, and we are developing a late-stage pipeline asset, for whichwe have received orphan drug designation. We have commercial capabilities in North America, Europe, Japan and Latin America, and seek to maximize thepotential of our current marketed compounds while creating a strong foundation for other future rare disease therapies by investing in science and clinicaldevelopment.We, through Aegerion, now have two commercial products:◦Metreleptin, a recombinant analog of human leptin, is marketed in the U.S. under the brand name MYALEPT (metreleptin) for injection (MYALEPT).MYALEPT is approved in the U.S. as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenitalor acquired generalized lipodystrophy (GL). In December 2016, we submitted a marketing authorization application (MAA) to the European MedicinesAgency (EMA) to seek approval for metreleptin, under the brand name MYALEPTA, as replacement therapy to treat complications of leptin deficiency inpatients with GL and in a subset of patients with partial lipodystrophy (PL). We also expect to submit a supplemental biologics licensing application(sBLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2017, seeking to expand MYALEPT’s indication in the U.S. to the PL subsetand plan to file for formal regulatory approvals for metreleptin throughout 2017 and early 2018 in other key markets, including Brazil and Colombia. Weoffer metreleptin through expanded access programs in countries where permitted by applicable regulatory authorities and under applicable laws, andgenerate revenue in certain markets where named patient sales are permitted based on the approval of metreleptin in the U.S. In addition to the PL subset,we plan to use our knowledge of the diverse effects of leptin on various physiologic functions to explore new opportunities for metreleptin as a platformdrug to potentially treat patients suffering from a range of low leptin-mediated rare and metabolic diseases. We are evaluating and prioritizing thesepotential opportunities and plan to provide an update in mid-2017.◦Lomitapide is marketed in the U.S. under the brand name JUXTAPID (lomitapide) capsules (JUXTAPID). JUXTAPID is approved in the U.S. as anadjunct to a low-fat diet and other lipid-lowering treatments, including low-density lipoprotein (LDL) apheresis where available, to reduce low-densitylipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non-high-density lipoprotein cholesterol (non-HDL-C) in adultpatients with homozygous familial hypercholesterolemia (HoFH). Lomitapide is approved in the EU, under the brand name LOJUXTA (lomitapide) hardcapsules (LOJUXTA) for the treatment of adult patients with HoFH, as well as in Japan, Canada, and a small number of other countries. In December2016, Aegerion out-licensed the rights to commercialize LOJUXTA in the EU and certain other jurisdictions to Amryt Pharma plc (Amryt) and willreceive sales milestones and royalties in the low double-digits on net sales in those jurisdictions. In December 2016, following receipt of reimbursementapproval, Aegerion launched JUXTAPID as a treatment for HoFH in Japan. Lomitapide is also sold, on a named patient basis, in Brazil and in a limitednumber of other countries outside the U.S. where such sales are permitted as a result of the approval of lomitapide in the U.S. or the EU.We have one orphan drug-designated product candidate, zuretinol acetate (zuretinol), an oral synthetic retinoid, in late stage development for the treatment ofInherited Retinal Disease caused by underlying mutations in retinal pigment epithelium protein 65 (RPE65) and lecithin: retinol acyltransferase (LRAT) genes(IRD), comprising Leber Congenital Amaurosis (LCA) and Retinitis Pigmentosa (RP). Our clinical and regulatory pathway for the zuretinol program is currentlyunder review, and we expect to provide an update in mid-2017. We are also exploring the potential of submitting to the FDA a request for Rare Pediatric DiseaseDesignation for zuretinol for the treatment of IRD. If zuretinol is approved by the FDA after being designated a Rare Pediatric Disease and we meet certainadditional criteria, we may qualify for a Rare Pediatric Disease Priority Review Voucher. Zuretinol was granted orphan drug designations for the treatment of LCA(due to inherited mutations in LRAT or RPE65 genes) and RP (all mutations) by the FDA, and for the treatment of LCA and RP (all mutations) by the EMA. Boththe FDA and EMA have acknowledged that the therapeutic indication of zuretinol for the treatment of IRD (patients phenotypically diagnosed as LCA or RPcaused by mutations in RPE65 or LRAT genes) falls within these orphan drug designations. The zuretinol program has also been granted two Fast Trackdesignations by the FDA for the treatment of LCA and RP due to inherited mutations in the LRAT and RPE65 genes.4We have a new management team and a reconstituted Board of Directors, consisting of four legacy QLT directors, four directors who were serving on the Board ofDirectors of Aegerion at the time of the Merger and two directors appointed by significant shareholders pursuant to contractual arrangements. Our newmanagement team is comprised of executives who were serving as officers of Aegerion at the time of the Merger and includes individuals with significantexperience in the biopharmaceutical industry and with a successful track record of developing and commercializing rare disease and other pharmaceutical products.During the year ended December 31, 2016, net product sales of lomitapide and metreleptin were $13.6 million , of which $10.8 million was derived fromprescriptions for lomitapide and metreleptin written in the U.S. and $2.8 million was derived from prescriptions for lomitapide and metreleptin written outside theU.S. As of December 31, 2016, we had approximately $108.9 million in cash and cash equivalents. Aegerion has approximately $325.0 million principal amount of2.0% convertible senior notes due August 15, 2019 (the Convertible Notes) outstanding. As further described below in “Investigations and Legal Proceedings ” ,Aegerion reached, in May 2016, preliminary agreements in principle with the DOJ and the SEC that provide for, among other things, a consolidated monetarypackage that covers payments due to both the DOJ and the SEC by Aegerion totaling approximately $40 million in the aggregate; to be payable over three years,which is updated from the originally proposed five -year payment schedule contemplated when the preliminary agreement in principle was reached in May 2016.See the “ Management’s Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources ” section of this AnnualReport for further information.In the near-term, we expect that the majority of our revenues will continue to be derived from sales of MYALEPT and JUXTAPID in the U.S. We also expect togenerate revenues from (i) sales of lomitapide in those countries outside the U.S. in which we have or expect to receive marketing approval, are able to obtainpricing and reimbursement approval at acceptable levels, and elect to commercialize lomitapide, and (ii) sales of both products in a limited number of othercountries where they are, or may in the future be, available on a named patient sales basis as a result of existing approvals in the U.S. or EU. We expect that in thenear-term, named patient sales of lomitapide and metreleptin in Brazil will continue to be our second largest source of revenues for each product, on a country-by-country basis. We have received named patient sales orders for metreleptin in Argentina in 2016, and have had or expect to continue to have named patient sales ofmetreleptin in Brazil, Colombia and a select number of countries in the EU, including France and Turkey. We expect net product sales from named patient sales tofluctuate significantly quarter-over-quarter given that named patient sales are derived from unsolicited requests from prescribers. In some countries, includingBrazil, orders for named patient sales are for multiple months of therapy, which can lead to some fluctuations in sales depending on the ordering pattern. Webelieve the investigations into Aegerion’s activities in Brazil have adversely affected named patient sales of lomitapide and metreleptin in that country. See the“Legal Proceedings” section of this Annual Report for further information regarding these investigations. In addition, a proceeding is currently pending with theBrazil Supreme Federal Court to decide whether the government has an obligation to continue to provide, on a named patient sales basis, drugs that have notreceived regulatory and/or pricing and reimbursement approval in Brazil, like JUXTAPID and MYALEPT. We intend to file for marketing approval in Brazil forboth JUXTAPID and MYALEPT, and are currently assessing the timing of these submissions. The result of this above trial and other issues could significantlynegatively affect product revenues from named patient sales of JUXTAPID and MYALEPT in Brazil. Key Operational ObjectivesWe expect that our near-term efforts will be focused on the following:•building and maintaining market acceptance for MYALEPT in the U.S. for the treatment of complications of leptin deficiency in GL patients, andsupporting named patient sales of metreleptin in GL in Brazil, particularly in light of local economic challenges and ongoing governmental investigations,and other key countries, including France and Turkey, where such sales are permitted as a result of the U.S. approval or under local law;•preparing for the launch of metreleptin in Europe as a treatment for complications of leptin deficiency in GL patients and a subset of PL, in the event weobtain regulatory, pricing and reimbursement approvals in the EU for metreleptin;•evaluating the potential for future clinical development of metreleptin in additional indications, including a subset of PL, if we are unable to secureapproval of such indication with the current metreleptin clinical data package, as well as potentially other low leptin-mediated rare and metabolicdiseases;•stabilizing sales of JUXTAPID as a treatment for adult HoFH patients in the U.S. despite competition from PCSK9 inhibitor products, among otherfactors, which have had a significant adverse impact on sales of JUXTAPID, and gaining market acceptance in the other countries where lomitapide isapproved and being commercialized, or may in the future receive approval and be commercialized;5•managing our costs and expenses to better align with our revenues, and strengthening our capital structure, while supporting approved products in acompliant manner;•continuing to support patient access to and reimbursement for our products in the U.S. without significant restrictions, particularly given the availabilityof PCSK9 inhibitor products in the U.S., which has adversely impacted reimbursement of JUXTAPID, and given the considerable number of JUXTAPIDpatients in the U.S. who are on Medicare Part D and the significant percentage of such patients who may not be able to afford their out-of-pocket co-payments for our products, given that the only source of financial support for some such patients may be through patient assistance programs operated byindependent charitable 501(c)(3) organizations that may not provide adequate financial assistance;•implementing the modified JUXTAPID Risk Evaluation Management Strategy (REMS) program in the U.S., which includes requirements to recertify allprescribers and pharmacies and a new patient counseling and acknowledgment requirement for existing and new patients, by the July 2, 2017implementation deadline, while working to limit adult HoFH patient attrition from JUXTAPID as a result of such new requirements;•supporting the recent launch of JUXTAPID in Japan;•continuing to support sales of lomitapide as a treatment for HoFH in Brazil on a named patient basis, particularly in light of the economic challenges,ongoing government investigations, and ongoing court proceedings reviewing the regulatory framework for named patient sales in Brazil, and in otherkey countries where named patient sales are permitted, despite the availability of PCSK9 inhibitors on a named patient sales basis in such countries;•gaining regulatory, pricing and reimbursement approvals to market our products in countries in which the products are not currently approved and/orreimbursed or for new indications, including obtaining approval of the MAA seeking marketing approval of metreleptin in the EU as a treatment forcomplications of leptin deficiency in GL patients and a subset of PL, and seeking approval of metreleptin in the U.S. for a subset of PL based on theexisting clinical data package for metreleptin;•reviewing the clinical and regulatory pathway for zuretinol to determine the optimal development and business strategy for this product candidate;•engaging in possible further development efforts related to our existing products, and assessing, and possibly acquiring, potential new product candidatestargeted at rare diseases where we believe we can leverage our infrastructure and expertise;•minimizing the number of patients who are eligible to receive but decide not to commence treatment with our products, or who discontinue treatment, bysupporting activities such as patient support programs, to the extent permitted in a particular country;•continuing to embed a culture of compliance, ethics and integrity throughout Novelion and its subsidiaries;•Aegerion reaching a definitive agreement with the DOJ and the SEC with respect to its ongoing investigations in accordance with the terms of theagreements in principle it entered into in May 2016 and managing other ongoing government investigations pertaining to its products;•Aegerion reaching a definitive agreement with respect to its ongoing securities class action in accordance with the terms of the memorandum ofunderstanding entered into in December 2016 (the MOU); and•defending challenges to the patents or our claims of exclusivity for lomitapide in the U.S., including against potential generic submission with the FDAwith respect to lomitapide; and expanding the intellectual property portfolio for our products.Investigations and Legal ProceedingsAs noted above, Aegerion has been the subject of certain ongoing investigations and other legal proceedings, including investigations by the DOJ and the SEC ofAegerion’s marketing and sales activities related to JUXTAPID, an investigation by federal and state authorities in Brazil to determine whether there have beenviolations of Brazilian laws related to the promotion of JUXTAPID, and a putative class action lawsuit alleging certain misstatements and omissions related to themarketing of6JUXTAPID and the Company’s financial performance in violation of the federal securities laws (the Class Action Litigation). Aegerion reached agreements inprinciple with the DOJ and the SEC in May 2016 that provides for Aegerion to pay a fine of $40 million, to plead guilty to two misdemeanor misbrandingviolations of the Food, Drug and Cosmetics Act and to enter into a five-year deferred prosecution agreement with regard to charges that it violated the HealthInsurance Portability and Accountability Act (HIPAA) and engaged in obstruction of justice relating to the JUXTAPID REMS program. Aegerion also entered intothe MOU with respect to the Class Action Litigation, which provides for a settlement payment by or on behalf of Aegerion of $22.25 million, of which we expect$22.0 million to be funded by insurance carriers and $0.25 million to be funded by Aegerion. See the “Legal Proceedings ” section of this Annual Report forfurther information regarding these and other legal proceedings.Recent Corporate and Securities TransactionsMerger Transaction with Aegerion. On June 14, 2016, we entered into an Agreement and Plan of Merger (as amended, the Merger Agreement) with Aegerion,pursuant to which on November 29, 2016, our indirect wholly-owned subsidiary, Isotope Acquisition Corp, merged with and into Aegerion, with Aegerionsurviving as our wholly-owned subsidiary. Upon completion of the Merger, we changed our name from QLT Inc. to Novelion Therapeutics Inc. and eachoutstanding share of Aegerion common stock was converted into a right to receive 1.0256 Novelion common shares and Aegerion’s common stock was cancelledand delisted from the NASDAQ Global Select Market (NASDAQ).Under the Merger Agreement, we also issued certain warrants to the pre-closing shareholders of Novelion. These warrants (the Merger Agreement Warrants) maybe exercised for up to an aggregate of 11,301,791 Novelion common shares at an exercise price of $0.05 per share if (i) the previously disclosed DOJ and SECinvestigations are settled for amounts in excess of $40 million and/or (ii) the Class Action Litigation is settled for an amount that exceeds the amounts, if any,available under Aegerion’s director and officer insurance coverage in respect of that matter (together, the negotiated thresholds). The number of Novelion commonshares for which the Merger Agreement Warrants may be exercised, if any, will vary based on the extent to which the settlements of the matters described aboveexceed the negotiated thresholds. The Merger Agreement Warrants will not be exercisable for any shares to the extent any excess in respect of such matters isequal to or less than $1.0 million in the aggregate.Pursuant to the Merger Agreement, effective upon the closing of the Merger, the Board of Directors is composed of four individuals designated by Aegerion, fourindividuals designated by Novelion, one individual designated by Broadfin Capital, LLC (Broadfin) and one individual designated by Sarissa Capital ManagementLP (Sarissa). For a specified period of time following the Merger, Sarissa will also have the right to designate one additional member of the Board of Directors.The aggregate consideration delivered to the former holders of Aegerion common stock in connection with the Merger was approximately 6,060,288 Novelioncommon shares. Shareholders of Novelion immediately prior to the Merger, including the private placement pursuant to the Unit Subscription Agreement(described below), owned approximately 68% of the outstanding Novelion common shares upon completion of the Merger and stockholders of Aegerion as ofimmediately prior to the Merger owned approximately 32% of the outstanding Novelion common shares upon completion of the Merger.Private Placement. Also on June 14, 2016, we entered into a unit subscription agreement (the Unit Subscription Agreement) with the investors’ party thereto (theInvestors). Pursuant to the Unit Subscription Agreement, immediately prior to the Merger, the Investors acquired units, for $8.80 per unit, on a post-Consolidation(as defined below) basis, consisting of (i) 2,472,727 Novelion common shares, which includes up to 568,181 Novelion common shares issuable upon exercise offully paid-up warrants, and (ii) warrants (the Unit Subscription Warrants) exercisable for up to an aggregate of 2,644,952 Novelion common shares at an exerciseprice of $0.05 per share. The Unit Subscription Agreement Warrants were issued on the same terms and conditions as the Merger Agreement Warrants and arereferred to collectively with the Merger Agreement Warrants as the "Warrants" in this Annual Report. The aggregate consideration paid under the UnitSubscription Agreement was approximately $21.8 million, which we intend to continue to use to support future operations and business development initiatives.Share Consolidation. On December 16, 2016, we completed a one-for-five (1:5) consolidation of all of our issued and outstanding common shares without parvalue for shareholders of record as of December 16, 2016 (the Consolidation), resulting in a reduction in the issued and outstanding common shares fromapproximately 92,653,562 to approximately 18,530,323 as of that date. Each shareholder’s percentage ownership in Novelion and proportional voting powerremained unchanged after the Consolidation, except for minor changes resulting from the treatment of fractional shares. In connection with the Consolidation, theconversion rate of the Convertible Notes was automatically adjusted from 24.9083 common shares per $1,000 principal amount of such Convertible Notes to4.9817 common shares per $1,000 principal amount of such Convertible Notes. All share and per-share data presented in the Company's Consolidated FinancialStatements and notes have been retrospectively restated to reflect the Consolidation unless otherwise noted.7Aralez Investment and Distribution. On December 7, 2015, we entered into an Amended and Restated Share Subscription Agreement (the Amended and RestatedSubscription Agreement) with Tribute Pharmaceuticals Canada Inc. (Tribute), POZEN Inc. (POZEN), Aralez Pharmaceuticals plc, (formally known as AguonoLimited) (Aralez Ireland), Aralez Pharmaceuticals Inc. (Aralez Canada), Deerfield Private Design Fund II, L.P., Deerfield International Master Fund, L.P.,Deerfield Partners, L.P. (together Deerfield), Broadfin and JW Partners, LP, JW Opportunities Fund, LLC and J.W. Opportunities Master Fund, Ltd. (together theJW Parties) (the Company, Deerfield, Broadfin and the JW Parties are referred to herein collectively as the Co-Investors). The Amended and Restated SubscriptionAgreement amended and restated a share subscription agreement entered into on June 8, 2015, among QLT, Tribute, POZEN, Aralez Ireland, the Co-Investors andcertain other investors. Pursuant to the Amended and Restated Subscription Agreement, immediately prior to and contingent upon the consummation of the mergerof Tribute and POZEN (the Aralez Merger), Tribute agreed to sell to us and the other Co-Investors $75.0 million of the common shares of Tribute (the TributeShares) in a private placement at a purchase price per share equal to: (a) the lesser of (i) $7.20, and (ii) a five percent discount off of the five-day volume weightedaverage price per share of POZEN common stock calculated over the five trading days immediately preceding the date of closing of the Aralez Merger, not to beless than $6.25 per share; multiplied by (b) the Aralez Merger exchange ratio of 0.1455. Upon consummation of the Aralez Merger on February 5, 2016, theTribute Shares were exchanged for common shares of Aralez Canada (the Aralez Shares). We entered into the transaction contemplated by the Amended andRestated Subscription Agreement for the purpose of returning capital to our shareholders pursuant to a special election distribution, payable, at the election of eachshareholder of the Company, in either Aralez Shares (approximately 0.13629 of an Aralez Share for each common share of the Company) or cash, subject to pro-ration (the Aralez Distribution), up to a maximum of $15.0 million funded pursuant to the terms of the Backstop Agreement (as described below).In connection with the Aralez Distribution, on June 8, 2015, we entered into a share purchase agreement (as amended, the Backstop Agreement) with Broadfin andthe JW Parties, pursuant to which Broadfin and the JW Parties agreed to purchase up to $15.0 million of the Aralez Shares from us at $6.25 per share. Thisarrangement provided our shareholders with the opportunity to elect to receive, in lieu of Aralez Shares, up to an aggregate of $15.0 million in cash, subject toproration among the shareholders. As a result, on April 5, 2016 (the Distribution Date), we distributed 4,799,619 Aralez Shares, with a fair value of $19.3 million,and $15.0 million of cash.Upon consummation of the Aralez Merger on February 5, 2016, we purchased 7,200,000 Aralez Shares (representing 10.1% of the issued and outstanding AralezShares), for an aggregate price of $45.0 million. We held the Aralez Shares from February 5, 2016 to the Distribution Date and the Aralez Shares were marked-to-market. As a result, we recognized a $10.7 million loss during the fiscal year ended December 31, 2016, to reflect the change in value from the acquisition date tothe Distribution Date.Marketed ProductsAs noted above, metreleptin and lomitapide are products that have been and continue to be developed and commercialized by our subsidiary Aegerion. Allreferences to “we”, “us”, “our” and the like in this Annual Report in relation to metreleptin and lomitapide are references to the activities and plans of Aegerion orsubsidiaries of Aegerion.MetreleptinMetreleptin, a recombinant analog of human leptin, is currently marketed in the U.S. under the brand name MYALEPT. MYALEPT received marketing approvalfrom the FDA in February 2014 as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquiredGL. In December 2016, we submitted an MAA to the EMA seeking approval for metreleptin as replacement therapy to treat complications of leptin deficiency inpatients with GL and in a subset of patients with PL.We intend to evaluate potential future development of metreleptin in additional indications, including the PL subset, if we are unable to obtain approval of suchindication based on the current clinical data package. The role of leptin in human physiology has been further understood during the 20 years since its initialdiscovery in 1994. In addition to its central role in the regulation of energy homeostasis and glucose and fat metabolism, leptin has diverse effects on variousphysiologic functions, including the regulation of neuroendocrine function, reproduction, vascular function, bone metabolism, and the immune system.Accordingly, we intend to explore the pleiotropic effects of metreleptin to determine the extent of its potential to treat a wide range of low leptin-mediated rare andmetabolic diseases. In furtherance of this, we are evaluating and prioritizing these potential opportunities and plan to provide an update in mid-2017.LipodystrophyLipodystrophy (LD) is a heterogeneous group of rare syndromes characterized by selective but variable loss of fat tissue. The loss of fat tissue in patients with LDcan range from partial to more generalized, and some patients have concomitant accumulation of excess fat tissue centrally. Because of the loss of fat tissue, levelsof the fat cell secreted hormone leptin are very low. Leptin is a8naturally occurring, hormone derived from fat cells and an important regulator of energy, fat and glucose metabolism, reproductive capacity, and otherphysiological functions. Circulating levels of leptin closely correlate with the amount of fat mass present.Due to the lack of fat cells in individuals with LD, energy can no longer be stored as fat in adipose tissues (fat cells) and fat accumulates in the muscles and organssuch as heart, liver, and pancreas causing lipotoxicity and end-organ damage. In addition, deposition of fat in these unusual locations leads to extreme insulinresistance and its associated complications, such as diabetes mellitus, hypertriglyceridemia, hepatic steatosis, polycystic ovary syndrome, and high blood pressure.These severe metabolic abnormalities are typically resistant to conventional therapies. As a result of the deficiency of leptin associated with LD, patientsexperience significant fatigue as well as unregulated appetite. The voracious appetite itself significantly aggravates the metabolic abnormalities that these patientshave, and further reduces the ability to successfully treat these metabolic abnormalities with conventional therapies.Generalized LipodystrophyGL is characterized by a near complete lack of adipose tissue and, consequently, leads to early and significant morbidity and mortality. Differentiation ofgeneralized LD (versus PL) is made based on the anatomical distribution of fat loss, which is widespread in GL patients, and the younger age and greater rapidityof onset and severity of the metabolic abnormalities. The severe metabolic abnormalities associated with GL may result in premature diabetic nephropathy,retinopathy, cardiomyopathy, recurrent attacks of acute pancreatitis, hepatomegaly, and organ failure. These complications themselves increase morbidity andmortality due to their known long-term impacts.Partial LipodystrophyPL is characterized by a less uniform loss of fat cells and with a later age of onset. There can be considerable heterogeneity in the extent of fat cell loss, levels ofleptin, and degree of metabolic abnormalities. Within the spectrum of PL, there are a subset of patients with more severe disease presentation. In PL patients withrelative or near complete leptin deficiency, the metabolic abnormalities and longer impact on disease progression can closely mirror that of patients with GL.We have defined a subgroup of patients with PL who have clinically similar metabolic disturbances as those patients with GL and who demonstrated clinicallysignificant improvements in metabolic parameters on metreleptin treatment in clinical studies. See Phase 3 Clinical Studies below. Specifically, this subsetincludes patients with lower leptin levels, and more advanced metabolic abnormalities.Status in the U.S.The FDA approved MYALEPT in February 2014, as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients withcongenital or acquired GL. The U.S. prescribing information for MYALEPT specifies that the safety and effectiveness of MYALEPT for the treatment ofcomplications of PL or for the treatment of liver disease, including nonalcoholic steatohepatitis (NASH), have not been established. MYALEPT is not indicated foruse in patients with HIV-related lipodystrophy or in patients with metabolic disease without concurrent evidence of congenital or acquired GL.MYALEPT has a boxed warning, citing the risk of anti-metreleptin antibodies with neutralizing activity and risk of lymphoma. The consequences of neutralizingantibodies are not well characterized but could reduce how well the leptin found naturally in the body works or how well MYALEPT works. Lymphoma has beenobserved in acquired forms of LD with or without metreleptin therapy. Since patients with acquired LD typically have underlying autoimmune conditions that maypredispose them to risk of lymphoma, a causal link to the use of metreleptin has not been established.Because of the risk of neutralizing antibodies and the risk of lymphoma, MYALEPT is available in the U.S. only through a restricted program under a RiskEvaluation and Mitigation Strategy (REMS) (referred to as the MYALEPT REMS program). Under the MYALEPT REMS program, we certify all qualifiedhealthcare providers who prescribe MYALEPT and the pharmacies that dispense the medicine. The goals of the MYALEPT REMS program are to:•educate prescribers about the risk of neutralizing antibodies and the risk of lymphoma associated with the use of MYALEPT; and•restrict access to therapy with MYALEPT to patients with a clinical diagnosis consistent with GL.The FDA has granted seven years of orphan drug exclusivity for MYALEPT in the U.S. in the treatment of metabolic disorders secondary to lipodystrophy.We plan to seek approval of MYALEPT in the U.S. for the PL subset based on the existing clinical data package for MYALEPT, through the submission of asupplemental biologics licensing application (sBLA) with the FDA in the first half of 2017.9Status outside the U.S.MYALEPT is currently approved only in the U.S. and Japan. Pursuant to an existing distribution agreement assigned to Aegerion as part of its purchase ofmetreleptin rights, Shionogi & Co., Ltd. (Shionogi) has rights to market metreleptin in Japan, South Korea and Taiwan. Shionogi received marketing andmanufacturing approval in Japan for metreleptin for lipodystrophy in March 2013.There are currently no approved treatments for GL or PL in the EU. In December 2016, we filed an MAA with the EMA seeking approval for metreleptin asreplacement therapy to treat complications of leptin deficiency in patients with GL and in the PL subset. If approved, metreleptin would be marketed in the EUunder the tradename MYALEPTA. Metreleptin was granted orphan designation by the European Commission (EC) for the treatment of Barraquer-Simonssyndrome (acquired PL), Berardinelli-Seip syndrome (congenital GL), Lawrence syndrome (acquired GL) and familial PL.We also plan to file applications for regulatory approval of MYALEPT to treat GL and the PL subset in Brazil, Colombia, Argentina and certain other markets overthe course of 2017 and early 2018.When Aegerion acquired metreleptin from AstraZeneca in January 2015, a number of patients were receiving metreleptin therapy free of charge in certaincountries outside the U.S. that allow use of a drug, under a compassionate use or other type of expanded access program, before marketing approval has beenobtained in such country. Where permitted in accordance with applicable requirements, we have continued to make metreleptin available free of charge under sucha program, which has resulted in significant costs to us, given that we have more than 100 patients participating in this program; many of these patients are GL andsubset PL patients who will be eligible for paid commercial therapy if we obtain regulatory, pricing and reimbursement approvals in the EU for metreleptin. In2016, we began generating revenues from named patient sales of metreleptin in certain markets where such sales of metreleptin are possible and to the extentpermitted by applicable law and local regulatory authorities. In particular, we are in the process of converting all GL and PL patients currently in the expandedaccess program in France to a paid program of Autorisation Temporaire d’Utilisation (Temporary Authorization for Use). Metreleptin has also been approved forreimbursement by the Turkish Social Security Association (SGK), and we plan to provide metreleptin on a named patient basis for GL patients, includingcongenital GL (CGL) patients, and other subsets of lipodystrophy patients, subject to individual assessment in response to unsolicited requests from clinicians.Further, we now supply paid product for individual patients in certain other markets and anticipate further unsolicited requests from clinicians may follow in thesecountries and potentially other selected markets in the EU where there is a formal mechanism for named patient sales in place. Outside of the EU, we have namedpatients sales in Brazil, Argentina, and certain other markets.Phase 3 Clinical StudyThe safety and efficacy of metreleptin for the treatment of metabolic disorders associated with LD syndromes in pediatric and adult patients were evaluated in along-term, open-label, single-arm study conducted at the National Institutes of Health (the NIH). The objective of the NIH trial was to evaluate the efficacy ofmetreleptin for improving metabolic disorders associated with acquired or inherited lipodystrophy. This investigator-sponsored study was initiated in August 2000.A total of 107 patients (>= 6 months of age) with a clinical diagnosis of GL or PL, low baseline leptin levels (men < 8 ng/mL, women < 12 ng/mL), and at leastone metabolic abnormality (diabetes mellitus, hypertriglyceridemia > 200 mg/dL, fasting insulin levels > 30µU/mL) were enrolled in the NIH study. A total of 66of the 107 patients had GL and 41 had PL, including 31 patients who were included in the PL subgroup, i.e. those PL patients who have similar metabolicdisturbances as patients with GL and who were defined as patients with baseline Hemoglobin A1c (HbA1c) ≥6.5% and/or triglycerides ≥5.65 mmol/L. Among the66 patients with GL, 45 (68%) had CGL and 21 (32%) had acquired GL. Most patients in the PL subgroup had the familial form (27 patients, 87%); 4 patients(13%) had acquired PL.Metreleptin was administered subcutaneously once or twice daily in a gender-dependent, weight-based protocol, with step-wise specified titration over the first twomonths of the study and subsequent dose adjustments based on clinical response. The co-primary efficacy endpoints in the NIH study were defined as:•Actual change from baseline in HbA1c at Month 12, and•Percent change from baseline in fasting serum triglycerides at Month 12.Treatment with metreleptin led to substantial and sustained improvements in glycemic control and hypertriglyceridemia in patients with GL and in the PLsubgroup.The observed primary efficacy results in GL patients are as follows:•A mean change from baseline to Month 12 in HbA1c of -2.2%.10A mean percent change from baseline to Month 12 in triglycerides of -32.1%. The observed primary efficacy results in PL subgroup patients are as follows:•A mean change from baseline to Month 12 in HbA1c of -0.9%; and•A mean percent change from baseline to Month 12 in triglycerides of -37.4%.In general, changes in fasting plasma glucose followed a similar pattern to changes in HbA1c.Patients who met target decreases in both parameters were also assessed. In the GL group, 55% of patients achieved both an actual decrease in HbA1c of ≥1% anda ≥30% reduction in triglycerides at Month 12; with over one-third of patients achieving the highest target reductions of a ≥2% actual decrease in HbA1c and a≥40% reduction in triglycerides. These levels of reduction in baseline metabolic abnormalities were also observed in patients in the PL subgroup. In this subgroup,30% of patients achieved both an actual decrease in HbA1c of ≥1% and a ≥30% reduction in triglycerides at Month 12. Based on the overall mixed-model repeatedmeasures analysis, which evaluates average levels of HbA1c and triglycerides across all visits, statistically significant decreases in HbA1c from baseline over allanalysis visits was observed in the GL group and in the PL subgroup.Median overall duration of metreleptin treatment was 49.9 months and 29.3 months in GL patients and in PL subgroup patients respectively.The most common adverse drug reactions (ADRs) occurring in GL patients were weight decrease (reported by fifteen patients; 22.7%) and hypoglycemia (reportedby eight patients; 12.1%), followed by decreased appetite, fatigue and neutralizing antibodies (each reported by four patients; 6.1%). The most common ADRsoccurring in PL subgroup patients were hypoglycemia and fatigue (each reported by three patients; 9.7%), followed by alopecia (reported by two patients; 6.5%).Over the 14-year study duration, treatment-emergent deaths were reported in 4 (4%) of the 107 patients; treatment-emergent adverse events (TEAEs) leading todeath were consistent with the underlying morbidity of LD and included renal failure, cardiac arrest (with pancreatitis and septic shock), progressive end-stageliver disease (chronic hepatic failure), and hypoxic-ischemic encephalopathy. None of the deaths were assessed as drug-related.The presence of neutralizing antibodies in a small minority of patients did not result in clearly identified clinical sequelae.Two cases of peripheral T-cell lymphoma and one case of a localized anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (a type of T-celllymphoma) were reported, all in patients with acquired GL. Lymphoma is known to be associated with autoimmune disease. As the boxed warning for MYALEPTstates, T-cell lymphoma has been reported in patients with acquired GL, both treated and not treated with MYALEPT. There was evidence of pre-existinglymphoma and/or bone marrow/hematologic abnormalities in the two patients with peripheral T-cell lymphoma prior to metreleptin therapy, and the third case ofanaplastic large cell lymphoma occurred in the context of a specific chromosomal translocation.Post-Marketing CommitmentsAs part of the post-marketing commitments to the FDA for metreleptin, we have initiated a long-term, prospective, observational study (product exposure registry)in patients to evaluate serious risks related to the use of the product. The registry will attempt to enroll at least 100 new patients treated with metreleptin.Enrollment will close after five years or after 100 new patients have been enrolled, whichever occurs first. The registry will continue for ten years from the date oflast patient’s enrollment.We have also committed to the EMA, as part of our pediatric investigation plan (PIP), to conduct a study in GL patients under 6 years old to further evaluate thepharmacokinetics, efficacy and safety of metreleptin in this pediatric sub-population.In addition, three programs are expected to expand the understanding of the immunogenicity of metreleptin. These programs consist of:•the development, validation, and implementation of a ligand binding assay to supplement the neutralizing bioassay that tests for the presence ofneutralizing antibodies in serum samples from patients with GL, which we have completed;•testing all banked clinical samples from the GL clinical program for the presence of neutralizing antibodies against leptin using the ligand binding assayand to correlate neutralizing antibodies with clinical events, which we have initiated and is ongoing; and•a prospective study to assess the immunogenicity of metreleptin in patients receiving metreleptin, which is in the planning phase.The presence of neutralizing antibodies will be assessed using both a validated cell-based assay and a validated ligand-binding assay in samples that are confirmedpositive for binding antibodies to leptin. In addition, we are required to conduct certain studies related to the manufacture of metreleptin, including in order tovalidate new test methods, implement a risk-based reference standard program approach, and reassess product acceptance criteria with a larger data set from moremanufactured batches. The remaining three post-marketing commitments related to manufacturing metreleptin are on track for completion by approximately mid-2017,11mid-2018 and mid-2019, their respective commitment deadlines. Finally, we have an ongoing commitment to assess spontaneous reports of serious risks related tothe use of metreleptin, including the risk to exposed pregnancies and pregnancy outcomes, regardless of indication, for ten years from the date of approval ofmetreleptin in the U.S.Estimated Prevalence of GL and PLThere is no patient registry or other method of establishing with precision the actual number of patients with GL and PL in any geography. The data to date suggestthat the approximate prevalence of GL in the U.S. is slightly under 1 in 1,000,000 persons and for PL overall is 3 in 1,000,000 persons. Although the data are evenmore limited, the prevalence in the U.S. of a subset of more severe PL is estimated to be between 0.5 and 1 in 1,000,000 persons. We believe that the prevalencerate of GL and PL, and correspondingly the PL subset, in countries outside the U.S. is likely to be consistent with the prevalence rate in the U.S. There is noguarantee, however, that our estimates are correct. The actual prevalence of GL, PL and the PL subset may be significantly lower than we expect. Ultimately, theactual size of the total addressable market in the U.S. and other key markets where metreleptin is sold, if approved, will be determined only after we havesubstantial commercial history selling metreleptin.LomitapideLomitapide, a small molecule microsomal triglyceride transfer protein (MTP) inhibitor, or MTP-I, is currently approved and marketed in a number of countriesglobally, including the U.S., Japan, Israel, Canada and Colombia under the brand name JUXTAPID, and in the EU under the brand name LOJUXTA, as an adjunctto a low-fat diet and other lipid lowering treatments, to reduce low density lipoprotein cholesterol (LDL-C) in adult patients with HoFH.HoFHHoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing LDL-C (bad cholesterol) from the blood. An impairmentof low density lipoprotein receptor (LDL-R) function results in significant elevation of blood cholesterol levels.Cholesterol is a naturally occurring molecule that is transported in the blood. The liver and the intestines are the two main sites where cholesterol is packaged andreleased within the body. The liver synthesizes cholesterol, and provides the body’s intrinsic supply. The intestines are the conduit through which cholesterol entersthe body for metabolism. The delivery of cholesterol to peripheral cells in the body provides necessary sources of cellular energy and cell structure. However,excess levels of cholesterol in the blood, also known as hypercholesterolemia, can be the source of significant diseases in humans. HoFH is most commonly causedby genetic mutations in both alleles of the LDL-R gene, but can also be caused by mutations in other genes. To date, more than 1,700 mutations have beenidentified that can impair the function of the LDL-R gene, with some mutations leading to a total lack of LDL-R activity and others leading to significantly reducedactivity in the LDL-R gene. As a result of elevated levels of LDL-C, HoFH patients very often develop premature and progressive atherosclerosis, a narrowing orblocking of the arteries (usually in combination with arterial thrombosis), and are at very high risk of experiencing premature cardiovascular events, such as heartattack or stroke.There are no universally accepted criteria for the diagnosis of HoFH. Diagnosis is typically made clinically, using the following criteria:•significantly elevated LDL-C cholesterol levels (treated or untreated);•physical signs, which may include the presence of cutaneous xanthomas, Achilles tendon thickening, xanthelasma and/or corneal arcus;•limited response to statins that is not attributed to statin intolerance or to another identifiable cause (usually dependent on functional LDL receptors), orlimited and/or inadequate response to a PCSK9;•evidence of premature cardiovascular disease (often in the second and third decade of life); and•a positive history of high cholesterol and/or premature cardiovascular disease, consistent with having familial hypercholesterolemia (FH) on both sides ofthe family.HoFH is a rare form of FH and not all patients with the above characteristics will be HoFH patients. Genetic testing may be performed to make a diagnosis ofHoFH, but is not routinely used in the U.S. because it has not been widely available, and because genetic testing can fail to detect certain defects given the largenumber of possible mutations and the number of genes that could be involved, as described above. HoFH patients may have the same defect on both copies of thesame gene or may have different defects, one inherited from each parent, on the same gene or defects inherited from each parent on two different genes eachaffecting the function of the LDL-R. A 2013 article in the European Heart Journal (EHJ), as well as a 2015 article from the American Heart Association (AHA)estimate that current genetic tests may fail to positively detect 10% to 40% of patients with FH. As a result, most physicians in the U.S. and in many othercountries use clinical findings and family history on both sides to make a clinical diagnosis of HoFH. Although not widely used, HoFH may also be diagnosedthrough an assessment of LDL-R function in cultured skin fibroblasts.12Physicians treating patients with hypercholesterolemia, including HoFH, are highly focused on lowering levels of LDL-C in their patients. In the U.S., for example,organizations such as the National Cholesterol Education Program (NCEP), the American Heart Association, and the American College of Cardiology haveemphasized aggressive management of LDL-C. NCEP guidelines currently recommend that patients at high risk of experiencing a heart attack achieve LDL-Clevels of 100 mg/dL or lower through lifestyle changes and drug therapy as appropriate based on their starting levels. International guidelines for adult patients athigh risk of experiencing a heart attack, such as those published in the International Journal of Cardiology and the Canadian Journal of Cardiology, and guidelinespublished in the EHJ in 2014 (2014 EHJ HoFH Guidelines) that are specific to HoFH support LDL-C treatment targets for such patients as low as 70 mg/dL orlower. The American College of Cardiology and the American Heart Association released guidelines in 2013 for patients at high risk of cardiovascular diseasecaused by atherosclerosis that are focused first on lifestyle changes and statin therapy. The 2014 EHJ HoFH Guidelines made similar recommendations regardinglifestyle changes and statin therapy for the treatment of HoFH and also recommended the use of LDL apheresis, in which cholesterol is removed from the bodythrough mechanical filtration, and the use of other adjunctive treatments, such as lomitapide and mipomersen, for HoFH patients who are within the indication forsuch products (adults for lomitapide). More recent guidance, such as “The Agenda for Familial Hypercholesterolemia: A Scientific Statement from the AmericanHeart Association” in 2015, added PCSK9 inhibitor treatment for HoFH patients as a recommended treatment. In February 2017, the American Association ofClinical Endocrinologists and American College of Endocrinology published guidelines for management of dyslipidemia and prevention of atherosclerosis.Patients in this “extreme risk” category, including men aged 55 years and younger and women aged 65 years and younger who have established cardiovasculardisease accompanied by familial hypercholesterolemia, have an LDL-C goal of <55 mg/dL. The clinical approach taken with HoFH patients has typically involved an aggressive treatment plan to reduce lipid levels as much as possible through dietarymodifications and a combination of available lipid lowering drug therapies. Conventional drug therapies include statins, cholesterol absorption inhibitors and bileacid sequestrants. Less frequently, other drugs, such as niacin and fibrates, have been added to provide some incremental reductions in LDL-C levels, althoughthese agents are typically used to modify mostly lipids other than LDL-C. Because many of these therapies, including statins, act by increasing the activity of LDL-R, HoFH patients, given their impaired LDL-R function, or lack of function, often have an inadequate response to standard therapies. For example, high dose statintherapies that typically produce 46% to 55% reductions in LDL-C levels in the broad hypercholesterolemic patient population, on average, produce a 10% to 25%reduction in patients with HoFH. Patients with HoFH who are unable to reach their recommended target LDL-C levels on drug therapy are sometimes treated usingLDL apheresis. Although levels of LDL-C are reduced acutely using apheresis, there is a rapid rebound (usually after approximately four days). Because apheresisprovides only temporary reductions in LDL-C levels, it must be repeated frequently. However, typically it is performed one or two times per month. In addition,except in many countries in the EU, apheresis is not readily available, particularly in the U.S., due to the limited number of treatment centers that perform thisprocedure.Status in the U.S. and European UnionIn December 2012, the FDA approved JUXTAPID as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, toreduce LDL-C, total cholesterol, apoliporotein B (apo B) and non-high-density lipoprotein cholesterol (non-HDL-C) in adult patients with HoFH. Our subsidiary,Aegerion, launched JUXTAPID in the U.S. in January 2013. The FDA has granted seven years of orphan drug exclusivity from the date of approval forJUXTAPID in the U.S. in the treatment of HoFH, expiring in December 2019. The U.S. prescribing information for JUXTAPID specifies that the safety andeffectiveness of lomitapide have not been established in patients with hypercholesterolemia who do not have HoFH, including those with HeFH, or in pediatricpatients, and that the effect of lomitapide on cardiovascular morbidity and mortality has not been determined.In July 2013, Aegerion received marketing authorization for LOJUXTA in the EU as an adjunct to a low-fat diet and other lipid-lowering medicinal products withor without LDL apheresis in adult patients with HoFH. Despite the prevalence rate, lomitapide does not have orphan medicinal product exclusivity in the EU forthe treatment of HoFH because the EMA views the relevant condition, for orphan drug purposes, to include both HoFH and HeFH. The Summary of ProductCharacteristics (SmPC) approved by the EC for LOJUXTA describes that genetic confirmation of HoFH should be obtained whenever possible, and that otherforms of primary hyperlipoproteinemia and secondary causes of hypercholesterolemia (e.g., nephrotic syndrome, hypothyroidism) must be excluded. The SmPCalso specifies that the effect of lomitapide on cardiovascular morbidity and mortality has not been determined. As a result of difficulty in obtaining pricing andreimbursement approvals from governmental authorities in key markets of the EU and in an effort to minimize operating expenses required to support EMA post-marketing requirements, Aegerion elected to cease commercialization in the EU and, in December 2016, entered into a license agreement with Amryt under whichAmryt was granted an exclusive right to develop and commercialize LOJUXTA in the European Economic Area (EEA), Switzerland, Turkey and certain MiddleEastern and North African territories, including Israel. Under the license agreement, Aegerion maintains the marketing authorizations for LOJUXTA; however,Amryt is responsible for ongoing regulatory and post-marketing obligations and commitments for LOJUXTA. Amryt is also required to pay Aegerion certain sales-related milestone payments and royalties on net product sales in the licensed territories.13The prescribing information for lomitapide in the U.S. and the EU warns physicians that lomitapide can cause hepatotoxicity as manifested by elevations intransaminases and increases in hepatic fat, and that physicians are recommended to measure alanine aminotransferase (ALT), aspartate aminotransferase (AST),alkaline phosphatase, and total bilirubin before initiating treatment and then to measure ALT and AST regularly during treatment. During the first year oftreatment, physicians must conduct a liver-related test prior to each increase in the dose of lomitapide or monthly, whichever occurs first. After the first year,physicians are required to perform these tests every three months and before increases in dose. The prescribing information in the EU provides furtherrecommendations for monitoring for hepatic steatohepatitis/fibrosis and the risk of progressive liver disease, including annual imaging for tissue elasticity, andmeasuring of biomarkers and/or scoring methods in consultation with a hepatologist.Because of the risk of hepatotoxicity, JUXTAPID is available in the U.S. only through a REMS, referred to as the JUXTAPID REMS program. Under theJUXTAPID REMS program, patients must receive education on the JUXTAPID REMS program requirements and we must certify all qualified healthcareproviders before they can prescribe JUXTAPID and the pharmacies that will dispense the medicine. The FDA assesses on a periodic basis whether a REMSprogram is meeting its goals and whether the goals or elements of the program should be modified. In June 2015, Aegerion received a letter from the FDAexpressing concern that the JUXTAPID REMS program is not meeting its goals of educating healthcare professionals about the risks of hepatotoxicity and theneed to periodically conduct liver tests to monitor patients during treatment with JUXTAPID as set forth on the product label. The letter also expressed concernabout the difficulty in assessing whether the goal of restricting access to JUXTAPID to patients with a clinical or laboratory diagnosis consistent with HoFH wasbeing met. In response to the FDA’s concerns, we proposed to the FDA modifications to the JUXTAPID REMS program to improve prescriber awareness of therisk of hepatotoxicity associated with JUXTAPID and the need to monitor patients during treatment, and to reinforce the approved indication and thecharacteristics of HoFH. On March 11, 2016, Aegerion received from the FDA an additional letter describing certain modifications the FDA considered necessaryto the labeling for JUXTAPID and to the JUXTAPID REMS program. In response to the FDA’s proposed modifications to the labeling for JUXTAPID, on April 8,2016, Aegerion submitted a prior approval labeling supplement to the FDA addressing certain of the FDA’s proposed modifications, including an instruction thatpatients cease therapy upon the occurrence of severe diarrhea. The labeling changes were approved by the FDA on May 23, 2016. Aegerion submitted a responseto the FDA’s proposal regarding modifications to the JUXTAPID REMS program in a prior approval supplement on July 7, 2016. The FDA approved themodifications to the JUXTAPID REMS program on January 3, 2017. The goal of the JUXTAPID REMS program, as modified, is to mitigate the risk ofhepatotoxicity associated with the use of JUXTAPID by ensuring that: a) prescribers are educated about the approved indication for JUXTAPID, the risk ofhepatotoxicity associated with the use of JUXTAPID, and the need to monitor patients during treatment with JUXTAPID as per product labeling; b) JUXTAPID isdispensed only to patients with a clinical or laboratory diagnosis consistent with HoFH; and c) patients are informed about the risk of hepatotoxicity associatedwith the use of JUXTAPID and the need for baseline and periodic monitoring. The FDA’s approval letter for the modified REMS program also specified that anauthorized generic drug under JUXTAPID’s NDA must have an FDA-approved REMS program prior to marketing.The originally approved JUXTAPID REMS program consisted of Elements To Assure Safe Use (ETASU), an implementation system, a communication plan and atimetable for submission of assessments of the JUXTAPID REMS program. It also required healthcare professionals who prescribe JUXTAPID and pharmaciesthat dispense JUXTAPID to be certified, and that JUXTAPID must only be dispensed to patients with evidence or other documentation of safe-use conditions. TheETASU in the modified JUXTAPID REMS program approved by the FDA on January 3, 2017 has been significantly enhanced and requires, among other things,that healthcare professionals and pharmacies complete a recertification process, which includes, for healthcare professionals, required online training and learningassessments by July 2, 2017, in order to continue prescribing and dispensing JUXTAPID; healthcare professionals counsel existing and new JUXTAPID patientson the goals of the JUXTAPID REMS program and, in connection therewith, imposes a new requirement that healthcare professionals and their patients sign aform acknowledging that this counseling has taken place and that the patient understands the goals of the JUXTAPID REMS program; and prescriptions written toa JUXTAPID patient before the healthcare professional completes recertification and the counseling requirements with the patient, including the submission to theREMS coordinating center of an acknowledgment form signed by the healthcare professional and the patient, will not be honored after July 2, 2017. The modifiedREMS program also requires that prescriptions written after July 2, 2017 must be written on an updated prescription authorization form and includes changes toexisting REMS documentation, along with additional required documentation, and new training modules for healthcare professionals and certified pharmacies. TheFDA required the modifications to the JUXTAPID REMS program to be implemented by March 2, 2017, and, as noted above, that healthcare professionals andpharmacies complete the recertification process, and healthcare professionals and patients complete the counseling and acknowledgment processes, by July 2,2017. We have completed the implementation of the modifications to the JUXTAPID REMS program, and we are in the process of educating healthcareprofessionals, pharmacies, and patients about the JUXTAPID REMS program requirements, including the requirements that must be met by July 2, 2017, andtracking achievement with respect to these requirements. However, we may lose JUXTAPID patients temporarily or permanently, or add new adult HoFH patientsat a slower than expected pace, as a result of the implementation of, and enhancements to, the modified JUXTAPID REMS program, as described above, for avariety of reasons, including: the inability to recertify healthcare professionals with existing patients or to certify healthcare professionals who may want to putnew patients on14JUXTAPID, on a timely basis or at all; the failure of the healthcare professionals and patients, existing or new, to meet the patient counseling requirements andsign and submit the patient acknowledgment form, as required, on a timely basis or at all; the failure of prescriptions for JUXTAPID to meet all of therequirements of the modified JUXTAPID REMS program on or after July 2, 2017 and therefore not being honored by the certified pharmacies after such date, asrequired under the modified JUXTAPID REMS program, and any payer issues or delays that arise out of new prescriptions being written for patients under themodified JUXTAPID REMS program; and that the enhanced education of the goals of the JUXTAPID REMS program, and related documentation, may causehealthcare professionals to stop or delay treatment with JUXTAPID, or try alternative therapies for adult HoFH patients before starting or continuing JUXTAPIDtreatment. The ongoing investigations of the SEC and the DOJ, including the consent decree that Aegerion will enter into with FDA related to JUXTAPID REMSprogram as part of the settlement of these investigations, may also have an effect on the FDA’s requirements for the JUXTAPID REMS program.Similarly, in the EU, we have adopted risk management plans to help educate physicians on the safety information for LOJUXTA and appropriate precautions tobe followed by healthcare professionals and patients. Status outside the U.S. and the EUIn September 2016, JUXTAPID was approved by the Ministry of Health, Labor and Welfare (MHLW) in Japan for patients with HoFH. Approval in Japan wasbased on a Phase 3 study we conducted to evaluate the safety and efficacy of JUXTAPID to reduce LDL-C levels in nine adult Japanese HoFH patients. The resultsof the Phase 3 study were consistent with the known safety and efficacy profile of JUXTAPID. On November 17, 2016, the MHLW approved pricing ofJUXTAPID and in December 2016 we launched JUXTAPID in Japan. HoFH is listed as an intractable disease in Japan, and as part of that designation,reimbursement is mandated and patients register with the government to receive comprehensive treatment benefits, including apheresis. According to the 2014MHLW Japanese Intractable Diseases Information Centers Listing, there are approximately 160 patients registered as diagnosed with HoFH in Japan. JUXTAPIDhas received orphan drug designation in the treatment of HoFH from the MHLW, which provides ten years of exclusivity.Lomitapide has also been approved as an adjunct treatment for adult patients with HoFH in other countries outside the U.S. and EU, including Colombia, Mexico,Canada, Israel, Norway, Iceland, Liechtenstein, Taiwan and South Korea. In 2016, we withdrew lomitapide from Mexico and Taiwan, and on February 22, 2017,we withdrew the marketing authorization for lomitapide in South Korea. INVIMA, the regulatory agency responsible for reviewing marketing authorizationapplications in Colombia, has also granted JUXTAPID five years of post-approval data exclusivity. The indications and prescribing information, including riskinformation, for lomitapide in these countries are generally comparable to those in the U.S.Lomitapide is subject to risk management plans in each country in which it is approved outside the U.S. and the EU, except Israel, and such plans require theapproval of regulatory authorities prior to reimbursement approval and marketing. The goal of the risk management plans is to help educate physicians on thesafety information for lomitapide and appropriate precautions to be followed by healthcare professionals and patients.We have also filed for marketing approval in Argentina and may file for marketing approval in other countries where, in light of the potential size of the marketand other relevant commercial and regulatory factors, it makes business sense to do so. To obtain marketing approval and commercialize JUXTAPID whereapproved, we must establish, and comply with, numerous and varying regulatory requirements of other countries regarding safety and efficacy and governing,among other things, clinical trials, pricing, promotion and distribution of the respective product.We are also making lomitapide available in certain countries that allow use of a drug, on a named patient basis or under a compassionate use or other type of so-called expanded access program, before marketing approval has been obtained in such country. We charge for lomitapide for authorized pre-approval uses in someof the countries where it is available under an expanded access program, to the extent permitted by applicable law and local regulatory authorities. In 2016, thesubstantial majority of our revenues from named patient sales of lomitapide were derived from orders from Brazil, where patients have the right to bring legalaction through the judicial system to seek access to unapproved drugs for which there are no therapeutic alternatives. We are also generating, or expect to generate,revenues from sales of lomitapide in several other countries on a named patient sales basis in the near-term. In some countries, including Brazil, orders forlomitapide on a named patient sales basis are for multiple patients and multiple months of therapy. We expect net product sales from named patient sales oflomitapide to fluctuate quarter-over-quarter significantly more than sales in the U.S., as a result of the types of orders and unpredictable ordering patterns,government actions, including the ongoing investigations in Brazil, media coverage, economic pressures and political unrest. In addition, a proceeding is currentlypending with the Brazil Supreme Federal Court to decide whether the government has an obligation to continue to provide, on a named patient sales basis, drugsthat have not received regulatory and/or pricing and reimbursement approval in Brazil, like JUXTAPID and MYALEPT. We intend to file for marketing approvalin Brazil for both JUXTAPID and MYALEPT, and are currently assessing the timing of these submissions. The result of the trial and other issues couldsignificantly negatively affect product revenues from named patient sales of JUXTAPID and MYALEPT in Brazil. In certain countries where we charge forlomitapide during the pre-approval phase, we are able to establish the price for lomitapide, while in other countries15we need to negotiate the price. In other countries or under certain circumstances, we are providing lomitapide free of charge for permitted pre-approval uses and tothe extent permitted by applicable law and local regulatory agencies.Clinical Development and Post-Marketing CommitmentsAs part of our post-marketing commitments to the FDA for lomitapide, we completed a juvenile toxicology study in rodents to ascertain the impact, if any, oflomitapide on growth and development prior to initiating a clinical study of lomitapide in pediatric HoFH patients, and have submitted the results of this study tothe FDA. In the first quarter of 2015, the FDA issued a Written Request for a study to evaluate lomitapide in pediatric HoFH patients, which, if completed asdescribed, would provide for six months of pediatric exclusivity under the Federal Food, Drug, and Cosmetic Act (FDCA). In the second quarter of 2015, Aegeriondecided to decline the FDA’s Written Request regarding its planned study in pediatric HoFH patients, because it believed that the size and complexity of therequested trial created a considerable barrier to the feasibility of the study. Given that we have declined to conduct the study requested by the FDA, we will not beentitled to the six months of additional exclusivity available for conducting a study that is the subject of a Written Request issued by the FDA.As part of Aegerion’s post-marketing commitments to both the FDA and the EMA for lomitapide, we initiated an observational cohort study in 2014 to generateadditional data on the long-term safety profile of lomitapide, the patterns of use and compliance and the long-term effectiveness of lomitapide in controlling LDL-C levels. Our commitment to the FDA is to target enrollment of 300 HoFH patients worldwide, and to study enrolled patients for a period of ten years. The EMAhas required that all patients taking lomitapide in the EU be encouraged to participate in the study, and that the study period be open-ended. In connection with thelicense agreement with Amryt in December 2016, Amryt agreed to bear the costs of conducting this study in the EEA and other relevant territories. In the study,investigators will follow each patient to track malignancies, tumors, teratogenicity, hepatic effects, and gastrointestinal (GI) adverse reactions, events associatedwith coagulopathy, major adverse cardiovascular events and death. The EMA also required that a vascular imaging study be conducted to determine the impact oflomitapide on vascular endpoints, which Aegerion initiated in 2014 and is now the responsibility of Amryt pursuant to our license agreement with Amryt. Inaddition, we have completed certain drug-drug interactions studies and submitted the results to the EMA.Phase 3 Clinical Study (HoFH)Our Phase 3 clinical study of lomitapide evaluated the safety and effectiveness of lomitapide to reduce LDL-C levels in 29 adult patients with HoFH. The studywas a multinational, single-arm, open-label, 78-week trial.In the Phase 3 study, each patient’s background lipid-lowering therapies were stabilized during a six-week run-in phase prior to dosing, and were maintainedthrough at least the end of the 26-week efficacy phase. All patients received dietary counseling and were instructed to consume a diet containing <20% of energyfrom total dietary fat. Lomitapide was initiated at a dose of 5 mg daily and gradually escalated to doses of 10 mg, 20 mg, 40 mg, up to 60 mg daily, based ontolerability and acceptable liver enzyme levels. When added to the existing lipid-lowering therapy of the HoFH patients in the study, lomitapide reduced LDL-C byan average of 40% at week 26 in the intent-to-treat population with last observation carried forward for the patients who discontinued prematurely, and reducedLDL-C by an average of 50% for the 23 patients who completed the study through week 26.Also, approximately 65% of all patients completing the study experienced LDL-C reductions of 50% to 93% from their baseline as measured at the end of week26. After week 26, during the 52-week safety phase of the study, adjustments to concomitant lipid-lowering treatments were allowed. Average reductions in LDL-C were sustained during chronic therapy.The most common adverse reactions in the Phase 3 study were gastrointestinal, reported by 27 (93%) of 29 patients. Adverse reactions, reported by greater than orequal to 8 patients (28%) in the HoFH clinical trial, included diarrhea, nausea, vomiting, dyspepsia and abdominal pain. Other common adverse reactions, reportedby five to seven (17-24%) patients, included weight loss, abdominal discomfort, abdominal distension, constipation, flatulence, increased ALT, chest pain,influenza, nasopharyngitis, and fatigue. Elevations in liver enzymes and hepatic (liver) fat were also observed. Ten of the 29 patients in the study had at least oneelevation in liver enzymes greater than or equal to three times the upper limit of normal (ULN), including four patients who experienced liver enzymes greater thanor equal to five times the ULN. During the clinical trial, liver enzyme elevations were managed through dose reduction or temporary discontinuation of dose. Therewere no clinically meaningful elevations of total bilirubin, international normalized ratio (INR) or alkaline phosphatase, which are other markers of potentialharmful effects on the liver. Hepatic fat increased from a baseline of 1% to a median absolute increase of 6% at 26 and 78 weeks.Nineteen of 23 patients who completed the 78-week pivotal study entered a Phase 3 long-term extension study, and continued lomitapide at their individualizedmaintenance dose, with 17 (89%) completing 126 weeks of treatment. The primary efficacy endpoint of the extension study was mean percent change in LDL-Cfrom the patient’s baseline, measured at the start of the original pivotal trial, to week 126. In the extension study, mean LDL-C levels were reduced by 45.5% frombaseline at week 126. Similar mean percent reductions were observed for apo B, non-HDL-C, and total cholesterol.16The adverse reaction profile observed in the extension study was consistent with that observed during the pivotal trial. Gastrointestinal symptoms were the mostcommon adverse reaction, reported in 63% (12/19) of patients in the extension study. Transient aminotransferase elevations (ALT or AST) >= 3x ULN occurred innine of the patients who completed week 126 of the extension study either in the pivotal phase or the extension phase or both, including five patients who hadelevations >= 5x ULN. Of these patients, one patient had an ALT elevation of 24x ULN that was reversible with temporary suspension of lomitapide, and a secondpatient had a reversible ALT elevation of >= 10-20x ULN following co-administration of other drugs that may precipitate liver injury or interact with lomitapide.One patient who used excessive alcohol was withdrawn from the extension study due to persistent ALT elevations >= 5x ULN. No Hy’s law cases were reported.One sudden cardiac death occurred in a 58 year old patient with known coronary artery disease. Median hepatic fat levels (measured by nuclear magneticresonance spectroscopy) were 0.7% at baseline and 6.5% at entry to the extension phase and remained stable during approximately 2.5 years of further follow-up(median 7.7% (range 0.6 to 35.2)).Estimated Prevalence of HoFHThere is no patient registry or other method of establishing with precision the actual number of patients with HoFH in any geography. Medical literature hashistorically reported the prevalence rate of HoFH as one person in a million, based on an estimated prevalence rate for HeFH of one person in 500. Analysis ofHoFH prevalence have been evolving in recent years cumulating in published medical literature that suggests that the actual prevalence of both HeFH and HoFHmay be significantly higher than the historical estimate of one person in a million. For example, in 2014, the European Atherosclerosis Society (EAS) ConsensusPanel on Familial Hypercholesterolaemia (FH) published an article citing research that would result in an estimate of the prevalence of HoFH in the range ofbetween one person in 300,000 and one person in 160,000 or 3.33 persons per million to 6.25 persons per million, which is consistent with estimates that can bederived from other publications from the last few years. The FDA cited this estimate in its review of PCSK9 inhibitor products in June 2015. There is no guaranteethat the prevalence of HoFH is higher than the current medical literature suggests or is even higher than reported in the historical literature. The number of patientswith HoFH could actually be significantly lower than we expect. Ultimately the actual size of the total addressable HoFH market in the U.S. will be determinedonly after we and others have substantial commercial history selling products for the treatment of HoFH.We believe that the prevalence rate of HoFH in countries outside the U.S. is likely to be consistent with the prevalence rate in the U.S.; however, we expect thatour net product sales in countries outside the U.S. are likely to be lower than in the U.S. given significant economic pressures to reduce healthcare costs in certainex-U.S. countries, resulting in pricing controls, reimbursement restrictions and caps on patients treated and/or drug expenditures, the more widespread availabilityof apheresis, in certain countries, like Japan, and the possibility that genotyping may be required in some countries, reducing the number of patients diagnosed withHoFH.Commercialization and Patient SupportWe market and sell MYALEPT and JUXTAPID through our Aegerion subsidiary. We believe that the key priorities for the successful commercialization of ourproducts in the countries in which we have received marketing approval, and the preparation for commercialization in the countries in which our products may beapproved include:•commercializing MYALEPT and JUXTAPID in the U.S. with a new commercialization strategy featuring, among other things, the use of a small contractsales force and analysis of claims data and other information to help identify potential GL and adult HoFH patients; and reorganizing and realigning oursales organization in support of key centers of excellence for both MYALEPT and JUXTAPID;•stabilizing sales of JUXTAPID as a treatment for adult HoFH patients in the U.S. despite competition from PCSK9 inhibitor products, among otherfactors, which have had a significant adverse impact on sales of JUXTAPID;•educating and training healthcare providers about our products and the diseases they are approved to treat;•continuing to support patient access to and reimbursement for our products in the U.S. without significant restrictions, particularly given the availabilityof PCSK9 inhibitor products in the U.S., which has adversely impacted reimbursement of JUXTAPID, and given the considerable number of JUXTAPIDpatients in the U.S. who are on Medicare Part D and the significant percentage of such patients who may not be able to afford their out-of-pocket co-payments for our products, given that the only source of financial support for some such patients may be through patient assistance programs operated byindependent charitable 501(c)(3) organizations that may not provide adequate financial assistance;•obtaining pricing and reimbursement approval for metreleptin on acceptable terms and price levels if it is approved in the EU and other countries outsidethe U.S., and for lomitapide in countries outside the U.S. where it is or becomes approved; and17•minimizing the number of patients who, although eligible to receive treatment with our products, decide not to commence such treatment, or whodiscontinue treatment, through activities such as patient support programs, to the extent permitted in a particular country.Our commercial initiatives are designed to support these priorities. We believe that it is possible to commercialize our products in the U.S. and other select marketswith a relatively small specialty sales force. As part of a broad cost-reduction plan to significantly reduce operating expenses and extend our cash position as theavailability of competitive therapies continues to impact lomitapide sales in the U.S., approximately 116 positions were eliminated from Aegerion’s workforce in2016, including significant reductions in the U.S. sales force and related functions, such as marketing and sales operations.In connection with the cost-reduction plan, the significant decline in JUXTAPID sales, and an acknowledgment that there is a lack of widespread medicalawareness of the diseases that our products are intended to treat, we undertook a re-evaluation of our commercial strategy. We have defined and implemented anew global strategy to achieve our commercial objectives for metreleptin and lomitapide in approved markets in a cost-effective manner. Our new commercialstrategy involves a reorganization and realignment of our sales organization, which includes the use of small contract sales forces in the U.S. and Japan. Theprincipal goals of our commercial strategy are to grow sales of MYALEPT in the U.S. and to stabilize and support current and future sales of JUXTAPID, as wellas prepare for launch in other jurisdictions in which we have submitted for approval of our products, such as MYALEPTA in the EU, if approved for sale.As noted above, our commercial organization in the U.S. includes a small, recently hired contract sales force, experienced in marketing drugs for the treatment ofrare disorders or endocrinology indications. This contract sales force works with our sales management to educate and train healthcare providers who treat GL andadult HoFH patients about the safety and efficacy of MYALEPT or JUXTAPID, as applicable. The most frequent physician call points for our products areendocrinologists, lipidologists and cardiologists. In addition to reorganizing our sales force, we have implemented the use of de-identified claims data to moreprecisely target physicians who may have treated patients with GL or adult HoFH.Outside the U.S., we mainly use country managers to market and sell our products where they are approved, and plan to hire similar employees in other keycountries as business needs dictate. In Japan, we sell JUXTAPID through a small contract sales force. The rights to commercialize LOJUXTA in the EU andcertain other jurisdictions were out-licensed to Amryt in December 2016. In certain other countries outside the U.S., we have engaged, or plan to engage localdistributors to conduct permitted commercial and pre-approval activities.We also have an in-house global marketing team that, along with third-party contractors, supports our commercialization and disease awareness efforts in thecountries in which our products are approved, and permitted educational and disease awareness activities in other parts of the world.Another key aspect of our commercialization efforts is obtaining market access for our products, which primarily represents securing pricing and reimbursementapprovals on acceptable levels, without the imposition of significant restrictions, such as caps, significant step edits or other similar measures, from private andgovernment payers where our products are approved. In the U.S., we have a small U.S. market access team, which is primarily responsible for working withinsurance plans, health maintenance organizations and other payers on securing reimbursement and formulary status for MYALEPT and JUXTAPID. Outside theU.S., we support this effort through the work of global asset teams and country managers. One of our main market access objectives, which is conducted inconjunction with our medical and health economics teams, is to strengthen the value proposition for MYALEPT and JUXTAPID for payers through the generationof critical market access studies to enhance patient, physician and payer knowledge of GL and HoFH and the real-world burden of these diseases.We believe the pricing for our products in the U.S. is consistent with the level of pricing for other ultra-orphan drugs that treat diseases with comparable prevalencerates. The majority of payers in the U.S. are providing coverage for our products, and with respect to JUXTAPID, most payers in the U.S. have not requiredgenotyping. Many payers in the U.S. have, however, imposed requirements, conditions or limitations as conditions to coverage and reimbursement for JUXTAPIDas a result of the commercial availability of PCSK9 inhibitor products, which often includes a requirement that HoFH patients have not achieved an adequate LDL-C response on PCSK9 inhibitor products before access to lomitapide is approved. For patients currently taking JUXTAPID, several U.S. pharmacy benefitmanagers (PBMs) are using prior authorization requiring current JUXTAPID patients to “step through” the less expensive PCSK9 inhibitor product, and additionalPBMs and payers may follow this practice. We have been engaging with PBMs to discuss and negotiate potential agreements to limit these so-called “step edits”,which may require us to provide discounts and other price protections and would impact the net revenues from JUXTAPID. One of the key goals of our U.S.market access team is to work with key payers to try to reach contractual terms to address these and similar issues. For MYALEPT, some U.S. payers requireadditional information such as a leptin level test for patients, which may delay or otherwise impact reimbursement. The cost of MYALEPT and JUXTAPID in theU.S. may result in co-pay amounts for some patients that are prohibitive, and prevent these patients from being able to commence therapy on MYALEPT orJUXTAPID, respectively. We provide support to eligible commercial patients for certain drug co-pays and co-insurance obligations for MYALEPT treatment.18We also have a direct co-pay assistance program that provides support to eligible commercial patients for certain drug co-pays and co-insurance obligations forJUXTAPID. From time to time, we make donations to support patient assistance programs operated by independent charitable 501(c)(3) organizations in the U.S.that assist eligible GL and adult HoFH patients, as determined solely by the organization, with certain co-payments or co-insurance requirements for their drugtherapies, which may include metreleptin or lomitapide. We do not have control or input into the decisions of these organizations. We believe that investigationsand enforcement actions by certain government agencies, however, may have caused a reduction in contributions to these third-party patient organizations, whichmay prevent these organizations from providing adequate financial assistance, including assistance with co-payment obligations, to individuals who wouldotherwise be unable to afford our products. A considerable number of JUXTAPID patients in the U.S. are Medicare Part D patients and a significant percentage ofsuch patients may not be able to afford their out-of-pocket co-payments for JUXTAPID, which could result in such patients seeking an alternative free drug orceasing treatment with our products, given that the only source of financial support for such patients may be through patient assistance programs operated byindependent charitable 501(c)(3) organizations that may not provide adequate financial assistance, due to reductions in contributions to such organizations.A comprehensive patient support program for MYALEPT in the U.S. is provided through our specialty pharmacy, which includes educational resources aboutMYALEPT and GL; insurance verification and reimbursement support; disease education; monitoring and support of adherence; injection training; providingpatients with information about potential sources of financial assistance; and a free drug program for certain eligible uninsured and underinsured patients. A similarprogram for patients who have been prescribed JUXTAPID, providing comparable education, adherence and insurance verification services as those describedabove, plus nutritional counseling, is provided by a small internal team of customer care managers. These customer care managers are supported in their efforts toprovide support to JUXTAPID patients by a small internal team of reimbursement case managers and field-based clinical nurse or dietitian educators.Medical AffairsWe have a medical affairs function in the U.S., the EU and certain other countries which supports independent medical education programs and investigator-initiated studies by providing financial grants in a number of medical and disease-related areas. The responsibilities of medical affairs personnel also includeassisting in organizing scientific and medical advisory boards to obtain input from experts and practitioners on a variety of medical topics relevant to our productsand the diseases our products treat; providing training; providing education to physicians through the dissemination of medical information and publications; andproviding support in connection with our post-approval clinical commitments. We are in the process of rebuilding the global medical affairs department to helpfacilitate execution of our strategic plans.Significant CustomersFor the year ended December 31, 2016, one customer accounted for 34.5% of Aegerion’s net product sales, and such customer accounted for 28.5% of ouraccounts receivable balance.Products in DevelopmentIn addition to the lifecycle management initiatives described above, our research and development efforts are also focused on our product candidate, zuretinolacetate (zuretinol, formerly known as QLT091001). Zuretinol is an orally administered synthetic retinoid replacement for 11- cis -retinal, which is a keybiochemical component of the visual retinoid cycle.Zuretinol for IRD caused by RPE65 and LRAT Gene MutationsWe are currently developing zuretinol for the treatment of IRD caused by RPE65 and LRAT gene mutations, and we intend to develop zuretinol for this indication,which includes LCA and RP, in adult and pediatric subjects.IRD caused by RPE65 and LRAT Gene Mutations (LCA and RP)IRDs are clinically and genetically heterogeneous diseases caused by 261 known gene mutations. LCA and RP are inherited, progressive, retinal degenerativediseases that arise from genetic mutations of enzymes or proteins required in the biochemistry of vision. There are no FDA or EMA approved pharmacologictherapeutic treatments for LCA or RP.LCA is characterized by abnormalities such as roving eye movements and sensitivity to light, and manifests in severe vision loss from birth. Both rod and conephotoreceptors are affected in LCA. Eye examinations of infants with LCA reveal normal appearing retinas; however, low level of retinal activity, measured byelectroretinography, indicates very little visual function. RP is a set of hereditary retinal diseases demonstrating clinical features similar to LCA. RP is alsocharacterized by degeneration of rod and cone photoreceptors, but it presents with a more variable loss of vision in late childhood to adulthood. Deficits in darkadaptation and peripheral vision are particular hallmarks of RP. LCA and RP diseases result from genetic mutations, including RPE65 or19LRAT , which result in an inadequate production of 11- cis -retinal, an essential component of the visual retinoid cycle. Zuretinol is a replacement therapy for 11-cis- retinal.The clinical characteristics and progression of disease in LCA and RP overlap as do some of their genetic causes. At least seven of the known LCA disease genes,including LRAT and RPE65 , have also been linked to the clinical appearance of RP. Despite disease heterogeneity and terminology, there is an overlap in thegenetic mechanisms underlying some forms of LCA and RP such as those caused by LRAT and RPE65 gene mutations where 11-cis-retinal production is eitherseverely or completely compromised. RP is the most common inherited retinal disease, and is generally the diagnosis given to patients who begin to lose visionafter the first decade of life, whereas the diagnosis of LCA is given to patients who have central vision loss soon after birth. There is no universally accepteddiagnostic term for patients with characteristics in between; clinicians have considered such cases as either LCA or severe RP. As a result of these factors, we haveclassified both LCA and RP due to inherited deficiency of RPE65 and LRAT genes as IRD.Status in the U.S. and EUZuretinol has received orphan drug designations for the treatment of LCA (due to inherited mutations in the LRAT and RPE65 genes) and RP (all mutations) by theFDA, and for the treatment of LCA and RP (all mutations) by the EMA. These designations provide market exclusivity for the drug for this use in the applicablejurisdiction after a product is approved for 10 years (possibly subject to reduction) in the EU and seven years in the U.S. Orphan drug designation in the EU canalso provide an additional two years of market exclusivity for pediatric orphan drug designated drug products. The FDA has also formally acknowledged that theorphan drug designations granted by the FDA on zuretinol for the treatment of LCA (due to inherited mutations in LRAT or RPE65 genes) and RP (allmutations) also cover zuretinol for the treatment of IRD caused by LRAT or RPE65 gene mutations, including severe early childhood onset retinal dystrophy,which disease/condition we believe comprises both LCA due to inherited mutations in LRAT or RPE65 genes and RP. The EMA also formally acknowledgedthat a therapeutic indication of zuretinol for the treatment of patients with IRD, who have been phenotypically diagnosed as LCA or RP caused by mutations inRPE65 or LRAT gene , would fall under the orphan drug designations of treatment of LCA and treatment of RP.Zuretinol has also been granted two Fast Track designations by the FDA for the treatment of LCA and autosomal recessive RP due to mutations in LRAT andRPE65 genes. The FDA has also acknowledged that our two Fast Track designations encompass the treatment of IRD caused by LRAT or RPE65 gene mutations.The FDA’s Fast Track is a process designed to facilitate the development and expedite the review of drugs that are intended for the treatment of serious or life-threatening diseases or conditions and demonstrate the potential to address an unmet medical need.In addition to the Fast Track and orphan drug designations previously granted to us by the FDA for zuretinol, we are currently exploring the potential of submittingto the FDA a request for rare pediatric disease designation of zuretinol for the treatment of IRD caused by LRAT or RPE65 gene mutations, which indicationincludes LCA and RP. In order to obtain a rare pediatric disease designation for zuretinol, we must demonstrate to the FDA’s satisfaction that this indication is forthe treatment or prevention of a rare disease or condition that affects fewer than 200,000 individuals in the U.S., or that affects more than 200,000 individuals in theU.S. and there is no reasonable expectation that the cost of developing and making available in the U.S. a drug for this disease or condition will be recovered fromsales in the U.S. for that product, and is a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals agedfrom birth to 18 years. Under the FDCA, a sponsor who receives approval of an NDA for a rare pediatric disease and meets certain additional criteria, may qualifyfor a rare pediatric disease priority review voucher (PRV). A PRV can be redeemed to receive priority review under an expedited timeframe for a subsequentmarketing application for a different product. A PRV may also be sold or transferred from the initial sponsor to another sponsor. The voucher may be furthertransferred any number of times before it is used. Pursuant to the 21 st Century Cures Act, FDA’s authority to award rare pediatric disease PRVs has been extendeduntil 2020, and until 2022 for products that receive rare pediatric disease designation by 2020.The molecule in zuretinol is not eligible for composition of matter protection per se, as it was previously known in the scientific community. However, upon FDAapproval, we believe that the active pharmaceutical ingredient in zuretinol may qualify as a new chemical entity, or NCE, which provides for five years ofexclusivity following approval. This five-year period of market exclusivity would run concurrently with the seven year period of orphan drug exclusivity periodthat we expect to receive should zuretinol be approved by the FDA. We intend to seek NCE exclusivity; however, there is no assurance that zuretinol will qualifyand gain the five-year exclusivity period, even if zuretinol is approved. We also plan to secure regulatory exclusivity for zuretinol in the EU; however, there can beno assurance that we will be successful in securing approval or regulatory exclusivity in the EU.Clinical Studies and Compassionate UsePhase 1b studies. We have completed a Phase 1b multi-center, open-label clinical proof-of-concept trial to evaluate the safety profile and effects of a single seven-day course of treatment with zuretinol on various parameters of retinal function and quality of life in patients with LCA and autosomal recessive RP due toinherited mutations in RPE65 or LRAT genes.20We have also completed a Phase 1b multi-center, open-label clinical trial of repeated treatments of zuretinol in patients with LCA and autosomal recessive RP dueto inherited mutations in RPE65 or LRAT genes. In this study, patients that were treated with a single course of zuretinol in our previously completed Phase 1bclinical trial received up to three 7-day courses of zuretinol to assess visual outcomes and safety following retreatment. Visual field (VF) was assessed usingGoldman Visual Field (GVF) and visual acuity (VA) was assessed using best-corrected visual acuity (BCVA) at baseline and days 7, 14, 30 and 60 after eachtreatment course, then bimonthly until the next treatment course. Patients received treatment with doses of 10, 40 or 60 mg/m 2 , with the majority of patientsreceiving 40 mg/m 2 .Results of the Phase 1b retreatment study reported in September 2014 showed clinically meaningful improvements in VF and VA. Nineteen of 27 patients(70%) had an increase in VF retinal area from baseline of at least ³ 20% in at least 1 eye at 2 consecutive visits within 6 months from the start of any zuretinoltreatment course. In addition, 70% of patients had an increase in VA from baseline of at least ³ 5 letters in at least 1 eye at 2 consecutive visits within 6 monthsfrom the start of any zuretinol treatment course. The percentage of VF and VA responders identified by disease and mutation is summarized below. Over thecourse of the entire study spanning multiple treatment courses, these responses were durable, with the visual field response lasting an average of 235 days (min-max = 7 - 742 days), and the visual acuity response lasting an average of 232 days (min-max = 7 - 616 days). From the cumulative data, mean GVF improvementover baseline throughout the study time period following a single, seven-day dosing period was 117% in LCA patients and 30% for RP patients.Table: Results for Visual Field and Visual Acuity Responders NVisual FieldResponders( a) Number (%) of PatientsVisual AcuityResponders ( b) Number (%) of Patients All Patients27 19 (70%)19 (70%)All LCA13 7 (54%)10 (77%)All RP14 12 (86%)9 (64%)All RPE6515 11 (73%)8 (53%)All LRAT12 8 (67%)11 (92%)a: > 20% change in retinal area from baseline at 2 consecutive visits in at least 1 eye within 6 months of any treatment course.b: > 5 letter increase from baseline at 2 consecutive visits in at least 1 eye within 6 months of any treatment course.Adverse events reported in the trial were consistent with the retinoid class of medications and were transient and/or reversible. One serious adverse drug reaction(intracranial hypertension (ICH), a known class effect of retinoids), was reported in the study and it was resolved.Natural History Study. In 2016, we completed a retrospective, uncontrolled, multicenter, case history study to determine the natural history of visual function insubjects with IRD phenotypically diagnosed as LCA or RP caused by autosomal recessive mutations in RPE65 or LRAT (IRD). The objective of the natural historystudy was to gather data on the natural progression of the disease in subjects over time, including from childhood to adulthood. The study included both subjectswho had previously received treatment in clinical trials with our synthetic oral retinoid product, zuretinol, as well as subjects who had not received prior treatmentwith zuretinol. For subjects who had received prior treatment with zuretinol, the study included a retrospective review of subjects’ medical records prior to andafter treatment with zuretinol. The intention of the study was to assess and compare visual outcomes in patients treated with zuretinol, relative to the treatment ofnaïve patients, in order to assess the extent to which zuretinol may improve or prolong visual function relative to the natural disease progression in these subjects.The preliminary analysis of the study data suggests that IRD subjects, without therapeutic intervention, demonstrate a continuing decline in VF and eventually VAover time. Final analysis of the study data is ongoing and expected to be completed in the first half of 2017.Compassionate Use Program. We provide zuretinol to patients under our compassionate use program on a named-patient basis. Under the compassionate useprogram, zuretinol may be made available to patients who participated in our completed Phase 1b clinical trial of zuretinol for the treatment of LCA and RP.Estimated Prevalence of LCA and RPGiven the very low prevalence in these ultra-orphan diseases, there is limited epidemiological data available to determine definitively the potential patientpopulation for treatment with zuretinol, and as such, there is significant uncertainty around the estimated total potential addressable patient population worldwide.Current epidemiological estimates based on medical literature suggest that approximately 2.5% of the autosomal recessive RP subjects and 6-10% of all LCAsubjects possess mutations in the RPE65 gene, while approximately 1% of RP and LCA subjects have mutations in the LRAT gene. LCA is estimated to affect21approximately one in 81,000 newborns worldwide, while the overall RP prevalence is estimated at one in 4,000 newborns worldwide. Based on our current marketresearch, we estimate the total potential addressable LCA patient population for zuretinol at 1,000 to 2,000 patients worldwide and the total potential addressableRP patient population at 2,000 to 4,000 patients worldwide. Our most recent epidemiological data estimate the prevalence of IRD subjects with RPE65 or LRATmutations at 4100 patients in the U.S. and the five major European markets, a portion of whom have the late stage of the disease and may not benefit from zuretinoltherapy. While geographic differences in the gene pool may cause fluctuations, the prevalence of LCA, RP, and LRAT and RPE65 mutation distribution in othercountries are believed to be comparable with the U.S. and five major European markets based on current medical literature. However, there is no guarantee thesecurrent estimates are correct, and the analysis of the prevalence in IRD remains ongoing in the medical literature.Our estimates of the total potential addressable patient population are based on our current market research, including estimated diagnosis rates. The uncertaintyaround the estimated total potential addressable patient population is exacerbated by the fact that the course and progression of photoreceptor dysfunction anddegeneration in the retina over time varies considerably between individuals with IRD, and the rate and progression of decline of vision function in patients iscurrently not well understood. Over the course of the disease, we believe that IRD patients who do not retain a sufficient number of functionally viablephotoreceptors may not benefit from treatment with zuretinol.Zuretinol Development StatusFollowing completion of our Phase 1b studies of zuretinol, we have engaged in discussions with the FDA and EMA to determine the regulatory pathway andoptimal clinical trial protocol study design for potential registration trials for zuretinol. We continue to undertake clinical and development activities towards futureclinical studies of zuretinol. In parallel, we are currently conducting a review of our regulatory and clinical pathway for the zuretinol program, taking into accountthe current competitive and regulatory landscape. We are scheduled to meet with the FDA in May 2017 to further discuss our development plans, and also intend torequest a meeting with the EMA to discuss our program following our meeting with the FDA. We expect to provide an update in mid-2017.Manufacturing, Supply and DistributionWe and our contract manufacturers are subject to the FDA’s current Good Manufacturing Practices (cGMP) regulations and other rules and regulations prescribedby regulatory authorities outside the U.S.Metreleptin is a recombinant protein biologic that is produced using conventional fermentation, isolation, and purification processing techniques. The drug productis provided in nominal 10 mg vials that are reconstituted prior to injection. We are considering development of new presentations in nominal 2.5 mg and 5 mgvials. Lomitapide is a small molecule drug that is synthesized with readily available raw materials using conventional chemical processes. Hard gelatin capsulesare prepared in 5 mg, 10 mg, 20 mg, 30 mg, 40 mg and 60 mg strengths.We currently have no manufacturing facilities, and limited personnel with manufacturing experience. We rely on contract manufacturers to produce drug substancefor metreleptin and lomitapide and to produce drug product for commercial supplies and for our clinical trials. Aegerion has long-term supply agreements withmetreleptin drug substance and drug product manufacturers, which were assigned to Aegerion in connection with the acquisition of metreleptin in 2015. InFebruary 2017, the contract manufacturer for metreleptin drug product received a Warning Letter from the FDA citing significant violations of current goodmanufacturing practice (CGMP) regulations at the manufacturing facility where metreleptin drug product is manufactured. In response, the manufacturer maymake modifications to the line on which metreleptin drug product is filled, and has committed, in the long-term, to transition the filling of certain drug products,including metreleptin drug product, to a newer line at the same facility and to cooperating with customers on a transition timeline to re-validate the filling processon the new line, such that this transition does not impact supply. Assuming a reasonable timeline for the future transition to and validation of the new filling line,we would have sufficient inventory to handle any downtime in the manufacturing process. Aegerion also has long-term supply agreements with lomitapide drugsubstance and drug product manufacturers. We have sufficient inventory of metreleptin and lomitapide drug substance to maintain a supply for more than one year.We do not have any other agreements in place for redundant supply or a second source for drug substance or drug product for either product.In the U.S., metreleptin and lomitapide are each distributed through a single specialty pharmacy that distributes the product directly to patients and, under limitedcircumstances, to other purchasers. The specialty pharmacy that distributes MYALEPT takes title upon delivery of MYALEPT to such pharmacy. The specialtypharmacy that distributes JUXTAPID does not take title to JUXTAPID. Title transfers upon delivery of JUXTAPID to the purchaser. Both of our specialtypharmacies also provide certain patient program support services, accounts receivables and other order-to-cash services on our behalf. For named patient sales andother expanded access distribution, we use third-party providers to distribute our products either directly to the purchaser in the applicable country or to our localthird-party distributor or service provider for such country.22In connection with our development of zuretinol, we utilize a small number of qualified third-party contractors, currently located in North America and Europe, tomanufacture and supply key raw materials, active pharmaceutical ingredient and drug product. Key raw materials in the production of the active pharmaceuticalingredient and drug product can be sourced from multiple vendors.Financial Information about Segments and Geographic AreasWe operate in one segment. Financial information about this segment required herein is contained in the “ Consolidated Financial Statements and SupplementaryData ” section of this Annual Report, and the geographic information required herein is contained in Note 19 - Segmentation Information in the Notes to theConsolidated Financial Statements and is incorporated by reference herein.CompetitionOur industry is highly competitive and subject to rapid and significant technological change. Our competitors and potential competitors include largepharmaceutical and biotechnology companies, specialty pharmaceutical and generic drug companies, academic institutions, government agencies and researchinstitutions. All of these competitors currently engage in, have engaged in or may engage in the future in the development, manufacturing, marketing andcommercialization of pharmaceuticals that compete with or may in the future compete with lomitapide, metreleptin, zuretinol or other products or productcandidates we may develop or acquire. Smaller or early stage companies may also prove to be significant competitors, particularly through collaborativearrangements with large, established companies. Academic institutions, government agencies and other public and private research organizations also areconducting research activities, seeking patent protection and may commercialize products on their own or through joint ventures. The existence of these products,or other products or treatments of which we are not aware, or products or treatments that may be developed in the future, may adversely affect the marketability ofproducts developed by us. Key competitive factors affecting the commercial success of lomitapide, metreleptin, zuretinol and any other products or productcandidates that we develop or acquire include efficacy, safety and tolerability profile, reliability, physician acceptance, level of generic competition, convenienceof dosing, price and reimbursement.MYALEPT is the first and only product approved in the U.S. for the treatment of complications of leptin deficiency in patients with GL. There are, however, anumber of therapies approved to treat these complications independently that are not specific to GL. Certain clinical complications of GL, including diabetes andhypertriglyceridemia, may be treated with insulin and/or oral medications, such as metformin, insulin secretagogues, fibrates, or statins. Patients with GL oftenhave an inadequate response to these therapies.We are seeking regulatory approval of metreleptin as a treatment for GL and a PL subset in the EU and intend to seek regulatory approval of metreleptin for thatPL subset in the U.S. and in other key countries where it makes business sense to do so. We are aware of an investigational drug currently in development byAkcea Therapeutics (Akcea), a subsidiary of Ionis Pharmaceuticals, Inc. (Ionis), being studied in patients with familial PL with diagnosed type 2 diabetes mellitusor hypertriglyceridemia, which, if approved and depending on the labeled indication, could potentially compete with metreleptin, if metreleptin is approved for thetreatment of a subset of PL which comprises a portion of familial PL.The market for cholesterol-lowering therapeutics is large and competitive with many drug classes. Lomitapide is approved in the U.S., Japan, the EU and in certainother countries as an adjunct to a low-fat diet and other lipid-lowering treatments to reduce LDL-C in adult HoFH patients. As a treatment for HoFH, JUXTAPIDcompetes in the U.S. and certain other countries with Kynamro. Developed by Ionis and acquired by Ionis and Kastle Therapeutics in May 2016, Kynamro is anantisense apolipoprotein B-100 inhibitor which is taken as a weekly subcutaneous injection. JUXTAPID also faces significant competition in the treatment of adultHoFH patients with a class of drugs known as PCSK9 inhibitors. In July 2015, Regeneron Pharmaceuticals, Inc. (Regeneron) and Sanofi announced that the FDAhad approved the BLA for their PCSK9 inhibitor candidate, alirocumab, for use in addition to diet and maximally tolerated statin therapy in adult HeFH patientsand in patients with clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-C. In September 2015, following the positive opinionof the Committee for Medicinal Products for Human Use (CHMP) of the EMA, the EC approved alirocumab for the treatment of adult patients with HeFH ormixed dyslipidemia as an adjunct to diet, either in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated statin, or alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or forwhom a statin is contraindicated. The FDA approved Amgen Inc.’s (Amgen) BLA for its anti-PCSK9 antibody, evolocumab, in August 2015, as an adjunct to dietand maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic cardiovascular disease, who require additional lowering ofLDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with HoFH, who require additional lowering of LDL-C. In July2015, the EC Commission approved the marketing authorization of evolocumab for the same indication as alirocumab, and for the treatment for certain patientswith high cholesterol, including patients aged 12 years and over with HoFH in combination with other lipid-lowering therapies. In January 2016, the MHLWapproved evolocumab for the treatment of patients with FH or hypercholesterolemia who have high risk of cardiovascular events and do not adequately23respond to statins, and in July 2016 the MHLW approved alirocumab for the same indication. Health Canada and ANVISA, the regulatory agency responsible forreviewing marketing authorization applications in Brazil, have approved evolocumab for the treatment of patients with HoFH. Other companies, including RocheHolding AG and Alnylam Pharmaceuticals, Inc., in collaboration with The Medicines Company, are also developing PCSK9 inhibitor products.The introduction of PCSK9 inhibitors in the U.S. has negatively impacted sales of JUXTAPID and we expect this negative trend to continue. This impact resultsfrom several factors, including: healthcare professionals switching some existing JUXTAPID patients to a PCSK9 inhibitor product; healthcare professionals tryingmost new adult HoFH patients on a PCSK9 inhibitor product before trying JUXTAPID; the provision of free PCSK9 drug to adult HoFH patients by the companiesthat are commercializing PCSK9 inhibitor products, which such companies may have ceased, but which historically has had a negative impact on the rate at whichnew patients start treatment on JUXTAPID and has caused more patients than we expected to discontinue JUXTAPID and switch their treatment to PCSK9inhibitor products; and actions by insurance companies, managed care organizations and other private payers in the U.S. that have required, or may require in thefuture, HoFH patients to demonstrate an inability to achieve an adequate LDL-C response on PCSK9 inhibitor products before access to JUXTAPID is approved,or may impose other hurdles to access or other significant restrictions or limitations on reimbursement, or may require switching of JUXTAPID patients to PCSK9inhibitor products. Many U.S. insurance companies, managed care organizations and other private payers now require that HoFH patients fail to achieve anadequate response in LDL-C reduction on PCSK9 inhibitor products before providing reimbursement for JUXTAPID. For patients currently taking JUXTAPID,we believe that all U.S. payers require prior authorization, which may influence a switch of the current JUXTAPID patients to the less expensive PCSK9 inhibitorproduct. We believe that many of the PCSK9 inhibitor switches from current JUXTAPID patients have been at the direction of the prescribing physician.Ultimately, the physician may decide to switch the adult HoFH patient back to JUXTAPID, if the patient does not reach a goal of LDL-C response while beingtreated with a PCSK9 inhibitor product. It is unknown how many adult HoFH patients, if any, may be switched back to JUXTAPID or the period of time in whichthis would take place. We expect physicians will continue to consider use of JUXTAPID for those adult HoFH patients who do not adequately respond to PCSK9inhibitor products. Additionally, we expect that the availability of PCSK9 inhibitor products in commercial markets outside of the U.S., will have similarlynegative effects on sales, including named patient sales, of lomitapide outside the U.S., particularly in Brazil, Canada and Japan, where PCSK9 inhibitor productshave been approved by the regulatory authorities. If the continued negative impact of PCSK9 inhibitors is greater than we expect, it may make it more difficult forus to generate revenues and achieve profitability. Also, although there are no other MTP-I compounds currently approved by the FDA for the treatment ofhyperlipidemia in humans, there may be other MTP-I compounds in development.In addition, in the EU, patients with HoFH who are unable to reach their recommended target LDL-C levels on conventionally used drug therapies are commonlytreated using LDL apheresis, in which cholesterol is removed from the body through mechanical filtration. Although levels of LDL-C are reduced acutely usingapheresis, there is a rapid rebound. Because apheresis provides only temporary reductions in LDL-C levels, it must be repeated frequently, typically one or twotimes per month. The widespread use and availability of apheresis as a treatment for HoFH in the EU, combined with the lower cost of apheresis as compared toLOJUXTA, made it more difficult for us to obtain commercially acceptable pricing and reimbursement approvals for LOJUXTA in the key markets of the EU. Asa result of this, and in an effort to reduce costs associated with EMA post-marketing requirements, Aegerion elected to cease commercialization in the EU, and inDecember 2016, entered into a license agreement with Amryt under which Amryt was granted an exclusive right to develop and commercialize LOJUXTA in theEuropean Economic Area, Switzerland, Turkey, and certain Middle Eastern and North African countries, including Israel.We may also face future competition from companies selling generic alternatives of lomitapide or metreleptin in countries where we do not have patent coverage,orphan drug status or another form of data or marketing exclusivity or where patent coverage or data or marketing exclusivity has expired, is not enforced, or may,in the future, be challenged.Inherited retinal diseases are clinically and genetically heterogeneous diseases caused by 261 known gene mutations. Zuretinol is currently under investigation forthe treatment of IRD caused by RPE65 or LRAT genetic mutations, which includes LCA and RP. Both RPE65 and LRAT genes are essential for the production of11-cis-retinal in the visual retinoid cycle to enable vision. Zuretinol may potentially serve to replace 11-cis-retinal in patients with either RPE65 or LRAT genemutations manifested clinically as LCA2, LCA14, RP20, or RP Juvenile. Spark Therapeutics, Inc.’s (Spark) product candidate, SPK-RPE65 (voretigeneneparvovec), is a form of RPE65 gene therapy targeting treatment of inherited retinal disease caused by mutations in the RPE65 gene, manifested clinically aseither LCA2 or RP20. Spark has completed Phase 3 trials with SPK-RPE65 and has publicly disclosed that it has initiated a rolling BLA submission with the FDAwhich is expected to be completed in 2017, and expects to file an MAA with the EMA thereafter. Spark recently released four year data from its Phase 1 trialsuggesting an extended duration of action and efficacy in bilateral mobility testing (MT) and full field sensitivity threshold testing (FST) correlated to VFimprovement. SPK-RPE65 has received breakthrough therapy and orphan drug designations from the FDA and orphan drug designation from the EMA. Inaddition, we are aware of a number of early stage gene therapy and optogenetic approaches in development for LCA patients. We are also aware of a retinalimplant (Argus ® II) developed by Second Sight Medical Products Inc. (Second Sight) to treat late stage RP,24which received FDA approval under a Humanitarian Device Exemption in February 2013, as well as two implantable medical devices for RP that are approved inthe European market: Argus ® II (Second Sight) and Alpha IMS (Retina Implant AG).We may also face future competition from companies selling generic alternatives of our products in countries where we do not have patent coverage, orphan drugstatus or another form of data or marketing exclusivity or where patent coverage or data or marketing exclusivity has expired or may, in the future, be challenged.Many of our competitors and potential competitors have substantially greater financial, technical and human resources than we do, which is exacerbated by severalfactors related to our business, including the negative impact of PCSK9 inhibitor products on the JUXTAPID business, recent reductions in force, and theuncertainty about the timing and magnitude of the financial and other aspects of the resolution of Aegerion’s ongoing DOJ and SEC investigations. Many of thesecompanies also have significantly greater experience in the discovery and development of drug candidates, obtaining FDA and other regulatory approvals ofproducts and the commercialization of those products. Accordingly, competitors may be more successful than we may be in commercialization, obtainingmarketing approvals for drugs and achieving and maintaining widespread market acceptance.Patents, Trademarks and Proprietary RightsOur business relies on patents covering inventions licensed from third parties, and on other means to protect our technology, inventions and improvements that arecommercially important to our business. Our policy is to file patent applications on a worldwide basis in those jurisdictions where we consider it beneficial,depending on the subject matter and our commercialization strategy.Our success will depend significantly on our ability to:•obtain and maintain patent and other proprietary protection for the products, technology, inventions and improvements we consider important to ourbusiness;•defend our patents;•preserve the confidentiality of our trade secrets; and•operate without infringing the patents and proprietary rights of third parties.Patent RightsLomitapide. Our lomitapide patent portfolio consists of seven issued U.S. patents and issued patents in Europe, Australia, South Korea, New Zealand and Japanand pending applications in the U.S., Japan, Canada, and India, all of which have been licensed to us in a specific field. A five-year patent term extension has beengranted for our U.S. patent covering the composition of matter of lomitapide, originally scheduled to expire in early 2015, and will now expire in 2020. The non-U.S. patents directed to the composition of matter of lomitapide have expired. Our five method of use patents in the U.S. cover certain dosing regimens forlomitapide, with one such patent expiring in 2027 and the other four patents expiring in 2025. Two separate inter partes review (IPR) petitions were filed with thePatent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office in August 2015 by the Coalition for Affordable Drugs VIII L.L.C. (CFAD)challenging the validity of two of these method of use patents. On March 6, 2017, the PTAB determined that the CFAD failed to show that the claims of thesepatents were unpatentable. Our non-U.S. patents, including the European Patent Office (EPO) methods of use patent, expire in 2025. The EPO method of usepatents may be eligible for up to three years of supplemental protection in certain EPO countries, and we are seeking such protection in the countries in whichLOJUXTA is approved, on a country-by-country basis. An opposition was filed with respect to the EPO method of use patent, but has since been revoked.Since December 21, 2016, an ANDA or 505(b)(2) NDA may be submitted for JUXTAPID if it contains a Paragraph IV certification of patent invalidity or non-infringement. If we instigate a suit against an ANDA or 505(b)(2) applicant for patent infringement within 45 days of receiving a Paragraph IV notice, the FDA isprohibited from approving the ANDA or 505(b)(2) application for a period of 30 months. If the notice is given and suit filed between December 21, 2016 andDecember 21, 2017, the 30-month stay does not begin until December 21, 2017. The FDA may approve the proposed competitor product before the expiration ofthe 30-month stay if a court finds our patents invalid or not infringed or if the court shortens the period because the parties have failed to cooperate in expeditingthe litigation.Moreover, if one or more ANDA filers were to receive approval to sell a generic or follow-on version of JUXTAPID, those competitor products could potentiallybe marketed as early as December 21, 2019 (the date on which JUXTAPID’s orphan drug exclusivity ends) and JUXTAPID would become subject to increasedcompetition at that time. The FDA’s approval letter for the modified JUXTAPID REMS program, received on January 3, 2017, specified that an authorized genericdrug under the JUXTAPID NDA must have an FDA-approved REMS program prior to marketing.Metreleptin . Our metreleptin patent portfolio consists of three issued U.S. patents and issued patents in Europe, Canada, Israel, Australia, New Zealand, Mexico,China, South Korea and Japan, all of which have been licensed to us. The U.S. patent covering25the composition of matter of metreleptin was scheduled to expire in 2016, but an interim extension has been granted extending the term for one year until a finaldetermination of a request for patent term extension is made. The non-U.S. patents directed to the composition of matter of metreleptin have expired. The patentfamily covering metreleptin methods of use, directed to treating human lipoatrophy, is co-owned by Amgen, University of Texas and the National Institutes ofHealth, and is licensed to us from Amgen. We are in discussions with one of the co-owners to obtain the co-owner’s consent to the sublicense granted by Amgen,and to in-license the co-owners’ rights. We do not have a direct license from this co-owner. The two method of use patents in the U.S. expire in 2022 and 2023,and the non-U.S. patents issued in certain European countries, Canada, and Australia, and pending in Japan, expire in 2022. An application for a patent termextension in the U.S. with respect to MYALEPT has been filed which, if granted, will be applied to either the U.S. composition of matter patent or the method ofuse patent, to extend one of these patents by 1,206 days. Also, metreleptin qualifies for 12-year biologic exclusivity under the Biologics Price Competition andInnovation Act (the BPCI Act), which will expire in 2026. If approved by the EMA, metreleptin would be entitled to 10 years of market exclusivity in the EU.Zuretinol . Our zuretinol patent portfolio consists of six issued U.S. patents, and issued patents in Europe, Japan, Canada, and other countries, as well as pendingpatent applications in countries including the U.S. and Europe. These patents and patent applications relate to zuretinol pharmaceutical compositions and usesthereof, including methods of using of zuretinol for the treatment of LCA and RP, and expire between 2025 and 2032. Certain zuretinol patent families are ownedby the University of Washington, which has licensed the patents and patent applications to Retinagenix LLC (Retinagenix), and are exclusively sub-licensed to usby Retinagenix.Other Patents , Trademarks and Proprietary RightsIn addition to patent protection, we also rely on trade secrets, proprietary know-how and continuing technological innovation to develop and maintain acompetitive position in our product areas.We require our potential business collaborators, clinical investigators, sponsored researchers, employees and consultants who might have access to or be providedwith proprietary information to sign confidentiality agreements.We have included information about risks and uncertainties relating to protection of our proprietary information in the “ Risk Factors ” section of this AnnualReport.We or Aegerion own registered trademarks including NOVELION, MYALEPT, JUXTAPID, MYALEPTA, and LOJUXTA in the U.S., EU and in otherjurisdictions.LicensingMetreleptinAmgen Inc.In connection with Aegerion’s acquisition of MYALEPT in January 2015, Aegerion acquired a license agreement between Amgen and Amylin Pharmaceuticals,Inc., dated February 7, 2006 (the Amgen License) pursuant to which Aegerion obtained an exclusive worldwide license from Amgen to certain know-how andpatents and patent applications covering the composition of matter and methods of use of metreleptin to develop, manufacture and commercialize a preparationcontaining metreleptin (the Amgen Licensed Products).As part of the Amgen License, Aegerion also obtained an exclusive sublicense of Amgen’s exclusive rights to certain metreleptin-related patents and patentapplications owned by the Rockefeller University and exclusively licensed to Amgen under a license agreement dated April 14, 1995, as amended (the RockefellerLicense) and an exclusive sublicense of Amgen’s non-exclusive rights to certain metreleptin-related patents and patent applications owned by The Regents of theUniversity of California and non-exclusively licensed to Amgen under a license agreement dated July 13, 2005 (the UCSF License). Amgen retains rights toconduct research, development, manufacturing and commercialization activities with respect to products other than the Amgen Licensed Products.Aegerion may grant sublicenses under the licenses and sublicenses granted by Amgen, subject to certain limitations, including Amgen’s right of first offer for anyout-license, partnership, co-development, commercialization, co-promotion or similar agreement related to metreleptin or the Amgen Licensed Products, whichexpires in February 2021. Under this license agreement, Amgen must notify Aegerion of any potential third-party partnership regarding any intellectual propertyrights controlled by Amgen in the neurology field and Aegerion will have a right of first negotiation for any license, partnership, co-development,commercialization, co-promotion or similar agreement, which expires in February 2021.Aegerion is required to make royalty payments to Amgen, Rockefeller University and BMS on net sales of each Amgen Licensed Product on a country-by-countrybasis (i) at a royalty rate in the low double digits where the Amgen Licensed Product has patent26protection or market exclusivity granted by a regulatory authority at the time of regulatory approval in the applicable country during the applicable royalty term,which runs on a country-by-country basis until the later of (a) the expiration of the last-to-expire valid claim covering an Amgen Licensed Product in the applicablecountry, (b) expiration of any market exclusivity granted by a regulatory authority, and (c) ten years from the date on which an Amgen Licensed Product is firstsold to a third party in a country after regulatory approval for the Amgen Licensed Product has been granted in such country (Amgen Royalty Term) or (ii) at aroyalty rate in the mid-single digits to low double digits where the Amgen Licensed Product receives patent protection or market exclusivity following the time ofregulatory approval in the applicable country, in either case subject to a variety of customary reductions.Under the Amgen License, Aegerion is also required to directly meet certain payment obligations under the Rockefeller License and UCSF License. Aegerion isrequired to make royalty payments to Rockefeller University on net sales of each product with patent rights or know-how in the field of obesity genes, obesity geneproducts, and molecules that modulate or mediate their action and/or regulation on a country-by-country basis at a range of royalty rates in the low single digitsdepending on whether the product has an orphan product designation or not until the later to occur of expiration of (i) patent protection, (ii) any market exclusivityperiod granted in the applicable country, or (iii) any data exclusivity period in the applicable country (with certain limitations related to the number of units sold).Since acquiring this license agreement in January 2015, Aegerion has paid a one-time $5.0 million milestone payment to Rockefeller in February 2015, which wasdue twelve months following the receipt of marketing approval for MYALEPT in the U.S. Aegerion will also be required to pay to Rockefeller University apercentage in the low double digits of any upfront license fees or one-time fees Aegerion receives in consideration for a sublicense of the licensed rights. There areno material payment obligations outstanding under the UCSF License.The Amgen License will terminate upon the expiration of the last Amgen Royalty Term for any Amgen Licensed Product. Aegerion has the right to terminate theAmgen License for convenience upon 90 days prior written notice to Amgen or for Amgen’s uncured material breach of the Amgen License, or becoming subjectto specified bankruptcy or liquidation events. Amgen may terminate the Amgen License for Aegerion’s uncured failure to make payments to Amgen or if Aegerionis the subject of specified bankruptcy or liquidation events.Aegerion made royalty payments to Amgen related to the sales of MYALEPT through November 29, 2016. There were no royalty payments made to Amgen fromNovember 30, 2016 to December 31, 2016. We had $1.2 million remaining balance in royalties payable as of December 31, 2016.Shionogi & Co., Ltd.In connection with Aegerion’s acquisition of MYALEPT in January 2015, Aegerion acquired a license agreement between Shionogi and Amylin Pharmaceuticals,Inc., dated July 8, 2009 pursuant to which Shionogi was granted an exclusive sublicense to the patent rights licensed under the Amgen License and the RockefellerLicense to develop and commercialize the Amgen Licensed Products and know-how for use in the treatment of lipodystrophy in humans in Japan, South Korea andTaiwan (the Shionogi Territory). This license agreement does not provide Shionogi with manufacturing rights. Shionogi may grant further sublicenses under thelicense, subject to certain limitations.The license agreement requires that Shionogi use commercially reasonable efforts to develop, obtain regulatory approvals for, and commercialize the AmgenLicensed Products in the Shionogi Territory. Shionogi is required to make royalty payments to Aegerion on net sales of each Amgen Licensed Product at a range ofroyalty rates in the mid-to high-single digits dependent on the amount of net sales. Shionogi made royalty payments to Aegerion related to sales of MYALEPT inJapan through November 29, 2016. During the period from November 30, 2016 to December 31, 2016, Aegerion did not receive any royalty payments fromShionogi. Shionogi will be required to make milestone payments to Aegerion of up to an aggregate of approximately $25.0 million if and when Shionogi achievescertain commercialization milestones. Such milestone payments are payable only once. Under the license agreement, Shionogi has also agreed to directly complywith the payment obligations under the Rockefeller License and Amgen License, as set forth under those agreements, relating to its activities under this licenseagreement.The license agreement with Shionogi will terminate upon the expiration of the last Amgen Royalty Term for any Amgen Licensed Product with respect to whichShionogi has a license under this license agreement. Aegerion has the right to terminate this license agreement for Shionogi’s uncured material breach of thelicense agreement, failure to make any payment due to Aegerion, a procedural default, or becoming subject to specified bankruptcy or liquidation events. Shionogimay terminate this license agreement for Aegerion’s uncured material breach of this license agreement, failure to make payments due to Shionogi, or if Aegerion isthe subject of specified bankruptcy or liquidation events, or if Shionogi determines it is not feasible to develop, launch or sell the Amgen Licensed Products due toscientific, technical, regulatory or commercial reasons. Aegerion may also terminate this license agreement at any time without cause by exercising our buy-backoption for a one-time fee to Shionogi equal to (i) a number in the low single digits times the amount of expenses and fees incurred by Shionogi in developing theAmgen Licensed Products plus (ii) an amount no more than a number in the mid-double digits times monthly net sales of the Amgen Licensed Products byShionogi in the month the option is exercised.27LomitapideUniversity of PennsylvaniaIn May 2006, Aegerion entered into a license agreement with The Trustees of the University of Pennsylvania, (UPenn) pursuant to which Aegerion obtained anexclusive, worldwide license from UPenn to certain know-how and a range of patent rights applicable to lomitapide. In particular, Aegerion obtained a license tocertain patents and patent applications owned by UPenn relating to the dosing of MTP-I compounds, including lomitapide, and certain patents and patentapplications and know-how covering the composition of matter of lomitapide that were assigned to UPenn by Bristol-Myers Squibb Company (BMS) for use eitheras a monotherapy or with other dyslipidemic therapies to treat patients with HoFH. Aegerion also has the right to use lomitapide in the field of monotherapy or incombination with other dyslipidemic therapies for treatment of patients with other severe forms of hypercholesterolemia unable to come within 15% of NCEP’sLDL-C goal on maximal tolerated oral therapy, as determined by the patient’s prescribing physician, or with severe combined hyperlipidemia unable to comewithin 15% of NCEP’s non-HDL-C goal on maximal tolerated oral therapy, as determined by the patient’s prescribing physician, or with severehypertriglyceridemia unable to reduce TG <1,000 on maximal tolerated therapy. We refer to the patents and patent applications assigned by BMS to UPenn andlicensed to Aegerion by UPenn as the BMS-UPenn assigned patents.To the extent that rights under the BMS-UPenn assigned patents were not licensed to Aegerion under our license agreement with UPenn or were retained by UPennfor non-commercial education and research purposes, those rights, other than with respect to lomitapide, were licensed by UPenn back to BMS on an exclusivebasis pursuant to a technology donation agreement between UPenn and BMS. In the technology donation agreement, BMS agreed not to develop or commercializeany compound, including lomitapide, covered by the composition of matter patents included in the BMS-UPenn assigned patents in the field licensed to Aegerionexclusively by UPenn. Through our license with UPenn, as provided in the technology donation agreement, we have the exclusive right with respect to the BMS-UPenn assigned patents regarding their enforcement and prosecution in the field licensed exclusively to Aegerion by UPenn.The license from UPenn covers, among other things, the development and commercialization of lomitapide alone or in combination with other active ingredients inthe licensed field. The license is subject to customary non-commercial rights retained by UPenn for non-commercial educational and research purposes. Aegerionmay grant sublicenses under the license, subject to certain limitations. Aegerion is required to make royalty payments to UPenn at a range of royalty rates in thehigh single digits on net sales of lomitapide in countries where lomitapide has patent protection, and of any other products covered by the license (subject to avariety of customary reductions), and share with UPenn specified percentages of sublicensing royalties and certain other consideration that we receive under anysublicenses that we may grant. Aegerion made royalty payments to UPenn through November 29, 2016. There were no royalty payments made to UPenn duringthe period from November 30, 2016 to December 31, 2016. We had $1.3 million remaining balance in royalties payable to UPenn as of December 31, 2016.Aegerion will be required to make development milestone payments to UPenn of up to an aggregate of approximately $2.6 million if we decide to developlomitapide for indications within the licensed field other than HoFH, and we achieve certain milestones in such development efforts. All such developmentmilestone payments for these other indications are payable only once, no matter how many licensed products for these other indications are developed.The license agreement with UPenn will remain in effect on a country-by-country basis until the expiration of the last-to-expire licensed patent right covering theproduct in the applicable country. Aegerion has the right to terminate this license agreement for convenience upon 60 days prior written notice to UPenn or forUPenn’s uncured material breach of the license agreement. UPenn may terminate this license agreement for Aegerion’s uncured material breach of the licenseagreement, uncured failure to make payments to UPenn or if Aegerion is the subject of specified bankruptcy or liquidation events.ZuretinolRetinagenix LLCUnder the terms of a co-development agreement (the Retinagenix Agreement) we entered into with Retinagenix in April 2006, we obtained an exclusive,worldwide license and sub-license under certain intellectual property rights owned by Retinagenix or licensed to Retinagenix by the University of Washington,related to zuretinol, the synthetic retinoid compound under development. We have been responsible for using commercially reasonable and diligent efforts todevelop and commercialize, in certain major markets and other markets as we reasonably determine, one or more products covered by the licensed rights ordeveloped using such licensed rights for use in diagnosing, treating or preventing certain human diseases and conditions. We are also responsible for committingcertain annual funding to support research and development of such products. Under the license agreement between Retinagenix and the University of Washington(the UW Agreement), Retinagenix has similar obligations, and is required to meet specific development milestones within certain timeframes, one of which wasrequired to be achieved by December 31, 2016. However, the UW Agreement contains provisions for extensions of those dates in certain circumstances. Based onthe terms of the Retinagenix Agreement and the UW Agreement, and our significant development clinical spend on the zuretinol program, we28believe that we are entitled to an extension of that milestone date until December 31, 2017, and that we may be entitled to certain additional extensions toDecember 31, 2019, along with a potential additional extension of up to 12 months should enrollment in a planned trial be delayed, provided that we continue tocomply with the relevant provisions of the license agreements and expend certain minimum amounts on the development of zuretinol. However, it is possible thatwe may not be able to achieve the specified development milestone by December 31, 2019. As a result, we and Retinagenix have begun discussing a renegotiationof that milestone with the University of Washington. We are currently conducting a review of the zuretinol development program, the results of which will assistus in determining when we believe that the remaining development milestone can be expected to be achieved.Pursuant to the Retinagenix Agreement, Retinagenix is eligible to receive the following milestone payments: (i) $1.0 million upon initiation of the first pivotal trialfor the first target indication which uses such products, (ii) $1.5 million upon completion of a filing seeking EU approval or Japan approval for the use of suchproducts in the first indication and (iii) up to a total of an additional $10.0 million upon the achievement of other specified development or regulatory milestonesand, for each of up to two additional indications, up to a total of $9.0 million upon achievement of specified development or regulatory milestones. If wecommercialize such products, we will also pay Retinagenix royalties of between 4% and 6% of net sales, subject to reduction under certain specifiedcircumstances. Retinagenix is also eligible to receive up to a total of $15.0 million upon achievement of specified cumulative sales milestones for such products.The term of the Retinagenix Agreement expires on the later of the expiration of 10 years after first commercial sale of licensed products, or the expiration, lapse orabandonment of all licensed patents. Retinagenix can terminate the agreement earlier if we fail in any material respect to meet our diligence requirements, and wemay terminate the agreement for convenience. Each party may terminate the agreement for uncured material breach by the other party.Government RegulationGovernment authorities in the U.S., at the federal, state and local level, the EU, EU Member States, and in other countries extensively regulate, among other things,the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution,marketing and export and import of lomitapide, metreleptin, zuretinol and other products that we may acquire or develop. Our products must be approved by theFDA through the NDA or the BLA process before they may be legally marketed in the U.S., and must be approved by foreign regulatory authorities via variousprocedures before they can be marketed in the applicable country, including the EMA or the competent authorities of the EU Member States before they can beplaced on the market in the EU.U.S. Drug and Biologic Development ProcessIn the U.S., the FDA regulates drugs under the Federal Food, Drug and Cosmetic Act (FDCA) and implementing regulations, and regulates biologics under thePublic Health Service Act (PHSA). The process of obtaining marketing approvals and the subsequent compliance with appropriate federal, state, local, and foreignstatutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any timeduring the product development process, approval process or after approval, may subject a company to administrative or judicial sanctions. These sanctions couldinclude, among other things, the FDA’s refusal to approve pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of warningletters and other types of enforcement-related letters, product recalls, product seizures, changes to the conditions surrounding marketing approval such as labelingchanges or changes to a Risk Evaluation and Mitigation Strategies (REMS) program, total or partial suspension of production or distribution, injunctions, civilmoney penalties, fines, refusals of government contracts, debarment, restitution, disgorgement of profits, or civil or criminal investigations and penalties.The process required by the FDA before a drug or biologic may be marketed in the U.S. is extensive and generally involves the following:•completion of preclinical laboratory tests, animal studies and formulation studies according to Good Laboratory Practices (GLP) and other applicableregulations;•submission to the FDA of an investigational new drug application (IND), which must become effective before human clinical trials may begin;•performance of human clinical trials, including adequate and well-controlled trials, according to Good Clinical Practices (GCP) to establish the safety andefficacy of the proposed drug for its intended use, or the safety, purity, and potency of a biological product;•approval by an independent Institutional Review Board (IRB), representing each clinical site before each clinical trial may be initiated;•submission to the FDA of an NDA or BLA;•completion of registration batches and validation of the manufacturing process to show that we are capable of consistently producing quality batches ofproduct;29•satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with currentGood Manufacturing Practice (cGMP) to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality andpurity; and•FDA review and approval of the NDA or BLA.The testing and approval process requires substantial time, effort and financial resources, and we cannot be certain that any approvals for our product candidateswill be granted on a timely basis, if at all, and for what indications they will be approved, if any.Once a pharmaceutical candidate is identified for development it enters the preclinical testing stage. Preclinical tests include laboratory evaluations of productchemistry, toxicity and formulation, as well as animal studies, to assess the safety and quality of the product. Animal studies must be performed in compliance withFDA’s GLP regulations and the U.S. Department of Agriculture’s Animal Welfare Act. Human clinical trials cannot commence until an IND application issubmitted and becomes effective. An IND sponsor must submit the results of the preclinical tests, together with manufacturing information and analytical data, tothe FDA as part of the IND. The sponsor also will include a protocol detailing, among other things, the objectives of the first phase of the clinical trial, theparameters to be used in monitoring safety and the effectiveness criteria to be evaluated, if the first phase lends itself to an efficacy evaluation. Preclinical testingmay continue after the IND is submitted. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day timeperiod, places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial canbegin. Clinical holds also may be imposed by the FDA at any time before or during studies due to safety concerns or non-compliance, or other reasons.All clinical trials must be conducted under the supervision of one or more qualified investigators. The conduct of clinical trials is subject to extensive regulation,including FDA’s bioresearch monitoring regulations and GCP requirements, which establish standards for conducting, recording data from, and reporting theresults of, clinical trials, and are intended to assure that the data and reported results are credible and accurate, and that the rights, safety, and well-being of studyparticipants are protected. These regulations include the requirement that all research subjects provide informed consent. Further, an IRB must review and approvethe plan for any clinical trial before it commences at any institution. An IRB considers, among other things, whether the risks to individuals participating in thetrials are minimized and are reasonable in relation to anticipated benefits. The IRB also approves the information regarding the trial and the consent form that mustbe provided to each trial subject or his or her legal representative, and continues to provide oversight of the study until it is completed. Additionally, companiessponsoring the clinical trials, investigators, and IRBs also must comply with regulations and guidelines for complying with the protocol and investigational plan,adequately monitoring the clinical trial, and timely reporting of adverse events. Foreign studies conducted under an IND must meet the same requirements thatapply to studies being conducted in the U.S. Data from a foreign study not conducted under an IND may be submitted in support of an NDA or BLA if the studywas conducted in accordance with GCP and the FDA is able to validate the data.Each new clinical protocol must be submitted for FDA review, and to the IRBs for approval. Protocols detail, among other things, the objectives of the study, theprimary and secondary endpoints of the study, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety.Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:•Phase 1. The investigational drug is initially introduced into healthy human subjects, and tested for safety, dosage tolerance, absorption, metabolism,distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic toethically administer to healthy volunteers, the initial human testing may be conducted in patients with the target diseases.•Phase 2. This phase involves trials in a limited patient population to identify possible adverse effects and safety risks, to preliminarily evaluate theefficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage.•Phase 3. This phase involves trials undertaken after preliminary evidence of effectiveness has been obtained and are intended to further evaluate dosageand clinical efficacy and safety of the drug, or the safety, purity, and potency of a biological product, in an expanded patient population, often atgeographically dispersed clinical trial sites. These trials are intended to establish the overall risk/benefit ratio of the product, and to provide an adequatebasis for product approval and product labeling.Progress reports detailing developments associated with the clinical testing program must be submitted at least annually to the FDA, and safety reports must besubmitted to the FDA and the investigators for serious and unexpected adverse events or animal test results that suggest a significant risk to human subjects. Phase1, Phase 2, and Phase 3 testing may not be completed successfully within any specified period, if at all. The FDA or the sponsor may suspend or terminate aclinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk. Similarly, an30IRB can suspend or terminate approval of a clinical trial at its institution if the clinical trial is not being conducted in accordance with the IRB’s requirements or ifthe drug has been associated with unexpected serious harm to patients. Further, success in either preclinical studies or early-stage clinical trials does not assuresuccess in later-stage clinical trials. Sponsors of all controlled clinical trials, except for Phase 1 trials, are required to submit certain clinical trial information forinclusion in the public clinical trial registry and results data bank maintained by the National Institutes of Health, which are publicly available athttp://clinicaltrials.gov.Concurrent with clinical trials, companies usually complete additional studies in non-human models, and must also develop additional information about thechemistry and physical characteristics of the product, and finalize a process for manufacturing the product in commercial quantities in accordance with cGMPrequirements.The manufacturing process must be capable of consistently producing quality batches of the product candidate and, among other things, the manufacturer mustdevelop methods for testing the identity, strength, quality and purity of the final product. Additionally, appropriate packaging must be selected and tested, andstability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.U.S. Review and Approval ProcessesThe results of product development, preclinical studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on thechemistry of the product, proposed labeling, and other relevant information are submitted to the FDA as part of an NDA or BLA requesting approval to market theproduct. The submission of an NDA or BLA generally is subject to the payment of a user fee, although NDAs or BLAs for designated orphan drugs are exemptfrom this fee.In addition, under the Pediatric Research Equity Act of 2007 (PREA) an application or supplement to an application must contain data to assess the safety andeffectiveness of the drug or biologic for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatricsubpopulation for which the drug is safe and effective. The FDA may grant deferrals or full or partial waivers for submission of this data. Unless otherwiserequired by regulation, PREA does not apply to any drug or biologic for an indication for which orphan designation has been granted.The FDA conducts a preliminary review of all NDAs and BLAs submitted to ensure that they are sufficiently complete for substantive review before it acceptsthem for filing. The FDA may request additional information rather than accept an application for filing. In this event, the application must be resubmitted with theadditional information. The resubmitted application also is subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, theFDA begins an in-depth substantive review. FDA is required to refer an NDA for a new chemical entity (NCE) to an advisory committee for review, evaluationand recommendation as to whether the application should be approved and under what conditions, or explain why such review is not necessary. Other NDAs orBLAs may also be referred to an advisory committee for evaluation and recommendation. The FDA is not bound by the recommendation of an advisorycommittee, but it generally follows such recommendations. The approval or licensure process is lengthy and difficult, and the FDA may refuse to approve an NDAor BLA if the applicable regulatory criteria are not satisfied or may require additional clinical or other data and information. Even if such data and information aresubmitted, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval or licensure. Data obtained from clinical trialsare not always conclusive; and the FDA may interpret data differently than we interpret the same data. The FDA may issue a complete response letter, whichgenerally outlines the deficiencies in the submission and may require additional clinical or other data or impose other conditions that must be met in order to securefinal approval of the application. The FDA reviews an application to determine, among other things, whether a drug is safe and effective for its intended use, orwhether a biologic is safe, pure, and potent, and whether its manufacturing is cGMP-compliant to assure and preserve the product’s identity, strength, quality andpurity. Before approving an NDA or BLA, the FDA will typically inspect the facility or facilities where the product is manufactured. In addition, the FDA oftenwill conduct a bioresearch monitoring inspection of the clinical trial sites involved in conducting pivotal studies to ensure data integrity and compliance withapplicable GCP requirements.Applications receive either standard or priority review. A product representing a major advance in treatment or treatment where no adequate therapy exists mayreceive priority review. Under the goals and policies agreed to by the FDA under the Prescription Drug User Fee Act (PDUFA), FDA has ten months in which tocomplete its initial review of a standard new molecular entity (NME) NDA or original BLA and six months for a priority review NME NDA, BLA, or efficacysupplement. FDA does not always meet its PDUFA goal dates and in certain circumstances the PDUFA goal date may be extended. In addition, products studiedfor their safety and effectiveness in treating serious or life-threatening illnesses and which provide meaningful therapeutic benefit over existing treatments, mayreceive accelerated approval. In that situation, the product may be approved on the basis of adequate and well-controlled clinical trials establishing that the producthas an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit or on the basis of an effect on a clinical endpoint other than survival orirreversible morbidity. As a condition of approval, a sponsor of a drug or biologic receiving accelerated approval must perform post-marketing studies to validatethe surrogate endpoint or otherwise confirm the effect of the product on a clinical endpoint, and the product may be subject to accelerated withdrawal procedures.Priority review and accelerated approval do not change the standards for approval, but may expedite the approval process for certain products.31If a product receives marketing approval, the approval may be significantly limited to specific diseases, dosages or patient populations, or the indications for usemay otherwise be limited, which could restrict the commercial value of the product. In addition, the FDA may impose distribution and use restrictions and otherlimitations on labeling and communication activities with respect to an approved product via a REMS program, to mitigate serious risks, which could includeMedication Guides, patient package inserts, physician communication plans, and/or Elements To Assure Safe Use (ETASU). ETASU may include restricteddistribution methods, patient registries and other risk minimization tools. MYALEPT is subject to a REMS program, due to the risks of serious adverse sequelae, asa result of the development of anti-metreleptin antibodies that neutralize endogenous leptin and/or MYALEPT, and the risk of lymphoma. The MYALEPT REMSprogram aims to educate prescribers about these risks and to restrict access to MYALEPT by requiring prescriber certification, pharmacy certification, andprescriber attestation that each patient has a diagnosis consistent with GL. Because of the risk of liver toxicity, JUXTAPID is also available in the U.S. onlythrough a REMS program, which was modified and approved by the FDA on January 3, 2017. The goal of the modified JUXTAPID REMS program, as discussedearlier in the “B usiness” section of this Annual Report, is to mitigate the risk of hepatotoxicity associated with the use of JUXTAPID by ensuring that: a)prescribers are educated about the approved indication for JUXTAPID, the risk of hepatotoxicity associated with the use of JUXTAPID, and the need to monitorpatients during treatment with JUXTAPID as per product labeling; b) JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistentwith homozygous familial hypercholesterolemia; and c) patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the needfor baseline and periodic monitoring. The ETASU in the modified JUXTAPID REMS program approved by the FDA on January 3, 2017 has been significantlyenhanced and imposes requirements on healthcare professionals, pharmacies, and patients. See the “Business-Lomitapide” section of this Annual Report for furtherinformation regarding the modified JUXTAPID REMS program. The REMS programs for each product restrict distribution and sales of our products and imposeongoing implementation requirements that could be burdensome or costly.The Hatch-Waxman Act, Marketing Exclusivity in the U.S. and Patent Term RestorationThe Drug Price Competition and Patent Term Restoration Act of 1984, or the Hatch-Waxman Act, established two abbreviated approval pathways for drugproducts that are in some way follow-on versions of already approved NDA products.Generic Drugs. A generic version of an approved drug is approved by means of an Abbreviated New Drug Application (ANDA) through which the sponsordemonstrates that the proposed product is identical or bioequivalent to the approved, brand-name drug, referred to as the Reference Listed Drug (RLD). Generally,an ANDA must contain data and information showing that the proposed generic product and RLD have the same active ingredient(s), in the same strength anddosage form, to be delivered via the same route of administration; are intended for the same uses; have the same labeling; and has been showing throughbioequivalence testing to be therapeutically equivalent to the RLD. An ANDA need not independently demonstrate the proposed product’s safety andeffectiveness; rather the proposed product’s safety and effectiveness are inferred from the fact that the product is demonstrated to be bioequivalent to the RLD,which the FDA previously found to be safe and effective. These drugs are commonly referred to as “generic equivalents” to the RLD, and they can be substitutedby pharmacists under prescriptions written for the RLD.505(b) (2) NDAs. If a product is similar, but not identical, to an already approved product, it may be submitted for approval via an NDA under FDCA section505(b) (2). Unlike an ANDA, the sponsor is permitted to rely to some degree on the FDA’s finding that the RLD is safe and effective, but the sponsor must submitits own product-specific safety and effectiveness data to support the differences between the proposed and reference products.RLD Patents. An NDA sponsor must identify to the FDA any patents that claim the drug substance, drug product or method of using the drug. These patents areamong the information about the product that is listed in the FDA publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the OrangeBook). The sponsor of an ANDA or 505(b) (2) application seeking to rely on an approved product as the RLD must make one of several certifications regardingeach listed patent. For example, a “Paragraph III” certification is the sponsor’s statement that it will wait for the patent to expire before obtaining approval for itsproduct. A “Paragraph IV” certification is an assertion that the patent does not block approval of the later product, either because the patent is invalid orunenforceable or because the patent, even if valid, is not infringed by the new product. If the ANDA applicant does not challenge the listed patents, the ANDA willnot be approved until all the listed patents claiming the referenced product have expired.Marketing Exclusivities in the U.S.The Hatch-Waxman Act provides periods of regulatory exclusivity for products that would serve as RLDs for an ANDA, or 505(b) (2) application. If a drug is anNCE, generally meaning that the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule or ion responsiblefor the action of the drug substance, there is a period of five years from the product’s approval during which the FDA may not accept for filing any ANDA or505(b) (2) application for a drug with the same active moiety. However, an ANDA or 505(b) (2) NDA may be submitted after four years if it contains a ParagraphIV certification of patent invalidity or non-infringement. According to the Orange Book, JUXTAPID has NCE exclusivity that will expire on December 21, 2017,which means that since December 21, 2016 an ANDA or 505(b) (2) NDA may be submitted for32JUXTAPID. We believe that the active pharmaceutical ingredient in zuretinol may qualify as a NCE, in which case it would receive five years of marketexclusivity following FDA approval. We intend to seek NCE exclusivity; however, there is no assurance that zuretinol will qualify and gain the five-yearexclusivity period, even if zuretinol is approved.A product that is not an NCE may qualify for three years of marketing exclusivity following approval of a drug product that contains an active moiety that has beenpreviously approved, when the application contains new clinical investigations, other than bioavailability studies, were conducted or sponsored by the applicantand are deemed by the FDA to be essential to the approval of the application, for example, for new indications, strengths or dosage forms of an existing drug. Thisexclusivity period does not preclude filing or review of an ANDA or 505(b) (2) application; rather, FDA is precluded from granting final approval to the ANDA or505(b) (2) application until three years after approval of the RLD. In addition, this three-year exclusivity covers only the conditions of use associated with the newclinical investigations and, as a general matter, does not prohibit the FDA from approving ANDAs or 505(b)(2) NDAs for generic versions of the original,unmodified drug product.Once the FDA accepts for filing an ANDA or 505(b) (2) application containing a Paragraph IV certification, the applicant must within 20 days provide notice tothe RLD NDA holder and patent owner that the application with patent challenge has been submitted, and provide the factual and legal basis for the applicant’sassertion that the patent is invalid or not infringed. If the NDA holder or patent owner files suit against the ANDA or 505(b) (2) applicant for patent infringementwithin 45 days of receiving the Paragraph IV notice, the FDA is prohibited from approving the ANDA or 505(b) (2) application for a period of 30 months from thedate of receipt of the notice. If the RLD has NCE exclusivity and the notice is given and suit filed during the fifth year of exclusivity, the 30-month stay does notbegin until five years after the RLD approval. The FDA may approve the proposed product before the expiration of the 30-month stay if, within that time period,the patent involved expires, the parties settle the lawsuit or a court finds the patent invalid or not infringed or if the court shortens the period because the partieshave failed to cooperate in expediting the litigation.Pediatric exclusivity is another type of exclusivity available in the U.S. under Section 505A of the FDCA. Pediatric exclusivity, if granted, provides an additionalsix months to an existing exclusivity period, including orphan drug exclusivity, or delay in approval resulting from certain patent certifications. This six-monthexclusivity, which runs from the end of other exclusivity protection or patent delay, may be granted based on the voluntary completion of a pediatric trial or trialsand submission of pediatric data that fairly responds to an FDA-issued “Written Request” for such a trial or trials. The data need not show the product to be safe oreffective in the pediatric population studied; rather if the clinical trial is deemed to fairly respond to the FDA’s request, the additional protection is granted. Ifreports of requested pediatric studies are submitted to and accepted by FDA within statutory time limits, any periods of regulatory exclusivity or Orange Book -listed patent protections that cover the drug are extended by six months. This is not a patent term extension, but it effectively extends the regulatory period duringwhich the FDA cannot approve an ANDA or 505(b) (2) application owing to regulatory exclusivity or listed patents. In the first quarter of 2015, the FDA issued aWritten Request for a study to evaluate lomitapide in pediatric HoFH patients, which, if completed as described, would provide for 6 months of pediatricexclusivity under the FDCA. In the second quarter of 2015, we decided to decline the FDA’s Written Request regarding the study in pediatric HoFH patients,because we believe that the size and complexity of the requested trial created a considerable barrier to the feasibility of the study. Given that we have declined toconduct the study requested by the FDA, we will not be entitled to the six months of additional exclusivity available for conducting a study that is the subject of aWritten Request issued by the FDA.Patent Term RestorationThe Hatch-Waxman Act established a patent restoration term of up to five years as compensation for patent term lost during product development and the FDAregulatory review process. The maximum period of restoration is five years and cannot extend the remaining term of a patent beyond a total of 14 years from theproduct’s approval date. The patent term restoration period is generally one-half the time between the effective date of an IND, and the submission date of anNDA, plus the time between the submission date of an NDA and the approval of that application. Only one patent applicable to an approved drug is eligible for theextension, and the extension must be applied for prior to expiration of the patent and within 60 days of the NDA approval. The PTO, in consultation with the FDA,reviews and approves the application for any patent term extension or restoration. A five year patent term extension has been granted for our U.S. patent coveringthe composition of matter of lomitapide, extending the patent term to 2020 from the originally scheduled expiration of early 2015. An application for a patent termextension in the U.S. with respect to MYALEPT has been filed which, if granted, we will apply to either the U.S. composition of matter patent or the method ofuse patent, to extend one of these patents by 1,206 days.The Biologics Price Competition and Innovation ActThe BPCI Act, enacted in 2010, as part of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (theHealth Care Reform Act), authorizes the FDA to license a biological product that is biosimilar to, and possibly interchangeable with, a PHSA-licensed referencebiological product through an abbreviated pathway. The BPCI Act establishes criteria for determining that a product is biosimilar to an already-licensed biologic (areference product), and33establishes a process by which an abbreviated BLA for a biosimilar product is submitted, reviewed and approved. The BPCI Act provides periods of exclusivitythat protect a reference product from biosimilar competition. Under the BPCI Act, innovator manufacturers of original reference products are granted twelve yearsof exclusive use before biosimilar versions of such products can be licensed for marketing in the U.S. This means that the FDA may not approve an application fora biosimilar version of a reference product until twelve years after the date of approval of the reference product (with a potential six-month extension of exclusivityif certain pediatric studies are conducted and the results reported to FDA), although a biosimilar application may be submitted four years after the date of licensureof the reference product. Additionally, the BPCI Act establishes procedures by which the biosimilar applicant must provide information about its application andproduct to the reference product sponsor, and by which information about potentially relevant patents is shared and litigation over patents may proceed in advanceof approval. The BPCI Act also provides a period of exclusivity for the first biosimilar to be determined by the FDA to be interchangeable with the referenceproduct. Under the BPCI Act, metreleptin has twelve years of exclusivity in the U.S. from February 24, 2014, the date of the product’s approval by the FDA.The objectives of the BPCI Act are conceptually similar to those of the Hatch-Waxman Act, which established abbreviated pathways for the approval of smallmolecule drug products. The FDA has not yet issued proposed regulations setting forth its interpretation of the BPCI Act’s provisions but has issued guidancedocuments in 2015 related to BPCI Act implementation concerning biosimilarity and interchangeability, BLA submission requirements, and exclusivity. Weanticipate that contours of the BPCI Act will be further defined through issuance of additional guidance documents by the FDA, proposed regulations, anddecisions in the course of considering specific applications.Like pediatric exclusivity applicable to drug products approved under the FDCA, pediatric exclusivity applicable to biological reference products is subject to anexception. Pediatric exclusivity will not apply to either the 12-year reference product or the seven-year orphan drug exclusivity periods if the FDA determines laterthan nine months prior to the expiration of such period that the study reports a BLA sponsor submitted in response to a written request for pediatric studies met theterms of that request.The BPCI Act sets forth a complex mechanism for resolving patent disputes that involves a step-wise exchange of information prior to the initiation of a patentinfringement lawsuit against a biosimilar or interchangeable product sponsor. Unlike the Hatch-Waxman Act, the BPCI Act provides no automatic stay onapproval of a biosimilar or interchangeable product application.Modifications to or repeal of all or certain provisions of the Health Care Reform Act are expected as a result of the outcome of the recent presidential election andRepublicans maintaining control of Congress, consistent with statements made by President Donald Trump and members of Congress during the presidentialcampaign and following the election. As noted above, the BPCI Act was enacted as part of the Healthcare Reform Act. Although there has been no directdiscussion, to our knowledge, of repealing the BPCI Act, if there is a repeal of all or parts of the Health Care Reform Act, this could impact the BPCI Actprovisions as well. We cannot predict the ultimate content, timing or effect of any changes to the Health Care Reform Act or any resulting impact on the BPCI Act.U.S. Orphan Drug DesignationUnder the Orphan Drug Act, the FDA may grant orphan drug designation to a drug or biological product intended to treat a rare disease or condition, which isgenerally a disease or condition that affects fewer than 200,000 individuals in the U.S., or for which there is no reasonable expectation that development andproduction costs will be recovered from sales of the drug for such disease or condition in the U.S. Orphan drug designation must be requested before submitting anNDA or BLA. After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. Ifa product that has orphan drug designation subsequently receives FDA approval and is the first drug approved for the disease for which it has such designation, theproduct is entitled to orphan product exclusivity, which means that the FDA may not approve for seven years any other applications to market the same drug forthe same indication, except in limited circumstances such as a demonstration that the subsequent drug is clinically superior or the inability of the existingmanufacturer to supply the market. Orphan drug exclusivity also could block the approval of one of our products for seven years if a competitor obtains approvalfor an orphan product that the FDA finds to be the “same drug” as our product candidate for the same indication or disease. If a drug or biologic designated as anorphan drug receives marketing approval for an indication broader than the scope of its designation, it may be no longer entitled to orphan drug exclusivity. Inaddition to creating a 12-year period of reference product exclusivity, the BPCI Act clarifies the interaction of that exclusivity with orphan drug exclusivity, suchthat the licensure of a biosimilar or interchangeable version of a reference biological product that was designated and approved as an orphan drug may only occurafter the later of the expiration of any applicable seven-year orphan drug exclusivity or the 12-year reference product exclusivity (or seven and one-half years and12.5 years with pediatric exclusivity). The FDA has granted seven years of orphan drug exclusivity for JUXTAPID in the treatment of HoFH which is scheduled toexpire on December 21, 2019, and seven years of orphan drug exclusivity for MYALEPT in the treatment of GL which is scheduled to expire on February 24,2021. Zuretinol has received orphan drug designations for the treatment of LCA (due to inherited mutations in the LRAT or RPE65 genes) and RP (all mutations)by the FDA. The FDA has also formally acknowledged that the orphan drug designations granted by the FDA on zuretinol also cover the treatment of IRD causedby LRAT or RPE65 gene mutations, which disease/condition we believe comprises both LCA due to34inherited mutations in LRAT or RPE65 genes and RP. Since the extent and scope of our patent protection for zuretinol is limited, orphan drug designation isespecially important for this product candidate.Fast Track DesignationThe FDA’s Fast Track program is intended to facilitate the development and review of drugs that are intended to treat a serious or life-threatening disease orcondition and demonstrate the potential to address unmet medical needs for such a disease or condition. Under the program, the sponsor of a new drug may requestthat the FDA designate the drug for a specific indication as a Fast Track product concurrent with or after the filing of the IND for the product candidate. A drugthat receives Fast Track designation may be eligible for more frequent meetings with the FDA to discuss the drug’s development; more frequent writtencorrespondence from the FDA about the design of the proposed clinical trials; and rolling review, meaning the sponsor may submit its NDA in sections rather thanwait until the entire NDA is complete. Drugs with Fast Track designation may be more likely to become eligible for a Priority Review, which provides for FDAreview of an NDA for a NME within a six-month time frame from the time the complete NDA is accepted for filing (60 days after submission), as opposed to theten-month time frame for a Standard Review. The FDA grants Priority Review for products that demonstrate the potential to be a significant improvement in thesafety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. Zuretinol has been granted Fast Track designations by the FDA for thetreatment of LCA and autosomal recessive RP due to inherited mutations in the LRAT and RPE65 genes.Rare Pediatric Disease Priority Review VoucherIn addition to the Fast Track and orphan drug designations previously granted to us by the FDA for zuretinol, we are currently exploring the potential of submittingto the FDA a request for rare pediatric disease designation of zuretinol for the treatment of IRD caused by LRAT or RPE65 gene mutations, which indicationincludes LCA and RP. In order to obtain a rare pediatric disease designation for zuretinol, we must demonstrate to FDA’s satisfaction that this indication is for thetreatment or prevention of a rare disease or condition that affects fewer than 200,000 individuals in the U.S., or that affects more than 200,000 individuals in theU.S. and there is no reasonable expectation that the cost of developing and making available in the U.S. a drug for this type of disease or condition will berecovered from sales in the U.S. for that product, and is a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affectindividuals aged from birth to 18 years. Under the FDCA, a sponsor who receives approval of an NDA for a product that is for the prevention or treatment of a rarepediatric disease and meets certain additional criteria, may qualify for a rare pediatric disease priority review voucher (PRV). A PRV can be redeemed to receivepriority review under an expedited timeframe for a subsequent marketing application for a different product. A PRV may also be sold or transferred from the initialsponsor to another sponsor. The voucher may be further transferred any number of times before it is used. Pursuant to the 21 st Century Cures Act, FDA’s authorityto award rare pediatric disease PRVs has been extended until 2020, and until 2022 for products that receive rare pediatric disease designation by 2020.Post-Approval Requirements in the U.S.Once an approval is granted, products are subject to continuing regulation by the FDA. The FDA may withdraw the approval, following notice and an opportunityfor a hearing, if, among other things, compliance with certain regulatory standards is not maintained or if safety or efficacy problems occur after the productreaches the market. Later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of theproduct from the market. If new safety issues are identified following approval, the FDA may require the NDA sponsor to take certain measures, such as revisingthe approved labeling to reflect the new safety information, conducting post-market studies or clinical trials to assess the new safety information, and/orimplementing or changing a REMS program to mitigate newly-identified risks. These are often referred to as Phase 4 or post-marketing studies, and may involveadditional clinical trials, nonclinical testing and surveillance programs to monitor the safety of approved products which have been commercialized. Afterapproval, most changes to the approved product, such as adding new indications, manufacturing changes and additional labeling claims, are subject to prior FDAreview and approval. Manufacturers and other entities involved in the manufacture and distribution of approved drugs or licensed biologics are required to registertheir establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies forcompliance with cGMP requirements and other laws. In its approval of JUXTAPID, the FDA required three post-marketing requirements; the MYALEPT approvalwas associated with 15 post-marketing requirements and commitments. See Marketed Products - Lomitapide - Post-Marketing Commitments and MarketedProducts - Metreleptin - Post-Marketing Commitments for details of our post-marketing commitments to applicable regulatory authorities.Companies engaged in manufacturing drug products or their components must comply with applicable cGMP requirements and product-specific regulationsenforced by the FDA and other regulatory agencies. Compliance with cGMP includes adhering to requirements relating to organization of personnel, buildings andfacilities, equipment, control of components and drug product containers and closures, production and process controls, packaging and labeling controls, holdingand distribution, laboratory controls, and records and reports. The FDA regulates and inspects equipment, facilities, and processes used in manufacturingpharmaceutical products prior to approval. If, after receiving approval, a company makes a material change in manufacturing35equipment, location, or process (all of which are, to some degree, incorporated in the NDA or BLA), additional regulatory review and approval may be required.Manufacturers of approved products also are subject to significant annual establishment and product user fees.The FDA also conducts regular, periodic visits to re-inspect equipment, facilities, and processes following the initial approval of a product. Failure to comply withapplicable cGMP requirements and conditions of product approval may lead the FDA to take enforcement actions, which may range from issuing a warning letterto seeking sanctions, including fines, civil penalties, injunctions, suspension of manufacturing operations, operating restrictions, withdrawal of FDA approval,seizure or recall of products, and criminal prosecution. Accordingly, manufacturers must continue to spend time, money and effort to maintain cGMP compliance.We cannot be certain that our present or future third-party manufacturers will consistently comply with cGMP and other applicable FDA regulatory requirements.In addition, companies manufacturing or distributing drug products pursuant to FDA approvals are subject to record-keeping requirements; requirements onreporting of adverse experiences with the drug, and providing the FDA with updated safety and efficacy or safety, purity, and potency information for drugs andbiologics, respectively; compliance within REMS program reporting obligations; drug and biologic sampling and distribution requirements; compliance withcertain electronic records and signature requirements, and compliance with FDA promotion and advertising requirements. As discussed more fully below, the FDAstrictly regulates labeling, advertising, promotion and other types of information regarding marketed products that are placed on the market. Drugs and biologicsmay be promoted only for their approved indications and in accordance with the provisions of the approved labeling.From time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing the testing, approval,manufacturing and marketing of products regulated by the FDA. In addition to new legislation, FDA regulations and guidance are often revised or interpreted bythe agency in ways that may significantly affect our business and our products. It is impossible to predict whether or when further legislative changes or changes toFDA regulations, guidance or interpretations may occur or what the impact of such changes, if any, may be.Foreign RegulationIn addition to regulations in the U.S., our business will be subject to a variety of foreign regulations governing clinical trials and commercial sales and distributionof our products. Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory authorities of foreigncountries before we can commence clinical trials or marketing of the product in those countries. In addition, the requirements governing the conduct of clinicaltrials, product licensing, pricing and reimbursement vary greatly from country to country. For example, in the EU, the conduct of clinical trials is currentlygoverned by the EU Clinical Trials Directive 2001/20/EC, which imposes obligations and procedures that are similar to those provided in applicable U.S. laws.The EU Good Clinical Practice and EU Good Laboratory Practice standards must also be respected during the conduct of the trials. Prior to commencement of aclinical trial in an EU Member State, an application for authorization of a clinical trial must be submitted to the competent authority and the competent EthicsCommittee of the relevant EU Member State in which the clinical trial takes place. The competent authorities of the EU Member States in which the clinical trial isconducted must authorize the conduct of the trial, and the independent Ethics Committee must grant a positive opinion in relation to the conduct of the clinical trialin the relevant EU Member State before the commencement of the trial. Any substantial changes to trial protocol or other information submitted with the clinicaltrial applications must be notified to or approved by the relevant competent authorities and ethics committees. However, under the new EU Clinical TrialsRegulation No. 536/2014, which is expected to take effect in late 2018, a more harmonized procedure will apply, with clinical trial authorization and otherapplications or notifications being submitted through a centralized EU clinical trials portal.The approval process for clinical trials in other countries outside the U.S. and the EU varies from country to country, and the time may be longer or shorter thanthat required for FDA approval. In all cases, clinical trials are conducted in accordance with GCP and the applicable regulatory requirements and the ethicalprinciples that have their origin in the Declaration of Helsinki.To obtain marketing authorization for a medicinal product in the EU, companies must submit an application for marketing authorization based on the ICHCommon Technical Document to the competent authorities of the EU Member States or to the EMA. Applicants need to demonstrate the quality, safety andefficacy of the medicinal product in the application for marketing authorization. This requires applicants to conduct human clinical trials to generate the necessaryclinical data. Moreover, applicants are required to include, as part of the application for marketing authorization, the results of all studies performed and details ofall information collected in compliance with an agreed Pediatric Investigation Plan (PIP) approved by the PDCO, or a decision by the EMA granting a product-specific or class waiver for pediatric use or deferral for the conduct of the PIP.Medicinal products are authorized in the EU through one of several different procedures, either by the competent authorities of the EU Member States through thedecentralized procedure, mutual recognition procedure, or national procedure, or through the36centralized authorization procedure by which the EC takes a decision to grant a marketing authorization following a positive opinion by the EMA.The centralized procedure provides for the grant of a single marketing authorization by the EC that is valid for all EU Member States and three of the four EFTAStates (Iceland, Liechtenstein and Norway). The centralized procedure is compulsory for certain medicinal products, including medicinal products derived fromcertain biotechnological processes, orphan medicinal products, advanced therapy medicinal products and products with a new active substance indicated for thetreatment of certain diseases. It is optional for those products that are a significant therapeutic, scientific or technical innovation, or the authorization of whichwould be in the interest of public. Under the centralized procedure in the EU, the timeframe for the evaluation of a marketing authorization application by the EMACommittee for Medicinal Products for Human Use (CHMP) is, in principle, 210 days from receipt of a valid application for marketing authorization. This timeperiod excludes any clock stops when additional written or oral information is to be provided by the applicant in response to questions asked by the CHMP and ifthe applicant requests a re-examination of the CHMP opinion. Accelerated evaluation might be granted, following a substantiated request from the applicant, bythe CHMP in exceptional cases, when a medicinal product is of a major public health interest particularly from the point of view of therapeutic innovation.Justification of what constitutes a major public interest is on a case by case basis. The justification should include the major benefits expected and present thearguments to support the claim that the medicinal product introduces new methods of therapy or improves on existing methods, thereby addressing to a significantextent the greater unmet needs for maintaining and improving public health. In this circumstance of an accelerated assessment, the opinion of the CHMP is given,in principle, within 150 days. Regardless of the assessment procedure, the opinion of the CHMP will be provided to the EC who will take the final decision on theapplication for centralized marketing authorization of a medicinal product. In light of the United Kingdom’s (UK) vote in 2016 to leave the EU, the so-calledBrexit vote, there may be changes forthcoming in the scope of the centralized approval procedure as the terms of that exit are negotiated between the UK and theEU.The decentralized marketing authorization procedure requires a separate application to, and leads to separate approval by, the competent authorities of each EUMember State in which the product is to be marketed. One national competent authority, the “reference” Member State, selected by the applicant, assesses theapplication for marketing authorization. As part of this procedure, an applicant submits an application for marketing authorization, or dossier, and related materials,including a draft summary of product characteristics (SmPC), and draft labeling and package leaflet, to the reference EU Member State and the concerned EUMember States. This application is identical to the application that would be submitted to the EMA for authorization through the centralized procedure. Thereference EU Member State prepares a draft assessment report and drafts of the related SmPC, labeling and package leaflet within 120 days after receipt of a validapplication. The competent authorities of the other EU Member States, the “concerned” Member States, are subsequently required to grant marketing authorizationfor their territory on the basis of this assessment within 90 days of receipt thereof. The only exception to this obligation arises where the competent authoritiesprovide evidence of potential serious risk to public health which would require this authorization to be refused. Similarly, the mutual recognition procedure isbased on the acceptance by the competent authorities of the EU Member States of the marketing authorization of a medicinal product by the competent authoritiesof other EU Member States. The holder of a national marketing authorization may submit an application to the competent authority of an EU Member Staterequesting that this authority recognize the marketing authorization delivered by the competent authority of another EU Member State. The reference EU MemberState prepares a draft assessment report and drafts of the related SmPC, labeling and package leaflet within 90 days after receipt of a valid application. Theresulting assessment report is submitted to the concerned EU Member States, which within 90 days of receipt must each decide whether to approve the assessmentreport and the related materials. For both the decentralized and mutual recognition procedures, if a concerned EU Member State does not approve the assessmentreport and related materials on the grounds of potential serious risk to public health, the disputed points may eventually be referred to the Coordination Group forMutual Recognition and Decentralized Procedures (CMDh) whose decision is binding on all EU Member States. If the CMDh does not reach an agreement, thedisputed points are forwarded to the CHMP. The CHMP then adopts an opinion in the matter, which is forwarded to the EC, which makes the final decisionregarding the application for a decentralized or mutual recognition marketing authorization. LOJUXTA was granted a marketing authorization by the EC under thecentralized procedure. Because Aegerion was not able to provide comprehensive clinical data on efficacy and safety under normal conditions of use due to therarity of the disease, and in light of Aegerion’s commitments to conduct an appropriate risk-mitigation program, LOJUXTA was approved under exceptionalcircumstances. This type of marketing authorization requires an annual reassessment of the risk/benefit of LOJUXTA by the CHMP, for which Amryt is nowresponsible. As part of the post-marketing commitments to the FDA, Aegerion is conducting an observational cohort study to generate more data on the long-termsafety profile of lomitapide in the treatment of patients with HoFH, the patterns of use and compliance and the long-term effectiveness of controlling LDL-Clevels. The EMA has required that all patients taking lomitapide in the EU be encouraged to participate in the study, and that the study period be open-ended.Amryt will bear the costs of conducting this study in the EEA and other relevant territories. In the study, physicians will follow each patient to track malignancies,tumors, teratogenicity, hepatic effects, and GI adverse reactions, events associated with coagulopathy, major adverse cardiovascular events and death. The EMAalso required that a vascular imaging study be conducted to determine the impact of lomitapide on vascular endpoints, which is now the responsibility of Amryt.37Innovative medicinal products authorized in the EU on the basis of a full marketing authorization application (as opposed to an application for a generic marketingauthorization that relies on the results of pre-clinical and clinical trials available in the marketing authorization dossier for another, previously approved, referencemedicinal product) are entitled to eight years’ data exclusivity beginning on the date of the grant of the first marketing authorization for the innovative product inthe EU. During this period applicants for approval of generics of these innovative products cannot rely on data contained in the marketing authorization dossiersubmitted for the innovative medicinal product. Innovative medicinal products are also entitled to ten years’ marketing exclusivity, which also begins on the dateof the grant of the first marketing authorization for the innovative product in the EU. During this ten-year period no generic medicinal product can be placed on theEU market. The ten-year period of market exclusivity can be extended to a maximum of eleven years if, during the first eight years of those ten years, themarketing authorization holder for the innovative product obtains an authorization for one or more new therapeutic indications which, during the scientificevaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies. Lomitapide has eight years’ dataexclusivity and ten years’ marketing exclusivity in the EU from July 31, 2013, the date of the EC’s approval of lomitapide.The EMA grants orphan designation to promote the development of products that treat life-threatening or chronically debilitating conditions affecting not morethan five in 10,000 people in the EU. In addition, orphan drug designation can be granted only if, for economic reasons, the medicinal product would be unlikely tobe developed without incentives and if there is no other satisfactory method approved in the EU of diagnosing, preventing, or treating the condition, or if such amethod exists, the proposed medicinal product must potentially be of significant benefit to patients affected by the condition. The application for orphandesignation must be granted by the EC before an application for marketing authorization of the medicinal product is submitted. Upon grant of marketingauthorization for the medicinal products, orphan designation provides ten years of market exclusivity for the orphan medicinal product in the orphan indication.During this ten-year period, with a limited number of exceptions, the competent authorities of the EU Member States and the EMA may not accept applications formarketing authorization, accept an application to extend an existing marketing authorization or grant marketing authorization for other similar medicinal productsfor the same orphan indication. Under an exception, marketing authorization could be granted to a similar medicinal product with the same orphan indicationbefore the expiry of the ten years if the holder of the marketing authorization for the original orphan medicinal product has given its consent or if the manufacturerof the original orphan medicinal product is unable to supply sufficient quantities. Marketing authorization may also be granted to a similar medicinal product withthe same orphan indication if this product is safer, more effective or otherwise clinically superior to the original orphan medicinal product. Moreover, theexclusivity period for the original orphan medicinal product may be reduced to six years if the designation criteria are no longer met, including where it is shownthat the product is sufficiently profitable not to justify maintenance of market exclusivity. Despite the prevalence rate, lomitapide does not have orphan medicinalproduct exclusivity in the EU for the treatment of HoFH because the EMA views the relevant condition, for orphan drug purposes, to include both HoFH andHeFH. In 2012, metreleptin was granted orphan designation by the EC for the treatment of Barraquer-Simons syndrome (acquired PL), Berardinelli-Seip syndrome(congenital GL), Lawrence syndrome (acquired GL) and familial PL. Zuretinol was granted orphan designation by the EMA in 2011 for the treatment of LCA andRP (all mutations) and in 2014, the EMA also formally acknowledged that a therapeutic indication of zuretinol for the treatment of patients with IRD, who havebeen phenotypically diagnosed as LCA or RP caused by mutations in RPE65 or LRAT genes, would fall under the orphan drug designations of treatment of LCAand treatment of RP. We also plan to seek regulatory exclusivity for zuretinol in the EU; however, there can be no assurance that we will be successful in securingapproval or regulatory exclusivity in the EU.In the EU, certain patents may qualify for a supplemental protection certificate that would extend patent protection for up to five years after patent expiration uponmarketing authorization in the EU. Grant of such supplemental protection certificate is, however, subject to strict conditions and it is not automatic. We believethat our EPO method of use patent covering certain dosing regimens for lomitapide which expires in 2025 may be eligible for up to three years of supplementalprotection in certain EPO countries, and we are seeking such protection in the EU Member States, on a country-by-country basis.Similar to the U.S., marketing authorization holders and manufacturers of medicinal products are subject to comprehensive regulatory oversight by the EMAand/or the competent authorities of the EU Member States. This oversight applies both before and after grant of manufacturing and marketing authorizations. Itincludes control of compliance with EU GMP rules, manufacturing authorizations, pharmacovigilance rules and requirements governing advertising, promotion,sale, and distribution, recordkeeping, importing and exporting of medicinal products.Failure to comply with the EU Member State laws implementing the EU Community Code on medicinal products and other EU Member State laws that apply tothe promotion of medicinal products, statutory health insurance, bribery and anti-corruption or with other applicable regulatory requirements can result inenforcement action by the EU Member State authorities, which may include any of the following: fines, imprisonment, orders forfeiting products or prohibiting orsuspending their supply to the market, orders to suspend, vary, or withdraw the marketing authorization or requiring the manufacturer to issue public warnings, orto conduct a product recall. The collection and use of personal health data and other personal information in the EU is governed by the provisions of the DataProtection Directive as implemented into national laws by the EU Member States. This Directive38imposes a number of strict obligations and restrictions on the ability to collect, analyze and transfer personal data, including health data from clinical trials andadverse event reporting. There is, moreover, a growing trend towards imposition of an obligation of public disclosure of clinical trial data in the EU which adds tothe complexity of obligations relating to the processing of health data from clinical trials. Such public disclosure obligations are provided in the new EU ClinicalTrials Regulation, EMA disclosure initiatives, and voluntary commitments by industry. The Data Protection Directive also includes requirements relating to theconsent of the individuals to whom the personal data relates, the information provided to the individuals prior to processing their personal data or personal healthdata, notification of data processing obligations to the competent national data protection authorities and the security and confidentiality of the personal data. TheData Protection Directive also prohibits the transfer of personal data to countries outside of the EU Member States that are not considered by the EC to provide anadequate level of data protection. These countries include the U.S. Failure to comply with the requirements of the Data Protection Directive and the related nationaldata protection laws of the EU Member States may result in fines and other administrative penalties. Data protection authorities from the different EU MemberStates may interpret the EU Data Protection Directive and national laws differently, which adds to the complexity of processing personal data in the EU. Guidancedeveloped at both EU level and at national level in individual EU Member States concerning implementation and compliance practices are often updated orotherwise revised. The EU General Data Protection Regulation (EU No. 2016/679), which will apply from May 25, 2018, will introduce new data protectionrequirements in the EU and substantial fines for breaches of the data protection rules. The EU Data Protection Regulation, which will be applicable two years afterthe date of its publication in the Official Journal for the European Union, will increase our responsibility and liability in relation to personal data that we processand we may be required to put in place additional mechanisms ensuring compliance with the new EU data protection rules. This may be onerous and increase ourcost of doing business.Expanded AccessIn certain countries, drug products approved in the U.S. or EU can be accessed by patients before the drug has obtained marketing approval in such country. Thereare various forms of this access. They include the actual purchase of product by the purchaser, which is often times the government for patients, on a named patientbasis, providing the product free of charge on a named patient basis, and providing the product on a compassionate use basis. Each country has its own laws andregulations that apply to these forms of access and the extent and nature of such laws and regulations vary by country. We have made lomitapide available in Braziland other countries that allow such use, and we plan to continue to consider access to additional countries in compliance with applicable laws and regulations.When Aegerion acquired metreleptin from AstraZeneca in January 2015, there were a number of patients receiving metreleptin therapy free of charge in certaincountries outside the U.S. that allow use of a drug, under a compassionate use or other type of expanded access program, before marketing approval has beenobtained in such country. Where permitted in accordance with applicable requirements, we have continued to make metreleptin available free of charge under sucha program, which has resulted in significant costs to us. In 2016, we began generating revenues from named patient sales of metreleptin in certain markets wherenamed patient sales of metreleptin are possible and to the extent permitted by applicable law and local regulatory authorities. In particular, we are in the process ofconverting all GL and PL patients currently in the expanded access program in France to a paid program under the Autorisation Temporaire d’Utilisation(Temporary Authorization for Use). Metreleptin has also been approved for reimbursement by the Turkish Social Security Association (SGK), and we plan toprovide metreleptin on a named patient basis for GL patients, including CGL patients, and other subsets of lipodystrophy patients, subject to individual assessmentin response to unsolicited requests from clinicians. We also provide zuretinol to patients under our compassionate use program on a named-patient basis to patientswho participated in our completed Phase 1b clinical trial of zuretinol for the treatment of LCA and RP.Pharmaceutical Coverage, Pricing and ReimbursementSignificant uncertainty exists regarding the coverage and reimbursement status of products approved by the FDA and other government authorities. Sales ofpharmaceutical products depend in significant part on the availability and adequacy of third-party reimbursement. Third-party payers include government healthadministrative authorities, including authorities at the U.S. federal and state level, managed care providers, private health insurers and other organizations. Third-party payers are increasingly challenging the prices charged for, examining the medical necessity of, and assessing the cost-effectiveness of medical products andservices.In the U.S., the Medicare program provides health insurance for people who are 65 or older, as well as certain people with disabilities and other conditionsirrespective of their age. The Medicare program is funded by the federal government and administered by the Centers for Medicare & Medicaid Services (CMS).Medicare Part D is a voluntary prescription drug benefit, through which beneficiaries may enroll in prescription drug plans offered by private entities undercontract with CMS for coverage of certain outpatient prescription drugs. Medicare Part D generally provides coverage for medically necessary self-administereddrugs (i.e. drugs that do not need to be administered by a healthcare practitioner). JUXTAPID and MYALEPT may be covered under Medicare Part D. Coverageand reimbursement for outpatient drugs under Part D is not standardized. Part D prescription drug plan sponsors are not required to pay for all covered Part Ddrugs, and each drug plan can develop its own drug formulary that identifies which drugs the plan will cover and at what tier or level. The availability of coverageunder Medicare Part D may affect demand for39JUXTAPID and MYALEPT. In order for JUXTAPID and MYALEPT to remain on or be included on the formularies of Part D prescription drug plans, we mayhave to offer discounts on the price of those products. In addition, manufacturers, including Aegerion, are required to provide a 50% discount on brand nameprescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries reach the so-called “donut hole” in their drug benefits in a particular year (i.e.a coverage gap between initial coverage and catastrophic coverage). We believe that investigations and enforcement actions by certain government agencies mayhave caused a reduction in contributions to third-party patient assistance programs operated by independent charitable 501(c)(3) organizations that assist patients,including Medicare Part D beneficiaries, in accessing treatment for certain diseases and conditions. If a lack of available funds prevents these patient assistanceprograms from providing adequate financial assistance, including assistance with co-payment obligations, to individuals who would otherwise be unable to affordour products, our revenues may decline below our expectations.Medicaid is a health insurance program with mandatory coverage for certain low-income children, families, pregnant women, and people with disabilities. Statesalso have the option of expanding Medicaid coverage to low-income individuals generally and many states have done so. Medicaid is jointly funded by the federaland state governments, but administered by the states. In general, state Medicaid programs are required to cover drugs and biologics of manufacturers that haveentered into a Medicaid Drug Rebate Agreement, as discussed further below, although such drugs and biologics may be subject to prior authorization or otherutilization controls.Coverage of drugs and biologics by private health insurance varies. Private payers may use a variety of utilization management techniques designed to controlcosts, including requiring pre-approval of coverage for drug therapies before reimbursing healthcare providers or patients that use such therapies. In addition, apayer’s decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be provided. Coverage may not be sufficient tomaintain price levels high enough to realize an appropriate return on investment in product development.Government and private third-party payers have a variety of methodologies for paying for drugs and biologics. Payers are increasingly considering new metrics asthe basis for reimbursement rates, such as average sales price, average manufacturer price (AMP) or actual acquisition cost. Recent changes to the Medicaid DrugRebate Program, effective April of 2016, require state Medicaid programs to reimburse certain brand name covered outpatient drugs at actual acquisition cost plusa dispensing fee. The impact of these evolving reimbursement mechanics on the willingness of providers to furnish JUXTAPID or MYALEPT or other productswe may market and the prices we can command for these products is difficult to predict.We participate in various government programs or contracts that require us to calculate and report certain prices for our products to government agencies orprovide rebates or discounted pricing on products purchased to certain purchasers or government payers. The requirements for calculating prices and rebates arecomplex and subject to change. We may also have reimbursement obligations or be subject to penalties if we fail to provide timely and accurate information to thegovernment, pay the correct rebates or offer the correct discounted pricing.We participate in the Medicaid Drug Rebate Program. Under the Medicaid Drug Rebate Program, we are required to pay a rebate for each unit of our productreimbursed by a state Medicaid program as a condition of having federal funds made available to the states for our drugs under Medicaid and Medicare Part B.Those rebates are based on pricing data that we report on a monthly and quarterly basis to CMS, the federal agency that administers the Medicaid Drug RebateProgram. We may also participate in state Medicaid supplemental rebate programs which require payment of an incremental rebate to state Medicaid programs forcovered utilization of our products. Price reductions as well as price increases that exceed the rate of inflation for our products, such as the price increase forMYALEPT in February of 2015, may result in increasing the rebates we are required to pay under the Medicaid Drug Rebate Program or state Medicaidsupplemental rebate programs and the discounts we are required to offer under the Public Health Service (PHS) 340B drug pricing discount program (the 340BProgram), as discussed below.To maintain coverage of our products under the Medicaid Drug Rebate Program and Medicare Part B, we are required to extend significant discounts to certain“covered entities” (defined by statute to include certain types of hospitals and other healthcare providers that receive federal grants) that purchase products underthe 340B Program. The 340B Program requires participating manufacturers to agree to charge such covered entities no more than the 340B “ceiling price” for themanufacturers’ covered outpatient drugs. The 340B ceiling price is calculated using a statutory formula, which is based on the AMP and rebate amount for thecovered outpatient drug as calculated under the Medicaid Drug Rebate Program. “Orphan drugs” -those designated under section 526 of the FDCA, such asJUXTAPID and MYALEPT-are exempt from the ceiling price requirements with respect to drugs purchased by certain covered entities (i.e. rural referral centers,sole community hospitals, critical access hospitals, and free-standing cancer hospitals). The Healthcare Reform Act also obligates the Health Resources andServices Administration (HRSA), the agency which administers the 340B Program, to promulgate various regulations and implement processes to improve theintegrity of the 340B Program. The status of new and pending regulations and guidance is uncertain under the new presidential administration.40Drug products are subject to discounted pricing when purchased by federal agencies via the Federal Supply Schedule (FSS). FSS participation is required for adrug product to be covered and reimbursed by certain federal agencies and for coverage under Medicaid, Medicare Part B and the 340B Program. FSS pricing isnegotiated periodically with the Department of Veterans Affairs. FSS pricing is intended not to exceed the price that a manufacturer charges its most-favored non-federal customer for its product. In addition, prices for drugs purchased by the Veterans Administration, Department of Defense (including drugs purchased bymilitary personnel and dependents through the Tricare Retail Pharmacy program), Coast Guard, and PHS are subject to a cap on pricing (known as the federalceiling price) and may be subject to an additional discount if pricing increases more than the rate of inflation. Aegerion participates in the FSS. Aegerion alsoparticipates in the Tricare Retail Pharmacy program, under which we pay quarterly rebates on utilization of JUXTAPID and MYALEPT when the products aredispensed through the Tricare Retail Pharmacy network to Tricare beneficiaries.In addition, in the U.S., the cost of pharmaceuticals continues to generate substantial governmental and third-party payer interest. We expect that thepharmaceutical industry will experience pricing pressures due to the increasing influence of managed care (and related implementation of managed care strategiesto control utilization), additional federal and state legislative and regulatory proposals to regulate pricing of drugs, limit coverage of drugs or reduce reimbursementfor drugs, public scrutiny and the presidential administration’s agenda to control the price of pharmaceuticals through government negotiations of drug prices inMedicare Part D and importation of cheaper products from abroad.In addition, in some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drugpricing vary widely from country to country. For example, in the EU, the sole legal instrument at the EU level governing the pricing and reimbursement ofmedicinal products is Council Directive 89/105/EEC (the Price Transparency Directive). The aim of this Directive is to ensure that pricing and reimbursementmechanisms established in the EU Member States are transparent and objective, do not hinder the free movement of and trade in medicinal products in the EU, anddo not hinder, prevent or distort competition on the market. The Price Transparency Directive does not provide any guidance concerning the specific criteria on thebasis of which pricing and reimbursement decisions are to be made in individual EU Member States, nor does it have any direct consequence for pricing norreimbursement levels in individual EU Member States. The EU Member States are free to restrict the range of medicinal products for which their national healthinsurance systems provide reimbursement, and to control the prices and/or reimbursement levels of medicinal products for human use. An EU Member State mayapprove a specific price or level of reimbursement for the medicinal product, or alternatively adopt a system of direct or indirect controls on the profitability of thecompany responsible for placing the medicinal product on the market, including volume-based arrangements, caps and reference pricing mechanisms.Health Technology Assessment (HTA) of medicinal products is becoming an increasingly common part of the pricing and reimbursement procedures in some EUMember States, including the United Kingdom, France, Germany, Ireland, Italy and Sweden. The HTA process in the EU Member States is governed by thenational laws of these countries. HTA is the procedure according to which the assessment of the public health impact, therapeutic impact, and the economic andsocietal impact of use of a given medicinal product in the national healthcare systems of the individual country is conducted. HTA generally focuses on the clinicalefficacy and effectiveness, safety, cost, and cost-effectiveness of individual medicinal products as well as their potential implications for the healthcare system.Those elements of medicinal products are compared with other treatment options available on the market. The outcome of HTA regarding specific medicinalproducts will often influence the pricing and reimbursement status granted to these medicinal products by the competent authorities of individual EU MemberStates. The extent to which pricing and reimbursement decisions are influenced by the HTA of the specific medicinal product vary between EU Member States. Anegative HTA of one of our products by a leading and recognized HTA body, such as the National Institute for Health and Care Excellence (NICE) in the UnitedKingdom, could not only undermine our ability to obtain reimbursement for such product in the EU Member State in which such negative assessment was issued,but also in other EU Member States. For example, EU Member States that have not yet developed HTA mechanisms could rely to some extent on the HTAperformed in countries with a developed HTA framework, such as the United Kingdom, when adopting decisions concerning the pricing and reimbursement of aspecific medicinal product.In 2011, Directive 2011/24/EU was adopted at EU level. This Directive concerns the application of patients’ rights in cross-border healthcare. The Directive isintended to establish rules for facilitating access to safe and high-quality cross-border healthcare in the EU. It also provides for the establishment of a voluntarynetwork of national authorities or bodies responsible for HTA in the individual EU Member States. The purpose of the network is to facilitate and support theexchange of scientific information concerning HTAs. This could lead to harmonization between EU Member States of the criteria taken into account in the conductof HTA and their impact on pricing and reimbursement decisions.To obtain reimbursement or pricing approval in some countries, including the EU Member States, we may be required to conduct studies that compare the cost-effectiveness of our product candidates to other therapies that are considered the local standard of care. In the case of metreleptin, in preparation for seekingreimbursement and pricing approval, if metreleptin is approved by the41EMA, we are conducting local and regional studies to ascertain the impact of metreleptin on morbidity, mortality and patients' quality of life, in order to maximizethe product's value proposition to payers. There can be no assurance that any country will allow favorable pricing, reimbursement and market access conditions forany of our products, or that it will be feasible to conduct additional cost-effectiveness studies, if required.In certain of the EU Member States, products that are designated as orphan medicinal products may be exempted or waived from having to provide certain clinical,cost-effectiveness and other economic data in connection with their filings for pricing/reimbursement approval. As noted above, LOJUXTA was not grantedorphan designation by the EMA for treatment of HoFH. As such, it is not eligible for benefits related to orphan designation. Therefore, Amryt may not be able toprovide all of the data required to obtain pricing/reimbursement approvals in certain EU Member States, which has and could, in the future, result in delays ofpricing/reimbursement approvals for LOJUXTA, LOJUXTA not obtaining pricing/reimbursement approval at all, or LOJUXTA obtaining approvals at less thanacceptable levels or with significant restrictions on use or reimbursement, all of which thereby potentially negatively impacting sales milestone and royaltypayments Aegerion receives under its license agreement with Amryt.U. S. Healthcare ReformOur revenue and operations could be affected by changes in healthcare spending and policy in the U.S. We operate in a highly regulated industry and new laws,regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions, related to health care availability, the method of delivery orpayment for health care products and services could negatively impact our business, operations and financial condition. As noted above, the U.S. Congress andstate legislatures from time to time propose and adopt initiatives aimed at cost containment, which could impact our ability to sell our products profitably. Forexample, the Healthcare Reform Act substantially changed the way healthcare is financed by both governmental and private insurers. The law contains a number ofprovisions that affect coverage and reimbursement of drug products and/or that could potentially reduce the demand for our products such as:•increasing drug rebates under state Medicaid programs for brand name prescription drugs and extending those rebates to Medicaid managed care; and•requiring drug manufacturers to provide a 50% discount on Medicare Part D brand name prescription drugs sold to Medicare beneficiaries whoseprescription drug costs cause the beneficiaries to be subject to the Medicare Part D coverage cap (i.e. the so-called donut hole).In 2012, the Supreme Court of the U.S. heard challenges to the constitutionality of the individual mandate and the viability of certain provisions of the HealthcareReform Act. The Supreme Court’s decision upheld most of the Healthcare Reform Act and determined that requiring individuals to maintain “minimum essential”health insurance coverage or pay a penalty to the Internal Revenue Service was within Congress’s constitutional taxing authority. However, the Supreme Courtstruck down a provision in the Healthcare Reform Act that penalized states that choose not to expand their Medicaid programs through an increase in the Medicaideligibility income limit from a state’s current eligibility levels to 133% of the federal poverty limit. As a result of the Supreme Court’s ruling, some states havedecided not to expand Medicaid. For each state that does not choose to expand its Medicaid program, there will be fewer insured patients overall. Any reduction inthe number of insured patients could impact our sales, business and financial condition.Modifications to or repeal of all or certain provisions of the Healthcare Reform Act are expected as a result of the outcome of the recent presidential election andRepublicans maintaining control of Congress, consistent with statements made by President Donald Trump and members of Congress during the presidentialcampaign and following the election. We cannot predict the ultimate content, timing or effect of any changes to the Healthcare Reform Act or other federal andstate reform efforts.In addition, other legislative changes have been proposed and adopted since the Healthcare Reform Act was enacted. The Budget Control Act of 2011 includesprovisions to reduce the federal deficit. The Budget Control Act, as amended, resulted in the imposition of 2% reductions in Medicare payments to providers whichbegan in April, 2013 and will remain in effect through 2025 unless additional congressional action is taken.Promotional Activities and Interactions with Healthcare Providers and PatientsThe FDA and other regulatory agencies strictly regulate promotional claims about prescription drug and biological products through, among other things, standardsand regulations for direct-to-consumer advertising, communications regarding unapproved uses, industry-sponsored scientific and educational activities, andpromotional activities involving the Internet and social media. A product cannot be commercially promoted before it is approved. In general, after approval, a drugproduct may not be promoted for uses that are not approved by the FDA, the EC, and the competent authorities of the EU Member States or such other regulatoryagencies as reflected in the product’s prescribing information. Moreover, the promotion of prescription-only medicinal products to non-healthcare professionals isprohibited in the EU. In the U.S., healthcare professionals are generally permitted to prescribe42drugs and biologics for “off-label” uses-that is, uses not described in the drug’s labeling-because the FDA does not regulate the practice of medicine. However,FDA regulations impose stringent restrictions on manufacturers’ communications regarding off-label uses. A manufacturer may not promote a drug or biologic foroff-label use, but under very specific conditions, it may be permissible for a manufacturer to engage in non-promotional, truthful, non-misleading communicationregarding off-label information. If a company is found to have promoted off-label uses, it may become subject to adverse publicity and enforcement action by theFDA, the DOJ, or the Office of the Inspector General of the Department of Health and Human Services, as well as state authorities. This could subject a companyto a range of penalties that could have a significant commercial impact, including civil and criminal fines and agreements that materially restrict the manner inwhich a company promotes or distributes drug or biological products. The federal government has levied large civil and criminal fines against companies foralleged improper promotion, and has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conductis changed or curtailed.Healthcare providers and other stakeholders will play a primary role in the recommendation and prescription of our products. Our future arrangements with third-party payers and customers will expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business orfinancial arrangements and relationships through which we market, sell and distribute the products for which we obtain marketing approval. Restrictions underapplicable U.S. federal and state healthcare laws and regulations include the following:•The federal healthcare Anti-Kickback Statute prohibits persons from, among other things, knowingly and willfully offering, paying, soliciting, orreceiving remuneration, directly or indirectly, in cash or in kind, to induce or reward the purchasing, leasing, ordering, or arranging for or recommendingthe purchase, lease, or order of any healthcare item or service for which payment may be made, in whole or in part, by federal healthcare programs suchas Medicare and Medicaid. This statute has been interpreted to apply to, among others, arrangements between pharmaceutical manufacturers, on the onehand, and prescribers, purchasers, formulary managers and organizations that provide financial assistance to patients, on the other. Violations of thefederal Anti-Kickback Statute are punishable by imprisonment, criminal fines, civil monetary penalties and exclusion from participation in federalhealthcare programs. The Healthcare Reform Act, among other things, clarified that liability may be established under the federal Anti-Kickback Statutewithout proving actual knowledge of the statute or specific intent to violate it. In addition, the Healthcare Reform Act amended the Social Security Act toprovide that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutesa false or fraudulent claim for purposes of the federal civil False Claims Act. There are a number of statutory exceptions and regulatory safe harbors to thefederal Anti-Kickback Statute that protect certain common activities from prosecution or other regulatory sanctions, however, the exceptions and safeharbors are drawn narrowly, and practices that do not fit squarely within an exception or safe harbor may be subject to scrutiny.•The federal civil False Claims Act imposes civil penalties and provides for civil whistleblower or qui tam actions, against individuals or entities for,among other things, knowingly presenting, or causing to be presented false or fraudulent claims for payment of government funds, or knowingly making,using or causing to be made or used, a false record or statement material to an obligation to pay money to the government, or knowingly concealing orknowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government. Several pharmaceutical and otherhealthcare companies have faced enforcement actions under these laws for allegedly inflating drug prices they report to pricing services, which in turnwere used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with theexpectation that the customers would bill federal programs for the product. In addition, federal Anti-Kickback Statute violations and certain marketingpractices, including off-label promotion, may also implicate the federal civil False Claims Act. Federal civil False Claims Act violations may result intreble monetary damages and penalties and exclusion from participation in federal healthcare programs. Civil liability under the False Claims Act ormisdemeanor violation of federal health care laws gives the Inspector General of the Department of Health and Human Services (IG) the discretion toexclude a company’s products from reimbursement by federal healthcare programs. This discretion to exclude often leads companies to negotiatecorporate integrity agreements with the IG so their products may continue to receive reimbursement.•The federal criminal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact, making any materiallyfalse, fictitious, or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materiallyfalse, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services. There are alsocriminal penalties, including imprisonment and criminal fines, for making or presenting a false, fictitious or fraudulent claim to the federal government.Conviction under any of the aforementioned federal criminal statutes requires mandatory exclusion from participation in federal healthcare programs.•The federal Physician Payment Sunshine Act, being implemented as the Open Payments Program, requires certain pharmaceutical manufacturers toengage in extensive tracking of payments and other transfers of value to physicians and teaching hospitals and to submit such data to CMS, which willthen make all of this data publicly available on the CMS website. Pharmaceutical manufacturers, such as our subsidiary, Aegerion, with products forwhich payment is available43under Medicare, Medicaid, or the State Children’s Health Insurance Program are required to track reportable payments and transfers of value during eachcalendar year and must submit a report on or before the 90th day of each calendar year disclosing reportable payments made in the previous calendar year.Failure to comply with the reporting obligations may result in civil monetary penalties.•Analogous state laws and regulations, such as state anti-kickback and false claims laws, apply to sales or marketing arrangements and claims involvinghealthcare items or services reimbursed by Medicaid or other state programs or, in several states, apply regardless of the payer. Several states now requirepharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products in those states and to report gifts andpayments to certain healthcare providers in those states. Some of these states also prohibit certain marketing-related activities including the provision ofgifts, meals, or other items to certain healthcare providers. In addition, several states require pharmaceutical companies to implement complianceprograms or marketing codes.We are also subject to laws and regulations covering data privacy and the protection of health-related and other personal information. The legislative andregulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues which mayaffect our business, including recently enacted laws in many jurisdictions where we operate. Numerous U.S. federal and state laws and regulations, including statesecurity breach notification laws, state health information privacy laws and federal and state consumer protection laws, govern the collection, use, disclosure andprotection of personal information. Failure to comply with laws and regulations covering data privacy and the protection of health-related and other personalinformation could result in government enforcement actions, which could include civil or criminal penalties, private litigation and/or adverse publicity and couldnegatively affect our operating results and business. In addition, we obtain patient health information from most healthcare providers who prescribe our productsand research institutions we collaborate with, and they are subject to privacy and security requirements under the Health Insurance Portability and AccountabilityAct of 1996, as amended by HIPAA. Although we are not directly subject to HIPAA other than with respect to providing certain employee benefits, we couldpotentially be subject to criminal penalties if we knowingly obtain or disclose individually identifiable health information maintained by a HIPAA-covered entityin a manner that is not authorized or permitted by HIPAA.Efforts to ensure that our business activities and business arrangements will comply with applicable healthcare laws and regulations could be costly. It is possiblethat governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicablefraud and abuse or other healthcare laws and regulations. As noted above, in late 2013, our subsidiary, Aegerion, received a subpoena from the DOJ, representedby the U.S. Attorney’s Office in Boston, requesting documents regarding its marketing and sale of JUXTAPID in the U.S., as well as disclosures related to thesame. See the “Legal Proceedings” section of this Annual Report for further information regarding ongoing investigations, including the preliminary agreementsin principle Aegerion reached with the SEC and the DOJ, and other legal proceedings.The number and complexity of both federal and state laws continues to increase, and additional governmental resources are being used to enforce these laws and toprosecute companies and individuals who are believed to be violating them. In particular, the Healthcare Reform Act includes a number of provisions aimed atstrengthening the government’s ability to pursue anti-kickback and false claims cases against pharmaceutical manufacturers and other healthcare entities, includingsubstantially increased funding for healthcare fraud enforcement activities, enhanced investigative powers, and amendments to the False Claims Act that make iteasier for the government and whistleblowers to pursue cases for alleged kickback and false claim violations. While it is too early to predict what effect thesechanges will have on our business, we anticipate that government scrutiny of pharmaceutical sales and marketing practices will continue for the foreseeable futureand subject us to the risk of government investigations and enforcement actions. For example, federal enforcement agencies recently have shown interest inpharmaceutical companies’ product and patient assistance programs, including manufacturer reimbursement support services and relationships with specialtypharmacies. Some of these investigations have resulted in significant civil and criminal settlements. As noted above, our subsidiary, Aegerion, is the subject ofcertain ongoing investigations by the DOJ and the SEC and is also the subject of a putative class action lawsuit filed against it and certain of its former executiveofficers in the U.S. District Court for the District of Massachusetts alleging certain misstatements and omissions related to the marketing of JUXTAPID andAegerion’s financial performance in violation of the federal securities laws. See the “Legal Proceedings” section of this Annual Report for further informationregarding these investigations and other legal proceedings.In the EU, the advertising and promotion of our products is also subject to EU Member States’ laws concerning promotion of medicinal products, interactions withphysicians, misleading and comparative advertising and unfair commercial practices. In addition, other legislation of individual EU Member States may apply tothe advertising and promotion of medicinal products. These laws require that promotional materials and advertising in relation to medicinal products comply withthe product’s SmPC as approved by the competent authorities. The SmPC is the document that provides information to physicians concerning the safe and effectiveuse of the medicinal product. It forms an intrinsic and integral part of the marketing authorization granted for the medicinal product. Promotion of a medicinalproduct that does not comply with the SmPC is considered to constitute off-label promotion. The off-label promotion of medicinal products is prohibited in the EU.The applicable laws at EU level and in the individual EU Member States also prohibit the direct-to-consumer advertising of prescription-only medicinal products.Violations44of the rules governing the promotion of medicinal products in the EU could be penalized by administrative measures, fines and imprisonment. These laws mayfurther limit or restrict the advertising and promotion of our products to the general public and may also impose limitations on our promotional activities withhealthcare professionals.Interactions between pharmaceutical companies and physicians are also governed by strict laws, regulations, industry self-regulation codes of conduct andphysicians’ codes of professional conduct in the individual EU Member States. The provision of benefits or advantages to physicians to induce or encourage theprescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is prohibited in the EU. The provision of benefits or advantagesto physicians is also governed by the national anti-bribery laws of the EU Member States. One example is the UK Bribery Act 2010 (the UK Bribery Act). ThisAct applies to any company incorporated in or “carrying on business” in the UK, irrespective of where in the world the alleged bribery activity occurs. This Actcould have implications for our interactions with physicians both in and outside the UK. Violation of these laws could result in substantial fines and imprisonment.Payments made to physicians in certain EU Member States must be publicly disclosed. Moreover, agreements with physicians must often be the subject of priornotification and approval by the physician’s employer, his/her competent professional organization, and/or the competent authorities of the individual EU MemberStates. These requirements are provided in the national laws, industry codes, or professional codes of conduct, applicable in the EU Member States. Failure tocomply with these requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.Other RegulationOur international operations are subject to compliance with the Foreign Corrupt Practices Act (FCPA) which prohibits corporations and individuals from paying,offering to pay, or authorizing the payment of anything of value to any foreign government official, government staff member, political party, or political candidatein an attempt to obtain or retain business or to otherwise influence a person working in an official capacity. We also may be implicated under the FCPA by theactivities of our partners, collaborators, contract research organizations, vendors or other agents. The FCPA also requires us, as a public company, to make andkeep books and records that accurately and fairly reflect all of our transactions and to devise and maintain an adequate system of internal accounting controls. Anaspect of the SEC’s ongoing investigation into Aegerion’s disclosures and activities relates to alleged FCPA violations in Brazil. These potential violations areexcluded from the preliminary agreements in principle with the DOJ and the SEC.Our international operations could also be subject to compliance with national laws of the individual EU Member States, such as the UK Bribery Act. The UKBribery Act applies to any company incorporated in or “carrying on business” in the UK, irrespective of where in the world the offending conduct occurs. The UKBribery Act prohibits the provision of an “advantage” intended to induce or reward “improper performance” of the recipient’s function. Offenses under the UKBribery Act include the offer, promise or provision of a bribe to any person including non-UK government officials and private persons, as well as the request,acceptance or agreement to receive a bribe. The failure by a company to prevent third parties from providing a bribe on its behalf could also constitute an offenseunder the UK Bribery Act. This Act applies to bribery activities both in the public and private sector. Liability in relation to breaches of the UK Bribery Act isstrict. This means that it is unnecessary to demonstrate elements of a corrupt state of mind. However, a defense of having in place adequate procedures designed toprevent bribery is available.We are also subject to compliance with the anti-bribery laws of other countries, including Brazil. Our activities outside the U.S. or those of our employees,licensees, distributors, manufacturers, clinical research organizations, or other third parties who act on our behalf or with whom we do business could subject us toinvestigation or prosecution under foreign or U.S. laws. For example, federal and São Paulo authorities in Brazil are each conducting an investigation to determinewhether there have been any violations of Brazilian laws related to the sales of JUXTAPID in Brazil. See the “Legal Proceedings” section of this Annual Reportfor further information regarding these investigations and other legal proceedings.We are subject to a variety of financial disclosure and securities trading regulations as a public company in Canada and the U.S., including laws relating to theoversight activities of the Canadian securities administrators and the SEC, and the rules and regulations of NASDAQ and the Toronto Stock Exchange (TSX), onwhich our shares are traded. In addition, the Financial Accounting Standards Board, the Canadian securities administrators, the SEC, and other bodies that havejurisdiction over the form and content of our Consolidated Financial Statements and other public disclosure are issuing and amending proposed and existingpronouncements designed to ensure that companies display relevant and transparent information relating to their respective businesses.Our present and future business has been and will continue to be subject to various other laws and regulations. Various laws, regulations and recommendationsrelating to safe working conditions, laboratory practices, the experimental use of animals, and the purchase, storage, movement, import and export and use anddisposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used or that we may use in the future inconnection with our development work are or may be applicable to our activities. Certain agreements entered into by us involving exclusive license45rights or acquisitions may be subject to national or supranational antitrust regulatory control, the effect of which cannot be predicted. The extent of governmentregulation, which might result from future legislation or administrative action, cannot accurately be predicted.Research and Development CostsA significant portion of our operating expenses are related to research and development. During the years ended December 31, 2016, 2015, and 2014, our totalcompany-sponsored research and development expenses were 14.8 million , 9.8 million , and 13.8 million , respectively. See the Products in Development sectionabove and in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of this Annual Report.EmployeesAs of December 31, 2016, Novelion and its subsidiaries had approximately 163 employees, 113 of whom were engaged in research, development, commercial,clinical and regulatory affairs, quality control and assurance, and 50 of whom were engaged in finance, business development, information technology, humanresources, intellectual property and legal.When required, we also engage independent consultants and contractors to perform various professional services including, but not limited to, financial, advisory,clinical, regulatory, supply chain, sales and other commercial services.Corporate InformationNovelion, formerly known as QLT, was originally formed in 1981 under the laws of the Province of British Columbia. Our principal headquarters are located at887 Great Northern Way, Suite 250, Vancouver, British Columbia, Canada, and our telephone number is 604-707-7000.Where You Can Find More InformationYou are advised to read this Annual Report in conjunction with other reports and documents that we file from time to time with the SEC. Copies of our annualreports on Form 10-K will be furnished without charge to any person who submits a written request directed to the attention of our Secretary, at our offices locatedat 887 Great Northern Way, Suite 250, Vancouver, B.C., Canada V5T 4T5. You may also obtain copies of these reports from the SEC at the SEC’s PublicReference Room at 100 F Street, N.E. Washington, D.C. 20549. In addition, the SEC maintains information for electronic filers (including Novelion) at its websiteat www.sec.gov. The public may obtain information regarding the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The System forElectronic Document Analysis and Retrieval (SEDAR) also provides access to most public securities documents and information filed by issuers (includingNovelion) with the thirteen provincial and territorial securities regulatory authorities (Canadian Securities Administrators or CSA) at its website atwww.sedar.com. We make our periodic and current reports available on our internet website, free of charge, as soon as reasonably practicable after such material iselectronically filed with, or furnished to, the SEC. Our internet address is www.novelion.com. Item 1A. Risk Factors.Risks Associated with Product Development and CommercializationOur business depends on the success of metreleptin and lomitapide. We may not be able to meet expectations with respect to sales of these products andrevenues from such sales and if we are not able to meet such expectations, we may not be able to attain or maintain positive cash flow and profitability in thetime periods we anticipate, or at all.Our business depends on the success of metreleptin and lomitapide. Through Aegerion, we have a limited history of generating revenues from the sale of suchproducts, and we anticipate that we will continue to incur significant costs and expend significant operating and management resources associated with developingand commercializing them. Even with these investments, which we may not be able to make on a timely basis or at the levels we would desire due to the decline inour total revenues, these products may not be successful.Our ability to meet expectations with respect to sales of these products and revenues from such sales, and to attain profitability and maintain positive cash flowfrom operations, in the time periods we anticipate, or at all, will depend on the commercial success of these products in the U.S. and other markets, which willdepend on, among other factors, obtaining timely regulatory approvals, without onerous restrictions or limitations in the resulting label, obtaining or maintainingfavorable pricing for and reimbursement of these products in the U.S. and in key countries outside the U.S., and the availability of financial assistance forindividuals who otherwise cannot afford our products. Commercial success also will depend on continued acceptance by the medical community and marketdemand and medical need for these products, including, in the case of lomitapide, in light of the availability of PCSK946inhibitor products, which has had a significant adverse impact on sales of lomitapide in the U.S. We expect that named patient sales in Brazil in the near-term willcontinue to be our largest source of revenues on a country-by-country basis outside the U.S.; however, we expect net product sales from named patient sales inBrazil and other countries to continue to fluctuate quarter-over-quarter significantly more than sales in the U.S. If metreleptin or lomitapide does not achieve ormaintain commercial success, our future operating results and financial condition may be materially adversely affected, and we may not achieve profitability.We may not be able to maintain or expand market acceptance for metreleptin and lomitapide in the U.S. or to gain market acceptance in markets outside theU.S. where we commercialize such products, and, for lomitapide, we may continue to see a significant number of patients who choose not to start or stay ontherapy.The commercial success of metreleptin and lomitapide will depend primarily upon our ability to maintain and expand the acceptance of these products by themedical community, including physicians and healthcare payers, and by the relevant patients in the U.S., and to gain and maintain such acceptance in countriesoutside the U.S. where such products are commercialized.Some physicians and congenital or acquired GL patients may determine that the benefits of metreleptin in treating complications of leptin deficiency in GL do notoutweigh the risks, including those risks set forth in the boxed warning for MYALEPT in the U.S., which warn of the risk of anti-metreleptin antibodies withneutralizing activity and the risk of lymphoma. Likewise, some physicians and homozygous familial hypercholesterolemia (HoFH) patients may determine that thebenefits of lomitapide in reducing low-density lipoprotein cholesterol (LDL-C) levels do not outweigh the risks, including those risks described in the boxedwarning for JUXTAPID in the U.S. and in the prescribing information for lomitapide in the other countries in which it is approved, which warn that lomitapide cancause hepatotoxicity.Because of the risk of hepatotoxicity, JUXTAPID is available in the U.S. only through a Risk Evaluation Management Strategy (REMS) program, referred to asthe JUXTAPID REMS program. Under the JUXTAPID REMS program, patients must receive education on the JUXTAPID REMS program requirements and wemust certify all qualified healthcare providers before they can prescribe JUXTAPID and the pharmacies that will dispense the medicine. The U.S. Food and DrugAdministration (FDA) assesses on a periodic basis whether a REMS program is meeting its goals and whether the goals or elements of the program should bemodified. In June 2015, Aegerion Pharmaceuticals, Inc. (Aegerion) received a letter from the FDA expressing concern that the JUXTAPID REMS program is notmeeting its goals of educating healthcare professionals about the risks of hepatotoxicity and the need to periodically conduct liver tests to monitor patients duringtreatment with JUXTAPID as set forth on the product label. The letter also expressed concern about the difficulty in assessing whether the goal of restricting accessto JUXTAPID to patients with a clinical or laboratory diagnosis consistent with HoFH was being met. In response to the FDA’s concerns, we proposed to the FDAmodifications to the JUXTAPID REMS program to improve prescriber awareness of the risk of hepatotoxicity associated with JUXTAPID and the need to monitorpatients during treatment, and to reinforce the approved indication and the characteristics of HoFH. On March 11, 2016, Aegerion received from the FDA anadditional letter describing certain modifications the FDA considered necessary to the labeling for JUXTAPID and to the JUXTAPID REMS program. In responseto the FDA’s proposed modifications to the labeling for JUXTAPID, on April 8, 2016, Aegerion submitted a prior approval labeling supplement to the FDAaddressing certain of the FDA’s proposed modifications, including an instruction that patients cease therapy upon the occurrence of severe diarrhea. The labelingchanges were approved by the FDA on May 23, 2016. Aegerion submitted a response to the FDA’s proposal regarding modifications to the JUXTAPID REMSprogram in a prior approval supplement on July 7, 2016. The FDA approved the modifications to the JUXTAPID REMS program on January 3, 2017. The goal ofthe JUXTAPID REMS program, as modified, is to mitigate the risk of hepatotoxicity associated with the use of JUXTAPID by ensuring that: a) prescribers areeducated about the approved indication for JUXTAPID, the risk of hepatotoxicity associated with the use of JUXTAPID, and the need to monitor patients duringtreatment with JUXTAPID as per product labeling; b) JUXTAPID is dispensed only to patients with a clinical or laboratory diagnosis consistent with homozygousfamilial hypercholesterolemia; and c) patients are informed about the risk of hepatotoxicity associated with the use of JUXTAPID and the need for baseline andperiodic monitoring. The FDA’s approval letter for the modified REMS Program also specified that an authorized generic drug under JUXTAPID’s New DrugApplication (NDA) must have an FDA-approved REMS program prior to marketing.The originally approved JUXTAPID REMS program consisted of Elements To Assure Safe Use (ETASU), an implementation system, a communication plan and atimetable for submission of assessments of the JUXTAPID REMS program. It also required healthcare professionals who prescribe JUXTAPID and pharmaciesthat dispense JUXTAPID to be certified, and that JUXTAPID must only be dispensed to patients with evidence or other documentation of safe-use conditions. TheETASU in the modified JUXTAPID REMS program approved by the FDA on January 3, 2017 has been significantly enhanced and requires, among other things,that healthcare professionals and pharmacies complete a recertification process, which includes, for healthcare professionals, required online training and learningassessments, by July 2, 2017 in order to continue prescribing and dispensing JUXTAPID; healthcare professionals counsel existing and new JUXTAPID patientson the goals of the JUXTAPID REMS program and, in connection therewith, imposes a new requirement that healthcare professionals and their patients sign aform acknowledging that this counseling has taken place and that the patient understands the goals of the JUXTAPID REMS program; and prescriptions47written to a JUXTAPID patient before the healthcare professional completes recertification and the counseling requirements with the patient, including thesubmission to the REMS coordinating center of an acknowledgment form signed by the healthcare professional and the patient, will not be honored after July 2,2017. The modified REMS program also requires that prescriptions written after July 2, 2017 must be written on an updated prescription authorization form andincludes changes to existing REMS documentation, along with additional required documentation, and new training modules for healthcare professionals andcertified pharmacies. The FDA required the modifications to the JUXTAPID REMS program to be implemented by March 2, 2017 and, as noted above, thathealthcare professionals and pharmacies complete the recertification process, and healthcare professionals and patients complete the counseling andacknowledgment processes, by July 2, 2017. We have completed the implementation of the modifications to the JUXTAPID REMS program, and we are in theprocess of educating healthcare professionals, pharmacies, and patients about the JUXTAPID REMS program requirements, including the requirements that mustbe met by July 2, 2017, and tracking achievement with respect to these requirements. However, we may lose JUXTAPID patients temporarily or permanently, oradd new adult HoFH patients at a slower than expected pace, as a result of the implementation of, and enhancements to, the modified JUXTAPID REMS program,as described above, for a variety of reasons, including: the inability to recertify healthcare professionals with existing patients or to certify healthcare professionalswho may want to put new patients on JUXTAPID, on a timely basis or at all; the failure of the healthcare professionals and patients, existing or new, to meet thepatient counseling requirements and sign and submit the patient acknowledgment form, as required, on a timely basis or at all; the failure of prescriptions forJUXTAPID to meet all of the requirements of the modified JUXTAPID REMS program on or after July 2, 2017 and therefore not being honored by the certifiedpharmacies after such date, as required under the modified JUXTAPID REMS program, and any payer issues or delays that arise out of new prescriptions beingwritten for patients under the modified JUXTAPID REMS program; and that the enhanced education of the goals of the JUXTAPID REMS program, and relateddocumentation, may cause healthcare professionals to stop or delay treatment with JUXTAPID, or try alternative therapies for adult HoFH patients before startingor continuing JUXTAPID treatment. The ongoing investigations of the Securities and Exchange Commission (SEC) and the Department of Justice (DOJ),including the consent decree that Aegerion will enter into with FDA related to JUXTAPID REMS program as part of the settlement of these investigations, mayalso have an effect on the FDA’s requirements for the JUXTAPID REMS program.In addition, we have adopted risk management plans in other countries where we have obtained approval of lomitapide to help educate physicians on the safetyinformation for lomitapide and appropriate precautions to be followed by healthcare professionals and patients. Other countries that may approve metreleptin orlomitapide may require risk management plans that may be similar to or more onerous than those we have adopted to date. The prescribing information for eachproduct also describes a number of additional contraindications, warnings, and precautions, including those related to pregnancy and potential adverse interactionswith other drugs, and other potential adverse reactions, that could limit the market acceptance of metreleptin and lomitapide. These contraindications, warnings,and precautions make it more difficult for some patients to decide to begin therapy or to stay on therapy. GI adverse reactions, which are common with lomitapideand the risk of which can be reduced only by adherence to a low-fat diet, and elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) alsolead to treatment discontinuation in a significant percentage of lomitapide patients. With respect to metreleptin, concerns related to the route of administration ofmetreleptin, as a daily injection, may deter some patients from beginning therapy or staying on therapy. As a result, even if a physician prescribes one of ourproducts, the prescription may not result in a patient beginning therapy or staying on therapy. The degree of market acceptance of our products will also depend ona number of other factors, including:•physicians’ views as to the scope of the approved indication and limitations on use and warnings and precautions contained in the approved labeling orprescribing information for our products, including the boxed warnings on the MYALEPT and JUXTAPID labels and the modifications to theJUXTAPID label to include language instructing patients to cease therapy upon the occurrence of severe diarrhea;•the willingness of insurance companies, managed care organizations, other private payers, and government entities in the U.S. that provide reimbursementfor medical costs to continue to provide reimbursement for MYALEPT and JUXTAPID at the price at which we offer them and without imposingrestrictions on the use of the product, such as, for MYALEPT, leptin level tests, which delay or otherwise impact reimbursement;•the ability and willingness of GL and HoFH patients to pay, or to arrange for payment assistance with respect to, any patient cost-sharing amounts forMYALEPT applicable under their insurance coverage, and the availability of co-pay assistance;•the extent to which the changes to the JUXTAPID REMS program, approved by the FDA on January 3, 2017, including the requirements set forth above,may negatively affect the ability or willingness of a physician to prescribe JUXTAPID, a patient to be willing to initiate or continue on JUXTAPIDtherapy, or insurance companies, managed care organizations, other private payers, and government entities that provide reimbursement for medical coststo continue to provide reimbursement for JUXTAPID;48•the extent to which changes to the labeling for JUXTAPID instructing patients to cease therapy upon the occurrence of severe diarrhea may negativelyaffect the ability or willingness of a physician to prescribe JUXTAPID, a patient to be willing to initiate or continue on JUXTAPID therapy, or insurancecompanies, managed care organizations, other private payers, and government entities that provide reimbursement for medical costs to continue toprovide reimbursement for JUXTAPID;•the efficacy, safety and tolerability of competitive therapies, including, in the case of lomitapide, PCSK9 inhibitor products;•the extent of the negative impact of the availability of PCSK9 inhibitor products on sales of JUXTAPID in the U.S., which has caused a significantnumber of JUXTAPID patients to discontinue JUXTAPID and switch to a PCSK9 inhibitor product, and has significantly decreased the rate at which newHoFH patients start treatment with JUXTAPID;•the provision of free PCSK9 inhibitor drug to adult HoFH patients by the companies that are commercializing PCSK9 inhibitor products, which suchcompanies may have ceased, but which historically has had a negative impact on the rate at which new patients start treatment with lomitapide and hascaused more patients than we expected to discontinue lomitapide and switch their treatment to PCSK9 inhibitor products;•pricing and the perception of physicians and payers as to cost effectiveness of our products in relation to other therapies that treat GL and HoFH,respectively, including therapies with a price substantially lower than that of our products, which, in the case of lomitapide, includes PCSK9 inhibitorproducts and apheresis; and•the effectiveness of our sales, marketing and distribution strategies and our ability to achieve these strategies, particularly in light of our conversion froma full-time employee sales force to the use of primarily a contract sales force in the U.S. in early 2017, the use of a contract sales force in Japan, and thecontinuing challenges to the lomitapide business, including, among other things, the impact of competitive products on JUXTAPID sales.If we are not able to achieve a high degree of market acceptance of metreleptin in the treatment of GL and lomitapide in the treatment of adult patients with HoFH,we may not be able to achieve our revenue goals or other financial goals or to achieve profitability or to maintain cash-flow positive operations in the time periodswe expect, or at all.If we fail to obtain or maintain orphan drug exclusivity for our products or product candidate in any country where exclusivity is available, we will have to relyon our data and marketing exclusivity, if any, and on our intellectual property rights, to the extent there is coverage in such country, which may reduce thelength of time that we can prevent competitors from selling generic versions of our products or product candidate.We have obtained orphan drug exclusivity for JUXTAPID in the U.S. for the treatment of HoFH, for MYALEPT in the U.S. for the treatment of GL, and forzuretinol in the U.S. for the treatment of LCA (due to inherited mutations in the LRAT or RPE65 genes) and RP (all mutations), which the FDA has formallyacknowledged also cover zuretinol for the treatment of IRD, including SECORD, which disease/condition we believe comprises both LCA (due to inheritedmutations in the LRAT or RPE65) genes and RP. Since the extent and scope of our patent protection for zuretinol is limited, orphan drug designation is especiallyimportant for this product candidate.Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug or biological product intended to treat a rare disease or condition, which isgenerally a disease or condition that affects fewer than 200,000 individuals in the U.S., or for which there is no reasonable expectation that development andproduction costs will be recovered from sales of the drug for such disease or condition in the U.S. Orphan drug designation must be requested before submitting anNDA or Biologics License Application (BLA). After the FDA grants orphan drug designation, the identity of the therapeutic agent and its potential orphan use aredisclosed publicly by the FDA. If a product that has orphan drug designation subsequently receives FDA approval and is the first drug approved for the disease forwhich it has such designation, the product is entitled to orphan product exclusivity, which means that the FDA may not approve for seven years any otherapplications to market the same drug for the same indication, except in limited circumstances such as a demonstration that the subsequent drug is clinicallysuperior or the inability of the existing manufacturer to supply the market. Orphan drug exclusivity also could block the approval of one of our products for sevenyears if a competitor obtains approval for an orphan product that the FDA finds to be the “same drug” as our product candidate for the same indication or disease.If a drug or biologic designated as an orphan drug receives marketing approval for an indication broader than the scope of its designation, it may be no longerentitled to orphan drug exclusivity. In addition to creating a 12-year period of reference product exclusivity, the Biologics Price Competition and Innovation Act(BPCI Act) clarifies the interaction of that exclusivity with orphan drug exclusivity, such that the licensure of a biosimilar or interchangeable version of a referencebiological product that was designated and approved as an orphan drug may only occur after the later of the expiration of any applicable seven-year orphan drugexclusivity or the 12-year reference product exclusivity (or seven and one-half years and 12.5 years with pediatric exclusivity).49The BPCI Act, enacted in 2010, as part of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (theHealth Care Reform Act), authorizes the FDA to license a biological product that is biosimilar to, and possibly interchangeable with, a Public Health Service Act(PHSA)-licensed reference biological product through an abbreviated pathway. The BPCI Act establishes criteria for determining that a product is biosimilar to analready-licensed biologic (a reference product), and establishes a process by which an abbreviated BLA for a biosimilar product is submitted, reviewed andapproved. The BPCI Act provides periods of exclusivity that protect a reference product from biosimilar competition. Under the BPCI Act, innovatormanufacturers of original reference products are granted twelve years of exclusive use before biosimilar versions of such products can be licensed for marketing inthe U.S. This means that the FDA may not approve an application for a biosimilar version of a reference product until twelve years after the date of approval of thereference product (with a potential six-month extension of exclusivity if certain pediatric studies are conducted and the results of such studies are reported to FDA),although a biosimilar application may be submitted four years after the date of licensure of the reference product. Additionally, the BPCI Act establishesprocedures by which the biosimilar applicant must provide information about its application and product to the reference product sponsor, and by whichinformation about potentially relevant patents is shared and litigation over patents may proceed in advance of approval. The BPCI Act also provides a period ofexclusivity for the first biosimilar to be determined by the FDA to be interchangeable with the reference product. Under the BPCI Act, metreleptin has twelve yearsof exclusivity in the U.S. from February 24, 2014, the date of the product’s approval by the FDA.The European Medicines Agency (EMA) grants orphan designation to promote the development of products that treat life-threatening or chronically debilitatingconditions affecting not more than five in 10,000 people in the European Union (EU). In addition, orphan drug designation can be granted only if, for economicreasons, the medicinal product would be unlikely to be developed without incentives and if there is no other satisfactory method approved in the EU of diagnosing,preventing, or treating the condition, or if such a method exists, the proposed medicinal product must potentially be of significant benefit to patients affected by thecondition. The application for orphan designation must be granted by the European Commission (EC) before an application for marketing authorization of themedicinal product is submitted. Upon grant of marketing authorization for the medicinal products, orphan designation provides ten years of market exclusivity forthe orphan medicinal product in the orphan indication. During this ten-year period, with a limited number of exceptions, the competent authorities of the EUMember States and the EMA may not accept applications for marketing authorization, accept an application to extend an existing marketing authorization or grantmarketing authorization for other similar medicinal products for the same orphan indication. Under an exception, marketing authorization could be granted to asimilar medicinal product with the same orphan indication before the expiry of the ten years if the holder of the marketing authorization for the original orphanmedicinal product has given its consent or if the manufacturer of the original orphan medicinal product is unable to supply sufficient quantities. Marketingauthorization may also be granted to a similar medicinal product with the same orphan indication if this product is safer, more effective or otherwise clinicallysuperior to the original orphan medicinal product. Moreover, the exclusivity period for the original orphan medicinal product may be reduced to six years if thedesignation criteria are no longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity.Despite the prevalence rate, lomitapide does not have orphan medicinal product exclusivity in the EU for the treatment of HoFH because the EMA views therelevant condition, for orphan drug purposes, to include both HoFH and HeFH. In 2012, metreleptin was granted orphan designation by the EC for the treatment ofBarraquer-Simons syndrome (acquired partial lipodystrophy (PL)), Berardinelli-Seip syndrome (congenital GL), Lawrence syndrome (acquired GL) and familialPL. Zuretinol was granted orphan designation by the EMA in 2011 for the treatment of LCA and RP (all mutations) and in 2014, the EMA also formallyacknowledged that a therapeutic indication of zuretinol for the treatment of patients with IRD, who have been phenotypically diagnosed as LCA or RP caused bymutations in RPE65 or LRAT genes, would fall under the orphan drug designations of treatment of LCA and treatment of RP. We also plan to seek regulatoryexclusivity for zuretinol in the EU; however, there can be no assurance that we will be successful in securing approval or regulatory exclusivity in the EU.Orphan drug exclusive marketing rights in the U.S. may also be lost if the FDA later determines that the request for designation was materially defective or if themanufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition. Our failure to obtain or maintainorphan drug exclusivity would require us to rely on our data and marketing exclusivity, if any, and on our intellectual property rights for our products and productcandidate, which may reduce the length of time that we can prevent competitors from selling generic versions of our products or product candidate. For furtherinformation, see “Risks Related to Our Intellectual Property.” If we do not obtain data exclusivity for our products or product candidate, our business may bematerially harmed.In Japan, where we launched JUXTAPID in December 2016, we have received orphan drug designation for JUXTAPID in the treatment of HoFH from Japan’sregulatory authority, the MHLW. We also have other forms of regulatory exclusivity for our products and product candidate in certain other markets. However,there are many other countries, including some key markets for lomitapide, like Brazil, in which we do not have intellectual property coverage for our products orproduct candidate, and where neither orphan drug exclusivity nor data and marketing exclusivity is available.50Even if we obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs can beapproved for the same condition. In the U.S., even after an orphan drug is approved, the FDA can subsequently approve the same drug for the same condition if theFDA concludes that the later drug is safer, more effective or makes a major contribution to patient care, which could materially adversely affect our financialcondition.The number of patients affected by the diseases for which our products are approved, or for which we may seek approval, is small, and has not beenestablished with precision. Our assumptions and estimates regarding prevalence may be wrong. If the actual number of patients is smaller than we estimate orif any approval is based on a narrower definition of these patient populations, our revenue and ability to achieve profitability and to maintain cash-flowpositive operations from our product businesses will be adversely affected, possibly materially.There is no patient registry or other method of establishing with precision the actual number of HoFH or GL and PL patients with the diseases our products treat inany geography. There is significant uncertainty around the estimated total potential addressable patient population for treatment with zuretinol worldwide.Medical literature has historically reported the prevalence rate of HoFH as one person in a million, based on an estimated prevalence rate for HeFH of one personin 500. Analysis of HoFH prevalence have been evolving in recent years cumulating in published medical literature that suggests that the actual prevalence of bothHeFH and HoFH may be significantly higher than the historical estimate of one person in a million. For example, in 2014, the European Atherosclerosis Society(EAS) Consensus Panel on Familial Hypercholesterolemia (FH) published an article citing research that would result in an estimate of the prevalence of HoFH inthe range of between one person in 300,000 and one person in 160,000 or 3.33 persons per million to 6.25 persons per million, which is consistent with estimatesthat can be derived from other publications from the last few years. The FDA cited this estimate in its review of PCSK9 inhibitor products in June 2015. There isno guarantee that the prevalence of HoFH is higher than the current medical literature suggests or is even higher than reported in the historical literature. Thenumber of patients with HoFH could actually be significantly lower than we expect. Ultimately the actual size of the total addressable HoFH market in the U.S.will be determined only after we and others have substantial commercial history selling products for the treatment of HoFH.We believe that the prevalence rate of HoFH in countries outside the U.S. is likely to be consistent with the prevalence rate in the U.S.; however, we expect thatour net product sales in countries outside the U.S. are likely to be lower than in the U.S. given significant economic pressures to reduce healthcare costs in certainex-U.S. countries, resulting in pricing controls, reimbursement restrictions and caps on patients treated and/or drug expenditures, the more widespread availabilityof apheresis, in certain countries, like Japan, and the possibility that genotyping may be required in some countries, reducing the number of patients diagnosed withHoFH.The data to date suggest that the approximate prevalence of GL in the U.S. is slightly under 1 in 1,000,000 persons and for PL overall is 3 in 1,000,000 persons.Although the data are even more limited, the prevalence in the U.S. of a subset of more severe PL is estimated to be between 0.5 and 1 in 1,000,000 persons. Webelieve that the prevalence rate of GL and PL, and correspondingly the PL subset, in countries outside the U.S. is likely to be consistent with the prevalence rate inthe U.S. There is no guarantee, however, that our estimates are correct. The actual prevalence of GL, PL and the PL subset may be significantly lower than weexpect. Ultimately, the actual size of the total addressable market in the U.S. and other key markets where metreleptin is sold, if approved, will be determined onlyafter we have substantial commercial history selling metreleptin.Current epidemiological estimates based on medical literature suggest that approximately 2.5% of the autosomal recessive RP subjects and 6-10% of all LCAsubjects possess mutations in the RPE65 gene, while approximately 1% of RP and LCA subjects have mutations in the LRAT gene. LCA is estimated to affectapproximately one in 81,000 newborns worldwide, while the overall RP prevalence is estimated at one in 4,000 newborns worldwide. Based on our current marketresearch, we estimate the total potential addressable LCA patient population for zuretinol at 1,000 to 2,000 patients worldwide and the total potential addressableRP patient population at 2,000 to 4,000 patients worldwide. Our most recent epidemiological data estimate the prevalence of IRD subjects with RPE65 or LRATmutations at 4,100 patients in the U.S. and the five major European markets, a portion of whom have the late stage of the disease and may not benefit fromzuretinol therapy. While geographic differences in the gene pool may cause fluctuations, the prevalence of LCA, RP, and LRAT and RPE65 mutation distributionin other countries are believed to be comparable with the U.S. and five major European markets based on current medical literature. However, there is noguarantee these current estimates are correct, and the analysis of the prevalence in IRD remains ongoing in the medical literature.Estimating the prevalence of a rare disease is difficult and may rely on an amalgam of information from multiple sources, resulting in potential under- or over-reporting. There is no guarantee that our assumptions and beliefs are correct, or that the methodologies used have generated accurate estimates. Medical literaturehas historically estimated the prevalence of the diseases our products treat to be significantly lower than our estimates. The actual prevalence of these diseases maybe significantly lower than we expect. Ultimately, the actual size of the total addressable market will be determined only after we have substantial commercial51history selling the relevant product. If the total addressable market for our products and product candidate, if eventually approved and commercialized, in the U.S.and other key markets is smaller than we expect, then it may be more difficult for us to achieve our revenue goals and estimates and to attain profitability and meetour expectations with respect to cash flow operations.Our market is subject to intense competition. If we are unable to compete effectively, we may not be able to achieve our revenue goals or achieve profitabilityor maintain cash-flow positive operations in the time periods we expect, or at all, and lomitapide, metreleptin or any other product candidate that we develop oracquire may be rendered noncompetitive or obsolete.Our industry is highly competitive and subject to rapid and significant technological change. Our potential competitors include large pharmaceutical andbiotechnology companies, specialty pharmaceutical and generic drug companies, academic institutions, government agencies and research institutions. All of thesecompetitors currently engage in, have engaged in or may engage in the future in the development, manufacturing, marketing and commercialization of newpharmaceuticals, some of which may compete with lomitapide, metreleptin, zuretinol or other products or product candidates we may acquire, license or develop.Smaller or early stage companies may also be significant competitors, particularly through collaborative arrangements with large, established companies. Keycompetitive factors affecting the commercial success of lomitapide, metreleptin and any other products that we develop or acquire are likely to be efficacy, safetyand tolerability profile, reliability, convenience of dosing, price and reimbursement.The market for cholesterol-lowering therapeutics is large and competitive with many drug classes. Lomitapide is approved in the U.S., Japan, the EU and in certainother countries as an adjunct to a low-fat diet and other lipid-lowering treatments to reduce LDL-C in adult HoFH patients. As a treatment for HoFH, JUXTAPIDcompetes in the U.S. and certain other countries with Kynamro. Developed by Ionis Pharmaceuticals, Inc. (Ionis) and acquired by Ionis and Kastle Therapeutics inMay 2016, Kynamro is an antisense apolipoprotein B-100 inhibitor which is taken as a weekly subcutaneous injection. JUXTAPID also faces significantcompetition in the treatment of adult HoFH patients with a class of drugs known as PCSK9 inhibitors. In July 2015, Regeneron Pharmaceuticals, Inc. (Regeneron)and Sanofi announced that the FDA had approved the BLA for their PCSK9 inhibitor candidate, alirocumab, for use in addition to diet and maximally toleratedstatin therapy in adult HeFH patients and in patients with clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-C. In September2015, following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the EMA, the EC approved alirocumab for the treatmentof adult patients with HeFH or mixed dyslipidemia as an adjunct to diet, either in combination with a statin, or statin with other lipid-lowering therapies in patientsunable to reach their LDL-C goals with the maximally-tolerated statin, or alone or in combination with other lipid-lowering therapies for patients who are statinintolerant, or for whom a statin is contraindicated. The FDA approved Amgen Inc.’s (Amgen) BLA for its anti-PCSK9 antibody, evolocumab, in August 2015, asan adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic cardiovascular disease, who requireadditional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with HoFH, who require additionallowering of LDL-C. In July 2015, the EC Commission approved the marketing authorization of evolocumab for the same indication as alirocumab, and for thetreatment for certain patients with high cholesterol, including patients aged 12 years and over with HoFH in combination with other lipid-lowering therapies. InJanuary 2016, the MHLW approved evolocumab for the treatment of patients with FH or hypercholesterolemia who have high risk of cardiovascular events and donot adequately respond to statins, and in July 2016 the MHLW approved alirocumab for the same indication. Health Canada and Brazil’s National HealthSurveillance Agency (ANVISA) have approved evolocumab for the treatment of patients with HoFH. Other companies, including Roche Holding AG and AlnylamPharmaceuticals, Inc., in collaboration with The Medicines Company, are also developing PCSK9 inhibitor products.The introduction of PCSK9 inhibitors in the U.S. has negatively impacted sales of JUXTAPID and we expect this negative trend to continue. This impact resultsfrom several factors, including: healthcare professionals switching some existing JUXTAPID patients to a PCSK9 inhibitor product; healthcare professionals tryingmost new adult HoFH patients on a PCSK9 inhibitor product before trying JUXTAPID; the provision of free PCSK9 drug to adult HoFH patients by the companiesthat are commercializing PCSK9 inhibitor products, which such companies may have ceased, but which historically has had a negative impact on the rate at whichnew patients start treatment on JUXTAPID and has caused more patients than we expected to discontinue JUXTAPID and switch their treatment to PCSK9inhibitor products; and actions by insurance companies, managed care organizations and other private payers in the U.S. that have required, or may require in thefuture, HoFH patients to demonstrate an inability to achieve an adequate LDL-C response on PCSK9 inhibitor products before access to JUXTAPID is approved,or may impose other hurdles to access or other significant restrictions or limitations on reimbursement, or may require switching of JUXTAPID patients to PCSK9inhibitor products. Many U.S. insurance companies, managed care organizations and other private payers now require that HoFH patients fail to achieve anadequate response in LDL-C reduction on PCSK9 inhibitor products before providing reimbursement for JUXTAPID. For patients currently taking JUXTAPID,we believe that all U.S. payers require prior authorization, which may influence a switch of the current JUXTAPID patients to the less expensive PCSK9 inhibitorproduct. We believe that many of the PCSK9 inhibitor switches from current JUXTAPID patients have been at the direction of the prescribing physician.Ultimately, the physician may decide to switch the adult HoFH patient back to JUXTAPID, if the patient does not reach a goal of52LDL-C response while being treated with a PCSK9 inhibitor product. It is unknown how many adult HoFH patients, if any, may be switched back to JUXTAPIDor the period of time in which this would take place. We expect physicians will continue to consider use of JUXTAPID for those adult HoFH patients who do notadequately respond to PCSK9 inhibitor products. Additionally, we expect that the availability of PCSK9 inhibitor products in commercial markets outside of theU.S. will have similarly negative effects on sales, including named patient sales, of lomitapide outside the U.S., particularly in Brazil, Canada and Japan, wherePCSK9 inhibitor products have been approved by the regulatory authorities. If the continued negative impact of PCSK9 inhibitors is greater than we expect, it maymake it more difficult for us to generate revenues and achieve profitability. Also, although there are no other microsomal triglyceride transfer protein (MTP)inhibitor (MTP-I) compounds currently approved by the FDA for the treatment of hyperlipidemia in humans, there may be other MTP-I compounds indevelopment.In addition, in the EU, patients with HoFH who are unable to reach their recommended target LDL-C levels on conventionally used drug therapies are commonlytreated using LDL apheresis, in which cholesterol is removed from the body through mechanical filtration. Although levels of LDL-C are reduced acutely usingapheresis, there is a rapid rebound. Because apheresis provides only temporary reductions in LDL-C levels, it must be repeated frequently, typically one or twotimes per month. The widespread use and availability of apheresis as a treatment for HoFH in the EU, combined with the lower cost of apheresis as compared toLOJUXTA (lomitapide) hard capsules (LOJUXTA), made it more difficult for us to obtain commercially acceptable pricing and reimbursement approvals forLOJUXTA in the key markets of the EU. As a result of this, and in an effort to reduce costs associated with EMA post-marketing requirements, Aegerion electedto cease commercialization in the EU, and in December 2016, entered into a license agreement with Amryt Pharma plc (Amryt) under which Amryt was granted anexclusive right to develop and commercialize LOJUXTA in the European Economic Area, Switzerland, Turkey, and certain Middle Eastern and North Africancountries, including Israel.MYALEPT is the first and only product approved in the U.S. for the treatment of complications of leptin deficiency in patients with GL. There are, however, anumber of therapies approved to treat these complications independently that are not specific to GL. Certain clinical complications of GL, including diabetes andhypertriglyceridemia, may be treated with insulin and/or oral medications, such as metformin, insulin secretagogues, fibrates, or statins. Patients with GL oftenhave an inadequate response to these therapies.We may also face future competition from companies selling generic alternatives of our products in countries where we do not have patent coverage, orphan drugstatus or another form of data or marketing exclusivity or where patent coverage or data or marketing exclusivity has expired, is not enforced, or may, in the future,be challenged.Many of our current and potential competitors have substantially greater financial, technical and human resources than we do, and significantly greater experiencein the discovery and development of drug candidates, obtaining FDA and other regulatory approvals of products and the commercialization of those products.Accordingly, our competitors may be more successful than we may be in obtaining marketing approvals for drugs and achieving and maintaining widespreadmarket acceptance.Our competitors’ drugs may be more effective, or more effectively marketed and sold, than any drug we may commercialize, and may render lomitapide,metreleptin, zuretinol or any other product or product candidate that we acquire, license or develop obsolete or non-competitive before we can recover the expensesof developing and commercializing the product. We anticipate that we will face intense and increasing competition as new drugs enter the market and advancedtechnologies become available. Finally, the development of new treatment methods for the diseases we are targeting could render lomitapide, metreleptin, zuretinolor any other product or product candidate that we acquire, license or develop non-competitive or obsolete.As a result of the side effects observed in the clinical and preclinical studies for each of lomitapide and metreleptin, the prescribing information for each oflomitapide and metreleptin contains or is expected to contain significant limitations on use and other important warnings and precautions, including boxedwarnings in the U.S. labeling. Our products may continue to cause such side effects or have other properties that could impact market acceptance and dropoutrates, result in adverse limitations in any approved labeling or other adverse regulatory consequences, including delaying or preventing additional marketingapproval in territories outside the U.S., EU and other countries where lomitapide is approved, or in the case of metreleptin, marketing approval outside theU.S.The MYALEPT label in the U.S. has a boxed warning, citing the risk of anti-metreleptin antibodies with neutralizing activity and risk of lymphoma. Theprescribing information for lomitapide in the U.S. and the EU and in the other countries in which lomitapide is approved contains significant limitations on use andother important warnings and precautions, including a boxed warning in the JUXTAPID labeling, and warnings in the LOJUXTA prescribing information citingconcerns over liver toxicity associated with use of lomitapide.53The most common adverse reactions in a Phase 3 study of lomitapide were gastrointestinal, reported by 27 (93%) of 29 patients. Adverse reactions, reported bygreater than or equal to 8 patients (28%) in the HoFH clinical trial, included diarrhea, nausea, vomiting, dyspepsia and abdominal pain. Other common adversereactions, reported by five to seven (17-24%) patients, included weight loss, abdominal discomfort, abdominal distension, constipation, flatulence, increased ALT,chest pain, influenza, nasopharyngitis, and fatigue. Elevations in liver enzymes and hepatic (liver) fat were also observed. Ten of the 29 patients in the study had atleast one elevation in liver enzymes greater than or equal to three times the upper limit of normal (ULN), including four patients who experienced liver enzymesgreater than or equal to five times the ULN. During the clinical trial, liver enzyme elevations were managed through dose reduction or temporary discontinuationof dose. There were no clinically meaningful elevations of total bilirubin, international normalized ratio (INR) or alkaline phosphatase, which are other markers ofpotential harmful effects on the liver. Hepatic fat increased from a baseline of 1% to a median absolute increase of 6% at 26 and 78 weeks.In a Phase 3 study of metreleptin, the most common adverse drug reactions occurring in GL patients were weight decrease (reported by fifteen patients; 22.7%) andhypoglycemia (reported by eight patients; 12.1%), followed by decreased appetite, fatigue and neutralizing antibodies (each reported by four patients; 6.1%). Themost common adverse drug reactions (ADRs) occurring in PL subgroup patients were hypoglycemia and fatigue (each reported by three patients; 9.7%), followedby alopecia (reported by two patients; 6.5%). Over the 14-year study duration, treatment-emergent deaths were reported in 4 (4%) of the 107 patients; treatment-emergent adverse events (TEAEs) leading to death were consistent with the underlying morbidity of lipodystrophy (LD) and included renal failure, cardiac arrest(with pancreatitis and septic shock), progressive end-stage liver disease (chronic hepatic failure), and hypoxic-ischemic encephalopathy. None of the deaths wereassessed as drug-related.The safety and efficacy of metreleptin for the treatment of metabolic disorders associated with LD syndromes in pediatric and adult patients were evaluated in along-term, open-label, single-arm study conducted at the National Institutes of Health (the NIH). The objective of the NIH trial was to evaluate the efficacy ofmetreleptin for improving metabolic disorders associated with acquired or inherited lipodystrophy. This investigator-sponsored study was initiated in August 2000.Two cases of peripheral T-cell lymphoma and one case of a localized anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (a type of T-celllymphoma) were reported, all in patients with acquired GL. Lymphoma is known to be associated with autoimmune disease. As the boxed warning for MYALEPTstates, T-cell lymphoma has been reported in patients with acquired GL, both treated and not treated with MYALEPT. There was evidence of pre-existinglymphoma and/or bone marrow/hematologic abnormalities in the two patients with peripheral T-cell lymphoma before metreleptin therapy, and the third case ofanaplastic large cell lymphoma occurred in the context of a specific chromosomal translocation.As part of our post-marketing commitment to the FDA and Health Canada for lomitapide, we have initiated an observational cohort study to generate more data onthe long-term safety profile of lomitapide, the patterns of use and compliance and the long-term effectiveness of controlling LDL-C levels. As part of the post-marketing commitments to the FDA for metreleptin, we plan to initiate a long-term, prospective, observational study (product exposure registry) in patients toevaluate serious risks related to the use of the product. We have completed the first, and have begun the second, of three sequential programs to expand theunderstanding of the immunogenicity of metreleptin, and we have initiated certain studies related to the manufacturing of metreleptin. A failure to meet post-marketing commitments to the FDA or other regulatory authorities could impact our ability to continue to market lomitapide or metreleptin, respectively, incountries where we are unable to meet such commitments.In addition, as part of our observational cohort studies or in the conduct of additional clinical studies or in post-marketing surveillance of our products, we or othersmay identify additional safety information on known side effects or new undesirable side effects caused by our products, or the data may raise other issues withrespect to our products, and, in that event, a number of potentially significant negative consequences could result, including:•we may experience a negative impact on market acceptance and dropout rates;•regulatory authorities may suspend, withdraw or alter their approval of the relevant product;•regulatory authorities may require the addition of labeling statements, such as warnings or contraindications or distribution and use restrictions, such as,for example, the modifications to the JUXTAPID label to include language instructing patients to cease therapy upon the occurrence of severe diarrhea;•regulatory authorities may require us to issue specific communications to healthcare professionals, such as “Dear Doctor” letters;•regulatory authorities may issue negative publicity regarding the relevant product, including safety communications;•we may be required to change the way the relevant product is administered, conduct additional preclinical studies or clinical trials or restrict thedistribution or use of the relevant product;•we could be sued and held liable for harm caused to patients;54•the regulatory authorities may require us to amend the relevant REMS or risk management plan; and•our reputation may suffer.As part of the development of the commercial manufacturing process of lomitapide, we tightened specifications for lomitapide drug substance such that thecommercial drug substance differs from the material used in our Phase 3 trial in certain physical parameters and specifications that we assessed not to be clinicallymeaningful. Exposure measurements collected in the Japanese pharmacokinetic and pharmacodynamic (PK/PD) study using material meeting current commercialspecifications, however, do not align with certain earlier data generated under different circumstances using pre-commercial materials. Importantly, there was noevidence of a relationship between increases in dose or exposure and elevations in ALT or AST levels in the PK/PD study. While we do not expect the differencesbetween our commercial material and our clinical material to have adverse efficacy or safety consequences, there is a risk that we may see unexpected differencesin the type or severity of side effects with the commercial product from those observed in our Phase 3 trial. There is also the risk that regulatory authorities may notagree with our assessment of the differences between the materials or the potential impact of such differences or may require changes in the prescribinginformation.Any known safety concerns for our products and product candidate or any unknown safety issues that may develop could prevent us from achieving or maintainingmarket acceptance of the respective product or product candidate, could affect our ability to obtain or retain marketing approval of the respective product orproduct candidate in one or more countries, or result in onerous restrictions on such approval, or could affect our ability to achieve our financial goals.If we are unable to establish and maintain effective sales, marketing and distribution capabilities, or to enter into agreements with third parties to do so, we willbe unable to successfully commercialize our products or product candidates.We are selling JUXTAPID and MYALEPT in the U.S., in part, by using a contract sales force, and are also selling JUXTAPID in Japan using a contract salesforce. We are marketing and selling, or plan to market and sell, lomitapide directly, using our own marketing and sales resources, in certain key countries outsidethe U.S. in which lomitapide is, or may be, approved, or where we can make lomitapide available on a named patient sales basis, in either case where it makesbusiness sense to do so. We also plan to market and sell metreleptin directly in key countries outside of the U.S., if approved in such countries. We use, and plan touse, third parties to provide warehousing, shipping, third-party logistics, invoicing, collections and other distribution services on our behalf in the U.S. and in othercountries throughout the world. For example, we currently have a contract with a single specialty pharmacy distributor in the U.S. for the distribution oflomitapide, a single specialty pharmacy distributor in the U.S. for the distribution of metreleptin, a single distributor in Brazil, and single distributors, importersand/or specialty pharmacies in certain other countries. We have entered into, or may selectively seek to establish, distribution and similar forms of arrangements toreach patients in certain geographies that we do not believe we can cost-effectively address with our own sales and marketing capabilities. If we are unable toestablish and maintain the capabilities to sell, market and distribute our products, either through our own capabilities or through arrangements with third parties,and to effectively manage those third parties when we choose to use them, or if we are unable to enter into distribution agreements in those countries that we do notbelieve we can cost-effectively address with our own sales and marketing capabilities, we may not be able to successfully sell our products. We cannot guaranteethat we will be able to establish and maintain our own capabilities or to enter into and maintain favorable distribution agreements with third-parties on acceptableterms, if at all.To the extent that we enter into arrangements with third parties to perform sales, marketing or distribution services, our product revenues or the profitability ofthese product revenues to us are likely to be lower than if we were to commercialize our products ourselves. We likely will have limited control over such thirdparties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively, and may also, despite our compliancediligence reviews, audits and training, engage in non-compliant activities that, directly or indirectly, impact the use or sales of our products or damage ourrelationships with relevant stakeholders. Any performance failure, inability or refusal to perform on the part of our specialty pharmacy distributors in the U.S., ourthird-party sales forces in the U.S. or Japan, our distributor in Brazil, or our third-party service providers in certain other countries, or any failure to renew existingagreements or enter into new agreements when these relationships expire, could, for a period of time, impair our marketing, sales or named patient supply of ourproducts. Furthermore, even following Aegerion’s 2016 reductions in force, which were intended to align overall company expenses with top-line revenues, inlight of decreasing lomitapide revenues, our expenses associated with building up and maintaining the sales force and distribution capabilities around the worldmay be substantial compared to the revenues we may be able to generate on sales of our products. If we are unable to establish and effectively maintain adequatesales, marketing and distribution capabilities, whether independently or with third parties, particularly as we continue to assess our cost structure in light ofdeclining revenues of JUXTAPID in the U.S., we may not be able to generate product revenue consistent with our expectations and may not become profitable ormaintain cash flow positive operations.55Our success is dependent upon obtaining regulatory approval for our products and product candidates. The regulatory approval process is costly and lengthy,and we may not receive the regulatory approvals we seek for commercialization and reimbursement of our products and product candidates.We are currently permitted to market lomitapide in only a small number of countries on a commercial basis, and to market metreleptin in the U.S. Shionogi holds amarketing authorization for metreleptin in Japan under a distribution agreement assigned to us as part of the our acquisition of the metreleptin assets. There is noassurance that we will be able to obtain marketing authorizations for either product in additional countries, or any marketing authorization for zuretinol. To obtainmarketing approvals, we must establish, and comply with, numerous and varying regulatory requirements regarding safety and efficacy and governing, amongother things, clinical trials, pricing, promotion and distribution of the respective product. Approval procedures vary among countries, and can involve additionalproduct testing and additional administrative review periods. Marketing approval in one country does not ensure such approval in another.Regulatory authorities in countries where we seek approval for our products may not be satisfied with the design, size, endpoints or efficacy and safety results ofthe pivotal trial of the product, or the risk/benefit profile of the product, and may reject our applications for approval. For example, we filed to register JUXTAPIDas a marketed product in Brazil, and, in May 2014, appealed a rejection of the registration by ANVISA. We subsequently withdrew our appeal, and while weintend to resubmit our marketing application with additional data and information, we are currently assessing the timing of this submission. Even if we do resubmitour application, as we intend to do, we may not be successful in receiving regulatory approval to market JUXTAPID in Brazil. It is also possible that regulatoryauthorities in countries where we are seeking, or may in the future seek, approval may disagree with our assessment that certain changes made to lomitapide’sphysical parameters and specifications as compared to the material used in the pivotal trial are not clinically meaningful. If regulatory authorities require additionalstudies or trials for either of our products or changes to specifications, we would incur increased costs and delays in the marketing approval process and may not beable to obtain approval.In addition, regulatory authorities in countries outside the U.S. and EU are increasingly requiring risk management plans and post-marketing commitments, whichmay be more onerous than those required in the U.S. and EU. In certain countries, if the post-marketing commitment is a post-marketing study that would qualifyas an interventional or similar form of study, we may be required to provide free product to participants in the study in such country even if our products arereimbursed there. The time required to obtain approval in other countries may differ from that required to obtain FDA approval or marketing authorization in theEU. In several countries outside the U.S. in which we are commercializing lomitapide, and in which we intend to commercialize metreleptin, if approved by therelevant regulatory authority, a product must also receive pricing and reimbursement approval before it can be commercialized broadly. This can result insubstantial delays in commercializing products in such countries, and the price that is ultimately approved may be lower than the price for which we expect tooffer, or would be willing to offer, lomitapide or metreleptin, in such countries, and may impact pricing in other countries. Pricing and reimbursement approval inone country does not ensure such approvals in another. Failure to obtain the approvals necessary to commercialize lomitapide or metreleptin in other countries atreimbursement levels that are acceptable to us or any delay or setback in obtaining such approvals would impair our ability to develop foreign markets forlomitapide and metreleptin. For example, because commercially acceptable pricing and reimbursement approvals for LOJUXTA were not obtained in several ofthe key markets of the EU, and in an effort to reduce costs associated with EMA post-marketing requirements, Aegerion elected to cease commercialization ofLOJUXTA in the EU and, in December 2016, entered into a license agreement with Amryt under which Amryt was granted an exclusive license to develop andcommercialize LOJUXTA in the EEA, Switzerland, Turkey, and certain Middle Eastern and North African countries, including Israel.We rely on named patient sales in certain territories, but there is no assurance that named patient sales of lomitapide will continue at current levels, or at all,or that significant levels of named patient sales of metreleptin will be achieved in any country, or at all.In Brazil and in a limited number of other countries where permitted based on U.S. or EU approval, lomitapide and metreleptin are available on a named patientsales or equivalent basis. There is no assurance that named patient sales will continue to be authorized in any particular country. If violations of any laws orgovernmental regulations are found to have occurred, significant civil lawsuits may be filed by the Public Prosecution office, and administrative penalties imposedby Brazilian regulatory authorities and additional damages and fines. Under certain circumstances, we could be barred from further sales to federal and/or stategovernments in Brazil, including sales of JUXTAPID and/or MYALEPT, due to penalties imposed by Brazilian regulatory authorities or through civil actionsinitiated by federal or state public prosecutors. We believe significant media coverage in Brazil in 2016 may increase the likelihood that such authorities willinitiate inquiries and/or litigation. In addition, we believe the investigations in Brazil have contributed to a slower turn-around between price quotation and orders,including re-orders, from the federal government, and, in some cases, delays in orders and re-orders from the government of the State of São Paulo after a patienthas obtained access to JUXTAPID through the judicial process. These delays may continue, and we may experience other56delays or suspension of the ordering process. Similarly, there has been, and may continue to be, some reluctance by physicians to prescribe JUXTAPID, and somepatients to take or stay on JUXTAPID, while the investigations are ongoing, particularly given that some of the investigators in Brazil made formal inquiries ofcertain prescribers of JUXTAPID in 2016 and there has been significant local media coverage of such inquiries and our activities in Brazil. For example, in thesecond quarter of 2015 and in the second quarter of 2016, we observed a significant increase in patients discontinuing therapy in Brazil, and we believe that theincreases during those times were due in part to the investigations. In addition, a proceeding is currently pending with the Brazil Supreme Federal Court to decidewhether the government has an obligation to continue to provide, on a named patient sales basis, drugs that have not received regulatory and/or pricing andreimbursement approval in Brazil, like JUXTAPID and MYALEPT. We intend to file for marketing approval in Brazil for both JUXTAPID and MYALEPT, andare currently assessing the timing of these submissions. The result of the trial and other issues could negatively affect product revenues from named patient sales ofJUXTAPID and MYALEPT in Brazil.We do not yet know the full extent of the impact that the approval of PCSK9 inhibitor products in the U.S., or the approval of a PCSK9 inhibitor product in Brazilin April 2016, will have on the named patient sales of lomitapide in Brazil or any other country. We also do not know whether we will be permitted to sellmetreleptin on a named patient basis in any countries besides Brazil, Argentina, Colombia, and the few other countries where we are currently permitted to do so.In certain countries, we may decide not to pursue named patient sales even if permitted to do so. Even if named patient sales or their equivalent sales are permittedin a certain country, and we elect to make lomitapide or metreleptin available on such basis in such country, there is no guarantee that physicians in such countrywill prescribe the product, and that patients will be willing to start therapy, or that the country will agree to pay for the product at all or at a level that is acceptableto us or, after access is granted, will continue to pay for the product at the levels initially approved, without delay or imposing other hurdles on payment, or at all,particularly in Brazil, in light of the recent approval of a PCSK9 inhibitor by the local Brazilian regulatory authority, ongoing state and federal governmentinvestigations, a decision by the Brazilian pharmaceutical industry association that we violated its Code of Conduct, and recent coverage by Brazilian media. Thereis no guarantee that we will generate sales or substantial revenue from such sales.If named patient sales do not meet our expectations in key named patient sales markets, particularly Brazil, we may not be able to meet our expectations withrespect to sales of lomitapide and metreleptin or revenues from such sales, maintain cash flow positive operations, or meet our expectations with respect toprofitability in the time periods we anticipate or at all. There are also countries where we choose to make lomitapide and metreleptin available under an expandedaccess program at no cost prior to approval in such country. This program may result in significant expenses, and could impact our financial results.We depend on single third-party manufacturers to produce our drug substance and drug product for each of our products and our product candidate. This mayincrease the risk that we will not have sufficient quantities of our products or product candidate, or will not be able to obtain such quantities at an acceptablecost, which could negatively impact commercialization of our products or delay, prevent or impair our clinical development programs.We currently have no manufacturing facilities and limited personnel with manufacturing experience. We rely on contract manufacturers to produce drug substanceand drug product for commercial supplies and for our clinical trials.We have long-term supply agreements with our lomitapide drug product and drug substance manufacturers, as well as supply agreements with our metreleptin drugsubstance and drug product manufacturers. We do not have agreements in place for redundant supply or a second source for drug substance or drug product foreither of our products or our product candidate, zuretinol. Any termination or non-renewal of our agreements with our contract manufacturers could impactavailability of lomitapide or metreleptin for commercial sale in any country where such product is approved for commercial sale or sold on a named patient basis,or may delay further clinical development or marketing approval of such product in additional countries. If for any reason our contract manufacturers cannot orwill not perform as agreed, we may be required to replace such manufacturer. If we are unable to maintain arrangements for third-party manufacturing, or areunable to do so on commercially reasonable terms, or are unable to obtain timely regulatory approvals in connection with our contract manufacturers, we may notbe able to successfully commercialize our products or complete development of our products or product candidate. We may incur significant added costs andsubstantial delays in identifying and qualifying any replacement manufacturers, and in obtaining regulatory approval to use such replacement manufacturer in themanufacture of our products. Any such delays could result in significant delay in the supply of a product candidate for an ongoing trial due to the need to replace athird-party manufacturer could delay completion of the trial. If for any reason we are unable to obtain adequate supplies of lomitapide, metreleptin, zuretinol or anyother product candidate that we develop or acquire, or the drug substances used to manufacture them, it will be more difficult for us to compete effectively,generate revenue, meet our expectations for financial performance and further develop our products or product candidate. In addition, if we are unable to assure asufficient quantity of the drug for patients with rare diseases or conditions, we may lose any orphan drug exclusivity to which the product otherwise would beentitled.57We rely on our contract manufacturers to utilize processes that consistently produce drug substance and drug product to their required specifications, includingthose imposed by the FDA, the EMA and other regulatory authorities, as applicable. There can be no assurance that our contractors will consistently be able toproduce commercial supplies of drug substance or drug product meeting the approved specifications. A number of factors could cause production interruptions atthe facilities of our contract manufacturers, including equipment malfunctions, facility contamination, labor problems, raw material shortages or contamination,natural disasters, disruption in utility services, terrorist activities, human error or disruptions in the operations of our suppliers. We have experienced failures by ourthird-party manufacturers to produce product that meets our specifications in the past, and any future failure by our third-party manufacturers to produce productthat meets specifications could lead to a shortage of lomitapide or metreleptin.The manufacture of biologic pharmaceuticals, such as metreleptin, is more difficult and more risky than the manufacture of small molecule pharmaceuticals, suchas lomitapide or zuretinol. The process of manufacturing biologics is highly susceptible to product loss due to contamination, oxidation, equipment failure orimproper installation or operation of equipment, or vendor or operator error. Even minor deviations from normal manufacturing processes could result in reducedproduction yields, product defects and other supply disruptions. If microbial, viral or other contaminations are discovered in metreleptin or the facilities of ourcontract manufacturer, we may need to cease manufacturing for an extended period of time to investigate and remediate the contaminant. A contamination, recall,raw material shortage, or other supply disruption could adversely impact or disrupt commercial manufacturing of metreleptin or could result in a withdrawal ofmetreleptin from the market. This, in turn, could adversely affect our ability to satisfy demand for metreleptin, which could materially and adversely affect ouroperating results and expectations for financial performance.The FDA, the EMA and other regulatory authorities require that product candidates and drug products be manufactured according to current Good ManufacturingPractice (cGMP). Any failure by our third-party manufacturers to comply with cGMP could lead to a shortage of our products. In addition, such failure could bethe basis for action by the FDA, the EMA or regulatory authorities in other territories or countries to withdraw approvals previously granted to us and for otherregulatory action, including seizure, injunction or other civil or criminal penalties. For example, in February 2017, the contract manufacturer for metreleptin drugproduct received a Warning Letter from the FDA citing significant violations of cGMP regulations at the manufacturing facility where metreleptin drug product ismanufactured. In response, the manufacturer may make modifications to the line on which metreleptin drug product is filled, and has committed, in the long-term,to transition the filling of certain drug products, including metreleptin drug product, to a newer line at the same facility and to cooperating with customers on atransition timeline to re-validate the filling process on the new line, such that this transition does not impact supply. Assuming a reasonable timeline for the futuretransition to and validation of the new filling line, we would have sufficient inventory to handle any downtime in the manufacturing process. The failure by themetreleptin drug product manufacturer to respond adequately to the Warning Letter, a delay in the future transition to, or validation of, a new filling line formetreleptin drug product, or the failure of any of our third-party manufacturers to address any concerns raised by the FDA or foreign regulators, could lead to plantshutdown or the delay or withholding of product approval by the FDA in additional indications, or by foreign regulators in any indication, including, with respectto metreleptin, the MAA in the EMA for GL and the PL subset. Certain countries may impose additional requirements on the manufacturing of drug products ordrug substance, and on our third-party manufacturers, as part of the regulatory approval process for our products in such countries. The failure by us or our third-party manufacturers to satisfy such requirements could impact our ability to obtain or maintain approval of our products in such countries.We may face resistance from certain private, government and other third-party payers and from healthcare professionals and patients given the prices wecharge for metreleptin and lomitapide. We may not be able to achieve our revenue goals or achieve profitability or maintain cash-flow positive operations fromthe metreleptin or lomitapide businesses in the time periods we expect, or at all, if reimbursement for these products is limited or delayed.Market acceptance and sales of metreleptin and lomitapide will continue to depend on insurance coverage and reimbursement policies, and may be affected byhealthcare reform measures. Government authorities and third-party payers, such as private health insurers and health maintenance organizations, decide whichmedications they will pay for and establish reimbursement levels. A primary trend in the U.S. healthcare industry and elsewhere is cost containment andpredictability. Government authorities and these third-party payers have attempted to control costs by limiting coverage and limiting the amount of reimbursementfor particular medications. If we fail to successfully secure and maintain reimbursement coverage for our products at levels that are acceptable to us or aresignificantly delayed in doing so or if onerous conditions are imposed or announced by private payers, government authorities or other third-party payers on suchreimbursement, we will have difficulty achieving or maintaining market acceptance of our products and our business and ability to achieve our financialexpectations will be harmed.Given that GL and HoFH are rare diseases with extremely small patient populations, we have set prices for MYALEPT and JUXTAPID in the U.S. that aresignificantly higher than that of most pharmaceuticals, in order to generate enough revenue to fund our operating costs and potentially enable us to becomeprofitable. We also expect to increase the price of metreleptin and lomitapide58from time to time in the future. We believe our pricing for our products in the U.S. is consistent with the level of pricing for other ultra-orphan drugs that treatdiseases with comparable prevalence rates. The majority of payers in the U.S. are providing coverage for our products and, with respect to JUXTAPID, mostpayers in the U.S. have not required genotyping to determine a diagnosis of HoFH for reimbursement purposes. Many payers in the U.S. have, however, imposedrequirements, conditions or limitations as conditions to coverage and reimbursement for JUXTAPID as a result of commercial availability of PCSK9 inhibitorproducts, which often includes a requirement that HoFH patients have not achieved an adequate LDL-C response on PCSK9 inhibitor products before access tolomitapide is approved. For patients currently taking JUXTAPID, several U.S. pharmacy benefit managers (PBMs) are using a prior authorization requiring currentJUXTAPID patients to “step through” the less expensive PCSK9 inhibitor product, and additional PBMs and payers may follow this practice. We have beenengaging with pharmacy benefit managers (PBMs) to discuss and negotiate potential agreements to limit these so-called “step edits”, which may require us toprovide discounts and other price protections and would impact our net revenues from JUXTAPID.During the payer review process for MYALEPT in the U.S., some U.S. payers are requiring additional patient information, such as a leptin level test, which maydelay or otherwise impact reimbursement. The cost of JUXTAPID and MYALEPT in the U.S. may result in cost-sharing amounts for some patients that areprohibitive, and prevent these patients from being able to commence therapy on JUXTAPID or MYALEPT, respectively. We provide support to eligiblecommercial patients for certain drug co-pays and co-insurance obligations for JUXTAPID and MYALEPT treatment. From time to time, we provide financialsupport to patient assistance programs operated by independent charitable 501(c)(3) organizations in the U.S. that assist eligible HoFH and GL patients, asdetermined solely by the organization, with certain co-payments or co-insurance requirements for their drug therapies, which may include lomitapide ormetreleptin. We do not have control or input into the decisions of these organizations. Our support of any 501(c)(3) organization and our own co-pay assistanceprograms could result in significant costs to us.In certain countries outside the U.S. where lomitapide is or may be approved, or where metreleptin may be approved, we are seeking or expect to seek a price thatis significantly higher than that of most pharmaceuticals, and which reflects the rare nature of the diseases our products treat. There is no assurance thatgovernment agencies in such countries that are responsible for reimbursement of healthcare costs or other third-party payers in such countries will agree to providecoverage for our products at the prices we expect to propose, or at all. In many countries outside the U.S., the proposed pricing for a drug must be approved bygovernmental authorities before it may be lawfully sold. The requirements governing drug pricing vary widely from country to country. For example, in March2015, as part of negotiating a price agreement for lomitapide in Italy with the Italian Medicines Agency (AIFA), we, among other things, agreed to an annualpayment cap for the first twelve months after the final publication of the agreement. In July 2016, because pharmaceutical expenses in Italy in 2015 exceededAIFA’s planned budget, AIFA requested that pharmaceutical companies, including Aegerion, refund part of their 2015 revenues in Italy to manage this over-expenditure. As a result, LOJUXTA 2015 revenues in Italy were subject to a 20% rebate, which was paid in the third quarter of 2016. We expect AIFA will requesta similar refund in connection with 2016 revenues in Italy. Amryt is responsible for any rebate applied to a period after it had assumed commercializationresponsibility for the EEA. We expect that other countries will seek, and in certain cases, have sought and received, price and patient number and other pricerestrictions for our products and product candidates, if approved, or in some cases, if sold on a named patient basis. In some countries outside the U.S., we havefaced, and will continue to face significant delays or impediments to obtaining reimbursement due to lengthy pricing negotiations with governmental authorities orthe decisions of pricing authorities or authorities that indirectly impact pricing or reimbursement. To obtain reimbursement or pricing approval in some countries,we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies, which may not be possiblefor us to do.Outside the U.S., the macroeconomic climate, or local regulations or practices, may adversely affect our ability to set and charge a sufficiently high price togenerate adequate revenue in those markets. The price of lomitapide, or metreleptin if approved, in one country may adversely affect the price in other countries.We may elect not to launch our products in any country where it does not make commercial sense to do so given the approved price or other conditions. Inaddition, while we do not expect to obtain approval of our products outside of rare disease indications, in the future if we were to obtain such approval for newindications with a higher prevalence rate than our existing indications, it may be more difficult for us to obtain or maintain our current price levels and targets forlomitapide and metreleptin. For example, due to the broader indication for MYALEPT in Japan, MYALEPT is sold by Shionogi in Japan at a price significantlylower than the U.S. price. Even if we are successful in obtaining pricing and reimbursement approval for lomitapide in a country, such countries may imposeonerous conditions on reimbursement, which may include genotyping or the use of other therapies, such as apheresis, prior to the use of lomitapide.In addition, outside the U.S., products that have orphan designation may be exempted or waived from having to provide certain clinical, cost-effectiveness andother economic data in connection with their filings for pricing/reimbursement approval or filings for therapeutic reviews which impact pricing and reimbursementapprovals or negotiations. We may not be able to provide all of the data required to obtain pricing/reimbursement approvals in certain countries outside the U.S.where we seek to commercialize our products, if approved, or we may not satisfactorily meet the technical or substantive requirements of such submissions orreceive ratings from pricing or other regulatory authorities commensurate with our expectations or that would support the price59levels we want for our products, which could result in delays of pricing/reimbursement approvals for our products, our products not obtainingpricing/reimbursement approval at all, or our products obtaining approvals at less than acceptable levels or with significant restrictions on use or reimbursement.We may also face pricing and reimbursement pressure in the U.S. and other countries as a result of prices charged for competitive products or therapies.We are making lomitapide and metreleptin available, or plan to do so, in countries that allow use of a drug, on a named patient basis or under a compassionate useor other type of so-called expanded access program, before marketing approval has been obtained in such countries. We obtain reimbursement for lomitapide andmetreleptin for authorized pre-approval uses in some of these countries to the extent permitted by applicable law and local regulatory authorities. In other countriesor under certain circumstances, we are providing our products free of charge for permitted pre-approval uses. We do not yet know the impact that the availability inthe U.S., Japan, and Brazil of PCSK9 inhibitor products will have on our named patient sales in Brazil and in other countries where we currently sell lomitapide ona named patient sales basis. There is no assurance that we will be able to obtain reimbursement at all or at acceptable levels or to maintain reimbursement for ourproducts in any country under an expanded access program. In certain countries where we seek reimbursement for the product during the pre-approval phase, weare able to establish the price for the product, while in other countries we need to negotiate the price. Such negotiations may not result in a price acceptable to us, inwhich case we may elect not to distribute our products in such country prior to approval or we may curtail distribution. In addition, in certain countries, such asBrazil, the price we are able to charge for named patient sales prior to approval may be higher than the price that is approved by governmental authorities afterapproval.The amount of reimbursement for JUXTAPID and MYALEPT and the manner in which government and private payers in the U.S. may reimburse for ourpotential future products are uncertain.The impact of evolving reimbursement mechanics on the willingness of providers to furnish JUXTAPID or MYALEPT or other products we may market and theprices we can command for these products is difficult to predict. Legislative changes to the Public Health Service Section 340B drug pricing program (the 340BProgram), the Medicaid Drug Rebate Program, and the Medicare Part D prescription drug benefit also could impact our revenues. If reimbursement is not availableor available only to limited levels or if the mix of patients for our products is more heavily weighted to patients reimbursed under government programs, we maynot be able to generate sufficient revenue to meet our operating costs or to achieve our revenue and profitability goals and to achieve and maintain positive cashflow in the timeframe that we expect, or at all. Price reductions and other discounts we offer or may offer for our products, and significant price increases, such asthe price increase for MYALEPT in February 2015, typically result in increasing the rebates we are required to pay under the Medicaid Drug Rebate Program orstate Medicaid supplemental rebate programs and the discounts we are required to offer under the 340B Program. For example, we currently pay a significantrebate for MYALEPT that could offset the majority of revenues from Medicaid patients and will have a continued significant impact in future quarters. The degreeof such impact on our overall financial performance will depend on the percentage of MYALEPT patients that have Medicaid as their primary insurance coverageand the quantity of units ordered per patient. In addition, a considerable number of JUXTAPID patients in the U.S. are Medicare Part D patients and a significantpercentage of such patients may not be able to afford their out-of-pocket co-payments for JUXTAPID and MYALEPT, which could result in such patients seekingan alternative free drug or ceasing treatment with our products, given that the only source of financial support for such patients may be through independent 501(c)(3) patient organizations that may not provide adequate financial assistance, due to reductions in contributions to such patient organizations. This could have amaterial adverse effect on our revenues or financial condition.In addition, in the U.S., the cost of pharmaceuticals continues to generate substantial governmental and third-party payer interest. We expect that thepharmaceutical industry will experience pricing pressures due to the increasing influence of managed care (and related implementation of managed care strategiesto control utilization), additional federal and state legislative and regulatory proposals to regulate pricing of drugs, limit coverage of drugs or reduce reimbursementfor drugs, public scrutiny, and the current presidential administration’s agenda to control the price of pharmaceuticals through government negotiations of drugprices in Medicare Part D and importation of cheaper products from abroad. While we cannot predict what executive, legislative and regulatory proposals will beadopted or other actions will occur, such events could have a material adverse effect on our business, financial condition and profitability.The FDA, the EU Member States and other regulatory agencies outside the U.S. and the EU enforce laws and regulations prohibiting the promotion of off-label uses. Aegerion is currently the subject of a DOJ investigation regarding its marketing and selling of JUXTAPID in the U.S. Enforcement actions bythese agencies can result in significant liability.The FDA, the competent authorities of the EU Member States and other regulatory agencies outside the U.S. and the EU strictly regulate the promotional claimsthat may be made about prescription drug products. In particular, a drug product may not be promoted in a jurisdiction prior to approval or for uses that are notapproved by the FDA, the EC, the competent authorities of the EU Member States or such other regulatory agencies, as applicable, as reflected in the product’sapproved prescribing information60or summary of product characteristics. In the U.S., promotion of products for unapproved (or off-label) uses may result in enforcement letters, inquiries andinvestigations, and civil and criminal sanctions by the FDA. Promotion of products for off-label uses in the U.S. can also result in false claims litigation underfederal and state statutes, which can lead to consent decrees, civil money penalties, restitution, criminal fines and imprisonment, and exclusion from participationin Medicare, Medicaid and other federal and state healthcare programs. As noted above, Aegerion has been the subject of certain investigations by the DOJ and theSEC, for which it reached preliminary agreements in principle in 2016. The preliminary agreements in principle reached with the DOJ contemplates that Aegerionwill enter into a corporate integrity agreement, FDA consent decree and deferred prosecution agreement, each of which will be costly to negotiate and may requireAegerion to expend significant costs and resources to implement and maintain compliance. In addition, Aegerion may see new governmental investigations of oractions against it citing additional theories of recovery. Aegerion may also be subject to regulatory and/or enforcement action by federal agencies, private insurersand states’ attorneys general. See the “Legal Proceedings” section of this Annual Report for further information regarding ongoing investigations, including thepreliminary agreements in principle reached with the SEC and the DOJ, and other legal proceedings.The ongoing investigations and litigation involving Aegerion and future investigations or litigation in which we are involved could have a material adverse effecton our business, financial condition, results of operations, and share price, and divert the attention of our management from operating our business and may bedisruptive to our employees, possibly resulting in further employee attrition. In addition, the existence of the investigations and related activities has impacted, andmay continue to impact, the willingness of some physicians prescribe JUXTAPID and/or MYALEPT.Our relationships with customers and payers in the U.S. are subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations,which could expose us to criminal sanctions, civil penalties, contractual damages, and reputational harm and could diminish future earnings and prevent usfrom achieving our forecasted financial results.Healthcare providers and others play an important role in the recommendation and prescription of our products. Our arrangements with third-party payers andcustomers in the U.S. expose us to broadly applicable fraud and abuse and other healthcare laws and regulations, including the federal healthcare Anti-KickbackStatute, the False Claims Act, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Physician Payment Sunshine Act, that mayconstrain the business or financial arrangements and relationships through which we market, sell and distribute our products. Restrictions under applicable U.S.federal and state healthcare laws and regulations include the following:•The federal healthcare Anti-Kickback Statute prohibits persons from, among other things, knowingly and willfully offering, paying, soliciting, orreceiving remuneration, directly or indirectly, in cash or in kind, to induce or reward the purchasing, leasing, ordering, or arranging for or recommendingthe purchase, lease, or order of any healthcare item or service for which payment may be made, in whole or in part, by federal healthcare programs suchas Medicare and Medicaid. This statute has been interpreted to apply to, among others, arrangements between pharmaceutical manufacturers, on the onehand, and prescribers, purchasers, formulary managers and organizations that provide financial assistance to patients, on the other. Violations of thefederal Anti-Kickback Statute are punishable by imprisonment, criminal fines, civil monetary penalties and exclusion from participation in federalhealthcare programs. The Healthcare Reform Act, among other things, clarified that liability may be established under the federal Anti-Kickback Statutewithout proving actual knowledge of the statute or specific intent to violate it. In addition, the Healthcare Reform Act amended the Social Security Act toprovide that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutesa false or fraudulent claim for purposes of the federal civil False Claims Act. There are a number of statutory exceptions and regulatory safe harbors to thefederal Anti-Kickback Statute that protect certain common activities from prosecution or other regulatory sanctions, however, the exceptions and safeharbors are drawn narrowly, and practices that do not fit squarely within an exception or safe harbor may be subject to scrutiny.•The federal civil False Claims Act imposes civil penalties and provides for civil whistleblower or qui tam actions, against individuals or entities for,among other things, knowingly presenting, or causing to be presented false or fraudulent claims for payment of government funds, or knowingly making,using or causing to be made or used, a false record or statement material to an obligation to pay money to the government, or knowingly concealing orknowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government. Several pharmaceutical and otherhealthcare companies have faced enforcement actions under these laws for allegedly inflating drug prices they report to pricing services, which in turnwere used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing free product to customers with theexpectation that the customers would bill federal programs for the product. In addition, federal Anti-Kickback Statute violations and certain marketingpractices, including off-label promotion, may also implicate the federal civil False Claims Act. Federal civil False Claims Act violations may result intreble monetary damages and penalties and exclusion from participation in federal healthcare programs. Civil liability under the False Claims Act ormisdemeanor violation of federal health care laws gives the Inspector General (IG) of the61Department of Health and Human Services the discretion to exclude a company’s products from reimbursement by federal healthcare programs. Thisdiscretion to exclude often leads companies to negotiate corporate integrity agreements with the IG so their products may continue to receivereimbursement.•The federal criminal false statements statute prohibits knowingly and willfully falsifying, concealing or covering up a material fact, making any materiallyfalse, fictitious, or fraudulent statement or representation, or making or using any false writing or document knowing the same to contain any materiallyfalse, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services. There are alsocriminal penalties, including imprisonment and criminal fines, for making or presenting a false, fictitious or fraudulent claim to the federal government.Conviction under any of the aforementioned federal criminal statutes requires mandatory exclusion from participation in federal healthcare programs.•The federal Physician Payment Sunshine Act, being implemented as the Open Payments Program, requires certain pharmaceutical manufacturers toengage in extensive tracking of payments and other transfers of value to physicians and teaching hospitals and to submit such data to Centers forMedicare & Medicaid Services (CMS), which will then make all of this data publicly available on the CMS website. Pharmaceutical manufacturers, suchas our subsidiary, Aegerion, with products for which payment is available under Medicare, Medicaid, or the State Children’s Health Insurance Programare required to track reportable payments and transfers of value during each calendar year and must submit a report on or before the 90th day of eachcalendar year disclosing reportable payments made in the previous calendar year. Failure to comply with the reporting obligations may result in civilmonetary penalties.•Analogous state laws and regulations, such as state anti-kickback and false claims laws, apply to sales or marketing arrangements and claims involvinghealthcare items or services reimbursed by Medicaid or other state programs or, in several states, apply regardless of the payer. Several states now requirepharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products in those states and to report gifts andpayments to certain healthcare providers in those states. Some of these states also prohibit certain marketing-related activities including the provision ofgifts, meals, or other items to certain healthcare providers. In addition, several states require pharmaceutical companies to implement complianceprograms or marketing codes.We are also subject to laws and regulations covering data privacy and the protection of health-related and other personal information. The legislative andregulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues which mayaffect our business, including recently enacted laws in many jurisdictions where we operate. Numerous U.S. federal and state laws and regulations, including statesecurity breach notification laws, state health information privacy laws and federal and state consumer protection laws, govern the collection, use, disclosure andprotection of personal information. Failure to comply with laws and regulations covering data privacy and the protection of health-related and other personalinformation could result in government enforcement actions, which could include civil or criminal penalties, private litigation and/or adverse publicity and couldnegatively affect our operating results and business. In addition, we obtain patient health information from most healthcare providers who prescribe our productsand research institutions we collaborate with, and they are subject to privacy and security requirements under the Health Insurance Portability and AccountabilityAct of 1996, as amended by HIPAA. Although we are not directly subject to HIPAA other than with respect to providing certain employee benefits, we couldpotentially be subject to criminal penalties if we knowingly obtain or disclose individually identifiable health information maintained by a HIPAA-covered entityin a manner that is not authorized or permitted by HIPAA.Failure to comply with these regulatory frameworks could result in government enforcement actions, which could include civil or criminal penalties, privatelitigation and/or adverse publicity and could negatively affect our operating results and business.In addition to the DOJ investigation of Aegerion described in detail in the “Legal Proceedings” section of this Annual Report, we or our subsidiaries could becomesubject to other government investigations and related subpoenas. Subpoenas are often associated with previously filed qui tam actions, or lawsuits filed under sealunder the federal civil False Claims Act. Qui tam actions are brought by private plaintiffs suing on behalf of the federal government for alleged federal civil FalseClaims Act violations. The time and expense associated with responding to subpoenas, and any related qui tam or other actions, may be extensive, and we cannotpredict the results of our review of the responsive documents and underlying facts or the results of such actions. Any investigation, including the investigationsdescribed in detail in the “Legal Proceedings” section of this Annual Report, could result in civil and/or criminal sanctions being levied against us or Aegerion,including significant fines, sanctions, and other negative consequences that will have a material adverse effect on our business, financial condition, results ofoperations and/or cash flows. Aegerion’s preliminary agreements in principle with the DOJ and the SEC, if finalized, will result in material fines, sanctions andother remedies against Aegerion, as described in detail in the “Legal Proceedings” section of this Annual Report. Even if such matters can be resolved withoutincurring significant additional penalties, responding to subpoenas and investigations in general is costly and time-consuming. Moreover, responding to anyadditional government investigations, defending any claims raised, and any resulting fines, restitution, damages and penalties, settlement payments andadministrative actions, as well as any related62actions brought by shareholders or other third parties, could have further material adverse impacts beyond those attributable to the DOJ and the SEC investigationsdescribed in detail in the “Legal Proceedings” section of this Annual Report, including on our reputation, our business, financial condition, results of operations,and share price. These investigations have diverted, and may continue to divert, the attention of our management from operating our business, and have beendisruptive, and may continue to be disruptive, to our employees, possibly resulting in employee attrition. In addition, the existence of the investigations describedin detail in the “Legal Proceedings” section of this Annual Report and related activities have impacted, and may continue to impact, the willingness of somephysicians to prescribe JUXTAPID and/or MYALEPT.The number and complexity of both federal and state laws continues to increase, and additional governmental resources are being used to enforce these laws and toprosecute companies and individuals who are believed to be violating them. In particular, the Healthcare Reform Act includes a number of provisions aimed atstrengthening the government’s ability to pursue anti-kickback and false claims cases against pharmaceutical manufacturers and other healthcare entities, includingsubstantially increased funding for healthcare fraud enforcement activities, enhanced investigative powers, and amendments to the False Claims Act that make iteasier for the government and whistleblowers to pursue alleged violations of the Anti-Kickback Statute, the Food, Drug and Cosmetics Act (FDCA), the FalseClaims Act and other relevant laws. While it is too early to predict what effect these changes will have on our business, we anticipate that government scrutiny ofpharmaceutical sales and marketing practices will continue for the foreseeable future and subject us to the risk of government investigations and enforcementactions. For example, federal enforcement agencies recently have shown interest in pharmaceutical companies’ product and patient assistance programs, includingmanufacturer reimbursement support services and relationships with specialty pharmacies, as well as contributions by companies to third-party 501(c)(3)organizations that assist patients in accessing treatment for certain diseases and conditions. Some of these investigations have resulted in significant civil andcriminal settlements. Responding to a government investigation or enforcement action would be expensive and time-consuming, and could have a material adverseeffect on our business and financial condition and growth prospects. As noted above, Aegerion is the subject of certain ongoing investigations by the DOJ and theSEC and is also the subject of a putative class action lawsuit filed against it and certain of its former executive officers in the U.S. District Court for the District ofMassachusetts alleging certain misstatements and omissions related to the marketing of JUXTAPID and Aegerion’s financial performance in violation of thefederal securities laws. See the “Legal Proceedings” section of this Annual Report for further information regarding these investigations and other legalproceedings.Enacted and future legislation and related implementing regulations may increase the difficulty and cost for us to commercialize lomitapide, metreleptin,zuretinol or any other product candidate for which we obtain marketing approval, and may affect the prices we are able to obtain for them, if and whereapproved.In the U.S., there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system that restrict or regulate post-approval activities, and may affect our ability to profitably sell JUXTAPID, MYALEPT, zuretinol or any other product candidate for which we obtain marketingapproval. Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities forpharmaceutical products. We are not sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations willbe changed, or what the impact of such changes for JUXTAPID or MYALEPT may be. In addition, increased scrutiny by Congress of the FDA’s approval processmay subject us to more stringent product labeling and post-marketing testing and other requirements.In the U.S., most outpatient prescription drugs, including JUXTAPID and MYALEPT, may be covered under Medicare Part D. Medicare Part D prescription drugplans are authorized to use formularies where they can limit the number of drugs that will be covered in any therapeutic class and/or impose differential costsharing or other utilization management techniques. This places pressure on us to contain and reduce costs. Changes to Medicare Part D that give plans morefreedom to limit coverage or manage utilization, and/or other cost reduction initiatives in the program could decrease the coverage and price that we receive for anyapproved products, and could seriously harm our business.The Healthcare Reform Act substantially changed the way healthcare is financed by both governmental and private insurers. The law contains a number ofprovisions that affect coverage and reimbursement of drug products and/or that could potentially reduce the demand for our products such as:•increasing drug rebates under state Medicaid programs for brand name prescription drugs and extending those rebates to Medicaid managed care; and•requiring drug manufacturers to provide a 50% discount on Medicare Part D brand name prescription drugs sold to Medicare beneficiaries whoseprescription drug costs cause the beneficiaries to be subject to the Medicare Part D coverage cap (i.e. the so-called donut hole).In 2012, the Supreme Court of the U.S. heard challenges to the constitutionality of the individual mandate and the viability of certain provisions of the HealthcareReform Act. The Supreme Court’s decision upheld most of the Healthcare Reform Act and63determined that requiring individuals to maintain “minimum essential” health insurance coverage or pay a penalty to the Internal Revenue Service was withinCongress’s constitutional taxing authority. However, the Supreme Court struck down a provision in the Healthcare Reform Act that penalized states that choose notto expand their Medicaid programs through an increase in the Medicaid eligibility income limit from a state’s current eligibility levels to 133% of the federalpoverty limit. As a result of the Supreme Court’s ruling, some states have decided not to expand Medicaid. For each state that does not choose to expand itsMedicaid program, there will be fewer insured patients overall. Any reduction in the number of insured patients could impact our sales, business and financialcondition.Modifications to or repeal of all or certain provisions of the Healthcare Reform Act are expected as a result of the outcome of the recent presidential election andRepublicans maintaining control of Congress, consistent with statements made by President Donald Trump and members of Congress during the Presidentialcampaign and following the election. We cannot predict the ultimate content, timing or effect of any changes to the Healthcare Reform Act or other federal andstate reform efforts. There is no assurance that federal or state health care reform will not adversely affect our business and financial results, and we cannot predicthow future federal or state legislative, judicial or administrative changes relating to healthcare reform will affect our business.In addition, other legislative changes have been proposed and adopted since the Healthcare Reform Act was enacted. The Budget Control Act of 2011 includesprovisions to reduce the federal deficit. The Budget Control Act, as amended (BCA), resulted in the imposition of 2% reductions in Medicare payments toproviders which began in April 2013 and will remain in effect through 2025 unless additional congressional action is taken. Any significant spending reductionsaffecting Medicare, Medicaid or other publicly funded or subsidized health programs that may be implemented and/or any significant taxes or fees that may beimposed on us, as part of any broader deficit reduction effort or legislative replacement to the BCA, could have an adverse impact on our results of operations.Countries outside the U.S. may make changes to their healthcare systems which may in the future affect the revenues we generate from sales of lomitapide and, ifapproved outside of the U.S., metreleptin, zuretinol and other product candidates for which we obtain approval.We face extensive regulatory requirements, and may still face future development and regulatory difficulties.Even after marketing approval, a regulatory authority may still impose significant restrictions on a product’s indications, conditions for use, distribution ormarketing or impose ongoing requirements for post-marketing surveillance, post-approval studies or clinical trials. JUXTAPID is available in the U.S. onlythrough the JUXTAPID REMS program. We must certify all healthcare providers who prescribe JUXTAPID and the pharmacies that dispense the medicine, andunder the modified REMS program approved by the FDA on January 3, 2017, as described below, existing and new patients must now formally acknowledge thatthey understand the goals of the JUXTAPID REMS program and have undergone counseling by their prescriber to this effect. The FDA has also required that weperiodically assess the effectiveness of the JUXTAPID REMS program. The FDA assesses on a periodic basis whether a REMS program is meeting its goals andwhether the goals or elements of the plan should be modified. The FDA approved changes to the JUXTAPID REMS program on January 3, 2017. Suchmodifications to the JUXTAPID REMS program, which are extensive and need to be implemented by July 2, 2017, and the labeling modifications may negativelyaffect the ability or willingness of a healthcare professional to prescribe JUXTAPID, a patient to be willing to initiate or continue on therapy, or insurancecompanies, managed care organizations, other private payers, and government entities that provide reimbursement for medical costs to continue to providereimbursement for JUXTAPID, in which case we will have difficulty achieving or maintaining market acceptance of JUXTAPID, and our business and ability toachieve our financial expectations will be harmed. The outcome of the investigations of the SEC and the DOJ may also have an effect on the FDA’s requirementsfor the JUXTAPID REMS program. For additional information regarding changes to the JUXTAPID REMS program, see the risk factor captioned “ We may notbe able to maintain or expand market acceptance for metreleptin and lomitapide in the U.S. or to gain market acceptance in markets outside the U.S. where wecommercialize such products, and, for lomitapide, we may continue to see a significant number of patients who choose not to start or stay on therapy .”MYALEPT is also available only through the MYALEPT REMS program, due to potential for development of anti-metreleptin antibodies and the associated risksof serious adverse sequelae (such as severe infections, excessive weight gain, glucose intolerance, diabetes mellitus) and risk of lymphoma. As a part of thisprogram, we must certify all healthcare providers who prescribe MYALEPT, certify the pharmacies that dispense the medicine, and obtain prescriber attestationthat each patient has a diagnosis consistent with GL. We are responsible for maintaining, monitoring and evaluating the implementation of the MYALEPT REMSprogram.Regulatory authorities have significant post-marketing authority, including, the authority to require labeling changes based on new safety information, and torequire post-marketing studies or clinical trials to evaluate serious safety risks related to the use of a drug or biologic. For example, in July 2015, the FDA notifiedAegerion that they considered post-marketing reports of64anaphylaxis to be new safety information, and requested that we add it to the prescribing information for MYALEPT. Aegerion complied with that request. We aresubject to certain post-marketing commitments to the FDA and the EMA with respect to lomitapide and metreleptin. We expect that the regulatory authorities incertain other countries outside the U.S. and EU where our products are, or may be, approved may impose post-approval obligations, including patient registries,and requirements that may in some countries be more onerous than those imposed by the FDA and EMA. Depending on the nature of these post-marketing studies,we may be required to provide our products free of charge to participants in the studies in certain countries even if we have pricing and reimbursement approval insuch countries, which would negatively impact our level of revenues.Where our products are approved outside the U.S. or are in the future approved, we are and will also be subject to other ongoing regulatory requirements governingthe labeling, packaging, storage, advertising, distribution, promotion, recordkeeping and submission of safety, REMS, risk management program and other post-marketing information, including adverse reactions, and any changes to the approved product, product labeling, or manufacturing process. As a company withlimited internal resources and expertise in these areas, we rely on third parties to facilitate our compliance with many of these extensive regulatory requirements,which often include detailed record keeping and reporting requirements. We and the third parties we work with may not be able to fully comply with theserequirements or the reports we file with regulatory authorities may result in changes to our post-marketing compliance requirements. In addition, manufacturers ofdrug products and their facilities are subject to continual review and periodic inspections by the FDA, the EMA, the competent authorities of the EU MemberStates and other regulatory authorities for compliance with cGMP, and other regulations.If we, or third-party service providers acting on our behalf, or our drug substance or drug product or the manufacturing facilities for our drug substance or drugproduct, fail to comply with applicable regulatory requirements, including global pharmacovigilance requirements and meeting the requirements of the JUXTAPIDREMS program, a regulatory agency may:•issue warning letters or untitled letters;•seek an injunction or impose civil or criminal penalties or monetary fines;•suspend, withdraw or alter the conditions of our marketing approval;•require us to provide corrective information to healthcare practitioners;•require us to modify our product labels;•suspend any ongoing clinical trials;•require entrance into a consent decree, which is a component of Aegerion’s preliminary agreement in principle with the DOJ related to the JUXTAPIDREMS program, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penaltiesfor noncompliance;•refuse to approve pending applications or supplements to applications submitted by us;•suspend or impose restrictions on operations, including costly new manufacturing requirements;•seize or detain products, refuse to permit the import or export of products or request that we initiate a product recall;•impose further refinements and enhanced obligations under existing risk management and other forms of post-marketing requirements and programs; or•refuse to allow us to enter into supply contracts, including government contracts.The occurrence of any event or penalty described above may inhibit our ability to commercialize our products and product candidate and to generate revenue.If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in theU.S., we could be subject to additional reimbursement requirements, penalties, sanctions and fines which could have a material adverse effect on our business,financial condition, results of operations and growth prospects.We participate in various government programs or contracts that require us to calculate and report certain prices for our products to government agencies orprovide rebates or discounted pricing on products purchased to certain purchasers or government payers. The requirements for calculating prices and rebates arecomplex and subject to change. For example, new regulations that govern our obligations under the Medicaid Drug Rebate Program took effect in April of 2016.Changes to such requirements may affect our business and operations. We may also have reimbursement obligations or be subject to penalties if we fail to providetimely and accurate information to the government, pay the correct rebates or offer the correct discounted pricing.65We participate in the Medicaid Drug Rebate Program. Under the Medicaid Drug Rebate Program, we are required to pay a rebate for each unit of our productreimbursed by a state Medicaid program as a condition of having federal funds made available to the states for our drugs under Medicaid and Medicare Part D.Those rebates are based on pricing data that we report on a monthly and quarterly basis to CMS, the federal agency that administers the Medicaid Drug RebateProgram. We may also participate in state Medicaid supplemental rebate programs which require payment of an incremental rebate to state Medicaid programs forcovered utilization of our products. Price reductions as well as price increases that exceed the rate of inflation for our products, such as the price increase forMYALEPT in February of 2015, may result in increasing the rebates we are required to pay under the Medicaid Drug Rebate Program or state Medicaidsupplemental rebate programs and the discounts we are required to offer under the Public Health Service (PHS) 340B drug pricing discount program (the 340BProgram), as discussed below.To maintain coverage of our products under the Medicaid Drug Rebate Program and Medicare Part D, we are required to extend significant discounts to certain“covered entities” (defined by statute to include certain types of hospitals and other healthcare providers that receive federal grants) that purchase products underthe 340B Program. The 340B Program requires participating manufacturers to agree to charge such covered entities no more than the 340B “ceiling price” for themanufacturers’ covered outpatient drugs. The 340B ceiling price is calculated using a statutory formula, which is based on the average manufacturer price (AMP)and rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate Program. “Orphan drugs” - those designated under section 526 ofthe FDCA, such as JUXTAPID and MYALEPT - are exempt from the ceiling price requirements with respect to drugs purchased by certain covered entities (i.e.rural referral centers, sole community hospitals, critical access hospitals, and free-standing cancer hospitals). The Healthcare Reform Act also obligates the HealthResources and Services Administration (HRSA), the agency which administers the 340B Program, to promulgate various regulations and implement processes toimprove the integrity of the 340B Program. The status of new and pending regulations and guidance is uncertain under the new presidential administration.Pricing and rebate calculations vary among products and programs. The calculations are complex and are often subject to interpretation by governmental orregulatory agencies and the courts. For example, the Medicaid rebate amount is computed each quarter based on our submission to the CMS of our AMP and bestprice for the quarter. If we become aware that our reporting for prior quarters was incorrect, or has changed as a result of recalculation of the pricing data, we willbe obligated to resubmit the corrected data for a period not to exceed twelve quarters from the quarter in which the data originally were due. Such restatements andrecalculations would serve to increase our costs for complying with the laws and regulations governing the Medicaid Drug Rebate Program. Any corrections to ourrebate calculations could result in an overage or underage in our rebate liability for past quarters, depending on the nature of the correction. Price recalculationsalso may affect the price that we will be required to charge certain safety net providers under the Public Health Service 340B drug discount program. In February2015, we significantly increased the U.S. wholesale acquisition cost per 11.3 mg vial of MYALEPT. As a result of this substantial price increase, we continue toexpect a significant gross-to-net adjustment for Medicaid rebates which will offset the majority of revenue from Medicaid and negatively impact net product salesin future quarters, since Medicaid rebates directly reduce our net product sales. The degree of such impact on our overall financial performance will depend on thepercentage of MYALEPT patients that have Medicaid as their primary insurance coverage and the quantity of units ordered per patient. To date, approximately34% of patients prescribed MYALEPT have been Medicaid beneficiaries. The number of patients prescribed MYALEPT in the future who are Medicaidbeneficiaries could be higher than historical rates.We are liable for errors associated with our submission of pricing data and for overcharging government payers. For example, in addition to retroactive rebates andthe potential for 340B Program refunds, if we are found to have knowingly submitted false AMP or best price information to the government, we may be liable forcivil monetary penalties in the amount of $100,000 per item of false information. Our failure to submit monthly/quarterly AMP and best price data on a timelybasis could result in a civil monetary penalty of $10,000 per day for each day the submission is late beyond the due date. In the event that CMS were to terminateour rebate agreement, no federal payments would be available under Medicaid or Medicare Part D for our products. In addition, if we overcharge the governmentin connection with our Federal Supply Schedule (FSS) contract or under any other government program, we will be required to refund the difference to thegovernment. Failure to make necessary disclosures and/or to identify contract overcharges could result in allegations against us under the federal civil False ClaimsAct and other laws and regulations.To maintain coverage of our products under the Medicaid Drug Rebate Program and Medicare Part D and when purchased by four federal agencies, we arerequired to participate in the FSS pricing program. Under this program, we are obligated to make JUXTAPID and MYALEPT available for procurement on an FSScontract at a negotiated price and also charge a price to four federal agencies-VA, Department of Defense (DoD), Public Health Service, and Coast Guard-that is nohigher than the statutory Federal Ceiling Price (FCP). The FCP is based on the non-federal average manufacturer price (Non-FAMP), which we calculate andreport to the VA on a quarterly and annual basis. If a company misstates Non-FAMPs or FCPs it must restate these figures. Pursuant to the Veterans Health CareAct of 1992 (VHCA), knowing provision of false information in connection with a Non-FAMP filing can subject a manufacturer to penalties of $100,000 for eachitem of false information.66FSS contracts are federal procurement contracts that include standard government terms and conditions, separate pricing for each product, and extensive disclosureand certification requirements. In addition to the four agencies described above, all other federal agencies and some non-federal entities are authorized to accessFSS contracts. FSS contractors are permitted to charge FSS purchasers other than the four federal agencies “negotiated pricing” for covered drugs that is notcapped by the FCP; instead, such pricing is negotiated based on a mandatory disclosure of the contractor’s commercial “most favored customer” pricing.Moreover, all items on FSS contracts are subject to a standard FSS contract clause that requires FSS contract price reductions under certain circumstances wherepricing to an agreed “tracking” customer is reduced. In July 2016, we concluded negotiations with the Department of Veterans Affairs (VA), and effective August15, 2016, we have an FSS contract for both JUXTAPID and MYALEPT.We also participate in the Tricare Retail Pharmacy program, under which we pay quarterly rebates on utilization of JUXTAPID and MYALEPT when the productsare dispensed through the Tricare Retail Pharmacy network to Tricare beneficiaries. The rebates are calculated as the difference between annual Non-FAMP andFCP.If we overcharge the government in connection with VA FSS pricing program or Tricare Retail Pharmacy program, whether due to a misstated FCP or otherwise,we are required to refund the difference to the government. Failure to make necessary disclosures and/or to identify contract overcharges could result in allegationsagainst us under the False Claims Act and other laws and regulations.Unexpected refunds to the U.S. government, and responding to a government investigation or enforcement action, would be expensive and time-consuming, andcould have a material adverse effect on our business, financial condition, results of operations and growth prospects.Product development is a long, expensive and uncertain process, and we may terminate one or more of our development programs. If we do not achieve ourprojected development goals in the timeframes we expect and announce, or otherwise terminate one or more of our development programs, marketing approvaland commercialization of our product candidates may be delayed or otherwise cease. As a result, our credibility may suffer, our share price may decline and wemay incur significant expenses that could adversely affect our prospects, our financial condition, or results of operations.For strategic and operational planning purposes, we may estimate the timing of the accomplishment of various scientific, clinical, regulatory and other productdevelopment goals. These milestones may include the commencement or completion of scientific studies and clinical trials and the submission and approval ofregulatory filings. From time to time, we may publicly announce the expected timing of some of these milestones. All of these milestones are based on a variety ofassumptions. The actual timing of these milestones can vary dramatically compared to our estimates, in many cases for reasons beyond our control.We may determine to discontinue certain programs because we determine they do not have potential or we may elect to suspend, terminate or modify one or moreof our programs, which could include changing our clinical or business model for further development, including by attempting to extract or monetize value fromthe program by either selling, out-licensing or potentially partnering part or all of the program. For example, our product candidate, zuretinol, is under evaluation inclinical programs for the treatment of (i) IRD caused by RPE65 and LRAT gene mutations, which includes LCA and RP (autosomal recessive) (IRD 02) and(ii) RP (autosomal dominant) (RP 01). In addition, through Aegerion, we expect to submit a supplemental biologics licensing application (sBLA) to the FDA in thefirst half of 2017 to expand MYALEPT’s indication in the U.S. to the PL subset, to seek formal regulatory approvals for metreleptin in GL and the PL subset inother key markets, including Brazil and Colombia, and to use our knowledge of the diverse effects of leptin on many physiologic functions to explore newopportunities for metreleptin as a platform drug to potentially treat patients suffering from a range of low leptin-mediated rare and metabolic diseases. We areevaluating and prioritizing these potential opportunities and plan to provide an update in mid-2017. If we terminate and seek to monetize part or all of a program inwhich we have invested significant resources, or we continue to expend further resources on a program and subsequently fail to achieve our intended goals, ourprospects may suffer, as we will have expended resources on a program that may not provide a suitable return, if any, on our investment and we may have missedthe opportunity to allocate those resources to potentially more productive uses. In addition, in the event of a termination of a product candidate or program, we mayincur significant expenses and costs associated with the termination of the program, which could adversely affect our financial condition or results of operations.Failures or delays in the completion or commencement of any of our ongoing or planned clinical trials of our products or product candidate could result inincreased costs to us and delay, prevent or limit our ability to generate revenue with respect to the relevant product or product candidate in a new territory orindication.The commencement and completion of clinical trials may be delayed or prevented for a number of reasons, including:67•difficulties obtaining regulatory clearance to commence a clinical trial or complying with conditions imposed by a regulatory authority regarding thescope or term of a clinical trial;•delays in reaching or failing to reach agreement on acceptable terms with prospective clinical research organizations (CROs) and trial sites, and problemswith the performance of CROs;•insufficient or inadequate supply or quality of a product candidate or other materials necessary to conduct our clinical trials, or other manufacturingissues;•difficulties obtaining institutional review board (IRB) approval or Ethics Committee’s positive opinion to conduct a clinical trial at a prospective site;•challenges recruiting and enrolling patients to participate in clinical trials for a variety of reasons, including the size and nature of a patient population, theproximity of patients to clinical sites, the eligibility criteria for the trial, the nature of trial protocol, the availability of approved treatments for the relevantdisease and the competition from other clinical trial programs for similar indications;•severe or unexpected drug-related side effects experienced by patients in a clinical trial; and•difficulties retaining patients who have enrolled in a clinical trial but may be prone to withdraw due to the rigors of the trials, lack of efficacy, side effectsor personal issues, or who are lost to further follow-up.For example, in May 2016, in connection with our MAA filing for metreleptin for the treatment of GL patients and a subset of PL patients in the EU, the EMA’sPDCO issued a summary report regarding the metreleptin pediatric investigation plan (PIP). The PDCO expressed concern that the number of young patients withlipodystrophy included in the clinical trials proposed to be included in the PIP is very limited, and that no information on metreleptin as used by European patientswas provided. In July 2016, the PDCO approved our proposal that we conduct a study in GL patients below the age of 6, as a deferred commitment. Given theprevalence of GL and other factors, conducting a clinical trial in GL patients in the EU below a defined age will likely make such a trial lengthy in nature andpotentially difficult to complete. Even if we conduct a study in pediatric GL patients, we may not be able to show, to the satisfaction of the EMA, that metreleptinis safe and effective in pediatric patients under the age of 6, and we may never receive approval for this indication in the EMA. The lack of approval to marketmetreleptin for the pediatric GL population outside of the U.S. would limit expansion of our product revenue potential.Clinical trials may also be delayed or terminated as a result of ambiguous or negative interim results or the results of other clinical, preclinical or nonclinicalstudies. In addition, a clinical trial may be suspended or terminated by us, the FDA, the competent authorities of the EU Member States and other countries, theIRBs or the Ethics Committees at the sites, or a data safety monitoring board overseeing the clinical trial at issue, or other regulatory authorities due to a number offactors, including:•failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;•failure to respect applicable data privacy obligations;•inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities;•unforeseen safety issues or lack of effectiveness; and•lack of adequate funding to continue the clinical trial.If we do not meet our timelines or milestones as publicly announced, the market approval and commercialization of the relevant product or product candidate maybe delayed, and our credibility may be adversely affected and, as a result, our share price may decline.We rely on third parties to conduct our clinical trials and registry studies and to perform related services, and those third parties may not perform satisfactorily,including failing to meet established deadlines for the completion of such clinical trials and compliance with post-marketing requirements. We may becomeinvolved in commercial disputes with these parties.We do not have the ability to independently conduct clinical trials or registry studies, or perform pharmacovigilance and REMS monitoring and reporting, and werely on third parties such as contract research organizations, medical institutions, academic institutions, clinical investigators, specialty pharmacies and other third-party service providers to perform these functions. Our reliance on these third parties for clinical development, pharmacovigilance and REMS activities reducesour control over these activities. However, if we sponsor clinical trials, we are responsible for ensuring that each of our clinical trials is conducted in accordancewith the general investigational plan and protocols for the trial. Given our ownership of lomitapide, metreleptin, and zuretinol, we are responsible for REMSactivities in connection with marketing lomitapide and metreleptin in the U.S. and pharmacovigilance monitoring and reporting for all of our products on a globalbasis, except that Shionogi is responsible for these68activities for metreleptin in Japan, Korea and Taiwan and Amryt is responsible for these activities for lomitapide in the EEA, Switzerland, Turkey and certainMiddle Eastern and North African territories, including Israel. Moreover, the FDA and the competent authorities in the EU and Japan require us to comply withstandards, commonly referred to as Good Clinical Practices, for conducting, recording, and reporting the results of clinical trials to assure that data and reportedresults are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Our reliance on third parties does not relieve usof these responsibilities and requirements. Furthermore, these third parties may have relationships with other entities, some of which may be our competitors. Ifthese third parties do not successfully carry out their contractual duties or meet expected deadlines, if they need to be replaced or if the quality or accuracy of thedata they provide is compromised or delayed due to the failure to adhere to regulatory requirements or our clinical trial protocols, or for other reasons, ourdevelopment programs may be extended, delayed or terminated, additional marketing approvals for lomitapide, metreleptin, zuretinol or any other productcandidate may be delayed or denied in the targeted indication or jurisdiction, and we may be delayed or precluded in our efforts to successfully commercializelomitapide, metreleptin, zuretinol or any other product for targeted indications or in the targeted jurisdiction or it may impact existing approvals.In addition, we may, from time to time, become involved in commercial disputes with these third parties, for example regarding the quality of the services providedby these third parties or our ultimate liability to pay for services they purported to provide, or the value of such services. In some cases, we may be required to payfor work that was not performed to our specifications or not utilized by us, and these obligations may be material.We do not have in-house drug discovery capabilities, and will need to acquire or license existing drug compounds from third parties to expand our productcandidate pipeline.We currently have no in-house drug discovery capabilities. Accordingly, if we are to expand our product candidate pipeline, we will need to acquire or licenseexisting compounds from third parties. We will face significant competition in seeking to acquire or license promising drug compounds. Many of our competitorsfor such promising compounds may have significantly greater financial resources and more extensive experience in preclinical testing and clinical trials, obtainingregulatory approvals and manufacturing and marketing pharmaceutical products, and thus, may be a more attractive option to a potential licensor than us. Further,the ongoing SEC and DOJ investigations may negatively impact our ability to complete strategic acquisitions or licensing arrangements. If we are unable toacquire or license additional promising drug compounds, we will not be able to expand our product candidate pipeline, which may adversely impact our futureprofitability and growth prospects and increase the risk of insolvency.Positive results in preclinical studies and earlier clinical trials of our products or product candidates may not be replicated in later clinical trials , or changes inregulatory requirements and guidance or unanticipated events during our clinical trials may occur, which could result in development delay or a failure toobtain marketing approval or affect market acceptance.Positive results in preclinical or clinical studies of lomitapide, metreleptin, zuretinol or any other product candidate that we acquire, license or develop may not bepredictive of similar results in humans during further clinical trials. Accordingly, there is, for example, a possibility that any potential future clinical developmentof metreleptin in pediatric patients or new indications may generate results that are not consistent with the results of the Phase 3 clinical study for the product orother relevant studies. The results of such clinical trials may not be sufficient to gain approval of metreleptin in any pediatric population or new indication or maygenerate data that negatively impact the existing data and labels for approved indications. Our preclinical studies or clinical trials may produce negative orinconclusive results, and we may decide, or regulators may require us, to conduct additional preclinical studies or clinical trials. Moreover, preclinical and clinicaldata can be susceptible to varying interpretations and analysis, and many companies that believed their product candidates performed satisfactorily in preclinicalstudies and clinical trials have nonetheless failed to obtain FDA or other regulatory approval for their products.Changes in regulatory requirements and guidance or unanticipated events during our clinical trials may occur, as a result of which we may need to amend clinicaltrial protocols. Amendments may require us to resubmit our clinical trial protocols to the FDA, IRBs, Ethics Committees or the competent authorities of theapplicable jurisdictions for review and approval, which may impact the cost, timing or successful completion of a clinical trial. If we experience delays incompletion of, or if we terminate, any of our clinical trials or generate results that differ from earlier clinical trial results, the commercial prospects for theapplicable product may be harmed.Recent federal legislation and actions by state and local governments may permit re-importation of drugs from foreign countries into the U.S., includingforeign countries where the drugs are sold at lower prices than in the U.S. Similarly, purchasers in the EU are permitted to purchase products in one EUMember State and import it into another EU Member State where the price may be higher. These practices could materially adversely affect our operatingresults and our overall financial condition.69The Medicare Prescription Drug, Improvement and Modernization Act contains provisions that may change importation laws and expand pharmacists’ andwholesalers’ ability to import lower priced versions of an approved drug and competing products from Canada, where there are government price controls. Thesechanges to U.S. importation laws, which will not take effect unless and until the Secretary of Health and Human Services certifies that the changes will pose noadditional risk to the public’s health and safety, may result in a significant reduction in the cost of products to consumers. While the Secretary of Health andHuman Services has not yet announced any plans to make this required certification, we may ultimately face the risk that a distributor or other purchaser ofJUXTAPID or MYALEPT in the U.S. will be permitted to import lower priced product from a country outside the U.S. that places price controls onpharmaceutical products. This risk may be particularly applicable to JUXTAPID and MYALEPT as drugs that currently command premium prices, and especiallyto JUXTAPID, as a drug that is formulated for oral delivery. In addition, some states and local governments have implemented importation schemes for theircitizens and, in the absence of federal action to curtail such activities, other states and local governments may launch importation efforts.In the EU, a purchaser cannot be restricted from purchasing a medicinal procedure in one EU Member State and importing the product into another EU MemberState in which it is also subject to marketing authorization. This activity is called parallel importing. As a result, a purchaser in one EU Member State wherelomitapide or, if approved, metreleptin, is sold at a high price may seek to import the product from another EU country where the product is sold at a lower price.The re-importation of lomitapide or metreleptin into the U.S. market from a foreign market and the parallel importation of lomitapide, and, if approved,metreleptin, among countries of the EU or other regions could negatively impact our revenue and anticipated financial results, possibly materially.We face potential product liability exposure, and, if claims are brought against us, we may incur substantial liability.The use of any product or product candidate in clinical trials and the sale of any product for which we have or obtain marketing approval expose us to the risk ofproduct liability claims. Product liability claims might be brought against us by consumers, healthcare providers or others selling or otherwise coming into contactwith our product and product candidates. If we cannot successfully defend ourselves against product liability claims, we could incur substantial liabilities. Inaddition, regardless of merit or eventual outcome, product liability claims may result in:•decreased demand for our products and any product candidate for which we obtain marketing approval;•impairment of our business reputation and exposure to adverse publicity;•increased warnings on product labels;•withdrawal of clinical trial participants;•costs as a result of related litigation;•distraction of management’s attention from our primary business;•substantial monetary awards to patients or other claimants;•loss of revenue; and•the inability to successfully commercialize our products or any product candidate for which we obtain marketing approval.We have obtained product liability insurance coverage for both our clinical trials and our commercial exposures with a $25.0 million annual aggregate coveragelimit. However, our insurance coverage may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becomingincreasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us againstlosses due to liability. On occasion, large judgments have been awarded in class action lawsuits relating to drugs that had unanticipated side effects or warningsfound to be inadequate. The cost of any product liability litigation or other proceedings, even if resolved in our favor, could be substantial. A product liability claimor series of claims brought against us could harm our reputation and cause our share price to decline and, if the claim is successful and judgments exceed ourinsurance coverage, could have a material adverse impact on our business, financial condition, results of operations and prospects.A variety of risks associated with our business operations outside the U.S. could materially adversely affect our business.In each country outside the U.S. in which lomitapide is approved, or where we are making lomitapide or metreleptin available on a named patient or compassionateuse basis before it has obtained marketing approval, we are subject to additional risks related to international business operations, directly and as a result of theactivities of third parties with whom we do business, including:•differing regulatory requirements for drug approvals in foreign countries;70•pricing, pricing deals and reimbursement approvals that have a negative impact on our global pricing strategy;•potentially reduced protection for intellectual property rights;•the potential for parallel importing;•unexpected changes in tariffs, trade barriers and regulatory requirements;•economic weakness, including inflation, or political instability in particular foreign economies and markets, including, for example, the current politicalinstability in Brazil, our largest source of revenues on a country-by-country basis outside the U.S.;•compliance with foreign and U.S. laws, rules, regulations or industry codes, including data privacy requirements, labor relations laws, anti-competitionregulations, import, export and trade restrictions, and required reporting of payments to healthcare professionals and others;•negative consequences from changes in applicable tax laws;•foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business inanother country;•workforce uncertainty in countries where labor unrest is more common than in the U.S.;•production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad;•dependence upon third parties to perform distribution, pharmacovigilance, quality control testing, collections and other aspects of the distribution, supplychain and commercialization of our products that are required to be performed in order to conduct such activities in international markets, and our abilityto effectively manage such third parties; and•business interruptions resulting from geopolitical and economic events or actions, including social unrest, economic crises, war, terrorism, or naturaldisasters.In addition to the foregoing, we are subject to anti-corruption laws, including the Foreign Corrupt Practices Act (FCPA) and various other anti-corruption laws.The FCPA generally prohibits companies and their intermediaries from making improper payments to foreign officials for the purpose of obtaining or keepingbusiness and/or other benefits. An aspect of the SEC’s ongoing investigation into Aegerion’s disclosures and activities relates to alleged FCPA violations inBrazil. These potential violations are excluded from the preliminary agreements in principle with the DOJ and the SEC.Our activities outside the U.S. and those of our employees, licensees, distributors, manufacturers, clinical research organizations and other third parties who act onour behalf or with whom we do business subject us to the risk of investigation and prosecution under foreign and U.S. laws. For example, as described in detail inthe “Legal Proceedings” section of this Annual Report, federal and state authorities in Brazil are conducting an investigation to determine whether there have beenviolations of Brazilian laws related to the promotion of JUXTAPID in Brazil. These issues could negatively affect our ability to generate product revenue forJUXTAPID consistent with our expectations, and may impact our ability to achieve and maintain profitability or maintain cash-flow-positive operations.Prescriptions for and sales of MYALEPT in Brazil may also be negatively affected.Despite our ongoing efforts to ensure compliance with foreign and domestic laws, our employees, agents, and companies with which we do business maynevertheless take actions in violation of our policies, for which we may be ultimately held responsible. If so, we may be subject to criminal or civil penalties orother punitive measures, including restrictions on our ability to continue selling in certain markets. Any such outcome, or any allegation or investigation regardingsuch actions involving us, could harm our reputation and have a material adverse impact on our business, financial condition, results of operations and prospects.We may not be able to obtain a rare pediatric disease priority review voucher for zuretinol, if we decide to request it.We are exploring the potential of submitting to the FDA a request for rare pediatric disease designation for zuretinol for the treatment of IRD caused by LRAT orRPE65 gene mutations. If zuretinol is approved by the FDA after being designated a rare pediatric disease and we meet certain additional criteria, we may qualifyfor a rare pediatric disease priority review voucher. There can be no assurance that the FDA will conclude that zuretinol for the treatment of IRD caused by LRATor RPE65 gene mutations meets the requirements for rare pediatric disease designation. Even if we decide to submit this request to the FDA, we obtain rarepediatric disease designation and zuretinol is approved for this indication, there is no guarantee that the FDA will conclude that the requirements for a rare pediatricdisease priority review voucher are met. Additionally, the FDA generally may not grant rare pediatric disease priority review vouchers after September 30, 2020,although a drug that has received rare pediatric disease designation by September 30, 2020, remains eligible to receive a rare disease priority review voucher if it isapproved for marketing71no later than September 30, 2022. In light of these deadlines, there is no guarantee that if we request and obtain rare pediatric disease designation, the FDA willapprove zuretinol in time for us to receive a rare pediatric disease priority review voucher.The occurrence of cyber incidents, or a deficiency in cybersecurity, could negatively impact our business by causing a disruption to our operations, acompromise or corruption of confidential information, exposure to legal and regulatory action, or damage to our patient, partner or employee relationships,any of which could subject us to loss and harm our reputation.A cyber incident is considered to be any event that threatens the confidentiality, integrity or availability of information resources. More specifically, a cyberincident is an intentional attack or an unintentional event that can include gaining unauthorized access to systems to disrupt operations, corrupt data or stealconfidential information about patients, suppliers, partners or employees. A number of companies have recently experienced serious cyber incidents and breachesof their information technology systems. Cyber incidents pose risks both to our internal systems and to those we have outsourced, including the risk of operationalinterruption, damage to our reputation and relationships with patients, partners and employees, and private data exposure. We have implemented processes,procedures and controls to help mitigate these risks. However, these measures, as well as our increased awareness of the risk of a cyber incident, do not guaranteethat our reputation, operations and financial results would not be adversely affected by such an incident.In the ordinary course of our business, we collect and store sensitive data, including intellectual property, proprietary business information and patient data. Thisincludes, where required or permitted by applicable laws, personally identifiable information. Certain third parties with whom we contract also collect and storesuch data related to clinical trial subjects and patients. The secure maintenance of this information is critical to our operations and business strategy. Despite oursecurity measures, our information technology and infrastructure may be vulnerable to attacks by hackers or breached due to employee error, malfeasance or otherdisruptions. Any such breach could compromise information stored on our networks or those of our partners. Any access, disclosure or other loss of informationcould result in legal claims or proceedings, liability under laws that protect the privacy of personal information, recovery costs, disruption our operations, includingdelays in our regulatory approval efforts, and damage our reputation, which could adversely affect our business.Risks Related to Our Intellectual PropertyIf our patent position does not adequately protect our products and product candidate, others could compete against us more directly, which would harm ourbusiness, possibly materially.Our lomitapide patent portfolio consists of seven issued U.S. patents and issued patents in Europe, Australia, New Zealand, South Korea and Japan and pendingapplications in the U.S., Japan, Canada, and India, all of which have been licensed to us in a specific field. A five-year patent term extension for our U.S. patentcovering the composition of matter of lomitapide, which was originally scheduled to expire in early 2015, has been granted and the patent will now expire in2020. The non-U.S. patents directed to the composition of matter of lomitapide issued in certain jurisdictions of the EU, Canada, Israel and Japan have expired.Our five method-of-use patents in the U.S. cover certain dosing regimens for lomitapide, with one such patent expiring in 2027 and the other four patents expiringin 2025. The non-U.S. patents directed to methods-of-use issued in certain jurisdictions of the EU, Japan, and South Korea are scheduled to expire in 2025. Themethod-of-use patent may be eligible for up to three years of supplemental protection in certain European countries, and we are seeking such protection in thecountries in which LOJUXTA is approved, on a country-by-country basis. An opposition was filed by a third-party with respect to the European method-of-usepatent, but such opposition has since been revoked.On August 28, 2015, the Coalition for Affordable Drugs VIII L.L.C. (CFAD) filed two separate inter partes review (IPR) petitions with the Patent Trial and AppealBoard (PTAB) of the U.S. Patent and Trademark Office (U.S. PTO), challenging the validity of U.S. Patent Nos. 7,932,268, and 8,618,135, which are directed tomethods-of-use for lomitapide. On March 6, 2017, the PTAB determined that the CFAD failed to show that the claims of these patents were unpatentable. Wecannot predict whether an appeal or a request for a rehearing on this determination will be filed, or if additional IPR challenges will be filed by another entity, orthe outcome of any future IPR.An Abbreviated New Drug Application (ANDA) or 505(b)(2) NDA may be submitted for JUXTAPID on or after December 21, 2016 if it contains a Paragraph IVcertification of patent invalidity or non-infringement. If we instigate a suit against an ANDA or 505(b)(2) applicant for patent infringement within 45 days ofreceiving a Paragraph IV notice, the FDA is prohibited from approving the ANDA or 505(b)(2) application for a period of 30 months. If the notice is given andsuit filed between December 21, 2016 and December 21, 2017, the 30-month stay does not begin until December 21, 2017. The FDA may approve the proposedcompetitor product before the expiration of the 30-month stay if a court finds our patents invalid or not infringed or if the court shortens the period because theparties have failed to cooperate in expediting the litigation.72Moreover, if one or more ANDA filers were to receive approval to sell a generic or follow-on version of JUXTAPID, those competitor products could potentiallybe marketed, and we would become subject to increased competition, as early as December 21, 2019, the date on which JUXTAPID’s orphan drug exclusivityends, although we expect that any such launch would be delayed until February 21, 2020, the date on which JUXTAPID's composition of matter patent expires.Our metreleptin patent portfolio consists of three issued U.S. patents and issued patents in Europe, Canada, Israel, Australia, New Zealand, Mexico, China, SouthKorea and Japan, all of which have been licensed to us. The U.S. patent covering the composition of matter of metreleptin was scheduled to expire in 2016, but aninterim extension has been granted extending the term for one year until a final determination of a request for patent term extension is made. The non-U.S. patentsdirected to the composition of matter of metreleptin have expired. The patent family covering metreleptin methods of use, directed to treating human lipoatrophy,is co-owned by Amgen, University of Texas and the National Institutes of Health, and is sublicensed to us from Amgen. We have each additional co-owner’sconsent to the sublicense granted by Amgen, and we have an exclusive license from one of the co-owners to this patent family in addition to the sublicense fromAmgen. If we are unable to maintain license and/or enforcement rights from each of the co-owners, we may be prevented from enforcing these patent rights againsta competitor in the U.S. or in foreign jurisdictions. The two method-of-use patents in the U.S. expire in 2022 and 2023, and the non-U.S. patents issued in certainEuropean countries, Canada, and Australia, and pending in Japan, expire in 2022. An application for a patent term extension in the U.S. with respect to MYALEPThas been filed which, if granted, will be applied to either the U.S. composition of matter patent or the method-of-use patent, to extend one of these patents by 1,206days. Also, as noted above, metreleptin qualifies for 12-year biologic exclusivity under the BPCI Act, which will expire in 2026. If approved by the EMA,metreleptin would be entitled to 10 years of market exclusivity in the EU.Our zuretinol patent portfolio includes six granted U.S. patents, and issued patents in Europe, Japan, Canada, and other countries, as well as pending patentapplications in countries including the U.S. and Europe. These patents and patent applications relate to zuretinol pharmaceutical compositions and uses thereof,including methods of using of zuretinol for the treatment of LCA and RP, and expire between 2025 and 2032. Certain zuretinol patent families are owned by theUniversity of Washington, which has licensed the patents and patent applications to Retinagenix LLC (Retinagenix), and are exclusively sub-licensed to us byRetinagenix. For additional information regarding the license agreement with Retinagenix, see the risk factor captioned “ If we fail to comply with our obligationsin our license agreements for our product candidates, we could lose license rights that are important to our business .” Zuretinol has been granted orphan drugdesignations for the treatment of LCA (due to inherited mutations in LRAT or RPE65 genes) and RP (all mutations) by the FDA, and for the treatment of LCA andRP (all mutations) by the EMA, which would entitle it to orphan drug exclusivity, if submitted for approval to and approved by the FDA and EMA. The moleculezuretinol acetate is not, however, eligible for composition of matter protection in the U.S. or elsewhere, because it was previously known in the scientificcommunity. Therefore, we may not be able to prevent competitors from commercializing zuretinol acetate for the treatment of diseases that fall outside of thescope of our patents protecting these methods.Our commercial success with respect to our products will depend significantly on our ability to protect our existing patent position with respect to our products andproduct candidate, as well as our ability to obtain and maintain adequate protection of other intellectual property for our technologies, product candidates and anyfuture products in the U.S. and other countries. If we do not adequately protect our intellectual property, competitors may be able to use our technologies and erodeor negate any competitive advantage we may have, which could harm our business and ability to achieve our expected financial results. Our ability to use thepatents and patent applications licensed to us to protect our business will also depend on our ability to comply with the terms of the applicable licenses and otheragreements and to obtain requisite licenses. The laws of some foreign countries do not protect our proprietary rights to the same extent as the laws of the U.S., andwe may encounter significant problems in protecting our proprietary rights in these countries.There are many countries, including some key markets for lomitapide and metreleptin, like Brazil, in which we do not have intellectual property coverage, andwhere neither orphan drug exclusivity nor data and marketing exclusivity is available.The patent positions of biotechnology and pharmaceutical companies, including our patent position, involve complex legal and factual questions, and, therefore,validity and enforceability cannot be predicted with certainty. Patents may be challenged, deemed unenforceable, invalidated or circumvented. U.S. patents andpatent applications may also be subject to interference proceedings, ex parte reexamination, IPR and post-grant review proceedings and supplemental examinationand may be challenged in district court. Patents granted in certain other countries may be subjected to opposition or comparable proceedings lodged in variousnational and regional patent offices. These proceedings could result in either loss of the patent or denial of the patent application or loss or reduction in the scope ofone or more of the claims of the patent or patent application. In addition, such interference, re-examination, opposition, post-grant review, IPR, supplementalexamination or revocation proceedings may be costly. We will be able to protect our proprietary rights from unauthorized use by third parties only to the extentthat our proprietary technologies, product candidates and any future products are covered by valid and enforceable patents or are effectively maintained as tradesecrets.73The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that:•we will be able to successfully commercialize our product before some or all of our relevant patents expire, or in countries where we do not have patentprotection;•we or our licensors were the first to make the inventions covered by each of our pending patent applications and patents;•we or our licensors were the first to file patent applications for these inventions;•others will not independently develop similar or alternative technologies or duplicate any of our technologies;•any of our pending patent applications or those we have licensed will result in issued patents;•any of our patents or those we have licensed will be valid or enforceable;•we are able to license patents or pending patents that are necessary or desirable to enforce or protect our patent rights on commercially reasonable termsor at all;•any patents issued to us or our licensors and collaborators will provide a basis for any additional commercially viable products, will provide us with anycompetitive advantages or will not be challenged by third parties;•we will develop additional proprietary technologies or product candidates that are patentable; or•the patents of others will not have an adverse effect on our business.If we do not obtain protection under the Hatch-Waxman Act, the BPCI Act and similar foreign legislation by extending the patent terms and obtainingregulatory exclusivity for our products or product candidates, our business may be materially harmed.The Hatch-Waxman Act established a patent restoration term of up to five years as compensation for patent term lost during product development and the FDAregulatory review process. Our application seeking a five-year patent term extension for our U.S. patent covering the composition of matter of lomitapide, hasbeen granted, extending the patent term of this patent to 2020. An application for a patent term extension in the U.S. with respect to MYALEPT has been filedwhich, if granted, we will apply to either the U.S. composition of matter patent or the method-of-use patent, to extend one of these patents by 1,206 days. We arealso seeking three years of supplemental protection for our European Patent Office (EPO) method-of-use patent in certain EPO countries in which LOJUXTA isapproved. However, we may not be granted an extension in a particular country if we, for example, fail to apply within applicable deadlines, fail to apply prior toexpiration of relevant patents or otherwise fail to satisfy applicable requirements. Moreover, the applicable time period of the extension or the scope of patentprotection afforded could be less than we request. If we are unable to obtain patent term extension or restoration of the term of any such extension is less than werequest, our competitors, including manufacturers of generic alternatives, may obtain approval of competing products following our patent expiration, and ourrevenue could be reduced, possibly materially.In addition, the FDA has classified lomitapide as a new chemical entity (NCE) in the U.S. and it is therefore eligible for data exclusivity under the Hatch-WaxmanAct. A drug can be classified as a NCE if the FDA has not previously approved any other new drug containing the same active moiety. An NCE that is grantedmarketing approval may, even in the absence of patent protection, be eligible for five years of data exclusivity in the U.S. following marketing approval. This dataexclusivity precludes submission of 505(b)(2) applications or ANDAs that reference the NCE application for four years if certain patents covering the NCE or itsmethod-of-use expire or are challenged by a generic applicant. In addition, the FDA has granted seven years of orphan drug exclusivity from the date of approvalfor JUXTAPID in the U.S. in the treatment of HoFH, expiring in December 2019.With the enactment of the BPCI Act, an abbreviated pathway for the approval of biosimilar and interchangeable biological products was created. The abbreviatedregulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as“interchangeable” based on its similarity to an existing reference product. Under the BPCI Act, an application for a biosimilar product cannot be approved by theFDA until 12 years after the original reference product was approved under a BLA. The law is complex and is still being interpreted and implemented by the FDA.As a result, its ultimate impact, implementation, and meaning are subject to uncertainty. The BPCI Act is described in detail in the risk factor captioned “If we failto obtain or maintain orphan drug exclusivity for our products or product candidate in any country where exclusivity is available, we will have to rely on our dataand marketing exclusivity, if any, and on our intellectual property rights, to the extent there is coverage in such country, which may reduce the length of time thatwe can prevent competitors from selling generic versions of our products or product candidate.” While it is uncertain when such processes intended to implementthe BPCI Act may be fully adopted by the FDA, any such processes could have a material adverse effect on the future commercial prospects for metreleptin. Inparticular, the approval of a biological product biosimilar to one of our products could have a material impact on our business because it may be significantly lesscostly to bring to market and may be priced significantly lower than our products.74While metreleptin, which is approved under a BLA, qualifies for the 12-year period of exclusivity, there is a risk that this exclusivity could be shortened due tocongressional action or otherwise, or that the FDA will not consider metreleptin to be a reference product for competing products, potentially creating theopportunity for competition sooner than anticipated. Moreover, the extent to which a biosimilar, once approved, will be substituted for metreleptin in a way that issimilar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that arestill developing.Innovative medicinal products authorized in the EU on the basis of a full marketing authorization application (as opposed to an application for marketingauthorization that relies on data in the marketing authorization dossier for another, previously approved medicinal product) are entitled to eight years’ dataexclusivity. During this period, applicants for approval of generics of these innovative products cannot rely on data contained in the marketing authorizationdossier submitted for the innovative medicinal product. Innovative medicinal products are also entitled to ten years’ market exclusivity. During this ten-year periodno generic medicinal product can be placed on the EU market. The ten-year period of market exclusivity can be extended to a maximum of 11 years if, during thefirst eight years of those ten years, the Marketing Authorization Holder for the innovative product obtains an authorization for one or more new therapeuticindications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing therapies.If we are not able to gain or exploit the period of data exclusivity, we may face significant competitive threats to our commercialization of these compounds fromother manufacturers, including the manufacturers of generic alternatives. Further, even though our compounds are considered to be NCEs and we were able to gainthe period of data exclusivity, another company nevertheless could also market another version of the drug if such company submits a full NDA or a fullapplication for marketing authorization in the EU with a complete human clinical trial program and obtains marketing approval of its product.If we are not able to adequately prevent disclosure of trade secrets and other proprietary information, the value of our technology, products and any productcandidates could be significantly diminished.We may rely on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is appropriate or obtainable. However,trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsoredresearchers and other advisors to protect our trade secrets and other proprietary information. These agreements may not effectively prevent disclosure ofconfidential information, and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others mayindependently discover our trade secrets and proprietary information. For example, the FDA is currently considering whether to make additional informationpublicly available on a routine basis, and the EMA is planning to amplify its disclosure rules. These changes could mean that information that we may consider tobe trade secrets or other proprietary information may be disclosed, and it is not clear at the present time how the FDA’s and EMA’s disclosure policies may changein the future, if at all. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain ormaintain trade secret protection could adversely affect our competitive business position.We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts and stop us from commercializing orincrease the costs of commercializing our products and any product candidates.Our success will depend in part on our ability to operate without infringing the proprietary rights of third parties. There could be issued patents of which we are notaware that our products or product candidates infringe. There also could be patents that we believe we do not infringe, but that we may ultimately be found toinfringe. Moreover, patent applications are in some cases maintained in secrecy until patents are issued. The publication of discoveries in the scientific or patentliterature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications were filed. Because patents cantake many years to issue, there may be currently pending applications of which we are unaware that may later result in issued patents that our products or productcandidates infringe. For example, pending applications may exist that provide support or can be amended to provide support for a claim that results in an issuedpatent that our product infringes.The pharmaceutical industry is characterized by extensive litigation regarding patents and other intellectual property rights. Other parties may obtain patents in thefuture and allege that our products or product candidates or the use of our technologies infringes these patent claims or that we are employing their proprietarytechnology without authorization. Likewise, third parties may challenge or infringe upon our existing or future patents.Proceedings involving our patents or patent applications or those of others could result in adverse decisions regarding:•the patentability of our inventions relating to our product or any product candidates; and•the enforceability, validity or scope of protection offered by our patents relating to our product or any product candidates.75Even if we are successful in these proceedings, we may incur substantial costs and divert management’s time and attention in pursuing these proceedings, whichcould have a material adverse effect on us. If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, defend aninfringement action or challenge the validity of the patents in court. Patent litigation is costly and time consuming. We may not have sufficient resources to bringthese actions to a successful conclusion.In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patentsdeclared invalid, we may:•incur substantial monetary damages;•encounter significant delays in bringing our product candidates to market; and•be precluded from manufacturing or selling our product candidates.In such event, our business could be adversely affected, possibly materially.If we fail to comply with our obligations in our license agreements for our product candidates, we could lose license rights that are important to our business.Our existing license agreements with respect to our products and product candidate impose, and we expect any future license agreements that we enter into willimpose, various diligence, milestone payment, royalty, insurance and other obligations on us. If we fail to comply with such obligations, we could lose licenserights that are important to our business. For example, under the terms of a co-development agreement (the Retinagenix Agreement) we entered into withRetinagenix in April 2006, we obtained an exclusive, worldwide license and sub-license under certain intellectual property rights owned by Retinagenix or licensedto Retinagenix by the University of Washington related to zuretinol, the synthetic retinoid compound under development. We have been responsible for usingcommercially reasonable and diligent efforts to develop and commercialize in certain major markets, and other markets as we reasonably determine, one or moreproducts covered by the licensed rights or developed using such licensed rights for use in diagnosing, treating or preventing certain human diseases and conditions.We are also responsible for committing certain annual funding to support research and development of such products. Under the license agreement betweenRetinagenix and the University of Washington (the UW Agreement), Retinagenix has similar obligations, and is required to meet specific development milestoneswithin certain timeframes, one of which was required to be achieved by December 31, 2016. However, the UW Agreement contains provisions for extensions ofthose dates in certain circumstances. Based on the terms of the Retinagenix Agreement, the UW Agreement, and our significant development clinical spend on thezuretinol program, we believe that we are entitled to an extension of that milestone date until December 31, 2017, and that we may in the future be entitled tocertain additional extensions to December 31, 2019, along with a potential additional extension of up to 12 months should enrollment in a planned trial be delayed,provided that we continue to comply with the relevant provisions of the license agreements and expend certain minimum amounts on the development of zuretinol.However, it is possible that we may not be able to achieve the specified development milestone by December 31, 2019, or such later date to which we may beentitled to an extension under the agreements. As a result, we and Retinagenix have begun discussing a renegotiation of that milestone with the University ofWashington. We are currently conducting a review of the zuretinol development program, the results of which will assist us in determining when we believe thatthe remaining development milestone can be expected to be achieved. The failure to successfully renegotiate amendments to one or both of the license agreementsrelated to zuretinol to allow for additional time beyond December 31, 2019 to achieve the remaining development milestone would greatly limit the future potentialof the zuretinol program and could have a material adverse effect on our financial condition and business plans.If we fail to comply with the obligations and restrictions under our license agreements, the applicable licensor may have the right to terminate the license, in whichcase we might not be able to market any product that is covered by the licensed patents. Any breach or termination of the license agreements applicable to ourproducts would have a significant adverse effect on our business because of our reliance on the commercial success of our products.Risks Related to Employee Matters and the Recently Completed MergerOur future success depends on our ability to hire and retain our key executives and to attract, retain, and motivate qualified personnel.Our success depends upon retaining, recruiting and motivating key employees. Experienced employees in the biopharmaceutical and biotechnology industries arein high demand and competition for their talents can be intense. We have entered into employment agreements with certain members of our executive,commercial, medical, finance, legal, development, and regulatory teams, but any employee may terminate his or her employment with us at any time. Employeesmay experience uncertainty about their future76roles in light of the Merger and ongoing integration of the companies. Uncertainty may also adversely affect our ability to attract, motivate and retain executivesand other key employees and keep them focused on applicable strategies and goals. The loss of the services of any of these executives or key employees, or ourinability to recruit desirable candidates, could impede the achievement of our development and commercialization objectives.The size of our organization, and the Aegerion organization, has been significantly reduced, and we may encounter difficulties in managing the Aegerionbusiness as a result of this reduction, or the attrition that has occurred since Aegerion’s reductions in force in February and July 2016, which could disruptoperations. In addition, the anticipated benefits and savings from the reductions may not be achieved.In February 2016, the Board of Directors of Aegerion approved a cost-reduction plan that eliminated 80 positions from its workforce, representing a reduction inemployees of approximately 25% of Aegerion. In July 2016, the Board of Directors of Aegerion approved an additional cost-reduction and restructuring plan thateliminated approximately 28 positions from its workforce, representing a reduction in employees of approximately 13% of Aegerion. Additional reductions in thesize of the organization have occurred due to the restructuring of Aegerion’s commercial organization and in connection with the Merger, representing, in theaggregate, the elimination of approximately 27 positions from the workforces of Aegerion and Novelion. The reductions in force, and the attrition thereafter, haveresulted in the loss of longer-term employees, the loss of institutional knowledge and expertise and the reallocation and combination of certain roles andresponsibilities across the organization, all of which could adversely affect our operations.Given the complexity and global nature of our business, we must continue to implement and improve our managerial, operational and financial systems, manageour facilities and continue to recruit and retain qualified personnel. This will be made more challenging given the reductions in force described above, theintegration efforts in respect of the recently completed Merger and additional measures we may take to reduce costs to better align with projected revenues,particularly lower revenues for JUXTAPID in the U.S. As a result, our management may need to divert a disproportionate amount of its attention away from ourday-to-day activities, and devote a substantial amount of time to managing these activities. Further, the restructuring, integration efforts in respect of the recentlycompleted Merger and possible additional cost containment measures may yield unintended consequences, such as attrition beyond our intended reductions inforce or as a result of the recently completed Merger and reduced employee morale. This has resulted in employees who were not affected by the reductions inforce or recently completed Merger seeking alternate employment. In addition, we may not achieve anticipated benefits from the reductions in force. Due to ourlimited resources, we may not be able to effectively manage our operations or recruit and retain qualified personnel, which may result in weaknesses in ourinfrastructure and operations, risks that we may not be able to comply with legal and regulatory requirements, loss of business opportunities, loss of employees andreduced productivity among remaining employees. If our management is unable to effectively manage these transitions, reductions in force and additional costcontainment measures, our expenses may be more than expected, our ability to generate or increase our revenue could be reduced and we may not be able toimplement our business strategy. As a result, our future financial performance and our ability to commercialize lomitapide and metreleptin successfully, and tocompete effectively, would be negatively affected.We incurred substantial expenses in connection with the Merger and expect to continue to incur substantial expenses related to integration of the companies,and our failure to successfully integrate the businesses of Aegerion and Novelion in the expected timeframe or manage our expanded operations wouldadversely affect our future results.We have incurred and expect to continue to incur substantial expenses related to the Merger and the integration of Aegerion and Novelion. Our ability to realize theanticipated benefits from the Merger will depend, in part, on our ability to successfully integrate the companies’ operations. If the companies are not able toachieve these objectives within the anticipated timeframe, or at all, the anticipated benefits of the Merger may not be realized fully, or at all, or may take longer torealize than expected, and the value of our common shares may be adversely affected. In addition, the integration of Novelion’s and Aegerion’s respectivebusinesses will be a time-consuming and expensive process. For example, there are a large number of processes, policies, procedures, operations, technologies andsystems that must be integrated, including purchasing, accounting and finance, sales, billing, payroll, research and development, sales and marketing and benefits. In addition, the ongoing operation of locations in Cambridge, Massachusetts and Vancouver, British Columbia could result in inefficiencies, creating additionalexpenses for the companies. Proper planning and effective and timely implementation will be critical to avoid any significant disruption to the companies’operations. It is possible that the integration process could result in the loss of key employees, the disruption of ongoing business or the identification ofinconsistencies in standards, controls, procedures and policies that adversely affect the companies’ abilities to maintain relationships with customers, suppliers,manufacturers, creditors, lessors, clinical trial investigators or managers and other business partners or to achieve the anticipated benefits of the Merger. Delaysencountered in the integration process could have a material adverse effect on the companies’ revenues, expenses, operating results and financial condition,including the value of our common shares. Specifically, risks include, among other factors, the companies’ inability to effectively:77•coordinate standards, compliance programs, controls, procedures and policies, business cultures and compensation structures;•integrate and harmonize financial reporting and information technology systems of the two companies;•manage operations in a manner that supports and protects the tax benefits related to, and that may be realized from, our Canadian domicile;•coordinate research and drug candidate development efforts to effectuate their product capabilities;•compete against companies serving the market opportunities expected to be available to the companies following the Merger;•manage inefficiencies associated with integrating the operations of the companies;•identify and eliminate redundant or underperforming personnel, operations and assets;•manage the diversion of management’s attention from business matters to integration issues;•control additional costs and expenses in connection with, and as a result of, the Merger;•conduct successful clinical development programs for their respective strategic product candidates and products and achieve regulatory approval forproduct candidates in major geographic areas;•define and develop successful commercial strategies for our products in markets in which they are approved for sale and obtain reimbursement for suchproducts in these markets;•resolve Aegerion’s ongoing investigations and litigation and manage any future litigation and investigations that may arise from any such resolution of theongoing investigations and litigation;•service Aegerion’s significant indebtedness;•commercialize Aegerion’s products at commercially attractive margins and generate revenues in line with our expectations, particularly in light ofAegerion’s 2016 reductions in force, the impact of competitive products on JUXTAPID sales and the continuing challenges to the lomitapide business;and•raise capital through equity or debt financing on attractive terms to support the development and commercialization of our products and productcandidate.While we have assumed that a certain level of expenses will be incurred, there are many factors beyond our control that could affect the total amount or timing ofintegration expenses. Moreover, many of the expenses that will be incurred are, by their nature, difficult to estimate accurately. These expenses likely will result inour taking significant charges against consolidated earnings, and the amount and timing of such charges are uncertain at present.In addition, the actual integration may result in additional and unforeseen expenses, and the anticipated benefits of the integration plan may not be realized. Actualcost synergies, if achieved at all, may be lower than we expect and may take longer to achieve than anticipated. If we are not able to adequately address thesechallenges, we may be unable to successfully integrate the operations of our business, or to realize the anticipated benefits and cost synergy savings of theintegration.As a result of the Merger, our business became significantly more complex. There can be no assurance that we will effectively manage the increased complexitywithout experiencing operating inefficiencies or control deficiencies. Significant management time and effort is required to effectively manage the increasedcomplexity of the larger organization and our failure to successfully do so could have a material adverse effect on our business, financial condition, results ofoperations and growth prospects.Risks Related to Our Financial Position and Capital RequirementsWe have incurred significant operating losses since our inception, and have not yet achieved profitability for any fiscal year .We have incurred losses in each year since our inception. As of December 31, 2016, we had an accumulated deficit of approximately $587.2 million . Substantiallyall of our operating losses resulted from costs incurred in connection with our development programs and from selling, general and administrative costs associatedwith our operations. The losses we have incurred to date, combined with potential future losses, have had and may continue to have an adverse effect on ourshareholders’ (deficit) equity and working capital.78We expect to incur expenses related to the commercialization of metreleptin and lomitapide in the U.S. and in the key countries in which lomitapide is currentlyapproved and in which we intend to commercialize lomitapide, including Japan, or in which lomitapide or metreleptin may be approved and commercialized in thefuture, and expected distribution of our products in Brazil and certain other countries as part of named patient supply or compassionate use; manufacturing costsfor both metreleptin and lomitapide; the conduct of our observational cohort studies and other post-marketing commitments to the FDA for lomitapide andmetreleptin, including the implementation of the modified JUXTAPID REMS program and change to the coordinating center for such program; the conduct of anypost-marketing commitments imposed by regulatory authorities in countries outside the U.S. and EU where our products are, or may be, approved; other possibleclinical development activities for our products and product candidate, including an anticipated clinical trial for metreleptin in the pediatric population or a subsetthereof, and activities related to metreleptin lifecycle management and the evolution of the zuretinol program; regulatory activities for our products; and businessdevelopment activities. We expect to incur significant royalties, sales, marketing, and outsourced manufacturing expenses, as well as research and developmentexpenses. In addition, we expect to continue to incur additional costs associated with operating as a public company and in connection with ongoing governmentinvestigations, and the potential outcome thereof, including the proposed payments to the DOJ and the SEC totaling approximately $40 million, implementing andcomplying with the corporate integrity agreement, FDA consent decree and deferred prosecution agreement contemplated by the preliminary agreement inprinciple with the DOJ, and a securities class action lawsuit, as described in detail in the “Legal Proceedings” section of this Annual Report.Because of the numerous risks and uncertainties associated with developing and commercializing pharmaceutical products, we are unable to predict with certaintythe extent of any future losses or when we will become profitable, if at all.Servicing Aegerion’s debt requires a significant amount of cash. Aegerion may not have sufficient cash flow from its business to make payments on its debt,and it may not have the ability to raise the funds necessary to settle conversions of, or to repurchase, the Convertible Notes upon a fundamental change, whichcould adversely affect our business, financial condition and results of operations on a consolidated basis.In August 2014, Aegerion incurred indebtedness in the amount of $325.0 million in aggregate principal with additional accrued interest under the 2.00%convertible senior notes due August 15, 2019 (the Convertible Notes), for which interest is payable semi-annually in arrears on February 15 and August 15 of eachyear. Aegerion’s business may not generate cash flow from operations in the future sufficient to service its debt. If Aegerion is unable to generate such cash flow, itmay be required to adopt one or more alternatives, such as selling or licensing assets, further reducing the size of its workforce and curtailing operations andplanned development activities, restructuring debt or obtaining financing on terms that may be onerous. Aegerion’s ability to refinance this indebtedness willdepend on the capital markets and our financial condition on a consolidated basis at such time. Aegerion may not be able to engage in any of these activities orengage in these activities on desirable terms, which could result in a default on these debt obligations.In addition, holders of the Convertible Notes have the right to require the repurchase of their notes for cash upon the occurrence of a fundamental change at arepurchase price equal to 100% of the respective principal amount, plus accrued and unpaid interest, if any. Subject to certain exceptions as provided in theindenture governing the Convertible Notes, a fundamental change includes (a) delisting of Novelion’s common shares, (b) liquidation of Aegerion, (c) theacquisition of 50% or more of the voting interests in Aegerion, (d) an event in which Aegerion merges or consolidates with another entity and (e) an event in whichAegerion conveys, sells, transfers or leases all or substantially all of its assets to another entity. Among the exceptions provided in the indenture are for transactionsdescribed in (c), (d) and (e) in which (i) Aegerion’s common stock holders immediately prior to the transaction have the right to exercise, directly or indirectly,50% or more of the total voting power of the capital stock of the continuing or surviving entity or transferee or parent thereof following the transaction or (ii) 90%of the consideration paid for Aegerion’s common stock in a transaction consists of stock that is or will be quoted on the New York Stock Exchange or NASDAQ.Further, unless Aegerion elects to deliver solely our common shares to settle a conversion of Convertible Notes, Aegerion would be required to settle a portion orall of the conversion obligation through the payment of cash, which could adversely affect its liquidity. Aegerion may not have enough available cash or be able toobtain financing at the time it is required to make repurchases of Convertible Notes surrendered therefor or Convertible Notes being converted. The failure torepurchase Convertible Notes at a time when the repurchase is required by the indenture or to pay any cash payable on future conversions of the Convertible Notesas required by the indenture would constitute a default under the indenture. A default under the indenture or a fundamental change itself could also lead to a defaultunder agreements governing our or Aegerion’s current and future indebtedness. If the repayment of the related indebtedness were to be accelerated after anyapplicable notice or grace periods, Aegerion may not have sufficient funds to repay the indebtedness and repurchase the Convertible Notes or make cash paymentsupon conversions thereof. In addition, even if holders of the Convertible Notes do not elect to convert their Convertible Notes, Aegerion could be required underapplicable accounting rules to reclassify all or a portion of the outstanding principal of the Convertible Notes as a current rather than long-term liability, whichwould result in a material reduction of Aegerion’s net working capital.79Aegerion’s indebtedness and other financial obligations and contractual commitments, could adversely affect our financial health and our ability to respond tochanges in our business.Aegerion’s significant indebtedness, and our financial obligations and contractual commitments, could have important consequences. For example, it could:•make us more vulnerable to adverse changes in general U.S. and worldwide economic, industry and competitive conditions and adverse changes ingovernment regulation;•limit our flexibility in planning for, or reacting to, changes in our business and our industry;•place us at a disadvantage compared to our competitors who have less debt; and•limit our ability to borrow additional amounts for working capital, capital expenditures, acquisitions, general corporate purposes or other purposes, orraise additional capital through equity or other types of financings.Our leverage resulting from our or Aegerion’s debt could materially and adversely affect our ability to finance our operations or capital needs or to engage in otherbusiness activities. In addition, we cannot be sure that additional financing will be available when required or, if available, will be on terms satisfactory to us.Further, even if we are able to obtain additional financing, we may be required to use proceeds to repay a portion of Aegerion’s debt. Any of these factors couldmaterially and adversely affect our business, financial condition and results of operations on a consolidated basis. In addition, if we or Aegerion incur additionalindebtedness, the risks related to our business and our ability to service or repay our indebtedness would increase.Our internal controls over financial reporting could fail to prevent or detect misstatements or have material weaknesses.Our internal controls over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods aresubject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures maydeteriorate. Any failure to maintain effective internal controls or to timely effect any necessary improvement or remediate any lapse in our internal control anddisclosure controls could, among other things, result in losses from fraud or error, require significant resources and divert management’s attention, harm ourreputation, causing investors to lose confidence in our reported financial and other information, and expose use to legal or regulatory proceedings, all of whichcould have a material adverse effect on our financial condition, results of operations and cash flows.During 2016, a material weakness in internal control over financial reporting was identified relating to business combinations. Management is taking steps toremediate this material weakness and performed additional analysis and procedures to conclude that the Consolidated Financial Statements included in this AnnualReport fairly present, in all material respects, our financial condition and results of operations as of and for the year ended December 31, 2016. See "Management'sAnnual Report On Internal Control Over Financial Reporting." However, we may be unable to remediate this weakness effectively, and, even if we do remediatethis weakness, we may in the future identify additional material weaknesses.We may never be profitable.Our ability to become profitable depends upon our ability to generate significant revenue. We may never generate substantial revenues from the sale of metreleptinor lomitapide. Our ability to generate revenues sufficient to achieve profitability currently depends on a number of factors, including our ability to:•build and maintain market acceptance for MYALEPT in the U.S. for the treatment of GL, and supporting named patient sales of metreleptin in GL inBrazil, France, Turkey, and other key countries where such sales are permitted as a result of the U.S. approval or under local law;•prepare for the launch of metreleptin in Europe as a treatment for complications of leptin deficiency in GL patients and a subset of PL, in the event weobtain regulatory, pricing and reimbursement approvals in the EU for metreleptin;•pursue possible lifecycle management opportunities for metreleptin, including potential future clinical development of metreleptin in additionalindications;•stabilize sales of JUXTAPID as a treatment for adult HoFH patients in the U.S. despite competition from PCSK9 inhibitor products, among other factors,which have had a significant adverse impact on sales of JUXTAPID, and gain such market acceptance in the other countries where lomitapide is approvedand being commercialized, including Japan, or may in the future receive approval and be commercialized; •manage our costs and expenses to better align with our revenues and strengthening our capital structure, while supporting approved products in acompliant manner;80•continue to have named patient sales of our products in Brazil and other key countries where such sales can occur as a result of the FDA approval,particularly in light of local economic challenges, ongoing governmental investigations, and ongoing court proceedings in Brazil reviewing the regulatoryframework for named patient sales;•obtain timely regulatory approval of metreleptin in the EU and other key international markets as a treatment for patients with GL or a subset of PL, andan expansion of the indication in the U.S. to include the PL subset, subject to discussions with the FDA, and obtain timely regulatory approval oflomitapide in other key international markets as a treatment for patients with HoFH where it makes business sense to seek approval, in each case withoutonerous restrictions or limitations in the resulting label;•gain pricing and reimbursement approvals to market our products in countries in which we elect to seek, and eventually obtain, regulatory approval, atacceptable prices and without significant restrictions, discounts, caps or other cost containment measures, and to effectively launch our products in thosecountries where it makes business sense to do so, including approval of metreleptin in the EU for GL and the PL subset and in the U.S. for the PL subset,subject to discussions with the FDA;•reviewing the clinical and regulatory pathway for zuretinol to determine the optimal development and business strategy for this product candidate;•minimize the number of patients who are eligible to receive but decide not to commence treatment with our products, or who discontinue treatment,including with lomitapide, due to tolerability issues, and with metreleptin, due to its route of administration as a daily injection, through activities such aspatient support programs, to the extent permitted in a particular country;•effectively estimate the size of the total addressable market for our products;•maintain reimbursement policies for JUXTAPID and MYALEPT in the U.S. that do not impose significant restrictions on reimbursement and a payer mixthat does not include significantly more Medicaid patients than the current payer mix;•minimize the expected negative impact of the availability of PCSK9 inhibitor products on sales of lomitapide outside the U.S., including in Japan, wherewe launched JUXTAPID in December 2016 and where a PCSK9 inhibitor product is available, and the degree to which the availability of PCSK9inhibitor products outside the U.S., and the potential availability of named patient sales of PCSK9 inhibitor products outside the U.S., impacts namedpatient sales of lomitapide outside the U.S., particularly in Brazil; and•effectively respond to requirements of insurance companies, managed care organizations, other private payers, and government entities that providereimbursement for medical costs in the U.S. to require that newly diagnosed adult HoFH patients be treated with PCSK9 inhibitor products prior toJUXTAPID treatment, that current JUXTAPID patients switch to PCSK9 inhibitor products, and that potential JUXTAPID patients fail to adequatelyrespond to PCSK9 inhibitor products before providing reimbursement for JUXTAPID at the prices at which we offer JUXTAPID.In addition, as described above, federal enforcement agencies recently have shown interest in pharmaceutical companies’ product and patient assistance programs,including manufacturer reimbursement support services and relationships with specialty pharmacies, and contributions to charitable organizations that assistpatients in accessing treatment for certain diseases and conditions. In addition to the risks associated with the costs of responding to government investigation orenforcement actions (such as a False Claims Act action), federal enforcement agencies’ increased attention to such programs and contributions may lead to changesthat adversely affect our business. For example, we believe that investigations and enforcement actions by these agencies have resulted in a reduction incontributions to third-party 501(c)(3) organizations that assist patients in accessing treatment for certain diseases and conditions. If a lack of available fundsprevents these third-party 501(c)(3) organizations from providing adequate financial assistance, including assistance with co-payment obligations, to individualswho would otherwise be unable to afford our products, our revenues may decline below our expectations.Our products may not gain or maintain long-term market acceptance or achieve or maintain commercial success. In addition, we anticipate incurring significantcosts associated with commercializing our products, and meeting our post-marketing commitments, in connection with our ongoing clinical efforts related to ourproducts and in connection with defense against government investigations and other legal actions. We may not continue to generate substantial revenue from salesof lomitapide, or generate substantial revenue from sales of metreleptin. We may not achieve profitability. If we are unable to continue to generate significantproduct revenue, we will not become profitable, and may be unable to continue operations without additional funding.We will likely need to raise substantial additional capital in the future. If additional capital is not available at all or on acceptable terms when we need it, wewill have to delay, reduce or cease operations.Aegerion's acquisition of metreleptin, the significant negative impact of PCSK9 inhibitor products on U.S. JUXTAPID sales, the payments by Aegerion to thegovernment under the preliminary agreements in principle with respect to the ongoing investigations, if finalized, and the costs and expenses Aegerion hasincurred, and expects to continue to incur, in connection with ongoing government investigations have significantly diminished the capital we have to fundanticipated and unanticipated expenses. 81In light of the reduction in capital available for Aegerion’s operations in 2016, Aegerion implemented reductions in force intended to better align our operatingexpenses with our expected revenues, out-licensed lomitapide in the EU, and withdrew lomitapide from certain other global markets. We may need to implementadditional cost containment measures based on our updated forecast of expected revenues, particularly due to the declining revenues from JUXTAPID in the U.S.There can be no assurance, however, that these reductions in force and cost containment measures will result in the cost savings we anticipate or that additionalcost containment measures will be capable of being obtained or implemented. Accordingly, we will likely need to seek additional capital through debt or equityfinancing to service our indebtedness, strengthen our cash position and fund our operations. We may not be able to obtain additional capital when we need it orsuch capital may not be available on terms that are favorable to us, particularly while Aegerion’s preliminary agreements in principle to resolve the aspects of theongoing DOJ and SEC government investigations remain subject to final approvals and while the Convertible Notes are outstanding. We may also pursueopportunities to obtain additional external financing in the future through lease arrangements related to facilities and capital equipment, collaborative research anddevelopment agreements, and license agreements, in order to, among other things, finance additional potential product acquisitions and maintain sufficientresources for unanticipated events. Any such additional financing may not be available when we need it or may not be available on terms that are favorable to us.Our need to raise additional capital in the future, and the size of any such financings, will depend on many factors, including:•the success of our commercialization efforts and the level of revenues generated from sales of metreleptin and lomitapide in the U.S.;•the level of revenue received from named patient sales of metreleptin and lomitapide in Brazil and other key countries where a mechanism exists to sellthe product on a pre-approval basis in such country based on U.S. approval of such products or EU approval of lomitapide, particularly in light of theavailability of a PCSK9 inhibitor product in Brazil and the ongoing court proceedings in Brazil reviewing the regulatory framework for named patientsales;•the level of physician, patient and payer acceptance of lomitapide and metreleptin;•our ability to continue to manage our costs and expenses to better align with our revenues and strengthen our capital structure, while supporting approvedproducts in a compliant manner;•gaining regulatory and pricing and reimbursement approvals to market our products in countries in which the products are not currently approved and/orreimbursed, where it makes business sense to seek such approval, without significant restrictions, discounts, caps or other cost containment measures,including regulatory and pricing and reimbursement approval of metreleptin in the EU, in connection with which we filed an MAA in the EMA inDecember 2016, and regulatory approval of metreleptin in the U.S. for a subset of PL based on the existing clinical data package for metreleptin, subjectto discussions with the FDA;•the extent of the negative impact of the availability of PCSK9 inhibitor products on sales of JUXTAPID in the U.S., which, among other factors, havecaused a significant number of JUXTAPID patients to discontinue JUXTAPID and switch to a PCSK9 inhibitor product, and significantly decreased therate at which new HoFH patients start treatment with lomitapide;•the provision of free PCSK9 inhibitor drug to adult HoFH patients by the companies that are commercializing PCSK9 inhibitor products, which suchcompanies may have ceased, but which historically has had a negative impact on the rate at which new patients start treatment with lomitapide and hascaused more patients than we expected to discontinue lomitapide and switch their treatment to PCSK9 inhibitor products;•requirements of insurance companies, managed care organizations, other private payers, and government entities that provide reimbursement for medicalcosts in the U.S. to require that newly diagnosed adult HoFH patients be treated with PCSK9 inhibitor products prior to JUXTAPID, that currentJUXTAPID patients switch to PCSK9 inhibitor products, and that patients fail to adequately respond to PCSK9 inhibitor products before providingreimbursement for JUXTAPID at the prices at which we offer JUXTAPID;•the willingness of insurance companies, managed care organizations, other private payers, and government entities that provide reimbursement formedical costs in the U.S. to continue to provide reimbursement for our products at the prices at which we offer our products without imposing anyadditional major hurdles to access or other significant restrictions or limitations, and the ability and willingness of HoFH and GL patients to pay, or toarrange for payment assistance with respect to, any patient cost-sharing amounts for our products applicable under their insurance coverage, particularlyin light of recent reductions in contributions to 501(c)(3) patient organizations by pharmaceutical companies;•the cost of building and maintaining the sales and marketing capabilities necessary for the commercialization of our products for their targeted indicationsin the market(s) in which each has received regulatory approval and we elect to commercialize such products, to the extent reimbursement and pricingapprovals are obtained, and certain other key international markets, if approved;•the timing and costs of future business development opportunities;•the timing and cost of seeking regulatory approvals and conducting potential future clinical development of metreleptin in additional indications, pursuingpossible lifecycle management opportunities for metreleptin, and conducting potential development of the zuretinol program;82•the cost of filing, prosecuting and enforcing patent claims, including the cost of defending any challenges to the patents or our claims of exclusivity;•the status of ongoing government investigations and lawsuits, including the disclosure of possible or actual outcomes, including regarding the preliminaryagreements in principle that have been reached with the DOJ and the SEC;•the costs of our manufacturing-related activities and the other costs of commercializing our products;•the costs associated with ongoing government investigations and lawsuits, including any damages, settlement amounts, fines or other payments, orimplementation of compliance related agreements or consent decrees, that may result from settlements or enforcement actions related to governmentinvestigations or whether we are successful in our efforts to defend ourselves in, or to settle on acceptable terms, ongoing or future litigation;•the levels, timing and collection of revenue received from sales of our products in the future;•the timing and costs of satisfying our debt obligations, including interest payments and any amounts due upon the maturity of such debt, including underthe Convertible Notes;•the cost of our observational cohort studies and other post-marketing commitments, including to the FDA and in any other countries where our productsare ultimately approved; and•the timing and cost of other clinical development activities.We may be unable to obtain additional financing on favorable terms, or at all. If we are unable to obtain additional financing, including for purposes of settlingconversions of the Convertible Notes, we may be required to delay, reduce or cease operations, including our planned development, sales and marketing andbusiness development efforts. Any of these outcomes would harm our business, financial condition and operating results. The source, timing and availability of anyfuture financing will depend principally upon equity and debt market conditions, interest rates and, more specifically, on our commercial success, the status ofAegerion’s ongoing government investigations and the results of our future development efforts. Any additional sources of financing could involve the issuance ofour equity securities, which would have a dilutive effect on our shareholders.Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights. Shareholders may alsoexperience dilution as a result of the exercise of outstanding warrants or the conversion of Convertible Notes into shares.We may seek additional capital through a combination of private and public equity offerings, debt financings and collaborations and strategic and licensingarrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existingshareholders will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our shareholders.For example, our existing shareholders may be diluted if the Convertible Notes are converted by their holders into Novelion common shares. Additionally, inconnection with the acquisition of Aegerion and the private placement that immediately preceded such acquisition, we issued the Warrants. Shareholders may bediluted if the Warrants become exercisable following the settlement of the Class Action Litigation and/or the settlement of the DOJ and the SEC investigations, ineach case, for an amount in excess of the negotiated thresholds. Debt financing, if available, would result in increased fixed payment obligations and may involveagreements that include covenants limiting or restricting our ability to take specific actions such as incurring debt, making capital expenditures or declaringdividends. If we raise additional funds through collaboration, strategic alliance and licensing arrangements with third parties, we may have to relinquish valuablerights to our technologies, future revenue streams or product candidates, or grant licenses on terms that are not favorable to us.Risks Related to our Common Shares and Jurisdiction of IncorporationThe market price of our common shares has been, and may continue to be, highly volatile.Our share price is highly volatile and is subject to wide fluctuations in price in response to various factors, many of which are beyond our control, including thefollowing:•the short-term or long-term success or failure of our commercialization efforts and the level of revenues generated from sales of our products in the U.S.;•the level of revenue we receive from named patient sales of our products in Brazil and other key countries where a mechanism exists to sell the product ona pre-approval basis in such country based on U.S. approval of such products or EU approval of lomitapide, particularly in light of the regulatory approvalof Amgen’s PCSK9 inhibitor product in Brazil in April 2016, the potential availability of that and other PCSK9 inhibitor products on a named patientsales basis in Brazil, and the ongoing court proceedings in Brazil reviewing the regulatory framework for named patient sales;•the short-term or long-term success or failure of the commercialization of our products in key countries outside the U.S. in which we have or obtainapproval, and the level of revenues we generate;83•our ability to accurately forecast net product sales and operating expenses, and to meet such forecasts;•our ability, or lack thereof, to manage our costs and expenses to better align with our revenues, and strengthen our capital structure, while supportingapproved products in a compliant manner;•the timing and cost of seeking regulatory approvals and conducting potential future clinical development of metreleptin in additional indications, pursuingpossible lifecycle management opportunities for metreleptin, and conducting potential development of the zuretinol program;•any issues that may arise with our supply chain for our products;•any adverse regulatory decisions, or regulatory issues that arise, made with respect to our products;•any issues that may arise with respect to the safety of our products;•the perception of the terms of the preliminary agreements in principle reached with the DOJ and the SEC and in connection with their investigations, andany adverse consequences that may result from such preliminary agreements in principle, such as additional litigation or investigations, and risks relatedto finalization of the preliminary agreements in principle and outstanding required approvals in respect thereof; •our ability to defend ourselves successfully against claims made in securities class action lawsuits, and, if we are unsuccessful in such defense or decide tosettle, the type and amount of any damages, settlement amounts, fines or other payments or adverse consequences that may result;•the extent to which the changes to the JUXTAPID REMS program, approved by the FDA on January 3, 2017, including the requirements set forthelsewhere in these “Risk Factors” and the “Business” section of this Annual Report, may negatively affect the ability or willingness of a physician toprescribe JUXTAPID, a patient to be willing to initiate or continue on JUXTAPID therapy, or insurance companies, managed care organizations, otherprivate payers, and government entities that provide reimbursement for medical costs to continue to provide reimbursement for JUXTAPID;•the extent to which changes to the labeling for JUXTAPID instructing patients to cease therapy upon the occurrence of severe diarrhea may negativelyaffect the ability or willingness of a healthcare professional to prescribe JUXTAPID, a patient to be willing to initiate or continue on therapy, or insurancecompanies, managed care organizations, other private payers, and government entities that provide reimbursement for medical costs to continue toprovide reimbursement for JUXTAPID;•any adverse actions or decisions related to our intellectual property or marketing or data exclusivity, or any action by a third party to gain approval of ageneric or biosimilar product, including, for lomitapide, for which a generic challenge could have been filed with the FDA as of December 21, 2016;•fluctuations in stock market prices and trading volumes of similar companies;•general market conditions and overall fluctuations in U.S. and Canadian equity markets;•low trading volume and short interest positions in our common shares;•international financial market conditions, including the ongoing sovereign debt crisis in the EU;•variations in our quarterly operating results;•changes in our financial guidance or securities analysts’ estimates of our financial performance;•announcements of investigations or litigation, and updates to the status of investigations and litigation, or other notifications from enforcement orregulatory authorities related to our business or business practices;•announcements of clinical data, regulatory submissions, product launches, new products, services or technologies, commercial relationships, acquisitionsor other events by us or our competitors;•changes in or materially incorrect application of accounting principles;•issuance by us of new securities, or sales of large blocks of our common shares, including sales by our executive officers, directors and significantshareholders;•the dilutive effect of the Convertible Notes or any other equity or equity-linked financings or alternative strategic arrangements;•the acceleration of our or Aegerion’s long-term debt;•additional changes in, or loss of, key personnel;•success or failure of products within our therapeutic areas of focus;84•discussion of us or our share price by the financial press and in online investor communities;•our relationships with and the conduct of third parties on which we depend; and•other risks and uncertainties described in these risk factors.In particular, our revenue guidance relating to 2017 is predicated on many assumptions, most notably that we have correctly forecast our U.S. and non-U.S.revenues for both of our products, including for sales of JUXTAPID in Japan and for named patient sales of both products to the federal Ministry of Health inBrazil, and that sales continue as we have forecasted to those patients who have previously received JUXTAPID or MYALEPT and, in Brazil, to new patients whohave obtained federal court orders for JUXTAPID or MYALEPT treatment, particularly in light of the ongoing investigations in Brazil and the trial currently beingheard by the Brazil Supreme Federal Court to decide whether the government has an obligation to provide drugs, such as JUXTAPID and MYALEPT, that havenot received regulatory and/or pricing and reimbursement approval in Brazil. Such factors may cause additional delays or eventually the suspension of the orderingprocess in Brazil. We have also assumed that our forecasts concerning named patient sales of metreleptin in other key markets, including France and Turkey, arecorrect. If any of our assumptions turn out to be incorrect, including our assumptions with respect to our ability to build and maintain market acceptance for ourproducts for GL and HOFH in territories in which they have been approved or are eligible for named patient sales, or the extent of the negative impact of theavailability of PCSK9 inhibitor products in the U.S., the EU, Japan, and Brazil on our sales of lomitapide in those countries and in other countries where PCSK9inhibitors are, in the future, approved or available on a named patient basis, our 2017 financial results could be weaker than expected, and the price of our commonshares could decline, perhaps precipitously.In addition, the stock market in general, and the market for small pharmaceutical and biotechnology companies in particular, have experienced extreme price andvolume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Also, broad market and industry factorsmay negatively affect the market price of our common shares, regardless of our actual operating performance. In the past, following periods of volatility in themarket in a company’s stock, securities class-action litigation has often been instituted against such a company. Aegerion, and certain of its former executiveofficers, have been named as defendants in a federal securities class action lawsuit filed against it alleging that Aegerion and the officers made certain false andmisleading statements in violation of federal securities laws. See “Legal Proceedings” section of this Annual Report for further information. These proceedingshave, and similar litigation could, if instituted against us, result in substantial costs and diversion of management’s attention and resources, which could materiallyand adversely affect our business and financial condition.Our business could be negatively affected as a result of proxy contests and other actions of activist shareholders.Proxy contests have been waged against many companies in the biopharmaceutical industry over the last few years. If faced with a proxy contest, we may not beable to successfully defend against the contest, which would be disruptive to our business. Even if we are successful, our business could be adversely affected by aproxy contest because:•responding to proxy contests and other actions by activist shareholders may be costly and time-consuming and may disrupt our operations and divert theattention of our management and our employees;•perceived uncertainties as to our future direction may result in our inability to consummate potential acquisitions, collaborations or in-licensingopportunities and may make it more difficult to attract and retain qualified personnel and business partners; and•if individuals are elected to our Board of Directors with a specific agenda different from our strategy for creating long-term shareholder value, it mayadversely affect our ability to effectively and timely execute on our strategic plans and create additional value for our shareholders.Anti-takeover provisions in our Articles, certain provisions under the BCBCA, the Canadian take-over bid rules and our advance notice policy could prevent ordelay transactions that our shareholders may favor and may prevent shareholders from changing the direction of our business or management.Provisions of our Articles and certain provisions under the British Columbia Business Corporations Act (BCBCA) may discourage, delay or prevent a merger oracquisition that our shareholders may consider favorable, including transactions in which shareholders might otherwise receive a premium for their shares, andmay also frustrate or prevent any attempt by shareholders to change our direction or management. For example, these provisions:•require a 66 2/3% majority of shareholder votes cast in favor of a resolution to effect various amendments to our Articles; and85•require shareholder proposals for matters to be acted upon by shareholders at shareholder meetings to be submitted pursuant to, and in accordance with,the applicable provisions of the BCBCA for inclusion in the Company’s proxy materials by a date that is not later than three months prior to theanniversary date of the prior year’s shareholder meeting.Canada’s take-over bid rules provide that take-over bids for Canadian issuers will be subject to a minimum 105-day deposit period, subject to certain exceptions.The take-over bid rules, together with the above-noted provisions, among others, whether alone or together, could delay or impede hostile takeovers and changes incontrol. Any provision of our constating documents that has the effect of delaying or deterring a change in control could limit the opportunity for our shareholdersto receive a premium for their common shares and could also affect the price that some investors are willing to pay for our common shares.We also have a shareholder-approved advance notice policy which establishes advance notice requirements for nominations for election to our Board of Directors.This policy may delay or impede changes to the composition of our Board of Directors or management.Provisions of Canadian law may delay, prevent or make undesirable an acquisition of all or a significant portion of our common shares or assets.The Investment Canada Act subjects an acquisition of control of us by a non-Canadian to government review if our enterprise value as calculated pursuant to thelegislation exceeds a threshold amount. A reviewable acquisition may not proceed unless the relevant Minister is satisfied that the investment is likely to be of netbenefit to Canada. This could prevent or delay a change of control and may eliminate or limit strategic opportunities for shareholders to sell their common shares.The rights of our shareholders may differ from the rights typically offered to shareholders of a U.S. corporation, including the right to bring actions or enforcejudgments against us and certain of our directors, and these differences may make our common shares less attractive to investors.We are incorporated under the laws of the Province of British Columbia, Canada, and therefore certain of the rights of holders of its shares are governed byCanadian law, including the provisions of the BCBCA, and by our Notice of Articles and Articles. These rights differ in certain respects from the rights ofshareholders in typical U.S. corporations and these differences may make our common shares less attractive to investors. For example, certain of our directors andofficers reside principally outside of the U.S. and a portion of our assets and a portion of the assets of these persons are located outside the U.S., and, as aconsequence, it may not be possible for an investor to effect service of process within the U.S. on us or those persons. Furthermore, it may not be possible for aninvestor to enforce judgments obtained in U.S. courts based upon the civil liability provisions of U.S. federal securities laws or other laws of the U.S. against us orthose persons.An investor may be unable to bring actions or enforce judgments against us and certain of our directors.We are incorporated under the laws of the Province of British Columbia. Certain of our directors and officers reside principally outside of the U.S. and a portion ofour assets and a portion of the assets of these persons are located outside the U.S. Consequently, it may not be possible for an investor to effect service of processwithin the U.S. on us or those persons. Furthermore, it may not be possible for an investor to enforce judgments obtained in U.S. courts based upon the civilliability provisions of U.S. federal securities laws or other laws of the U.S. against us or those persons.We do not intend to pay dividends on our common shares and, consequently, a shareholder’s ability to achieve a return on investment will depend onappreciation in the price of our common shares.We have never declared or paid any cash dividend on our common shares, and do not currently intend to do so for the foreseeable future. We currently anticipatethat we will retain any future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividendsfor the foreseeable future. Therefore, the success of an investment in our common shares will depend upon any future appreciation in the value of such shares.There is no guarantee that our common shares will appreciate in value or even maintain the price at which our shareholders have purchased their common shares.Future sales of our common shares may cause our share price to decline.Sales of a substantial number of shares of our common shares in the public market or a sale of securities convertible into common shares or the perception thatthese sales might occur, could significantly reduce the market price of our common shares and impair our ability to raise adequate capital through the sale ofadditional equity securities. If our existing shareholders sell, or if the market believes our existing shareholders will sell, substantial amounts of our common sharesin the public market, the trading price of our common shares could decline significantly. If additional shares are sold, or if it is perceived that they will be sold, inthe public86market, the price of our common shares could decline substantially. We have registered approximately 13,000,000 common shares that are subject to outstandingoptions to purchase common shares and restricted stock unit awards and reserved for issuance under our equity plans, and will need additional shares for equityawards in the near future. These common shares can be freely sold in the public market upon issuance, subject to vesting restrictions.Changes in our effective income tax rate could adversely affect our results of operations.We or our subsidiaries are subject to income and other taxes in Canada, the U.S., and many other tax jurisdictions throughout the world. Tax rates in thesejurisdictions may be subject to significant change. Our effective income tax rate can vary significantly between periods due to a number of complex factors,including, but not limited to: (i) interpretations of existing tax laws; (ii) the accounting for business combinations, including accounting for contingentconsideration; (iii) the tax impact of existing or future healthcare reform legislation; (iv) changes in accounting standards; (v) changes in the mix of earnings in thevarious tax jurisdictions in which we operate; (vi) the outcome of examinations by the Canada Revenue Agency, the U.S. Internal Revenue Service (IRS) and otherforeign tax authorities; (vii) adjustments to income taxes upon finalization of income tax returns; (viii) the accuracy of our estimates for unrecognized tax benefits;and (ix) increases or decreases to valuation allowances recorded against deferred tax assets. If our effective tax rate increases, our operating results and cash flowcould be adversely affected.Any changes to existing accounting pronouncements or taxation rules or practices may cause adverse fluctuations in our reported results of operations oraffect how we conduct our business.A change in accounting pronouncements or taxation rules or practices can have a significant effect on our reported results and may affect our reporting oftransactions completed before the change is effective. New accounting pronouncements, taxation rules and varying interpretations of accounting pronouncementsor taxation rules have occurred in the past and may occur in the future. The change to existing rules, future changes, if any, or the need for us to modify a currenttax or accounting position may adversely affect our reported financial results or the way we conduct our business.We may be treated as a U.S. domestic corporation for U.S. federal income tax purposes.Under current U.S. federal tax law, a corporation is generally considered for U.S. federal income tax purposes to be a tax resident in the jurisdiction of itsorganization or incorporation. Accordingly, under the generally applicable U.S. federal income tax rules, because we are incorporated under the laws of BritishColumbia, Canada, we would be classified as a non-U.S. corporation (and, therefore, not a U.S. tax resident) for U.S. federal income tax purposes. Section 7874 ofthe Internal Revenue Code of 1986, as amended (the Code) provides an exception to this general rule, under which a non-U.S. incorporated entity will neverthelessbe treated as a U.S. corporation for U.S. federal income tax purposes (and, therefore, as a U.S. tax resident subject to U.S. federal income tax on its worldwideincome) if each of the following three conditions are met: (i) the non-U.S. corporation, directly or indirectly, acquires substantially all of the properties helddirectly or indirectly by a U.S. corporation (including through the acquisition of all of the outstanding shares of the U.S. corporation), (ii) the non-U.S.corporation’s “expanded affiliated group” does not have “substantial business activities” in the non-U.S. corporation’s country of organization or incorporation andtax residence relative to the expanded affiliated group’s worldwide activities and (iii) after the acquisition, the former shareholders of the acquired U.S. corporationhold at least 80% (by either vote or value) of the shares of the non-U.S. acquiring corporation by reason of holding shares in the U.S. acquired corporation (takinginto account the receipt of the non-U.S. corporation’s shares in exchange for the U.S. corporation’s shares) as determined for purposes of Section 7874 (this test isreferred to as the 80% ownership test).On April 4, 2016, the U.S. Treasury Department (Treasury) and the IRS issued the Temporary Section 7874 Regulations, which, among other things, requirecertain adjustments that generally increase, for purposes of the 80% ownership test, the percentage of the shares of the acquiring non-U.S. corporation deemedowned (within the meaning of Section 7874) by the former shareholders of the acquired U.S. corporation by reason of holding shares in such U.S. corporation. Itis possible that Aegerion shareholders could be deemed to acquire for purposes of Section 7874 more than 80% of Novelion in the Merger and that as a result wewill be treated as a U.S. corporation for U.S. federal income tax purposes. If we were to be treated as a U.S. corporation for U.S. federal tax purposes, we couldsuffer adverse tax consequences, including potential U.S. income taxes on future profits distributed from non-U.S. subsidiaries and loss of eligibility for benefitsunder the income tax treaty between Canada and the U.S.If the Section 7874 percentage is calculated to be at least 60% or more (but less than 80%), Section 7874 can limit the ability of the acquired U.S. corporation andits U.S. affiliates to utilize U.S. tax attributes such as net operating losses to offset U.S. taxable income resulting from certain transactions. Additionally, relatedrules may impose an excise tax under Section 4985 of the Code on the gain recognized by certain “disqualified individuals” (including officers and directors of aU.S. company) on certain stock-based compensation held by such individuals at a rate equal to 15%. We may, if we determine that it is appropriate, providedisqualified individuals with payments to offset this excise tax, so that, on a net after-tax basis, they would be in the same position as if no such excise tax had beenapplied.87After taking into account the relevant adjustments under the temporary 7874 regulations and based on the facts and circumstances as of the date of the Merger, theSection 7874 percentage following the Merger is expected to be less than 60% and, thus, we do not expect the excise tax to apply to "disqualified individuals."However, if the IRS determines that the exercise tax does apply, the payment of such excise tax will be costly to us.We may not be able to achieve tax savings as a result of the Merger.Even if we are not treated as a U.S. corporation for U.S. federal income tax purposes under the inversion rules discussed above, there can be no assurance as to theeffective tax rates applicable to our future revenue. For example, the ability of the companies to locate personnel and to integrate and manage operations in amanner that supports and protects the tax benefits that potentially may be realized from Novelion’s Canadian tax domicile is uncertain and complex.Potential improvements to our effective tax rate that may result from Novelion’s Canadian tax domicile have not been reflected in the pro forma financialinformation.We may not be able to use our net operating loss carryforwards (NOLs) to offset future taxable income for U.S. or Canadian federal income tax purposes.As of December 31, 2016, we had NOLs for U.S. federal income tax purposes of approximately $14.3 million, which expire at various dates through 2036.Under Section 382 of the Code, if a corporation subject to the Code undergoes an “ownership change,” generally defined as a greater than 50% change (by value)in its equity ownership over a three-year period, the corporation’s ability to use its pre-change U.S. net operating loss carryforwards (NOLs), and other pre-changetax attributes (such as research tax credits) to offset its post-change income may be limited. We underwent an “ownership change” within the meaning of Section382 and 383 of the Code as a result of the Merger, and therefore an annual limit may be imposed on the amount of NOLs that may be used to offset future taxableincome. Such annual limit is generally the product of the total value of a company’s outstanding equity immediately prior to an “ownership change” (subject tocertain adjustments) and the applicable federal long term tax exempt interest rate. Certain of our U.S. subsidiaries underwent an “ownership change” (as definedabove) and triggered the limitation on use of NOLs in 2005, 2012, and 2016. Due to the ownership changes, we have determined that our U.S. subsidiaries,including Aegerion, will only be able to utilize a small percentage of their NOLs and tax attributes. In connection with the Merger, we have determined thatAegerion had a net unrealized built-in-loss (“NUBIL”). The NUBIL was determined based on the difference between the fair market value of Aegerion’s assetsand their tax basis as of the ownership change date. Because of the NUBIL, certain deductions recognized during the five-year period beginning on the date of theSection 382 ownership change are subject to the same limitation as the NOL carryforwards. Our U.S. subsidiaries may also experience ownership changes in thefuture as a result of subsequent shifts in share ownership. As a result, if our U.S. subsidiaries earn net taxable income, their ability to use their pre-change NOLcarryforwards to offset U.S. federal taxable income may be subject to limitations, which could potentially result in increased future tax liabilities. In addition, at theU.S. state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxesowed.As of December 31, 2016, we had NOLs for Canadian federal income tax purposes of approximately $152.6 million, which expire at various dates through2036. The extent to which we can utilize any or all of our NOLs will depend on many factors, including the jurisdiction applicable to any future taxable revenue ofNovelion.Our ability to use NOLs will also depend on the amount of taxable income generated in future periods. The NOLs may expire before we can generate sufficienttaxable income to use the NOLs.We may be treated as a passive foreign investment corporation (a PFIC) for U.S. federal income tax purposes, which could result in adverse U.S. federalincome tax consequences to U.S. holders and may deter certain U.S. investors from purchasing our shares.We believe that we were a PFIC for the taxable years ended December 31, 2008 through 2015. Based on the price of our common shares and the composition ofour assets, we believe that we will not be deemed a PFIC for U.S. federal income tax purposes for the taxable year ended December 31, 2016. The determination ofwhether we are a PFIC is made annually and depends on the particular facts and circumstances (such as the valuation of its assets, including goodwill and otherintangible assets) and also may be affected by the application of the PFIC rules, which are subject to differing interpretations.The rules governing PFICs can have adverse tax effects on U.S. holders which may be mitigated by making certain elections for U.S. federal income tax purposes,which elections may or may not be available. If we are determined to be a PFIC in any year, a U.S. holder of common shares in such year will be required to file anannual information return on IRS Form 8621 regarding88distributions received on such common shares and any gain realized on disposition of such common shares and will generally be required to file an annualinformation return with the IRS (also on IRS Form 8621, which PFIC shareholders are required to file with their U.S. federal income tax or information return)relating to their ownership of our common shares. Additionally, if we are classified as a PFIC in any taxable year, with respect to which a U.S. holder ownscommon shares, we generally will continue to be treated as a PFIC with respect to such U.S. holder in all succeeding taxable years, regardless of whether wecontinue to meet the tests described above, unless the U.S. holder makes a “deemed sale election.” Treatment as a PFIC could deter certain U.S. investors frompurchasing our common shares, which could have an adverse impact on our share price. For purposes of this risk factor, a “U.S. holder” is a beneficial owner ofour common shares or warrants that is for U.S. federal income tax purposes: (a) an individual who is a citizen or resident of the U.S.; (b) a corporation (or otherentity taxable as a corporation for U.S. federal income tax purposes) created or organized in or under the laws of the U.S., any state thereof or the District ofColumbia; (c) an estate the income of which is subject to U.S. federal income taxation regardless of its source; or (d) a trust (i) if a court within the U.S. canexercise primary supervision over its administration, and one or more U.S. persons have the authority to control all of the substantial decisions of that trust, or (ii)that has a valid election in effect under applicable Treasury regulations to be treated as a U.S. person.Item 1B.Unresolved Staff Comments.Not applicable.Item 2.Properties.During 2016, we exercised a one-year renewal option on our existing lease in Vancouver, British Columbia, where our head office is located. We currently leaseapproximately 8,475 square feet of space under the terms of this agreement. The lease term applicable to this space expires on August 31, 2017.Our U.S. operational office, which is located at One Main Street in Cambridge, Massachusetts, consists of approximately 31,571 square feet of office space under alease that expires in April 2019.We also lease office spaces in Japan, the UK, Switzerland, Germany, France, Italy, Canada, Brazil, and Turkey, with approximately 8,414 square feet of officespace in the aggregate. Our international lease agreements expire at various dates through the year 2021.In addition to the locations listed above, we hold inventory at various locations, including international locations, managed by third parties.Item 3.Legal Proceedings.In late 2013, our subsidiary, Aegerion, received a subpoena from the DOJ, represented by the U.S. Attorney’s Office in Boston, requesting documents regardingour marketing and sale of JUXTAPID in the U.S., as well as related disclosures. We believe the DOJ is seeking to determine whether Aegerion, or any of itscurrent or former employees, violated civil and/or criminal laws, including, but not limited to, the securities laws, the Federal False Claims Act, the FDCA, theAnti-Kickback Statute, and the FCPA. The investigation is ongoing.In late 2014, Aegerion received a subpoena from the SEC requesting certain information related to Aegerion’s sales activities and disclosures related toJUXTAPID. The SEC also has requested documents and information on a number of other topics, including documents related to the investigations by governmentauthorities in Brazil into whether Aegerion’s activities in Brazil violated Brazilian anti-corruption laws, and whether Aegerion’s activities in Brazil violated theFCPA. We believe the SEC is seeking to determine whether Aegerion, or any of its current or former employees, violated securities laws. The investigation isongoing.In May 2016, Aegerion reached preliminary agreements in principle with the DOJ and the SEC to resolve their investigations into the marketing and sales activitiesand disclosures relating to JUXTAPID. Under the terms of the preliminary agreement in principle with the DOJ, Aegerion would plead guilty to two misdemeanormisbranding violations of the FDCA. One count would be based on its alleged marketing of JUXTAPID with inadequate directions for use (21 U.S.C. §§ 352(f)),and the second count would involve an alleged failure to comply with a requirement of the JUXTAPID REMS program (21 U.S.C. §§ 352(y)). Aegerion wouldseparately enter into a five-year deferred prosecution agreement with regard to a charge that Aegerion violated HIPAA. As part of the resolution of the DOJinvestigation, we expect Aegerion to enter into a civil settlement agreement with the DOJ to resolve alleged violations of the False Claims Act, and a non-monetaryconsent decree with the FDA. We also expect to negotiate a corporate integrity agreement with the Department of Health and Human Services.Under the terms of the preliminary agreement in principle with the SEC staff, the SEC’s Division of Enforcement will recommend that the SEC accept a settlementoffer from Aegerion on a neither-admit-nor-deny basis that contains alleged negligent violations89of Sections 17(a)(2) and (3) of the Securities Act of 1933, as amended, related to certain statements we made in 2013 regarding the conversion rate of patientsreceiving JUXTAPID prescriptions, with remedies that include censure, an order prohibiting future violations of the securities laws and payment of a civil penalty.The preliminary agreements in principle provide for a consolidated monetary package that covers payments due to both the DOJ and the SEC. The consolidatedmonetary package covers payments due to both the DOJ and the SEC by Aegerion totaling approximately $40 million in the aggregate, to be payable over threeyears, which is updated from the originally proposed five-year payment schedule contemplated when the preliminary agreement in principle was reached in May2016. Certain outstanding amounts would accrue interest at a rate of 1.75% per annum. Such payments are subject to acceleration in the event of certain change ofcontrol transactions or the sale of JUXTAPID or MYALEPT. As of December 31, 2016, Aegerion had accrued an aggregate of $40.6 million for the payments tobe provided to the DOJ and the SEC under the consolidated monetary package, and an aggregate of $1.0 million for any relator attorney fees and settlement. InMarch 2017, the final relator agreements were signed and the Company paid out the attorney fees and settlement payments.The terms of the preliminary agreements in principle described above may change following further negotiations and other terms of the final settlement remainsubject to further negotiation. The preliminary agreement in principle with the DOJ is subject to approval of supervisory personnel within the DOJ and relevantfederal and state agencies, and approval by a U.S. District Court judge of the criminal plea and sentence and the civil settlement agreement. The preliminaryagreement in principle with the SEC is subject to review by other groups in the SEC and approval by the Commissioners of the SEC.The preliminary agreements in principle do not cover the DOJ and the SEC’s inquiries concerning Aegerion’s operations in Brazil, any potential claims by relatorsfor attorneys’ fees, or any employment claims that may been brought by relators.We continue to cooperate with the DOJ and the SEC with respect to their investigations. As part of this cooperation, the DOJ has requested documents andinformation related to donations Aegerion made in 2015 and 2016 to 501(c)(3) organizations that provide financial assistance to patients. As part of this inquiry,the DOJ may pursue theories that will not be covered by the preliminary agreement in principle with the DOJ. Other pharmaceutical and biotechnology companieshave disclosed similar inquiries regarding donations to patient assistance programs operated by independent charitable 501(c)(3) organizations.In addition, federal and state authorities in Brazil are conducting an investigation to determine whether there have been violations of Brazilian laws related to thepromotion of JUXTAPID in Brazil. In July 2016, the Ethics Council of Interfarma fined Aegerion approximately $0.5 million for violations of the industryassociation’s Code of Conduct, to which Aegerion is bound due to its affiliation with Interfarma. Also, the Board of Directors of Interfarma imposed an additionalpenalty of suspension of Aegerion’s membership, without suspension of Aegerion’s membership contribution, for a period of 180 days for Aegerion todemonstrate the implementation of effective measures to cease alleged irregular conduct, or exclusion of our membership in Interfarma if such measures are notimplemented. Aegerion paid approximately $0.5 million related to this fine during the third quarter of 2016. On March 27, 2017, after the suspension period ended,Interfarma’s Board of Directors decided to reintegrate Aegerion, enabling it to participate regularly in Interfarma activities, subject to meeting certain obligations.Also in July 2016, Aegerion received an inquiry from a Public Prosecutor Office of the Brazilian State of Paraná asking it to respond to questions related to recentmedia coverage regarding JUXTAPID and its relationship with a patient association to which Aegerion made donations for patient support. At this time, we do notknow whether the Public Prosecutor’s inquiry will result in the commencement of any formal proceeding against Aegerion, but if Aegerion’s activities in Brazil arefound to violate any laws or governmental regulations, Aegerion may be subject to significant civil lawsuits to be filed by the Public Prosecution office, andadministrative penalties imposed by Brazilian regulatory authorities and additional damages and fines. Under certain circumstances, Aegerion could be barred fromfurther sales to federal and/or state governments in Brazil, including sales of JUXTAPID and/or MYALEPT, due to penalties imposed by Brazilian regulatoryauthorities or through civil actions initiated by federal or state public prosecutors. As of the filing date of this Annual Report, we cannot determine if a loss isprobable as a result of the investigations and inquiry in Brazil and whether the outcome will have a material adverse effect on our business and, as a result, noamounts have been recorded for a loss contingency.In January 2014, a putative class action lawsuit was filed against Aegerion and certain of its former executive officers in the U.S. District Court for the District ofMassachusetts (the Court) alleging certain misstatements and omissions related to the marketing of JUXTAPID and Aegerion’s financial performance in violationof the federal securities laws. The case is captioned KBC Asset Management NV et al. v. Aegerion Pharmaceuticals, Inc. et al. , No. 14-cv-10105-MLW. OnMarch 11, 2015, the Court appointed co-lead plaintiffs and lead counsel. Co-lead plaintiffs filed an amended complaint on June 1, 2015. Aegerion filed a motion todismiss the amended complaint for failure to state a claim on July 31, 2015. On August 21, 2015, co-lead plaintiffs filed a putative second amendedcomplaint. On September 4, 2015, Aegerion moved to strike the second amended complaint for the co-lead plaintiffs’ failure to seek leave of court to file a secondamended pleading. Oral argument on the motion to strike was held on March 9, 2016. On March 23, 2016, plaintiffs filed a motion for leave to amend. Aegerionopposed this motion to amend, and following a hearing on April 29, 2016, the Court took defendants’ motion to strike and plaintiffs’ motion for leave to amendunder90advisement. On May 13, 2016, co-lead plaintiffs and defendants filed a joint motion wherein the parties stipulated that co-lead plaintiffs could file a third amendedpleading within 30 days of the motion, which the Court granted on May 18, 2016, thereby mooting defendants’ pending motion to strike the second amendedpleading and co-lead plaintiffs’ motion for leave to file a second amended pleading. The Court also entered a briefing schedule for defendants to file responsivepleadings, co-lead plaintiffs to file any opposition, and defendants to file reply briefs. A third amended complaint was filed on June 27, 2016. On July 22, 2016,co-lead plaintiffs and defendants filed a joint motion to stay the briefing schedule while they pursued mediation, which the Court granted on August 10, 2016. Through mediation, the co-lead plaintiffs and defendants reached an agreement in principle to settle the litigation on November 29, 2016. On January 17, 2017, theco-lead plaintiffs filed a stipulation of settlement with the Court that contained the settlement terms as agreed upon by the parties, including that Aegerion and itsinsurance carriers would contribute $22.25 million to a settlement fund for the putative class. The insurance carriers have agreed to cover $22.0 million of thisamount, with Aegerion responsible for the remainder of $0.25 million. The proposed settlement is subject to a number of procedural steps and is subject toapproval by the Court. Accordingly, we cannot predict the outcome of this action or when it will be resolved. We have recorded a loss contingency of $22.25million and insurance proceeds receivable of $22.0 million at December 31, 2016.On September 22, 2015, we commenced an action in the Supreme Court of British Columbia against Valeant Pharmaceuticals International, Inc. for breach ofcontract under the terms of the asset purchase agreement with Valeant (the Valeant Agreement), entered into on September 21, 2012, pursuant to which we sold allof our assets related to Visudyne ®, including our Qcellus™ laser and certain other photodynamic therapy intellectual property, with respect to failure to pay a$5.0 million laser earn-out payment and failure to use commercially reasonable efforts to promptly obtain the laser registrations for the Qcellus laser in the U.S. Asof December 31, 2016, we have recorded a long-term accounts receivable at its estimated fair value of zero and this zero fair value reflected management’sassessment of collection risk, the impact of the passage of time and the potential collection costs associated with the Valeant litigation. For additional information,refer to Note 16 - Contingencies, Commitments and Guarantees - Related to the Sale of Visudyne.Item 4.Mine Safety Disclosures.Not applicable.91PART IIItem 5.Market for Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities.Our common shares are traded in Canada on TSX and in the U.S. on NASDAQ under the symbol “NVLN”. The following table sets forth the high and low salesprices for our common shares in each of 2016 and 2015, as quoted on TSX and NASDAQ, as adjusted to give effect to the Consolidation discussed in Note 1-Description of Business , included in the “Consolidated Financial Statements and Supplementary Data” section of this Annual Report: Toronto Stock ExchangeNASDAQ Global Select Market2016High (CAD$)Low (CAD$)High (U.S.$)Low (U.S.$)First QuarterC$19.40C$12.55$11.85$8.19Second QuarterC$14.10C$8.00$9.37$6.10Third QuarterC$14.10C$8.50$10.95$6.52Fourth QuarterC$14.75C$10.25$13.80$7.652015First QuarterC$28.95C$23.25$21.19$16.13Second QuarterC$27.50C$21.50$19.18$14.03Third QuarterC$27.60C$17.75$18.92$11.46Fourth Quarter (1)C$21.15C$17.00$14.30$10.81 (1) Prior to completing the Merger with Aegerion on November 29, 2016, our shares traded under the symbol “QLTI” on NASDAQ.The last reported sale price of the common shares on TSX and on NASDAQ on March 1, 2017 was CAD$14.40 and USD$10.80, respectively.As of February 28, 2017, there were 1,119 registered holders of our common shares, 1,002 of whom were residents of the U.S. Of the total 18,533,029 commonshares outstanding, the portion held by registered holders resident in the U.S. was 15,954,267 or 86.09%. We have never paid any cash dividends on our common shares and we do not anticipate paying such cash dividends in the foreseeable future. We currentlyanticipate that we will retain all future earnings, if any, for use in the development of our business.Equity Compensation Plan Information as of December 31, 2016Information regarding our equity compensation plans is included in the “Security Ownership of Certain Beneficial Owners and Management and RelatedShareholder Matters” section of this Annual Report and incorporated in this Item 5 by reference.Performance GraphThe following performance graph compares cumulative total shareholder return on the common shares of NVLN for the last five fiscal years with the totalcumulative return of the NASDAQ Composite Index (U.S.), the NASDAQ Biotechnology Index, and the S&P/TSX Composite Index over the same period.Pursuant to applicable SEC rules, all values assume reinvestment of the full amount of all dividends, however no dividends have been declared on our commonshares to date.92 December 31, 2011December 31, 2012December 31, 2013December 31, 2014December 31, 2015December 31, 2016Novelion Therapeutics Inc.100.00109.17146.40105.4069.9259.79S&P/TSX Composite Index100.00109.52115.83117.1790.22112.31NASDAQ Biotechnology Index100.00132.74220.37296.19331.05260.37The graph above assumes $100 invested on December 31, 2011 in common shares of Novelion and in each index. The shareholder return shown above arehistorical and not necessarily indicative of future price performance, and we do not make or endorse any predictions as to future shareholder returns.Dividend PolicyWe have not declared or paid any dividends on our common shares since inception. The declaration of dividend payments is at the sole discretion of our Board ofDirectors. The Board of Directors may declare dividends in the future depending upon numerous factors that ordinarily affect dividend policy, including the resultsof our operations, our financial position and general business conditions.Recent Sales of Unregistered SecuritiesOn June 14, 2016, we entered into the Unit Subscription Agreement with the Investors. Pursuant to the Unit Subscription Agreement, immediately prior to theMerger, the Investors acquired units, for $8.80 per unit, on a post-Consolidation basis, consisting of (i) 2,472,727 Novelion common shares, which includes up to568,181 Novelion common shares issuable upon exercise of fully paid-up warrants, and (ii) Warrants exercisable for up to an aggregate of 2,644,952 Novelioncommon shares at an exercise price of $0.05 per common share. The aggregate consideration received under the Unit Subscription Agreement was approximately$21.8 million, which we intend to continue to use to support future operations and business development initiatives.Use of Proceeds from Registered SecuritiesNot applicable.93Purchases of Equity Securities by the Issuer and Affiliated PurchasersDuring the year ended December 31, 2016, there were no common share repurchases.Exchange Controls and Other Limitations Affecting Holders of Common SharesThere is no limitation imposed by Canadian law or the Notice of Articles or Articles of the Company on the right of non-residents to hold or vote common sharesin the Company, other than those imposed by the Investment Canada Act (Canada) (the Investment Act). Generally speaking, the Investment Act establishes thefollowing two principal procedures for certain investments involving Canadian businesses, as defined by the Investment Act, by an individual, government oragency thereof, corporation, partnership, trust or joint venture that is not a “Canadian,” as defined in the Investment Act (a non-Canadian): either the filing of anapplication for review which, except in certain limited circumstances, must be filed before closing and the non-Canadian cannot complete its investment until theMinister responsible for the Investment Act has determined that the investment is “likely to be of net benefit to Canada,” or the filing of a notice, which must befiled within 30 days after the completion of the investment. A notice is not subject to substantive review and is required for investments by a non-Canadian thatinvolve either the establishment of a new Canadian business or that involve an acquisition of control of a Canadian business but the prescribed thresholds forreview are not exceeded. Subject to the possible application of the national security provisions, the Investment Act does not apply to investments in existingCanadian businesses that do not result in an acquisition of control, as defined under the Investment Act.A direct investment by a non-Canadian to acquire control of a Canadian business is a reviewable investment where the value of the assets of the corporation, basedon the corporation’s fiscal year immediately preceding the investment, is CAD$5 million or more. Higher limits apply for direct acquisitions by or from WorldTrade Organization (WTO) member country investors, as described below.The acquisition of a majority of the voting interests of an entity or of a majority of the undivided ownership interests in the voting shares of an entity that is acorporation is deemed to be acquisition of control of that entity. The acquisition of less than a majority but one-third or more of the voting shares of a corporationor of an equivalent undivided ownership interest in the voting shares of the corporation is presumed to be acquisition of control of that corporation unless it can beestablished that, on the acquisition, the corporation is not controlled in fact by the acquirer through the ownership of voting shares. The acquisition of less thanone-third of the voting shares of a corporation or of an equivalent undivided ownership interest in the voting shares of the corporation is deemed not to beacquisition of control of that corporation. Certain transactions in relation to common shares in the Company would be exempt from review from the InvestmentAct, including:a.acquisition of common shares by a person in the ordinary course of that person’s business as a trader or dealer in securities;b.acquisition of control of us in connection with the realization of security granted for a loan or other financial assistance and not for any purpose related tothe provisions of the Investment Act; andc.acquisition of control of us by reason of an amalgamation, merger, consolidation or corporate reorganization following which the ultimate direct orindirect control in fact of the Company, through the ownership of voting interests, remains unchanged. Under the Investment Act, a direct investment in common shares of the Company by a non-Canadian who is a WTO investor (as defined in the Investment Act)would be reviewable only if it were an investment to acquire control of the Company and the enterprise value of the Company was CAD$600 million or more.Legislation has been introduced to increase this threshold to CAD$1 billion on April 24, 2017. A different threshold applies to an acquisition by a state-ownedenterprise (SOE). Currently, where the acquisition is by a SOE, the investment would be reviewable if the value of our assets was CAD$375 million or more. Thisthreshold is expected to increase to CAD$379 million in the near-term future as it is subject to an annual adjustment on the basis of a prescribed formula in theInvestment Act to reflect the change in Canada’s gross domestic product.The Minister responsible under the Investment Act can, within a prescribed period, require the review of an investment by a non-Canadian (even one that does notamount to an acquisition of control, and/or does not meet the review thresholds set out above) on grounds that it is likely to be injurious to national security.Ultimately, the Cabinet can prohibit the completion of an investment, or require divestment of control of a completed investment, or impose terms and conditionson an investment where the investment is injurious to national security.See also the “Management’s Discussion and Analysis of Financial Condition and Results of Operations - Certain Canadian and U.S. Federal Income TaxInformation for U.S. Residents - U.S. Federal Income Tax Information” section of this Annual Report.94Item 6.Selected Financial Data.Annual Financial DataThe following selected financial data should be read in conjunction with our Consolidated Financial Statements and notes to our Consolidated Financial Statementsand “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained elsewhere in this Annual Report on Form 10-K (AnnualReport). The selected Consolidated Statements of Operations data for the years ended December 31, 2016, 2015 and 2014 and Consolidated Balance Sheets data asof December 31, 2016 and 2015 have been derived from our Consolidated Financial Statements appearing elsewhere in this Annual Report. The selectedConsolidated Statements of Operations data for the years ended December 31, 2013 and 2012 and Consolidated Balance Sheets data as of December 31, 2014,2013 and 2012 have been derived from our Consolidated Financial Statements prepared in accordance with U.S. GAAP which are not included in this AnnualReport. All per-share data has been retrospectively adjusted to give effect to the Consolidation discussed in Note 1. Historical results are not necessarily indicativeof future results. Years Ended December 31,2016 (1)2015 (3) 2014 (4)2013 (5) 2012 (6)CONSOLIDATED STATEMENTS OF OPERATIONS DATA(in thousands, except per share amounts)Net product sales$13,574$—$—$—$—Cost of product sales5,971————Selling, general and administrative expenses29,52516,22217,6826,98615,082Research and development expenses14,7849,790 13,80318,509 24,578Loss from continuing operations(52,870) (23,009)(4,005) (25,838)(42,264)Net (loss) income(52,870) (23,009)(4,071) (24,871)45,698Basic and diluted net (loss) income per common share (2) Continuing operations(4.69) (2.20)(0.40) (2.55)(4.20)Discontinued operations— — — 0.108.75 Net (loss) income per common share (2)$(4.69)$(2.20)$(0.40)$(2.45)$4.55 As of December 31, 2016 (1)2015 (3) 2014 (4)2013 (5) 2012 (6)CONSOLIDATED BALANCE SHEETS DATA(in thousands)Cash and cash equivalents (7)$108,927$141,824$155,908$118,521$307,384Total assets480,782145,166160,371163,867401,218Working capital47,337139,253153,900157,587352,014Debt financing and convertible notes225,584————Accumulated deficit(587,208)(534,338)(511,329)(507,258)(482,387)Total shareholders’ equity$135,787$141,341$156,512$157,784$388,318 1.On November 29, 2016, we completed the Merger. Our financial position at the end of 2016 included Aegerion’s financial position. Our results of operations for 2016 consisted ofAegerion’s financial performance from November 29, 2016 to December 31, 2016.2.Per share amounts have been retrospectively restated to reflect the one -for- five share consolidation of Novelion’s common stock effective on December 16, 2016.3.On September 15, 2015, the InSite Merger Agreement was terminated after InSite’s board of directors notified QLT that they had reviewed a second unsolicited offer from SunPharmaceuticals Industries Ltd. and determined that it was superior to the proposed InSite Merger with QLT. The Sun Proposal was an all-cash offer to acquire InSite for $0.35 pershare of InSite common stock. As a result, InSite notified QLT that it was exercising its right to terminate the InSite Merger Agreement in order to enter into an agreement with Sun,and InSite paid QLT a termination fee of $2.7 million. During the year ended December 31, 2015, QLT incurred consulting and transaction fees of $9.4 million in connection with thepursuit of the InSite Merger and the strategic transactions as described below under Note 3 - Terminated Merger Transactions.4.On October 8, 2014, the Auxilium Merger Agreement among QLT, Auxilium, HoldCo, and AcquireCo, terminated after Auxilium delivered a notice of termination to QLT informingQLT that Auxilium’s board of directors had determined that the Endo Proposal was a superior proposal under the terms of the Auxilium Merger Agreement. Due to this change inrecommendation by Auxilium’s board of directors and in accordance with the termination95provisions of the Auxilium Merger Agreement, on October 9, 2014 Auxilium paid QLT a termination fee of $28.4 million. On October 22, 2014, pursuant to the terms of our financialadvisory services agreement with Credit Suisse, we paid Credit Suisse a fee of $5.7 million in connection the termination of the Auxilium Merger Agreement. During the year endedDecember 31, 2014, QLT incurred consulting and transaction fees of $10.2 million in connection with our pursuit of the Auxilium Merger.5.On June 27, 2013, we completed a $200.0 million special cash distribution, by way of a reduction of the paid-up capital of the Company’s common shares (the Cash Distribution).The Cash Distribution was approved by the Company’s shareholders at QLT’s annual and special shareholders’ meeting on June 14, 2013. All shareholders of record as of June 24,2013 (the Record Date) were eligible to participate in the Cash Distribution and received a payment of approximately $3.92 per share based upon the 51,081,878 common sharesissued and outstanding on the Record Date.6.On April 3, 2013, we completed the sale of our punctal plug drug delivery system technology to Mati pursuant to an asset purchase agreement. During the year ended December 31,2013, we recognized a $1.1 million gain within discontinued operations, which represented $1.2 million of sale proceeds net of the $0.2 million carrying value of certain equipmentsold and a negligible amount of other transaction fees.7.On September 24, 2012, we completed the sale of our Visudyne business to Valeant pursuant to an asset purchase agreement. During the year ended December 31, 2012, werecognized a pre-tax gain of $101.4 million related to this transaction within discontinued operations.Quarterly Financial Data (Unaudited)Set out below is selected consolidated financial information for each of the fiscal quarters of 2016 and 2015. (In thousands, except per share information) Quarter EndedDecember 31 (a)September 30 June 30March 31 2016 Net product sales$13,574$—$—$—Cost of product sales5,971———Selling, general and administrative expenses16,0383,1384,4515,898Research and development expenses6,0102,8552,9292,990Loss from continuing operations(19,920)(5,936)(5,120)(21,894)Net loss(19,920)(5,936)(5,120)(21,894)Basic and diluted net loss per common share (b) (d)(1.48)(0.55)(0.50)(2.05)(In thousands, except per share information) Quarter EndedDecember 31September 30 June 30March 31 2015 (c) Net product sales$—$—$—$—Cost of product sales————Research and development expenses2,0362,1423,4042,208Loss from continuing operations(3,680)(2,682)(10,751)(5,896)Net loss(3,680)(2,682)(10,751)(5,896)Basic and diluted net loss per common share (b) (d)(0.30)(0.25)(1.05)(0.60)a.On November 29, 2016, we completed the Merger. Our financial position at the end of Q4 2016 included Aegerion’s financial position. Our results of operations for Q4 2016included Aegerion’s financial performance from November 29, 2016 to December 31, 2016.b.Per share amounts have been retrospectively restated to reflect the one -for- five share consolidation of Novelion’s common stock effective on December 16, 2016.c.On September 15, 2015, the InSite Merger Agreement was terminated after InSite’s board of directors notified QLT that they had reviewed a second unsolicited offer from SunPharmaceuticals Industries Ltd. and determined that it was superior to the proposed InSite Merger with QLT. The Sun Proposal was an all-cash offer to acquire InSite for $0.35 pershare of InSite common stock. Due to this change in recommendation by InSite’s board of directors and in accordance with the termination provisions of the InSite MergerAgreement, InSite paid QLT a termination fee of $2.7 million. During the year ended December 31, 2015, QLT incurred consulting and transaction fees of $9.4 million in connectionwith the pursuit of the InSite Merger (as described under Note 3 - Terminated Merger Transactions ).d.Basic and diluted income (loss) per share are determined separately for each quarter. As a result, the sum of the quarterly amounts may differ from the annual amounts disclosed in theConsolidated Financial Statements due to the use of different weighted average numbers of shares outstanding.96Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations.All statements included or incorporated by reference into this Annual Report on Form 10-K (Annual Report), other than statements or characterizations ofhistorical fact, are “forward-looking statements” under applicable laws, regulations and other legal principles and constitute “forward-looking information” withinthe meaning of applicable Canadian securities laws. Forward-looking statements and information are often identified by words such as “anticipates,” “expects,”“intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “forecasts,” “may,” “will,” “should,” “would,” “could,” “potential,” “guidance,” “continue,”“ongoing” and similar expressions, and variations or negatives of these words. Examples of forward-looking statements and information contained in this AnnualReport include our statements regarding: the commercial potential for, and market acceptance of, our products; our estimates as to the potential number of patientswith the diseases for which our products are approved or for which our product candidates are being developed; our expectations with respect to reimbursement ofour products in the U.S. and elsewhere; our expectations with respect to named patient sales of our products in Brazil and in other countries where such sales arepermitted; the potential for and possible timing of approval of our products in countries where we have not yet obtained approval; our plans for further clinicaldevelopment of our products; the potential for zuretinol to obtain a rare pediatric disease designation and/or priority review voucher, if approved; our expectationsregarding future regulatory filings for our products, including planned marketing approval applications with respect to metreleptin to expand the indication formetreleptin in the U.S., subject to discussions with the FDA; our plans for commercial marketing, sales, manufacturing and distribution of our products; ourexpectations with respect to the impact of competition on our future operations and results; our beliefs with respect to our intellectual property portfolio for ourproducts and the extent to which it allows us to exclusively develop and commercialize our products and product candidates; our expectations regarding theavailability of data and marketing exclusivity for our products in the U.S., the EU, Japan and other countries; our view of potential outcomes of Aegerion’songoing Department of Justice (DOJ) and Securities and Exchange Commission (SEC) investigations and shareholder litigation, including the terms of theagreements in principle with respect to the investigations and the memorandum of understanding with respect to the settlement of Aegerion’s shareholderlitigation, and investigations in Brazil, and the possible impact and additional consequences of each on our business; our expectations regarding the impact on U.S.sales and patient attrition of JUXTAPID ® as a result of the implementation of the modified JUXTAPID Risk Evaluation and Mitigation Strategy program; ourexpectations regarding our global consolidated tax structure and planning, our ability to achieve tax savings or utilize net operating loss carryforwards and other taxand tax planning activities, including whether we are characterized as a U.S. domestic corporation or passive foreign investment company for U.S. federal incometax purposes; our forecasts regarding sales of our products, our future expenses, our cash position and the timing of any future need for additional capital to fundoperations; our ability to successfully integrate the businesses of Aegerion and Novelion; and our ability to manufacture and supply sufficient amounts of ourproducts to meet demand.The forward-looking statements contained in this Annual Report and in the documents incorporated into this Annual Report by reference are based on our currentbeliefs and assumptions with respect to future events, all of which are subject to change. Forward-looking statements are based on estimates and assumptionsregarding, for example, our financial position and execution of our business strategy, post-merger integration and synergies, resolution of litigation andinvestigations, future competitive conditions and market acceptance of products, the possibility and timing of future regulatory approvals, expectations regardingour core capabilities, and the availability of sufficient liquidity, each made in light of current conditions and expected future developments, as well as other factorsthat we believe are appropriate in the circumstances. Forward-looking statements are not guarantees of future performance, and are subject to risks, uncertaintiesand assumptions that are difficult to predict, including those discussed in the “Risk Factors” section of this Annual Report. It is not possible for us to predict allrisks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors may impact our operations or results.New risks may emerge from time to time. Past financial or operating performance is not necessarily a reliable indicator of future performance. Given these risksand uncertainties, we can give no assurances that any of the events anticipated by the forward-looking statements will occur or, if any of them does occur, whatimpact such event will have on our results of operations and financial condition. Our actual results could differ materially and adversely from those expressed inany forward-looking statement in this Annual Report or in our other filings with the SEC.This Annual Report also contains “forward-looking information” that constitutes “financial outlooks” within the meaning of applicable Canadian securities laws.This information is provided to give investors general guidance on management’s current expectations of certain factors affecting our business, including ourfinancial results. Given the uncertainties, assumptions and risk factors associated with this type of information, including those described above, investors arecautioned that the information may not be appropriate for other purposes.Except as required by law, we undertake no obligation to revise our forward-looking statements to reflect events or circumstances that arise after the date of thisAnnual Report or the respective dates of documents incorporated into this Annual Report by reference that include forward-looking statements. Therefore, youshould not assume that our silence over time means that actual events are bearing out as expressed or implied in these forward-looking statements.97BackgroundAs described above, on November 29, 2016, we closed the Merger with Aegerion Pharmaceuticals, Inc. (Aegerion). As of November 29, 2016, after giving effectto the Merger, the pre-Merger shareholders of QLT Inc. (QLT) collectively owned approximately 68% and the pre-Merger stockholders of Aegerion ownedapproximately 32% of our outstanding common shares.The Merger has been accounted for as a business combination in which Novelion was considered the acquirer of Aegerion. As such, the Consolidated FinancialStatements of Novelion are treated as the historical financial statements of the combined companies, with the results of Aegerion being included from November29, 2016. We have a new management team and a reconstituted Board of Directors, consisting of four legacy QLT directors, four directors who were serving onthe Board of Directors of Aegerion at the time of the Merger and two directors appointed by significant shareholders pursuant to contractual arrangements. Ournew management team is comprised of executives who were serving as officers of Aegerion at the time of the Merger and includes individuals with significantexperience in the biopharmaceutical industry and a successful track record of developing and commercializing rare disease and other pharmaceutical products.For periods prior to the closing of the Merger, therefore, our discussion below relates to the historical business and operations of Novelion. Certain portions of thisAnnual Report may contain information that may no longer be material to our business related to Aegerion’s historical operations. Any comparison of pre-MergerAegerion revenues and operations with ours may not be helpful to an understanding of our results for the fiscal year ended December 31, 2016 or future periods.As noted above, all references in this Annual Report to “we,” “us,” “our” and the “Company” refer to Novelion and its consolidated subsidiaries. For periodsfollowing the closing of the Merger, such references include Aegerion. As described more fully in this Annual Report, following the Merger, Novelion continues toconduct research and development related to zuretinol and Aegerion continues to develop and commercialize lomitapide and metreleptin, and each maintain itsrespective ownership of or licenses covering intellectual property related to such products and remain as party to the regulatory filings and approvals for suchproducts.Business OverviewWe are a biopharmaceutical company dedicated to developing new standards of care for individuals living with rare diseases. On November 29, 2016, wecompleted the Merger with Aegerion. We, through Aegerion, now have two commercial products:◦Metreleptin, a recombinant analog of human leptin, is marketed in the United States (U.S.) under the brand name MYALEPT (metreleptin) for injection(MYALEPT). MYALEPT is approved in the U.S. as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patientswith congenital or acquired generalized lipodystrophy (GL). In December 2016, we submitted a marketing authorization application (MAA) to theEuropean Medicines Agency (EMA) to seek approval for metreleptin, under the brand name MYALEPTA, as replacement therapy to treat complicationsof leptin deficiency in patients with GL and in a subset of patients with partial lipodystrophy (PL). We also expect to submit a supplemental biologicslicensing application (sBLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2017, seeking to expand MYALEPT’s indication in theU.S. to the PL subset and plan to file for formal regulatory approvals for metreleptin in GL and the PL subset throughout 2017 and early 2018 in other keymarkets, including Brazil and Colombia. We offer metreleptin through expanded access programs in countries where permitted by applicable regulatoryauthorities and under applicable laws, and generate revenue in certain markets where named patient sales are permitted based on the approval ofmetreleptin in the U.S. In addition to the PL subset, we plan to use our knowledge of the diverse effects of leptin on various physiologic functions toexplore new opportunities for metreleptin as a platform drug to potentially treat patients suffering from a range of low leptin-mediated rare and metabolicdiseases. We are evaluating and prioritizing these potential opportunities and plan to provide an update in mid-2017.◦Lomitapide is marketed in the U.S. under the brand name JUXTAPID (lomitapide) capsules (JUXTAPID). JUXTAPID is approved in the U.S. as anadjunct to a low-fat diet and other lipid-lowering treatments, including low-density lipoprotein (LDL) apheresis where available, to reduce low-densitylipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non-high-density lipoprotein cholesterol (non-HDL-C) in adultpatients with homozygous familial hypercholesterolemia (HoFH). Lomitapide is approved in the European Union (EU), under the brand name LOJUXTA(lomitapide) hard capsules (LOJUXTA) for the treatment of adult patients with HoFH, as well as in Japan, Canada, and a small number of other countries.In December 2016, Aegerion out-licensed the rights to commercialize LOJUXTA in the EU and certain other jurisdictions to Amryt Pharma plc (Amryt)and will receive sales milestones and royalties on net sales in those jurisdictions. In December 2016, Aegerion launched JUXTAPID as a treatment forHoFH in Japan, after receiving reimbursement approval. Lomitapide is also sold, on a named patient basis, in Brazil and in a limited number of othercountries outside the U.S. where such sales are permitted as a result of the approval of lomitapide in the U.S. or the EU.98We also have one orphan drug-designated product candidate, zuretinol acetate (zuretinol), an oral synthetic retinoid, in late stage development for the treatment ofIRD caused by underlying mutations in retinal pigment epithelium protein 65 ( RPE65 ) and lecithin: retinol acyltransferase ( LRAT ) genes, comprising LeberCongenital Amaurosis (LCA) and Retinitis Pigmentosa (RP). Our clinical and regulatory pathway for the zuretinol program is currently under review, and weexpect to provide an update in mid-2017. We are also exploring the potential of submitting to the FDA a request for Rare Pediatric Disease Designation forzuretinol for the treatment of IRD. If zuretinol is approved by the FDA after being designated a Rare Pediatric Disease and we meet certain additional criteria, wemay qualify for a Rare Pediatric Disease Priority Review Voucher. Zuretinol was granted orphan drug designations for the treatment of LCA (due to inheritedmutations in LRAT or RPE65 genes) and RP (all mutations) by the FDA, and for the treatment of LCA and RP (all mutations) by the EMA. Both the FDA andEMA have acknowledged that the therapeutic indication of zuretinol for the treatment of IRD (patients phenotypically diagnosed as LCA or RP caused bymutations in RPE65 or LRAT genes) falls within these orphan drug designations. The drug has also been granted two Fast Track designations by the FDA for thetreatment of LCA and RP due to inherited mutations in the LRAT and RPE65 genes.We have a new management team and a reconstituted Board of Directors, consisting of four legacy QLT directors, four directors who were serving on the Board ofDirectors of Aegerion at the time of the Merger and two directors appointed by significant shareholders pursuant to contractual arrangements. Our newmanagement team is comprised of executives who were serving as officers of Aegerion at the time of the Merger and includes individuals with significantexperience in the biopharmaceutical industry and a successful track record of developing and commercializing rare disease and other pharmaceutical products.During the year ended December 31, 2016, in the period after completion of the Merger, net product sales of lomitapide and metreleptin were $13.6 million , ofwhich $10.8 million was derived from prescriptions for lomitapide and metreleptin written in the U.S., and $2.8 million was derived from prescriptions forlomitapide and metreleptin written outside the U.S. As of December 31, 2016, we had approximately $108.9 million in cash and cash equivalents. Aegerion hasapproximately $325.0 million principal amount of 2.0% convertible senior notes due August 15, 2019 (the Convertible Notes). See the “ Management’s Discussionand Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources ” section of this Annual Report for further information.In the near-term, we expect that the majority of revenues will continue to be derived from sales of MYALEPT and JUXTAPID in the U.S. We also expect togenerate revenues from (i) sales of lomitapide in those countries outside the U.S. in which we have or expect to receive marketing approval, are able to obtainpricing and reimbursement approval at acceptable levels, and elect to commercialize lomitapide, particularly in Japan and (ii) sales of both products in a limitednumber of other countries where they are, or may in the future be, available on a named patient sales basis as a result of existing approvals in the U.S. or EU. Weexpect that in the near-term, named patient sales of lomitapide and metreleptin in Brazil will continue to be our second largest source of revenues for each product,on a country-by-country basis. We received named patient sales orders for metreleptin in Argentina in 2016, and have had and expect to continue to have namedpatient sales of metreleptin in Brazil, Colombia and a select number of countries in the EU, including France and Turkey. We expect net product sales from namedpatient sales to fluctuate significantly quarter-over-quarter given that named patient sales are derived from unsolicited requests from prescribers. In some countries,including Brazil, orders for named patient sales are for multiple months of therapy, which can lead to some fluctuations in sales depending on the ordering pattern.We believe the investigations into Aegerion’s activities in Brazil have adversely affected named patient sales of lomitapide and metreleptin in that country. See the“ Legal Proceedings ” section of this Annual Report for further information regarding these investigations. In addition, a proceeding is currently pending with theBrazil Supreme Federal Court to decide whether the government has an obligation to continue to provide, on a named patient sales basis, drugs that have notreceived regulatory and/or pricing and reimbursement approval in Brazil, like JUXTAPID and MYALEPT. We intend to file for marketing approval in Brazil forboth JUXTAPID and MYALEPT, and are currently assessing the timing of these submissions. The result of the trial and other issues could significantly negativelyaffect product revenues from named patient sales of JUXTAPID and MYALEPT in Brazil.We expect that our near-term efforts will be focused on the following:•building and maintaining market acceptance for MYALEPT in the U.S. for the treatment of complications of leptin deficiency in GL patients, andsupporting named patient sales of metreleptin in GL in Brazil, particularly in light of local economic challenges and ongoing governmental investigations,and other key countries, including France and Turkey, where such sales are permitted as a result of the U.S. approval or under local law;•preparing for the launch of metreleptin in Europe as a treatment for complications of leptin deficiency in GL patients and a subset of PL, in the event weobtain regulatory, pricing and reimbursement approvals in the EU for metreleptin;•evaluating the potential for future clinical development of metreleptin in additional indications, including a subset of PL, if we are unable to secureapproval of such indication with the current metreleptin clinical data package, as well as potentially other low leptin-mediated rare and metabolicdiseases;99•stabilizing sales of JUXTAPID as a treatment for adult HoFH patients in the U.S. despite competition from PCSK9 inhibitor products, among otherfactors, which have had a significant adverse impact on sales of JUXTAPID, and gaining market acceptance in the other countries where lomitapide isapproved and being commercialized, or may in the future receive approval and be commercialized;•managing our costs and expenses to better align with our revenues, and strengthening our capital structure, while supporting approved products in acompliant manner;•continuing to support patient access to and reimbursement for our products in the U.S. without significant restrictions, particularly given the availabilityof PCSK9 inhibitor products in the U.S., which has adversely impacted reimbursement of JUXTAPID, and given the considerable number of JUXTAPIDpatients in the U.S. who are on Medicare Part D and the significant percentage of such patients who may not be able to afford their out-of-pocket co-payments for our products, given that the only source of financial support for some such patients may be through patient assistance programs operated byindependent charitable 501(c)(3) organizations that may not provide adequate financial assistance;•implementing the modified JUXTAPID Risk Evaluation Management Strategy (REMS) program in the U.S., which includes requirements to recertify allprescribers and pharmacies and a new patient counseling and acknowledgment requirement for existing and new patients, by the July 2, 2017implementation deadline, while working to limit adult HoFH patient attrition from JUXTAPID as a result of such new requirements;•supporting the recent launch of JUXTAPID in Japan;•continuing to support sales of lomitapide as a treatment for HoFH in Brazil on a named patient basis, particularly in light of the economic challenges,ongoing government investigations, and ongoing court proceedings reviewing the regulatory framework for named patient sales in Brazil, and in otherkey countries where named patient sales are permitted, despite the availability of PCSK9 inhibitors on a named patient sales basis in such countries;•gaining regulatory, pricing and reimbursement approvals to market our products in countries in which the products are not currently approved and/orreimbursed or for new indications, including obtaining approval of the MAA seeking marketing approval of metreleptin in the EU as a treatment forcomplications of leptin deficiency in GL patients and a subset of PL, and seeking approval of metreleptin in the U.S. for a subset of PL based on theexisting clinical data package for metreleptin;•reviewing the clinical and regulatory pathway for zuretinol to determine the optimal development and business strategy for this product candidate;•engaging in possible further development efforts related to our existing products, and assessing, and possibly acquiring, potential new product candidatestargeted at rare diseases where we believe we can leverage our infrastructure and expertise;•minimizing the number of patients who are eligible to receive but decide not to commence treatment with our products, or who discontinue treatment, bysupporting activities such as patient support programs, to the extent permitted in a particular country;•continuing to embed a culture of compliance, ethics and integrity throughout Novelion and its subsidiaries;•Aegerion reaching a definitive agreement with the DOJ and the SEC with respect to its ongoing investigations in accordance with the terms of theagreements in principle it entered into in May 2016 and managing other ongoing government investigations pertaining to its products;•Aegerion reaching a definitive agreement with respect to its ongoing securities class action in accordance with the terms of the memorandum ofunderstanding entered into in December 2016 (the MOU); and•defending challenges to the patents or our claims of exclusivity for lomitapide in the U.S., including against potential generic submission with the FDAwith respect to lomitapide; and expanding the intellectual property portfolio for our products.100Investigations and Legal ProceedingsAs noted above, Aegerion has been the subject of certain ongoing investigations and other legal proceedings, including investigations of Aegerion’s marketing andsales activities of JUXTAPID by the DOJ and the SEC, an investigation by federal and state authorities in Brazil to determine whether there have been violationsof Brazilian laws related to the promotion of JUXTAPID, and a putative class action lawsuit alleging certain misstatements and omissions related to the marketingof JUXTAPID and the Company’s financial performance in violation of the federal securities laws (the Class Action Litigation). Aegerion reached agreements inprinciple with the DOJ and the SEC in May 2016 that provide for Aegerion to pay a fine of $40 million, to plead guilty to two misdemeanor misbranding violationsof the Food, Drug and Cosmetics Act and to enter into a five-year deferred prosecution agreement with regard to charges that it violated the Health InsurancePortability and Accountability Act (HIPAA) and engaged in obstruction of justice relating to the JUXTAPID REMS program. Aegerion also entered into the MOUwith respect to the Class Action Litigation, which provides for a settlement payment by or on behalf of Aegerion of $22.25 million, of which we expect $22.0million will be funded by insurance carriers and $250,000 will be funded by Aegerion. See the “ Legal Proceedings ” section of this Annual Report for furtherinformation regarding these investigations and legal proceedings.Recent Corporate and Securities TransactionsMerger Transaction with Aegerion. On June 14, 2016, we entered into an Agreement and Plan of Merger (as amended, the Merger Agreement) with Aegerion,pursuant to which on November 29, 2016 our indirect wholly-owned subsidiary, Isotope Acquisition Corp, merged with and into Aegerion, with Aegerionsurviving as our wholly-owned subsidiary (the Merger). Upon completion of the Merger, on November 29, 2016, each outstanding share of Aegerion commonstock was converted into a right to receive 1.0256 Novelion (pre-Consolidation) common shares and Aegerion’ s common stock was cancelled and delistedfrom NASDAQ.Pursuant to the Merger Agreement, we also issued certain warrants to the pre-closing shareholders of Novelion. These warrants (the Merger Agreement Warrants)may be exercised for up to an aggregate of 11,301,791 Novelion common shares at an exercise price of $0.05 per share if (i) the previously disclosed DOJ and SECinvestigations are settled for amounts in excess of $40 million and/or (ii) the Class Action Litigation is settled for an amount that exceeds the amounts, if any,available under Aegerion’s director and officer insurance coverage in respect of that matter (together, the negotiated thresholds). The number of Novelion commonshares for which the Merger Agreement Warrants may be exercised, if any, will vary based on the extent to which the settlements of the matters described aboveexceed the negotiated thresholds. The Merger Agreement Warrants will not be exercisable for any shares to the extent any excess in respect of such matters isequal to or less than $1.0 million in the aggregate.Pursuant to the Merger Agreement, effective upon the closing of the Merger, the Novelion board of directors is composed of four individuals designated byAegerion, four individuals designated by Novelion, one individual designated by Broadfin Capital, LLC (Broadfin) and one individual designated by SarissaCapital Management LP (Sarissa). For a specified period of time following the Merger, Sarissa will also have the right to designate one additional member of theboard of directors of Novelion.The aggregate consideration delivered to the former holders of Aegerion common stock in connection with the Merger was approximately 6,060,288 Novelioncommon shares. Shareholders of Novelion immediately prior to the Merger, including the private placement pursuant to the Unit Subscription Agreement(described below), owned approximately 68% of the outstanding Novelion common shares upon completion of the Merger and stockholders of Aegerion as ofimmediately prior to the Merger owned approximately 32% of the outstanding Novelion common shares upon completion of the Merger.Private Placement. Also on June 14, 2016, we entered into a unit subscription agreement (the Unit Subscription Agreement) with the investors party thereto (theInvestors). Pursuant to the Unit Subscription Agreement, immediately prior to the Merger, the Investors acquired units, for $8.80 per unit, on a post-Consolidation(as defined below) basis, consisting of (i) 2,472,727 Novelion common shares, which includes up to 568,181 Novelion common shares issuable upon exercise offully paid-up warrants, and (ii) warrants (the Unit Subscription Agreement Warrants) exercisable for up to an aggregate of 2,644,952 Novelion common shares atan exercise price of $0.05 per share. The Unit Subscription Agreement Warrants were issued on the same terms and conditions as the Merger Agreement Warrantsand are referred to collectively with the Merger Agreement Warrants as the Warrants in this Annual Report. The aggregate consideration paid under the UnitSubscription Agreement was approximately $21.8 million, which we intend to continue to use to support future operations and business development initiatives.Share Consolidation. On December 16, 2016, we completed a one-for-five (1:5) consolidation of all of our issued and outstanding common shares, without parvalue, for shareholders of record as of December 16, 2016 (the Consolidation), resulting in a reduction in the issued and outstanding common shares fromapproximately 92,653,562 to approximately 18,530,323 as of that date. Each shareholder’s percentage ownership in Novelion and proportional voting powerremained unchanged after the Consolidation, except for minor changes resulting from the treatment of fractional shares. In connection with the Consolidation, theconversion rate of the Convertible Notes was automatically adjusted from 24.9083 common shares per $1,000 principal amount of such Convertible Notes to4.9817 common shares per $1,000 principal amount of such Convertible Notes.101Aralez Investment and Distribution. On December 7, 2015, we entered into an Amended and Restated Share Subscription Agreement (the Amended and RestatedSubscription Agreement) with Tribute Pharmaceuticals Canada Inc. (Tribute), POZEN Inc. (POZEN), Aralez Pharmaceuticals plc, (formally known as AguonoLimited) (Aralez Ireland), Aralez Pharmaceuticals Inc. (Aralez Canada), Deerfield Private Design Fund II, L.P., Deerfield International Master Fund, L.P.,Deerfield Partners, L.P. (together Deerfield), Broadfin and JW Partners, LP, JW Opportunities Fund, LLC and J.W. Opportunities Master Fund, Ltd. (together theJW Parties) (the Company, Deerfield, Broadfin and the JW Parties are referred to herein collectively as the Co-Investors). The Amended and Restated SubscriptionAgreement amended and restated a share subscription agreement entered into on June 8, 2015 among the Company, Tribute, POZEN, Aralez Ireland, the Co-Investors and certain other investors. Pursuant to the Amended and Restated Subscription Agreement, immediately prior to and contingent upon the consummationof the merger of Tribute and POZEN (the Aralez Merger), Tribute agreed to sell to us and the other Co-Investors $75.0 million of the common shares of Tribute(the Tribute Shares) in a private placement at a purchase price per share equal to: (a) the lesser of (i) $7.20, and (ii) a five percent discount off of the five-dayvolume weighted average price per share of POZEN common stock calculated over the five trading days immediately preceding the date of closing of the AralezMerger, not to be less than $6.25 per share; multiplied by (b) the Aralez Merger exchange ratio of 0.1455. Upon consummation of the Aralez Merger on February5, 2016, the Tribute Shares were exchanged for common shares of Aralez Canada (the Aralez Shares). We entered into the transaction contemplated by theAmended and Restated Subscription Agreement for the purpose of returning capital to our shareholders pursuant to a special election distribution, payable, at theelection of each shareholder of the Company, in either Aralez Shares (approximately 0.13629 of an Aralez Share for each common share of the Company) or cash,subject to pro-ration (the Aralez Distribution), up to a maximum of $15.0 million funded pursuant to the terms of the Backstop Agreement (as described below).In connection with the Aralez Distribution, on June 8, 2015, we entered into a share purchase agreement (as amended, the Backstop Agreement) with Broadfin andthe JW Parties, pursuant to which Broadfin and the JW Parties agreed to purchase up to $15.0 million of the Aralez Shares from us at $6.25 per share. Thisarrangement provided our shareholders with the opportunity to elect to receive, in lieu of Aralez Shares, up to an aggregate of $15.0 million in cash, subject toproration among the shareholders. As a result, on April 5, 2016 (the Distribution Date), we distributed 4,799,619 Aralez Shares, with a fair value of $19.3 million,and $15.0 million of cash.Upon consummation of the Aralez Merger on February 5, 2016, we purchased 7,200,000 Aralez Shares (representing 10.1% of the issued and outstanding AralezShares), for an aggregate price of $45.0 million. We held the Aralez Shares from February 5, 2016 to the Distribution Date and the Aralez Shares were marked-to-market. As a result, we recognized a $10.7 million loss during the fiscal year ended December 31, 2016, to reflect the change in value from the acquisition date tothe Distribution Date.Terminated Merger Transactions. On June 8, 2015, QLT entered into an agreement and plan of merger (as amended and restated on each of July 16, 2015 andAugust 26, 2015) (the InSite Merger Agreement) with InSite Vision Incorporated, a Delaware corporation (InSite). On September 15, 2015, the InSite MergerAgreement was terminated by InSite and InSite paid QLT a termination fee of $2.7 million. Refer to Note 3 - Terminated Merger Transactions in the Notes to theConsolidated Financial Statements for further details.On June 25, 2014, QLT entered into an agreement and plan of merger (the Auxilium Merger Agreement) with Auxilium Pharmaceuticals, Inc., a Delawarecorporation (Auxilium). On October 8, 2014, the Auxilium Merger Agreement was terminated by Auxilium and Auxilium paid QLT a termination fee of $28.4million. Refer to Note 3 - Terminated Merger Transactions in the Notes to the Consolidated Financial Statements for further details.AcquisitionOn November 29, 2016, we completed the Merger. Commencing from the acquisition date, our Consolidated Financial Statements reflect the assets, liabilities,operating results and cash flows of Aegerion, and, in accordance with our domestic and international reporting periods, our Consolidated Financial Statements forthe year ended December 31, 2016 reflect legacy Aegerion operations from November 29, 2016 to December 31, 2016. For additional information related to thistransaction, see Note 5 - Acquisition to our Consolidated Financial Statements included in this Annual Report.Financial Highlights•Total revenue was $13.6 million for 2016, representing revenue from selling lomitapide and metreleptin through our indirect wholly-owned subsidiary,Aegerion, after the acquisition date in 2016.•Costs of sale were $6.0 million for 2016 representing costs of selling lomitapide and metreleptin through our indirect wholly-owned subsidiary, Aegerion,after the acquisition date in 2016.102•Selling, general and administrative expenses increased from $16.2 million in 2015 to $29.5 million in 2016, a 82.0% increase. This increase was primarilydue to our recognition, starting on November 29, 2016, of 100% of Aegerion’s financial performance due to our acquisition of Aegerion on November 29,2016 and our recognition of $8.0 million in total in relation to the advisory fees we paid to Greenhill for the completion of QLT’s $45 million investmentin Aralez and the completion of the Merger.•Research and development expenses increased from $9.8 million in 2015 to $14.8 million in 2016, a 51.0% increase. This increase was primarily drivenby our recognition, starting on November 29, 2016, of 100% of Aegerion’s financial performance due to our acquisition of Aegerion on November 29,2016.•We used $34.4 million of net cash flows from operations for 2016, which were primarily due to our recognition, starting from November 29, 2016, of100% of Aegerion’s financial performance including cash activities due to our acquisition of Aegerion on November 29, 2016. Cash and cash equivalentstotaled approximately $108.9 million as of December 31, 2016.Critical Accounting Policies and EstimatesOur management’s discussion and analysis of our financial condition and results of operations are based on our Consolidated Financial Statements, which havebeen prepared in accordance with accounting principles generally accepted in the U.S. (GAAP). The preparation of these Consolidated Financial Statementsrequires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses. On an ongoing basis, we evaluate theseestimates and judgments, including those described below. We base our estimates on historical experience and on various other assumptions that we believe to bereasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities thatare not readily apparent from other sources. Actual results and experiences may differ materially from these estimates.While our significant accounting policies are more fully described in Note 2 - Summary of Significant Accounting Policies in the Notes to the ConsolidatedFinancial Statements appearing in the “ Consolidated Financial Statements and Supplementary Data ” section of this Annual Report, we believe that theaccounting policy related to Purchase Price Allocation for Business Combinations is the most critical to aid you in fully understanding and evaluating our reportedfinancial results, and affecting the more significant judgments and estimates that we use in the preparation of our Consolidated Financial Statements.Business CombinationsAcquired businesses are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired attheir respective fair values. Any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill. We report provisionalamounts when measurements are incomplete as of the end of the reporting period. We complete our purchase price allocation within a measurement period andwhich does not extend beyond one year after the acquisition date.The present-value models used to estimate the fair values of acquired inventory and intangible assets incorporate significant assumptions, including, but not limitedto: assumptions regarding the probability of obtaining marketing approval; estimated selling price, estimates of the timing and amount of future cash flows frompotential product sales and related expenses; and the appropriate discount rate selected to measure the risks inherent in the future cash flows, the assessment of theasset’s life cycle and the competitive trends impacting the assets, including consideration of any technical, legal, regulatory or economic barrier to entry as well asexpected changes in standards of practice for indications addressed by the asset and tax rates.Recently Issued and Recently Adopted Accounting StandardsSee Note 2 - Summary of Significant Accounting Policies in the Notes to the Consolidated Financial Statements for a discussion of recently adopted and newaccounting pronouncements.Results of OperationsComparison of the Years Ended December 31, 2016 and 2015The following table summarizes the results of our operations for each of the years ended December 31, 2016 and 2015, together with the changes in those items indollars and as a percentage:103 Years Ended December 31,(in thousands except percentage and per share information)2016 (1)2015Change%Net product sales$13,574$—$13,574100.0 %Costs of product sales5,971—5,971100.0 %Operating expenses: Selling, general and administrative expenses29,52516,22213,30382.0 %Research and development expenses14,7849,7904,99451.0 %Termination fee—(2,667)2,667(100.0)%Total operating expenses44,30923,34520,96489.8 %Loss from operations(36,706)(23,345)(13,361)57.2 %Interest (expense) income, net(2,960)277(3,237)(1,168.6)%Fair value loss on investment(10,740)—(10,740)(100.0)%Other (expense) income, net(1,999)81(2,080)(2,567.9)%Loss before provision for income taxes(52,405)(22,987)(29,418)128.0 %Provision for income tax expense(465)(22)(443)2,013.6 %Net loss$(52,870)$(23,009)$(29,861)129.8 %Basic and diluted net loss per common share$(4.69)$(2.20)$(2.49)113.2 %(1) On November 29, 2016, we completed the Merger. Our financial position at the end of 2016 included Aegerion’s financial position. Our results of operations for 2016 consisted ofAegerion’s financial performance from November 29, 2016 to December 31, 2016.For 2016 compared to 2015, the increase in net product sales, costs of product sales, selling, general and administrative (SG&A) expenses and research anddevelopment (R&D) expenses, other income, and interest expense was primarily due to our recognition, starting on November 29, 2016, of 100% of Aegerion’sfinancial performance due to our acquisition of Aegerion on November 29, 2016.We expect that revenues, cost of product sales, SG&A and R&D expenses and interest expense will increase significantly in 2017 and beyond compared to 2016,relative to prior periods, as we will incorporate a full year of financial performance of Aegerion in 2017 and beyond while 2016 only includes Aegerion's financialperformance subsequent to the acquisition date of November 29, 2016.RevenueWe reported revenue for the first year in 2016, which represented net product sales of MYALEPT and JUXTAPID from November 29, 2016 to December 31, 2016by our newly acquired wholly-owned subsidiary Aegerion. In 2015, we did not have any commercial product and did not generate any revenue.MetreleptinWe generated revenues from net product sales of MYALEPT of approximately $5.0 million for the year ended December 31, 2016. Sales generated werecomprised primarily of sales to patients within the U.S. Prospectively, outside of sales generated within the U.S., we expect that prescriptions for named patientsales in Brazil will be our largest source of revenues, on a country-by-country basis. The future net product sales of metreleptin are highly dependent on our abilityto continue to find GL patients and to build market acceptance for MYALEPT in the U.S. In addition, we will continue to pay significant Medicaid rebates forMYALEPT, which will have a negative impact in future quarters. The degree of such impact on our overall financial performance will depend on the percentage ofMYALEPT patients that have Medicaid as their primary insurance coverage and the quantity of units ordered per patient. LomitapideWe generated revenues from net product sales of JUXTAPID of $8.6 million in the year ended December 31, 2016. This amount is comprised primarily of sales topatients within the U.S. Prospectively, outside of sales generated within the U.S., we expect that prescriptions for named patient sales in Brazil will be our largestsource of revenues, on a country-by-country basis. However, we expect that net product sales from named patient sales in Brazil will fluctuate quarter-over-quartergiven that orders for named patient sales are typically for multiple months of therapy which can lead to some fluctuation in sales depending on the ordering pattern.Future revenues may also be negatively affected by the availability of PCSK9 inhibitor products.104We expect net product sales from named patient sales of lomitapide and metreleptin in Brazil to fluctuate quarter-over-quarter significantly more than sales in theU.S., as a result of the types of orders and unpredictable ordering patterns, government actions, including the ongoing investigations in Brazil, media coverage, andeconomic pressure.Costs of Product SalesWe reported costs of product sales in 2016 to recognize the costs of selling MYALEPT and JUXTAPID by Aegerion from November 29, 2016 to December 31,2016. In 2015, we did not have any net product sales or revenues, and therefore we did not recognize costs of product sales.We recorded costs of product sales of $6.0 million for the year ended December 31, 2016. Costs of sales includes the cost of inventory sold, amortization ofacquired product rights, which result from the acquisition of JUXTAPID and MYALEPT as of the acquisition date, manufacturing and supply chain costs, productshipping and handling costs, as well as estimated royalties payable related to the sale of MYALEPT and JUXTAPID. We expect cost of product sales for bothproducts to fluctuate consistently with expected changes in net product sales.Selling, General and Administrative ExpensesDuring the year ended December 31, 2016, SG&A expenses from continuing operations increased by $13.3 million to $29.5 million , compared to $16.2 millionfor the same period in 2015. A portion of the increase was attributed to our recognition of $8.0 million in total in relation to the advisory fees we paid to Greenhillfor the completion of Novelion's $45.0 million investment in Aralez and the completion of the Merger. The remaining increase was mainly due to our recognition,starting on November 29, 2016, of 100% of the SG&A expenses of our newly acquired wholly-owned subsidiary, Aegerion, which were primarily comprised ofemployee-related expenses, including stock-based compensation, and litigation expense.Research and Development ExpensesDuring the year ended December 31, 2016, R&D expenditures from continuing operations were $14.8 million compared to $9.8 million for the same period in2015. The $5.0 million increase was primarily due to our recognition, starting on November 29, 2016, of 100% of the R&D expenses of MYALEPT (metreleptin)and JUXTAPID (lomitapide) due to our acquisition of Aegerion on November 29, 2016. These expenses were primarily comprised of employee related expenses,including stock-based compensation, and consulting costs for the period.Termination FeesWe did not incur termination fees during the year ended December 31, 2016.In 2015, we recognized a $2.7 million termination fees in connection with the termination of the Insite Merger Agreement on September 15, 2015.Interest ExpenseWe recognized $3.0 million interest expense in 2016, which represents the amortization of the debt discount and interest incurred in December 2016 in relation tothe issuance by Aegerion in August 2014 of $325.0 million in aggregate principal of 2.00% convertible senior notes due August 15, 2019 (the Convertible Notes)for which interest is payable semi-annually in arrears on February 15 and August 15 of each year. Before 2015, we financed our operations through equity andexisting resources and did not have any debt.Fair Value Loss on InvestmentWe recognized $10.7 million fair value loss on investment in 2016, which represents realized loss as a result of the mark-to-market of the Aralez shares held byQLT from February 5, 2016 to April 5, 2016 (the Distribution Date). Refer to Note 4 - Strategic Transactions in the Notes to the Consolidated FinancialStatements for further details.Income TaxesDuring the year ended December 31, 2016, the provision for income taxes was $0.5 million , an increase of $0.4 million over the same period in 2015. Theprovision for income taxes consisted of a current tax expense, which relates primarily to our profitable operations in our foreign tax jurisdictions offset by a currenttax benefit for the reversal of interest related to our liability on uncertain tax positions.During the year ended December 31, 2015, the provision for income taxes from continuing operations was insignificant and primarily relates to the accrual ofinterest on uncertain tax provisions.105For the years ended December 31, 2016 and 2015, we considered it more likely than not that some portion or all of the recorded deferred tax assets will not berealized in a future period based on all available evidence. As a result of our evaluations, we concluded that there was insufficient positive evidence to overcomethe more objective negative evidence related to our cumulative losses and other factors. Accordingly, for the year ended December 31, 2015, we maintained a fullvaluation against our domestic and foreign deferred tax assets. For the year ended December 31, 2016, we maintained a full valuation allowance against our U.S.,Canadian and Swiss deferred tax assets. The Company did not maintain a valuation allowance against its remaining foreign subsidiaries as these companies aregenerally profitable under the Company’s transfer pricing model and those earnings are further considered permanently invested in the respective foreignjurisdictions. In future periods, we will continue to evaluate whether there is sufficient positive evidence to overcome the more objective negative evidence indetermining whether we will continue to maintain a full valuation allowance.The Company has not provided for U.S. income taxes on the undistributed earnings of its foreign subsidiaries, as it currently plans to permanently reinvest theseamounts and has the intent and ability to do so. As of December 31, 2016, the Company has approximately $1.5 million of undistributed foreign earnings.As of December 31, 2016, prior to the deferred income tax asset offset described below, our provision for uncertain tax benefits (UTP Provision) was $7.7 million,compared to $7.3 million as of December 31, 2015. Given that we have sufficient deferred tax assets to shelter these potential liabilities, approximately $7.3million of the UTP Provision has been offset on the Consolidated Balance Sheet as of December 31, 2016, compared to $6.9 million as of December 31, 2015 inaccordance with ASU No. 2013-11 - Income Taxes (Topic 740): Presentation of Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a SimilarTax Loss, or a Tax Credit Carryforward Exists, which was adopted prospectively effective January 1, 2014. The remaining net UTP Provision of $0.4 million atDecember 31, 2016 and $0.3 million at December 31, 2015 is reflected on the Consolidated Balance Sheet.Comparison of the Years Ended December 31, 2015 and 2014The following table summarizes the results of our operations for each of the years ended December 31, 2015 and 2014, together with the changes in those items indollars and as a percentage: Years Ended December 31,(in thousands except percentage and per share information)20152014Change%Net product sales$—$—$—— %Cost of product sales———— %Operating expenses:Selling, general and administrative expenses15,64616,791(1,145)(6.8)%Research and development expenses9,79013,803(4,013)(29.1)%Depreciation576891(315)(35.4)%Restructuring charges—744(744)(100.0)%Termination fee(2,667)(28,400)25,733(90.6)%Total operating expenses23,3453,82919,516509.7 %Loss from operations(23,345)(3,829)(19,516)509.7 %Interest income, net277113164145.1 %Other income (expense), net81(481)562(116.8)%Loss from continuing operations before income taxes(22,987)(4,197)(18,790)447.7 %Provision for income tax (expense) recovery(22)192(214)(111.5)%Net loss from continuing operations(23,009)(4,005)(19,004)474.5 %Loss from discontinued operations, net of income taxes—(66)66(100.0)%Net loss$(23,009)$(4,071)$(18,938)465.2 %Basic and diluted net loss per common share$(2.20)$(0.40)$(1.80)450.0 %Research and Development ExpensesDuring the year ended December 31, 2015, research and development (R&D) expenditures from continuing operations were $9.8 million compared to $13.8million for the same period in 2014. The $4.0 million (29%) decrease was primarily due to higher costs106incurred in 2014 related to certain toxicity studies, preparatory activities for the zuretinol pivotal trial, our zuretinol study in impaired dark adaptation (IDA)subjects, and trailing costs from the zuretinol Phase 1b retreatment study in LCA and RP subjects (the Retreatment Study), which was substantially completed in2013. The 2015 decline in R&D expenditures was also attributable to lower salary and overhead costs resulting from R&D headcount attrition, the foreignexchange impact of the weakening Canadian dollar, and downsizing of our lease space as described under the Contractual Obligations section below.During the year ended December 31, 2014, R&D expenditures from continuing operations were $13.8 million compared to $18.5 million for the same period in2013. The $4.7 million (25%) decrease was primarily due to higher costs incurred in 2013 related to our Retreatment Study and savings realized in 2014 related tothe continuing impact of our 2012 workforce reduction and other restructuring activities. These R&D expenditure decreases were partially offset by higher costsincurred in 2014 related to our preparatory activities for the zuretinol pivotal trial, IDA study, and higher stock-based compensation expense associated with stockoption grants.Trailing R&D expenditures related to our former Visudyne® business and former punctal plug drug delivery technology (the PPDS Technology) are presented asdiscontinued operations on the Consolidated Statements of Operations. For additional discussion on these expenditures, refer to the Income from DiscontinuedOperations, Net of Income Taxes section below.Total cumulative costs incurred through December 31, 2015 related to zuretinol were $118.0 million.For a more detailed description of our zuretinol development program, refer to the “Business - Our Products in Development ” section of this Annual Report.Selling, General and Administrative ExpensesDuring the year ended December 31, 2015, selling, general and administration (SG&A) expenses were $15.7 million compared to $16.8 million for the sameperiod in 2014. The $1.1 million (7%) decrease was primarily due to a decrease in transaction and consulting fees related to our exploration and pursuit of certainstrategic alternatives. During the year ended December 31, 2015, we incurred $9.4 million of transaction and consulting fees related to our pursuit of the InSiteMerger and strategic transactions described above, compared to $10.2 million of similar fees incurred in 2014 related to our pursuit of the Auxilium Merger. Inaddition, during the year ended December 31, 2015, we incurred $0.2 million of general consulting fees related to our consideration of future strategic options,compared to $0.6 million of similar fees incurred in 2014. Furthermore, 2015 SG&A expense was positively impacted by a decrease in directors fees related to ourOctober 2014 appointment of Dr. Geoffrey Cox as Interim Chief Executive Officer and a decrease in overall operating costs related to the downsizing of our leasespace as well as the foreign exchange impact of the weakening Canadian dollar. These cost savings were substantially offset by higher stock-based compensationexpense associated with the June 7, 2015 accelerated vesting of all unvested stock options as described above and a decrease in the amount of overhead expensesallocated to our R&D programs due to R&D headcount attrition.DepreciationDuring the years ended December 31, 2015 and 2014, depreciation expense was $0.6 million, and $0.9 million, respectively. The progressive decline indepreciation expense is primarily due to assets reaching the end of their useful lives.Restructuring chargesDuring the year ended December 31, 2012, we restructured our operations to focus our resources on our clinical development programs related to our syntheticretinoid, zuretinol, for the treatment of certain inherited retinal diseases. The cumulative cost of the restructuring, which was substantially complete in 2014, was$19.6 million. We did not incur restructuring expenses during the year ended December 31, 2015.During the year ended December 31, 2014, we recorded a charge of $0.7 million related to certain severance and termination benefits paid to QLT’s former SeniorVice President, Business Development and Commercial Operations, whose employment terminated effective May 31, 2014.Termination FeesIn connection with the termination of the InSite Merger Agreement on September 15, 2015, InSite paid us a $2.7 million termination fee.In connection with the termination of the Auxilium Merger Agreement on October 9, 2014, Auxilium paid us a $28.4 million termination fee.107Net Foreign Exchange LossesFor the years ended December 31, 2015 and 2014, net foreign exchange gains (losses) represent the impact of foreign exchange fluctuations on our monetary assetsand liabilities that are denominated in currencies other than the U.S. dollar (principally the Canadian dollar). See the Liquidity and Capital Resources: Interest andForeign Exchange Rates section below.Interest IncomeDuring the years ended December 31, 2015 and 2014, interest income was $0.3 million and $0.1 million, respectively. Interest income in 2015 includes $0.1million of interest earned on a secured note granted to InSite in connection with the proposed InSite Merger described under Note 4 - Strategic Transactions in theNotes to the Consolidated Financial Statements.Fair Value Change in Contingent ConsiderationAssets recognized in connection with contingent consideration owed to Novelion related to previous divestitures are estimated, measured and recorded at thepresent value of future expected payments. Fair value changes primarily arise from the following factors: accretion; cash collected during the period, whichdecreases the balance of future expected cash flows owed to us; and changes in the projected amount and timing of the expected future cash flows.No fair value changes were recorded in 2015 given that the remaining contingent consideration owing from our previous sale of our subsidiary, QLT USA, Inc.,and Eligard ® to TOLMAR Holding, Inc. (Eligard Contingent Consideration) was collected in full by the end of 2014.During the year ended December 31, 2014, we recorded a net fair value loss of $0.5 million, which consisted of a $1.5 million fair value gain related to our EligardContingent Consideration offset by a $2.0 million fair value decrease recorded for the Laser Earn-Out Payment to account for the increased uncertainty, collectionrisk associated with the passage of time and potential collection costs.Income from Discontinued Operations, Net of Income TaxesIn accordance with the accounting standard for discontinued operations, the results of operations related to our former PPDS Technology and Visudyne businesshave been excluded from continuing operations and reported as discontinued operations for all periods presented.During the year ended December 31, 2014, we incurred a loss of $0.1 million from discontinued operations, which primarily consisted of certain residual costsrelated to the former sale of our Visudyne business.Income TaxesDuring the year ended December 31, 2015, the provision for income taxes from continuing operations was insignificant and primarily relates to the accrual ofinterest on uncertain tax provisions.During the year ended December 31, 2014, the $0.2 million income tax recovery from continuing operations primarily relates to a $0.4 million reversal of interestaccrued on uncertain tax positions which decreased in 2014 due to the expiration of the statute of limitations. This recovery was partially offset by the tax impact ofgains from fair value changes in our previous Eligard related contingent consideration asset balance and interest accrued on remaining uncertain tax positions.The 2015 and 2014 provisions for income taxes also reflect that we had insufficient evidence to support the current or future realization of the tax benefitsassociated with our development expenditures.As of December 31, 2015, prior to the deferred income tax asset offset described below, our provision for uncertain tax positions (UTP Provision) was $7.3million, compared to $5.6 million as of December 31, 2014 - $5.6 million. Approximately $5.5 million of this UTP Provision as of December 31, 2015 relates totax filing positions taken on certain transaction costs incurred in 2015 and 2014, $1.4 million relates to uncertain tax positions that are currently under auditexamination and the remaining balance relates to other tax positions on uncertain tax matters from prior years. Given that we have sufficient tax deferred tax assetsto shelter these potential liabilities, approximately $6.9 million of the UTP Provision has been offset on the Consolidated Balance Sheet as of December 31, 2016,compared to $5.2 million as of December 31, 2014 in accordance with ASU No. 2013-11- Income Taxes (Topic 740): Presentation of Unrecognized Tax BenefitWhen a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists, which was adopted prospectively effective January 1, 2014.The remaining net UTP Provision of $0.3 million as of December 31, 2015, compared to $0.4 million as of December 31, 2014 is reflected on ConsolidatedBalance Sheet and is expected to decrease in 2016 upon the expiration of the statute of limitations applicable to certain tax positions taken on uncertain tax mattersin prior years.108As of December 31, 2015 and 2014, our respective net deferred tax assets were zero given that we had a full valuation allowance applied against these specific taxassets. The valuation allowance is reviewed periodically and if management’s assessment of the “more likely than not” criterion for accounting purposes changes,the valuation allowance is adjusted accordingly. See Note 13 - Income Taxes in the Notes to the Consolidated Financial Statements.Liquidity and Capital ResourcesGeneralWe have historically financed our operating and capital expenditures through existing cash resources. As a result of the Merger, we now have, through Aegerion,two commercial products, metreleptin and lomitapide, which generate revenues. In connection with the Merger, we entered into the Unit Subscription Agreementwith the Investors. The aggregate consideration received pursuant to the Unit Subscription Agreement was approximately $21.8 million, which we intend to use tosupport future operations and business development initiatives. In August 2014, Aegerion issued $325.0 million in aggregate principal amount of 2.00%convertible senior notes due August 15, 2019 (the Convertible Notes), for which interest is payable semi-annually in arrears on February 15 and August 15 of eachyear. Aegerion’s ability to refinance this indebtedness will depend on the capital markets and our financial condition on a consolidated basis at such time, if anythat it elects to pursue refinancing. In addition, as further described in the “ Legal Proceeding ” section above, Aegerion reached, in May 2016, preliminaryagreements in principle with the DOJ and the SEC that provide for, among other things, a consolidated monetary package that covers payments due to both theDOJ and the SEC by Aegerion totaling approximately $40 million in the aggregate, to be payable over three years, changed from the originally proposed five-yearpayment schedule contemplated when the preliminary agreement in principle was reached in May 2016.During the year ended December 31, 2016, we generated $13.6 million of revenues from net product sales. As of December 31, 2016, we had $108.9 million incash and cash equivalents on hand.Going forward, we expect to fund our current and planned operating requirements principally through our cash flows from operations, as well as our existing cashresources and proceeds from Aegerion’s potential refinancing of the Convertible Notes, and other potential financing methods, including utilizing equity. Webelieve that our existing funds, when combined with cash generated from operations, are sufficient to satisfy our operating needs and our working capital,milestone payments, capital expenditure and debt service requirements for at least one year from the date of this Annual Report. We may, from time to time, alsoseek additional funding through strategic alliances and additional equity and debt financings or from other sources, should we identify a significant newopportunity. For information related to certain risks that could negatively impact our financial position or future results of operations, see the “ Risk Factors ” and “Quantitative and Qualitative Disclosures About Market Risk ” sections of this Annual Report.Sources and Uses of CashThe following table sets forth the major sources and uses of cash for the years ended December 31, 2016, 2015 and 2014: Years Ended December 31,(in thousands)201620152014Net cash (used in)/provided by: Operating activities$(34,356)$(19,359)$455Investing activities25,3273436,672Financing activities(23,519)5,508509Effect of exchange rates on cash(349)(267)(249)Net (decrease) increase in cash and cash equivalents$(32,897)$(14,084)$37,387Changes in net cash provided by(used in) operating activities, investing activities and financing activities in 2016 compared to 2015 and 2014 were mainlyattributable to our recognition, starting on November 29, 2016, of 100% of the cash flow activities of our newly acquired indirect, wholly-owned subsidiaryAegerion, including, among others, cash generated from the net product sales of MYALEPT and JUXTAPID, cash used to maintain inventory of those products,and cash used to support the SG&A and R&D activities.We expect operating and financing cash flow activities to increase significantly in 2017 and beyond compared to 2016, relative to prior periods, as we willincorporate a full year of cash flow activities of Aegerion in 2017 and beyond, while in 2016 only cash activities after the acquisition date of November 29, 2016was included.109Cash (Used in) Provided by Operating ActivitiesDuring the year ended December 31, 2016, cash used by operating activities was $34.4 million compared to $19.4 million of cash used in operating activities in thesame period in 2015. The $15.0 million decrease in operating cash flows was primarily attributable to the following:•A significant increase in the net loss recognized by the Company year-over-year.•A negative operating cash flow variance of $8.0 million related to advisory fees paid to Greenhill in connection with the completion of Novelion's $45.0million investment in Aralez and the completion of Novelion's acquisition of Aegerion.•A positive operating cash flow variance of $10.7 million related to a loss recorded based on the mark-to-market adjustment on the Aralez investment toreflect changes in value from the acquisition date, February 5, 2016, through the distribution date, April 5, 2016.•Negative operating cash flows were noted as a result of the Company's acquisition of Aegerion, which included cash flows from the acquisition date ofNovember 29, 2016 through December 31, 2016. Significant items noted related to payments made for deal-related consulting fees and litigation duringthe period. These negative operating cash outflows were offset by period amortization of the JUXTAPID and MYALEPT intangible assets recognized inconjunction with the Merger.During the year ended December 31, 2015, cash used by operating activities was $19.4 million compared to $0.5 million of cash provided by operating activities inthe same period in 2014. The $19.9 million decrease in operating cash flows was primarily attributable to the following:•A $25.7 million negative cash flow variance related to a $28.4 million termination fee received in 2014 related to the proposed Auxilium Merger ascompared to the $2.7 million termination received in 2015 related to the proposed InSite Merger (refer to Note 3 - Terminated Merger Transactions formore information);•A negative operating cash flow variance of $1.5 million related to the portion of the Eligard Contingent Consideration that was received in 2014 andrecognized as part of cash used in operations.•A positive cash flow variance of $5.0 million resulting from: (i) lower salary costs related to changes in the R&D and SG&A head count, lower leasecosts and the foreign exchange impact of the weakening Canadian dollar, and (ii) higher cash outlays in the prior year related to the following 2014research and development activities: toxicity studies, preparatory activities for the zuretinol pivotal trial and trailing costs from our Retreatment Study.These positive cash flow variances were partially offset by increased cash outlays in 2015 related to: (i) the transfer and outsourcing of our analytical andbio-analytical testing functions to certain contract research organizations and (ii) spending related to the commencement of our natural history study.•A positive cash flow variance of $1.5 million due to lower consulting and advisory fees paid during the year ended December 31, 2015 as compared to thesame period in 2014. During the year ended December 31, 2015, we paid $8.7 million of transaction and consulting fees related to our exploration andpursuit of the InSite Merger and the Aralez Distribution. In comparison, during the year ended December 31, 2014, we paid $10.2 million of transactionand consulting fees related to our pursuit of the Auxilium Merger.•A $0.9 million positive cash flow variance associated with restructuring charges paid out in 2014 for accrued severance and termination benefits.During the year ended December 31, 2014, cash provided by operating activities was $0.5 million compared to $25.8 million of cash used in the same period in2013. The $26.3 million increase in operating cash flows was primarily attributable to the following factors:•A positive cash flow variance related to the $28.4 million termination fee received in connection with the proposed Auxilium Merger.•A positive cash flow variance of $2.9 million from lower spending on restructuring costs;•A positive operating cash flow variance from $8.8 million of lower operational spending associated with our 2012 restructuring initiatives;•A negative cash flow variance of $10.2 million associated with consulting and transaction fees paid in 2014 in connection with the proposed AuxiliumMerger;•A negative operating cash flow variance related to the fair value change in contingent consideration of $2.6 million;•A negative operating cash flow variance of $0.6 million related to the reversal of certain liabilities recorded for uncertain tax positions; and•A negative operating cash flow variance from other income items of $0.4 million. 110Cash Provided by Investing ActivitiesDuring the year ended December 31, 2016, cash flows provided by investing activities was $25.3 million compared to $0.03 million in 2015, a $25.3 millionincrease, which was mainly attributable to the cash the Company acquired from Aegerion as a result of the Merger.During the year ended December 31, 2015, cash flows provided by investing activities was insignificant.During the year ended December 31, 2014, cash flows provided by investing activities primarily consisted of $36.6 million of Eligard Contingent Considerationreceived and $0.1 million of net proceeds related to the sale of certain property, plant and equipment.Cash (Used in) Provided By Financing ActivitiesDuring the year ended December 31, 2016, $23.5 million cash used in financing activities was mainly attributable to the $45.0 million cash outflows used topurchase 7,200,000 Aralez Shares (representing 10.1% of the issued and outstanding Aralez Shares) at a price of $6.25 per share in connection with the AralezMerger on February 5, 2016, offset by $21.5 million of proceeds received in connection with the issuance of the Company’s common shares in a private placementto the Investors in connection with the Merger.During the year ended December 31, 2015, cash flows provided by financing activities consisted of $5.5 million of proceeds received in connection with theissuance of common shares for stock options exercised.During the year ended December 31, 2014, cash flows provided by financing activities consisted of $0.5 million of proceeds received in connection with theissuance of common shares for stock options exercised.Interest and Foreign Exchange RatesWe are exposed to market risk related to changes in interest and foreign currency exchange rates, each of which could adversely affect the value of our currentassets and liabilities. At December 31, 2016, we had $108.9 million in cash and cash equivalents and our cash equivalents had an average remaining maturity ofapproximately 27.6 days. If market interest rates were to increase immediately and uniformly by one hundred basis points from levels at December 31, 2016, thefair value of the cash equivalents would decline by an immaterial amount due to the short remaining maturity period.To the extent that Novelion holds a portion of its monetary assets and liabilities in a currency other than the functional currency of the entity, we are subject torevaluation gains and losses. These revaluation gains and losses are included in operations for the period.At December 31, 2016 and 2015, we had no outstanding forward foreign currency contracts.Contractual ObligationsIn the normal course of business, we enter into purchase commitments related to daily operations. We have entered into certain operating lease agreements with thefollowing minimum annual commitment: Payments due by periodContractual Obligations (1) (inthousands)TotalLess than 1 year1-3 years3-5 yearsMore than 5 yearsLong-term debt (including interest) (2)$342,060$6,500$335,560$—$—Operating Leases6,5083,0833,284141—Total contractual obligations (3)$348,568$9,583$338,844$141$—(1) The following contractual obligations have been excluded from the table above due to the reasons stated below:i.Uncertain Tax PositionsAs disclosed under Note 13 - Income Taxes in the Notes to the Consolidated Financial Statements for the year ended December 31, 2016, we have identified certain potential long-termliabilities associated with uncertain tax positions. Given that we are unable to reasonably or reliably estimate the timing of these future payments, if any, due to uncertainties about the timingand/or future outcomes of tax audits that may arise, these uncertain tax liabilities have been excluded from the table above.111ii.Purchase OrdersAs of December 31, 2016, we have certain open purchase orders related to potential and/or expected future expenditures. The total $17.7 million value of these purchase orders is not currentlyreflected on our Consolidated Balance Sheets and has been excluded from the table above given that the amounts are not fixed contractual obligations and would only give rise to liabilities tothe extent that goods and services are provided to Novelion. In addition, all of our material research contracts with third-parties have normal course termination and cancellation provisions.These purchase orders reflect estimated future expenditures based on existing arrangements and do not reflect any future modifications to, or terminations of, existing contracts or potential newcontracts. Approximately $17.4 million of our open purchase orders consists of expected expenditures related to ongoing research contracts with third-party organizations and $0.3 millionrelates to expected general and administrative expenses that are in the normal course of business.iii.Contract Research Organization (CRO) AgreementWe have engaged CROs to provide research, safety and project management services (the “Services”) in connection with the execution of our potential clinical trials and existing registries. Theestimated amount of Services is excluded from the table above given that Services have not yet been performed as of the December 31, 2016 balance sheet date and they would only give rise toliabilities to the extent that Services are provided to us and pass through expenses are incurred. As of December 31, 2016, the Company had total potential commitments of approximately $42.1million under these agreements. The amount reflected is based on the existing contracts and does not reflect any inflation, future modification to, or termination of, the existing contracts oranticipated or potential new contracts. The agreements with our selected CROs contain normal course termination and cancellation provisions. In the event of cancellation of these agreements,the Company would be obligated to pay for all direct fees, pass through costs, and services performed or incurred through the termination date. In addition, we would be required to reimbursethe CROs for all future non-cancelable obligations to third parties, where such obligations were created in connection with services authorized by Novelion.iv.Milestone ObligationsWe have also committed to make potential future milestone payments to certain third parties as part of our licensing, development, and purchase agreements. Payments under these arrangementsare generally contingent and payable upon achievement of certain developmental, regulatory or commercial milestones. During the year ended December 31, 2016, none of these payments havebeen triggered by the specified developmental, regulatory or commercial milestones. For more information refer to Note 16 - Contingencies, Commitments and Guarantees in the Notes to theConsolidated Financial Statements for the year ended December 31, 2016 and Item 1. Business of this Annual Report.Under Aegerion's license agreement with UPenn, Aegerion will be required to make development milestone payments of up to an aggregate amount of $2.6 million if we decide to developlomitapide for indications within the licensed field other than HoFH. All such development milestone payments for these other indications are payable only once, no matter how many licensedproducts for these other indications are developed. We have not initiated plans to develop lomitapide for indications within the licensed field other than HoFH.As described in the Business Overview section above, under the license agreement between Retinagenix and the University of Washington (the UW Agreement), a specific developmentmilestone was required to be achieved by December 31, 2016. However, the UW Agreement contains provisions for extensions of that date in certain circumstances. Based on the terms of theRetinagenix Agreement and the UW Agreement, and our significant development clinical spend on the zuretinol program, we believe that we are entitled to an extension of that milestone dateuntil December 31, 2017, and that we may be entitled to certain additional extensions to December 31, 2019, along with a potential additional extension of up to 12 months should enrollment ina planned trial be delayed, provided that we continue to comply with the relevant provisions of the license agreements and expend certain minimum amounts on the development of zuretinol.However, it is possible that we may not be able to achieve the specified development milestone by December 31, 2019. As a result, we and Retinagenix have begun discussing a renegotiation ofthat milestone with the University of Washington. We are currently conducting a review of the zuretinol development program, the results of which will assist us in determining when webelieve that the remaining development milestone can be expected to be achieved. (2) Included in the long-term debt (including interest) line within the contractual obligations table is $325.0 million in convertible debt, which can potentially be settled in our common shares.(3)This table does not include (i) any milestone payments which may become payable to third parties under license agreements as the timing and likelihood of such payments are not known;(ii) any royalty payments to third parties as the amounts, timing and likelihood of such payments are not known; and (iii) contracts that are entered into in the ordinary course of business whichare not material in the aggregate in any period presented above.In January 2015, Aegerion acquired metreleptin pursuant to the Asset Purchase Agreement with AstraZeneca. Metreleptin, a recombinant analog of human leptin,is currently marketed in the U.S. under the brand name MYALEPT. MYALEPT received marketing approval from the FDA in February 2014 as an adjunct to dietas replacement therapy to treat the complications of leptin deficiency in patients with GL. Under the terms of the Asset Purchase Agreement, Aegerion paidAstraZeneca $325.0 million to acquire the global rights to develop, manufacture and commercialize metreleptin, subject to an existing distributor license withShionogi covering Japan, South Korea and Taiwan. The distribution agreement with Shionogi was assigned to Aegerion as part of the transaction. Aegerion alsoassumed certain other assets and liabilities of AstraZeneca related to the metreleptin program. In connection with the acquisition, Aegerion assumed an agreement,as amended, with a contract manufacturer of MYALEPT. An amendment, which was disclosed to us after the closing of the MYALEPT acquisition, commits us tospend approximately 0.37 million Euros per week in contract manufacturing costs for a minimum of twelve weeks per year with a maximum of sixteen weeks peryear. The amount does not reflect any inflation, future modification to, or termination of, the existing contract or anticipated or potential new contract.In connection with the acquisition of MYALEPT in January 2015, Aegerion acquired a license agreement between Amgen Inc. (Amgen) and AmylinPharmaceuticals, Inc., dated February 7, 2006 (the Amgen License) pursuant to which Aegerion obtained an exclusive worldwide license from Amgen to certainknow-how and patents and patent applications covering the composition of matter and methods of use of metreleptin to develop, manufacture and commercialize apreparation containing metreleptin (the Amgen Licensed Products).112As part of the Amgen License, Aegerion also obtained an exclusive sublicense of Amgen’s exclusive rights to certain metreleptin-related patents and patentapplications owned by the Rockefeller University and exclusively licensed to Amgen under a license agreement dated April 14, 1995, as amended (the RockefellerLicense) and an exclusive sublicense of Amgen’s non-exclusive rights to certain metreleptin-related patents and patent applications owned by The Regents of theUniversity of California and non-exclusively licensed to Amgen under a license agreement dated July 13, 2005 (the UCSF License). Amgen retains rights toconduct research, development, manufacturing and commercialization activities with respect to products other than the Amgen Licensed Products.Aegerion may grant sublicenses under the licenses and sublicenses granted by Amgen, subject to certain limitations, including Amgen’s right of first offer for anyout-license, partnership, co-development, commercialization, co-promotion or similar agreement related to metreleptin or the Amgen Licensed Products, whichexpires in February 2021. Under this license agreement, Amgen must notify Aegerion of any potential third-party partnership regarding any intellectual propertyrights controlled by Amgen in the neurology field and we will have a right of first negotiation for any license, partnership, co-development, commercialization, co-promotion or similar agreement, which expires in February 2021.Aegerion is required to make royalty payments to Amgen, Rockefeller University and BMS on net sales of each Amgen Licensed Product on a country-by-countrybasis (i) at a royalty rate in the low double digits where the Amgen Licensed Product has patent protection or market exclusivity granted by a regulatory authorityat the time of regulatory approval in the applicable country during the applicable royalty term, which runs on a country-by-country basis until the later of (a) theexpiration of the last-to-expire valid claim covering an Amgen Licensed Product in the applicable country, (b) expiration of any market exclusivity granted by aregulatory authority, and (c) ten years from the date on which an Amgen Licensed Product is first sold to a third-party in a country after regulatory approval for theAmgen Licensed Product has been granted in such country (Amgen Royalty Term) or (ii) at a royalty rate in the mid-single digits to low double digits where theAmgen Licensed Product receives patent protection or market exclusivity following the time of regulatory approval in the applicable country, in either case subjectto a variety of customary reductions.Under the Amgen License, Aegerion is also required to directly meet certain payment obligations under the Rockefeller License and UCSF License. Aegerion isrequired to make royalty payments to Rockefeller University on net sales of each product with patent rights or know-how in the field of obesity genes, obesity geneproducts, and molecules that modulate or mediate their action and/or regulation on a country-by-country basis at a range of royalty rates in the low single digitsdepending on whether the product has an orphan product designation or not until the later to occur of expiration of (i) patent protection, (ii) any market exclusivityperiod granted in the applicable country, or (iii) any data exclusivity period in the applicable country (with certain limitations related to the number of units sold).Since acquiring this license agreement in January 2015, Aegerion has paid a one-time $5.0 million milestone payment to Rockefeller in February 2015, which wasdue twelve months following the receipt of marketing approval for MYALEPT in the U.S. Aegerion will also be required to pay to Rockefeller University apercentage in the low double digits of any upfront license fees or one-time fees it receives in consideration for a sublicense of the licensed rights. There are nomaterial payment obligations outstanding under the UCSF License.The Amgen License will terminate upon the expiration of the last Amgen Royalty Term for any Amgen Licensed Product. Aegerion has the right to terminate theAmgen License for convenience upon 90 days prior written notice to Amgen or for Amgen’s uncured material breach of the Amgen License, or becoming subjectto specified bankruptcy or liquidation events. Amgen may terminate the Amgen License for our uncured failure to make payments to Amgen or if we are thesubject of specified bankruptcy or liquidation events.Aegerion made royalty payments related to the sales of MYALEPT under the Amgen license through November 29, 2016 and there were no payments madebetween the period from November 30, 2016 to December 31, 2016. We had $1.2 million remaining balance in royalties payable as of December 31, 2016.In addition, Aegerion is required to make royalty payments at a range of royalty rates in the high single digits on net sales of lomitapide in countries wherelomitapide has patent protection, and in respect of any other products covered by the license (subject to a variety of customary reductions), and share with UPennspecified percentages of sublicensing royalties and other consideration that we receive under any sublicenses that we may grant.In December 2016, Aegerion entered into a license agreement with Amryt under which Amryt was granted an exclusive right to develop and commercializeLOJUXTA in the European Economic Area (EEA), Switzerland, Turkey and certain Middle Eastern and North African territories, including Israel. Under thelicense agreement, Aegerion maintains the marketing authorizations for LOJUXTA; however, Amryt is responsible for ongoing regulatory and post-marketingobligations and commitments for LOJUXTA. Amryt is also required to pay us certain sales-related milestone payments and royalties on net product sales in thelicensed territories.113Aegerion made royalty payments to UPenn through November 29, 2016 and there were no payments made during the period from November 30, 2016 toDecember 31, 2016. We had $1.3 million remaining balance in royalties payable to UPenn as of December 31, 2016.Future Funding RequirementsOur need to raise additional capital in the future, and the size of any such financings, will depend on many factors, including:•the success of our commercialization efforts and the level of revenues generated from sales of metreleptin and lomitapide in the U.S.;•the level of revenue received from named patient sales of metreleptin and lomitapide in Brazil and other key countries where a mechanism exists to sellthe product on a pre-approval basis in such country based on U.S. approval of such products or EU approval of lomitapide, particularly in light of theavailability of a PCSK9 inhibitor product in Brazil and the ongoing court proceedings in Brazil reviewing the regulatory framework for named patientsales;•the level of physician, patient and payer acceptance of lomitapide and metreleptin;•our ability to manage our costs and expenses to better align with our revenues and strengthen our capital structure, while supporting approved products ina compliant manner;•gaining regulatory and pricing and reimbursement approvals to market our products in countries in which the products are not currently approved and/orreimbursed, where it makes business sense to seek such approval, without significant restrictions, discounts, caps or other cost containment measures,including regulatory and pricing and reimbursement approval of metreleptin in the EU, in connection with which we filed an MAA in the EMA inDecember 2016, and regulatory approval of metreleptin in the U.S. for a subset of PL based on the existing clinical data package for metreleptin, subjectto discussions with the FDA;•the extent of the negative impact of the availability of PCSK9 inhibitor products on sales of JUXTAPID in the U.S., which, among other factors, havecaused a significant number of JUXTAPID patients to discontinue JUXTAPID and switch to a PCSK9 inhibitor product, and significantly decreased therate at which new HoFH patients start treatment with lomitapide;•the provision of free PCSK9 inhibitor drug to adult HoFH patients by the companies that are commercializing PCSK9 inhibitor products, which suchcompanies may have ceased, but which historically has had a negative impact on the rate at which new patients start treatment with lomitapide and hascaused more patients than we expected to discontinue lomitapide and switch their treatment to PCSK9 inhibitor products;•requirements of insurance companies, managed care organizations, other private payers, and government entities that provide reimbursement for medicalcosts in the U.S. to require that newly diagnosed adult HoFH patients be treated with PCSK9 inhibitor products prior to JUXTAPID, that currentJUXTAPID patients switch to PCSK9 inhibitor products, and that patients fail to adequately respond to PCSK9 inhibitor products before providingreimbursement for JUXTAPID at the prices at which we offer JUXTAPID;•the willingness of insurance companies, managed care organizations, other private payers, and government entities that provide reimbursement formedical costs in the U.S. to continue to provide reimbursement for our products at the prices at which we offer our products without imposing anyadditional major hurdles to access or other significant restrictions or limitations, and the ability and willingness of HoFH and GL patients to pay, or toarrange for payment assistance with respect to, any patient cost-sharing amounts for our products applicable under their insurance coverage, particularlyin light of recent reductions in contributions to 501(c)(3) patient organizations by pharmaceutical companies;•the cost of building and maintaining the sales and marketing capabilities necessary for the commercialization of our products for their targeted indicationsin the market(s) in which each has received regulatory approval and we elect to commercialize such products, to the extent reimbursement and pricingapprovals are obtained, and certain other key international markets, if approved;•the timing and costs of future business development opportunities;•the timing and cost of seeking regulatory approvals and conducting potential future clinical development of metreleptin in additional indications, pursuingpossible lifecycle management opportunities for metreleptin, and conducting potential development of the zuretinol program;•the cost of filing, prosecuting and enforcing patent claims, including the cost of defending any challenges to the patents or our claims of exclusivity;114•the status of ongoing government investigations and lawsuits, including the disclosure of possible or actual outcomes, including regarding the preliminaryagreements in principle that have been reached with the DOJ and the SEC;•the costs of our manufacturing-related activities and the other costs of commercializing our products;•the costs associated with ongoing government investigations and lawsuits, including any damages, settlement amounts, fines or other payments, orimplementation of compliance related agreements or consent decrees, that may result from settlements or enforcement actions related to governmentinvestigations or whether we are successful in our efforts to defend ourselves in, or to settle on acceptable terms, ongoing or future litigation;•the levels, timing and collection of revenue received from sales of our products in the future;•the timing and costs of satisfying our debt obligations, including interest payments and any amounts due upon the maturity of such debt, including underthe Convertible Notes;•the cost of our observational cohort studies and other post-marketing commitments, including to the FDA and in any other countries where our productsare ultimately approved; and•the timing and cost of other clinical development activities.We may seek additional capital due to favorable market conditions or strategic considerations, even if we believe we have sufficient funds for our current or futureoperating plans. The source, timing and availability of any future financing will depend principally upon equity and debt market conditions, interest rates and, morespecifically, on the extent of our commercial success and our continued progress in our regulatory and development activities. There can be no assurance thatexternal funds will be available on favorable terms, if at all.Off-Balance Sheet ArrangementsIn connection with the sale of assets and businesses, we provide indemnities with respect to certain matters, including product liability, patent infringement,contractual breaches and misrepresentations, and we provide other indemnities to third parties under the clinical trial, license, service, manufacturing, supply,distribution and other agreements that we enter into in the normal course of our business. If the indemnified party were to make a successful claim pursuant to theterms of the indemnity, we would be required to reimburse the loss. These indemnities are generally subject to threshold amounts, specified claims periods andother restrictions and limitations. As of December 31, 2016, no amounts have been accrued in connection with such indemnities.Except as described above and the contractual arrangements described in the Contractual Obligations section above, we do not have any off-balance sheetarrangements that have, or are reasonably likely to have, a current or future material effect on our financial condition, changes in financial condition, revenues orexpenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.CERTAIN CANADIAN AND U.S. FEDERAL INCOME TAX INFORMATION FOR U.S. RESIDENTSThe following is a summary of certain Canadian and U.S. federal income tax considerations applicable to holders of common shares of the Company. These taxconsiderations are stated in brief and general terms and are based on Canadian and U.S. law currently in effect. There are other potentially significant Canadian andU.S. federal income tax considerations and provincial, state and local income tax considerations with respect to ownership and disposition of the common shareswhich are not discussed herein. The tax considerations relative to ownership and disposition of the common shares may vary from shareholder to shareholderdepending on the shareholder’s particular status. Accordingly, shareholders and prospective shareholders are encouraged to consult with their tax advisorsregarding tax considerations which may apply to the particular situation.Canadian Federal Tax InformationThe following is a general summary of the principal Canadian federal income tax considerations generally applicable to a holder of common shares of theCompany who, at all relevant times, for purposes of the Income Tax Act (Canada) (the Canadian Tax Act) (i) is not, or is not deemed to be, a resident of Canada,(ii) holds the common shares as capital property, (iii) deals at arm’s length with, and is not affiliated with, the Company and (iv) does not and will not use or hold,and is not and will not be deemed to use or hold, common shares of the Company in connection with carrying on a business in Canada (a Non-ResidentHolder).Special rules, which are not discussed in this summary, may apply to a Non-Resident Holder that is an insurer carrying on business in Canada andelsewhere. Common shares of the Company will generally be considered to be capital property to a holder thereof, unless the shares are held in the course ofcarrying on a business or were acquired in a transaction considered to be an adventure in the nature of trade.Dividends paid, deemed to be paid, or credited on the common shares held by Non-Resident Holders will generally be subject to Canadian withholding tax at therate of 25% of the gross amount of the dividend unless the rate is reduced by an applicable income115tax convention or treaty. The Canada-U.S. Income Tax Convention (1980) (the Convention) provides that the withholding tax rate on dividends paid on thecommon shares to U.S. residents who qualify for the benefit of the Convention will generally be reduced to 15% of the gross amount of the dividend.A Non-Resident Holder will generally not be subject to Canadian income tax in respect of any gain realized on the disposition of common shares unless thecommon shares constitute “taxable Canadian property” to such Non-Resident Holder and such Non-Resident Holder is not entitled to relief under an applicableincome tax treaty or convention. Generally, provided the common shares are then listed on a designated stock exchange for purposes of the Canadian Tax Act(which includes the TSX and the NASDAQ), the common shares will not be “taxable Canadian property” to a Non-Resident Holder unless, at any particular timeduring the 60-month period immediately preceding the disposition (i) 25% or more of the issued shares of any class or series of the capital stock of the Companywere owned by such Non-Resident Holder, by persons with whom the Non-Resident Holder did not deal at arm’s length, or any combination thereof and (ii) theshares derived more than 50% of their fair market value directly or indirectly from one or any combination of real or immovable property situated in Canada,Canadian resource properties or timber resource properties (as defined in the Canadian Tax Act), or options in respect of, or interests or rights in any of theforegoing. A gain realized upon the disposition of the common shares by a U.S. resident who qualifies for the benefits of the Convention that is otherwise subjectto Canadian tax may be exempt from Canadian tax under the Convention.Where the common shares are disposed of by way of an acquisition of such common shares by the Company, other than a purchase in the open market in themanner in which common shares normally would be purchased by any member of the public in the open market, the amount paid by the Company in excess of thepaid-up capital of such common shares will be treated as a dividend and will be subject to non-resident withholding tax as described above.U.S. Federal Income Tax InformationSpecial U.S. federal income tax rules apply to “U.S. Holders” (as defined below) of shares of a “passive foreign investment company” (a PFIC). As previouslydisclosed, the Company believes, but cannot offer any assurance, that it was classified as a PFIC for one or more taxable years prior to 2000, and that it was not aPFIC during any of the taxable years from the taxable year ended December 31, 2000 through the taxable year ended December 31, 2007. The Company furtherbelieves that it was a PFIC for the taxable years ended December 31, 2008 through 2015, which significantly impacts the U.S. federal income tax consequences toU.S. Holders. The Company believes that it will not be deemed a PFIC for the taxable years ending December 31, 2016 and December 31, 2017. The Company’sactual PFIC status for a given taxable year will not be determinable until the close of such year and, accordingly, no assurances can be given regarding theCompany’s PFIC status in 2017 or any future year. See further discussion of the PFIC rules below. In addition, the following assumes that the common shares areheld as a capital asset within the meaning of Section 1221 of the Internal Revenue Code of 1986, as amended (the Code).This summary is of a general nature only and is not intended for non-U.S. Holders. Furthermore, it is not intended to constitute, and should not be construed toconstitute, legal or tax advice to any particular U.S. Holder, and it does not address U.S. federal income tax considerations that may be relevant to U.S. Holdersthat are subject to special treatment under U.S. federal income tax law. U.S. Holders are urged to consult their own tax advisors as to the tax consequences in theirparticular circumstances.U.S. HoldersA “U.S. Holder” is a holder of the Company’s common shares that is (i) an individual who is a citizen or resident of the U.S. for U.S. federal income tax purposes;(ii) a corporation (or other entity taxed as a corporation for U.S. federal income tax purposes) created or organized under the laws of the U.S., any U.S. state or theDistrict of Columbia; (iii) an estate the income of which is subject to U.S. federal income taxation regardless of the income’s source; or (iv) a trust (a) if a U.S.court is able to exercise primary supervision over the trust’s administration and one or more U.S. persons, as defined under Section 7701(a)(30) of the Code, haveauthority to control all of the trust’s substantial decisions; or (b) that was in existence on August 20, 1996, was treated as a U.S. person under the Code on theprevious day and has a valid election in effect under applicable U.S. Treasury regulations to be treated as a U.S. person.Sale or Other Disposition of Common SharesSubject to different treatment pursuant to the PFIC rules discussed below, if a U.S. Holder engages in a sale, exchange or other taxable disposition of such U.S.Holder’s common shares, (i) such U.S. Holder will recognize gain or loss equal to the difference between the amount realized by such U.S. Holder and such U.S.Holder’s adjusted tax basis in the common shares, (ii) any such gain or loss will be capital gain or loss, and (iii) such capital gain or loss will be long-term capitalgain or loss if the holding period of the common shares exceeds one year as of the date of the sale. Such gain generally is treated as U.S. source gain for U.S.foreign tax credit limitation purposes.If the Company purchases common shares from a U.S. Holder, such transaction will be treated as a taxable sale or exchange of the common shares by the U.S.Holder if the transaction meets certain conditions under U.S. federal income tax rules, or otherwise will be treated as a distribution by the Company in respect ofthe U.S. Holder’s common shares, as described below.116Distributions on Common SharesSubject to different treatment pursuant to the PFIC rules discussed below, a distribution with respect to our common shares generally will be treated as a dividend,taxable as ordinary income, to the extent of the Company’s current or accumulated earnings and profits, as determined under U.S. federal income tax principles. Ingeneral, to the extent that the amount of the distribution exceeds the Company’s current and accumulated earnings and profits, the excess first will be treated as atax-free return of capital that will reduce the holder’s tax basis in the holder’s common shares, and to the extent of any remaining portion in excess of such taxbasis, the excess will be taxable as capital gain. Any such capital gain will be long-term capital gain if the U.S. Holder has held the common shares for more thanone year at the time of the distribution. However, under U.S. Treasury regulations regarding the treatment of PFICs, a purchase of common shares from a U.S.Holder by the Company that does not qualify as a “sale or exchange” under U.S. federal income tax rules, and hence is treated as a distribution, is in fact treated asa distribution in full for PFIC purposes regardless of whether there are any earnings and profits.A dividend received by a corporate U.S. Holder generally will not be eligible for a dividends-received deduction. In addition, a dividend received by an individualU.S. Holder will not qualify for the 15% reduced maximum rate if the Company is a PFIC in the year in which the dividend is paid or in the preceding year.Dividends will constitute foreign source income for foreign tax credit limitation purposes. The limitation on foreign taxes eligible for credit is calculated separatelywith respect to specific classes of income. For this purpose, dividends distributed by the Company with respect to our common shares will constitute “passivecategory income” or, in the case of certain U.S. Holders, “general category income.”Passive Foreign Investment CompanyA non-U.S. corporation generally will be classified as a PFIC for U.S. federal income tax purposes in any taxable year in which, after applying relevant look-through rules with respect to the income and assets of subsidiaries, either 75% or more of its gross income is “passive income” (the income test) or 50% or more ofthe average value of its assets consists of assets that produce, or are held for the production of, passive income (the asset test). For this purpose, passive incomegenerally includes, among other things, dividends, interest, certain rents and royalties and gains from the disposition of passive assets.The Company believes that it was a PFIC for 2008 through 2015 but that it will not be deemed a PFIC for 2016. Please be aware that the Company’sstatus as a PFIC can have significant adverse tax consequences for U.S. Holders.A U.S. Holder that holds common shares while the Company is a PFIC may be subject to increased tax liability upon the sale, exchange or other disposition of thecommon shares or upon the receipt of certain distributions, regardless of whether the Company is a PFIC in the year in which such disposition or distributionoccurs. These adverse tax consequences will not apply, however, if (i) a U.S. Holder timely filed and maintained (and in certain cases, continues to maintain), ortimely files and maintains, as the case may be, a qualified electing fund (QEF) election to be taxed annually on the U.S. Holder’s pro rata portion of theCompany’s earnings and profits, (ii) the U.S. Holder timely made or makes, as the case may be, a mark-to-market election as described below, or (iii) a U.S.Holder is eligible to make a “purging” election and timely does so, as described below.The adverse tax consequences include:a.“Excess distributions” by the Company are subject to the following special rules. An excess distribution generally is the excess of the amount a PFICdistributes to a shareholder during a taxable year over 125% of the average amount it distributed to the shareholder during the three preceding taxableyears or, if shorter, the part of the shareholder’s holding period before the taxable year. Distributions with respect to the common shares made by theCompany during the taxable year to a U.S. Holder that are excess distributions must be allocated ratably to each day of the U.S. Holder’s holding period.The amounts allocated to the current taxable year and to taxable years prior to the first year in which the Company was classified as a PFIC are includedas ordinary income in a U.S. Holder’s gross income for that year. The amount allocated to each other prior taxable year is taxed as ordinary income at thehighest tax rate in effect for the U.S. Holder in that prior year (without offset by any net operating loss for such year) and the tax is subject to an interestcharge at the rate applicable to deficiencies in income taxes (the special interest charge).b.The entire amount of any gain realized upon the sale or other disposition of the common shares will be treated as an excess distribution made in the yearof sale or other disposition and as a consequence will be treated as ordinary income and, to the extent allocated to years prior to the year of sale ordisposition, will be subject to the special interest charge described above.QEF Election. A U.S. Holder of shares in a PFIC may make a QEF election with respect to such PFIC to elect out of the tax treatment discussed above. Generally,a QEF election, on U.S. Internal Revenue Service (IRS) Form 8621, should be made with117the filing of a U.S. Holder’s U.S. federal income tax return for the first taxable year for which both (i) the U.S. Holder holds common shares of the Company, and(ii) the Company was a PFIC. A U.S. Holder that timely makes a valid QEF election with respect to a PFIC will generally include in gross income for a taxableyear (i) as ordinary income, such holder’s pro rata share of the corporation’s ordinary earnings for the taxable year, and (ii) as long-term capital gain, such holder’spro rata share of the corporation’s net capital gain for the taxable year. However, the QEF election is available only if such PFIC provides such U.S. Holder withcertain information regarding its earnings and profits as required under applicable U.S. Treasury regulations. The Company will provide, upon request, allinformation and documentation that a U.S. Holder making a QEF election is required to obtain for U.S. federal income tax purposes (e.g., the U.S. Holder’s prorata share of ordinary income and net capital gain, and a “PFIC Annual Information Statement” as described in applicable U.S. Treasury regulations, which will bemade available on the Company’s website).Deemed Sale Election. If the Company is a PFIC for any year during which a U.S. Holder holds common shares, but the Company ceases in a subsequent year tobe a PFIC (which could occur, for example, if the Company were a PFIC for 2015 but is not a PFIC for 2016), then a U.S. Holder can make a “purging” election,in the form of a deemed sale election, for such subsequent year in order to avoid the adverse PFIC tax treatment described above that would otherwise continue toapply because of the Company having previously been a PFIC. If such election is timely made, the U.S. Holder would be deemed to have sold the common sharesheld by the holder at their fair market value, and any gain from such deemed sale would be taxed as an excess distribution (as described above). The basis of thecommon shares would be increased by the gain recognized, and a new holding period would begin for the common shares for purposes of the PFIC rules. The U.S.Holder would not recognize any loss incurred on the deemed sale, and such a loss would not result in a reduction in basis of the common shares. After the deemedsale election, the U.S. Holder’s common shares with respect to which the deemed sale election was made would not be treated as shares in a PFIC, unless theCompany subsequently becomes a PFIC. A U.S. Holder may also be able to make a deemed sale election with respect to the Company’s subsidiaries that arePFICs, if any. The rules regarding deemed sale elections are very complex. U.S. Holders are strongly urged to consult their tax advisors about the deemedsale election with regard to the Company and any subsidiaries.Mark-to-Market Election. Alternatively, a U.S. Holder of “marketable shares” (as defined below) in a PFIC may make a mark-to-market election for such shares toelect out of the adverse PFIC tax treatment discussed above. If a U.S. Holder makes a mark-to-market election for shares of marketable shares, the holder willinclude in income each year an amount equal to the excess, if any, of the fair market value of the shares as of the close of the holder’s taxable year over theholder’s adjusted basis in such shares. A U.S. Holder is allowed a deduction for the excess, if any, of the adjusted basis of the shares over their fair market value asof the close of the taxable year. However, deductions are allowable only to the extent of any net mark-to-market gains on the shares included in the holder’sincome for prior taxable years. Amounts included in a U.S. Holder’s income under a mark-to-market election, as well as gain on the actual sale or other dispositionof the shares, are treated as ordinary income. Ordinary loss treatment also applies to the deductible portion of any mark-to-market loss on the shares, as well as toany loss realized on the actual sale or disposition of the shares, to the extent that the amount of such loss does not exceed the net mark-to-market gains previouslyincluded for such shares. A U.S. Holder’s basis in the shares will be adjusted to reflect any such income or loss amounts. However, the special interest charge andrelated adverse tax consequences described above for non-electing holders may continue to apply on a limited basis if the U.S. Holder makes the mark-to-marketelection after such holder’s holding period for the shares has begun.The mark-to-market election is available only for “marketable shares,” which are shares that are traded in other than de minimis quantities on at least 15 daysduring each calendar quarter on a qualified exchange or other market, as defined in applicable U.S. Treasury regulations. The Company’s common shares are listedon TSX and quoted on NASDAQ, each of which constitutes a “qualified exchange or other market” under applicable U.S. Treasury regulations. U.S. Holders ofcommon shares are urged to consult their tax advisors as to whether the common shares would qualify for the mark-to-market election.Subsidiary PFICs. To the extent any of the Company’s subsidiaries is also a PFIC, a U.S. Holder will also be deemed to own shares in such lower-tier PFIC andcould incur a liability for the deferred tax and special interest charge described above if either (i) the Company receives a distribution from, or disposes of all orpart of its interest in, the lower-tier PFIC, or (ii) the U.S. Holder disposes of all or part of such holder’s common shares. In addition, the mark-to-market electioncannot be made for a subsidiary of a PFIC if the shares of such subsidiary is not itself marketable shares.PFIC Reporting Requirement. Unless otherwise provided by the U.S. Treasury, each U.S. person that is a direct or indirect shareholder of a PFIC is required to filean annual report on IRS Form 8621 containing such information as the U.S. Treasury may require. U.S. Holders should consult their tax advisors regarding anyreporting requirements that may apply to them and the effect, if any, this reporting may have on their ownership and disposition of our common shares.THE APPLICABILITY AND CONSEQUENCES OF THE PFIC RULES ARE EXCEEDINGLY COMPLEX. IN ADDITION, THE FOREGOINGSUMMARY DOES NOT ADDRESS ALL OF THE POTENTIAL U.S. FEDERAL INCOME TAX CONSEQUENCES WITH RESPECT TO PFICSTATUS THAT MAY BE RELEVANT TO A PARTICULAR INVESTOR IN LIGHT OF SUCH INVESTOR’S PARTICULAR CIRCUMSTANCESOR THAT MAY BE RELEVANT TO INVESTORS THAT ARE SUBJECT TO SPECIAL TREATMENT UNDER U.S. FEDERAL INCOME118TAX LAW. ACCORDINGLY, INVESTORS ARE STRONGLY URGED TO CONSULT THEIR TAX ADVISORS REGARDING THE APPLICATIONOF THE PFIC RULES TO THEM AND THE ADVISABILITY OF MAKING ANY OF THE ELECTIONS DESCRIBED ABOVE.Outstanding Share DataUnder the Novelion 2016 Equity Incentive Plan (formerly known as the QLT 2000 Incentive Stock Plan) dated April 25, 2013 and amended and restated effectiveNovember 29, 2016 and further amended and restated effective December 1, 2016 (the NVLN Plan), the maximum number of common shares, without par value,that are allotted for stock option and restricted stock unit grants under the NVLN Plan is 3,067,994. As of December 31, 2016, there are 648,432 remainingcommon shares available for future grants under the NVLN Plan.As of February 17, 2017, there were 18,533,029 common shares issued and outstanding, which totaled $199.8 million in share capital. As of February 17, 2017, wehad 1,729,927 stock options outstanding of which 224,304 were exercisable at a weighted average exercise price of $8.87 per share. Each stock option isexercisable for one common share. As of February 17, 2017, we had 889,220 RSU’s outstanding and none of which were vested, and 28,400 deferred share unitsoutstanding of which 28,400 were vested. The cash value of the deferred share units outstanding as of February 17, 2017 were $236,800.Under the amended and restated Aegerion 2010 Stock Option and Incentive Plan (the Aegerion 2010 Plan), the maximum number of common shares, without parvalue, that are allotted for stock option and restricted stock unit grants under the Aegerion 2010 Plan is 143,912. As of December 31, 2016, there are no remainingcommon shares available for future grants under the Aegerion 2010 Plan. As of February 17, 2017, we had 10,561 stock options outstanding at a weighted averageexercise price of $7.70 per share, none of which were exercisable. Each stock option is exercisable for one common share. As of February 17, 2017, we had129,164 RSU’s outstanding, none of which are vested.Item 7A.Quantitative and Qualitative Disclosures About Market Risk.Market risk is the potential loss arising from adverse changes in the financial markets, including interest rates and foreign currency exchange rates.Interest Rate RiskAegerion has outstanding $325.0 million 2.0% Convertible Notes due August 15, 2019 (the Convertible Notes). The Convertible Notes have a fixed annual interestrate of 2.0% and we, therefore, do not have economic interest rate exposure on the Convertible Notes. However, the fair value of the Convertible Notes is exposedto interest rate risk. Generally, the fair value of the Convertible Notes will increase as interest rates fall and decrease as interest rates rise. These Convertible Notesare also affected by the price and volatility of our common shares and will generally increase or decrease as the market price of our common shares changes. As ofDecember 31, 2016, the fair value of the Convertible Notes was estimated by us to be $240.4 million . For additional discussion on the Convertible Notes, refer tothe Note 10 - Convertible Notes, Net in the Notes to the Consolidated Financial Statements for the year ended December 31, 2016. As of December 31, 2016 and2015, we had no other assets or liabilities with significant interest rate sensitivity.Foreign Currency Exchange RiskWe are also exposed to risks associated with foreign currency exchange rate fluctuations related to our international subsidiaries in which we continue to helpsupport operations with financial contributions. We do not currently hedge our foreign currency exchange rate risk. We manage this foreign currency risk, in part,through operational means including managing foreign currency revenues in relation to same currency costs as well as managing foreign currency assets in relationto same currency liabilities. We are also exposed to the potential earnings effects from intercompany foreign currency assets and liabilities that arise from normaltrade receivables and payables and other intercompany loans. These subsidiaries’ financial statements are re-measured into their respective functional currenciesusing current or historical exchange rates. Such re-measurement adjustments could have an adverse effect on the Company’s results of operations.Investment RiskAt December 31, 2016 and 2015, the Company did not have any investments in debt or equity securities and as such was not exposed to risks associated with anyother-than-temporary decline in fair value of these investments. At December 31, 2016, the Company had $50.0 million investment in treasury bills and $18.3million investment in money market funds, which collectively have a weighted average remaining maturity of approximately 27.6 days. Any fluctuation in fairvalue of these cash equivalents will be an immaterial amount due to the short remaining maturity period.See the “ Management’s Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources - Interest and ForeignExchange Rates ” section of this Annual Report, which is incorporated by reference herein.119120Item 8.Consolidated Financial Statements and Supplementary Data. PageReport of Independent Registered Public Accounting Firm 122Consolidated Balance Sheets as of December 31, 2016 and 2015123Consolidated Statements of Operations for the years ended December 31, 2016, 2015, and 2014 124Consolidated Statements of Comprehensive Income for the years ended December 31, 2016, 2015 and 2014125Consolidated Statements of Shareholders’ Equity for the years ended December 31, 2016, 2015 and 2014 126Consolidated Statements of Cash Flows for the years ended December 31, 2016, 2015 and 2014127Notes to Consolidated Financial Statements 128121Report of Independent Registered Public Accounting FirmTo the Board of Directors and Shareholders ofNovelion Therapeutics Inc. (formerly QLT Inc.)We have audited the accompanying consolidated balance sheets of Novelion Therapeutics Inc. and subsidiaries (the “Company”) as of December 31, 2016 and2015, and the consolidated statements of operations, comprehensive loss, shareholders’ equity, and cash flows for each of the three years in the period endedDecember 31, 2016. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financialstatements based on our audits.We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that weplan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining,on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used andsignificant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basisfor our opinion.In our opinion, such Consolidated Financial Statements present fairly, in all material respects, the financial position of Novelion Therapeutics Inc. and subsidiariesas of December 31, 2016 and 2015, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2016, inconformity with accounting principles generally accepted in the United States of America.We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company’s internal control overfinancial reporting as of December 31, 2016, based on the criteria established in Internal Control - Integrated Framework (2013) issued by the Committee ofSponsoring Organizations of the Treadway Commission and our report dated March 30, 2017, expressed an adverse opinion on the Company’s internal controlover financial reporting because of a material weakness./s/Deloitte LLPChartered Professional AccountantsMarch 30, 2017Vancouver, Canada122Novelion Therapeutics Inc. (Formerly QLT Inc.)Consolidated Balance Sheets As of December 31,(in thousands, except share information)20162015ASSETS Current assets Cash and cash equivalents (Note 14) $108,927$141,824Restricted cash (Note 14)390—Accounts receivable, net (Note 2)9,339287Inventories - current (Note 6)15,718—Insurance proceeds receivable (Note 16)22,000—Prepaid expenses and other current assets9,762625Total current assets166,136142,736Inventories - non-current (Note 6)59,003—Property and equipment, net (Note 7)4,159430Accounts receivable - non-current (Note 16)—2,000Intangible assets, net (Note 8)250,324—Other assets1,160—Total assets$480,782$145,166LIABILITIES Current liabilities Accounts payable$17,609$1,656Accrued liabilities (Note 9)37,1801,827Provision for legal settlement (Note 16)64,010—Total current liabilities118,7993,483Long-term liabilities: Convertible notes, net (Note 10)225,584—Uncertain tax position liabilities, net (Note 13)381342Other liabilities231—Total liabilities344,9953,825Contingencies, Commitments and Guarantees (Note 16)SHAREHOLDERS’ EQUITY Share capital (Note 11)Common shares, without par value, 100,000,000 (1) shares authorized at December 31, 2016 and 2015; 18,530,323 and10,565,489 (1) shares issued at December 31, 2016 and 2015, respectively.551,259475,333Additional paid-in-capital69,14997,377Accumulated deficit(587,208)(534,338)Accumulated other comprehensive items102,587102,969Total shareholders’ equity135,787141,341Total liabilities and shareholders’ equity$480,782$145,166(1) Amounts have been retrospectively restated for all prior periods presented to reflect the one-for-five share consolidation of the Company’s common stock effected on December 16, 2016. See Note 1- Description of the Business fordetails.See the accompanying Notes to the Consolidated Financial Statements.123Novelion Therapeutics Inc. (Formerly QLT Inc.)Consolidated Statements of OperationsFor the Years Ended December 31,(in thousands, except per share information)201620152014Net product sales$13,574$—$—Cost of product sales5,971——Operating expenses Selling, general and administrative29,52516,22217,682Research and development14,7849,79013,803Restructuring charges——744Termination Fee (Note 3)—(2,667)(28,400)Total operating expenses44,30923,3453,829Loss from operations(36,706)(23,345)(3,829)Interest (expense) income, net(2,960)277113Fair value loss on investment (Note 4)(10,740)——Other income (expense), net(1,999)81(481)Loss from continuing operations before income taxes(52,405)(22,987)(4,197)Provision for Income tax (expense) recovery (Note 13)(465)(22)192Loss from continuing operations$(52,870)$(23,009)$(4,005)Loss from discontinued operations, net of income taxes——(66)Net loss$(52,870)$(23,009)$(4,071)Basic and diluted net loss per common share (1) (Note 15)Continuing operations (1)$(4.69)$(2.20)$(0.40)Discontinued operations (1) (2)———Net loss per common share (1)$(4.69)$(2.20)$(0.40)Weighted-average shares outstanding—basic and diluted (thousands) (1)Basic and diluted (1)11,28410,43410,225(1) Amounts have been retrospectively restated for all prior periods presented to reflect the one-for-five share consolidation of the Company’s common stock effected on December 16, 2016. See Note 1 - Description of Business for details.(2) Rounded to zero.See the accompanying Notes to the Consolidated Financial Statements.124Novelion Therapeutics Inc. (Formerly QLT Inc.)Consolidated Statements of Comprehensive LossFor the Years Ended December 31,(in thousands)201620152014Net loss$(52,870)$(23,009)$(4,071)Other comprehensive loss, net of tax: Foreign currency translation(382)——Other comprehensive loss(382)——Comprehensive loss$(53,252)$(23,009)$(4,071)See the accompanying Notes to the Consolidated Financial Statements.125Novelion Therapeutics Inc. (Formerly QLT Inc.)Consolidated Statements of Shareholders’ Equity (in thousands, except share and per share information)Common SharesAdditionalPaid-InAccumulatedAccumulatedOtherComprehensiveTotalShareholders’ Shares (1)AmountCapitalDeficitIncomeEquityBalance at December 31, 201310,215,985$466,229$95,844$(507,258)$102,969$157,784Exercise of stock options, for cash, at prices rangingfrom CAD $22.7 to CAD $26.9 per share (1)20,809750(241)——509Shares issued in connection with RSUs vested (Note 12)2,80055(55)———Uncertain tax position liability recovery (Note 13)——837——837Stock-based compensation expense (Note 12)——1,453——1,453Net loss and comprehensive loss——(4,071)—(4,071)Balance at December 31, 201410,239,594467,03497,838(511,329)102,969156,512Exercise of stock options, for cash, at prices rangingfrom CAD $20.4 to CAD $22.7 per share (1)313,0958,077(2,569)——5,508Shares issued in connection with RSUs vested (Note 12)12,800222(222)———Stock-based compensation expense (Note 12)——2,330——2,330Net loss and comprehensive loss——(23,009)—(23,009)Balance at December 31, 201510,565,489475,33397,377(534,338)102,969141,341Shares issued in connection with the Acquisition ofAegerion (Note 5)6,060,28859,381———59,381Shares issued in a private placement net of shareissuance cost (Note 11)1,904,54616,5454,936——21,481Stock-based compensation expense (Note 12)—797——797Cash distribution to shareholders (Note 4)——(15,000)——(15,000)Aralez shares distributed to shareholders (Note 4)——(19,296)——(19,296)Uncertain tax position liability recovery (Note 13)——335——335Foreign currency translation adjustment— — — — (382) (382)Net loss———(52,870)—(52,870)Balance at December 31, 201618,530,323$551,259$69,149$(587,208)$102,587$135,787(1) Amounts have been retrospectively restated for all prior periods presented to reflect the one-for-five share consolidation of the Company’s common stock effected on December 16, 2016. Refer to Note 1 -Description of Business for further details.See the accompanying Notes to the Consolidated Financial Statements.126Novelion Therapeutics Inc. (Formerly QLT Inc.)Consolidated Statements of Cash FlowsFor the Years Ended December 31,(in thousands)2016 2015 2014Cash (used in) provided by operating activities Net loss$(52,870) $(23,009) $(4,071)Adjustments to reconcile net loss to net cash (used in) provided by operating activities: Depreciation264 576 891Amortization of intangible assets2,134 — —Stock-based compensation797 2,330 1,453Noncash interest expense2,676 — —Fair value change in contingent consideration (Notes 14, 16)2,042 — 2,000Unrealized foreign exchange gain (losses)118 (120) 75Loss (gain) on sale of long-lived assets50 (36) —Fair value loss on investment (Note 4)10,704 — —Deferred income taxes(214) 18 (177)Impairment of long-lived assets— 11 —Changes in assets and liabilities, excluding the effect of acquisition: Accounts receivable(893) 10 73Inventories2,079 — —Prepaid and other assets705 442 810Accounts payable4,441 (184) (607)Accrued liabilities(6,389) 570 108Accrued restructuring— — (130)Income taxes receivable/payable— 33 30Net cash (used in) provided by operating activities(34,356) (19,359) 455Cash provided by investing activities Cash acquired through acquisition (Note 5)28,290 — —Cash consideration for acquisition - loan to Aegerion (Note 5)(3,000) — —Proceeds from sale of long-lived assets192 43 115Purchases of property and equipment(155) (9) (25)Proceeds from contingent consideration (Notes 16)— — 36,582Net cash provided by investing activities25,327 34 36,672Cash (used in) provided by financing activities Issuance of common shares21,481 5,508 509Cash distribution paid to common shareholders(15,000) — —Settlement of Backstop Agreement (Note 4)15,000 — —Aralez investment(45,000) — —Net cash (used in) provided by financing activities(23,519) 5,508 509Exchange rate effect on cash(349) (267) (249)Net (decrease) increase in cash and cash equivalents(32,897) (14,084) 37,387Cash and cash equivalents, beginning of period141,824 155,908 118,521Cash and cash equivalents, end of period$108,927 $141,824 $155,908Supplemental cash flow information Cash paid for interest$33 $— $—Cash paid for taxes$105 $— $—Non-cash financing activities Shares issued in the acquisition (Note 5)$59,088$—$—Convertible notes of Aegerion, at fair value (Note 10)$222,900$—$—Non-cash investment activitiesPurchases of property and equipment included in accounts payable$61$—$— See the accompanying Notes to the Consolidated Financial Statements. 127Novelion Therapeutics Inc. (Formerly QLT Inc.)Notes to Consolidated Financial Statements1. Description of Business.Novelion Therapeutics Inc. (Novelion or the Company) (formerly QLT, Inc.) is a biopharmaceutical company dedicated to developing new standards of care forindividuals living with rare diseases. On June 14, 2016, the Company entered into an Agreement and Plan of Merger (as amended, the Merger Agreement) withAegerion Pharmaceuticals, Inc. (Aegerion), pursuant to which on November 29, 2016, Novelion completed the acquisition (the Merger) of Aegerion. Aegerion is arare disease biopharmaceutical company with two commercial products and global operations, through which the Company assumed certain assets and liabilities ofthe acquired entity, including $28.7 million in cash, cash equivalents and restricted cash and two revenue streams which will serve as further funding forNovelion's operations. Upon closing the acquisition, QLT Inc. changed its name to Novelion Therapeutics Inc. As further detailed in Note 5, the acquisition hasbeen accounted for as a business combination in which Novelion was considered the accounting acquirer of Aegerion. As such, the Consolidated FinancialStatements of Novelion include the results of Aegerion from November 29, 2016.Novelion has two commercial products, metreleptin and lomitapide from the acquisition of Aegerion and one orphan drug-designated product candidate, zuretinolacetate (zuretinol). Metreleptin, a recombinant analog of human leptin, is currently marketed in the U.S. under the brand name MYALEPT for injection.MYALEPT is approved in the U.S. as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital oracquired generalized lipodystrophy (GL). Lomitapide, which is marketed in the U.S. under the brand name JUXTAPID capsules, is approved in the U.S. as anadjunct to a low-fat diet and other lipid-lowering treatments, including low-density lipoprotein (LDL) apheresis where available, to reduce low-density lipoproteincholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non-high-density lipoprotein cholesterol (non-HDL-C) in adult patients withhomozygous familial hypercholesterolemia (HoFH). Lomitapide is also approved in the European Union (EU), under the brand name LOJUXTA hard capsules forthe treatment of adult patients with HoFH, as well as in Japan, Canada, and a small number of other countries. Zuretinol is an oral synthetic retinoid that is in latestage development for the treatment of inherited retinal disease (IRD) caused by underlying mutations in RPE65 and LRAT genes, comprising LCA and RP.Under the Merger Agreement, the Company issued certain warrants to the pre-closing shareholders of Novelion. These warrants (the Merger Agreement Warrants)may be exercised for up to an aggregate of 11,301,791 Novelion common shares at an exercise price of $0.05 per share if (i) the previously disclosed DOJ and SECinvestigations are settled for amounts in excess of $40 million and/or (ii) the putative class action lawsuit alleging certain misstatements and omissions related tothe marketing of JUXTAPID and the Company’s financial performance in violation of the federal securities laws is settled for an amount that exceeds the amounts,if any, available under Aegerion’s director and officer coverage in respect of that matter (together, the negotiated thresholds). The number of common shares forwhich the Merger Agreement Warrants may be exercised, if any, will vary based on the extent to which the settlements of the matters described above exceed thenegotiated thresholds. The Merger Agreement Warrants will not be exercisable for any shares to the extent any excess in respect of such matters is equal to or lessthan $1.0 million in the aggregate.Also on June 14, 2016, the Company entered into a unit subscription agreement (the Unit Subscription Agreement) with the investors’ party thereto (the Investors).Pursuant to the Unit Subscription Agreement, immediately prior to the Merger, the Investors acquired units, for $8.80 per unit, consisting of (i) 1,904,546 Novelioncommon shares and 531,208 fully paid-up warrants (the Paid-Up Warrants), which may be exercised for up to 568,181 Novelion common shares, and (ii)2,472,727 warrants (the Unit Subscription Agreement Warrants) exercisable for up to an aggregate of 2,644,952 Novelion common shares at an exercise price of$0.05 per share. The Unit Subscription Agreement Warrants were issued on the same terms and conditions as the Merger Agreement Warrants and are referred tocollectively with the Merger Agreement Warrants as the “Contingent Warrants” in the Notes to the Consolidated Financial Statements. Refer to Note 11- ShareCapital and Note 16 - Contingencies, Commitments and Guarantees for further information.On December 16, 2016, the Company completed a one-for-five (1:5) consolidation of all of its issued and outstanding common shares (the Consolidation),resulting in a reduction in the issued and outstanding common shares from approximately 92,653,562 to approximately 18,530,323 . Shares reserved under theCompany’s equity and incentive plans were adjusted to reflect the Consolidation. All share and per-share data presented in the Company's Consolidated FinancialStatements and notes have been retrospectively restated to reflect the Consolidation unless otherwise noted. Since the par value of the common shares is zero ,neither the recorded value for common shares nor the paid-in capital has been retrospectively restated to reflect the Consolidation.As noted above, all references in the notes to the Consolidated Financial Statements to the “Company” refer to Novelion and its consolidated subsidiaries. Forperiods before the closing of the Merger, where the specific entities are referred to within the Consolidated Financial Statements, unless otherwise stated, “QLT”refers to QLT Inc. and its wholly-owned subsidiaries and128“Aegerion” refers to Aegerion Pharmaceuticals, Inc. and its wholly-owned subsidiaries. Following the Merger, Novelion continues to conduct research anddevelopment related to zuretinol and Aegerion continues to develop and commercialize lomitapide and metreleptin, and each maintains its respective ownership ofor licenses covering intellectual property related to such products and remains as party to the regulatory filings and approvals for such products.2. Significant Accounting Policies.Basis of Presentation and Principles of ConsolidationThe accompanying Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States(GAAP). All amounts herein are expressed in U.S. dollars (USD) unless otherwise noted.The accompanying Consolidated Financial Statements include operations of Novelion Therapeutics Inc. and its wholly-owned subsidiaries. All intercompanytransactions and balances have been eliminated.In management’s opinion, the Consolidated Financial Statements reflect all adjustments (including reclassifications of normal recurring adjustments) necessary topresent fairly the financial position of Novelion as of December 31, 2016 and 2015 and the result of operations and cash flows for all periods presented.Use of EstimatesThe preparation of Consolidated Financial Statements in accordance with GAAP requires management to make estimates and assumptions that affect the reportedamounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the Consolidated Financial Statements, and the reported amounts ofexpenses during the reporting periods presented. Significant estimates and assumptions are required when determining the fair value of contingent assets andliabilities, the valuation of the convertible notes, and the valuation of the assets and liabilities acquired in a business combination including inventory andintangible assets. Significant estimates and assumptions are also required in determination of stock-based compensation and income tax. Our estimates often arebased on complex judgments, probabilities and assumptions that we believe to be reasonable but that are inherently uncertain and unpredictable. For any givenindividual estimate or assumption made by us, there may also be other estimates or assumptions that are reasonable. Actual results may differ from estimates madeby management. Changes in estimates are reflected in reported results in the period in which they become known.Reporting and Functional CurrencyNovelion’s reporting currency is the USD and the Company's operations utilize the USD or local currency as the functional currency, where applicable.Transactions in other currencies are recorded in the functional currency at the rate of exchange prevailing when the transactions occur. Monetary assets andliabilities denominated in other currencies are re-measured into the functional currency at rate of exchange in effect at the balance sheet date. Exchange gains andlosses arising from re-measurement of foreign currency-denominated monetary assets and liabilities are included in income in the period in which they occur.For foreign entities where the local currency is the functional currency, assets and liabilities denominated in local currencies are translated into USD at end-of-period exchange rates and the resultant translation adjustments are reported, net of their related tax effects, as a component of accumulated other comprehensiveitems in equity.Discontinued OperationsThe results of operations, including the gain on disposal for businesses that have been sold or are classified as held for sale, are excluded from continuingoperations and reported as discontinued operations for all periods presented. The Company sold its Visudyne business in 2012 and sold its punctal plug drugdelivery system technology (PPDS Technology) in 2013. The Company has not had any continued involvement with the Visudyne business or the PPDSTechnology following their sale. Amounts billed in connection with the provision of these transition services are included within discontinued operations.Cash and Cash EquivalentsCash and cash equivalents consist of highly liquid instruments purchased with an original maturity of three months or less at the date of purchase. As ofDecember 31, 2016 and December 31, 2015 , the Company held $108.9 million and $141.8 million in cash and cash equivalents, respectively, consisting of cashand money market funds.129Restricted CashRestricted cash represents amounts deposited with Silicon Valley Bank (SVB) to collateralize the Company’s corporate credit card program and a letter of creditfor the Company’s facility lease in Cambridge, Massachusetts. As of December 31, 2016, $0.4 million was held at SVB as security and hence is presented asrestricted cash on the Consolidated Balance Sheet.Accounts ReceivableThe majority of the Company's accounts receivable arise from product sales and primarily represent amounts due from distributors, named patients, and otherentities. The Company monitors the financial performance and creditworthiness of large customers to properly assess and respond to changes in their credit profile.The Company provides reserves against account receivables for estimated losses that may result from a customer’s inability to pay. Amounts determined to beuncollectible are charged or written-off against the reserve. To date, the Company's historical reserves and write-offs of accounts receivable have not beensignificant.Inventories and Cost of Product SalesInventories are stated at the lower of cost or market price with cost determined on a first-in, first-out basis. Inventories acquired in a business combination arerequired to be fair valued at initial recognition. See " Business Combinations" section below for details.Inventory is maintained on the Company’s Consolidated Balance Sheets until the inventory is sold, donated as part of the Company’s compassionate use program,or used for clinical development. Inventory that is sold is recognized as cost of product sales in the Consolidated Statements of Operations, inventory that isdonated as part of the Company’s compassionate use program is recognized as a selling, general and administrative expense in the Consolidated Statements ofOperations, expired inventory is disposed of and the related costs are recognized as cost of product sales in the Consolidated Statements of Operations, andinventory used for clinical development is recognized as research and development expense in the Consolidated Statements of Operations.Inventories are reviewed periodically to identify slow-moving inventory based on sales activity, both projected and historical, as well as product shelf-life. Theportion of the slow-moving inventory not expected to be sold within one year is classified as long-term inventory in the Company's accompanying ConsolidatedBalance Sheets.If the asset becomes impaired or is abandoned, the carrying value is written down to its fair value, and an impairment charge is recorded in the period in which theimpairment occurs. In evaluating the recoverability of inventories produced, the Company considers the probability that revenue will be obtained from the futuresale of the related inventory.Cost of product sales includes the cost of inventory sold, manufacturing and supply chain costs, product shipping and handling costs, charges for excess andobsolete inventory, amortization of acquired intangibles, as well as royalties payable to The Trustees of the University of Pennsylvania (UPenn) related to the saleof lomitapide and royalties payable to Amgen Inc. (Amgen), Rockefeller University and Bristol-Myers Squibb (BMS) related to the sale of metreleptin.Contingent ConsiderationThe contingent consideration is initially recognized and measured at fair value, and are subsequently revalued at the end of each reporting period. Resultingchanges in fair value are reported in continuing operations on the Consolidated Statements of Operations and comprehensive loss. See Note 16 - Contingencies,Commitments and Guarantees and Note 14 - Fair Value of Financial Instruments for more information on the Company’s historic contingent consideration assetbalance.Prepaid Manufacturing CostsCash advances paid by the Company prior to receipt of the inventory are recorded as prepaid manufacturing costs and included in prepaid expenses and othercurrent assets. The cash advances are subject to forfeiture if the Company terminates the scheduled production. The Company expects the carrying value of theprepaid manufacturing costs to be fully realized. As of December 31, 2016, $1.4 million was recorded as prepaid manufacturing costs and hence was reportedunder prepaid expenses and other current assets on the Consolidated Balance Sheet. As of December 31, 2015, the Company did no t record any prepaidmanufacturing costs.Property and EquipmentProperty and equipment are stated at cost and depreciated using the straight-line method based on estimated economic lives of 3 to 5 years for computer softwareand hardware, and 5 years for office furniture, fixtures, research equipment and other equipment. Leasehold improvements are amortized over the lesser of theestimated useful lives of the improvements or the remaining lease term, which include lease extensions when reasonably assured. Repair and maintenance costs areexpensed as incurred.Intangible AssetsIntangible assets with definite useful lives are amortized to their estimated residual values over their estimated useful lives and reviewed for impairment if certainevents occur.130Impairment of Long-lived AssetsImpairment testing and assessments of remaining useful lives are performed when a triggering event occurs that could indicate a potential impairment. Such testfirst entails comparison of the carrying value of the long-lived asset to the undiscounted cash flows expected from that asset. If impairment is indicated by this test,the long-lived assets are written down by the amount, if any, by which the discounted cash flows expected from the long-lived asset exceeds its carrying value.Business CombinationsThe Company evaluates acquisitions of assets and other similar transactions to assess whether or not each such transaction should be accounted for as a businesscombination by assessing whether or not the Company has acquired inputs and processes that have the ability to create outputs. If the Company determines that anacquisition qualifies as a business, the Company applies the acquisition method of accounting which requires that the purchase price be allocated to the net assetsacquired at their respective fair values. Goodwill is calculated as the excess of the consideration transferred over the net assets recognized and represents the futureeconomic benefits arising from other assets acquired that could not be individually identified and separately recognized. Goodwill is not amortized and is notdeductible for tax purposes. The Company reports provisional amounts when measurements are incomplete as of the end of the reporting period. We complete ourpurchase price allocation within a measurement period and which does not extend beyond one year after the acquisition date.Contingent consideration in a business combination is included as part of the acquisition cost and is recognized at fair value as of the acquisition date. Fair value isgenerally estimated by using a probability-weighted discounted cash flow approach. Any liability resulting from contingent consideration is re-measured to fairvalue at each reporting date until the contingency is resolved. These changes in fair value are recognized in earnings in other income (expense), net.The present-value models used to estimate the fair values of acquired inventory and intangibles incorporate significant assumptions, including, but not limited to:assumptions regarding the probability of obtaining marketing approval; estimated selling price, estimates of the timing and amount of future cash flows frompotential product sales and related expenses; and the appropriate discount rate selected to measure the risks inherent in the future cash flows, the assessment of theasset’s life cycle and the competitive trends impacting the assets, including consideration of any technical, legal, regulatory or economic barrier.Transaction costs associated with business combinations are expensed as incurred. The Company's Consolidated Financial Statements include the results fromoperations of an acquired business after transaction date.ContingenciesThe Company records a liability in the Consolidated Financial Statements for litigation related matters when a loss is considered probable and the amount can bereasonably estimated. If the loss is not probable or a range cannot reasonably be estimated, no liability is recorded in the Consolidated Financial Statements.Convertible NotesThe accounting guidance for convertible notes requires the Company to separately account for the liability and equity components of the Convertible Notes byallocating the proceeds between the liability component and the embedded conversion option. The carrying amount of the liability component is initially valued atthe fair value of a similar liability that does not have an associated convertible feature. The equity component of the Convertible Notes was determined bydeducting the fair value of the liability component from the fair value of the Convertible Notes as a whole on the date of acquisition. The excess of the principalamount of the liability component over its carrying amount, or debt discount, is amortized to interest expense using the effective interest method over the life of theConvertible Notes. The equity component is not re-measured as long as it continues to meet the conditions for equity classification.Contingent WarrantsThe Company accounted for the Contingent Warrants in accordance with the guidance regarding the accounting for derivative financial instruments indexed to, andpotentially settled in, a company’s own stock. The Contingent Warrants met the requirements to be accounted for as derivative instruments as the ContingentWarrants are variable and indexed to an event other than the fair value of the Company’s shares. See Note 11 (e) - Share Capital - Cash, Share and WarrantDistributions and Note 11 (d) - Share Capital - Private Placement for more information.Paid-Up WarrantsThe Company accounted for the Paid-Up Warrants issued in the Private Placement in accordance with the guidance regarding the accounting for derivativefinancial instruments indexed to, and potentially settled in, a company’s own stock. The Paid-Up Warrants met the requirements to be accounted for as equityinstruments. The proceeds related to the sale of the Paid-Up Warrants are included in additional paid-in capital in the Consolidated Balance Sheets. See Note 11(d)- Share Capital - Private Placement for more information.131Revenue RecognitionThe Company applies the revenue recognition guidance in accordance with Financial Accounting Standards Board Accounting Standards Codification (ASC)Subtopic No. 605-15, Revenue Recognition—Products. The Company recognizes revenue from product sales when there is persuasive evidence that anarrangement exists, title to product and associated risk of loss has passed to the customer, the price is fixed or determinable, collectability is reasonably assured andthe Company has no further performance obligations.LomitapideIn the U.S., JUXTAPID® is only available for distribution through a specialty pharmacy, and is shipped directly to the patient. JUXTAPID is not available in retailpharmacies. Prior authorization and confirmation of coverage level by a patient’s private insurance plan or government payer are currently prerequisites to theshipment of product to the patient in the U.S. Revenue from sales in the U.S. covered by the patient’s private insurance plan or government payer is recognizedonce the product has been received by the patient. For uninsured amounts billed directly to the patient, revenue is recognized at the time of cash receipt ascollectability is not reasonably assured at the time the product is received by the patient. To the extent amounts are billed in advance of delivery to the patient, theCompany defers revenue until the product has been received by the patient.The Company also records revenue on sales in countries where lomitapide is available on a named patient basis, and typically paid for by a government authorityor institution. In many cases, these sales are facilitated through a third-party distributor that takes title to the product upon acceptance. Because of factors such asthe pricing of lomitapide, the limited number of patients, the short period from product sale to delivery to the end-customer and the limited contractual returnrights, these distributors typically only hold inventory to supply specific orders for the product. The Company recognizes revenue for sales under these namedpatient programs upon product acceptance by either the named patient or the third-party distributor. In the event the payer’s creditworthiness has not beenestablished, the Company recognizes revenue on a cash basis if all other revenue recognition criteria have been met.The Company records distribution and other fees paid to its distributors as a reduction of revenue, unless the Company receives an identifiable and separate benefitfor the consideration and the Company can reasonably estimate the fair value of the benefit received. If both conditions are met, the Company records theconsideration paid to the distributor as an operating expense. At this time, neither condition has been met and therefore, the fees paid to the Company’s distributorsare recorded as a reduction of revenue. The Company records revenue net of estimated discounts and rebates, including those provided to Medicare, Medicaid,Tricare and other government programs in the U.S. and other countries. Allowances are recorded as a reduction of revenue at the time revenues from product salesare recognized. Allowances for government rebates and discounts are established based on the actual payer information, which is reasonably estimated at the timeof delivery. These allowances are adjusted to reflect known changes in the factors that may impact such allowances in the quarter those changes are known.From time to time, the Company provides financial support to patient assistance programs operated by independent charitable 501(c)(3) organizations which assistpatients in the U.S. in accessing treatment for HoFH. These patient assistance programs assist HoFH patients according to eligibility criteria defined independentlyby the charitable organization. The Company records donations made to these patient assistance programs as selling, general and administrative expense. Anypayments received from these patient assistance programs on behalf of a patient who is taking lomitapide for the treatment of HoFH are recorded as a reduction ofselling, general and administrative expense rather than as revenue.Beginning in 2015, the Company also offers a branded co-pay assistance program for eligible patients with commercial insurance in the U.S. who are onJUXTAPID therapy. The branded co-pay assistance program assists commercially insured patients who have coverage for JUXTAPID, and is intended to reduceeach participating patient’s portion of the financial responsibility for JUXTAPID’s purchase price up to a specified dollar amount of assistance. The Companyrecords revenue net of amounts paid under the branded specific co-pay assistance program for each patient.MetreleptinIn the U.S., MYALEPT is only available through an exclusive third-party distributor that takes title to the product upon shipment. MYALEPT is not available inretail pharmacies. The distributor may contractually hold inventory for no more than 21 business days. The Company recognizes revenue for these sales once theproduct is received by the patient as it is currently unable to reasonably estimate the rebates owed to certain government payers at the time of receipt by thedistributor. Prior authorization and confirmation of coverage level by a patient’s private insurance plan or government payer are currently prerequisites to theshipment of product to a patient in the U.S. Revenue from sales in the U.S. covered by the patient’s private insurance plan or government payer is recognized oncethe product has been received by the patient.The Company records distribution and other fees paid to its distributor as a reduction of revenue, unless the Company receives an identifiable and separate benefitfor the consideration and the Company can reasonably estimate the fair value of the benefit132received. If both conditions are met, the Company records the consideration paid to the distributor as an operating expense. At this time, neither condition has beenmet and therefore, these fees paid to the distributor are recorded as a reduction of revenue. The Company records revenue from sales of MYALEPT net ofestimated discounts and rebates, including those provided to Medicare and Medicaid in the U.S. Allowances for government rebates and discounts are establishedbased on the actual payer information, which is reasonably estimable at the time of delivery, and the government-mandated discounts applicable to government-funded programs. These allowances are adjusted to reflect known changes in the factors that may impact such allowances in the quarter those changes are known.To date, such adjustments have not been significant.From time to time, the Company provides financial support to patient assistance programs operated by independent charitable 501(c)(3) organizations which assisteligible patients in the U.S. in accessing treatment for GL. These patient assistance programs assists GL patients according to eligibility criteria definedindependently by the organization. The Company records donations made to these patient assistance programs as selling, general and administrative expense.Beginning in 2015, the Company also offers a branded co-pay assistance program for eligible patients with commercial insurance in the U.S. who are onMYALEPT therapy. The branded co-pay assistance program assists commercially insured patients who have coverage for MYALEPT, and is intended to reduceeach participating patient’s portion of the financial responsibility for MYALEPT’s purchase price up to a specified dollar amount of assistance. The Companyrecords revenue net of amounts paid under the branded specific co-pay assistance program for each patient.Research and Development ExpensesResearch and development expenses are charged to expense as incurred. Research and development expenses comprise costs incurred in performing research anddevelopment activities, including personnel-related costs, stock-based compensation, facilities-related overhead, clinical trial costs, costs to support certain medicalaffairs activities, manufacturing costs for clinical and pre-clinical materials as well as other contracted services, license fees, and other external costs.Nonrefundable advance payments for goods and services that will be used in future research and development activities are expensed when the activity has beenperformed or when the goods have been received rather than when the payment is made in accordance with the provisions of ASC No. 730 - Research andDevelopment . Income TaxesIncome taxes are reported using the asset and liability method, whereby deferred tax assets and liabilities are recognized for the future tax consequencesattributable to: (i) differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases, and (ii) operatingloss and tax credit carryforwards using applicable enacted tax rates. An increase or decrease in these tax rates will increase or decrease the carrying value of futurenet tax assets resulting in an increase or decrease to net income. Income tax credits, such as investment tax credits, are included as part of the provision for incometaxes. Current income taxes are provided for in accordance with the laws of the relevant taxing authorities. Significant estimates are required in determining theCompany’s provision for income taxes and uncertain tax positions. Some of these estimates are based on interpretations of existing tax laws or regulations. Variousinternal and external factors may have favorable or unfavorable effects on the Company’s future effective tax rate. These factors include, but are not limited to,changes in tax laws, regulations and/or rates, changing interpretations of existing tax laws or regulations, changes in estimates of prior years’ items, results of taxaudits by tax authorities, future levels of research and development spending, changes in estimates related to repatriation of undistributed earnings of foreignsubsidiaries, and changes in overall levels of pre-tax earnings. The realization of the Company’s deferred tax assets is primarily dependent on whether theCompany is able to generate sufficient capital gains and taxable income prior to expiration of any loss carry forward balance. A valuation allowance is providedwhen it is more likely than not that a deferred tax asset will not be realized. The assessment of whether or not a valuation allowance is required often requiressignificant judgment including the long-range forecast of future taxable income and the evaluation of tax planning initiatives. Adjustments to the deferred taxvaluation allowances are made to earnings in the period when such assessments are made.The Company records tax benefits for all years subject to examination based upon management’s evaluation of the facts, circumstances and information availableat the reporting date. There is inherent uncertainty in quantifying income tax positions. The Company has recorded tax benefits for those tax positions where it ismore likely than not that a tax benefit will result upon ultimate settlement with a tax authority that has all relevant information. For those income tax positionswhere it is not more likely than not that a tax benefit will result, no tax benefit has been recognized in the Consolidated Financial Statements. See Note 13 - IncomeTaxes for additional information.Stock-Based CompensationThe Company accounts for its stock-based compensation to employees in accordance with ASC No. 718 - Compensation - Stock Compensation and to non-employees in accordance with ASC No. 505-50 - Equity-Based Payments to Non-Employees. For service-based awards, compensation expense is recognized usingthe ratable method over the requisite service period, which is typically the vesting period. For awards that vest or begin vesting upon achievement of a performancecondition, the Company recognizes compensation expense when achievement of the performance condition is deemed probable using a straight-line model133over the implicit service period. Certain of the Company’s awards that contain performance conditions also require the Company to estimate the number of awardsthat will vest, which the Company estimates when the performance condition is deemed probable of achievement. For awards that vest upon the achievement of amarket condition, the Company recognizes compensation expense over the derived service period. For equity awards that have previously been modified, anyincremental increase in the fair value over the original award has been recorded as compensation expense on the date of the modification for vested awards or overthe remaining service period for unvested awards. See Note 12 - Stock-Based Payments for further information about the Company’s equity incentive plans.The Company has a Directors’ Deferred Share Unit Plan ("DDSU Plan") for the Company’s directors. Given that vested Deferred Share Units ("DSUs") areconvertible to cash only, the Company recognizes compensation expense for DSUs based on the market price of the Company’s shares. The Company also recordsan accrued liability to recognize the expected financial obligation related to the future settlement of these DSUs as they vest. Each reporting period, the expectedobligation is revalued for changes in the market value of Novelion’s common shares.The Company issues restricted stock units ("RSUs") to its employees and directors as consideration for their provision of future services. Restricted stock-basedcompensation expense is measured based on the fair value market price of Novelion’s common shares on the grant date and is recognized over the requisite serviceperiod, which coincides with the vesting period. RSUs can only be exchanged and settled for Novelion’s common shares, on a one-to-one basis, upon vesting.Comprehensive LossComprehensive loss combines net loss and other comprehensive items. Other comprehensive items represent certain amounts that are reported as components ofshareholders’ equity in the accompanying Consolidated Balance Sheets, including currency translation adjustments.Net Loss Per Common ShareBasic net loss per common share is computed using the weighted average number of common shares outstanding during the period. Diluted net income percommon share is computed in accordance with the treasury-shares and if-converted methods, which uses the weighted average number of common sharesoutstanding during the period and also includes the dilutive effect of common shares potentially issuable from outstanding stock-based awards.Recent Accounting Pronouncements- Not Yet AdoptedIn May 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards update (ASU) No. 2014-09, “Revenue from Contracts withCustomers” (ASU 2014-09). ASU 2014-09 represents a comprehensive new revenue recognition model that requires a company to recognize revenue to depict thetransfer of promised goods or services to customers in an amount that reflects the consideration to which a company expects to be entitled in exchange for thosegoods or services. This ASU sets forth a new five-step revenue recognition model which replaces the prior revenue recognition guidance in its entirety and isintended to eliminate numerous industry-specific pieces of revenue recognition guidance that have historically existed. In August 2015, the FASB issued ASUNo. 2015-14, “ Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date,” which defers the effective date of ASU 2014-09 by one year,but permits companies to adopt one year earlier if they choose (i.e. the original effective date). As such, ASU 2014-09 will be effective for annual and interimreporting periods beginning after December 15, 2017. In March and April 2016, the FASB issued ASU No. 2016-08 “Revenue from Contracts with Customers(Topic 606): Principal versus Agent Consideration (Reporting Revenue Gross versus Net)” and ASU No. 2016-10 “Revenue from Contracts with Customers(Topic 606): Identifying Performance Obligations and Licensing,” respectively, which clarify the guidance on reporting revenue as a principal versus agent,identifying performance obligations and accounting for intellectual property licenses. In addition, in May 2016, the FASB issued ASU No. 2016-12 “Revenue fromContracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients,” which amends certain narrow aspects of Topic 606, and inDecember 2016, the FASB issued ASU No. 2016-20 “Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers,” whichamends certain narrow aspects of Topic 606. The new standard may be adopted using either the full retrospective method, in which case the standard would beapplied to each prior reporting period presented, or the modified retrospective method, in which case the cumulative effect of applying the standard would berecognized at the date of initial application. In the fourth quarter of 2016, the Company engaged an external accounting firm to assist with the new standardadoption and has made significant progress in the assessment. Based on the progress, the Company expects to complete its assessment by the second quarter of2017.In July 2015, the FASB issued ASU No. 2015-11, “ Simplifying the Measurement of Inventory” (ASU 2015-11). ASU 2015-11 states that an entity shouldmeasure inventory at the lower of cost or net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonablypredictable costs of completion, disposal, and transportation. For public entities, ASU 2015-11 is effective for fiscal years beginning after December 15, 2016,including interim periods within those fiscal years. The amendments in this update should be applied prospectively and early application is permitted. TheCompany134does not expect the adoption of ASU 2015-11 to impact the Company’s consolidated results of operations and financial position.On February 25, 2016, the FASB issued ASU No. 2016-02 - Leases , its new standard on accounting for leases. The new guidance will require organizations thatlease assets (referred to as lessees) for terms of more than 12 months, to recognize on the balance sheet the assets and liabilities associated with the rights andobligations created by those leases. Consistent with current guidance, the recognition, measurement, and presentation of the expenses and cash flows associatedwith a particular lease will depend on its classification as a capital or operating lease. However, unlike current GAAP, which only requires capital leases to bereflected on the balance sheet, ASU No. 2016- 02 will require both types of leases to be recognized on the balance sheet. ASU No. 2016-02 also aligns many of theunderlying principles of the new lessor model with those in ASC No. 606 - Revenue from Contracts with Customers, and will require lessors to increase thetransparency of their exposure to changes in value of their residual assets and how they manage the associated exposure. ASU No. 2016-02 will be effective forannual periods beginning after December 15, 2018, and interim periods within those annual reporting periods. Management is currently assessing the impact ASUNo. 2016-02 will have on the Company’s Consolidated Financial Statements.On March 30, 2016, the FASB issued ASU No. 2016-09 - Improvements to Employee Stock-Based Payment Accounting, ASU 2016-09 changes how companiesaccount for certain aspects of share-based payments to employees including: (a) requiring all income tax effects of awards to be recognized in the incomestatement, rather than in additional paid in capital, when the awards vest or are settled, (b) eliminating the requirement that excess tax benefits be realized beforecompanies can recognize them, (c) requiring companies to present excess tax benefits as an operating activity on the statement of cash flows rather than as afinancing activity, (d) increasing the amount an employer can withhold to cover income taxes on awards and still qualify for the exception to liability classificationfor shares used to satisfy the employer’s statutory income tax withholding obligation, (e) requiring an employer to classify the cash paid to a tax authority whenshares are withheld to satisfy its statutory income tax withholding obligation as a financing activity on its statement of cash flows and (f) electing whether toaccount for forfeitures of share-based payments by (1) recognizing forfeitures of awards as they occur or (2) estimating the number of awards expected to beforfeited and adjusting the estimate when it is likely to change, as is currently required. ASU 2016-09 is effective for fiscal years beginning after December 15,2016, and interim periods within those fiscal years. The Company has adopted the new guidance on January 1, 2017. Upon adoption the Company will account forforfeitures when they occur, instead of estimating the number of awards that are expected to vest under current GAAP. The Company will retrospectively adopt theprovision of this guidance related to forfeitures by utilizing the modified retrospective transition method. The adoption of ASU No. 2016-09 will not materiallyimpact the Company’s Consolidated Financial Statements.On August 26, 2016, the FASB issued ASU No. 2016-15 - Classification of Certain Cash Receipts and Cash Payments, which amends the guidance in ASC No.230 on the classification of certain items in the statement of cash flows. The primary purpose of ASU No. 2016-15 is to reduce the diversity in practice by makingamendments that add or clarify the guidance on eight specific cash flow issues. ASU No. 2016-15 is effective for fiscal years beginning after December 15, 2017,including interim periods within those fiscal years. ASU No. 2016-15 must be applied retrospectively to all periods presented, but may be applied prospectivelyfrom the earliest date practicable if retrospective application would be impracticable. Management is currently assessing the impact ASU No. 2016-15 will have onthe Company’s Consolidated Financial Statements.On October 24, 2016, the FASB issued ASU No. 2016-16 - Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other than Inventory , which improves theaccounting for the income tax consequences of intra-entity transfers of assets other than inventory and eliminates the exception for an intra-entity transfer of anasset other than inventory. ASU No. 2016-16 is effective for annual reporting periods beginning after December 15, 2017, including interim reporting periodswithin those annual reporting periods. ASU No. 2016-16 should be applied on a modified retrospective basis through a cumulative-effect adjustment directly toretained earnings as of the beginning of the period of adoption. Upon adoption, prior periods will be retrospectively adjusted. Management does not expect theadoption of ASU No. 2016-16 will materially impact the Company’s Consolidated Financial Statements.On November 17, 2016, the FASB issued ASU No. 2016-18 “ Statement of Cash Flows (Topic 230) - Restricted Cash ” (ASU 2016-18). ASU 2016-18 states that astatement of cash flows should explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash orrestricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cashequivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for fiscalyears beginning after December 15, 2017, and interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period, andall updates should be applied using a retrospective transition method. The Company is currently evaluating the impact ASU 2016-18 will have on the Company’sConsolidated Statement of Cash Flows.On January 5, 2017, the FASB issued ASU No. 2017-01 Business Combinations (Topic 805): Clarifying the Definition of a Business , which provides a morerobust framework to use in determining when a set of assets and activities is a business. It also provides more consistency in applying the guidance, reduces thecosts of application and makes the definition of a business more operable. ASU No. 2017-01 is effective for annual periods beginning after December 15, 2017,including interim periods within those135periods. Management is currently assessing the impact ASU No. 2017-01 will have on the Company’s Consolidated Financial Statements.Recently Adopted Accounting PronouncementsOn September 25, 2015, the FASB issued Accounting Standards Update (ASU) No. 2015-16 - Business Combinations (Topic 805) Simplifying the Accounting forMeasurement-Period Adjustments. Under the guidance, an acquirer must recognize adjustments to provisional amounts that are identified during the measurementperiod in the reporting period in which the adjustment amounts are determined. ASU No. 2015-16 also requires acquirers to present separately on the face of theincome statement, or disclose in the notes, the portion of the amount recorded in current-period earnings by line item that would have been recorded in previousreporting periods if the adjustment to the provisional amounts had been recognized as of the acquisition date. ASU No. 2015-16 was effective for annual periods,and interim periods, beginning after December 15, 2015 and did not impact the Company’s financial position or results of operations.3. Terminated Merger Transactions.On June 8, 2015, QLT entered into an Agreement and Plan of Merger (as amended and restated on each of July 16, 2015 and August 26, 2015) (the InSite MergerAgreement) with InSite Vision Incorporated, a Delaware corporation (InSite). On September 15, 2015, the InSite Merger Agreement was terminated by InSite'sboard of directors. As a result, InSite paid QLT a termination fee of $2.7 million . In addition, in conjunction with the entry into the InSite Merger Agreement, onJune 8, 2015 QLT granted InSite a secured line of credit (the Secured Note) for up to $9.9 million to fund continuing operations through to the completion of theproposed InSite merger. Upon termination of the InSite Merger Agreement, InSite’s repayment obligations under the Secured Note were accelerated and InSitepaid QLT $5.8 million on September 15, 2015, which consisted of $5.7 million of principal drawn from the Secured Note and $0.1 million of accrued interest.On June 25, 2014, the Company entered into an Agreement and Plan of Merger (the Auxilium Merger Agreement) with Auxilium Pharmaceuticals, Inc., aDelaware corporation (Auxilium). On October 8, 2014, the Auxilium Merger Agreement was terminated by Auxilium's board of directors. In connection with thetermination of the Auxilium Merger Agreement, on October 9, 2014, Auxilium paid QLT a termination fee of $28.4 million . On October 22, 2014, pursuant to theterms of QLT's financial advisory services agreement with Credit Suisse Securities (USA) LLC (Credit Suisse), QLT paid Credit Suisse a portion of the breakupfee equal to $5.7 million . QLT’s financial advisory services agreement with Credit Suisse was subsequently terminated.During the year ended December 31, 2015 and 2014, QLT incurred $10.2 million and $9.4 million of consulting and transaction fees in connection with QLT’spursuit of the Auxilium and InSite Mergers, respectively. These $19.6 million of consulting and transaction fees, which is net of the $5.7 million portion of thebreakup fee paid to Credit Suisse, has been reflected as part of Selling, General and Administrative expenses on the Consolidated Statements of Operations.4. Strategic Transactions.Aralez Investment and DistributionOn December 7, 2015, QLT entered into an Amended and Restated Share Subscription Agreement (the Amended and Restated Subscription Agreement) withTribute Pharmaceuticals Canada Inc. (Tribute), POZEN Inc. (POZEN), Aralez Pharmaceuticals plc, (formally known as Aguono Limited) (Aralez Ireland) andcertain other investors for the purpose of returning capital to QLT's shareholders in either Aralez Shares (approximately 0.13629 of an Aralez Share for eachcommon share of the Company) or cash, subject to pro-ration (the Aralez Distribution), up to a maximum of $15.0 million funded pursuant to the terms of theBackstop Agreement (as described below).In connection with the Aralez Distribution, on June 8, 2015, QLT entered into a share purchase agreement (as amended, the Backstop Agreement) with BroadfinHealthcare Master Fund, Ltd. (Broadfin) and the JW Partners, LP, JW Opportunities Fund, LLC and JW Opportunities Master Fund, Ltd. (together the JW Parties),pursuant to which Broadfin and the JW Parties agreed to purchase up to $15.0 million of the Aralez Shares from the QLT at $6.25 per share. This arrangementprovided QLT’s shareholders with the opportunity to elect to receive, in lieu of Aralez Shares, up to an aggregate of $15.0 million in cash, subject to prorationamong the shareholders.On February 5, 2016, QLT purchased 7,200,000 Aralez Shares (representing 10.1% of the issued and outstanding Aralez Shares), for an aggregate price of $45.0million . On April 5, 2016 (the Distribution Date), QLT distributed 4,799,619 Aralez Shares with a fair value of $19.3 million , and $15.0 million of cash toshareholders of record on February 16, 2016.136QLT held the Aralez Shares from February 5, 2016 to the Distribution Date and the Aralez Shares were marked-to-market. As a result, QLT recognized a $10.7million loss during the year ended December 31, 2016, to reflect the change in value from the acquisition date to the Distribution Date.Pursuant to QLT’s financial advisory services agreement with Greenhill dated December 4, 2014 (as amended, the Greenhill Agreement), QLT paid Greenhill a$4.0 million advisory fee in connection with the completion of QLT’s $45.0 million investment in Aralez and exploration of other strategic initiatives describedunder Note 3 - T erminated Merger Transactions.Private Placement related to AralezOn June 8, 2015, QLT entered into a Share Purchase and Registration Rights Agreement (as amended, the Share Purchase and Registration Rights Agreement)with Broadfin, JW Partners, LP, JW Opportunities Fund, LLC, EcoR1 Capital Fund Qualified, L.P. and EcoR1 Capital Fund, LP (the QLT Investors). The SharePurchase and Registration Rights Agreement provided that QLT would, following the completion of the Aralez Distribution, issue and sell to the QLT Investors acertain number of QLT common shares for an aggregate purchase price of $20.0 million , reflecting a per share purchase price of $1.87 . In light of the terminationof the InSite Merger Agreement and the board’s determination that QLT’s cash requirements at that time did not justify the dilution that would be caused by thisprivate placement, on April 28, 2016, QLT and the QLT Investors mutually agreed to terminate the Share Purchase and Registration Rights Agreement.5. Acquisition.Aegerion Pharmaceuticals, Inc.On November 29, 2016, Novelion completed its acquisition of Aegerion and each share of Aegerion’s common stock was exchanged for 1.0256 Novelion (pre-Consolidation) common shares (the Exchange Ratio). Immediately after the Merger, the Company had approximately 18,530,323 common shares outstanding;former shareholders of Novelion held approximately 68% of the Company, and former stockholders of Aegerion held approximately 32% of the Company.The Merger has been accounted for as a business combination under the acquisition method, with Novelion as the accounting acquirer and Aegerion as the“acquired” company. The operating results of Aegerion from November 29, 2016 are included in the accompanying Consolidated Statements of Operations for theyear ended December 31, 2016. The Consolidated Balance Sheet as of December 31, 2016 reflect the acquisition of Aegerion, effective November 29, 2016.The acquisition consideration in connection with the Merger was approximately $62.4 million and consisted of the following (in thousands, except for share andper share information):Number of Novelion common shares issued in connection with theacquisition of Aegerion6,060,288Novelion share price on November 29, 2016$9.75Fair value of Novelion common shares issued to Aegerion stockholders$59,088Liability assumed (2)(3)3,000Stock compensation assumed (1)293Total acquisition consideration$62,381(1) The fair value of Aegerion in-the-money options and RSUs attributed to pre-combination services that were outstanding on November 29, 2016 and settled in connection with the Merger.(2) Represents a term loan facility provided by QLT to Aegerion on June 14, 2016, concurrently with the execution of the Merger Agreement. Aegerion borrowed $3 million against the term loan and the loan remained outstanding asof November 29, 2016.(3) Includes 10,565,879 Merger Agreement Warrants to purchase up to 11,301,791 common shares issued pursuant to the Merger Agreement, which were recognized as a liability with a fair value of zero as of November 29, 2016.Refer to Note 11 - Share Capital and Note 16 - Contingencies, Commitments and Guarantees for further details.The estimated fair value of the assets acquired and liabilities assumed are provisional as of December 31, 2016 and are based on information that is currentlyavailable to the Company. Additional information is being gathered to finalize these provisional measurements, particularly with respect to intangible assets,inventory, and deferred income taxes. Accordingly, the measurement of the assets acquired and liabilities assumed may change significantly upon finalization ofthe Company’s valuations and completion of the purchase price allocation, both of which are expected to occur no later than one year from the acquisition date.The following table summarizes the provisional fair values of the assets acquired and liabilities assumed at the Merger date (in thousands):137 November 29, 2016Cash and cash equivalents $28,290Restricted cash 390Accounts receivable (1) 8,182Inventories 76,800Prepaid expenses and other current assets 9,839Insurance proceeds receivable 22,000Property and equipment, net 4,020Intangible assets 252,458Other Assets 1,352Accounts payable (11,459)Accrued liabilities (41,883)Provision for legal settlement (63,968)Long-term debt (222,908)Other liabilities (732)Net assets acquired $62,381(1) As of the Merger date, the fair value of accounts receivable approximated the book value acquired. The amount not expected to be collected was insignificant.•Legal Matters - Aegerion has been the subject of certain ongoing investigations and other legal proceedings. See Note 16 - Contingencies, Commitmentsand Guarantees for further information regarding these and other legal proceedings.•Tax Matters - Net liabilities for income taxes payable approximated $0.1 million and unrecognized tax benefits approximated $0.9 million as of theacquisition date. A net deferred tax asset related to Aegerion’s foreign subsidiaries approximated $1.1 million as of the acquisition date.The valuation of the intangible assets acquired and related amortization periods are as follows:Valuation ( in thousands )Amortization period (in years)Developed Technology:JUXTAPID$42,30010.75MYALEPT210,1589.25Total$252,458The preliminary fair values of the intangibles were estimated using a multi-period excess earnings approach. Under this method, an intangible assets fair value isequal to the present value of the after-tax cash flows attributable solely to the intangible asset over its remaining useful life. To calculate fair value, the Companyused cash flows discounted at 11% .The fair values of the purchased inventories were also estimated using a discounted present value income approach. To calculate fair value, the Company used cashflows discounted at 11% . There was no goodwill recorded as part of the acquisition of Aegerion on the acquisition date.Novelion recognized acquisition-related transaction costs associated with the Merger during the year ended December 31, 2016 totaling approximately $4.0 million. These costs, which related primarily to bank fees, legal and accounting services, and fees for other professional services, were expensed as incurred, and reportedas the selling, general and administrative expenses (SG&A) in the accompanying Consolidated Statements of Operations.Actual and Pro Forma Impact of AcquisitionThe following table presents the amount of Aegerion net product sales and net loss included in the Company's Consolidated Statement of Operations fromNovember 29, 2016 through December 31, 2016:138(in millions, except for per share information)November 29, 2016 -December 31, 2016Net product sales$13.6Net loss(6.3)Basic and diluted net loss per share$(0.34)The following supplemental unaudited pro forma information presents the financial results as if the Merger had occurred on January 1, 2015 for the years endedDecember 31, 2016 and 2015.Unaudited Supplemental Pro Forma Consolidated ResultsYear ended December 31,(in millions, except for per share information)20162015Net product sales$153.2$239.9Net loss(207.8)(96.3)Basic and diluted loss per share$(18.41)$(9.23)This supplemental pro forma information has been prepared for comparative purposes and does not purport to reflect what the Company’s results of operationswould have been had the acquisition occurred on January 1, 2015, nor does it project the future results of operations of the Company or reflect the expectedrealization of any cost savings associated with the acquisition. The actual results of operations of the Company may differ significantly from the pro formaadjustments reflected here due to many factors. The unaudited supplemental pro forma financial information includes various assumptions, including those relatedto the provisional purchase price allocation of the assets acquired and the liabilities assumed from Aegerion.6. Inventories.The components of inventory are as follows: December 31, 2016 2015 ( in thousands )Work-in-process$20,219$—Finished goods54,502—Total$74,721$— As part of the Merger, the Company acquired $76.8 million of inventory. During the years ended December 31, 2016, 2015 and 2014, the Company did no t recordany expense related to the excess or obsolete inventory in the Consolidated Statements of Operations. 7. Property and Equipment.Property and equipment consists of the following: December 31, 2016( in thousands )CostAccumulated DepreciationNet Book ValueLeasehold improvements$1,869$263$1,606Office furniture and equipment53920519Research equipment1,9621,810152Computer and office equipment10,2368,6931,543Construction in progress339$—339 $14,945$10,786$4,159 139 December 31, 2015( in thousands )CostAccumulated DepreciationNet Book ValueLeasehold improvements$207$207$—Office furniture and equipment25824612Research equipment3,4713,092379Computer and office equipment9,8449,80539 $13,780$13,350$430 Depreciation expense was $0.3 million , $0.6 million and $0.9 million for the years ended December 31, 2016 , 2015 and 2014 , respectively.As part of the Merger, the Company acquired $4.0 million of property and equipment.In connection with the downsizing of the Company’s lease space in 2015 (see Note 16 - Contingencies, Commitments and Guarantees for more information), theCompany retired the use of certain property, plant and equipment with zero or minimal net book values.8. Intangible Assets.The following is a summary of intangible assets held by the Company at December 31, 2016 and 2015 (in thousands):Cost basis:Balance as of December 31,20152016 AcquisitionsBalance as of December31, 2016Definite-lived intangibles:Developed Technology - Juxtapid (weighted average life of 10.75 years)$—$42,300$42,300Developed Technology - Myalept (weighted average life of 9.25 years)—210,158210,158Total definite-lived intangibles (weighted average life of 9.50 years)$—$252,458$252,458Accumulated amortization:Balance as of December 31,20152016 AmortizationBalance as of December31, 2016Definite-lived intangibles: Developed Technology - Juxtapid$—$(328)$(328)Developed Technology - Myalept—(1,806)(1,806)Total definite-lived intangibles$—$(2,134)$(2,134)Net intangible assets$—$250,324As part of the Merger, the Company acquired $252.5 million of intangible assets. Amortization expense for the year ended December 31, 2016 totaled $2.1 million, and zero for the years ended December 31, 2015 and 2014 , respectively. Estimated amortization of intangible assets for the five fiscal years subsequent toDecember 31, 2016 is as followings (in thousands):Years Ending December 31, Estimated Amortization ofIntangible Assets2017 $25,6142018 25,6142019 25,6142020 25,6142021 $25,614140Novelion will test definite-lived intangible assets for impairment when events and changes in circumstances indicate that the carrying amount of these definite-lived intangible assets may not be recoverable. Impairment loss is recognized if the carrying value of definite-lived intangible is not recoverable and its carryingvalue exceeds its fair value. Any impairment charges resulting from intangible asset impairment assessments are recorded to asset impairments charges on theCompany’s Consolidated Statements of Operations.9. Accrued Liabilities.Accrued liabilities consist of the following:December 31(in thousands)20162015Accrued employee compensation and related costs$7,920$1,460Accrued sales allowances7,849—Other accrued liabilities21,411367Total$37,180$1,827 10. Convertible Notes, Net.In August 2014, Aegerion issued Convertible Notes with an aggregate principal amount of $325.0 million . The Convertible Notes are governed by the terms of anindenture and a supplemental indenture between Aegerion and The Bank of New York Mellon Trust Company, N.A., as the Trustee. The following are the keyterms of the Convertible Notes:•The Convertible Notes are senior unsecured obligations of Aegerion and bear interest at a rate of 2.0% per year, payable semi-annually in arrears onFebruary 15 and August 15 of each year, beginning on February 15, 2015. The Convertible Notes will mature on August 15, 2019, unless earlierrepurchased or converted.•After the Merger, the Convertible Notes are convertible into the Company’s common shares at a conversion rate of 4.9817 common shares per $1,000principal amount of the Convertible Notes, as adjusted for the Exchange Ratio and the Consolidation. Aegerion can, at its election, settle the conversion ofthe Convertible Notes through payment or delivery of cash, common shares, or a combination of cash and common shares.•On or after February 15, 2019 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders mayconvert all or any portion of their Convertible Notes, in multiples of $1,000 principal amount, at the option of the holder.•The indenture does not contain any financial covenants or restrict the Company’s ability to repurchase the Company’s securities, pay dividends or makerestricted payments in the event of a transaction that substantially increases the Company’s level of indebtedness.•The indenture contains customary terms and covenants and events of default. If an event of default (other than certain events of bankruptcy, insolvency orreorganization involving Aegerion) occurs and is continuing, the Trustee by notice to Aegerion, or the holders of at least 25% in principal amount of theoutstanding Convertible Notes by written notice to Aegerion and the Trustee, may declare 100% of the principal of and accrued and unpaid interest, ifany, on all of the Convertible Notes to be due and payable. Upon such a declaration of acceleration, such principal and accrued and unpaid interest, if any,will be due and payable immediately. Upon the occurrence of certain events of bankruptcy, insolvency or reorganization involving Aegerion, 100% of theprincipal and accrued and unpaid interest, if any, on the Convertible Notes will become due and payable automatically. Notwithstanding the foregoing,the indenture provides that, upon Aegerion’s election, and for up to 180 days, the sole remedy for an event of default relating to certain failures byAegerion to comply with certain reporting covenants in the indenture consists exclusively of the right to receive additional interest on the ConvertibleNotes.On November 29, 2016, the Company completed its acquisition of Aegerion. The acquisition method of accounting requires an accounting acquirer to measureliabilities assumed at fair value on the acquisition date, as such, both the liability and equity component of the Convertible Notes were re-measured at fair value atthe Merger date. The fair value of the Convertible Notes as of the Merger date was approximately $222.9 million , which was determined by taking intoconsideration valuations obtained from third-party pricing services. The pricing services utilize pricing model incorporating variables such as coupon, maturity,delta, conversion ratio, parity, corporate actions and equity market closing prices to calculate conversion premiums and sensitivity values and to generate the fairvalue of the Convertible Notes. As of the Merger date, management attributed the fair value entirely141to the liability component of the Convertible Notes for the following reasons: 1) as of the Merger date, the conversion price ( $200.74 ) was significantly higherthan the price of Novelion common shares ( $9.75 ), and 2) management did not expect the price of Novelion common shares to raise above the conversion pricebefore the Convertible Notes expire in August 2019. Novelion recorded $222.9 million as the opening balance for the liability component of the Convertible Notesand reported zero balance for the equity component of the Convertible Notes post-Merger on its Consolidated Financial Statements.The Company’s outstanding Convertible Notes balances as of December 31, 2016 consisted of the following (in thousands):Liability component: Principal$324,998Less: debt discount(99,414)Net carrying amount$225,584Equity component$— (1) Represents interest payable within one year after December 31, 2016.The Company determined that the expected life of the debt was equal to the five year term on the Convertible Notes. The effective interest rate on the liabilitycomponent was 16.42% for the period from the acquisition date through December 31, 2016 . The following table sets forth total interest expense recognizedrelated to the Convertible Notes during the year ended December 31, 2016 (in thousands): Years EndingDecember 31, 2016Contractual interest expense$577Amortization of debt discount2,676Total$3,253Future minimum payments under the Company’s Convertible Notes are as follows (in thousands):Years Ending December 31, 2017$6,50020186,5002019329,060 342,060Less amounts representing interest(17,062)Less amortization of debt discount, net(99,414)Net carrying amount of convertible notes$225,584 11. Share Capital.(a) Authorized SharesAt December 31, 2016 and 2015, the Company was authorized to issue 100 million shares without par value. Dividends on the common shares will be paid when,and if, declared by the Board of Directors. Each holder of common shares is entitled to vote on all matters and is entitled to one vote for each share held.The Company will, at all times, reserve and keep available, out of its authorized but unissued common share, sufficient shares to affect the conversion of shares forstock options, restricted stock units, convertible notes and warrants. (b) Share ConsolidationOn December 16, 2016 , the Company effected a one-for-five consolidation of all of its issued and outstanding common shares without par value. As noted above,all share and per-share data presented in the Company’s Consolidated Financial Statements and notes have been retrospectively restated to reflect theConsolidation unless otherwise noted. Shares reserved and outstanding under the Company’s equity and incentive plans were adjusted to reflect the Consolidation .142(c) Merger ConsiderationOn November 29, 2016, an indirect wholly-owned subsidiary of Novelion acquired Aegerion for total consideration of $62.4 million . The consideration included6,060,288 Novelion common shares valued at $59.1 million and 10,565,879 Merger Agreement Warrants exercisable for up to an aggregate of 11,301,791common shares at an exercise price of $0.05 per share that were valued at zero on November 29, 2016 on the Company’s Consolidated Balance Sheet. Refer toNote 5 - Acquisition for additional information.(d) Private PlacementAlso on June 14, 2016, the Company entered into the Unit Subscription Agreement with the Investors. Pursuant to the Unit Subscription Agreement, immediatelyprior to the Merger, the Investors acquired units, for $8.80 per unit, consisting of (i) 2,472,727 Novelion common shares, which includes up to 568,181 Novelioncommon shares issuable upon exercise of the 531,208 Paid-Up Warrants, and (ii) 2,472,727 Unit Subscription Agreement Warrants exercisable for a maximum of2,644,952 Novelion common shares at an exercise price of $0.05 per common share. The net consideration received from the private placement was $21.5 million ($21.8 million gross consideration net of $0.3 million share issuance cost), which was recorded as equity and allocated based on the relative fair values of thecommon shares and the Paid-Up Warrants at the time of issuance. The Unit Subscription Agreement Warrants were issued on the same terms and conditions as theMerger Agreement Warrants. As of December 31, 2016 , the Unit Subscription Agreement Warrants were recognized as a liability on the Company's ConsolidatedBalance Sheet with a fair value of zero .(e) Cash, Share and Warrant DistributionsOn April 5, 2016, based on the shareholder election, Novelion distributed $15 million of cash and 4,799,619 Aralez Shares, with a fair value of $19.3 million , toits shareholders of record on February 16, 2016 according to the Amended and Restated Subscription Agreement.On November 23, 2016, the Company issued 10,565,879 Merger Agreement Warrants to its shareholders of record on November 17, 2016. As of December 31,2016 , the Merger Agreement Warrants were recognized as a liability on the Company's Consolidated Balance Sheet with a fair value of zero .12. Stock-Based Payments.The Company currently maintains one equity incentive plan, the Novelion 2016 Equity Incentive Plan (the NVLN Plan), formerly known as QLT 2000 IncentiveStock Plan, under which it may grant non-qualified stock options, incentive stock options, and restricted stock units (“RSUs”) to employees, directors andconsultants of Novelion and its affiliates. Common shares of Novelion will be issued upon exercise of stock options and the vesting of RSUs.The Company issues stock options and RSUs with service conditions, which are generally the vesting periods of the awards. The Company has also issued RSUsthat vest upon the satisfaction of certain performance conditions or the satisfaction of certain market conditions.No financial assistance is provided by Novelion to the participants under the NVLN Plan. Under the terms of the NVLN Plan, Novelion is entitled to grant awardsin respect of its unissued common shares up to a maximum of 4,760,000 shares.In connection with the Merger, Novelion assumed the Aegerion 2010 Stock Option and Incentive Plan (Aegerion’s 2010 Option Plan) from Aegerion. On theclosing of the Merger, on November 29, 2016, all the outstanding out-of-the-money Aegerion stock options were cancelled. All the outstanding and unexercised in-the-money Aegerion stock options were exchanged for adjusted options of Novelion and all the outstanding Aegerion RSUs held by Aegerion RSU holders wereexchanged for adjusted RSUs of Novelion, in each case appropriately adjusted to reflect the Exchange Ratio.Aegerion’s 2010 Option Plan was approved by Aegerion’s stockholders in October 2010 . Aegerion’s 2010 Option Plan allowed Aegerion to make grants ofincentive stock options, non-qualified stock options, stock appreciation rights, restricted stock awards, restricted stock units, unrestricted stock awards, cash-basedawards, performance share awards and dividend equivalent rights. All full-time and part-time officers, employees, non-employee directors and other key persons,including consultants and prospective employees, of Aegerion were eligible to participate in Aegerion’s 2010 Option Plan.The Company does not plan to issue additional awards under Aegerion’s 2010 Option Plan. There are 10,561 options and 133,351 RSUs outstanding underAegerion’s 2010 Stock Option Plan as of December 31, 2016.Determining the Fair Value of Stock Awards(a) Stock Options143The fair value of stock options is measured with service-based and performance-based vesting criteria to employees, consultants and directors on the date of grantusing the Black-Scholes option pricing model.The Black-Scholes option pricing model was developed for use in estimating the value of traded options that have no vesting restrictions and are fully transferable.In addition, option pricing models require the input of highly subjective assumptions, including the expected stock price volatility. The expected volatility andexpected life of the Company’s stock options is projected based upon historical and other economic data trended into future years. The risk-free interest rateassumption is based upon observed interest rates appropriate for the expected life of the Company’s stock options. The risk-free interest rate is determined byreference to implied yields available from U.S. Treasury securities with a remaining term equal to the expected life assumed at the date of grant. Forfeitures areestimated based on the Company’s historical analysis of both options and awards that forfeited prior to vesting.The weighted-average grant date fair values of stock options granted during the years ended December 31, 2016 , 2015 and 2014 , were USD $7.12 , CAD $10.60, and CAD $9.35 , respectively.The following weighted-average assumptions were used to value stock options granted in each of the following years: Years Ended December 31, 2016 2015 2014Expected share price volatility38.23% 41.30% 42.40%Risk-free interest rate1.93% 1.40% 1.60%Expected life of options (years)6.19 6.80 6.80Expected dividend yield— — —As of December 31, 2016, 205,030 options were outstanding under the NVLN Plan, which are exercisable at prices ranging between $7.15 and $35.51 per commonshare. The number of options issued and outstanding under the NVLN Plan represents 9.1% (2015 - 0.8% , 2014 - 4.1% ) of the Company’s issued andoutstanding common shares. The Company’s stock option activity for the year ended December 31, 2016 is as follows: Weighted Weighted- Average Average Remaining Aggregate Number of Exercise Price Contractual Intrinsic Value (2) stock options (2) Per Share (2) Life (years) (in thousands)Outstanding at December 31, 2015 (3)85,630 C$25.35 8.26 C$—Granted (1)1,629,563 $8.27 Exercised— $— $—Forfeited/cancelled(600) $25.35 Outstanding at December 31, 20161,714,593 $9.01 9.65 $528Vested and expected to vest at December 31, 20161,231,203 $9.24 9.58 $437Exercisable at December 31, 2016205,030 $13.86 8.49 $140 (1) The Aegerion stock options assumed by the Company in connection with the Merger are included in grants made during the year ended December 31, 2016 in the above table. The totalnumber of assumed Aegerion stock options was 10,561 with a weighted-average exercise price of $7.70 per share.(2) Shares and per share amounts have been retrospectively restated for all prior periods presented to reflect the one-for-five share consolidation.(3) Intrinsic value and exercise price of the stock options granted before 2016 were based on the underlying Novelion common shares listed on the Toronto Stock Exchange (TSX), and thus inCanadian dollars. Stock options granted in 2016 and after are and will be based on the underlying Novelion common shares listed on NASDAQ and thus in USD.In connection with the strategic transactions announced on June 8, 2015 as described under Note 3 - Terminated Merger Transactions and Note 4 - StrategicTransactions, on June 7, 2015 the Board of Directors accelerated the vesting provisions applicable to 217,294 options outstanding and unvested at that date. Theimpact of the accelerated vesting of these stock options on stock-based compensation expense for the year ended December 31, 2015 was $1.5 million .1,509,563 stock options were outstanding and unvested at December 31, 2016 (2015 - zero , 2014 - 256,796 ) and the total estimated unrecognized compensationcost related to unvested stock options is $4,922,028 (2015 - zero , 2014 - $ 2,021,000 )and the weighted-144average period over which such costs are expected to be recognized is 2.83 years (December 31, 2015 - 0 years, December 31, 2014 - 2.20 years).The aggregate intrinsic values of options outstanding and exercisable as of December 31, 2016, 2015, and 2014 are as follows:(In thousands)2016 2015 2014Aggregate intrinsic value of options outstanding (1)$528 C$— C$2,435Aggregate intrinsic value of options exercisable (1)140 — 240 (1) Intrinsic value of the stock options granted before 2016 were based on the underlying Novelion common shares listed on the Toronto Stock Exchange (TSX), and thus in Canadian dollars.Stock options granted in 2016 and after are and will be based on the underlying Novelion common shares listed on NASDAQ and thus in USD.New common shares are issued upon exercise of stock options. The intrinsic value of stock options exercised and the related cash from exercise of stock optionsduring the years ended December 31, 2016, 2015 and 2014 are as follows:(In thousands)2016 2015 2014 Intrinsic value of stock options exercised$— $4,930 $230Cash from exercise of stock options— 5,508 509 (b) Deferred Share UnitsUnder the DDSU Plan, at the discretion of the Board of Directors, directors can receive all or a percentage of their equity-based compensation in the form of DSUs.DSUs vest in thirty-six ( 36 ) successive and equal monthly installments beginning on the first day of the first month after the grant date. A vested DSU can only besettled by conversion to cash ( no share is issued), and is automatically converted after the director ceases to be a member of the Board unless the director isremoved from the Board for just cause. Prior to conversion, the value of each DSU, at any point in time, is equivalent to the latest closing price of Novelion’scommon shares on TSX on that trading day. When converted to cash, the value of a vested DSU is equivalent to the closing price of a Novelion’s common shareon the trading day immediately prior to the conversion date.DSU activity is presented below: Number of DSUs (1)Outstanding at December 31, 2015 30,800Granted 8,960Redeemed (11,360)Cancelled —Outstanding at December 31, 2016 28,400Vested at December 31, 2016 28,400 (1) Shares and per share amounts have been retrospectively restated for all prior periods presented to reflect the one-for-five share consolidation.The obligation to settle DSUs in cash is recorded as a liability in the Company’s Consolidated Financial Statements and is marked-to-market at the end of eachreporting period. See Note 9 - Accrued Liabilities. Cash payments under the DDSU Plan during the years ended December 31, 2016, 2015, and 2014 were asfollows:(in thousands)2016 2015 2014 Cash payments under the DDSU plan$105 $— $— 145The cash payments in 2016 related to two former members of the Novelion board of directors who departed from the board after the acquisition closed onNovember 29, 2016. The Company’s obligation to settle the remaining vested and unsettled 28,400 common shares underlying DSUs held by former directors was$0.2 million as of December 31, 2016.In connection with the Merger, the vesting provisions applicable to all of the outstanding and unvested DSUs were accelerated on November 29, 2016. Theacceleration of the vesting provisions of all the outstanding and unvested DSUs during the year ended December 31, 2016 resulted in an additional $62,251 DSUcompensation expense recognized on the Company's accompanying Consolidated Statements of Operations.(c) Restricted Stock UnitsThe Company has outstanding time-vested, market-based and performance-based RSUs. Time-vested RSUs are awarded to eligible employees and entitle thegrantee to receive common shares at the end of a vesting period, subject solely to the employee’s continuing employment. The majority of time-vested RSUs vestin two equal annual installments beginning a year from the grant date. Aegerion’s market-based RSUs were awarded to employees of Aegerion on July 29, 2014and were replaced by Novelion’s market-based RSUs at the time of the acquisition. All the market-based RSUs vest when the price the day the stock price closeson the value at or above the value of the original new hire strike price and expire on July 29, 2019. Because the current stock price of the Company is significantlylower than the original new hire strike price, we expect all the market-based RSUs will expire without being vested. The performance-based RSUs are awarded toeligible employees and entitle the grantee to receive shares of common stock if specified performance goals are achieved during the performance period and thegrantee remains employed during the subsequent vesting period. The majority of performance-based RSUs vest in three equal annual installments beginning upongoal achievement. Upon vesting, each RSU represents the right to receive one common share of the Company.RSU transactions for the years ended December 31, 2016 are as following: Number of RSUs (3)Outstanding at December 31, 2015 —Granted (1) (2) 1,036,735Redeemed —Cancelled (7,854)Outstanding at December 31, 2016 1,028,881 (1) The weighted-average grant date fair value of the RSUs granted during the year ended December 31, 2016 was $8.82 (December 31, 2015 - zero , December 31, 2014 - CAD $20.4 ).(2) The assumed Aegerion RSUs from the Merger are included in grants made during the fiscal year ended December 31, 2016 in the above table. The total number of assumed Aegerion RSUswas 140,605 with a weighted-average merger date valuation of $9.53 per share.(3) Shares and per share amounts have been retrospectively restated for all prior periods presented to reflect the one-for-five share consolidation.RSUs are generally subject to forfeiture if employment terminates prior to the release of vesting restrictions. The Company expenses the cost of the RSUs withservice-based vesting conditions, which is determined to be the fair value of the shares of common stock underlying the RSUs at the date of grant, ratably over theperiod during which the vesting restrictions lapse. The fair value of RSUs with market-based vesting conditions is determined using a Monte Carlo simulation andthe Company recognizes compensation expense over the derived service period.In connection with the strategic transactions announced on June 8, 2015 (see Note 3 - Terminated Merger Transactions and Note 4 - Strategic Transactions), theBoard of Directors accelerated the vesting provisions applicable to 12,800 RSUs that were outstanding and unvested on June 7, 2015. The impact of the acceleratedvesting of these RSUs during the year ended December 31, 2015 was an additional $0.2 million RSU compensation expenses recognized in the Company's 2015results of operations.1,028,881 RSUs were outstanding and unvested as of December 31, 2016 (December 31, 2015 - zero , December 31, 2014 - 12,800 ). In addition, the totalestimated unrecognized compensation cost related to RSUs as of December 31, 2016 is $9.0 million (December 31, 2015 - zero , December 31, 2014 - $0.2million ) and the weighted-average period over which such costs are expected to be recognized is 1.77 years (December 31, 2015 - zero years , December 31, 2014- 2.34 years).The impact on the Company’s results of operations of stock-based compensation expense for the years ended December 31, 2016, 2015, and 2014 is as follows:146(in thousands)2016 2015 2014Research and development$155 $1,267 $911Selling, general and administrative683 1,108 702Total stock-based compensation expense$838 $2,375 $1,613 13. Income Taxes.Loss before provision for income taxes, classified by source of (loss)/income, is as follows:(in thousands)December 31, 2016 December 31, 2015 December 31, 2014Canada$(46,733) $(22,987) $(4,197)U.S.(9,521) — —Other Foreign3,849 — —Loss before provision for income taxes$(52,405) $(22,987) $(4,197) Provision for income taxes for the years ended December 31, 2016 , 2015 and 2014 are as follows: (in thousands)2016 2015 2014Current: Canada$105 $— $—U.S. state, net of federal income tax benefit(2) — —Other Foreign(517) — — $(414) $— $—Deferred: Canada$— $(22) $192Other Foreign(51) — — (51) (22) 192(Provision for) recovery of income taxes$(465) $(22) $192 Differences between the Company’s statutory income tax rates and its effective income tax rates, as applied to the loss from continuing operations before incometaxes, are reconciled as follows:(in thousands)2016 2015 2014Loss from continuing operations before income taxes$(52,405) $(22,987) $(4,197)Canadian statutory tax rates26.00% 26.00% 26.00%Expected income tax recovery13,625 5,977 1,091Net decrease (increase) in valuation allowance(13,684) (2,486) 731Non-taxable portion of capital gains— — 230Investment tax credits868 (222) 1,628Stock-based compensation(133) (606) (377)Foreign rate differential532 — —Non-taxable (deductible) expenditures— 76 1,752Changes in uncertain tax positions— (1,784) (4,793)Adjustments to capital losses for settlement of uncertain tax positions— (560) —Other(1,673) (417) (70) (Provision for) recovery of income taxes$(465) $(22) $192 147Deferred taxes are recognized for temporary differences between the basis of assets and liabilities for financial statement and income tax purposes. The primarycomponents of the Company’s deferred tax assets and liabilities comprised of the following:(in thousands)2016 2015Deferred tax assets: Net operating loss carryforwards$51,808 $45,365Research and development credits14,028 14,164Stock-based compensation108 —Capitalized research expenses2,124 —Capital loss carryforwards37,452 36,207Depreciable and amortizable assets13,597 1,645Other temporary differences13,736 197Total gross deferred tax assets132,853 97,578Valuation allowance(131,858) (97,578)Net deferred tax assets$995 $— As of December 31, 2016, the Company has a $1.0 million net deferred tax asset attributable to its profitable foreign subsidiaries. Additionally, as of December 31,2016 , the Company has $131.9 million of valuation allowance recorded against its Canadian, U.S. and Switzerland deferred tax assets. The valuation allowanceincrease of $34.3 million is primarily the result of the acquisition of Aegerion. If the Company is subsequently able to utilize all or a portion of the deferred taxassets for which the remaining valuation allowance has been established, then the Company may be required to recognize these deferred tax assets through thereduction of the valuation allowance which could result in a material benefit to results of operations in the period in which the benefit is determined.The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets and concluded that based on the Company’shistory of operating losses that it is more likely than not that the benefit of its deferred tax assets will not be realized.At December 31, 2016 , the Company had approximately $166.9 million of foreign and federal net operating loss carryforwards, of which $152.6 million relate toCanada and $14.3 million relate to the Company’s U.S. subsidiaries. The loss carryforwards expire at various dates through 2036. As of December 31, 2016, theCompany also had approximately $11.8 million of state net operating loss carryforwards that expire at various dates through 2036. As of December 31, 2016 , theCompany also had approximately $13.5 million of Canadian national and provincial research and development credits available for carryforward. The research anddevelopment credit carryforwards expire at various dates through 2036. As of December 31, 2016 , the Company's Canadian Scientific, Research and ExperimentalDevelopment pool was $13.4 million . Furthermore, as of December 31, 2016 , the Company had approximately $289.5 million of Canadian capital losscarryforwards, which carryforward indefinitely. The deferred tax benefit of these loss carryforwards and research and development credits is ultimately subject tofinal determination by the respective taxation authorities.Upon acquiring a company that has U.S. federal and state net operating loss carryforwards and federal and state tax credits, the Company prepared an assessmentto determine if it has a legal right to use the acquired net operating losses and tax credits. In performing this assessment the Company followed the regulationswithin the Internal Revenue Code Sections 382 and 383. The Company determined that the U.S. net operating losses and tax credits acquired in the Aegerionacquisition will be subject to limitations under Internal Revenue Code Sections 382 and 383. Due to the ownership changes, the Company has determined that itsU.S. subsidiaries, including Aegerion, will only be able to utilize approximately $14.3 million of its NOLs before expiration as a result of the annual Section 382limitation. For Aegerion, $166.6 million of federal net operating losses and $30.2 million of federal general business credits will expire before becoming availableunder the Section 382 limitation. Additionally, $96.9 million of state net operating losses and $0.2 million of state credits will expire before becoming availableunder the Section 382 limitation. The U.S. subsidiaries may also experience ownership changes in the future as a result of subsequent shifts in share ownership thatcould further limit the use of the available net operating losses and credits. Additionally, Aegerion determined that at the date of the ownership change, it had a netunrealized built-in loss (“NUBIL”). The NUBIL is determined based on the difference between the fair market value of the Company’s assets and their tax basis atthe ownership change.In accordance with ASC 740, the Company recorded a reserve for uncertain tax positions of approximately $7.7 million offset by $7.3 million of the Company'sdeferred tax assets at December 31, 2016, for a net of $0.4 million for unrecognized tax benefits as of December 31, 2016 .The following table summarizes the activity related to the Company’s unrecognized tax benefits:148(in thousands) 20162015 2014Total uncertain tax position liabilities as of January 1, $7,278$5,557$1,846Current year acquisitions 911——Increases related to current year tax positions —3475,169Changes in tax positions of a prior period —1,93411Lapse due to statute of limitations (342)—(1,469)Settlements with taxing authorities (187)(560)—Total uncertain tax position liabilities as of December 31, $7,660$7,278$5,557 Of this amount of unrecognized tax benefits, approximately $7.3 million , $6.9 million and $5.2 million would be fully offset by the Company's deferred tax assetat December 31, 2016, 2015 and 2014. The Company recognizes interest and penalties as a component of income tax expense. At December 31, 2016 , 2015 and2014 the Company had no t accrued interest or penalties as a result of the deferred assets available to offset its unrecognized tax benefits. The increase inunrecognized tax benefits during the year was the result of transfer pricing adjustments made at the Company’s Swiss subsidiary as a result of its acquisition ofAegerion. During 2016, the Company settled a dispute with the Canadian Revenue Authority surrounding its capital loss carryover as a result of its divestiture ofits Eligard contingent consideration which resulted in a decrease of the unrecognized tax benefits. Additionally during 2016, the period in which the 2008 Canadianincome tax return was subject to reassessment expired, which resulted in a reduction of the unrecognized tax benefits surrounding its share by buyback costs thatarose during that tax year.Given that the potential net 2016 liability increase of $0.4 million , the potential 2015 liability increase of $1.7 million and the potential net 2014 liability increaseof $3.7 million are fully or partially sheltered by the Company’s existing deferred tax assets, the Company has offset a portion of the total liability on theCompany’s Consolidated Balance Sheets in accordance with ASU No. 2013-11 - Income Taxes (Topic 740): Presentation of Unrecognized Tax Benefit When a NetOperating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists . ASU No. 2013-11 was adopted on a prospective basis effectiveJanuary 1, 2014.The Company and its subsidiaries file income tax returns in Canada, the U.S., and various U.S. states and in foreign jurisdictions. The Canadian income tax returnsare generally subject to tax examination for the tax years ended December 31, 2010 through December 31, 2016. The U.S., U.S. state and foreign income taxreturns are generally subject to tax examinations for the tax years ended December 31, 2013 through December 31, 2016. To the extent the Company has taxattribute carryforwards, the tax years in which the attribute was generated may still be adjusted upon examination by the tax authorities.The Company monitors the undistributed earnings of its foreign subsidiaries and, as necessary, provides for income taxes on those earnings that are not deemedpermanently invested. As of December 31, 2016 the Company has approximately $1.5 million of undistributed earnings at its foreign subsidiaries. These earningare deemed permanently invested by the Company.14. Fair Value of Financial Instruments.Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageousmarket for the asset or liability in an orderly transaction between market participants at the measurement date. ASC No. 820 - Fair Value Measurements andDisclosures established a fair value hierarchy for those instruments measured at fair value that distinguishes between fair value measurements based on marketdata (observable inputs) and those based on the Company’s own assumptions (unobservable inputs). This hierarchy maximizes the use of observable inputs andminimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows:•Level 1 —Quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date. TheCompany’s Level 1 assets consist of cash, money market investments, and restricted cash.•Level 2 —Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly. The Company’sLevel 2 liabilities consist of convertible notes.•Level 3 —Inputs that are unobservable for the asset or liability. The Company does not have any Level 3 assets and liabilities as of December 31,2016.149The fair value measurements of the Company’s financial instruments at December 31, 2016 and 2015 are summarized in the tables below: December 31, 2016 Significant Quoted Prices inOtherSignificant Active Markets forObservableUnobservableBalance atIdentical AssetsInputsInputsDecember 31,(in thousands)(Level 1)(Level 2)(Level 3)2016Assets: Cash$40,693$—$—$40,693Money market funds68,234——68,234Restricted cash390——390Total assets$109,317$—$—$109,317Liabilities:Convertible notes, net - long-term—225,584—225,584Total liabilities$—$225,584$—$225,584 December 31, 2015 Significant Quoted Prices inOtherSignificant Active Markets forObservableUnobservableBalance atIdentical AssetsInputsInputsDecember 31,(in thousands)(Level 1)(Level 2)(Level 3)2015Assets: Cash$141,824$—$—$141,824Accounts receivable - Laser Earn-Out Payment (1)——2,0002,000Total assets$141,824$—$2,000$143,824 (1) Represents the estimated fair value of the Laser Earn-Out Payment as described in Note 16 - Contingencies, Commitments and Guarantees. The fair value of the Laser Earn-Out Paymentwas estimated using a probability weighted approach to examine various possible outcomes with respect to the timing and amount that may be collected.The fair value of the Convertible Notes, which differs from their carrying values, is influenced by interest rates, the Company’s share price and share pricevolatility and is determined by prices for the Convertible Notes observed in market trading which are Level 2 inputs. The estimated fair value of the ConvertibleNotes at December 31, 2016 was $240.4 million . See Note 10 - Convertible Notes, Net for further information.The Company’s financial instruments that are exposed to credit risks consist primarily of cash, cash equivalents, restricted cash and accounts receivable. To limitthe Company’s credit exposure, cash and cash equivalents are deposited with high-quality financial institutions in accordance with its treasury policy goal topreserve capital and maintain liquidity. The Company’s treasury policy limits investments to certain money market securities issued by governments, financialinstitutions and corporations with investment-grade credit ratings, and places restrictions on maturities and concentration by issuer. The Company maintains itscash, cash equivalents and restricted cash in bank accounts, which, at times, exceed federally insured limits. The Company has not experienced any credit losses inthese accounts and does not believe it is exposed to any significant credit risk on these funds.The Company is subject to credit risk from its accounts receivable related to its product sales of lomitapide and metreleptin. The majority of the Company’saccounts receivable arise from product sales in the U.S. For accounts receivable that have arisen from named patient sales outside of the U.S., the payment termsare predetermined and the Company evaluates the creditworthiness of each customer or distributor on a regular basis. The Company periodically assesses thefinancial strength of the holders of its accounts receivable to establish allowances for anticipated losses, if necessary. The Company does not recognize revenue foruninsured amounts billed directly to a patient until the time of cash receipt as collectability is not reasonably assured at the time the product is received. To date,the Company has not incurred any credit losses.15015. Basic and Diluted Net Loss per Common Share.Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period.Diluted net loss per common share is computed by dividing the net loss by the weighted-average number of unrestricted common shares and dilutive commonshare equivalents outstanding for the period, determined using the treasury-shares and if-converted methods. Since the Company has had net losses for all periodspresented, all potentially dilutive securities are anti-dilutive. Accordingly, basic and diluted net loss per common share are equal.The following table sets out the computation of basic and diluted net loss per common share:(in thousands, except per share data) 2016 2015 2014 Numerator: Loss from continuing operations $(52,870) $(23,009) $(4,005)Loss from discontinued operations, net of income taxes — — (66)Net loss $(52,870) $(23,009) $(4,071) Denominator: (thousands) weighted-average common shares outstanding 11,284 10,434 10,225Basic and diluted net loss per common share Continuing operations $(4.69) $(2.20) $(0.40)Discontinued operations (1) — — — Net loss per common share $(4.69) $(2.20) $(0.40) (1) Rounded to zero.The following table sets forth potential common shares issuable upon the exercise of outstanding options, warrants, the vesting of RSUs and the conversion of theConvertible Notes (prior to consideration of the treasury shares and if-converted methods) (see Note 12 - Stock-Based Payments for details), which were excludedfrom the computation of diluted net loss per share because such instruments were anti-dilutive (in thousands):December 31, 2016December 31, 2015December 31, 2014Stock options1,71586418Unvested restricted stock units1,029—13Warrants14,515568—Convertible notes1,619——Total18,87865443116. Contingencies, Commitments and Guarantees.Lease ObligationsThe Company leased certain office facilities and office equipment under operating leases. The future estimated operating lease payments for office space and officeequipment over the next five years are summarized as follows (in thousands): 151Year Ending December 31:Lease Commitments2017$3,08320182,40020198842020128Thereafter13Total$6,508Rent expense under operating leases was approximately $0.5 million , $0.4 million , and $0.5 million for the years ended December 31, 2016 , 2015 and 2014 ,respectively.During 2015, the Company entered into a sublease agreement (as amended, the Lease Agreement) to downsize its existing space in Vancouver, British Columbia,where its headquarters is located. The Company currently leases approximately 8,475 square feet of space under the terms of the Lease Agreement. The lease termapplicable to this space expires on August 31, 2017.The Company's U.S. operational office, which is located at One Main Street in Cambridge, Massachusetts, consists of approximately 31,571 square feet of officespace under a lease that expires in April 2019.The Company also leases office spaces in Japan, the UK, Switzerland, Germany, France, Italy, Canada, Brazil, and Turkey, with approximately 8,414 square feetof office space in the aggregate. The Company's international lease agreements expire at various dates through the year 2021.In addition to the locations listed above, the Company holds inventory at various locations, including international locations, managed by third parties.Other CommitmentsAmgen Licensing AgreementsMetreleptin. In connection with Aegerion's acquisition of MYALEPT in January 2015, Aegerion acquired a license agreement between Amgen Inc. (Amgen) andAmylin Pharmaceuticals, Inc., dated February 7, 2006 (the Amgen License) pursuant to which an exclusive worldwide license was obtained from Amgen to certainknow-how and patents and patent applications covering the composition of matter and methods of use of metreleptin to develop, manufacture and commercialize apreparation containing metreleptin (the Amgen Licensed Products).As part of the Amgen License, an exclusive sublicense of Amgen’s exclusive rights to certain metreleptin-related patents and patent applications owned by theRockefeller University and exclusively licensed to Amgen under a license agreement dated April 14, 1995, as amended (the Rockefeller License) and an exclusivesublicense of Amgen’s non-exclusive rights to certain metreleptin-related patents and patent applications owned by The Regents of the University of California andnon-exclusively licensed to Amgen under a license agreement dated July 13, 2005 (the UCSF License) were obtained. Amgen retains rights to conduct research,development, manufacturing and commercialization activities with respect to products other than the Amgen Licensed Products.Sublicenses under the licenses are permitted and are subject to certain limitations, including Amgen’s right of first offer for any out-license, partnership, co-development, commercialization, co-promotion or similar agreement related to metreleptin or the Amgen Licensed Products, which expires in February 2021.Under this license agreement, Amgen must notify us of any potential third-party partnership regarding any intellectual property rights controlled by Amgen in theneurology field and the Company will have a right of first negotiation for any license, partnership, co-development, commercialization, co-promotion or similaragreement, which expires in February 2021.Aegerion is required to make royalty payments to Amgen, Rockefeller University and BMS on net sales of each Amgen Licensed Product on a country-by-countrybasis (i) at a royalty rate in the low double digits where the Amgen Licensed Product has patent protection or market exclusivity granted by a regulatory authorityat the time of regulatory approval in the applicable country during the applicable royalty term, which runs on a country-by-country basis until the later of (a) theexpiration of the last-to-expire valid claim covering an Amgen Licensed Product in the applicable country, (b) expiration of any market exclusivity granted by aregulatory authority, and (c) 10 years from the date on which an Amgen Licensed Product is first sold to a third-party in a country after regulatory approval for theAmgen Licensed Product has been granted in such country (Amgen Royalty Term) or (ii) at a royalty rate in the mid-single digits to low double digits where theAmgen Licensed Product receives patent protection or152market exclusivity following the time of regulatory approval in the applicable country, in either case subject to a variety of customary reductions.Under the Amgen License, Aegerion is also required to directly meet certain payment obligations under the Rockefeller License and UCSF License. Aegerion isrequired to make royalty payments to Rockefeller University on net sales of each product with patent rights or know-how in the field of obesity genes, obesity geneproducts, and molecules that modulate or mediate their action and/or regulation on a country-by-country basis at a range of royalty rates in the low single digitsdepending on whether the product has an orphan product designation or not until the later to occur of expiration of (i) patent protection, (ii) any market exclusivityperiod granted in the applicable country, or (iii) any data exclusivity period in the applicable country (with certain limitations related to the number of units sold).Aegerion is required to pay to Rockefeller University a percentage in the low double digits of any upfront license fees or one-time fees it receives in considerationfor a sublicense of the licensed rights. There are no material payment obligations outstanding under the UCSF License.The Amgen License will terminate upon the expiration of the last Amgen Royalty Term for any Amgen Licensed Product. Aegerion has the right to terminate theAmgen License for convenience upon 90 days prior written notice to Amgen or for Amgen’s uncured material breach of the Amgen License, or becoming subjectto specified bankruptcy or liquidation events. Amgen may terminate the Amgen License for the Aegerion’s uncured failure to make payments to Amgen or if theCompany is the subject of specified bankruptcy or liquidation events.During the period from November 30, 2016 to December 31, 2016, there were no royalty payments made by the Company related to sales of MYALEPT. As ofDecember 31, 2016 , $1.2 million remained as an accrual balance in royalties payable to Amgen.Shionogi & Co., Ltd.Metreleptin. In connection with Aegerion's acquisition of MYALEPT in January 2015, Aegerion acquired a license agreement between Shionogi and AmylinPharmaceuticals, Inc., dated July 8, 2009 pursuant to which Shionogi was granted an exclusive sublicense to the patent rights licensed under the Amgen Licenseand the Rockefeller License to develop and commercialize the Amgen Licensed Products and know-how for use in the treatment of lipodystrophy in humans inJapan, South Korea and Taiwan (the Shionogi Territory). This license agreement does not provide Shionogi with manufacturing rights. Shionogi may grant furthersublicenses under the license, subject to certain limitations.The license agreement requires that Shionogi use commercially reasonable efforts to develop, obtain regulatory approvals for, and commercialize the AmgenLicensed Products in the Shionogi Territory. Shionogi is required to make royalty payments to Aegerion on net sales of each Amgen Licensed Product at a range ofroyalty rates in the mid-to high-single digits dependent on the amount of net sales. During the period from November 30, 2016 to December 31, 2016, Aegeriondid not receive any royalty payments from Shionogi. Shionogi will be required to make milestone payments to Aegerion of up to an aggregate of approximately$25.0 million if and when Shionogi achieves certain commercialization milestones. Such milestone payments are payable only once. Under the license agreement,Shionogi has also agreed to directly comply with the payment obligations under the Rockefeller License and Amgen License, as set forth under those agreements,relating to its activities under this license agreement.The license agreement with Shionogi will terminate upon the expiration of the last Amgen Royalty Term for any Amgen Licensed Product with respect to whichShionogi has a license under this license agreement. Aegerion has the right to terminate this license agreement for Shionogi’s uncured material breach of thelicense agreement, failure to make any payment due to Aegerion, a procedural default, or becoming subject to specified bankruptcy or liquidation events. Shionogimay terminate this license agreement for Aegerion’s uncured material breach of this license agreement, failure to make payments due to Shionogi, or if Aegerion isthe subject of specified bankruptcy or liquidation events, or if Shionogi determines it is not feasible to develop, launch or sell the Amgen Licensed Products due toscientific, technical, regulatory or commercial reasons. Aegerion may also terminate this license agreement at any time without cause by exercising its buy-backoption for a one-time fee to Shionogi equal to (i) a number in the low single digits times the amount of expenses and fees incurred by Shionogi in developing theAmgen Licensed Products plus (ii) an amount no more than a number in the mid-double digits times monthly net sales of the Amgen Licensed Products byShionogi in the month the option is exercised.University of Pennsylvania Licensing AgreementLomitapide. In May 2006, Aegerion entered into license agreement with The Trustees of the University of Pennsylvania, (UPenn) pursuant to which it obtained anexclusive, worldwide license from UPenn to certain know-how and a range of patent rights applicable to lomitapide. In particular, Aegerion obtained a license tocertain patent and patent applications owned by UPenn relating to the dosing of microsomal triglyceride transfer protein inhibitors, including lomitapide, andcertain patents and patent applications and know-how covering the composition of matter of lomitapide that were assigned to UPenn by BMS in the field ofmonotherapy or in combination with other dyslipidemic therapies, which are therapies for the treatment of patients, with abnormally high or low levels of plasmacholesterol or triglycerides.153Aegerion is obligated under this license agreement to use commercially reasonable efforts to develop, commercialize, market and sell at least one product coveredby the licensed patent rights, such as lomitapide.Aegerion will be required to make specified royalty payments on net sales of products, at a range of royalty rates in the high single digits on net sales of lomitapidein countries where lomitapide has patent protection, and of any other products covered by the license (subject to a variety of customary reductions), and share withUPenn specified percentages of sublicensing royalties and certain other consideration that the Company receives under any sublicenses that Aegerion may grant.During the period from November 30, 2016 to December 31, 2016, there were no royalty payments made to UPenn. As of December 31, 2016 , $1.3 millionremained as an accrual balance in royalty payable UPenn.This license agreement will remain in effect on a country-by-country basis until the expiration of the last-to-expire licensed patent right in the applicable country.Aegerion has the right to terminate this license agreement for UPenn’s uncured material breach of the license agreement or for convenience upon 60 days ’ priorwritten notice to UPenn, subject to certain specific conditions and consequences. UPenn may terminate this license agreement for Aegerion’s uncured materialbreach of the license agreement, its uncured failure to make payments to UPenn or if Aegerion is the subject of specified bankruptcy or liquidation events.Retinagenix LLCZuretinol. Under the terms of the April 2006 co-development agreement (as amended, the Retinagenix Agreement) QLT entered into with Retinagenix LLC(Retinagenix), it obtained an exclusive, worldwide license and sub-license to certain intellectual property rights owned or controlled by Retinagenix related to thesynthetic retinoid compound under development. Under the terms of this agreement, QLT is responsible for using commercially reasonable and diligent efforts todevelop and commercialize in certain major markets and other markets as it reasonably determines, one or more products covered by the licensed rights ordeveloped using such licensed rights for use in diagnosing, treating or preventing certain human diseases and conditions. QLT is also responsible for committingcertain annual funding to support research and development of such products. Under the license agreement between Retinagenix and the University of Washington(the UW Agreement), Retinagenix has similar obligations, and is required to meet specific development milestones within certain timeframes, one of which wasrequired to be achieved by December 31, 2016. However, the UW Agreement contains provision for extensions of those dates in certain circumstances. Based onthe terms of the Retinagenix Agreement and the UW Agreement, and the Company’s significant development clinical spend on the zuretinol program, managementbelieves that the Company is entitled to an extension of that milestone date until December 31, 2017, and that the Company may be entitled to certain additionalextensions to December 31, 2019, along with a potential additional extension of up to 12 months should enrollment in a planned trial be delayed, provided that theCompany continues to comply with the relevant provisions of the license agreements and expend certain minimum amounts on the development of zuretinol.However, it is possible that the Company may not be able to achieve the specified development milestone by December 31, 2019. As a result, management of theCompany and Retinagenix have begun discussing a renegotiation of that milestone with the University of Washington. The Company is currently conducting areview of the zuretinol development program, the results of which will assist the Company in determining when the remaining development milestone can beexpected to be achieved.Pursuant to the Retinagenix Agreement, Retinagenix is eligible to receive the following milestone payments: (i) $1.0 million upon initiation of the first pivotaltrial for the first target indication which uses such products, (ii) $1.5 million upon completion of a filing seeking EU approval or Japan approval for the use of suchproducts in the first indication and (iii) up to a total of an additional $10.0 million upon the achievement of other specified development or regulatory milestonesand, for each of up to two additional indications, up to a total of $9.0 million upon achievement of specified development or regulatory milestones. If the Companycommercializes such products, it will also pay Retinagenix royalties of between 4% and 6% of net sales, subject to reduction under certain specified circumstances.Retinagenix is also eligible to receive up to a total of $15.0 million upon achievement of specified cumulative sales milestones for such products. The term of theRetinagenix Agreement expires on the later of the expiration of 10 years after first commercial sale of licensed products, or the expiration, lapse or abandonment ofall licensed patents. Retinagenix can terminate the agreement earlier if the Company fails in any material respect to meet its diligence requirements, and theCompany may terminate the agreement for convenience. Each party may terminate the agreement for uncured material breach by the other party.Financial Advisory Services Milestone ObligationOn February 5, 2016, pursuant to the Greenhill Agreement, QLT paid Greenhill a $4.0 million advisory fee in connection with the completion of QLT’s $45.0million investment in Aralez and exploration of other strategic initiatives described under Note 3 - Terminated Merger Transactions and Note 4 - StrategicTransactions. The recognition and payment of the advisory fee was both contingent upon the satisfaction of various terms and conditions, which were met onFebruary 5, 2016, and subject to the outcome of certain external factors and uncertainties, which were settled by February 5, 2016 but were beyond the Company’scontrol.154IndemnitiesIn connection with the sale of assets, the Company provided indemnities with respect to certain matters, including product liability, patent infringement,contractual breaches and misrepresentations, and the Company provides other indemnities to third parties under the clinical trial, license, service, supply and otheragreements that it enters into in the normal course of its business. If the indemnified party were to make a successful claim pursuant to the terms of the indemnity,the Company would be required to reimburse the loss. These indemnities are generally subject to threshold amounts, specified claims periods and other restrictionsand limitations. As of December 31, 2016, no amounts have been accrued in connection with such indemnities.Development and Post Marketing Regulatory CommitmentsNovelion and Aegerion have engaged Contract Research Organizations (CROs) to provide research, safety and project management services (the Services) inconnection with the execution of their potential clinical trials and existing registries. Services would only give rise to liabilities to the extent that services areprovided to Novelion or Aegerion, as applicable, and pass through expenses are incurred. As of December 31, 2016 , the Services have not yet been performed andthe Company has potential commitments of approximately $42.1 million under these agreements. The amount reflected is based on the existing contracts and doesnot reflect any inflation, future modification to, or termination of, the existing contract or anticipated or potential new contracts. ContingenciesUpon the acquisition of Aegerion, the Company assumed the assets and liabilities related to the following contingencies (in thousands):Insurance Proceeds Receivable Class action lawsuit insurance proceeds $22,000 Provision for Legal Settlement Class action lawsuit settlement $(22,250)DOJ and SEC settlement (40,635)Relator legal settlement (620)Relators legal fees (405)Other litigation settlement (100)Total provision for legal settlement $(64,010) DOJ/SEC InvestigationsIn late 2013, Aegerion received a subpoena from the DOJ, represented by the U.S. Attorney’s Office in Boston, requesting documents regarding Aegerion’smarketing and sale of JUXTAPID in the U.S., as well as related disclosures. Aegerion believes the DOJ is seeking to determine whether it, or any of its current orformer employees, violated civil and/or criminal laws, including but not limited to, the securities laws, the Federal False Claims Act, the Food and Drug CosmeticAct, the Anti-Kickback Statute, and the Foreign Corrupt Practices Act of 1977 (FCPA). The investigation is ongoing.In late 2014, Aegerion received a subpoena from the SEC requesting certain information related to its sales activities and disclosures related to JUXTAPID. TheSEC also has requested documents and information on a number of other topics, including documents related to the investigations by government authorities inBrazil into whether Aegerion’s activities in Brazil violated Brazilian anti-corruption laws, and whether Aegerion’s activities in Brazil violated the U.S. ForeignCorrupt Practices Act. Aegerion believes the SEC is seeking to determine whether Aegerion, or any of its current or former employees, violated securitieslaws. The investigation is ongoing.In May 2016, Aegerion reached preliminary agreements in principle with the DOJ and the SEC to resolve their investigations into the marketing and sales activitiesand disclosures relating to JUXTAPID. Under the terms of the preliminary agreement in principle with the DOJ, Aegerion would plead guilty to two misdemeanormisbranding violations of the Food, Drug and Cosmetic Act. One count would be based on its alleged marketing of JUXTAPID with inadequate directions for use(21 U.S.C. §§ 352(f)), and the second count would involve an alleged failure to comply with a requirement of the JUXTAPID Risk Evaluation and MitigationStrategies (REMS) program (21 U.S.C. §§ 352(y)). Aegerion would separately enter into a five -year deferred prosecution agreement with regard to a charge thatAegerion violated the Health Insurance Portability and Accountability Act. As part of the resolution of the DOJ investigation, Aegerion is expected to enter into acivil settlement agreement with the DOJ to resolve alleged violations of the False Claims Act and, a non-monetary consent decree with the FDA. Aegerion alsoexpects to negotiate a corporate integrity agreement with the Department of Health and Human Services.155Under the terms of the preliminary agreement in principle with the SEC staff, the SEC’s Division of Enforcement will recommend that the SEC accept a settlementoffer from Aegerion on a neither-admit-nor-deny basis that contains alleged negligent violations of Sections 17(a)(2) and (3) of the Securities Act of 1933, asamended, related to certain statements Aegerion made in 2013 regarding the conversion rate of patients receiving JUXTAPID prescriptions, with remedies thatinclude censure, an order prohibiting future violations of the securities laws and payment of a civil penalty.The preliminary agreements in principle provide for a consolidated monetary package that covers payments due to both the DOJ and the SEC. The consolidatedmonetary package includes payments to the DOJ and the SEC by Aegerion totaling approximately $40 million in the aggregate, to be payable over three years,which is updated from the originally proposed five -year payment schedule contemplated when the preliminary agreement in principle was reached in May 2016.Certain outstanding amounts would accrue interest at a rate of 1.75% per annum. Such payments are subject to acceleration in the event of certain change ofcontrol transactions or the sale of JUXTAPID or MYALEPT. Upon completion of the Merger, the Company fair valued the contingent liability related to the DOJand the SEC investigations as $40.6 million , which is consistent with the amounts to be provided to the DOJ and the SEC under the consolidated monetarypackage, and an aggregate of $1.0 million for any relator attorney fees and settlement. In March 2017, the final relator agreements were signed and we paid out theattorney fees and settlement payments.The terms of the preliminary agreements in principle described above may change following further negotiations and other terms of the final settlement remainsubject to further negotiation. The preliminary agreement in principle with the DOJ is subject to approval of supervisory personnel within the DOJ and relevantfederal and state agencies, and approval by a U.S. District Court judge of the criminal plea and sentence and the civil settlement agreement. The preliminaryagreement in principle with the SEC is subject to review by other groups in the SEC and approval by the Commissioners of the SEC.The preliminary agreements in principle do not cover the DOJ and the SEC’s inquiries concerning Aegerion’s operations in Brazil, any potential claims by relatorsfor attorneys’ fees, or any employment claims that may been brought by relators.DOJ inquiries into patient assistance programsAegerion continues to cooperate with the DOJ and the SEC with respect to their investigations. As part of this cooperation, the DOJ has requested documents andinformation related to donations Aegerion made in the years ended December 31, 2015 and 2016 to patient assistance programs operated by independent charitable501(c)(3) organizations. As part of this inquiry, the DOJ may pursue theories that will not be covered by the preliminary agreement in principle with the DOJ.Other pharmaceutical and biotechnology companies have disclosed similar inquiries regarding donations to patient assistance programs operated by independentcharitable 501(c)(3) organizations.Investigations in BrazilIn addition, federal and state authorities in Brazil are each conducting investigations to determine whether there have been violations of Brazilian laws related tothe promotion of JUXTAPID in Brazil. In July 2016, the Ethics Council of the national pharmaceutical industry association, Interfarma, fined Aegerionapproximately $0.5 million for violations of the industry association’s Code of Conduct, to which Aegerion is bound due to its affiliation with Interfarma. Also, theBoard of Directors of Interfarma imposed an additional penalty of suspension of Aegerion’s membership, without suspension of Aegerion’s membershipcontribution, for a period of 180 days for Aegerion to demonstrate the implementation of effective measures to cease alleged irregular conduct, or exclusion of itsmembership in Interfarma if such measures are not implemented. Aegerion paid approximately $0.5 million related to this fine during the third quarter of 2016. OnMarch 27, 2017, after the suspension period ended, Interfarma’s Board of Directors decided to reintegrate Aegerion, enabling it to participate regularly inInterfarma activities, subject to meeting certain obligations. Also, in July 2016, Aegerion received an inquiry from a Public Prosecutor Office of the Brazilian Stateof Paraná asking it to respond to questions related to recent media coverage regarding JUXTAPID and its relationship with a patient association to which Aegerionmade donations for patient support. At this time, Aegerion does not know whether the Public Prosecutor’s inquiry will result in the commencement of any formalproceeding against Aegerion, but if Aegerion’s activities in Brazil are found to violate any laws or governmental regulations, Aegerion may be subject tosignificant civil lawsuits to be filed by the Public Prosecution office, and administrative penalties imposed by Brazilian regulatory authorities and additionaldamages and fines. Under certain circumstances, Aegerion could be barred from further sales to federal and/or state governments in Brazil, including sales ofJUXTAPID and/or MYALEPT, due to penalties imposed by Brazilian regulatory authorities or through civil actions initiated by federal or state public prosecutors.As of December 31, 2016, Aegerion cannot determine if a loss is probable as a result of the investigations and inquiry in Brazil and whether the outcome will havea material adverse effect on its business and, as a result, no amounts have been recorded for a loss contingency.Shareholder Class Action LawsuitIn January 2014, a putative class action lawsuit was filed against Aegerion and certain of its former executive officers in the U.S. District Court for the District ofMassachusetts (the Court) alleging certain misstatements and omissions related to the marketing of JUXTAPID and Aegerion’s financial performance in violationof the federal securities laws. The case is captioned KBC Asset Management NV et al. v. Aegerion Pharmaceuticals, Inc. et al. , No. 14-cv-10105-MLW. Throughmediation, the co-lead plaintiffs156and defendants reached an agreement in principle to settle the litigation on November 29, 2016. On January 17, 2017, the co-lead plaintiffs filed a stipulation ofsettlement with the Court that contained the settlement terms as agreed upon by the parties, including that Aegerion and its insurance carriers would contribute$22.25 million to a settlement fund for the putative class. The insurance carriers have agreed to cover $22.0 million of this amount, with Aegerion responsible forthe remainder of $0.25 million . The proposed settlement is subject to a number of procedural steps and is subject to approval by the Court. Accordingly,management of the Company cannot predict the outcome of this action or when it will be resolved. Upon the completion of the Merger, the Company estimatedthe fair value of the amounts and recorded a loss contingency of $22.25 million and $22 million to reflect the insurance proceeds it expects to receive.Contingent ConsiderationRelated to the Sale of Visudyne ®On September 24, 2012, the Company completed the sale of its Visudyne business to Valeant Pharmaceuticals International, Inc. (Valeant). Subject to theachievement of certain future milestones, the Company is eligible to receive the following additional consideration: (i) a milestone payment of $5.0 million ifreceipt of the registration required for commercial sale of the Qcellus ™ laser in the U.S. (the Laser Registration) is obtained by December 31, 2013, $2.5 million ifthe Laser Registration is obtained after December 31, 2013 but before January 1, 2015, and $0 if the Laser Registration is obtained thereafter (the Laser Earn-OutPayment); (ii) up to $5.0 million in each calendar year commencing January 1, 2013 (up to a maximum of $15.0 million in the aggregate) for annual net royaltiesexceeding $8.5 million pursuant to the Amended and Restated PDT Product Development, Manufacturing and Distribution Agreement with Novartis Pharma AG(the Novartis Agreement) or from other third-party sales of Visudyne outside of the U.S.; and (iii) a royalty on net sales attributable to new indications forVisudyne, if any should be approved by the U.S. Food and Drug Administration (FDA).On September 26, 2013, the FDA approved the premarket approval application (PMA) supplement for the Qcellus laser and on October 10, 2013, the Companyinvoiced Valeant for the $5.0 million Laser Earn-Out Payment. Valeant subsequently disputed payment on the basis that it believes the Laser Earn-Out Paymentremains contingent upon receipt of additional governmental authorizations with regard to the Qcellus laser. As a result, on September 22, 2015 the Companycommenced an action in the Supreme Court of British Columbia against Valeant for breach of contract. See "Legal Proceedings" section of this Annual Report forfurther details.While management of the Company believes that the $5.0 million Laser Earn-Out Payment has been triggered and is currently due and payable by Valeant, theoutcome of such a dispute and litigation is uncertain and there may be difficulty in recovering damages and collecting the Laser Earn-Out Payment in full. As ofDecember 31, 2015, Laser Earn-Out Payment was recorded as a long-term accounts receivable on the Company’s Consolidated Balance Sheet at its estimated fairvalue of $2.0 million . As of December 31, 2016, the fair value for the Laser Earn-Out Payment was reduced to zero . The fair value estimate of the Laser Earn-OutPayment was derived using a probability weighted approach to examine various possible outcomes with respect to the timing and amount that may be collected. Inaddition, it also reflects management’s assessment of collection risk, the impact of the passage of time and potential collection costs associated with the Valeantlitigation. The remaining estimated fair value of the contingent consideration, which relates to estimated future net royalties pursuant to the Novartis Agreement, iscurrently valued at zero . For the years ended December 31, 2016 and 2015, the Company received no proceeds related to the collection of the contingentconsideration for the Company’s previous sale of Visudyne.Related to the Sale of the PPDS TechnologyOn April 3, 2013, Novelion completed the sale of its punctal plug drug delivery system technology for approximately $1.3 million (the PPDS Technology) to MatiTherapeutics Inc. (Mati) pursuant to the terms of Novelion’s asset purchase agreement with Mati (the Mati Agreement). Under the terms of the Mati Agreement,Novelion is eligible to receive future potential payments upon completion of certain product development and commercialization milestones that could reach $19.5million (or exceed that amount if more than two products are commercialized), a low single digit royalty on worldwide net sales of all products using or developedfrom the PPDS Technology and a fee on payments received by Mati in respect of the PPDS Technology other than net sales revenues. For the years endedDecember 31, 2016 and 2015, the Company received no proceeds related to the collection of this contingent consideration.17. Employee Benefit Plan.The Company maintains a defined contribution 401(k) plan (the Plan) in which substantially all of its or its subsidiaries’ permanent U.S. employees are eligible toparticipate. Employee contributions are voluntary and are determined on an individual basis, limited by the maximum amounts allowable under U.S. federal taxregulations. The Company makes matching contributions of 50% of the first 6% of its U.S. employees’ contributions to the Plan. Additionally, for certainemployees outside of the U.S., the Company contributes amounts for retirement benefits required by applicable local laws. The Company recorded employercontribution157expense of $27,331 during the year ended December 31, 2016 and recorded employer contribution expense of zero during the years ended 2015, and 2014. TheCompany assumed the Plan upon the completion of the Merger.18. Related Party Transactions.The Company did not enter into any transactions with related parties, other than compensation arrangements, expense allowances and other similar items in theordinary course of business in the years ended December 31, 2016 , 2015 and 2014 .19. Segmentation information.The Company currently operates in one business segment, pharmaceuticals, which is focusing on the development and commercialization of its lead products. TheCompany's CEO is the Company's chief operating decision maker (CODM). The Company does not operate any separate lines of business or separate businessentities with respect to its products. Accordingly, the Company does not accumulate discrete financial information with respect to separate service lines and doesnot have separately reportable segments. Enterprise-wide disclosures about product revenues and long-lived assets by geographic area and information relating tomajor customers are presented below.Net Product SalesThe following table summarizes total net product sales from external customers by product and by geographic region. Net product sales represent sale ofMYALEPT and JUXTAPID through Aegerion subsequent to the acquisition, from November 29, 2016 to December 31, 2016 and are attributed to countries basedon the location of the customer.For the Year Ended December 31, 2016(in thousands)U.S.Italy Other Foreign CountriesTotalMYALEPT$4,685$— $268$4,953JUXTAPID6,1341,209 1,2788,621Total$10,819$1,209 $1,546$13,574 Net product sales generated from customers outside of the U.S. were primarily derived from named patient sales in Argentina, Colombia and Italy.The total net product sales from customers in Canada subsequent to the Merger, from November 29, 2016 to December 31, 2016 was approximately $0.1 million ,which related to the sales of JUXTAPID.Significant CustomersFor the year ended December 31, 2016 , one customer accounted for 34.5% of the Company’s net product sales, and such customer accounted for 28.5% of theCompany’s accounts receivable balance.Long-lived AssetsThe Company’s long-lived assets primarily comprised intangible assets, inventories, and properties and equipment. As of December 31, 2016, 100% of theCompany's intangible assets were held by Aegerion. 65.5% of the intangible assets were attributable to Aegerion's U.S. business and the remaining 34.5% wereattributable to Aegerion's Bermuda business. Approximately 92.7% of the Company’s properties and equipment were located in the U.S., 5.1% were located inCanada, and the remaining 2.2% were located in other foreign countries. For the Company's long-term inventory, approximately 52.0% was located in the U.S. and48.0% was located in countries outside of the U.S.Item 9.Changes in and Disagreements With Accountants on Accounting and Financial DisclosureNone.Item 9A.Controls and ProceduresDisclosure Controls and ProceduresOur management, with the participation of our principal executive officer and our principal financial officer, evaluated, as of the end of the period covered by thisAnnual Report, the effectiveness of our disclosure controls and procedures. Based on that evaluation, our principal executive officer and principal financial officerconcluded that our disclosure controls and procedures as of such date were not effective due to a material weakness in our internal controls over the financialreporting process related158to business combinations. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required tobe disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executiveofficer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.Management’s Report on Internal Control over Financial ReportingOur management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under theExchange Act). Our internal control over financial reporting is a process designed under the supervision of our principal executive officer and principal financialofficer to provide reasonable assurance regarding the reliability of financial reporting and the preparation of our financial statements for external purposes inaccordance with accounting principles generally accepted in the United States. Management evaluated the effectiveness of our internal control over financialreporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-IntegratedFramework (2013). Management’s evaluation did not include an assessment of the effectiveness of internal control over financial reporting for Aegerion, which weacquired effective November 29, 2016. Aegerion's financial statements represent approximately 39% and 82% of the net and total assets, respectively, 100% ofrevenues and 12% of the net loss of the Company's Consolidated Financial Statements as of and for the year ended December 31, 2016.Management, under the supervision and with the participation of the principal executive officer and principal financial officer, assessed the effectiveness of ourinternal control over financial reporting. Based on this evaluation, management determined that there was a material weakness in our controls over the financialreporting process as we did not design and maintain sufficiently precise or effective review and approval controls over business combinations. As a result,management concluded that we did not maintain effective internal control over financial reporting as of December 31, 2016.The Company is committed to remediating the control deficiencies that constituted the above material weakness by implementing changes to its internal controlover financial reporting. Management is responsible for implementing changes and improvements in the internal control over financial reporting and forremediating the control deficiencies that gave rise to the material weaknesses. To remediate the material weakness described above, the Company is currentlyevaluating the controls and procedures the Company will design and put in place to address this material weakness and plan to implement appropriate measures aspart of this effort.Our independent registered public accounting firm, Deloitte LLP, has audited our Consolidated Financial Statements included in this Annual Report and haveissued a report on the effectiveness of our internal control over financial reporting as of December 31, 2016 . Their report on the audit of internal control overfinancial reporting appears below.Changes to Internal Controls over Financial ReportingDuring our fourth quarter of fiscal 2016 , except as described above, there were no changes made in our internal control over financial reporting (as such term isdefined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) that have materially affected, or are reasonably likely to materially affect, our internal control overfinancial reporting.Item 9B.Other InformationNone.159Report of Independent Registered Public Accounting FirmT o the Board of Directors and Shareholders ofNovelion Therapeutics Inc. (formerly QLT Inc.)We have audited the internal control over financial reporting of Novelion Therapeutics Inc. and subsidiaries (the “Company”) as of December 31, 2016, based oncriteria established in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Asdescribed in Management’s Report on Internal Control over Financial Reporting, management excluded from its assessment the internal control over financialreporting at Aegerion Pharmaceuticals Inc., which was acquired on November 29, 2016 and whose financial statements represents approximately 39% and 82% ofthe net and total assets, respectively, 100% of revenues, and 12% of the net loss of the Company’s Consolidated Financial Statements as of and for the year endedDecember 31, 2016. Accordingly, our audit did not include the internal control over financial reporting at Aegerion Pharmaceuticals Inc. The Company'smanagement is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control overfinancial reporting, included in the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinionon the Company's internal control over financial reporting based on our audit.We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that weplan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluatingthe design and operating effectiveness of internal control based on that risk, and performing such other procedures as we considered necessary in thecircumstances. We believe that our audit provides a reasonable basis for our opinion.A company's internal control over financial reporting is a process designed by, or under the supervision of, the company's principal executive and principalfinancial officers, or persons performing similar functions, and effected by the company's board of directors, management, and other personnel to providereasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generallyaccepted accounting principles. A company's internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance ofrecords that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance thattransactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receiptsand expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonableassurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on thefinancial statements.Because of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management override of controls,material misstatements due to error or fraud may not be prevented or detected on a timely basis. Also, projections of any evaluation of the effectiveness of theinternal control over financial reporting to future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or thatthe degree of compliance with the policies or procedures may deteriorate.A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that amaterial misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis. The following materialweakness has been identified and included in management’s assessment. Management has identified a material weakness in the Company’s controls over thefinancial reporting process as the Company did not design and maintain sufficiently precise or effective review and approval controls over business combinations.This material weakness was considered in determining the nature, timing and extent of audit tests applied in our audit of the Consolidated Financial Statements asof and for the year ended December 31, 2016 of the Company, and this report does not affect our report on such financial statements.In our opinion, because of the effect of the material weakness identified above on the achievement of the objectives of the control criteria, the Company has notmaintained effective internal control over financial reporting as of December 31, 2016, based on the criteria established in Internal Control-Integrated Framework(2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Consolidated FinancialStatements as of and for the year ended December 31, 2016 of the Company and our report dated March 30, 2017 expressed an unqualified opinion on thosefinancial statements./s/Deloitte LLPChartered Professional AccountantsMarch 30, 2017Vancouver, Canada 160PART IIIItem 10.Directors, Executive Officers and Corporate GovernanceThe information required by this item will be contained in our definitive proxy statement, or Proxy Statement, which will be filed with the SEC in connection withour 2017 Annual General Meeting of Shareholders. Such information is incorporated herein by reference.Code of EthicsOur Board of Directors has adopted a code of conduct (the Code) that applies to our directors, officers and employees. The Code is available on the corporategovernance section of our website (which is a subsection of the “Investors” section of our website) at the following address: www.novelion.com. We intend todisclose on our website any amendments or waivers to the Code that are required to be disclosed by SEC rules. You may also request a printed copy of the code,without charge, by writing to us at Novelion Therapeutics Inc., 887 Great Northern Way, Suite 250, Vancouver, B.C., Canada V5T 4T5 Attn: Investor Relations.Item 11.Executive Compensation The information required by this item will be contained in our Proxy Statement, which will be filed with the SEC in connection with our 2017 Annual GeneralMeeting of Shareholders. Such information is incorporated herein by reference.Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Shareholder MattersThe information required by this item will be contained in our Proxy Statement, which will be filed with the SEC in connection with our 2017 Annual GeneralMeeting of Shareholders. Such information is incorporated herein by reference.Item 13.Certain Relationships and Related Transactions, and Director IndependenceThe information required by this item will be contained in our Proxy Statement, which will be filed with the SEC in connection with our 2017 Annual GeneralMeeting of Shareholders. Such information is incorporated herein by reference.Item 14.Principal Accountant Fees and ServicesThe information required by this item will be contained in our Proxy Statement, which will be filed with the SEC in connection with our 2017 Annual GeneralMeeting of Shareholders. Such information is incorporated herein by reference.161PART IVItem 15.Exhibits, Financial Statement Schedules(a) The following documents are filed as part of this Annual Report:1.Consolidated Financial Statements (see Item 8).2.All information is included in the Consolidated Financial Statements or notes thereto.3.Exhibits:See Exhibit Index.162Item 16.SummaryNot applicable.SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by theundersigned, thereunto duly authorized. NOVELION THERAPEUTICS INC. Date: March 30, 2017By:/s/ Mary Szela Mary Szela Chief Executive Officer (principal executive officer) and Director Date: March 30, 2017By:/s/ Gregory D. Perry Gregory D. Perry Chief Financial and Administrative Officer (principal financial officer ) Date: March 30, 2017By:/s/ Barbara Chan Barbara Chan President and Chief Accounting Officer, Aegerion Pharmaceuticals, Inc. (principal accounting officer )POWER OF ATTORNEYKNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below appoints severally, Mary Szela, Gregory D. Perry andBenjamin Harshbarger, and each one of them, his or her attorneys-in-fact, each with the power of substitution for him or her in any and all capacities, to sign anyand all amendments to this Annual Report on Form 10-K and to file the same, with exhibits thereto and other documents in connection therewith, with the SEC,hereby ratifying and confirming all that each attorneys-in-fact, or his or her substitute or substitutes, may do or cause to be done by virtue hereof.Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and inthe capacities and on the dates indicated.Signature Capacity Date /s/ Mary Szela Chief Executive Officer (principal executive officer) and Director March 30, 2017Mary Szela /s/ Gregory D. Perry Chief Financial and Administrative Officer (principal financial officer) March 30, 2017Gregory D. Perry /s/ Barbara Chan President and Chief Accounting Officer, Aegerion Pharmaceuticals, Inc. (principalaccounting officer) March 30, 2017Barbara Chan /s/ Jason Aryeh Chairman of the Board of Directors March 30, 2017Jason Aryeh /s/ Geoffrey Cox Director March 30, 2017Geoffrey Cox 163 /s/ Kevin Kotler Director March 30, 2017Kevin Kotler /s/ Jorge Plutzky Director March 30, 2017Jorge Plutzky /s/ Stephen Sabba Director March 30, 2017Stephen Sabba /s/ Sandford D. Smith Vice Chair of the Board of Directors March 30, 2017Sandford D. Smith /s/ Donald K. Stern Director March 30, 2017Donald K. Stern /s/ John Thomas, Jr. Director March 30, 2017John Thomas, Jr. /s/ Anne VanLent Director March 30, 2017Anne VanLent 164EXHIBIT INDEXThe exhibits listed below are filed as part of this Annual Report. References under the caption “Location” to exhibits or other filings indicate that the exhibit orother filing has been filed, that the indexed exhibit and the exhibit or other filing referred to are the same and that the exhibit or other filing referred to isincorporated by reference.Table of ContentsExhibit Description of Document Location2.1#Asset Purchase Agreement, dated September 21, 2012, by and between theCompany and Valeant. Exhibit 10.65 to the Company’s Current Report on Form 8-K,filed with the SEC on September 27, 2012.2.2#Asset Purchase Agreement, dated April 3, 2013, by and between the Companyand Mati Therapeutics Inc. Exhibit 10.70 to the Company’s Current Report on Form 8-K,filed with the SEC on April 9, 2013.2.3#Asset Purchase Agreement, dated November 5, 2014, by and among AegerionPharmaceuticals, Inc., Amylin Pharmaceuticals, LLC and, solely for purposes ofSections 2.1.1, 2.2.1 and 2.3.2, AstraZeneca Pharmaceuticals LP. Exhibit 10.29 to Aegerion Pharmaceuticals, Inc.’s AmendmentNo. 1 to the Annual Report on Form 10-K, filed with the SECon July 7, 2015.2.4 First Amendment to Asset Purchase Agreement dated January 9, 2015, by andamong Aegerion Pharmaceuticals, Inc., Amylin Pharmaceuticals, LLC and,solely for purposes of Sections 2.1.1, 2.2.1 and 2.3.2, AstraZenecaPharmaceuticals LP. Exhibit 10.30 to Aegerion Pharmaceuticals, Inc.’s AnnualReport on Form 10-K, filed with the SEC on March 2, 2015.2.5 Share Purchase Agreement, dated June 8, 2015, by and among the Company,Broadfin Healthcare Master Fund, Ltd., JW Partners, LP, JW OpportunitiesFund, LLC, EcoR1 Capital Fund Qualified, L.P. and EcoR1 Capital Fund, L.P. Exhibit 2.3 to the Company’s Current Report on Form 8-K,filed with the SEC on June 12, 2015.2.6 Share Purchase and Registration Rights Agreement, dated June 8, 2015, by andamong the Company, Broadfin Healthcare Master Fund, Ltd., JW Partners, LP,JW Opportunities Fund, LLC, EcoR1 Capital Fund Qualified, L.P. and EcoR1Capital Fund, L.P. Exhibit 2.4 to the Company’s Current Report on Form 8-K,filed with the SEC on June 12, 2015.2.7 Letter agreement, dated June 8, 2015, by and among the Company, BroadfinHealthcare Master Fund, Ltd., JW Partners, LP, JW Opportunities Fund, LLC,EcoR1 Capital Fund Qualified, L.P. and EcoR1 Capital Fund, L.P. Exhibit 2.5 to the Company’s Current Report on Form 8-K,filed with the SEC on June 12, 2015.2.8 Second Amended and Restated Agreement and Plan of Merger, dated August26, 2015, by and among InSite Vision Incorporated, the Company and IsotopeAcquisition Corp. Exhibit 2.1 to the Company’s Current Report on Form 8-K,filed with the SEC on August 28, 2015.2.9 Amended and Restated Share Subscription Agreement, dated December 7, 2015,among the Company, Tribute Pharmaceuticals Canada Inc., POZEN Inc., AralezPharmaceuticals, Inc., Aralez Pharmaceuticals Plc, Deerfield Private DesignFund III, L.P., Deerfield International Master Fund, L.P., Deerfield Partners,L.P.,Broadfin Healthcare Master Fund, Ltd., JW Partners, LP, JW OpportunitiesFund, LLC, and J.W. Opportunities Master Fund, Ltd. Exhibit 10.1 to the Company’s Current Report on Form 8-K,filed with the SEC on December 11, 2015.2.10 Unit Subscription Agreement, dated June 14, 2016, by and among the Company,Deerfield International Master Fund, L.P., Deerfield Partners, L.P., BroadfinHealthcare Master Fund, Ltd., JW Partners LP, JW Opportunities Master Fund,Ltd., The K2 Principal Fund L.P., Healthcare Value Partners, L.P., TigerLegatus Capital Management, LLC, Sarissa Capital Domestic Fund LP, SarissaCapital Offshore Master Fund LP, Armistice Capital Master Fund, Ltd., LevcapAlternative Fund, L.P., Ulysses Partners, L.P., Ulysses Offshore Fund, Ltd. andJason Aryeh, as amended as applied to Broadfin Healthcare Master Fund, Ltd.on September 9, 2016. Exhibit 10.1 to the Company’s Current Report on Form 8-K,filed with the SEC on December 5, 2016.165Exhibit Description of Document 2.11 Agreement and Plan of Merger, dated June 14, 2016, and Amendment No. 1thereto, by and among Aegerion Pharmaceuticals, Inc., the Company andIsotope Acquisition Corp. Annex A to the Company’s Amendment No. 1 to theRegistration Statement on Form S-4, filed with the SEC onSeptember 12, 2016.3.1 Articles of the Company, dated May 25, 2005. Exhibit 3.2 to the Company’s Current Report on Form 8-K,filed with the SEC on June 1, 2005.3.2 Notice of Articles of the Company, dated November 29, 2016. Exhibit 3.1 to the Company’s Current Report on Form 8-K,filed with the SEC on December 5, 2016.4.1 Specimen Common Share Certificate of the Company. Exhibit 4.1 to the Company’s Current Report on Form 8-K,filed with the SEC on December 16, 2016.4.2 Indenture, dated August 15, 2014, by and between Aegerion Pharmaceuticals,Inc. and The Bank of New York Mellon Trust Company, N.A., as Trustee,relating to the 2.00% Convertible Senior Notes Due 2019. Exhibit 4.1 to Aegerion Pharmaceuticals, Inc.’s CurrentReport on Form 8-K, filed with the SEC on August 15, 2014.4.3 Supplemental Indenture, dated November 29, 2016, by and between AegerionPharmaceuticals, Inc. and The Bank of New York Mellon Trust Company, N.A.,as Trustee, relating to the 2.00% Convertible Senior Notes Due 2019. Exhibit 4.1 to Aegerion Pharmaceuticals, Inc.’s CurrentReport on Form 8-K, filed with the SEC on November 29,2016.10.1#License Agreement, dated February 7, 2006, by and between AmylinPharmaceuticals, LLC and Amgen Inc. Exhibit 10.32 to Aegerion Pharmaceuticals, Inc.’s AnnualReport on Form 10-K, filed with the SEC on March 2, 2015.10.2#Patent License Agreement, dated May 19, 2006, as amended September 27,2006, by and between Aegerion Pharmaceuticals, Inc. and University ofPennsylvania. Exhibit 10.6 to Aegerion Pharmaceuticals, Inc.’s RegistrationStatement on Form S-1, as amended, filed with the SEC onAugust 10, 2010.10.3#License Agreement, dated July 8, 2009, by and between AmylinPharmaceuticals, LLC and Shionogi & Co., Ltd. Exhibit 10.31 to Aegerion Pharmaceuticals, Inc.’s AnnualReport on Form 10-K, filed with the SEC on March 2, 2015.10.4 Amended and Restated PDT Product Development, Manufacturing andDistribution Agreement, dated October 16, 2009, by and between the Companyand Novartis Pharma AG. Exhibit 10.48 to the Company’s Current Report on Form 8-K,filed with the SEC on October 22, 2009.10.5#Co-Development Agreement, dated April 4, 2006, by and between the Companyand Retinagenix, LLC, as amended by letter agreements dated August 10, 2006,September 11, 2008 and October 20, 2010. Exhibit 10.54 to the Company’s Annual Report on Form 10-K,filed with the SEC on March 1, 2011.10.6 Sublease, dated June 2, 2015, by and between Discovery Parks Realty Corp. andthe Company. Filed herewith.10.7 Sublease Amending and Expansion Agreement, dated January 4, 2016, by andbetween Discovery Parks Realty Corp. and the Company. Filed herewith.10.8 Sublease Renewal Agreement, dated May 18, 2016, by and between DiscoveryParks Realty Corp. and the Company. Filed herewith.10.9 Lease, dated January 1, 2011, by and between Aegerion Pharmaceuticals, Inc.and RREEF America REIT II CORP. PPP. Exhibit 10.1 to Aegerion Pharmaceuticals, Inc.’s CurrentReport on Form 8-K, filed with the SEC on January 6, 2011.10.10 First Amendment to Lease, dated November 7, 2011, by and between AegerionPharmaceuticals, Inc. and RREEF America REIT II CORP. PPP. Exhibit 10.22 to Aegerion Pharmaceuticals, Inc.’s AnnualReport on Form 10-K, filed with the SEC on March 15, 2012.10.11 Second Amendment to Lease, dated September 4, 2012, by and betweenAegerion Pharmaceuticals, Inc. and RREEF America REIT II Corp. PPP. Exhibit 10.1 to Aegerion Pharmaceuticals, Inc.’s QuarterlyReport on Form 10-Q, filed with the SEC on November 9,2012.10.12 Third Amendment to Lease, dated June 19, 2013, by and between AegerionPharmaceuticals, Inc. and RREEF America REIT II Corp. PPP. Exhibit 10.1 to Aegerion Pharmaceuticals, Inc.’s QuarterlyReport on Form 10-Q, filed with the SEC on August 9, 2013.166Exhibit Description of Document Location10.13 Fourth Amendment to Lease, dated January 1, 2014, by and between AegerionPharmaceuticals, Inc. and RREEF America REIT II Corp. PPP. Exhibit 10.25 to Aegerion Pharmaceuticals, Inc.’s AnnualReport on Form 10-K, filed with the SEC on March 3, 2014.10.14 Fifth Amendment to Lease, dated July 19, 2016, by and between AegerionPharmaceuticals, Inc. and RREEF America REIT II Corp. PPP. Exhibit 10.3 to Aegerion Pharmaceuticals, Inc.’s QuarterlyReport on Form 10-Q, filed with the SEC on November 4,2016.10.15 Loan and Security Agreement, dated June 14, 2016, by and between theCompany and Aegerion Pharmaceuticals, Inc. Exhibit 10.2 to Aegerion Pharmaceuticals, Inc.’s CurrentReport on Form 8-K, filed with the SEC on June 15, 2016.10.16 Letter agreement, dated December 7, 2015, by and among the Company,Broadfin Healthcare Master Fund, Ltd., JW Partners, LP, JW OpportunitiesFund, LLC, and J.W. Opportunities Master Fund, Ltd. Exhibit 10.2 to the Company’s Current Report on Form 8-K,filed with the SEC on December 11, 2015.10.17 Form of Warrant Agreement. Exhibit C of Amendment No. 1 to the Agreement and Plan ofMerger from Annex A to the Company’s Amendment No. 1 tothe Registration Statement on Form S-4, filed with the SEC onSeptember 12, 2016.10.18*Deferred Share Unit Plan For Non-Employee Directors of the Company. Exhibit 10.32 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 9, 2005.10.19*Aegerion Pharmaceuticals, Inc. 2010 Stock Option and Incentive Plan. Exhibit 10.2 to Aegerion Pharmaceuticals, Inc.’s RegistrationStatement on Form S-1, as amended, filed with the SEC onAugust 10, 2010.10.20*Aegerion Pharmaceuticals, Inc. Form of Incentive Stock Option Agreement forExecutive Officers and forms of Non-Qualified Stock Option Agreement andRestricted Stock Award Agreement for Directors. Exhibit 10.6 to Aegerion Pharmaceuticals, Inc.’s AnnualReport on Form 10-K, filed with the SEC on March 18, 2013.10.21*Novelion 2016 Equity Incentive Plan. Exhibit 99.4 to the Company’s Registration Statement onForm S-8, filed with the SEC on December 5, 2016.10.22*Form of Stock Option Award Grant Notice and Stock Option Award Agreement(Directors) under the Novelion 2016 Equity Incentive Plan. Filed herewith.10.23*Form of Stock Option Award Grant Notice and Stock Option Award Agreement(Employees) under the Novelion 2016 Equity Incentive Plan. Filed herewith.10.24*Form of Stock Option Award Grant Notice and Stock Option Award Agreement(Executives) under the Novelion 2016 Equity Incentive Plan. Filed herewith.10.25*Form of Performance Restricted Stock Unit Award Grant Notice andPerformance Restricted Stock Unit Award Agreement under the Novelion 2016Equity Incentive Plan. Filed herewith.10.26*Form of Restricted Stock Unit Award Grant Notice and Restricted Stock UnitAward Agreement under the Novelion 2016 Equity Incentive Plan. Filed herewith.10.27 Form of Indemnity Agreement (Directors). Filed herewith.10.28*Form of Indemnity Agreement (Officers). Filed herewith.10.29*Employment Agreement, dated January 7, 2016, by and between AegerionPharmaceuticals, Inc. and Mary T. Szela. Exhibit 10.1 to Aegerion Pharmaceuticals, Inc.’s Form 8-K,filed with the SEC on January 11, 2016.10.30*Employment Agreement, dated October 23, 2014, by and between the Companyand Geoffrey F. Cox. Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on October 28, 2014.10.31*Amendment to Employment Agreement, dated April 22, 2015, by and betweenthe Company and Geoffrey F. Cox. Exhibit 10.79 to the Company’s Current Report on Form 8-K,filed with the SEC on April 23, 2015.167Exhibit Description of Document Location10.32*Second Amendment to Employment Agreement, dated October 8, 2015, byand between the Company and Geoffrey F. Cox. Exhibit 10.1 to the Company’s Current Report on Form 8-K,filed with the SEC on October 9, 2015.10.33*Third Amendment to Employment Agreement, dated April 7, 2016, by andbetween the Company and Geoffrey F. Cox. Exhibit 10.1 to the Company’s Current Report on Form 8-K,filed with the SEC on April 11, 2016.10.34*Fourth Amendment to Employment Agreement, dated June 17, 2016, by andbetween the Company and Geoffrey F. Cox. Exhibit 10.9 to the Company’s Quarterly Report on Form 10-Q,filed with the SEC on August 9, 2016.10.35*Fifth Amendment to Employment Agreement, dated September 16, 2016, byand between the Company and Geoffrey F. Cox. Exhibit 10.1 to the Company’s Current Report on Form 8-K,filed with the SEC on September 16, 2016.10.36*Form of employee stock option grant to Geoffrey F. Cox. Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q,filed with the SEC on October 28, 2014.10.37*Employment Offer Letter, dated November 28, 2016, between NovelionServices USA, Inc. and Gregory D. Perry. Filed herewith.10.38*Employment Agreement, dated January 5, 2015, by and between the Companyand Glen Ibbott. Exhibit 10.76 to the Company’s Current Report on Form 8-K,filed with the SEC on January 5, 2015.10.39*Amendment to Employment Agreement, dated November 5, 2015, by andbetween the Company and Glen Ibbott. Exhibit 10.1 to the Company’s Current Report on Form 8-K,filed with the SEC on November 12, 2015.10.40*Second Amendment to Employment Agreement, dated June 17, 2016, by andbetween the Company and Glen Ibbott. Exhibit 10.10 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 9, 2016.10.41*Employment Agreement, by and between the Company and Dori Assaly, datedJune 14, 2013, as amended November 5, 2015. Exhibit 10.29 to the Company’s Annual Report on Form 10-K,filed with the SEC on February 25, 2016.10.42*Amendment to Employment Agreement, dated June 17, 2016, by and betweenthe Company and Dori Assaly. Exhibit 10.11 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 9, 2016.10.43*Employment Agreement, by and between the Company and Lana Janes, datedJanuary 1, 2010, as amended November 5, 2015. Exhibit 10.27 to the Company’s Annual Report on Form 10-K,filed with the SEC on February 25, 2016.10.44*Change of Control Agreement between the Company and Lana Janes, datedJune 1, 2015. Exhibit 10.28 to the Company’s Annual Report on Form 10-K,filed with the SEC on February 25, 2016.10.45*Amendment to Employment Agreement, dated June 17, 2016, by and betweenthe Company and Lana Janes. Exhibit 10.12 to the Company’s Quarterly Report on Form 10-Q, filed with the SEC on August 9, 2016.10.46*Employment Offer Letter, dated November 28, 2016, between NovelionServices USA, Inc. and Benjamin Harshbarger. Filed herewith.10.47*Employment Offer Letter, dated November 28, 2016, between NovelionServices USA, Inc. and Roger Louis. Filed herewith.10.48*Employment Offer Letter, dated November 28, 2016, between NovelionServices USA, Inc. and Remi Menes. Filed herewith.21.1 Subsidiaries of the Company. Filed herewith.23.1 Consent of Deloitte LLP. Filed herewith.24.1 Power of Attorney. Contained on signature page hereto.31.1 Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant toSection 302 of the Sarbanes-Oxley Act of 2002: Mary Szela, Chief ExecutiveOfficer (Principal Executive Officer). Filed herewith.168Exhibit Description of Document Location31.2 Certification pursuant to 18 U.S.C. Section 1350. as adopted pursuant toSection 302 of the Sarbanes-Oxley Act of 2002: Gregory D. Perry, ChiefFinancial and Administrative Officer (Principal Financial Officer). Filed herewith.32.1 Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant toSection 906 of the Sarbanes-Oxley Act of 2002: Mary Szela, Chief ExecutiveOfficer (Principal Executive Officer). Filed herewith.32.2 Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant toSection 906 of the Sarbanes-Oxley Act of 2002: Gregory D. Perry, ChiefFinancial and Administrative Officer (Principal Financial Officer). Filed herewith.101.1 The following financial statements from the Company’s Annual Report onForm 10-K for the year ended December 31, 2016, formatted in ExtensibleBusiness Reporting Language:Consolidated Balance Sheets;Consolidated Statements of Operations;Consolidated Statements of Comprehensive Income;Consolidated Statements of Cash Flows;Consolidated Statements of Shareholders’ Equity; and Notes to ConsolidatedFinancial Statements. ________________________________Notes:* Denotes executive compensation plans or arrangements.# Confidential treatment has been received for certain provisions of this Exhibit. Confidential portions have been omitted and filed separately with the SEC. 169Exhibit 10.6SUBLEASETHIS SUBLEASE dated for reference June 2, 2015,BETWEEN: DISCOVERY PARKS REALTY CORP.(the “ Sublandlord ”)AND: QLT INC.(the “ Subtenant ”)WHEREAS:A. By a lease (the “Head Lease”) executed as of the 5th day of April, 2013, a copy of which is annexed hereto as Schedule “A”, Dundee PropertiesLimited Partnership and 560677 B.C. Ltd. (together, the “Head Landlord”) leased to Discovery Parks Holdings Ltd., in its capacity as trustee of Discovery ParksTrust (“DPT”), upon and subject to the terms of the Head Lease, certain premises (the “Leased Premises”) located in the building (the “Building”) with a civicaddress at 887 Great Northern Way, Vancouver, British Columbia, which premises are more particularly described in the Head Lease and shown on the floor planannexed as Schedule “A” to the Head Lease;B. The Sublandlord is the successor in interest to all right and interest of DPT in and to the Head Lease and the Leased Premises; andC. The Sublandlord and the Subtenant wish to enter into this Sublease for a portion of the Leased Premises (the “ Sublet Premises ”) comprised of aportion of the second floor of the Building and containing approximately 5,850 square feet of Rentable Area as shown outlined and denoted as “A1” (“Premises A1 ”) and “A2” (“ Premises A2 ”, and together with Premises A1, “ Premises A ”) on the floor plan of the Leased Premises attached hereto as Schedule“B” (the “ Floor Plan ”), together with another portion of the second floor of the Building and containing approximately 2,275 square feet of Rentable Area asshown outlined and denoted as “B1” (“ Premises B1 ”) and “B2” (“ Premises B2 ”, and together with Premises B1, “ Premises B ”) on the Floor Plan, on theterms specified in this Sublease.NOW THEREFORE in consideration of the premises and other consideration, the receipt and sufficiency of which are hereby acknowledged by each of the parties,the parties agree as follows:1.0 Capitalized Terms1.1 Capitalized terms used in this Sublease will have the meanings ascribed thereto in the Head Lease unless otherwise defined in this Sublease.2.0 Grant of Sublease2.1 The Sublandlord subleases to the Subtenant and the Subtenant subleases from the Sublandlord:(a)Premises A for a term (the “ Premises A Term ”) commencing on September 1, 2015 (the “ Commencement Date ”) and expiring onAugust 31, 2016; and(b)Premises B for a term (the “ Premises B Term ”) commencing on the Commencement Date and expiring on February 28, 2016,upon and subject to the terms of this Sublease. The Premises A Term and the Premises B Term are hereinafter together referred to as the “ Sublease Term ”.2.2 The Subtenant will have the right to use and enjoy the Common Areas and Facilities of the Building, including the cafeteria, common meeting rooms, fitnessfacility (if any), shipping and receiving area, washrooms, entrances, hallways and elevators, if and to the extent such Common Areas and Facilities are madeavailable for the use and benefit of the Sublandlord under the terms of the Head Lease. Without limiting the Subtenant’s use of the Common Areas and Facilitiesand the general right of egress to and from the Building, the Subtenant acknowledges and agrees that access from the second floor elevator lobby of the Building toPremises A and Premises B will be provided through the common area hallways shown on the plan of the second floor common areas attached hereto asSchedule “C”.3.0 Renewal Option3.1 The Sublandlord covenants and agrees with the Subtenant that if the Subtenant duly and punctually observes and performs the Subtenant’s covenants,agreements, and provisos in this Sublease, the Sublandlord will, at the expiration of the Premises A Term and upon the Subtenant’s written request delivered to theSublandlord not later than three months prior to the expiration of the Premises A Term, grant to the Subtenant a renewal lease of Premises A for a term of one (1)year less a day expiring on August 30, 2017 (the “ Premises A Renewal Term ”), upon all the terms, covenants, agreements, and provisos contained in thisSublease, except for this option to renew. For certainty, the Sublease Gross Rent payable during the Premises A Renewal Term will be equal to that paid during theinitial Premises A Term.3.2 The Sublandlord covenants and agrees with the Subtenant that if the Subtenant duly and punctually observes and performs the Subtenant’s covenants,agreements, and provisos in this Sublease, and provided further that this Sublease remains in effect for Premises A, the Subtenant may, at its option and upondelivering written notice to the Sublandlord not later than one month prior to expiration of the Premises B Term or then current Premises B Renewal Term, as thecase may be, renew this Sublease with respect to all of Premises B or with respect to only either Premises B1 or Premises B2 on a month-to-month basis (each, a “Premises B Renewal Term ”) upon all the terms, covenants, agreements, and provisos contained in this Sublease, provided that the Sublease for Premises B maynot in any event be renewed beyond August 30, 2017, and except that either the Sublandlord or the Subtenant may, during any Premises B Renewal Term,terminate this Sublease with respect to all of Premises B or with respect to only Premises B1 or Premises B2, on one month’s prior written notice to the other. Forgreater certainty, the Sublease Gross Rent payable during any Premises B Renewal Term will be equal to that paid during the initial Premises B Term.4.0 Sublease Gross Rent4.1 It is the stated purpose and intent of the Sublandlord and Subtenant that this Sublease is a gross lease and will be fully gross to the Sublandlord, with theexception of any other items expressly set out in this Sublease.4.2 The Subtenant will pay to the Sublandlord as Sublease Gross Rent (as hereinafter defined) the following amounts:(c)$14,500 plus applicable value-added tax (“ GST ”) per month in respect of Premises A during the Premises A Term (being the sum of $13,000per month plus GST in respect of Premises A1, and $1,500 per month plus GST in respect of Premises A2); and(d)$5,500 plus GST per month in respect of Premises B during the Premises B Term (being the sum of $2,000 per month plus GST in respect ofPremises B1, and $3,500 per month plus GST in respect of Premises B2),payable, in advance without demand, deduction, set-off or abatement on the first day of each and every month commencing on the Commencement Date. “Sublease Gross Rent ” is defined as the total rent payable by the Subtenant in respect of Premises A during the Premises A Term and in respect of Premises Bduring the Premises B Term, and for greater certainty, includes all items defined in the Head Lease as Rent, Basic Rent, Additional Rent and off-peak utilities.5.0 Sublease Rent5.1 The Subtenant covenants and agrees with the Sublandlord to pay to the Sublandlord or to its order in lawful money of Canada, at the office of the Sublandlordhereinafter set forth, or at such other place as the Sublandlord may in writing direct, without notice or demand, except as otherwise specifically provided herein,and without abatement, deduction or set-off for any reason whatsoever (unless otherwise herein provided), a rent comprised of:(a) the Sublease Gross Rent plus GST hereby reserved in the manner herein provided; and(b) all other amounts which become due and payable to the Sublandlord from time to time pursuant to the terms of this Sublease,all of which amounts will be payable and recoverable as “ Sublease Rent ”.6.0 Adjustments to Sublease Gross Rent6.1 If, after the Commencement Date, there is any change to the Leased Premises or any parts thereof that would change the Rentable Area of the Sublet Premises,then, as at the effective date of such change, the Sublease Gross Rent will be adjusted appropriately with appropriate adjustment to the Sublease Gross Rent andany other Sublease Rent paid by the Subtenant in respect of any period of time after the date of such change.7.0 Apportionment of Sublease Gross Rent7.1 Sublease Gross Rent will be considered as accruing from day to day under this Sublease. If it is necessary to calculate Sublease Gross Rent for a period of lessthan one year or less than one calendar month, an appropriate apportionment and adjustment on a pro rata daily basis will be made.8.0 Amounts Chargeable as Sublease Rent8.1 All costs incurred by the Sublandlord in collecting any amounts payable under this Sublease or enforcing any right or obligation of the Subtenant under thisSublease will be payable by the Subtenant on demand and will be deemed to be Sublease Rent for all purposes from the date demand therefor is made. In additionto Sublease Rent under this Sublease, the Subtenant will remit to the Sublandlord any GST or other tax or imposition collectible by the Sublandlord for the use ofthe Sublet Premises by the Subtenant or goods or services provided to the Subtenant, and the Sublandlord will be entitled to exercise all remedies in respect of anyfailure by the Subtenant to pay such amounts as if they were Sublease Rent in arrears.8.2 If the Subtenant fails to make any payment to the Sublandlord or otherwise hereunder when due, the Subtenant will pay to the Sublandlord a fee of $200.00 foreach such late or missed payment, and interest calculated from the date that the payment was due until the date payment is actually made to the Sublandlord, at therate of interest per annum designated from time to time by the Sublandlord’s principal bank (the “ Bank ”) as being the prime commercial lending rate charged bythe Bank for demand loans in Canadian funds made at the main branch of the Bank in Vancouver, British Columbia, calculated daily, not in advance. Acceptanceof any late payment without the fee or interest will not constitute a waiver of the Sublandlord’s right to require the fee and interest. The Subtenant will be deemedto have failed to make a payment on, and the fee and interest will be due from, the date such payment is first payable, and not the date after the expiry of notice ofnon‑payment, if any notice is required to be given or is given.9.0 Deposits9.1 The Subtenant will pay to the Sublandlord a security deposit (the “ Security Deposit ”) of $20,000 plus GST, and the Sublandlord will hold and deal with theSecurity Deposit as follows:(a) the Security Deposit will be applied to the costs incurred by the Sublandlord to repair the Sublet Premises at the end of the Sublease Term if theSubtenant fails to do so as required hereunder (provided that the amount of the Security Deposit will not be deemed to be a limit on the amountrecoverable in respect of the costs incurred by the Sublandlord under this Section) and will be repaid to the Subtenant within 30 days after the expiry orearlier termination of this Sublease as it relates to Premises A if not otherwise applied by the Sublandlord in accordance with this Section 9.1;(b) in the event of termination of this Sublease by reason of default by the Subtenant the Security Deposit will be applied by the Sublandlord on accountof Sublease Rent and damages incurred by the Sublandlord for which the Subtenant is liable hereunder and any balance remaining will be refunded to theSubtenant within 30 days after the termination of this Sublease as it relates to Premises A.9.2 The Sublandlord will have no obligation to invest the Security Deposit for interest and the Subtenant will not be entitled to any interest thereon.10.0 As Is10.1 The Subtenant will accept the Sublet Premises on an “as is” basis:11.0 Alterations to the Sublet Premises11.1 The Subtenant will not remove, alter, or add to the Sublet Premises or any part thereof (the “ Subtenant’s Work ”) without first having submitted workingdrawings and specifications of such work to the Sublandlord and the Head Landlord for the Sublandlord’s and the Head Landlord’s prior written approval.11.2 Preparation of working drawings and specifications and the performance of the Subtenant’s Work will be entirely at the expense of the Subtenant and theSubtenant will be responsible, at its sole cost, for all Subtenant’s Work.11.3 The Subtenant will engage contractors and subcontractors to perform the Subtenant’s Work and will ensure that the Subtenant’s Work is performed in a goodand workmanlike manner in compliance with all applicable laws, bylaws, and regulations, and the Subtenant will obtain and comply with all building, electrical, orother permits that may be required in respect of the Subtenant’s Work and will pay all fees and procure all applicable inspections.11.4 The Subtenant will include in its contracts with contractors for Subtenant’s Work:(a) a statement to the effect that; and(b) a covenant of the applicable contractor to notify any of its subcontractors or suppliers involved with the Subtenant’s Work that,any work undertaken in respect of the Subtenant’s Work is undertaken solely at the request of, on the credit of, on behalf of and for the benefit of the Subtenant andthat the contractor accordingly has no builders’ lien rights in respect of the interest of the Sublandlord or the Head Landlord in the Building or the Lands.11.5 At the Sublandlord’s option, the Sublandlord may submit its own proposal to construct the Subtenant’s Work at the Subtenant’s cost, which the Subtenantmay accept or reject without consequence hereunder.11.6 The Subtenant agrees that all Subtenant’s Work made or installed at any time prior to or after the Commencement Date, whether by the Subtenant or theSublandlord, will, immediately upon affixation or installation become the property of the Sublandlord and will remain upon the Sublet Premises and the Building,other than the Subtenant’s trade fixtures and personal property.11.7 The Subtenant will not be required to restore the Sublet Premises or remove its Leasehold Improvements from the Sublet Premises at the expiration or earliertermination of this Sublease.12.0 Delay12.1 The Sublandlord will not be deemed to be in default in the performance of any of its obligations in this Sublease during any period when the Sublandlord isprevented from performance by reason of being unable, using reasonable efforts (without expenditure of any funds other than reimbursement of the HeadLandlord’s legal costs) to obtain the consent of the Head Landlord, and neither the Sublandlord nor the Subtenant will be deemed to be in default of their respectiveobligations during any period when such party is prevented from performance by reason of the default of the other party, or by reason of being unable to obtain thematerials, goods, equipment, service, or labour required by reason of any statute, law, bylaw, ordinance, or regulation, or by reason of any strikes, lockouts,slowdowns, or other combined action of workmen or shortages of material or any other cause beyond its control, and the time for the performance of any suchobligation will be extended accordingly. The inability to perform an obligation due to lack of financial resources will not be deemed to be beyond a party’s control.13.0 Liens13.1 If any lien or encumbrance arising out of work done by or on behalf of the Subtenant in respect of the Sublet Premises is filed or attached against the Buildingor title to the Lands, the Subtenant will, within five days after notice of the lien or encumbrance, procure its discharge, failing which the Sublandlord may, at itsoption and in addition to any other remedies it may have under the Sublease arising out of defaults by the Subtenant, make any payments into court required toprocure such discharge; and the Subtenant will promptly reimburse the Sublandlord for any payment, cost, or expense incurred in so doing, whether or not suchlien or encumbrance was without merit or excessive.14.0 Subtenant’s Covenants14.1 The Subtenant acknowledges having received and read a copy of the Head Lease and covenants and agrees with the Sublandlord:(a) to perform all of the obligations of the Tenant under the Head Lease except for payment of Rent, including Basic Rent and Tenant’s ProportionateShare of Operating Costs and Taxes, and to be bound by the terms of the Head Lease in each and every case as they relate to the Sublet Premises,(b) to abide by any rules and regulations governing the use of the Sublet Premises and the Building appended to the Head Lease, as the Head Lease maybe amended from time to time of which the Subtenant receives written notice;(c) to pay Sublease Rent and perform all of the obligations of the Subtenant under this Sublease;(d) not to do or omit to do any act in or around the Sublet Premises that would cause a breach of the Sublandlord’s obligations as Tenant under the HeadLease; and(e) to indemnify and save harmless the Sublandlord against and from any and all expenses, costs, damages, suits, actions, or liabilities arising or growingout of the failure of the Subtenant to perform any of its obligations under this Sublease and from all claims and demands of every kind and nature madeby any person or persons to or against the Sublandlord for all and every manner of costs, damages, or expenses incurred by or injury or damage to suchperson or persons or his, her, or their property, to the extent that such claims or demands arise out of the use and occupation of the Sublet Premises by theSubtenant or its officers, employees, or any other person authorized or permitted by the Subtenant to be on the Sublet Premises or in or about theBuilding, and from all costs, counsel fees, expenses, and liabilities incurred by reason of any such claim or any action or proceeding brought on suchclaim.15.0 Subtenant’s Breach15.1 If the Subtenant fails to perform any of its obligations herein, the Sublandlord will have all of the remedies against the Subtenant that the Head Landlord hasunder the Head Lease for a breach of it, whether expressly set out in the Head Lease or arising in law or equity.16.0 Sublandlord’s Covenants16.1 Subject to the due performance by the Subtenant of its obligations in this Sublease, the Sublandlord covenants and agrees with the Subtenant:(a) for quiet enjoyment of the Sublet Premises;(b) to enforce against the Head Landlord for the benefit of the Subtenant the obligations of the Head Landlord under the Head Lease that materially affectthe Sublet Premises;(c) to perform all of the obligations of the Sublandlord under this Sublease;(d) to perform all of the obligations of the Sublandlord under the Head Lease that materially affect the Sublet Premises, including without limitation thepayment of Rent pursuant to the Head Lease; and(e) not to exercise any option to renew or extend the Head Lease that the Sublandlord may have thereunder.17.0 Use17.1 The Subtenant will not, without the prior written consent of the Sublandlord, use the Sublet Premises, nor permit them to be used, for any purpose other thanfor the purposes permitted under the Head Lease.17.2 The Subtenant has satisfied itself that the Sublet Premises will be suitable for the use permitted herein for which the Sublet Premises are subleased and thetaking of occupation of the Sublet Premises by the Subtenant will be deemed to be acknowledgement by the Subtenant of acceptance of the Sublet Premiseswithout the requirement of further work by the Sublandlord but subject to the warranties made by the Sublandlord herein.18.0 Insurance18.1 The Subtenant will take out and maintain, throughout the Premises A Term and any renewal thereof insurance in respect of Premises A and throughout thePremises B Term and any renewal thereof insurance in respect of Premises B, providing for the coverages and upon the terms required in the Head Lease to bemaintained by the Sublandlord. The Subtenant will ensure that the Sublandlord and the Head Landlord are shown as additional insureds on all liability policies,with a cross liability and severability of interest endorsement, and the Subtenant will ensure that each property insurance policy contains a waiver of subrogationwith respect to the Head Landlord and the Sublandlord. The Subtenant releases the Sublandlord from any claim the Subtenant may have that is or would be insuredagainst by the insurance policies that the Subtenant is required to maintain by this Sublease.19.0 Subtenant’s Assignment, Subletting and Licensing19.1 The Subtenant covenants not to sell, assign, sublet, or transfer or part with possession of this Sublease or any portion of the Sublease Term or the SubletPremises or any interest therein except with the prior consent of the Sublandlord, such consent not to be unreasonably withheld, and except as expressly providedherein, and then only to a party (a “ Transferee ”) who covenants with the Sublandlord in accordance with Section 19.4 and only if such Transferee carries on theuses described in Section 17.1 or other similar activity consented to by the Sublandlord in writing prior to such sale, subletting, assignment, or other disposition.19.2 Any consent of the Sublandlord to any assignment or subletting under this Section 19.0 will not constitute a waiver of necessity for such consent to anysubsequent assignment or subletting.19.3 No sublease or assignment or agreement to grant the same will grant rights to a Transferee beyond the scope of this Sublease and a Transferee will have norights to the Sublet Premises except under the Subtenant. Any sublease or assignment will be expressly subject to this Sublease and will contain covenants by theTransferee:(e)to comply with and fulfil each of the obligations undertaken by the Subtenant in this Sublease, including the termination of this Sublease or thesublease in the event of default by the Transferee;(f)not to further sublease, assign, transfer or licence the interest of the Subtenant (including a deemed assignment under this Sublease) or part withpossession without first obtaining the consent of the Sublandlord as required for an assignment, sublease or transfer of this Sublease;(g)not to do or permit upon the Sublet Premises anything which is, or will result in, a contravention of any term of this Sublease; and(h)to observe and perform each and every one of the covenants and agreements on the part of the Subtenant under this Sublease to be observed andperformed other than rent payment and to provide the indemnities provided in this Sublease.19.4 Upon the termination, forfeiture, or acceptance of surrender of this Sublease prior to the expiry of the Premises A Term or any renewal thereof in respect ofPremises A or of the Premises B Term or any renewal thereof in respect of Premises B, any sublease or assignment, or other interests created by the Subtenant inrespect of the Sublet Premises and the rights of all persons claiming thereunder, will be extinguished.19. 5 If requested by the Sublandlord, a copy of any or all instruments and documents evidencing the assignment, subletting, or licensing, including assignments oflease and sublease, will be furnished to the Sublandlord by the Subtenant.19.6 If there is a permitted assignment, the Sublandlord may collect rent from the Transferee and apply the net rent collected to the Sublease Rent required to bepaid pursuant to this Sublease, but no acceptance by the Sublandlord of any payment by a Transferee will be deemed a waiver of any covenants under this Subleaseincluding this Section 19.0 on the part of the Subtenant to be observed or performed, or the acceptance of the Transferee as subtenant. No assignment, subletting,licensing or other disposition will release the Subtenant from its obligations under this Sublease.20.0 Sublandlord’s Assignment1. The Subtenant acknowledges and agrees that the Sublandlord will be entitled to assign its interest as Sublandlord under this Sublease to a third party at any timewithout the consent of the Subtenant. In the event of an assignment as contemplated in this Section 20.1, the Sublandlord will deliver to the Subtenant notice inwriting setting out the name and address for delivery of notices of the assignee.21.0 Additional Sublandlord’s Remedy21.1 The parties acknowledge and agree that, as between themselves only, notwithstanding the benefit of any law to the contrary, if the Subtenant is in default inthe payment of any Sublease Rent the Sublandlord may seize and may sell all of the Subtenant’s goods, chattels and property within the Sublet Premises and mayapply the proceeds of such sale upon rental or upon any other amounts outstanding hereunder and upon the costs of the seizure and sale; in the same manner asmight have been done if such law had not been passed. The Subtenant further agrees that if it vacates the Sublet Premises, leaving any rental or other moneysprovided to be paid hereunder unpaid, the Sublandlord, in addition to any remedy otherwise provided by law, may seize and sell the goods and chattels of theSubtenant at any place to which the Subtenant or any other person may have removed them, in the same manner as if such goods and chattels had remained uponthe Sublet Premises.22.0 Exercise of Rights22.1 The determination of any state of facts, the promulgation of any rules or regulations, or the taking of any other action or exercise of any other rights under theHead Lease that is permitted to the Head Landlord will, upon written notice to the Subtenant of such action or exercise, be binding upon the Subtenant and theSublet Premises.23.0 Paramountcy of Head Lease23.1 The Subtenant acknowledges and agrees that it has no greater interest in the Sublet Premises than the Sublandlord under the Head Lease. To the extent thatany right or benefit conferred by this Sublease contravenes or is incompatible with the Head Lease, such right or benefit will be amended or modified so as not tocontravene or be incompatible with the Head Lease.24.0 Notices24.1 All notices, consents, and approvals permitted or required to be given under this Sublease will be in writing and will be sufficiently given if deliveredpersonally, sent by prepaid registered mail, or transmitted by electronic mail as follows:(a)to the Sublandlord at the Leased PremisesAttention: Laura CassinEmail: lauracassin@discoveryparks.com(b)to the Subtenant at the Sublet PremisesAttention: Glenn IbbottEmail: gibbott@qltinc.comprovided that either party may designate another address or email address by giving notice of it to the other party in accordance with the terms of this Sublease.Notices will be deemed received as follows: if mailed, except during a period of interruption of normal postal service, on the fifth Business Day following the dateof mailing; if delivered personally, at the time of delivery if delivered on a Business Day, and if not delivered on a Business Day, then on the next Business Dayfollowing delivery; if transmitted by email, at the time (at the location of the recipient) of transmission, provided transmission occurs before 5:00 p.m. on aBusiness Day at the location of the recipient, and if not, then on the next Business Day at the location of the recipient.25.0 Parking25.1 The Subtenant will comply with the reasonable rules and regulations of the Head Landlord generally adopted in accordance with Section 27.1 of the HeadLease and with any reasonable rules and regulations of the Sublandlord adopted from time to time for parking in the parking areas on the Lands. The Subtenant andits invitees and licensees will not park except in the areasdesignated by the Sublandlord for parking, and then only with valid parking permits permitting parking in such area properly displayed in accordance with therules and regulations adopted in accordance with Section 27.1 by the Head Landlord from time to time. During the Sublease Term the Subtenant will be entitled tohave the use of 14 parking stalls within the parking areas within the Building and will pay therefor, monthly in advance, the market rate for such parking stallswhich, as of the Commencement Date, is $70 per parking stall per month, and which market rate is subject to annual review and adjustment. The Sublandlord maymake up to 20 additional parking stalls within the parking areas within the Building available to rent by the Subtenant on a re-callable basis at the same rate as the14 aforementioned parking stalls. The Subtenant shall pay all parking fees directly to the operator of the parking areas within the Building, which at the date of thisSublease is Imperial Parking Corporation.26.0 Reimbursement of Legal Expenses26.1 The Subtenant will reimburse the Sublandlord for its reasonable legal fees and expenses incurred in connection with the preparation of this Sublease (the “Legal Expenses ”) within 30 days of receiving a copy of an invoice therefor. If the Subtenant fails to pay to the Sublandlord the sum of the Legal Expenses, theSublandlord may add the same to the Sublease Rent and recover the same by all remedies available to the Sublandlord for the recovery of Sublease Rent in arrears.27.0 Successors and Assigns27.1 Except as otherwise provided in this Sublease, all of the rights and obligations of a party enure to the benefit of and are binding upon the successors andassigns of that party.28.0 Further Assurances28.1 Each party agrees to execute such further assurances as may be reasonably required from time to time by any other party to more fully effect the true intent ofthis Sublease.29.0 Entire Agreement and “As Is”29.1 This Sublease merges and supersedes all prior negotiations, representations, and agreements between the parties relating in any way to the Sublet Premises.The parties agree that there are no representations, covenants, agreements, warranties, or conditions in any way relating to the subject matter of this Sublease or theoccupation or use of the Sublet Premises, whether express or implied or otherwise, except as provided in this Sublease. The Sublandlord will not be responsible forany alteration or improvement required or desired by the Subtenant to the Sublet Premises. The Subtenant acknowledges that the Sublandlord has made norepresentations as to the condition of the Sublet Premises or the fitness of the Sublet Premises for any purpose, except as expressly provided in this Sublease.30.0 Waiver30.1 No waiver by the Sublandlord of a condition or the performance of an obligation of the Subtenant under this Sublease binds the Sublandlord unless in writingand executed by it, and no waiver given by the Sublandlord will constitute a waiver of any other condition or performance by the Subtenant of its obligations underthis Sublease in any other case.31.0 Sublease Execution31.1 This Sublease and all subsequent amendments to this Sublease are only binding on the Sublandlord and the Subtenant respectively, if in writing and executedby authorized signatories for the Sublandlord and the Subtenant and if executed copies of this Sublease have been delivered to each party.32.0 Governing Law32.1 This Sublease will be governed in accordance with laws applicable in the Province of British Columbia, and the parties irrevocably submit to the non-exclusive jurisdiction of the courts of British Columbia.33.0 Counterparts33.1 This Sublease may be executed by the parties in counterpart, each of which when delivered will be deemed to be an original and all of which together willconstitute one and the same document binding on the parties.IN WITNESS WHEREOF the parties have duly executed this Sublease as of the date set out above.DISCOVERY PARKS REALTY CORP.Per: /s/ Mark BetteridgeAuthorized SignatoryQLT INC.Per:/s/ W. Glen IbbottAuthorized Signatory[ Remainder of this page intentionally left blank ]SCHEDULE “A”HEAD LEASESCHEDULE “B”SUBLET PREMISESSCHEDULE “C”SECOND FLOOR COMMON AREASExhibit 10.7SUBLEASE AMENDING AND EXPANSION AGREEMENT887 Great Northern Way , VancouverTHIS AGREEMENT, dated for reference the 4 th day of January, 2016, but effective the 1 st day of January, 2016 (the “ Effective Date ”),BETWEEN : DISCOVERY PARKS REALTY CORP(the " Sublandlord " )AND: QLT INC .(the "Subtenant")WITNESSES THAT WHEREAS :A.By a lease (the " Head Lease ") executed as of the 5 th day of April, 2013 , Dundee Properties Limited Partnership and 560677 B . C. Ltd . (together,the " Head Landlord ") leased to Discovery Parks Holdings Ltd . , in its capacity as trustee of Discovery Parks Trust (" DPT " ) , upon and subjectto the terms of the Head Lease, certain premises (the " Leased Premises ") located in the building with a civic address at 887 Great Northern Way,Vancouver , British Columbia , which premises are more particularly described in the Head Lease and shown on the floor plan annexed as Schedule" A” to the Head Lease ;B.The Sublandlord is the successor in interest to all right and interest of DPT in and to the Head Lease and the Leased Premises ;C.Pursuant to a sublease dated for reference June 2, 2015 (the " Sublease "),the Sublandlord sublet to the Subtenant a portion of the Leased Premises(the " Sublet Premises " ), which Sublet Premises were described in Recital C of the Sublease as comprising a portion of the second floor of theBuilding and containing approximately 5,850 square feet of Rentable Area ("Premises A " ), together with another portion of the second floor of theBuilding and containing approximately 2,275 square feet of Rentable Area (" Premises B " ); andD.The Sublandlord and the Subtenant wish to amend the Sublease in order to include add i tional premises located on the second floor of the Buildingand containing approximately 350 square feet of Rentable Area as shown outlined and denoted as "B3" on the floor plan of the Leased Premisesattached hereto as Schedule "B" (" Premises B3 "), on the terms and conditions set out herein.NOW THEREFORE THIS AGREEMENT WITNESSES that in consideration of the mutual covenants and agreements between the parties to this Agreementand the sum of Ten Dollars ($10.00) now paid by each party to the other (the receipt and sufficiency of which are hereby acknowledged), the parties agree asfollows :1.0Interpretation1.1Unless otherwise defined in this Agreement, capitalized terms used in this Ag r eement have the meanings ascribed to them in the Sublease .1.2All schedules attached to this Agreement will form an integral part of this Agreement.2.0Demise2.1As of the Effective Date, in consideration of the rents, covenants, conditions , and agreements respectively reserved and contained in the Sublease asamended hereby, the Sublandlord demises to the Subtenant , and the Subtenant accepts , Premises B3 , on an " as is , where is " basis .2.2For certainty, the parties acknowledge and agree that any reference in the Sublease to any rights to rent free periods or requirements on the Sublandlord'spart to pay to the Subtenant any tenant improvement allowance , inducement or other amount will not apply to Premises B3 .3.0Sublease Amendments3.1From and after the Effective Date , the Sublease is hereby amended as follows :(a)by deleting Recital C in its entirety and replacing i t with the following :" C.The Sublandlord and the Subtenant wish to enter Into this Sublease for a portion of the Leased Premises (the " Sublet Premises ")comprised of a portion of the second floor of the Building and containing approximately 5,850 square feet of Rentable Area as shownoutlined and denoted as " A1 " (" Premises A1 " ) and " A2 " ( " Premises A2 " , and together with Premises A1, " Premises A " ) onthe floor plan of the Le a sed P r em i ses attached hereto a s Schedule " B" (the " Floor Plan " ) , together with another portion of thesecond floor of the Building and containing appro x imately 2,6 2 5 square feet of Rentab l e Area as shown outlined and denoted as "B 1" (" Premises B1 " ) , " B 2" (" Premises B2 " ) and " B3" ( " Premises B3 " , and together with Premises B1 and Premises B2, "Premises B " ) on t h e Floor Plan , on the te r ms specified in this Sublease ;"(b) by deleting Section 2.1 in its entirety and replacing it with the following:" 2 . 1The Sublandlord subleases to the Subtenant and the Subtenant subleases from the Sublandlord:(a)Premises A for a term (the " Premises A Term ") commencing on September 1, 2015 (the " Commencement Date ") andexpiring on August 31, 2016 (the " Expiration Date ");(b)Premises B1 and Premises B2 for a term (the " Premises B1 and B2 Term ") commencing on the Commencement Date andexpiring on the Expiration Date; and(c)Premises B3 for a term (the " Premises B3 Term ") commencing on January 1, 2016 (the " Premises B3 CommencementDate ") and expiring on the Expiration Date,upon and subject to the terms of this Sublease. The Premises A Term, the Premises B1 and B2 Term, and the Premises B3 Term arehereinafter together referred to as the " Sublease Term "."(d) by deleting Section 3.2 in its entirety and replacing it with the following :" 3.2 The Sublandlord covenants and agrees with the Subtenant that if the Subtenant duly and punctually observes and performs the Subtenant'scovenants, agreements, and provisos in this Sublease, and provided further that this Sublease remains in effect for Premises A, the Subtenantmay, at its option and upon delivering written notice to the Sublandlord not later than one month prior to the Expiration Date or the expiration ofthe then current Premises B Renewal Term, as the case may be, renew this Sublease with respect to all of Premises B or with respect to one ortwo of any of Premises B1, Premises B2 and Premises B3, on a month-to-month basis (each, a " Premises B Renewal Term ") upon all theterms, covenants, agreements, and provisos contained in this Sublease, provided that the Sublease for Premises B may not in any event berenewed beyond August 30, 2017, and except that either the Sublandlord or the Subtenant may, during any Premises B Renewal Term, terminatethis Sublease with respect to all of Premises B or with respect to one or more of any of Premises B1, Premises B2 and Premises B3, on onemonth's prior written notice to the other. For greater certainty, the Sublease Gross Rent payable during any Premises B Renewal Term will beequal to that paid during the initial Premises B1 and B2 Term, or initial Premises B3 Term, as the case may be."(e)by deleting Section 4 . 2 in its entirety and replacing it w it h the following :"4.2The Subtenant will pay to the Sublandlord as Sublease Gross Rent (as hereinafter defined) the following amounts :(a)$14,500 plus applicable value-added tax ( " GST " ) per month i n respect of Premises A during the Premises A Term (beingthe sum of $13 , 000 pe r month plus GST in respect of Prem i ses A1 , and $1,500 per month plus GST in respect of PremisesA2) ;(b)$5,500 plus GST per month in respect of Premises B1 and Prem i ses B2 during the Premises B1 and B2 Term ( being the sumof $2 , 000 per month plus GST in respect of Premises B1, and $3,500 per month plus GST in respect of Premises B2);and(c)$750 plus GST per month in respect of Premises B3 during the Premises B3 Term,payable , in advance without demand, deduction , set-off or abatement on the first day of each and every month commencing on theCommencement Date in respect of Prem i ses A , Premises B1 and Premise B2 , and commencing on the P r emises B3 Commencement Date inrespect of Premises B3. " Sublease Gross Rent " is defined as the total rent payable by the Subtenant in respect of Premises A during thePremises A Term, in respect of PremisesB1 and Premises B2 during the Premises B1 and B2 Term , and in respect of Premises B3 during thePremises B3 Term , and for greater certainty, includes all items defined in the Head Lease as Rent, Basic Rent, Addit i onal Rent and off-peakutilities. "(f)by replacing Schedule " B " attached to the Sublease with Schedule " B " attached to this Agreement.4.0Sublease Remains in Force4.1Except as amended by this Agreement , all other terms and cond i tions conta in ed in the Sublease remain unamended and in full force and effect.5.0Binding Effect5.1This Agreement will enure to the benefit of the part i es and their r espect iv e permitted successors and permitted assigns .6.0Counterparts6.1This Agreement may be executed in one or more counterparts, each of which will be deemed an original , and all of which will constitute one instrumentand may be delivered by electronic means .IN WITNESS WHEREOF the Sublandlord and the Subtenant have duly executed this Agreement as of the date and year first written above .DISCOVERY PARKS REALTY CORP Per: /s/ Laura Cassin________________ Authorized Signatory QLT INC.Per: /s/ Glen Ibbott________________ Authorized Signatory SCHEDULE"B"Exhibit 10.8SUBLEASE RENEWAL AGREEMENT887 Great Northern Way, VancouverTHIS AGREEMENT, dated the 18 th day of May, 2016 (the “ Effective Date ”),BETWEEN: DISCOVERY PARKS REALTY CORP.(the “ Sublandlord ”)AND: QLT INC.(the “ Subtenant ”)WITNESSES THAT WHEREAS:A. By a lease (the “Head Lease”) executed as of the 5th day of April, 2013, Dundee Properties Limited Partnership and 560677 B.C. Ltd. (together, the“Head Landlord”) leased to Discovery Parks Holdings Ltd., in its capacity as trustee of Discovery Parks Trust (“DPT”), upon and subject to the terms of the HeadLease, certain premises (the “Leased Premises”) located in the building with a civic address at 887 Great Northern Way, Vancouver, British Columbia, whichpremises are more particularly described in the Head Lease and shown on the floor plan annexed as Schedule “A” to the Head Lease;B. The Sublandlord is the successor in interest to all right and interest of DPT in and to the Head Lease and the Leased Premises;C. Pursuant to a sublease dated for reference June 2, 2015 (the “ Original Sublease ”), the Sublandlord sublet to the Subtenant a portion of the LeasedPremises (the “ Original Sublet Premises ”), which Original Sublet Premises were described in Recital C of the Sublease as comprising a portion of the secondfloor of the Building and containing approximately 5,850 square feet of Rentable Area (“ Premises A ”), together with another portion of the second floor of theBuilding and containing approximately 2,275 square feet of Rentable Area (“ Premises B1 and B2 ”);D. Pursuant to a sublease amending and expansion agreement dated for reference the 4 th day of January, 2016 but effective the 1 st day of January, 2016(the “ First Sublease Amending Agreement ”, and together with the Original Sublease, the “ Sublease ”), the parties amended the Sublease to include additionalpremises located on the second floor of the Building and containing approximately 350 square feet of Rentable Area (“ Premises B3 ”, and together with PremisesB1 and B2, “ Premises B ” and together with Premises “A”, the “ Sublet Premises ”) and to amend the expiration date for the Sublease Term to August 31, 2016;andE. The parties wish to renew the Sublease for an additional period of one year less a day on the terms and conditions hereinafter set forth.NOW THEREFORE THIS AGREEMENT WITNESSES that in consideration of the mutual covenants and agreements between the parties to this Agreement andthe sum of Ten Dollars ($10.00) now paid by each party to the other (the receipt and sufficiency of which are hereby acknowledged), the parties agree as follows:1.0 Interpretation1.1 Unless otherwise defined in this Agreement, capitalized terms used in this Agreement have the meanings ascribed to them in the Sublease.2.0 Sublease Renewal2.1 The Sublandlord and Subtenant acknowledge and agree that the Sublease in respect of the Sublet Premises is hereby renewed for an additional term of one yearless a day commencing on September 1, 2016 and expiring on August 30, 2017 (the “ Renewal Term ”) on all of the terms and conditions of the Sublease exceptas amended hereby.2.2 For certainty, the parties acknowledge and agree that any reference in the Sublease to any rights to rent free periods or requirements on the Sublandlord’s partto pay to the Subtenant any tenant improvement allowance, inducement or other amount will not apply to the Renewal Term, such rights and requirements beingdeemed to have expired with the expiry of the original Sublease Term.3.0 Condition of Sublet Premises3.1 The Subtenant confirms that it accepts the Sublet Premises on an “as is” basis, and acknowledges that the Sublandlord has made no representations orwarranties respecting the Sublet Premises.4.0 Sublease Gross Rent4.1 The parties agree that the Sublease Gross Rent payable during the Renewal Term for the Sublet Premises pursuant to Section 4.2 of the Sublease will be equalto that paid during the original Sublease Term. For greater certainty, the Subtenant will pay to the Sublandlord as Sublease Gross Rent the following amountsduring the Renewal Term:(a)$14,500 plus GST per month in respect of Premises A (being the sum of $13,000 per month plus GST in respect of Premises A1, and $1,500 permonth plus GST in respect of Premises A2);(b)$5,500 plus GST per month in respect of Premises B1 and Premises B2 (being the sum of $2,000 per month plus GST in respect of Premises B1,and $3,500 per month plus GST in respect of Premises B2); and(c)$750 plus GST per month in respect of Premises B3.5.0 Sublease Amendments5.1 From and after the Effective Date, the Sublease is hereby amended by deleting Sections 3.1 and 3.2 in their entirety.6.0 Sublease Remains in Force6.1 Except as amended by this Agreement, all other terms and conditions contained in the Sublease remain unamended and in full force and effect.7.0 Binding Effect7.1 This Agreement will enure to the benefit of the parties and their respective permitted successors and permitted assigns.8.0 Counterparts8.1 This Agreement may be executed in one or more counterparts, each of which will be deemed an original, and all of which will constitute one instrument andmay be delivered by electronic means.IN WITNESS WHEREOF the Sublandlord and the Subtenant have duly executed this Agreement as of the date and year first written above.DISCOVERY PARKS REALTY CORP.Per: /s/ Laura CassinAuthorized SignatoryQLT INC.Per: /s/ W. Glen IbbottAuthorized SignatoryExhibit 10.22NOVELION THERAPEUTICS INC.NOVELION 2016 EQUITY INCENTIVE PLANSTOCK OPTION AWARD GRANT NOTICE ANDSTOCK OPTION AWARD AGREEMENT(Directors)Novelion Therapeutics Inc. (the “ Company ”), pursuant to its 2016 Equity Incentive Plan, as amended from time to time (the “ Plan ”), hereby grants tothe individual listed below (“ Grantee ”), an award (“ Award ”) of an option (“ Option ”) to purchase a number of Common Shares, as set forth below. The Optionis subject to the conditions and limitations set forth in this Stock Option Award Grant Notice (the “ Grant Notice ”), the Stock Option Award Agreement attachedhereto as Exhibit A (the “ Award Agreement ”) and the Plan. Unless otherwise defined in this Grant Notice or the Award Agreement, defined terms shall have themeaning set forth in the Plan.Grantee’s Name:Grant Date:Number of Common SharesSubject to Option:Option Exercise Price:Expiry Date:Vesting Commencement Date:Vesting Schedule:By accepting the Award, Grantee agrees to be bound by the terms and conditions of the Plan, the Award Agreement and this Grant Notice. Grantee hasreviewed the Award Agreement, the Plan and this Grant Notice in their entirety and fully understands all provisions of the Award Agreement, the Plan and thisGrant Notice. Additionally, by accepting the Award, Grantee agrees that he or she has read, fully understands and agrees to abide by the terms of the Company’sInsider Trading Policy and has read and fully understands the Plan Prospectus, copies of which have been made available to Grantee. Grantee hereby agrees toaccept as binding, conclusive and final all decisions or interpretations of the Committee regarding any questions arising under the Plan or relating to the Option.NOVELION THERAPEUTICS Inc.By: Linda Buono Senior Vice President, Human Resources, Novelion Therapeutics, Inc.EXHIBIT ASTOCK OPTION AWARD AGREEMENT(DIRECTORS)1.General . Pursuant to the Grant Notice (the “ Grant Notice ”) to which this Stock Option Award Agreement (the “ Award Agreement ”) is attached,Novelion Therapeutics Inc. (the “ Company ”) has granted to Grantee an award of an Option under the Company’s 2016 Equity Incentive Plan, asamended from time to time (the “ Plan ”).2.Defined Terms . All capitalized terms which are not defined in the Grant Notice or below have the meaning given to them in the Plan.3.Term . Subject to the terms and conditions of the Plan and this Award Agreement, the Option will terminate on the earlier of:(a)The date on which the Option is exercised with respect to all Common Shares subject to the Option; and(b)5:00 p.m. (Vancouver time) on the Expiry Date.4.Vesting . The vesting provisions applicable to the Option shall be as set forth in the Grant Notice.5.Exercise of Options .(a)Exercise Notice . No portion of the Option may be exercised until such portion vests. Grantee may exercise some or all of the vested portion of theOption by giving written notice of exercise (the “ Exercise Notice ”) signed and dated by Grantee (and not postdated), stating that Grantee elects toexercise his or her rights to purchase Common Shares subject to the Option and specifying the number of Common Shares in respect of which theOption is being exercised and specifying the Option Exercise Price to be paid therefor.(b)Delivery and Payment . Grantee shall deliver the Exercise Notice to the Company at its principal office at 887 Great Northern Way, Suite 101,Vancouver, British Columbia, Canada, V5T 4T5 (or at such other address as the principal office of the Company may be located at the time ofexercise) addressed to the attention of the Secretary or assistant secretary (if any) of the Company (or a designee notified in writing from time to timeby the Company) and such Exercise Notice shall be accompanied by full payment (payable at par in Vancouver, British Columbia) in anycombination of the following (subject to all applicable laws):(i)cash, bank draft or certified cheque;(ii)if and so long as the Common Shares are listed on an Exchange, delivery of a properly executed Exercise Notice, together with irrevocableinstructions, to(A) a brokerage firm designated by the Company to deliver promptly to the Company the aggregate amount of sale proceeds to pay the OptionExercise Price and any withholding tax obligations that may arise in connection with the exercise, and(B) the Company to deliver the certificates for such purchased shares directly to such brokerage firm,all in accordance with the regulations of any relevant regulatory authorities; and(iii)with prior written consent of the Company and subject to Section 13.3 of the Plan, written instructions from Grantee to the Company to effect anet settlement of Common Shares subject to the Option having a value equal to the Option Exercise Price of any Option and/or the withholdingtaxes due with respect to the exercise of the Option; and(c)Certificate . As soon as practicable after any exercise of the Option, a certificate or certificates representing the Common Shares into which theOption is exercised will be delivered by the Company to Grantee or to Grantee’s designated brokered firm, as applicable.6.Rules Upon Termination of Service . The Option will terminate on the earlier of the expiry of the Option under Section 3 above and the 90th day(effective following the close of trading on the Exchange, if such day is a trading day) after the date of Grantee’s Termination of Service as a director ofthe Company or its Affiliates, provided that, upon Grantee’s Termination of Service as a result of::(a)ceasing to meet the qualifications set forth in subsection 124(2) of the Business Corporations Act (British Columbia), as amended, or such otherqualifications required by the corporate laws in any other jurisdiction under which the Company is continued or amalgamated,(b)a special resolution having been passed by the shareholders of the Company pursuant to subsection 128(3) of the Business Corporations Act (BritishColumbia), as amended, or an equivalent enactment pursuant to the corporate laws in any other jurisdiction under which the Company is continued oramalgamated, or(c)by order of a securities commission, the TSX, NASDAQ or any other regulatory body having jurisdiction to so order,unless otherwise determined by the Committee and approved by the Exchange (if applicable), the Option (whether vested or unvested) will expireautomatically on the date of Grantee’s Termination of Service.For the avoidance of doubt, the Option will cease to vest after the date of Grantee’s Termination of Service as a director of the Company.7.Other .(a)Sale Event . In the event that Grantee is party to an effective employment or similar individual agreement with the Company or its Affiliates thatprovides for the treatment of an equity award in connection with “Sale Event” (as defined in such agreement), such provision shall only apply inconnection with a “Sale Event” that occurs on or after the Grant Date (and shall not, for the avoidance of doubt, apply in connection with a “SaleEvent” that occurred prior to the Grant Date).(b)Section 4985 . If any amount payable or paid by the Company or any of its affiliates pursuant to this Agreement or otherwise to or for the benefit ofGrantee becomes subject to the excise tax imposed by Section 4985 of the Code (including any interest, penalties or additions to tax relating thereto)(the “ 4985 Excise Tax ”) by reason of the consummation of the transactions contemplated by the Agreement and Plan of Merger, dated as of June14, 2016 (as amended), among QLT, Inc., Aegerion Pharmaceuticals, Inc. and certain other parties thereto, as reasonably determined by theCompany, then the Company shall pay to Grantee (1) an amount equal to the 4985 Excise Tax, and (2) an amount (the “ 4985 Gross-up Payment ”)equal to the amount necessary to put Grantee in the same net after-tax position (taking into account any and all applicable Federal, state, local andforeign income, employment, excise and other taxes) that Grantee would have been in if Grantee had not incurred any liability for taxes underSection 4985 of the Code. Any determination regarding the amount of any payment or payments hereunder shall be made in writing by theCompany’s independent accountants or other accounting or consulting firm selected by the Company, whose determination shall be conclusive andbinding upon Grantee and the Company for all purposes.8.Conditions to Exercise . Notwithstanding any of the provisions of the Award Agreement, the Company’s obligation to issue Common Shares to Granteeupon exercise of the Option is subject to the following:(c)Qualification . Completion of registration or other qualification of the Common Shares or obtaining approval of such governmental authority as theCompany determines is necessary or advisable in connection with the authorization, issuance or sale of the Common Shares;(d)Listing . The admission of the Common Shares to listing or quotation on the Exchange; and(e)Undertakings . The receipt by the Company from Grantee of such representations, agreements and undertakings, including as to future dealings in theCommon Shares, as the Company or its counsel determines are necessary or advisable in order to safeguard against the violation of securities laws ofany jurisdiction.9.Tax . Grantee is solely responsible for the payment of any applicable taxes arising from the grant, vesting, settlement or exercise of the Option and anypayment is to be in a manner satisfactory to the Company. Notwithstanding the foregoing, the Company will have the right to withhold from any amountpayable to Grantee, either under the Plan or otherwise, such amount as may be necessary to enable the Company to comply with the applicablerequirements of any federal, provincial, state, local or foreign law, or any administrative policy of any applicable tax authority, relating to the withholdingof tax or any other required deductions with respect to the Option (the “ Withholding Obligations ”). The Company may require Grantee, as a conditionto the exercise or settlement of the Option, to make such arrangements as the Company may require so that the Company can satisfy applicableWithholding Obligations, including, without limitation, requiring Grantee to (i) remit the amount of any such Withholding Obligations to the Company inadvance; (ii) reimburse the Company for any such Withholding Obligations; (iii) deliver written instructions contemplated in Section 5(b)(iii) hereof, toeffect a net settlement of Common Shares subject to the Option in an amount required to satisfy any such Withholding Obligations; or (iv) pursuant toSection 5(b)(ii) hereof, cause such broker to withhold from the proceeds realized from such transaction the amount required to satisfy any suchWithholding Obligations and to remit such amount directly to the Company.10.Black Out Periods . Grantee acknowledges and agrees that the Award Agreement and the grant of the Option to Grantee is subject to Grantee’sagreement to at all times comply with the Company’s policies with respect to black out periods, as more particularly set out in the Company’s TradingPolicy, as amended from time to time.11.No Rights as Shareholder . Grantee will not have any rights as a Shareholder with respect to any of the Common Shares subject to the Option until suchtime as Grantee becomes the record owner of such Common Shares.12.No Effect on Service . Nothing in the Award Agreement will:(a)Continue Service . Confer upon Grantee any right to continue in the service of the Company or any Affiliate or affect in any way the right of theCompany or any Affiliate to terminate his or her service at any time.(b)Extend Service . Be construed to constitute an agreement, or an expression of intent, on the part of the Company or any Affiliate to extend the serviceof Grantee beyond the time that he or she would normally be retired pursuant to the provisions of any present or future retirement plan or policy ofthe Company or any Affiliate, or beyond the time at which he or she would otherwise be retired pursuant to the provisions of any contract of servicewith the Company or any Affiliate.13.Enurement . The Award Agreement shall enure to the benefit of and be binding upon the parties to the Award Agreement and upon the successors orassigns of the Company and upon the executors, administrators and legal personal representatives of Grantee.14.Further Assurances . Each of the parties to the Award Agreement will do such further acts and execute such further documents as may required to giveeffect to and carry out the intent of the Award Agreement.15.Non-Assignable . The Option is personal to Grantee and may not be assigned or transferred in whole or in part, except by will or by the operation of thelaws of devolution or distribution and descent.16.Amendments . Any amendments to the Award Agreement must be in writing duly executed by the parties and will (if required) be subject to the approvalof the applicable regulatory authorities.17.Time of the Essence . Time is of the essence of the Award Agreement.18.Governing Law . The Award Agreement shall be governed, construed and enforced according to the laws of the Province of British Columbia and issubject to the exclusive jurisdiction of the courts of the Province of British Columbia.19.Interpretation of the Award Agreement and the Plan . If any question or dispute arises as to the interpretation of the Award Agreement, the questionor dispute will be determined by the Committee and such determination will be final, conclusive and binding for all purposes on both the Company andGrantee.20.Conflict Between Award Agreement and the Plan . If there is any conflict between this Award Agreement and the Plan, the Plan, as amended fromtime to time, will govern.EXHIBIT 10.23NOVELION THERAPEUTICS INC.NOVELION 2016 EQUITY INCENTIVE PLANSTOCK OPTION AWARD GRANT NOTICE ANDSTOCK OPTION AWARD AGREEMENT(Employees)Novelion Therapeutics Inc. (the “ Company ”), pursuant to its 2016 Equity Incentive Plan, as amended from time to time (the “ Plan ”), hereby grants tothe individual listed below (“ Grantee ”), an award (“ Award ”) of an option (“ Option ”) to purchase a number of Common Shares, as set forth below. The Optionis subject to the conditions and limitations set forth in this Stock Option Award Grant Notice (the “ Grant Notice ”), the Stock Option Award Agreement attachedhereto as Exhibit A (the “ Award Agreement ”) and the Plan. Unless otherwise defined in this Grant Notice or the Award Agreement, defined terms shall have themeaning set forth in the Plan.Grantee’s Name:Grant Date:Number of Common SharesSubject to Option:Option Exercise Price:Expiry Date:Vesting Commencement Date:Vesting Schedule:By accepting the Award, Grantee agrees to be bound by the terms and conditions of the Plan, the Award Agreement and this Grant Notice. Grantee hasreviewed the Award Agreement, the Plan and this Grant Notice in their entirety and fully understands all provisions of the Award Agreement, the Plan and thisGrant Notice. Additionally, by accepting the Award, Grantee agrees that he or she has read, fully understands and agrees to abide by the terms of the Company’sInsider Trading Policy and has read and fully understands the Plan Prospectus, copies of which have been made available to Grantee. Grantee hereby agrees toaccept as binding, conclusive and final all decisions or interpretations of the Committee regarding any questions arising under the Plan or relating to the Option.NOVELION THERAPEUTICS Inc.By: Linda Buono Senior Vice President, Human Resources, Novelion Therapeutics, Inc.EXHIBIT ASTOCK OPTION AWARD AGREEMENT(EMPLOYEES)1.General . Pursuant to the Grant Notice (the “ Grant Notice ”) to which this Stock Option Award Agreement (the “ Award Agreement ”) is attached,Novelion Therapeutics Inc. (the “ Company ”) has granted to Grantee an award of an Option under the Company’s 2016 Equity Incentive Plan, asamended from time to time (the “ Plan ”).2.Defined Terms . All capitalized terms which are not defined in the Grant Notice or below have the meaning given to them in the Plan.3.Term . Subject to the terms and conditions of the Plan and this Award Agreement, the Option will terminate on the earlier of:(a)The date on which the Option is exercised with respect to all Common Shares subject to the Option; and(b)5:00 p.m. (Vancouver time) on the Expiry Date.4.Vesting . The vesting provisions applicable to the Option shall be as set forth in the Grant Notice.5.Exercise of Options .(a)Exercise Notice . No portion of the Option may be exercised until such portion vests. Grantee may exercise some or all of the vested portion of theOption by giving written notice of exercise (the “ Exercise Notice ”) signed and dated by Grantee (and not postdated), stating that Grantee elects toexercise his or her rights to purchase Common Shares subject to the Option and specifying the number of Common Shares in respect of which theOption is being exercised and specifying the Option Exercise Price to be paid therefor.(b)Delivery and Payment . Grantee shall deliver the Exercise Notice to the Company at its principal office at 887 Great Northern Way, Suite 101,Vancouver, British Columbia, Canada, V5T 4T5 (or at such other address as the principal office of the Company may be located at the time ofexercise) addressed to the attention of the Secretary or assistant secretary (if any) of the Company (or a designee notified in writing from time to timeby the Company) and such Exercise Notice shall be accompanied by full payment (payable at par in Vancouver, British Columbia) in anycombination of the following (subject to all applicable laws):(i)cash, bank draft or certified cheque;(ii)if and so long as the Common Shares are listed on an Exchange, delivery of a properly executed Exercise Notice, together with irrevocableinstructions, to(A) a brokerage firm designated by the Company to deliver promptly to the Company the aggregate amount of sale proceeds to pay the OptionExercise Price and any withholding tax obligations that may arise in connection with the exercise, and(B) the Company to deliver the certificates for such purchased shares directly to such brokerage firm,all in accordance with the regulations of any relevant regulatory authorities; and(iii)with prior written consent of the Company and subject to Section 13.3 of the Plan, written instructions from Grantee to the Company to effect anet settlement of Common Shares subject to the Option having a value equal to the Option Exercise Price of any Option and/or the withholdingtaxes due with respect to the exercise of the Option; and(c)Certificate . As soon as practicable after any exercise of the Option, a certificate or certificates representing the Common Shares into which theOption is exercised will be delivered by the Company to Grantee or to Grantee’s designated brokered firm, as applicable.6.Rules Upon Termination of Service . The Option will terminate on the earlier of the expiry of the Option under Section 3 above and the 90th day(effective following the close of trading on the Exchange, if such day is a trading day) after the date of Grantee’s Termination of Service, provided thatupon Grantee’s Termination of Service by the Company or any Affiliate for Cause (as defined below) (as determined by the Company in its solediscretion), unless otherwise determined by the Committee and approved by the Exchange (if applicable), the Option (whether vested or unvested) willexpire automatically on the date of Grantee’s Termination of Service.For purposes of this Agreement, “ Cause ” shall have the meaning set forth in Grantee’s employment agreement with the Company for so long as suchagreement remains in effect or, if there is no such agreement between Grantee and theCompany, shall mean: (i) Grantee’s failure (except where due to complete disability), neglect, or refusal to perform in any material respect Grantee’sduties and responsibilities, (ii) any act of Grantee that has, or could reasonably be expected to have, the effect of injuring the business of the Company orits affiliates in any material respect, (iii) Grantee’s conviction of, or plea of guilty or no contest to: (A) a felony or (B) any other criminal charge that has,or could be reasonably expected to have, an adverse impact on the performance of Grantee’s duties to the Company or otherwise result in material injuryto the reputation or business of the Company, (iv) the commission by Grantee of an act of fraud or embezzlement against the Company, or any other actthat creates or reasonably could create negative or adverse publicity for the Company; (v) any violation by Grantee of the policies of the Company,including but not limited to those relating to sexual harassment or business conduct, and those otherwise set forth in the manuals or statements of policyof the Company, (vi) Grantee’s violation of federal or state securities laws, or (vii) Grantee’s breach of any agreement between the Company or itsaffiliates and Grantee, including Grantee’s breach of any non-competition, non-solicitation, confidentiality or other restrictive covenant agreement withthe Company.For the avoidance of doubt, the Option will cease to vest after the date of Grantee’s Termination of Service.7.Sale Event . In the event that Grantee is party to an effective employment or similar individual agreement with the Company or its Affiliates that providesfor the treatment of an equity award in connection with “Sale Event” (as defined in such agreement), such provision shall only apply in connection with a“Sale Event” that occurs on or after the Grant Date (and shall not, for the avoidance of doubt, apply in connection with a “Sale Event” that occurred priorto the Grant Date).8.Conditions to Exercise . Notwithstanding any of the provisions of the Award Agreement, the Company’s obligation to issue Common Shares to Granteeupon exercise of the Option is subject to the following:(a)Qualification . Completion of registration or other qualification of the Common Shares or obtaining approval of such governmental authority as theCompany determines is necessary or advisable in connection with the authorization, issuance or sale of the Common Shares;(b)Listing . The admission of the Common Shares to listing or quotation on the Exchange; and(c)Undertakings . The receipt by the Company from Grantee of such representations, agreements and undertakings, including as to future dealings in theCommon Shares, as the Company or its counsel determines are necessary or advisable in order to safeguard against the violation of securities laws ofany jurisdiction.9.Tax . Grantee is solely responsible for the payment of any applicable taxes arising from the grant, vesting, settlement or exercise of the Option and anypayment is to be in a manner satisfactory to the Company. Notwithstanding the foregoing, the Company will have the right to withhold from any amountpayable to Grantee, either under the Plan or otherwise, such amount as may be necessary to enable the Company to comply with the applicablerequirements of any federal, provincial, state, local or foreign law, or any administrative policy of any applicable tax authority, relating to the withholdingof tax or any other required deductions with respect to the Option (the “ Withholding Obligations ”). The Company may require Grantee, as a conditionto the exercise or settlement of the Option, to make such arrangements as the Company may require so that the Company can satisfy applicableWithholding Obligations, including, without limitation, requiring Grantee to (i) remit the amount of any such Withholding Obligations to the Company inadvance; (ii) reimburse the Company for any such Withholding Obligations; (iii) deliver written instructions contemplated in Section 5(b)(iii) hereof, toeffect a net settlement of Common Shares subject to the Option in an amount required to satisfy any such Withholding Obligations; or (iv) pursuant toSection 5(b)(ii) hereof, cause such broker to withhold from the proceeds realized from such transaction the amount required to satisfy any suchWithholding Obligations and to remit such amount directly to the Company.10.Black Out Periods . Grantee acknowledges and agrees that the Award Agreement and the grant of the Option to Grantee is subject to Grantee’sagreement to at all times comply with the Company’s policies with respect to black out periods, as more particularly set out in the Company’s TradingPolicy, as amended from time to time.11.No Rights as Shareholder . Grantee will not have any rights as a Shareholder with respect to any of the Common Shares subject to the Option until suchtime as Grantee becomes the record owner of such Common Shares.12.No Effect on Employment . Nothing in the Award Agreement will:(a)Continue Employment . Confer upon Grantee any right to continue in the employ of or under contract with the Company or any Affiliate or affect inany way the right of the Company or any Affiliate to terminate his or her employment or service at any time.(b)Extend Employment . Be construed to constitute an agreement, or an expression of intent, on the part of the Company or any Affiliate to extend theemployment or service of Grantee beyond the time that he or she would normally be retired pursuant to the provisions of any present or futureretirement plan or policy of the Company or any Affiliate,or beyond the time at which he or she would otherwise be retired pursuant to the provisions of any contract of employment with the Company or anyAffiliate.13.Clawback . The Option (whether or not vested) is subject to forfeiture, termination and rescission, and Grantee will be obligated to return to the Companythe value received with respect to the Option (including any gain realized on a subsequent sale or disposition of Common Shares) in accordance with anyclawback or similar policy maintained by the Company, as such policy may be amended and in effect from time to time, or as otherwise required by lawor applicable stock exchange listing standards, including, without limitation, Section 10D of the Securities Exchange Act of 1934, as amended.14.Enurement . The Award Agreement shall enure to the benefit of and be binding upon the parties to the Award Agreement and upon the successors orassigns of the Company and upon the executors, administrators and legal personal representatives of Grantee.15.Further Assurances . Each of the parties to the Award Agreement will do such further acts and execute such further documents as may required to giveeffect to and carry out the intent of the Award Agreement.16.Non-Assignable . The Option is personal to Grantee and may not be assigned or transferred in whole or in part, except by will or by the operation of thelaws of devolution or distribution and descent.17.Amendments . Any amendments to the Award Agreement must be in writing duly executed by the parties and will (if required) be subject to the approvalof the applicable regulatory authorities.18.Time of the Essence . Time is of the essence of the Award Agreement.19.Governing Law . The Award Agreement shall be governed, construed and enforced according to the laws of the Province of British Columbia and issubject to the exclusive jurisdiction of the courts of the Province of British Columbia.20.Interpretation of the Award Agreement and the Plan . If any question or dispute arises as to the interpretation of the Award Agreement, the questionor dispute will be determined by the Committee and such determination will be final, conclusive and binding for all purposes on both the Company andGrantee.21.Conflict Between Award Agreement and the Plan . If there is any conflict between this Award Agreement and the Plan, the Plan, as amended fromtime to time, will govern.Exhibit 10.24NOVELION THERAPEUTICS INC.NOVELION 2016 EQUITY INCENTIVE PLANSTOCK OPTION AWARD GRANT NOTICE ANDSTOCK OPTION AWARD AGREEMENT(Executives)Novelion Therapeutics Inc. (the “ Company ”), pursuant to its 2016 Equity Incentive Plan, as amended from time to time (the “ Plan ”), hereby grants tothe individual listed below (“ Grantee ”), an award (“ Award ”) of an option (“ Option ”) to purchase a number of Common Shares, as set forth below. The Optionis subject to the conditions and limitations set forth in this Stock Option Award Grant Notice (the “ Grant Notice ”), the Stock Option Award Agreement attachedhereto as Exhibit A (the “ Award Agreement ”) and the Plan. Unless otherwise defined in this Grant Notice or the Award Agreement, defined terms shall have themeaning set forth in the Plan.Grantee’s Name:Grant Date:Number of Common SharesSubject to Option:Option Exercise Price:Expiry Date:Vesting Commencement Date:Vesting Schedule:By accepting the Award, Grantee agrees to be bound by the terms and conditions of the Plan, the Award Agreement and this Grant Notice. Grantee hasreviewed the Award Agreement, the Plan and this Grant Notice in their entirety and fully understands all provisions of the Award Agreement, the Plan and thisGrant Notice. Additionally, by accepting the Award, Grantee agrees that he or she has read, fully understands and agrees to abide by the terms of the Company’sInsider Trading Policy and has read and fully understands the Plan Prospectus, copies of which have been made available to Grantee. Grantee hereby agrees toaccept as binding, conclusive and final all decisions or interpretations of the Committee regarding any questions arising under the Plan or relating to the Option.NOVELION THERAPEUTICS Inc.By: Linda Buono Senior Vice President, Human Resources, Novelion Therapeutics, Inc.EXHIBIT ASTOCK OPTION AWARD AGREEMENT(Executives)1.General . Pursuant to the Grant Notice (the “ Grant Notice ”) to which this Stock Option Award Agreement (the “ Award Agreement ”) is attached,Novelion Therapeutics Inc. (the “ Company ”) has granted to Grantee an award of an Option under the Company’s 2016 Equity Incentive Plan, asamended from time to time (the “ Plan ”).2.Defined Terms . All capitalized terms which are not defined in the Grant Notice or below have the meaning given to them in the Plan.3.Term . Subject to the terms and conditions of the Plan and this Award Agreement, the Option will terminate on the earlier of:(a)The date on which the Option is exercised with respect to all Common Shares subject to the Option; and(b)5:00 p.m. (Vancouver time) on the Expiry Date.4.Vesting . The vesting provisions applicable to the Option shall be as set forth in the Grant Notice.5.Exercise of Options .(a)Exercise Notice . No portion of the Option may be exercised until such portion vests. Grantee may exercise some or all of the vested portion of theOption by giving written notice of exercise (the “ Exercise Notice ”) signed and dated by Grantee (and not postdated), stating that Grantee elects toexercise his or her rights to purchase Common Shares subject to the Option and specifying the number of Common Shares in respect of which theOption is being exercised and specifying the Option Exercise Price to be paid therefor.(b)Delivery and Payment . Grantee shall deliver the Exercise Notice to the Company at its principal office at 887 Great Northern Way, Suite 101,Vancouver, British Columbia, Canada, V5T 4T5 (or at such other address as the principal office of the Company may be located at the time ofexercise) addressed to the attention of the Secretary or assistant secretary (if any) of the Company (or a designee notified in writing from time to timeby the Company) and such Exercise Notice shall be accompanied by full payment (payable at par in Vancouver, British Columbia) in anycombination of the following (subject to all applicable laws):(i)cash, bank draft or certified cheque;(ii)if and so long as the Common Shares are listed on an Exchange, delivery of a properly executed Exercise Notice, together with irrevocableinstructions, to(A) a brokerage firm designated by the Company to deliver promptly to the Company the aggregate amount of sale proceeds to pay the OptionExercise Price and any withholding tax obligations that may arise in connection with the exercise, and(B) the Company to deliver the certificates for such purchased shares directly to such brokerage firm, all in accordance with the regulations ofany relevant regulatory authorities; and(iii)with prior written consent of the Company and subject to Section 13.3 of the Plan, written instructions from Grantee to the Company to effect anet settlement of Common Shares subject to the Option having a value equal to the Option Exercise Price of any Option and/or the withholdingtaxes due with respect to the exercise of the Option; and(c)Certificate . As soon as practicable after any exercise of the Option, a certificate or certificates representing the Common Shares into which theOption is exercised will be delivered by the Company to Grantee or to Grantee’s designated brokered firm, as applicable.6.Rules Upon Termination of Service . The Option will terminate on the earlier of the expiry of the Option under Section 3 above and the 90th day(effective following the close of trading on the Exchange, if such day is a trading day) after the date of Grantee’s Termination of Service, provided thatupon Grantee’s Termination of Service by the Company or any Affiliate for Cause (as defined below) (as determined by the Company in its solediscretion), unless otherwise determined by the Committee and approved by the Exchange (if applicable), the Option (whether vested or unvested) willexpire automatically on the date of Grantee’s Termination of Service.For purposes of this Agreement, “ Cause ” shall have the meaning set forth in Grantee’s employment agreement with the Company for so long as suchagreement remains in effect or, if there is no such agreement between Grantee and the Company, shall mean: (i) Grantee’s failure (except where due tocomplete disability), neglect, or refusal to perform inany material respect Grantee’s duties and responsibilities, (ii) any act of Grantee that has, or could reasonably be expected to have, the effect of injuringthe business of the Company or its affiliates in any material respect, (iii) Grantee’s conviction of, or plea of guilty or no contest to: (A) a felony or (B) anyother criminal charge that has, or could be reasonably expected to have, an adverse impact on the performance of Grantee’s duties to the Company orotherwise result in material injury to the reputation or business of the Company, (iv) the commission by Grantee of an act of fraud or embezzlementagainst the Company, or any other act that creates or reasonably could create negative or adverse publicity for the Company; (v) any violation by Granteeof the policies of the Company, including but not limited to those relating to sexual harassment or business conduct, and those otherwise set forth in themanuals or statements of policy of the Company, (vi) Grantee’s violation of federal or state securities laws, or (vii) Grantee’s breach of any agreementbetween the Company or its affiliates and Grantee, including Grantee’s breach of any non-competition, non-solicitation, confidentiality or other restrictivecovenant agreement with the Company.For the avoidance of doubt, the Option will cease to vest after the date of Grantee’s Termination of Service.7.Other .(a)Sale Event . In the event that Grantee is party to an effective employment or similar individual agreement with the Company or its Affiliates thatprovides for the treatment of an equity award in connection with “Sale Event” (as defined in such agreement), such provision shall only apply inconnection with a “Sale Event” that occurs on or after the Grant Date (and shall not, for the avoidance of doubt, apply in connection with a “SaleEvent” that occurred prior to the Grant Date).(b)Section 4985 . If any amount payable or paid by the Company or any of its affiliates pursuant to this Agreement or otherwise to or for the benefit ofGrantee becomes subject to the excise tax imposed by Section 4985 of the Code (including any interest, penalties or additions to tax relating thereto)(the “ 4985 Excise Tax ”) by reason of the consummation of the transactions contemplated by the Agreement and Plan of Merger, dated as of June14, 2016 (as amended), among QLT, Inc., Aegerion Pharmaceuticals, Inc. and certain other parties thereto, as reasonably determined by theCompany, then the Company shall pay to Grantee (1) an amount equal to the 4985 Excise Tax, and (2) an amount (the “ 4985 Gross-up Payment ”)equal to the amount necessary to put Grantee in the same net after-tax position (taking into account any and all applicable Federal, state, local andforeign income, employment, excise and other taxes) that Grantee would have been in if Grantee had not incurred any liability for taxes underSection 4985 of the Code. Any determination regarding the amount of any payment or payments hereunder shall be made in writing by theCompany’s independent accountants or other accounting or consulting firm selected by the Company, whose determination shall be conclusive andbinding upon Grantee and the Company for all purposes.8.Conditions to Exercise . Notwithstanding any of the provisions of the Award Agreement, the Company’s obligation to issue Common Shares to Granteeupon exercise of the Option is subject to the following:(a)Qualification . Completion of registration or other qualification of the Common Shares or obtaining approval of such governmental authority as theCompany determines is necessary or advisable in connection with the authorization, issuance or sale of the Common Shares;(b)Listing . The admission of the Common Shares to listing or quotation on the Exchange; and(c)Undertakings . The receipt by the Company from Grantee of such representations, agreements and undertakings, including as to future dealings in theCommon Shares, as the Company or its counsel determines are necessary or advisable in order to safeguard against the violation of securities laws ofany jurisdiction.9.Tax . Grantee is solely responsible for the payment of any applicable taxes arising from the grant, vesting, settlement or exercise of the Option and anypayment is to be in a manner satisfactory to the Company. Notwithstanding the foregoing, the Company will have the right to withhold from any amountpayable to Grantee, either under the Plan or otherwise, such amount as may be necessary to enable the Company to comply with the applicablerequirements of any federal, provincial, state, local or foreign law, or any administrative policy of any applicable tax authority, relating to the withholdingof tax or any other required deductions with respect to the Option (the “ Withholding Obligations ”). The Company may require Grantee, as a conditionto the exercise or settlement of the Option, to make such arrangements as the Company may require so that the Company can satisfy applicableWithholding Obligations, including, without limitation, requiring Grantee to (i) remit the amount of any such Withholding Obligations to the Company inadvance; (ii) reimburse the Company for any such Withholding Obligations; (iii) deliver written instructions contemplated in Section 5(b)(iii) hereof, toeffect a net settlement of Common Shares subject to the Option in an amount required to satisfy any such Withholding Obligations; or (iv) pursuant toSection 5(b)(ii) hereof, cause such broker to withhold from the proceeds realized from such transaction the amount required to satisfy any suchWithholding Obligations and to remit such amount directly to the Company.10.Black Out Periods . Grantee acknowledges and agrees that the Award Agreement and the grant of the Option to Grantee is subject to Grantee’sagreement to at all times comply with the Company’s policies with respect to black out periods, as more particularly set out in the Company’s TradingPolicy, as amended from time to time.11.No Rights as Shareholder . Grantee will not have any rights as a Shareholder with respect to any of the Common Shares subject to the Option until suchtime as Grantee becomes the record owner of such Common Shares.12.No Effect on Employment . Nothing in the Award Agreement will:(a)Continue Employment . Confer upon Grantee any right to continue in the employ of or under contract with the Company or any Affiliate or affect inany way the right of the Company or any Affiliate to terminate his or her employment or service at any time.(b)Extend Employment . Be construed to constitute an agreement, or an expression of intent, on the part of the Company or any Affiliate to extend theemployment or service of Grantee beyond the time that he or she would normally be retired pursuant to the provisions of any present or futureretirement plan or policy of the Company or any Affiliate, or beyond the time at which he or she would otherwise be retired pursuant to theprovisions of any contract of employment with the Company or any Affiliate.13.Clawback . The Option (whether or not vested) is subject to forfeiture, termination and rescission, and Grantee will be obligated to return to the Companythe value received with respect to the Option (including any gain realized on a subsequent sale or disposition of Common Shares) in accordance with anyclawback or similar policy maintained by the Company, as such policy may be amended and in effect from time to time, or as otherwise required by lawor applicable stock exchange listing standards, including, without limitation, Section 10D of the Securities Exchange Act of 1934, as amended.14.Enurement . The Award Agreement shall enure to the benefit of and be binding upon the parties to the Award Agreement and upon the successors orassigns of the Company and upon the executors, administrators and legal personal representatives of Grantee.15.Further Assurances . Each of the parties to the Award Agreement will do such further acts and execute such further documents as may required to giveeffect to and carry out the intent of the Award Agreement.16.Non-Assignable . The Option is personal to Grantee and may not be assigned or transferred in whole or in part, except by will or by the operation of thelaws of devolution or distribution and descent.17.Amendments . Any amendments to the Award Agreement must be in writing duly executed by the parties and will (if required) be subject to the approvalof the applicable regulatory authorities.18.Time of the Essence . Time is of the essence of the Award Agreement.19.Governing Law . The Award Agreement shall be governed, construed and enforced according to the laws of the Province of British Columbia and issubject to the exclusive jurisdiction of the courts of the Province of British Columbia.20.Interpretation of the Award Agreement and the Plan . If any question or dispute arises as to the interpretation of the Award Agreement, the questionor dispute will be determined by the Committee and such determination will be final, conclusive and binding for all purposes on both the Company andGrantee.21.Conflict Between Award Agreement and the Plan . If there is any conflict between this Award Agreement and the Plan, the Plan, as amended fromtime to time, will govern.Exhibit 10.25NOVELION THERAPUETICS INC.NOVELION 2016 EQUITY INCENTIVE PLANPERFORMANCE RESTRICTED STOCK UNIT AWARD GRANT NOTICE ANDPERFORMANCE RESTRICTED STOCK UNIT AWARD AGREEMENTNovelion Therapeutics Inc. (the “ Company ”), pursuant to its 2016 Equity Incentive Plan, as amended from time to time (the “ Plan ”), hereby grants tothe individual listed below (“ Grantee ”), an award (“ Award ”) consisting of the target number of performance Restricted Stock Units (“ PSUs ” ) set forth below.Each PSU represents the conditional right to receive, without payment but subject to the conditions and limitations set forth in this Performance Restricted StockUnit Award Grant Notice (the “ Grant Notice ”), the Performance Restricted Stock Unit Award Agreement attached hereto as Exhibit A (the “ Award Agreement ”)and the Plan, one Common Share, subject to adjustment pursuant to Section 16 of the Plan in respect of transactions occurring on or after the date hereof. Theportion of the Award that may become vested and earned by Grantee will be determined in accordance with Schedule I to the Award Agreement. Unless otherwisedefined in this Grant Notice or Award Agreement, defined terms shall have the meaning set forth in the Plan.Grantee’s Name:Grant Date:Number of PSUs:Performance Criteria:Vesting Schedule:By accepting the Award, Grantee agrees to be bound by the terms and conditions of the Plan, the Award Agreement and this Grant Notice. Grantee hasreviewed the Award Agreement, the Plan and this Grant Notice in their entirety and fully understands all provisions of the Award Agreement, the Plan and thisGrant Notice. Additionally, by accepting the Award, Grantee agrees that he or she has read, fully understands and agrees to abide by the terms of the Company’sInsider Trading Policy and has read and fully understands the Plan Prospectus, copies of which have been made available to Grantee. Grantee hereby agrees toaccept as binding, conclusive and final all decisions or interpretations of the Committee regarding any questions arising under the Plan or relating to the PSUs.NOVELION THERAPEUTICS Inc.By: Linda Buono Senior Vice President, Human Resources, Novelion Therapeutics, Inc.Accepted and agreed to: Date: EXHIBIT APERFORMANCE RESTRICTED STOCK UNIT AWARD AGREEMENTPursuant to the Performance Restricted Stock Unit Award Grant Notice (the “ Grant Notice ”) to which this Performance Restricted Stock Unit AwardAgreement (the “ Award Agreement ”) is attached, Novelion Therapeutics Inc. (the “ Company ”) has granted to Grantee an award of performance RestrictedStock Units (“ PSUs ” ) under the Company’s 2016 Equity Incentive Plan, as amended from time to time (the “ Plan ”).ARTICLE I.GENERAL1.1 Defined Terms . Capitalized terms not specifically defined herein shall have the meanings specified in the Plan and the Grant Notice.1.2 Incorporation of Terms of Plan . PSUs are subject to the terms and conditions of the Plan which are incorporated herein by reference. In the event of anyinconsistency between the Plan and this Award Agreement, the terms of the Plan shall control.ARTICLE II.GRANT OF PERFORMANCE RESTRICTED STOCK UNITS2.1 Grant of PSUs . In consideration of Grantee’s service as an officer, employee or Consultant of the Company and for other good and valuableconsideration, effective as of the Grant Date set forth in the Grant Notice (the “ Grant Date ”), the Company grants to Grantee the target number of PSUs as setforth in the Grant Notice (the “ Award ”). Each PSU represents the conditional right to receive, without payment but subject to the conditions and limitations setforth in the Grant Notice, this Award Agreement and the Plan, one Common Share, subject to adjustment pursuant to Section 16 of the Plan in respect oftransactions occurring after the date hereof.2.2 Earned PSUs . The portion of the PSUs that may be earned by the Grantee and the corresponding number of PSUs that may become Earned PSUs (asdefined in Schedule I ) following the end of an applicable performance period will be determined in accordance with Schedule I hereto, which Schedule I isincorporated by reference and made part of this Agreement.2.3 Vesting Schedule . No portion of the Award is vested as of the date hereof. Subject to Section 2.4 below, to the extent the PSUs become earned PSUshereunder, the Earned PSUs will vest and become nonforfeitable according to the vesting schedule set forth on the Grant Notice (the “ Vesting Schedule ”). Unlessand until Earned PSUs have vested in the manner set forth in Article II hereof, Grantee will have no right to receive any Common Shares in respect of any suchEarned PSUs.2.4 Forfeiture, Termination and Cancellation upon Termination of Services .(a) Termination of Service . Except to the extent contemplated in the Vesting Schedule, if applicable, or as otherwise set forth in subsection (b) below, uponGrantee’s Termination of Service for any reason, all unvested PSUs will be automatically forfeited, terminated and cancelled as of the applicable termination datewithout payment of any consideration by the Company, and Grantee, or Grantee’s beneficiary or personal representative, as the case may be, shall have no furtherrights hereunder.(b) Sale Event . Notwithstanding anything contained in an employment or similar individual agreement by and between the Company or its Affiliates and Granteeto the contrary, upon a Termination of Service by the Company without Cause or by Grantee for Good Reason within eighteen (18) months following a Sale Eventthat occurs on or after the Grant Date, to the extent the PSUs are then outstanding, (A) one hundred (100%) of the PSUs that are eligible to, but have not as of thetermination date, become Earned PSUs, shall be deemed earned and will become immediately vested hereunder, and (B) one hundred percent (100%) of the EarnedPSUs that are unvested as of the termination date will become immediately vested hereunder. For the avoidance of doubt, if a PSU is no longer eligible to becomean Earned PSU in accordance with Schedule I (for example, because the performance criteria was not satisfied within the requisite performance period), such PSUsshall not be eligible to become earned and vested in accordance with this Section 2.4(b).(c) For purposes of this Award Agreement:i. “ Cause ” shall have the meaning set forth in the Grantee’s employment agreement with the Company for so longas such agreement remains in effect or, if there is no such agreement between the Grantee and the Company, shall mean: (A) Grantee’s failure (exceptwhere due to Disability), neglect, or refusal to perform in any material respect Grantee’s duties and responsibilities, (B) any act of Grantee that has, orcould reasonably be expected to have, the effect of injuring the business of the Company or its affiliates in any material respect, (C) Grantee’s convictionof, or plea of guilty or no contest to: (1) a felony or (2) any other criminal charge that has, or could be reasonably expected to have, an adverse impact onthe performance of Grantee’s duties to the Company or otherwise result in material injury to the reputation or business of the Company, (D) thecommission by Grantee of an act of fraud or embezzlement against the Company, or any other act that creates or reasonably could create negative oradverse publicity for the Company; (E)any violation by Grantee of the policies of the Company, including but not limited to those relating to sexual harassment or business conduct, and thoseotherwise set forth in the manuals or statements of policy of the Company, (F) Grantee’s violation of federal or state securities laws, or (G) Grantee’sbreach of any agreement between the Company or its affiliates and Grantee, including Grantee’s breach of any non-competition, non-solicitation,confidentiality or other restrictive covenant agreement with the Company.ii. “ Good Reason ” shall have the meaning set forth in Grantee’s employment agreement with the Company for solong as such agreement remains in effect or, if there is no such agreement between the Grantee and the Company, shall mean: without Grantee’s consent,(A) a material diminution in Grantee’s title, duties, or responsibilities, (B) a material reduction in Grantee’s base salary (other than pursuant to an across-the-board reduction applicable to all similarly situated employees), (C) the relocation of Grantee’s principal place of employment more than fifty (50)miles from its current location, or (D) any material breach of a provision of this Award Agreement by the Company. Grantee may terminate his or heremployment with Good Reason by providing the company thirty (30) days’ written notice setting forth in reasonable specificity the event that constitutesGood Reason, which written notice, to be effective, must be provided to the Company within sixty (60) days of the occurrence of such event. During suchthirty (30) day notice period, the Company shall have a cure right (if curable), and if not cured within such period, Grantee’s termination will be effectiveupon the expiration of such cure period. For the avoidance of doubt, if the Company so effect a cure, Good Reason shall be deemed not to exist and thenotice of Good Reason by Grantee shall be deemed rescinded and of no force or effect.iii. “ Sale Event ” shall have the meaning set forth in the Grantee’s employment agreement with the Company for solong as such agreement remains in effect or, if there is no such agreement between the Grantee and the Company: (A) the sale of all or substantially all ofthe assets of the Company on a consolidated basis to an unrelated person or entity, (B) a merger, reorganization or consolidation pursuant to which theholders of the Company’s outstanding voting power immediately prior to such transaction do not own a majority of the outstanding voting power of theresulting or successor entity (or its ultimate parent, if applicable) immediately upon completion of such transaction, or (C) the sale of all of the Stock ofthe Company to an unrelated person or entity.2.5 Payment after Vesting .(a) As soon as administratively practicable following the vesting of any Earned PSUs (but in no event later than March 15 of the year following the year in whichthe Earned PSUs become vested), the Company shall deliver to Grantee (or, in the event of the Grantee’s death or Disability, to the person to whom the Award haspassed by will or the laws of descent and distribution or to Grantee’s legal guardian or representative, as applicable) a number of Common Shares equal to thenumber of Earned PSUs that vested on the applicable vesting date. Notwithstanding the foregoing, in the event Common Shares cannot be issued pursuant toSection 2.7(a) or (b) hereof, then the Common Shares shall be issued pursuant to the preceding sentence as soon as administratively practicable after theCommittee determines that Common Shares can again be issued in accordance with Sections 2.7(a) or (b) hereof.(b) Grantee will be solely responsible for paying any applicable withholding taxes arising from the grant, vesting or settlement of any PSUs and any payment is tobe in a manner satisfactory to the Company. Notwithstanding the foregoing, the Company will have the right to withhold from any amount payable to Grantee,either under the Plan or otherwise, such amount as may be necessary to enable the Company to comply with the applicable requirements of any federal, provincial,state, local or foreign law, or any administrative policy of any applicable tax authority, relating to the withholding of tax or any other required deductions (the “Withholding Obligations ”). The Company may require Grantee, as a condition to the vesting or settlement of a PSU, to make such arrangements as the Companymay require so that the Company can satisfy applicable Withholding Obligations, including, without limitation, requiring Grantee to (i) remit the amount of anysuch Withholding Obligations to the Company in advance; (ii) reimburse the Company for any such Withholding Obligations; (iii) deliver written instructionscontemplated in Section 13.1(c) of the Plan, to effect a net settlement of Common Shares under a PSU in an amount required to satisfy any such WithholdingObligations; or (iv) pursuant to a transaction as contemplated in Section 13.1(b) of the Plan, cause such broker to withhold from the proceeds realized from suchtransaction the amount required to satisfy any such Withholding Obligations and to remit such amount directly to the Company.Notwithstanding any other provision of this Award Agreement or the Plan to the contrary, if Grantee is an “executive officer” of the Company within themeaning of Section 13(k) of the U.S. Exchange Act, Grantee shall not be permitted to make payment with respect to any PSUs, or continue any extension of creditwith respect to such payment, with a loan from the Company or a loan arranged by the Company in violation of Section 13(k) of the U.S. Exchange Act.The Company shall not be obligated to deliver any new certificate representing Common Shares to Grantee or Grantee’s legal representative or enter suchCommon Shares in book entry form unless and until Grantee or Grantee’s legal representative shall have paid or otherwise satisfied in full the amount of allfederal, state, provincial and local taxes applicable to the taxable income of Grantee resulting from vesting and settlement of PSUs into Common Shares.2.6 Rights as Shareholder . Unless otherwise determined by the Committee, Grantee shall possess no incidents of ownership with respect to the CommonShares underlying the PSUs and deliverable hereunder unless and until such Common Shares are transferred to Grantee pursuant to the terms of the Plan and thisAward Agreement.2.7 Conditions to Delivery of Common Shares . Subject to Section 13.5 of the Plan, the Common Shares deliverable hereunder, or any portion thereof,may be either previously authorized but unissued Common Shares or issued Common Shares which have then been reacquired by the Company. Such CommonShares shall be fully paid and nonassessable.(a) The Company shall not be required to issue or deliver any Common Shares deliverable hereunder or portion thereof prior to fulfillment of all of the followingconditions:iv. The completion of such registration or other qualification of such Common Shares or obtaining approval of suchgovernmental authority as the Company will determine to be necessary or advisable in connection with the authorization, issuance or sale thereof;v. The admission of such Common Shares to listing or quotation on the Exchange;vi. The obtaining of any approval or other clearance from any state, provincial or federal governmental agency which theCommittee shall, in its absolute discretion, determine to be necessary or advisable;vii. the receipt from Grantee of such representations, agreements and undertakings, including as to future dealings in suchCommon Shares, as the Company or its counsel determines to be necessary or advisable in order to safeguard against the violation of the securities laws of anyjurisdiction;(b) No fractional Common Shares shall be issued under this Award Agreement and any such fractional shares shall be eliminated by rounding down.ARTICLE III.OTHER PROVISIONS3.1 Administration . The Committee shall have the power to interpret the Plan and this Award Agreement and to adopt such rules for the administration,interpretation and application of the Plan as are consistent therewith and to interpret, amend or revoke any such rules. All actions taken and all interpretations anddeterminations made by the Committee in good faith shall be final and binding upon Grantee, the Company and all other interested persons. No member of theCommittee or the Board shall be personally liable for any action, determination or interpretation made in good faith with respect to the Plan, this Award Agreementor the PSUs. 3.2 Adjustments upon Specified Events . Upon the occurrence of certain events relating to the Common Shares contemplated by Section 16.1 of the Plan(including, without limitation, an extraordinary cash dividend on such Common Shares), the Committee shall make such adjustments as the Committee deemsappropriate in the number of PSUs then outstanding and the number and kind of securities that may be issued in respect of the PSUs. Grantee acknowledges thatthe PSUs are subject to modification and termination in certain events as provided in this Award Agreement and Sections 15 and 16 of the Plan.3.3 Grant is not Transferable . During the lifetime of Grantee, this grant and the rights and privileges conferred hereby will not be transferred, assigned,pledged or hypothecated in any way (whether by operation of law or otherwise) and will not be subject to sale under execution, attachment or similar process.Upon any attempt to transfer, assign, pledge, hypothecate or otherwise dispose of the PSUs, or any right or privilege conferred hereby, or upon any attempted saleunder any execution, attachment or similar process, the PSUs and the rights and privileges conferred hereby immediately will become null and void.Notwithstanding anything herein to the contrary, this Section 3.3 shall not prevent transfers by will or by operation of the laws of devolution or distribution anddescent or pursuant to a qualified domestic relations order, as defined by the U.S. Code.3.4 Binding Agreement . Subject to the limitation on the transferability of the PSUs contained herein, this Award Agreement will be binding upon andinure to the benefit of the heirs, legatees, legal representatives, successors and assigns of the parties hereto.3.5 Notices . Any notice to be given under the terms of this Award Agreement to the Company shall be addressed to the Company in care of the Secretaryof the Company at the Company’s principal office in Vancouver, B.C., and any notice to be given to Grantee shall be addressed to Grantee at Grantee’s lastaddress reflected on the records of the Company or its Affiliate. By a notice given pursuant to this Section 3.5, either party may hereafter designate a differentaddress for notices to be given to that party. Any notice shall be deemed duly given when sent via email or when sent by certified mail (return receipt requested)and deposited (with postage prepaid) in a post office or branch post office regularly maintained by the United States Postal Service or Canada Post, as applicable.3.6 Titles . The division of this Award Agreement into Sections and Articles and the insertion of headings are for convenience of reference only and willnot affect the construction or interpretation of this Award Agreement or the Plan.3.7 Governing Law; Severability . The laws of the Province of British Columbia shall govern the interpretation, validity, administration, enforcement andperformance of the terms of this Award Agreement regardless of the law that might be applied under principles of conflicts of laws.3.8 Conformity to Securities Laws . Grantee acknowledges that the Plan and this Award Agreement are intended to conform to the extent necessary withall applicable provisions of the U.S. Securities Act and the U.S. Securities Exchange Act and any and all regulations and rules promulgated by the U.S. Securitiesand Exchange Commission thereunder, and applicable state and Canadian securities laws and regulations. This Award Agreement, the Plan, the granting of PSUs,earning of Earned PSUs and vesting of PSUs under the Plan and this Award Agreement, and the settlement and delivery of Common Shares hereunder are subjectto compliance with all applicable federal, state, provincial, local and foreign laws, rules and regulations (including but not limited to state, provincial, federal andforeign securities law and margin requirements) and to such approvals by any stock exchange, regulatory or governmental authority as may, in the opinion ofcounsel for the Company, be necessary or advisable in connection therewith. Any securities delivered under this Award Agreement or the Plan shall be subject tosuch restrictions, and the person acquiring such securities shall, if requested by the Company, provide such assurances and representations to the Company as theCompany may deem necessary or desirable to assure compliance with all applicable legal requirements. To the extent permitted by applicable law, this AwardAgreement, the Plan and the PSUs granted hereunder shall be deemed amended to the extent necessary to conform to such laws, rules and regulations.3.9 Suspension, Amendment or Termination . To the extent permitted by the Plan, this Award Agreement may be wholly or partially amended orotherwise modified, suspended or terminated at any time or from time to time by the Committee , provided, that, the Committee will not have the right, without theconsent of the Grantee, to affect in a manner that is adverse or prejudicial to, or that impairs, the benefits and/or rights of the Grantee under this Award Agreement(subject to any necessary adjustment pursuant to Article 16 of the Plan).3.10 Successors and Assigns . The Company may assign any of its rights under this Award Agreement to single or multiple assignees, and this AwardAgreement shall inure to the benefit of the successors and assigns of the Company. Subject to the restrictions on transfer herein set forth in Section 3.3 hereof, thisAgreement shall be binding upon Grantee and his or her heirs, executors, administrators, successors and assigns.3.11 Limitations Applicable to Section 16 Persons . Notwithstanding any other provision of the Plan or this Award Agreement, if Grantee is subject toSection 16 of the U.S. Exchange Act, the Plan, the PSUs and this Award Agreement shall be subject to any additional limitations set forth in any applicableexemptive rule under Section 16 of the U.S. Exchange Act (including any amendment to Rule 16b-3 of the U.S. Exchange Act) that are requirements for theapplication of such exemptive rule. To the extent permitted by applicable law, this Award Agreement shall be deemed amended to the extent necessary to conformto such applicable exemptive rule.3.12 Not a Contract of Employment . Nothing in this Award Agreement or the Plan will confer upon Grantee any right to continue in the employ orservice of or under contract with the Company or any Affiliate or affect in any way the right of the Company or any such Affiliate to terminate his or heremployment or service at any time; nor will anything in this Award Agreement or the Plan be deemed or construed to constitute an agreement, or an expression ofintent, on the part of the Company or any such Affiliate to extend the employment or the service of Grantee beyond the time that he or she would normally beretired pursuant to the provisions of any present or future retirement plan of the Company or any Affiliate or any present or future retirement policy of theCompany or any Affiliate, or beyond the time at which he or she would otherwise be retired pursuant to the provisions of any contract of employment with theCompany or any Affiliate.3.13 Entire Agreement . The Plan, the Grant Notice and this Award Agreement constitute the entire agreement of the parties and supersede in theirentirety all prior undertakings and agreements of the Company and Grantee with respect to the subject matter hereof, except for provisions of an employmentagreement that cover the subject matter hereof.3.14 Section 409A . The PSUs are not intended to constitute “nonqualified deferred compensation” within the meaning of Section 409A of the U.S. Code(together with any Department of Treasury regulations and other interpretive guidance issued thereunder, including without limitation any such regulations or otherguidance that may be issued after the date hereof, “ Section 409A ”). However, notwithstanding any other provision of the Plan, the Grant Notice or this AwardAgreement, if at any time the Committee determines that the PSUs (or any portion thereof) may be subject to Section 409A, the Committee shall have the right inits sole discretion (without any obligation to do so or to indemnify Grantee or any other person for failure to do so) to adopt such amendments to the Plan, thisAward Agreement or the Grant Notice or adopt other policies and procedures (including amendments, policies and procedures with retroactive effect), or take anyother actions, as the Committee determines are necessary or appropriate either for the PSUs to be exempt from the application of Section 409A or to comply withthe requirements of Section 409A. Neither the Company, nor any subsidiary, nor the Committee or Board, nor any person acting on behalf of the Company, anysubsidiary, or the Committee or Board, shall be liable to Grantee or to the estate or beneficiary of Grantee by reason of anyacceleration of income, or any additional tax, asserted by reason of the failure of the Grant Notice, this Award Agreement or any payment hereunder to satisfy therequirements of Section 409A.3.15 Limitation on Grantee’s Rights . Participation in the Plan confers no rights or interests other than as herein provided. This Award Agreement createsonly a contractual obligation on the part of the Company as to amounts payable and shall not be construed as creating a trust. Neither the Plan nor any underlyingprogram, in and of itself, has any assets. Grantee shall have only the rights of a general unsecured creditor of the Company with respect to amounts credited andbenefits payable, if any, with respect to the PSUs, and rights no greater than the right to receive Common Shares as a general unsecured creditor with respect toPSUs, as and when payable hereunder.3.16 Election Under Section 83(b) . Grantee expressly acknowledges that because this Award consists of an unfunded and unsecured promise by theCompany to deliver Common Shares in the future, subject to the terms hereof, it is not possible to make a so-called “83(b) election” with respect to the Award.3.17 Section 4985 . If any amount payable or paid by the Company or any of its affiliates pursuant to this Agreement or otherwise to or for the benefitof Grantee becomes subject to the excise tax imposed by Section 4985 of the Code (including any interest, penalties or additions to tax relating thereto) (the “ 4985Excise Tax ”) by reason of the consummation of the transactions contemplated by the Agreement and Plan of Merger, dated as of June 14, 2016 (as amended),among QLT, Inc., Aegerion Pharmaceuticals, Inc. and certain other parties thereto, as reasonably determined by the Company, then the Company shall pay toGrantee (1) an amount equal to the 4985 Excise Tax, and (2) an amount (the “ 4985 Gross-up Payment ”) equal to the amount necessary to put Grantee in the samenet after-tax position (taking into account any and all applicable Federal, state, local and foreign income, employment, excise and other taxes) that Grantee wouldhave been in if Grantee had not incurred any liability for taxes under Section 4985 of the Code. Any determination regarding the amount of any payment orpayments hereunder shall be made in writing by the Company’s independent accountants or other accounting or consulting firm selected by the Company, whosedetermination shall be conclusive and binding upon Grantee and the Company for all purposes.Exhibit 10.26NOVELION THERAPEUTICS INC.NOVELION 2016 EQUITY INCENTIVE PLANRESTRICTED STOCK UNIT AWARD GRANT NOTICE ANDRESTRICTED STOCK UNIT AWARD AGREEMENTNovelion Therapeutics Inc. (the “ Company ”), pursuant to its 2016 Equity Incentive Plan, as amended from time to time (the “ Plan ”), hereby grants tothe individual listed below (“ Grantee ”), an award (“ Award ”) consisting of the number of restricted stock units ( “ Restricted Stock Units ” or “ RSUs ” ) setforth below. Each RSU represents the conditional right to receive, without payment but subject to the conditions and limitations set forth in this Restricted StockUnit Award Grant Notice (the “ Grant Notice ”), the Restricted Stock Unit Award Agreement attached hereto as Exhibit A (the “ Award Agreement ”) and thePlan, one Common Share, subject to adjustment pursuant to Section 16 of the Plan in respect of transactions occurring on or after the date hereof. Unless otherwisedefined in this Grant Notice or the Award Agreement, defined terms shall have the meaning set forth in the Plan.Grantee’s Name:Grant Date:Number of RSUs:Vesting Commencement Date:Vesting Schedule:By accepting the Award, Grantee agrees to be bound by the terms and conditions of the Plan, the Award Agreement and this Grant Notice. Grantee hasreviewed the Award Agreement, the Plan and this Grant Notice in their entirety and fully understands all provisions of the Award Agreement, the Plan and thisGrant Notice. Additionally, by accepting the Award, Grantee agrees that he or she has read, fully understands and agrees to abide by the terms of the Company’sInsider Trading Policy and has read and fully understands the Plan Prospectus, copies of which have been made available to Grantee. Grantee hereby agrees toaccept as binding, conclusive and final all decisions or interpretations of the Committee regarding any questions arising under the Plan or relating to the RSUs.NOVELION THERAPEUTICS Inc.By: Linda Buono Senior Vice President, Human Resources, Novelion Therapeutics, Inc.EXHIBIT ARESTRICTED STOCK UNIT AWARD AGREEMENTPursuant to the Restricted Stock Unit Award Grant Notice (the “ Grant Notice ”) to which this Restricted Stock Unit Award Agreement (the “ AwardAgreement ”) is attached, Novelion Therapeutics Inc. (the “ Company ”) has granted to Grantee award of restricted stock units ( “ Restricted Stock Units ” or “RSUs ” ) under the Company’s 2016 Equity Incentive Plan, as amended from time to time (the “ Plan ”).ARTICLE I.GENERAL1.1 Defined Terms . Capitalized terms not specifically defined herein shall have the meanings specified in the Plan and the Grant Notice.1.2 Incorporation of Terms of Plan . RSUs are subject to the terms and conditions of the Plan which are incorporated herein by reference. In the event of anyinconsistency between the Plan and this Award Agreement, the terms of the Plan shall control.ARTICLE II.GRANT OF RESTRICTED STOCK UNITS2.1 Grant of RSUs . In consideration of Grantee’s service as an officer, employee or Consultant of the Company or its Affiliates and for other good and valuableconsideration, effective as of the Grant Date set forth in the Grant Notice (the “ Grant Date ”), the Company grants to Grantee the number of RSUs as set forth inthe Grant Notice (the “ Award ”). Each RSU represents the conditional right to receive, without payment but subject to the conditions and limitations set forth inthe Grant Notice, this Award Agreement and the Plan, one Common Share, subject to adjustment pursuant to Section 16 of the Plan in respect of transactionsoccurring after the date hereof.2.2 Company’s Obligation . Unless and until the RSUs have vested in a manner set forth in Article II hereof, Grantee will have no right to receive any CommonShares in respect of any such RSUs.2.3 Vesting Schedule . No portion of the Award is vested as of the date hereof. Subject to Section 2.4 below, the RSUs will vest and become nonforfeitableaccording to the vesting schedule set forth on the Grant Notice to which this Award Agreement is attached (the “ Vesting Schedule ”).2.4 Forfeiture, Termination and Cancellation upon Termination of Services .(a) Termination of Service . Except to the extent contemplated in the Vesting Schedule, if applicable, upon Grantee’s Termination ofService for any reason, all unvested RSUs will be automatically forfeited, terminated and cancelled as of the applicable termination date without payment of anyconsideration by the Company, and Grantee, or Grantee’s beneficiary or personal representative, as the case may be, shall have no further rights hereunder.(b) Sale Event . In the event that Grantee is party to an effective employment or similar individual agreement with the Company or itsAffiliates that provides for the treatment of an equity award in connection with “Sale Event” (as defined in such agreement), such provision shall only apply inconnection with a “Sale Event” that occurs on or after the Grant Date (and shall not, for the avoidance of doubt, apply in connection with a “Sale Event” thatoccurred prior to the Grant Date).2.5 Payment after Vesting .(a) As soon as administratively practicable following the vesting of any RSUs (but in no event later than March 15 of the year following the year in which theRSUs become vested), the Company shall deliver to Grantee (or, in the event of Grantee’s death or complete disability, to the person to whom the Award haspassed by will or the laws of descent and distribution or to Grantee’s legal guardian or representative, as applicable) a number of Common Shares equal to thenumber of RSUs that vested on the applicable vesting date. Notwithstanding the foregoing, in the event Common Shares cannot be issued pursuant to Section2.7(a) or (b) hereof, then the Common Shares shall be issued pursuant to the preceding sentence as soon as administratively practicable after the Committeedetermines that Common Shares can again be issued in accordance with Sections 2.7(a) or (b) hereof.(b) Grantee will be solely responsible for paying any applicable withholding taxes arising from the grant, vesting or settlement of any RSUs and any payment is tobe in a manner satisfactory to the Company. Notwithstanding the foregoing, the Company will have the right to withhold from any amount payable to Grantee,either under the Plan or otherwise, such amount as may be necessary to enable the Company to comply with the applicable requirements of any federal, provincial,state, local or foreign law, or any administrative policy of any applicable tax authority, relating to the withholding of tax or any other required deductions (the“Withholding Obligations”). The Company may require Grantee, as a condition to the vesting or settlement of an RSU, to make such arrangements as theCompany may require so that the Company can satisfy applicable Withholding Obligations,including, without limitation, requiring Grantee to (i) remit the amount of any such Withholding Obligations to the Company in advance; (ii) reimburse theCompany for any such Withholding Obligations; (iii) deliver written instructions contemplated in Section 13.1(c) of the Plan, to effect a net settlement of CommonShares under an RSU in an amount required to satisfy any such Withholding Obligations; or (iv) pursuant to a transaction as contemplated in Section 13.1(b) of thePlan, cause such broker to withhold from the proceeds realized from such transaction the amount required to satisfy any such Withholding Obligations and to remitsuch amount directly to the Company.Notwithstanding any other provision of this Award Agreement or the Plan to the contrary, if Grantee is an “executive officer” of the Company within themeaning of Section 13(k) of the U.S. Exchange Act, Grantee shall not be permitted to make payment with respect to any RSUs, or continue any extension of creditwith respect to such payment, with a loan from the Company or a loan arranged by the Company in violation of Section 13(k) of the U.S. Exchange Act.The Company shall not be obligated to deliver any new certificate representing Common Shares to Grantee or Grantee’s legal representative or enter suchCommon Shares in book entry form unless and until Grantee or Grantee’s legal representative shall have paid or otherwise satisfied in full the amount of allfederal, state, provincial and local taxes applicable to the taxable income of Grantee resulting from the vesting and settlement of RSUs into Common Shares.2.6 Rights as Shareholder . Unless otherwise determined by the Committee, Grantee shall possess no incidents of ownership with respect to the Common Sharesunderlying the RSUs and deliverable hereunder unless and until such Common Shares are transferred to Grantee pursuant to the terms of the Plan and this AwardAgreement.2.7 Conditions to Delivery of Common Shares . Subject to Section 13.5 of the Plan, the Common Shares deliverable hereunder, or any portion thereof, may beeither previously authorized but unissued Common Shares or issued Common Shares which have then been reacquired by the Company. Such Common Sharesshall be fully paid and nonassessable.(a) The Company shall not be required to issue or deliver any Common Shares deliverable hereunder or portion thereof prior to fulfillment of all of the followingconditions:(i) The completion of such registration or other qualification of such Common Shares or obtaining approval of suchgovernmental authority as the Company will determine to be necessary or advisable in connection with the authorization, issuance or sale thereof;(ii) The admission of such Common Shares to listing or quotation on the Exchange;(iii) The obtaining of any approval or other clearance from any state, provincial or federal governmental agency which theCommittee shall, in its absolute discretion, determine to be necessary or advisable;(iv) the receipt from Grantee of such representations, agreements and undertakings, including as to future dealings in suchCommon Shares, as the Company or its counsel determines to be necessary or advisable in order to safeguard against the violation of the securities laws of anyjurisdiction;(b) No fractional Common Shares shall be issued under this Award Agreement and any such fractional shares shall be eliminated by rounding down.ARTICLE III.OTHER PROVISIONS3.1 Administration . The Committee shall have the power to interpret the Plan and this Award Agreement and to adopt such rules for the administration,interpretation and application of the Plan as are consistent therewith and to interpret, amend or revoke any such rules. All actions taken and all interpretations anddeterminations made by the Committee in good faith shall be final and binding upon Grantee, the Company and all other interested persons. No member of theCommittee or the Board shall be personally liable for any action, determination or interpretation made in good faith with respect to the Plan, this Award Agreementor the RSUs.3.2 Adjustments upon Specified Events . Upon the occurrence of certain events relating to the Common Shares contemplated by Section 16.1 of the Plan(including, without limitation, an extraordinary cash dividend on such Common Shares), the Committee shall make such adjustments as the Committee deemsappropriate in the number of RSUs then outstanding and the number and kind of securities that may be issued in respect of the RSUs. Grantee acknowledges thatthe RSUs are subject to modification and termination in certain events as provided in this Award Agreement and Sections 15 and 16 of the Plan.3.3 Grant is not Transferable . During the lifetime of Grantee, this grant and the rights and privileges conferred hereby will not be transferred, assigned, pledged orhypothecated in any way (whether by operation of law or otherwise) and will not be subject to sale under execution, attachment or similar process. Upon anyattempt to transfer, assign, pledge, hypothecate or otherwise dispose of the RSUs, or any right or privilege conferred hereby, or upon any attempted sale under anyexecution, attachment or similar process, the RSUs and the rights and privileges conferred hereby immediately will become null and void. Notwithstandinganything herein to the contrary, this Section 3.3 shall not prevent transfers by will or by operation of the laws of devolution or distribution and descent or pursuantto a qualified domestic relations order, as defined by the U.S. Code.3.4 Binding Agreement . Subject to the limitation on the transferability of the RSUs contained herein, this Award Agreement will be binding upon and inure to thebenefit of the heirs, legatees, legal representatives, successors and assigns of the parties hereto.3.5 Notices . Any notice to be given under the terms of this Award Agreement to the Company shall be addressed to the Company in care of the Secretary of theCompany at the Company’s principal office in Vancouver, B.C., and any notice to be given to Grantee shall be addressed to Grantee at Grantee’s last addressreflected on the records of the Company or its Affiliate. By a notice given pursuant to this Section 3.5, either party may hereafter designate a different address fornotices to be given to that party. Any notice shall be deemed duly given when sent via email or when sent by certified mail (return receipt requested) and deposited(with postage prepaid) in a post office or branch post office regularly maintained by the United States Postal Service or Canada Post, as applicable.3.6 Titles . The division of this Award Agreement into Sections and Articles and the insertion of headings are for convenience of reference only and will not affectthe construction or interpretation of this Award Agreement or the Plan.3.7 Governing Law; Severability . The laws of the Province of British Columbia shall govern the interpretation, validity, administration, enforcement andperformance of the terms of this Award Agreement regardless of the law that might be applied under principles of conflicts of laws.3.8 Conformity to Securities Laws . Grantee acknowledges that the Plan and this Award Agreement are intended to conform to the extent necessary with allapplicable provisions of the U.S. Securities Act and the U.S. Securities Exchange Act and any and all regulations and rules promulgated by the U.S. Securities andExchange Commission thereunder, and applicable state and Canadian securities laws and regulations. This Award Agreement, the Plan, the granting and vesting ofthe RSUs under the Plan and this Award Agreement, and the settlement and delivery of Common Shares hereunder are subject to compliance with all applicablefederal, state, provincial, local and foreign laws, rules and regulations (including but not limited to state, provincial, federal and foreign securities law and marginrequirements) and to such approvals by any stock exchange, regulatory or governmental authority as may, in the opinion of counsel for the Company, be necessaryor advisable in connection therewith. Any securities delivered under this Award Agreement or the Plan shall be subject to such restrictions, and the personacquiring such securities shall, if requested by the Company, provide such assurances and representations to the Company as the Company may deem necessary ordesirable to assure compliance with all applicable legal requirements. To the extent permitted by applicable law, this Award Agreement, the Plan and the RSUsgranted hereunder shall be deemed amended to the extent necessary to conform to such laws, rules and regulations.3.9 Suspension, Amendment or Termination . To the extent permitted by the Plan, this Award Agreement may be wholly or partially amended or otherwisemodified, suspended or terminated at any time or from time to time by the Committee , provided, that, the Committee will not have the right, without the consentof Grantee, to affect in a manner that is adverse or prejudicial to, or that impairs, the benefits and/or rights of Grantee under this Award Agreement (subject to anynecessary adjustment pursuant to Article 16 of the Plan).3.10 Successors and Assigns . The Company may assign any of its rights under this Award Agreement to single or multiple assignees, and this Award Agreementshall inure to the benefit of the successors and assigns of the Company. Subject to the restrictions on transfer herein set forth in Section 3.3 hereof, this Agreementshall be binding upon Grantee and his or her heirs, executors, administrators, successors and assigns.3.11 Limitations Applicable to Section 16 Persons . Notwithstanding any other provision of the Plan or this Award Agreement, if Grantee is subject to Section 16of the U.S. Exchange Act, the Plan, the RSUs and this Award Agreement shall be subject to any additional limitations set forth in any applicable exemptive ruleunder Section 16 of the U.S. Exchange Act (including any amendment to Rule 16b-3 of the U.S. Exchange Act) that are requirements for the application of suchexemptive rule. To the extent permitted by applicable law, this Award Agreement shall be deemed amended to the extent necessary to conform to such applicableexemptive rule.3.12 Not a Contract of Employment . Nothing in this Award Agreement or the Plan will confer upon Grantee any right to continue in the employ or service of orunder contract with the Company or any Affiliate or affect in any way the right of the Company or any such Affiliate to terminate his or her employment or serviceat any time; nor will anything in this Award Agreement or the Plan be deemed or construed to constitute an agreement, or an expression of intent, on the part of theCompany or any such Affiliate to extend the employment or the service of Grantee beyond the time that he or she would normally be retired pursuant to theprovisions of any present or future retirement plan of the Company or any Affiliate or any present or future retirement policy of the Company or any Affiliate, orbeyond the time at which he or she would otherwise be retired pursuant to the provisions of any contract of employment with the Company or any Affiliate.3.13 Entire Agreement . The Plan, the Grant Notice and this Award Agreement constitute the entire agreement of the parties and supersede in their entirety all priorundertakings and agreements of the Company and Grantee with respect to the subject matter hereof.3.14 Section 409A . The RSUs are not intended to constitute “nonqualified deferred compensation” within the meaning of Section 409A of the U.S. Code (togetherwith any Department of Treasury regulations and other interpretive guidance issued thereunder, including without limitation any such regulations or other guidancethat may be issued after the date hereof, “ Section 409A ”). However, notwithstanding any other provision of the Plan, the Grant Notice or this Award Agreement,if at any time the Committee determines that the RSUs (or any portion thereof) may be subject to Section 409A, the Committee shall have the right in its solediscretion (without any obligation to do so or to indemnify Grantee or any other person for failure to do so) to adopt such amendments to the Plan, this AwardAgreement or the Grant Notice or adopt other policies and procedures (including amendments, policies and procedures with retroactive effect), or take any otheractions, as the Committee determines are necessary or appropriate either for the RSUs to be exempt from the application of Section 409A or to comply with therequirements of Section 409A. Neither the Company, nor any subsidiary, nor the Committee or Board, nor any person acting on behalf of the Company, anysubsidiary, or the Committee or Board, shall be liable to Grantee or to the estate or beneficiary of Grantee by reason of any acceleration of income, or anyadditional tax, asserted by reason of the failure of the Grant Notice, this Award Agreement or any payment hereunder to satisfy the requirements of Section 409A.3.15 Limitation on Grantee’s Rights . Participation in the Plan confers no rights or interests other than as herein provided. This Award Agreement creates only acontractual obligation on the part of the Company as to amounts payable and shall not be construed as creating a trust. Neither the Plan nor any underlyingprogram, in and of itself, has any assets. Grantee shall have only the rights of a general unsecured creditor of the Company with respect to amounts credited andbenefits payable, if any, with respect to the RSUs, and rights no greater than the right to receive Common Shares as a general unsecured creditor with respect toRSUs, as and when payable hereunder.3.16 Election Under Section 83(b) . Grantee expressly acknowledges that because this Award consists of an unfunded and unsecured promise by the Company todeliver Common Shares in the future, subject to the terms hereof, it is not possible to make a so-called “83(b) election” with respect to the Award.Exhibit 10.27INDEMNITY AGREEMENTThis AGREEMENT made effective as of the __th day of ______, 201_BETWEEN:NOVELION THERAPEUTICS INC. , a British Columbia company having a principal place of business at 887 Great Northern Way, Suite101, Vancouver, British Columbia, Canada V5T 4T5(the “Company”)AND:_____________ , a Director of the Company, of________________________________________________________________________________________________________(the “Indemnitee”)WHEREAS, it is essential to the Company to retain and attract as Directors and Officers the most capable persons available;AND WHEREAS, the substantial increase in corporate litigation subjects Directors and Officers to expensive litigation risks at the same time that theavailability of Directors’ and Officers’ liability insurance has been severely limited;AND WHEREAS, it is now and has always been the express policy of the Company to indemnify its Directors and Officers so as to provide them with themaximum possible protection permitted by law;AND WHEREAS, the Company does not regard the protection available to the Indemnitee as adequate in the present circumstances, and realizes that theIndemnitee may not be willing to serve as an Officer without adequate protection, and the Company desires the Indemnitee to serve in such capacity;NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein and other good and valuableconsideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:1.Definitions . In this Agreement, except as otherwise expressly provided:(a)the phrase “decided in a Proceeding” shall mean a decision by a court, arbitrator(s), administrative tribunal, regulatory authority or other entity,having the requisite legal authority to make such a decision, which decision has become final and from which no appeal or other reviewproceeding is permissible.(b)the terms “Director” and “Officer” include:(i)the Indemnitee’s service as a director or officer of the Company;(ii)the Indemnitee’s service as a director or officer of another corporation:(A)at a time when the corporation is or was an affiliate of the Company as defined in the Business Corporations Act (BritishColumbia), as amended from time to time, or any successor legislation; or(B)at the request of the Company; and(iii)the Indemnitee’s service in a position equivalent to that of a director or officer of a partnership, trust, joint venture or otherunincorporated entity, at the request of the Company.(c)the term “Expenses” include costs, charges and expenses, including legal and other fees, and any expenses of establishing a right toindemnification under this Agreement, but does not include judgements, penalties, fines, statutory liabilities or amounts paid in settlement of aProceeding;(d)the term “Indemnitee” includes his or her heirs and personal or other legal representatives;(e)the term “Liability” includes a judgement, penalty or fine awarded or imposed in, or an amount paid in settlement of, a Proceeding, includingany liability which is or may be imposed upon the Indemnitee by statute, rule or regulation; and(f)the term “Proceeding” includes but is not limited to, any action, suit or proceeding, whether current, threatened, pending or completed andwhether brought by or in the right of the Company or otherwise and whether of a civil, criminal, administrative or investigative nature in whichthe Indemnitee, by reason of being or having been a Director or Officer:(i)is or may be joined as a party; or(ii)is or may be liable for, or in respect of, a Liability or Expenses related to such action, suit or proceeding.2.Indemnity of Director or Officer . Subject only to the limitations set forth in Section 3, the Company shall indemnify the Indemnitee against anyLiability to which the Indemnitee is or may be liable and shall pay the Expenses actually and reasonably incurred by the Indemnitee because of any claimor claims made against him or her in a Proceeding by reason of the fact that he or she is or was a Director and/or Officer.3.Limitations on Indemnity . The Company shall not be obligated under this Agreement to indemnify the Indemnitee against any Liability or pay anyExpenses of the Indemnitee:(a)if the Company is prohibited by applicable law from making such payments;(b)if such payments have been paid to, or on behalf of, the Indemnitee under an insurance policy, except in respect of any excess beyond theamount paid under such insurance;(c)for which payments the Indemnitee is indemnified by the Company otherwise than pursuant to this Agreement; or(d)resulting from a claim decided in a Proceeding adversely to the Indemnitee based upon or attributable to the Indemnitee gaining in fact anypersonal profit or advantage to which he or she was not legally entitled, including any profits made from the purchase or sale by the Indemniteeof securities of the Company.4.Advance Payment Of Expenses . Expenses incurred by the Indemnitee in defending a claim against him in a Proceeding shall be paid by the Companyas incurred and in advance of the final disposition of such Proceeding; provided, however, that Expenses of defence need not be paid as incurred and inadvance where a court of competent jurisdiction has decided that the Indemnitee is not entitled to be indemnified pursuant to this Agreement or otherwise.The Indemnitee hereby agrees and undertakes to repay such amounts advanced if it shall be decided in a Proceeding that he or she is not entitled to beindemnified by the Company pursuant to this Agreement or otherwise.5.Enforcement . If a claim under this Agreement is not paid by the Company, or on its behalf, within thirty days after a written claim has been received bythe Company, the Indemnitee may at any time thereafter bring suit against the Company to recover the unpaid amount of the claim and if successful inwhole or in part, the Indemnitee shall also be entitled to be paid the Expenses of prosecuting such claim.6.Subrogation . In the event of payment under this Agreement, the Company shall be subrogated to the extent of such payment to all of the rights ofrecovery of the Indemnitee, who shall execute all papers required and shall do everything that may be necessary to secure such rights, including theexecution of such documents necessary to enable the Company effectively to bring suit to enforce such rights.7.Notice . The Indemnitee, as a condition precedent to his or her right to be indemnified under this Agreement, shall give to the Company notice in writingas soon as practicable of any claim made against him or her for which indemnity will or could be sought under this Agreement. Notice to the Companyshall be given at its principal office and shall be directed to the President (or such other address as the Company shall designate in writing to theIndemnitee); notice shall be deemed received if sent by prepaid mail properly addressed, the date of such notice being the date postmarked. In addition,the Indemnitee shall give the Company such information and co-operation as it may reasonably require.8.Indemnification Hereunder Not Exclusive . Nothing herein shall be deemed to diminish or otherwise restrict the Indemnitee’s right to indemnificationunder any provision of the Notice of Articles or Articles of the Company or under applicable corporate law.9.Continuation of Indemnification . The indemnification under this Agreement shall continue as to the Indemnitee even though he or she may have ceasedto be a Director and/or Officer and shall inure to the benefit of the heirs and personal representatives of the Indemnitee.10.Coverage of Indemnification . The indemnification under this Agreement shall cover the Indemnitee’s service as a Director and/or Officer prior to orafter the date of the Agreement.11.Applicable Law . This Agreement is governed by and construed in accordance with the laws of the Province of British Columbia and the federal laws ofCanada applicable therein.12.Benefit . This Agreement will inure to the benefit of and be binding upon the parties and their respective heirs, executors, administrators, successors andassigns.13.Severability . If any provision of this Agreement is determined at any time by a court of competent jurisdiction to be invalid, illegal or unenforceablesuch provision or part thereof shall be severable from this Agreement and the remainder of this Agreement will be construed as if such invalid, illegal orunenforceable provision or part thereof had been deleted herefrom.14.Further Assurances . Each party agrees to take all such actions and execute all such documents within its power as may be necessary or desirable tocarry out or implement and give full effect to the provisions and intent of this Agreement.15.Time Of Essence . Time is the essence of this Agreement and no extension of time shall constitute a waiver of this provision.16.Waivers . No waiver of, no consent with respect to, and no approval required under any provision of this Agreement will be effective unless in writingexecuted by the party against whom such waiver, consent or approval is sought to be enforced, and then any such waiver, consent or approval will beeffective only in the specific instance and for the specific purpose given.17.Counterparts . This Agreement may be executed in one or more counterparts, each of which when taken together will constitute this Agreement.IN WITNESS WHEREOF the parties have executed this Agreement.NOVELION THERAPEUTICS INC.Per: Authorized signatorySIGNED, SEALED and DELIVERED by __________ in the presence of:[NAME] Name Address OccupationExhibit 10.28INDEMNITY AGREEMENTThis AGREEMENT made effective as of the 29th day of November, 2016.BETWEEN:NOVELION THERAPEUTICS INC. , a British Columbia company having a principal place of business at 887 Great Northern Way,Vancouver, British Columbia, Canada V5T 4T5(the “Company”) AND:___________ , an Officer of the Company, of ________________________________________________________________________________________________________(the “Indemnitee”) WHEREAS, it is essential to the Company to retain and attract as Directors and Officers the most capable persons available;AND WHEREAS, the substantial increase in corporate litigation subjects Directors and Officers to expensive litigation risks at the same time that theavailability of Directors’ and Officers’ liability insurance has been severely limited;AND WHEREAS, it is now and has always been the express policy of the Company to indemnify its Directors and Officers so as to provide them with themaximum possible protection permitted by law;AND WHEREAS, the Company does not regard the protection available to the Indemnitee as adequate in the present circumstances, and realizes that theIndemnitee may not be willing to serve as an Officer without adequate protection, and the Company desires the Indemnitee to serve in such capacity;NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein and other good and valuableconsideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:1.Definitions . In this Agreement, except as otherwise expressly provided:(a)the phrase “decided in a Proceeding” shall mean a decision by a court, arbitrator(s), administrative tribunal, regulatory authority or other entity,having the requisite legal authority to make such a decision, which decision has become final and from which no appeal or other reviewproceeding is permissible.(b)the terms “Director” and “Officer” include:(i)the Indemnitee’s service as a director or officer of the Company;(ii)the Indemnitee’s service as a director or officer of another corporation:(A)at a time when the corporation is or was an affiliate of the Company as defined in the Business Corporations Act (BritishColumbia), as amended from time to time, or any successor legislation; or(B)at the request of the Company; and(iii)the Indemnitee’s service in a position equivalent to that of a director or officer of a partnership, trust, joint venture or otherunincorporated entity, at the request of the Company.(c)the term “Expenses” include costs, charges and expenses, including legal and other fees, and any expenses of establishing a right toindemnification under this Agreement, but does not include judgements, penalties, fines, statutory liabilities or amounts paid in settlement of aProceeding;(d)the term “Indemnitee” includes his or her heirs and personal or other legal representatives;(e)the term “Liability” includes a judgement, penalty or fine awarded or imposed in, or an amount paid in settlement of, a Proceeding, includingany liability which is or may be imposed upon the Indemnitee by statute, rule or regulation; and(f)the term “Proceeding” includes but is not limited to, any action, suit or proceeding, whether current, threatened, pending or completed andwhether brought by or in the right of the Company or otherwise and whether of a civil, criminal, administrative or investigative nature in whichthe Indemnitee, by reason of being or having been a Director or Officer or legal counsel to the Company:(i)is or may be joined as a party; or(ii)is or may be liable for, or in respect of, a Liability or Expenses related to such action, suit or proceeding.2.Indemnity of Director or Officer . Subject only to the limitations set forth in Section 3, the Company shall indemnify the Indemnitee against anyLiability to which the Indemnitee is or may be liable and shall pay the Expenses actually and reasonably incurred by the Indemnitee because of any claimor claims made against him or her in a Proceeding by reason of the fact that he or she is or was a Director and/or Officer and/or legal counsel to theCompany.3.Limitations on Indemnity . The Company shall not be obligated under this Agreement to indemnify the Indemnitee against any Liability or pay anyExpenses of the Indemnitee:(a)if the Company is prohibited by applicable law from making such payments;(b)if a claim is made by the Company and decided in a Proceeding for breach of the Indemnitee's employment agreement (provided the subjectmatter of such breach is the subject matter of the claim for indemnity);(c)if such payments have been paid to, or on behalf of, the Indemnitee under an insurance policy, except in respect of any excess beyond theamount paid under such insurance;(d)for which payments the Indemnitee is indemnified by the Company otherwise than pursuant to this Agreement; or(e)resulting from a claim decided in a Proceeding adversely to the Indemnitee based upon or attributable to the Indemnitee gaining in fact anypersonal profit or advantage to which he or she was not legally entitled, including any profits made from the purchase or sale by the Indemniteeof securities of the Company.4.Advance Payment Of Expenses . Expenses incurred by the Indemnitee in defending a claim against him or her in a Proceeding shall be paid by theCompany as incurred and in advance of the final disposition of such Proceeding; provided, however, that Expenses of defence need not be paid asincurred and in advance where a court of competent jurisdiction has decided that the Indemnitee is not entitled to be indemnified pursuant to thisAgreement or otherwise. The Indemnitee hereby agrees and undertakes to repay such amounts advanced if it shall be decided in a Proceeding that he orshe is not entitled to be indemnified by the Company pursuant to this Agreement or otherwise.5.Enforcement . If a claim under this Agreement is not paid by the Company, or on its behalf, within thirty days after a written claim has been received bythe Company, the Indemnitee may at any time thereafter bring suit against the Company to recover the unpaid amount of the claim and if successful inwhole or in part, the Indemnitee shall also be entitled to be paid the Expenses of prosecuting such claim.6.Subrogation . In the event of payment under this Agreement, the Company shall be subrogated to the extent of such payment to all of the rights ofrecovery of the Indemnitee, who shall execute all papers required and shall do everything that may be necessary to secure such rights, including theexecution of such documents necessary to enable the Company effectively to bring suit to enforce such rights.7.Notice . The Indemnitee, as a condition precedent to his or her right to be indemnified under this Agreement, shall give to the Company notice in writingas soon as practicable of any claim made against him or her for which indemnity will or could be sought under this Agreement. Notice to the Companyshall be given at its principal office and shall be directed to the Chief Executive Officer (or such other address as the Company shall designate in writingto the Indemnitee); notice shall be deemed received if sent by prepaid mail properly addressed, the date of such notice being the date postmarked. Inaddition, the Indemnitee shall give the Company such information and co-operation as it may reasonably require.8.Indemnification Hereunder Not Exclusive . Nothing herein shall be deemed to diminish or otherwise restrict the Indemnitee’s right to indemnificationunder any provision of the Notice of Articles and Articles of the Company or under applicable corporate law.9.Continuation of Indemnification . The indemnification under this Agreement shall continue as to the Indemnitee even though he or she may have ceasedto be a Director and/or Officer and/or legal counsel and shall inure to the benefit of the heirs and personal representatives of the Indemnitee.10.Coverage of Indemnification . The indemnification under this Agreement shall cover the Indemnitee’s service as a Director and/or Officer and/or legalcounsel prior to or after the date of the Agreement.11.Applicable Law . This Agreement is governed by and construed in accordance with the laws of the Province of British Columbia and the federal laws ofCanada applicable therein.12.Benefit . This Agreement will inure to the benefit of and be binding upon the parties and their respective heirs, executors, administrators, successors andassigns.13.Severability . If any provision of this Agreement is determined at any time by a court of competent jurisdiction to be invalid, illegal or unenforceablesuch provision or part thereof shall be severable from this Agreement and the remainder of this Agreement will be construed as if such invalid, illegal orunenforceable provision or part thereof had been deleted herefrom.14.Further Assurances . Each party agrees to take all such actions and execute all such documents within its power as may be necessary or desirable tocarry out or implement and give full effect to the provisions and intent of this Agreement.15.Time Of Essence . Time is the essence of this Agreement and no extension of time shall constitute a waiver of this provision.16.Waivers . No waiver of, no consent with respect to, and no approval required under any provision of this Agreement will be effective unless in writingexecuted by the party against whom such waiver, consent or approval is sought to be enforced, and then any such waiver, consent or approval will beeffective only in the specific instance and for the specific purpose given.17.Counterparts . This Agreement may be executed in one or more counterparts, each of which when taken together will constitute this Agreement.IN WITNESS WHEREOF the parties have executed this Agreement.NOVELION THERAPEUTICS INC.Per: Authorized signatory SIGNED, SEALED and DELIVERED by __________ in the presence of:[NAME] Name Address OccupationEXHIBIT 10.37Novelion Services USA, Inc.2711 Centerville RoadSuite 400Wilmington, DE 19808November 28, 2016Gregory Perryc/o Aegerion Pharmaceuticals, Inc.One Main StreetSuite 800Cambridge, MA 02142Dear Greg:RE: Offer of EmploymentAs you are aware, Aegerion Pharmaceuticals, Inc. (“ Aegerion ”), QLT Inc. and Isotope Acquisition Corp. have agreed to carry out a merger (the “ Merger ”) onthe terms set out in the Agreement and Plan of Merger dated June 14, 2016 (the “ Merger Agreement ”).Following the Merger, Aegerion will become an indirect subsidiary of Novelion Services USA, Inc., a Delaware corporation (“ Novelion Services ”). NovelionServices is currently a subsidiary of QLT Inc., a British Columbia company, which we anticipate will change its name to “Novelion Therapeutics Inc.” (“ NovelionCanada ”).We are pleased to offer you employment with Novelion Services in the position of Chief Financial and Administrative Officer, commencing effective on thecompletion of the Merger, which is currently anticipated to be November 29, 2016 (the “ Commencement Date ”).Should you choose to accept this offer, the terms and conditions of your employment with Novelion Services will be the same as those set out in your currentemployment agreement with Aegerion which is attached as Schedule “A” to this letter (the “ Aegerion Agreement ”), except that the terms and conditions of theAegerion Agreement will be modified and supplemented as follows:1. Defined Terms: In the Aegerion Agreement, references to the “ Company ” or “ Aegerion ” (or any other references indicating your employer) will be deemedto be references to Novelion Services, references to the “ Board ” will be deemed to be references to the Board of Directors of Novelion Services, and referencesto the “ Agreement ” or the “ Employment Agreement ” (or any other references to the terms and conditions of your employment) will mean the AegerionAgreement as modified and supplemented by this letter. In this letter, “ Affiliate ” has the meaning given to it in the Delaware General Corporation Law, and anyother capitalized terms that are not defined in this letter will have the meanings given to them in the Aegerion Agreement.2. Responsibilities and Reporting: As, Chief Financial and Administrative Officer, you will have the duties and responsibilities set out in Section 3(a) of theAegerion Agreement in respect of Novelion Services. As described below, under the Master Service Agreement between Novelion Canada and Novelion Servicesthat will be entered into on or about the completion date of the Merger, as amended from time to time (the “ Service Agreement ”) you may also be required toperform services to Novelion Canada and other Affiliates of Novelion Canada, including holding an office in Novelion Canada. For certainty, you will be anemployee of Novelion Services and not an employee of Novelion Canada, and when you provide services to Novelion Canada you will be doing so as an employeeof Novelion Services in the context of certain management services it provides to Novelion Canada under the Service Agreement. You will report to the ChiefExecutive Officer of Novelion Services.3. Base Salary: You will be paid the Base Salary reflected in the Aegerion Agreement, subject to adjustment by the Board or Compensation Committee thereoffrom time to time.4. Length of Service: Novelion Services will recognize your length of service with Aegerion for all purposes related to your employment with Novelion Services,including for the purpose of determining your entitlements on termination of your employment pursuant to the Aegerion Agreement.5. Accrued Obligations: Your employment with Aegerion will cease immediately prior to the Commencement Date and Aegerion will be responsible forproviding you with all accrued but unpaid Base Salary and unreimbursed expenses incurred in accordance with the Aegerion Agreement up to such date. Aegerionwill also be responsible for making the Incentive Payment set out in Section 4(e)(iii) of the Aegerion Agreement and paying any Retention Bonus AmountAegerion agreed to pay you and that remains unpaid as of the Commencement Date. Any vacation time that you have accrued under Aegerion’s vacation policy asof the Commencement Date, but not used as of such date, will be “rolled over” to Novelion Services. Novelion Services will credit youwith this time for purposes of its vacation policy. By accepting this offer, you consent to the rollover of this vacation time and acknowledge and agree that you arenot entitled to any payment for this vacation time in connection with the transfer of your employment from Aegerion to Novelion Services. For certainty, you willcontinue to be obligated to repay your Relocation Transition Allowance pursuant to Section 6 of the Aegerion Agreement if you resign from employment withNovelion Services other than for Good Reason or are terminated for Cause, and you will pay such amount to Aegerion and/or Novelion Services at the direction ofNovelion Services.6. No Severance or Good Reason: You agree that (a) the transfer of your employment from Aegerion to Novelion Services and any other changes to the termsand conditions of your employment that are expressly contemplated by this letter, and/or (b) any changes to your duties or responsibilities that directly result fromthe Merger (including without limitation any such changes directly resulting from your new status as an executive officer of a subsidiary of Novelion Canada) shallnot, individually or in the aggregate, constitute Good Reason for purposes of the Aegerion Agreement or the Employment Agreement or entitle you to anySeverance Benefits, Accelerated Equity Benefit, Retention Bonus Amount or any other severance benefits or the acceleration of any vesting or other rights, towhich you might otherwise be entitled. You agree that, to the extent required by law to permit Aegerion to rely on this paragraph 6, Novelion Services is and willbe deemed to be acting as agent or trustee on behalf of and for the benefit of Aegerion.7. Stock Options / Equity Grants: Any stock options, restricted stock units, or other equity awards that you may have been granted pursuant to the InducementPlan or 2010 Stock Option and Incentive Plan will be dealt with as set out in the Merger Agreement. Once the Merger is completed, any such outstandingentitlements will be governed by and subject to the applicable stock option plan and stock option agreement.8. Right to Work in Canada: You will cooperate with Novelion Services to seek, obtain, and maintain the right to work in Canada to provide services on behalfof Novelion Services to Novelion Canada and any of its other Affiliates. Novelion Services will pay the reasonable costs associated with obtaining a permit towork in Canada.9. Commuting to Canada: You acknowledge that travel will be required in connection with your employment, including commuting on a regular basis to suchlocations in Canada as are required for Novelion Services to provide its management services to Novelion Canada and its Canadian Affiliates.10. Tax Consultation Expenses: Each year so long as you are providing management services, you will be entitled to reimbursement for your reasonable expensesup to a maximum of USD $5,000 for an independent tax consultation regarding the Canadian tax implications of your work on behalf of Novelion Services inCanada and/or preparation of your Canadian tax return.11. Tax Equalization:(a) As you will be subject to income tax and social security obligations arising from your services performed in Canada on behalf of Novelion Services, NovelionServices is prepared to address the overall tax and social security burden that you experience with the intention that your total tax and social security burden whileworking in both the United States and Canada will be equal to what your tax and social security burden would have been had you remained working solely in yourEqualization State, as defined in subparagraph (b) below. Novelion Services will provide you with tax equalization in connection with all income tax and socialsecurity liabilities arising from the performance of your employment duties within Canada. Novelion Services intends that the income taxes and social securitylevies payable by you on all taxable employment income and related benefits, as prescribed by the applicable tax and social security laws, should be no better orworse than the personal taxes and social security levies you would have been required to pay on such amounts if your employment duties had been performedsolely in your Equalization State. Where your annual tax and social security obligation yields a higher total obligation than if your employment duties were solelyperformed in your Equalization State, Novelion Services will reimburse you for the difference. Where your annual tax and social security obligations yields alower total tax and social security impact than if your employment duties were solely performed in your Equalization State, you will reimburse Novelion Servicesfor the difference.(b) “Equalization State” means, at your election, either Massachusetts or Rhode Island or in the absence of an election by you within 30 days of theCommencement Date, Novelion Services may choose which of those two states will be your Equalization State.(c) You will provide all information necessary for the preparation of a tax equalization calculation.(d) Novelion Services will pay all reasonable costs and professional fees related to calculating this equalization payment, and reserves the discretion to establishthe process and criteria for determining the tax equalization calculation. For clarity, the tax equalization payments described in this paragraph 11 will not take intoconsideration or apply to any taxable income from sources other than your employment with Novelion Services, and you will remain responsible for all incometaxes arising from your personal income.(e) If you establish your primary residence in Canada, Novelion Services’ obligations under this paragraph 11 will cease, provided that there will be a pro-ratedadjustment for any partial year.(f) If your employment is terminated for any of the reasons described under Section 7 of the Aegerion Agreement, then between January 1 and July 31 of thecalendar year following the calendar year in which such termination occurs, Novelion Services will pay you any remaining tax equalization payments owed inaccordance with this paragraph 11 or, in the event that the reconciliation results in you owing money to Novelion Services, you will make such payment toNovelion Services.12. Release: The form of Release of Claims contemplated in the Aegerion Agreement will be the form attached as Schedule “B” to this Agreement.13. Employment Standards: This provision applies only if and to the extent that the employment laws of Canada apply to your employment. If the minimumstandards in the British Columbia Employment Standards Act or Ontario Employment Standards Act, 2000 , or any other applicable employment standardslegislation, as they exist from time to time are more favorable to you in any respect than provided for in the Employment Agreement, including but not limited tothe provisions in respect of notice of termination, the provisions of the applicable Employment Standards Act or legislation will apply.14. Confidentiality, Assignment of Intellectual Property and Non-Competition: As a condition of your employment with Novelion Services, and inconsideration of the commitments set forth in this letter, you agree to execute and deliver to Novelion Services the Confidentiality, Assignment of IntellectualProperty and Non-Competition Agreement attached as Schedule “C” to this letter (the “ Ancillary Agreement ”), which will take effect on the CommencementDate, following which any references to the “Confidentiality Agreement” in the Aegerion Agreement will be deemed to be references to the Ancillary Agreement.Your acceptance of this offer of employment or execution of the Ancillary Agreement does not affect your obligations to Aegerion or the rights of Aegerion underthe Confidentiality Agreement arising from your employment with Aegerion prior to the Commencement Date.15. Priority: If there is any conflict or inconsistency between these Supplementary Terms and the Aegerion Agreement, these Supplementary Terms will takeprecedence.If the terms and conditions of your employment described in this letter and the terms and conditions of the Ancillary Agreement are acceptable to you, please signthis letter (where indicated on the next page) and the enclosed Ancillary Agreement, and return signed copies of the foregoing to us by November 28, 2016.If you have any questions or concerns, please do not hesitate to contact Geoffrey Cox.[ Remainder of this page intentionally left blank ]Gregory Perry - Employment AgreementYours truly,NOVELION SERVICES USA, INC.Per: /s/ Geoffrey CoxAuthorized SignatoryI, Gregory Perry, have read, understand and agree with the terms and conditions of employment referenced in this letter. I have had a reasonable opportunity toconsider these terms and conditions and seek independent legal advice, and I accept employment with Novelion Services on these terms and conditions./s/ Gregory D. Perry November 28, 2016SignatureDate Gregory Perry – Employment AgreementSCHEDULE “A”AEGERION AGREEMENT[See attached]EMPLOYMENT AGREEMENTThis Employment Agreement (this “ Agreement ”) is made and entered into as of this 26th day of June 2015, by and between AegerionPharmaceuticals, Inc., a Delaware corporation (the “ Company ”), and Gregory Perry (the “ Employee ”).W I T N E S S E T H :WHEREAS, the Company desires to employ Employee and to enter into this Agreement embodying the terms of such employment, andEmployee desires to enter into this Agreement and to accept such employment, subject to the terms and provisions of this Agreement.NOW, THEREFORE, in consideration of the promises and mutual covenants contained herein and for other good and valuable consideration,the receipt and sufficiency of which are mutually acknowledged, the Company and Employee hereby agree as follows:Section 1. Definitions.(a) “ Accrued Obligations ” shall mean (i) all accrued but unpaid Base Salary through the Date of Termination, (ii) any unpaid orunreimbursed expenses incurred in accordance with Section 6 hereof, and (iii) any accrued but unused vacation time through the Date of Termination.(b) “ Base Salary ” shall mean the salary provided for in Section 4(a) hereof.(c) “ Board ” shall mean the Board of Directors of the Company.(d) “ Confidentiality Agreement ” shall mean the Company’s Confidentiality, Assignment and Noncompetition Agreement attachedhereto as Exhibit A .(e) “ Cause ” shall mean (i) Employee’s failure (except where due to a Disability), neglect, or refusal to perform in any material respectEmployee’s duties and responsibilities, (ii) any act of Employee that has, or could reasonably be expected to have, the effect of injuring the business of theCompany or its affiliates in any material respect, (iii) Employee’s conviction of, or plea of guilty or no contest to: (x) a felony or (y) any other criminal charge thathas, or could be reasonably expected to have, an adverse impact on the performance of Employee’s duties to the Company or otherwise result in material injury tothe reputation or business of the Company, (iv) the commission by Employee of an act of fraud or embezzlement against the Company, or any other act that createsor reasonably could create negative or adverse publicity for the Company; (v) any violation by Employee of the policies of the Company, including but not limitedto those relating to sexual harassment or business conduct, and those otherwise set forth in the manuals or statements of policy of the Company, (vi) Employee’sviolation of federal or state securities laws, or (vii) Employee’s breach of this Agreement or breach of the Confidentiality Agreement.(f) “ Code ” shall mean the Internal Revenue Code of 1986, as amended, and the rules and regulations promulgated thereunder.(g) “ Date of Termination ” shall mean the date on which Employee’s employment terminates.(h) “ Disability ” shall mean any physical or mental disability or infirmity of Employee that prevents the performance of Employee’sduties for a period of (i) ninety (90) consecutive days or (ii) one hundred twenty (120) non-consecutive days during any twelve (12) month period. Any question asto the existence, extent, or potentiality of Employee’s Disability upon which Employee and the Company cannot agree shall be determined by a qualified,independent physician selected by the Company and approved by Employee (which approval shall not be unreasonably withheld). The determination of any suchphysician shall be final and conclusive for all purposes of this Agreement.(i) “ Effective Date ” shall mean July 6, 2015.(j) “ Good Reason ” shall mean, without Employee’s consent, (i) a material diminution in Employee’s duties, or responsibilities, (ii) amaterial reduction in Base Salary as set forth in Section 4(a) hereof (other than pursuant to an across-the-board reduction applicable to all similarly situatedexecutives), (iii) the relocation of Employee’s principal place of employment more than fifty (50) miles from its current location, or (iv) any other material breachof a provision of this Agreement by the Company (other than a provision that is covered by clause (i), (ii), or (iii) above). Employee acknowledges and agrees thatEmployee’s exclusive remedy in the event of any breach of this Agreement shall be to assert Good Reason pursuant to the terms and conditions of Section 7(e)hereof. Notwithstanding the foregoing, during the Term, in the event that the Company reasonably believes that Employee may have engaged in conduct that couldconstitute Cause hereunder, the Company may, in its sole and absolute discretion, suspend Employee from performing Employee’s duties hereunder, and in noevent shall any such suspension constitute an event pursuant to which Employee may terminate employment with Good Reason or otherwise constitute a breachhereunder; provided , that no such suspension shall alter the Company’s obligations under this Agreement during such period of suspension.(k) “ Release of Claims ” shall mean a separation agreement in a form acceptable to the Company under which Employee releases theCompany from any and all claims and causes of action and the execution of which is a condition precedent to Employee’s eligibility for Severance Benefits in theevent his employment is terminated by the Company without Cause or by Employee for Good Reason, as described in Sections 7(d) and 7(e).(l) “ Severance Benefits ” shall mean (i) continued payment of Base Salary during the Severance Term, payable in accordance with theCompany’s regular payroll practices, and (ii) subject to the Employee’s timely election of COBRA and copayment of premium amounts at the active employees’rate, payment of the employer portion of the premiums for the Company’s group health and dental program for the Employee in order to allow him to continue toparticipate in the Company’s group health and dental program until the earlier of (Y) 12 months from the Date of Termination, and (Z) the date the Employeebecomes re-employed and eligible for health and/or dental insurance; provided, however , that this subsection (ii) is to be modified, as required, and by mutualagreement of the parties, to comply with the non-discrimination rules and other provisions and requirements of the Patient Protection and Affordable Care Act.(m) “ Severance Term ” shall mean the twelve (12) month period, which commences on the first pay day that is at least thirty-five (35)days from the Date of Termination following termination by the Company without Cause or by Employee for Good Reason.Section 2. Acceptance and Term.The Company agrees to employ Employee on an at-will basis, and Employee agrees to accept such employment and serve the Company, inaccordance with the terms and conditions set forth herein. The term of employment (referred to herein as the “ Term ) shall commence on the Effective Date andshall continue until terminated by either party at any time, subject to the provisions herein.Section 3. Position, Duties, and Responsibilities; Place of Performance.(a) Position, Duties, and Responsibilities . During the Term, Employee shall be employed and serve as Chief Financial Officer of theCompany (together with such other position or positions consistent with Employee’s title or as the Company shall specify from time to time) and shall have suchduties and responsibilities commensurate therewith, and such other duties as may be assigned and/or prescribed from time to time by the Chief Executive Officerand/or the Board.(b) Performance . Employee shall devote his full business time, attention, skill, and best efforts to the performance of his duties underthis Agreement and shall not engage in any other business or occupation during the Term, including, without limitation, any activity that (x) conflicts with theinterests of the Company, (y) interferes with the proper and efficient performance of Employee’s duties for the Company, or (z) interferes with Employee’sexercise of judgment in the Company’s best interests. Notwithstanding the foregoing, nothing herein shall preclude Employee from (i) serving, with the priorwritten consent of the Board, as a member of the boards of directors or advisory boards (or their equivalents in the case of a non-corporate entity) of non-competing businesses and charitable organizations, (ii) engaging in charitable activities and community affairs, and (iii) managing Employee’s personalinvestments and affairs; provided , however , that the activities set out in clauses (i), (ii), and (iii) shall be limited by Employee so as not to interfere, individuallyor in the aggregate, with the performance of Employee’s duties and responsibilities hereunder. Employee represents that he has provided the Company with acomprehensive list of all outside professional activities with which he is currently involved or reasonably expects to become involved. In the event that, during hisemployment by the Company, the Employee desires to engage in other outside professional activities, not included on such list, Employee will first seek writtenapproval from the CEO or President and such approval shall not be unreasonably withheld.Section 4. Compensation.(a) Base Salary . In exchange for Employee’s satisfactory performance of his duties and responsibilities, Employee initially shall bepaid a semi-monthly Base Salary of $16,250 ($390,000 on an annualized basis), payable in accordance with the regular payroll practices of the Company. Allpayments in this Agreement are on a gross, pre-tax basis and shall be subject to all applicable federal, state and local withholding, payroll and other taxes.(b) Bonus . In addition to the Base Salary, Employee will be eligible for the following bonus compensation:(i) Target Bonus : Employee will be eligible to earn an annual target bonus of up to 45% of his Base Salary (the “ Target Bonus ”),prorated in 2015 to reflect his start date. The actual amount of such bonus, if any, including any overachievement component, will be determined by theBoard and Employee’s manager in their sole discretion, based upon Company performance, Employee’s achievement of a series of mutually agreed uponperformance milestones, and any other factors that the Board, in its discretion, deem appropriate. Employee’s achievement of such milestones,as well as the amount of any bonus, shall be determined by the Board and Employee’s manager in their sole discretion. For 2015, the individual portion ofEmployee’s target bonus (20% of eligible pro-rated earnings) shall be guaranteed to be paid in full at target; provided that, if the Company’s executiveteam, in its entirety, does not receive a 2015 bonus payout, Employee shall not receive any portion of his 2015 bonus target. Typically, bonuses, if any,are paid out no later than March 15 of the year following the applicable bonus year. Employee must be employed by Aegerion at the time of any suchbonus payment in order to be eligible for any such payment.(c) Signing Bonus . In addition to the above bonus, Employee will be eligible to receive a one-time cash sign-on bonus in the amount of$85,000, which will be paid out as soon as practical following the Effective Date. Employee must be employed by Aegerion at the time of the bonus payment inorder to be eligible for any such payment. If, prior to the 12-month anniversary of the Effective Date, Employee resigns other than for Good Reason or Aegerionterminates Employee’s employment for Cause, then Employee agrees to repay to Aegerion the net amount of the signing bonus within 30 days of such terminationof employment.(d) Stock Options/Equity Grants . Subject to Board approval, the Company will offer to Employee the option (the “ Option Award ”) topurchase 200,000 shares of the Company’s common stock, $0.001 par value per share (the “ Common Stock ”). The Option Award shall have an exercise priceequal to the fair market value of the Common Stock on the date of grant (as determined by the Board or Compensation Committee thereof). The Option Awardshall be subject to vesting and shall be issued pursuant to the terms of the Company’s 2010 Stock Option and Incentive Plan (or a successor plan, if any) andsubject to the terms of a stock option agreement thereunder (collectively the “ Equity Documents ”). The vesting schedule for Employee’s Option Award will bethe vesting schedule outlined in the Equity Documents (i.e., the option to purchase 200,000 shares will vest as follows: 25% of the option subject to the OptionAward to vest on the first anniversary of the grant date, with the remaining 75% to vest in equal monthly installments over the three year period thereafter). Thefull terms and conditions related to these option grants shall be set forth in the Equity Documents and to the extent that there is any inconsistency between thisAgreement and the Equity Documents, the Equity Documents shall control.Section 5. Employee Benefits.During the Term, Employee shall be eligible to participate in health insurance and other benefits provided generally to similarly situatedemployees of the Company, subject to the terms and conditions of the applicable benefit plans (which shall govern). Employee also shall be eligible for the samenumber of holidays and vacation days as well as any other benefits, in each case as are generally allowed to similarly situated employees of the Company inaccordance with the Company policy as in effect from time to time. Nothing contained herein shall be construed to limit the Company’s ability to amend, suspend,or terminate any employee benefit plan or policy at any time without providing Employee notice, and the right to do so is expressly reserved.Section 6. Reimbursement of Business Expenses; Relocation and Temporary Living Assistance.During the Term of Employment, the Company shall pay (or promptly reimburse Employee) for documented, out-of-pocket expenses reasonablyincurred by Employee in the course of performing his duties and responsibilities hereunder, which are consistent with the Company’s policies in effect from timeto time with respect to business expenses, subject to the Company’s requirements with respect to reporting of such expenses.In addition, during a period ending on the earlier of (i) 24 months from the Effective Date or (ii) termination of Employee’s employment,Employee shall be eligible for a relocation transition allowance to cover the following expenses: (a) temporary housing, not to exceed $4,500 per month, for his usetowards renting a suitable apartment in the Cambridge, Massachusetts area; and (b) commuting costs to include airfare/train fare not to exceed $250 weekly roundtrip, and taxi/car services to and from the airport/train station, which comply with the Company’s Global mobility policy (collectively with (a), the “ RelocationTransition Allowance ”); and (c) a “gross-up” payment in the amount necessary to offset the tax liability associated with the Relocation Transition Allowanceoutlined in (a) and (b); provided, that (x) Employee shall submit expense reports with supporting documentation in such form and containing such information asthe Company may request to be reimbursed for all Relocation Transition Allowance expenses, and (y) if, prior to the 12-month anniversary of the payment of anyRelocation Transition Allowance, the Employee resigns other than for Good Reason or the Company terminates the Employee’s employment for cause, theEmployee shall repay to the Company the appropriate pro-rated amount of such Relocation Transition Allowance within 30 days of such termination ofemployment. For the avoidance of doubt, Employee’s eligibility for any Relocation Transition Allowance shall terminate on July 6, 2017.Section 7. Termination of Employment.(a) General . Employee’s employment with the Company shall terminate upon the earliest to occur of: (i) Employee’s death, (ii) atermination by reason of a Disability, (iii) a termination by the Company with or without Cause, and (iv) a termination by Employee with or without Good Reason.Notwithstanding anything herein to the contrary, the payment (or commencement of a series of payments) hereunder of any nonqualified deferred compensation(within the meaning of Section 409A of the Code) upon a termination of employment shall be delayed until such time as Employee has also undergone a“separation from service” as defined in Treas. Reg. 1.409A-1(h), at which time such nonqualified deferred compensation (calculated as of the date of Employee’stermination of employment hereunder) shall be paid (or commence to be paid) to Employee on the schedule set forth in this Section 7 as if Employee hadundergone such termination of employment (under the same circumstances) on the date of Employee’s ultimate “separation from service.”(b) Termination Due to Death or Disability . Employee’s employment under this Agreement shall terminate automatically uponEmployee’s death. The Company also may terminate Employee’s employment immediately upon the occurrence of a Disability, such termination to be effectiveupon Employee’s receipt of written notice of such termination. In the event of Employee’s termination as a result of Employee’s death or Disability, Employee orEmployee’s estate or beneficiaries, as the case may be, shall be entitled only to the Accrued Obligations, and Employee shall have no further rights to anycompensation or any other benefits under this Agreement.(c) Termination by the Company with Cause .(i) The Company may terminate Employee’s employment at any time with Cause, effective upon Employee’s receipt ofwritten notice of such termination; provided , however , that with respect to any Cause termination relying on clause (i) or (ii) of the definition of Causeset forth in Section 1(d) hereof, to the extent that such act or acts or failure or failures to act are curable, Employee shall be given ten (10) days’ writtennotice by the Company of its intention to terminate him with Cause, such notice to state the act or acts or failure or failures to act that constitute thegrounds on which the proposed termination with Cause is based, and such termination shall be effective at the expiration of such ten (10) day noticeperiod unless Employee has fully cured such act or acts or failure or failures to act, to the Company’s complete satisfaction, that give rise to Cause duringsuch period.(ii) In the event that the Company terminates Employee’s employment with Cause, Employee shall be entitled only to theAccrued Obligations. Following such termination of Employee’s employment with Cause, except as set forth in this Section 7(c)(ii), Employee shall haveno further rights to any compensation or any other benefits under this Agreement. For the avoidance of doubt, Employee’s sole and exclusive remedyupon a termination of employment by the Company with Cause shall be receipt of the Accrued Obligations.(d) Termination by the Company without Cause . The Company may terminate Employee’s employment at any time without Cause,effective upon Employee’s receipt of written notice of such termination. In the event that Employee’s employment is terminated by the Company without Cause(other than due to death or Disability) and provided that he fully executes an effective Release of Claims as described in Section 7(g), Employee shall be eligiblefor:(i) The Accrued Obligations;(ii) The Severance Benefits; and(iii) Acceleration of the vesting of 100% of Employee’s then outstanding unvested equity awards, such that all unvested equityawards vest and become fully exercisable or non-forfeitable as of the Date of Termination; provided that such termination without Cause and the Date ofTermination occurs within eighteen (18) months after a Sale Event (the “ Accelerated Equity Benefit ”), in which case Employee shall have ninety (90)days from the Date of Termination to exercise the vested equity awards.Notwithstanding the foregoing, the Severance Benefits shall immediately terminate, and the Company shall have no further obligations to Employee with respectthereto, in the event that Employee breaches any provision of the Confidentiality Agreement or the Release of Claims. Any such termination of payment or benefitsshall have no effect on the Release of Claims or any of Employee’s post-employment obligations to the Company. Following such termination of Employee’semployment by the Company without Cause, except as set forth in this Section 7(d), Employee shall have no further rights to any compensation or any otherbenefits under this Agreement. For the avoidance of doubt, Employee’s sole and exclusive remedy upon a termination of employment by the Company withoutCause shall be receipt of the Severance Benefits (and, in the case of such a termination within eighteen (18) months after a Sale Event, the Accelerated EquityBenefit), subject to his execution of the Release of Claims, and the Accrued Obligations.In addition, the Severance Benefit set forth in Section 1(l)(i) shall be reduced dollar for dollar by any compensation Employee receives from another employerduring the Severance Term. Employee agrees to give prompt notice of any employment during the Severance term and promptly shall respond to any reasonableinquiries concerning his professional activities. If the Companymakes overpayments of Severance Benefits, Employee promptly shall return any such overpayments to the Company and/or hereby authorizes deductions fromfuture Severance Benefit amounts. The foregoing shall not create any obligation on the Employee’s part to seek re-employment after the Date of Termination.(e) Termination by Employee with Good Reason . Employee may terminate his employment with Good Reason by providing theCompany thirty (30) days’ written notice setting forth in reasonable specificity the event that constitutes Good Reason, which written notice, to be effective, mustbe provided to the Company within sixty (60) days of the occurrence of such event. During such thirty (30) day notice period, the Company shall have a cure right(if curable), and if not cured within such period, Employee’s termination will be effective upon the expiration of such cure period, and Employee shall be entitledto the same payments and benefits as provided in Section 7(d) hereof for a termination by the Company without Cause, subject to the same conditions on paymentand benefits as described in Section 7(d) hereof. Following such termination of Employee’s employment by Employee with Good Reason, except as set forth inthis Section 7(e), Employee shall have no further rights to any compensation or any other benefits under this Agreement. For the avoidance of doubt, Employee’ssole and exclusive remedy upon a termination of employment with Good Reason shall be receipt of the Severance Benefits (and, in the case of such a terminationwithin eighteen (18) months after a Sale Event, the Accelerated Equity Benefit), subject to his execution of the Release of Claims, and the Accrued Obligations.(f) Termination by Employee without Good Reason . Employee may terminate his employment without Good Reason by providing theCompany thirty (30) days’ written notice of such termination. In the event of a termination of employment by Employee under this Section 7(f), Employee shall beentitled only to the Accrued Obligations. In the event of termination of Employee’s employment under this Section 7(f), the Company may, in its sole and absolutediscretion, by written notice accelerate such date of termination without changing the characterization of such termination as a termination by Employee withoutGood Reason. Following such termination of Employee’s employment by Employee without Good Reason, except as set forth in this Section 7(f), Employee shallhave no further rights to any compensation or any other benefits under this Agreement. For the avoidance of doubt, Employee’s sole and exclusive remedy upon atermination of employment by Employee without Good Reason shall be receipt of the Accrued Obligations.(g) Release . Notwithstanding any provision herein to the contrary, the payment of the Severance Benefits pursuant to subsection (d) or(e) of this Section 7 (other than the Accrued Obligations) shall be conditioned upon Employee’s execution, delivery to the Company, and non-revocation of theRelease of Claims (and the expiration of any revocation period contained in such Release of Claims) in accordance with the time limits set forth therein. IfEmployee fails to execute the Release of Claims in such a timely manner, or timely revokes Employee’s acceptance of such release following its execution,Employee shall not be entitled to any of the Severance Benefits. Further, to the extent that any of the Severance Benefits constitutes “nonqualified deferredcompensation” for purposes of Section 409A of the Code, any payment of any amount or provision of any benefit otherwise scheduled to occur prior to the thirty-fifth (35 th ) day following the date of Employee’s termination of employment hereunder, but for the condition on executing the Release of Claims as set forthherein, shall not be made until the first regularly scheduled payroll date following such thirty-fifth (35 th ) day, after which any remaining Severance Benefits shallthereafter be provided to Employee according to the applicable schedule set forth herein.Section 8. Confidentiality Agreement; Cooperation.(a) Confidentiality Agreement . As a condition of Employee’s employment with the Company under the terms of this Agreement,Employee shall execute and deliver to the Company the Confidentiality Agreement, in the form attached hereto as Exhibit A. The parties hereto acknowledge andagree that this Agreement and the Confidentiality Agreement shall be considered separate contracts. In addition, Employee represents and warrants that he shall beable to and will perform the duties of this position without utilizing any confidential and/or proprietary information that Employee may have obtained inconnection with employment with any prior employer, and that he shall not (i) disclose any such information to Aegerion, or (ii) induce any Aegerion employee touse any such information, in either case in violation of any confidentiality obligation, whether by agreement or otherwise.(b) Litigation and Regulatory Cooperation . During and after Employee’s employment, Employee shall cooperate fully with theCompany in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company whichrelate to events or occurrences that transpired while the Company employed Employee, provided, that the Employee will not have an obligation under thisparagraph with respect to any claim in which the Employee has filed directly against the Company or related persons or entities. The Employee’s full cooperationin connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as awitness on behalf of the Company at mutually convenient times. During and after Employee’s employment, Employee also shall cooperate fully with the Companyin connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrencesthat transpired while Employee was employed by the Company, provided Employee will not have any obligation under this paragraph with respect to any claim inwhich Employee has filed directly against the Company or related persons or entities. The Company shall reimburse Employeefor any reasonable out-of-pocket expenses incurred in connection with Employee’s performance of obligations pursuant to this Section 8(b).Section 9. Taxes.The Company may withhold from any payments made under this Agreement all applicable taxes, including but not limited to income,employment, and social insurance taxes, as shall be required by law. Employee acknowledges and represents that the Company has not provided any tax advice tohim in connection with this Agreement and that Employee has been advised by the Company to seek tax advice from Employee’s own tax advisors regarding thisAgreement and payments that may be made to him pursuant to this Agreement, including specifically, the application of the provisions of Section 409A of theCode to such payments. The Company shall have no liability to Employee or to any other person if any of the provisions of this Agreement are determined toconstitute deferred compensation subject to Section 409A but that do not satisfy an exemption from, or the conditions of, that section.Section 10. Additional Section 409A Provisions.Notwithstanding any provision in this Agreement to the contrary:(a) If at the time of the Employee’s separation from service within the meaning of Section 409A of the Code, the Company determinesthat the Employee is a “specified employee” within the meaning of Section 409A(a)(2)(B)(i) of the Code, then to the extent any payment or benefit that theEmployee becomes entitled to under this Agreement on account of the Employee’s separation from service would be considered deferred compensation subject tothe 20 percent additional tax imposed pursuant to Section 409A(a) of the Code as a result of the application of Section 409A(a)(2)(B)(i) of the Code, such paymentshall not be payable and such benefit shall not be provided until the date that is the earlier of (i) six months and one day after the Employee’s separation fromservice, or (ii) the Employee’s death. If any such delayed cash payment is otherwise payable on an installment basis, the first payment shall include a catch-uppayment covering amounts that would otherwise have been paid during the six-month period but for the application of this provision, and the balance of theinstallments shall be payable in accordance with their original schedule.(b) Each payment in a series of payments hereunder shall be deemed to be a separate payment for purposes of Section 409A of theCode. Neither the Company nor Employee shall have the right to accelerate or defer the delivery of any such payments except to the extent specifically permittedor required by Section 409A.(c) To the extent that any right to reimbursement of expenses or payment of any benefit in-kind under this Agreement constitutesnonqualified deferred compensation (within the meaning of Section 409A of the Code), (i) any such expense reimbursement shall be made by the Company nolater than the last day of the taxable year following the taxable year in which such expense was incurred by Employee, (ii) the right to reimbursement or in-kindbenefits shall not be subject to liquidation or exchange for another benefit, and (iii) the amount of expenses eligible for reimbursement or in-kind benefits providedduring any taxable year shall not affect the expenses eligible for reimbursement or in-kind benefits to be provided in any other taxable year; provided , that theforegoing clause shall not be violated with regard to expenses reimbursed under any arrangement covered by Section 105(b) of the Code solely because suchexpenses are subject to a limit related to the period the arrangement is in effect.(d) To the extent that any payment or benefit described in this Agreement constitutes “non-qualified deferred compensation” underSection 409A of the Code, and to the extent that such payment or benefit is payable upon the Employee’s termination of employment, then such payments orbenefits shall be payable only upon the Employee’s “separation from service.” The determination of whether and when a separation from service has occurred shallbe made in accordance with the presumptions set forth in Treasury Regulation Section 1.409A‑1(h).(e) The parties intend that this Agreement will be administered in accordance with Section 409A of the Code. To the extent that anyprovision of this Agreement is ambiguous as to its compliance with Section 409A of the Code, the provision shall be read in such a manner so that all paymentshereunder comply with Section 409A of the Code. The parties agree that this Agreement may be amended, as reasonably requested by either party, and as may benecessary to fully comply with Section 409A of the Code and all related rules and regulations in order to preserve the payments and benefits provided hereunderwithout additional cost to either party. While the payments and benefits provided hereunder are intended to be structured in a manner to avoid the implication ofany penalty taxes under Section 409A of the Code, in no event whatsoever shall the Company or any of its affiliates be liable for any additional tax, interest, orpenalties that may be imposed on Employee as a result of Section 409A of the Code or any damages for failing to comply with Section 409A of the Code (otherthan for withholding obligations or other obligations applicable to employers, if any, under Section 409A of the Code).Section 11. Successors and Assigns.(a) The Company . This Agreement shall inure to the benefit of the Company and its respective successors and assigns. This Agreementmay be assigned by the Company without Employee’s prior consent.(b) Employee . Employee’s rights and obligations under this Agreement shall not be transferable by Employee by assignment orotherwise, without the prior written consent of the Company; provided , however , that if Employee shall die, all amounts then payable to Employee hereundershall be paid in accordance with the terms of this Agreement to Employee’s devisee, legatee, or other designee, or if there be no such designee, to Employee’sestate.Section 12. Waiver and Amendments.Any waiver, alteration, amendment, or modification of any of the terms of this Agreement shall be valid only if made in writing and signed byeach of the parties hereto; provided , however , that any such waiver, alteration, amendment, or modification must be consented to on the Company’s behalf by theBoard. No waiver by either of the parties hereto of their rights hereunder shall be deemed to constitute a waiver with respect to any subsequent occurrences ortransactions hereunder unless such waiver specifically states that it is to be construed as a continuing waiver.Section 13. Severability.If any covenants or such other provisions of this Agreement are found to be invalid or unenforceable by a final determination of a court ofcompetent jurisdiction, (a) the remaining terms and provisions hereof shall be unimpaired, and (b) the invalid or unenforceable term or provision hereof shall bedeemed replaced by a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term orprovision hereof.Section 14. Governing Law and Jurisdiction.This is a Massachusetts contract and shall be construed under and be governed in all respects by the laws of the Commonwealth ofMassachusetts without giving effect to the conflict of laws principles of such state. With respect to any disputes concerning federal law, such disputes shall bedetermined in accordance with the law as it would be interpreted and applied by the United States Court of Appeals for the First Circuit. To the extent that anycourt action is initiated to enforce this Agreement, the parties hereby consent to the jurisdiction of the state and federal courts of the Commonwealth ofMassachusetts. Accordingly, with respect to any such court action, Employee (a) submits to the personal jurisdiction of such courts; (b) consents to service ofprocess; and (c) waives any other requirement (whether imposed by statute, rule of court, or otherwise) with respect to personal jurisdiction or service of process.Section 15. Notices.(a) Place of Delivery . Every notice or other communication relating to this Agreement shall be in writing, and shall be mailedto or delivered to the party for whom or which it is intended at such address as may from time to time be designated by it in a notice mailed or deliveredto the other party as herein provided; provided , that unless and until some other address be so designated, all notices and communications by Employee tothe Company shall be mailed or delivered to the Company at its principal executive office, and all notices and communications by the Company toEmployee may be given to Employee personally or may be mailed to Employee at Employee’s last known address, as reflected in the Company’s records.(b) Date of Delivery . Any notice so addressed shall be deemed to be given or received (i) if delivered by hand, on the date of suchdelivery, (ii) if mailed by courier or by overnight mail, on the first business day following the date of such mailing, and (iii) if mailed by registered or certifiedmail, on the third business day after the date of such mailing.Section 16. Section Headings.The headings of the sections and subsections of this Agreement are inserted for convenience only and shall not be deemed to constitute a partthereof or affect the meaning or interpretation of this Agreement or of any term or provision hereof.Section 17. Entire Agreement.This Agreement, together with the Confidentiality Agreement attached hereto and the Equity Documents, constitutes the entire understandingand agreement of the parties hereto regarding the employment of Employee. This Agreement supersedes all prior negotiations, discussions, correspondence,communications, understandings, and agreements between the parties (including any offer letter given to Employee) relating to the subject matter of thisAgreement; provided however, that Employee remains subject to those conditions set forth in the offer letter regarding completion of an employment applicationand background and/or reference checks to the Company’s satisfaction, in addition to executing those forms necessary for the processing of such backgroundcheck.Section 18. Survival of Operative Sections.Upon any termination of Employee’s employment, the provisions of Section 7 through Section 19 of this Agreement (together with any relateddefinitions set forth in Section 1 hereof) shall survive to the extent necessary to give effect to the provisions thereof.Section 19. Counterparts.This Agreement may be executed in two or more counterparts, each of which shall be deemed to be an original but all of which together shallconstitute one and the same instrument. The execution of this Agreement may be by actual or facsimile signature.Section 20. Gender Neutral.Wherever used herein, a pronoun in the masculine gender shall be considered as including the feminine gender unless the context clearlyindicates otherwise.IN WITNESS WHEREOF, the undersigned have executed this Agreement as of the date first above written.AEGERION PHARMACEUTICALS, INC./s/ Mary WegerBy: Mary WegerTitle: Chief Performance OfficerEMPLOYEE/s/ Gregory D. PerryGregory D. PerryAMENDMENT NO. 1 TO EMPLOYMENT AGREEMENTThis Amendment No. 1 to Employment Agreement (this “ Amendment ”), is entered into as of November 5, 2015, by and between AegerionPharmaceuticals, Inc., a Delaware corporation (the “ Company ”), and Gregory Perry (the “ Employee ”).WHEREAS, Employee and Company are parties to that certain Employment Agreement, dated as of June 26, 2015 (the “ Employment Agreement ); andWHEREAS, Employee and Company have agreed to amend certain provisions of the Employment Agreement;NOW, THEREFORE, in consideration of the mutual promises set forth herein, Company and Employee agree as follows:1.The following new definition shall be added to the Employment Agreement:“ Retention Bonus Amount ” shall mean any cash retention bonus awarded prior to the Date of Termination.2.The final sentence of Section 7(b) of the Employment Agreement (entitled “Termination Due to Death or Disability”) shall be deleted in its entirety andreplaced with the following:“In the event of Employee’s termination as a result of Employee’s death or Disability, Employee or Employee’s estate or beneficiaries, as the case maybe, shall be entitled only to the Accrued Obligations and the Retention Bonus Amount, and Employee shall have no further rights to any compensation orany other benefits under this Agreement.”3.Section 7(d) of the Employment Agreement (entitled “Termination by the Company without Cause”) shall be deleted in its entirety and replaced with thefollowing:“(d) Termination by the Company without Cause. The Company may terminate Employee’s employment at any time withoutCause, effective upon Employee’s receipt of written notice of such termination. In the event that Employee’s employment is terminated by the Companywithout Cause (other than due to death or Disability) and provided that he fully executes and does not revoke an effective Release of Claims as describedin Section 7(g), Employee shall be eligible for:(i) The Accrued Obligations;(ii) The Severance Benefits;(iii) At the end of the Severance Term, the Retention Bonus Amount; and(iv) If such termination without Cause and the Date of Termination occur within eighteen (18) months after a Sale Event (as such term is defined inthe Company’s 2010 Stock Option and Incentive Plan), acceleration of the vesting of 100% of Employee’s then outstanding unvested equity awards, suchthat all unvested equity awards vest and become fully exercisable or non-forfeitable as of the Date of Termination (the “Accelerated Equity Benefit”), inwhich case Employee shall have ninety (90) days from the Date of Termination to exercise the vested equity awards.Notwithstanding the foregoing, the Severance Benefits shall immediately terminate, and the Company shall have no further obligations to Employee withrespect thereto, in the event that Employee breaches any provision of the Confidentiality Agreement or the Release of Claims. Any such termination ofpayment or benefits shall have no effect on the Release of Claims or any of Employee’s post-employment obligations to the Company. Following suchtermination of Employee’s employment by the Company without Cause, except as set forth in this Section 7(d), Employee shall have no further rights toany compensation or any other benefits under this Agreement. For the avoidance of doubt, Employee’s sole and exclusive remedy upon a termination ofemployment by the Company without Cause shall be receipt of (i) the Severance Benefits (and, in the case of such a termination within eighteen(18) months after a Sale Event, the Accelerated Equity Benefit), subject to his execution of the Release of Claims, (ii) the Accrued Obligations, and (iii) atthe end of the Severance Term, the Retention Bonus Amount, subject to his execution of the Release of Claims.If the Company makes overpayments of Severance Benefits, Employee promptly shall return any such overpayments to the Company and/or herebyauthorizes deductions from future Severance Benefit amounts.”4.The final sentence of Section 7(e) of the Employment Agreement (entitled “Termination by Employee with Good Reason”) shall be deleted in its entiretyand replaced with the following:“For the avoidance of doubt, Employee’s sole and exclusive remedy upon a termination of employment with Good Reason shall be receipt of (i) theSeverance Benefits (and, in the case of such a termination within eighteen (18) months after a Sale Event, the Accelerated Equity Benefit), subject to hisexecution of the Release of Claims, (ii) the Accrued Obligations, and (iii) at the end of the Severance Term, the Retention Bonus Amount, subject to hisexecution of the Release of Claims.”5.The first sentence of Section 7(g) of the Employment Agreement (entitled “Release”) shall be deleted in its entirety and replaced with the following:“Notwithstanding any provision herein to the contrary, the payment of the Severance Benefits and the Retention Bonus Amount pursuant to subsection(d) or (e) of this Section 7 (other than the Accrued Obligations) shall be conditioned upon Employee’s execution, delivery to the Company, and non-revocation of the Release of Claims (and the expiration of any revocation period contained in such Release of Claims) in accordance with the time limitsset forth therein.”6.Other Provisions . The Employment Agreement, as modified by this Amendment, shall remain in full force and effect. This Amendment may be executedin two or more counterparts, each of which shall be deemed to be an original but all of which together shall constitute one and the same instrument. Theexecution of this Amendment may be by actual or facsimile signature.[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]IN WITNESS WHEREOF, the undersigned have executed this Amendment No. 3 to Employment Agreement as a sealed instrumentas of the date first above written.AEGERION PHARMACEUTICALS, INC. EMPLOYEE /s/ Mary Weger /s/ Gregory D. PerryBy: Mary Weger Gregory D. PerryTitle: Chief Performance Officer Title: Chief Financial OfficerAMENDMENT NO. 2 TO EMPLOYMENT AGREEMENTThis Amendment No. 2 to Employment Agreement (the “ Second Amendment ”) is made and entered into as of May 3, 2016 by and between AegerionPharmaceuticals, Inc., a Delaware corporation (the “ Company ”) and Gregory Perry (the “ Employee ”), and effective as of February 12, 2016. Capitalized termsnot defined in this Second Amendment will have the meanings ascribed to them in the Employment Agreement (as defined below).RECITALSWHEREAS, Employee and the Company entered into that certain Employment Agreement dated as of June 26, 2015, as amended November 5, 2015(together, the “ Employment Agreement ”), which addresses the terms and conditions of Employee’s employment;WHEREAS, Employee and the Company have agreed to further amend certain provisions of the Employment Agreement; andWHEREAS, Employee and the Company each acknowledge and reaffirm their obligations under the Employment Agreement, as amended by this SecondAmendment.NOW, THEREFORE, in consideration of the foregoing premises and of the mutual covenants, terms, provisions, and conditions set forth herein,Employee and the Company hereby agree as follows:1.Position . Section 3(a) of the Employment Agreement is hereby amended by deleting the reference to “Chief Financial Officer” and inserting “ChiefFinancial and Administration Officer” in its place.2.Base Salary . Section 4(a) of the Employment Agreement is hereby amended by deleting the reference to “$16,250 ($390,000)” and inserting “EighteenThousand Seven Hundred and Fifty Dollars ($18,750) (Four Hundred Fifty Thousand Dollars ($450,000) on an annualized basis)” in its place.3.Target Bonus . Section 4(b)(i) of the Employment Agreement is hereby deleted in its entirety and replaced with the following:Employee will be eligible to earn an annual target bonus of up to fifty percent (50%) of his Base Salary (the “ Target Bonus ”). The actual amount of suchbonus, if any, including any overachievement component, will be determined by the Board and Employee’s manager in their sole discretion, based uponCompany performance and any other factors that the Board, in its discretion, deems appropriate. Typically, bonuses, if any, are paid out no later thanMarch 15 of the year following the applicable bonus year. Employee must be employed by the Company at the time of any such bonus payment in orderto be eligible to receive any such payment.4.Incentive Payments . Section 4 of the Employment Agreement is hereby amended by adding the following the new Section 4(e):(e) Incentive Payments . In addition to the Target Bonus, Employee is eligible to receive a series of incentive payments as set forth in clauses (i)through (iv) below (each, an “ Incentive Payment ” and together, the “ Incentive Payments ”); provided, however, that if a Sale Event (as defined in theCompany’s 2010 Stock Option and Incentive Plan) occurs prior to December 31, 2016, any unpaid Incentive Payments will become earned upon theclosing of a Sale Event and will be paid to Employee within thirty (30) days of the closing of the Sale Event, regardless of whether the underlyingperformance goals have been met. To be eligible to be paid any Incentive Payment, Employee must remain continuously employed by the Companythrough the date that the payment is earned. In the event Employee remains continuously employed through such earned date(s), he shall be paid suchIncentive Payment(s) at the date(s) described herein, regardless of whether Employee’s employment terminates after the earned date but before thepayment date, and regardless of the timing or reason for such termination.(i) Resolution of Regulatory Litigation. If there is public disclosure by the Company of an agreement in principle to resolve the U.S.Department of Justice and the Securities and Exchange Commission investigations on or before December 31, 2016, the Employee will bedeemed to have earned as of the date of such public disclosure an Incentive Payment in the amount of $250,000, which the Company shall pay toEmployee within thirty (30) days following the date of such public disclosure.(ii) Reconfiguration. If, on or before February 28, 2016, Employee satisfactorily completes the reconfiguration of the Company (which willinclude without limitation an expansion of current responsibilities for coordination of supply chain and program management), as determined bythe Board in its sole discretion, the Company will pay Employee an Incentive Payment in the amount of $100,000 within thirty (30) daysfollowing the public announcement of such reconfiguration.(iii) Business Development. If, on or before December 31, 2016, the Company completes a business development deal resulting in theCompany’s access to a new product or portfolio of products, the Employee will be deemed to have earned as of the date of such deal closing anIncentive Payment in the amount of $100,000, which the Company shall pay to Employee within thirty (30) days following the closing of anysuch deal.(iv) Satisfactory/Timely Completion of Audit and 10-K Filing. If the Company’s financial audit in respect of fiscal year 2015 is completed andthe Company’s 10-K is filed on or prior to March 15, 2016, the Company will pay Employee an Incentive Payment in the amount of $85,000within thirty (30) days following the filing of the 10-K.5.Miscellaneous . Except as expressly amended herein, the Employment Agreement will continue in full force and effect in accordance with its originalterms. This Second Amendment may not be modified or amended, and no breach will be deemed to be waived, unless agreed to in writing by Employeeand a duly authorized designee of the Company. The headings and captions in this Second Amendment are for convenience only and in no way define ordescribe the scope or content of any provision of this Second Amendment. This Second Amendment is a Massachusetts contract and shall be construedunder and be governed in all respects by the laws of the Commonwealth of Massachusetts without giving effect to any conflict of laws principles thatwould result in the application of the laws of any other jurisdiction. This Second Amendment may be executed in one or more counterparts, each of whichwill be an original and all of which together will constitute one and the same instrument.[Remainder of page intentionally left blank.]IN WITNESS WHEREOF, this Second Amendment has been executed by the Company, by its duly authorized representative, and by Employee, as of thedate first written above.AEGERION PHARMACEUTICALS, INC. By: ___/s/ Mary T. Szela_________________________Name: Mary T. Szela Title: Chief Executive Officer Accepted and Agreed:/s/ Gregory D. Perry____________________________Gregory D. PerrySCHEDULE “B”GENERAL RELEASE AND WAIVER OF CLAIMSIn exchange for the severance benefits to be provided to me under the employment agreement between me and Novelion Services USA, Inc. (“NovelionServices”), dated as of November 28, 2016 (the “Employment Agreement”), to which I would not otherwise be entitled, on my own behalf and that of my heirs,executors, administrators, beneficiaries, personal representatives and assigns, I agree that this General Release and Waiver of Claims (the “Release of Claims”)shall be in complete and final settlement of any and all causes of action, rights and claims, whether known or unknown, accrued or unaccrued, contingent orotherwise, that I have had in the past, now have, or might now have, in any way related to, connected with or arising out of my employment or its termination,under the Employment Agreement, or pursuant to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Age Discrimination inEmployment Act, as amended by the Older Workers Benefit Protection Act, the Worker Adjustment and Retraining Notification Act, the Employee RetirementIncome Security Act, the wage and hour, wage payment and fair employment practices laws and statutes of the Commonwealth of Massachusetts (each as amendedfrom time to time), and/or any other federal, state or local law, regulation or other requirement and, if the employment laws of Canada apply to my employment,the Ontario and British Columbia Employment Standards Acts, the Ontario and British Columbia Human Rights Codes, and any other applicable Canadian orprovincial law, regulation or other requirement (each as amended from time to time) (collectively, the “Claims”), and I hereby release and forever dischargeNovelion Services, its Affiliates (as defined in the Employment Agreement, and including for certainty and without limitation QLT Inc. and AegerionPharmaceuticals, Inc.), and all of their respective past, present and future directors, shareholders, officers, members, managers, general and limited partners,employees, employee benefit plans, administrators, trustees, agents, representatives, successors and assigns, and all others connected with any of them (the“Releasees”), both individually and in their official capacities, from, and I hereby waive, any and all such Claims.This release shall not apply to (a) any claims that arise after I sign this Release of Claims, including my right to enforce the terms of this Release of Claims; (b) anyclaims that may not be waived pursuant to applicable law; (c) any right to indemnification that I may have under the certificate of incorporation or by-laws ofNovelion Services, and any indemnification agreement between me and Novelion Services or any insurance policies maintained by Novelion Services; or (d) anyright to receive any vested benefits under the terms of any employee benefit plans and my award agreements thereunder.I agree that the Releasees have satisfied all obligations to me under the legislation referred to in the previous paragraph in relation to my employment and thecessation of my employment, and I have considered any and all human rights complaints, concerns, or issues arising out of or in respect to my employment withNovelion Services, I am aware of my rights under the legislation referred to in the previous paragraph, and I confirm that I am not asserting such rights oradvancing a human rights claim or complaint against the Releasees.Nothing contained in this Release of Claims shall be construed to prohibit me from filing a charge with or participating in any investigation or proceedingconducted by the federal Equal Employment Opportunity Commission or a comparable state or local agency, provided, however, that I hereby agree to waive myright to recover monetary damages or other individual relief in any charge, complaint or lawsuit filed by me or by anyone else on my behalf.In signing this Release of Claims, I acknowledge my understanding that I may consider the terms of this Release of Claims for up to [twenty-one (21) /forty-five(45)]1 days from the date I receive it and that I may not sign this Release of Claims until after the date my employment with Novelion Services terminates. I alsoacknowledge that I am hereby advised by Novelion Services to seek the advice of an attorney prior to signing this Release of Claims; that I have had sufficient timeto consider this Release of Claims and to consult with an attorney, if I wished to do so, or to consult with any other person of my choosing before signing; and thatI am signing this Release of Claims voluntarily and with a full understanding of its terms.I further acknowledge that, in signing this Release of Claims, I have not relied on any promises or representations, express or implied, that are not set forthexpressly in the Release of Claims. I understand that I may revoke this Release of Claims at any time within seven (7) days of the date of my signing by writtennotice to the Board of Directors of Novelion Services and that this Release of Claims will take effect only upon the expiration of such seven-day revocation periodand only if I have not timely revoked it.[Remainder of page intentionally left blank.]Intending to be legally bound, I have signed this Release of Claims under seal as of the date written below.Signature: /s/ Gregory D. PerryName: Gregory D. PerryDate Signed: _______________________ 1 To be determined by Novelion Services at the time of termination.SCHEDULE “C”CONFIDENTIALITY, ASSIGNMENT OF INTELLECTUAL PROPERTY ANDNON-COMPETITION AGREEMENT[See attached]NOVELION SERVICES USA, INC.Employee Confidentiality, Assignment of Intellectual Property and Non-Competition AgreementIn consideration and as a condition of my employment or continued employment by Novelion Services USA, Inc. (the "Company"), I agree as follows:1. Employee Acknowledgments . I acknowledge that I will be provided, and/or have been provided, with trade secrets and/or valuable confidentialbusiness information belonging to the Company and/or its Affiliates (as defined in paragraph 19), and have developed and/or will develop substantial relationshipswith prospective and existing customers and clients of the Company and its Affiliates, and, as a result, shall benefit from the good will of the Company and itsAffiliates. I also acknowledge that the Company and its Affiliates have invested substantial resources in the development of their trade secrets, confidentialbusiness information, client relationships and good will and in recruiting, hiring and training their professionals and staff. I further acknowledge that I havereceived and/or will receive substantial training from the Company and its Affiliates. I hereby acknowledge and agree that the Company and its Affiliates have alegitimate interest in protecting their substantial investment in their development of trade secrets, confidential information, good will and a highly trained staff andthat the covenants to which I agree to be bound herein are necessary to protect such legitimate interests.2. Proprietary Information . I agree that all information, whether or not in writing, concerning the business, technology, business relationships orfinancial affairs of the Company and its Affiliates which the Company (or applicable Affiliate) has not released to the general public (collectively, "ProprietaryInformation") is and will be the exclusive property of the Company (or applicable Affiliate). By way of illustration, Proprietary Information may includeinformation or material which has not been made generally available to the public, such as: (a) corporate information, including plans, strategies, methods, policies,resolutions, negotiations or litigation; (b) marketing information, including strategies, methods, customer identities or other information about customers, prospectidentities or other information about prospects, or market analyses or projections; (c) financial information, including cost and performance data, debtarrangements, equity structure, investors and holdings, purchasing and sales data and price lists; and (d) operational and technological information, including plans,specifications, manuals, forms, templates, software, designs, methods, procedures, formulas, discoveries, inventions, improvements, concepts and ideas; and (e)personnel information, including personnel lists, reporting or organizational structure, resumes, personnel data, compensation structure, performance evaluationsand termination arrangements or documents. Proprietary Information also includes information received in confidence by the Company or its Affiliates fromcustomers or suppliers or other third parties.3. Recognition of Company’s Rights . I will not, at any time, without the Company's prior written permission, either during or after my employment,disclose any Proprietary Information to anyone outside of the Company, or use or permit to be used any Proprietary Information for any purpose other than theperformance of my duties as an employee of the Company. I will cooperate with the Company and its Affiliates and use my best efforts to prevent the unauthorizeddisclosure of all Proprietary Information. I will deliver to the Company all copies of Proprietary Information in my possession or control upon the earlier of arequest by the Company or termination of my employment.4. Rights of Others . I understand that the Company and its Affiliates are now and may hereafter be subject to nondisclosure or confidentialityagreements with third persons which require the Company (or applicable Affiliate) to protect or refrain from use of proprietary information. I agree to be bound bythe terms of such agreements in the event I have access to such proprietary information.5. Commitment to Company: Avoidance of Conflict of Interest . While an employee of the Company, I will devote my full-time efforts to theCompany's business and I will not engage in any other business activity that conflicts with my duties to the Company (including the services the Companyprovides to its Affiliates). I will advise the Chief Executive Officer of the Company at such time as any activity of either the Company or another business presentsme with a conflict of interest or the appearance of a conflict of interest as an employee of the Company. I will take whatever action is requested of me by theCompany to resolve any conflict or appearance of conflict which it finds to exist.6. Developments . I will make full and prompt disclosure to the Company of all inventions, discoveries, designs, developments, methods, modifications,improvements, processes, algorithms, databases, computer programs, formulae, techniques, trade secrets, graphics or images, and audio or visual works and otherworks of authorship, whether or not patentable or copyrightable, that are created, made, conceived or reduced to practice by me (alone or jointly with others) orunder my direction during the period of my employment (collectively, the "Developments"). I acknowledge that all work performed by me is on a "work for hire"basis, and I hereby do assign and transfer and, to the extent any such assignment cannot be made at present, will assign and transfer, to the Company (or anyAffiliate designated by the Company) and its successors and assigns all my right, title and interest in all Developments that: (a) relate to the business of theCompany or its Affiliates or any customer of the Company or its Affiliates or any of the products or services being researched, developed, manufactured or sold bythe Company or itsAffiliates or which may be used with such products or services; or (b) result from tasks assigned to me by the Company; or (c) result and/or are developed duringor after my employment from the use of premises or personal property (whether tangible or intangible) owned, leased or contracted for by the Company or itsAffiliates (collectively, "Company-Related Developments"), and all related patents, patent applications, trademarks and trademark applications, copyrights andcopyright applications, and other intellectual property rights in all countries and territories worldwide and under any international conventions ("IntellectualProperty Rights").To preclude any possible uncertainty, I have set forth on Exhibit A attached hereto a complete list of Developments that I have, alone or jointly with others,conceived, developed or reduced to practice prior to the commencement of my employment with the Company that I consider to be my property or the property ofthird parties and that I wish to have excluded from the scope of this Agreement ("Prior Inventions"). If disclosure of any such Prior Invention would cause me toviolate any prior confidentiality agreement, I understand that I am not to list such Prior Inventions in Exhibit A but am only to disclose a cursory name for eachsuch invention, a listing of the party(ies) to whom it belongs and the fact that full disclosure as to such inventions has not been made for that reason. I have alsolisted on Exhibit A all patents and patent applications in which I am named as an inventor, other than those which have been assigned to the Company ("OtherPatent Rights"). If no such disclosure is attached, I represent that there are no Prior Inventions or Other Patent Rights. If, in the course of my employment with theCompany, I incorporate a Prior Invention into a Company or Affiliate product, process or machine or other work done for the Company or an Affiliate, I herebygrant to the Company (or any Affiliate designated by the Company) a nonexclusive, royalty-free, paid-up, irrevocable, worldwide license (with the full right tosublicense) to make, have made, modify, use, sell, offer for sale and import such Prior Invention. Notwithstanding the foregoing, I will not incorporate, or permit tobe incorporated, Prior Inventions in any Company-Related Development without the Company's prior written consent.This Agreement does not obligate me to assign to the Company of any of its Affiliates any Development which, in the sole judgment of the Company, reasonablyexercised, is developed entirely on my own time and does not relate to the business efforts or research and development efforts in which, during the period of myemployment, the Company or its Affiliates actually are engaged or reasonably would be engaged, and does not result from the use of premises or equipment ownedor leased by the Company or its Affiliates. However, I will also promptly disclose to the Company any such Developments for the purpose of determining whetherthey qualify for such exclusion. I understand that to the extent this Agreement is required to be construed in accordance with the laws of any jurisdiction whichprecludes a requirement in an employee agreement to assign certain classes of inventions made by an employee, this paragraph 6 will be interpreted not to apply toany invention which a court rules and/or the Company agrees, falls within such classes. I also hereby waive all claims to any moral rights or other special rightswhich may have or accrue in any Company-Related Developments or Intellectual Property Rights.7. Documents and Other Materials . I will keep and maintain adequate and current records of: (a) all Proprietary Information and Company-RelatedDevelopments developed by me during my employment; and (b) all documentation regarding any Intellectual Property Rights, which relate to such ProprietaryInformation and Company-Related Developments. Such records will be available to and remain the sole property of the Company (or applicable Affiliate of theCompany) at all times.All files, letters, notes, memoranda, reports, records, data, sketches, drawings, notebooks, layouts, charts, quotations and proposals, specification sheets, or otherwritten, photographic or other tangible material containing Proprietary Information, whether created by me or others, which come into my custody or possession,are the exclusive property of the Company (or applicable Affiliate) to be used by me only in the performance of my duties for the Company. Any property situatedon the premises of the Company or its Affiliates, owned or purchased by the Company or its Affiliates, disseminated by the Company or its Affiliates, and/or usedor created by me for business purposes in the course of my duties for the Company, including without limitation computers, email accounts, cell phone records andtext messages, disks and other storage media, filing cabinets or other work areas, is the property of the Company (or, if applicable, an Affiliate) and is subject toinspection by the Company at any time with or without notice. In the event of the termination of my employment for any reason, I will deliver to the Company allCompany and Affiliate property, including, without limitation, all Proprietary Information, all documents related to Company-Related Developments, allcomputers, keys, passwords, cell phones, entry cards, files, letters, notes, memoranda, reports, records, data, sketches, drawings, notebooks, layouts, charts,quotations and proposals, specification sheets, or other written, photographic or other tangible material, and will not take or keep in my possession any Company orAffiliate property or any copies (electronic or hard-copy) of such property.8. Enforcement of Intellectual Property . I will cooperate fully with the Company, both during and after my employment with the Company, withrespect to the procurement, maintenance and enforcement of Intellectual Property Rights in Company-Related Developments. I will sign, both during and after theterm of this Agreement, all papers, including without limitation copyright applications, patent applications, declarations, oaths, assignments of priority rights, andpowers of attorney, which the Company may deem necessary or desirable in order to protect its (or any Affiliate’s) rights and interests in any Company-RelatedDevelopment. If the Company is unable, after reasonable effort, to secure my signature on any such papers, I hereby irrevocably designate and appoint each officerof the Company as my agent and attorney-in-fact to execute any such papers on my behalf, andto take any and all actions as the Company may deem necessary or desirable in order to protect its (or any Affiliate’s) rights and interests in any Company-RelatedDevelopment.9. Non-Competition and Non-Solicitation . In order to protect the Proprietary Information and good will of the Company and its Affiliates, during myemployment and for a period of twelve (12) months following the termination of my employment for any reason (the "Restricted Period"), I will not directly orindirectly, whether as owner, partner, shareholder, director, manager, consultant, agent, employee, co-venturer or otherwise, engage, participate or invest in anybusiness activity anywhere in the world that develops, manufactures or markets any products, or performs any services, that are competitive (directly or indirectly)with the products or services of the Company or its Affiliates, or products or services that the Company or its Affiliates have under development or that are thesubject of active planning at any time during the last 24 months of my employment; provided that this shall not prohibit any possible investment in publicly tradedstock of a company representing less than one percent of the stock of such company. In addition, during the Restricted Period, I will not, directly or indirectly, inany manner, for any purpose that is competitive with or detrimental to the business of the Company or an Affiliate, (a) call upon, solicit, divert, take away, acceptor conduct any business from or with any of the customers or prospective customers of the Company or its Affiliates, or any suppliers thereof, and/or (b) solicit,entice, or attempt to persuade any other employee or consultant of the Company or an Affiliate to leave the Company or Affiliate for any reason. I acknowledgeand agree that if I violate any of the provisions of this paragraph 9, the running of the Restricted Period will be extended by the time during which I engage in suchviolation(s).10. Government Contracts . I acknowledge that the Company and/or its Affiliates may have from time to time agreements with other persons orgovernmental authorities which impose obligations or restrictions on the Company and/or its Affiliates regarding inventions made during the course of work undersuch agreements or regarding the confidential nature of such work. I agree to comply with any such obligations or restrictions upon the direction of the Company.In addition to the rights assigned under paragraph 6, I also assign to the Company (or any of its nominees) all rights which I have or acquired in any Developments,full title to which is required to be held by the particular governmental authority under any contract between the Company and the given governmental authority.11. Prior Agreements . I hereby represent that, except as I have fully disclosed previously in writing to the Company, I am not bound by the terms of anyagreement with any previous employer (other than Aegerion Pharmaceuticals, Inc.) or other party to refrain from using or disclosing any trade secret orconfidential or proprietary information in the course of my employment with the Company or to refrain from competing, directly or indirectly, with the business ofsuch previous employer or any other party. I further represent that my performance of all the terms of this Agreement as an employee of the Company does not andwill not breach any agreement to keep in confidence proprietary information, knowledge or data acquired by me in confidence or in trust prior to my employmentwith the Company. I will not disclose to the Company or its Affiliates or induce the Company or its Affiliates to use any confidential or proprietary information ormaterial belonging to any previous employer (other than Aegerion Pharmaceuticals, Inc.) or others.12. Remedies Upon Breach .(a) Equitable Relief. I understand that the restrictions contained in this Agreement are necessary for the protection of the business and goodwill of theCompany and its Affiliates and I consider them to be reasonable for such purpose. Any breach of this Agreement is likely to cause the Company and its Affiliatessubstantial and irrevocable damage and therefore, in the event of such breach, the Company and/or any Affiliate affected by such breach, in addition to such otherremedies which may be available, will be entitled to seek specific performance and other injunctive relief, without the posting of a bond.(b) Indemnification. If I violate this Agreement, in addition to all other remedies available to the Company and any affected Affiliates at law, in equity,and under contract, I agree that I am obligated to pay all the Company's (or, if applicable, Affiliate’s) costs of enforcement of this Agreement, including attorneys'fees and expenses. I also agree that I will defend, indemnify and/or hold the Company and its Affiliates harmless from and against any and all liabilities, losses,damages, claims or demands whatsoever (including expenses, court costs and reasonable attorneys' fees) asserted against or incurred by the Company or anyAffiliate as a result of or by reason of the Company or such Affiliate having to defend any claim arising from my use of proprietary or trade secret information of aprior employer or my breach of a restrictive covenant with any prior employer, and from any damages resulting from a final judgment or reasonable settlement ofsuch claims. This indemnification shall include, but not be limited to, claims for infringement of patents, trademarks or copyrights, misappropriation of tradesecrets or confidential information, and/or breach of any restrictive covenants, and is without prejudice to any other rights held by, or remedies available to, theCompany or its Affiliates at law.13. Use of Voice, Image and Likeness . During the period of my employment, I give the Company and its Affiliates permission to use any and all ofmy voice, image and likeness, with or without using my name, in connection with the products and/or services of the Company and/or its Affiliates, for thepurposes of advertising and promoting such products and/or servicesand/or the Company and/or its Affiliates, and/or for other purposes deemed appropriate by the Company in its reasonable discretion, except to the extent expresslyprohibited by law.14. Publications and Public Statements . I will obtain the Company's written approval before publishing or submitting for publication any material thatrelates to my work at the Company (including in connection with its Affiliates) and/or incorporates any Proprietary Information.15. No Employment Obligation . I understand that this Agreement does not create an obligation on the Company or any other person to continue myemployment. I acknowledge that, unless otherwise agreed in a formal written employment agreement signed on behalf of the Company by an authorized officer,my employment with the Company is at will and therefore may be terminated by the Company or me at any time and for any reason, with or without cause.16. Survival and Assignment by the Company . I understand that my obligations under this Agreement will continue in accordance with its expressterms regardless of any changes in my title, position, duties, salary, compensation or benefits or other terms and conditions of employment. I further understandthat my obligations under this Agreement will continue following the termination of my employment regardless of the manner of such termination and will bebinding upon my heirs, executors and administrators. The Company will have the right to assign this Agreement to its Affiliates, successors and assigns. Iexpressly consent to be bound by the provisions of this Agreement for the benefit of the Company or any parent, subsidiary or affiliate to whose employ I may betransferred without the necessity that this Agreement be resigned at the time of such transfer.17. Updating Information to the Company: Disclosure to Future Employers . For twelve (12) months following termination of my employment, Iwill (a) notify the Company of any change in my address and of each subsequent employment or business activity, including the name and address of my employeror other post-Company employment plans and the nature of my activities, and (b) provide a copy of this Agreement to any prospective employer, partner or co-venturer prior to entering into an employment, partnership or other business relationship with such person or entity.18. Reimbursement . I hereby authorize the Company at any time during or after the term of my employment to withhold from any amounts otherwiseowed to me (including, but not limited to, salary, bonus, severance, commissions and expense reimbursements) to the fullest extent permitted by applicable law:any and all amounts due to the Company from me, including, but not limited to, cash advances, draws, travel advances, overpayments made by the Company tome, amounts received by me due to the Company's error, unpaid personal credit card or phone charges or any other debt I owe to the Company for any reason,including amounts with respect to misuse or misappropriation of Company assets or breach of this Agreement.19. Application to Affiliates . I acknowledge that my duties as an employee of the Company may include providing certain management services to QLTInc., Aegerion Pharmaceuticals, Inc., and other current or future affiliates of the Company within the meaning of the Delaware General Corporation Law(collectively the “Affiliates” and each an “Affiliate”), on behalf of the Company. I agree that each such Affiliate will have the same rights that the Company hasunder this Agreement (including the right to indemnification and other remedies under paragraph 12), and that I will have the same obligations to each Affiliate asI have to the Company under this Agreement, as if such Affiliate was a signatory to this Agreement instead of the Company, except that if there is any conflictbetween my obligations under this Agreement to the Company and to one or more of its Affiliates, my obligations to the Affiliate will prevail. I acknowledge toeach Affiliate that it has direct rights against me under this Agreement. To the extent required by law to give full effect to these direct rights, I acknowledge andagree that the Company is and will be deemed to be acting as agent or trustee on behalf of and for the benefit of each Affiliate.20. Severability . In case any provisions (or portions thereof) contained in this Agreement shall, for any reason, be held invalid, illegal or unenforceablein any respect, such invalidity, illegality or unenforceability shall not affect the other provisions of this Agreement, and this Agreement shall be construed as ifsuch invalid, illegal or unenforceable provision had never been contained herein. If, moreover, any one or more of the provisions contained in this Agreement shallfor any reason be held to be excessively broad as to duration, geographical scope, activity or subject, it shall be construed by limiting and reducing it, so as to beenforceable to the extent compatible with the applicable law as it shall then appear.21. Interpretation . This Agreement will be deemed to be made and entered into in the Commonwealth of Massachusetts, and will in all respects beinterpreted, enforced and governed under the laws of the Commonwealth of Massachusetts. I hereby agree to consent to personal jurisdiction of the state andfederal courts situated within Suffolk County, Massachusetts for purposes of enforcing this Agreement, and waive any objection that I might have to personaljurisdiction or venue in those courts.[Remainder of this page intentionally left blank]I UNDERSTAND THAT THIS AGREEMENT AFFECTS IMPORTANT RIGHTS. BY SIGNING BELOW, I CERTIFY THAT I HAVE READ ITCAREFULLY AND AM SATISFIED THAT I UNDERSTAND IT COMPLETELY.IN WITNESS WHEREOF, the undersigned has executed this Employee Confidentiality, Assignment of Intellectual Property and Non-CompetitionAgreement as a sealed instrument as of the date set forth below.Signed: /s/ Gregory D. Perry Name: Gregory D. PerryDate: _____________________________________EXHIBIT ATo: Novelion Services USA, Inc. (the “Company”)From: Gregory D. PerryDate: __________________________SUBJECT: Prior InventionsThe following is a complete list of all inventions or improvements that have been made or conceived or first reduced to practice by me alone or jointlywith others prior to my engagement by the Company:No inventions or improvementsSee below:_____________________________________________________________________________________________________________________________________________________________________________________________________________________Additional sheets attachedThe following is a list of all patents and patent applications in which I have been named as an inventor:NoneSee below:_____________________________________________________________________________________________________________________________________________________________________________________________________________________EXHIBIT 10.46Novelion Services USA, Inc.2711 Centerville RoadSuite 400Wilmington, DE 19808November 28, 2016Ben Harshbargerc/o Aegerion Pharmaceuticals, Inc.One Main StreetSuite 800Cambridge, MA 02142Dear Ben:RE: Offer of EmploymentAs you are aware, Aegerion Pharmaceuticals, Inc. (“ Aegerion ”), QLT Inc. and Isotope Acquisition Corp. have agreed to carry out a merger (the “ Merger ”) onthe terms set out in the Agreement and Plan of Merger dated June 14, 2016 (the “ Merger Agreement ”).Following the Merger, Aegerion will become an indirect subsidiary of Novelion Services USA, Inc., a Delaware corporation (“ Novelion Services ”). NovelionServices is currently a subsidiary of QLT Inc., a British Columbia company, which we anticipate will change its name to “Novelion Therapeutics Inc.” (“ NovelionCanada ”).We are pleased to offer you employment with Novelion Services in the position of General Counsel & Secretary commencing effective on the completion of theMerger, which is currently anticipated to be November 29, 2016 (the “ Commencement Date ”).Should you choose to accept this offer, the terms and conditions of your employment with Novelion Services will be the same as those set out in your currentemployment agreement with Aegerion which is attached as Schedule “A” to this letter (the “ Aegerion Agreement ”), except that the terms and conditions of theAegerion Agreement will be modified and supplemented as follows:1.Defined Terms: In the Aegerion Agreement, references to the “ Company ” or “ Aegerion ” (or any other references indicating your employer) will bedeemed to be references to Novelion Services, references to the “ Board ” will be deemed to be references to the Board of Directors of NovelionServices, and references to the “ Agreement ” or the “ Employment Agreement ” (or any other references to the terms and conditions of youremployment) will mean the Aegerion Agreement as modified and supplemented by this letter. In this letter, “ Affiliate ” has the meaning given to it in theDelaware General Corporation Law, and any other capitalized terms that are not defined in this letter will have the meanings given to them in theAegerion Agreement.2.Responsibilities and Reporting: As General Counsel & Secretary, you will have the duties and responsibilities set out in Section 3(a) of the AegerionAgreement in respect of Novelion Services. Your duties and responsibilities will include acting as member of the Board and of the board of directors ofNovelion Canada and any Affiliates, if appointed or elected to such positions. As described below, under the Master Service Agreement betweenNovelion Canada and Novelion Services that will be entered into on or about the completion date of the Merger, as amended from time to time (the “Service Agreement ”) you may also be required to perform services to Novelion Canada and other Affiliates of Novelion Canada, including holding anoffice in Novelion Canada. For certainty, you will be an employee of Novelion Services and not an employee of Novelion Canada, and when you provideservices to Novelion Canada you will be doing so as an employee of Novelion Services in the context of certain management services it provides toNovelion Canada under the Service Agreement. You will report to the Chief Executive Officer of Novelion Services.3.Base Salary: Notwithstanding Section 4(a) of the Aegerion Agreement, you will be paid a semi-monthly base salary of USD $14,583.33 (USD $350,000on an annualized basis). The other terms and condition of Section 4(a) of the Aegerion Agreement will continue to apply.4.Length of Service: Novelion Services will recognize your length of service with Aegerion for all purposes related to your employment with NovelionServices, including for the purpose of determining your entitlements on termination of your employment pursuant to the Aegerion Agreement.5.Accrued Obligations: Your employment with Aegerion will cease immediately prior to the Commencement Date and Aegerion will be responsible forproviding you with all accrued but unpaid Base Salary and unreimbursed expenses incurred in accordance with the Aegerion Agreement up to such date.Any vacation time that you have accrued under Aegerion’s vacation policy as of the Commencement Date, but not used as of such date, will be “rolledover” to Novelion Services. Novelion Services will credit you with this time for purposes of its vacation policy. By accepting this offer, you consent tothe rollover of this vacation time and acknowledge and agree that you are not entitled to any payment for this vacation time in connection with the transferof your employment from Aegerion to Novelion Services.6.No Severance or Good Reason: You agree that (a) the transfer of your employment from Aegerion to Novelion Services and any other changes to theterms and conditions of your employment that are expressly contemplated by this letter, and/or (b) any changes to your duties or responsibilities thatdirectly result from the Merger (including without limitation any such changes directly resulting from your new status as an executive officer of asubsidiary of Novelion Canada) shall not, individually or in the aggregate, constitute Good Reason for purposes of the Aegerion Agreement or theEmployment Agreement or entitle you to any Severance Benefits, Accelerated Equity Benefit, Retention Bonus Amount, or any other severance benefitsor the acceleration of any vesting or other rights, to which you might otherwise be entitled. You agree that, to the extent required by law to permitAegerion to rely on this paragraph 6, Novelion Services is and will be deemed to be acting as agent or trustee on behalf of and for the benefit of Aegerion.7.Stock Options / Equity Grants: Any stock options, restricted stock units, or other equity awards that you may have been granted pursuant to theInducement Plan or 2010 Stock Option and Incentive Plan will be dealt with as set out in the Merger Agreement. Once the Merger is completed, any suchoutstanding entitlements will be governed by and subject to the applicable stock option plan and stock option agreement.8.Right to Work in Canada: You will cooperate with Novelion Services to seek, obtain, and maintain the right to work in Canada to provide services onbehalf of Novelion Services to Novelion Canada and any of its other Affiliates. Novelion Services will pay the reasonable costs associated with obtaininga permit to work in Canada.9.Commuting to Canada: You acknowledge that travel will be required in connection with your employment, including commuting on a regular basis tosuch locations in Canada as are required for Novelion Services to provide its management services to Novelion Canada and its Canadian Affiliates.10.Tax Consultation Expenses: Each year so long as you are providing management services, you will be entitled to reimbursement for your reasonableexpenses up to a maximum of USD $5,000 for an independent tax consultation regarding the Canadian tax implications of your work on behalf ofNovelion Services in Canada and/or preparation of your Canadian tax return.11.Tax Equalization:(a)As you will be subject to income tax and social security obligations arising from your services performed in Canada on behalf of Novelion Services,Novelion Services is prepared to address the overall tax and social security burden that you experience with the intention that your total tax and socialsecurity burden while working in both the United States and Canada will be equal to what your tax and social security burden would have been hadyou remained working solely in Massachusetts. Novelion Services will provide you with tax equalization in connection with all income tax and socialsecurity liabilities arising from the performance of your employment duties within Canada. Novelion Services intends that the income taxes andsocial security levies payable by you on all taxable employment income and related benefits, as prescribed by the applicable tax and social securitylaws, should be no better or worse than the personal taxes and social security levies you would have been required to pay on such amounts if youremployment duties had been performed solely in the state of Massachusetts. Where your annual tax and social security obligation yields a highertotal obligation than if your employment duties were solely performed in the state of Massachusetts, Novelion Services will reimburse you for thedifference. Where your annual tax and social security obligations yields a lower total tax and social security impact than if your employment dutieswere solely performed in the state of Massachusetts, you will reimburse Novelion Services for the difference.(b)You will provide all information necessary for the preparation of a tax equalization calculation.(c)Novelion Services will pay all reasonable costs and professional fees related to calculating this equalization payment, and reserves the discretion toestablish the process and criteria for determining the tax equalization calculation. For clarity, the tax equalization payments described in thisparagraph 11 will not take into consideration or apply to any taxable income from sources other than your employment with Novelion Services, andyou will remain responsible for all income taxes arising from your personal income.(d)If you establish your primary residence in Canada, Novelion Services’ obligations under this paragraph 11 will cease, provided that there will be apro-rated adjustment for any partial year.(e)If your employment is terminated for any of the reasons described under Section 7 of the Aegerion Agreement, then between January 1 and July 31of the calendar year following the calendar year in which such termination occurs, Novelion Services will pay you any remaining tax equalizationpayments owed in accordance with this paragraph 11 or, in the event that the reconciliation results in you owing money to Novelion Services, youwill make such payment to Novelion Services.12.Release: The form of Release of Claims contemplated in the Aegerion Agreement will be the form attached as Schedule “B” to this Agreement.13.Employment Standards: This provision applies only if and to the extent that the employment laws of Canada apply to your employment. If theminimum standards in the British Columbia Employment Standards Act or Ontario Employment Standards Act, 2000 , or any other applicableemployment standards legislation, as they exist from time to time are more favorable to you in any respect than provided for in the EmploymentAgreement, including but not limited to the provisions in respect of notice of termination, the provisions of the applicable Employment Standards Act orlegislation will apply.14.Confidentiality, Assignment of Intellectual Property and Non-Competition: As a condition of your employment with Novelion Services, and inconsideration of the commitments set forth in this letter, you agree to execute and deliver to Novelion Services the Confidentiality, Assignment ofIntellectual Property and Non-Competition Agreement attached as Schedule “C” to this letter (the “ Ancillary Agreement ”), which will take effect onthe Commencement Date, following which any references to the “Confidentiality Agreement” in the Aegerion Agreement will be deemed to be referencesto the Ancillary Agreement. Your acceptance of this offer of employment or execution of the Ancillary Agreement does not affect your obligations toAegerion or the rights of Aegerion under the Confidentiality Agreement arising from your employment with Aegerion prior to the Commencement Date.15.Priority: If there is any conflict or inconsistency between these Supplementary Terms and the Aegerion Agreement, these Supplementary Terms will takeprecedence.If the terms and conditions of your employment described in this letter and the terms and conditions of the Ancillary Agreement are acceptable to you, please signthis letter (where indicated on the next page) and the enclosed Ancillary Agreement, and return signed copies of the foregoing to us by November 28, 2016.If you have any questions or concerns, please do not hesitate to contact Geoffrey Cox.[ Remainder of this page intentionally left blank ]Yours truly,NOVELION SERVICES USA, INC.Per: /s/ Geoffrey CoxAuthorized SignatoryI, Benjamin Harshbarger, have read, understand and agree with the terms and conditions of employment referenced in this letter. I have had a reasonableopportunity to consider these terms and conditions and seek independent legal advice, and I accept employment with Novelion Services on these terms andconditions./s/ Benjamin HarshbargerSignature November 28, 2016DateBenjamin Harshbarger - Employment AgreementSCHEDULE “A”AEGERION AGREEMENT[See attached]EMPLOYMENT AGREEMENTThis Employment Agreement (this “ Agreement ”) is made and entered into as of this 9th day of December 2015, by and between AegerionPharmaceuticals, Inc., a Delaware corporation (the “ Company ”), and Benjamin Harshbarger (the “ Employee ”).W I T N E S S E T H :WHEREAS, the Company and Employee previously entered into that certain offer letter agreement, dated as of March 7, 2012 (the “ OfferLetter ”) and that certain Letter of Understanding, dated as of October 28, 2013 (the “ Expatriate Assignment Letter ”); andWHEREAS, the Company desires to replace and restate the Offer Letter in full, and the first paragraph of the “Responsibilities/Compensation”section of the Expatriate Assignment Letter, and enter into this Agreement regarding the terms of the Employee’s employment, and Employee desires to enter intothis Agreement and to accept the terms and provisions of such employment, as embodied in this Agreement and the Expatriate Assignment Letter.Section 1. Definitions.(a) “ Accrued Obligations ” shall mean (i) all accrued but unpaid Base Salary through the Date of Termination, (ii) any unpaid orunreimbursed expenses incurred in accordance with Section 6 hereof, and (iii) any accrued but unused vacation time through the Date of Termination.(b) “ Base Salary ” shall mean the salary provided for in Section 4(a) hereof.(c) “ Board ” shall mean the Board of Directors of the Company.(d) “ Confidentiality Agreement ” shall mean the Company’s Confidentiality, Assignment and Noncompetition Agreement attachedhereto as Exhibit A .(e) “ Cause ” shall mean (i) Employee’s failure (except where due to a Disability), neglect, or refusal to perform in any material respectEmployee’s duties and responsibilities, (ii) any act of Employee that has, or could reasonably be expected to have, the effect of injuring the business of theCompany or its affiliates in any material respect, (iii) Employee’s conviction of, or plea of guilty or no contest to: (x) a felony or (y) any other criminal charge thathas, or could be reasonably expected to have, an adverse impact on the performance of Employee’s duties to the Company or otherwise result in material injury tothe reputation or business of the Company, (iv) the commission by Employee of an act of fraud or embezzlement against the Company, or any other act that createsor reasonably could create negative or adverse publicity for the Company; (v) any violation by Employee of the policies of the Company, including but not limitedto those relating to sexual harassment or business conduct, and those otherwise set forth in the manuals or statements of policy of the Company, (vi) Employee’sviolation of federal or state securities laws, or (vii) Employee’s breach of this Agreement or breach of the Confidentiality Agreement.(f) “ Code ” shall mean the Internal Revenue Code of 1986, as amended, and the rules and regulations promulgated thereunder.(g) “ Date of Termination ” shall mean the date on which Employee’s employment terminates.(h) “ Disability ” shall mean any physical or mental disability or infirmity of Employee that prevents the performance of Employee’sduties for a period of (i) ninety (90) consecutive days or (ii) one hundred twenty (120) non-consecutive days during any twelve (12) month period. Any question asto the existence, extent, or potentiality of Employee’s Disability upon which Employee and the Company cannot agree shall be determined by a qualified,independent physician selected by the Company and approved by Employee (which approval shall not be unreasonably withheld). The determination of any suchphysician shall be final and conclusive for all purposes of this Agreement.(i) “ Effective Date ” shall mean December 9, 2015.(j) “ Good Reason ” shall mean, without Employee’s consent, (i) a material diminution in Employee’s duties, or responsibilities, (ii) amaterial reduction in Base Salary as set forth in Section 4(a) hereof (other than pursuant to an across-the-board reduction applicable to all similarly situatedexecutives), (iii) the relocation of Employee’s principal place of employment more than fifty (50) miles from its then current location (other than any relocationback to work in Cambridge, MA headquarters or as otherwise agreed in writing by Employee in connection with the conclusion of Employee’s expatriateassignment in Switzerland (the “ Expatriate Assignment ”)), or (iv) any other material breach of a provision of this Agreement by the Company (other than aprovision that is covered by clause (i), (ii), or (iii) above). Employee acknowledges and agrees that Employee’s exclusive remedy in the event of any breach of thisAgreement shall be to assert Good Reason pursuant to the terms and conditions of Section 7(e) hereof. Notwithstanding the foregoing, during the Term, in theevent that the Company reasonably believes thatEmployee may have engaged in conduct that could constitute Cause hereunder, the Company may, in its sole and absolute discretion, suspend Employee fromperforming Employee’s duties hereunder, and in no event shall any such suspension constitute an event pursuant to which Employee may terminate employmentwith Good Reason or otherwise constitute a breach hereunder; provided , that no such suspension shall alter the Company’s obligations under this Agreementduring such period of suspension.(k) “ Release of Claims ” shall mean a separation agreement in a form acceptable to the Company under which Employee releases theCompany from any and all claims and causes of action and the execution of which is a condition precedent to Employee’s eligibility for Severance Benefits in theevent his employment is terminated by the Company without Cause or by Employee for Good Reason, as described in Sections 7(d) and 7(e).(l) “ Retention Bonus Amount ” shall mean any cash retention bonus awarded prior to the Date of Termination.(m) “ Severance Benefits ” shall mean (i) continued payment of Base Salary during the Severance Term, payable in accordance with theCompany’s regular payroll practices, and (ii) subject to the Employee’s timely election of COBRA and copayment of premium amounts at the active employees’rate, payment of the employer portion of the premiums for the Company’s group health and dental program for the Employee in order to allow him to continue toparticipate in the Company’s group health and dental program until the earlier of (Y) 12 months from the Date of Termination, and (Z) the date the Employeebecomes re-employed and eligible for health and/or dental insurance; provided, however , that this subsection (ii) is to be modified, as required, and by mutualagreement of the parties, to comply with the non-discrimination rules and other provisions and requirements of the Patient Protection and Affordable Care Act.(n) “ Severance Term ” shall mean the twelve (12) month period, which commences on the first day following the Date of Terminationfollowing termination by the Company without Cause or by Employee for Good Reason.Section 2. Acceptance and Term.The Company agrees to continue to employ Employee on an at-will basis, and Employee agrees to accept such employment and serve theCompany, in accordance with the terms and conditions set forth herein. The term of employment (referred to herein as the “ Term ”) shall continue until terminatedby either party at any time, subject to the provisions herein.Section 3. Position, Duties, and Responsibilities; Place of Performance.(a) Position, Duties, and Responsibilities . During the Term, Employee shall be employed and serve as Acting General Counsel andSecretary of the Company (together with such other position or positions consistent with Employee’s title or as the Company shall specify from time to time) andshall have such duties and responsibilities commensurate therewith, and such other duties as may be assigned and/or prescribed from time to time by the ChiefExecutive Officer and/or the Board or its designee.(b) Performance . Employee shall devote his full business time, attention, skill, and best efforts to the performance of his duties underthis Agreement and shall not engage in any other business or occupation during the Term, including, without limitation, any activity that (x) conflicts with theinterests of the Company, (y) interferes with the proper and efficient performance of Employee’s duties for the Company, or (z) interferes with Employee’sexercise of judgment in the Company’s best interests. Notwithstanding the foregoing, nothing herein shall preclude Employee from (i) serving, with the priorwritten consent of the Board, as a member of the boards of directors or advisory boards (or their equivalents in the case of a non-corporate entity) of non-competing businesses and charitable organizations, (ii) engaging in charitable activities and community affairs, and (iii) managing Employee’s personalinvestments and affairs; provided , however , that the activities set out in clauses (i), (ii), and (iii) shall be limited by Employee so as not to interfere, individuallyor in the aggregate, with the performance of Employee’s duties and responsibilities hereunder. Employee represents that he has provided the Company with acomprehensive list of all outside professional activities with which he is currently involved or reasonably expects to become involved. In the event that, during hisemployment by the Company, the Employee desires to engage in other outside professional activities, not included on such list, Employee will first seek writtenapproval from the CEO or President and such approval shall not be unreasonably withheld.Section 4. Compensation.(a) Base Salary . In exchange for Employee’s satisfactory performance of his duties and responsibilities, Employee initially shall bepaid a semi-monthly Base Salary of $11,120.96 ($266,903 on an annualized basis), payable in accordance with the regular payroll practices of the Company. Allpayments in this Agreement are on a gross, pre-tax basis and shall be subject to all applicable federal, state and local withholding, payroll and other taxes.(b) Target Bonus . In addition to the Base Salary, Employee will be eligible to earn an annual target bonus of up to 40% of his Base Salary(the “ Target Bonus ”). There is an overachievement component to this bonus target, as determined by the Board (or a committee thereof) and Employee’s managerin their sole discretion. The actual amount of suchbonus, if any, will be determined by the Board (or a committee thereof) and Employee’s manager in their sole discretion, based upon Company performance,Employee’s achievement of a series of performance milestones, and any other factors that the Board (or a committee thereof), in its discretion, deem appropriate.Employee’s achievement of such milestones, as well as the amount of any bonus, shall be determined by the Board and Employee’s manager in their solediscretion. Typically, bonuses, if any, are paid out no later than March 15 of the year following the applicable bonus year. Employee must be employed byAegerion at the time of any such bonus payment in order to be eligible for any such payment.Section 5. Employee Benefits.During the Term, Employee shall be eligible to participate in health insurance and other benefits provided generally to similarly situatedemployees of the Company, subject to the terms and conditions of the applicable benefit plans (which shall govern) and, during the period of the ExpatriateAssignment, the Expatriate Assignment Letter. Employee also shall be eligible for the same number of holidays and vacation days as well as any other benefits, ineach case as are generally allowed to similarly situated employees of the Company in accordance with the Company policy as in effect from time to time. Nothingcontained herein shall be construed to limit the Company’s ability to amend, suspend, or terminate any employee benefit plan or policy at any time withoutproviding Employee notice, and the right to do so is expressly reserved.Section 6. Reimbursement of Business Expenses; Relocation and Temporary Living Assistance.During the Term of Employment, the Company shall pay (or promptly reimburse Employee) for documented, out-of-pocket expenses reasonablyincurred by Employee in the course of performing his duties and responsibilities hereunder, which are consistent with the Company’s policies in effect from timeto time with respect to business expenses, subject to the Company’s requirements with respect to reporting of such expenses; provided that, the terms of theExpatriate Assignment Letter shall govern the payment or reimbursement of expenses incurred in connection with the Expatriate Assignment.Section 7. Termination of Employment.(a) General . Employee’s employment with the Company shall terminate upon the earliest to occur of: (i) Employee’s death, (ii) atermination by reason of a Disability, (iii) a termination by the Company with or without Cause, and (iv) a termination by Employee with or without Good Reason.Notwithstanding anything herein to the contrary, the payment (or commencement of a series of payments) hereunder of any nonqualified deferred compensation(within the meaning of Section 409A of the Code) upon a termination of employment shall be delayed until such time as Employee has also undergone a“separation from service” as defined in Treas. Reg. 1.409A-1(h), at which time such nonqualified deferred compensation (calculated as of the date of Employee’stermination of employment hereunder) shall be paid (or commence to be paid) to Employee on the schedule set forth in this Section 7 as if Employee hadundergone such termination of employment (under the same circumstances) on the date of Employee’s ultimate “separation from service.”(b) Termination Due to Death or Disability . Employee’s employment under this Agreement shall terminate automatically uponEmployee’s death. The Company also may terminate Employee’s employment immediately upon the occurrence of a Disability, such termination to be effectiveupon Employee’s receipt of written notice of such termination. In the event of Employee’s termination as a result of Employee’s death or Disability, Employee orEmployee’s estate or beneficiaries, as the case may be, shall be entitled only to the Accrued Obligations and the Retention Bonus Amount, and Employee shallhave no further rights to any compensation or any other benefits under this Agreement.(c) Termination by the Company with Cause .(i) The Company may terminate Employee’s employment at any time with Cause, effective upon Employee’s receipt of written noticeof such termination; provided , however , that with respect to any Cause termination relying on clause (i) or (ii) of the definition of Cause set forth in Section 1(d)hereof, to the extent that such act or acts or failure or failures to act are curable, Employee shall be given ten (10) days’ written notice by the Company of itsintention to terminate him with Cause, such notice to state the act or acts or failure or failures to act that constitute the grounds on which the proposed terminationwith Cause is based, and such termination shall be effective at the expiration of such ten (10) day notice period unless Employee has fully cured such act or acts orfailure or failures to act, to the Company’s complete satisfaction, that give rise to Cause during such period.(ii) In the event that the Company terminates Employee’s employment with Cause, Employee shall be entitled only to the AccruedObligations. Following such termination of Employee’s employment with Cause, except as set forth in this Section 7(c)(ii), Employee shall have no further rightsto any compensation or any other benefits under this Agreement. For the avoidance of doubt, Employee’s sole and exclusive remedy upon a termination ofemployment by the Company with Cause shall be receipt of the Accrued Obligations.(d) Termination by the Company without Cause . The Company may terminate Employee’s employment at any time without Cause,effective upon Employee’s receipt of written notice of such termination. In the event that Employee’semployment is terminated by the Company without Cause (other than due to death or Disability) and provided that he fully executes and does not revoke aneffective Release of Claims as described in Section 7(g), Employee shall be eligible for:(i) The Accrued Obligations;(ii) The Severance Benefits;(iii) At the end of the Severance Term, the Retention Bonus Amount; and(iv) If such termination without Cause and the Date of Termination occur within eighteen (18) months after a Sale Event (as suchterm is defined in the Company’s 2010 Stock Option and Incentive Plan), acceleration of the vesting of 100% of Employee’s then outstanding unvestedequity awards, such that all unvested equity awards vest and become fully exercisable or non-forfeitable as of the Date of Termination (the “ AcceleratedEquity Benefit ”) , in which case Employee shall have ninety (90) days from the Date of Termination to exercise the vested equity awards.Notwithstanding the foregoing, the Severance Benefits shall immediately terminate, and the Company shall have no further obligations to Employee with respectthereto, in the event that Employee breaches any provision of the Confidentiality Agreement or the Release of Claims. Any such termination of payment or benefitsshall have no effect on the Release of Claims or any of Employee’s post-employment obligations to the Company. Following such termination of Employee’semployment by the Company without Cause, except as set forth in this Section 7(d), Employee shall have no further rights to any compensation or any otherbenefits under this Agreement. For the avoidance of doubt, Employee’s sole and exclusive remedy upon a termination of employment by the Company withoutCause shall be receipt of (i) the Severance Benefits (and, in the case of such a termination within eighteen (18) months after a Sale Event, the Accelerated EquityBenefit), subject to his execution of the Release of Claims, (ii) the Accrued Obligations, and (iii) at the end of the Severance Term, the Retention Bonus Amount,subject to his execution of the Release of Claims.If the Company makes overpayments of Severance Benefits, Employee promptly shall return any such overpayments to the Company and/or hereby authorizesdeductions from future Severance Benefit amounts.(e) Termination by Employee with Good Reason . Employee may terminate his employment with Good Reason by providing theCompany thirty (30) days’ written notice setting forth in reasonable specificity the event that constitutes Good Reason, which written notice, to be effective, mustbe provided to the Company within sixty (60) days of the occurrence of such event. During such thirty (30) day notice period, the Company shall have a cure right(if curable), and if not cured within such period, Employee’s termination will be effective upon the expiration of such cure period, and Employee shall be entitledto the same payments and benefits as provided in Section 7(d) hereof for a termination by the Company without Cause, subject to the same conditions on paymentand benefits as described in Section 7(d) hereof. Following such termination of Employee’s employment by Employee with Good Reason, except as set forth inthis Section 7(e), Employee shall have no further rights to any compensation or any other benefits under this Agreement. For the avoidance of doubt, Employee’ssole and exclusive remedy upon a termination of employment with Good Reason shall be receipt of (i) the Severance Benefits (and, in the case of such atermination within eighteen (18) months after a Sale Event, the Accelerated Equity Benefit), subject to his execution of the Release of Claims, (ii) the AccruedObligations, and (iii) at the end of the Severance Term, the Retention Bonus Amount, subject to his execution of the Release of Claims.(f) Termination by Employee without Good Reason . Employee may terminate his employment without Good Reason by providing theCompany thirty (30) days’ written notice of such termination. In the event of a termination of employment by Employee under this Section 7(f), Employee shall beentitled only to the Accrued Obligations. In the event of termination of Employee’s employment under this Section 7(f), the Company may, in its sole and absolutediscretion, by written notice accelerate such date of termination without changing the characterization of such termination as a termination by Employee withoutGood Reason. Following such termination of Employee’s employment by Employee without Good Reason, except as set forth in this Section 7(f), Employee shallhave no further rights to any compensation or any other benefits under this Agreement. For the avoidance of doubt, Employee’s sole and exclusive remedy upon atermination of employment by Employee without Good Reason shall be receipt of the Accrued Obligations.(g) Release . Notwithstanding any provision herein to the contrary, the payment of the Severance Benefits and the Retention BonusAmount pursuant to subsection (d) or (e) of this Section 7 (other than the Accrued Obligations) shall be conditioned upon Employee’s execution, delivery to theCompany, and non-revocation of the Release of Claims (and the expiration of any revocation period contained in such Release of Claims) in accordance with thetime limits set forth therein. If Employee fails to execute the Release of Claims in such a timely manner, or timely revokes Employee’s acceptance of such releasefollowing its execution, Employee shall not be entitled to any of the Severance Benefits. Further, to the extent that any of the Severance Benefits constitutes“nonqualified deferred compensation” for purposes of Section 409A of the Code, any payment of any amount or provision of any benefit otherwise scheduled tooccur prior to the thirty-fifth (35 th ) day following the date of Employee’s termination of employment hereunder, but for the condition on executing the Release ofClaims as set forth herein, shall not bemade until the first regularly scheduled payroll date following such thirty-fifth (35 th ) day, after which any remaining Severance Benefits shall thereafter beprovided to Employee according to the applicable schedule set forth herein.Section 8. Confidentiality Agreement; Cooperation.(a) Confidentiality Agreement . As a condition of Employee’s employment with the Company under the terms of this Agreement,Employee has executed and delivered to the Company a Confidentiality Agreement. The parties hereto acknowledge and agree that this Agreement and theConfidentiality Agreement shall be considered separate contracts. In addition, Employee represents and warrants that he shall be able to and will perform the dutiesof this position without utilizing any confidential and/or proprietary information that Employee may have obtained in connection with employment with any prioremployer, and that he shall not (i) disclose any such information to Aegerion, or (ii) induce any Aegerion employee to use any such information, in either case inviolation of any confidentiality obligation, whether by agreement or otherwise.(b) Litigation and Regulatory Cooperation . During and after Employee’s employment, Employee shall cooperate fully with theCompany in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company whichrelate to events or occurrences that transpired while the Company employed Employee, provided, that the Employee will not have an obligation under thisparagraph with respect to any claim in which the Employee has filed directly against the Company or related persons or entities. The Employee’s full cooperationin connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as awitness on behalf of the Company at mutually convenient times. During and after Employee’s employment, Employee also shall cooperate fully with the Companyin connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrencesthat transpired while Employee was employed by the Company, provided Employee will not have any obligation under this paragraph with respect to any claim inwhich Employee has filed directly against the Company or related persons or entities. The Company shall reimburse Employee for any reasonable out-of-pocketexpenses incurred in connection with Employee’s performance of obligations pursuant to this Section 8(b).Section 9. Taxes.The Company may withhold from any payments made under this Agreement all applicable taxes, including but not limited to income,employment, and social insurance taxes, as shall be required by law. Employee acknowledges and represents that the Company has not provided any tax advice tohim in connection with this Agreement and that Employee has been advised by the Company to seek tax advice from Employee’s own tax advisors regarding thisAgreement and payments that may be made to him pursuant to this Agreement, including specifically, the application of the provisions of Section 409A of theCode to such payments. The Company shall have no liability to Employee or to any other person if any of the provisions of this Agreement are determined toconstitute deferred compensation subject to Section 409A but that do not satisfy an exemption from, or the conditions of, that section.Section 10. Additional Section 409A Provisions.Notwithstanding any provision in this Agreement to the contrary:(a) If at the time of the Employee’s separation from service within the meaning of Section 409A of the Code, the Company determinesthat the Employee is a “specified employee” within the meaning of Section 409A(a)(2)(B)(i) of the Code, then to the extent any payment or benefit that theEmployee becomes entitled to under this Agreement on account of the Employee’s separation from service is “non-qualified deferred compensation” subject toSection 409A of the Code and not otherwise exempt, such payment shall not be payable and such benefit shall not be provided until the date that is the earlier of (i)six months and one day after the Employee’s separation from service, or (ii) the Employee’s death. If any such delayed cash payment is otherwise payable on aninstallment basis, the first payment shall include a catch-up payment covering amounts that would otherwise have been paid during the six-month period but for theapplication of this provision, and the balance of the installments shall be payable in accordance with their original schedule.(b) Each payment in a series of payments hereunder shall be deemed to be a separate payment for purposes of Section 409A of theCode. Neither the Company nor Employee shall have the right to accelerate or defer the delivery of any such payments except to the extent specifically permittedor required by Section 409A.(c) To the extent that any right to reimbursement of expenses or payment of any benefit in-kind under this Agreement constitutesnonqualified deferred compensation (within the meaning of Section 409A of the Code), (i) any such expense reimbursement or payment shall be made by theCompany no later than the last day of the taxable year following the taxable year in which such expense was incurred by Employee, (ii) the right to reimbursement,payment or in-kind benefits shall not be subject to liquidation or exchange for another benefit, and (iii) the amount of expenses eligible for reimbursement,payment or in-kind benefits provided during any taxable year shall not affect the expenses eligible for reimbursement or in-kind benefits to be provided in anyother taxable year; provided , that the foregoing clause shall not be violated with regard to expenses reimbursed under anyarrangement covered by Section 105(b) of the Code solely because such expenses are subject to a limit related to the period the arrangement is in effect.(d) To the extent that any payment or benefit described in this Agreement constitutes “non-qualified deferred compensation” underSection 409A of the Code, and to the extent that such payment or benefit is payable upon the Employee’s termination of employment, then such payments orbenefits shall be payable only upon the Employee’s “separation from service.” The determination of whether and when a separation from service has occurred shallbe made in accordance with the presumptions set forth in Treasury Regulation Section 1.409A‑1(h).(e) The parties intend that this Agreement will be administered in accordance with Section 409A of the Code. To the extent that anyprovision of this Agreement is ambiguous as to its compliance with Section 409A of the Code, the provision shall be read in such a manner so that all paymentshereunder comply with Section 409A of the Code. The parties agree that this Agreement may be amended, as reasonably requested by either party, and as may benecessary to fully comply with Section 409A of the Code and all related rules and regulations in order to preserve the payments and benefits provided hereunderwithout additional cost to either party. While the payments and benefits provided hereunder are intended to be structured in a manner to avoid the implication ofany penalty taxes under Section 409A of the Code, in no event whatsoever shall the Company or any of its affiliates be liable for any additional tax, interest, orpenalties that may be imposed on Employee as a result of Section 409A of the Code or any damages for failing to comply with Section 409A of the Code (otherthan for withholding obligations or other obligations applicable to employers, if any, under Section 409A of the Code).Section 11. Successors and Assigns.(a) The Company . This Agreement shall inure to the benefit of the Company and its respective successors and assigns. This Agreementmay be assigned by the Company without Employee’s prior consent.(b) Employee . Employee’s rights and obligations under this Agreement shall not be transferable by Employee by assignment orotherwise, without the prior written consent of the Company; provided , however , that if Employee shall die, all amounts then payable to Employee hereundershall be paid in accordance with the terms of this Agreement to Employee’s devisee, legatee, or other designee, or if there be no such designee, to Employee’sestate.Section 12. Waiver and Amendments.Any waiver, alteration, amendment, or modification of any of the terms of this Agreement shall be valid only if made in writing and signed byeach of the parties hereto; provided , however , that any such waiver, alteration, amendment, or modification must be consented to on the Company’s behalf by theBoard. No waiver by either of the parties hereto of their rights hereunder shall be deemed to constitute a waiver with respect to any subsequent occurrences ortransactions hereunder unless such waiver specifically states that it is to be construed as a continuing waiver.Section 13. Severability.If any covenants or such other provisions of this Agreement are found to be invalid or unenforceable by a final determination of a court ofcompetent jurisdiction, (a) the remaining terms and provisions hereof shall be unimpaired, and (b) the invalid or unenforceable term or provision hereof shall bedeemed replaced by a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term orprovision hereof.Section 14. Governing Law and Jurisdiction.This is a Massachusetts contract and shall be construed under and be governed in all respects by the laws of the Commonwealth ofMassachusetts without giving effect to the conflict of laws principles of such state. With respect to any disputes concerning federal law, such disputes shall bedetermined in accordance with the law as it would be interpreted and applied by the United States Court of Appeals for the First Circuit. To the extent that anycourt action is initiated to enforce this Agreement, the parties hereby consent to the jurisdiction of the state and federal courts of the Commonwealth ofMassachusetts. Accordingly, with respect to any such court action, Employee (a) submits to the personal jurisdiction of such courts; (b) consents to service ofprocess; and (c) waives any other requirement (whether imposed by statute, rule of court, or otherwise) with respect to personal jurisdiction or service of process.Section 15. Notices.(a) Place of Delivery. Every notice or other communication relating to this Agreement shall be in writing, and shall be mailed to ordelivered to the party for whom or which it is intended at such address as may from time to time be designated by it in a notice mailed or delivered to the otherparty as herein provided; provided, that unless and until some other address be so designated, all notices and communications by Employee to the Company shallbe mailed or delivered to the Company at its principal executive office, and all notices and communications by the Company to Employee may be given toEmployee personally or may be mailed to Employee at Employee’s last known address, as reflected in the Company’s records.(b) Date of Delivery . Any notice so addressed shall be deemed to be given or received (i) if delivered by hand, on the date of suchdelivery, (ii) if mailed by courier or by overnight mail, on the first business day following the date of such mailing, and (iii) if mailed by registered or certifiedmail, on the third business day after the date of such mailing.Section 16. Section Headings.The headings of the sections and subsections of this Agreement are inserted for convenience only and shall not be deemed to constitute a partthereof or affect the meaning or interpretation of this Agreement or of any term or provision hereof.Section 17. Entire Agreement.This Agreement, together with the Expatriate Assignment Letter, Confidentiality Agreement, the Company’s 2010 Stock Option and IncentivePlan and any stock option agreement entered into between the Company and Employee thereunder, constitute the entire understanding and agreement of the partieshereto regarding the employment of Employee. This Agreement supersedes all prior negotiations, discussions, correspondence, communications, understandings,and agreements between the parties (including any offer letter given to Employee) relating to the subject matter of this Agreement; provided that, the ExpatriateAssignment Letter shall, except as specifically amended herein, govern the terms of the Expatriate Assignment.Section 18. Survival of Operative Sections.Upon any termination of Employee’s employment, the provisions of Section 7 through Section 19 of this Agreement (together with any relateddefinitions set forth in Section 1 hereof) shall survive to the extent necessary to give effect to the provisions thereof.Section 19. Counterparts.This Agreement may be executed in two or more counterparts, each of which shall be deemed to be an original but all of which together shallconstitute one and the same instrument. The execution of this Agreement may be by actual or facsimile signature.Section 20. Gender Neutral.Wherever used herein, a pronoun in the masculine gender shall be considered as including the feminine gender unless the context clearlyindicates otherwise.IN WITNESS WHEREOF, the undersigned have executed this Agreement as of the date first above written.AEGERION PHARMACEUTICALS, INC./s/ Mary WegerBy: Mary WegerTitle: Chief Performance OfficerEMPLOYEE/s/ Benjamin HarshbargerBenjamin HarshbargerLETTER OF UNDERSTANDINGExpatriate Assignment to SwitzerlandOctober 28, 2013 ·Dear Ben:T his is . a letter of understanding, outlining the terms and conditions of your assignment to Aegerion in Nyon, Switzerland hereafter referred to as the "Company".This letter is a complete and full expression of the understanding between you and the Company as to the specifics of the terms and conditions covering your offerand transfer. This letter understands that your transfer and appointment is effective January 1, 2014 and your expatriate assignment will be i n effective on or aboutJune 30, 2014 coinciding with the end of the school year for your children.Final acceptance of this position is subject to medical clearance, granting of appropriate work authorization and acceptance of the terms and conditions of thisletter.ASSIGNMENTThe effective date of your transfer has been tentatively set to begin in January, 2014 and your expatiate assignment as of June, 2014. This transfer is viewed as anexpatriate assignment. Expatriate is defined as being on your home country payroll and benefits. The transfer is viewed as a 24-month time assignment. This timeframe may be extended should it be deemed appropriate for business reasons, but will not exceed 36 months. If at the end of the agreed-upon assignment, it isdetermined you will remain in a position outside of the United States, you will be immediately localized and this agreement will no longer be in force. In thisinstance, 60 days notice will be provided. Should you elect to return to your home country, the company will guarantee to return you, your family and yourbelongings, following the below shipment of . personal and household effects provisions, to your point of origin within 90 days of terminating your assignment.RESPONSIBILITIES/COMPENSATIONYour position will be as Vice President, EMEA, Legal Counsel for Aegerion. The salary for this position remains at your current salary of $245,620 gross per yearand will be effective upon your transfer to Switzerland in January, 2014. As an Expatriate, you will continue to be paid from the United States and you willcontinue, in addition to this base compensation, to be eligible to participate in Aegerion's Bonus Plan, which would target you for a bonus of 30% of your basesalary earnings, based on the achievement of agreed upon performance objectives. Actual awards are based on individual as well as company performance and arepaid annually, typically during the end of the first quarter following the applicable plan year. The award may be at, above or below the target level, but you canpotentially earn up to 150% of your target award based upon achievement of applicable performance objectives. Based upon performance you will also be eligiblefor annual merit adjustments during the company's annual performance and merit cycle each year.You will be an employee of Aegerion Pharmaceutica l s and will remain on the United States payroll system, through which your salary will continue t o beadministered. Your duties and responsibilities have been separately agreed with your manager, Anne Marie Cook and Massimo Boriero. You will observe theSwitzerland holidays and work hours. Your vacation · will be granted according to Aegerion United States policy based on your current service date, recognizingyour cumulative service with Aegerion. Aegerion Switzerland and Aegerion Corporate's personnel policies and practices will apply to the extent they areapplicable in Switzerland. You will also be enrolled in an Aegerion Benefit Plan for Expatriates to provide appropriate health and dental coverage for you and yourfamily during Your deployment in Switzerland. The premium for this coverage will be 100% paid by the company - you will be responsible for any out-of-pocketcharges commensurate with reasonable and customary US costs. Regarding other benefits, 401K and Life Insurance you will remain eligible to participate in theseprograms. Further information will be provided under separate cover on the medical and dental plan. ·RELOCATION ASSESSMENTYou are eligible for one (1) preview relocation assessment trip and (1) relocation selection trip for you and your family, to assist in making appropriate decisionssuch as where to live in the new assignment area. Our relocation vendor, Coldwell Banker Relocation, wi ll assist in assessing housing and general livingconditions. Each trip should be no more than seven (7) working days in length. Reimbursement for the trip will include airfare, hotel,rental vehicle, and mealswithin reasonable costs per Aegerion's Travel and Entertainment Policy.PHYSICAL · EXAMINATIONPrior to your move, we suggest that you complete a medical check-up and physical examination and receive any necessary immunizations prior to the assignment.Aegerion will reimburse any costs associated with the examination that are not covered by the assignee's medical insurance.TAXESPrior to your decision to accept this assignment, you will be required to use the services of Aegerion's designated tax firm, PriceWaterhouse Cooper, "PWC", toreview your personal tax and social insurance situation and resulting implications of the transfer. All personal tax issues should be discussed at this time and priorto making your final decis i on . We will finalize yourhome and host tax treatment after you have met with . PWC and after we determine the most favorable position under each country's law. You will be eligible forboth home and host country tax filing support from PWC at the compa ny's expense, through your Expatriate Assignment and for one year post the assignment.Any tax refunds received by the employee for tax paid by Aegerion on allowances or premiums must be returned to Aegerion.TAX EQUALIZATIONBased on the foregoing,you will be tax equalized for purposes of tax impact. This means that you will be no better or worse from a tax perspective relative to yourpersonal taxes. Should your tax preparation yield a higher tax impact based upon your expatriation to Switzerland, Aegerion agrees to cover the difference betweenyour former tax position and the higher tax rate effective in Switzerland and any related costs will be grossed up to ensure you will remain tax equalized.TRANSPORTATIONYou and your family will be provided with direct-route air transportation to your new location per the Aegerion Travel & Entertainment policy. You will also beeligible for one (1) excess baggage charge per family member, not to exceed US $100 . 00 per bag at Aegerion's expense.IMMIGRATIONAND VISAAegerion will assist in payment for completion of all immigration paper work and visa applications including all work and residence permits for you and yourfamily. This process will be facilitated through Emigra. The assignment may not begin until Aegerion has received approval of a visa authorizing you to work inSwitzerland.HOUSING EXPENSESAegerion will assist in locating, securing and covering the cost for appropriate housing in the host country. An assigned amount has been allocated based uponlocal market comparable availability not to exceed $8,000 USO per month. The lease for such housing will be between you and the landlord.Aegerion will cover the cost of reasonable furniture rentals for your family home rental. Additionally, based on your transition date, Aegerion will cover the cost ofa reasonable temporary living apartment during this transition period beginning in January through your rental of your family home anticipated to be in May orJune, 2014. During this time the company will pay for temporary living including lodging and meals only. All housing should be arranged through Aegerion'srelocation provider Coldwell Banker.Aegerion and Coldwell Banker will facilitate the down payment to secure housing, if required, in accordance with local practices in Switzerland. The refund of thedown payment at the conclusion of the assignment shall be reimbursed to Aegerion. .Aegerion will be fully responsible for any remaining expenses on your host location housing contract under the terms of this agreement should Aegerion terminateyour employment or end your assignment for any reason (other than for cause).SCHOOLINGAegerion will cover the cost of tuition and fees for your three children to attend an International School in the Nyon area. All such costs will be covered by thecompany. The payment of these fees will be agreed upon with our Finance function and in an efficient manner and so as not to create any out of pocket expense onyour part .SHIPMENT OF PERSONAL AND HOUSEHOLD EFFECTSColdwell Banker will facilitate the shipment of your personal belonging and household effects to Switzerland should this be needed. This includes full packing andcrating of your furniture and personal effects, limited to an aggregate 40-ft container size. lnsurance protection is limited to US $100,000. You will be responsibleto comply with the mover's requirements for inventorylistings.Also as needed . you are eligible for an airfreight shipment of personal effects, based on your family size, according to the following schedule:1 Standard "D" Container for you and your spouse1 Standard "E" Container for each dependentHOME LEAVETwo trips to Cambridge will be provided as home visits to you and your family annually. You will be eligible for direct-route air transportation to your homelocation per the Aegerion Travel& Entertainment policy . This amount will be based on a 30 day advance purchase business class fare between home and hostcountries. This amount will be tax assisted and paid to you in a lump sum.We will also provide transportation home for you and your family in the event of a family emergency or death of an immediate family member .CAR ALLOWANCEYou will be eligible for one automobile or car allowance whichever is most tax appropriate in Switzerland while you are on assignment in Switzerland. ·INCIDENTAL RELOCATION AU.OWANCE (RA)You will receive an Incidental Relocation Allowance of one month's salary to cover expenses associated with the need for adapters,small appliances, boarding andtransporting pets, personal telephone calls, and other miscellaneous relocation expenses .ENHANCEMENTSCost of Living AdjustmentYou will be eligible for a cost of living adjustment in the amount of $50,000 per year. This is based on a family size of five in Switzerland. This is to cover theincremental cost of goods and services in the host country vs. the home country and is benchmarked through a third party provider. Air-inc, a leader in expatriatecompensation management. This amount is covered in the Air Inc . Report as attached. This amount will be pro-rated according l y based upon your beginning andend date of your assignment.REPAYMENT OF RELOCAT ONEXPENSESShould you voluntarily terminate your employment with Aegerion either While on assignment or with in one year of the date of you r relocation back to the homecountry, you must repay 50% of costs associated with the household goods and personal effects shipments incurred by Aegerion. Aegerion will not be responsiblefor moving you and your family or personal possessions back to the home country in this event.REPATRIATIONUpon completion of the assignment, you will be relocated to a position of comparable status and responsibility in the home . country. Once the assignment iscompleted, Coldwell Banker will again facilitate the shipment of your personal belongings and household effects to your home country . This includes full packingand crating of your furniture and personal effects, limited to an aggregate 40-ft container size . Insurance protection is limited to US $100,000. You will again beresponsible to comply with the mover's requirements for inventory listings.Also as needed, you are eligible for an airfreight shipment of personal effects, based on your family size, according to the following schedule:1Standard D" Container for you and your spouse1Standard E" Container for each dependentORIf you elect to end the assignment and rel.um to the home country, or Aegerion ends the assignment or terminates your employment for any reason prior tocompletion (other than cause), Aegerion will pay for the actual cost of airfare and shipment of personal effects for you and your family to return to the homecountry, up to the following maximum amounts:Airfare: Actual cost of appropriate class tickets,per the Aegerion Travel & Entertainment policy.Excess Baggage: US$100.00 per bagShipment of Personal and Household effects: US$4,000 . 00Switzerland laws, which govern your employment with Aegerion Switzerland,will govern this letter . You and Aegerion hereby consent to the exclusivejurisdiction of the Switzerland court system for resolution of any disputes relating to this letter or to your employment with Aegerion Switzerland .Change of ControlShould a change of control occur during your expatriate assignment,at your sole decis i on,you may elect to end the assignment and return to the homecountry.Aegerion will pay for all reasonable and customary costs to relocate you back to the home country including costs related to termination of your lease , theactual cost of airfare,packing and shipment of personal effects fur you and your family to return to the home country, up to the following maximum amounts:Airfare: Actual cost of appropriate class tickets. per the Aegerion Travel & Entertainment policy.Excess Baggage: US$100.00 per bagSh i pment of Personal and Household effects: US$4,000.00The company will not pay for any costs related to damage of property and any such damage resulting in the forfeiture of the security deposit in full must be repaidto Aegerion regardless of legal or administrative proceedings which may result in dispute of such findings.A rep o rt from Air Inc outlining the cost estimate for "covered" items included and not included in the Letter of Agreement s attached. These reflect approximatemarket pricing for each area covered and may differ in pricing once quoted from each related provider. I n the event covered costs are not i ncluded in the report ,but are in this letter, the costs will be covered as outlined in this letter.If you are in agreement with the terms and conditions outlined in this letter , Which will affect your transfer , please sign and send a PDF of this letter to me./s/ Benjamin Harshbarger 11/4/13Name (Date)Aegerion Expatriate/s/ Mary Weger 11/1/13Mary Weger (Date)Senior Vice PresidentHuman Resources/s/ Anne Marie Cook 11/4/13Supervisor's Name (Date)TitleSCHEDULE “B”GENERAL RELEASE AND WAIVER OF CLAIMSIn exchange for the severance benefits to be provided to me under the employment agreement between me and Novelion Services USA, Inc. (“NovelionServices”), dated as of November 28, 2016 (the “Employment Agreement”), to which I would not otherwise be entitled, on my own behalf and that of my heirs,executors, administrators, beneficiaries, personal representatives and assigns, I agree that this General Release and Waiver of Claims (the “Release of Claims”)shall be in complete and final settlement of any and all causes of action, rights and claims, whether known or unknown, accrued or unaccrued, contingent orotherwise, that I have had in the past, now have, or might now have, in any way related to, connected with or arising out of my employment or its termination,under the Employment Agreement, or pursuant to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Age Discrimination inEmployment Act, as amended by the Older Workers Benefit Protection Act, the Worker Adjustment and Retraining Notification Act, the Employee RetirementIncome Security Act, the wage and hour, wage payment and fair employment practices laws and statutes of the Commonwealth of Massachusetts (each as amendedfrom time to time), and/or any other federal, state or local law, regulation or other requirement and, if the employment laws of Canada apply to my employment,the Ontario and British Columbia Employment Standards Acts, the Ontario and British Columbia Human Rights Codes, and any other applicable Canadian orprovincial law, regulation or other requirement (each as amended from time to time) (collectively, the “Claims”), and I hereby release and forever dischargeNovelion Services, its Affiliates (as defined in the Employment Agreement, and including for certainty and without limitation QLT Inc. and AegerionPharmaceuticals, Inc.), and all of their respective past, present and future directors, shareholders, officers, members, managers, general and limited partners,employees, employee benefit plans, administrators, trustees, agents, representatives, successors and assigns, and all others connected with any of them (the“Releasees”), both individually and in their official capacities, from, and I hereby waive, any and all such Claims. This release shall not apply to (a) any claims thatarise after I sign this Release of Claims, including my right to enforce the terms of this Release of Claims; (b) any claims that may not be waived pursuant toapplicable law; (c) any right to indemnification that I may have under the certificate of incorporation or by-laws of Novelion Services, and any indemnificationagreement between me and Novelion Services or any insurance policies maintained by Novelion Services; or (d) any right to receive any vested benefits under theterms of any employee benefit plans and my award agreements thereunder.I agree that the Releasees have satisfied all obligations to me under the legislation referred to in the previous paragraph in relation to my employment and thecessation of my employment, and I have considered any and all human rights complaints, concerns, or issues arising out of or in respect to my employment withNovelion Services, I am aware of my rights under the legislation referred to in the previous paragraph, and I confirm that I am not asserting such rights oradvancing a human rights claim or complaint against the Releasees.Nothing contained in this Release of Claims shall be construed to prohibit me from filing a charge with or participating in any investigation or proceedingconducted by the federal Equal Employment Opportunity Commission or a comparable state or local agency, provided, however, that I hereby agree to waive myright to recover monetary damages or other individual relief in any charge, complaint or lawsuit filed by me or by anyone else on my behalf.In signing this Release of Claims, I acknowledge my understanding that I may consider the terms of this Release of Claims for up to [twenty-one (21) /forty-five(45)] To be determined by Novelion Services at the time of termination. days from the date I receive it and that I may not sign this Release of Claims until after thedate my employment with Novelion Services terminates. I also acknowledge that I am hereby advised by Novelion Services to seek the advice of an attorney priorto signing this Release of Claims; that I have had sufficient time to consider this Release of Claims and to consult with an attorney, if I wished to do so, or toconsult with any other person of my choosing before signing; and that I am signing this Release of Claims voluntarily and with a full understanding of its terms.I further acknowledge that, in signing this Release of Claims, I have not relied on any promises or representations, express or implied, that are not set forthexpressly in the Release of Claims. I understand that I may revoke this Release of Claims at any time within seven (7) days of the date of my signing by writtennotice to the Board of Directors of Novelion Services and that this Release of Claims will take effect only upon the expiration of such seven-day revocation periodand only if I have not timely revoked it.Intending to be legally bound, I have signed this Release of Claims under seal as of the date written below.Signature: /s/ Benjamin HarshbargerName: Benjamin HarshbargerDate Signed: _______________________ 1 To be determined by Novelion Services at the time of termination .SCHEDULE “C”CONFIDENTIALITY, ASSIGNMENT OF INTELLECTUAL PROPERTY AND NON-COMPETITION AGREEMENT[See attached]NOVELION SERVICES USA, INC.Employee Confidentiality, Assignment of Intellectual Property and Non-Competition AgreementIn consideration and as a condition of my employment or continued employment by Novelion Services USA, Inc. (the "Company"), I agree as follows:1. Employee Acknowledgements . I acknowledge that I will be provided, and/or have been provided, with trade secrets and/or valuable confidentialbusiness information belonging to the Company and/or its Affiliates (as defined in paragraph 19), and have developed and/or will develop substantial relationshipswith prospective and existing customers and clients of the Company and its Affiliates, and, as a result, shall benefit from the good will of the Company and itsAffiliates. I also acknowledge that the Company and its Affiliates have invested substantial resources in the development of their trade secrets, confidentialbusiness information, client relationships and good will and in recruiting, hiring and training their professionals and staff. I further acknowledge that I havereceived and/or will receive substantial training from the Company and its Affiliates. I hereby acknowledge and agree that the Company and its Affiliates have alegitimate interest in protecting their substantial investment in their development of trade secrets, confidential information, good will and a highly trained staff andthat the covenants to which I agree to be bound herein are necessary to protect such legitimate interests.2. Proprietary Information . I agree that all information, whether or not in writing, concerning the business, technology, business relationships orfinancial affairs of the Company and its Affiliates which the Company (or applicable Affiliate) has not released to the general public (collectively, "ProprietaryInformation") is and will be the exclusive property of the Company (or applicable Affiliate). By way of illustration, Proprietary Information may includeinformation or material which has not been made generally available to the public, such as: (a) corporate information, including plans, strategies, methods, policies,resolutions, negotiations or litigation; (b) marketing information, including strategies, methods, customer identities or other information about customers, prospectidentities or other information about prospects, or market analyses or projections; (c) financial information, including cost and performance data, debtarrangements, equity structure, investors and holdings, purchasing and sales data and price lists; and (d) operational and technological information, including plans,specifications, manuals, forms, templates, software, designs, methods, procedures, formulas, discoveries, inventions, improvements, concepts and ideas; and (e)personnel information, including personnel lists, reporting or organizational structure, resumes, personnel data, compensation structure, performance evaluationsand termination arrangements or documents. Proprietary Information also includes information received in confidence by the Company or its Affiliates fromcustomers or suppliers or other third parties.3. Recognition of Company’s Rights . I will not, at any time, without the Company's prior written permission, either during or after my employment,disclose any Proprietary Information to anyone outside of the Company, or use or permit to be used any Proprietary Information for any purpose other than theperformance of my duties as an employee of the Company. I will cooperate with the Company and its Affiliates and use my best efforts to prevent the unauthorizeddisclosure of all Proprietary Information. I will deliver to the Company all copies of Proprietary Information in my possession or control upon the earlier of arequest by the Company or termination of my employment.4. Rights of Others . I understand that the Company and its Affiliates are now and may hereafter be subject to nondisclosure or confidentialityagreements with third persons which require the Company (or applicable Affiliate) to protect or refrain from use of proprietary information. I agree to be bound bythe terms of such agreements in the event I have access to such proprietary information.5. Commitment to Company: Avoidance of Conflict of Interest . While an employee of the Company, I will devote my full-time efforts to theCompany's business and I will not engage in any other business activity that conflicts with my duties to the Company (including the services the Companyprovides to its Affiliates). I will advise the Chief Executive Officer of the Company at such time as any activity of either the Company or another business presentsme with a conflict of interest or the appearance of a conflict of interest as an employee of the Company. I will take whatever action is requested of me by theCompany to resolve any conflict or appearance of conflict which it finds to exist.6. Developments . I will make full and prompt disclosure to the Company of all inventions, discoveries, designs, developments, methods, modifications,improvements, processes, algorithms, databases, computer programs, formulae, techniques, trade secrets, graphics or images, and audio or visual works and otherworks of authorship, whether or not patentable or copyrightable, that are created, made, conceived or reduced to practice by me (alone or jointly with others) orunder my direction during the period of my employment (collectively, the "Developments"). I acknowledge that all work performed by me is on a "work for hire"basis, and I hereby do assign and transfer and, to the extent any such assignment cannot be made at present, will assign and transfer, to the Company (or anyAffiliate designated by the Company) and its successors and assigns all my right, title and interest in all Developments that: (a) relate to the business of theCompany or its Affiliates or any customer of the Company or its Affiliates or any of the products or services being researched, developed, manufactured or sold bythe Company or itsAffiliates or which may be used with such products or services; or (b) result from tasks assigned to me by the Company; or (c) result and/or are developed duringor after my employment from the use of premises or personal property (whether tangible or intangible) owned, leased or contracted for by the Company or itsAffiliates (collectively, "Company-Related Developments"), and all related patents, patent applications, trademarks and trademark applications, copyrights andcopyright applications, and other intellectual property rights in all countries and territories worldwide and under any international conventions ("IntellectualProperty Rights").To preclude any possible uncertainty, I have set forth on Exhibit A attached hereto a complete list of Developments that I have, alone or jointly with others,conceived, developed or reduced to practice prior to the commencement of my employment with the Company that I consider to be my property or the property ofthird parties and that I wish to have excluded from the scope of this Agreement ("Prior Inventions"). If disclosure of any such Prior Invention would cause me toviolate any prior confidentiality agreement, I understand that I am not to list such Prior Inventions in Exhibit A but am only to disclose a cursory name for eachsuch invention, a listing of the party(ies) to whom it belongs and the fact that full disclosure as to such inventions has not been made for that reason. I have alsolisted on Exhibit A all patents and patent applications in which I am named as an inventor, other than those which have been assigned to the Company ("OtherPatent Rights"). If no such disclosure is attached, I represent that there are no Prior Inventions or Other Patent Rights. If, in the course of my employment with theCompany, I incorporate a Prior Invention into a Company or Affiliate product, process or machine or other work done for the Company or an Affiliate, I herebygrant to the Company (or any Affiliate designated by the Company) a nonexclusive, royalty-free, paid-up, irrevocable, worldwide license (with the full right tosublicense) to make, have made, modify, use, sell, offer for sale and import such Prior Invention. Notwithstanding the foregoing, I will not incorporate, or permit tobe incorporated, Prior Inventions in any Company-Related Development without the Company's prior written consent.This Agreement does not obligate me to assign to the Company of any of its Affiliates any Development which, in the sole judgment of the Company, reasonablyexercised, is developed entirely on my own time and does not relate to the business efforts or research and development efforts in which, during the period of myemployment, the Company or its Affiliates actually are engaged or reasonably would be engaged, and does not result from the use of premises or equipment ownedor leased by the Company or its Affiliates. However, I will also promptly disclose to the Company any such Developments for the purpose of determining whetherthey qualify for such exclusion. I understand that to the extent this Agreement is required to be construed in accordance with the laws of any jurisdiction whichprecludes a requirement in an employee agreement to assign certain classes of inventions made by an employee, this paragraph 6 will be interpreted not to apply toany invention which a court rules and/or the Company agrees, falls within such classes. I also hereby waive all claims to any moral rights or other special rightswhich may have or accrue in any Company-Related Developments or Intellectual Property Rights.7. Documents and Other Materials . I will keep and maintain adequate and current records of: (a) all Proprietary Information and Company-RelatedDevelopments developed by me during my employment; and (b) all documentation regarding any Intellectual Property Rights, which relate to such ProprietaryInformation and Company-Related Developments. Such records will be available to and remain the sole property of the Company (or applicable Affiliate of theCompany) at all times.All files, letters, notes, memoranda, reports, records, data, sketches, drawings, notebooks, layouts, charts, quotations and proposals, specification sheets, or otherwritten, photographic or other tangible material containing Proprietary Information, whether created by me or others, which come into my custody or possession,are the exclusive property of the Company (or applicable Affiliate) to be used by me only in the performance of my duties for the Company. Any property situatedon the premises of the Company or its Affiliates, owned or purchased by the Company or its Affiliates, disseminated by the Company or its Affiliates, and/or usedor created by me for business purposes in the course of my duties for the Company, including without limitation computers, email accounts, cell phone records andtext messages, disks and other storage media, filing cabinets or other work areas, is the property of the Company (or, if applicable, an Affiliate) and is subject toinspection by the Company at any time with or without notice. In the event of the termination of my employment for any reason, I will deliver to the Company allCompany and Affiliate property, including, without limitation, all Proprietary Information, all documents related to Company-Related Developments, allcomputers, keys, passwords, cell phones, entry cards, files, letters, notes, memoranda, reports, records, data, sketches, drawings, notebooks, layouts, charts,quotations and proposals, specification sheets, or other written, photographic or other tangible material, and will not take or keep in my possession any Company orAffiliate property or any copies (electronic or hard-copy) of such property.8. Enforcement of Intellectual Property . I will cooperate fully with the Company, both during and after my employment with the Company, withrespect to the procurement, maintenance and enforcement of Intellectual Property Rights in Company-Related Developments. I will sign, both during and after theterm of this Agreement, all papers, including without limitation copyright applications, patent applications, declarations, oaths, assignments of priority rights, andpowers of attorney, which the Company may deem necessary or desirable in order to protect its (or any Affiliate’s) rights and interests in any Company-RelatedDevelopment. If the Company is unable, after reasonable effort, to secure my signature on any such papers, I hereby irrevocably designate and appoint each officerof the Company as my agent and attorney-in-fact to execute any such papers on my behalf, andto take any and all actions as the Company may deem necessary or desirable in order to protect its (or any Affiliate’s) rights and interests in any Company-RelatedDevelopment.9. Non-Competition and Non-Solicitation . In order to protect the Proprietary Information and good will of the Company and its Affiliates, during myemployment and for a period of twelve (12) months following the termination of my employment for any reason (the "Restricted Period"), I will not directly orindirectly, whether as owner, partner, shareholder, director, manager, consultant, agent, employee, co-venturer or otherwise, engage, participate or invest in anybusiness activity anywhere in the world that develops, manufactures or markets any products, or performs any services, that are competitive (directly or indirectly)with the products or services of the Company or its Affiliates, or products or services that the Company or its Affiliates have under development or that are thesubject of active planning at any time during the last 24 months of my employment; provided that this shall not prohibit any possible investment in publicly tradedstock of a company representing less than one percent of the stock of such company. In addition, during the Restricted Period, I will not, directly or indirectly, inany manner, for any purpose that is competitive with or detrimental to the business of the Company or an Affiliate, (a) call upon, solicit, divert, take away, acceptor conduct any business from or with any of the customers or prospective customers of the Company or its Affiliates, or any suppliers thereof, and/or (b) solicit,entice, or attempt to persuade any other employee or consultant of the Company or an Affiliate to leave the Company or Affiliate for any reason. I acknowledgeand agree that if I violate any of the provisions of this paragraph 9, the running of the Restricted Period will be extended by the time during which I engage in suchviolation(s).10. Government Contracts . I acknowledge that the Company and/or its Affiliates may have from time to time agreements with other persons orgovernmental authorities which impose obligations or restrictions on the Company and/or its Affiliates regarding inventions made during the course of work undersuch agreements or regarding the confidential nature of such work. I agree to comply with any such obligations or restrictions upon the direction of the Company.In addition to the rights assigned under paragraph 6, I also assign to the Company (or any of its nominees) all rights which I have or acquired in any Developments,full title to which is required to be held by the particular governmental authority under any contract between the Company and the given governmental authority.11. Prior Agreements . I hereby represent that, except as I have fully disclosed previously in writing to the Company, I am not bound by the terms of anyagreement with any previous employer (other than Aegerion Pharmaceuticals, Inc.) or other party to refrain from using or disclosing any trade secret orconfidential or proprietary information in the course of my employment with the Company or to refrain from competing, directly or indirectly, with the business ofsuch previous employer or any other party. I further represent that my performance of all the terms of this Agreement as an employee of the Company does not andwill not breach any agreement to keep in confidence proprietary information, knowledge or data acquired by me in confidence or in trust prior to my employmentwith the Company. I will not disclose to the Company or its Affiliates or induce the Company or its Affiliates to use any confidential or proprietary information ormaterial belonging to any previous employer (other than Aegerion Pharmaceuticals, Inc.) or others.12. Remedies Upon Breach .(a) Equitable Relief. I understand that the restrictions contained in this Agreement are necessary for the protection of the business and goodwill of theCompany and its Affiliates and I consider them to be reasonable for such purpose. Any breach of this Agreement is likely to cause the Company and its Affiliatessubstantial and irrevocable damage and therefore, in the event of such breach, the Company and/or any Affiliate affected by such breach, in addition to such otherremedies which may be available, will be entitled to seek specific performance and other injunctive relief, without the posting of a bond.(b) Indemnification. If I violate this Agreement, in addition to all other remedies available to the Company and any affected Affiliates at law, in equity,and under contract, I agree that I am obligated to pay all the Company's (or, if applicable, Affiliate’s) costs of enforcement of this Agreement, including attorneys'fees and expenses. I also agree that I will defend, indemnify and/or hold the Company and its Affiliates harmless from and against any and all liabilities, losses,damages, claims or demands whatsoever (including expenses, court costs and reasonable attorneys' fees) asserted against or incurred by the Company or anyAffiliate as a result of or by reason of the Company or such Affiliate having to defend any claim arising from my use of proprietary or trade secret information of aprior employer or my breach of a restrictive covenant with any prior employer, and from any damages resulting from a final judgment or reasonable settlement ofsuch claims. This indemnification shall include, but not be limited to, claims for infringement of patents, trademarks or copyrights, misappropriation of tradesecrets or confidential information, and/or breach of any restrictive covenants, and is without prejudice to any other rights held by, or remedies available to, theCompany or its Affiliates at law.13. Use of Voice, Image and Likeness . During the period of my employment, I give the Company and its Affiliates permission to use any and all ofmy voice, image and likeness, with or without using my name, in connection with the products and/or services of the Company and/or its Affiliates, for thepurposes of advertising and promoting such products and/or servicesand/or the Company and/or its Affiliates, and/or for other purposes deemed appropriate by the Company in its reasonable discretion, except to the extent expresslyprohibited by law.14. Publications and Public Statements . I will obtain the Company's written approval before publishing or submitting for publication any material thatrelates to my work at the Company (including in connection with its Affiliates) and/or incorporates any Proprietary Information.15. No Employment Obligation . I understand that this Agreement does not create an obligation on the Company or any other person to continue myemployment. I acknowledge that, unless otherwise agreed in a formal written employment agreement signed on behalf of the Company by an authorized officer,my employment with the Company is at will and therefore may be terminated by the Company or me at any time and for any reason, with or without cause.16. Survival and Assignment by the Company . I understand that my obligations under this Agreement will continue in accordance with its expressterms regardless of any changes in my title, position, duties, salary, compensation or benefits or other terms and conditions of employment. I further understandthat my obligations under this Agreement will continue following the termination of my employment regardless of the manner of such termination and will bebinding upon my heirs, executors and administrators. The Company will have the right to assign this Agreement to its Affiliates, successors and assigns. Iexpressly consent to be bound by the provisions of this Agreement for the benefit of the Company or any parent, subsidiary or affiliate to whose employ I may betransferred without the necessity that this Agreement be resigned at the time of such transfer.17. Updating Information to the Company: Disclosure to Future Employers . For twelve (12) months following termination of my employment, Iwill (a) notify the Company of any change in my address and of each subsequent employment or business activity, including the name and address of my employeror other post-Company employment plans and the nature of my activities, and (b) provide a copy of this Agreement to any prospective employer, partner or co-venturer prior to entering into an employment, partnership or other business relationship with such person or entity.18. Reimbursement . I hereby authorize the Company at any time during or after the term of my employment to withhold from any amounts otherwiseowed to me (including, but not limited to, salary, bonus, severance, commissions and expense reimbursements) to the fullest extent permitted by applicable law:any and all amounts due to the Company from me, including, but not limited to, cash advances, draws, travel advances, overpayments made by the Company tome, amounts received by me due to the Company's error, unpaid personal credit card or phone charges or any other debt I owe to the Company for any reason,including amounts with respect to misuse or misappropriation of Company assets or breach of this Agreement.19. Application to Affiliates . I acknowledge that my duties as an employee of the Company may include providing certain management services to QLTInc., Aegerion Pharmaceuticals, Inc., and other current or future affiliates of the Company within the meaning of the Delaware General Corporation Law(collectively the “Affiliates” and each an “Affiliate”), on behalf of the Company. I agree that each such Affiliate will have the same rights that the Company hasunder this Agreement (including the right to indemnification and other remedies under paragraph 12), and that I will have the same obligations to each Affiliate asI have to the Company under this Agreement, as if such Affiliate was a signatory to this Agreement instead of the Company, except that if there is any conflictbetween my obligations under this Agreement to the Company and to one or more of its Affiliates, my obligations to the Affiliate will prevail. I acknowledge toeach Affiliate that it has direct rights against me under this Agreement. To the extent required by law to give full effect to these direct rights, I acknowledge andagree that the Company is and will be deemed to be acting as agent or trustee on behalf of and for the benefit of each Affiliate.20. Severability . In case any provisions (or portions thereof) contained in this Agreement shall, for any reason, be held invalid, illegal or unenforceablein any respect, such invalidity, illegality or unenforceability shall not affect the other provisions of this Agreement, and this Agreement shall be construed as ifsuch invalid, illegal or unenforceable provision had never been contained herein. If, moreover, any one or more of the provisions contained in this Agreement shallfor any reason be held to be excessively broad as to duration, geographical scope, activity or subject, it shall be construed by limiting and reducing it, so as to beenforceable to the extent compatible with the applicable law as it shall then appear.21. Interpretation . This Agreement will be deemed to be made and entered into in the Commonwealth of Massachusetts, and will in all respects beinterpreted, enforced and governed under the laws of the Commonwealth of Massachusetts. I hereby agree to consent to personal jurisdiction of the state andfederal courts situated within Suffolk County, Massachusetts for purposes of enforcing this Agreement, and waive any objection that I might have to personaljurisdiction or venue in those courts.[Remainder of this page intentionally left blank]I UNDERSTAND THAT THIS AGREEMENT AFFECTS IMPORTANT RIGHTS. BY SIGNING BELOW, I CERTIFY THAT I HAVE READ ITCAREFULLY AND AM SATISFIED THAT I UNDERSTAND IT COMPLETELY.IN WITNESS WHEREOF, the undersigned has executed this Employee Confidentiality, Assignment of Intellectual Property and Non-CompetitionAgreement as a sealed instrument as of the date set forth below.Signed: /s/ Benjamin HarshbargerName: Benjamin HarshbargerDate: _____________________________________EXHIBIT ATo: Novelion Services USA, Inc. (the “Company”)From: Benjamin HarshbargerDate: __________________________SUBJECT: Prior InventionsThe following is a complete list of all inventions or improvements that have been made or conceived or first reduced to practice by me alone or jointlywith others prior to my engagement by the Company:No inventions or improvementsSee below:_____________________________________________________________________________________________________________________________________________________________________________________________________________________Additional sheets attachedThe following is a list of all patents and patent applications in which I have been named as an inventor:NoneSee below:_____________________________________________________________________________________________________________________________________________________________________________________________________________________EXHIBIT 10.47Novelion Services USA, Inc.2711 Centerville RoadSuite 400Wilmington, DE 19808November 28, 2016Roger Louisc/o Aegerion Pharmaceuticals, Inc.One Main StreetSuite 800Cambridge, MA 02142Dear Roger:RE: Offer of EmploymentAs you are aware, Aegerion Pharmaceuticals, Inc. (“ Aegerion ”), QLT Inc. and Isotope Acquisition Corp. have agreed to carry out a merger (the “ Merger ”) onthe terms set out in the Agreement and Plan of Merger dated June 14, 2016 (the “ Merger Agreement ”).Following the Merger, Aegerion will become an indirect subsidiary of Novelion Services USA, Inc., a Delaware corporation (“ Novelion Services ”). NovelionServices is currently a subsidiary of QLT Inc., a British Columbia company, which we anticipate will change its name to “Novelion Therapeutics Inc.” (“ NovelionCanada ”).We are pleased to offer you employment with Novelion Services in the position of Global Chief Compliance Officer, commencing effective on the completion ofthe Merger, which is currently anticipated to be November 29, 2016 (the “ Commencement Date ”).Should you choose to accept this offer, the terms and conditions of your employment with Novelion Services will be the same as those set out in your currentemployment agreement with Aegerion which is attached as Schedule “A” to this letter (the “ Aegerion Agreement ”), except that the terms and conditions of theAegerion Agreement will be modified and supplemented as follows:1.Defined Terms: In the Aegerion Agreement, references to the “ Company ” or “ Aegerion ” (or any other references indicating your employer) will bedeemed to be references to Novelion Services, references to the “ Board ” will be deemed to be references to the Board of Directors of NovelionServices, and references to the “ Agreement ” or the “ Employment Agreement ” (or any other references to the terms and conditions of youremployment) will mean the Aegerion Agreement as modified and supplemented by this letter. In this letter, “ Affiliate ” has the meaning given to it in theDelaware General Corporation Law, and any other capitalized terms that are not defined in this letter will have the meanings given to them in theAegerion Agreement.2.Responsibilities and Reporting: As Global Chief Compliance Officer, you will have the duties and responsibilities set out in Section 3(a) of theAegerion Agreement in respect of Novelion Services. As described below, under the Master Service Agreement between Novelion Canada and NovelionServices that will be entered into on or about the completion date of the Merger, as amended from time to time (the “ Service Agreement ”) you may alsobe required to perform services to Novelion Canada and other Affiliates of Novelion Canada, including holding an office in Novelion Canada. Forcertainty, you will be an employee of Novelion Services and not an employee of Novelion Canada, and when you provide services to Novelion Canadayou will be doing so as an employee of Novelion Services in the context of certain management services it provides to Novelion Canada under the ServiceAgreement. You will report to the Chief Executive Officer of Novelion Services.3.Base Salary: You will be paid the Base Salary reflected in the Aegerion Agreement, subject to adjustment by the Board or Compensation Committeethereof from time to time.4.Length of Service: Novelion Services will recognize your length of service with Aegerion for all purposes related to your employment with NovelionServices, including for the purpose of determining your entitlements on termination of your employment pursuant to the Aegerion Agreement.5.Accrued Obligations: Your employment with Aegerion will cease immediately prior to the Commencement Date and Aegerion will be responsible forproviding you with all accrued but unpaid Base Salary and unreimbursed expenses incurred in accordance with the Aegerion Agreement up to such date.Any vacation time that you have accrued underAegerion’s vacation policy as of the Commencement Date, but not used as of such date, will be “rolled over” to Novelion Services. Novelion Serviceswill credit you with this time for purposes of its vacation policy. By accepting this offer, you consent to the rollover of this vacation time andacknowledge and agree that you are not entitled to any payment for this vacation time in connection with the transfer of your employment from Aegerionto Novelion Services. For certainty, you will continue to be obligated to repay your Signing Bonus pursuant to Section 4(c) of the Aegerion Agreement ifyou resign from employment with Novelion Services other than for Good Reason or are terminated for Cause, and you will pay such amount to Aegerionand/or Novelion Services at the direction of Novelion Services.6.No Severance or Good Reason: You agree that (a) the transfer of your employment from Aegerion to Novelion Services and any other changes to theterms and conditions of your employment that are expressly contemplated by this letter, and/or (b) any changes to your duties or responsibilities thatdirectly result from the Merger (including without limitation any such changes directly resulting from your new status as an executive officer of asubsidiary of Novelion Canada) shall not, individually or in the aggregate, constitute Good Reason for purposes of the Aegerion Agreement or theEmployment Agreement or entitle you to any Severance Benefits, Accelerated Equity Benefit, Retention Bonus Amount, or any other severance benefitsor the acceleration of any vesting or other rights, to which you might otherwise be entitled. You agree that, to the extent required by law to permitAegerion to rely on this paragraph 6, Novelion Services is and will be deemed to be acting as agent or trustee on behalf of and for the benefit of Aegerion.7.Stock Options / Equity Grants: Any stock options, restricted stock units, or other equity awards that you may have been granted pursuant to theInducement Plan or 2010 Stock Option and Incentive Plan will be dealt with as set out in the Merger Agreement. Once the Merger is completed, any suchoutstanding entitlements will be governed by and subject to the applicable stock option plan and stock option agreement.8.Right to Work in Canada: You will cooperate with Novelion Services to seek, obtain, and maintain the right to work in Canada to provide services onbehalf of Novelion Services to Novelion Canada and any of its other Affiliates. Novelion Services will pay the reasonable costs associated with obtaininga permit to work in Canada.9.Commuting to Canada: You acknowledge that travel will be required in connection with your employment, including commuting on a regular basis tosuch locations in Canada as are required for Novelion Services to provide its management services to Novelion Canada and its Canadian Affiliates.10.Tax Consultation Expenses: Each year so long as you are providing management services, you will be entitled to reimbursement for your reasonableexpenses up to a maximum of USD $5,000 for an independent tax consultation regarding the Canadian tax implications of your work on behalf ofNovelion Services in Canada and/or preparation of your Canadian tax return.11.Tax Equalization:(a)As you will be subject to income tax and social security obligations arising from your services performed in Canada on behalf of Novelion Services,Novelion Services is prepared to address the overall tax and social security burden that you experience with the intention that your total tax and socialsecurity burden while working in both the United States and Canada will be equal to what your tax and social security burden would have been hadyou remained working solely in Massachusetts. Novelion Services will provide you with tax equalization in connection with all income tax and socialsecurity liabilities arising from the performance of your employment duties within Canada. Novelion Services intends that the income taxes andsocial security levies payable by you on all taxable employment income and related benefits, as prescribed by the applicable tax and social securitylaws, should be no better or worse than the personal taxes and social security levies you would have been required to pay on such amounts if youremployment duties had been performed solely in the state of Massachusetts. Where your annual tax and social security obligation yields a highertotal obligation than if your employment duties were solely performed in the state of Massachusetts, Novelion Services will reimburse you for thedifference. Where your annual tax and social security obligations yields a lower total tax and social security impact than if your employment dutieswere solely performed in the state of Massachusetts, you will reimburse Novelion Services for the difference.(b)You will provide all information necessary for the preparation of a tax equalization calculation.(c)Novelion Services will pay all reasonable costs and professional fees related to calculating this equalization payment, and reserves the discretion toestablish the process and criteria for determining the tax equalization calculation. For clarity, the tax equalization payments described in thisparagraph 11 will not take into consideration or apply to any taxable income from sources other than your employment with Novelion Services, andyou will remain responsible for all income taxes arising from your personal income.(d)If you establish your primary residence in Canada, Novelion Services’ obligations under this paragraph 11 will cease, provided that there will be apro-rated adjustment for any partial year.(e)If your employment is terminated for any of the reasons described under Section 7 of the Aegerion Agreement, then between January 1 and July 31of the calendar year following the calendar year in which such termination occurs, Novelion Services will pay you any remaining tax equalizationpayments owed in accordance with this paragraph 11 or, in the event that the reconciliation results in you owing money to Novelion Services, youwill make such payment to Novelion Services.12.Release: The form of Release of Claims contemplated in the Aegerion Agreement will be the form attached as Schedule “B” to this Agreement.13.Employment Standards: This provision applies only if and to the extent that the employment laws of Canada apply to your employment. If theminimum standards in the British Columbia Employment Standards Act or Ontario Employment Standards Act, 2000 , or any other applicableemployment standards legislation, as they exist from time to time are more favorable to you in any respect than provided for in the EmploymentAgreement, including but not limited to the provisions in respect of notice of termination, the provisions of the applicable Employment Standards Act orlegislation will apply.14.Confidentiality, Assignment of Intellectual Property and Non-Competition: As a condition of your employment with Novelion Services, and inconsideration of the commitments set forth in this letter, you agree to execute and deliver to Novelion Services the Confidentiality, Assignment ofIntellectual Property and Non-Competition Agreement attached as Schedule “C” to this letter (the “ Ancillary Agreement ”), which will take effect onthe Commencement Date, following which any references to the “Confidentiality Agreement” in the Aegerion Agreement will be deemed to be referencesto the Ancillary Agreement. Your acceptance of this offer of employment or execution of the Ancillary Agreement does not affect your obligations toAegerion or the rights of Aegerion under the Confidentiality Agreement arising from your employment with Aegerion prior to the Commencement Date.15.Priority: If there is any conflict or inconsistency between these Supplementary Terms and the Aegerion Agreement, these Supplementary Terms will takeprecedence.If the terms and conditions of your employment described in this letter and the terms and conditions of the Ancillary Agreement are acceptable to you, please signthis letter (where indicated on the next page) and the enclosed Ancillary Agreement, and return signed copies of the foregoing to us by November 28, 2016.If you have any questions or concerns, please do not hesitate to contact Geoffrey Cox.[ Remainder of this page intentionally left blank ]Yours truly,NOVELION SERVICES USA, INC.Per: /s/ Geoffrey CoxAuthorized SignatoryI, Roger Louis, have read, understand and agree with the terms and conditions of employment referenced in this letter. I have had a reasonable opportunity toconsider these terms and conditions and seek independent legal advice, and I accept employment with Novelion Services on these terms and conditions./s/ Roger Louis Signature November 28, 2016DateRoger Louis - Employment AgreementSCHEDULE “A”AEGERION AGREEMENT[See attached]EMPLOYMENT AGREEMENTThis Employment Agreement (this “ Agreement ”) is made and entered into as of this 5th day of November 2015, by and between AegerionPharmaceuticals, Inc., a Delaware corporation (the “ Company ”), and Roger Louis (the “ Employee ”).W I T N E S S E T H :WHEREAS, the Company and Employee previously entered into that certain offer letter agreement, dated as of October 23, 2015 (the “ OfferLetter ”); andWHEREAS, the Company desires to replace and restate the Offer Letter in full, and enter into this Agreement regarding the terms of theEmployee’s employment, and Employee desires to enter into this Agreement and to accept the terms and provisions of such employment, as embodied in thisAgreement.Section 1. Definitions.(a) “ Accrued Obligations ” shall mean (i) all accrued but unpaid Base Salary through the Date of Termination, (ii) any unpaid orunreimbursed expenses incurred in accordance with Section 6 hereof, and (iii) any accrued but unused vacation time through the Date of Termination.(b) “ Base Salary ” shall mean the salary provided for in Section 4(a) hereof.(c) “ Board ” shall mean the Board of Directors of the Company.(d) “ Confidentiality Agreement ” shall mean the Company’s Confidentiality, Assignment and Noncompetition Agreement attachedhereto as Exhibit A .(e) “ Cause ” shall mean (i) Employee’s failure (except where due to a Disability), neglect, or refusal to perform in any material respectEmployee’s duties and responsibilities, (ii) any act of Employee that has, or could reasonably be expected to have, the effect of injuring the business of theCompany or its affiliates in any material respect, (iii) Employee’s conviction of, or plea of guilty or no contest to: (x) a felony or (y) any other criminal charge thathas, or could be reasonably expected to have, an adverse impact on the performance of Employee’s duties to the Company or otherwise result in material injury tothe reputation or business of the Company, (iv) the commission by Employee of an act of fraud or embezzlement against the Company, or any other act that createsor reasonably could create negative or adverse publicity for the Company; (v) any violation by Employee of the policies of the Company, including but not limitedto those relating to sexual harassment or business conduct, and those otherwise set forth in the manuals or statements of policy of the Company, (vi) Employee’sviolation of federal or state securities laws, or (vii) Employee’s breach of this Agreement or breach of the Confidentiality Agreement.(f) “ Code ” shall mean the Internal Revenue Code of 1986, as amended, and the rules and regulations promulgated thereunder.(g) “ Date of Termination ” shall mean the date on which Employee’s employment terminates.(h) “ Disability ” shall mean any physical or mental disability or infirmity of Employee that prevents the performance of Employee’sduties for a period of (i) ninety (90) consecutive days or (ii) one hundred twenty (120) non-consecutive days during any twelve (12) month period. Any question asto the existence, extent, or potentiality of Employee’s Disability upon which Employee and the Company cannot agree shall be determined by a qualified,independent physician selected by the Company and approved by Employee (which approval shall not be unreasonably withheld). The determination of any suchphysician shall be final and conclusive for all purposes of this Agreement.(i) “ Effective Date ” shall mean November 23, 2015.(j) “ Good Reason ” shall mean, without Employee’s consent, (i) a material diminution in Employee’s duties, or responsibilities, (ii) amaterial reduction in Base Salary as set forth in Section 4(a) hereof (other than pursuant to an across-the-board reduction applicable to all similarly situatedexecutives), (iii) the relocation of Employee’s principal place of employment more than fifty (50) miles from its then current, or (iv) any other material breach of aprovision of this Agreement by the Company (other than a provision that is covered by clause (i), (ii), or (iii) above). Employee acknowledges and agrees thatEmployee’s exclusive remedy in the event of any breach of this Agreement shall be to assert Good Reason pursuant to the terms and conditions of Section 7(e)hereof. Notwithstanding the foregoing, during the Term, in the event that the Company reasonably believes that Employee may have engaged in conduct that couldconstitute Cause hereunder, the Company may, in its sole and absolute discretion, suspend Employee from performing Employee’s duties hereunder, and in noevent shall any such suspension constitute an event pursuant to which Employee may terminate employment with Good Reason or otherwise constitute a breachhereunder; provided , that no such suspension shall alter the Company’s obligations under this Agreement during such period of suspension.(k) “ Release of Claims ” shall mean a separation agreement in a form acceptable to the Company under which Employee releases theCompany from any and all claims and causes of action and the execution of which is a condition precedent to Employee’s eligibility for Severance Benefits in theevent his employment is terminated by the Company without Cause or by Employee for Good Reason, as described in Sections 7(d) and 7(e).(l) “ Retention Bonus Amount ” shall mean any cash retention bonus awarded prior to the Date of Termination.(m) “ Severance Benefits ” shall mean (i) continued payment of Base Salary during the Severance Term, payable in accordance with theCompany’s regular payroll practices, and (ii) subject to the Employee’s timely election of COBRA and copayment of premium amounts at the active employees’rate, payment of the employer portion of the premiums for the Company’s group health and dental program for the Employee in order to allow him to continue toparticipate in the Company’s group health and dental program until the earlier of (Y) 12 months from the Date of Termination, and (Z) the date the Employeebecomes re-employed and eligible for health and/or dental insurance; provided, however , that this subsection (ii) is to be modified, as required, and by mutualagreement of the parties, to comply with the non-discrimination rules and other provisions and requirements of the Patient Protection and Affordable Care Act.(n) “ Severance Term ” shall mean the twelve (12) month period, which commences on the first day following the Date of Terminationfollowing termination by the Company without Cause or by Employee for Good Reason.Section 2. Acceptance and Term.The Company agrees to continue to employ Employee on an at-will basis, and Employee agrees to accept such employment and serve theCompany, in accordance with the terms and conditions set forth herein. The term of employment (referred to herein as the “ Term ”) shall continue until terminatedby either party at any time, subject to the provisions herein.Section 3. Position, Duties, and Responsibilities; Place of Performance.(a) Position, Duties, and Responsibilities . During the Term, Employee shall be employed and serve as Global Chief ComplianceOfficer of the Company (together with such other position or positions consistent with Employee’s title or as the Company shall specify from time to time) andshall have such duties and responsibilities commensurate therewith, and such other duties as may be assigned and/or prescribed from time to time by the ChiefExecutive Officer and/or the Board or its designee.(b) Performance . Employee shall devote his full business time, attention, skill, and best efforts to the performance of his duties underthis Agreement and shall not engage in any other business or occupation during the Term, including, without limitation, any activity that (x) conflicts with theinterests of the Company, (y) interferes with the proper and efficient performance of Employee’s duties for the Company, or (z) interferes with Employee’sexercise of judgment in the Company’s best interests. Notwithstanding the foregoing, nothing herein shall preclude Employee from (i) serving, with the priorwritten consent of the Board, as a member of the boards of directors or advisory boards (or their equivalents in the case of a non-corporate entity) of non-competing businesses and charitable organizations, (ii) engaging in charitable activities and community affairs, and (iii) managing Employee’s personalinvestments and affairs; provided , however , that the activities set out in clauses (i), (ii), and (iii) shall be limited by Employee so as not to interfere, individuallyor in the aggregate, with the performance of Employee’s duties and responsibilities hereunder. Employee represents that he has provided the Company with acomprehensive list of all outside professional activities with which he is currently involved or reasonably expects to become involved. In the event that, during hisemployment by the Company, the Employee desires to engage in other outside professional activities, not included on such list, Employee will first seek writtenapproval from the CEO or President and such approval shall not be unreasonably withheld.Section 4. Compensation.(a) Base Salary . In exchange for Employee’s satisfactory performance of his duties and responsibilities, Employee initially shall bepaid a semi-monthly Base Salary of $14,583.34 ($350,000.00 on an annualized basis), payable in accordance with the regular payroll practices of the Company.All payments in this Agreement are on a gross, pre-tax basis and shall be subject to all applicable federal, state and local withholding, payroll and other taxes.(b) Target Bonus . In addition to the Base Salary, Employee will be eligible to earn an annual target bonus of up to 40% of his Base Salary(the “ Target Bonus ”). There is an overachievement component to this bonus target, as determined by the Board (or a committee thereof) and Employee’s managerin their sole discretion. The actual amount of such bonus, if any, will be determined by the Board (or a committee thereof) and Employee’s manager in their solediscretion, based upon Company performance, Employee’s achievement of a series of performance milestones, and any other factors that the Board (or acommittee thereof), in its discretion, deem appropriate. Employee’s achievement of such milestones, as well as the amount of any bonus, shall be determined bythe Board and Employee’s manager in their sole discretion. Typically, bonuses, if any, are paid out no later than March 15 of the year following the applicablebonus year. Employee will be eligible to receive a TargetBonus following the 2016 bonus year. Employee must be employed by the Company at the time of any such bonus payment in order to be eligible for any suchpayment.(c) Signing Bonus . In addition to the above bonus, Employee will be eligible to receive a one-time cash sign-on bonus in the amount of$100,000, which will be paid out as soon as practical following the Effective Date. Employee must be employed by the Company at the time of the bonus paymentin order to be eligible for any such payment. If, prior to the 12-month anniversary of the Effective Date, Employee resigns or the Company terminates Employee’semployment for Cause, then Employee agrees to repay to the Company the net amount of the signing bonus within 30 days of such termination of employment.(d) Stock Options/Equity Grants . Subject to Board approval, the Company will offer to Employee the option (the “ Option Award ”) topurchase 85,000 shares of the Company’s common stock, $0.001 par value per share (the “ Common Stock ”), issued pursuant to the terms of the Company’sInducement Award Stock Option Plan (or a successor plan, if any) (the “ Inducement Plan ”) and subject to the terms of a stock option agreement thereunder. Theoptions subject to the Option Award shall have an exercise price equal to the fair market value of the Common Stock on the date of grant (as determined by theBoard or Compensation Committee thereof). The Option Award shall be subject to vesting and shall be issued pursuant to the terms of the Company’s InducementPlan and subject to the terms of a stock option agreement thereunder (collectively the “ Equity Documents ”). The vesting schedule for Employee’s Option Awardwill be the vesting schedule outlined in the Equity Documents (i.e., the option to purchase 85,000 shares will vest over four years in equal monthly installmentscommencing immediately upon the grant date). The full terms and conditions related to these option grants shall be set forth in the Equity Documents and to theextent that there is any inconsistency between this Agreement and the Equity Documents, the Equity Documents shall control.Section 5. Employee Benefits.During the Term, Employee shall be eligible to participate in health insurance and other benefits provided generally to similarly situatedemployees of the Company, subject to the terms and conditions of the applicable benefit plans (which shall govern). Employee also shall be eligible for the samenumber of holidays and vacation days as well as any other benefits, in each case as are generally allowed to similarly situated employees of the Company inaccordance with the Company policy as in effect from time to time. Nothing contained herein shall be construed to limit the Company’s ability to amend, suspend,or terminate any employee benefit plan or policy at any time without providing Employee notice, and the right to do so is expressly reserved.Section 6. Reimbursement of Business Expenses; Relocation and Temporary Living Assistance.During the Term of Employment, the Company shall pay (or promptly reimburse Employee) for documented, out-of-pocket expenses reasonablyincurred by Employee in the course of performing his duties and responsibilities hereunder, which are consistent with the Company’s policies in effect from timeto time with respect to business expenses, subject to the Company’s requirements with respect to reporting of such expenses.Section 7. Termination of Employment.(a) General . Employee’s employment with the Company shall terminate upon the earliest to occur of: (i) Employee’s death, (ii) atermination by reason of a Disability, (iii) a termination by the Company with or without Cause, and (iv) a termination by Employee with or without Good Reason.Notwithstanding anything herein to the contrary, the payment (or commencement of a series of payments) hereunder of any nonqualified deferred compensation(within the meaning of Section 409A of the Code) upon a termination of employment shall be delayed until such time as Employee has also undergone a“separation from service” as defined in Treas. Reg. 1.409A-1(h), at which time such nonqualified deferred compensation (calculated as of the date of Employee’stermination of employment hereunder) shall be paid (or commence to be paid) to Employee on the schedule set forth in this Section 7 as if Employee hadundergone such termination of employment (under the same circumstances) on the date of Employee’s ultimate “separation from service.”(b) Termination Due to Death or Disability . Employee’s employment under this Agreement shall terminate automatically uponEmployee’s death. The Company also may terminate Employee’s employment immediately upon the occurrence of a Disability, such termination to be effectiveupon Employee’s receipt of written notice of such termination. In the event of Employee’s termination as a result of Employee’s death or Disability, Employee orEmployee’s estate or beneficiaries, as the case may be, shall be entitled only to the Accrued Obligations and the Retention Bonus Amount, and Employee shallhave no further rights to any compensation or any other benefits under this Agreement.(c) Termination by the Company with Cause .(i) The Company may terminate Employee’s employment at any time with Cause, effective upon Employee’s receipt ofwritten notice of such termination; provided , however , that with respect to any Cause termination relying on clause (i) or (ii) of the definition of Causeset forth in Section 1(d) hereof, to the extent that such act or acts or failure or failures to act are curable, Employee shall be given ten (10) days’ writtennotice by the Company of itsintention to terminate him with Cause, such notice to state the act or acts or failure or failures to act that constitute the grounds on which the proposedtermination with Cause is based, and such termination shall be effective at the expiration of such ten (10) day notice period unless Employee has fullycured such act or acts or failure or failures to act, to the Company’s complete satisfaction, that give rise to Cause during such period.(ii) In the event that the Company terminates Employee’s employment with Cause, Employee shall be entitled only to theAccrued Obligations. Following such termination of Employee’s employment with Cause, except as set forth in this Section 7(c)(ii), Employee shall haveno further rights to any compensation or any other benefits under this Agreement. For the avoidance of doubt, Employee’s sole and exclusive remedyupon a termination of employment by the Company with Cause shall be receipt of the Accrued Obligations.(d) Termination by the Company without Cause . The Company may terminate Employee’s employment at any time without Cause,effective upon Employee’s receipt of written notice of such termination. In the event that Employee’s employment is terminated by the Company without Cause(other than due to death or Disability) and provided that he fully executes and does not revoke an effective Release of Claims as described in Section 7(g),Employee shall be eligible for:(i) The Accrued Obligations;(ii) The Severance Benefits;(iii) At the end of the Severance Term, the Retention Bonus Amount; and(iv) If such termination without Cause and the Date of Termination occur within eighteen (18) months after a Sale Event (as suchterm is defined in the Company’s 2010 Stock Option and Incentive Plan), acceleration of the vesting of 100% of Employee’s then outstanding unvestedequity awards, such that all unvested equity awards vest and become fully exercisable or non-forfeitable as of the Date of Termination (the “ AcceleratedEquity Benefit ”) , in which case Employee shall have ninety (90) days from the Date of Termination to exercise the vested equity awards.Notwithstanding the foregoing, the Severance Benefits shall immediately terminate, and the Company shall have no further obligations to Employee with respectthereto, in the event that Employee breaches any provision of the Confidentiality Agreement or the Release of Claims. Any such termination of payment or benefitsshall have no effect on the Release of Claims or any of Employee’s post-employment obligations to the Company. Following such termination of Employee’semployment by the Company without Cause, except as set forth in this Section 7(d), Employee shall have no further rights to any compensation or any otherbenefits under this Agreement. For the avoidance of doubt, Employee’s sole and exclusive remedy upon a termination of employment by the Company withoutCause shall be receipt of (i) the Severance Benefits (and, in the case of such a termination within eighteen (18) months after a Sale Event, the Accelerated EquityBenefit), subject to his execution of the Release of Claims, (ii) the Accrued Obligations, and (iii) at the end of the Severance Term, the Retention Bonus Amount,subject to his execution of the Release of Claims.If the Company makes overpayments of Severance Benefits, Employee promptly shall return any such overpayments to the Company and/or hereby authorizesdeductions from future Severance Benefit amounts.(e) Termination by Employee with Good Reason . Employee may terminate his employment with Good Reason by providingthe Company thirty (30) days’ written notice setting forth in reasonable specificity the event that constitutes Good Reason, which written notice, to beeffective, must be provided to the Company within sixty (60) days of the occurrence of such event. During such thirty (30) day notice period, theCompany shall have a cure right (if curable), and if not cured within such period, Employee’s termination will be effective upon the expiration of suchcure period, and Employee shall be entitled to the same payments and benefits as provided in Section 7(d) hereof for a termination by the Companywithout Cause, subject to the same conditions on payment and benefits as described in Section 7(d) hereof. Following such termination of Employee’semployment by Employee with Good Reason, except as set forth in this Section 7(e), Employee shall have no further rights to any compensation or anyother benefits under this Agreement. For the avoidance of doubt, Employee’s sole and exclusive remedy upon a termination of employment with GoodReason shall be receipt of (i) the Severance Benefits (and, in the case of such a termination within eighteen (18) months after a Sale Event, theAccelerated Equity Benefit), subject to his execution of the Release of Claims, (ii) the Accrued Obligations, and (iii) at the end of the Severance Term, theRetention Bonus Amount, subject to his execution of the Release of Claims.(f) Termination by Employee without Good Reason . Employee may terminate his employment without Good Reason by providing theCompany thirty (30) days’ written notice of such termination. In the event of a termination of employment by Employee under this Section 7(f), Employee shall beentitled only to the Accrued Obligations. In the event of termination of Employee’s employment under this Section 7(f), the Company may, in its sole and absolutediscretion, by written notice accelerate such date of termination without changing the characterization of such termination as a termination by Employee withoutGood Reason. Following such termination of Employee’s employment by Employee without Good Reason, except as set forth in this Section 7(f), Employee shallhave no further rights to any compensation or any other benefits under this Agreement.For the avoidance of doubt, Employee’s sole and exclusive remedy upon a termination of employment by Employee without Good Reason shall be receipt of theAccrued Obligations.(g) Release . Notwithstanding any provision herein to the contrary, the payment of the Severance Benefits and the Retention BonusAmount pursuant to subsection (d) or (e) of this Section 7 (other than the Accrued Obligations) shall be conditioned upon Employee’s execution, delivery to theCompany, and non-revocation of the Release of Claims (and the expiration of any revocation period contained in such Release of Claims) in accordance with thetime limits set forth therein. If Employee fails to execute the Release of Claims in such a timely manner, or timely revokes Employee’s acceptance of such releasefollowing its execution, Employee shall not be entitled to any of the Severance Benefits. Further, to the extent that any of the Severance Benefits constitutes“nonqualified deferred compensation” for purposes of Section 409A of the Code, any payment of any amount or provision of any benefit otherwise scheduled tooccur prior to the thirty-fifth (35 th ) day following the date of Employee’s termination of employment hereunder, but for the condition on executing the Release ofClaims as set forth herein, shall not be made until the first regularly scheduled payroll date following such thirty-fifth (35 th ) day, after which any remainingSeverance Benefits shall thereafter be provided to Employee according to the applicable schedule set forth herein.Section 8. Confidentiality Agreement; Cooperation.(a) Confidentiality Agreement . As a condition of Employee’s employment with the Company under the terms of this Agreement,Employee has executed and delivered to the Company a Confidentiality Agreement. The parties hereto acknowledge and agree that this Agreement and theConfidentiality Agreement shall be considered separate contracts. In addition, Employee represents and warrants that he shall be able to and will perform the dutiesof this position without utilizing any confidential and/or proprietary information that Employee may have obtained in connection with employment with any prioremployer, and that he shall not (i) disclose any such information to the Company, or (ii) induce any Company employee to use any such information, in either casein violation of any confidentiality obligation, whether by agreement or otherwise.(b) Litigation and Regulatory Cooperation . During and after Employee’s employment, Employee shall cooperate fully with theCompany in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company whichrelate to events or occurrences that transpired while the Company employed Employee, provided, that the Employee will not have an obligation under thisparagraph with respect to any claim in which the Employee has filed directly against the Company or related persons or entities. The Employee’s full cooperationin connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as awitness on behalf of the Company at mutually convenient times. During and after Employee’s employment, Employee also shall cooperate fully with the Companyin connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrencesthat transpired while Employee was employed by the Company, provided Employee will not have any obligation under this paragraph with respect to any claim inwhich Employee has filed directly against the Company or related persons or entities. The Company shall reimburse Employee for any reasonable out-of-pocketexpenses incurred in connection with Employee’s performance of obligations pursuant to this Section 8(b).Section 9. Taxes.The Company may withhold from any payments made under this Agreement all applicable taxes, including but not limited to income,employment, and social insurance taxes, as shall be required by law. Employee acknowledges and represents that the Company has not provided any tax advice tohim in connection with this Agreement and that Employee has been advised by the Company to seek tax advice from Employee’s own tax advisors regarding thisAgreement and payments that may be made to him pursuant to this Agreement, including specifically, the application of the provisions of Section 409A of theCode to such payments. The Company shall have no liability to Employee or to any other person if any of the provisions of this Agreement are determined toconstitute deferred compensation subject to Section 409A but that do not satisfy an exemption from, or the conditions of, that section.Section 10. Additional Section 409A Provisions.Notwithstanding any provision in this Agreement to the contrary:(a) If at the time of the Employee’s separation from service within the meaning of Section 409A of the Code, the Company determinesthat the Employee is a “specified employee” within the meaning of Section 409A(a)(2)(B)(i) of the Code, then to the extent any payment or benefit that theEmployee becomes entitled to under this Agreement on account of the Employee’s separation from service is “non-qualified deferred compensation” subject toSection 409A of the Code and not otherwise exempt, such payment shall not be payable and such benefit shall not be provided until the date that is the earlier of (i)six months and one day after the Employee’s separation from service, or (ii) the Employee’s death. If any such delayed cash payment is otherwise payable on aninstallment basis, the first payment shall include a catch-up payment covering amounts that would otherwise have been paid during the six-month period but for theapplication of this provision, and the balance of the installments shall be payable in accordance with their original schedule.(b) Each payment in a series of payments hereunder shall be deemed to be a separate payment for purposes of Section 409A of theCode. Neither the Company nor Employee shall have the right to accelerate or defer the delivery of any such payments except to the extent specifically permittedor required by Section 409A.(c) To the extent that any right to reimbursement of expenses or payment of any benefit in-kind under this Agreement constitutesnonqualified deferred compensation (within the meaning of Section 409A of the Code), (i) any such expense reimbursement or payment shall be made by theCompany no later than the last day of the taxable year following the taxable year in which such expense was incurred by Employee, (ii) the right to reimbursement,payment or in-kind benefits shall not be subject to liquidation or exchange for another benefit, and (iii) the amount of expenses eligible for reimbursement,payment or in-kind benefits provided during any taxable year shall not affect the expenses eligible for reimbursement or in-kind benefits to be provided in anyother taxable year; provided, that the foregoing clause shall not be violated with regard to expenses reimbursed under any arrangement covered by Section 105(b)of the Code solely because such expenses are subject to a limit related to the period the arrangement is in effect.(d) To the extent that any payment or benefit described in this Agreement constitutes “non-qualified deferred compensation” underSection 409A of the Code, and to the extent that such payment or benefit is payable upon the Employee’s termination of employment, then such payments orbenefits shall be payable only upon the Employee’s “separation from service.” The determination of whether and when a separation from service has occurred shallbe made in accordance with the presumptions set forth in Treasury Regulation Section 1.409A‑1(h).(e) The parties intend that this Agreement will be administered in accordance with Section 409A of the Code. To the extent that anyprovision of this Agreement is ambiguous as to its compliance with Section 409A of the Code, the provision shall be read in such a manner so that all paymentshereunder comply with Section 409A of the Code. The parties agree that this Agreement may be amended, as reasonably requested by either party, and as may benecessary to fully comply with Section 409A of the Code and all related rules and regulations in order to preserve the payments and benefits provided hereunderwithout additional cost to either party. While the payments and benefits provided hereunder are intended to be structured in a manner to avoid the implication ofany penalty taxes under Section 409A of the Code, in no event whatsoever shall the Company or any of its affiliates be liable for any additional tax, interest, orpenalties that may be imposed on Employee as a result of Section 409A of the Code or any damages for failing to comply with Section 409A of the Code (otherthan for withholding obligations or other obligations applicable to employers, if any, under Section 409A of the Code).Section 11. Successors and Assigns.(a) The Company . This Agreement shall inure to the benefit of the Company and its respective successors and assigns. This Agreementmay be assigned by the Company without Employee’s prior consent.(b) Employee . Employee’s rights and obligations under this Agreement shall not be transferable by Employee by assignment orotherwise, without the prior written consent of the Company; provided , however , that if Employee shall die, all amounts then payable to Employee hereundershall be paid in accordance with the terms of this Agreement to Employee’s devisee, legatee, or other designee, or if there be no such designee, to Employee’sestate.Section 12. Waiver and Amendments.Any waiver, alteration, amendment, or modification of any of the terms of this Agreement shall be valid only if made in writing and signed byeach of the parties hereto; provided , however , that any such waiver, alteration, amendment, or modification must be consented to on the Company’s behalf by theBoard. No waiver by either of the parties hereto of their rights hereunder shall be deemed to constitute a waiver with respect to any subsequent occurrences ortransactions hereunder unless such waiver specifically states that it is to be construed as a continuing waiver.Section 13. Severability.If any covenants or such other provisions of this Agreement are found to be invalid or unenforceable by a final determination of a court ofcompetent jurisdiction, (a) the remaining terms and provisions hereof shall be unimpaired, and (b) the invalid or unenforceable term or provision hereof shall bedeemed replaced by a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term orprovision hereof.Section 14. Governing Law and Jurisdiction.This is a Massachusetts contract and shall be construed under and be governed in all respects by the laws of the Commonwealth ofMassachusetts without giving effect to the conflict of laws principles of such state. With respect to any disputes concerning federal law, such disputes shall bedetermined in accordance with the law as it would be interpreted and applied by the United States Court of Appeals for the First Circuit. To the extent that anycourt action is initiated to enforce this Agreement, the parties hereby consent to the jurisdiction of the state and federal courts of the Commonwealth ofMassachusetts. Accordingly, with respect to any such court action, Employee (a) submits to the personal jurisdiction of such courts; (b) consents to service ofprocess; and (c) waives any other requirement (whether imposed by statute, rule of court, or otherwise) with respect to personaljurisdiction or service of process.Section 15. Notices.(a) Place of Delivery . Every notice or other communication relating to this Agreement shall be in writing, and shall be mailedto or delivered to the party for whom or which it is intended at such address as may from time to time be designated by it in a notice mailed or deliveredto the other party as herein provided; provided , that unless and until some other address be so designated, all notices and communications by Employee tothe Company shall be mailed or delivered to the Company at its principal executive office, and all notices and communications by the Company toEmployee may be given to Employee personally or may be mailed to Employee at Employee’s last known address, as reflected in the Company’s records.(b) Date of Delivery . Any notice so addressed shall be deemed to be given or received (i) if delivered by hand, on the date of suchdelivery, (ii) if mailed by courier or by overnight mail, on the first business day following the date of such mailing, and (iii) if mailed by registered or certifiedmail, on the third business day after the date of such mailing.Section 16. Section Headings.The headings of the sections and subsections of this Agreement are inserted for convenience only and shall not be deemed to constitute a partthereof or affect the meaning or interpretation of this Agreement or of any term or provision hereof.Section 17. Entire Agreement.This Agreement, together with Confidentiality Agreement, the Company’s Inducement Plan and any stock option agreement entered intobetween the Company and Employee thereunder, constitute the entire understanding and agreement of the parties hereto regarding the employment of Employee.This Agreement supersedes all prior negotiations, discussions, correspondence, communications, understandings, and agreements between the parties (includingany offer letter given to Employee) relating to the subject matter of this Agreement.Section 18. Survival of Operative Sections.Upon any termination of Employee’s employment, the provisions of Section 7 through Section 19 of this Agreement (together with any relateddefinitions set forth in Section 1 hereof) shall survive to the extent necessary to give effect to the provisions thereof.Section 19. Counterparts.This Agreement may be executed in two or more counterparts, each of which shall be deemed to be an original but all of which together shallconstitute one and the same instrument. The execution of this Agreement may be by actual or facsimile signature.Section 20. Gender Neutral.Wherever used herein, a pronoun in the masculine gender shall be considered as including the feminine gender unless the context clearlyindicates otherwise.IN WITNESS WHEREOF, the undersigned have executed this Agreement as of the date first above written.AEGERION PHARMACEUTICALS, INC./s/ Mary WegerBy: Mary WegerTitle: Chief Performance OfficerEMPLOYEE/s/ Roger LouisBy: Roger LouisSCHEDULE “B”GENERAL RELEASE AND WAIVER OF CLAIMSIn exchange for the severance benefits to be provided to me under the employment agreement between me and Novelion Services USA, Inc. (“NovelionServices”), dated as of November 28, 2016 (the “Employment Agreement”), to which I would not otherwise be entitled, on my own behalf and that of my heirs,executors, administrators, beneficiaries, personal representatives and assigns, I agree that this General Release and Waiver of Claims (the “Release of Claims”)shall be in complete and final settlement of any and all causes of action, rights and claims, whether known or unknown, accrued or unaccrued, contingent orotherwise, that I have had in the past, now have, or might now have, in any way related to, connected with or arising out of my employment or its termination,under the Employment Agreement, or pursuant to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Age Discrimination inEmployment Act, as amended by the Older Workers Benefit Protection Act, the Worker Adjustment and Retraining Notification Act, the Employee RetirementIncome Security Act, the wage and hour, wage payment and fair employment practices laws and statutes of the Commonwealth of Massachusetts (each as amendedfrom time to time), and/or any other federal, state or local law, regulation or other requirement and, if the employment laws of Canada apply to my employment,the Ontario and British Columbia Employment Standards Acts, the Ontario and British Columbia Human Rights Codes, and any other applicable Canadian orprovincial law, regulation or other requirement (each as amended from time to time) (collectively, the “Claims”), and I hereby release and forever dischargeNovelion Services, its Affiliates (as defined in the Employment Agreement, and including for certainty and without limitation QLT Inc. and AegerionPharmaceuticals, Inc.), and all of their respective past, present and future directors, shareholders, officers, members, managers, general and limited partners,employees, employee benefit plans, administrators, trustees, agents, representatives, successors and assigns, and all others connected with any of them (the“Releasees”), both individually and in their official capacities, from, and I hereby waive, any and all such Claims. This release shall not apply to (a) any claims thatarise after I sign this Release of Claims, including my right to enforce the terms of this Release of Claims; (b) any claims that may not be waived pursuant toapplicable law; (c) any right to indemnification that I may have under the certificate of incorporation or by-laws of Novelion Services, and any indemnificationagreement between me and Novelion Services or any insurance policies maintained by Novelion Services; or (d) any right to receive any vested benefits under theterms of any employee benefit plans and my award agreements thereunder.I agree that the Releasees have satisfied all obligations to me under the legislation referred to in the previous paragraph in relation to my employment and thecessation of my employment, and I have considered any and all human rights complaints, concerns, or issues arising out of or in respect to my employment withNovelion Services, I am aware of my rights under the legislation referred to in the previous paragraph, and I confirm that I am not asserting such rights oradvancing a human rights claim or complaint against the Releasees.Nothing contained in this Release of Claims shall be construed to prohibit me from filing a charge with or participating in any investigation or proceedingconducted by the federal Equal Employment Opportunity Commission or a comparable state or local agency, provided, however, that I hereby agree to waive myright to recover monetary damages or other individual relief in any charge, complaint or lawsuit filed by me or by anyone else on my behalf.In signing this Release of Claims, I acknowledge my understanding that I may consider the terms of this Release of Claims for up to [twenty-one (21) /forty-five(45)] 1 days from the date I receive it and that I may not sign this Release of Claims until after the date my employment with Novelion Services terminates. I alsoacknowledge that I am hereby advised by Novelion Services to seek the advice of an attorney prior to signing this Release of Claims; that I have had sufficient timeto consider this Release of Claims and to consult with an attorney, if I wished to do so, or to consult with any other person of my choosing before signing; and thatI am signing this Release of Claims voluntarily and with a full understanding of its terms.I further acknowledge that, in signing this Release of Claims, I have not relied on any promises or representations, express or implied, that are not set forthexpressly in the Release of Claims. I understand that I may revoke this Release of Claims at any time within seven (7) days of the date of my signing by writtennotice to the Board of Directors of Novelion Services and that this Release of Claims will take effect only upon the expiration of such seven-day revocation periodand only if I have not timely revoked it.Intending to be legally bound, I have signed this Release of Claims under seal as of the date written below.Signature: /s/ Roger LouisName: Roger LouisDate Signed: _______________________ 1 To be determined by Novelion Services at the time of terminationSCHEDULE “C”CONFIDENTIALITY, ASSIGNMENT OF INTELLECTUAL PROPERTY AND NON-COMPETITION AGREEMENT[See attached]NOVELION SERVICES USA, INC.Employee Confidentiality, Assignment of Intellectual Property and Non-Competition AgreementIn consideration and as a condition of my employment or continued employment by Novelion Services USA, Inc. (the "Company"), I agree as follows:1. Employee Acknowledgements . I acknowledge that I will be provided, and/or have been provided, with trade secrets and/or valuable confidentialbusiness information belonging to the Company and/or its Affiliates (as defined in paragraph 19), and have developed and/or will develop substantial relationshipswith prospective and existing customers and clients of the Company and its Affiliates, and, as a result, shall benefit from the good will of the Company and itsAffiliates. I also acknowledge that the Company and its Affiliates have invested substantial resources in the development of their trade secrets, confidentialbusiness information, client relationships and good will and in recruiting, hiring and training their professionals and staff. I further acknowledge that I havereceived and/or will receive substantial training from the Company and its Affiliates. I hereby acknowledge and agree that the Company and its Affiliates have alegitimate interest in protecting their substantial investment in their development of trade secrets, confidential information, good will and a highly trained staff andthat the covenants to which I agree to be bound herein are necessary to protect such legitimate interests.2. Proprietary Information . I agree that all information, whether or not in writing, concerning the business, technology, business relationships orfinancial affairs of the Company and its Affiliates which the Company (or applicable Affiliate) has not released to the general public (collectively, "ProprietaryInformation") is and will be the exclusive property of the Company (or applicable Affiliate). By way of illustration, Proprietary Information may includeinformation or material which has not been made generally available to the public, such as: (a) corporate information, including plans, strategies, methods, policies,resolutions, negotiations or litigation; (b) marketing information, including strategies, methods, customer identities or other information about customers, prospectidentities or other information about prospects, or market analyses or projections; (c) financial information, including cost and performance data, debtarrangements, equity structure, investors and holdings, purchasing and sales data and price lists; and (d) operational and technological information, including plans,specifications, manuals, forms, templates, software, designs, methods, procedures, formulas, discoveries, inventions, improvements, concepts and ideas; and (e)personnel information, including personnel lists, reporting or organizational structure, resumes, personnel data, compensation structure, performance evaluationsand termination arrangements or documents. Proprietary Information also includes information received in confidence by the Company or its Affiliates fromcustomers or suppliers or other third parties.3. Recognition of Company’s Rights . I will not, at any time, without the Company's prior written permission, either during or after my employment,disclose any Proprietary Information to anyone outside of the Company, or use or permit to be used any Proprietary Information for any purpose other than theperformance of my duties as an employee of the Company. I will cooperate with the Company and its Affiliates and use my best efforts to prevent the unauthorizeddisclosure of all Proprietary Information. I will deliver to the Company all copies of Proprietary Information in my possession or control upon the earlier of arequest by the Company or termination of my employment.4. Rights of Others . I understand that the Company and its Affiliates are now and may hereafter be subject to nondisclosure or confidentialityagreements with third persons which require the Company (or applicable Affiliate) to protect or refrain from use of proprietary information. I agree to be bound bythe terms of such agreements in the event I have access to such proprietary information.5. Commitment to Company: Avoidance of Conflict of Interest . While an employee of the Company, I will devote my full-time efforts to theCompany's business and I will not engage in any other business activity that conflicts with my duties to the Company (including the services the Companyprovides to its Affiliates). I will advise the Chief Executive Officer of the Company at such time as any activity of either the Company or another business presentsme with a conflict of interest or the appearance of a conflict of interest as an employee of the Company. I will take whatever action is requested of me by theCompany to resolve any conflict or appearance of conflict which it finds to exist.6. Developments . I will make full and prompt disclosure to the Company of all inventions, discoveries, designs, developments, methods, modifications,improvements, processes, algorithms, databases, computer programs, formulae, techniques, trade secrets, graphics or images, and audio or visual works and otherworks of authorship, whether or not patentable or copyrightable, that are created, made, conceived or reduced to practice by me (alone or jointly with others) orunder my direction during the period of my employment (collectively, the "Developments"). I acknowledge that all work performed by me is on a "work for hire"basis, and I hereby do assign and transfer and, to the extent any such assignment cannot be made at present, will assign and transfer, to the Company (or anyAffiliate designated by the Company) and its successors and assigns all my right, title and interest in all Developments that: (a) relate to the business of theCompany or its Affiliates or any customer of the Company or its Affiliates or any of the products or services being researched, developed, manufactured or sold bythe Company or itsAffiliates or which may be used with such products or services; or (b) result from tasks assigned to me by the Company; or (c) result and/or are developed duringor after my employment from the use of premises or personal property (whether tangible or intangible) owned, leased or contracted for by the Company or itsAffiliates (collectively, "Company-Related Developments"), and all related patents, patent applications, trademarks and trademark applications, copyrights andcopyright applications, and other intellectual property rights in all countries and territories worldwide and under any international conventions ("IntellectualProperty Rights").To preclude any possible uncertainty, I have set forth on Exhibit A attached hereto a complete list of Developments that I have, alone or jointly with others,conceived, developed or reduced to practice prior to the commencement of my employment with the Company that I consider to be my property or the property ofthird parties and that I wish to have excluded from the scope of this Agreement ("Prior Inventions"). If disclosure of any such Prior Invention would cause me toviolate any prior confidentiality agreement, I understand that I am not to list such Prior Inventions in Exhibit A but am only to disclose a cursory name for eachsuch invention, a listing of the party(ies) to whom it belongs and the fact that full disclosure as to such inventions has not been made for that reason. I have alsolisted on Exhibit A all patents and patent applications in which I am named as an inventor, other than those which have been assigned to the Company ("OtherPatent Rights"). If no such disclosure is attached, I represent that there are no Prior Inventions or Other Patent Rights. If, in the course of my employment with theCompany, I incorporate a Prior Invention into a Company or Affiliate product, process or machine or other work done for the Company or an Affiliate, I herebygrant to the Company (or any Affiliate designated by the Company) a nonexclusive, royalty-free, paid-up, irrevocable, worldwide license (with the full right tosublicense) to make, have made, modify, use, sell, offer for sale and import such Prior Invention. Notwithstanding the foregoing, I will not incorporate, or permit tobe incorporated, Prior Inventions in any Company-Related Development without the Company's prior written consent.This Agreement does not obligate me to assign to the Company of any of its Affiliates any Development which, in the sole judgment of the Company, reasonablyexercised, is developed entirely on my own time and does not relate to the business efforts or research and development efforts in which, during the period of myemployment, the Company or its Affiliates actually are engaged or reasonably would be engaged, and does not result from the use of premises or equipment ownedor leased by the Company or its Affiliates. However, I will also promptly disclose to the Company any such Developments for the purpose of determining whetherthey qualify for such exclusion. I understand that to the extent this Agreement is required to be construed in accordance with the laws of any jurisdiction whichprecludes a requirement in an employee agreement to assign certain classes of inventions made by an employee, this paragraph 6 will be interpreted not to apply toany invention which a court rules and/or the Company agrees, falls within such classes. I also hereby waive all claims to any moral rights or other special rightswhich may have or accrue in any Company-Related Developments or Intellectual Property Rights.7. Documents and Other Materials . I will keep and maintain adequate and current records of: (a) all Proprietary Information and Company-RelatedDevelopments developed by me during my employment; and (b) all documentation regarding any Intellectual Property Rights, which relate to such ProprietaryInformation and Company-Related Developments. Such records will be available to and remain the sole property of the Company (or applicable Affiliate of theCompany) at all times. All files, letters, notes, memoranda, reports, records, data, sketches, drawings, notebooks, layouts, charts, quotations and proposals,specification sheets, or other written, photographic or other tangible material containing Proprietary Information, whether created by me or others, which come intomy custody or possession, are the exclusive property of the Company (or applicable Affiliate) to be used by me only in the performance of my duties for theCompany. Any property situated on the premises of the Company or its Affiliates, owned or purchased by the Company or its Affiliates, disseminated by theCompany or its Affiliates, and/or used or created by me for business purposes in the course of my duties for the Company, including without limitation computers,email accounts, cell phone records and text messages, disks and other storage media, filing cabinets or other work areas, is the property of the Company (or, ifapplicable, an Affiliate) and is subject to inspection by the Company at any time with or without notice. In the event of the termination of my employment for anyreason, I will deliver to the Company all Company and Affiliate property, including, without limitation, all Proprietary Information, all documents related toCompany-Related Developments, all computers, keys, passwords, cell phones, entry cards, files, letters, notes, memoranda, reports, records, data, sketches,drawings, notebooks, layouts, charts, quotations and proposals, specification sheets, or other written, photographic or other tangible material, and will not take orkeep in my possession any Company or Affiliate property or any copies (electronic or hard-copy) of such property.8. Enforcement of Intellectual Property . I will cooperate fully with the Company, both during and after my employment with the Company, withrespect to the procurement, maintenance and enforcement of Intellectual Property Rights in Company-Related Developments. I will sign, both during and after theterm of this Agreement, all papers, including without limitation copyright applications, patent applications, declarations, oaths, assignments of priority rights, andpowers of attorney, which the Company may deem necessary or desirable in order to protect its (or any Affiliate’s) rights and interests in any Company-RelatedDevelopment. If the Company is unable, after reasonable effort, to secure my signature on any such papers, I hereby irrevocably designate and appoint each officerof the Company as my agent and attorney-in-fact to execute any such papers on my behalf, andto take any and all actions as the Company may deem necessary or desirable in order to protect its (or any Affiliate’s) rights and interests in any Company-RelatedDevelopment.9. Non-Competition and Non-Solicitation . In order to protect the Proprietary Information and good will of the Company and its Affiliates, during myemployment and for a period of twelve (12) months following the termination of my employment for any reason (the "Restricted Period"), I will not directly orindirectly, whether as owner, partner, shareholder, director, manager, consultant, agent, employee, co-venturer or otherwise, engage, participate or invest in anybusiness activity anywhere in the world that develops, manufactures or markets any products, or performs any services, that are competitive (directly or indirectly)with the products or services of the Company or its Affiliates, or products or services that the Company or its Affiliates have under development or that are thesubject of active planning at any time during the last 24 months of my employment; provided that this shall not prohibit any possible investment in publicly tradedstock of a company representing less than one percent of the stock of such company. In addition, during the Restricted Period, I will not, directly or indirectly, inany manner, for any purpose that is competitive with or detrimental to the business of the Company or an Affiliate, (a) call upon, solicit, divert, take away, acceptor conduct any business from or with any of the customers or prospective customers of the Company or its Affiliates, or any suppliers thereof, and/or (b) solicit,entice, or attempt to persuade any other employee or consultant of the Company or an Affiliate to leave the Company or Affiliate for any reason. I acknowledgeand agree that if I violate any of the provisions of this paragraph 9, the running of the Restricted Period will be extended by the time during which I engage in suchviolation(s).10. Government Contracts . I acknowledge that the Company and/or its Affiliates may have from time to time agreements with other persons orgovernmental authorities which impose obligations or restrictions on the Company and/or its Affiliates regarding inventions made during the course of work undersuch agreements or regarding the confidential nature of such work. I agree to comply with any such obligations or restrictions upon the direction of the Company.In addition to the rights assigned under paragraph 6, I also assign to the Company (or any of its nominees) all rights which I have or acquired in any Developments,full title to which is required to be held by the particular governmental authority under any contract between the Company and the given governmental authority.11. Prior Agreements . I hereby represent that, except as I have fully disclosed previously in writing to the Company, I am not bound by the terms of anyagreement with any previous employer (other than Aegerion Pharmaceuticals, Inc.) or other party to refrain from using or disclosing any trade secret orconfidential or proprietary information in the course of my employment with the Company or to refrain from competing, directly or indirectly, with the business ofsuch previous employer or any other party. I further represent that my performance of all the terms of this Agreement as an employee of the Company does not andwill not breach any agreement to keep in confidence proprietary information, knowledge or data acquired by me in confidence or in trust prior to my employmentwith the Company. I will not disclose to the Company or its Affiliates or induce the Company or its Affiliates to use any confidential or proprietary information ormaterial belonging to any previous employer (other than Aegerion Pharmaceuticals, Inc.) or others.12. Remedies Upon Breach .(a) Equitable Relief. I understand that the restrictions contained in this Agreement are necessary for the protection of the business and goodwill of theCompany and its Affiliates and I consider them to be reasonable for such purpose. Any breach of this Agreement is likely to cause the Company and its Affiliatessubstantial and irrevocable damage and therefore, in the event of such breach, the Company and/or any Affiliate affected by such breach, in addition to such otherremedies which may be available, will be entitled to seek specific performance and other injunctive relief, without the posting of a bond.(b) Indemnification. If I violate this Agreement, in addition to all other remedies available to the Company and any affected Affiliates at law, in equity,and under contract, I agree that I am obligated to pay all the Company's (or, if applicable, Affiliate’s) costs of enforcement of this Agreement, including attorneys'fees and expenses. I also agree that I will defend, indemnify and/or hold the Company and its Affiliates harmless from and against any and all liabilities, losses,damages, claims or demands whatsoever (including expenses, court costs and reasonable attorneys' fees) asserted against or incurred by the Company or anyAffiliate as a result of or by reason of the Company or such Affiliate having to defend any claim arising from my use of proprietary or trade secret information of aprior employer or my breach of a restrictive covenant with any prior employer, and from any damages resulting from a final judgment or reasonable settlement ofsuch claims. This indemnification shall include, but not be limited to, claims for infringement of patents, trademarks or copyrights, misappropriation of tradesecrets or confidential information, and/or breach of any restrictive covenants, and is without prejudice to any other rights held by, or remedies available to, theCompany or its Affiliates at law.13. Use of Voice, Image and Likeness . During the period of my employment, I give the Company and its Affiliates permission to use any and all ofmy voice, image and likeness, with or without using my name, in connection with the products and/or services of the Company and/or its Affiliates, for thepurposes of advertising and promoting such products and/or servicesand/or the Company and/or its Affiliates, and/or for other purposes deemed appropriate by the Company in its reasonable discretion, except to the extent expresslyprohibited by law.14. Publications and Public Statements . I will obtain the Company's written approval before publishing or submitting for publication any material thatrelates to my work at the Company (including in connection with its Affiliates) and/or incorporates any Proprietary Information.15. No Employment Obligation . I understand that this Agreement does not create an obligation on the Company or any other person to continue myemployment. I acknowledge that, unless otherwise agreed in a formal written employment agreement signed on behalf of the Company by an authorized officer,my employment with the Company is at will and therefore may be terminated by the Company or me at any time and for any reason, with or without cause.16. Survival and Assignment by the Company . I understand that my obligations under this Agreement will continue in accordance with its expressterms regardless of any changes in my title, position, duties, salary, compensation or benefits or other terms and conditions of employment. I further understandthat my obligations under this Agreement will continue following the termination of my employment regardless of the manner of such termination and will bebinding upon my heirs, executors and administrators. The Company will have the right to assign this Agreement to its Affiliates, successors and assigns. Iexpressly consent to be bound by the provisions of this Agreement for the benefit of the Company or any parent, subsidiary or affiliate to whose employ I may betransferred without the necessity that this Agreement be resigned at the time of such transfer.17. Updating Information to the Company: Disclosure to Future Employers . For twelve (12) months following termination of my employment, Iwill (a) notify the Company of any change in my address and of each subsequent employment or business activity, including the name and address of my employeror other post-Company employment plans and the nature of my activities, and (b) provide a copy of this Agreement to any prospective employer, partner or co-venturer prior to entering into an employment, partnership or other business relationship with such person or entity.18. Reimbursement . I hereby authorize the Company at any time during or after the term of my employment to withhold from any amounts otherwiseowed to me (including, but not limited to, salary, bonus, severance, commissions and expense reimbursements) to the fullest extent permitted by applicable law:any and all amounts due to the Company from me, including, but not limited to, cash advances, draws, travel advances, overpayments made by the Company tome, amounts received by me due to the Company's error, unpaid personal credit card or phone charges or any other debt I owe to the Company for any reason,including amounts with respect to misuse or misappropriation of Company assets or breach of this Agreement.19. Application to Affiliates . I acknowledge that my duties as an employee of the Company may include providing certain management services to QLTInc., Aegerion Pharmaceuticals, Inc., and other current or future affiliates of the Company within the meaning of the Delaware General Corporation Law(collectively the “Affiliates” and each an “Affiliate”), on behalf of the Company. I agree that each such Affiliate will have the same rights that the Company hasunder this Agreement (including the right to indemnification and other remedies under paragraph 12), and that I will have the same obligations to each Affiliate asI have to the Company under this Agreement, as if such Affiliate was a signatory to this Agreement instead of the Company, except that if there is any conflictbetween my obligations under this Agreement to the Company and to one or more of its Affiliates, my obligations to the Affiliate will prevail. I acknowledge toeach Affiliate that it has direct rights against me under this Agreement. To the extent required by law to give full effect to these direct rights, I acknowledge andagree that the Company is and will be deemed to be acting as agent or trustee on behalf of and for the benefit of each Affiliate.20. Severability . In case any provisions (or portions thereof) contained in this Agreement shall, for any reason, be held invalid, illegal or unenforceablein any respect, such invalidity, illegality or unenforceability shall not affect the other provisions of this Agreement, and this Agreement shall be construed as ifsuch invalid, illegal or unenforceable provision had never been contained herein. If, moreover, any one or more of the provisions contained in this Agreement shallfor any reason be held to be excessively broad as to duration, geographical scope, activity or subject, it shall be construed by limiting and reducing it, so as to beenforceable to the extent compatible with the applicable law as it shall then appear.21. Interpretation . This Agreement will be deemed to be made and entered into in the Commonwealth of Massachusetts, and will in all respects beinterpreted, enforced and governed under the laws of the Commonwealth of Massachusetts. I hereby agree to consent to personal jurisdiction of the state andfederal courts situated within Suffolk County, Massachusetts for purposes of enforcing this Agreement, and waive any objection that I might have to personaljurisdiction or venue in those courts.[Remainder of this page intentionally left blank]I UNDERSTAND THAT THIS AGREEMENT AFFECTS IMPORTANT RIGHTS. BY SIGNING BELOW, I CERTIFY THAT I HAVE READ ITCAREFULLY AND AM SATISFIED THAT I UNDERSTAND IT COMPLETELY.IN WITNESS WHEREOF, the undersigned has executed this Employee Confidentiality, Assignment of Intellectual Property and Non-CompetitionAgreement as a sealed instrument as of the date set forth below.Signed: /s/ Roger LouisName: Roger LouisDate: _____________________________________EXHIBIT ATo: Novelion Services USA, Inc. (the “Company”)From: Roger LouisDate: __________________________SUBJECT: Prior InventionsThe following is a complete list of all inventions or improvements that have been made or conceived or first reduced to practice by me alone or jointlywith others prior to my engagement by the Company:No inventions or improvementsSee below:_____________________________________________________________________________________________________________________________________________________________________________________________________________________Additional sheets attachedThe following is a list of all patents and patent applications in which I have been named as an inventor:NoneSee below:_____________________________________________________________________________________________________________________________________________________________________________________________________________________Exhibit 10.48Novelion Services USA, Inc.2711 Centerville RoadSuite 400Wilmington, DE 19808November 28, 2016Remi Menesc/o Aegerion Pharmaceuticals, Inc.One Main StreetSuite 800Cambridge, MA 02142Dear Remi:RE: Offer of EmploymentAs you are aware, Aegerion Pharmaceuticals, Inc. (“ Aegerion ”), QLT Inc. and Isotope Acquisition Corp. have agreed to carry out a merger (the “ Merger ”) onthe terms set out in the Agreement and Plan of Merger dated June 14, 2016 (the “ Merger Agreement ”).Following the Merger, Aegerion will become an indirect subsidiary of Novelion Services USA, Inc., a Delaware corporation (“ Novelion Services ”). NovelionServices is currently a subsidiary of QLT Inc., a British Columbia company, which we anticipate will change its name to “Novelion Therapeutics Inc.” (“ NovelionCanada ”).We are pleased to offer you employment with Novelion Services in the position of Global Chief Commercial Officer, commencing effective on the completion ofthe Merger, which is currently anticipated to be November 29, 2016 (the “ Commencement Date ”).Should you choose to accept this offer, the terms and conditions of your employment with Novelion Services will be the same as those set out in your currentemployment agreement with Aegerion which is attached as Schedule “A” to this letter (the “ Aegerion Agreement ”), except that the terms and conditions of theAegerion Agreement will be modified and supplemented as follows:1.Defined Terms: In the Aegerion Agreement, references to the “ Company ” or “ Aegerion ” (or any other references indicating your employer) will bedeemed to be references to Novelion Services, references to the “ Board ” will be deemed to be references to the Board of Directors of NovelionServices, and references to the “ Agreement ” or the “ Employment Agreement ” (or any other references to the terms and conditions of youremployment) will mean the Aegerion Agreement as modified and supplemented by this letter. In this letter, “ Affiliate ” has the meaning given to it in theDelaware General Corporation Law, and any other capitalized terms that are not defined in this letter will have the meanings given to them in theAegerion Agreement.2.Responsibilities and Reporting: As Global Chief Commercial Officer, you will have the duties and responsibilities set out in Section 3(a) of theAegerion Agreement in respect of Novelion Services. As described below, under the Master Service Agreement between Novelion Canada and NovelionServices that will be entered into on or about the completion date of the Merger, as amended from time to time (the “ Service Agreement ”) you may alsobe required to perform services to Novelion Canada and other Affiliates of Novelion Canada, including holding an office in Novelion Canada. Forcertainty, you will be an employee of Novelion Services and not an employee of Novelion Canada, and when you provide services to Novelion Canadayou will be doing so as an employee of Novelion Services in the context of certain management services it provides to Novelion Canada under the ServiceAgreement. You will report to the Chief Executive Officer of Novelion Services.3.Base Salary: You will be paid the Base Salary reflected in the Aegerion Agreement, subject to adjustment by the Board or Compensation Committeethereof from time to time.4.Length of Service: Novelion Services will recognize your length of service with Aegerion for all purposes related to your employment with NovelionServices, including for the purpose of determining your entitlements on termination of your employment pursuant to the Aegerion Agreement.5.Accrued Obligations: Your employment with Aegerion will cease immediately prior to the Commencement Date and Aegerion will be responsible forproviding you with all accrued but unpaid Base Salary and unreimbursed expensesincurred in accordance with the Aegerion Agreement up to such date. Any vacation time that you have accrued under Aegerion’s vacation policy as of theCommencement Date, but not used as of such date, will be “rolled over” to Novelion Services. Novelion Services will credit you with this time forpurposes of its vacation policy. By accepting this offer, you consent to the rollover of this vacation time and acknowledge and agree that you are notentitled to any payment for this vacation time in connection with the transfer of your employment from Aegerion to Novelion Services. For certainty, youwill continue to be obligated to repay your Signing Bonus pursuant to Section 4(c) of the Aegerion Agreement and your Relocation Transition Allowancepursuant to Section 6 of the Aegerion Agreement if you resign from employment with Novelion Services or are terminated for Cause, and you will paythose amounts to Aegerion and/or Novelion Services at the direction of Novelion Services.6.No Severance or Good Reason: You agree that (a) the transfer of your employment from Aegerion to Novelion Services and any other changes to theterms and conditions of your employment that are expressly contemplated by this letter, and/or (b) any changes to your duties or responsibilities thatdirectly result from the Merger (including without limitation any such changes directly resulting from your new status as an executive officer of asubsidiary of Novelion Canada) shall not, individually or in the aggregate, constitute Good Reason for purposes of the Aegerion Agreement or theEmployment Agreement or entitle you to any Severance Benefits, Accelerated Equity Benefit or any other severance benefits or the acceleration of anyvesting or other rights, to which you might otherwise be entitled. You agree that, to the extent required by law to permit Aegerion to rely on thisparagraph 6, Novelion Services is and will be deemed to be acting as agent or trustee on behalf of and for the benefit of Aegerion.7.Stock Options / Equity Grants: Any stock options, restricted stock units, or other equity awards that you may have been granted pursuant to theInducement Plan or 2010 Stock Option and Incentive Plan will be dealt with as set out in the Merger Agreement. Once the Merger is completed, any suchoutstanding entitlements will be governed by and subject to the applicable stock option plan and stock option agreement.8.Right to Work in Canada: You will cooperate with Novelion Services to seek, obtain, and maintain the right to work in Canada to provide services onbehalf of Novelion Services to Novelion Canada and any of its other Affiliates. Novelion Services will pay the reasonable costs associated with obtaininga permit to work in Canada.9.Commuting to Canada: You acknowledge that travel will be required in connection with your employment, including commuting on a regular basis tosuch locations in Canada as are required for Novelion Services to provide its management services to Novelion Canada and its Canadian Affiliates.10.Tax Consultation Expenses: Each year so long as you are providing management services, you will be entitled to reimbursement for your reasonableexpenses up to a maximum of USD $5,000 for an independent tax consultation regarding the Canadian tax implications of your work on behalf ofNovelion Services in Canada and/or preparation of your Canadian tax return.11.Tax Equalization:(a)As you will be subject to income tax and social security obligations arising from your services performed in Canada on behalf of Novelion Services,Novelion Services is prepared to address the overall tax and social security burden that you experience with the intention that your total tax and socialsecurity burden while working in both the United States and Canada will be equal to what your tax and social security burden would have been hadyou remained working solely in Massachusetts. Novelion Services will provide you with tax equalization in connection with all income tax and socialsecurity liabilities arising from the performance of your employment duties within Canada. Novelion Services intends that the income taxes andsocial security levies payable by you on all taxable employment income and related benefits, as prescribed by the applicable tax and social securitylaws, should be no better or worse than the personal taxes and social security levies you would have been required to pay on such amounts if youremployment duties had been performed solely in the state of Massachusetts. Where your annual tax and social security obligation yields a highertotal obligation than if your employment duties were solely performed in the state of Massachusetts, Novelion Services will reimburse you for thedifference. Where your annual tax and social security obligations yields a lower total tax and social security impact than if your employment dutieswere solely performed in the state of Massachusetts, you will reimburse Novelion Services for the difference.(b)You will provide all information necessary for the preparation of a tax equalization calculation.(c)Novelion Services will pay all reasonable costs and professional fees related to calculating this equalization payment, and reserves the discretion toestablish the process and criteria for determining the tax equalization calculation. For clarity, the tax equalization payments described in thisparagraph 11 will not take into consideration or apply to anytaxable income from sources other than your employment with Novelion Services, and you will remain responsible for all income taxes arising fromyour personal income.(d)If you establish your primary residence in Canada, Novelion Services’ obligations under this paragraph 11 will cease, provided that there will be apro-rated adjustment for any partial year.(e)If your employment is terminated for any of the reasons described under Section 7 of the Aegerion Agreement, then between January 1 and July 31of the calendar year following the calendar year in which such termination occurs, Novelion Services will pay you any remaining tax equalizationpayments owed in accordance with this paragraph 11 or, in the event that the reconciliation results in you owing money to Novelion Services, youwill make such payment to Novelion Services.12.Release: The form of Release of Claims contemplated in the Aegerion Agreement will be the form attached as Schedule “B” to this Agreement.13.Employment Standards: This provision applies only if and to the extent that the employment laws of Canada apply to your employment. If theminimum standards in the British Columbia Employment Standards Act or Ontario Employment Standards Act, 2000 , or any other applicableemployment standards legislation, as they exist from time to time are more favorable to you in any respect than provided for in the EmploymentAgreement, including but not limited to the provisions in respect of notice of termination, the provisions of the applicable Employment Standards Act orlegislation will apply.14.Confidentiality, Assignment of Intellectual Property and Non-Competition: As a condition of your employment with Novelion Services, and inconsideration of the commitments set forth in this letter, you agree to execute and deliver to Novelion Services the Confidentiality, Assignment ofIntellectual Property and Non-Competition Agreement attached as Schedule “C” to this letter (the “ Ancillary Agreement ”), which will take effect onthe Commencement Date, following which any references to the “Confidentiality Agreement” in the Aegerion Agreement will be deemed to be referencesto the Ancillary Agreement. Your acceptance of this offer of employment or execution of the Ancillary Agreement does not affect your obligations toAegerion or the rights of Aegerion under the Confidentiality Agreement arising from your employment with Aegerion prior to the Commencement Date.15.Priority: If there is any conflict or inconsistency between these Supplementary Terms and the Aegerion Agreement, these Supplementary Terms will takeprecedence.If the terms and conditions of your employment described in this letter and the terms and conditions of the Ancillary Agreement are acceptable to you, please signthis letter (where indicated on the next page) and the enclosed Ancillary Agreement, and return signed copies of the foregoing to us by November 28, 2016.If you have any questions or concerns, please do not hesitate to contact Geoffrey Cox.[ Remainder of this page intentionally left blank ]Yours truly,NOVELION SERVICES USA, INC.Per: /s/ Geoffrey CoxAuthorized SignatoryI, Remi Renes, have read, understand and agree with the terms and conditions of employment referenced in this letter. I have had a reasonable opportunity toconsider these terms and conditions and seek independent legal advice, and I accept employment with Novelion Services on these terms and conditions./s/ Remi RenesSignatureNovember 28, 2016DateRemi Menes – Employment AgreementSCHEDULE “A”AEGERION AGREEMENT[See attached]EMPLOYMENT AGREEMENTThis Employment Agreement (this “ Agreement ”) is made and entered into as of this 21st day of September, 2016, by and between AegerionPharmaceuticals, Inc., a Delaware corporation (the “ Company ”), and Remi Menes (the “ Employee ”).W I T N E S S E T H :WHEREAS, the Company desires to employ Employee and desires to enter into this Agreement embodying the terms of such employment, andEmployee desires to enter into this Agreement and to accept the terms and provisions of such employment, as embodied in this Agreement.NOW, THEREFORE, in consideration of the promises and mutual covenants contained herein and for other good and valuable consideration,the receipt and sufficiency of which are mutually acknowledged, the Company and Employee hereby agree as follows:Section 1. Definitions.(a) “ Accrued Obligations ” shall mean (i) all accrued but unpaid Base Salary through the Date of Termination, (ii) any unpaid orunreimbursed expenses incurred in accordance with Section 6 hereof, and (iii) any accrued but unused vacation time through the Date of Termination.(b) “ Base Salary ” shall mean the salary provided for in Section 4(a) hereof.(c) “ Board ” shall mean the Board of Directors of the Company.(d) “ Confidentiality Agreement ” shall mean the Company’s Confidentiality, Assignment and Noncompetition Agreement attachedhereto as Exhibit A .(e) “ Cause ” shall mean (i) Employee’s failure (except where due to a Disability), neglect, or refusal to perform in any material respectEmployee’s duties and responsibilities, (ii) any act of Employee that has, or could reasonably be expected to have, the effect of injuring the business of theCompany or its affiliates in any material respect, (iii) Employee’s conviction of, or plea of guilty or no contest to: (x) a felony or (y) any other criminal charge thathas, or could be reasonably expected to have, an adverse impact on the performance of Employee’s duties to the Company or otherwise result in material injury tothe reputation or business of the Company, (iv) the commission by Employee of an act of fraud or embezzlement against the Company, or any other act that createsor reasonably could create negative or adverse publicity for the Company; (v) any violation by Employee of the policies of the Company, including but not limitedto those relating to sexual harassment or business conduct, and those otherwise set forth in the manuals or statements of policy of the Company, (vi) Employee’sviolation of federal or state securities laws, or (vii) Employee’s breach of this Agreement or breach of the Confidentiality Agreement.(f) “ Code ” shall mean the Internal Revenue Code of 1986, as amended, and the rules and regulations promulgated thereunder.(g) “ Date of Termination ” shall mean the date on which Employee’s employment terminates.(h) “ Disability ” shall mean any physical or mental disability or infirmity of Employee that prevents the performance of Employee’sduties for a period of (i) ninety (90) consecutive days or (ii) one hundred twenty (120) non-consecutive days during any twelve (12) month period. Any question asto the existence, extent, or potentiality of Employee’s Disability upon which Employee and the Company cannot agree shall be determined by a qualified,independent physician selected by the Company and approved by Employee (which approval shall not be unreasonably withheld). The determination of any suchphysician shall be final and conclusive for all purposes of this Agreement.(i) “ Effective Date ” shall mean September 21, 2016.(j) “ Good Reason ” shall mean, without Employee’s consent, (i) a material diminution in Employee’s title, duties, or responsibilities asset forth in Section 3 hereof, (ii) a material reduction in Base Salary as set forth in Section 4(a) hereof (other than pursuant to an across-the-board reductionapplicable to all similarly situated executives), (iii) the relocation of Employee’s principal place of employment more than fifty (50) miles from its current location,or (iv) any other material breach of a provision of this Agreement by the Company (other than a provision that is covered by clause (i), (ii), or (iii) above).Employee acknowledges and agrees that Employee’s exclusive remedy in the event of any breach of this Agreement shall be to assert GoodReason pursuant to the terms and conditions of Section 7(e) hereof. Notwithstanding the foregoing, during the Term, in the event that the Company reasonablybelieves that Employee may have engaged in conduct that could constitute Cause hereunder, the Company may, in its sole and absolute discretion, suspendEmployee from performing Employee’s duties hereunder, and in no event shall any such suspension constitute an event pursuant to which Employee mayterminate employment with Good Reason or otherwise constitute a breach hereunder; provided , that no such suspension shall alter the Company’s obligationsunder this Agreement during such period of suspension.(k) “ Release of Claims ” shall mean a separation agreement in a form acceptable to the Company under which Employee releases theCompany from any and all claims and causes of action and the execution of which is a condition precedent to Employee’s eligibility for Severance Benefits in theevent Employee’s employment is terminated by the Company without Cause or by Employee for Good Reason, as described in Sections 7(d) and 7(e).(l) Intentionally omitted.(m) “ Severance Benefits ” shall mean (i) continued payment of Base Salary during the Severance Term, payable in accordance with theCompany’s regular payroll practices, and (ii) subject to the Employee’s timely election of COBRA and copayment of premium amounts at the active employees’rate, payment of the employer portion of the premiums for the Company’s group health and dental program for the Employee in order to allow him to continue toparticipate in the Company’s group health and dental program until the earlier of (Y) twelve (12) months from the Date of Termination, and (Z) the date theEmployee becomes re-employed and eligible for health and/or dental insurance.(n) “ Severance Term ” shall mean the twelve (12) month period, which commences on the first pay day that is at least thirty-five (35)days from the Date of Termination following termination by the Company without Cause or by Employee for Good Reason.Section 2. Acceptance and Term.The Company agrees to employ Employee on an at-will basis, and Employee agrees to accept such employment and serve the Company, inaccordance with the terms and conditions set forth herein. The term of employment (referred to herein as the “ Term ) shall commence on the Effective Date andshall continue until terminated by either party at any time, subject to the provisions herein.Section 3. Position, Duties, and Responsibilities; Place of Performance.(a) Position, Duties, and Responsibilities . During the Term, Employee shall be employed and serve as Global Chief CommercialOfficer (together with such other position or positions consistent with Employee’s title or as the Company shall specify from time to time) and shall have suchduties and responsibilities commensurate therewith, and such other duties as may be assigned and/or prescribed from time to time by Employee’s supervisor and/orthe Board.(b) Performance . Employee shall devote Employee’s full business time, attention, skill, and best efforts to the performance ofEmployee’s duties under this Agreement and shall not engage in any other business or occupation during the Term, including, without limitation, any activity that(x) conflicts with the interests of the Company, (y) interferes with the proper and efficient performance of Employee’s duties for the Company, or (z) interfereswith Employee’s exercise of judgment in the Company’s best interests. Notwithstanding the foregoing, nothing herein shall preclude Employee from (i) serving,with the prior written consent of the Board, as a member of the boards of directors or advisory boards (or their equivalents in the case of a non-corporate entity) ofnon-competing businesses and charitable organizations, (ii) engaging in charitable activities and community affairs, and (iii) managing Employee’s personalinvestments and affairs; provided , however , that the activities set out in clauses (i), (ii), and (iii) shall be limited by Employee so as not to interfere, individuallyor in the aggregate, with the performance of Employee’s duties and responsibilities hereunder. Employee represents that he has provided the Company with acomprehensive list of all outside professional activities with which he is currently involved or reasonably expects to become involved. In the event that, duringEmployee’s employment by the Company, the Employee desires to engage in other outside professional activities, not included on such list, Employee will firstseek written approval from the CEO or President and such approval shall not be unreasonably withheld.Section 4. Compensation.(a) Base Salary . In exchange for Employee’s satisfactory performance of Employee’s duties and responsibilities, Employee initiallyshall be paid a semi-monthly Base salary of $16,666.67 ($400,000 on an annualized basis), payable in accordance with the regular payroll practices of theCompany. All payments in this Agreement are on a gross, pre-tax basis and shall be subject to all applicable federal, state and local withholding, payroll and othertaxes.(b) Target Bonus . In addition to Employee’s Base Salary, Employee will be eligible to earn an annual target bonus of up to 45% ofEmployee’s Base Salary. The actual amount of such bonus, if any, will be determined by the Board and Employee’s manager in their sole discretion, based uponCompany performance, Employee’s achievement of a series of performance milestones, and any other factors that the Board, in its discretion, deem appropriate.Employee’s achievement ofsuch milestones, as well as the amount of any bonus, shall be determined by the Board and Employee’s manager in their sole discretion. Typically, bonuses, if any,are paid out no later than March 31 of the year following the applicable bonus year. Employee must be employed by Aegerion at the time of any such bonuspayment in order to be eligible for any such payment.(c) Signing Bonus . In addition to the above bonus, Employee will be eligible to receive a one-time cash sign-on bonus in the amount of$200,000, which will be paid out as soon as practical following the Effective Date. Employee must be employed by the Company at the time of the bonus paymentin order to be eligible for any such payment. If, prior to the 12-month anniversary of the Effective Date, Employee resigns or the Company terminates Employee’semployment for Cause, then Employee agrees to repay to the Company the net amount of the signing bonus within 30 days of such termination of employment.Section 5. Employee Benefits.During the Term, Employee shall be eligible to participate in health insurance and other benefits provided generally to similarly situatedemployees of the Company, subject to the terms and conditions of the applicable benefit plans (which shall govern). Employee also shall be eligible for the samenumber of holidays and vacation days as well as any other benefits, in each case as are generally allowed to similarly situated employees of the Company inaccordance with the Company policy as in effect from time to time. Nothing contained herein shall be construed to limit the Company’s ability to amend, suspend,or terminate any employee benefit plan or policy at any time without providing Employee notice, and the right to do so is expressly reserved.Section 6. Reimbursement of Business Expenses; Relocation and Temporary Living Assistance.During the Term of Employment, the Company shall pay (or promptly reimburse Employee) for documented, out-of-pocket expenses reasonablyincurred by Employee in the course of performing Employee’s duties and responsibilities hereunder, which are consistent with the Company’s policies in effectfrom time to time with respect to business expenses, subject to the Company’s requirements with respect to reporting of such expenses.In addition, Employee shall be eligible for a relocation transition allowance to cover the following expenses: (a) temporary housing, not toexceed $4,500 per month, for Employee’s use towards renting suitable housing in the Cambridge, Massachusetts area for no longer than six months from theEffective Date; and (b) shipment of Employee’s household goods from Finland to Cambridge, Massachusetts (collectively with (a), the “ Relocation TransitionAllowance ”); and (c) a “gross-up” payment in the amount necessary to offset the tax liability associated with the Relocation Transition Allowance outlined in (a)and (b); provided, that (x) Employee shall submit expense reports with supporting documentation in such form and containing such information as the Companymay request to be reimbursed for all Relocation Transition Allowance expenses, and (y) if, prior to the 12-month anniversary of the payment of any RelocationTransition Allowance, the Employee resigns other than for Good Reason or the Company terminates the Employee’s employment for cause, the Employee shallrepay to the Company the appropriate pro-rated amount of such Relocation Transition Allowance within 30 days of such termination of employment. For theavoidance of doubt, Employee’s eligibility for any Relocation Transition Allowance shall not exceed a total cost of $60,000.Section 7. Termination of Employment.(a) General . Employee’s employment with the Company shall terminate upon the earliest to occur of: (i) Employee’s death, (ii) atermination by reason of a Disability, (iii) a termination by the Company with or without Cause, and (iv) a termination by Employee with or without Good Reason.Notwithstanding anything herein to the contrary, the payment (or commencement of a series of payments) hereunder of any nonqualified deferred compensation(within the meaning of Section 409A of the Code) upon a termination of employment shall be delayed until such time as Employee has also undergone a“separation from service” as defined in Treas. Reg. 1.409A-1(h), at which time such nonqualified deferred compensation (calculated as of the date of Employee’stermination of employment hereunder) shall be paid (or commence to be paid) to Employee on the schedule set forth in this Section 7 as if Employee hadundergone such termination of employment (under the same circumstances) on the date of Employee’s ultimate “separation from service.”(b) Termination Due to Death or Disability . Employee’s employment under this Agreement shall terminate automatically uponEmployee’s death. The Company also may terminate Employee’s employment immediately upon the occurrence of a Disability, such termination to be effectiveupon Employee’s receipt of written notice of such termination. In the event of Employee’s termination as a result of Employee’s death or Disability, Employee orEmployee’s estate or beneficiaries, as the case may be, shall be entitled only to the Accrued Obligations, and Employee shall have no further rights to anycompensation or any other benefits under this Agreement.(c) Termination by the Company with Cause .(i) The Company may terminate Employee’s employment at any time with Cause, effective upon Employee’s receipt ofwritten notice of such termination; provided , however , that with respect to any Cause terminationrelying on clause (i) or (ii) of the definition of Cause set forth in Section 1(d) hereof, to the extent that such act or acts or failure or failures to act arecurable, Employee shall be given ten (10) days’ written notice by the Company of its intention to terminate him with Cause, such notice to state the act oracts or failure or failures to act that constitute the grounds on which the proposed termination with Cause is based, and such termination shall be effectiveat the expiration of such ten (10) day notice period unless Employee has fully cured such act or acts or failure or failures to act, to the Company’scomplete satisfaction, that give rise to Cause during such period.(ii) In the event that the Company terminates Employee’s employment with Cause, Employee shall be entitled only to theAccrued Obligations. Following such termination of Employee’s employment with Cause, except as set forth in this Section 7(c)(ii), Employee shall haveno further rights to any compensation or any other benefits under this Agreement. For the avoidance of doubt, Employee’s sole and exclusive remedyupon a termination of employment by the Company with Cause shall be receipt of the Accrued Obligations.(d) Termination by the Company without Cause . The Company may terminate Employee’s employment at any time without Cause,effective upon Employee’s receipt of written notice of such termination. In the event that Employee’s employment is terminated by the Company without Cause(other than due to death or Disability) and provided that he fully executes an effective Release of Claims as described in Section 7(g), Employee shall be eligiblefor:(i) The Accrued Obligations;(ii) The Severance Benefits; and(iii) If such termination without Cause and the Date of Termination occur within eighteen (18) months after a Sale Event (assuch term is defined in the Company’s 2010 Stock Option and Incentive Plan), acceleration of the vesting of 100% of Employee’s then outstandingunvested equity awards, if any, such that all unvested equity awards vest and become fully exercisable or non-forfeitable as of the Date of Termination(the “ Accelerated Equity Benefit ”), in which case Employee shall have ninety (90) days from the Date of Termination to exercise the vested equityawards, if any.Notwithstanding the foregoing, the Severance Benefits shall immediately terminate, and the Company shall have no further obligations to Employee with respectthereto, in the event that Employee breaches any provision of the Confidentiality Agreement or the Release of Claims. Any such termination of payment or benefitsshall have no effect on the Release of Claims or any of Employee’s post-employment obligations to the Company. Following such termination of Employee’semployment by the Company without Cause, except as set forth in this Section 7(d), Employee shall have no further rights to any compensation or any otherbenefits under this Agreement. For the avoidance of doubt, Employee’s sole and exclusive remedy upon a termination of employment by the Company withoutCause shall be receipt of (i) the Severance Benefits (and, in the case of such a termination within eighteen (18) months after a Sale Event, the Accelerated EquityBenefit), subject to Employee’s execution of the Release of Claims and (ii) the Accrued Obligations.If the Company makes overpayments of Severance Benefits, Employee promptly shall return any such overpayments to the Company and/or hereby authorizesdeductions from future Severance Benefit amounts.(e) Termination by Employee with Good Reason . Employee may terminate Employee’s employment with Good Reason by providingthe Company thirty (30) days’ written notice setting forth in reasonable specificity the event that constitutes Good Reason, which written notice, to be effective,must be provided to the Company within sixty (60) days of the occurrence of such event. During such thirty (30) day notice period, the Company shall have a cureright (if curable), and if not cured within such period, Employee’s termination will be effective upon the expiration of such cure period, and Employee shall beentitled to the same payments and benefits as provided in Section 7(d) hereof for a termination by the Company without Cause, subject to the same conditions onpayment and benefits as described in Section 7(d) hereof. Following such termination of Employee’s employment by Employee with Good Reason, except as setforth in this Section 7(e), Employee shall have no further rights to any compensation or any other benefits under this Agreement. For the avoidance of doubt,Employee’s sole and exclusive remedy upon a termination of employment with Good Reason shall be receipt of (i) the Severance Benefits (and, in the case of sucha termination within eighteen (18) months after a Sale Event, the Accelerated Equity Benefit), subject to Employee’s execution of the Release of Claims and (ii)the Accrued Obligations.(f) Termination by Employee without Good Reason . Employee may terminate Employee’s employment without Good Reason byproviding the Company thirty (30) days’ written notice of such termination. In the event of a termination of employment by Employee under this Section 7(f),Employee shall be entitled only to the Accrued Obligations. In the event of termination of Employee’s employment under this Section 7(f), the Company may, inits sole and absolute discretion, by written notice accelerate such date of termination without changing the characterization of such termination as a termination byEmployee without Good Reason. Following such termination of Employee’s employment by Employee without Good Reason, except as set forth in this Section7(f), Employee shall have no further rights to any compensation or any other benefits under this Agreement.For the avoidance of doubt, Employee’s sole and exclusive remedy upon a termination of employment by Employee without Good Reason shall be receipt of theAccrued Obligations.(g) Release . Notwithstanding any provision herein to the contrary, the payment of the Severance Benefits pursuant to subsection (d) or(e) of this Section 7 (other than the Accrued Obligations) shall be conditioned upon Employee’s execution, delivery to the Company, and non-revocation of theRelease of Claims (and the expiration of any revocation period contained in such Release of Claims) in accordance with the time limits set forth therein. IfEmployee fails to execute the Release of Claims in such a timely manner, or timely revokes Employee’s acceptance of such release following its execution,Employee shall not be entitled to any of the Severance Benefits. Further, to the extent that any of the Severance Benefits constitutes “nonqualified deferredcompensation” for purposes of Section 409A of the Code, any payment of any amount or provision of any benefit otherwise scheduled to occur prior to the thirty-fifth (35 th ) day following the date of Employee’s termination of employment hereunder, but for the condition on executing the Release of Claims as set forthherein, shall not be made until the first regularly scheduled payroll date following such thirty-fifth (35 th ) day, after which any remaining Severance Benefits shallthereafter be provided to Employee according to the applicable schedule set forth herein.Section 8. Confidentiality Agreement; Cooperation.(a) Confidentiality Agreement . As a condition of Employee’s employment with the Company under the terms of this Agreement,Employee shall execute and deliver to the Company the Confidentiality Agreement, in the form attached hereto as Exhibit A. The parties hereto acknowledge andagree that this Agreement and the Confidentiality Agreement shall be considered separate contracts. In addition, Employee represents and warrants that he shall beable to and will perform the duties of this position without utilizing any confidential and/or proprietary information that Employee may have obtained inconnection with employment with any prior employer, and that she shall not (i) disclose any such information to Aegerion, or (ii) induce any Aegerion employee touse any such information, in either case in violation of any confidentiality obligation, whether by agreement or otherwise.(b) Litigation and Regulatory Cooperation . During and after Employee’s employment, Employee shall cooperate fully with theCompany in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company whichrelate to events or occurrences that transpired while the Company employed Employee, provided, that the Employee will not have an obligation under thisparagraph with respect to any claim in which the Employee has filed directly against the Company or related persons or entities. The Employee’s full cooperationin connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as awitness on behalf of the Company at mutually convenient times. During and after Employee’s employment, Employee also shall cooperate fully with the Companyin connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrencesthat transpired while Employee was employed by the Company, provided Employee will not have any obligation under this paragraph with respect to any claim inwhich Employee has filed directly against the Company or related persons or entities. The Company shall reimburse Employee for any reasonable out-of-pocketexpenses incurred in connection with Employee’s performance of obligations pursuant to this Section 8(b).Section 9. Taxes.The Company may withhold from any payments made under this Agreement all applicable taxes, including but not limited to income,employment, and social insurance taxes, as shall be required by law. Employee acknowledges and represents that the Company has not provided any tax advice tohim in connection with this Agreement and that Employee has been advised by the Company to seek tax advice from Employee’s own tax advisors regarding thisAgreement and payments that may be made to him pursuant to this Agreement, including specifically, the application of the provisions of Section 409A of theCode to such payments. The Company shall have no liability to Employee or to any other person if any of the provisions of this Agreement are determined toconstitute deferred compensation subject to Section 409A but that do not satisfy an exemption from, or the conditions of, that section.Section 10. Additional Section 409A Provisions.Notwithstanding any provision in this Agreement to the contrary:(a) If at the time of the Employee’s separation from service within the meaning of Section 409A of the Code, the Company determinesthat the Employee is a “specified employee” within the meaning of Section 409A(a)(2)(B)(i) of the Code, then to the extent any payment or benefit that theEmployee becomes entitled to under this Agreement on account of the Employee’s separation from service is “non-qualified deferred compensation” subject toSection 409A of the Code and not otherwise exempt, such payment shall not be payable and such benefit shall not be provided until the date that is the earlier of (i)six months and one day after the Employee’s separation from service, or (ii) the Employee’s death. If any such delayed cash payment is otherwise payable on aninstallment basis, the first payment shall include a catch-up payment covering amounts thatwould otherwise have been paid during the six-month period but for the application of this provision, and the balance of the installments shall be payable inaccordance with their original schedule.(b) Each payment in a series of payments hereunder shall be deemed to be a separate payment for purposes of Section 409A of theCode. Neither the Company nor Employee shall have the right to accelerate or defer the delivery of any such payments except to the extent specifically permittedor required by Section 409A.(c) To the extent that any right to reimbursement of expenses or payment of any benefit in-kind under this Agreement constitutesnonqualified deferred compensation (within the meaning of Section 409A of the Code), (i) any such expense reimbursement or payment shall be made by theCompany no later than the last day of the taxable year following the taxable year in which such expense was incurred by Employee, (ii) the right to reimbursement,payment or in-kind benefits shall not be subject to liquidation or exchange for another benefit, and (iii) the amount of expenses eligible for reimbursement,payment or in-kind benefits provided during any taxable year shall not affect the expenses eligible for reimbursement or in-kind benefits to be provided in anyother taxable year; provided , that the foregoing clause shall not be violated with regard to expenses reimbursed under any arrangement covered by Section 105(b)of the Code solely because such expenses are subject to a limit related to the period the arrangement is in effect.(d) To the extent that any payment or benefit described in this Agreement constitutes “non-qualified deferred compensation” underSection 409A of the Code, and to the extent that such payment or benefit is payable upon the Employee’s termination of employment, then such payments orbenefits shall be payable only upon the Employee’s “separation from service.” The determination of whether and when a separation from service has occurred shallbe made in accordance with the presumptions set forth in Treasury Regulation Section 1.409A‑1(h).(e) The parties intend that this Agreement will be administered in accordance with Section 409A of the Code. To the extent that anyprovision of this Agreement is ambiguous as to its compliance with Section 409A of the Code, the provision shall be read in such a manner so that all paymentshereunder comply with Section 409A of the Code. The parties agree that this Agreement may be amended, as reasonably requested by either party, and as may benecessary to fully comply with Section 409A of the Code and all related rules and regulations in order to preserve the payments and benefits provided hereunderwithout additional cost to either party. While the payments and benefits provided hereunder are intended to be structured in a manner to avoid the implication ofany penalty taxes under Section 409A of the Code, in no event whatsoever shall the Company or any of its affiliates be liable for any additional tax, interest, orpenalties that may be imposed on Employee as a result of Section 409A of the Code or any damages for failing to comply with Section 409A of the Code (otherthan for withholding obligations or other obligations applicable to employers, if any, under Section 409A of the Code).Section 11. Successors and Assigns.(a) The Company . This Agreement shall inure to the benefit of the Company and its respective successors and assigns. This Agreementmay be assigned by the Company without Employee’s prior consent.(b) Employee . Employee’s rights and obligations under this Agreement shall not be transferable by Employee by assignment orotherwise, without the prior written consent of the Company; provided , however , that if Employee shall die, all amounts then payable to Employee hereundershall be paid in accordance with the terms of this Agreement to Employee’s devisee, legatee, or other designee, or if there be no such designee, to Employee’sestate.Section 12. Waiver and Amendments.Any waiver, alteration, amendment, or modification of any of the terms of this Agreement shall be valid only if made in writing and signed byeach of the parties hereto; provided , however , that any such waiver, alteration, amendment, or modification must be consented to on the Company’s behalf by theBoard. No waiver by either of the parties hereto of their rights hereunder shall be deemed to constitute a waiver with respect to any subsequent occurrences ortransactions hereunder unless such waiver specifically states that it is to be construed as a continuing waiver.Section 13. Severability.If any covenants or such other provisions of this Agreement are found to be invalid or unenforceable by a final determination of a court ofcompetent jurisdiction, (a) the remaining terms and provisions hereof shall be unimpaired, and (b) the invalid or unenforceable term or provision hereof shall bedeemed replaced by a term or provision that is valid and enforceable and that comes closest to expressing the intention of the invalid or unenforceable term orprovision hereof.Section 14. Governing Law and Jurisdiction. This is a Massachusetts contract and shall be construed under and be governedin all respects by the laws of the Commonwealth of Massachusetts without giving effect to the conflict of laws principles of such state. With respect to any disputesconcerning federal law, such disputes shall be determined in accordance with the law as it would be interpreted and applied by the United States Court of Appealsfor the First Circuit. To the extent that any court action is initiated to enforce this Agreement, the parties hereby consent to the jurisdiction of the state and federalcourtsof the Commonwealth of Massachusetts. Accordingly, with respect to any such court action, Employee (a) submits to the personal jurisdiction of such courts; (b)consents to service of process; and (c) waives any other requirement (whether imposed by statute, rule of court, or otherwise) with respect to personal jurisdictionor service of process.Section 15. Notices.(a) Place of Delivery . Every notice or other communication relating to this Agreement shall be in writing, and shall be mailed to ordelivered to the party for whom or which it is intended at such address as may from time to time be designated by it in a notice mailed or delivered to the otherparty as herein provided; provided, that unless and until some other address be so designated, all notices and communications by Employee to the Company shallbe mailed or delivered to the Company at its principal executive office, and all notices and communications by the Company to Employee may be given toEmployee personally or may be mailed to Employee at Employee’s last known address, as reflected in the Company’s records.(b) Date of Delivery . Any notice so addressed shall be deemed to be given or received (i) if delivered by hand, on the date of suchdelivery, (ii) if mailed by courier or by overnight mail, on the first business day following the date of such mailing, and (iii) if mailed by registered or certifiedmail, on the third business day after the date of such mailing.Section 16. Section Headings.The headings of the sections and subsections of this Agreement are inserted for convenience only and shall not be deemed to constitute a partthereof or affect the meaning or interpretation of this Agreement or of any term or provision hereof.Section 17. Entire Agreement.This Agreement supersedes all prior negotiations, discussions, correspondence, communications, understandings, and agreements between theparties (including any offer letter given to Employee) relating to the subject matter of this Agreement; provided however, that Employee remains subject to thoseconditions set forth in the offer letter regarding completion of an employment application and background and/or reference checks to the Company’s satisfaction,in addition to executing those forms necessary for the processing of such background check. In the event the Company awards Employee any equity in theCompany, the full terms and conditions related to such award shall be set forth in the stock option plan pursuant to which the award is issued, and the award shallbe subject to the terms of an equity agreement thereunder (collectively, the “ Equity Documents ”). To the extent that there is any inconsistency between thisAgreement and the Equity Documents, the Equity Documents shall control. This Agreement, together with the Confidentiality Agreement attached hereto and theEquity Documents, constitutes the entire understanding and agreement of the parties hereto regarding the employment of Employee.Section 18. Survival of Operative Sections.Upon any termination of Employee’s employment, the provisions of Section 7 through Section 19 of this Agreement (together with any relateddefinitions set forth in Section 1 hereof) shall survive to the extent necessary to give effect to the provisions thereof.Section 19. Counterparts.This Agreement may be executed in two or more counterparts, each of which shall be deemed to be an original but all of which together shallconstitute one and the same instrument. The execution of this Agreement may be by actual or facsimile signature.Section 20. Gender Neutral.Wherever used herein, a pronoun in the masculine gender shall be considered as including the feminine gender unless the context clearlyindicates otherwise.* * *IN WITNESS WHEREOF, the undersigned have executed this Agreement as of the date first above written.AEGERION PHARMACEUTICALS, INC./s/ Mary SzelaBy: Mary SzelaTitle: Chief Executive OfficerEMPLOYEE/s/ Remi Alexis MenesRemi Alexis MenesSCHEDULE “B”GENERAL RELEASE AND WAIVER OF CLAIMSIn exchange for the severance benefits to be provided to me under the employment agreement between me and Novelion Services USA, Inc. (“NovelionServices”), dated as of November 28, 2016 (the “Employment Agreement”), to which I would not otherwise be entitled, on my own behalf and that of my heirs,executors, administrators, beneficiaries, personal representatives and assigns, I agree that this General Release and Waiver of Claims (the “Release of Claims”)shall be in complete and final settlement of any and all causes of action, rights and claims, whether known or unknown, accrued or unaccrued, contingent orotherwise, that I have had in the past, now have, or might now have, in any way related to, connected with or arising out of my employment or its termination,under the Employment Agreement, or pursuant to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Age Discrimination inEmployment Act, as amended by the Older Workers Benefit Protection Act, the Worker Adjustment and Retraining Notification Act, the Employee RetirementIncome Security Act, the wage and hour, wage payment and fair employment practices laws and statutes of the Commonwealth of Massachusetts (each as amendedfrom time to time), and/or any other federal, state or local law, regulation or other requirement and, if the employment laws of Canada apply to my employment,the Ontario and British Columbia Employment Standards Acts, the Ontario and British Columbia Human Rights Codes, and any other applicable Canadian orprovincial law, regulation or other requirement (each as amended from time to time) (collectively, the “Claims”), and I hereby release and forever dischargeNovelion Services, its Affiliates (as defined in the Employment Agreement, and including for certainty and without limitation QLT Inc. and AegerionPharmaceuticals, Inc.), and all of their respective past, present and future directors, shareholders, officers, members, managers, general and limited partners,employees, employee benefit plans, administrators, trustees, agents, representatives, successors and assigns, and all others connected with any of them (the“Releasees”), both individually and in their official capacities, from, and I hereby waive, any and all such Claims. This release shall not apply to (a) any claims thatarise after I sign this Release of Claims, including my right to enforce the terms of this Release of Claims; (b) any claims that may not be waived pursuant toapplicable law; (c) any right to indemnification that I may have under the certificate of incorporation or by-laws of Novelion Services, and any indemnificationagreement between me and Novelion Services or any insurance policies maintained by Novelion Services; or (d) any right to receive any vested benefits under theterms of any employee benefit plans and my award agreements thereunder.I agree that the Releasees have satisfied all obligations to me under the legislation referred to in the previous paragraph in relation to my employment and thecessation of my employment, and I have considered any and all human rights complaints, concerns, or issues arising out of or in respect to my employment withNovelion Services, I am aware of my rights under the legislation referred to in the previous paragraph, and I confirm that I am not asserting such rights oradvancing a human rights claim or complaint against the Releasees.Nothing contained in this Release of Claims shall be construed to prohibit me from filing a charge with or participating in any investigation or proceedingconducted by the federal Equal Employment Opportunity Commission or a comparable state or local agency, provided, however, that I hereby agree to waive myright to recover monetary damages or other individual relief in any charge, complaint or lawsuit filed by me or by anyone else on my behalf.In signing this Release of Claims, I acknowledge my understanding that I may consider the terms of this Release of Claims for up to [twenty-one (21) /forty-five(45)] To be determined by Novelion Services at the time of termination. days from the date I receive it and that I may not sign this Release of Claims until after thedate my employment with Novelion Services terminates. I also acknowledge that I am hereby advised by Novelion Services to seek the advice of an attorney priorto signing this Release of Claims; that I have had sufficient time to consider this Release of Claims and to consult with an attorney, if I wished to do so, or toconsult with any other person of my choosing before signing; and that I am signing this Release of Claims voluntarily and with a full understanding of its terms.I further acknowledge that, in signing this Release of Claims, I have not relied on any promises or representations, express or implied, that are not set forthexpressly in the Release of Claims. I understand that I may revoke this Release of Claims at any time within seven (7) days of the date of my signing by writtennotice to the Board of Directors of Novelion Services and that this Release of Claims will take effect only upon the expiration of such seven-day revocation periodand only if I have not timely revoked it.Intending to be legally bound, I have signed this Release of Claims under seal as of the date written below.Signature: /s/ Remi Alexis MenesName: Remi Alexis MenesDate Signed: _______________________1 To be determined by Novelion Services at the time of termination.SCHEDULE “C”CONFIDENTIALITY, ASSIGNMENT OF INTELLECTUAL PROPERTY AND NON-COMPETITION AGREEMENT[See attached] NOVELION SERVICES USA, INC.Employee Confidentiality, Assignment of Intellectual Property and Non-Competition AgreementIn consideration and as a condition of my employment or continued employment by Novelion Services USA, Inc. (the "Company"), I agree as follows:1. Employee Acknowledgements . I acknowledge that I will be provided, and/or have been provided, with trade secrets and/or valuable confidentialbusiness information belonging to the Company and/or its Affiliates (as defined in paragraph 19), and have developed and/or will develop substantial relationshipswith prospective and existing customers and clients of the Company and its Affiliates, and, as a result, shall benefit from the good will of the Company and itsAffiliates. I also acknowledge that the Company and its Affiliates have invested substantial resources in the development of their trade secrets, confidentialbusiness information, client relationships and good will and in recruiting, hiring and training their professionals and staff. I further acknowledge that I havereceived and/or will receive substantial training from the Company and its Affiliates. I hereby acknowledge and agree that the Company and its Affiliates have alegitimate interest in protecting their substantial investment in their development of trade secrets, confidential information, good will and a highly trained staff andthat the covenants to which I agree to be bound herein are necessary to protect such legitimate interests.2. Proprietary Information . I agree that all information, whether or not in writing, concerning the business, technology, business relationships orfinancial affairs of the Company and its Affiliates which the Company (or applicable Affiliate) has not released to the general public (collectively, "ProprietaryInformation") is and will be the exclusive property of the Company (or applicable Affiliate). By way of illustration, Proprietary Information may includeinformation or material which has not been made generally available to the public, such as: (a) corporate information, including plans, strategies, methods, policies,resolutions, negotiations or litigation; (b) marketing information, including strategies, methods, customer identities or other information about customers, prospectidentities or other information about prospects, or market analyses or projections; (c) financial information, including cost and performance data, debtarrangements, equity structure, investors and holdings, purchasing and sales data and price lists; and (d) operational and technological information, including plans,specifications, manuals, forms, templates, software, designs, methods, procedures, formulas, discoveries, inventions, improvements, concepts and ideas; and (e)personnel information, including personnel lists, reporting or organizational structure, resumes, personnel data, compensation structure, performance evaluationsand termination arrangements or documents. Proprietary Information also includes information received in confidence by the Company or its Affiliates fromcustomers or suppliers or other third parties.3. Recognition of Company’s Rights . I will not, at any time, without the Company's prior written permission, either during or after my employment,disclose any Proprietary Information to anyone outside of the Company, or use or permit to be used any Proprietary Information for any purpose other than theperformance of my duties as an employee of the Company. I will cooperate with the Company and its Affiliates and use my best efforts to prevent the unauthorizeddisclosure of all Proprietary Information. I will deliver to the Company all copies of Proprietary Information in my possession or control upon the earlier of arequest by the Company or termination of my employment.4. Rights of Others . I understand that the Company and its Affiliates are now and may hereafter be subject to nondisclosure or confidentialityagreements with third persons which require the Company (or applicable Affiliate) to protect or refrain from use of proprietary information. I agree to be bound bythe terms of such agreements in the event I have access to such proprietary information.5. Commitment to Company: Avoidance of Conflict of Interest . While an employee of the Company, I will devote my full-time efforts to theCompany's business and I will not engage in any other business activity that conflicts with my duties to the Company (including the services the Companyprovides to its Affiliates). I will advise the Chief Executive Officer of the Company at such time as any activity of either the Company or another business presentsme with a conflict of interest or the appearance of a conflict of interest as an employee of the Company. I will take whatever action is requested of me by theCompany to resolve any conflict or appearance of conflict which it finds to exist.6. Developments . I will make full and prompt disclosure to the Company of all inventions, discoveries, designs, developments, methods, modifications,improvements, processes, algorithms, databases, computer programs, formulae, techniques, trade secrets, graphics or images, and audio or visual works and otherworks of authorship, whether or not patentable or copyrightable, that are created, made, conceived or reduced to practice by me (alone or jointly with others) orunder my direction during the period of my employment (collectively, the "Developments"). I acknowledge that all work performed by me is on a "work for hire"basis, and I hereby do assign and transfer and, to the extent any such assignment cannot be made at present, will assign and transfer, to the Company (or anyAffiliate designated by the Company) and its successors and assigns all my right, title and interest in all Developments that: (a) relate to the business of theCompany or its Affiliates or any customer of the Company or its Affiliates or any of the products or services being researched, developed, manufactured or sold bythe Company or its Affiliates or which may be used with such products or services; or (b) result from tasks assigned to me by the Company; or (c) result and/or aredeveloped during or after my employment from the use of premises or personal property (whether tangible orintangible) owned, leased or contracted for by the Company or its Affiliates (collectively, "Company-Related Developments"), and all related patents, patentapplications, trademarks and trademark applications, copyrights and copyright applications, and other intellectual property rights in all countries and territoriesworldwide and under any international conventions ("Intellectual Property Rights").To preclude any possible uncertainty, I have set forth on Exhibit A attached hereto a complete list of Developments that I have, alone or jointly with others,conceived, developed or reduced to practice prior to the commencement of my employment with the Company that I consider to be my property or the property ofthird parties and that I wish to have excluded from the scope of this Agreement ("Prior Inventions"). If disclosure of any such Prior Invention would cause me toviolate any prior confidentiality agreement, I understand that I am not to list such Prior Inventions in Exhibit A but am only to disclose a cursory name for eachsuch invention, a listing of the party(ies) to whom it belongs and the fact that full disclosure as to such inventions has not been made for that reason. I have alsolisted on Exhibit A all patents and patent applications in which I am named as an inventor, other than those which have been assigned to the Company ("OtherPatent Rights"). If no such disclosure is attached, I represent that there are no Prior Inventions or Other Patent Rights. If, in the course of my employment with theCompany, I incorporate a Prior Invention into a Company or Affiliate product, process or machine or other work done for the Company or an Affiliate, I herebygrant to the Company (or any Affiliate designated by the Company) a nonexclusive, royalty-free, paid-up, irrevocable, worldwide license (with the full right tosublicense) to make, have made, modify, use, sell, offer for sale and import such Prior Invention. Notwithstanding the foregoing, I will not incorporate, or permit tobe incorporated, Prior Inventions in any Company-Related Development without the Company's prior written consent.This Agreement does not obligate me to assign to the Company of any of its Affiliates any Development which, in the sole judgment of the Company, reasonablyexercised, is developed entirely on my own time and does not relate to the business efforts or research and development efforts in which, during the period of myemployment, the Company or its Affiliates actually are engaged or reasonably would be engaged, and does not result from the use of premises or equipment ownedor leased by the Company or its Affiliates. However, I will also promptly disclose to the Company any such Developments for the purpose of determining whetherthey qualify for such exclusion. I understand that to the extent this Agreement is required to be construed in accordance with the laws of any jurisdiction whichprecludes a requirement in an employee agreement to assign certain classes of inventions made by an employee, this paragraph 6 will be interpreted not to apply toany invention which a court rules and/or the Company agrees, falls within such classes. I also hereby waive all claims to any moral rights or other special rightswhich may have or accrue in any Company-Related Developments or Intellectual Property Rights.7. Documents and Other Materials . I will keep and maintain adequate and current records of: (a) all Proprietary Information and Company-RelatedDevelopments developed by me during my employment; and (b) all documentation regarding any Intellectual Property Rights, which relate to such ProprietaryInformation and Company-Related Developments. Such records will be available to and remain the sole property of the Company (or applicable Affiliate of theCompany) at all times.All files, letters, notes, memoranda, reports, records, data, sketches, drawings, notebooks, layouts, charts, quotations and proposals, specification sheets, or otherwritten, photographic or other tangible material containing Proprietary Information, whether created by me or others, which come into my custody or possession,are the exclusive property of the Company (or applicable Affiliate) to be used by me only in the performance of my duties for the Company. Any property situatedon the premises of the Company or its Affiliates, owned or purchased by the Company or its Affiliates, disseminated by the Company or its Affiliates, and/or usedor created by me for business purposes in the course of my duties for the Company, including without limitation computers, email accounts, cell phone records andtext messages, disks and other storage media, filing cabinets or other work areas, is the property of the Company (or, if applicable, an Affiliate) and is subject toinspection by the Company at any time with or without notice. In the event of the termination of my employment for any reason, I will deliver to the Company allCompany and Affiliate property, including, without limitation, all Proprietary Information, all documents related to Company-Related Developments, allcomputers, keys, passwords, cell phones, entry cards, files, letters, notes, memoranda, reports, records, data, sketches, drawings, notebooks, layouts, charts,quotations and proposals, specification sheets, or other written, photographic or other tangible material, and will not take or keep in my possession any Company orAffiliate property or any copies (electronic or hard-copy) of such property.8. Enforcement of Intellectual Property . I will cooperate fully with the Company, both during and after my employment with the Company, withrespect to the procurement, maintenance and enforcement of Intellectual Property Rights in Company-Related Developments. I will sign, both during and after theterm of this Agreement, all papers, including without limitation copyright applications, patent applications, declarations, oaths, assignments of priority rights, andpowers of attorney, which the Company may deem necessary or desirable in order to protect its (or any Affiliate’s) rights and interests in any Company-RelatedDevelopment. If the Company is unable, after reasonable effort, to secure my signature on any such papers, I hereby irrevocably designate and appoint each officerof the Company as my agent and attorney-in-fact to execute any such papers on my behalf, and to take any and all actions as the Company may deem necessary ordesirable in order to protect its (or any Affiliate’s) rights and interests in any Company-Related Development.9. Non-Competition and Non-Solicitation . In order to protect the Proprietary Information and good will of the Company and its Affiliates, during myemployment and for a period of twelve (12) months following the termination of my employment for any reason (the "Restricted Period"), I will not directly orindirectly, whether as owner, partner, shareholder, director, manager, consultant, agent, employee, co-venturer or otherwise, engage, participate or invest in anybusiness activity anywhere in the world that develops, manufactures or markets any products, or performs any services, that are competitive (directly or indirectly)with the products or services of the Company or its Affiliates, or products or services that the Company or its Affiliates have under development or that are thesubject of active planning at any time during the last 24 months of my employment; provided that this shall not prohibit any possible investment in publicly tradedstock of a company representing less than one percent of the stock of such company. In addition, during the Restricted Period, I will not, directly or indirectly, inany manner, for any purpose that is competitive with or detrimental to the business of the Company or an Affiliate, (a) call upon, solicit, divert, take away, acceptor conduct any business from or with any of the customers or prospective customers of the Company or its Affiliates, or any suppliers thereof, and/or (b) solicit,entice, or attempt to persuade any other employee or consultant of the Company or an Affiliate to leave the Company or Affiliate for any reason. I acknowledgeand agree that if I violate any of the provisions of this paragraph 9, the running of the Restricted Period will be extended by the time during which I engage in suchviolation(s).10. Government Contracts . I acknowledge that the Company and/or its Affiliates may have from time to time agreements with other persons orgovernmental authorities which impose obligations or restrictions on the Company and/or its Affiliates regarding inventions made during the course of work undersuch agreements or regarding the confidential nature of such work. I agree to comply with any such obligations or restrictions upon the direction of the Company.In addition to the rights assigned under paragraph 6, I also assign to the Company (or any of its nominees) all rights which I have or acquired in any Developments,full title to which is required to be held by the particular governmental authority under any contract between the Company and the given governmental authority.11. Prior Agreements . I hereby represent that, except as I have fully disclosed previously in writing to the Company, I am not bound by the terms of anyagreement with any previous employer (other than Aegerion Pharmaceuticals, Inc.) or other party to refrain from using or disclosing any trade secret orconfidential or proprietary information in the course of my employment with the Company or to refrain from competing, directly or indirectly, with the business ofsuch previous employer or any other party. I further represent that my performance of all the terms of this Agreement as an employee of the Company does not andwill not breach any agreement to keep in confidence proprietary information, knowledge or data acquired by me in confidence or in trust prior to my employmentwith the Company. I will not disclose to the Company or its Affiliates or induce the Company or its Affiliates to use any confidential or proprietary information ormaterial belonging to any previous employer (other than Aegerion Pharmaceuticals, Inc.) or others.12. Remedies Upon Breach .(a) Equitable Relief. I understand that the restrictions contained in this Agreement are necessary for the protection of the business and goodwill of theCompany and its Affiliates and I consider them to be reasonable for such purpose. Any breach of this Agreement is likely to cause the Company and its Affiliatessubstantial and irrevocable damage and therefore, in the event of such breach, the Company and/or any Affiliate affected by such breach, in addition to such otherremedies which may be available, will be entitled to seek specific performance and other injunctive relief, without the posting of a bond.(b) Indemnification. If I violate this Agreement, in addition to all other remedies available to the Company and any affected Affiliates at law, in equity,and under contract, I agree that I am obligated to pay all the Company's (or, if applicable, Affiliate’s) costs of enforcement of this Agreement, including attorneys'fees and expenses. I also agree that I will defend, indemnify and/or hold the Company and its Affiliates harmless from and against any and all liabilities, losses,damages, claims or demands whatsoever (including expenses, court costs and reasonable attorneys' fees) asserted against or incurred by the Company or anyAffiliate as a result of or by reason of the Company or such Affiliate having to defend any claim arising from my use of proprietary or trade secret information of aprior employer or my breach of a restrictive covenant with any prior employer, and from any damages resulting from a final judgment or reasonable settlement ofsuch claims. This indemnification shall include, but not be limited to, claims for infringement of patents, trademarks or copyrights, misappropriation of tradesecrets or confidential information, and/or breach of any restrictive covenants, and is without prejudice to any other rights held by, or remedies available to, theCompany or its Affiliates at law.13. Use of Voice, Image and Likeness . During the period of my employment, I give the Company and its Affiliates permission to use any and all ofmy voice, image and likeness, with or without using my name, in connection with the products and/or services of the Company and/or its Affiliates, for thepurposes of advertising and promoting such products and/or services and/or the Company and/or its Affiliates, and/or for other purposes deemed appropriate by theCompany in its reasonable discretion, except to the extent expressly prohibited by law.14. Publications and Public Statements . I will obtain the Company's written approval before publishing or submitting for publication any material thatrelates to my work at the Company (including in connection with its Affiliates) and/or incorporates any Proprietary Information.15. No Employment Obligation . I understand that this Agreement does not create an obligation on the Company or any other person to continue myemployment. I acknowledge that, unless otherwise agreed in a formal written employment agreement signed on behalf of the Company by an authorized officer,my employment with the Company is at will and therefore may be terminated by the Company or me at any time and for any reason, with or without cause.16. Survival and Assignment by the Company . I understand that my obligations under this Agreement will continue in accordance with its expressterms regardless of any changes in my title, position, duties, salary, compensation or benefits or other terms and conditions of employment. I further understandthat my obligations under this Agreement will continue following the termination of my employment regardless of the manner of such termination and will bebinding upon my heirs, executors and administrators. The Company will have the right to assign this Agreement to its Affiliates, successors and assigns. Iexpressly consent to be bound by the provisions of this Agreement for the benefit of the Company or any parent, subsidiary or affiliate to whose employ I may betransferred without the necessity that this Agreement be resigned at the time of such transfer.17. Updating Information to the Company: Disclosure to Future Employers . For twelve (12) months following termination of my employment, Iwill (a) notify the Company of any change in my address and of each subsequent employment or business activity, including the name and address of my employeror other post-Company employment plans and the nature of my activities, and (b) provide a copy of this Agreement to any prospective employer, partner or co-venturer prior to entering into an employment, partnership or other business relationship with such person or entity.18. Reimbursement . I hereby authorize the Company at any time during or after the term of my employment to withhold from any amounts otherwiseowed to me (including, but not limited to, salary, bonus, severance, commissions and expense reimbursements) to the fullest extent permitted by applicable law:any and all amounts due to the Company from me, including, but not limited to, cash advances, draws, travel advances, overpayments made by the Company tome, amounts received by me due to the Company's error, unpaid personal credit card or phone charges or any other debt I owe to the Company for any reason,including amounts with respect to misuse or misappropriation of Company assets or breach of this Agreement.19. Application to Affiliates . I acknowledge that my duties as an employee of the Company may include providing certain management services to QLTInc., Aegerion Pharmaceuticals, Inc., and other current or future affiliates of the Company within the meaning of the Delaware General Corporation Law(collectively the “Affiliates” and each an “Affiliate”), on behalf of the Company. I agree that each such Affiliate will have the same rights that the Company hasunder this Agreement (including the right to indemnification and other remedies under paragraph 12), and that I will have the same obligations to each Affiliate asI have to the Company under this Agreement, as if such Affiliate was a signatory to this Agreement instead of the Company, except that if there is any conflictbetween my obligations under this Agreement to the Company and to one or more of its Affiliates, my obligations to the Affiliate will prevail. I acknowledge toeach Affiliate that it has direct rights against me under this Agreement. To the extent required by law to give full effect to these direct rights, I acknowledge andagree that the Company is and will be deemed to be acting as agent or trustee on behalf of and for the benefit of each Affiliate.20. Severability . In case any provisions (or portions thereof) contained in this Agreement shall, for any reason, be held invalid, illegal or unenforceablein any respect, such invalidity, illegality or unenforceability shall not affect the other provisions of this Agreement, and this Agreement shall be construed as ifsuch invalid, illegal or unenforceable provision had never been contained herein. If, moreover, any one or more of the provisions contained in this Agreement shallfor any reason be held to be excessively broad as to duration, geographical scope, activity or subject, it shall be construed by limiting and reducing it, so as to beenforceable to the extent compatible with the applicable law as it shall then appear.21. Interpretation . This Agreement will be deemed to be made and entered into in the Commonwealth of Massachusetts, and will in all respects beinterpreted, enforced and governed under the laws of the Commonwealth of Massachusetts. I hereby agree to consent to personal jurisdiction of the state andfederal courts situated within Suffolk County, Massachusetts for purposes of enforcing this Agreement, and waive any objection that I might have to personaljurisdiction or venue in those courts.[Remainder of this page intentionally left blank]I UNDERSTAND THAT THIS AGREEMENT AFFECTS IMPORTANT RIGHTS. BY SIGNING BELOW, I CERTIFY THAT I HAVE READ ITCAREFULLY AND AM SATISFIED THAT I UNDERSTAND IT COMPLETELY.IN WITNESS WHEREOF, the undersigned has executed this Employee Confidentiality, Assignment of Intellectual Property and Non-CompetitionAgreement as a sealed instrument as of the date set forth below.Signed: /s/ Remi Alexis MenesName: Remi Alexis MenesDate: _____________________________________EXHIBIT ATo: Novelion Services USA, Inc. (the “Company”)From: Remi Alexis MenesDate: __________________________SUBJECT: Prior InventionsThe following is a complete list of all inventions or improvements that have been made or conceived or first reduced to practice by me alone or jointlywith others prior to my engagement by the Company:No inventions or improvementsSee below:_____________________________________________________________________________________________________________________________________________________________________________________________________________________Additional sheets attachedThe following is a list of all patents and patent applications in which I have been named as an inventor:NoneSee below:_____________________________________________________________________________________________________________________________________________________________________________________________________________________Exhibit 21.1SUBSIDIARIES OF NOVELION THERAPEUTICS INC.Entity NameJurisdiction of Organization or IncorporationAegerion Pharmaceuticals, Inc.DelawareAegerion Pharmaceuticals Ltd.BermudaAegerion Pharmaceuticals (Canada) Ltd.CanadaAegerion Pharmaceuticals Holdings, Inc.DelawareAegerion Mexico, S. DE R.L. DE C.V.MexicoAegerion Argentina S.R.L.ArgentinaAegerion Pharmaceuticals K.K.JapanAegerion Taiwan LimitedTaiwanAegerion Securities CorporationUnited StatesAegerion Pharmaceuticals LimitedUnited KingdomAegerion Brasil Servicos de Promocao e Administracao de Vendas LTDABrazilAegerion Servicios, S. DE R.L. DE C.V.MexicoAegerion Pharmaceuticals, SASFranceAegerion Pharmaceuticals S.r.l.ItalyAegerion Pharmaceuticals GmbHGermanyAegerion Pharmaceuticals SARLSwitzerlandAegerion Ýlaç Ticaret Limited ÞirketiTurkeyAegerion Colombia S.A.S.ColombiaAegerion International Ltd.BermudaNovelion Services USA, Inc.Delaware405030 B.C. Ltd.British ColumbiaCoast Mercantile Enterprises Inc.British ColumbiaQLT Phototherapeutics Inc.DelawareQLT Ophthalmics (UK), Ltd.United KingdomQLT Therapeutics, Inc.DelawareQLT Plug Delivery, Inc.DelawareQLT Ophthalmics, Inc.DelawareQLT Medevice Inc.CanadaQLT (Delaware), Inc.DelawareQLT Holdings Corp.DelawareQLT Acquisition Corp.DelawareQuest Intermediate One Corp. 1DelawareQuest Intermediate Two Corp.DelawarePharmical Manufacturing Ltd.British ColumbiaExhibit 23.1CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMWe consent to the incorporation by reference in the Registration Statement Nos. 333-190221, 333-100070, 333-120657, 333-162465 and 333-214907 on Form S-8and Registration No. 333-214202 on Form S-3 of our reports dated March 30, 2017 , relating to the consolidated financial statements of Novelion Therapeutics Inc.and subsidiaries (formerly QLT Inc.)(the “Company”) and the internal control over financial reporting (which report expresses an adverse opinion on theeffectiveness of the Company's internal control over financial reporting due to a material weakness) appearing in this Annual Report on Form 10-K of NovelionTherapeutics Inc. (formerly QLT Inc.) for the year ended December 31, 2016./s/ DELOITTE LLPVancouver, CanadaMarch 30, 2017Exhibit 31.1CERTIFICATIONSI, Mary Szela, certify that:1.I have reviewed this annual report on Form 10-K of Novelion Therapeutics Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))for the registrant and have:(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within thoseentities, particularly during the period in which this report is being prepared;(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles;(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely tomaterially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 30, 2017 /s/ Mary Szela Name:Mary Szela Title:Chief Executive Officer (principal executive officer) andDirector Exhibit 31.2CERTIFICATIONSI, Gregory D. Perry, certify that:1.I have reviewed this annual report on Form 10-K of Novelion Therapeutics Inc.;2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make thestatements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by thisreport;3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects thefinancial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;4.The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined inExchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))for the registrant and have:(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within thoseentities, particularly during the period in which this report is being prepared;(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under oursupervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements forexternal purposes in accordance with generally accepted accounting principles;(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about theeffectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s mostrecent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely tomaterially affect, the registrant’s internal control over financial reporting; and5.The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to theregistrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which arereasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internalcontrol over financial reporting.Date: March 30, 2017 /s/ Gregory D. Perry Name:Gregory D. Perry Title:Chief Financial and Administrative Officer (principal financialofficer) Exhibit 32.1CERTIFICATIONS PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002In connection with this Annual Report on Form 10-K of Novelion Therapeutics Inc. (the “Company”) for the fiscal year ended December 31, 2016 as filed with theSecurities and Exchange Commission on the date hereof (the “Report”), each of the undersigned officers of the Company hereby certifies, pursuant to 18 U.S.C.(section) 1350, as adopted pursuant to (section) 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:(1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and(2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. /s/ Mary Szela Name:Mary Szela Title:Chief Executive Officer (principal executive officer)and Director Date:March 30, 2017 Exhibit 32.2CERTIFICATIONS PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES-OXLEY ACT OF 2002In connection with this Annual Report on Form 10-K of Novelion Therapeutics Inc. (the “Company”) for the fiscal year ended December 31, 2016 as filed with theSecurities and Exchange Commission on the date hereof (the “Report”), each of the undersigned officers of the Company hereby certifies, pursuant to 18 U.S.C.(section) 1350, as adopted pursuant to (section) 906 of the Sarbanes-Oxley Act of 2002, that to the best of his knowledge:(1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and(2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. /s/ Gregory D. Perry Name:Gregory D. Perry Title:Chief Financial and AdministrativeOfficer (principal financial officer) Date:March 30, 2017
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