AMAG Pharmaceuticals, Inc.
Annual Report 2016

Plain-text annual report

UNITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549____________________ ______FORM 10-K(Mark One) xANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934For the Fiscal Year Ended December 31, 2016or¨TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACTOF 1934For the transition period from toCommission file number 001-10865AMAG Pharmaceuticals, Inc.(Exact Name of Registrant as Specified in Its Charter)Delaware(State or Other Jurisdiction ofIncorporation or Organization)04-2742593(I.R.S. EmployerIdentification No.)1100 Winter StreetWaltham, Massachusetts(Address of Principal Executive Offices)02451(Zip Code)(617) 498-3300(Registrant’s Telephone Number, Including Area Code)Securities registered pursuant to Section 12(b) of the Act: Title of each class Name of each exchange on which registeredCommon Stock, par value $0.01 per sharePreferred Share Purchase Rights NASDAQ Global Select MarketSecurities registered pursuant to Section 12(g) of the Act: NoneIndicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes x No ¨ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ¨ No xIndicate 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 the preceding12 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 the past 90 days. Yes x No ¨ Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted andposted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorterperiod that the registrant was required to submit and post such files). Yes x 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 of the registrant’sknowledge, 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. xIndicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definition of“accelerated filer,” “large accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):Large accelerated filer xAccelerated filer ¨Non-accelerated filer ¨(Do not check if asmaller reporting company)Smaller Reporting Company ¨Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ¨ No x The aggregate market value of the registrant’s voting stock held by non-affiliates as of June 30, 2016 was approximately $813.4 million based on the closing price of $23.92 ofthe Common Stock of the registrant as reported on the NASDAQ Global Select Market on such date. As of February 13, 2017, there were 34,339,448 shares of the registrant’sCommon Stock, par value $0.01 per share, outstanding.DOCUMENTS INCORPORATED BY REFERENCEPortions of the Proxy Statement to be filed in connection with the solicitation of proxies for the Annual Meeting of Stockholders are incorporated by reference into Part III ofthis Annual Report on Form 10-K.Table of ContentsAMAG PHARMACEUTICALS, INC.FORM 10-KFOR THE YEAR ENDED DECEMBER 31, 2016TABLE OF CONTENTS PART I Item 1.Business2Item 1A.Risk Factors32Item 1B.Unresolved Staff Comments66Item 2.Properties66Item 3.Legal Proceedings67Item 4.Mine Safety Disclosures67 PART II Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities68Item 6.Selected Financial Data71Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations73Item 7A.Quantitative and Qualitative Disclosures About Market Risk101Item 8.Financial Statements and Supplementary Data103Item 9.Changes in and Disagreements With Accountants on Accounting and Financial Disclosure156Item 9A.Controls and Procedures156Item 9B.Other Information157 PART III Item 10.Directors, Executive Officers and Corporate Governance157Item 11.Executive Compensation157Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters157Item 13.Certain Relationships and Related Transactions, and Director Independence157Item 14.Principal Accountant Fees and Services157 PART IV Item 15.Exhibits and Financial Statement Schedules158 Signatures164Table of ContentsPART IExcept for the historical information contained herein, the matters discussed in this Annual Report on Form 10-K may be deemed to be forward-lookingstatements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private SecuritiesLitigation Reform Act of 1995 and other federal securities laws. In this Annual Report on Form 10-K terminology such as “may,” “will,” “could,” “should,”“would,” “expect,” “anticipate,” “continue,” “believe,” “plan,” “estimate,” “intend” or other similar words and expressions (as well as other words orexpressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.Examples of forward-looking statements contained in this report include, without limitation, statements regarding the following: our plans to continueto expand the impact of our portfolio by delivering on our growth strategy; expected timing of the Feraheme sNDA filing in mid-2017; expected timing of aRekynda NDA in early 2018; anticipated FDA review timeline of the Makena auto-injector sNDA filing; anticipated Feraheme utilization in the non-dialysisCKD patient population; significant growth opportunities for Feraheme in the IV iron market; our plans to raise awareness and education of FSD; ourexpected investment in FSD label expansion for Intrarosa; expansion of our sales force in mid-2017, maintenance of our current Makena and CBR salesforces and the commercialization impact of our sales forces; the timing and amounts of Palatin and Endoceutics milestone and royalty payments; plans todiversify and grow our portfolio, including our intent to continue to expand and diversify our portfolio through the in-license or purchase of additionalpharmaceutical products, services or companies; expectations that Velo will begin its Phase 2b/3a study in the first quarter of 2017; expectations and plansas to regulatory and commercial developments and activities, including the pursuit of a broader indication for Feraheme, requirements and initiatives forclinical trials and studies, post-approval commitments for our products and the next generation development programs for Makena; the growth of ourmaternal health portfolio; expectations as to what impact recent regulatory developments will have on our business and competition, including changes tothe Feraheme product information and label; expectations regarding our intellectual property, including patent protection, and the impact generics andother competition could have on our business; the market opportunities for each of our products and services; plans regarding our sales and marketinginitiatives, including our contracting and discounting strategy and efforts to increase patient compliance and access; the expected timing and occurrenceof consummation of the Endoceutics License Agreement; our expectation of costs to be incurred in connection with revenue sources to fund our futureoperations; our expectations regarding the contribution of revenues from our products or services to the funding of our on-going operations; expectationsregarding the manufacture of all drug substances, drug products and key materials at our third-party manufacturers or suppliers; the availability of rawmaterials; the strategic fit of Palatin and Rekynda in our product portfolio; our expectations regarding customer returns and other revenue-related reservesand accruals; estimates regarding our effective tax rate and our ability to realize our net operating loss carryforwards and other tax attributes; the impactof accounting pronouncements; the effect of product price increases; expected increases in research and development expenses and the timing of ourplanned research and development projects; expectations regarding our financial results, including revenues, cost of product sales and services, selling,general and administrative expenses, restructuring costs, amortization and other income (expense); our investing activities; expectations relating to theEndoceutics License Agreement; estimates and beliefs related to our debt, including our 2023 Senior Notes, Convertible Notes and the 2015 Term LoanFacility; the impact of volume-based and other rebates and incentives; the valuation of certain intangible assets, goodwill, contingent consideration, debtand other assets and liabilities, including our methodology and assumptions regarding fair value measurements; our expectations regarding competitivepressures and the impact on growth of our product revenues; the manner in which we intend or are required to settle the conversion of our ConvertibleNotes; and our expectations for our cash, revenue, cash equivalents, investments balances, capital needs and information with respect to any other plansand strategies for our business. Our actual results and the timing of certain events may differ materially from the results discussed, projected, anticipated orindicated in any forward-looking statements.Any forward-looking statement should be considered in light of the factors discussed in Part I, Item 1A below under “Risk Factors” and elsewhere inthis Annual Report on Form 10-K. We caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the datethey are made. We disclaim any obligation, except as specifically required by law and the rules of the U.S. Securities and Exchange Commission, to publiclyupdate or revise any such statements to reflect any change in company expectations or in events, conditions or circumstances on which any such statementsmay be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.1Table of ContentsITEM 1. BUSINESS:OverviewAMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. We are a biopharmaceutical company focused on developing and deliveringimportant therapeutics, conducting clinical research in areas of unmet need and creating education and support programs for the patients and families weserve. Our currently marketed products support the health of patients in the areas of women’s health, anemia management and cancer supportive care,including Makena® (hydroxyprogesterone caproate injection), Feraheme® (ferumoxytol) for Intravenous (“IV”) use and MuGard® Mucoadhesive Oral WoundRinse. Through services related to the preservation of umbilical cord blood stem cell and cord tissue units (the “CBR Services”) operated through CordBlood Registry® (“CBR”), we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood,immune and metabolic disorders, and which we believe have the potential to play a valuable role in the ongoing development of regenerative medicine. Inaddition, on February 2, 2017, we closed a license agreement in which we received the rights to research, develop and commercialize RekyndaTM(bremelanotide), which is being developed for the treatment of hypoactive sexual desire disorder (“HSDD”) in pre-menopausal women. On February 13, 2017,we signed a license agreement in which we will acquire the rights to market IntrarosaTM (prasterone) in the U.S. for the treatment of moderate-to-severedyspareunia, a common symptom of vulvar and vaginal atrophy (“VVA”), due to menopause.We intend to continue to expand the impact of these and future products and services for patients by delivering on our growth strategy, which includesorganic growth, as well as the pursuit of products and companies that align with our existing therapeutic areas or those that could benefit from our provencore competencies. Currently, our primary sources of revenue are from product sales of Makena and Feraheme and service revenue from the CBR Services.Our common stock trades on the NASDAQ Global Select Market (“NASDAQ”) under the trading symbol “AMAG.”2Table of ContentsProducts and ServicesThe following table summarizes the current uses and, subject to regulatory approval, potential uses of the products and services we own or to which wehave rights, their current status and the nature of our rights. Currently, our therapeutic products are marketed and sold solely in the U.S. and the CBR Servicesare marketed and sold primarily in the U.S.Product or Service Uses/Potential Uses Regulatory Status Nature of Rights toProduct or ServiceMakena®(hydroxyprogesterone caproateinjection) (5 mL multidose vial) A progestin indicated to reduce the risk ofpreterm birth in women pregnant with asingle baby who have a history of singletonspontaneous preterm birth. Approved and marketed. Own worldwide rights. Makena®(hydroxyprogesterone caproateinjection) (1 mL single-dosevial) A progestin indicated to reduce the risk ofpreterm birth in women pregnant with asingle baby who have a history of singletonspontaneous preterm birth. Approved and marketed. Own worldwide rights. Makena®(hydroxyprogesterone caproateinjection) (Auto-injector device) An auto-injector device for subcutaneousadministration of Makena (the “Makenaauto-injector”). Supplemental new drug application(“sNDA”) expected to be filed in the secondquarter of 2017. Own worldwide rights to drug product;exclusively license rights to auto-injectordevice from Antares Pharma, Inc.(“Antares”). Cord Blood Registry® Services related to the collection, processingand storage of umbilical cord blood and cordtissue units. Privately banked umbilical cord blood stemcells and cord tissue are regulated by theFDA in the U.S. (no prior approval needed).Facilities are inspected by the FDA. Services are marketed and sold primarily inthe U.S. and we have certain commercialagreements in Chili, Mexico and theDominican Republic. Feraheme®(ferumoxytol) IV iron replacement therapeutic agent for thetreatment of iron deficiency anemia (“IDA”)in adult patients with chronic kidney disease(“CKD”). Approved and marketed. Own worldwide rights. Feraheme®(ferumoxytol) IV iron replacement therapeutic agent for thetreatment of patients with a history ofunsatisfactory oral iron therapy or in whomoral iron cannot be used. sNDA filed December 2012. Completeresponse letter received January 2014. Phase3 clinical trial ongoing and sNDA expectedto be filed in mid-2017. Own worldwide rights. MuGard®Mucoadhesive OralWound Rinse Management of oral mucositis/stomatitis andall types of oral wounds. Cleared and marketed. Exclusively license rights to develop and sellMuGard in the U.S. from AbeonaTherapeutics, Inc. (“Abeona”). RekyndaTM (bremelanotide)(Auto-injector device) An investigational product designed for on-demand treatment of HSDD in pre-menopausal women. New Drug Application (“NDA”) expectedto be filed in early 2018. Exclusively license rights to research,develop and sell Rekynda in North Americafrom Palatin Technologies, Inc. (“Palatin”). Digoxin immune fab (“DIF”) A polyclonal antibody for the treatment ofsevere preeclampsia in pregnant women. In clinical development. Own option to obtain exclusive license fromVelo Bio LLC (“Velo”) to U.S. rights uponcompletion of Phase 2b/3a development.3Table of ContentsMakenaOverviewMakena is the only FDA-approved drug indicated to reduce the risk of preterm birth in women pregnant with a single baby who have a history ofsingleton spontaneous preterm birth. We acquired the rights to Makena in connection with our acquisition of Lumara Health Inc. (“Lumara Health”) inNovember 2014. Additional details regarding our acquisition of Lumara Health can be found in Note C, “Business Combinations,” to our consolidatedfinancial statements included in this Annual Report on Form 10-K.Makena is an intramuscular injection administered weekly by a healthcare professional at a dose of 250 mg (1 mL) with treatment beginning between16 weeks and 20 weeks and six days of gestation and continuing until 36 weeks and six days of gestation or delivery, whichever happens first. Makena is aprogestin whose active ingredient is hydroxyprogesterone caproate (“HPC”), which is a synthetic chemical structurally related to progesterone. Progestins,such as HPC, and progesterone belong to a class of drugs called progestogens. Progestogens have been studied to reduce preterm birth and have shownvarying results depending upon the subjects enrolled. The Society for Maternal Fetal Medicine (the “SMFM”) Publications Committee published clinicalguidelines for the use of progestogens to reduce the risk of preterm birth in the American Journal of Obstetrics and Gynecology in May 2012, and which wereaffirmed in 2014. The SMFM Clinical Guidelines recommend the use of an intramuscular HPC injection, such as Makena, to reduce the risk of recurrentpreterm birth for clinically indicated patients. Further, in January 2017, the SMFM stated that vaginal progesterone should not be considered a substitute forhydroxyprogesterone caproate in women with a history of spontaneous preterm birth.We sell Makena primarily to specialty pharmacies, specialty distributors, home infusion companies and pharmacies which, in turn, sell Makena tohealthcare providers, hospitals, government agencies and integrated delivery systems. In 2016, sales of Makena accounted for approximately 63% of ourtotal net revenues. Makena was approved by the FDA in February 2011 and was granted orphan drug exclusivity through February 3, 2018.Preterm BirthPreterm birth is defined as a birth prior to 37 weeks of pregnancy. According to the National Center for Health Statistics Report, in 2015, preterm birthsaffected nearly 400,000 babies, or one of every ten infants born in the U.S. Although the causes of preterm births are not fully understood, certain women areat a greater risk for preterm birth, including those who have had a previous preterm birth, are pregnant with multiples or have certain uterine or cervicalproblems. High blood pressure, pregnancy complications (such as placental problems) and certain other health or lifestyle factors may also be contributingfactors. Makena is indicated only for women with a history of singleton spontaneous preterm birth who are pregnant with a single baby, which accounts forapproximately 140,000 pregnancies annually in the U.S.Preterm birth can increase the risk of infant death and can also result in serious long-term health issues for the child, including respiratory problems,gastrointestinal conditions, cerebral palsy, developmental delays, and vision and hearing impairments. According to a 2007 report by the Institute ofMedicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcome, the annual societal economic cost associated with preterm birthis at least $26.2 billion and includes medical and healthcare costs for the baby, labor and delivery costs for the mother, early intervention and specialeducation services, and costs associated with lost work and pay.Post-Approval Commitments for MakenaMakena was approved under the provisions of the FDA’s “Subpart H” Accelerated Approval regulations. The Subpart H regulations allow certain drugs,for serious or life-threatening conditions, to be approved on the basis of surrogate endpoints or clinical endpoints other than survival or irreversiblemorbidity. As a condition of approval under Subpart H, the FDA required that Makena’s sponsor perform certain adequate and well-controlled post-approvalclinical studies to verify and describe the clinical benefit of Makena as well as fulfill certain other post-approval commitments. We have completed apharmacokinetic (“PK”) study of women taking Makena. In addition, the following clinical studies for Makena are currently ongoing: (a) an efficacy andsafety clinical study of Makena and (b) a follow-up study of the babies born to mothers from the efficacy and safety clinical study. Given the patientpopulation (i.e., pregnant women who are at high risk for recurrent preterm delivery based on their pregnancy history) and the informed risk of receiving aplacebo instead of the active approved drug, the pool of prospective subjects for such clinical trials in the U.S. is small and we have therefore soughtenrollment on a global scale. In response to our request to extend our agreed-upon completion dates for the ongoing clinical studies, the FDA approved atwo-year extension to December 2018 and October 2020.4Table of ContentsNext Generation Development ProgramsWe continue to advance our next generation development program for Makena, seeking to enhance the product profile for patients and their healthcareproviders. As part of this program, in February 2016 the FDA approved a single-dose preservative-free formulation of Makena manufactured by the PfizerCentreOne group of Pfizer, Inc., (“Pfizer”) (formerly Hospira, Inc.), who also manufactures our multidose vial of Makena. We began promoting the single-dosepreservative-free formulation of Makena to physicians in the second quarter of 2016. In July 2016, we received approval of our prior approval supplement forPiramal Pharma Solutions (formerly Coldstream Laboratories, Inc.) to also manufacture the single-dose preservative-free formulation of Makena.We are developing an auto-injector device for subcutaneous administration of Makena (the “Makena auto-injector”), including chemistry,manufacturing and controls (“CMC”) development with Antares. During 2016, we met with the FDA to discuss our proposed development and regulatorystrategy, focusing on our plans to conduct a definitive PK study designed to demonstrate comparable bioavailability of the subcutaneous Makena auto-injector to the current intramuscular (“IM”) injection form of Makena. We believe that demonstrating bioequivalence for area under the curve is the mostrelevant PK parameter for Makena. In October 2016, we initiated an open label parallel study which enrolled approximately 120 healthy post-menopausalwomen in a 1:1 randomization. In February 2017, we announced topline results from this definitive PK study. Makena administered subcutaneouslydemonstrated bioequivalence to the IM injection on area under the curve (“AUC”) (AUC0-to-inf 2,386 ng/mL compared to 2,086 ng/mL) with the 90%confidence interval for the ratio of AUC (105.17 to 124.39) falling within the 80% to 125% range, which the FDA uses to define bioequivalence. The meanmaximum or peak plasma concentration (“Cmax”) for Makena administered subcutaneously was slightly higher than for the IM (7.3 ng/mL compared to 6.3ng/mL) with the 90% confidence interval for the ratio of Cmax (96.6% to 138.7%) falling outside of the bioequivalence range of 80% to 125%. No seriousadverse events were reported and the drug was generally well tolerated, although there was a higher reporting rate of injection site related adverse events (e.g.transient burning/stinging sensation), in the subcutaneous injection arm of the study. Similar observations were also reported in the subcutaneous arm of ouropen label, parallel comparative pain study (also initiated in October 2016), which we recently elected to discontinue. We will not be requesting orphanexclusivity as part of the sNDA filing and, therefore, anticipate a six-month FDA review timeline. There are multiple device and drug-device combinationpatents and patent applications in-licensed from Antares which relate to the subcutaneous Makena auto-injector and we intend to request Orange Booklisting of eligible Antares drug-device patents. We expect to file an sNDA for approval of the Makena auto-injector in the second quarter of 2017.CBR ServicesOverviewCBR is the largest private newborn stem cell bank in the world and offers pregnant women and their families the ability to preserve their newborns’umbilical cord blood and cord tissue for potential future use (the “CBR Services”). We acquired CBR from CBR Acquisition Holdings in August 2015.Additional details regarding our acquisition of CBR can be found in Note C, “Business Combinations,” to our consolidated financial statements included inthis Annual Report on Form 10-K.We market and sell the CBR Services directly to consumers, who pay for the services directly, as third-party insurance and reimbursement are notavailable. Even though our business is limited to the sale of our services required to collect, process, and store umbilical cord blood stem cells and cordtissue, the FDA regulates them as products.The CBR Services include the collection, processing and storage of both umbilical cord blood and cord tissue. As of December 31, 2016, CBR storedapproximately 665,000 umbilical cord blood and cord tissue units, which we estimate to represent approximately more than half of all privately stored cordblood and cord tissue units in the U.S. In 2016, revenue from the CBR Services accounted for approximately 19% of our total net revenues.CBR is the first family newborn stem cell bank to partner with reputable research institutions on FDA-regulated clinical trials exploring the potentialregenerative ability of cord blood stem cells to help treat conditions that have no cure today, including acquired hearing loss, autism and cerebral palsy. Inaddition, in an effort to realize the full potential of newborn stem cells, CBR’s Newborn Possibilities Program® provides free processing and five years of freestorage of cord blood and cord tissue for families with a qualifying medical need, as further discussed below.In 2005, the Institute of Medicine (“IOM”) issued a comprehensive report to Congress on cord blood banking. The report contained clearrecommendations that healthcare professionals should provide all expectant parents with fair and balanced education on cord blood preservation prior tolabor and delivery, thereby enabling families to make an informed decision regarding their options: preserve their newborns’ stem cells for potential futurefamily use, donate the cells for public use or5Table of Contentsresearch, or dispose of the cord blood. The IOM report has helped guide health policy at the state level and to date, 29 states have passed some form of cordblood education legislation, the majority of which follow the IOM recommendations. Several other states are in various stages of developing similarlegislation to help inform healthcare providers and expectant parents of all medically appropriate options for preserving cord blood stem cells In support ofthis legislation, CBR collaborates with outside organizations to develop education initiatives to provide quality, relevant information to expectant parents,and medical professionals, including courses where continuing medical education credits can be earned, regarding new parents’ options for newborn stemcell preservation.CBR has been accredited by the AABB (formerly known as the American Association of Blood Banks) since 1998 and the company’s quality standardshave been recognized through International Organization for Standardization (ISO) 9001:2008 certification - the global business standard for quality. Inaddition, CBR is also certified by CLIA (Clinical Laboratory Improvement Amendments), a federal program to ensure quality laboratory testing. We believethat maintaining these accreditations, while not a requirement for preserving stem cells, are an important indicator of the quality of our services and the CBRbrand.Cord Blood and Cord TissueCord blood comes from a newborn’s umbilical cord and can only be collected immediately after birth. It contains hematopoietic stem cells, which havebeen used in the treatment of over 80 diseases, including various cancers, blood disorders, immune disorders and metabolic disorders. Cord blood alsocontains a variety of other types of stem cells and monocytes that are being investigated for a variety of other therapeutic applications. Cord tissue containsmesenchymal stem cells, which are unique stem cells that are being investigated for their ability to help repair and heal the body in different ways than cordblood stem cells. Although there are not yet any conditions proven to be treatable with cord tissue, these cells have potential for use in regenerative medicineand are currently being evaluated in over 30 clinical trials outside of the U.S. for their potential to treat heart disease, stroke and spinal cord damage, amongother conditions. Approximately 79% of the stem cell units released by CBR have been used for experimental regenerative therapies.Feraheme for the treatment of IDA in patients with CKDOverviewFeraheme was approved for marketing by the FDA in June 2009 for use as an IV iron replacement therapy for the treatment of IDA in adult patients withCKD.While Feraheme is approved for IDA in all stages of CKD, beginning in 2010, due to changes in the way the federal government reimburses providers forthe care of dialysis patients, the utilization of Feraheme shifted to non-dialysis patients. The non-dialysis CKD IDA market is made up of a range ofhealthcare providers who administer IV iron, including hematologists and oncologists and nephrologists, both in outpatient and hospital settings and otherend-users who treat IDA patients with CKD. We anticipate the majority of all Feraheme utilization will continue to be in the non-dialysis CKD patientpopulation if and until Feraheme receives a broader label to include non-CKD patients. We began selling Feraheme in the U.S. in July 2009 through ourcommercial organization, including a specialty sales force. We sell Feraheme to authorized wholesalers and specialty distributors, who, in turn, sellFeraheme to healthcare providers who administer Feraheme primarily within hospitals, hematology and oncology centers and nephrology clinics. In 2016,sales of Feraheme accounted for approximately 18% of our total net revenues.On February 5, 2016, we received a Paragraph IV certification notice letter regarding an Abbreviated New Drug Application (an “ANDA”) submitted to theFDA by Sandoz Inc. (“Sandoz”) requesting approval to engage in commercial manufacture, use and sale of a generic version of ferumoxytol. A genericversion of Feraheme can be marketed only with the approval of the FDA of the respective application for such generic version. The Drug Price Competitionand Patent Term Restoration Act of 1984, as amended (the “Hatch-Waxman Act”) requires an ANDA applicant whose proposed drug is a generic version of apreviously-approved drug listed in the FDA publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” also known as the “OrangeBook,” to certify to any patents listed in the Orange Book for the previously-approved drug and, in the case of a Paragraph IV certification, to notify theowner of the approved application and the relevant patent-holder. The Paragraph IV certification notice is required to contain a detailed factual and legalstatement explaining the basis for the applicant’s opinion that the proposed product does not infringe the subject patents, that such patents are invalid orunenforceable, or both. If a patent infringement suit is filed within 45 days of receipt of the Paragraph IV notice, a so-called 30-month stay is triggered thatgenerally prevents the FDA from approving the ANDA until the expiration of the 30-month stay period, conclusion of the litigation in the generic applicant’sfavor, or expiration of the patent, whichever is earlier. In its notice letter, Sandoz claims that our ferumoxytol patents are invalid, unenforceable and/or notinfringed by Sandoz’s manufacture,6Table of Contentsuse, sale or offer for sale of the generic version. In March 2016, we initiated a patent infringement suit alleging that Sandoz’ ANDA filing itself constituted anact of infringement and that if it is approved, the manufacture, use, offer for sale, sale or importation of Sandoz’ ferumoxytol products would infringe ourpatents. By the filing of this complaint, we believe a 30-month stay was triggered and that the FDA is prohibited from granting approval of Sandoz’application until the earliest of 30 months from the date of receipt of the notice of certification by the patent owner, the conclusion of litigation in thegeneric’s favor, or expiration of the patent(s). If the litigation is resolved in favor of the applicant or the challenged patent expires during the 30 months stayperiod, the stay is lifted and the FDA may thereafter approve the application based on the applicable standards for approval. On May 2, 2016, Sandoz filed aresponse to our patent infringement suit and the trial is scheduled for March 12, 2018. Any future unfavorable outcome in this matter could negatively affectthe magnitude and timing of future Feraheme revenues. We intend to vigorously enforce our intellectual property rights relating to ferumoxytol. The ANDAprocess is discussed in more detail below under the heading “Pharmaceutical Product Approval Process - Abbreviated New Drug Application.”Chronic kidney disease, anemia, and iron deficiencyCKD is a progressive condition that leads to chronic and permanent loss of kidney function. It contributes to the development of many complications,including anemia, hypertension, fluid and electrolyte imbalances, acid/base abnormalities, bone disease and cardiovascular disease. According to theNational Kidney Foundation, 26 million Americans are living with CKD and millions of others are at risk. Anemia, a common condition among CKDpatients, is associated with cardiovascular complications, decreased quality of life, hospitalizations, and increased mortality. Anemia develops early duringthe course of CKD and worsens with advancing kidney disease. Patients with anemia can look pale, feel fatigued, experience shortness of breath, low energy,headaches, palpitations or chest pains, and have a loss of appetite, trouble sleeping and trouble concentrating. Anemia in CKD patients is most often causedby an insufficient production of erythropoietin, a hormone made by the kidneys which tells the body to produce red blood cells, and iron deficiency, due toinadequate iron intake, blood loss or because the body cannot use iron stores. Regardless of the cause of the iron deficiency, iron replacement therapy isessential to increase iron stores and raise hemoglobin levels. Iron is also essential for effective treatment with erythropoiesis stimulating agents (“ESAs”),which are commonly used in anemic patients to stimulate red blood cell production. Based on data contained in a 2009 publication in the Journal of theAmerican Society of Nephrology, we estimate that there are at least 1.6 million adults in the U.S. diagnosed with IDA in stages 3 through 5 of CKD, who arepatients in the mid to later stages of CKD but not yet on dialysis and could therefore benefit from receiving IV iron.Currently there are two methods of iron therapy used to treat IDA in CKD patients: oral iron supplements and IV iron. The National Kidney Foundation’sKidney Disease Outcomes Quality Initiative guidelines recommend either oral or IV iron for peritoneal dialysis patients and non-dialysis patients withstages 1 through 5 of CKD. Oral iron is currently the first-line iron replacement therapy for most physicians. However, oral iron supplements are poorlyabsorbed by many patients, which may adversely impact their effectiveness, and are associated with certain side effects, such as constipation, diarrhea, andcramping, that may adversely affect patient compliance in using such products. In addition, it can take an extended time for hemoglobin levels to improvefollowing the initiation of oral iron treatment, and even then the targeted hemoglobin levels may not be reached. Conversely, iron given intravenouslyallows larger amounts of iron to be provided to patients in a shorter time frame while avoiding many of the side effects and treatment compliance issuesassociated with oral iron, and can result in faster rises in hemoglobin levels. The administration of IV iron has been shown to be effective in treating anemiaeither when used alone or in combination with an ESA. Current treatment guidelines indicate that treating first with IV iron alone may delay or reduce theneed for ESA therapy. Iron supplementation is widely used in CKD patients to treat iron deficiency, prevent its development in ESA-treated patients, raisehemoglobin levels in the presence or absence of ESA treatment, and reduce ESA doses in patients receiving ESA treatment. We believe that IV iron isunderutilized in non-dialysis CKD patients who are diagnosed with IDA, and thus a significant opportunity remains to grow the market for IV iron in thispatient population.Post-Marketing Commitments of Feraheme in CKDWe had initiated a randomized, active-controlled pediatric study of Feraheme for the treatment of IDA in pediatric CKD patients to meet our FDA post-approval Pediatric Research Equity Act requirement to support pediatric labeling of Feraheme in the U.S. The study covered both dialysis-dependent andnon-dialysis dependent CKD pediatric patients and was intended to assess the safety and efficacy of Feraheme treatment as compared to oral iron inapproximately 288 pediatric patients. During 2015, we terminated this trial due to difficulty in enrollment. In December 2016, we met with the FDA todevelop a plan forward in order to satisfy this post-approval commitment for Feraheme and recently proposed a protocol to the FDA for a new pediatric study.7Table of ContentsFeraheme for the treatment of IDA in a broad range of patientsIDA not associated with CKD is widely prevalent in many different patient populations. For many of these patients, treatment with oral iron isunsatisfactory. In the U.S., over one million grams of IV iron were administered for the treatment of non-dialysis patients with IDA in 2016. We believe thatapproximately half, or 500,000 grams, of the IV iron administered was for the treatment of non-dialysis patients with CKD and the other half was for non-CKDpatients with IDA due to other causes, including patients with gastrointestinal diseases or disorders, abnormal uterine bleeding, inflammatory diseases, andchemotherapy-induced anemia. It is estimated that more than 4.5 million patients in the U.S. have IDA (CKD and non-CKD) and we estimate that a smallfraction of these non-dialysis patients who are diagnosed with IDA regardless of the underlying cause are currently being treated with IV iron.In December 2016, in order to support an sNDA seeking approval for Feraheme for the treatment of IDA in adult patients who had failed or could nottolerate oral iron, or in whom oral iron was contraindicated, we completed enrollment in a randomized, double-blind multicenter non-inferiority trial that willevaluate the incidence of moderate-to-severe hypersensitivity reactions (including anaphylaxis) and moderate-to-severe hypotension with Ferahemecompared to ferric carboxymaltose infusion (the “Feraheme comparator trial”). Approximately 2,000 patients were randomized in a 1:1 ratio into one of twotreatment groups, those receiving 1.02 grams of Feraheme IV infusion or those receiving 1.5 grams of ferric carboxymaltose IV infusion. As background, inDecember 2012, we submitted an sNDA to the FDA seeking approval for this broader label, which included data from two controlled, multi-center Phase 3clinical trials, including more than 1,400 patients, which evaluated the safety and efficacy of ferumoxytol for the treatment of IDA in this broader patientpopulation. Both studies met the primary efficacy endpoints related to improvements in hemoglobin. In January 2014, we received a complete response letterfrom the FDA for the sNDA informing us that our sNDA could not be approved in its present form and stating that we had not provided sufficient informationto permit labeling of Feraheme for safe and effective use for the proposed broader indication. The FDA suggested, among other things, that we submitadditional clinical trial data in the proposed broad IDA patient population and, following discussions with the FDA, we determined to undertake theFeraheme comparator trial in pursuit of the broader indication. We currently expect to file an sNDA for this broader indication in mid-2017. MuGardMuGard is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oralwounds (mouth sores and injuries), including certain ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures orbraces. We acquired the U.S. commercial rights to MuGard under a license agreement with Abeona in June 2013. (the “MuGard Rights”) MuGard waslaunched in the U.S. by Abeona in 2010 after receiving 510(k) clearance from the FDA. Additional details regarding the acquisition of the MuGard Rightscan be found in Note Q, “Collaboration, License and Other Strategic Agreements,” to our consolidated financial statements included in this Annual Reporton Form 10-K.Based on interactions with government payors during 2016, we determined that broader reimbursement coverage for MuGard by was unlikely and weassessed the MuGard Rights for potential impairment. From this assessment, we concluded that based on the lack of broad reimbursement and insurancecoverage for MuGard and the resulting decrease in expected revenues and cash flows, the projected undiscounted cash flows were less than the book value,indicating impairment of this intangible asset. As a result of an analysis of the fair value of the net MuGard Rights intangible asset as compared to itsrecorded book value, we recognized an impairment charge for the full $15.7 million net intangible asset in 2016. RekyndaOverviewOn January 8, 2017, we entered into a license agreement (the “Palatin License Agreement”) with Palatin Technologies, Inc. (“Palatin”) under which weacquired (a) an exclusive license in all countries of North America (the “Rekynda Territory”), with the right to grant sub-licenses, to research, develop andcommercialize Rekynda and any other products containing bremelanotide (collectively, the “Rekynda Products”), an investigational product designed to bean on-demand treatment for HSDD in pre-menopausal women, (b) a worldwide non-exclusive license, with the right to grant sub-licenses, to manufacture theRekynda Products, and (c) a non-exclusive license in all countries outside the Rekynda Territory, with the right to grant sub-licenses, to research, developand manufacture (but not commercialize) the Rekynda Products. Following the satisfaction of the conditions to closing under the Palatin License Agreement,the transaction closed on February 2, 2017. Additional details regarding the Palatin License Agreement can be found below under the heading“Collaboration, License and Other Strategic Agreements-Palatin.”8Table of ContentsRekynda, bremelanotide, is a melanocortin-4 receptor agonist designed to activate pathways in the brain that are involved in the body’s normal sexualresponses, which is currently being developed for the treatment of HSDD in pre-menopausal women. Rekynda is designed to be an on-demand therapy givenprior to anticipated sexual activity and is self-administrated by the patient in the thigh or abdomen via a single-use subcutaneous auto-injector. Two recentlycompleted Phase 3 Rekynda studies conducted by Palatin for the treatment of HSDD in pre-menopausal women met the pre-specified co-primary efficacyendpoints of median improvement in desire and decrease in distress associated with low sexual desire as measured using validated patient-reported outcomeinstruments. Both trials consisted of double-blind placebo-controlled, randomized parallel group studies comparing a subcutaneous dose of 1.75 mg Rekyndaversus placebo, in each case, delivered via an auto-injector. The co-primary endpoints for these trials were evaluated using Question One and Two of theFemale Sexual Function Index: Desire Domain (“FSFI-D”) and Female Sexual Distress Scale-Desires/Arousal/Orgasm (“FSDS-DAO”) Item 13 scores. Forwomen taking Rekynda compared to placebo, the change in FSFI-D was measured using the median change and showed statistically significant improvementin measures of desire in both Phase 3 studies, with one study demonstrating a median change of 0.60 vs. 0.00 and p=0.0002, and the other studydemonstrating a median change of 0.60 vs. 0.00 and p<0.0001. These studies also demonstrated statistically significant mean changes in FSFI-D for womentaking Rekynda compared to placebo of 0.54 vs. 0.24 and 0.63 vs. 0.21. The FSDS-DAO Item 13 scores were also measured using the median change andshowed statistically significant decreases in measures of distress related to low sexual desire in both Phase 3 studies for women taking Rekynda compared toplacebo, with one study demonstrating a median change of -1.0 vs. 0.0 and p<0.0001, and the other study demonstrating a median change of -1.0 vs. 0.0 andp=0.0057. These studies also demonstrated statistically significant mean changes in FSDS-DAO Item 13 scores for women taking Rekynda compared toplacebo of -0.74 vs. -0.35 and -0.71 vs. -0.41. The change in the number of satisfying sexual events, a key secondary endpoint, was not significantly differentfrom placebo in either clinical trial. Each trial consisted of over 600 patients randomized in a 1:1 ratio to either the treatment arm or placebo, each with a 24week evaluation period. The most frequent adverse events were nausea, flushing and headache, which were generally mild-to-moderate in severity.Approximately 18% of patients discontinued participation in the Rekynda arm due to adverse events in both studies. Women in the trials had the option, aftercompletion of the randomized trial, to continue in an ongoing open-label safety extension study for an additional 52 weeks, which is intended to gatheradditional data on the safety of long-term and repeated use of Rekynda. Nearly 80% of patients who completed the randomized portion of the study elected toremain in the ongoing open-label portion of the study. All of the patients in the extension study are receiving Rekynda. Palatin is continuing to oversee theconduct of the extension study, which we expect to be completed in the second half of 2017. We currently expect to submit an NDA in early 2018 followingcompletion of multiple Phase 1 drug interaction and safety pharmacology studies, including an abuse-liability study and drug-to-drug interaction studieswith anti-hypertensive and anti-arrhythmic therapies, as well as certain chemistry, manufacturing and controls activities, including drug product processvalidation studies by Palatin. Palatin will continue to conduct the remaining studies through clinical research organizations, and we will oversee suchdevelopment work to support our filing an NDA for Rekynda for the treatment of HSDD.The Phase 3 Rekynda studies were predicated on the results of a Phase 2b clinical study of bremelanotide conducted by Palatin. The Phase 2b clinicalstudy was a multicenter, placebo-controlled, randomized, parallel group, dose-finding trial testing three dose levels, 0.75 mg, 1.25 mg and 1.75 mg, ofsubcutaneously administered bremelanotide against placebo in pre-menopausal women diagnosed with HSDD, female sexual arousal disorder or both. Palatinreported that the 1.75 mg dose demonstrated clinically meaningful and statistically significant results for all predefined endpoints and was well-tolerated.Female Sexual Dysfunction and Hypoactive Sexual Desire DisorderFemale sexual dysfunction (“FSD”) is defined as persistent or recurring problems during one or more of the stages of a woman's sexual response, which,as a result, causes distress. HSDD is the most common type of FSD and is characterized by a decreased sexual desire with significant personal distress orinterpersonal difficulties as a result of the lack of desire. Studies suggest that approximately 15 million women in the U.S. are affected by HSDD andapproximately 5.8 million of these women are pre-menopausal and have a primary diagnosis of HSDD. Despite one FDA-approved HSDD therapy on themarket today for pre-menopausal women, we believe that patient awareness and understanding of the condition is extremely low, and that few womencurrently seek treatment. HSDD may go undiagnosed due to various factors such as embarrassment or stigma, lack of awareness of low sexual desire as amedical condition or attribution to other external factors, such as stress or fatigue. Recent market research commissioned by Palatin indicates that 95% of pre-menopausal women suffering from HSDD are unaware that it is a treatable medical condition. As a result, assuming FDA approval of our NDA, we expect thatthe initial focus of our Rekynda commercialization efforts will be raising awareness and education about the disease for both healthcare professionals andpatients with this disorder.9Table of ContentsIntrarosaOverviewOn February 13, 2017, we entered into a license agreement (the “Endoceutics License Agreement”) with Endoceutics, Inc. (“Endoceutics”) pursuant towhich Endoceutics has agreed to grant to us rights to Intrarosa, an FDA-approved product for the treatment of moderate-to-severe dyspareunia (pain duringsexual intercourse), a symptom of VVA due to menopause. The Endoceutics License Agreement grants us the right to develop and commercializepharmaceutical products containing dehydroepiandrosterone (“DHEA”), including Intrarosa, at dosage strengths of 13 mg or less per dose and formulated forintravaginal delivery, excluding any dosage strengths over 13 mg per dose and combinations with other active pharmaceutical ingredients, in the U.S. for thetreatment of VVA and FSD. The closing of the transactions contemplated by the Endoceutics License Agreement is subject to clearance under the Hart-Scott-Rodino Act and other customary closing conditions. At closing, we and Endoceutics will also enter into an exclusive commercial supply agreement, underwhich Endoceutics will supply Intrarosa to us.In addition to commercializing Intrarosa for VVA, we have also committed to co-fund a Phase 3 clinical program, which would be conducted byEndoceutics to support regulatory approval of Intrarosa for the treatment of certain types of FSD in post-menopausal women. We and Endoceutics haveagreed to share the direct costs related to such studies with our investment not to exceed $20.0 million. In addition, we have also committed to a minimummarketing spend in 2017 for Intrarosa. Additional details regarding the Endoceutics License Agreement can be found below under the heading“Collaboration, License and Other Strategic Agreements-Pending Endoceutics License Agreement.”Intrarosa is the only FDA-approved, vaginally administered, daily non-estrogen steroid, which is prescribed for the treatment of moderate-to-severedyspareunia. Intrarosa contains prasterone, also known as DHEA. DHEA is an inactive endogenous precursor of hormones, which is converted locally intoandrogens and estrogens to help restore the vaginal tissue as indicated by improvements in the percentage of superficial cells, parabasal cells, and pH. Themechanism of action is not fully established. The effectiveness of Intrarosa on moderate-to-severe dyspareunia was examined in two primary 12-weekplacebo-controlled efficacy trials. All women in both studies were assessed for improvement from baseline to week 12 for four co-primary efficacy endpoints:most bothersome moderate-to-severe symptom of dyspareunia, the percentage of vaginal superficial cells, the percentage of parabasal cells, and vaginalpH. All primary endpoints were statistically significant. Women taking Intrarosa experienced a significant reduction in moderate-to-severe dyspareunia, aswell as statistically significant improvements in the percentage of vaginal superficial cells, parabasal cells and vaginal pH.A 52-week long-term safety study of 422 post-menopausal women showed no evidence of endometrial hyperplasia, a potential precursor to endometrialcancer that is associated with the use of unopposed estrogen. Vaginal discharge and atypical pap smears were the most common adverse reactions and werewere reported as a treatment-emergent adverse reaction in at least 2% of women taking Intrarosa. Intrarosa is contraindicated in women with undiagnosedabnormal uterine bleeding. In clinical trials, the most common adverse reactions were vaginal discharge and abnormal pap smear. The label for Intrarosacontains a precaution that it has not been studied in women with a history of breast cancer.Vulvar and Vaginal AtrophyIn the U.S., there are an estimated 64 million post-menopausal women, with approximately half, or 32 million, of those women suffering from symptomsVVA, which we estimate is an approximately $1.0 billion-a-year market. Of the 32 million women who suffer from symptoms of VVA, there are an estimated44% to 78% who report symptoms of dyspareunia, a common symptom of VVA.As a non-estrogen-based product, Intrarosa is not subject to the labeling restrictions associated with the results of the Women’s Health Initiative (WHI),led to class labeling for all estrogen containing products, including a boxed safety warning of the increased risk of certain types of cancer, cardiovasculardisease, and probable dementia associated with the use of exogenous estrogen. Intrarosa is not subject to the boxed warning and dosing restrictions of allother currently approved prescription products to treat VVA.We plan to invest in a new sales force of approximately 150 sales representatives dedicated to support the Intrarosa launch, which we anticipate to takeplace in mid-2017. This new sales force will also allow for additional flexibility as our portfolio evolves, including opportunities for Intrarosa labelexpansion, preparing for the potential launch of Rekynda and for future products acquired in the women’s health space over time.10Table of ContentsCollaboration, License and Other Strategic AgreementsPalatinUnder the terms of the Palatin License Agreement, which closed on February 2, 2017, we paid Palatin $60.0 million as a one-time upfront payment. Wewill also reimburse Palatin up to an aggregate amount of $25.0 million for all reasonable, documented, out-of-pocket expenses incurred by Palatin inconnection with the development and regulatory activities necessary to submit an NDA for Rekynda for the treatment of HSDD, which we expect to incur in2017. In addition, the Palatin License Agreement provides for future contingent payments of (a) up to $80.0 million upon achievement of certain regulatorymilestones, including FDA approval, and (b) up to $300.0 million of aggregate sales milestone payments upon the achievement of certain annual net salesmilestones over the course of the license. The first sales milestone of $25.0 million will be triggered when Rekynda annual net sales exceed $250.0 million.We are also obligated to pay Palatin tiered royalties on annual net sales of the Rekynda Products, on a product-by-product basis, in the Rekynda Territoryranging from the high-single digits to the low double-digits. The royalties will expire on a product-by-product and country-by-country basis upon the latestto occur of (a) the earliest date on which there are no valid claims of Palatin patent rights covering such Rekynda Product in such country, (b) the expirationof the regulatory exclusivity period for such Rekynda Product in such country and (c) 10 years following the first commercial sale of such Rekynda Productin such country. These royalties are subject to reduction in the event that: (i) we must license additional third party intellectual property in order to develop,manufacture or commercialize a Rekynda Product or (ii) generic competition occurs with respect to a Rekynda Product in a given country, subject to anaggregate cap on such deductions of royalties otherwise payable to Palatin. After the expiration of the applicable royalties for any Rekynda Product in agiven country, the license for such Rekynda Product in such country would become a fully paid-up, royalty-free, perpetual and irrevocable license.The Palatin License Agreement expires on the date of expiration of all royalty obligations due thereunder unless earlier terminated in accordance withthe agreement. In addition, we have the right to terminate the Palatin License Agreement without cause, in its entirety or on a product-by-product andcountry-by-country basis upon at least 180 days’ prior written notice to Palatin. Either party may terminate the Palatin License Agreement for cause if theother party materially breaches or defaults in the performance of its obligations, and, if curable, such material breach remains uncured for 90 days.VeloIn July 2015, we entered into an option agreement with Velo, a privately held life-sciences company that granted us an option to acquire the rights to anorphan drug candidate, DIF, a polyclonal antibody in clinical development for the treatment of severe preeclampsia in pregnant women. We made an upfrontpayment of $10.0 million in the third quarter of 2015 for the option to acquire the global rights to the DIF program (the “DIF Rights”). DIF has been grantedboth orphan drug and fast-track review designations by the FDA for use in treating severe preeclampsia. Under the option agreement, Velo will complete adose ranging study and a Phase 2b/3a clinical study, which we expect to begin in the first quarter of 2017. Following the conclusion of the DIF Phase 2b/3astudy, we may terminate, or, for additional consideration, exercise or extend, our option to acquire the DIF Rights. If we exercise the option to acquire the DIFRights, we would be responsible for additional costs in pursuing FDA approval, and would be obligated to pay to Velo certain milestone payments andsingle-digit royalties based on regulatory approval and commercial sales of the product. If we exercise the option, we will be responsible for paymentstotaling up to $65.0 million (including the payment of the option exercise price and the regulatory milestone payments) and up to an additional $250.0million in sales milestone payments based on the achievement of annual sales milestones at targets ranging from $100.0 million to $900.0 million.AntaresThrough our acquisition of Lumara Health, we are party to a development and license agreement with Antares (the “Antares Agreement”), which grantsus an exclusive, worldwide, royalty-bearing license, with the right to sublicense, to certain intellectual property rights, including know-how, patents andtrademarks, to develop, use, sell, offer for sale and import and export the Makena auto-injector, an Antares’ auto-injection system for use with HPC. Inconsideration for the license, to support joint meetings and a development strategy with the FDA, and for initial tooling and process validation, LumaraHealth paid Antares an up-front payment in October 2014. Under the Antares Agreement, we are responsible for the clinical development and preparation,submission and maintenance of all regulatory applications in each country where we desire to market and sell the Makena auto-injector, including the U.S.We are required to pay royalties to Antares on net sales of the Makena auto-injector commencing on the launch of the Makena auto-injector in a particularcountry until the Makena auto-injector is no longer sold or offered for sale in such country (the “Antares Royalty Term”). The royalty rates range from highsingle digit to low double digits and are tiered based on levels of net sales of the Makena auto-injector and decrease after the expiration of licensed patents orwhere there are generic equivalents to the Makena auto-injector being sold in a particular11Table of Contentscountry. Antares is the exclusive supplier of our requirements for the auto-injection system devices for the Makena auto-injector and Antares remainsresponsible for the manufacture and supply of the devices and assembly of the Makena auto-injector. We are responsible for the supply of the drug in pre-filled syringes to be used in the assembly of the finished auto-injector product. The development and license agreement terminates at the end of the AntaresRoyalty Term, but is subject to early termination by us for convenience, by Antares if we do not submit regulatory filings in the U.S. by a certain date and byeither party upon an uncured breach by or bankruptcy of the other party.AbeonaIn June 2013, we entered into a license agreement (the "MuGard License Agreement") with under which Abeona granted us an exclusive, royalty-bearinglicense, with the right to grant sublicenses, to certain intellectual property rights, including know-how, patents and trademarks, to use, import, offer for sale,sell, manufacture and commercialize MuGard in the U.S. and its territories (the “MuGard Territory”) for the management of oral mucositis/stomatitis (thatmay be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including certain ulcers/canker sores andtraumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.In consideration for the license, we paid Abeona an upfront license fee of $3.3 million in June 2013. We are required to pay royalties to Abeona on netsales of MuGard until the later of (a) the expiration of the licensed patents or (b) the tenth anniversary of the first commercial sale of MuGard in the MuGardTerritory (the “MuGard Royalty Term”). These tiered, double-digit royalty rates decrease after the expiration of the licensed patents and are subject to off-setagainst certain of our expenses. After the expiration of the MuGard Royalty Term, the license shall become a fully paid-up, royalty-free and perpetual licensein the MuGard Territory.Abeona remains responsible for the manufacture of MuGard and we have entered into a quality agreement and a supply agreement under which wepurchase MuGard inventory from them. Our inventory purchases are at the price actually paid by Abeona to purchase it from a third-party plus a mark-up tocover administration, handling and overhead.Abeona is responsible for maintenance of the licensed patents at its own expense, and we retain the first right to enforce any licensed patent against third-party infringement. The MuGard License Agreement terminates at the end of the MuGard Royalty Term, but is subject to early termination by us forconvenience and by either party upon an uncured breach by or bankruptcy of the other party.Pending Endoceutics License AgreementUnder the terms of the Endoceutics License Agreement, which we entered into with Endoceutics on February 13, 2017, Endoceutics has agreed to grantto us rights to Intrarosa, an FDA-approved product for the treatment of moderate-to-severe dyspareunia. The Endoceutics License Agreement grants us theright to develop and commercialize pharmaceutical products containing DHEA, including Intrarosa, at dosage strengths of 13 mg or less per dose andformulated for intravaginal delivery, excluding any dosage strengths over 13 mg per dose and combinations with other active pharmaceutical ingredients, inthe U.S. for the treatment of VVA and FSD. The closing of the transactions contemplated by the Endoceutics License Agreement (the “Effective Date”) issubject to clearance under the Hart-Scott-Rodino Act and other customary closing conditions.Subject to the terms of the Endoceutics License Agreement, Endoceutics has agreed to conduct clinical studies for the use of Intrarosa in FSD to supportan application for regulatory approval for Intrarosa for the treatment of FSD in the U.S. We and Endoceutics have agreed to share the direct costs related tosuch studies based upon a negotiated allocation with us funding up to $20.0 million. We may, with Endoceutics’ consent (not to be unreasonably withheld,conditioned or delayed), conduct any other studies of Intrarosa for the treatment of VVA and FSD anywhere in the world for the purpose of obtaining ormaintaining regulatory approval of or commercializing Intrarosa for the treatment of VVA or FSD in the U.S. All data generated in connection with the abovedescribed studies would be owned by Endoceutics and licensed to us pursuant to the Endoceutics License Agreement.We will have the exclusive right to commercialize Intrarosa for the treatment of VVA or FSD in the U.S., subject to the terms of the Endoceutics LicenseAgreement, including having final decision making authority with respect to commercial strategy, pricing and reimbursement and other commercializationmatters. We have agreed to use commercially reasonable efforts to market, promote and otherwise commercialize Intrarosa for the treatment of VVA or FSD inthe U.S., including a commitment to a minimum marketing spend for Intrarosa in 2017. Endoceutics has the right to directly conduct, itself or through itsaffiliates or subcontractors, additional commercialization activities for Intrarosa for the treatment of VVA or FSD in the U.S., which scope of activities will beagreed to by the parties acting reasonably and in good faith, and has the right to12Table of Contentsconduct activities related generally to the field of intracrinology, in each case, subject to our right to withhold approval in certain instances. Upon Closing, we will make an upfront payment of $50.0 million and, subject to certain conditions, will issue 600,000 shares of unregistered commonstock, to Endoceutics, 300,000 of which will be subject to a 180-day lock-up provision, and the other 300,000 of which will be subject to a one-year lock-upprovision. We have also agreed to make a payment to Endoceutics of up to $10.0 million upon the delivery of launch quantities of Intrarosa and a paymentof $10.0 million on the first anniversary of the closing. In addition, we have also agreed to pay tiered royalties to Endoceutics equal to a percentage of netsales of Intrarosa in the U.S. ranging from mid-teens (for calendar year net sales up to $150.0 million) to mid twenty percent (for any calendar year net salesthat exceed $1 billion) (such royalty rate to be dependent on the aggregate annual net sales of Intrarosa) for the commercial life of Intrarosa, with deductions(a) after the later of (i) the expiration date of the last to expire of a licensed patent containing a valid patent claim or (ii) ten years after the first commercialsale of Intrarosa for the treatment of VVA or FSD in the U.S., (b) for generic competition and (c) for third party payments. Endoceutics is also eligible toreceive certain sales milestone payments, including a first sales milestone payment of $15.0 million, which would be triggered when Intrarosa annual netU.S. sales exceed $150.0 million, and a second milestone payment of $30.0 million, which would be triggered when annual net U.S. sales exceed $300.0million. If annual net U.S. sales exceed $500.0 million, there are additional sales milestone payments totaling up to $850.0 million, which would be triggeredat various increasing sales thresholds.In connection with the Endoceutics License Agreement, we and Endoceutics have agreed to enter into an exclusive commercial supply agreement on orabout the Effective Date, pursuant to which Endoceutics, itself or through affiliates or contract manufacturers, would agree to manufacture and supplyIntrarosa to us (the “Supply Agreement”) and would be our exclusive supplier of Intrarosa in the U.S., subject to certain rights for us to manufacture andsupply Intrarosa in the event of a cessation notice or supply failure (as such terms are defined in the Supply Agreement). Under the Supply Agreement,Endoceutics would maintain at all times a second source supplier for the manufacture of DHEA and the drug product and identify and validate and transfermanufacturing intellectual property to the second source supplier within two years of the Effective Date. The Supply Agreement will remain in effect until thetermination of the Endoceutics License Agreement, unless terminated earlier by either party for an uncured material breach or insolvency of the other party,or by us if we exercise our rights to manufacture and supply Intrarosa following a cessation notice or supply failure.Under the Endoceutics License Agreement, except as permitted under the Endoceutics License Agreement or the Supply Agreement, and except for anycompounds or products affecting the melanocortin receptor pathway, including without limitation, bremelanotide (collectively, “Excluded Product”), we willnot be permitted to research, develop, manufacture, or commercialize (i) DHEA for delivery by any route of administration anywhere in world, (ii) anycompound (including DHEA) or product for use in VVA anywhere in the world, or (iii) commencing on the date of an approval of Intrarosa for the treatmentof FSD in the U.S. and continuing for the remainder of the term of the Endoceutics License Agreement, any compound (including DHEA) for use in FSD(each, a “Competing Product”). Any compound or product for use in FSD that would be a Competing Product in the United States but that (i) does notcontain DHEA and (ii) was acquired or licensed or for which the research, development, manufacture or commercialization of such compound or product isinitiated by us or our affiliates, in each case, prior to the date of an approval of Intrarosa for the treatment of FSD in the U.S., will be an Excluded Product andwill not be subject to the exclusivity obligations under the Endoceutics License Agreement in the treatment of FSD, subject to certain restrictions in theEndoceutics License Agreement. These noncompete restrictions are subject to certain exclusions relating to the acquisition of competing programs.The Endoceutics License Agreement expires on the date of expiration of all royalty obligations due thereunder unless earlier terminated in accordancewith the Endoceutics License Agreement. The Endoceutics License Agreement may be terminated by either Party if the Effective Date has not occurredwithin 180 days following the execution date or such date as the parties may mutually agree. The Endoceutics License Agreement may be terminated byeither Party for material breach that is either uncured after a 90-day notice period, or if such breach cannot be cured within such 90-day period, if thebreaching party does not commence appropriate and material actions to cure such breach within the notice period and continue to diligently cure such breachfor a period not to exceed 90 days, in either case, subject to tolling or determination of the arbitrators, if dispute resolution procedures are initiated within 30days’ of the termination notice. We have the ability to elect not to terminate the Endoceutics License Agreement in the case of a material breach, in whichcase future milestone and royalty payments owed to Endoceutics would be reduced by a negotiated percentage or by an amount determined by arbitration.Either party may terminate under certain situations relating to the bankruptcy or insolvency of the other party. We may terminate the Endoceutics LicenseAgreement for a valid business reason upon 365 days prior written notice to Endoceutics; or upon 60 days written notice in the event we reasonablydetermine in good faith, after due inquiry and after discussions with Endoceutics, that we cannot reasonably continue to develop or commercialize anyProduct as a result of a safety issue regarding the use of Intrarosa. We may also terminate the Endoceutics License Agreement upon 180 days’ notice if thereis a change of control of13Table of ContentsAMAG and the acquiring entity (alone or with its affiliates) is engaged in a competing program (as defined in the Licensed Agreement) in the U.S. or in atleast three countries within the European Union.ManufacturingOverviewWe do not own or operate, and currently do not plan to own or operate, facilities for the manufacture of our commercially distributed products, productcandidates or for any commercial products or product candidates we may acquire or in-license. We rely solely on third-party contract manufacturers and ourlicensors (who, in turn, may also rely on third-party contract manufacturers) to manufacture our products for our commercial and clinical use and for certainmaterials required to support the CBR Services. The business model for CBR Services is limited to charging customers for our services related to thecollection, processing and storage of umbilical cord blood stem cells and cord tissues. Nevertheless, the FDA considers those services to constitutemanufacturing of products, and enforces regulations to ensure that establishments that perform such services do so in accordance with current Good TissuePractices. Our third-party contract manufacturing facilities, and those of our licensors, are subject to current good manufacturing practices (“cGMP”) andregulations enforced by the FDA through periodic inspections to confirm such compliance. We target to maintain, where possible, second source suppliersand/or sufficient inventory levels throughout our supply chain to meet our projected near-term demand for all of our drug products in order to minimize risksof supply disruption at points in our single source supply chain. For example, although we do not currently have a manufacturer for the production ofMakena drug substance, our supply chain practices have resulted in inventory of Makena drug substance which we believe to be sufficient to meet demanduntil we can qualify a new drug substance manufacturer. We also rely upon third-party contractors to assist in supporting the CBR Services, including tosupply proprietary materials, some of whom are sole source providers. We intend to continue to outsource the manufacture and distribution of our productsfor the foreseeable future, and we believe this manufacturing strategy will enable us to direct more of our financial resources to the commercialization anddevelopment of our products and services.To support the commercialization and development of our products and services, we have developed a fully integrated manufacturing support system,including quality assurance, quality control, regulatory affairs and inventory control policies and procedures. These support systems are intended to enableus to maintain high standards of quality for our products and services.MakenaThe Makena drug product for our commercial and clinical use is currently manufactured by Pfizer under a Development and Supply Agreement (asamended and restated, the “Pfizer Agreement”). The Pfizer Agreement requires that we satisfy certain minimum purchase requirements but we are notobligated to use Pfizer as our sole supplier of drug product. The Pfizer Agreement expires on December 31, 2022, which term may be automatically extendedthereafter for additional 18 month periods, unless cancelled by us or Pfizer within an agreed-upon notice period.Antares is the exclusive supplier of our requirements for the auto-injection system devices for the Makena auto-injector and Antares remains responsiblefor the manufacture and supply of the devices and assembly of the Makena auto-injector. We are responsible for the supply of the drug in pre-filled syringesto be used in the assembly of the finished auto-injector product. The Antares Agreement terminates at the end of the Antares Royalty Term, but is subject toearly termination by us for convenience, by Antares if we do not submit regulatory filings in the U.S. by a certain date and by either party upon an uncuredbreach by or bankruptcy of the other party.FerahemeWe are party to a Commercial Supply Agreement with Sigma-Aldrich, Inc. (“SAFC”) pursuant to which SAFC agreed to manufacture and we agreed topurchase from SAFC the active pharmaceutical ingredient (“API”) for use in the finished product of ferumoxytol for commercial sale as well as for use inclinical trials (as amended, the “SAFC Agreement”). Subject to certain conditions, the SAFC Agreement provides that we purchase exclusively all of our APIfrom SAFC. In addition, the prices for each batch will decline as batches are produced in greater quantities throughout each year of the agreement. The SAFCAgreement has an initial term that ends December 31, 2020, which may be automatically extended thereafter for additional two year periods, unless cancelledby us or SAFC within an agreed-upon notice period.We are party to a Pharmaceutical Manufacturing and Supply Agreement with Patheon, Inc. (“Patheon”) pursuant to which Patheon agreed to manufactureferumoxytol finished drug product for commercial sale and for use in clinical trials at a fixed price per vial (as amended, the “Patheon Agreement”). ThePatheon Agreement will continue in force until December 31, 2020.14Table of ContentsThe Patheon Agreement may be terminated at any time upon mutual written agreement by us and Patheon or at any time by us subject to certain noticerequirements and early termination fees. In addition, the Patheon Agreement may be terminated by either us or Patheon in the event of a material breach ofthe agreement by the other party provided that the breaching party fails to cure such breach within an agreed-upon notice period.MuGardUnder the terms of the MuGard License Agreement, Abeona is responsible for all aspects of manufacturing MuGard. We have entered into a qualityagreement and a supply agreement with Abeona under which we purchase MuGard inventory from Abeona.RekyndaRekynda is a synthetic peptide and while the production process involves well-established technology, there are few manufacturers capable of scaling upto commercial quantities under cGMP at acceptable costs. Under the Palatin License Agreement, we assumed a long-term commercial supply agreement forfill, finish, and packaging services for Rekynda. We are currently negotiating other manufacturing and supply agreements for the drug substance and auto-injector sub-assemblies and may not be able to enter into such agreements on acceptable terms, if at all.Raw MaterialsWe, our licensors and our respective third-party product manufacturers currently purchase certain raw and other materials used to manufacture ourproducts from third-party suppliers and, at present, do not have long-term supply contracts with most of these third parties. We also rely upon third-partycontractors to assist in providing the CBR Services, including to supply proprietary materials. Although certain of our raw or other materials are readilyavailable, others may be obtained only from qualified suppliers. The qualification of an alternative source may require repeated testing of the new materialsand generate greater expenses to us or our licensors if materials that we test do not perform in an acceptable manner. In addition, we, our licensors or ourrespective third-party manufacturers sometimes obtain raw or other materials from one vendor only, even where multiple sources are available, to maintainquality control and enhance working relationships with suppliers, which could make us susceptible to price inflation by the sole supplier, thereby increasingour production costs. As a result of the high-quality standards imposed on our raw or other materials, we, our licensors or our respective third-partymanufacturers may not be able to obtain such materials of the quality required to manufacture Feraheme or Makena or support the CBR Services from analternative source on commercially reasonable terms, or in a timely manner, if at all.Patents, Trademarks and Trade SecretsWe consider the protection of our technology to be material to our business. Because of the substantial length of time and expense associated withbringing new products through development and regulatory approval to the marketplace, we place considerable importance on obtaining patent protectionand maintaining trade secret protection for our products. Our success depends, in large part, on our ability, and the ability of our licensors, collaborators andother business partners to maintain the proprietary nature of our technology and other trade secrets. To do so, we must prosecute and maintain existingpatents, obtain new patents and ensure trade secret protection. We must also operate without infringing the proprietary rights of third parties or allowing thirdparties to infringe our rights.Our policy is to aggressively protect our competitive technology position by a variety of means, including applying for patents in the U.S. and inappropriate foreign countries. We currently hold a number of U.S. patents for Feraheme, which expire at various times through 2023. One of our U.S.Feraheme patents is subject to a patent term extension under U.S. patent law and FDA regulations and will expire in June 2023. There are no issued patentscovering Makena or the CBR Services. We have a license to two U.S. patents relating to MuGard, which expire in 2022. We have licenses to issued patentsand pending applications that will provide protection for the Makena auto-injector we are developing. In addition, we have entered into an agreement thatgives us an exclusive option to acquire the rights to an orphan drug candidate for the treatment of severe preeclampsia in pregnant women. Under the optionagreement, at the conclusion of a Phase 2b/3a clinical trial, we may exercise, extend or terminate the acquisition option, at which time we have the right topurchase all intellectual property of Velo related to the DIF Rights.We have pending patent applications in the U.S. directed to Makena and Feraheme. Although further patents may be issued on pending applications, wecannot be sure that any such patents will be issued on a timely basis, if at all. In addition, any issued patents may not provide us with competitive advantagesor may be challenged by others, and the existing or future patents of third parties may limit our ability to commercialize our products.15Table of ContentsUnder the Palatin License Agreement, we have exclusive rights to a number of issued and pending U.S. and foreign patents related to bremelanotide thatare owned by Palatin. Certain of Palatin's U.S. patents include claims directed to the bremelanotide drug composition and methods of use thereof with termsexpiring in 2020, and another patent includes claims covering methods of treating FSD using subcutaneous administration of compositions that includebremelanotide with a term expiring in 2033, any one of which may be subject to patent term extension for a maximum period of up to five years but no longerthan 14 years after regulatory approval as compensation for patent term lost during drug development and the FDA regulatory review process, pursuant to theHatch-Waxman Act. Whether we, together with Palatin, will be able to obtain patent term extensions under the Hatch-Waxman Act and the length of any suchextension cannot be determined until a product covered by such patents receives FDA approval. In addition, the claims of issued patents covering Rekyndamay not provide meaningful protection and further, third parties may challenge the validity or scope of any such issued patents.Under the terms of the Endoceutics License Agreement, we received rights to Endoceutics’ three U.S. patents related to Intrarosa, including drug-productpatent claims with a term which expires in 2031 and two additional patents, including method of use claims and pharmaceutical dosage form claims withterms which expire in 2028.We also have numerous U.S. and foreign trademark registrations directed to our corporate and affiliate names, as well as our products, complianceprograms and services. These marks help to further distinguish our products and services and enhance our overall intellectual property position.CompetitionThe pharmaceutical and cord blood banking industries are intensely competitive and subject to rapid technological change. For Makena, most of ourcompetition comes from pharmacies that compound a non-FDA approved version of Makena, which is sold at a much lower list price than Makena. Many ofour competitors for Feraheme are large, well-known pharmaceutical companies and may benefit from significantly greater financial, sales and marketingcapabilities, greater technological or competitive advantages, and other resources. For the CBR Services, competition in the private cord blood and cordtissue banking business is already intense and is likely to increase as the number of competitors continues to grow given the relatively low barriers to entry.We also expect to face competition for Rekynda, including from an FDA-approved product for treatment of HSDD. Our existing or potential competitors maydevelop products or services that are more widely accepted than ours and may receive patent protection that dominates, blocks, makes obsolete or adverselyaffects our product development or business.MakenaAlthough Makena is the only FDA-approved drug indicated to reduce the risk of preterm birth in women pregnant with a single baby who have a historyof singleton spontaneous preterm birth, it competes for market share primarily with compounding pharmacies. HPC is the active ingredient in Makena.Compounding pharmacies have been manufacturing formulations of HPC (which compounded formulations we refer to as “c17P”) for many years and c17Pformulations will likely remain available at a lower cost to Makena even though Makena has been granted orphan drug exclusivity until February 2018. InNovember 2013, the FDA implemented the Drug Quality and Security Act (“DQSA”), which amended the FDC Act with respect to the regulation andmonitoring of the manufacturing of compounding drugs. Although the FDA has issued a public statement recommending the use of Makena instead of acompounded drug except when there is a specific medical need (i.e., an allergy) that cannot be met by the approved drug and has stated that when it identifiesa pharmacist that compounds regularly or in inordinate amounts of any drug products that are essentially copies of Makena, it intends to take enforcementaction as it deems appropriate, doctors continue to prescribe and compounders continue to manufacture and sell c17P.Makena is priced at a premium to c17P, which has negatively impacted coverage of Makena by some state Medicaid programs and certain commercialpayers. Although we are undertaking efforts to educate physicians and patients about progress made toward expanding coverage of Makena and about thebenefits of Makena, certain doctors continue to choose to prescribe non-FDA approved purported substitute products made by pharmacy compounders in lieuof prescribing Makena.Based on market research we have conducted, we estimate that the following represents the 2016 and 2015 U.S. market share allocation of the Makenaat-risk patient population (as calculated by shipments to physicians), including patients treated with Makena, patients treated with c17P, and the patientpopulation being treated either with other therapies, such as vaginal progesterone, that are not approved for women pregnant with a single baby with a priorhistory of singleton spontaneous preterm birth, or not treated at all.16Table of Contents 2016 2015Makena42% 30%c17P28% 40%Other therapies or untreated30% 30%Prior to the February 2016 approval of the single-dose preservative-free formulation of Makena, many healthcare providers who preferred a single-doseor preservative-free option were utilizing non-FDA-approved compounded versions of hydroxyprogesterone caproate. The launch of the single-doseformulation allowed us to capture market share from these compounders, increase the number of compounders in our distributor network and partner withorganizations formerly using compounded product.Additionally, in 1956, the FDA approved the drug Delalutin, which contained the same active ingredient as Makena. Delalutin was approved forconditions other than reducing the risk of preterm birth and was marketed by Bristol-Myers Squibb (“BMS”). BMS stopped marketing and manufacturingDelalutin and it was withdrawn from the market in 1999. In 2010, the FDA determined that Delalutin was not withdrawn from sale for reasons of safety orefficacy. As such, generic drug applications may reference the withdrawn Delalutin NDA. In August 2015, the FDA approved an ANDA for HPC, which wassubmitted by McGuff Pharmaceuticals, Inc. (“McGuff”) in 2009, and which was subsequently transferred to Aspen Global Incorporated (“Aspen”) in2015. The ANDA label approved by the FDA for the McGuff product is for the same patient population and indications as Delalutin (i.e., it is approved onlyfor use in non-pregnant women with indications such as uterine cancer or abnormal uterine bleeding). In June 2016, ANI Pharmaceuticals, Inc. (“ANI”),Aspen’s exclusive distributor, launched HPC in 5 mL vials in the U.S. Although Aspen’s generic version of Delalutin is not indicated for pregnant womenand is not therapeutically equivalent to Makena, doctors may elect to prescribe this product off-label for Makena’s orphan-protected indication, which couldhave an adverse impact on our business and results of operations. In addition, if such generic Delalutin product is priced at a discount to Makena, commercialor government insurers could prefer or encourage the use of the generic Delalutin product for patients who are indicated for Makena.In addition, generic Makena competitors could enter the market through approval of ANDAs that use Makena as a reference listed drug, which wouldallow generic competitors to rely on Makena’s safety and efficacy trials instead of conducting their own studies. Because entry into the market can occurupon the expiration of the reference listed drug’s exclusivity, we could face such competition when Makena’s orphan drug exclusivity expires in February2018.For a detailed discussion regarding the risks and uncertainties related to competition for Makena, please refer to our Risk Factors, “Our ability tosuccessfully commercialize Makena is dependent upon a number of factors, including maintaining the benefits of Makena’s orphan drug exclusivity and thelength of time before competitors begin selling generic versions of Makena” and “If we are unsuccessful in differentiating Makena from compounded HPCproducts, sales of Makena, and thus our profitability, could be materially adversely affected.”CBR ServicesIn the past ten years, the cord blood banking industry has seen significant change. For example, in 2013 approximately 2.6% of U.S. parents wereprivately storing cord blood as compared to 2004 when only 0.2% of parents were privately storing cord blood. Similarly, the storage of umbilical cord tissuehas grown substantially from when it was first offered to the public as a commercial option. CBR was the first major company in the U.S. to offer umbilicalcord tissue storage in 2010 and in 2016, most private U.S. cord blood banks offer this service. The barriers to entry into the cord blood and cord tissuebanking business are relatively low. We face competition from new entrants to the market, which could affect our market share or put downward pressure onthe pricing of the CBR Services. Furthermore, new market entrants may not abide by industry guidelines, regulations and standards, including quality,compliance and marketing standards. New entrants may also offer and promote similar services at lower prices and/or engage in marketing behaviors thatcommunicate false or misleading information. In addition to having a potential adverse impact on our business, these behaviors of such competitors couldcreate a negative perception of our industry if they violate regulations or pursue questionable business practices. Though the barriers to entry are low, webelieve that establishing a high-quality brand and nationwide reputation like CBR’s, and growing a bank to a size where long-term stability of operations isnot a primary concern for customers, gives CBR an advantage in the market. 17Table of ContentsIn the U.S., CBR is considered the largest private cord blood bank based on the number of cord blood and cord tissue units banked. CBR’s largest U.S.competitor is ViaCord®, a subsidiary of PerkinElmer, Inc. Two other banks, Cryo-Cell International, Inc.® and StemCyte™, are significantly smaller thaneither CBR or ViaCord®, but maintain a national footprint. In addition to these three competitors, CBR competes with more than 20 other blood banks in theU.S., most of whom have regional focuses. CBR differentiates itself from almost all of its competitors through its size and financial stability, its investmentsin research and its commercial reach. For a detailed discussion regarding the risks and uncertainties related to competition for CBR, please refer to our Risk Factor, “Competition in the cordblood and cord tissue banking business is significant and may be increasing. If we are unable to maintain our position as the market leader, our CBRbusiness may decline and our results of operations could suffer.”FerahemeFeraheme is approved in the U.S. for the treatment of IDA in adult patients with CKD, including both dialysis and non-dialysis CKD patients. Ourcommercial strategy is entirely focused on growing the utilization of Feraheme in non-dialysis dependent adult CKD patients who are diagnosed with IDA.We believe there is a significant opportunity for Feraheme for the treatment of IDA in CKD patients not yet on dialysis. The non-dialysis IV iron market iscomprised primarily of three sites of care where a substantial number of CKD patients are treated: hospitals, hematology and oncology centers, andnephrology clinics.Feraheme currently competes primarily with the following IV iron replacement therapies for the treatment of IDA in CKD patients:•Venofer®, an iron sucrose complex, which is approved for use in hemodialysis, peritoneal dialysis, non-dialysis dependent CKD patients andpediatric CKD patients and is marketed in the U.S. by Fresenius Medical Care North America and American Regent Laboratories, Inc. (“AmericanRegent”), a subsidiary of Luitpold Pharmaceuticals, Inc. Venofer® is typically administered as a slow intravenous injection over two to five minutesin doses of 100 to 200 milligrams, thus requiring five to ten physician visits to reach a standard one gram therapeutic course.•Injectafer®, a ferric carboxymaltose injection, was approved in the U.S. in July 2013 to treat IDA in adult patients who have intolerance to oral ironor have had an unsatisfactory response to oral iron. Injectafer® is also indicated for IDA in adult patients with non-dialysis dependent CKD.Injectafer® is marketed in the U.S. by American Regent, the same distributor of Venofer®. The labeled administration of Injectafer® is two slowinjections or infusion of 750 milligrams each separated by at least seven days for a total cumulative dose of 1.50grams, or one and a half grams pertherapeutic course;•Ferrlecit®, a sodium ferric gluconate, which is marketed by Sanofi-Aventis U.S. LLC, is approved for use only in hemodialysis patients. Therecommended dose of Ferrlecit® and the generic version of Ferrlecit® is 125 milligrams administered by intravenous infusion over one hour perdialysis session or undiluted as a slow intravenous injection per dialysis session, thus requiring eight physician visits to reach a standard one gramtherapeutic course;•A generic version of Ferrlecit® marketed by Teva Pharmaceuticals, Inc.; and•INFeD®, an iron dextran product marketed by Allergan, Inc. which is approved in the U.S. for the treatment of patients with documented irondeficiency in whom oral iron administration is unsatisfactory or impossible. The recommended dose of INFeD® is a slow push in 100 milligramdoses, which would require up to ten physician visits to receive a standard one gram therapeutic course.As compared to the dosing regimens described above for Feraheme’s competitors, Feraheme is currently administered as a 510 milligram infusionfollowed by a second 510 milligram infusion three to eight days later, thereby making it possible for the patient to receive a full gram of iron in as few asthree days. In March 2015, following discussions with the FDA and, in an effort to strengthen the warnings and precautions section of the label and mitigatethe risk of serious hypersensitivity reactions, including anaphylaxis, we updated our Feraheme label to include (a) the addition of a boxed warning related tothe risks of serious hypersensitivity reactions or anaphylaxis, which were previously described only in the Warnings and Precautions section; (b) revisions tothe Dosing and Administration section to indicate that Feraheme should only be administered by IV infusion; and (c) modifications to the Warnings andPrecautions section to include a statement that patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with any parenteraliron products. These or any future changes to the label/package could adversely impact our ability to successfully compete in the IV iron market.18Table of ContentsIn addition to the currently marketed products described above, Feraheme may also compete with AuryxiaTM (ferric citrate), an oral treatment, which is indevelopment to treat IDA in adults with non-dialysis CKD. In January 2017, Keryx Biopharmaceuticals, Inc. announced that it has submitted an sNDA forAuryxiaTM to the FDA. Further, Akebia Therapeutics, Inc. is developing Vadadustat, an oral HIF stabilizer, to treat anemia related to CKD and has recentlycommenced a Phase 3 trial.Feraheme may also face future competition from generic IV iron replacement therapy products. For example, as discussed above, in February 2016, wereceived a Paragraph IV certification notice letter regarding an ANDA submitted to the FDA by Sandoz requesting approval to engage in commercialmanufacture, use and sale of a generic version of ferumoxytol. In March 2016, we initiated a patent infringement suit alleging that Sandoz’ ANDA filing itselfconstituted an act of infringement and that if it is approved, the manufacture, use, offer for sale, sale or importation of Sandoz’ ferumoxytol products wouldinfringe our patents. By the filing of this complaint, the FDA is prohibited from granting approval of Sandoz’ application until the earliest of 30 months fromthe date of receipt of the notice of certification by the patent owner, the conclusion of litigation in the generic’s favor, or expiration of the patent(s). If thelitigation is resolved in favor of the applicant or the challenged patent expires during the 30 months stay period, the stay is lifted and the FDA may thereafterapprove the application based on the applicable standards for approval. In May 2016, Sandoz filed a response to our patent infringement suit and the trial isscheduled for March 12, 2018.Further, in 2011, a generic version of Ferrlecit® was launched in the U.S. for the treatment of IDA in adult patients and in pediatric patients ages six yearsand older undergoing chronic hemodialysis who are receiving supplemental epoetin therapy.Companies that manufacture generic products typically invest far fewer resources in research and development than the manufacturers of brandedproducts and can therefore price their products significantly lower than those branded products already on the market. Therefore, competition from generic IViron products could limit our sales.Based on sales data provided to us in January 2017 by IMS Health Incorporated (“IMS”), we estimate that the size of the total 2016 U.S. non-dialysis IViron replacement therapy market was approximately 1.1 million grams, which represents an increase of approximately 11% over 2015. Feraheme currentlycompetes in the CKD portion of this market, which we estimate is approximately half of the total market. Based on this IMS data, the following represents the2016 and 2015 U.S. market share allocation of the total non-dialysis IV iron market based on the volume of IV iron administered: 2016 U.S. Non-dialysis 2015 U.S. Non-dialysis IV Iron Market IV Iron Market (1,114,000 grams) (1,000,000 grams)Venofer®38% 40%Injectafer®21% 14%INFeD®15% 18%Feraheme13% 14%Generic sodium ferric gluconate9% 9%Ferrlecit®4% 5%The market share data listed in the table above is not necessarily indicative of the market shares in dollars due to the variations in selling prices amongthe IV iron products.MuGardThere are currently few effective treatments for the treatment or management of oral mucositis. The market for treating oral mucositis is driven primarilyby convenience, price and reimbursement and the products in this market remain mostly undifferentiated. There are a number of approaches used to treat ormanage oral mucositis, including the use of ice chips during chemotherapy treatments, various medicinal mouthwashes, topical anesthetics and analgesics,and oral gel treatments. For example, many physicians use what is commonly known as “magic mouthwash”, which may currently be the most commonlyprescribed medication to manage oral mucositis. Magic mouthwash is a combination of generic ingredients which are typically compounded in a pharmacyand is preferred by many physicians because of the availability of less expensive generic ingredients used to formulate the mouthwash.19Table of ContentsRekyndaIf Rekynda is approved for marketing by the FDA and if we are successful in launching and commercializing it, we expect Rekynda will face competition.Addyi® (flibanserin) was approved by the FDA for commercial use in the U.S. in August 2015 for the treatment of HSDD in pre-menopausal women and ismarketed by Valeant Pharmaceuticals International, Inc. (“Valeant”). Addyi® is only available through a risk evaluation and mitigation strategy (“REMS”)program because of an increased risk of severe hypotension and syncope due to the interaction between Addyi® and alcohol. In addition, Addyi® wasapproved with a boxed warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with Addyi®, inpatients who use Addyi® with moderate or strong CYP3A4 inhibitors, or in patients who have liver impairment.We are not aware of any company actively developing another melanocortin receptor agonist drug for the treatment of HSDD. However, we are aware ofseveral other drugs at various stages of development, most of which are taken on a chronic, typically once-daily, basis. LorexysTM, an oral, non-hormonal,fixed-dose combination of two antidepressants, bupropion and trazodone, is being developed by S1 Biopharma, Inc. (“S1 Biopharma”). S1 Biopharmaintends to seek approval of LorexysTM utilizing a 505(b)(2) strategy, which may allow S1 Biopharma an accelerated regulatory pathway as well as decreaseddevelopment costs. Emotional Brain BV is developing two different oral fixed-dose, on-demand combination drugs, one a combination of sildenafil andtestosterone and the other a combination of testosterone and buspirone hydrochloride, and has conducted Phase 2 studies. Libigel®, a testosterone gel beingdeveloped by ANI, completed two Phase 3 efficacy trials for treatment of FSD in surgically post-menopausal women but ANI reported that it did not show astatistically significant difference from placebo in those trials. Intrinsa, a transdermal testosterone patch, successfully completed a Phase 3 clinical program,but was not approved in the U.S. based on potential long-term use safety risks of cancer and cardiovascular adverse events. There may be other companiesdeveloping new drugs for FSD indications, some of which may be in clinical trials in the U.S. or elsewhere. In addition, other companies may sell theirproducts off-label for indications other than HSDD.Sales, Marketing and DistributionMakenaWe currently have sales representatives dedicated exclusively to Makena and the CBR Services, who are focused on calling on approximately 16,000obstetricians and maternal fetal medicine specialists in the U.S. Makena prescriptions are dispensed via the payer-preferred pharmacy or purchased directlyby hospitals, government agencies and integrated delivery systems.Based on market research we conducted, we estimate that Makena is currently used to treat approximately 42% of the at-risk patient population,allowing for significant potential to increase its market share. Our sales and marketing teams use a variety of strategies and focused, multi-channel methods topromote Makena, including dedicating a separate managed care team to focus on health plans, including commercial payers, pharmacy benefit managers, andmanaged Medicaid plans as well as fee-for-service Medicaid programs.In addition, we offer customer support through the Makena Care Connection, which is designed to help the prescriber and patient navigate eachindividual patient’s needs throughout the Makena prescription process. Maternity insurance benefits vary in terms of insurance coverage for certainmedications, required copays, coinsurance or deductibles, and how medications are dispensed. The Makena Care Connection provides customer support topatients in processing the prescription, including confirming insurance coverage, assisting with prior authorizations (when applicable), and working incollaboration with the payer-preferred pharmacy and home health agency to help ensure timely initiation of therapy.The Makena Care Connection also screens and enrolls patients in financial assistance programs including our copay assistance program, which helpslower the out-of-pocket cost for commercially insured patients whose plan covers Makena. The copay assistance program applies to copays, coinsurance anddeductibles with no upper level income cap. The Makena Care Connection also screens and enrolls patients in our patient assistance program, whichprovides a full course of therapy at no charge to eligible uninsured patients, with no upper level income cap. To be eligible for these programs, the patientmust meet the FDA-approved indication. In compliance with federal regulations, patients insured by a government-funded program are not eligible toparticipate.Our My Adherence Program, a telephonic 24/7 nursing services program to assist with increasing patient compliance, encourages adherence to theweekly Makena injection schedule, helps identify challenges that may interfere with patient compliance in receiving the weekly injection and offerspotential solutions, provides educational materials that address important topics during pregnancy, and empowers patients to take an active role in theirhealth. Program participants are paired20Table of Contentswith a dedicated maternal health nursing specialist to support them throughout their pregnancy. To be eligible for the My Adherence Program, patients mustmeet the FDA-approved indication.During 2016, we entered into an agreement with a leading provider of home nursing services (which had previously utilized compoundedhydroxyprogesterone caproate) pursuant to which the provider performs at-home administration of Makena and, in connection with a recent amendment, alsoco-promotes Makena to certain healthcare providers.CBR ServicesIn addition to calling on physicians, we directly market CBR Services to pregnant women and their families through various digital marketing channels,including social media, email and web properties, and believe that we have the potential to reach approximately two million pregnant women each year,representing approximately half of the pregnancies in the U.S. The CBR consumer sales team educates expectant parents on their cord blood banking optionsand the benefits of preserving their newborn’s stem cells. This team of inside sales representatives uses both telephone and online chat to interact withconsumers and is central to CBR’s direct-to-consumer approach that is coordinated with our digital marketing lead generation and qualification expertise andwith detailing efforts by our women's health field force. Additionally, we nurture and develop customer referrals from an existing base of over 385,000families through our customer service team and digital and social media marketing efforts.We also offer the Newborn Possibilities Program®, which provides free processing and five years of free storage for cord blood and cord tissue to familieswith a qualifying medical need. To date, over 7,500 families have been enrolled. Further, the Newborn Possibilities Program has been expanded with thelaunch of the first registry aimed at collecting family health data on diseases and conditions common among registry participants to help target medicalresearch on those that may be treatable with newborn stem cell therapy. Currently, over 150,000 families are participating in the Family Health Registry™.FerahemeWe sell Feraheme to authorized wholesalers and specialty distributors who, in turn, sell Feraheme to healthcare providers who administer Ferahemeprimarily within hospitals, hematology and oncology centers and nephrology clinics. Since many hospitals and hematology, oncology and nephrologypractices are members of group purchasing organizations (“GPOs”), which leverage the purchasing power of a group of entities to obtain discounts based onthe collective bargaining power of the group, we also routinely enter into pricing agreements with GPOs in these markets so the members of the GPOs haveaccess to Feraheme and to the related discounts or rebates.Our sales and marketing organization uses a variety of common pharmaceutical marketing strategies and methods to promote Feraheme including salescalls to purchasing entities, such as hospitals, hematology and oncology centers and nephrology practices in addition to individual physicians or otherhealthcare professionals, medical education symposia, personal and non-personal promotional materials, local and national educational programs, scientificmeetings and conferences and informational and disease state awareness websites. In addition, we provide customer service and other related programs forFeraheme including reimbursement support services, a patient assistance program for uninsured or under-insured patients and a customer service call center.Our commercial strategy currently focuses on the non-dialysis dependent CKD market in the U.S. We believe this segment of patients is under-diagnosedand under-treated and there is a significant opportunity in this market to provide IV iron to non-dialysis CKD patients. Our sales team has been working toeducate HCPs who manage CKD patients on the benefits of IV iron and the advantages of Feraheme, in order to identify appropriate CKD patients andexpand the IV iron use in physicians’ offices, clinics, and hospitals where CKD patients are treated for IDA.MuGardOur commercial team uses a variety of common pharmaceutical marketing strategies and methods to promote MuGard, including sales calls to providingentities, such as hematology and oncology centers and hospitals. In addition, other tactical programs may include personal and non-personal promotionalmaterials to individual physicians or other healthcare professionals, sponsoring local and national educational programs, participation in scientific meetingsand conferences and implementing informational product specific websites.We market and sell MuGard to wholesalers and specialty pharmacies. Patients primarily receive MuGard through specialty pharmacies, which receiveprescriptions from either our MuGard patient reimbursement and support center (the “HUB”) or from physicians directly. We utilize the HUB as a centralizedpatient intake and referral management center to process21Table of Contentsinsurance coverage issues and administer our patient assistance program. In order to make MuGard available to patients as soon as possible, we provide astarter kit to clinicians, including a sample bottle and all pertinent information that the patient or caregiver needs to immediately begin MuGard therapy.Product Supply ChainWe outsource a number of our product supply chain services for our products to third-party logistics providers, including services related to warehousingand inventory management, distribution, chargeback processing, accounts receivable management, sample distribution to our sales force, and customerservice call center management.Major CustomersThe following table sets forth customers who represented 10% or more of our total revenues for 2016, 2015, and 2014. Revenues from TakedaPharmaceutical Company Limited (“Takeda”), our former partner for the commercialization of Feraheme outside of the U.S., included payments under thelicense, development and commercialization agreement with Takeda and in connection with its subsequent 2015 termination. Years Ended December 31, 2016 2015 2014AmerisourceBergen Drug Corporation22% 25% 34%McKesson Corporation11% 11% 21%Takeda Pharmaceuticals Company Limited—% 12% 11%Cardinal Health, Inc.<10% <10% 15%The loss of any of these customers would have a material adverse effect on our business.Government RegulationOverviewOur activities are subject to extensive regulation by numerous governmental authorities in the U.S. The FDC Act and other federal and state statutes andregulations govern, among other things, the research and development, manufacturing, quality control, labeling, recordkeeping, approval, storage,distribution, and advertising and promotion of pharmaceutical products and medical devices. In addition, under the Public Health Service Act and itsimplementing regulations, we are required to register with the FDA, which governs all aspects of cord blood preservation, including the recovery, screening,testing, processing, storage, labeling, packaging and distribution of cord blood stem cells.Failure to comply with any of the applicable U.S. requirements may result in a variety of administrative or judicially imposed sanctions including,among other things, the regulatory agency’s refusal to approve pending applications, suspension, variations or withdrawals of approval, clinical holds,warning letters, product recalls, product seizures, total or partial suspension of operations, injunctions, fines, civil penalties, or criminal prosecution.Pharmaceutical Product Approval ProcessClinical DevelopmentBefore we may market a new drug product, we must obtain FDA approval of an NDA for that product. The FDA may approve an NDA if the safety andefficacy of the drug candidate can be established based on the results of pre-clinical and clinical studies.Preclinical studies include laboratory evaluation of product chemistry and formulation, as well as in vitro and animal studies to assess the potential foradverse events and in some cases to establish a rationale for therapeutic use. The conduct of preclinical studies is subject to federal regulations andrequirements, including good laboratory practice regulations. Clinical testing typically proceeds in three phases, which may overlap or be combined. Phase 1trials seek to collect initial data about safety, tolerability, and optimal dosing of the drug candidate in healthy human subjects or, less commonly, in patientswith the target disease or condition. The goal of Phase 2 trials is to provide preliminary evidence about the desired therapeutic efficacy of the productcandidate in limited studies with small numbers of carefully selected subjects with the target disease or condition. Phase 3 trials generally consist ofexpanded, large-scale, randomized, double-blind, multi-center studies of the safety and efficacy of the product in the target patient population and are used asthe primary basis for regulatory approval.22Table of ContentsInformation about certain clinical trials must be submitted within specific timeframes to the National Institutes of Health for public dissemination atwww.clinicaltrials.gov.Submission and FDA Review of NDAs and sNDAsFollowing the successful completion of clinical trials, the sponsor submits the results to the FDA as part of an NDA. The NDA must also include theresults of pre-clinical tests and studies, information related to the preparation and manufacturing of the drug candidate, analytical methods, and proposedpackaging and labeling. Pursuant to agreements reached during reauthorization of the Prescription Drug User Fee Act (“PDUFA”), the FDA has a goal ofacting on most original NDAs within six months or ten months of the application submission or filing date, depending on the nature of the drug. For drugcandidates intended to treat serious or life-threatening diseases and conditions, the FDA has a number of programs intended to help expedite testing, review,and approval. For example, under the provisions of the FDA’s Subpart H Accelerated Approval regulations, accelerated approval is permitted based on asurrogate endpoint for a new drug that is intended to treat a serious or life-threatening disease or condition and that provides a meaningful therapeutic benefitover existing treatments.If the FDA’s evaluations of the NDA and of the sponsor’s manufacturing facilities are favorable, the FDA will issue an approval letter, and the sponsormay begin marketing the drug for the approved indications, subject to any post-approval requirements, described further below. If the FDA determines itcannot approve the NDA in its current form, it will issue a complete response letter indicating that the application will not be approved in its current form.The complete response letter usually describes the specific deficiencies that the FDA identified in the application and may require additional clinical or otherdata or impose other conditions that must be met in order to obtain approval of the NDA. Addressing the deficiencies noted by the FDA could be impractical,and it is possible that the sponsor could withdraw its application or approval may not be obtained or may be costly and may result in significant delays priorto approval.Where a sponsor wishes to expand the originally approved prescribing information, such as adding a new indication, it must submit and obtain approvalof an sNDA. Changes to an indication generally require additional clinical studies, which can be time-consuming and require the expenditure of substantialadditional resources. Under PDUFA, the target timeframe for the review of an sNDA to add a new clinical indication is six or ten months from the receipt date,depending on whether or not the sNDA has priority review. As with an NDA, if the FDA determines that it cannot approve an sNDA in its current form, it willissue a complete response letter as discussed above. See the discussion above under “Feraheme for the treatment of IDA in a broad range of patients” for ourongoing post-marketing activities for Feraheme.Abbreviated New Drug ApplicationAn ANDA is filed when approval is sought to market a generic equivalent of a drug product previously approved under an NDA and listed in the OrangeBook. Rather than directly demonstrating the product’s safety and efficacy, as is required of an NDA, an ANDA must show that the proposed generic productis the same as the previously approved product in terms of active ingredient(s), strength, dosage form, route of administration and bioavailability. In addition,with certain exceptions, the generic product must have the same labeling as the product to which it refers.NDA applicants and holders must provide certain information about patents related to the branded drug for listing in the Orange Book. When an ANDAapplication is submitted, it must contain one of several possible certifications regarding each of the patents listed in the Orange Book for the branded productthat is the reference listed drug. A certification that a listed patent is invalid, unenforceable, or will not be infringed by the sale of the proposed product iscalled a Paragraph IV Certification. See the discussion above under “Feraheme for the treatment of IDA in patients with CKD - Overview” for a Paragraph IVcertification notice letter regarding an ANDA submitted to the FDA by Sandoz.Adverse Event ReportingThe FDA requires a sponsor to submit reports of certain information on side effects and adverse events associated with its products that occur eitherduring clinical trials or after marketing approval. These requirements include specific and timely notification of certain serious, unexpected and/or frequentadverse events, as well as regular periodic reports summarizing adverse drug experiences. Failure to comply with these FDA safety reporting requirementsmay result in FDA regulatory action that may include civil action or criminal penalties. In addition, as a result of these reports, the FDA could create aTracked Safety Issue for a product in the FDA’s Document Archiving, Reporting and Regulatory Tracking System, place additional limitations on anapproved product’s use, such as through labeling changes, or, potentially, could require withdrawal or suspension of the product from the market. In addition,FDA could require post-market studies or impose distribution and use restrictions and other requirements via a REMS based upon new safety informationobtained through adverse event reporting (discussed further below).23Table of ContentsFDA Post-Approval RequirementsEven if initial approval of an NDA or sNDA is granted, such approval may be subject to post-market regulatory requirements, any or all of which mayadversely impact a sponsor’s ability to effectively market and sell the approved product. The FDA may require the sponsor to conduct Phase 4 clinical trials,also known as post-marketing requirements or post-marketing commitments, to provide additional information on safety and efficacy. The results of suchpost-marketing studies may be negative and could lead to limitations on the further marketing of a product, including safety labeling changes. Also, underthe Pediatric Research Equity Act, the FDA may require pediatric assessment of certain drugs unless waived or deferred due to the fact that necessary studiesare impossible or highly impractical to conduct or where the drug is not likely to be used in a substantial number of pediatric patients. In addition, the FDAmay require a sponsor to implement a REMS, which may include distribution or use restrictions to manage a known or potential serious risk associated withthe product. Failure to comply with REMS requirements may result in civil penalties. Further, if an approved product encounters any safety or efficacy issues,including drug interaction problems, the FDA has broad authority to force the sponsor to take any number of actions, including but not limited to,undertaking post-approval clinical studies, implementing labeling changes, adopting a REMS, issuing Dear Health Care Provider letters, or removing theproduct from the market.FDA Regulation of our Products and ServicesFDA Regulation of Product Marketing and PromotionThe FDA also regulates all advertising and promotional activities for prescription drugs, both prior to and after approval. Approved drug products mustbe promoted in a manner consistent with their terms and conditions of approval, including the scope of their approved use. The FDA may take enforcementaction against a company for promoting unapproved uses of a product (“off-label promotion”) or for other violations of its advertising and labeling laws andregulations. Failure to comply with these requirements could lead to, among other things, adverse publicity, product seizures, civil or criminal penalties, orregulatory letters, which may include warnings and require corrective advertising or other corrective communications to healthcare professionals.Under the Subpart H regulations, until the Makena confirmatory post-marketing clinical trial is completed, we are subject to a special 30-daypromotional material review by the FDA’s Office of Promotional Drug Products. This extra requirement means that there is a longer lead time before we areable to introduce new promotional material to the market for Makena and we are subject to increased scrutiny prior to using promotional pieces to ensure fairbalance.FDA Regulation of Manufacturing FacilitiesManufacturing procedures and quality control for approved drugs must conform to cGMP. Domestic manufacturing establishments must follow cGMP atall times, and are subject to periodic inspections by the FDA in order to assess, among other things, cGMP compliance. In addition, prior to approval of anNDA or sNDA, the FDA will often perform a pre-approval inspection of the sponsor’s manufacturing facility, including its equipment, facilities, laboratoriesand processes, to determine the facility’s compliance with cGMP and other rules and regulations. Vendors that supply finished products or components to thesponsor that are used to manufacture, package, and label products are subject to similar regulation and periodic inspections. If the FDA identifies deficienciesduring an inspection, it may issue a formal notice, which may be followed by a warning letter if observations are not addressed satisfactorily. FDA guidelinesspecify that a warning letter be issued only for violations of “regulatory significance” for which the failure to adequately and promptly achieve correctionmay be expected to result in an enforcement action.Product approval may be delayed or denied due to cGMP non-compliance or other issues at the sponsor’s manufacturing facilities or contractor sites orsuppliers included in the NDA or sNDA, and the complete resolution of these inspectional findings may be beyond the sponsor’s control. If the FDAdetermines that the sponsor’s equipment, facilities, laboratories or processes do not comply with applicable FDA regulations and conditions of productapproval, the FDA may seek civil, criminal or administrative sanctions and/or remedies against the sponsor, including suspension of its manufacturingoperations.Orphan Drug ExclusivityUnder the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare disease or condition, defined, inpart, as a patient population of fewer than 200,000. The company that first obtains FDA approval for a designated orphan drug for the specified rare disease orcondition receives orphan drug marketing exclusivity for that drug for a period of seven years. This orphan drug exclusivity prevents the FDA fromapproving another application for the same drug for the same orphan indication during the exclusivity period, except in very limited circumstances. Adesignated24Table of Contentsorphan drug may not receive orphan drug exclusivity for an approved indication if that indication is for the treatment of a condition broader than that forwhich it received orphan designation. In addition, orphan drug exclusivity marketing rights may be lost if the FDA later determines that the request fordesignation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the raredisease or condition. Finally, the FDA may approve a subsequent drug that is otherwise the same as a currently approved orphan drug for the same orphanindication during the exclusivity period if the sponsor of the subsequent drug can demonstrate that the drug is clinically superior to the already approveddrug. According to the FDA, clinical superiority may be demonstrated by showing that a drug is more effective in a clinical trial, safer in a substantial portionof the target population, or provides a major contribution to patient care relative to the currently approved drug.Drug Quality and Security ActIn November 2013, the DQSA legislation was enacted to amend the FDC Act with respect to the regulation and monitoring of the manufacturing ofcompounded drugs. Among other provisions of the DQSA, compounding pharmacies may now elect to register as an “outsourcing facility” under FDC Act503B. Registration as an outsourcing facility requires that drugs be compounded according to cGMP standards; that facilities report adverse events to theFDA; and that facilities be subject to a risk-based inspection schedule, among other requirements. Additionally, FDC Act 503A describes the conditions thatmust be satisfied for drug products compounded by a licensed pharmacist or licensed physician to be exempt from approval, labeling, and cGMPrequirements. To qualify for these exemptions, a compounded drug product must, among other things, be compounded for an identified patient based on avalid prescription or in limited quantities before the receipt of a prescription for such individual patient in certain circumstances. Under both 503A and 503Bof the FDC Act, compounding pharmacies may not compound regularly or in inordinate amounts any drug products that are “essentially copies ofcommercially available drug products.”Fraud and Abuse RegulationOur general operations, and the research, development, manufacture, sale, and marketing of our products, are subject to extensive federal and stateregulation, including but not limited to FDA regulations, the Federal Anti-Kickback Statute (“AKS”), the Federal False Claims Act (“FCA”), and the ForeignCorrupt Practices Act (“FCPA”), and their state analogues, and similar laws in countries outside of the U.S., laws governing sampling and distribution ofproducts and government price reporting laws.•The AKS makes it illegal to knowingly and willfully solicit, offer, receive, or pay any remuneration, directly or indirectly, in cash or in kind, inexchange for, or to induce, purchasing, ordering, arranging for, or recommending the purchase or order of any item or service, including the purchaseor prescription of a particular drug, that is reimbursed by a federal healthcare program. Liability may be established without proving actualknowledge of the statute or specific intent to violate it. In addition, federal law now provides that the government may assert that a claim includingitems or services resulting from a violation of the AKS constitutes a false or fraudulent claim for purposes of the FCA, described below. Violations ofthe AKS carry potentially significant civil and criminal penalties, including imprisonment, fines, and exclusion from participation in federalhealthcare programs. Many states have enacted similar anti-kickback laws, including in some cases laws that prohibit paying or receivingremuneration to induce a referral or recommendation of an item or service reimbursed by any payer, including private payers.•The FCA prohibits, among other things, anyone from knowingly presenting, or causing to be presented, claims for reimbursement of drugs orservices to government payers such as Medicare or Medicaid, or other claims for payment of government funds, where those claims are false orfraudulent. The FCA also prohibits knowingly making, using, or causing to be made or used a false record or statement material to a false orfraudulent claim or having possession, custody, or control of property or money used, or to be used, by the federal government and knowinglydelivering or causing to be delivered, less than all of that money or property. The FCA permits a private individual acting as a “whistleblower” tobring an action on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery. Government enforcementagencies and private whistleblowers have asserted liability under the FCA for, among other things, claims for items or services not provided asclaimed or for medically unnecessary items or services, kickbacks, promotion of off-label uses, and misreporting of drug prices to federal agencies.Many states have enacted similar false claims laws, including in some cases laws that apply where a claim is submitted to any third-party payer, notjust government programs.•The FCPA prohibits companies and their intermediaries from making, or offering or promising to make improper payments to non-U.S. officials forthe purpose of obtaining or retaining business or otherwise seeking favorable treatment.25Table of ContentsOur activities relating to the sale and marketing of our products may be subject to scrutiny under these laws. Federal and state authorities continue todevote significant attention and resources to enforcement of these laws within the pharmaceutical industry, and private individuals have been active inbringing lawsuits on behalf of the government under the FCA. We have developed and implemented a corporate compliance program based on what webelieve are current best practices in the pharmaceutical industry; however, these laws are broad in scope and there may not be regulations, guidance, or courtdecisions that definitively interpret these laws in the context of particular industry practices. We cannot guarantee that we, our employees, our consultants, orour contractors are or will be in compliance will all federal, state, and foreign regulations. If we or our representatives fail to comply with any of these laws orregulations, a range of fines, penalties, and/or other sanctions could be imposed on us, including, but not limited to, restrictions on how we market and sellour products, significant fines, exclusions from government healthcare programs, including Medicare and Medicaid, litigation, or other sanctions. Even if weare not determined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources andgenerate negative publicity, which could also have an adverse effect on our business, financial condition and results of operations. Such investigations orsuits may also result in related shareholder lawsuits, which can also have an adverse effect on our business.Other U.S. Regulatory RequirementsSeveral states have enacted legislation requiring pharmaceutical companies operating within the state to establish marketing and promotionalcompliance programs or codes of conduct and/or file periodic reports with the state or make periodic public disclosures on sales, marketing, pricing, clinicaltrials and other activities. In addition, as part of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education ReconciliationAct of 2010 (the “Affordable Care Act”) manufacturers of drugs and medical devices are required to publicly report gifts and other payments or transfers ofvalue made to U.S. physicians and teaching hospitals. Several states have also adopted laws that prohibit certain marketing-related activities, including theprovision of gifts, meals or other items to certain healthcare providers. Many of these requirements are new and uncertain, and the likely extent of futureenforcement for failure to comply with these requirements is unclear. However, compliance with these laws is difficult, time-consuming, and costly, and if weare found not to be in full compliance with these laws, we may face enforcement actions, fines, and other penalties, and we could receive adverse publicitywhich could have an adverse effect on our business, financial condition, and results of operations.We are also subject to data protection laws and regulations (i.e., laws and regulations that address privacy and data security). The legislative andregulatory landscape for data protection continues to evolve, and in recent years there has been an increasing focus on privacy and data security issues. In theU.S., numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy laws, and federal andstate consumer protection laws, govern the collection, use, disclosure, and protection of health-related and other personal information. Failure to comply withdata protection laws and regulations could result in government enforcement actions (which could include civil or criminal penalties), private litigation,and/or adverse publicity and could negatively affect our operating results and business. In addition, we may obtain health information from third parties (i.e.,healthcare providers who prescribe our products) that are subject to privacy and security requirements under the Health Insurance Portability andAccountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”). Although we are notdirectly subject to HIPAA (other than potentially with respect to providing certain employee benefits) we could be subject to criminal penalties if weknowingly obtain or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized orpermitted by HIPAA. We are also subject to laws and regulations covering data privacy and the protection of health-related and other personal information.We obtain patient health information from most healthcare providers who prescribe our products and research institutions we collaborate with, and they aresubject to privacy and security requirements that may affect us. Claims that we have violated individuals’ privacy rights or breached our contractualobligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm ourbusiness. For example, through April 29, 2033, CBR is required to comply with a Federal Trade Commission (“FTC”) Order (the “FTC Order”). The FTCOrder requires CBR, among other things, to implement and maintain a comprehensive information security program and conduct a biennial assessment of itsinformation security program. CBR is also required not to make any misrepresentations, expressly or by implication, regarding its privacy practices or itsinformation security program. The costs of compliance with, and other burdens imposed by, these obligations are substantial and may impede ourperformance and our ability to develop the CBR Services, or lead to significant fines, penalties or liabilities for noncompliance.Regulation of Cord Blood and Cord Tissue BankingHuman tissues intended for transplantation, including umbilical cord blood stem cells and cord tissue, are subject to comprehensive regulations thataddress activities associated with human cells, tissues and cellular and tissue-based products26Table of Contents(“HCT/Ps”). One set of regulations requires that companies that engage in the recovery, processing, storage, labeling, packaging, or distribution of anyHCT/Ps, or the screening or testing of a cell or tissue donor, register with the FDA. This set of regulations also includes the criteria that must be met in orderfor the HCT/P to be eligible for distribution solely under Section 361 of the Public Health Service Act (the “PHSA”), and the regulations in 21 CFRPart 1271, rather than under the drug or device provisions of the FDC Act or the biological product licensing provisions of the PHSA. Another set ofregulations provides criteria that must be met for donors to be eligible to donate HCT/Ps and is referred to as the “Donor Eligibility” rule. A third set ofprovisions governs the processing and distribution of the tissues and is often referred to as the “Current Good Tissue Practices” rule. The Current Good TissuePractices rule covers all stages of HCT/P processing, from procurement to distribution of final allografts. Together these regulations are designed to ensurethat sound, high quality practices are followed to reduce the risk of tissue contamination and of communicable disease transmission to recipients.CBR is registered with the FDA as an HCT/P establishment that screens, packages, processes, stores, labels and distributes umbilical cord blood stem celland cord tissue by virtue of the services it provides to expectant parents as a private cord blood and cord tissue bank. The FDA periodically inspects suchregistered establishments to determine compliance with HCT/P requirements. If the FDA determines that we have failed to comply with applicable regulatoryrequirements, or any future regulatory requirements or standards, it can impose or initiate a variety of enforcement actions, including but not limited to,public warning or untitled letters, written recall or destruction orders, written cease manufacturing orders, court-ordered seizures, injunctions, consent decrees,civil penalties, or criminal prosecutions.Some states impose additional regulation and oversight of cord blood and cord tissue banks and of clinical laboratories operating within their bordersand impose regulatory compliance obligations on out-of-state laboratories providing services to their residents, and many states in which we and our businesspartners operate have licensing requirements that must be complied with.Medical Device RegulationMedical devices, such as MuGard, are similarly subject to FDA clearance or approval and extensive post-approval regulation under the FDC Act.Authorization to commercially distribute a new medical device in the U.S. is generally received in one of two ways. The first, known as premarketnotification (the “510(k) process”), requires a sponsor to demonstrate that the new medical device is substantially equivalent to a legally marketed medicaldevice that is not subject to premarket approval. The second, more rigorous process, known as premarket approval, requires a sponsor to independentlydemonstrate that the new medical device is safe and effective.Both before and after a device is commercially released, there are ongoing responsibilities under FDA regulations. The FDA reviews design andmanufacturing practices, labeling and record keeping, and manufacturers’ required reports of adverse experiences and other information to identify potentialproblems with marketed medical devices, similar to the reviews conducted in connection with drug product discussed above. If the FDA were to concludethat we are not in compliance with applicable laws or regulations, or that any of our medical devices are ineffective or pose an unreasonable health risk, theFDA could require us to notify health professionals and others that the devices present unreasonable risks of substantial harm to the public health, order arecall, repair, replacement, or refund of such devices, detain or seize adulterated or misbranded medical devices, or ban such medical devices. The FDA mayalso impose operating restrictions, enjoin and/or restrain certain conduct resulting in violations of applicable law pertaining to medical devices and assesscivil or criminal penalties against our officers, employees, or us.MuGard was launched in the U.S. by Abeona in 2010 after receiving 510(k) clearance from the FDA. Under the terms of the MuGard License Agreement,Abeona continues to hold the 510(k). MuGard is categorized as a pre-amendments device. This type of device has not been classified per se, but continues tobe subject to regulatory review under the 510(k) premarket clearance process.Pharmaceutical Pricing and ReimbursementOur ability to successfully commercialize our products is dependent, in significant part, on the availability and extent of reimbursement to end-usersfrom third-party payers for the use of our products, including governmental payers, health maintenance organizations (“HMOs”), managed care organizations,and private health insurers. The federal government provides health insurance for people who are 65 or older, and certain people with disabilities or certainconditions, irrespective of their age through the Medicare program, which is administered by the Centers for Medicare and Medicaid Services (“CMS”).Certain prescription drugs, including Makena and Feraheme, are covered under Medicare Part B. Coverage and reimbursement for products and servicesunder Medicare are determined in accordance with the Social Security Act and pursuant to regulations promulgated by CMS, as well as the agency’ssubregulatory coverage and reimbursement guidance and27Table of Contentsdeterminations. Medicaid is a health insurance program for low-income children, families, pregnant women, and people with disabilities that is jointlyfunded by the federal and state governments, but administered by the states. In general, state Medicaid programs are required to cover drugs and biologics ofmanufacturers that have entered into a Medicaid Drug Rebate Agreement, although such drugs and biologics may be subject to prior authorization or otherutilization controls. CMS also administers the Medicaid program through regulatory and policy guidance to the states.We participate in and have certain price reporting obligations to the Medicaid Drug Rebate program, and we have obligations to report Average SalesPrice (“ASP”) for the Medicare program. Under the Medicaid Drug Rebate program, we are required to pay a rebate to each state Medicaid program for ourcovered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds beingmade available to the states for our drugs under Medicaid and Medicare Part B. Those rebates are based on pricing data reported by us on a monthly andquarterly basis to CMS. These data include the average manufacturer price (“AMP”) and, in the case of innovator products such as Makena and Feraheme, thebest price for each drug.Federal law also requires that a company that participates in the Medicaid Drug Rebate program report ASP information to CMS for certain categories ofdrugs that are paid under Part B of the Medicare program, such as Makena and Feraheme. This ASP information forms the basis for reimbursement for themajority of our current Feraheme business, and to a lesser extent, for our Makena business. Manufacturers calculate ASP based on a statutorily definedformula and interpretations of the statute by CMS as to what should or should not be considered in computing ASP. An ASP for each National Drug Code fora product that is subject to the ASP reporting requirement must be submitted to CMS no later than 30 days after the end of each calendar quarter. CMS usesthese submissions to determine payment rates for drugs under Medicare Part B. Changes affecting the calculation of ASP could affect the ASP calculations forour products and the resulting Medicare payment rate, and could negatively impact our results of operations. Federal law requires that any company thatparticipates in the Medicaid Drug Rebate program also participate in the Public Health Service’s 340B drug pricing program in order for federal funds to beavailable for the manufacturer’s drugs under Medicaid and Medicare Part B. The 340B drug pricing program requires participating manufacturers to agree tocharge statutorily defined covered entities no more than the 340B “ceiling price” for the manufacturer’s covered outpatient drugs. These 340B coveredentities include a variety of community health clinics and other entities that receive health services grants from the Public Health Service, as well as hospitalsthat serve a disproportionate share of low-income patients. The 340B ceiling price is calculated using a statutory formula, which is based on AMP and rebateamount for the covered outpatient drug as calculated under the Medicaid Drug Rebate program. As described below, the Affordable Care Act introducedchanges to the definition of AMP and the Medicaid rebate formula and made changes to the 340B drug pricing program as well.The Affordable Care Act also expanded the Public Health Service’s 340B drug pricing program to include additional types of covered entities: certainfree-standing cancer hospitals, critical access hospitals, rural referral centers and sole community hospitals, each as defined by the Affordable Care Act. Forexample, the percentage of Feraheme sold to 340B institutions has grown from 11% in 2011 to 20% in 2016. Since these institutions are granted lower pricesthan those offered to our other customers, any further growth in our 340B business may have a negative impact on our sales price per gram and operatingmargins. The Affordable Care Act exempts “orphan drugs,” such as Makena, from the ceiling price requirements for the covered entity types newly added tothe program by the Affordable Care Act.The Affordable Care Act obligates the Health Resources and Services Administration (“HRSA”), the agency that administers the 340B program, to createregulations and processes to improve the integrity of the 340B drug pricing program and to update the agreement that manufacturers must sign to participatein the 340B drug pricing program to obligate a manufacturer to offer the 340B price to covered entities if the manufacturer makes the drug available to anyother purchaser at any price and to report to the government the ceiling prices for its drugs. In January 2017, HRSA issued a final rule regarding thecalculation of the 340B ceiling price and the imposition of civil monetary penalties on manufacturers that knowingly and intentionally overcharge coveredentities. We do not believe this rule will have a material impact on our business or results of operations. Additionally, in order to be eligible to have ourproducts paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies and grantees, we participatein the Department of Veterans Affairs (the “VA”), Federal Supply Schedule (the “FSS”) pricing program. As part of this program, we are obligated to make ourproducts available for procurement on an FSS contract under which we must comply with standard government terms and conditions and charge a price thatis no higher than the statutory Federal Ceiling Price (the “FCP”) to four federal agencies (VA, U.S. Department of Defense, DoD, Public Health Service, andCoast Guard, the “Big Four”). The FCP is based on the non-federal AMP (the “Non-FAMP”), which we calculate and report to the VA on a quarterly andannual basis. Pursuant to applicable law, knowing provision of false information in connection with a Non-FAMP filing can subject a manufacturer topenalties of $100,000 for each item of false information. These obligations also contain extensive disclosure and certification requirements. Under Section703 of the National Defense Authorization Act for Fiscal Year 2008, we are also required to pay28Table of Contentsquarterly rebates on utilization of innovator products that are dispensed through the Tricare Retail Pharmacy network to Tricare beneficiaries. The rebates arecalculated as the difference between the annual Non-FAMP and FCP.Reimbursement by private third-party payers depends on a number of factors, including the third-party’s determination that the product is competitivelypriced, safe and effective, appropriate for the specific patient, and cost-effective. Third-party payers are increasingly challenging the prices charged forpharmaceutical products, and have instituted and continue to institute cost containment measures to control or significantly influence the purchase ofpharmaceutical products. For example, to reduce expenditures associated with pharmaceutical products, many third-party payers use cost containmentmethods, including: (a) formularies, which limit coverage for drugs not included on a predetermined list; (b) variable copayments, which may make a certaindrug more expensive for patients as compared with a competing drug; (c) utilization management controls, such as requirements for prior authorization beforethe payer will cover the drug and limits on the number of prescriptions that will be paid over a set time period; and (d) other coverage policies that limitaccess to certain drugs for certain uses based on the payer-specific coverage policy.In addition, federal and state governments continue to attempt to curb healthcare costs through legislation, including legislation aimed at reducing thepricing and reimbursement of pharmaceutical products. The Affordable Care Act includes certain cost containment measures including an increase to theminimum rebates for products covered by Medicaid programs from 15.1% to 23.1% of AMP for most innovator products, and the expansion of the 340B Drugpricing program under the Public Health Service Act. Effective March 2010, the Affordable Care Act expanded manufacturer rebate liability under theMedicaid program from fee-for-service Medicaid utilization to include the utilization of Medicaid managed care organizations as well. In addition, theAffordable Care Act and subsequent legislation changed the definition of AMP. Further, federal budgetary concerns could result in the implementation ofsignificant federal spending cuts, including cuts in Medicare and other health related spending in the near-term. For example, past legislative enactmentsresulted in Medicare payments being subject to a two percent reduction, referred to as sequestration, until 2025. Finally, the Affordable Care Act requiredpharmaceutical manufacturers of branded prescription drugs to pay a branded prescription drug fee to the federal government. Each individualpharmaceutical manufacturer pays a prorated share of the branded prescription drug fee of $3.0 billion in 2016, based on the dollar value of its brandedprescription drug sales to certain federal programs identified in the law. “Orphan drugs” are specifically defined for purposes of the fee. For each indicationapproved by the FDA for the drug, such indication must have been designated as orphan by the FDA under section 526 of the FDCA, an orphan drug taxcredit under section 45C of the Internal Revenue Code must have been claimed with respect to such indication, and such tax credit must not have beendisallowed by the Internal Revenue Service. Finally, the FDA must not have approved the drug for any indication other than an orphan indication for which asection 45C orphan drug tax credit was claimed (and not disallowed). Makena was excluded from the branded prescription drug fee in 2015 and 2016. OnDecember 13, 2016, President Obama signed into law the 21st Century Cures Act which, among other things, expands the scope of health care economicinformation that manufacturers may use to promote drugs to payers, formulary committees and similar entities.In addition, the heightened focus on the healthcare industry by the federal government could result in the implementation of significant federal spendingcuts including cuts in Medicare and other health related spending in the near-term. In recent years, some states have also passed legislation to control theprices of drugs as well as begun a move toward managed care to relieve some of their Medicaid cost burden. These and any future changes in governmentregulation or private third-party payers’ reimbursement policies may reduce the extent of reimbursement for our products and adversely affect our futureoperating results. For example, since approximately half of Makena patients are Medicaid beneficiaries in 2016, the impact of future legislative changes mayhave a significant impact on Makena sales. Payers also are increasingly considering new metrics as the basis for reimbursement rates, such as average salesprice, average manufacturer price, actual acquisition cost and value-based programs that may require cost effectiveness data and analyses, along withexpanded packaging of products and services in alternative payment models. The existing data for reimbursement based on these metrics is relatively limited,although certain states have begun to survey acquisition cost data for the purpose of setting Medicaid reimbursement rates. CMS surveys and publishes retailcommunity pharmacy acquisition cost information in the form of National Average Drug Acquisition Cost (“NADAC”) files, which reflect retail communitypharmacy invoice costs, and National Average Retail Price (“NARP”) files to provide state Medicaid agencies with a basis of comparison for their ownreimbursement and pricing methodologies and rates. It may be difficult to project the impact of these evolving reimbursement mechanics on the willingnessof payers to cover our products. Any failure to cover our products appropriately, in addition to legislative and regulatory changes and others that may occurin the future, could impact our ability to maximize revenues in the federal marketplace.Currently, in physician clinic and hospital settings, Medicare Part B generally reimburses for physician-administered drugs at a rate of 104.3% of thedrug’s ASP. ASP is defined by statute based on sales and price concession data, including rebates and chargebacks, for a defined period of time. As notedabove, we submit the required information to CMS on a quarterly basis. In advance of the quarter in which the payment limit for drugs reimbursed underMedicare Part B program will go into effect, CMS calculates and publishes the payment limit. Under this methodology, payment rates change on a quarterlybasis, and29Table of Contentssignificant downward fluctuations in ASP, and therefore reimbursement rates, could negatively impact sales of a product. Because the ASP-based paymentrate is defined by statute, and changes to Medicare payment methodologies require legislative change, it is unclear if and when ASP reimbursementmethodology will change for the physician office setting. While the statute requires Medicare Part B payments for most drugs furnished in the physicianoffice setting to be at 104.3% of ASP, the statute does not have a similar requirement for hospital outpatient departments. For that setting, the Medicarepayment for many covered Part B drugs also is at 104.3% of ASP, but CMS could change that through regulations, without any intervening legislation. WhileMedicare is the predominant payer for Feraheme for treatment of patients with CKD, Medicare payment policy, in time, can also influence pricing andreimbursement in the non-Medicare markets, as private third-party payers and state Medicaid plans frequently adopt Medicare principles in settingreimbursement methodologies and payment levels. We cannot predict the impact that any changes in reimbursement policies may have on our ability tocompete effectively.For example, in the U.S. hospital inpatient setting, most drugs are not reimbursed separately within the Medicare prospective payment system, basedlargely on the drug costs, but are bundled as a per discharge reimbursement based on the diagnosis and/or procedure rather than actual costs incurred inpatient treatments, thereby increasing the incentive for a hospital to limit or control expenditures. As a result, we do not expect premium priced products,such as Feraheme, to be broadly used in the hospital inpatient setting.We believe reimbursement for HSDD will be similar to approved products treating erectile dysfunction. If this is the case, we expect that commercialpayors with a tiered formulary will place Rekynda into a Tier 3, which normally requires a higher co-pay or deductible than Tier 1 or 2 category drugs. As aresult, patients would be unlikely to receive full reimbursement by third-party commercial payers and may not receive any reimbursement from governmentalhealthcare programs. Additionally, a key focus of the recent presidential election was “repeal and replacement” of the Affordable Care Act. The extent, timing and details ofthe changes are not known, but the federally funded health care landscape could face significant changes during the current presidential administration,including in the near-term, and could impact state and local healthcare programs, including Medicaid and Medicare through reductions in payment levels fordrugs.If adequate reimbursement levels are not maintained by government and other third-party payers for our products, our ability to sell our products may belimited and/or our ability to establish acceptable pricing levels for our products may be impaired, thereby reducing anticipated revenues and ourprofitability.BacklogWe had a $7.1 million and $3.7 million product sales backlog as of December 31, 2016 and 2015, respectively. We expect to recognize the $7.1 millionin the first quarter of 2017, net of any applicable rebates or credits. These backlogs were largely due to timing of orders received from our third-party logisticsproviders. Generally, product orders from our customers are fulfilled within a relatively short time of receipt of a customer order.EmployeesAs of February 13, 2017, we had 545 employees. We also utilize consultants and independent contractors on a regular basis to assist in the developmentand commercialization of our products and services. Our success depends to a significant extent on our ability to continue to attract, retain and motivatequalified sales, technical and laboratory operations, managerial, scientific and medical personnel of all levels. Although we believe we have been relativelysuccessful to date in obtaining and retaining such personnel, we may not be successful in the future. During 2016 and 2015, we expanded our leadership teamand strengthened our commercial organization. We expect to continue these efforts in 2017 to support the growth of our business.None of our employees is represented by a labor union, and we consider our relationship with our employees to be good.Foreign OperationsWe have no foreign operations. We did not have material revenues from customers outside of the U.S. in 2016. Revenues from customers outside of theU.S. amounted to approximately 12% of our total revenues for both 2015 and 2014 and were principally related to collaboration revenues recognized inconnection with our former agreement with Takeda, which is headquartered in Japan, and which was terminated in June 2015 following a six-monthtransition period. We do not currently expect any material future sales outside of the U.S.30Table of ContentsResearch and DevelopmentWe have dedicated a significant portion of our resources over the last several years to our efforts to develop our products and product candidates,including both Feraheme and Makena. We incurred research and development expenses of $66.1 million, $42.9 million, and $24.2 million during 2016,2015 and 2014, respectively. We expect our research and development expenses to increase in 2017 as compared to 2016 mostly due to additional expensesassociated with research and development related to our commercial products, up to $25.0 million in clinical development and regulatory costs associatedwith our obligations under the Rekynda License Agreement and related anticipated increase in expenses in our regulatory and clinical functions, and a $60.0million upfront payment made to Palatin in February 2017.Segment ReportingWe conduct our operations in one business segment as further described in Note O, “Business Segments,” to our consolidated financial statementsincluded in this Annual Report on Form 10-K.Code of EthicsOur Board of Directors has adopted a code of ethics that applies to our officers, directors and employees. We have posted the text of our code of ethics onour website at http://www.amagpharma.com in the “Investors” section. We will provide to any person without charge a copy of such code of ethics, uponrequest in writing to Investor Relations, AMAG Pharmaceuticals, Inc., 1100 Winter Street, Waltham, MA 02451. In addition, should any changes be made toour code of ethics, we intend to disclose within four business days on our website (or in any other medium required by law or the NASDAQ): (a) the date andnature of any amendment to our code of ethics that applies to our principal executive officer, principal financial officer, principal accounting officer orcontroller, or persons performing similar functions and (b) the nature of any waiver, including an implicit waiver, from a provision of our code of ethics that isgranted to one of these specified officers, the name of such person who is granted the waiver, and the date of the waiver.Available InformationWe are subject to the information and reporting requirements of the Securities Exchange Act of 1934, under which we file periodic reports, proxy andinformation statements and other information with the U.S. Securities and Exchange Commission (the “SEC”). Copies of these reports may be examined bythe public without charge at 100 F. Street N.E., Room 1580, Washington D.C. 20549 or on the Internet at http://www. sec.gov. Copies of all or a portion ofsuch materials can be obtained from the SEC upon payment of prescribed fees. Please call the SEC at 1-800-SEC-0330 for further information. Our internetwebsite address is http://www.amagpharma.com. Through our website, we make available, free of charge, our annual reports on Form 10-K, quarterly reportson Form 10-Q, current reports on Form 8-K, proxy and registration statements, and all of our insider Section 16 reports (and any amendments to such filings),as soon as reasonably practicable after such material is electronically filed with, or furnished to, the SEC. These SEC reports can be accessed through the“Investors” section of our website. The information found on our website is not part of this or any other report we file with, or furnish to, the SEC. Papercopies of our SEC reports are available free of charge upon request in writing to Investor Relations, AMAG Pharmaceuticals, Inc., 1100 Winter Street,Waltham, MA 02451. The content on any website referred to in this Form 10-K is not incorporated by reference into this Form 10-K unless expressly noted.31Table of ContentsITEM 1A. RISK FACTORS:The following information sets forth material risks and uncertainties that may affect our business, including our future financial and operationalresults and could cause our actual results to differ materially from those contained in forward-looking statements we have made in this Annual Report onForm 10-K and elsewhere as discussed in the introduction to Part I above. You should carefully consider the risks described below, in addition to the otherinformation in this Annual Report on Form 10-K, before making an investment decision. The risks and uncertainties described below are not the only oneswe face. Additional risks not presently known to us or other factors not perceived by us to present material risks to our business at this time also may impairour business operations.Risks Related to Our Products and ServicesWe are primarily dependent on revenues from our principal products and services.We currently derive substantially all of our revenue from sales of Makena, services related to the collection, processing and storage of umbilical cordblood stem cell and cord tissue units (the “CBR Services”) and Feraheme. Although we may continue to introduce additional products or services forcommercialization to our portfolio, we may be substantially dependent on sales of our current products and services for many years. Our financial conditionwill be materially adversely affected, we may have to restructure our current operations, and our business prospects will be limited if we experience anysignificant negative developments relating to our products or services, including the following:•Actual or perceived safety or efficacy issues;•Restrictions on current or future labels or other regulatory actions;•The introduction or greater acceptance of competing products or services, including generic products, products that may be prescribed off-label (i.e.,outside of indications approved by the U.S. Food and Drug Administration (the “FDA”)), products made by compounding pharmacies orcryopreservation services offered by other cord blood banks;•Change in consumers’ perception of the value of the cryopreservation of cord blood and/or cord tissue;•Constraints on product or service pricing or the impact of price increases;•The success of our commercialization efforts, such as our ability to retain or grow our current customer base, realize the benefit of our current orphandrug exclusivity and successfully implement our next generation development programs; and•Changes in reimbursement policies or adverse regulatory or legislative developments.If our products face any safety or efficacy issues, including drug interaction problems, under the Federal Food, Drug and Cosmetic Act (the “FDC Act”),the FDA has broad authority to force us to take any number of actions, including, but not limited to the following:•Requiring us to conduct post-approval clinical studies to assess known risks or new signals of serious risks, or to evaluate unexpected serious risks;•Mandating changes to a product’s label;•Requiring us to implement a risk evaluation and mitigation strategy (“REMS”) where necessary to assure safe use of the drug; or•Removing an already approved product from the market.Further, prior to our acquisition of Cord Blood Registry (“CBR”), we had no experience providing services or maintaining a service-based businessmodel. The success of our expanded enterprise will be dependent on our ability to manage and promote the CBR Services, which is subject to a number ofrisks and uncertainties, including our ability to maintain compliance with all applicable FDA or accrediting organization regulations, including thoseregarding cord blood and cord tissue collection, processing and storage services, the application to and implications for CBR’s operations of certain laws,regulations and industry guidelines relating to healthcare or stem cell preservation companies, new and evolving regulatory32Table of Contentsrestrictions on cord blood and cord tissue banking, and those other risks described below under Risks Related to CBR. Similarly, we have minimalexperience with development-stage, investigational products such as RekyndaTM (bremelanotide), and the successful development and commercialization ofReykynda is dependent upon our ability to oversee the successful and timely completion of clinical development programs and to obtain regulatory approvalfor Rekynda in North America, as well as our ability to raise awareness and understanding of hypoactive sexual desire disorder (“HSDD”), a type of femalesexual dysfunction (“FSD”), and the potential benefits of Rekynda in treating HSDD.The commercial success of our products and services depends upon the level of market adoption and continued use by and the support of physicians,hospitals, patients, and/or healthcare payers, including government payers, health maintenance organizations (“HMOs”), consumers, managed careorganizations and specialty pharmacies. Our products and services might not be adopted if perceived to be no safer, less safe, no more effective, less effective,no more convenient, less convenient, or less valuable than currently available products or services. In addition, the pricing and/or reimbursement rates andterms of our products may not be viewed as advantageous to potential prescribers, and payers as compared to the pricing and/or reimbursement rates andterms of other available products, including, generic products and in the case of Makena, compounded products. If our products or services do not achieve ormaintain an adequate level of market adoption for any reason, our profitability and our future business prospects will be adversely impacted.Competition in the pharmaceutical and biopharmaceutical industries, including from companies marketing generic products, is intense. In addition,competition in the cord blood stem cell and cord tissue banking processing and storage business is increasing. If we fail to compete effectively, ourbusiness and market position will suffer.The pharmaceutical and cord blood banking industries are intensely competitive and subject to rapid technological change. For Makena, most of ourcompetition comes from pharmacies that compound a non-FDA approved version of Makena, which is sold at a much lower list price than Makena. Many ofour competitors for Feraheme are large, well-known pharmaceutical companies and may benefit from significantly greater financial, sales and marketingcapabilities, greater technological or competitive advantages, and other resources. For the CBR Services, competition in the private cord blood and cordtissue banking business is already intense and is likely to increase as the number of competitors continues to grow, given the relatively low barriers to entry.We also expect to face competition for Rekynda, including from an FDA-approved product for treatment of HSDD, flibanserin, which is sold under the tradename Addyi®, and started marketing in October 2015. Our existing or potential competitors may develop products or services that are more widely acceptedthan ours and may receive patent protection that dominates, blocks, makes obsolete or adversely affects our product development or business. Theintroduction by our competitors of alternatives to our products or services that would be, or are perceived to be, more efficacious, safer, less expensive, easierto administer, available for a broader patient population, capable of providing more favorable insurance coverage, reimbursement or terms, or less valuablethan currently available products or services could reduce our revenues and the value of our product development and commercialization efforts. For moreinformation on specific competition risks for our products or services, please see Risk Factors “Our ability to successfully commercialize Makena isdependent upon a number of factors, including maintaining the benefits of Makena’s orphan drug exclusivity and the length of time before competitorsbegin selling generic versions of Makena”; “Market acceptance of Feraheme may suffer as a result of the widespread use of competing iron replacementtherapy products, including Injectafer®, and as a result of the approval of generic drug products in the near-term, which would have a material adverseeffect on our operations and our profitability”; “Competition in the umbilical cord blood stem cell and cord tissue banking business is significant and maybe increasing. If we are unable to maintain our position as the market leader, our CBR business may decline and our results of operations could suffer”;“Competing products and technologies, minimal third party reimbursement opportunities and an uncertain market may limit Rekynda revenues even ifRekynda is approved by the FDA for commercialization” and “Intrarosa will face substantial competition and is expected to have minimal third partyreimbursement opportunities which may limit its market potential.”The success of our products depends on our ability to maintain the proprietary nature of our technology.We rely on a combination of patents, trademarks and trade secrets in the conduct of our business. The patent positions of pharmaceutical andbiopharmaceutical firms are generally uncertain and involve complex legal and factual questions. We may not be successful or timely in obtaining anypatents for which we submit applications. The breadth of the claims obtained in our patents may not provide sufficient protection for our technology. Thedegree of protection afforded by patents for proprietary or licensed technologies or for future discoveries may not be adequate to preserve our ability toprotect or commercially exploit those technologies or discoveries. The issuance of a patent is not conclusive as to its scope, validity or enforceability, andour owned or licensed patents may be challenged in the courts or patent offices in the U.S. or abroad. Such challenges may result in patent claims beingnarrowed, invalidated or held unenforceable, which could limit our ability to stop or prevent us from stopping others from using or commercializing similaror identical technologies and products, or limit the duration of the patent protection of our technology and products. As a result, our owned and licensedpatent portfolio may not provide us with33Table of Contentssufficient rights to exclude others from developing and commercializing products similar or identical to ours. As a result, the patents issued or licensed to usmay provide us with little or no competitive advantage.In addition, claims of infringement or violation of the proprietary rights of others may be asserted against us or intellectual property rights might besubject to liens or other encumbrances. If we are required to defend against such claims or to protect our own proprietary rights against others, it could resultin substantial financial and business costs, including the distraction of our management. An adverse ruling in any litigation or administrative proceedingcould put one or more of our patents at risk of being invalidated or interpreted narrowly, result in monetary damages, injunctive relief or otherwise harm ourcompetitive position, including by limiting our marketing and selling activities, increasing the risk for generic competition, limiting our development andcommercialization activities or requiring us to obtain licenses to use the relevant technology (which licenses may not be available on commerciallyreasonable terms, if at all).One of our U.S. Feraheme patents is subject to a patent term extension under U.S. patent law and FDA regulations and will expire in June 2023. Our otherU.S. patents relating to Feraheme expire in 2020. These and any other patents issued to or acquired by us may be contested or invalidated. There has beensubstantial litigation and other proceedings regarding patent and other intellectual property rights in the pharmaceutical and biotechnology industries. Wemay become a party to intellectual property litigation and other proceedings, including interference and reexamination proceedings declared by the UnitedStates Patent and Trademark Office (the “USPTO”). For example, on February 5, 2016, we received a Paragraph IV certification notice letter regarding anAbbreviated New Drug Application (“ANDA”) submitted to the FDA by Sandoz Inc. (“Sandoz”) requesting approval to engage in commercial manufacture,use and sale of a generic version of Feraheme (ferumoxytol), and we could therefore face generic competition in the near-term. In its notice letter, Sandozclaims that our ferumoxytol patents are invalid, unenforceable and/or not infringed by Sandoz’s manufacture, use, sale or offer for sale of the generic version.In March 2016, we initiated a patent infringement suit alleging that Sandoz’ ANDA filing itself constituted an act of infringement and that if it is approved,the manufacture, use, offer for sale, sale or importation of Sandoz’ ferumoxytol products would infringe our patents. By the filing of the complaint, the FDA isprohibited from granting approval of Sandoz’ application until the earliest of 30 months from the date of receipt of the notice of certification by the patentowner, the conclusion of litigation in the generic’s favor, or expiration of the patent(s). Such litigation is often time-consuming and costly, and may result ingeneric competition if such patents are not upheld or if the generic competitor is found not to infringe such patents. Further, Sandoz’s application couldencourage other generic entrants seeking a path to approval of a generic ferumoxytol to file an ANDA. Even if we are successful, such litigation will beexpensive and will consume considerable time and other resources, which could materially and adversely impact business.There are no issued patents covering Makena and thus the successful commercialization of Makena is significantly reliant on our ability to takeadvantage of its orphan drug exclusivity, which risks are described in the Risk Factor - Risks Related to Makena - “Our ability to successfully commercializeMakena is dependent upon a number of factors, including maintaining the benefits of Makena’s orphan drug exclusivity and the length of time beforecompetitors begin selling generic versions of Makena.”On January 8, 2017, we entered into a license agreement (the “Palatin License Agreement”) with Palatin Technologies (“Palatin”) under which weacquired the North American rights to develop and market Rekynda. Under the Palatin License Agreement, we have rights to a number of issued and pendingU.S. and foreign patents related to bremelanotide that are owned by Palatin. Certain of Palatin's U.S. patents include claims directed to the bremelanotidedrug composition and methods of use thereof with terms expiring in 2020, and another patent includes claims covering methods of treating FSD usingsubcutaneous administration of compositions that include bremelanotide, with a term expiring in 2033, any one of which may be subject to patent termextension pursuant to the Hatch-Waxman Act. In addition, on February 13, 2017, we entered into a license agreement (the “Endoceutics License Agreement”)with Endoceutics, Inc. (“Endoceutics”) under which we will acquire the U.S. rights to develop and market Intrarosa. Under the terms of the EndoceuticsLicense Agreement, at closing we will receive the rights to Endoceutics’ three U.S. patents related to Intrarosa, including drug-product patent claims with aterm which expires in 2031 and two additional patents, including method of use claims and pharmaceutical dosage form claims with terms which expire in2028. Although none of the issued patents under the Rekynda License Agreement and the Endoceutics License Agreement are currently subject to a patentreexamination or review or infringement proceeding, we cannot guarantee that they will not be subject to reexamination or review by the USPTO or aninfringement suit in the future. If any present or future patents relied on for the development or commercialization of Rekynda or Intrarosa are narrowed,invalidated or held unenforceable, this could have an adverse effect on our business and financial results. In addition, we believe that each of the patentslicensed under the Rekynda License Agreement and the Endoceutics License Agreement was rightfully issued and the respective portfolios give us sufficientfreedom to operate; however, if a third-party claims that the development, manufacture or commercialization of Rekynda or Intrarosa infringes its patents, ourbusiness and financial results could be harmed.34Table of ContentsWe also rely upon unpatented trade secrets and improvements, unpatented know-how and continuing technological innovation to develop and maintainour competitive position, which we seek to protect, in part, by confidentiality agreements with our corporate licensees, collaborators, contract manufacturers,employees and consultants. These agreements, however, may be breached. We may not have adequate remedies for any such breaches, and our trade secretsmight otherwise become known or might be independently discovered by our competitors. In addition, we cannot be certain that others will notindependently develop substantially equivalent or superseding proprietary technology, or that an equivalent product or service will not be marketed incompetition with our products, thereby substantially reducing the value of our proprietary rights.We may not be able to further expand our portfolio by entering into additional business development transactions, such as in-licensing arrangements,acquisitions, or collaborations or, if such arrangements are entered into, we may not realize the anticipated benefits and they could disrupt our business,decrease our profitability, result in dilution to our stockholders or cause us to incur significant additional debt or expense.As part of our business strategy to expand our portfolio, we are seeking to in-license or acquire additional pharmaceutical products or companies thatleverage our corporate infrastructure and commercial expertise, such as with the Rekynda License Agreement and Endoceutics License Agreement. There arelimited opportunities available that align with our business strategy and there can be no assurance that we will be able to identify or complete any additionaltransactions in a timely manner, on a cost-effective basis, or at all.Further, the valuation methods that we use for any acquired or licensed product or business require significant judgment and assumptions. Actual resultsand performance of the products or businesses that we may acquire, including anticipated synergies, economies of scale and other financial benefits, coulddiffer significantly from our original assumptions, especially during the periods immediately following the closing of the transaction. For example, if thetiming of FDA approval of Rekynda, the market for Rekynda or the cost of goods is different from what we predicted in our model, the anticipated financialbenefits of Rekynda could vary from the financial model. In addition, acquisitions may cause significant changes to our current organization and operations,may subject us to more rigid or constraining regulations or government oversight and may have negative tax and accounting consequences. These resultscould have a negative impact on our financial position or results of operations and result in significant charges in future periods.In addition, proposing, negotiating and implementing collaborations, in-licensing arrangements or acquisition agreements is a lengthy, complex, time-consuming and expensive process. Other companies, including those with substantially greater financial, marketing and sales resources, may compete with usfor these arrangements, and we may not be able to enter into such arrangements on acceptable terms or at all. Further, any such strategic transactions by uscould result in large and immediate write-offs or the incurrence of additional debt and contingent liabilities, each of which may contain restrictive covenantsthat could adversely impact or limit our ability to grow our business, enter into new agreements, and adversely affect our operating results. Management of alicense arrangement, collaboration, or other strategic arrangement and/or integration of an acquired asset or company may also disrupt our ongoing businessand require management resources that otherwise would be available for ongoing development of our existing enterprise.In addition, our cash, cash equivalents and investments may not be sufficient to finance any additional strategic transactions, and we may choose to issueshares of our common or preferred stock as consideration, which would result in dilution to our stockholders. Alternatively, it may be necessary for us to raiseadditional funds through public or private financings, and such additional funds may not be available on terms that are favorable to us, if at all, and ourstockholders may experience significant dilution. For example, our term loan facility, which provided us with $350.0 million to finance a portion our CBRacquisition (the “2015 Term Loan Facility”) contains restrictions on our ability to acquire additional pharmaceutical products and companies, toconsummate mergers, to enter into exclusive licensing arrangements, to incur or guarantee additional indebtedness, to create liens, to transfer or sell assets, topay dividends and to engage in businesses other than our current businesses. The 2015 Term Loan Facility will also require us to use a portion of our freecash flow to repay indebtedness under the facility on an annual basis. These provisions, and similar restrictions contained in the indenture governing our2023 Senior Notes, described below, may limit our ability to pursue attractive business development opportunities. If we are unable to successfully obtainrights to suitable products or if any acquisition or in-license arrangement we make is not successful, our business, financial condition and prospects forgrowth could suffer.Further, even if we do acquire or license additional products or businesses, the integration of the operations of such acquired products or businessesrequires significant efforts, including the coordination of information technologies, sales and marketing, operations, manufacturing, safety andpharmacovigilance, medical, finance and business systems and processes. These efforts result in additional expenses and involve significant amounts ofmanagement’s time. For example, with the acquisition of CBR in August 2015, our business is significantly larger and more complex than it had been prior tothe acquisition. Similarly, with the Rekynda License, we are adding a development stage product to our portfolio and will therefore35Table of Contentsneed to enhance our research and development expertise for product candidates. Our expanded portfolio may necessitate an expanded commercial team,which will take a considerable amount of time and effort to hire and train. Our future success will significantly depend upon our ability to manage ourexpanded enterprise, including multiple locations and various-staged products, which will pose substantial challenges for management, including challengesrelated to the management and monitoring of new operations and associated increased costs and complexity.In addition, under the Rekynda License, we will rely on Palatin, and we may have to rely on the other parties with whom we may enter into futureagreements, to perform or oversee certain functions, such as pharmacovigilance, research and development, regulatory or the manufacture of the product welicense from them, and any failure of such party to perform these functions for any reason, including ceasing doing business, could have a material effect onour ability to commercialize the product. Furthermore, we are dependent upon the contributions of Palatin for the development and regulatory activitiesnecessary to submit an NDA for Rekynda for the treatment of HSDD and Palatin has limited experience and relies on third parties for conducting a substantialportion of such development and regulatory activities. If we cannot successfully integrate businesses or products we may acquire or in-license into our company, we may experience material negativeconsequences to our business, financial condition or results of operations. For example, different skills and training are required for the promotion of varioustherapeutic products, especially as compared to a service business, such as CBR. Our revenues and profitability could suffer if we do not successfully expandour sales and commercial expertise into new areas, such as HSDD with respect to Rekynda, or if our integrated sales force focusing on both the CBR Servicesand Makena is unable to successfully promote a portfolio of products and services, especially since they may have limited experience with promoting boththerapeutics and a service business. We cannot be certain that, following any such acquisitions or in-licenses we will achieve the expected synergies andother benefits that justify the purchase price of such transaction.We are completely dependent on third parties to manufacture our commercial products and any difficulties, disruptions, delays or unexpected costs, or theneed to find alternative sources, could adversely affect our profitability and future business prospects.We do not own or operate, and currently do not plan to own or operate, facilities for the manufacture of our products or for any commercial products orproduct candidates we may acquire or in-license. We rely solely on third-party contract manufacturers and our licensors (who, in turn, may also rely on third-party contract manufacturers) to manufacture our products for our commercial and clinical use and for certain materials required to support our CBR Services.We or our licensors may not be able to enter into agreements with manufacturers or second source manufacturers whose facilities and procedures comply withcurrent good manufacturing practices (“cGMP”) regulations and other regulatory requirements on a timely basis and with terms that are favorable to us, if atall. For example, Rekynda is a synthetic peptide and while the production process involves well-established technology, there are few manufacturers capableof scaling up to commercial quantities under cGMP at acceptable costs. Further, we do not have commercial supply agreements to manufacture the drugsubstance and auto-injector sub-assemblies for Rekynda and may not be able to enter into such agreements on acceptable terms, including the cost of goods.Our ability to have our products manufactured in sufficient quantities and at acceptable costs to meet our commercial demand and clinical developmentneeds is dependent on the uninterrupted and efficient operation of our third-party contract manufacturers’ and licensors’ manufacturing facilities. Anydifficulties, disruptions or delays in the manufacturing process could result in product defects or shipment delays, suspension of manufacturing of, sale of orclinical development for the product, recall or withdrawal of product previously shipped for commercial or clinical purposes, inventory write-offs or theinability to meet commercial or clinical demand in a timely and cost-effective manner. Furthermore, our current third-party product manufacturers andlicensors do not manufacture for us exclusively and may exhaust some or all of their resources meeting the demand of other parties. In addition, securingadditional third-party contract manufacturers will require significant time for validating the necessary manufacturing processes, gaining regulatory approval,and for having the appropriate oversight and may increase the risk of certain problems, including cost overruns, process reproducibility, stability issues, theinability to deliver required quantities of product that conform to specifications in a timely manner, or the inability to manufacture our products or thepropriety materials for our services in accordance with cGMP.Further, we, our licensors and our respective third-party product manufacturers currently purchase certain raw and other materials used to manufacture ourproducts from third-party suppliers. At present, we do not have long-term supply contracts with most of these third parties. These third-party suppliers maycease to produce the raw or other materials used in our products or otherwise fail to supply these materials to us, our licensors or our respective third-partymanufacturers, or fail to supply sufficient quantities of these materials to us, our licensors or our respective third-party manufacturers in a timely manner for anumber of reasons, including but not limited to the following:36Table of Contents•Adverse financial developments at or affecting the supplier;•Unexpected demand for or shortage of raw or other materials;•Regulatory requirements or action;•An inability to provide timely scheduling and/or sufficient capacity;•Manufacturing difficulties;•Changes to the specifications of the raw materials such that they no longer meet our standards;•Lack of sufficient quantities or profit on the production of raw materials to interest suppliers;•Labor disputes or shortages; or•Import or export problems.Any other interruption in our or a licensor’s third-party supply chain could adversely affect our ability to satisfy commercial demand and our clinicaldevelopment needs for our products. For example, although we believe we have sufficient Makena drug substance in inventory to meet demand until we canqualify a new drug substance manufacturer, we do not currently have a manufacturer for the production of Makena drug substance. The qualification of analternative source may require repeated testing of the new materials and generate greater expenses to us if materials that we test do not perform in anacceptable manner. In addition, we, our licensors or our respective third-party manufacturers sometimes obtain raw or other materials from one vendor only,even where multiple sources are available, to maintain quality control and enhance working relationships with suppliers, which could make us susceptible toprice inflation by the sole supplier, thereby increasing our production costs. As a result of the high-quality standards imposed on our raw or other materials,we, our licensors or our respective third-party manufacturers may not be able to obtain such materials of the quality required to manufacture our productsfrom an alternative source on commercially reasonable terms, or in a timely manner, if at all.We also rely upon third-party contractors to assist in supporting the CBR Services, including to supply proprietary materials, some of which are solesource providers who we believe may have financial difficulty and be unable to fulfill their contractual obligations to us. Although we believe we havesufficient contingency plans in place, if current suppliers need to be changed or are disrupted, especially our sole source providers, we could face operationaldelays and lost revenue, as well as the need to reconfigure machinery and/or systems, which could be costly.If, because of the factors discussed above, we are unable to have our products manufactured on a timely or sufficient basis, or if our supply chainattendant to the CBR Services is disrupted, we may not be able to meet commercial demand or our clinical development needs for our products, may not beable to manufacture our products in a cost-effective manner or may be unable to adequately provide the CBR Services. As a result, we may lose sales, fail togenerate projected revenues or suffer regulatory setbacks, any of which could have an adverse impact on our profitability and future business prospects.We must work effectively and collaboratively with our licensors to develop, market and/or sell certain products in our portfolio. We have limited experience commercializing licensed products, and the addition of Rekynda to our product portfolio means that our future revenues aremore dependent upon our ability to work effectively and collaboratively with our licensors to develop, market and/or sell the licensed products in ourportfolio, including to obtain or maintain regulatory approval. Our arrangements with licensors will be critical to successfully bringing our licensed productsto market and successfully commercializing them. We rely on our licensors in various respects, including to undertake research and development programsand conduct clinical trials for our licensed products, manage or assist with the regulatory filings and approval process and maintenance and/or to assist withour commercialization efforts. We do not control our licensors, some of whom may be inexperienced, have a limited operating history, face financial andbusiness hardships (including solvency issues), have limited operations or financial or other resources or have limited or no experience withcommercialization activities; therefore, we cannot ensure that these third parties will adequately and timely perform all of their obligations to us. Forexample, under the Palatin License Agreement, Palatin is responsible for all remaining development and manufacturing work to support the NDA submissionfor Rekynda. If they fail to complete the remaining studies successfully, or at all, it could delay, adversely affect or prevent the FDA approval of Rekynda. Wecannot guarantee the satisfactory performance of any of our licensors and if any of37Table of Contentsour licensors breach or terminate their agreements with us, we may not be able to successfully commercialize the licensed product which could materially andadversely affect our business, financial condition, cash flows and results of operations.Further, even if contractual safeguards are in place in our licensing arrangements, our licensors may use their own or other technology to develop analternative product and withdraw their support of the licensed product, or to compete with the licensed product. Our licensing arrangements could also limitour activities, including our ability to compete with our licensors in certain geographic or therapeutic areas. Disputes may arise between us and a licensor andmay involve the ownership of technology developed under a license or other issues arising out of collaborative agreements. Such disputes could delay therelated program or result in expensive arbitration or litigation, which may not be resolved in our favor.If we fail to comply with our obligations under our license agreements, we could lose rights to the licensed products. Our license agreements impose various milestone payment, royalty, insurance and other obligations on us. If we fail to comply with our obligations,Palatin, Endoceutics, if closed, or Abeona Therapeutics, Inc. may have the right to terminate the license agreement, in which event we would not be able tocontinue developing or commercializing the licensed products. Termination of the license agreement or reduction or elimination of our licensed rights mayresult in our having to negotiate new or reinstated licenses with less favorable terms, and, if we lose rights to the licensed products it could materially andadversely affect our business.We rely on third parties in the conduct of our business, including our clinical trials and product distribution, and if they fail to fulfill their obligations, ourcommercialization and development plans may be adversely affected.We rely on and intend to continue to rely on third parties, including licensors, clinical research organizations (“CROs”), healthcare providers, third-partylogistics providers, packaging, storage and labeling providers, wholesale distributors and certain other important vendors and consultants in the conduct ofour business. For example, we, and in the case of Rekynda, Palatin, have contracted with, and plan to continue to contract with, certain CROs to provideclinical trial services for the Phase 3 clinical trial evaluating Feraheme in adults with IDA, the definitive PK study for the Makena auto-injector and theremaining drug interaction and other ancillary studies to support the submission of an NDA for Rekynda for the treatment of HSDD, including site selection,enrollment, monitoring, data management and other services, in connection with the conduct of our clinical trials and the preparation and filing of ourregulatory applications. In addition, third-parties who perform tests on behalf of CBR are responsible for performing such testing in compliance with the FDAregulations that govern those functions. CBR is dependent upon the actions of these third parties with whom CBR contracts.Although we depend heavily on these parties, we do not control them and, therefore, we cannot ensure that these third parties will adequately and timelyperform all of their obligations to us. If our third-party service providers cannot adequately fulfill their obligations to us or our licensors in a timely andsatisfactory manner, if the quality and accuracy of our clinical trial data or our regulatory submissions are compromised due to poor quality or failure toadhere to our protocols or regulatory requirements, or if such third parties otherwise fail to adequately discharge their responsibilities or meet deadlines, ourcurrent and future development plans and regulatory submissions, or our commercialization efforts in current indications and with the CBR Services, may bedelayed, terminated, limited or subject us to additional expense or regulatory action, which would adversely impact our ability to generate revenues.Further, in most cases, we do not currently have back-up suppliers or service providers to perform these tasks. If any of these third parties experiencesignificant difficulties in their respective processes, fail to maintain compliance with applicable legal or regulatory requirements, fail to meet expecteddeadlines or otherwise do not carry out their contractual duties to us or our licensors, or encounter physical or natural damages at their facilities, our ability todeliver our products to meet commercial demand could be significantly impaired. The loss of any third-party provider, especially if compounded by a delayor inability to secure an alternate distribution source for end-users in a timely manner, could cause the distribution of our products to be delayed orinterrupted, which would have an adverse effect on our business, financial condition and results of operations.Additionally, we have limited experience independently commercializing multiple pharmaceutical products and services and collaborating with partnersto commercialize multiple licensed products, including managing and maintaining a supply chain and distribution network for multiple products and theCBR Services, and we are placing substantial reliance on licensors and other third parties to perform this expanded network of supply chain and distributionservices for us. Any failure on our part to effectively execute on our portfolio-wide commercial plans or to effectively manage our supply chain anddistribution networks would have an adverse impact on our business.38Table of ContentsWe depend, to a significant degree, on the availability and extent of reimbursement from third-party payers for the use of our products, and a reduction inthe availability or extent of reimbursement could adversely affect our revenues and results of operations.Our ability to successfully commercialize our products is dependent, in significant part, on the availability and extent of reimbursement to end-usersfrom third-party payers for the use of our products, including governmental payers, HMOs, managed care organizations and private health insurers.Reimbursement by third-party payers depends on a number of factors, including the third-party’s determination that the product is competitively priced, safeand effective, appropriate for the specific patient, and cost-effective. Third-party payers are increasingly challenging the prices charged for pharmaceuticalproducts and have instituted and continue to institute cost containment measures to control or significantly influence the purchase of pharmaceuticalproducts, such as through the use of prior authorizations and step therapy. Certain specialty pharmaceuticals, pharmaceutical companies and pricingstrategies have been the subject of increased scrutiny and criticism by politicians and the media, which could also increase pricing pressure throughout theindustry or lead to new legislation that may limit our pricing flexibility. If these third-party payers do not provide coverage and reimbursement for ourproducts or provide an insufficient level of coverage and reimbursement, physicians and other healthcare providers may choose to use alternative products,which would have an adverse effect on our ability to generate revenues.In addition, the U.S. government continues to propose and pass legislation designed to reduce the cost of healthcare for patients. The Patient Protectionand Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the “Affordable Care Act”) includes certaincost containment measures including an increase to the minimum rebates for products covered by Medicaid programs, the extension of such rebates to drugsdispensed to Medicaid beneficiaries enrolled in Medicaid managed care organizations and the expansion of the 340B Drug pricing Program under the PublicHealth Services Act. In addition, federal budgetary concerns and the new presidential administration could result in the implementation of significant federalspending cuts or regulatory changes, including cuts in Medicare and other health related spending in the near-term or changes to the Affordable Care Act.The magnitude of the impact of these laws and developments on our business is uncertain. Further, in recent years, some states have also passed legislation tocontrol the prices of drugs as well as begun a move toward managed care to relieve some of their Medicaid cost burden. Given that approximately half ofMakena patients are Medicaid beneficiaries, the impact of future legislative changes may have a significant and adverse impact on Makena sales. Further,while Medicare is the predominant payer for Feraheme, Medicare payment policy, in time, can also influence pricing and reimbursement in the non-Medicaremarkets, as private third-party payers and state Medicaid plans frequently adopt Medicare principles in setting reimbursement methodologies. These and anyfuture changes in government regulation or private third-party payers’ reimbursement policies may reduce the extent of reimbursement for our products andadversely affect our future operating results.Additionally, a key focus of the recent presidential election was “repeal and replacement” of the Affordable Care Act. The extent, timing and details of thechanges are not known, but the federally funded health care landscape could face significant changes during the current presidential administration,including in the near-term, and could impact state and local healthcare programs, including Medicaid and Medicare, which could also have a negativeimpact on our future operating results. For more information on specific reimbursement risks related to Rekynda and Intrarosa, please see Risk Factors“Competing products and technologies, minimal third party reimbursement opportunities and an uncertain market may limit Rekynda revenues even ifRekynda is approved by the FDA for commercialization” and “Intrarosa will face substantial competition and is expected to have minimal third partyreimbursement opportunities which may limit its market potential.”Risks Related to MakenaWe may not be successful in developing, gaining regulatory approval for and commercializing any products from Makena’s next-generation developmentprogram, which could have a negative impact on our business.We are seeking to expand Makena’s drug delivery technologies and formulations as part of our multi-pronged next-generation development program todeliver new and improved versions of Makena. The next-generation development program for Makena is an important strategy for our business, especially inlight of the expiration of Makena’s orphan drug exclusivity in February 2018, and the possibility that generic versions of Makena could enter the marketfollowing such loss of exclusivity. In October 2016 we initiated a definitive pharmacokinetic (“PK”) study to demonstrate bioequivalence of a subcutaneous auto-injector product forMakena (the “Makena auto-injector”) to the current intramuscular injection form of Makena. In accordance with FDA guidance, we utilize the term‘bioequivalence’ in the context of a supplemental new drug application (“sNDA”) to mean “relative bioavailability,” and not the strict bioequivalence that istypically required for generic ANDA submissions. We expect to submit an sNDA for the Makena auto-injector in the second quarter of 2017. We can make noassurances that the FDA will determine that the study demonstrated adequate comparability on any or all PK parameters to39Table of Contentspermit approval without clinical data. For example, Makena administered subcutaneously demonstrated bioequivalence to the IM injection on area under thecurve (“AUC”) with the 90% confidence interval for the ratio of AUC (105.17 to 124.39) falling within the 80% to 125% range, which the FDA uses to definebioequivalence. However, the mean maximum or peak plasma concentration (“Cmax”) for Makena administered subcutaneously was higher than for the IMwith the 90% confidence interval for the ratio of Cmax (96.6% to 138.7%) falling outside of the bioequivalence range of 80% to 125%. We can make noassurances that the FDA will accept our rationale that these potential differences have no clinical impact on safety or efficacy, and the FDA may request thatwe conduct one or more additional clinical studies in order to gain approval. No serious adverse events were reported in the PK study and the drug was generally well tolerated, although there was a higher reporting rate of injectionsite related adverse events (e.g. transient burning/stinging sensation), in the subcutaneous injection arm of the study. In October 2016, we also initiated acomparative pain study intended to capture certain measures to support clinical superiority of the subcutaneous Makena auto-injector over the existingintramuscular injection to support an intended submission for new orphan drug exclusivity as part of our sNDA for the Makena auto-injector. Similarobservations reported in the PK study were also reported in the subcutaneous arm of the pain study, and we therefore elected to discontinue the pain study.Based on the adverse event information, the FDA may request additional studies or not approve the sNDA for the Makena auto-injector.We will not be seeking orphan exclusivity as part of the sNDA filing for the Makena auto-injector. Based on our current timelines and assumptions, weanticipate submitting an sNDA for the Makena auto-injector in the second quarter of 2017 and expect the review period to be six months. If we experienceany delays in this expected timeline, our ability to receive approval for the Makena auto-injector before the expiration of Makena’s orphan drug exclusivityperiod in February 2018 may be delayed, which could permit generics to enter the market prior to commercialization of the Makena auto-injector and couldhave an adverse impact on our Makena sales. Further, we are currently in discussions with third-party manufacturers to secure commercial supply of certain components. We may not be able to reachagreement on acceptable terms or encounter difficulties including problems involving scale-up, yields, quality control and assurance, product reliability, andmanufacturing costs, any of which could result in significant delays in production. Even if we succeed in gaining FDA approval of the Makena auto-injector, we will likely be competing against generics of the current formulationof Makena after February 2018. These generics could be less expensive than our potential new version of Makena. As a result of the lower cost for thegenerics and/or a lack of perceived benefit of the Makena auto-injector, such as lack of improvement in safety or efficacy, or perceptions about the painassociated with the Makena auto-injector, physicians may choose to prescribe the generic, which could cause sales of Makena to decline. In addition,insurance companies and government payors, such as state Medicaid agencies, who currently provide coverage for Makena may make it more difficult forphysicians to prescribe our new version of Makena by charging higher copays, implementing prior authorizations, or not reimbursing for our new version atall. Furthermore, other companies are or may be working on developing additional formulations or routes of administration for products that reduce orprevent preterm birth. For example, an oral hydroxyprogesterone caproate product is currently in development and its developer has stated that it intends todiscuss a Phase 3 development plan with the FDA. If such products are approved, they could be, or be perceived to be, more efficacious, safer, less expensive,easier to administer, available for a broader patient population, or provide more favorable insurance coverage or reimbursement, and could reduce ourrevenues and the value of our product development efforts. We have limited experience in the development of an auto-injector for Makena and in developing and implementing next-generation developmentprograms. If we are not successful in implementing Makena’s next-generation development programs, if the subcutaneous Makena auto-injector is notapproved before the expiration of Makena’s orphan drug exclusivity in February 2018 or at all, our business may suffer.Our ability to continue to successfully commercialize Makena is dependent upon a number of factors, including maintaining the benefits of Makena’sorphan drug exclusivity and the length of time before competitors begin selling generic versions of Makena.Makena has been granted orphan drug exclusivity in the U.S. until February 3, 2018 for reducing the risk of preterm birth in women pregnant with asingle baby who have a history of singleton spontaneous preterm birth. Our ability to successfully commercialize Makena is dependent upon maintainingMakena’s orphan drug exclusivity and our ability to differentiate Makena from other treatment options even after competitors enter the market once ourorphan drug exclusivity expires. Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a drug intended to treat a rare diseaseor condition, defined, in part, as a patient population of fewer than 200,000. The company that first obtains FDA approval for a designated orphan drug forthe specified rare disease or condition receives orphan drug marketing exclusivity for that drug for a40Table of Contentsperiod of seven years. This orphan drug exclusivity prevents the FDA from approving another application for the same drug for the same orphan indicationduring the exclusivity period, except in very limited circumstances. A designated orphan drug may not receive orphan drug exclusivity for an approvedindication if that indication is for the treatment of a condition broader than that for which it received orphan designation. In addition, Makena’s orphan drugexclusivity may be lost before February 2018 if the FDA determines that our request for orphan designation was materially defective or if we are unable toassure sufficient quantity of Makena to meet the needs of patients. Furthermore, the FDA may approve a subsequent drug that is otherwise the same asMakena for the same orphan indication during the orphan drug exclusivity period if the sponsor of the subsequent drug can demonstrate that the drug isclinically superior to Makena. Clinical superiority may be demonstrated by showing that a drug is more effective in a clinical trial, safer in a substantialportion of the target population, or provides a major contribution to patient care relative to the currently approved drug.Additionally, in 1956, the FDA approved the drug Delalutin, which contained the same active ingredient as Makena. Delalutin was approved forconditions other than reducing the risk of preterm birth and was marketed by Bristol-Myers Squibb (“BMS”). BMS stopped marketing and manufacturingDelalutin and it was withdrawn from the market in 1999. In 2010, the FDA determined that Delalutin was not withdrawn from sale for reasons of safety orefficacy. As such, generic drug applications may reference the withdrawn Delalutin New Drug Application (“NDA”). In August 2015, the FDA approved anANDA for hydroxyprogesterone caproate (“HPC”), which was submitted by McGuff Pharmaceuticals, Inc. (“McGuff”) in 2009, and which was subsequentlytransferred to Aspen Global Incorporated (“Aspen”) in 2015. The ANDA label approved by the FDA for the McGuff product is for the same patient populationand indications as Delalutin (i.e., it is approved only for use in non-pregnant women with indications such as uterine cancer or abnormal uterine bleeding). InJune 2016, ANI Pharmaceuticals, Inc. (“ANI”), Aspen’s exclusive distributor, launched HPC in 5 mL vials in the U.S. Although Aspen’s generic version ofDelalutin is not indicated for pregnant women and is not therapeutically equivalent to Makena, doctors may elect to prescribe this product off-labelfor Makena’s orphan-protected indication, which could have an adverse impact on our business and results of operations. In addition, the generic Delalutinproduct is priced at a discount to Makena, and as a result, commercial or government insurers could prefer or encourage the use of the generic Delalutinproduct for patients who are indicated for Makena.Moreover, if one or more ANDA applicants were to receive approval to sell a generic or follow-on version of Makena for the orphan indication, thosegeneric products could potentially be approved as early as February 3, 2018 (the date on which Makena’s orphan exclusivity ends) and we would becomesubject to increased competition at that time.Further, our ability to successfully commercialize Makena depends on a number of additional factors, including but not limited to the following:•The possibility that the benefit of the remaining exclusivity period resulting from the designation of Makena as an orphan drug may not be realizedas a result of on-label or off-label use by physicians of current or future FDA-approved drugs in the market where Makena competes;•The level of enforcement by the FDA to ensure that compounded copies of commercially available FDA-approved products manufactured bycompounding pharmacies, including compounded copies of Makena that may be in violation of the federal Drug Quality and Security Act(“DQSA”) and other relevant provisions of the FDC Act, are not produced and dispensed to patients;•The size of the pool of patients who meet the FDA-approved indication for Makena;•The actual or perceived safety and efficacy of Makena;•Our ability to increase patient compliance in line with the current label;•Our ability to gain or maintain insurance coverage for Makena for patients through both commercial insurance companies and government programssuch as Medicaid, and that such insurance coverage does not create difficulties for physicians or patients to gain access to Makena, such as throughprior authorizations to non-preferred status on hospital or insurance formularies; and•Our ability to successfully leverage our commercial organization and distribution networks in marketing, selling and supplying Makena.Failure to achieve any or all of these commercial objectives could have an adverse material effect on the growth of Makena and our ability to achieve ourrevenue forecasts, which could impact our financial condition or results of operations.41Table of ContentsIf we are unsuccessful in differentiating Makena from compounded HPC products, sales of Makena, and thus our profitability, could be materiallyadversely affected.Formulations of HPC have been available from compounding pharmacies for many years (which compounded formulations of HPC we refer to as “c17P”)at lower prices and will likely remain available even though Makena has been granted orphan drug exclusivity until February 3, 2018, and we have no priorexperience with facing such lower priced and less regulated competition. Further, if any safety or efficacy concerns arise with respect to the c17P products, itmay negatively impact sales of Makena if healthcare providers and patients do not distinguish between the compounded product and Makena.The commercial success and growth prospects for Makena will be dependent upon perceptions related to pricing and access.The initial list pricing of Makena was criticized in numerous news articles and internet postings following the FDA’s February 2011 approval of Makenafor reducing the risk of recurrent preterm birth in certain at-risk women. The list price of Makena was subsequently reduced in March 2011, and had not beenincreased until January 2016, at which time we increased the price in line with the rate of inflation over the past five years. Makena is priced at a premium toc17P, which has negatively impacted coverage of Makena by some state Medicaid programs and certain commercial payers. Although we are undertakingefforts to educate physicians and patients about progress made toward expanding coverage of Makena and about the benefits of Makena, certain doctorscontinue to prescribe non-FDA approved compounded formulations of HPC. In addition, efforts to appropriately respond to future concerns about pricing andaccess raised by the media, professional societies, advocacy groups, policymakers or regulatory agencies regarding patient access to Makena, are costly andmay not be successful, especially in light of the increasing scrutiny on specialty pharmaceuticals by politicians and the media. If we are unable to increasethe prescribing of Makena by physicians and strengthen relationships with professional societies, advocacy groups, policymakers and regulatory agencies,some of whom have been or are critical of Lumara Health, our sales of Makena may suffer, which would have a materially adverse impact on revenues and ourresults of operations.The FDA has required post-marketing studies to verify and describe the clinical benefit of Makena, and the FDA may limit further marketing of theproduct based on the results of these post-marketing studies, failure to complete these trials in a timely manner or evidence of safety risks or lack ofefficacy.Makena was approved by the FDA in February 2011 under the provisions of the FDA’s “Subpart H” Accelerated Approval regulations. As a condition ofapproval under Subpart H, the FDA required that Makena’s sponsor perform certain adequate and well-controlled post-marketing clinical studies to verifyand describe the clinical benefits of Makena as well as fulfill certain other post-approval commitments. Given the patient population (i.e., women pregnantand at an increased high risk for recurrent preterm delivery based on their pregnancy history) and the informed risk of receiving a placebo instead of theactive approved drug, the pool of prospective subjects for such clinical trials in the U.S. is small, and we have therefore sought enrollment on a global scale.These factors make the enrollment process slow, difficult, time-consuming and costly. If the required post-marketing studies fail to verify the clinical benefitsof the drug, if a sufficient number of participants cannot be enrolled, or if we fail to perform the required post-marketing studies with due diligence, the FDAhas the authority to withdraw approval of the drug following a hearing conducted under the FDA’s regulations, which would have a materially adverseimpact on our business. We cannot be certain of the results of the confirmatory clinical studies or what action the FDA may take if the results of those studiesare not as expected based on clinical data that FDA has already reviewed or if such studies are not completed in a timely manner.Risks Related to CBRThe potential for cord blood stem cell and cord tissue science and its recognition in regenerative medicine may not continue to grow.The growth of the CBR Services is partially dependent upon the potential for cord blood stem cell and cord tissue science and upon increasing itsrecognition, value, adoption and utility among the medical community for its currently approved uses and a broader set of applications than currentlyestablished and potentially FDA’s approval of those new uses. Although cord blood is utilized for certain homologous uses in the child from whom the cordblood was recovered or in first- or second-degree relatives, if clinical research lowers the perceived value of cord blood stem cell and cord tissue collection, isunable to demonstrate the utility of cord blood stem cells and cord tissue for use in treating diseases or injuries in a broader set of applications or if the FDAdoes not permit the clinical use of cord blood stem cells and cord tissue processed and stored using CBR’s methods for those applications, then healthcareprofessionals may discount its potential utility among patients, or may not have access at all to cord blood stem cells and cord tissue for such expanded uses.In addition, professional medical organizations periodically recommend certain practices that may negatively impact our business. For example, in January2017,42Table of Contentsthe American College of Obstetrics and Gynecology (“ACOG”) issued a new opinion on delayed cord clamping (“DCC”), a practice which has been shown tobe beneficial to preterm babies but that may also reduce the volume of cord blood available for cord blood preservation. In its opinion, ACOG noted thathealthcare providers should counsel their patients that the benefits of DCC may outweigh cord blood banking. As DCC can significantly decrease the volumeof cord blood stems cells collected, families may choose not to bank their newborn's cord blood stem cells. The perception of the future value and uses ofcord blood stem cells and cord tissue stored with CBR is a key driver of CBR’s business and therefore any significant changes to this perception, such as fromgenerational behavior and attitudes, could have an adverse impact on sales of CBR Services.If our cord blood and cord tissue processing and storage facility in Tucson, Arizona is damaged or destroyed, the CBR Services will be materiallydisrupted and impaired.Currently, all of our customers’ cord blood and cord tissue samples are stored in one facility in Tucson, Arizona. Our business would suffer, and we wouldlose credibility with and the trust of physicians, healthcare providers and consumers, if there were any material disruption in our ability to maintaincontinued and fully operating storage systems, or any loss or deterioration of cord blood and cord tissue stored in our storage systems, including in the eventof any damage or interruption from fire, earthquake, flood, break-ins, tornadoes and similar events.Competition in the cord blood and cord tissue banking business is significant and may be increasing. If we are unable to maintain our position as themarket leader, our CBR business may decline and our results of operations could suffer.The barriers to entry into the cord blood and cord tissue banking business are relatively low. We therefore face competition from new entrants to themarket, which could affect our market share or put downward pressure on the pricing of the CBR Services. Furthermore, new market entrants may not abide byindustry guidelines, regulations and standards, including quality, compliance and marketing standards that could allow them to offer and promote similarservices at lower prices and/or engage in marketing behaviors that communicate false or misleading information. In addition to having a potential adverseimpact on our business, these behaviors of such competitors could create a negative perception of our industry if they violate or operate outside ofregulations and/or pursue other questionable business practices.Further, we may face competition from market entrants outside of the cord blood and cord tissue banking business. For example, stem cell sciencegenerally is a relatively nascent field and is subject to potential new technological and/or medical and therapeutic developments, which could render stemcell usage for established applications obsolete and could limit the future value of stem cells for our customers resulting in an adverse impact on ourgrowth. Moreover, stem cell research continues to be an area of ethical and social controversy, and has suffered criticism that the benefits of private cordblood and cord tissue banking have been overstated. Any negative public opinion about stem cell therapy or the benefits of private cord blood and cordtissue banking could damage the perception and reputation of our industry, the CBR Services and our overall business, both among the medical communityand the public generally, which could cause our stock price to suffer and result in a materially adverse impact on our revenues and results of operations.CBR is subject to data security and privacy obligations. With the addition of the CBR Services to our portfolio, our existing data security and privacyobligations have expanded and the failure to comply with these obligations could adversely affect our financial condition and operating results.CBR is subject to data security and privacy obligations. Through April 29, 2033, CBR is required to comply with a Federal Trade Commission (“FTC”)Order (the “FTC Order”). The FTC Order requires CBR, among other things, to implement and maintain a comprehensive information security program andconduct a biennial assessment of its information security program. CBR is also required not to make any misrepresentations, expressly or by implication,regarding its privacy practices or its information security program. The costs of compliance with, and other burdens imposed by, these obligations aresubstantial and may impede our performance and our ability to develop the CBR Services, or lead to significant fines, penalties or liabilities fornoncompliance. The integration of CBR into our operations may also be impacted by the FTC Order. These limitations on our efforts to integrate CBR mayimpede our ability to operate and deploy our systems in the most efficient and cost effective manner.The regulatory landscape for cord blood and cord tissue banking is complex and evolving, and we could become subject to a more complicated andrigorous regulatory scheme, which could expose us to more severe FDA enforcement action or other regulatory implications, which could materially harmour business.Human tissues intended for transplantation, including cord blood stem cells and cord tissue, are subject to comprehensive regulations that addressactivities associated with human cells, tissues and cellular and tissue-based products (“HCT/Ps”). One set of regulations requires that companies that engagein the recovery, processing, storage, labeling, packaging, or distribution43Table of Contentsof any HCT/Ps, or the screening or testing of a cell or tissue donor, register with the FDA. This set of regulations also includes the criteria that must be met inorder for the HCT/P to be eligible for distribution solely under Section 361 of the Public Health Service Act (the “PHSA”), and the regulations in 21 CFRPart 1271, rather than under the drug or device provisions of the FDC Act or the biological product licensing provisions of the PHSA. Another set ofregulations provides criteria that must be met for donors to be eligible to donate HCT/Ps and is referred to as the “Donor Eligibility” rule. A third set ofprovisions governs the processing and distribution of the tissues and is often referred to as the “Current Good Tissue Practices” rule. The Current Good TissuePractices rule covers all stages of HCT/P processing, from procurement to distribution of final allografts. Together these regulations are designed to ensurethat sound, high quality practices are followed to reduce the risk of tissue contamination and of communicable disease transmission to recipients.CBR is registered with the FDA as an HCT/P establishment that screens, packages, processes, stores, labels and distributes umbilical cord blood stem celland cord tissue by virtue of the services it provides to expectant parents as a private cord blood and cord tissue bank. The FDA periodically inspects suchregistered establishments to determine compliance with HCT/P requirements. Violations of applicable regulations noted by the FDA during facilityinspections could adversely affect the continued operation and marketing of the CBR Services.In addition, the FDA could conclude that CBR cord blood stem cells and cord tissue do not meet the criteria for distribution solely under Section 361 ofthe PHSA, and therefore, CBR’s banked HCT/Ps would require the submission and approval or clearance of a marketing application in order for us tocontinue to process and distribute any cord blood stem cells or cord tissue. Such an action by the FDA could cause negative publicity, decreased ordiscontinued sales of CBR’s banking services for cord blood stem cells and cord tissue, and significant expense in obtaining required marketing approval orclearance, if we are able to obtain such approval or clearance at all, and in conforming our marketing approach to the FDA’s expectations.Some states impose additional regulation and oversight of cord blood and cord tissue banks and of clinical laboratories operating within their bordersand impose regulatory compliance obligations on out-of-state laboratories providing services to their residents, and many states in which we and our businesspartners operate have licensing requirements that must be complied with.Further, in the future, the FDA or state governments may promulgate new regulatory requirements and standards for HCT/Ps. We may not be able tocomply with any such future regulatory requirements or product standards. If the FDA or any state regulators determine that we have failed to comply withapplicable regulatory requirements or any future regulatory requirements or standards, it can impose or initiate a variety of enforcement actions, includingbut not limited to, public warning or untitled letters, written recall or destruction orders, written cease manufacturing orders, court-ordered seizures,injunctions, consent decrees, civil penalties, or criminal prosecutions. Regulatory or other developments could result in unexpected increases in expenses,which will be difficult to pass on to current CBR customers, some of whom have agreed to a set price for a period of future storage services, and potentialCBR customers who may be unwilling to pay for the CBR Services if prices were to increase significantly. We can make no assurances that our businesspartners, or members of our collection center network, will be able to obtain or maintain any necessary licenses required to conduct our business under thecurrent or future regulatory regime, which could in turn negatively impact our business and ability to comply with regulations. If any of these events were tooccur, our business could be materially and adversely affected.Risks Related to FerahemeThe market for Feraheme is limited because Feraheme is only indicated for the treatment of IDA in adult patients with CKD. Significant safety or druginteraction problems, or the evaluation or reevaluation of existing or future data by the FDA or other regulators, could have an adverse impact onFeraheme in this indication, which would adversely impact our future business prospects.The market for Feraheme is limited because Feraheme is only indicated for the treatment of iron deficiency anemia (“IDA”) in adult patients withchronic kidney disease (“CKD”). Although we intend to continue to dedicate significant resources to the commercialization of Feraheme, it may neverreceive approval for a broader indication and we may not be successful in our efforts to continue to successfully commercialize Feraheme in its currentmarket, which would have a materially adverse effect on our results of operations and future business prospects.Sales in the current indication may be limited or may decrease if label changes require us to provide additional warnings and/or restrictions related toFeraheme’s current or future indications or impose further limitations or changes to the method of administering the drug, thereby giving rise to increasedcompetitive pressures if Feraheme is viewed as less safe than other IV iron products. Significant safety or drug interaction problems with respect to Feraheme,including an increase in the severity or44Table of Contentsfrequency of known adverse events or the discovery of previously unknown adverse events, or the evaluation or reevaluation of data, includingpharmacovigilance data by the FDA, could result in lawsuits and increased regulatory scrutiny or a variety of adverse regulatory actions, including changesto the product label, the implementation of a REMS or any other enforcement actions. For example, in March 2015, following discussions with the FDA and,in an effort to strengthen the warnings and precautions section of the label and mitigate the risk of serious hypersensitivity reactions, including anaphylaxis,we updated our Feraheme label to include (a) the addition of a boxed warning related to the risks of serious hypersensitivity reactions or anaphylaxis, whichrisks were previously described only in the Warnings and Precautions section; (b) revisions to the Dosing and Administration section to indicate thatFeraheme should only be administered by IV infusion (replacing injection); and (c) modifications to the Warnings and Precautions section to include astatement that patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with any parenteral iron products. These or any futurechanges to the label/ package could adversely impact our ability to successfully compete in the IV iron market and could have an adverse impact onpotential sales of Feraheme and our future business prospects.Moreover, new safety or drug interaction issues may arise as Feraheme is used over longer periods of time by a wider group of patients, some of whommay be taking other medicines or have additional underlying health problems, which may require us to, among other things, provide additional warningsand/or restrictions on the label/package insert, notify healthcare providers of new safety information, narrow our approved indications, change the rate ofadministration, alter or terminate current or future trials for additional uses of Feraheme, or even remove Feraheme from the market, any of which could havea significant adverse impact on potential sales of Feraheme or require us to expend significant additional funds.We may never receive regulatory approval to market and sell Feraheme to the broader IDA patient population.In January 2014, we received a complete response letter from the FDA informing us that our supplemental new drug application (“sNDA”) for the broadIDA indication could not be approved in its present form. In the letter, the FDA stated that we had not provided sufficient information to permit labeling ofFeraheme for safe and effective use for the proposed indication. The FDA indicated that its decision was based on the cumulative ferumoxytol data,including the global Phase 3 IDA program and global post-marketing safety reports for the currently indicated CKD patient population. The FDA suggested,among other things, that we submit additional clinical trial data in the proposed broad IDA patient population. Following discussions with the FDA, in 2016we commenced and completed enrollment in a new head-to-head Phase 3 clinical trial evaluating Feraheme in adults with IDA, excluding patients onhemodialysis. This new trial is a randomized, double-blind multicenter non-inferiority trial that will evaluate the incidence of moderate-to-severehypersensitivity reactions (including anaphylaxis) and moderate-to-severe hypotension with Feraheme compared to ferric carboxymaltose infusion.Approximately 2,000 patients were randomized in a 1:1 ratio into one of two treatment groups, those receiving 1.02 grams of Feraheme IV infusion or thosereceiving 1.5 grams of ferric carboxymaltose IV infusion. We expect to file an sNDA for this broader indication in mid-2017. We will have to demonstrate,through the submission of clinical study reports and data sets from one or more controlled clinical trials, that the benefit of Feraheme use in the proposedpopulation would warrant the risks associated with Feraheme, including the potential for adverse events, including anaphylaxis, cardiovascular events, anddeath. The FDA has substantial discretion in the approval process and may decide that the results of this trial and the information we submit seeking approvalin the broader patient population or other information reviewed, such as post-marketing safety data, including reports of serious anaphylaxis, cardiovascularevents, and death, or any information we provide in response to FDA requests, are insufficient for approval or that Feraheme is not effective or safe for theproposed broader indication, or in any of the individual subpopulations of IDA patients.If we do not obtain approval to market and sell Feraheme for the treatment of IDA in a broad range of patients, or if we experience additional significantdelays or setbacks in obtaining approval, or if we receive approval with significant restrictions, or are required to incur significant costs as post-marketingcommitments, our cash position, our ability to increase revenues, our ability to leverage our portfolio, our profitability, and the future prospects of ourbusiness could be materially adversely affected.Efforts to pursue a broader indication could also have a negative impact on the commercialization of Feraheme in its current indication if informationsubmitted for purposes of the broader indication and any reevaluation of existing data, such as reports of serious anaphylaxis, cardiovascular events, anddeath, results in requirements to provide additional warnings and/or restrictions on our Feraheme label/package insert, change the rate of administration ofFeraheme, notify healthcare providers of changes to the label/package insert, narrow the current indication, alter or terminate current or future trials forFeraheme or incur significant costs related to post-marketing requirements/commitments. Such adverse developments could put us at a disadvantage to ourcompetitors and cause healthcare providers to choose to treat all of their IDA patients with competing IV irons based on the actual or perceived safety andefficacy of Feraheme in light of such activities.45Table of ContentsGeneric competitors are seeking approval of generic versions of Feraheme and the market entry of any such generic would limit Feraheme sales whichwould have an adverse impact on our business and results of operation.The Drug Price Competition and Patent Term Restoration Act of 1984, as amended (the “Hatch‑Waxman Act”) permits the FDA to approve ANDAs forgeneric versions of brand name drugs like Feraheme. The ANDA process permits competitor companies to obtain marketing approval for a drug product withthe same active ingredient, dosage form, strength, route of administration, and labeling as the approved brand name drug, but without having to conduct andsubmit clinical studies to establish the safety and efficacy of the proposed generic product. In place of such clinical studies, an ANDA applicant needs tosubmit data demonstrating that its product is bioequivalent to the brand name product, usually based on pharmacokinetic studies. The Hatch-Waxman Actrequires an applicant for a drug product that relies, in whole or in part, on the FDA’s prior approval of Feraheme, to notify us of its application, a Paragraph IVcertification notice, if the applicant is seeking to market its product prior to the expiration of the patents with claims directed to Feraheme. A bona fideParagraph IV certification notice may not be given under the Hatch-Waxman Act until after the generic company receives from the FDA an acknowledgmentletter stating that its ANDA is sufficiently complete to permit a substantive review.On February 5, 2016, we received a Paragraph IV certification notice letter regarding an ANDA submitted to the FDA by Sandoz requesting approval toengage in commercial manufacture, use and sale of a generic version of Feraheme (ferumoxytol), and we could therefore face generic competition in the near-term. As noted above, in its notice letter, Sandoz claims that our ferumoxytol patents are invalid, unenforceable and/or not infringed by Sandoz’smanufacture, use, sale or offer for sale of the generic version. In March 2016, we initiated a patent infringement suit alleging that Sandoz’ ANDA filing itselfconstituted an act of infringement and that if it is approved, the manufacture, use, offer for sale, sale or importation of Sandoz’ ferumoxytol products wouldinfringe our patents. Such litigation is often time-consuming and costly, and may result in generic competition if such patents are not upheld or if the genericcompetitor is found not to infringe such patents. Further, Sandoz’s application could encourage other generic entrants seeking a path to approval of a genericferumoxytol to file an ANDA. Even if we are successful, such litigation will be expensive and will consume considerable time and other resources, whichcould materially and adversely impact business.If an ANDA filer, such as Sandoz, is ultimately successful in patent litigation against us, meets the requirements for a generic version of Feraheme to thesatisfaction of the FDA under its ANDA, and is able to supply the product in significant commercial quantities, the generic company could introduce ageneric version of Feraheme. Such a market entry would likely limit our Feraheme sales, which would have an adverse impact on our business and results ofoperations.Market acceptance of Feraheme may suffer as a result of the widespread use of competing iron replacement therapy products, including Injectafer®, whichwould have a material adverse effect on our operations and our profitability.Market acceptance of Feraheme may suffer as a result of competing iron replacement therapy products, in part because most of these products have beenon the market longer and are currently widely used by physicians, and because certain of these products are approved for the treatment of IDA in a broadergroup of patients. For example, in July 2013, Injectafer® was approved by the FDA for the treatment of IDA in adult patients who have an unsatisfactoryresponse to oral iron or who have intolerance to oral iron, which is a broader indication than our current Feraheme indication. Injectafer® is approved in theU.S. with a recommended dose of two slow injections or infusions of 750 milligrams each separated by at least seven days apart for a total of1,500 milligrams. Given the 2015 changes to the Feraheme label, which provide, among other changes, that Feraheme be administered to patients byinfusion over at least 15 minutes (replacing injection), Feraheme has lost a competitive advantage to Injectafer® and other IV irons. Further, we may not beable to offer discounts, incentives or rebates to new or existing customers on terms as appealing as Injectafer® or other IV irons. Even if we eventually obtainlabeling of Feraheme in a broader population, Injectafer® will have already been available for a considerable period of time. During this period, physiciansmay continue to increase their use of Injectafer®, new physicians may begin to use Injectafer®, and physicians will gain increased familiarity with theproduct, making it more difficult for us to cause these physicians to use Feraheme in the future. In addition, manufacturers of Injectafer® may enter intocommercial contracts with key customers or group purchasing organizations (“GPOs”) during this period, which could prevent or make it more difficult forFeraheme to retain its existing customers, gain sales to new customers and gain market share in its existing indication with customers or GPOs, and may makeentry into the non-CKD market difficult if we were to receive approval for the broader patient population in the future. If we are not able to differentiateFeraheme from other marketed IV iron products, including Injectafer®, or convince physicians and other customers of Feraheme’s safe and effective use, ourability to maintain a premium price, generate revenues and maintain profitability, and our long-term business prospects could be adversely affected.46Table of ContentsFeraheme’s ability to maintain its current market share, or gain wider market acceptance in the future, depends on a number of other factors, includingbut not limited to the following:•Our ability to demonstrate to healthcare providers, particularly hematologists, oncologists, hospitals, nephrologists, and others who may purchase orprescribe Feraheme, the clinical efficacy and safety of Feraheme as an alternative to currently marketed IV iron products which treat IDA in adultCKD patients;•Our ability to convince physicians and other healthcare providers to use IV iron, and Feraheme in particular, rather than oral iron, which is thecurrent treatment of choice of most physicians for treating IDA in adult CKD patients;•The actual or perceived safety and efficacy profile of Feraheme as compared to alternative iron replacement therapeutic agents;•The relative price and level of reimbursement for Feraheme from payers, including government payers, such as Medicare and Medicaid, and privatepayers as compared to the price and level of reimbursement for alternative IV iron products;•The actual or perceived convenience and ease of administration of Feraheme as compared to alternative iron replacement therapeutic agents,including iron administered orally, in light of recent or potential changes to the methods of Feraheme administration;•Our ability to execute on our contracting strategy and offer competitive discounts, rebates and other incentives, which can result in increasing therebates we are required to pay under the Medicaid Drug Rebate program and the discounts we are required to offer under the 340B drug pricingprogram;•Current and future limitations on the approved indications and patient populations for Feraheme;•The introduction of generic versions of ferumoxytol, which may occur in the near-term given the ANDA submitted to the FDA by Sandoz requestingapproval to engage in commercial manufacture, use and sale of a generic version of ferumoxytol; and•The effectiveness of our commercial organization and distribution networks in marketing, selling and supplying Feraheme.The key component of our commercialization strategy for Feraheme is to market and sell Feraheme for use in non-dialysis adult CKD patients. Thecurrent non-dialysis CKD market is comprised primarily of three sites of care where a substantial number of CKD patients are treated: hospitals, hematologyand oncology centers, and nephrology clinics. Competition in these practices is intense and competitors such as Injectafer® are gaining market share,particularly in hematology practices. IV iron therapeutic products are not currently widely used by certain physicians who treat non-dialysis CKD patients,particularly nephrologists, due to safety concerns and the inconvenience and often impracticability of administering infusion IV iron therapeutic products intheir offices. It is often difficult to change physicians’ existing treatment paradigms even when supportive clinical data are available. In addition, our abilityto effectively market and sell Feraheme in the hospital market depends in part upon our ability to achieve acceptance of Feraheme onto hospital formularies.Since many hospitals and hematology, oncology and nephrology practices are members of GPOs, which leverage the purchasing power of a group of entitiesto obtain discounts based on the collective bargaining power of the group, our ability to attract customers in these sites of care also depends in part on ourability to effectively promote Feraheme to and enter into pricing agreements with GPOs. The GPOs can also offer opportunities for competitors to Ferahemethat provide the ability to quickly gain market share by offering a more attractive price or contracts and incentives that encourage the members of the GPO touse or switch to the competing product. If we are not successful in capturing a significant share of the non-dialysis CKD market or if we are not successful insecuring and maintaining formulary coverage for Feraheme, or if we cannot maintain strong relationships and offer competitive contracts to key customersand GPOs, our profitability as well as our long-term business prospects could be adversely affected.We derive a substantial amount of our Feraheme revenue from a limited number of customers and the loss of one or more of these customers, a change intheir fee structure, or a decline in revenue from one or more of these customers could have an adverse impact on our results of operations and financialcondition.We sell Feraheme primarily to wholesalers and specialty distributors and therefore a significant portion of our revenues is generated by a small numberof customers and most of these customers are not under long-term contracts with us. The loss of47Table of Contentsany of our customers, including if a customer views Feraheme as having a higher risk profile as compared to other IV iron products, especially in light of ourrecent label changes, could have a materially adverse impact on our results of operations. In addition, in 2016 three customers accounted for greater than 95%of our total Feraheme net revenues and accounts receivable balance. We pay these wholesalers and specialty distributors a fee for the services that theyprovide to us. Because our business is concentrated with such a small number of wholesalers and specialty distributors, we could be forced to accept increasesin their fees in order to maintain the current distribution networks through which Feraheme is sold. Any increase in fees could have a negative impact on ourcurrent and future sales of Feraheme and could have a negative impact on the reimbursement rate an individual physician, hospital or clinic would realizeupon using Feraheme.In addition, a significant portion of our Feraheme sales are generated through a small number of contracts with GPOs. For example, approximately 20%of our Feraheme end-user demand during the year ended December 31, 2016 was generated by members of a single GPO with whom we have contracted. As aresult of the significant percentage of our end-user demand being generated by a single GPO, we may be at a disadvantage in future contract or pricenegotiations with such GPO and that GPO may be able to influence the demand for Feraheme from its members in a particular quarter throughcommunications they make to their customers. In addition, competitors of Feraheme may be able to quickly gain market share if they are able to offer GPOs amore attractive price or contracts and incentives that encourage the members of the GPO to use or switch to the competing product, especially if suchcompeting drug can be administered to a broader patient population. The loss of some or all of this demand to a competitor, a material reduction in salesvolume, or a significant adverse change in our relationship with any of our key wholesalers, distributors or GPOs could have a material adverse effect on ourrevenue and results of operations.Risks Related to RekyndaRekynda is not approved for sale by the FDA and we cannot guarantee that Rekynda will receive regulatory approval on a timely basis, or at all, or thatsuch approval, if obtained, will not contain restrictions that the FDA may impose on the use or distribution of Rekynda.In January 2017, we entered into the Palatin License Agreement under which we acquired an exclusive license from Palatin to research, develop andcommercialize Rekynda in North America. Palatin recently completed two Phase 3 clinical trials to treat HSDD in pre-menopausal women. The trialsconsisted of double-blind placebo-controlled, randomized parallel group studies comparing a subcutaneous dose of 1.75 mg Rekynda versus placebo, in eachcase, delivered via an auto-injector. In both clinical trials, Rekynda met the pre-specified co-primary efficacy endpoints of median improvement in desire anddecrease in distress associated with low sexual desire as measured using validated patient-reported outcome instruments; however, the change in the numberof satisfying sexual events, a key secondary endpoint, was not significantly different from placebo in either clinical trial. The most frequent adverse eventswere nausea, flushing and headache, which were generally mild-to-moderate in severity. Approximately 18% of patients discontinued participation in theRekynda arm due to adverse events in both studies. Palatin is conducting Phase 1 drug interaction and safety pharmacology studies, including an abuse-liability study and drug-drug interaction studies with anti-hypertensive and anti-arrhythmic therapies, as well as certain chemistry, manufacturing andcontrols activities, including drug product process validation studies to support the filing of an NDA for Rekynda for the treatment of HSDD. We currentlyexpect to submit the Rekynda NDA in early 2018, subject to the successful and timely completion of the ongoing studies.Despite the successful completion of the Phase 3 clinical trials, the approval of Rekynda for commercial sale in the U.S. could be delayed or denied for anumber of reasons, including:•The FDA may determine that Rekynda does not demonstrate safety and efficacy in accordance with regulatory agency standards based on the resultsof the Phase 3 trial, including the co-primary and secondary endpoints and safety results;•The FDA may determine that the magnitude of efficacy demonstrated in the Rekynda studies does not amount to a clinically meaningful benefit topre-menopausal women with HSDD and thus that the product cannot be approved despite statically significant efficacy results;•The FDA could analyze and/or interpret data from pre-clinical testing and clinical trials in different ways than we or Palatin interpret it, such as thecalculation of effect size in our Phase 3 studies or the sufficiency of data to determine the timing of onset and the dosing of the product;•The initiation, conduct or results of the remaining drug interaction, safety pharmacology and other ancillary studies may be delayed or unsuccessful;48Table of Contents•The auto-injector device, supplied by an unaffiliated third party, that we plan to use to administer Rekynda may not be adequate or may not beapproved by the FDA;•Palatin's ability to establish, and obtain FDA approval for, a commercially viable manufacturing process for Rekynda;•Adverse medical events reported during the trials, including increases in blood pressure noted in prior clinical trials, could lead to requirements toconduct additional studies;•The failure of clinical investigational sites and the records kept at such sites, including the clinical trial data, to be in compliance with the FDA’sGCP, including the failure to pass FDA inspections of clinical trial sites; and•The FDA may change their approval policies or adopt new regulations.Any delay in obtaining regulatory approval for Rekynda could adversely affect our ability to successfully commercialize such product. In addition, shareprices have declined significantly in certain instances where companies have failed to obtain FDA approval of a product or where the timing of FDA approvalis delayed. If the remaining drug interaction, safety pharmacology or other ancillary studies or the FDA’s response to any application for approval are delayedor not favorable for Rekynda, our share price could decline significantly. In such circumstances, Palatin’s share price could also decline and Palatin may beunable to perform its obligations under the Rekynda License.Even if regulatory approval to market Rekynda is granted by the FDA, the approval may impose limitations on the indicated use for which the drugproduct may be marketed and additional post-approval requirements with which we and Palatin would need to comply in order to maintain Rekynda’sapproval. For example, demonstration of clinically important drug-drug interactions in the ongoing studies, may reduce the population for which Rekyndamay be approved. In addition, unexpected adverse findings in the safety pharmacology studies may cause FDA to impose restrictions on the distribution ofRekynda, which may limit its commercial potential. Similarly, commercialization efforts for the drug product are still ongoing, and based on the results ofthose efforts, including stability studies, the FDA approval may require that the product be kept refrigerated in the supply chain prior to being dispensed tothe patient, in order to lengthen the shelf life, which could affect the cost of goods, or the market acceptance of the product. Our business could be seriouslyharmed if we and/or Palatin do not complete any post-approval requirements and the FDA, as a result, requires us to change sections of the labeling.Even if Rekynda receives regulatory approval, it may never achieve market acceptance, in which case our business, financial condition and results ofoperation will be materially adversely affected.Regulatory approval for the marketing and sale of Rekynda does not assure the product’s commercial success. If approved, Rekynda will compete withother products that may be manufactured and marketed by major pharmaceutical and other biotechnology companies. If Rekynda does not achieve adequatemarket acceptance, our business, financial condition and results of operations will be materially adversely affected. The degree of market acceptance andcommercial success of Rekynda will depend on a number of factors, including:•Perceptions by members of the healthcare community, including physicians, about the safety and effectiveness of Rekynda;•The initiation, conduct or results of safety pharmacology studies and whether the FDA imposes any restrictions on the distribution of Rekynda:•Our ability to increase awareness of HSDD and treatment options, and to engage with and educate health care providers and potential consumersabout HSDD and the benefits of Rekynda;•Cost-effectiveness relative to competing products and technologies;•Availability of reimbursement from third-party payers;•Advantages over alternative treatment therapies, including the tolerability of any side effects and self-administration by auto-injector;•Our ability to maintain a commercially viable manufacturing process that is compliant with cGMP;49Table of Contents•Palatin and our ability to enforce Palatin's intellectual property rights in and to Rekynda to prohibit a third-party from marketing a generic productand our ability to avoid third-party patent interference or intellectual property infringement claims;•Our ability to hire and maintain an expanded sales force and experienced commercialization personnel to compete in the market; and•An increase in the occurrence or severity of the most common adverse events (nausea, headaches and flushing) or the occurrence of additionaladverse events causing patients to discontinue treatment.Competing products and technologies, minimal third party reimbursement opportunities and an uncertain market may limit Rekynda revenues even ifRekynda is approved by the FDA for commercialization.Flibanserin, a daily-use oral drug sold by Valeant Pharmaceuticals, Inc. under the trade name Addyi®, has been approved by the FDA to treat HSDD inpre-menopausal women and began being marketed in October 2015. We are aware of several other drugs for the treatment of HSDD and FSD in both pre-menopausal and post-menopausal patients under development, including certain drugs being developed by S1 BioPharma, Inc, Emotional Brain BV and ANIPharmaceuticals, Inc., some of which incorporate testosterone, antidepressants or PDE-5 inhibitors. If our competitors obtain FDA or other regulatoryapproval for their products more rapidly than we may obtain approval for ours, our competitors may establish a market position and could have competitiveadvantages over Rekynda and have a material adverse effect on our business, financial condition and results of operations.The actual market size and market dynamics for HSDD, particularly in pre-menopausal women, are unknown. While we believe that Rekynda, as an on-demand drug to treat HSDD, will have competitive advantages compared to chronic or daily use hormones and other drugs, we may not be able to realize thisperceived advantage in the market, in part because Rekynda is administered by subcutaneous auto-injection. While the single-use, disposable auto-injectorformat is designed to maximize market acceptability, apprehension associated with an injectable drug may impact Rekynda’s ability to achieve significantmarket acceptance, especially if an oral therapy is available as an alternative.There is also significant uncertainty concerning the extent and scope of third-party reimbursement for products treating HSDD. Payers frequently employa tiered system in reimbursing end-users for pharmaceutical products, with tier designation affecting copay or deductible amounts. Because Addyi® is theonly FDA-approved therapy to treat HSDD, there is little precedent on which to base expectations as to third-party reimbursement opportunities. We believereimbursement for HSDD will be similar to approved products treating erectile dysfunction. If this is the case, we expect that commercial payors with a tieredformulary will place Rekynda into a Tier 3 drug, which normally requires a higher co-pay or deductible than Tier 1 or 2 category drugs. As a result, patientswould be unlikely to receive full reimbursement by third-party commercial payers and may not receive any reimbursement from governmental healthcareprograms. Therefore, patients may be subject to substantial copays or deductible requirements. Less than full reimbursement by governmental and other third-party payers may adversely affect the market acceptance of Rekynda. If Rekynda does not achieve adequate market acceptance, if approved, at an acceptableprice point, our business, financial condition and results of operations may be materially adversely affected.Further, the market for HSDD may be particularly vulnerable to unfavorable economic conditions. Because we expect Rekynda to have significant copayor deductible requirements and to be only partially reimbursed by third-party payers, demand for Rekynda may be tied to discretionary spending levels of thetargeted patient population. Thus, any downturn in the economy could result in weakened demand for Rekynda.Risks Related to the Pending Intrarosa LicenseWe have undertaken efforts to expand our product portfolio with our pending license arrangement with Endoceutics. If we are unable to successfullycommercialize Intrarosa pursuant to the pending Endoceutics License Agreement, if consummated, our business and results of operations will suffer. On February 13, 2017, we entered into a license agreement (the “Endoceutics License Agreement”) with Endoceutics, Inc. (“Endoceutics”) pursuant towhich Endoceutics has agreed to grant to us rights to IntrarosaTM (prasterone), an FDA-approved product for the treatment of moderate-to-severe dyspareunia(pain during sexual intercourse). Upon closing of the Endoceutics License Agreement, our women’s health portfolio will be significantly larger and morecomplex than it is today. We have limited experience with licensed products and with commercializing a drug in the field of vulvar and vaginal atrophy(“VVA”), and were not granted any rights to physical assets and did not hire any employees from Endoceutics as part of the transaction. If the EndoceuticsLicense Agreement closes, our future success will significantly depend upon our ability to expand our50Table of Contentscommercial team, including hiring and training a new sales team to market Intrarosa, and to leverage our relationships in the obstetrics and gynecologycommunity. These activities will require our management team to spend considerable time and effort in hiring and monitoring new sales force members, andthere can be no guarantee that we will be able to identify and hire a sufficient number of qualified individuals to successfully commercialize Intrarosa. Ourmanagement team could face further challenges in effectively and collaboratively working with Endoceutics in accordance with the terms of the EndoceuticsLicense Agreement. In order to support our growing portfolio, we will need to achieve revenues from sales of and other financial goals for Intrarosaconsistent with our business expectations, which may prove more difficult than currently expected. Any failure to achieve expectations could affect ourprofitability. Further, we will be dependent upon the contributions of Endoceutics following the closing of the transaction, including exclusively providing us withall commercial supply and conducting certain clinical and commercialization activities. Endoceutics is a small company organized outside of the U.S. withlimited operations and resources with a history in vulvar and vaginal atrophy. Endoceutics has limited experience manufacturing a product at commercialscale, which imposes significant and complex regulatory and compliance obligations, and Endoceutics may face challenges and difficulties in satisfyingsuch obligations. Furthermore, given that Endoceutics' assets, including the intellectual property licensed to us, are subject to a security interest held by athird-party lender, our rights and remedies under the license agreement may be impaired or inadequate. Accordingly, if Endoceutics fails to perform itsobligations in an acceptable manner, or at all, or otherwise breaches the Endoceutics License Agreement or its loan documents, commercialization ofIntrarosa could suffer and/or our business, financial condition and results of operations may be materially adversely affected.The Endoceutics License Agreement has not been consummated and we can make no guarantee that the transaction will close on the anticipated timeline,or at all.The consummation of the Endoceutics License Agreement is subject to a number of closing conditions, including some that are out of our control,including the expiration of the applicable waiting period under the Hart-Scott-Rodino Act, and we can make no assurances that the transaction will close in atimely manner or at all. In the event that the Endoceutics License Agreement is not consummated, we will have spent considerable time and resources andincurred substantial costs, such as legal, accounting and advisory fees, which must be paid even if the transaction is not consummated. If the license is notconsummated, our reputation in our industry and in the investment community could be damaged and, as a result, the market price of our common stockcould decline.Even if the Endoceutics License Agreement is consummated, we may be unsuccessful in driving awareness of dyspareunia and the potential benefits ofIntrarosa. The market for VVA therapies is uncertain, and the number of women suffering from the condition is unclear, in part because of a reluctance to discussvaginal or sexual symptoms with healthcare providers. Despite significant marketing and educational efforts by industry participants intended to spreadawareness of the condition and its treatment, studies suggest that women often do not recognize VVA and are often not aware of treatment options. Althoughwe plan to undertake informational and educational programs to help spread awareness of VVA and the benefits of Intrarosa for the conditions indicated,such undertakings may not be successful, will be costly and could disrupt management’s and other personnel’s efforts in other, more profitable, endeavors.Intrarosa is indicated to treat only a portion of this unknown VVA market (those women suffering from moderate-to-severe dyspareunia), and althoughmoderate-to-severe dyspareunia is believed to be a common symptom of VVA, this subset of the VVA market is subject to the same and likely heighteneduncertainties and obstacles as the overall VVA market. If we have over-estimated the market opportunity for Intrarosa, or if we are unable to successfullyspread awareness and educate the community about VVA generally, and moderate-to-severe dyspareunia in particular, then our business and results ofoperations could be materially and adversely affected.Intrarosa will face substantial competition and is expected to have minimal third party reimbursement opportunities which may limit its market potential.There are a number of large pharmaceutical companies that currently market and sell products or are pursuing the development of products for thetreatment of VVA and dyspareunia. For example, Premarin Vaginal Cream® and Estrace® Cream are vaginal creams marketed by Pfizer, Inc. and Allergan Inc.,respectively, for the treatment of VVA. Vagifem® is a suppository marketed by Novo Nordisk A/S for the treatment of VVA and Yuvafem, a generic ofVagifem, is marketed by Amneal Pharmaceuticals LLC. In addition, Osphena® is an oral therapy marketed by Shionogi & Co. Ltd. for the treatment ofdyspareunia and Estring is a vaginal ring marketed by Pfizer for the treatment of dyspareunia. TherapeuticsMD, Inc. is also developing YuvvexyTM, a vaginalsoft gel for the treatment of dyspareunia and has a PDUFA date in May 2017. Many of the companies against which we will compete have significantlygreater financial resources and expertise in marketing products51Table of Contentsthan we do. In addition, there are numerous over the counter remedies that are marketed for dyspareunia, and over the counter products that containprasterone.The actual market size and market dynamics for dyspareunia is uncertain. While we believe that Intrarosa, as a FDA approved, non-estrogen containingdrug to treat moderate-to-severe dyspareunia, will have competitive advantages compared to estrogen-containing therapies, we may not be able to realize thisperceived advantage in the market. Our commercial opportunity could be reduced or eliminated if physicians or patients perceive that other products aremore effective, convenient or safe than Intrarosa, or if they are less expensive than Intrarosa.In addition, our ability to compete may be affected by the extent and scope of third-party reimbursement for products treating dyspareunia. While someof the products that Intrarosa will compete with receive reimbursement from governmental healthcare programs, we expect that Intrarosa will be classified asa Tier 3 drug, and as a result patients are unlikely to receive full reimbursement by third-party commercial payers and may not receive any reimbursementfrom governmental healthcare programs. As a result, patients may be subject to substantial copays or deductible requirements. Less than full reimbursementby governmental and other third-party payers may adversely affect the market acceptance of Intrarosa and put it at a competitive disadvantage to some of thecompeting products, including generic versions, which are often priced lower than brand products. If Intrarosa does not achieve adequate market acceptanceat an acceptable price point, our business, financial condition and results of operations may be materially adversely affected.Regulatory RisksThere have been, and we expect there will continue to be, a number of federal and state legislative initiatives implemented to reform the U.S. healthcaresystem in ways that could adversely impact our business and our ability to sell our products and services profitably.We expect that the Affordable Care Act, as currently enacted or as it may be amended in the future, the 21st Century Cures Act, and other healthcarereform measures that may be adopted in the future, could have a material adverse effect on our industry generally and on our ability to maintain or increaseour product sales. These changes might impact existing government healthcare programs and may result in the development of new programs, includingMedicare payment for performance initiatives and improvements to the physician quality reporting system and feedback program. Changes that may affectour business include, but are not limited to, those governing enrollment in federal healthcare programs, reimbursement changes, rules regarding prescriptiondrug benefits under the health insurance exchanges, expansion of the 340B drug pricing program, and fraud and abuse enforcement. For example, beginningApril 1, 2013, Medicare payments for all items and services under Part A and B, including drugs and biologics, and most payments to plans under MedicarePart D were reduced by 2% under the sequestration (i.e., automatic spending reductions) required by the Budget Control Act of 2011 (“BCA”) as amended bythe American Taxpayer Relief Act of 2012. The BCA requires sequestration for most federal programs, excluding Medicaid, Social Security, and certain otherprograms. The BCA caps the cuts to Medicare payments for items and services at 2% and subsequent legislation extended the 2% reduction, on average, to2025.While we are continuing to evaluate this legislation and its potential impact on our business, we cannot predict the impact that newly enacted laws orany future legislation or regulation will have on us. We expect that there will continue to be a number of U.S. federal and state proposals to implementgovernmental pricing controls and limit the growth of healthcare costs. These efforts could adversely affect our business by, among other things, limiting theprices that can be charged for our products or services, or the amount of reimbursement rates and terms available from governmental agencies or third-partypayers, limiting the profitability of our products and services, increasing our rebate liability or limiting the commercial opportunities for our products andservices, including acceptance by healthcare payers.Our partners, including our licensors, are subject to similar requirements and thus the attendant risks and uncertainties. If our partners, including ourlicensors, suffer material and adverse effects from such risks and uncertainties, our rights and benefits for our licensed products could be negatively impacted,which could have a material and adverse impact on our revenues.If our products and services are marketed or distributed in a manner that violates federal, state or foreign healthcare fraud and abuse laws, marketingdisclosure laws or other federal, state or foreign laws and regulations, we may be subject to civil or criminal penalties.In addition to FDA and related regulatory requirements, our general operations, and the research, development, manufacture, sale and marketing of ourproducts and services, are subject to extensive additional federal, state and foreign healthcare regulation, including the Federal Anti-Kickback Statute andthe Federal False Claims Act (“FCA”) (and their state52Table of Contentsanalogues), as discussed above in Item 1 under the heading “Government Regulation - Fraud and Abuse Regulation.” If we or our partners, such as licensors,fail to comply with any federal, state or foreign laws or regulations governing our industry, we could be subject to a range of regulatory actions that couldadversely affect our ability to commercialize our products and services, harm or prevent sales of our products and services, or substantially increase the costsand expenses of commercializing and marketing our products and services, all of which could have a material adverse effect on our business, financialcondition and results of operations.Our activities relating to the sale and marketing of our products and services may be subject to scrutiny under these laws, and private individuals havebeen active in bringing lawsuits on behalf of the government under the FCA and similar regulations in other countries. In addition, incentives exist underapplicable U.S. law that encourages employees and physicians to report violations of rules governing promotional activities for pharmaceutical products.These incentives could lead to so-called whistleblower lawsuits as part of which such persons seek to collect a portion of moneys allegedly overbilled togovernment agencies as a result of, for example, promotion of pharmaceutical products beyond labeled claims. For example, federal enforcement agenciesrecently have showed interest in pharmaceutical companies’ product and patient assistance programs, including manufacturer reimbursement support servicesand relationships with specialty pharmacies. Some of these investigations have resulted in government enforcement authorities intervening in relatedwhistleblower lawsuits and obtaining significant civil and criminal settlements. Such lawsuits, whether with or without merit, are typically time-consumingand costly to defend. Such suits may also result in related shareholder lawsuits, which are also costly to defend.Further, the FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products. In particular, aproduct may not be promoted for uses that are not approved by the FDA as reflected in the product’s approved labeling. For drug products like Makena thatare approved by the FDA under the FDA’s accelerated approval regulations, unless otherwise informed by the FDA, the sponsor must submit promotionalmaterials at least 30 days prior to the intended time of initial dissemination of the promotional materials, which delays and may negatively impact ourcommercial team’s ability to implement changes to Makena’s marketing materials, thereby negatively impacting revenues. Moreover, under Subpart H, theFDA may also withdraw approval of Makena if, among other things, the promotional materials are false or misleading, or other evidence demonstrates thatMakena is not shown to be safe or effective under its conditions of use.In recent years, several states have enacted legislation requiring pharmaceutical companies to establish marketing and promotional compliance programsor codes of conduct and/or to file periodic reports with the state or make periodic public disclosures on sales, marketing, pricing, clinical trials, and otheractivities. Several states have also adopted laws that prohibit certain marketing-related activities, including the provision of gifts, meals or other items tocertain healthcare providers. In addition, as part of the Affordable Care Act, substantial new provisions affecting compliance have been enacted, which mayrequire us to modify our business practices with healthcare providers and potentially incur additional costs. One such requirement is for manufacturers ofdrugs to publicly report gifts and other payments or transfers of value made to physicians and teaching hospitals.We have developed and implemented a corporate compliance program based on what we believe are current best practices in the pharmaceuticalindustry; however, these laws are broad in scope and there may not be regulations, guidance or court decisions that definitively interpret these laws in thecontext of particular industry practices. We cannot guarantee that we, our employees, our partners, our consultants or our contractors are or will be incompliance with all federal, state and foreign regulations. If we, our partners, or our representatives fail to comply with any of these laws or regulations, arange of fines, penalties and/or other sanctions could be imposed on us, including, but not limited to, restrictions on how we market and sell our products,significant fines, exclusions from government healthcare programs, including Medicare and Medicaid, litigation, or other sanctions. Even if we are notdetermined to have violated these laws, government investigations into these issues typically require the expenditure of significant resources and generatenegative publicity, which could also have an adverse effect on our business, financial condition and results of operations. Such investigations or suits mayalso result in related shareholder lawsuits, which can also have an adverse effect on our business.Further, we are subject to additional and complex regulations with regard to the CBR Services, as detailed above under the Risk Factors - Risks Relatedto CBR - “CBR is subject to data security and privacy obligations. With the addition of the CBR Services to our portfolio, our existing data security andprivacy obligations have expanded and the failure to comply with these obligations could adversely affect our financial condition and operating results”and “The regulatory landscape for cord blood and cord tissue banking is complex and evolving. This landscape coupled with our inexperience with theCBR Services could subject us to FDA enforcement action or other regulatory implications, which could materially harm our business.”Our partners, including our licensors, are subject to similar requirements and obligations as well as the attendant risks and uncertainties. If our partners,including our licensors, suffer material and adverse effects from such risks and uncertainties, our53Table of Contentsrights and benefits for our licensed products could be negatively impacted, which could have a material and adverse impact on our revenues.If we fail to comply with our reporting and payment obligations under governmental pricing programs, we could be required to reimburse governmentprograms for underpayments and could pay penalties, sanctions and fines which could have a material adverse effect on our business, financial conditionand results of operations.As a condition of reimbursement by various federal and state healthcare programs, we are required to calculate and report certain pricing information tofederal and state healthcare agencies. Please see our discussion above under the heading, “Pharmaceutical Pricing and Reimbursement” in Item 1. Businessfor more information regarding our price reporting obligations under the Medicaid Drug Rebate Program, Medicare Part B, and the Department of VeteransAffairs Federal Supply Schedule (the “FSS”) program.Price reporting and payment obligations are highly complex and vary among products and programs. The calculations are often subject to interpretationby us, governmental or regulatory agencies and the courts. Any corrections to our rebate calculations could result in an overage or underage in our rebateliability for past quarters, depending on the nature of the correction.If we have to restate our calculation of government price reports, we may be forced to refund certain monies back to payers to comply with federal pricingagreements. Such a restatement of our government price reports would also adversely impact our reported financial results of operations in the period of suchrestatement. As a result, our price reporting calculations remain subject to the risk of errors and our methodologies for calculating these prices could bechallenged under the FCA or other laws. In addition, the Affordable Care Act modified the rules related to certain price reports, among other things. Presently,uncertainty exists as many of the specific determinations necessary to implement this new legislation have yet to be decided and communicated to industryparticipants. This uncertainty in the interpretation of the legislation increases the chances of an error in price reporting, which could in turn lead to a legalchallenge, restatement or investigation.If we become subject to investigations, restatements, or other inquiries concerning our compliance with price reporting laws and regulations, we could berequired to pay or be subject to additional reimbursements, penalties, sanctions or fines, which could have a material adverse effect on our business, financialcondition and results of operations.Our processes for estimating amounts due under these governmental pricing programs involve subjective decisions and estimates. Often, state Medicaidprograms may be slow to invoice pharmaceutical companies for these rebates resulting in a significant lag between the time a sale is recorded and the time therebate is paid. This results in us having to carry a significant liability on our consolidated balance sheets for the estimate of rebate claims expected forMedicaid patients. For example, almost half of Makena sales are reimbursed through state Medicaid programs and are subject to the statutory Medicaidrebate, and in some cases, supplemental rebates offered by us. If actual claims are higher than current estimates, our financial position and results ofoperations could be adversely affected.We are liable for errors associated with our submission of pricing data. In addition to retroactive rebates and the potential for 340B drug pricing programrefunds, if we are found to have knowingly submitted any false price information related to the Medicaid Drug Rebate Program to CMS to the government,we may be liable for civil monetary penalties in the amount of $100,000 per item of false information. If we are found to have made a misrepresentation in thereporting of our average sales price, the Medicare statute provides for civil monetary penalties of up to $10,000 for each misrepresentation for each day inwhich the misrepresentation was applied. Our failure to submit the required price data to CMS on a timely basis could result in a civil monetary penalty of$10,000 per day for each day the information is late beyond the due date. Such failure could also be grounds for CMS to terminate our Medicaid drug rebateagreement, pursuant to which we participate in the Medicaid program. In the event that CMS terminates our rebate agreement, federal payments may not beavailable under government programs, including Medicaid or Medicare Part B, for our covered outpatient drugs.Additionally, if we overcharge the government in connection with the FSS contract or Tricare Retail Pharmacy Program, whether due to a misstated FCPor otherwise, we are required to refund the difference to the government. Failure to make necessary disclosures and/or to identify contract overcharges canresult in allegations against us under the FCA and other laws and regulations. Unexpected refunds to the government, and responding to a governmentinvestigation or enforcement action, would be expensive and time-consuming, and could have a material adverse effect on our business, financial condition,results of operations and growth prospects.Our partners, including our licensors, are subject to similar requirements and thus the attendant risks and uncertainties. If our partners, including ourlicensors, suffer material and adverse effects from such risks and uncertainties, our rights and54Table of Contentsbenefits for our licensed products could be negatively impacted, which could have a material and adverse impact on our revenues.We are subject to ongoing regulatory obligations and oversight of our products and services, and any failure by us to maintain compliance with applicableregulations may result in several adverse consequences including the suspension of the manufacturing, marketing and sale of our respective products andservices, the incurrence of significant additional expense and other limitations on our ability to commercialize our respective products and services.We are subject to ongoing regulatory requirements and review, including by periodic audits pertaining to the development, manufacture, labeling,packaging, adverse event reporting, distribution, storage, marketing, promotion, record keeping and export of our respective products and for theirpreservation and, storage and other activities associated with the CBR Services. Failure to comply with such regulatory requirements or the later discovery ofpreviously unknown problems with our products or services, or our third-party contract manufacturing facilities or processes by which we manufacture ourproducts or supply our services may result in restrictions on our ability to manufacture, market, distribute or sell our products or services, including potentialwithdrawal of our products from the market. Any such restrictions could result in a decrease in sales, damage to our reputation or the initiation of lawsuitsagainst us and/or our third-party contract manufacturers. We may also be subject to additional sanctions, including but not limited to the following:•Warning letters, public warnings and untitled letters;•Court-ordered seizures or injunctions;•Civil or criminal penalties, or criminal prosecutions;•Variation, suspension or withdrawal of regulatory approvals for our products or services;•Changes to the package insert of our products, such as additional warnings regarding potential side effects or potential limitations on the currentdosage and administration;•Requirements to communicate with physicians and other customers about concerns related to actual or potential safety, efficacy, or other issuesinvolving our products and services;•Implementation of risk mitigation programs and post-marketing obligations;•Restrictions on our continued manufacturing, marketing, distribution or sale of our products, or the ability to continue to market our services;•Temporary or permanent closing of the facilities of our third-party contract manufacturers;•Interruption of clinical trials;•For HCT/Ps, including umbilical cord blood stem cells and cord tissue, recalls, destruction orders, or cease manufacturing orders; and•Refusal by regulators to consider or approve applications for additional indications.Any of the above sanctions could have a material adverse impact on our revenues and profitability or the value of our brand, and cause us to incursignificant additional expenses.Further, our partners, including our licensors, are subject to similar requirements and obligations as well as the attendant risks and uncertainties. If ourpartners, including our licensors, suffer material and adverse effects from such risks and uncertainties, our rights and benefits for our licensed products couldbe negatively impacted, which could have a material and adverse impact on our revenues.55Table of ContentsRegulators could determine that our clinical trials and/or our manufacturing processes, and/or our storage or those of our third parties, were not properlydesigned or are not properly operated, which could cause significant costs or setbacks for our commercialization activities.We are obligated to conduct, and are in the process of conducting, certain post-approval clinical trials, including in pursuit of the broader IDA indicationfor Feraheme, and we may be required to conduct additional clinical trials, including if we pursue approval of additional indications, new formulations ormethods of administration for our products, seek commercialization in other jurisdictions, or in support of our current indications. Similarly, our licensorswill be conducting certain clinical trials to gain approval in various indications for product candidates. The FDA could determine that our clinical trials, orthose of our licensors, and/or our or their manufacturing processes were not properly designed, did not include enough patients or appropriate administration,were not conducted in accordance with applicable laws and regulations, or were otherwise not properly managed. In addition, according to current goodclinical practices regulations (“cGCP”) we and/or our licensors are responsible for conducting, recording and reporting the results of clinical trials to ensurethat the data and results are credible and accurate and that the trial participants are adequately protected. The FDA may conduct inspections of clinicalinvestigator sites which are involved in clinical development programs for our proprietary or licensed products to ensure their compliance with cGCPregulations. If the FDA determines that we, our licensors, our respective CROs or our respective study sites fail to comply with applicable cGCP regulations,the FDA may deem the clinical data generated in such clinical trials to be unreliable and may disqualify certain data generated from those sites or require usand/or our licensors to perform additional clinical trials. Clinical trials and manufacturing processes are subject to similar risks and uncertainties outside ofthe U.S. Any such deficiency in the design, implementation or oversight of clinical development programs or post-approval clinical studies could cause us toincur significant additional costs, experience delays or prevent us from commercializing our approved products in their current indications, or obtainingmarketing approval for additional indications or for product candidates, including the approval for the use of Feraheme for the broad IDA indication orRekynda for the treatment of HSDD in pre-menopausal women.In addition, the Current Good Tissue Practices rule governs the processing and distribution of cord blood stem cells and cord tissue and covers all stagesof HCT/P processing, from procurement to distribution of final allografts. CBR is registered with the FDA as an HCT/P establishment that screens, packages,processes, stores, labels and distributes umbilical cord blood stem cells and cord tissue by virtue of the services it provides to expectant parents as a privatecord blood and cord tissue bank. The FDA periodically inspects such registered establishments to determine compliance with HCT/P requirements.Violations of applicable regulations noted by the FDA during facility inspections could adversely affect the continued operation and marketing of the CBRServices.Further, our third-party contract manufacturing facilities and those of our licensors are subject to cGMP regulations enforced by the FDA and equivalentforeign regulations and regulatory agencies through periodic inspections to confirm such compliance. Contract manufacturers must continually expend time,money and effort in production, record-keeping and quality assurance and control to ensure that these manufacturing facilities meet applicable regulatoryrequirements. Failure to maintain ongoing compliance with cGMP or similar foreign regulations and other applicable manufacturing requirements of variousU.S. or foreign regulatory agencies could result in, among other things, the issuance of warning letters, fines, the withdrawal or recall of our products from themarketplace, failure to approve product candidates for commercialization, total or partial suspension of product production, the loss of inventory, suspensionof the review of our or our licensors’ current or future sNDAs or equivalent foreign filings, enforcement actions, injunctions or criminal prosecution andsuspension of manufacturing authorizations. A government-mandated recall or a voluntary recall could divert managerial and financial resources, could bedifficult and costly to correct, could result in the suspension of sales of our products and could have a severe adverse impact on our profitability and thefuture prospects of our business. If any regulatory agency inspects any of these manufacturing facilities and determines that they are not in compliance withcGMP or similar regulations or our contract manufacturers otherwise determine that they are not in compliance with these regulations, as applicable, suchcontract manufacturers could experience an inability to manufacture sufficient quantities of product to meet demand or incur unanticipated complianceexpenditures.We and our licensors have also established certain testing and release specifications with the FDA. This release testing must be performed in order toallow finished product to be used for commercial sale. If a finished product does not meet these release specifications or if the release testing is variable, wemay not be able to supply product to meet our projected demand. We monitor annual batches of our finished product for ongoing stability after it has beenreleased for commercial sale. If a particular batch of finished drug product exhibits variations in its stability or begins to generate test results that demonstratean adverse trend against our specifications, we may need to conduct an investigation into the test results, quarantine the product to prevent further use,destroy existing inventory no longer acceptable for commercial sale, or recall the batch or batches. If we or our licensors are unable to develop, validate,transfer or gain regulatory approval for the new release test, our ability to supply product will be adversely affected. Such setbacks could have an adverseimpact on our revenues, our profitability and the future prospects of our business.56Table of ContentsOur failure to comply with data protection laws and regulations could lead to government enforcement actions (which could include civil or criminalpenalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business.We are subject to data protection laws and regulations (i.e., laws and regulations that address privacy and data security). The legislative and regulatorylandscape for data protection continues to evolve, and in recent years there has been an increasing focus on privacy and data security issues. In the U.S.,numerous federal and state laws and regulations, including state data breach notification laws, state health information privacy laws, and federal and stateconsumer protection laws, govern the collection, use, disclosure, and protection of health-related and other personal information. Failure to comply with dataprotection laws and regulations could result in government enforcement actions (which could include civil or criminal penalties), private litigation, and/oradverse publicity and could negatively affect our operating results and business. In addition, we may obtain health information from third parties (e.g.,healthcare providers who prescribe our products) that are subject to privacy and security requirements under the Health Insurance Portability andAccountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”). Although we are notdirectly subject to HIPAA (other than potentially with respect to providing certain employee benefits) we could be subject to criminal penalties if weknowingly obtain or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized orpermitted by HIPAA.Risks Related to Our Business GenerallyWith our Lumara Health and CBR acquisitions, and with the Rekynda License, we have significantly expanded the size of our product portfolio and ouroverall organization and we may experience difficulties in managing this or future expansion.With the Lumara Health and CBR acquisitions, we more than doubled the size of our employee-base and with the Rekynda License Agreement we haveconsiderably expanded our product portfolio by obtaining certain commercialization rights to Rekynda. Management, personnel, systems and facilities thatwe currently have in place may not be adequate to support this recent growth (especially given that the Rekynda License Agreement did not include theacquisition of or rights to any infrastructure or personnel of our licensors) and the addition of a service-based business to our portfolio, and we may not beable to retain or recruit qualified personnel in the future in this competitive environment to adequately support our expanded organization and diversifiedportfolio. To manage this and any future growth effectively, we will be required to continue to manage and expand the sales and marketing efforts for ourexisting products and services while continuing to identify and acquire attractive additions to our portfolio, develop our oversight and collaboration effortsfor our licensed products, including development-staged products, enhance our operational, financial and management controls, reporting systems andprocedures, benefit plan maintenance, and establish and increase our access to commercial supplies of our products and call points for our services, whichwill be challenging and for which we might not be successful, especially given our newly-expanded organization. We will be required to expand andmaintain our facilities and equipment and manage our internal development efforts effectively while complying with our contractual obligations to licensors,licensees, contractors, collaborators, distributors and other third parties and we will have to manage multiple geographic locations across the U.S., which wehave limited experience doing. In addition, management may have to divert a disproportionate amount of its attention away from day-to-day activities andtowards managing these growth activities, which could be disruptive to our business. Our future financial performance and our ability to execute on ourbusiness plan will depend, in part, on our ability to effectively manage our recent and any future growth. If we experience difficulties or are unsuccessful inmanaging our expansion, our results of operations and business prospects will be negatively impacted.Further, as we continue to add acquired and licensed products to our portfolio, we may face legal, regulatory, and compliance scrutiny or increasedexpenses as a result of the target’s or licensor’s pre-acquisition or pre-license business practices, including if such targets or licensors were alleged to haveviolated any privacy, data security, or other healthcare compliance laws, or failed to comply with all applicable FDA laws and requirements, regardless ofwhether such allegations have merit. Our recourse for such risks may be limited depending upon the remedies we are able to negotiate in the relevanttransaction agreements. If any issues arise, we may not be entitled to sufficient, or any, indemnification or recourse from the licensor or the acquired company,which could have a materially adverse impact on our business and results of operations.Our level of indebtedness and the terms of the 2015 Term Loan Facility, 2023 Senior Notes and Convertible Notes could adversely affect our operationsand limit our ability to plan for or respond to changes in our business or acquire additional products for our portfolio. If we are unable to comply withrestrictions in the 2015 Term Loan Facility, or cannot repay or refinance the 2023 Senior Notes or Convertible Notes, the repayment of our indebtednesscould be accelerated.In order to consummate the CBR acquisition, we incurred a substantial amount of additional debt, which could adversely affect our business. As ofDecember 31, 2016, we had approximately $1.0 billion of total debt outstanding. In August 2015, we57Table of Contentsentered into the 2015 Term Loan Facility, with a floating annual interest rate (currently 4.75%), and issued $500.0 million in aggregate principal SeniorNotes due 2023 bearing interest at 7.875% annually (the “2023 Senior Notes”) to help fund our acquisition of CBR and the further expansion anddiversification of our portfolio through the in-license or purchase of additional pharmaceutical products or companies, among other things. We also incurredindebtedness in February 2014 in the amount of $200.0 million in aggregate principal convertible notes due February 15, 2019 bearing interest at 2.5%annually (the “Convertible Notes”). Our high level of indebtedness could adversely affect our business in the following ways, among other things:•Make it more difficult for us to satisfy our financial obligations under our current debt obligations, or other indebtedness, as well as our contractualand commercial commitments, and could increase the risk that we may default on our debt obligations;•Prevent us from raising the funds necessary to repurchase 2023 Senior Notes tendered to us if there is a change of control, which would constitute adefault under the indenture governing the 2023 Senior Notes, the Convertible Notes and the 2015 Term Loan Facility;•Require us to use a substantial portion of our cash flow from operations to pay interest and principal on our current debt obligations or otherindebtedness, which would reduce the funds available for working capital, capital expenditures and other general corporate purposes;•Limit our ability to obtain additional financing for working capital, capital expenditures, acquisitions and other investments or general corporatepurposes, which may limit the ability to execute our business strategy;•Heighten our vulnerability to downturns in our business, our industry or in the general economy, and restrict us from exploiting businessopportunities or making acquisitions;•Place us at a competitive disadvantage compared to those of our competitors that may have proportionately less debt;•Limit management’s discretion in operating our business;•Limit our flexibility in planning for, or reacting to, changes in our business, the industry in which we operate or the general economy; and•Result in higher interest expense if interest rates increase and we have outstanding floating rate borrowings such as our 2015 Term Loan Facility.Our ability to make scheduled payments of the principal of, to pay interest on or to refinance our indebtedness, including the 2015 Term Loan Facility,the 2023 Senior Notes and the Convertible Notes (“our current debt obligations”), depends on our future performance, which is subject to economic,financial, competitive and other factors that may be beyond our control. Our business may not generate cash flow from operations in the future sufficient toservice our debt and support our growth strategies. If we are unable to generate such cash flow, we may be required to adopt one or more alternatives, such asselling assets, restructuring debt or obtaining additional equity capital on terms that may be onerous or highly dilutive. Our ability to refinance ourindebtedness will depend on the capital markets and our financial condition at such time. We may not be able to engage in any of these activities or engagein these activities on desirable terms, which could result in a default on our debt obligations, including under our current debt obligations. In addition, if forany reason we are unable to meet our debt service and repayment obligations, we would be in default under the terms of the agreements governing ourindebtedness, which would allow our creditors at that time to declare all outstanding indebtedness to be due and payable. This would likely in turn triggercross-acceleration or cross-default rights between our applicable debt agreements. Under these circumstances, our lenders could compel us to apply all of ouravailable cash to repay our indebtedness or they could prevent us from making payments on our current debt obligations.The 2015 Term Loan Facility requires us to make certain payments of principal and interest over time and contains a number of other restrictivecovenants. The 2015 Term Loan Facility also contains covenants and terms limiting our ability to enter into new acquisitions, licenses, mergers, foreigninvestments, to take on new debt and sell assets, and requiring us to pay penalties in the event we want to prepay the 2015 Term Loan Facility early. Thematurity date of the 2015 Term Loan Facility could also be accelerated in certain circumstances, including in the event of an uncured event of default asoutlined in the 2015 Term Loan Facility. The 2015 Term Loan Facility has a floating interest rate based on the prevailing London Interbank Offered Rate,making interest payments subject to adjustment depending on the interest rate environment. These and other terms in the58Table of Contents2015 Term Loan Facility have to be monitored closely for compliance and could restrict our ability to grow our business or enter into transactions that webelieve will be beneficial to our business.Also, upon the occurrence of specific types of change of control events, we will be required to offer to repurchase all of the outstanding 2023 SeniorNotes at a price equal to 101% of the aggregate principal amount of the 2023 Senior Notes repurchased, plus accrued and unpaid interest up to, but notincluding, the date of repurchase. In addition, in connection with certain asset sales, we may be required to offer to repurchase a portion of the 2023 SeniorNotes at a price equal to 100% of the principal amount, plus accrued and unpaid interest and additional interest up to, but not including, the date ofrepurchase. We may not have sufficient funds available to repurchase all of the 2023 Senior Notes tendered pursuant to any such offer and any other debt thatwould become payable upon a change of control or in connection with such an asset sale offer. The 2015 Term Loan Facility also limits our ability torepurchase the 2023 Senior Notes. Our failure to repurchase the 2023 Senior Notes upon the occurrence of specific types of change of control events would bea default under the indenture governing the 2023 Senior Notes, which would in turn trigger a default under our 2015 Term Loan Facility, the indenturegoverning the Convertible Notes and may trigger a default under any future credit facility and the terms of our other indebtedness outstanding at such time.Further, holders of the Convertible Notes have the right to require us to repurchase their notes upon the occurrence of a fundamental change at arepurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest. Upon conversion of the ConvertibleNotes, unless we elect to deliver solely shares of our common stock to settle such conversion (other than paying cash in lieu of delivering any fractionalshare), we will be required to make cash payments in respect of the notes being converted. We may not have enough available cash or be able to obtainfinancing at the time we are required to make repurchases of Convertible Notes surrendered therefore or at the time Convertible Notes are being converted.Our failure to repurchase Convertible Notes at a time when the repurchase is required by the indenture or to pay any cash payable on future conversions of theConvertible Notes would constitute an event of default. Moreover, if our stock price increases, the parties with whom we entered into warrant transactions inconnection with the pricing of the Convertible Notes (the “Warrants”) could exercise such warrants, thereby causing substantial dilution to our stockholders.The Convertible Notes are, the Warrants may be, and any additional equity or equity-linked financings or alternative strategic arrangements would be,dilutive to our stockholders.Our 2015 Term Loan Facility and the indenture governing the 2023 Senior Notes impose operating and financial restrictions on us and our subsidiariesthat may prevent us from pursuing certain business opportunities and restrict our ability to operate our business.The terms of our current debt instruments or any additional debt financing could greatly restrict our ability to raise additional capital and may providerights and preferences to the investors in any such financing which are senior to those of, and not available to, current stockholders, impose restrictions onour day-to-day operations or place limitations on our ability to enter into combination transactions with other entities. Our inability to raise additionalcapital on terms and within a timeframe acceptable to us when needed could force us to dramatically reduce our expenses and delay, scale back or eliminatecertain of our activities and operations, including our commercialization and development activities, any of which would have a material adverse effect onour business, financial condition and future business prospects.Our 2015 Term Loan Facility and the indenture governing the 2023 Senior Notes contain covenants that restrict our and our restricted subsidiaries’ability to take various actions, such as:•Paying dividends, redeeming subordinated indebtedness or making other restricted payments, including certain investments;•Incurring or guaranteeing additional indebtedness or issuing preferred stock;•Creating or incurring liens;•Consummating a merger;•Consolidating or selling all or substantially all of our or our subsidiaries’ assets;•Entering into transactions with affiliates;•Transferring or selling assets;59Table of Contents•Engaging in businesses other than our current businesses and reasonably related extensions thereof;•Designating subsidiaries as unrestricted subsidiaries; and•Allowing to exist certain restrictions on the ability of restricted subsidiaries to pay dividends or make other payments to us.We cannot make any assurances that our future operating results will be sufficient to ensure compliance with the covenants in these arrangements or toremedy any such default. In the event of an acceleration of this indebtedness, we may not have or be able to obtain sufficient funds to make any acceleratedpayments. Any of the factors discussed above could materially and adversely affect our business, financial condition and results of operations. In addition, ifwe incur additional indebtedness, the risks related to our business and our ability to service or repay our indebtedness would increase.Our variable rate indebtedness subjects us to interest rate risk, which could cause our debt service obligations to increase significantly.Borrowings under our 2015 Term Loan Facility, and other indebtedness we incur in the future may, bear interest at variable rates exposing us to interestrate risk. If interest rates increase, our debt service obligations on the variable rate indebtedness would increase even though the amount borrowed remainedthe same, and our net income and cash available for servicing our indebtedness would decrease.We may need additional capital to achieve our business objectives and to service our debt obligations, including the 2015 Term Loan Facility, ourConvertible Notes, our 2023 Senior Notes and contingent payments that may become due under the Lumara Agreement, which could cause significantdilution to our stockholders.We may require additional funds or need to establish additional alternative strategic arrangements to execute a business development transaction. Wemay at any time seek funding through additional arrangements with collaborators through public or private equity or debt financings, subject to thecovenants in the documents governing our debt obligations. We may not be able to obtain financing or to secure alternative strategic arrangements onacceptable terms or within an acceptable timeframe, if at all, which would limit our ability to execute on our strategic plan. Moreover, the condition of thecredit markets can be unpredictable and we may experience a reduction in value or loss of liquidity with respect to our investments, which would put furtherstrain on our cash resources.Our current level of cash on hand may limit our ability to take advantage of attractive business development opportunities and execute on our strategicplan. In addition, our cash on hand may not be sufficient to service the principal and interest payments under our current debt obligations or any cashmilestone payments to the former Lumara Health security holders upon the achievement of sales milestones. Our ability to make these required paymentscould be adversely affected if we do not achieve expected revenue and cash flow forecasts or if we are unable to find other sources of cash in the future andwe may need to offer the former Lumara Health security holders shares of our common stock or issue shares of our common stock to raise cash resulting indilution to our stockholders. For example, if equity or debt investors perceive that our debt levels are too high relative to our profit, our stock price could benegatively affected and/or our ability to raise new equity or debt capital could be limited.Our long-term capital requirements will depend on many other factors, including, but not limited to the commercial success of our products and effortswe make in connection with commercialization and development, our ability to realize synergies and opportunities in connection with our acquisitions andportfolio expansion, the outcome of and costs associated with any material litigation or patent challenges to which we are or may become a party, the timingand magnitude of costs associated with qualifying additional manufacturing capacities and alternative suppliers, and our ability to raise additional capital onterms and within a timeframe acceptable to us, if necessary.Our ability to use net operating loss carryforwards and tax credit carryforwards is dependent on generating future taxable income and may be limited,including as a result of future transactions involving our common stock.In general, under Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”), a corporation that undergoes an “ownership change” issubject to limitations on its ability to utilize its pre-change net operating losses and certain other tax assets to offset future taxable income. In general, anownership change occurs if the aggregate stock ownership of certain stockholders increases by more than 50 percentage points over such stockholders’lowest percentage ownership during the testing period, which is generally three years. An ownership change could limit our ability to utilize our netoperating loss and tax credit carryforwards for taxable years including or following such “ownership change” by allowing us to utilize only a60Table of Contentsportion of the net operating losses and tax credits that would otherwise be available but for such ownership change. Limitations imposed on the ability to usenet operating losses and tax credits to offset future taxable income or the failure to generate sufficient taxable income could require us to pay more U.S.federal income taxes than we have estimated and could cause such net operating losses and tax credits to expire unused, in each case reducing or eliminatingthe benefit of such net operating losses and tax credits and potentially adversely affecting our financial position, including our after-tax net income. Similarrules and limitations may apply for state income tax purposes.In September 2014, we adopted an amendment to our shareholder rights plan to help preserve our tax assets by deterring certain stockholders fromincreasing their percentage ownership in our stock; however, such amendment is merely a deterrent that does not actually prevent Section 382 ownershiplimitations and there can be no assurance that we will not undergo an ownership change. Even minor accumulations by certain of our stockholders couldresult in triggering an ownership change under Section 382. If such an ownership change were to occur, we expect that our net operating losses could becomelimited; however, the amount of the limitation would depend on a number of factors including our market value at the time of the ownership change. For adiscussion of the amendment to our shareholder rights plan, see the discussion in Note N, “Stockholders’ Equity,” to our consolidated financial statementsincluded in this Annual Report on Form 10-K.In addition, we have recorded deferred tax assets based on our assessment that we will be able to realize the benefits of our net operating losses and otherfavorable tax attributes. Realization of deferred tax assets involve significant judgments and estimates which are subject to change and ultimately dependson generating sufficient taxable income of the appropriate character during the appropriate periods. Changes in circumstances may affect the likelihood ofsuch realization, which in turn may trigger a write-down of our deferred tax assets, the amount of which would depend on a number of factors. A write-downwould reduce our reported net income, which may adversely impact our financial condition or results of operations or cash flows. In addition, we arepotentially subject to ongoing and periodic tax examinations and audits in various jurisdictions, including with respect to the amount of our net operatinglosses and any limitation thereon. An adjustment to such net operating loss carryforwards, including an adjustment from a taxing authority, could result inhigher tax costs, penalties and interest, thereby adversely impacting our financial condition, results of operations or cash flows.An adverse determination in any current or future lawsuits in which we are a defendant could have a material adverse effect on us.The administration of our products to, or the use of our products by, humans may expose us to liability claims, whether or not our products are actually atfault for causing any harm or injury. As Feraheme is used over longer periods of time by a wider group of patients taking numerous other medicines or bypatients with additional underlying health problems, the likelihood of adverse drug reactions or unintended side effects, including death, may increase.While these adverse events are rare, all IV irons, including Feraheme, can cause patients to experience serious hypersensitivity reactions, includinganaphylactic-type reactions, some of which have been life-threatening and/or fatal. Makena is a prescription hormone medicine (progestin) used to lower therisk of preterm birth in women who are pregnant and who have previously delivered preterm in the past. It is not known if Makena is safe and effective inwomen who have other risk factors for preterm birth. In one clinical study, certain complications or events associated with pregnancy occurred more often inwomen who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), hospital admission for preterm labor,preeclampsia, gestational hypertension and gestational diabetes. In addition, other hormones administered during pregnancy have in the past been shown tocross the placenta and have negative effects on the offspring. Similarly, as Rekynda, if approved is introduced to the market, more serious adverse reactionsthan those reported during clinical trials could arise. Although we maintain product liability insurance coverage for claims arising from the use of ourproducts in clinical trials and commercial use, coverage is expensive, and we may not be able to maintain sufficient insurance at a reasonable cost, if at all.Product liability claims, whether or not they have merit, could also decrease demand for our products, subject us to product recalls or harm our reputation,cause us to incur substantial costs, and divert management’s time and attention.We may also be the target of claims asserting violations of securities and fraud and abuse laws and derivative actions or other litigation. Any suchlitigation could result in substantial costs and divert our management’s attention and resources, which could cause serious harm to our business, operatingresults and financial condition. Further, we may not be successful in defending ourselves in the litigation and, as a result, our business could be materiallyharmed. These lawsuits may result in large judgments or settlements against us, any of which could have a negative effect on our financial condition andbusiness if in excess of our insurance coverage. Though we maintain liability insurance, if any costs or expenses associated with litigation exceed ourinsurance coverage, we may be forced to bear some or all of these costs and expenses directly, which could be substantial.61Table of ContentsOur success depends on our ability to attract and retain key employees, and any failure to do so may be disruptive to our operations.We are a pharmaceutical company focused on marketing commercial products and services and we plan to continue to expand our portfolio, includingthrough the addition of commercial or development-stage products or services through acquisitions and in-licensing; thus, the range of skills of ourexecutive officers needs to be broad and deep. If we are not able to hire and retain talent to drive commercialization and expansion of our portfolio, we willbe unlikely to maintain profitability. Because of the specialized nature of our business, including the recent introductions of a service-based business modeland development-stage licensed product, our success depends to a significant extent on our ability to continue to attract, retain and motivate qualified sales,technical operations, managerial, scientific, regulatory compliance and medical personnel of all levels. The loss of key personnel or our inability to hire andretain personnel who have such sales, technical operations, managerial, scientific, regulatory compliance and medical backgrounds could materiallyadversely affect our business (including research and development efforts).Our operating results will likely fluctuate, including as a result of wholesaler, distributor and customer buying patterns, so you should not rely on theresults of any single quarter to predict how we will perform over time.Our future operating results will likely vary from quarter to quarter depending on a number of factors, including the factors described in these RiskFactors, many of which we cannot control, as well as the timing and magnitude of:•Product revenues;•The loss of a key customer or GPO;•Costs and liabilities incurred in connection with business development activities or business development transactions into which we mayenter;•Costs associated with the commercialization of our products and services;•Milestone payments we may be required to pay pursuant to contractual obligations, including the Lumara Health Agreement and the RekyndaLicense Agreement;•Tax payments and of principal and interest payments in connection with our debt obligations, including the 2015 Term Loan Facility, the 2023Notes and our Convertible Notes;•Costs associated with the manufacture of our products and collection, processing and storage services, including costs of raw and other materialsand costs associated with maintaining commercial inventory and qualifying additional manufacturing capacities and alternative suppliers;•The recognition of deferred tax assets during periods in which we generate taxable income and our ability to preserve our net operating losscarryforwards and other tax assets;•Costs associated with our ongoing and planned clinical studies of Feraheme, including costs associated with pursuing a broader indication ofFeraheme;•Costs associated with the ongoing and planned clinical studies of Makena in connection with current or future post-approval commitments, andour pursuit of our multi-pronged next generation development programs for Makena;•Costs associated with our obligations under the Rekynda License Agreement;•Any changes to the mix of our business;•Costs associated with manufacturing batch failures or inventory write-offs due to out-of-specification release testing or ongoing stability testingthat results in a batch no longer meeting specifications;•Changes in accounting estimates related to reserves on revenue, returns, contingent consideration, impairment of long-lived or intangible assetsor other accruals or changes in the timing and availability of government or customer discounts, rebates and incentives; and62Table of Contents•The implementation of new or revised accounting or tax rules or policies.Our results of operations, including, in particular, product revenues, may also vary from period to period due to the buying patterns of our wholesalers,distributors, pharmacies, clinics or hospitals and specialty pharmacies. Further, our contracts with GPOs often require certain performance from the membersof the GPOs on an individual account level or group level such as growth over prior periods or certain market share attainment goals in order to qualify fordiscounts off the list price of our products, and a GPO may be able to influence the demand for our products from its members in a particular quarter throughcommunications they make to their members. In the event wholesalers, distributors, pharmacies, clinics or hospitals with whom we do business determine tolimit their purchases of our products, our product revenues could be adversely affected. Also, in the event wholesalers, distributors, pharmacies, clinics orhospitals purchase increased quantities of our products to take advantage of volume discounts or similar benefits, our quarterly results will fluctuate as re-orders become less frequent, and our overall net pricing may decrease as a result of such discounts and similar benefits. In addition, these contracts are oftencancellable at any time by our customers, often without notice, and are non-exclusive agreements within the Feraheme or Makena markets. While thesecontracts are intended to support the use of our products, our competitors could offer better pricing, incentives, higher rebates or exclusive relationships.Because Feraheme is not indicated for the broad IDA population, the incentives in our contracts for a particular site of care are capped based on our estimateof their patients covered by our current CKD label. Because some of our competitors’ products have the broad IDA label, they may provide additionalincentives for all of a customer’s IV iron usage, essentially becoming an exclusive provider to that particular customer.Our contracting strategy can also have an impact on the timing of certain purchases causing product revenues to vary from quarter to quarter. Forexample, in advance of an anticipated or rumored price increase, including following the publication of our quarterly ASP, which affects the rate at whichFeraheme is reimbursed, or a reduction in expected rebates or discounts for one of our products, customers may order our products in larger than normalquantities, which could cause sales to be lower in subsequent quarters than they would have been otherwise. Further, any changes in purchasing patterns orinventory levels, changes to our contracting strategy, increases in product returns, delays in purchasing products or delays in payment for products by one ofour distributors or GPOs could also have a negative impact on our revenue and results of operations.As a result of these and other factors, our quarterly operating results could fluctuate, and this fluctuation could cause the market price of our commonstock to decline. Results from one quarter should not be used as an indication of future performance.If the estimates we make, or the assumptions on which we rely, in preparing our consolidated financial statements and/or our projected guidance proveinaccurate, our actual results may vary from those reflected in our projections and accruals.Our consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of theseconsolidated financial statements requires management to make certain estimates and assumptions that affect the reported amounts of our assets, liabilities,revenues and expenses, and the related disclosure of contingent assets and liabilities. On an ongoing basis, our management evaluates our critical and othersignificant estimates and assumptions, including among others those associated with revenue recognition related to product and services sales; product salesallowances and accruals; investments; inventory; acquisition date fair value and subsequent fair value estimates used to assess impairment of long-livedassets, including goodwill, in-process research and development and other intangible assets; contingent consideration; debt obligations; certain accruedliabilities, including clinical trial accruals and restructuring liabilities; income taxes and equity-based compensation expense. We base our estimates onmarket data, our observance of trends in our industry, and various other assumptions that we believe to be reasonable under the circumstances. If actualresults differ from these estimates, there could be a material adverse effect on our financial results and the performance of our stock.Further, in January 2017, we issued financial guidance, including expected 2017 total revenues and Makena, CBR and Feraheme and MuGard net sales,which is likewise based on estimates and the judgment of management. If, for any reason, we are unable to realize our projected 2017 revenue, we may notrealize our publicly announced financial guidance. If we fail to realize, or if we change or update any element of, our publicly disclosed financial guidance orother expectations about our business, our stock price could decline in value. For example, we intend to update our 2017 guidance to account for additionalexpenses related to the recently announced licensing transaction with Endoceutics.As part of our revenue recognition policy, our estimates of product returns, rebates and chargebacks, accounts receivable, fees and other discounts requiresubjective and complex judgments due to the need to make estimates about matters that are inherently uncertain. Any significant differences between ouractual results and our estimates could materially affect our financial position and results of operations.63Table of ContentsIn addition, to determine the required quantities of Feraheme, Makena, and the materials that support the CBR Services and their related manufacturingschedules, we also need to make significant judgments and estimates based on inventory levels, current market trends, anticipated sales, forecasts and otherfactors. Because of the inherent nature of estimates, there could be significant differences between our estimates and the actual amount of product need. Forexample, the level of our access to wholesaler and distributor inventory levels and sales data, which varies based on the wholesaler, distributor, clinic orhospital, affects our ability to accurately estimate certain reserves included in our financial statements. Any difference between our estimates and the actualamount of product or services demand could result in unmet demand or excess inventory, each of which would adversely impact our financial results andresults of operations.Our stock price has been and may continue to be volatile, and your investment in our stock could decline in value or fluctuate significantly, including as aresult of analysts’ activities.The market price of our common stock has been, and may continue to be, volatile, and your investment in our stock could decline in value or fluctuatesignificantly. Our stock price has ranged between $17.92 and $36.83 in the fifty-two week period through February 13, 2017. The stock market has from timeto time experienced extreme price and volume fluctuations, particularly in the biotechnology and pharmaceuticals sectors, which have often been unrelatedto the operating performance of particular companies. Various factors and events, including the factors and events described in these Risk Factors, many ofwhich are beyond our control, may have a significant impact on the market price of our common stock. Our stock price could also be subject to fluctuationsas a result of general market conditions, shareholder activism and attempts to disrupt our strategy by activist investors, sales of large blocks of our commonstock, the impact of our stock repurchase program or the dilutive effect of our Convertible Notes, other equity or equity-linked financings, or alternativestrategic arrangements.In addition, the trading market for our common stock relies in part on the research and reports that industry or financial analysts publish about us and ourbusiness. We do not control these or any other analysts. Furthermore, there are many large, well-established, publicly traded companies active in our industryand market, which may mean that it is less likely that we will receive widespread analyst coverage. In addition, our future operating results are subject tosubstantial uncertainty, and our stock price could decline significantly if we fail to meet or exceed analysts’ forecasts and expectations. If any of the analystswho cover us downgrade our stock, lower their price target or issue commentary or observations about us or our stock that are perceived by the market asnegative, our stock price would likely decline rapidly. In addition, if these analysts cease coverage of our company, we could lose visibility in the market,which in turn could also cause our stock price to decline.If we identify a material weakness in our internal controls over financial reporting, our ability to meet our reporting obligations and the trading price ofour stock could be negatively affected.A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonablepossibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Accordingly, amaterial weakness increases the risk that the financial information we report contains material errors.We regularly review and update our internal controls, disclosure controls and procedures, and corporate governance policies. In addition, we are requiredunder the Sarbanes-Oxley Act of 2002 to report annually on our internal control over financial reporting. Any system of internal controls, however welldesigned and operated, is based in part on certain assumptions and can provide only reasonable, not absolute, assurances that the objectives of the system aremet. If we, or our independent registered public accounting firm, determine that our internal controls over our financial reporting are not effective, or wediscover areas that need improvement in the future, or we experience high turnover of our personnel in our financial reporting functions, these shortcomingscould have an adverse effect on our business and financial results, and the price of our common stock could be negatively affected.If we cannot conclude that we have effective internal control over our financial reporting, or if our independent registered public accounting firm isunable to provide an unqualified opinion regarding the effectiveness of our internal control over financial reporting, investors could lose confidence in thereliability of our financial statements, which could lead to a decline in our stock price. Failure to comply with reporting requirements could subject us tosanctions and/or investigations by the U.S. Securities and Exchange Commission, NASDAQ or other regulatory authorities.64Table of ContentsOur shareholder rights plan, certain provisions in our charter and by-laws, certain provisions of our Convertible Notes, certain contractual relationshipsand certain Delaware law provisions could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders, andmay prevent attempts by our stockholders to replace or remove the current members of our Board.We have a shareholder rights plan, the provisions of which are intended to protect our net operating loss and tax credit carryforwards. Although the planwas put in place to protect these assets, its provisions could function to deter a hostile takeover by making any proposed hostile acquisition of us moreexpensive and less desirable to a potential acquirer by enabling our stockholders (other than the potential hostile acquiror) to purchase significant amountsof additional shares of our common stock at dilutive prices. The rights issued pursuant to our shareholder rights plan, as amended in September 2014, becomeexercisable generally upon the earlier of 10 days after a person or group acquires 4.99% or more of our outstanding common stock or 10 business days afterthe announcement by a person or group of an intention to acquire 4.99% of our outstanding common stock via tender offer or similar transaction. Theshareholder rights plan could delay or discourage transactions involving an actual or potential change in control of us or our management, includingtransactions in which stockholders might otherwise receive a premium for their shares over then-current prices.In addition, certain provisions in our certificate of incorporation and our by-laws may discourage, delay or prevent a change of control or takeoverattempt of our company by a third-party as well as substantially impede the ability of our stockholders to benefit from a change of control or effect a changein management and our Board. These provisions include:•The ability of our Board to increase or decrease the size of the Board without stockholder approval;•Advance notice requirements for the nomination of candidates for election to our Board and for proposals to be brought before our annual meetingof stockholders;•The authority of our Board to designate the terms of and issue new series of preferred stock without stockholder approval;•Non-cumulative voting for directors; and•Limitations on the ability of our stockholders to call special meetings of stockholders.As a Delaware corporation, we are subject to the provisions of Section 203 of the Delaware General Corporation Law (“Section 203”), which prevents usfrom engaging in any business combination with any “interested stockholder,” which is defined generally as a person that acquires 15% or more of acorporation’s outstanding voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder,unless the business combination is approved in the manner prescribed in Section 203. These provisions could have the effect of delaying or preventing achange of control, whether or not it is desired by, or beneficial to, our stockholders.In addition to the above factors, an acquisition of our company could be made more difficult by employment agreements we have in place with ourexecutive officers, as well as a company-wide change of control policy, which provide for severance benefits as well as the full acceleration of vesting of anyoutstanding options or restricted stock units in the event of a change of control and subsequent termination of employment. Further, our Third Amended andRestated 2007 Equity Incentive Plan generally permits our Board to provide for the acceleration of vesting of options granted under that plan in the event ofcertain transactions that result in a change of control.Furthermore, holders of the Convertible Notes have the right to require us to repurchase their notes at a price equal to 100% of the principal amountthereof and the conversion rate for the Convertible Notes may be increased as described in the indenture, in each case, upon the occurrence of certain changeof control transactions. Additionally, upon certain change of control transactions, the offsetting convertible bond hedge and warrant transactions that weentered into at the time we issued the Convertible Notes may be exercised and/or terminated early. Upon any such exercise and/or early termination, theproceeds we receive upon the exercise of the convertible bond hedge transactions may prove to be significantly lower than the amounts we would be requiredto pay upon termination of the warrant transactions. These features of the Convertible Notes and the convertible bond hedge and warrants, including thefinancial implications of any renegotiation of the above-mentioned provisions, could have the effect of preventing a change of control, whether or not it isdesired by, or beneficial to, our stockholders, or may result in the acquisition of us being on terms less favorable to our stockholders than it would otherwisebe.65Table of ContentsSignificant disruptions of information technology systems or security breaches could adversely affect our business.We are increasingly dependent upon information technology systems, infrastructure, and data to operate our business. In the ordinary course of business,we collect, store, and transmit large amounts of confidential information (including but not limited to intellectual property, proprietary business information,and personal information). It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such confidential information. Wealso have outsourced elements of our operations to third parties, and as a result we manage a number of third-party vendors who may or could have access toour confidential information. The size and complexity of our information technology systems, and those of third-party vendors with whom we contract, andthe large amounts of confidential information stored on those systems, make such systems potentially vulnerable to service interruptions or to securitybreaches from inadvertent or intentional actions by our employees, third-party vendors, and/or business partners, or from cyber-attacks by malicious thirdparties. Cyber-attacks are increasing in their frequency, sophistication, and intensity, and have become increasingly difficult to detect. Cyber-attacks couldinclude the deployment of harmful malware, denial-of-service attacks, social engineering, and other means to affect service reliability and threaten theconfidentiality, integrity, and availability of information. Significant disruptions of our information technology systems or security breaches could adverselyaffect our business operations and/or result in the loss, misappropriation, and/or unauthorized access, use, or disclosure of, or the prevention of access to,confidential information (including but not limited to trade secrets or other intellectual property, proprietary business information, and personal information),and could result in financial, legal, business, and reputational harm to us. For example, any such event that leads to unauthorized access, use, or disclosure ofpersonal information, including personal information regarding our patients or employees, could harm our reputation, require us to comply with federaland/or state breach notification laws and foreign law equivalents, and otherwise subject us to liability under laws and regulations that protect the privacy andsecurity of personal information. Security breaches and other inappropriate access can be difficult to detect, and any delay in identifying them may lead toincreased harm of the type described above. While we have implemented security measures to protect our information technology systems and infrastructure,there can be no assurance that such measures will prevent service interruptions or security breaches that could adversely affect our business.ITEM 1B. UNRESOLVED STAFF COMMENTS:None.ITEM 2. PROPERTIES:We own an 80,000 square foot facility located at 6550 S Bay Colony Drive #160, Tucson, Arizona, which stores all of our customers’ cord blood andcord tissue samples.In June 2013, we entered into a lease agreement with BP Bay Colony LLC (the “Landlord”) for the lease of certain real property located at 1100 WinterStreet, Waltham, Massachusetts for use as our principal executive offices. Beginning in September 2013, the initial term of the lease is five years and twomonths with one five-year extension term at our option. During 2015, we entered into several amendments to the original lease to add additional space and toextend the term of the original lease to June 2021. In addition to base rent, we are also required to pay a proportionate share of the Landlord’s operating costs.We lease certain real property located at 1200 Bayhill Drive, San Bruno, California. The lease expires in September 2017.See Note P, “Commitments and Contingencies” to our consolidated financial statements included in this Annual Report on Form 10‑K for additionalinformation.66Table of ContentsITEM 3. LEGAL PROCEEDINGSWe accrue a liability for legal contingencies when we believe that it is both probable that a liability has been incurred and that we can reasonablyestimate the amount of the loss. We review these accruals and adjust them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel andother relevant information. To the extent new information is obtained and our views on the probable outcomes of claims, suits, assessments, investigations orlegal proceedings change, changes in our accrued liabilities would be recorded in the period in which such determination is made. For certain matters, theliability is not probable or the amount cannot be reasonably estimated and, therefore, accruals have not been made. In addition, in accordance with therelevant authoritative guidance, for any matters in which the likelihood of material loss is at least reasonably possible, we will provide disclosure of thepossible loss or range of loss. If a reasonable estimate cannot be made, however, we will provide disclosure to that effect. See Note P, “Commitments andContingencies” to our consolidated financial statements included in this Annual Report on Form 10-K for a description of our legal proceedings.ITEM 4. MINE SAFETY DISCLOSURESNot Applicable.67Table of ContentsPART II ITEM 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITYSECURITIES:Market InformationOur common stock trades on the NASDAQ Global Select Market (“NASDAQ”) under the trading symbol “AMAG.” On February 13, 2017, the closingprice of our common stock, as reported on the NASDAQ, was $22.70 per share. The following table sets forth, for the periods indicated, the high and low saleprices per share for our common stock as reported on the NASDAQ. High LowYear Ended December 31, 2016 First quarter$29.65 $20.22Second quarter$28.98 $17.92Third quarter$29.59 $22.01Fourth quarter$36.83 $22.81Year Ended December 31, 2015 First quarter$59.29 $38.25Second quarter$74.21 $50.32Third quarter$77.73 $37.73Fourth quarter$42.95 $25.26StockholdersOn February 13, 2017, we had approximately 80 stockholders of record of our common stock, and we believe that the number of beneficial holders of ourcommon stock was approximately 11,000 based on responses from brokers to a search conducted by Broadridge Financial Solutions, Inc. on our behalf.DividendsWe have never declared or paid a cash dividend on our common stock. We currently anticipate that we will retain all of our earnings for use in thedevelopment of our business and do not anticipate paying any cash dividends in the foreseeable future.Repurchases of Equity SecuritiesThe following table provides certain information with respect to our purchases of shares of our stock during the three months ended December 31, 2016.PeriodTotal Numberof SharesPurchased (1) Average PricePaid Per Share Total Number of Shares Purchased as Part ofPublicly AnnouncedPlans or Programs (2) Maximum Number of Shares (or approximatedollar value)That May Yet BePurchased Under thePlans or Programs (2)October 1, 2016 through October 31, 2016— $— — 1,556,420November 1, 2016 through November 30, 20164,026 30.89 — 1,204,819December 1, 2016 through December 31, 20166,084 33.87 — 1,149,425Total10,110 $32.68 — _________________________(1)Represents the surrender of shares of our common stock withheld by us to satisfy the minimum tax withholding obligations in connection with thevesting of restricted stock units held by our employees.68Table of Contents(2)We did not repurchase any of our common stock during the fourth quarter of 2016. We have repurchased and retired $20.0 million of our common stockunder our share repurchase program to date. These shares were purchased pursuant to a repurchase program authorized by our board of directors that wasannounced in January 2016 to repurchase up to $60.0 million of our common stock, of which $40.0 million remains outstanding as of December 31,2016. The repurchase program does not have an expiration date and may be suspended for periods or discontinued at any time.Securities Authorized for Issuance Under Equity Compensation PlansSee Part III, Item 12 for information regarding securities authorized for issuance under our equity compensation plans. Such information is incorporatedby reference to our definitive proxy statement pursuant to Regulation 14A, which we intend to file with the U.S. Securities and Exchange Commission (the“SEC”) not later than 120 days after the close of our year ended December 31, 2016.Five‑Year Comparative Stock PerformanceThe following graph compares the yearly percentage change in the cumulative total stockholder return on our common stock with the cumulative totalreturn on the NASDAQ Biotechnology Index and the NASDAQ Global Select Market Index over the past five years. The comparisons assume $100 wasinvested on December 31, 2011 in our common stock, the NASDAQ Biotechnology Index and the NASDAQ Global Select Market Index, and assumesreinvestment of dividends, if any. 12/31/2011 12/31/2012 12/31/2013 12/31/2014 12/31/2015 12/31/2016AMAG Pharmaceuticals, Inc.100.00 77.79 128.40 225.38 159.65 184.03NASDAQ Biotechnology Index100.00 132.74 220.37 296.19 331.05 260.37NASDAQ Global Select Market Index100.00 115.52 192.75 204.34 204.31 196.43The stock price performance shown in this performance graph is not necessarily indicative of future price performance. Information used in the graph wasobtained from Zach’s Investment Research, Inc., a source we believe is reliable.69Table of ContentsThe material in this section captioned Five-Year Comparative Stock Performance is being furnished and shall not be deemed “filed” with the SEC forpurposes of Section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall the material in this section be deemed to beincorporated by reference in any registration statement or other document filed with the SEC under the Securities Act of 1933, except to the extent wespecifically and expressly incorporate it by reference into such filing.70Table of ContentsITEM 6. SELECTED FINANCIAL DATA:The following table sets forth selected financial data as of and for the years ended December 31, 2016, 2015, 2014, 2013 and 2012. The selectedfinancial data set forth below has been derived from our audited financial statements. This information should be read in conjunction with the financialstatements and the related notes thereto included in Part II, Item 8 of this Annual Report on Form 10-K and Management’s Discussion and Analysis ofFinancial Condition and Results of Operations included in Part II, Item 7 of this Annual Report on Form 10-K. Years Ended December 31, 2016 2015 (1) 2014 (2) 2013 2012 (in thousands, except per share data)Statements of Operations Data Revenues: U.S. product sales, net$432,170 $341,816 $109,998 $71,692 $58,903Service revenues, net99,604 24,132 — — —License fee, collaboration and other revenues (3)317 52,328 14,386 9,164 26,475Total revenues532,091 418,276 124,384 80,856 85,378Costs and expenses: Cost of product sales (excluding impairment) (4)96,314 78,509 20,306 11,960 14,220Cost of services20,575 9,992 — — —Research and development expenses66,084 42,878 24,160 20,564 33,296Selling, general and administrative expenses (5)249,870 160,309 72,254 59,167 53,071Impairment of intangible assets (6)19,663 — — — —Acquisition-related costs— 11,232 9,478 782 —Restructuring expenses715 4,136 2,023 — 2,215Total costs and expenses453,221 307,056 128,221 92,473 102,802Operating income (loss)78,870 111,220 (3,837) (11,617) (17,424)Other income (expense): Interest expense (7)(73,153) (53,251) (14,697) — —Loss on debt extinguishment (7)— (10,449) — — —Interest and dividend income, net3,149 1,512 975 1,051 1,286Other income (expense) (7)189 (9,188) 217 964 (1,466)Total other income (expense)(69,815) (71,376) (13,505) 2,015 (180)Net income (loss) before income taxes9,055 39,844 (17,342) (9,602) (17,604)Income tax expense (benefit) (8)11,538 7,065 (153,159) — (854)Net income (loss)$(2,483) $32,779 $135,817 $(9,602) $(16,750)Net income (loss) per share: Basic$(0.07) $1.04 $6.06 $(0.44) $(0.78)Diluted$(0.07) $0.93 $5.45 $(0.44) $(0.78)Weighted average shares outstanding used to compute netincome (loss) per share: Basic34,346 31,471 22,416 21,703 21,392Diluted34,346 35,308 25,225 21,703 21,39271Table of Contents December 31, 2016 2015 2014 2013 2012Balance Sheet Data Cash, cash equivalents and investments$579,086 $466,331 $144,186 $213,789 $227,043Working capital (current assets less current liabilities)$405,681 $360,753 $107,548 $211,284 $221,423Total assets$2,478,426 $2,476,210 $1,388,933 $265,459 $258,137Long-term liabilities$1,231,160 $1,298,025 $762,492 $59,930 $52,383Stockholders’ equity$934,389 $932,264 $459,953 $172,408 $172,797(1)Includes the results of operations of CBR during the post-acquisition period from August 17, 2015 through December 31, 2015. See Note C, “BusinessCombinations,” to our consolidated financial statements included in this Annual Report on Form 10-K for additional information.(2)Includes the results of operations of Lumara Health during the post-acquisition period from November 12, 2014 through December 31, 2014. See Note C,“Business Combinations,” to our consolidated financial statements included in this Annual Report on Form 10-K for additional information.(3)In 2015, we recognized $44.4 million in revenues associated with the amortization of the remaining deferred revenue balance as a result of thetermination of a license, development and commercialization agreement (the “Takeda Termination Agreement”) with Takeda Pharmaceutical CompanyLimited (“Takeda”) and $6.7 million of additional revenues related to payments made by Takeda upon the final termination date under the terms of theTakeda Termination Agreement.(4)Cost of product sales in 2016, 2015 and 2014 included approximately $77.8 million, $63.3 million and $6.1 million of non-cash expense related to theamortization of the step-up of Lumara Health’s inventories and intangible assets to fair value at the acquisition date, respectively. See Note C, “BusinessCombinations,” and Note H, “Goodwill and Intangible Assets, Net,” to our consolidated financial statements included in this Annual Report onForm 10-K for additional information.(5)Reflects a full year recognition of CBR Services selling, general and administrative expenses in 2016 compared to a partial period in 2015 following ourAugust 2015 acquisition of CBR as well as an increase in the Makena-related contingent consideration based on the expected timing of the milestonepayments.(6)In 2016, we recognized a $15.7 million impairment charge related to the impairment of the remaining net intangible asset for the MuGard Rights,impairment of the remaining $0.2 million, net, CBR-favorable lease intangible asset and a $3.7 million impairment charge related to the CBR tradenames and trademarks intangible asset.(7)Includes interest expense associated with our current debt obligations, including the 2023 Senior Notes and the 2015 Term Loan Facility entered into inAugust 2015, the 2014 Term Loan Facility entered into in November 2014 and repaid in August 2015, and the Convertible Notes entered into inFebruary 2014. In addition, a $10.4 million loss on debt extinguishment is included in 2015 as the result of the early repayment of the 2014 Term LoanFacility. 2015 also includes $9.2 million of other expense associated with the financing of the CBR acquisition.(8)The $153.2 million income tax benefit in 2014 reflects a $132.9 million decrease in our valuation allowance due to taxable temporary differencesavailable as a source of income to realize the benefit of certain of our pre-existing deferred tax assets as a result of the acquisition of Lumara Health. SeeNote J, “Income Taxes,” to our consolidated financial statements included in this Annual Report on Form 10-K for additional information.72Table of ContentsITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS:OverviewAMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. We are a biopharmaceutical company focused on developing and deliveringimportant therapeutics, conducting clinical research in areas of unmet need and creating education and support programs for the patients and families weserve. Our currently marketed products support the health of patients in the areas of women’s health, anemia management and cancer supportive care,including Makena® (hydroxyprogesterone caproate injection), Feraheme® (ferumoxytol) for Intravenous (“IV”) use and MuGard® Mucoadhesive Oral WoundRinse. Through services related to the preservation of umbilical cord blood stem cell and cord tissue units (the “CBR Services”) operated through CordBlood Registry® (“CBR”), we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood,immune and metabolic disorders, and which we believe have the potential to play a valuable role in the ongoing development of regenerative medicine. Inaddition, on February 2, 2017, we closed a license agreement in which we received the rights to research, develop and commercialize RekyndaTM(bremelanotide), which is being developed for the treatment of hypoactive sexual desire disorder (“HSDD”) in pre-menopausal women. On February 13, 2017,we signed a license agreement in which we will acquire the rights to market IntrarosaTM in the U.S. for the treatment of moderate-to-severe dyspareunia, acommon symptom of vulvar and vaginal atrophy (“VVA”), due to menopause.We intend to continue to expand the impact of these and future products and services for patients by delivering on our growth strategy, which includesorganic growth, as well as the pursuit of products and companies that align with our existing therapeutic areas or those that could benefit from our provencore competencies. Currently, our primary sources of revenue are from product sales of Makena and Feraheme and service revenue from the CBR Services.AMAG’s Portfolio of Products and Services Makena is the only FDA-approved drug indicated to reduce the risk of preterm birth in women pregnant with a single baby who have a history ofsingleton spontaneous preterm birth. We acquired the rights to Makena in connection with our acquisition of Lumara Health Inc. (“Lumara Health”) inNovember 2014. Makena was approved by the FDA in February 2011 and granted orphan drug exclusivity through February 3, 2018. We sell Makenaprimarily to specialty pharmacies, specialty distributors, home infusion companies and pharmacies which, in turn, sell Makena to healthcare providers,hospitals, government agencies and integrated delivery systems. In 2016, sales of Makena accounted for approximately 63% of our total net revenues.Additional details regarding the Lumara Health acquisition can be found in Note C, “Business Combinations,” to our consolidated financial statementsincluded in this Annual Report on Form 10‑K.CBR is the largest private newborn stem cell bank in the world and offers pregnant women and their families the ability to preserve their newborns’umbilical cord blood and cord tissue for potential future use. We acquired CBR from CBR Acquisition Holdings in August 2015. We market and sell theCBR Services directly to consumers, who pay for the services directly, as third-party insurance and reimbursement are not available. Even though ourbusiness is limited to the sale of our services required to collect, process, and store umbilical cord blood stem cells and cord tissue, the FDA regulates them asproducts. In 2016, revenues from CBR Services accounted for approximately 19% of our total net revenues. Additional details regarding the CBR acquisitioncan be found in Note C, “Business Combinations,” to our consolidated financial statements included in this Annual Report on Form 10-K.Feraheme was approved for marketing in the U.S. in June 2009 by the FDA for use as an IV iron replacement therapy for the treatment of iron deficiencyanemia (“IDA”) in adult patients with chronic kidney disease (“CKD”). We began selling Feraheme in July 2009 through our commercial organization,including a specialty sales force. We sell Feraheme to authorized wholesalers and specialty distributors, who, in turn, sell Feraheme to healthcare providerswho administer Feraheme primarily within hospitals, hematology and oncology centers, and nephrology clinics. In 2016, sales of Feraheme accounted forapproximately 18% of our total net revenues.On January 8, 2017, we entered into a license agreement (the “Palatin License Agreement”) with Palatin Technologies, Inc. (“Palatin”) under which weacquired the North American rights to develop and commercialize Rekynda, an investigational product designed to be an on-demand treatment for pre-menopausal women with HSDD, which is the most common type of female sexual dysfunction (“FSD”). Following the satisfaction of the conditions toclosing under the Palatin License Agreement, the transaction closed on February 2, 2017. Palatin recently completed two Phase 3 studies to treat HSDD inpre-menopausal women and an extension study is currently ongoing. Palatin is continuing to oversee the conduct of the extension study, which we expect tobe completed in the second half of 2017. We currently expect to submit an NDA in early 201873Table of Contentsfollowing completion of multiple Phase 1 drug interaction and safety pharmacology studies, including an abuse-liability study and drug-to-drug interactionstudies with anti-hypertensive and anti-arrhythmic therapies, as well as certain chemistry, manufacturing and controls activities, including drug productprocess validation studies by Palatin. Additional details regarding the Palatin License Agreement can be found in Note W, “Subsequent Events,” to ourconsolidated financial statements included in this Annual Report on Form 10-K.In July 2015, we entered into an option agreement with Velo Bio, LLC (“Velo”), a privately held life-sciences company that granted us an option toacquire the rights (the “DIF Rights”) to an orphan drug candidate, digoxin immune fab (“DIF”), a polyclonal antibody in clinical development for thetreatment of severe preeclampsia in pregnant women. Under the option agreement, Velo will complete a Phase 2b/3a clinical study, which we expect to beginin the first quarter of 2017. Following the conclusion of the DIF Phase 2b/3a study, we may terminate, or, for additional consideration, exercise or extend, ouroption to acquire the DIF Rights. Additional details regarding the Velo agreement can be found in Note Q, “Collaboration, License and Other StrategicAgreements,” to our consolidated financial statements included in this Annual Report on Form 10-K.In June 2013, we entered into a license agreement with Abeona Therapeutics, Inc., under which we acquired the U.S. commercial rights to MuGard®Mucoadhesive Oral Wound Rinse for the management of oral mucositis and stomatitis (the “MuGard Rights”). Additional details regarding the acquisition ofthe MuGard Rights can be found in Note Q, “Collaboration, License and Other Strategic Arrangements,” to our consolidated financial statements includedin this Annual Report on Form 10-K. Makena Developments We continue to advance our next generation development program for Makena, seeking to enhance the product profile for patients and their healthcareproviders. As part of this program, in February 2016 the FDA approved a single-dose preservative-free formulation of Makena manufactured by the PfizerCentreOne group of Pfizer, Inc., (“Pfizer”) (formerly Hospira, Inc.), who also manufactures our multidose vial of Makena. We began promoting the single-dosepreservative-free formulation of Makena to physicians in the second quarter of 2016. In July 2016, we received approval of our prior approval supplement forPiramal Pharma Solutions (formerly Coldstream Laboratories, Inc.) to also manufacture the single-dose preservative-free formulation of Makena.We are developing an auto-injector device for subcutaneous administration of Makena (the “Makena auto-injector”), including chemistry,manufacturing and controls (“CMC”) development with Antares. During 2016, we met with the FDA to discuss our proposed development and regulatorystrategy, focusing on our plans to conduct a definitive PK study designed to demonstrate comparable bioavailability of the subcutaneous Makena auto-injector to the current intramuscular (“IM”) injection form of Makena. We believe that demonstrating bioequivalence for area under the curve is the mostrelevant PK parameter for Makena. In October 2016, we initiated an open label parallel study which enrolled approximately 120 healthy post-menopausalwomen in a 1:1 randomization. In February 2017, we announced topline results from this definitive PK study. Makena administered subcutaneouslydemonstrated bioequivalence to the IM injection on area under the curve (“AUC”) (AUC0-to-inf 2,386 ng/mL compared to 2,086 ng/mL) with the 90%confidence interval for the ratio of AUC (105.17 to 124.39) falling within the 80% to 125% range, which the FDA uses to define bioequivalence. The meanmaximum or peak plasma concentration (“Cmax”) for Makena administered subcutaneously was slightly higher than for the IM (7.3 ng/mL compared to 6.3ng/mL) with the 90% confidence interval for the ratio of Cmax (96.6% to 138.7%) falling outside of the bioequivalence range of 80% to 125%. No seriousadverse events were reported and the drug was generally well tolerated, although there was a higher reporting rate of injection site related adverse events (e.g.transient burning/stinging sensation), in the subcutaneous injection arm of the study. Similar observations were also reported in the subcutaneous arm of ouropen label, parallel comparative pain study (also initiated in October 2016), which we recently elected to discontinue. We will not be requesting orphanexclusivity as part of the sNDA filing and, therefore, anticipate a six-month FDA review timeline. There are multiple device and drug-device combinationpatents and patent applications in-licensed from Antares which relate to the subcutaneous Makena auto-injector and we intend to request Orange Booklisting of eligible Antares drug-device patents. We expect to file an sNDA for approval of the Makena auto-injector in the second quarter of 2017.Feraheme Developments In pursuit of a broader indication for Feraheme to include the treatment of IDA in adult patients who had failed or could not tolerate oral iron or in whomoral iron was contraindicated, we are conducting a new head-to-head Phase 3 clinical trial evaluating Feraheme in adults with IDA, excluding patients onhemodialysis. This new trial is a randomized, double-blind multicenter non-inferiority trial that will evaluate the incidence of moderate-to-severehypersensitivity reactions (including anaphylaxis) and moderate-to-severe hypotension with Feraheme compared to ferric carboxymaltose infusion. InDecember 2016, we completed enrollment in a randomized, double-blind multicenter non-inferiority trial that will evaluate the incidence74Table of Contentsof moderate-to-severe hypersensitivity reactions (including anaphylaxis) and moderate-to-severe hypotension with Feraheme compared to ferriccarboxymaltose infusion. Approximately two thousand patients were randomized in a 1:1 ratio into one of two treatment groups, those receiving 1.02 gramsof Feraheme IV infusion or those receiving 1.5 grams of ferric carboxymaltose IV infusion. We currently expect to file an sNDA for this broader indication inmid-2017. MuGard Developments Based on interactions with government payors during 2016, we determined that broader reimbursement coverage for MuGard was unlikely and weassessed the MuGard Rights for potential impairment. From this assessment, we concluded that based on the lack of broad reimbursement and insurancecoverage for MuGard and the resulting decrease in expected revenues and cash flows, the projected undiscounted cash flows were less than the book value,indicating impairment of this intangible asset. As a result of an analysis of the fair value of the net MuGard Rights intangible asset as compared to itsrecorded book value, we recognized an impairment charge for the full $15.7 million net intangible asset in the second quarter of 2016. Other Licensing TransactionsIntrarosaOn February 13, 2017, we entered into a license agreement (the “Endoceutics License Agreement”) with Endoceutics, Inc. (“Endoceutics”) pursuant towhich Endoceutics has agreed to grant to us rights to Intrarosa, an FDA-approved product for the treatment of moderate-to-severe dyspareunia (pain duringsexual intercourse), a symptom of VVA due to menopause. The Endoceutics License Agreement grants us the right to develop and commercializepharmaceutical products containing dehydroepiandrosterone (“DHEA”), including Intrarosa, at dosage strengths of 13 mg or less per dose and formulated forintravaginal delivery, excluding any dosage strengths over 13 mg per dose and combinations with other active pharmaceutical ingredients, in the U.S. for thetreatment of VVA and FSD. The closing of the transactions contemplated by the Endoceutics License Agreement is subject to clearance under the Hart-Scott-Rodino Act and other customary closing conditions.Intrarosa is the only FDA-approved, vaginally administered, daily non-estrogen steroid, which is prescribed for the treatment of moderate-to-severedyspareunia. Intrarosa contains prasterone, also known as DHEA. DHEA is an inactive endogenous precursor of hormones, which is converted locally intoandrogens and estrogens to help restore the vaginal tissue as indicated by improvements in the percentage of superficial cells, parabasal cells, and pH. Themechanism of action is not fully established. The effectiveness of Intrarosa on moderate-to-severe dyspareunia was examined in two primary 12-weekplacebo-controlled efficacy trials. All women in both studies were assessed for improvement from baseline to week 12 for four co-primary efficacy endpoints:most bothersome moderate-to-severe symptom of dyspareunia, the percentage of vaginal superficial cells, the percentage of parabasal cells, and vaginalpH. All primary endpoints were statistically significant. Intrarosa was studied in two pivotal 12-week placebo-controlled Phase 3 efficacy trials. All primaryendpoints were statistically significant. Women taking Intrarosa experienced a significant reduction in moderate-to-severedyspareunia, as well asstatistically significant improvements in the percentage of vaginal superficial cells, parabasal cells, as well as vaginal pH. Additional details regarding theEndoceutics License Agreement can be found in Note W, “Subsequent Events,” to our consolidated financial statements included in this Annual Report onForm 10-K.Our common stock trades on the NASDAQ Global Select Market under the trading symbol “AMAG.”Critical Accounting PoliciesOur management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, whichhave been prepared in accordance with accounting principles generally accepted in the U.S. The preparation of these financial statements requiresmanagement to make certain estimates and assumptions that affect the reported amount of assets, liabilities, revenues and expenses, and the related disclosureof contingent assets and liabilities. Actual results could differ materially from those estimates. Management employs the following critical accountingpolicies affecting our most significant estimates and assumptions: revenue recognition and related sales allowances and accruals; business combinations,including goodwill, intangible assets and acquisition-related contingent consideration; valuation of investments; equity-based compensation; and incometaxes.1.Revenue Recognition and Related Sales Allowances and AccrualsOur primary sources of revenue during the reporting periods were: (i) product revenues from Makena and Feraheme; (ii) service revenues associated withthe CBR Services; and (iii) license fees, collaboration and other revenues, which primarily included revenue recognized under our collaboration agreements,royalties received from our license agreements, and75Table of Contentsinternational product revenues of Feraheme derived from our collaboration agreement with Takeda Pharmaceutical Company Limited (“Takeda”), which wasterminated in 2015. Revenue is recognized when the following criteria are met:•Persuasive evidence of an arrangement exists;•Delivery of product has occurred or services have been rendered;•The sales price charged is fixed or determinable; and•Collection is reasonably assured.Product RevenueWe recognize product revenues net of certain allowances and accruals in our consolidated statements of operations at the time of sale. Our contractualadjustments include provisions for returns, pricing and prompt payment discounts, as well as wholesaler distribution fees, and volume-based and othercommercial rebates. Governmental rebates relate to our reimbursement arrangements with state Medicaid programs. In addition, we also monitor ourdistribution channel to determine whether additional allowances or accruals are required based on inventory in our sales channel. Calculating these gross tonet sales adjustments involves estimates and judgments based primarily on actual product sales data, forecasted customer buying patterns, and marketresearch data related to utilization rates by various end-users. If we determine in future periods that our actual experience is not indicative of ourexpectations, if our actual experience changes, or if other factors affect our estimates, we may be required to adjust our allowances and accruals estimates,which would affect our net product sales in the period of the adjustment and could be significant.Classification of Product Sales Allowances and AccrualsProduct sales allowances and accruals are primarily comprised of both direct and indirect fees, discounts and rebates and provisions for estimated productreturns. Direct fees, discounts and rebates are contractual fees and price adjustments payable to wholesalers, specialty distributors and other customers thatpurchase products directly from us. Indirect fees, discounts and rebates are contractual price adjustments payable to healthcare providers and organizations,such as certain physicians, clinics, hospitals, group purchasing organizations (“GPOs”), and dialysis organizations that typically do not purchase productsdirectly from us but rather from wholesalers and specialty distributors. In accordance with guidance related to accounting for fees and consideration given bya vendor to a customer, including a reseller of a vendor’s products, these fees, discounts and rebates are presumed to be a reduction of the selling price.Product sales allowances and accruals are based on definitive contractual agreements or legal requirements (such as Medicaid laws and regulations) related tothe purchase and/or utilization of the product by these entities and are recorded in the same period that the related revenue is recognized. We estimateproduct sales allowances and accruals using either historical, actual and/or other data, including estimated patient usage, applicable contractual rebate rates,contract performance by the benefit providers, other current contractual and statutory requirements, historical market data based upon experience of ourproducts and other products similar to them, specific known market events and trends such as competitive pricing and new product introductions, current andforecasted customer buying patterns and inventory levels, and the shelf life of our products. As part of this evaluation, we also review changes to federal andother legislation, changes to rebate contracts, changes in the level of discounts, and changes in product sales trends. Although allowances and accruals arerecorded at the time of product sale, certain rebates are typically paid out, on average, up to three months or longer after the sale.Allowances against receivable balances primarily relate to prompt payment discounts, provider chargebacks and certain government agency rebates andare recorded at the time of sale, resulting in a reduction in product sales revenue and the reporting of product sales receivables net of allowances. Accrualsrelated to Medicaid and provider volume rebates, wholesaler and distributor fees, GPO fees, other discounts to healthcare providers and product returns arerecorded at the time of sale, resulting in a reduction in product sales and the recording of an increase in accrued expenses.DiscountsWe typically offer a 2% prompt payment discount to our customers as an incentive to remit payment in accordance with the stated terms of the invoice,generally thirty days. Because we anticipate that those customers who are offered this discount will take advantage of the discount, we accrue 100% of theprompt payment discount at the time of sale, based on the gross amount of each invoice. We adjust the accrual quarterly to reflect actual experience.76Table of ContentsChargebacksChargeback reserves represent our estimated obligations resulting from the difference between the prices at which we sell our products to wholesalers andthe sales price ultimately paid to wholesalers under fixed price contracts by third-party payers, including governmental agencies. We determine ourchargeback estimates based on actual product sales data and forecasted customer buying patterns. Actual chargeback amounts are determined at the time ofresale to the qualified healthcare provider, and we generally issue credits for such amounts within several weeks of receiving notification from the wholesaler.Estimated chargeback amounts are recorded at the time of sale, and we adjust the allowance quarterly to reflect actual experience.Distributor/Wholesaler and Group Purchasing Organization FeesFees under our arrangements with distributors and wholesalers are usually based upon units of product purchased during the prior month or quarter andare usually paid by us within several weeks of our receipt of an invoice from the wholesaler or distributor, as the case may be. Fees under our arrangementswith GPOs are usually based upon member purchases during the prior quarter and are generally billed by the GPO within 30 days after period end. Currentaccounting standards related to consideration given by a vendor to a customer, including a reseller of a vendor’s products, specify that cash considerationgiven by a vendor to a customer is presumed to be a reduction of the selling price of the vendor’s products or services and therefore should be characterizedas a reduction of product sales. Consideration should be characterized as a cost incurred if we receive, or will receive, an identifiable benefit (goods orservices) in exchange for the consideration and we can reasonably estimate the fair value of the benefit received. Because the fees we pay to wholesalers donot meet the foregoing conditions to be characterized as a cost, we have characterized these fees as a reduction of product sales and have included them incontractual adjustments or governmental rebates in the table below. We generally pay such amounts within several weeks of our receipt of an invoice fromthe distributor, wholesaler or GPO. Accordingly, we accrue the estimated fee due at the time of sale, based on the contracted price invoiced to the customer.We adjust the accrual quarterly to reflect actual experience.Product ReturnsConsistent with industry practice, we generally offer our wholesalers, specialty distributors and other customers a limited right to return our productsbased on the product’s expiration date. Currently the expiration dates for Feraheme and Makena are five and three years, respectively. We estimate productreturns based on the historical return patterns and known or expected changes in the marketplace. We track actual returns by individual production lots.Returns on lots eligible for credits under our returned goods policy are monitored and compared with historical return trends and rates.We expect that wholesalers and healthcare providers will not stock significant inventory due to the cost of the product, the expense to store our products,and/or that our products are readily available for distribution. We record an estimate of returns at the time of sale. If necessary, our estimated rate of returnsmay be adjusted for actual return experience as it becomes available and for known or expected changes in the marketplace. We did not significantly adjustour reserve for product returns during 2016 or 2015. During 2014, we reduced our reserve for Feraheme product returns by approximately $1.8 million,primarily as a result of a lower than expected rate of product returns. To date, returns of Feraheme have been relatively limited; however, returns experiencemay change over time. As we continue to gain more historical experience with actual returns and continue to gain additional experience with return rates forMakena, we may be required to make a future adjustment to our product returns estimate, which would result in a corresponding change to our net productsales in the period of adjustment and could be significant.Governmental RebatesGovernmental rebate reserves relate to our reimbursement arrangements with state Medicaid programs. We determine our estimates for Medicaid rebates,if applicable, based on actual product sales data and our historical product claims experience. In estimating these reserves, we provide for a Medicaid rebateassociated with both those expected instances where Medicaid will act as the primary insurer as well as in those instances where we expect Medicaid will actas the secondary insurer. Rebate amounts generally are invoiced quarterly and are paid in arrears, and we expect to pay such amounts within several weeks ofnotification by the Medicaid or provider entity. Estimated governmental rebates are recorded at the time of sale. During 2016, we revised our estimatedMedicaid reserve based on actual claims received since the 2011 launch of Makena, our expectations of state level utilization, and estimated rebate claimsnot yet submitted. This revision resulted in a $6.1 million reduction of our estimated Medicaid rebate reserve related to prior period Makena sales. During2015, we reduced our Makena-related Medicaid and chargeback reserves, which were initially recorded at the time of the Lumara Health acquisition, by $4.0million and $1.9 million, respectively. These measurement period adjustments were recorded to goodwill during 2015. We did not significantly adjust ourMedicaid rebate reserve during 2014. We regularly assess our Medicaid reserve balance and the rate at which we accrue for claims against product sales. If wedetermine in future periods that our actual rebate experience is not indicative of77Table of Contentsexpected claims, if actual claims experience changes, or if other factors affect estimated claims rates, we may be required to adjust our current Medicaidaccumulated reserve estimate, which would affect net product sales in the period of the adjustment and could be significant.Healthcare Reform LegislationThe Health Care and Education Reconciliation Act of 2010 (the “Affordable Care Act”) was enacted in the U.S. in March 2010 and includes certain costcontainment measures including an increase to the minimum rebates for products covered by Medicaid programs and the extension of such rebates to drugsdispensed to Medicaid beneficiaries enrolled in Medicaid managed care organizations as well as the expansion of the 340B Drug pricing program under thePublic Health Service Act. This legislation contains provisions that can affect the operational results of companies in the pharmaceutical industry andhealthcare related industries, including us, by imposing on them additional costs.The Affordable Care Act also requires pharmaceutical manufacturers to pay a prorated share of the overall Branded Drug Fee, based on the dollar value ofits branded prescription drug sales to certain federal programs identified in the legislation. The amount of our annual share of the Branded Drug Fee for eachof the 2016, 2015, and 2014 annual periods was approximately $0.1 million and these payments were non-deductible for income tax purposes. We haveincluded these amounts in selling, general and administrative expense in our consolidated statements of operations. The amount of this annual paymentcould increase in future years due to both higher eligible Feraheme sales and the increasing amount of the overall fee assessed across manufacturers, but anysuch increases are not expected to be material to our results of operations or financial condition. The Affordable Care Act exempts “orphan drugs” such asMakena from 340B ceiling price requirements for the covered entity types newly added to the program by the Affordable Care Act.In addition, the number of 340B institutions, which provide drugs at reduced rates, was expanded by the Affordable Care Act to include additionalhospitals. As a result, the volume of Feraheme business sold to 340B eligible entities has increased since the implementation of the Affordable Care Act.Feraheme sold to 340B eligible entities comprised approximately 20%, 20% and 17% of our total Feraheme sales in grams for 2016, 2015 and 2014,respectively. Because these institutions are eligible for federal pricing discounts, the revenue realized per unit of Feraheme sold to 340B institutions is lowerthan from some of our other customers.Further, under the sequestration required by the Budget Control Act of 2011, as amended by the American Taxpayer Relief Act of 2012, Medicarepayments for all items and services under Parts A and B incurred on or after April 1, 2013 have been reduced by up to 2%. Therefore, after adjustment fordeductible and co-insurance, the reimbursement rate for physician-administered drugs, including Feraheme, under Medicare Part B has been reduced fromaverage selling price (“ASP”) plus 6% to ASP plus 4.3%.We were not materially impacted by healthcare reform legislation during 2016, 2015 and 2014. Presently, we have not identified any provisions thatcould materially impact our business but we continue to monitor ongoing legislative developments and we are assessing what impact recent healthcarereform legislation will have on our business following the consummation of our recent acquisitions. Additionally, a key focus of the recent presidentialelection was “repeal and replacement” of the Affordable Care Act. The extent, timing and details of the changes are not known, but the federally fundedhealth care landscape could face significant changes during the current presidential administration, including in the near-term, and could impact state andlocal healthcare programs, including Medicaid and Medicare.Multiple Element ArrangementsWe evaluate revenue from arrangements that have multiple elements to determine whether the components of the arrangement represent separate units ofaccounting as defined in the accounting guidance related to revenue arrangements with multiple deliverables. Under current accounting guidance, whichgoverns any agreements that contain multiple elements that are either entered into or materially modified subsequent to January 1, 2011, companies arerequired to establish the selling price of its products and services based on a separate revenue recognition process using management’s best estimate of theselling price when there is no vendor-specific objective evidence or third-party evidence to determine the selling price of that item. If a delivered element isnot considered to have standalone value, all elements of the arrangement are recognized as revenue as a single unit of accounting over the period ofperformance for the last such undelivered item or services. Significant management judgment is required in determining what elements constitutedeliverables and what deliverables or combination of deliverables should be considered units of accounting.When multiple deliverables are combined and accounted for as a single unit of accounting, we base our revenue recognition pattern on the last to bedelivered element. Revenue is recognized using either a proportional performance or78Table of Contentsstraight-line method, depending on whether we can reasonably estimate the level of effort required to complete our performance obligations under anarrangement and whether such performance obligations are provided on a best-efforts basis. To the extent we cannot reasonably estimate our performanceobligations, we recognize revenue on a straight-line basis over the period we expect to complete our performance obligations. Significant managementjudgment is required in determining the level of effort required under an arrangement and the period over which we are expected to complete our performanceobligations under an arrangement. We may have to revise our estimates based on changes in the expected level of effort or the period we expect to completeour performance obligations.For multiple element arrangements, we allocate revenue to all deliverables based on their relative selling prices. We determine the selling price to beused for allocating revenue to deliverables as follows: (i) vendor specific objective evidence; (ii) third-party evidence of selling price and (iii) the bestestimate of the selling price. Vendor specific objective evidence generally exists only when we sell the deliverable separately and it is the price actuallycharged by us for that deliverable. Any discounts given to the customer are allocated by applying the relative selling price method.Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in our consolidated balance sheets. Deferredrevenue associated with our service revenues includes (i) amounts collected in advance of unit processing and (ii) amounts associated with unearned storagefees collected at the beginning of the storage contract term, net of allocated discounts. Amounts not expected to be recognized within the next year areclassified as long-term deferred revenues.Service RevenueWe have identified two deliverables contained in the revenue arrangements for the CBR Services, which include: (i) enrollment, including the provisionof a collection kit and cord blood and cord tissue unit processing, which are delivered at the beginning of the relationship (the “processing services”), withrevenue for this deliverable recognized after the collection and successful processing of the cord blood and cord tissue; and (ii) the storage of newborn cordblood and cord tissue units (the “storage services”), for either an annual fee or a prepayment of 18 years or the lifetime of the newborn donor (“lifetimeoption”), with revenue for this deliverable recognized ratably over the applicable storage period. For the lifetime option, storage fees are not chargedannually during the lifetime of the newborn donor. However, revenue is recognized based on the average of male and female life expectancies using lifetimeactuarial tables published by the Social Security Administration in effect at the time of the newborn’s birth. As there are other vendors who provideprocessing services and storage services at separately stated list prices, the processing services and storage services, including the first year storage, each havestandalone value to the customer, and therefore represent separate deliverables. The selling price for the processing services are estimated based on the bestestimate of selling price because we do not have vendor specific objective evidence or third-party evidence of selling price for these elements. The sellingprice for the storage services is determined based on vendor specific objective evidence as we have standalone renewals to support the selling price.License Fee, Collaboration and Other RevenuesThe terms of product development and commercialization agreements entered into between us and our collaborative licensees may include non-refundable license fees, payments based on the achievement of certain milestones and performance goals, reimbursement of certain out-of-pocket costs,including research and development expenses, payment for manufacturing services, and royalties on product sales. We recognize license fee and research anddevelopment revenue under collaborative arrangements over the term of the applicable agreements using a proportional performance model, if practical.Otherwise, we recognize such revenue on a straight-line basis. Under this model, revenue is generally recognized in an amount equal to the lesser of theamount due under the agreements or an amount based on the proportional performance to date. In cases where project costs or other performance metrics arenot estimable but there is an established contract period, revenues are recognized on a straight-line basis over the term of the relevant agreement. In caseswhere we are reimbursed for certain research and development costs associated with our collaboration agreements and where we are acting as the principal incarrying out these services, any reimbursement payments are recorded in license fee, collaboration and other revenues in our consolidated statement ofoperations to match the costs that we incur during the period in which we perform those services. Nonrefundable payments and fees are recorded as deferredrevenue upon receipt and may require deferral of revenue recognition to future periods.79Table of ContentsOur collaboration agreements may entitle us to additional payments upon the achievement of performance-based milestones. If a milestone involvessubstantive effort on our part and its achievement is not considered probable at the inception of the collaboration, we recognize the milestone considerationas revenue in the period in which the milestone is achieved only if it meets the following additional criteria:•The milestone consideration received is commensurate with either the level of effort required to achieve the milestone or the enhancement of thevalue of the item delivered as a result of a specific outcome resulting from our performance to achieve the milestone;•The milestone is related solely to our past performance; and•The milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement.There is significant judgment involved in determining whether a milestone meets all of these criteria. For milestones that do not meet the above criteriaand are therefore not considered substantive milestones, we recognize that portion of the milestone payment equal to the percentage of the performanceperiod completed at the time the milestone is achieved and the above conditions are met. The remaining portion of the milestone will be recognized over theremaining performance period using a proportional performance or straight-line method.2.Business CombinationsWe account for acquired businesses using the acquisition method of accounting, under which the total purchase price of an acquisition is allocated to thenet tangible and identifiable intangible assets acquired and liabilities assumed based on their estimated fair values as of the acquisition date. Acquisition-related costs are expensed as incurred. Any excess of the consideration transferred over the estimated fair values of the identifiable net assets acquired isrecorded as goodwill.The purchase price allocations are initially prepared on a preliminary basis and are subject to change as additional information becomes availableconcerning the fair value and tax basis of the assets acquired and liabilities assumed. Any adjustments to the purchase price allocations are made as soon aspracticable but no later than one year from the acquisition date.Acquired inventory is recorded at its fair value, which generally requires a step-up adjustment to recognize the inventory at its expected net realizablevalue. The inventory step-up is recorded to cost of product sales in our consolidated statements of operations when related inventory is sold, and we recordstep-up costs associated with clinical trial material as research and development expense.Goodwill and Intangible AssetsGoodwill is not amortized, but is reviewed for impairment annually as of October 31 or more frequently if indicators of impairment are present. Wedetermine whether goodwill may be impaired by comparing the carrying value of our single reporting unit, including goodwill, to the fair value of thereporting unit. If the fair value is less than the carrying amount, a more detailed analysis is performed to determine whether goodwill is impaired. Theimpairment loss, if any, is measured as the excess of the carrying value of the goodwill over the implied fair value of the goodwill and is recorded in ourconsolidated statements of operations. Finite-lived intangible assets are amortized to their estimated residual values using an economic consumption method over their estimated useful livesand reviewed for impairment if certain events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. When suchfacts and circumstances exist, management compares the projected undiscounted future cash flows associated with the asset over its estimated useful lifeagainst the carrying amount. The impairment loss, if any, is measured as the excess of the carrying amount of the asset over its fair value.Acquired in-process research and development (“IPR&D”) represents the fair value assigned to research and development assets that we acquire and havenot been completed at the acquisition date. The fair value of IPR&D acquired in a business combination is capitalized on our consolidated balance sheets atthe acquisition-date fair value and is determined by estimating the costs to develop the technology into commercially viable products, estimating theresulting revenue from the projects, and discounting the projected net cash flows to present value. IPR&D is not amortized, but rather is reviewed forimpairment on an annual basis or more frequently if indicators of impairment are present, until the project is completed or abandoned. If we determine thatIPR&D becomes impaired or is abandoned, the carrying value is written down to its fair value with the related impairment charge recognized in ourconsolidated statement of operations in the period in which the impairment occurs. Upon80Table of Contentssuccessful completion of each project and launch of the product, we will make a separate determination of the estimated useful life of the IPR&D intangibleasset and the related amortization will be recorded as an expense prospectively over its estimated useful life.The projected discounted cash flow models used to estimate our IPR&D reflect significant assumptions regarding the estimates a market participantwould make in order to evaluate a drug development asset, including the following:•Probability of successfully completing clinical trials and obtaining regulatory approval;•Market size, market growth projections, and market share;•Estimates regarding the timing of and the expected costs to advance our clinical programs to commercialization;•Estimates of future cash flows from potential product sales; and•A discount rate.Additionally, we have other indefinite-lived intangible assets which we acquired through our business combinations. These assets are reviewed forimpairment on an annual basis or more frequently if indicators of impairment are present. If we determine that the asset becomes impaired, the carrying valueis written down to its fair value with the related impairment charge recognized in our consolidated statements of operations in the period in which theimpairment occurs.Acquisition-related Contingent ConsiderationContingent consideration arising from a business combination is included as part of the purchase price and is recognized at its estimated fair value as ofthe acquisition date. Subsequent to the acquisition date, we measure contingent consideration arrangements at fair value for each period until thecontingency is resolved. These changes in fair value are recognized in our selling, general and administrative expenses in our consolidated statements ofoperations. Changes in fair values reflect new information about the likelihood of the payment of the contingent consideration and the passage of time.3.Valuation of investmentsWe account for and classify our investments as either “available-for-sale,” “trading,” or “held-to-maturity,” in accordance with the accounting guidancerelated to the accounting and classification of certain investments in debt and equity securities. The determination of the appropriate classification by us isbased primarily on management’s ability and intent to sell the investment at the time of purchase. As of December 31, 2016 and 2015, all of our investmentswere classified as available-for-sale securities.Available-for-sale securities are those securities which we view as available for use in current operations, if needed. We generally classify our available-for-sale securities as short-term investments, even though the stated maturity date may be one year or more beyond the current balance sheet date. Available-for-sale investments are stated at fair value with their unrealized gains and losses included in accumulated other comprehensive loss within the consolidatedstatements of stockholders’ equity until such gains and losses are realized in other income (expense) within the consolidated statements of operations or untilan unrealized loss is considered other-than-temporary.We recognize other-than-temporary impairments of our debt securities when there is a decline in fair value below the amortized cost basis and if (a) wehave the intent to sell the security or (b) it is more likely than not that we will be required to sell the security prior to recovery of its amortized cost basis. Ifeither of these conditions is met, we recognize the difference between the amortized cost of the security and its fair value at the impairment measurement datein our consolidated statements of operations. If neither of these conditions is met, we must perform additional analyses to evaluate whether the unrealizedloss is associated with the creditworthiness of the issuer of the security rather than other factors, such as interest rates or market factors. If we determine fromthis analysis that we do not expect to receive cash flows sufficient to recover the entire amortized cost of the security, a credit loss exists, the impairment isconsidered other-than-temporary and is recognized in our consolidated statements of operations.4.Equity-Based CompensationEquity-based compensation cost is generally measured at the estimated grant date fair value and recorded to expense over the requisite service period,which is generally the vesting period. Because equity-based compensation expense is based on81Table of Contentsawards ultimately expected to vest, we must make certain judgments about whether employees, officers, directors, consultants and advisors will complete therequisite service period, and reduce the compensation expense being recognized for estimated forfeitures. Forfeitures are estimated at the time of grant andrevised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Forfeitures are estimated based upon historical experience andadjusted for unusual events such as corporate restructurings, which can result in higher than expected turnover and forfeitures. If factors change and weemploy different assumptions in future periods, the compensation expense that we record in the future may differ significantly from what we have recorded inthe current period.We estimate the fair value of equity-based compensation involving stock options based on the Black-Scholes option pricing model. This model requiresthe input of several factors such as the expected option term, the expected risk-free interest rate over the expected option term, the expected volatility of ourstock price over the expected option term, and the expected dividend yield over the expected option term and are subject to various assumptions. The fairvalue of awards calculated using the Black-Scholes option pricing model is generally amortized on a straight-line basis over the requisite service period, andis recognized based on the proportionate amount of the requisite service period that has been rendered during each reporting period.We estimate the fair value of our restricted stock units (“RSUs”) whose vesting is contingent upon market conditions using the Monte-Carlo simulationmodel. The fair value of RSUs where vesting is contingent upon market conditions is amortized based upon the estimated derived service period. The fairvalue of RSUs granted to our employees and directors is determined based upon the quoted closing market price per share on the date of grant, adjusted forestimated forfeitures.We believe our valuation methodologies are appropriate for estimating the fair value of the equity awards we grant to our employees and directors. Ourequity award valuations are estimates and may not be reflective of actual future results or amounts ultimately realized by recipients of these grants. Theseamounts are subject to future quarterly adjustments based upon a variety of factors, which include, but are not limited to, changes in estimated forfeiture ratesand the issuance of new equity-based awards.5.Income TaxesWe use the asset and liability method of accounting for deferred income taxes. Under this method, deferred tax assets and liabilities are recognized forthe estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and theirrespective tax bases. A deferred tax asset is established for the expected future benefit of net operating loss (“NOL”) and credit carryforwards. Deferred taxassets and liabilities are measured using enacted rates in effect for the year in which those temporary differences are expected to be recovered or settled. Avaluation allowance against net deferred tax assets is required if, based on available evidence, it is more likely than not that some or all of the deferred taxassets will not be realized. Significant judgments, estimates and assumptions regarding future events, such as the amount, timing and character of income,deductions and tax credits, are required in the determination of our provision for income taxes and whether valuation allowances are required against deferredtax assets. In evaluating our ability to recover our deferred tax assets, we consider all available evidence, both positive and negative, including the existenceof taxable temporary differences, our past operating results, the existence of cumulative income in the most recent fiscal years, changes in the business inwhich we operate and our forecast of future taxable income. In determining future taxable income, we are responsible for assumptions utilized including theamount of state and federal operating income, the reversal of temporary differences and the implementation of feasible and prudent tax planning strategies.These assumptions require significant judgment about the forecasts of future taxable income and are consistent with the plans and estimates that we are usingto manage the underlying businesses. As of December 31, 2016, we maintained a valuation allowance on our state NOL carryforwards acquired from LumaraHealth as we do not anticipate that Lumara Health will have future taxable income in the states in which the NOLs were generated. Additionally, we havefederal capital loss carryforwards that can only be utilized to the extent that we generate future capital gains. Since we do not anticipate that we will havefuture capital gains, we have maintained a valuation allowance against the federal capital loss carryfowards. We account for uncertain tax positions using a “more-likely-than-not” threshold for recognizing and resolving uncertain tax positions. The evaluation ofuncertain tax positions is based on factors that include, but are not limited to, changes in tax law, the measurement of tax positions taken or expected to betaken in tax returns, the effective settlement of matters subject to audit, new audit activity, and changes in facts or circumstances related to a tax position. Weevaluate uncertain tax positions on a quarterly basis and adjust the level of the liability to reflect any subsequent changes in the relevant facts surroundingthe uncertain positions. Any changes to these estimates, based on the actual results obtained and/or a change in assumptions, could impact our income taxprovision in future periods. Interest and penalty charges, if any, related to unrecognized tax benefits would be classified as a provision for income tax in ourconsolidated statement of operations.82Table of ContentsImpact of Recently Issued and Proposed Accounting PronouncementsFrom time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies that areadopted by us as of the specified effective date. Unless otherwise discussed, we believe that the impact of recently issued standards that are not yet effectivewill not have a material impact on our financial position or results of operations upon adoption. For further discussion on recent accounting pronouncements,please see Note V, “Recently Issued and Pronounced Accounting Pronouncements,” to our consolidated financial statements included in this Annual Reporton Form 10-K for additional information.Results of Operations - 2016 as compared to 2015 Revenues Total revenues for 2016 and 2015 consisted of the following (in thousands except for percentages): Years Ended December 31, 2016 to 2015 2016 2015 $ Change % ChangeU.S. product sales, net Makena$334,050 $251,615 $82,435 33 %Feraheme97,058 88,452 8,606 10 %MuGard1,062 1,749 (687) (39)%Total432,170 341,816 90,354 26 %Service revenues, net99,604 24,132 75,472 >100 %License fee, collaboration and other revenues317 52,328 (52,011) (99)%Total Revenues$532,091 $418,276 $113,815 27 % Our total revenues for 2016 increased by $113.8 million as compared to the same period in 2015, primarily as the result of a $82.4 million increase in ournet Makena sales and a $75.5 million increase of CBR Services revenue due to the full period recognition of CBR Services revenue in 2016 compared to apartial period in 2015 following our August 2015 acquisition of CBR. This increase in revenues was partially offset by a $52.0 million decrease in licensefee, collaboration and other revenues during 2016 as compared to 2015. Under the terms of the 2014 termination of a license, development andcommercialization agreement (as amended, the “Takeda Agreement”) with Takeda related to the commercialization of Feraheme outside of the U.S., in 2015we recognized revenues of $6.7 million for payments made by Takeda as well as $44.4 million of previously deferred revenues associated with theamortization of the then-remaining deferred revenue balance under the Takeda Agreement.The following table sets forth customers who represented 10% or more of our total revenues for 2016 and 2015: Years Ended December 31, 2016 2015AmerisourceBergen Drug Corporation22% 25%McKesson Corporation11% 11%Takeda Pharmaceuticals Company Limited—% 12%83Table of ContentsProduct SalesTotal gross U.S. product sales were offset by product sales allowances and accruals for 2016 and 2015 as follows (in thousands except for percentages): Years Ended December 31, 2016 to 20152016 Percent ofgross U.S.product sales 2015 Percent ofgross U.S.product sales $ Change % ChangeGross U.S. product sales$748,839 $561,255 $187,584 33%Provision for U.S. product sales allowances andaccruals: Contractual adjustments229,686 31% 161,665 29% Governmental rebates86,983 12% 57,774 10% Total provision for U.S. product salesallowances and accruals316,669 42% 219,439 39% U.S. product sales, net$432,170 $341,816 $90,354 26% We expect gross product sales to increase in 2017 primarily based on increased units sold of our products.Gross U.S. product sales increased by $187.6 million, or approximately 33%, during 2016 as compared to 2015 primarily due to increases of $156.6million and $32.4 million of Makena and Feraheme gross sales for 2016 as compared to 2015. Of the $156.6 million increase in gross Makena sales in 2016,$135.3 million was due to increased volume of Makena and $21.3 million was due to price increases. Of the $32.4 million increase in gross Feraheme sales,$20.9 million was due to price increases and $11.5 million was due to increased volume sold. This total increase in gross product sales was partially offset by$97.2 million of additional allowances and accruals in 2016 as compared to the same period in 2015.Net U.S. product sales increased by $90.4 million, or approximately 26%, during 2016 as compared to 2015 primarily due to a $82.4 million increase innet Makena sales and a $8.6 million increase in net Feraheme sales. We anticipate that sales of Makena will continue to increase in 2017 as compared to2016 as we continue to gain market share from compounded product due to the availability of the single-dose, preservative-free formulation of Makena,which was approved in February 2016. We anticipate that we will also continue to gain market share through broader reimbursement of Makena, improvedpatient compliance and continued educational programs for patients and physicians regarding treatment with Makena. We anticipate that sales of Ferahemewill increase in 2017 as compared to 2016 due to our expectation of continued growth of the IV iron market. Product Sales Allowances and AccrualsWe recognize U.S. product sales net of certain allowances and accruals in our consolidated statement of operations at the time of sale. Our contractualadjustments include provisions for returns, pricing and prompt payment discounts, as well as wholesaler distribution fees, rebates to hospitals that qualify for340B pricing, and volume-based and other commercial rebates. Governmental rebates relate to our reimbursement arrangements with state Medicaidprograms. The increases in contractual adjustments and governmental rebates as a percentage of gross U.S. product sales primarily relate to the growth in salesto state Medicaid agencies. During 2016, we revised our estimated Medicaid reserve based on actual claims received since the 2011 launch of Makena, our expectations of statelevel utilization, and estimated rebate claims not yet submitted. This revision resulted in a $6.1 million reduction of our estimated Medicaid rebate reserverelated to prior period Makena sales. During 2015, we reduced our Makena-related Medicaid and chargeback reserves, which were initially recorded at thetime of the Lumara Health acquisition, by $4.0 million and $1.9 million, respectively. These measurement period adjustments were recorded to goodwillduring 2015. We may revise our estimated revenue reserves related to Makena as we continue to obtain additional experience or as our customer mixchanges. If we determine in future periods that our actual experience is not indicative of our expectations, if our actual experience changes, or if other factorsaffect our estimates, we may be required to adjust our allowances and accruals estimates, which would affect our net product sales in the period of theadjustment and could be significant.84Table of ContentsAn analysis of the amount of our product reserves for 2016 and 2015, is as follows (in thousands): Contractual Adjustments Governmental Rebates TotalBalance at January 1, 2015$26,408 $29,102 $55,510Measurement period adjustments - Lumara Health acquisition(2,619) (4,034) (6,653)Current provisions relating to sales in current year156,234 58,011 214,245Adjustments relating to sales in prior years172 (237) (65)Payments/returns relating to sales in current year(131,214) (33,073) (164,287)Payments/returns relating to sales in prior years(18,804) (24,002) (42,806)Balance at December 31, 2015$30,177 $25,767 $55,944Current provisions relating to sales in current year224,894 93,035 317,929Adjustments relating to sales in prior years(2,348) (6,052) (8,400)Payments/returns relating to sales in current year(181,150) (41,636) (222,786)Payments/returns relating to sales in prior years(23,973) (19,715) (43,688)Balance at December 31, 2016$47,600 $51,399 $98,999During 2016 and 2015, we implemented gross price increases for Feraheme, some portion of which were discounted back to customers under volume ormarket share based contracts. When portions of price increases are discounted back to customers, it can widen the gross to net adjustment percentage whilestill resulting in a greater net price per gram. In 2017, we expect contractual adjustments and governmental rebates to continue to increase as a percentage of gross product sales due to ourcontracting and discounting strategy, the mix of our business to different customers and increasing competitive pressure on our products. Service Revenues The $75.5 million increase in service revenues recorded in 2016 as compared to 2015 was due to the full period recognition of CBR Services revenue in2016 compared to a partial period in 2015 following our August 2015 acquisition of CBR. We expect service revenues to increase in 2017 due to continuedefforts to increase new enrollments of cord blood and cord tissue units in our storage facility and recurring revenue from our growing base of stored units.License Fee, Collaboration and Other Revenues Our license fee, collaboration and other revenues in 2016 decreased by $52.0 million as compared to 2015 primarily as the result of the 2015 recognitionof the $44.4 million balance of deferred revenue and $6.7 million of revenues recognized in 2015 in connection with the 2015 termination of the TakedaAgreement. We expect that our license fee, collaboration and other revenues, if any, will be immaterial in 2017.Costs and ExpensesCost of Product SalesCost of product sales for 2016 and 2015 were as follows (in thousands except for percentages): Years Ended December 31, 2016 to 2015 2016 2015 $ Change % ChangeCost of product sales$96,314 $78,509 $17,805 23%Percentage of net product sales22% 23% Our cost of product sales are primarily comprised of manufacturing costs, costs of managing our contract manufacturers, and costs for quality assuranceand quality control associated with our U.S. product sales, the amortization of product-related intangible assets and the inventory step-up in connection withthe November 2014 acquisition of Lumara Health. Cost of85Table of Contentsproduct sales excludes the impairment of intangible assets described separately below under “Impairments of Intangible Assets.” The $17.8 million increasein our cost of product sales for 2016 as compared to 2015 was primarily attributable to a $20.0 million net increase in amortization of the Makena andMuGard product intangible assets and a $5.8 million increase in production costs and overhead, partially offset by $4.4 million decrease of inventory write-offs and $3.5 million decrease in inventory step-up. We expect our cost of product sales as a percentage of net product sales excluding any impact from the amortization of the Makena intangible asset andthe amortization of inventory step-up of Makena inventory to continue to increase slightly in 2017 as compared to 2016 primarily due to increased sales ofthe single-dose preservative-free formulation of Makena, which we began promoting to physicians in the second quarter of 2016, compared to sales of themultidose vial of Makena. Cost of Services Cost of services for 2016 and 2015 were as follows (in thousands except for percentages): Years Ended December 31, 2016 to 2015 2016 2015 $ Change % ChangeCost of services$20,575 $9,992 $10,583 >100 %Percentage of service revenues21% 41% Cost of services includes the transportation of the umbilical cord blood stem cells and cord tissue from the hospital and direct material plus labor costsfor processing, cryogenic storage and collection kit materials. The $10.6 million increase in cost of services recorded in 2016 as compared to 2015 was due tothe full period recognition of CBR Services revenue in 2016 compared to a partial period in 2015 following our August 2015 acquisition of CBR. Thedecrease in the cost of services as a percentage of service revenues reflects a higher purchase accounting adjustment to the CBR deferred revenue balance in2015 as compared to 2016.We expect our cost of services as a percentage of service revenues to remain relatively constant in future periods as the deferred revenues adjustmentassociated with the CBR Services revenues becomes more consistent on an annual basis going forward.Research and Development Expenses Research and development expenses include external expenses, such as costs of clinical trials, contract research and development expenses, certainmanufacturing research and development costs, regulatory filing fees, consulting and professional fees and expenses, and internal expenses, such ascompensation of employees engaged in research and development activities, the manufacture of product needed to support research and development efforts,related costs of facilities, and other general costs related to research and development. Where possible, we track our external costs by major project. To theextent that external costs are not attributable to a specific project or activity, they are included in other external costs. Prior to the initial regulatory approvalof our products or development of new manufacturing processes, costs associated with manufacturing process development and the manufacture of drugproduct are recorded as research and development expenses, unless we believe regulatory approval and subsequent commercialization of the productcandidate is probable and we expect the future economic benefit from sales of the product to be realized, at which point we capitalize the costs as inventory.Research and development expenses for 2016 and 2015 consisted of the following (in thousands except for percentages): Years Ended December 31, 2016 to 2015 2016 2015 $ Change % ChangeExternal research and development expenses Makena-related costs$19,113 $10,820 $8,293 77 %Feraheme-related costs28,067 6,279 $21,788 >100 %Velo option— 10,000 $(10,000) (100)%Other external costs3,252 1,799 $1,453 81 %Total50,432 28,898 21,534 75 %Internal research and development expenses15,652 13,980 1,672 12 %Total research and development expenses$66,084 $42,878 $23,206 54 % 86Table of ContentsTotal research and development expenses incurred in 2016 increased by $23.2 million, or 54%, as compared to 2015. The $21.8 million increase inFeraheme-related costs was primarily attributed to new costs related to our Phase 3 clinical trial evaluating Feraheme in adults with IDA, which was initiatedand completed enrollment in 2016. The increase of Makena-related costs of $8.3 million was primarily attributed to $5.1 million in increased costs related toour Makena next-generation development program. The increase in total research and development expenses was partially offset by a $10.0 million 2015upfront payment related to the Velo option.We expect our research and development expenses to increase in 2017 as compared to 2016 mostly due to additional expenses associated with researchand development primarily related to our newly licensed products, including up to $25.0 million in clinical development and regulatory costs associatedwith our obligations under the Rekynda License Agreement, $60.0 million upfront payment made to Palatin in February 2017, our share of the clinicaldevelopment costs associated with the potential clinical studies for the use of Intrarosa in FSD and increased internal costs to support our regulatory filingsand clinical programs.Research and Development ActivitiesWe track our external costs on a major project basis, in most cases through the later of the completion of the last trial in the project or the last submissionof a regulatory filing to the FDA. We do not track our internal costs by project since our research and development personnel work on a number of projectsconcurrently and much of these costs benefit multiple projects or our operations in general. The following major research and development projects wereongoing as of December 31, 2016:•Makena: This project currently includes studies conducted as part of the post-approval commitments under the provisions of the FDA’s “Subpart H”Accelerated Approval regulations including: (a) an ongoing efficacy and safety clinical study of Makena; (b) an ongoing follow-up study of thechildren born to mothers from the efficacy and safety clinical study; and (c) a completed PK trial of women taking Makena. In addition, this projectincludes studies conducted as part of our Makena auto-injector development program, including a completion of the definitive PK study;•Feraheme to treat IDA in CKD patients: This project currently includes the following: (a) a completed clinical study evaluating Feraheme treatmentas compared to treatment to another IV iron and (b) a completed global multi-center randomized clinical trial to determine the safety and efficacy ofrepeat doses of Feraheme as compared to iron sucrose for the treatment of IDA in patients with hemodialysis dependent CKD (“FACT”). This projectalso includes a pediatric program as part of our post-approval Pediatric Research Equity Act requirement to support pediatric CKD labeling ofFeraheme, which we suspended in 2015 due to difficulty in enrollment. In December 2016, we met with the FDA to develop a plan forward in order tosatisfy this post-approval commitment for Feraheme and recently proposed a protocol to the FDA for a new pediatric study; and•Feraheme to treat IDA regardless of the underlying cause: This project currently includes a randomized, double-blind multicenter non-inferioritytrial that will evaluate the incidence of moderate-to-severe hypersensitivity reactions (including anaphylaxis) and moderate-to-severe hypotensionwith Feraheme compared to ferric carboxymaltose infusion in adults with IDA, which was initiated in the first quarter of 2016. We currently expect tofile an sNDA for this broader indication in mid-2017.From November 12, 2014 (the date of the Lumara Health acquisition) through December 31, 2016, we have incurred aggregate external research anddevelopment expenses of approximately $26.4 million related to our current program for Makena, described above. We currently estimate that the totalremaining external costs associated with this development project will be in the range of approximately $12.8 million to $18.3 million over the next severalyears. Through December 31, 2016, we have incurred aggregate external research and development expenses of approximately $41.8 million related to ourcurrent program for the development of Feraheme to treat IDA in CKD patients, described above. We do not anticipate additional external costs associatedwith this project. We incurred approximately $57.8 million of aggregate external research and development expenses related to our program for the development ofFeraheme to treat IDA regardless of the underlying cause up to the submission of our sNDA in 2013. In January 2014, after we received a complete responseletter from the FDA for the sNDA informing us that our sNDA could not be approved in its present form and stating that we had not provided sufficientinformation to permit labeling of Feraheme for safe and effective use for the proposed broader indication. We began enrolling patients in a head-to-headPhase 3 clinical trial, as described above, in the first quarter of 2016 and have spent approximately $27.6 million since the first quarter of 2016. We currentlyestimate that the total remaining external costs associated with this development project will be in the range of approximately $6.0 million to $8.0 millionthrough the second quarter of 2017, the expected time of our sNDA submission to the FDA.87Table of ContentsSelling, General and Administrative Expenses Our selling, general and administrative expenses include costs related to our commercial personnel, including our specialty sales forces, medicaleducation professionals, pharmacovigilance, and safety monitoring and commercial support personnel, costs related to our administrative personnel,including our legal, finance, business development and executive personnel, external and facilities costs required to support the marketing and sale of ourproducts and services, and other costs associated with our corporate activities.Selling, general and administrative expenses for 2016 and 2015 consisted of the following (in thousands except for percentages): Years Ended December 31, 2016 to 2015 2016 2015 $ Change % ChangeCompensation, payroll taxes and benefits$78,295 $62,122 $16,173 26%Professional, consulting and other outside services114,813 78,981 35,832 45%Fair value of contingent consideration liability25,683 4,271 21,412 >100%Amortization expense related to customer relationship intangible12,529 1,061 11,468 >100%Equity-based compensation expense18,550 13,874 4,676 34%Total selling, general and administrative expenses$249,870 $160,309 $89,561 56% Total selling, general and administrative expenses incurred in 2016 increased by $89.6 million, or approximately 56%, as compared to the same periodin 2015 for the following reasons:•$16.2 million increase in compensation, payroll taxes and benefits primarily due to increased headcount resulting from the August 2015 CBRacquisition;•$25.0 million increase in sales and marketing, consulting, professional fees, and other expenses due to costs related to CBR marketing activities andrevenue driven spend related to Makena;•$10.8 million increase in general and administrative, consulting, professional fees and other expenses primarily due to increased costs associatedwith the CBR acquisition;•$21.4 million increase to the contingent consideration liability due to a $22.8 million increase in the Makena-related contingent considerationbased on the expected timing of the milestone payments;•$11.5 million increase in amortization expense related to the CBR customer relationship intangible due to the full period recognition of CBRamortization expense in 2016 compared to a partial period in 2015 following our August 2015 acquisition of CBR; and•$4.7 million increase in equity-based compensation expense due primarily to an increase in the number of equity awards to new and existingemployees, including additional employees from the CBR acquisition.We expect that total selling, general and administrative expenses will increase substantially in 2017 as compared to 2016 due to significant increasedcosts associated with the license of Rekynda and Intrarosa, including the anticipated expansion of our sales force and certain marketing commitments tosupport the commercialization of Intrarosa.88Table of ContentsImpairment of Intangible AssetsDuring the year ended December 31, 2016, we recognized an impairment loss on our intangible assets of $19.7 million, due to a $15.7 millionimpairment charge related to the impairment of the remaining net intangible asset for the MuGard Rights based on the lack of broad reimbursement andinsurance coverage for MuGard and the impairment of the remaining $0.2 million, net, CBR-favorable lease intangible asset due the subleasing of a portionof our CBR office space in San Bruno, California at a rate below the market rate used to determine the favorable lease intangible asset. In addition, as part ofour annual impairment test, we recorded an impairment charge of $3.7 million in the fourth quarter of 2016 related to the impairment of a portion of the CBRtrade names and trademarks indefinite-lived intangible asset based on the revised long-term revenue forecast for CBR. As part of our ongoing assessment ofpotential impairment indicators related to our finite-lived and indefinite-lived intangible assets, we will closely monitor the performance of our productportfolio and our intangible assets. If our ongoing assessments reveal indications of impairment, we may determine that an impairment charge is necessaryand such charge could be material.Acquisition-related Costs Acquisition-related costs of $11.2 million incurred in 2015 included costs for financial advising, legal fees, due diligence, and other costs and expensesrelated to our August 2015 acquisition of CBR. We did not incur any acquisition-related costs in 2016.Restructuring ExpensesIn connection with the August 2015 CBR acquisition and the November 2014 Lumara Health acquisition, we initiated restructuring programs, whichincluded severance benefits related to former CBR and Lumara Health employees. We recorded charges of approximately $0.7 million and $4.1 million in2016 and 2015, respectively. We expect to pay the remaining restructuring costs by the end of the first quarter of 2017.Other Income (Expense)Other income (expense) for 2016 and 2015 consisted of the following (in thousands except for percentages): Years Ended December 31, 2016 to 2015 2016 2015 $ Change % ChangeInterest expense$(73,153) $(53,251) $(19,902) 37 %Loss on debt extinguishment— (10,449) 10,449 (100)%Interest and dividend income, net3,149 1,512 1,637 >100 %Other income (expense)189 (9,188) 9,377 <(100)%Total other income (expense)$(69,815) $(71,376) $1,561 (2)%Other expense for 2016 decreased by $1.6 million as compared to 2015 primarily as the result of the following:•$10.4 million loss on debt extinguishment in 2015 as the result of the early repayment of the remaining $323.0 million outstanding principalamount of our then existing five-year term loan facility (the “2014 Term Loan Facility”); and•$9.4 million decrease of other expenses as compared to 2015, including a payment of a $6.8 million bridge loan commitment fee and $2.4 million infees and expenses paid in 2015 as part of the early repayment of the 2014 Term Loan Facility.These decreases described above were partially offset by an additional $19.9 million in interest expense in 2016, which was primarily comprised of theamortization of debt discount, contractual interest expense and amortization of debt issuance costs due to the full period recognition in 2016 of the debtobligations incurred in the third quarter of 2015, compared to a partial period in in 2015.We expect our net other income (expense) to remain relatively constant in 2017 as compared to 2016.89Table of ContentsIncome Tax ExpenseThe following table summarizes our effective tax rate and income tax expense for 2016 and 2015 (in thousands except for percentages): Years Ended December 31, 2016 2015Effective tax rate127% 18%Income tax expense$11,538 $7,065For 2016, we recognized income tax expense of $11.5 million, representing an effective tax rate of 127%. The difference between the expected statutoryfederal tax rate of 35% and the 127% effective tax rate for 2016 was primarily attributable to the impact of contingent consideration associated with LumaraHealth, equity-based compensation expenses and other permanent items, including meals and entertainment expense, officers compensation andMakena-related expenses, offset by the benefit of the federal research and development and orphan drug tax credits generated during the year. For 2015, werecognized an income tax expense of $7.1 million, representing an effective tax rate of 18%. The difference between the expected statutory federal tax rate of35% and the 18% effective tax rate for 2015 was attributable to the impact of a valuation allowance release related to certain deferred tax assets and theimpact of state income taxes, partially offset by non-deductible transaction costs associated with the acquisition of CBR and non-deductible contingentconsideration expense associated with Lumara Health.Expectations Related to the Endoceutics License In addition to the trends and expectations noted above, we expect that the Endoceutics License Agreement will close during the first half of 2017.Pursuant to the terms of the agreement, we will make an up-front payment of $50.0 million, and (subject to certain customary conditions) will issue 600,000shares of unregistered common stock, to Endoceutics. We also agreed to make a payment to Endoceutics of up to $10.0 million upon the delivery ofIntrarosa launch quantities and a payment of $10.0 million on the first anniversary of the closing date. Payment of the consideration using cash on hand willlower our cash balance. We agreed to co-fund additional studies in FSD and our commitment is limited to $20.0 million. In addition, we have also committedto a minimum marketing spend in 2017 for Intrarosa and expect to incur significant increased costs associated with the anticipated expansion of our salesforce and certain marketing commitments to support the commercialization of Intrarosa. These obligations, as well as additional expenses that we expect toincur in 2017, including the expansion of our sales force, will lower our cash balance and our expected profitability in 2017. Further, the transaction,including issuing the consideration shares, will dilute earnings in the near term.Results of Operations - 2015 as compared to 2014Revenues Total revenues for 2015 and 2014 consisted of the following (in thousands except for percentages): Years Ended December 31, 2015 to 2014 2015 2014 $ Change % ChangeU.S. product sales, net Makena$251,615 $22,513 $229,102 >100%Feraheme88,452 86,282 2,170 3%MuGard1,749 1,203 546 45%Total341,816 109,998 231,818 >100%Service revenues, net24,132 — 24,132 N/ALicense fee, collaboration and other revenues52,328 14,386 37,942 >100%Total Revenues$418,276 $124,384 $293,892 >100% Our total revenues in 2015 increased by $293.9 million as compared to 2014, primarily as the result of a $229.1 million increase in Makena net productsales and $24.1 million of 2015 CBR service revenue following our November 2014 and August 2015 acquisitions of Lumara Health and CBR, respectively.In addition, under the terms of the 2014 termination of the Takeda Agreement, in 2015 we recognized revenues of $6.7 million for payments made by Takedaas well as $44.4 million of90Table of Contentspreviously deferred revenues associated with the amortization of the then-remaining deferred revenue balance under the Takeda Agreement.The following table sets forth customers who represented 10% or more of our total revenues for 2015 and 2014: Years Ended December 31, 2015 2014AmerisourceBergen Drug Corporation25% 34%Takeda Pharmaceuticals Company Limited12% 11%McKesson Corporation11% 21%Cardinal Health, Inc.<10% 15%Product SalesTotal gross U.S. product sales were offset by product sales allowances and accruals for 2015 as compared to 2014 as follows (in thousands except forpercentages):Years Ended December 31, 2015 to 20142015 Percent ofgross U.S.product sales 2014 Percent ofgross U.S.product sales $ Change % ChangeGross U.S. product sales$561,255 $190,512 $370,743 >100 %Provision for U.S. product sales allowances andaccruals: Contractual adjustments161,665 29% 73,262 38% Governmental rebates57,774 10% 7,252 4% Total provision for U.S. product salesallowances and accruals219,439 39% 80,514 42% U.S. product sales, net$341,816 $109,998 $231,818 >100 %Gross U.S. product sales increased by $370.7 million during 2015 as compared to 2014 primarily due to increases of $353.9 million and $15.9 million ofMakena and Feraheme gross sales in 2015 as compared to 2014, respectively. The $353.9 million increase in gross Makena sales in 2015 was due toincreased volume since we acquired Makena in November 2014. Of the $15.9 million increase in gross U.S. Feraheme sales, $21.8 million was due to priceincreases, partially offset by a decrease of $5.9 million due to decreased units sold. This total increase in gross product sales was partially offset by$138.9 million of additional allowances and accruals in 2015. As a result, total net product sales increased by $231.8 million, or greater than 100%, during2015 as compared to 2014.Product Sales Allowances and AccrualsThe increase in Makena contractual adjustments reflects the inclusion of a full year of Makena as part of our product portfolio in 2015. Total Ferahemecontractual adjustments for 2015 were $79.2 million, or 47% of total gross U.S. Feraheme product sales, as compared to $65.4 million, or 43%, in 2014. Theincrease in total contractual adjustments as a percentage of total gross U.S. Feraheme product sales was related primarily to a change in our customer mix.The increase in Makena governmental rebates reflects the inclusion of a full year in 2015. During 2015, we reduced our Makena-related Medicaid andchargeback reserves, which were initially recorded at the time of the Lumara Health acquisition, by $4.0 million and $1.9 million, respectively. Thesemeasurement period adjustments were recorded to goodwill during 2015. Total Feraheme governmental rebates were $0.7 million in 2015 as compared to$0.8 million in 2014. We did not significantly adjust our Medicaid rebate reserve during 2014.During 2014, we reduced our reserve for Feraheme product returns by approximately $1.8 million, primarily as the result of a lower than expected rate ofproduct returns. As a result, the product returns provision applied to gross product sales for 2014 was a credit of $1.2 million, resulting in an increase toproduct sales. There were no significant adjustments to our reserve for product returns in 2015.91Table of ContentsAn analysis of the amount of our product reserves for 2015 and 2014 is as follows (in thousands): Contractual Adjustments Governmental Rebates TotalBalance at January 1, 2014$7,059 $487 $7,546Product reserves resulting from the Lumara Health acquisition16,888 28,405 45,293Current provisions relating to sales in current year67,952 786 68,738Adjustments relating to sales in prior years(1,429) — (1,429)Payments/returns relating to sales in current year(58,464) (401) (58,865)Payments/returns relating to sales in prior years(5,598) (175) (5,773)Balance at December 31, 2014$26,408 $29,102 $55,510Measurement period adjustments - Lumara Health acquisition(2,619) (4,034) (6,653)Current provisions relating to sales in current year156,234 58,011 214,245Adjustments relating to sales in prior years172 (237) (65)Payments/returns relating to sales in current year(131,214) (33,073) (164,287)Payments/returns relating to sales in prior years(18,804) (24,002) (42,806)Balance at December 31, 2015$30,177 $25,767 $55,944During 2015 and 2014, we implemented gross price increases for Feraheme, some portion of which were discounted back to customers under volume ormarket share based contracts. When portions of price increases are discounted back to customers, it can widen the gross to net adjustment percentage whilestill resulting in a greater net price per gram.Service Revenues The $24.1 million in service revenues was due to the addition of the CBR Services in August 2015.License Fee, Collaboration and Other Revenues License fee, collaboration and other revenues for 2015 and 2014 consisted of the following (in thousands except for percentages): Years Ended December 31, 2015 to 2014 2015 2014 $ Change % ChangeDeferred license fee revenues recognized from Takeda$44,376 $8,217 $36,159 >100 %Other revenues7,952 5,169 2,783 54 %Deferred revenues recognized from 3SBio termination— 1,000 (1,000) (100)%Total license fee, collaboration and other revenues$52,328 $14,386 $37,942 >100 %Our license fee, collaboration and other revenues in 2015 increased by $37.9 million as compared to 2014 primarily as the result of the recognition of the$44.4 million balance of deferred revenue in connection with the effective termination of the Takeda Agreement in 2015. In addition, other revenuesincreased by $2.8 million primarily due to $6.7 million of revenues recognized in 2015 related to payments made by Takeda as required under the terms ofthe termination agreement with Takeda as compared to $3.0 million recognized in 2014 related to the termination agreement with Takeda, and which wasrecorded in other products sales and royalties in our 2014 consolidated statement of operations.92Table of ContentsCosts and ExpensesCost of Product SalesCost of product sales for 2015 and 2014 were as follows (in thousands except for percentages): Years Ended December 31, 2015 to 2014 2015 2014 $ Change % ChangeCost of product sales$78,509 $20,306 $58,203 >100 %Percentage of net product sales23% 18% The $58.2 million increase in our cost of product sales for 2015 as compared to 2014 was attributable to the following factors:•$57.2 million increase related to $46.9 million of amortization of the Makena product intangible asset and $10.3 million of amortization of theMakena inventory step-up;•$2.0 million increase in costs related to Makena for a full year of sales in 2015 as compared to a partial year in 2014;•$1.0 million increase in internal departmental costs, including salaries, benefits, and additional equity compensation; and•$2.8 million decrease in costs related to sales of Feraheme to Takeda, including the accelerated recognition of product costs in 2014 previouslydeferred as a result of the termination agreement with Takeda.Cost of Services Cost of services for 2015 and 2014 were as follows (in thousands except for percentages): Years Ended December 31, 2015 to 2014 2015 2014 $ Change % ChangeCost of services$9,992 $— $9,992 N/APercentage of service revenues41% —% The $10.0 million in cost of services was due to the addition of the CBR Services in August 2015.Research and Development Expenses Research and development expenses for 2015 and 2014 consisted of the following (in thousands except for percentages): Years Ended December 31, 2015 to 2014 2015 2014 $ Change % ChangeExternal research and development expenses Makena-related costs$10,820 $1,703 $9,117 100 %Feraheme-related costs6,279 10,588 (4,309) (41)%Velo option10,000 — 10,000 N/AOther external costs1,799 980 819 84 %Total28,898 13,271 15,627 100 %Internal research and development expenses13,980 10,889 3,091 28 %Total research and development expenses$42,878 $24,160 $18,718 77 % Total research and development expenses incurred in 2015 increased by $18.7 million, or 77%, as compared to 2014. The increase was primarily due to a$10.0 million upfront payment made to Velo in July 2015 for an option to acquire the rights to an orphan drug candidate in clinical development for thetreatment of severe preeclampsia in pregnant women. In addition, the increase reflects new costs related to Makena clinical trials and related developmentcosts.93Table of ContentsSelling, General and Administrative Expenses Selling, general and administrative expenses for 2015 and 2014 consisted of the following (in thousands except for percentages): Years Ended December 31, 2015 to 2014 2015 2014 $ Change % ChangeCompensation, payroll taxes and benefits$62,122 $31,261 $30,861 99 %Professional, consulting and other outside services78,981 34,767 44,214 >100 %Fair value of contingent consideration liability4,271 (681) 4,952 <(100)%Amortization expense related to customer relationship intangible1,061 — 1,061 N/AEquity-based compensation expense13,874 6,907 6,967 >100 %Total selling, general and administrative expenses$160,309 $72,254 $88,055 >100 % Total selling, general and administrative expenses incurred in 2015 increased by $88.1 million, or greater than 100%, as compared to 2014 for thefollowing reasons:•$30.9 million increase in compensation, payroll taxes and benefits primarily due to increased costs associated with additional personnel inconnection with the November 2014 Lumara Health and August 2015 CBR acquisitions;•$27.0 million increase in sales and marketing consulting, professional fees, and other expenses primarily due to costs related to Makena marketingactivities since the November 2014 acquisition and CBR activities since the August 2015 acquisition;•$17.2 million increase in general and administrative consulting, professional fees and other expenses primarily due to increased costs associatedwith consulting, finance, legal, and other infrastructure activities in support of our product portfolio expansion as well as costs associated withLumara Health and CBR after the November 2014 and August 2015 acquisitions, respectively;•$7.0 million increase in equity-based compensation expense due primarily to the expense associated with equity awards to new and existingemployees, including additional employees from the Lumara Health and CBR acquisitions as well as one-time charges associated with the departureof certain of our executive officers during 2015; and•$5.0 million increase to the contingent consideration liability due to a $6.7 million increase to the Lumara Health-related contingent consideration,partially offset by a $1.7 million reduction of the MuGard-related contingent consideration primarily resulting from a 2015 revision of our totalprojected MuGard sales.Acquisition-related CostsWe incurred approximately $11.2 million and $9.5 million of acquisition-related costs in 2015 and 2014, respectively, related to our acquisitions ofCBR and Lumara Health, which primarily represented financial advisory fees, legal fees, due diligence and other costs and expenses.Restructuring ExpensesIn connection with the August 2015 CBR acquisition and the November 2014 Lumara Health acquisition, we initiated restructuring programs, whichincluded severance benefits related to former CBR and Lumara Health employees. As a result of these restructurings, we recorded charges of approximately$4.1 million and $2.0 million in 2015 and 2014, respectively.94Table of ContentsOther Income (Expense)Other income (expense) for 2015 and 2014 consisted of the following (in thousands except for percentages): Years Ended December 31, 2015 to 2014 2015 2014 $ Change % ChangeInterest expense$(53,251) $(14,697) $(38,554) >100 %Loss on debt extinguishment(10,449) — (10,449) N/AInterest and dividend income, net1,512 975 537 55 %Other income (expense)(9,188) 217 (9,405) <(100)%Total other income (expense)$(71,376) $(13,505) $(57,871) >100 %Other expense for 2015 increased by $57.9 million as compared to 2014 primarily as the result of the following:•An additional $38.6 million in interest expense in 2015, which was primarily comprised of the amortization of debt discount, contractual interestexpense and amortization of debt issuance costs in connection with our current debt obligations as compared to 2014;•$10.4 million loss on debt extinguishment as the result of the early repayment in 2015 of the remaining $323.0 million outstanding principalamount of the 2014 Term Loan Facility; and•$9.4 million increase of other expense, which included a $6.8 million bridge loan commitment fee paid in the third quarter of 2015 as part of theplanned financing for the CBR acquisition, but which was not utilized to fund the acquisition, and $2.4 million in fees and expenses in 2015 fromthe 2014 Term Loan Facility that were expensed in accordance with accounting guidance for the modification of debt arrangements.Income Tax Expense (Benefit)The following table summarizes our effective tax rate and income tax expense (benefit) for 2015 and 2014 (in thousands except for percentages):Years Ended December 31,2015 2014Effective tax rate18% (883)%Income tax expense (benefit)$7,065 $(153,159)We recognized a $7.1 million income tax expense and a $153.2 million income tax benefit for 2015 and 2014, respectively. The $7.1 million taxexpense in 2015 reflected the impact of a valuation allowance release related to certain deferred tax assets, partially offset by non-deductible transactioncosts associated with the acquisition of CBR and non-deductible contingent consideration expense associated with Lumara Health. The $153.2 millionincome tax benefit in 2014 reflected a $132.9 million decrease in our valuation allowance due to taxable temporary differences available as a source ofincome to realize the benefit of certain of our pre-existing deferred tax assets as a result of the acquisition of Lumara Health.Liquidity and Capital Resources General We currently finance our operations primarily from the cash generated from our operating activities, including sales of our products and services. Weexpect to continue to incur significant expenses as we continue to market, sell and contract for the manufacture of Makena and Feraheme, market and sell theCBR Services, pursue the next-generation development program for Makena, further develop and seek U.S. regulatory approval for Feraheme for thetreatment of IDA in a broad range of patients and for Rekynda for the treatment of hypoactive sexual desire disorder. For a detailed discussion regarding therisks and uncertainties related to our liquidity and capital resources, please refer to our Risk Factors in Part I, Item 1A of this Annual Report on Form 10-K. 95Table of ContentsCash, cash equivalents, investments and certain financial obligations as of December 31, 2016 and 2015 consisted of the following (in thousands exceptfor percentages): December 31, 2016 2015 $ Change % ChangeCash and cash equivalents$274,305 $228,705 $45,600 20 %Investments304,781 237,626 67,155 28 %Total$579,086 $466,331 $112,755 24 % Outstanding principal on 2023 Senior Notes$500,000 $500,000 $— — %Outstanding principal on Convertible Notes199,998 200,000 (2) — %Outstanding principal on 2015 Term Loan Facility328,125 345,625 (17,500) (5)%Total$1,028,123 $1,045,625 $(17,502) (2)% We place our cash in instruments that meet high credit quality and diversification standards, as specified in our investment policy. Our investment policyalso limits the amount of our credit exposure to any one issue or issuer, excluding U.S. government entities and money market funds, and seeks to managethese assets to achieve our goals of preserving principal, maintaining adequate liquidity at all times, and maximizing returns.The $112.8 million increase in cash, cash equivalents and investments as of December 31, 2016, as compared to December 31, 2015, was primarily dueto cash flow from product and service sales, partially offset by expenditures to fund our operations, service our debt, including principal and interestpayments, a $100.0 million milestone paid in 2016 to the former Lumara Health security holders based on our achievement of a $300.0 million annual netMakena sales milestone, and $20.0 million of cash used to repurchase our common stock during 2016. In March 2015, we sold approximately 4.6 million shares of our common stock at a public offering price of $44.00 per share, resulting in net proceeds tous of approximately $188.8 million. In addition, in August 2015, we sold approximately 3.6 million shares of our common stock at a public offering price of$63.75 per share, resulting in net proceeds to us of approximately $218.6 million. We expect that our cash, cash equivalents and investments balances will be positively impacted by operating profits in 2017, which may be offset by themilestone payments and other commitments that we will make in connection with the Palatin and Endoceutics license agreements. Our expectation takes intoconsideration our commitments under these license agreements and assumes our continued investment in the development and commercialization of ourproducts and services, including: the $60.0 million upfront license payment to Palatin in February 2017, a $50.0 million upfront payment to be made toEndoceutics upon the close of the transaction, $10.0 million to be paid to Endoceutics for commercial supply of Intrarosa in preparation for its 2017 launch,as well as clinical development and regulatory costs associated with our obligations under the Rekynda License Agreement and the related anticipatedincrease in expenses in our regulatory and clinical functions, significant costs associated with the anticipated expansion of our sales force and certainmarketing commitments to support the commercialization of Intrarosa and a $100.0 million milestone payment expected to be paid in the second half of2017 to the former Lumara Health security holders based on the achievement of a net sales milestone of Makena. We believe that our cash, cash equivalentsand investments as of December 31, 2016, and the cash we currently expect to receive from sales of our products and services, and earnings on ourinvestments, will be sufficient to satisfy our cash flow needs for the foreseeable future. 96Table of ContentsBorrowings and Other LiabilitiesIn August 2015, in connection with the CBR acquisition, we completed a private placement of $500.0 million aggregate principal amount of 7.875%Senior Notes due 2023 (the “2023 Senior Notes”) and entered into a credit agreement with a group of lenders, including Jefferies Finance LLC, who acted asadministrative and collateral agent, that provided us with, among other things, a six-year $350.0 million term loan facility (the “2015 Term Loan Facility”).The 2023 Senior Notes, which are senior unsecured obligations, will mature on September 1, 2023 and will bear interest at a rate of 7.875% per year, withinterest payable semi-annually on September 1 and March 1 of each year (which began in March 2016). We borrowed the full $350.0 million available underthe 2015 Term Loan Facility in August 2015. In addition, the 2015 Term Loan Facility includes an annual mandatory prepayment of the debt in an amountequal to 50% of our excess cash flow (as defined in the 2015 Term Loan Facility) as measured on an annual basis, beginning with the fiscal year endingDecember 31, 2016. As a result, as of December 31, 2016, $3.7 million was estimated and reclassified from long-term debt to current portion of long-term debtin our consolidated balance sheet as the first excess payment is expected to be made in April 2017. On or after December 31, 2016, the applicable excess cashflow percentage shall be reduced based on the total net leverage ratio as of the last day of the period. For additional information, see Note R, “Debt,” to ourconsolidated financial statements included in this Annual Report on Form 10‑K. In February 2014, we issued $200.0 million aggregate principal amount of 2.5% convertible senior notes due February 15, 2019 (the “ConvertibleNotes”), as discussed in more detail in Note R, “Debt,” to our consolidated financial statements included in this Annual Report on Form 10-K. TheConvertible Notes are senior unsecured obligations and bear interest at a rate of 2.5% per year, payable semi-annually in arrears on February 15 and August15 of each year. The Convertible Notes will mature on February 15, 2019, unless repurchased or converted earlier. The Convertible Notes will be convertibleinto cash, shares of our common stock, or a combination thereof, at our election (subject to certain limitations in the 2015 Term Loan Facility), at aconversion rate of approximately 36.9079 shares of common stock per $1,000 principal amount of the Convertible Notes, which corresponds to a conversionprice of approximately $27.09 per share of our common stock. The conversion rate is subject to adjustment from time to time. Based on the last reported saleprice of our common stock during the last 30 trading days of 2016, the Convertible Notes were not convertible as of December 31, 2016. Share Repurchase Program In January 2016, we announced that our board of directors had authorized a program to repurchase up to $60.0 million in shares of our common stock.The repurchase program does not have an expiration date and may be suspended for periods or discontinued at any time. Under the program, we maypurchase our stock from time to time at the discretion of management in the open market or in privately negotiated transactions. The number of sharesrepurchased and the timing of the purchases will depend on a number of factors, including share price, trading volume and general market conditions, alongwith working capital requirements, general business conditions and other factors. We may also from time to time establish a trading plan under Rule 10b5-1of the Securities and Exchange Act of 1934 to facilitate purchases of our shares under this program. During 2016, we repurchased and retired 831,744 sharesof common stock under this repurchase program for $20.0 million, at an average purchase price of $24.05 per share. Cash Flow Activity for the Year Ended December 31, 2016Cash flows from operating activities Net cash provided by operating activities for 2016 was $246.2 million as compared to $96.0 million in 2015. The increase in net cash provided byoperating activities was primarily due to the following:•Non-cash operating items resulting in a net increase of $191.0 million, including deferred income taxes, equity-based compensation expense, awrite-down of inventory, amortization of debt discount and debt issuance costs, amortization of premium/discount on purchased securities, changein fair value of contingent consideration, depreciation and amortization, loss on debt extinguishment and other non-cash items;•Change in accounts receivable of $27.0 million, a net increase in CBR deferred revenues of $46.7 million, partially offset by a decrease in netincome of approximately $35.3 million.We expect to generate cash from operations as we continue to grow our business, partially offset by increased expenditures to support our growth. 97Table of ContentsCash flows from investing activities Net cash used in investing activities in 2016 was $72.7 million as compared to $899.0 million in 2015. Cash used in investing activities decreasedduring 2016 as compared to 2015 primarily due to a net decrease in the purchase and sales of our investments and the $682.4 million of net cash used in2015 to fund the CBR acquisition. Cash flows from financing activities Net cash used in financing activities in 2016 was $127.9 million as compared to net cash provided by financing activities of $912.5 million in 2015. The2016 financing activities primarily related to $92.1 million in contingent consideration payments related to the acquisition of Lumara Health, $20.0 millionof cash to repurchase shares of our common stock under our share repurchase program, and $17.5 million related to mandatory debt principal payments. In2015, the primary sources of cash from financing activities were $407.5 million in net proceeds from the aggregate issuance of common stock from our March2015 and August 2015 public offerings, $834.8 million received from the proceeds of new debt offerings in 2015.Cash Flow Activity for the Year Ended December 31, 2015Cash flows from operating activitiesNet cash provided by operating activities in 2015 was $96.0 million as compared to $11.4 million in 2014. The increase in cash provided by operatingactivities was primarily due to increased product sales from the addition of Makena and CBR to our product portfolio.During 2015, our $96.0 million of cash provided by operations was attributable to our net operating income of approximately $32.8 million, adjusted forthe following:•Non-cash operating items resulting in a net increase of $116.8 million, including deferred income taxes, equity-based compensation expense, awrite-down of inventory, amortization of debt discount and debt issuance costs, amortization of premium/discount on purchased securities, changein fair value of contingent consideration, depreciation and amortization, loss on debt extinguishment and other non-cash items;•$34.0 million of cash used in operating activities due to net increases in receivables and inventories, partially offset by decreases in prepaid andother current assets;•$9.2 million of cash provided by operating activities due to decreases in other long-term assets;•$7.9 million of cash provided by operating activities due to increases in accounts payable and accrued expenses;•$24.2 million of cash used in operating activities due to decreases in deferred revenues and other long-term liabilities; and•$12.5 million repayment of original issue discount related to the 2014 Term Loan Facility.Cash flows from investing activitiesNet cash used in investing activities in 2015 was $899.0 million as compared to $432.9 million in 2014. Cash used in investing activities increased in2015 primarily due to $682.4 million of net cash used to fund the acquisition of CBR and $424.8 million of cash used to purchase investments with theproceeds we received from our March 2015 and August 2015 public equity offerings, partially offset by $209.0 million of proceeds from the sales andmaturities of our investments.Cash flows from financing activitiesNet cash provided by financing activities in 2015 and 2014 was $912.5 million and $513.8 million, respectively. Cash provided by financing activitiesincreased during 2015 as compared to 2014 primarily due to the $407.5 million in net proceeds from the aggregate issuance of common stock from ourMarch 2015 and August 2015 public offerings, $824.7 million received from the proceeds of new debt offerings, partially offset by the repayment of the 2014Term Loan Facility.98Table of ContentsCash Flow Activity for the Year Ended December 31, 2014Cash flows from operating activitiesDuring 2014, our $11.4 million of cash provided by operations was attributable principally to our net operating income of approximately $135.8million, adjusted for the following:•Non-cash operating items resulting in a net decrease of $128.2 million, including deferred income taxes, equity-based compensation expense, awrite-down of inventory, amortization of debt discount and debt issuance costs, amortization of premium/discount on purchased securities, changein fair value of contingent consideration, depreciation and amortization, and other non-cash items;•$0.3 million of cash provided by operating activities due to increases in accounts receivable, inventories and prepaid and other current assets;•$10.7 million of cash provided by operating activities due to increases in accounts payable and accrued expenses;•$9.2 million of cash used in operating activities due to decreases in deferred revenues and other long-term liabilities; and•$2.0 million of cash provided by operating activities due to decreases in other long-term assets.Our net income of $135.8 million was primarily the result of the recognition of a $153.2 million income tax benefit resulting from our merger withLumara Health, partially offset by our costs to operate our business.Cash flows from investing activitiesCash used in investing activities in 2014 was $432.9 million and was primarily attributable to the $595.6 million net cash used to fund the acquisition ofLumara Health, partially offset by proceeds from the sales and maturities of our investments, including the liquidation of $170.4 million to partially fund theacquisition of Lumara Health as well as a $2.9 million change in restricted cash following the return of escrowed funds related to a 2013 businessdevelopment transaction that we did not complete.Cash flows from financing activitiesCash provided by financing activities in 2014 was $513.8 million and was primarily attributable to the $327.5 million proceeds from the Term LoanFacility, which were used to partially fund the acquisition of Lumara Health and $178.1 million in net proceeds received from the issuance of the ConvertibleNotes in February 2014. In addition, we received $8.5 million in proceeds from the exercise of stock options.Contractual ObligationsOur long-term contractual obligations include commitments and estimated purchase obligations entered into in the normal course of business. Theseinclude commitments related to our facility leases, purchases of inventory and other purchases related to our products, debt obligations (including interestpayments), and other purchase obligations. Future lease obligations and purchase commitments, as of December 31, 2016, are as follows (in thousands): Payment due by period Total Less than 1 year 1-3 years 3-5 years More than 5 yearsFacility lease obligations$10,801 $2,925 $6,711 $1,165 $—Purchase commitments5,260 2,630 2,630 — —2.5% Convertible Notes210,831 5,000 205,831 — —2015 Term Loan Facility391,096 36,310 62,706 292,080 —2023 Senior Notes775,625 39,375 78,750 78,750 578,750Total$1,393,613 $86,240 $356,628 $371,995 $578,75099Table of ContentsFacility Lease ObligationsIn June 2013, we entered into a lease agreement with BP Bay Colony LLC (the “Landlord”) for the lease of certain real property located at 1100 WinterStreet, Waltham, Massachusetts (the “Waltham Premises”) for use as our principal executive offices. Beginning in September 2013, the initial term of thelease is five years and two months with one five-year extension term at our option. During 2015, we entered into several amendments to the original lease toadd additional space and to extend the term of the original lease to June 2021. In addition to base rent, we are also required to pay a proportionate share ofthe Landlord’s operating costs.The Landlord agreed to pay for certain agreed-upon improvements to the Waltham Premises and we agreed to pay for any increased costs due to changesby us to the agreed-upon plans. We record all tenant improvements paid by us as leasehold improvements and amortize these improvements over the shorterof the estimated useful life of the improvement or the remaining life of the initial lease term. Amortization of leasehold improvements is included indepreciation expense.In addition, in connection with our facility lease for the Waltham Premises, in June 2013 we delivered to the Landlord a security deposit of $0.4 millionin the form of an irrevocable letter of credit. This security deposit was increased to $0.6 million in 2015. The cash securing this letter of credit is classified onour balance sheet as of December 31, 2016 and 2015 as a long-term asset and is restricted in its use.We lease certain real property located at 1200 Bayhill Drive, San Bruno, California. The lease expires in September 2017.Facility-related rent expense, net of deferred rent amortization, for all the leased properties was $2.8 million, $1.5 million, and $0.8 million for 2016,2015 and 2014, respectively.Purchase CommitmentsIn connection with our acquisition of CBR, we have certain minimum purchase commitments associated with an agreement entered into by CBR prior toour acquisition. This agreement expires in December 2018, with the remaining amount of minimum purchase commitments totaling $5.3 million as ofDecember 31, 2016.Contingent Consideration Related to Business CombinationsIn connection with our acquisition of Lumara Health in November 2014, we agreed to pay up to an additional $350.0 million based on the achievementof certain sales milestones. Due to the contingent nature of these milestone payments, we cannot predict the amount or timing of such payments withcertainty. During 2016, we paid $100.0 million of these milestone payments. We expect to pay the next $100.0 million milestone payment in 2017. See NoteC, “Business Combinations,” to our consolidated financial statements included in this Annual Report on Form 10-K for more information on the LumaraHealth acquisition and related milestone payments.As of December 31, 2016, the contingent consideration related to the Lumara Health and MuGard acquisitions are our only financial liabilities measuredand recorded using Level 3 inputs in accordance with accounting guidance for fair value measurements, and represent 100% of the total liabilities measuredat fair value. See Note E, “Fair Value Measurements” to our consolidated financial statements included in this Annual Report on Form 10-K for moreinformation.Contingent Regulatory and Commercial Milestone PaymentsIn connection with the option agreement entered into with Velo, if we exercise the option to acquire the DIF rights, we will be responsible for paymentstotaling up to $65.0 million (including the payment of the option exercise price and the regulatory milestone payments) and up to an additional $250.0million in sales milestone payments based on the achievement of annual sales milestones at targets ranging from $100.0 million to $900.0 million. Weexpect that Velo will begin its Phase 2b/3a clinical study in the first quarter of 2017, and as such no contingencies related to this agreement have beenrecorded in our consolidated financial statements as of December 31, 2016.In connection with the development and license agreement entered into with Antares (the “Antares Agreement”), we are required to pay royalties toAntares on net sales of the auto-injection system commencing on the launch of the Makena auto-injector in a particular country until the Makena auto-injector is no longer sold or offered for sale in such country. The royalty rates range from high single digit to low double digits and are tiered based on levelsof net sales of the Makena auto-injector and decrease after the expiration of licensed patents or where there are generic equivalents to the Makena auto-injector being sold in a particular country.100Table of ContentsOther Funding CommitmentsAs of December 31, 2016, we had several ongoing clinical studies in various clinical trial stages. Our most significant clinical trial expenditures were toclinical research organizations (“CROs”). The contracts with CROs are generally cancellable, with notice, at our option. We have recorded accrued expensesin our consolidated balance sheet of approximately $10.6 million representing expenses incurred with these organizations as of December 31, 2016, net ofany amounts prepaid to these CROs.Severance ArrangementsWe have entered into employment agreements or other arrangements with most of our executive officers and certain other employees, which provide forthe continuation of salary and certain benefits and, in certain instances, the acceleration of the vesting of certain equity awards to such individuals in theevent that the individual is terminated other than for cause, as defined in the applicable employment agreements or arrangements.Indemnification ObligationsIn the course of operating our business, we have entered into a number of indemnification arrangements under which we may be required to makepayments to or on behalf of certain third parties including our directors, officers, and certain employees as well as certain other third parties with whom weenter into agreements. For further discussion of how this may affect our business, see Note P, “Commitments and Contingencies,” to our consolidatedfinancial statements included in this Annual Report on Form 10-K.Legal ProceedingsFor detailed information on our legal proceedings, see Note P, “Commitments and Contingencies,” to our consolidated financial statements included inthis Annual Report on Form 10-K. Off-Balance Sheet ArrangementsAs of December 31, 2016, we did not have any off-balance sheet arrangements as defined in Regulation S-K, Item 303(a)(4)(ii).ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK:Interest Rate RiskAs of December 31, 2016 and 2015, our investments equaled $304.8 million and $237.6 million, respectively, and were invested in corporate debtsecurities, U.S. treasury and government agency securities, commercial paper, certificates of deposit and municipal securities. Our investments meet highcredit quality and diversification standards, as specified in our investment policy. Our investment policy also limits the amount of our credit exposure to anyone issue or issuer, excluding U.S. government entities, and seeks to manage these assets to achieve our goals of preserving principal, maintaining adequateliquidity at all times, and maximizing returns. These investments are subject to interest rate risk. The modeling technique used measures the change in fairvalues arising from an immediate hypothetical shift in market interest rates and assumes that ending fair values include principal plus accrued interest. Ifmarket interest rates for comparable investments were to increase immediately and uniformly by 50 basis points, or one-half of a percentage point, from levelsas of December 31, 2016 and 2015, this would have resulted in a hypothetical decline in fair value of our investments of approximately $1.4 million and$1.1 million, respectively, and if market interest rates for comparable investments were to decrease immediately and uniformly by 50 basis points, or one-halfof a percentage point, from levels as of December 31, 2016 and 2015, this would have resulted in a hypothetical increase in fair value of our investments ofapproximately $1.4 million and $1.1 million, respectively. These amounts are determined by considering the impact of the hypothetical interest ratemovements on our available-for-sale investment portfolios. This analysis does not consider the effect of credit risk as a result of the changes in overalleconomic activity that could exist in such an environment.101Table of ContentsThe 2015 Term Loan Facility bears interest, at our option, at the London Interbank Offered Rate (“LIBOR”) plus a margin of 3.75% or the prime rate plusa margin of 2.75%. The LIBOR is subject to a 1.00% floor and the prime rate is subject to a 2.00% floor. As of December 31, 2016, the stated interest rate,based on the LIBOR, was 4.75%, and the effective interest rate was 5.65%. An increase in the LIBOR of 50 basis points above the 1.00% LIBOR floor wouldincrease our interest expense by $1.6 million per year.Equity Price RiskConvertible NotesOn February 14, 2014, we issued $200.0 million aggregate principal amount of Convertible Notes. The Convertible Notes are senior unsecuredobligations and bear interest at a rate of 2.5% per year, payable semi-annually in arrears on February 15 and August 15 of each year. The Convertible Noteswill mature on February 15, 2019, unless repurchased or converted earlier. The Convertible Notes will be convertible into cash, shares of our common stock,or a combination thereof, at our election (subject to certain limitations in the 2015 Term Loan Facility), at a conversion rate of approximately 36.9079 sharesof common stock per $1,000 principal amount of the Convertible Notes, which corresponds to a conversion price of approximately $27.09 per share of ourcommon stock and represents a conversion premium of approximately 35% based on the last reported sale price of our common stock of $20.07 onFebruary 11, 2014, the date the notes offering was priced. As of December 31, 2016, the fair value of the Convertible Notes was $282.1 million. OurConvertible Notes include conversion and settlement provisions that are based on the price of our common stock at conversion or at maturity of the notes.The amount of cash we may be required to pay is determined by the price of our common stock. The fair values of our Convertible Notes are dependent on theprice and volatility of our common stock and will generally increase or decrease as the market price of our common stock changes.Convertible Bond Hedge and Warrant TransactionsIn order to reduce the potential dilution to our common stock and/or offset cash payments due upon conversion of the Convertible Notes, in February2014 we entered into convertible bond hedge transactions covering approximately 7.4 million shares of our common stock underlying the $200.0 millionaggregate principal amount of the Convertible Notes. The convertible bond hedges have an exercise price of approximately $27.09 per share, subject toadjustment upon certain events, and are exercisable when and if the Convertible Notes are converted. If upon conversion of the Convertible Notes, the priceof our common stock is above the exercise price of the convertible bond hedges, each of JPMorgan Chase Bank, National Association, London Branch,Morgan Stanley & Co. International plc and Royal Bank of Canada will deliver shares of our common stock and/or cash with an aggregate valueapproximately equal to the difference between the price of our common stock at the conversion date and the exercise price, multiplied by the number ofshares of our common stock related to the convertible bond hedges being exercised.In February 2014, we also entered into separate warrant transactions relating to, in the aggregate, approximately 7.4 million shares of our common stockunderlying the $200.0 million aggregate principal amount of the Convertible Notes. The initial exercise price of the warrants is $34.12 per share, subject toadjustment upon certain events, which is 70% above the last reported sale price of our common stock of $20.07 on February 11, 2014. The warrants wouldseparately have a dilutive effect to the extent that the market value per share of our common stock, as measured under the terms of the warrants, exceeds theapplicable exercise price of the warrants. 102Table of ContentsITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA:Index To Consolidated Financial StatementsManagement’s Annual Report on Internal Control over Financial Reporting104Report of Independent Registered Public Accounting Firm105Consolidated Balance Sheets - as of December 31, 2016 and 2015106Consolidated Statements of Operations - for the years ended December 31, 2016, 2015 and 2014107Consolidated Statements of Comprehensive Income (Loss) - for the years ended December 31, 2016, 2015 and 2014108Consolidated Statements of Stockholders’ Equity - as of December 31, 2016, 2015 and 2014109Consolidated Statements of Cash Flows- for the years ended December 31, 2016, 2015 and 2014110Notes to Consolidated Financial Statements111103Table of ContentsMANAGEMENT’S ANNUAL REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTINGManagement is responsible for establishing and maintaining adequate internal controls over financial reporting, as such term is defined in Rule 13a-15(f)and 15d-15(f) under the Securities and Exchange Act of 1934, as amended. Our internal control over financial reporting is a process designed under thesupervision of our principal executive officer and principal financial officer to provide reasonable assurance regarding the reliability of financial reportingand the preparation of our financial statements for external reporting purposes in accordance with U.S. generally accepted accounting principles. Because ofits inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectivenessto future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with thepolicies or procedures may deteriorate.Our management, including our principal executive officer and principal financial officer, assessed the effectiveness of our internal control over financialreporting as of December 31, 2016 based on the framework in Internal Control -Integrated Framework issued by the Committee of Sponsoring Organizationsof the Treadway Commission (COSO) in 2013. Based on this assessment, management concluded that our internal control over financial reporting waseffective as of December 31, 2016.The effectiveness of our internal control over financial reporting as of December 31, 2016, has been audited by PricewaterhouseCoopers LLP, anindependent registered public accounting firm, as stated in their report which is included herein.104Table of ContentsREPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRMTo the Board of Directors and Shareholders of AMAG Pharmaceuticals, Inc.In our opinion, the accompanying consolidated balance sheets and the related consolidated statements of operations, comprehensive income (loss),stockholders’ equity, and cash flows present fairly, in all material respects, the financial position of AMAG Pharmaceuticals, Inc. and its subsidiaries atDecember 31, 2016 and December 31, 2015, and the results of their operations and their cash flows for each of the three years in the period endedDecember 31, 2016 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Companymaintained, in all material respects, effective internal control over financial reporting as of December 31, 2016, based on criteria established in InternalControl -Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). The Company’smanagement is responsible for these financial statements, for maintaining effective internal control over financial reporting and for its assessment of theeffectiveness of internal control over financial reporting, included in the accompanying Management’s Annual Report on Internal Control over FinancialReporting. Our responsibility is to express opinions on these financial statements and on the Company’s internal control over financial reporting based onour integrated audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Thosestandards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free of material misstatementand whether effective internal control over financial reporting was maintained in all material respects. Our audits of the financial statements includedexamining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used andsignificant estimates made by management, and evaluating the overall financial statement presentation. Our audit of internal control over financial reportingincluded obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluatingthe design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as weconsidered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions.As discussed in Note V to the consolidated financial statements, the Company changed the manner in which it accounts for debt issuances costs in 2016.A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reportingand the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal controlover financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairlyreflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permitpreparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are beingmade only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention ortimely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation ofeffectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliancewith the policies or procedures may deteriorate./s/ PricewaterhouseCoopers LLPBoston, MassachusettsFebruary 17, 2017105Table of ContentsAMAG PHARMACEUTICALS, INC.CONSOLIDATED BALANCE SHEETS(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA) As of December 31, 2016 2015ASSETS Current assets: Cash and cash equivalents$274,305 $228,705Investments304,781 237,626Accounts receivable, net92,375 85,678Inventories37,258 40,645Receivable from collaboration— 428Prepaid and other current assets9,839 13,592Total current assets718,558 606,674Property, plant and equipment, net24,460 28,725Goodwill639,484 639,188Intangible assets, net1,092,178 1,196,771Restricted cash2,593 2,593Other long-term assets1,153 2,259Total assets$2,478,426 $2,476,210LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities: Accounts payable$3,684 $4,906Accrued expenses156,008 106,363Current portion of long-term debt21,166 17,500Current portion of acquisition-related contingent consideration97,068 96,967Deferred revenues34,951 20,185Total current liabilities312,877 245,921Long-term liabilities: Long-term debt, net785,992 803,669Convertible 2.5% notes, net179,363 170,749Acquisition-related contingent consideration50,927 125,592Deferred tax liabilities197,066 189,145Deferred revenues14,850 5,093Other long-term liabilities2,962 3,777Total liabilities1,544,037 1,543,946Commitments and contingencies (Note P) Stockholders’ equity: Preferred stock, par value $0.01 per share, 2,000,000 shares authorized; none issued— —Common stock, par value $0.01 per share, 117,500,000 shares authorized; 34,336,147 and34,733,117 shares issued and outstanding at December 31, 2016 and December 31, 2015,respectively343 347Additional paid-in capital1,238,031 1,233,786Accumulated other comprehensive loss(3,838) (4,205)Accumulated deficit(300,147) (297,664)Total stockholders’ equity934,389 932,264Total liabilities and stockholders’ equity$2,478,426 $2,476,210The accompanying notes are an integral part of these consolidated financial statements.106Table of ContentsAMAG PHARMACEUTICALS, INC.CONSOLIDATED STATEMENTS OF OPERATIONS(IN THOUSANDS, EXCEPT PER SHARE DATA) Years Ended December 31, 2016 2015 2014Revenues: U.S. product sales, net$432,170 $341,816 $109,998Service revenues, net99,604 24,132 —License fee, collaboration and other revenues317 52,328 14,386Total revenues532,091 418,276 124,384Costs and expenses: Cost of product sales (excluding impairment)96,314 78,509 20,306Cost of services20,575 9,992 —Research and development expenses66,084 42,878 24,160Selling, general and administrative expenses249,870 160,309 72,254Impairment of intangible assets19,663 — —Acquisition-related costs— 11,232 9,478Restructuring expenses715 4,136 2,023Total costs and expenses453,221 307,056 128,221Operating income (loss)78,870 111,220 (3,837)Other income (expense): Interest expense(73,153) (53,251) (14,697)Loss on debt extinguishment— (10,449) —Interest and dividend income3,149 1,512 975Other income (expense)189 (9,188) 217Total other income (expense)(69,815) (71,376) (13,505)Income (loss) before income taxes9,055 39,844 (17,342)Income tax expense (benefit)11,538 7,065 (153,159)Net income (loss)$(2,483) $32,779 $135,817Net income (loss) per share: Basic$(0.07) $1.04 $6.06Diluted$(0.07) $0.93 $5.45Weighted average shares outstanding used to compute net income (loss) per share: Basic34,346 31,471 22,416Diluted34,346 35,308 25,225The accompanying notes are an integral part of these consolidated financial statements.107Table of ContentsAMAG PHARMACEUTICALS, INC.CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)(IN THOUSANDS) Years Ended December 31, 2016 2015 2014Net income (loss)$(2,483) $32,779 $135,817Other comprehensive income (loss): Unrealized gains (losses) on securities: Holding gains (losses) arising during period, net of tax261 (4) (191)Reclassification adjustment for gains (losses) included in net income (loss), net of tax106 (584) 65Net unrealized gains (losses) on securities367 (588) (126)Total comprehensive income (loss)$(2,116) $32,191 $135,691The accompanying notes are an integral part of these consolidated financial statements.108Table of ContentsAMAG PHARMACEUTICALS, INC.CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY(IN THOUSANDS, EXCEPT SHARES) Common Stock Shares Amount AdditionalPaid-in Capital Accumulated OtherComprehensiveIncome (Loss) AccumulatedDeficit TotalStockholders'EquityBalance at December 31, 201321,772,571 $218 $641,941 $(3,491) $(466,260) $172,408Equity component of Convertible Notes, net of issuance costs— — 36,907 — — 36,907Purchase of convertible bond hedges, net of tax— — (39,760) — — (39,760)Sale of warrants— — 25,620 — — 25,620Net shares issued in connection with the acquisition of Lumara Health3,209,971 32 111,932 — — 111,964Net shares issued in connection with the exercise of stock options andvesting of restricted stock units617,008 6 8,492 — — 8,498Non-cash equity-based compensation— — 8,625 — — 8,625Unrealized losses on securities, net of tax— — — (126) — (126)Net income— — — — 135,817 135,817Balance at December 31, 201425,599,550 256 793,757 (3,617) (330,443) 459,953Shares issued in connection with financings, net of issuance costs of$24.7 million8,196,362 82 407,395 — — 407,477Net shares issued in connection with the exercise of stock options andvesting of restricted stock units937,205 9 15,397 — — 15,406Non-cash equity-based compensation— — 17,237 — — 17,237Unrealized losses on securities, net of tax— — — (588) — (588)Net income— — — — 32,779 32,779Balance at December 31, 201534,733,117 347 1,233,786 (4,205) (297,664) 932,264Net shares issued in connection with the exercise of stock options andvesting of restricted stock units355,450 3 227 — — 230Repurchase of common stock pursuant to the 2016 Share RepurchaseProgram(831,744) (8) (19,992) — — (20,000)Issuance of common stock under employee stock purchase plan79,324 1 1,467 — — 1,468Non-cash equity-based compensation— — 22,543 — — 22,543Unrealized gains on securities, net of tax— — — 367 — 367Net loss— — — — (2,483) (2,483)Balance at December 31, 201634,336,147 $343 $1,238,031 $(3,838) $(300,147) $934,389The accompanying notes are an integral part of these consolidated financial statements. 109Table of ContentsAMAG PHARMACEUTICALS, INC.CONSOLIDATED STATEMENTS OF CASH FLOWS(IN THOUSANDS) Years Ended December 31, 2016 2015 2014Cash flows from operating activities: Net income (loss)$(2,483) $32,779 $135,817Adjustments to reconcile net income (loss) to net cash provided by operating activities: Depreciation and amortization99,886 69,103 6,984Impairment of intangible assets19,663 — —Provision for bad debt expense3,209 — —Amortization of premium/discount on purchased securities624 2,152 2,080Write-down of inventory to net realizable value— 1,235 1,309Gain (loss) on disposal of property and equipment— — (103)Non-cash equity-based compensation expense 22,543 17,237 8,625Non-cash loss on debt extinguishment— 6,426 —Amortization of debt discount and debt issuance costs12,105 11,379 6,870Gains on investments, net38 (14) (114)Change in fair value of contingent consideration25,683 4,271 (681)Deferred income taxes7,279 5,007 (153,159)Changes in operating assets and liabilities: Accounts receivable, net(9,906) (36,913) 3,588Inventories(2,355) (5,237) (1,360)Receivable from collaboration428 4,090 (4,239)Prepaid and other current assets4,095 4,034 2,331Accounts payable and accrued expenses49,037 7,876 10,694Deferred revenues24,522 (22,197) (8,384)Payment of contingent consideration in excess of acquisition date fair value(8,116) — —Repayment of term loan attributable to original issue discount— (12,491) —Other assets and liabilities(30) 7,244 1,156Net cash provided by operating activities246,222 95,981 11,414Cash flows from investing activities: Acquisition of Lumara Health, net of acquired cash— 562 (595,602)Acquisition of CBR, net— (682,356) —Proceeds from sales or maturities of investments127,479 208,966 223,568Purchase of investments(194,723) (424,759) (63,747)Change in restricted cash— (195) 2,883Capital expenditures(5,460) (1,259) (44)Net cash used in investing activities(72,704) (899,041) (432,942)Cash flows from financing activities: Proceeds from the issuance of common stock, net of underwriting discount and other expenses— 407,477 —Long-term debt principal payments(17,502) (327,509) —Proceeds from long-term debt— 834,750 527,509Payment of debt issuance costs— (10,004) (7,760)Proceeds from issuance of warrants— — 25,620Purchase of convertible bond hedges— — (39,760)Payment of contingent consideration(92,130) (456) (270)Payment to former CBR shareholders— (7,195) —Payments for repurchases of common stock(20,000) — —Proceeds from the exercise of stock options1,468 15,406 8,499Proceeds from the issuance of common stock under ESPP2,417 — —Payments of employee tax withholding related to equity-based compensation(2,171) — —Net cash (used in) provided by financing activities(127,918) 912,469 513,838Net increase in cash and cash equivalents45,600 109,409 92,310Cash and cash equivalents at beginning of the year228,705 119,296 26,986Cash and cash equivalents at end of the year$274,305 $228,705 $119,296Supplemental data of cash flow information: Cash paid for taxes$5,309 $2,373 $—Cash paid for interest$62,381 $28,014 $2,500Non-cash investing activities: Fair value of acquisition-related contingent consideration$— $— $205,000Fair value of common stock issued in connection with the Lumara Health acquisition$— $— $111,964The accompanying notes are an integral part of these consolidated financial statements.110Table of ContentsAMAG PHARMACEUTICALS, INC.NOTES TO CONSOLIDATED FINANCIAL STATEMENTS A. DESCRIPTION OF BUSINESSAMAG Pharmaceuticals, Inc., a Delaware corporation, was founded in 1981. We are a biopharmaceutical company focused on developing and deliveringimportant therapeutics, conducting clinical research in areas of unmet need and creating education and support programs for the patients and families weserve. Our currently marketed products support the health of patients in the areas of women’s health, anemia management and cancer supportive care,including Makena® (hydroxyprogesterone caproate injection), Feraheme® (ferumoxytol) for intravenous (“IV”) use and MuGard® Mucoadhesive Oral WoundRinse. Through services related to the preservation of umbilical cord blood stem cell and cord tissue units (the “CBR Services”) operated through CordBlood Registry® (“CBR”), we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood,immune and metabolic disorders, and which we believe have the potential to play a valuable role in the ongoing development of regenerative medicine.We are subject to risks common to companies in the pharmaceutical industry including, but not limited to (as such risks pertain to our business) ourdependence on the success of our product portfolio and maintaining commercialization of our products and services, including Makena, the CBR Servicesand Feraheme; intense competition, including from generic products; maintaining and defending the proprietary nature of our technology; our ability toexpand our product portfolio through business development transactions; our dependence upon third-party manufacturers; our reliance on other third partiesin our business, including to conduct our clinical trials and undertake our product distribution; our reliance on and the extent of reimbursement from thirdparties for the use of our products, including Makena’s high Medicaid reimbursement concentration; the impact of Makena’s loss of orphan drug exclusivityin February 2018; competition from compounded pharmacies; our ability to implement Makena’s next generation development programs, includingregulatory approvals for such programs; our ability to differentiate Makena from compounded HPC products; perceptions related to pricing and access forMakena; the potential for cord blood stem cell and cord tissue science and its recognition in regenerative medicine; if our storage facility in Tucson, Arizonais damaged or destroyed; competition in the cord blood and tissue banking business; compliance with cord blood and tissue regulations and laws; post-approval commitments for Makena; limitations on Feraheme sales given its narrow chronic kidney disease indication and the potential impact on sales ofany actual or perceived safety problems; our ability to receive regulatory approval for Feraheme in the broader iron deficiency anemia indication andFeraheme’s ability to compete in such market even if regulatory approval is received; competition from generic versions of Feraheme and iron replacementtherapy products; our customer concentration, especially with regard to Feraheme; our ability to obtain approval for the sale of RekyndaTM (bremelanotide)by the FDA, our restrictions that may be imposed by the FDA; our ability to commercialize Rekynda; uncertainty regarding the market and competitors orRekynda and IntrarosaTM (prasterone); our ability to commercialize Intrarosa, including the ability to drive awareness of dyspareunia; our ability toconsummate the Intrarosa licensing transaction; uncertainties regarding federal and state legislative initiatives; potential inability to obtain raw or othermaterials; our potential failure to comply with federal, state or foreign healthcare fraud and abuse laws, marketing disclosure laws or other federal, state orforeign laws and regulations and potential civil or criminal penalties as a result thereof; our ability to managing our expanded product portfolio andoperations; uncertainties regarding reporting and payment obligations under government pricing programs and our level of indebtedness; our ability to repayour indebtedness, including upon a change of our variable rate indebtedness; restrictions on our business related to our indebtedness; our access to sufficientcapital; the availability of net operating loss carryforwards and other tax assets; employee retention; our ability to be profitable in the future; the potentialfluctuation of our operating results; potential differences between actual future results and the estimates or assumptions used by us in preparation of ourconsolidated financial statements; the volatility of our stock price; current or potential litigation, including securities and product liability suits; provisionsin our charter, by-laws and certain contracts that discourage an acquisition of our Company; the impact of disruptions to our information technology systemsand the impact of market overhang on our stock price.Throughout this Annual Report on Form 10-K, AMAG Pharmaceuticals, Inc. and our consolidated subsidiaries are collectively referred to as “theCompany,” “AMAG,” “we,” “us,” or “our.”B. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIESBasis of Presentation and Principles of ConsolidationThe accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the U.S.(“GAAP”) and include the accounts of our wholly-owned subsidiaries. Our results of operations for 2015 include the results of CBR, subsequent to August17, 2015, the date of acquisition and for 2014 include the results of Lumara Health Inc. (“Lumara Health”) and its product Makena subsequent to theNovember 12, 2014 acquisition date. See111Table of ContentsNote C, “Business Combinations,” for additional information. All intercompany balances and transactions have been eliminated in consolidation.Use of Estimates and AssumptionsThe preparation of consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions thataffect the reported amounts of assets, liabilities, revenues and expenses, and the related disclosure of contingent assets and liabilities. The most significantestimates and assumptions are used to determine amounts and values of, but are not limited to: revenue recognition related to product sales and servicesrevenue; product sales allowances and accruals; allowance for doubtful accounts; investments; inventory; acquisition date fair value and subsequent fairvalue estimates used to assess impairment of long-lived assets, including goodwill, in-process research and development (“IPR&D”) and other intangibleassets; contingent consideration; debt obligations; certain accrued liabilities, including clinical trial accruals and restructuring liabilities; income taxes andequity-based compensation expense. Actual results could differ materially from those estimates.Cash and Cash EquivalentsCash and cash equivalents consist principally of cash held in commercial bank accounts, money market funds and U.S. Treasury securities having anoriginal maturity of less than three months at the date of acquisition. We consider all highly liquid investments with a maturity of three months or less as ofthe acquisition date to be cash equivalents. At December 31, 2016 and 2015, substantially all of our cash and cash equivalents were held in eithercommercial bank accounts or money market funds.InvestmentsWe account for and classify our investments as either “available-for-sale,” “trading,” or “held-to-maturity,” in accordance with the accounting guidancerelated to the accounting and classification of certain investments in debt and equity securities. The determination of the appropriate classification by us isbased primarily on management’s ability and intent to sell the investment at the time of purchase. As of December 31, 2016 and 2015, all of our investmentswere classified as available-for-sale securities.Available-for-sale securities are those securities which we view as available for use in current operations, if needed. We generally classify our available-for-sale securities as short-term investments, even though the stated maturity date may be one year or more beyond the current balance sheet date. Available-for-sale investments are stated at fair value with their unrealized gains and losses included in accumulated other comprehensive income (loss) within theconsolidated statements of stockholders’ equity, until such gains and losses are realized in other income (expense) within the consolidated statements ofoperations or until an unrealized loss is considered other-than-temporary.We recognize other-than-temporary impairments of our debt securities when there is a decline in fair value below the amortized cost basis and if (a) wehave the intent to sell the security or (b) it is more likely than not that we will be required to sell the security prior to recovery of its amortized cost basis. Ifeither of these conditions is met, we recognize the difference between the amortized cost of the security and its fair value at the impairment measurement datein our consolidated statements of operations. If neither of these conditions is met, we must perform additional analyses to evaluate whether the unrealizedloss is associated with the creditworthiness of the issuer of the security rather than other factors, such as interest rates or market factors. If we determine fromthis analysis that we do not expect to receive cash flows sufficient to recover the entire amortized cost of the security, a credit loss exists, the impairment isconsidered other-than-temporary and is recognized in our consolidated statements of operations.Fair Value MeasurementsUnder current accounting standards, fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exitprice) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.Current accounting guidance establishes a hierarchy used to categorize how fair value is measured and is based on three levels of inputs, of which thefirst two are considered observable and the third unobservable, as follows:Level 1 - Quoted prices in active markets for identical assets or liabilities.112Table of ContentsLevel 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices inmarkets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of theassets or liabilities.Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.We hold certain assets and liabilities that are required to be measured at fair value on a recurring basis, including our cash equivalents, investments, andacquisition-related contingent consideration.InventoryInventory is stated at the lower of cost or market (net realizable value), with approximate cost being determined on a first-in, first-out basis. Prior to initialapproval from the FDA or other regulatory agencies, we expense costs relating to the production of inventory in the period incurred, unless we believeregulatory approval and subsequent commercialization of the product candidate is probable and we expect the future economic benefit from sales of theproduct to be realized, at which point we capitalize the costs as inventory. We assess the costs capitalized prior to regulatory approval each quarter forindicators of impairment, such as a reduced likelihood of approval. We expense costs associated with clinical trial material as research and developmentexpense.On a quarterly basis, we analyze our inventory levels to determine whether we have any obsolete, expired, or excess inventory. If any inventory isexpected to expire prior to being sold, has a cost basis in excess of its net realizable value, is in excess of expected sales requirements as determined byinternal sales forecasts, or fails to meet commercial sale specifications, the inventory is written-down through a charge to cost of product sales. Thedetermination of whether inventory costs will be realizable requires estimates by management of future expected inventory requirements, based on salesforecasts. Once packaged, Makena currently has a shelf-life of three years and Feraheme has a shelf-life of five years. As a result of comparison to internalsales forecasts, we expect to fully realize the carrying value of our current Makena and Feraheme finished goods inventory. If actual market conditions areless favorable than those projected by management, inventory write-downs may be required. Charges for inventory write-downs are not reversed if it is laterdetermined that the product is saleable.Restricted CashAs of December 31, 2016 and 2015, we classified $2.6 million of our cash as restricted cash, which included $2.0 million held in a restricted fundpreviously established by Lumara in connection with its Chapter 11 plan of reorganization to pay potential claims against its former directors and officers. Inaddition, the restricted cash balance as of December 31, 2016 and 2015 included a $0.6 million security deposit delivered to the landlord of our Waltham,Massachusetts headquarters in the form of an irrevocable letter of credit.Concentrations and Significant Customer InformationFinancial instruments which potentially subject us to concentrations of credit risk consist principally of cash and cash equivalents, investments, andaccounts receivable. We currently hold our excess cash primarily in institutional money market funds, corporate debt securities, U.S. treasury and governmentagency securities, commercial paper and certificates of deposit. As of December 31, 2016, we did not have a material concentration in any single investment.Our operations are located entirely within the U.S. We focus primarily on developing, manufacturing, and commercializing Makena and Feraheme andmarketing and selling the CBR Services, who pay for the services directly. We perform ongoing credit evaluations of our product sales customers andgenerally do not require collateral. The following table sets forth customers or partners who represented 10% or more of our total revenues for 2016, 2015 and2014: Years Ended December 31, 2016 2015 2014AmerisourceBergen Drug Corporation22% 25% 34%McKesson Corporation11% 11% 21%Cardinal Health, Inc.<10% <10% 15%Takeda Pharmaceuticals Company Limited—% 12% 11% 113Table of ContentsIn addition, approximately 12% of our total revenues for 2015 were principally related to deferred Feraheme collaboration revenue recognized inconnection with the termination of our license, development and commercialization agreement (the “Takeda Agreement”) with Takeda PharmaceuticalCompany Limited (“Takeda”), which is headquartered in Japan, and which revenues were thus generated from outside the U.S. Substantially all of therevenues generated during 2016 were generated within the U.S.Our net accounts receivable primarily represented amounts due for products sold directly to wholesalers, distributors, and specialty pharmacies andamounts due for CBR Services sold to consumers who pay for the services directly. Accounts receivable for our products and services are recorded net ofreserves for estimated chargeback obligations, prompt payment discounts and any allowance for doubtful accounts.As part of our credit management policy, we perform ongoing credit evaluations of our product sales customers, and we have not required collateral fromany customer. We have not experienced significant bad debts and have not established an allowance for doubtful accounts on our product sales at eitherDecember 31, 2016 or 2015. We maintain an allowance for doubtful accounts for estimated losses inherent in our CBR service revenues portfolio. Inestablishing the allowance, we consider historical losses adjusted to take into account current market conditions and customers’ financial conditions, theamount of receivables in dispute, and the current receivables aging and current payment patterns. Account balances are charged off against the allowanceafter all collection means have been exhausted and the potential for recovery is considered remote. If the financial condition of any of our significant productsales customers was to deteriorate and result in an impairment of its ability to make payments owed to us, an allowance for doubtful accounts may be requiredwhich could have a material effect on earnings in the period of any such adjustment.Customers which represented greater than 10% of our accounts receivable balance as of December 31, 2016 and 2015 were as follows: December 31, 2016 2015McKesson Corporation32% <10%AmerisourceBergen Drug Corporation13% 43% We are currently dependent on a single supplier for Feraheme drug substance (produced in two separate facilities) and finished drug product. In addition,we rely on single sources for certain materials required to support the CBR Services. We would be exposed to a significant loss of revenue from the sale of ourproducts and services if our suppliers and/or manufacturers could not fulfill demand for any reason.Property, Plant and Equipment, NetProperty, plant and equipment are recorded at cost and depreciated when placed into service using the straight-line method based on their estimateduseful lives as follows: Useful LifeBuildings and improvements15 - 40 YearsComputer equipment and software5 YearsFurniture and fixtures5 YearsLeasehold improvementsLesser of Lease or Asset LifeLaboratory and production equipment5 YearsLand improvements10 YearsCosts for capital assets not yet placed in service are capitalized on our balance sheets and will be depreciated in accordance with the above guidelinesonce placed into service. Costs for maintenance and repairs are expensed as incurred. Upon sale or other disposition of property, plant and equipment, thecost and related depreciation are removed from the accounts and any resulting gain or loss is charged to our consolidated statements of operations. Long-lived assets to be held and used are evaluated for impairment whenever events or changes in circumstances indicate that the carrying value of the asset maynot be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and itseventual disposition. In the event such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down totheir estimated fair values. Assets classified as held for sale are no longer subject to depreciation and are recorded at the lower of carrying value or estimatednet realizable value.114Table of ContentsBusiness CombinationsWe account for acquired businesses using the acquisition method of accounting, which requires that assets acquired and liabilities assumed berecognized at their estimated fair values as of the acquisition date. Acquisition-related costs are expensed as incurred. Any excess of the considerationtransferred over the estimated fair values of the identifiable net assets acquired is recorded as goodwill.Acquisition-Related Contingent ConsiderationContingent consideration arising from a business combination is included as part of the purchase price and is recognized at its estimated fair value as ofthe acquisition date. Subsequent to the acquisition date, we measure contingent consideration arrangements at fair value for each period until thecontingency is resolved. These changes in fair value are recognized in selling, general and administrative expenses in our consolidated statements ofoperations. Changes in fair values reflect new information about the likelihood of the payment of the contingent consideration and the passage of time.Goodwill and Intangible AssetsGoodwill is not amortized, but is reviewed for impairment annually as of October 31, or more frequently if indicators of impairment are present. Wedetermine whether goodwill may be impaired by comparing the carrying value of our single reporting unit, including goodwill, to the fair value of thereporting unit. If the fair value is less than the carrying amount, a more detailed analysis is performed to determine whether goodwill is impaired. Theimpairment loss, if any, is measured as the excess of the carrying value of the goodwill over the fair value of the goodwill and is recorded in our consolidatedstatements of operations.Finite-lived intangible assets are amortized to their estimated residual values over their estimated useful lives and reviewed for impairment if certainevents or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. When such facts and circumstances exist,management compares the projected undiscounted future cash flows associated with the asset over its estimated useful life against the carrying amount. Theimpairment loss, if any, is measured as the excess of the carrying amount of the asset over its fair value.Acquired IPR&D represents the fair value assigned to research and development assets that we acquire and have not been completed at the acquisitiondate. The fair value of IPR&D acquired in a business combination is capitalized on our consolidated balance sheet at the acquisition-date fair value and isdetermined by estimating the costs to develop the technology into commercially viable products, estimating the resulting revenue from the projects, anddiscounting the projected net cash flows to present value. IPR&D is not amortized, but rather is reviewed for impairment on an annual basis or morefrequently if indicators of impairment are present, until the project is completed or abandoned. If we determine that IPR&D becomes impaired or isabandoned, the carrying value is written down to its fair value with the related impairment charge recognized in our consolidated statement of operations inthe period in which the impairment occurs. Upon successful completion of each project and launch of the product, we will make a separate determination ofthe estimated useful life of the IPR&D intangible asset and the related amortization will be recorded as an expense prospectively over its estimated useful life.Additionally, we have other indefinite-lived intangible assets which we acquired through our business combinations. These assets are reviewed forimpairment on an annual basis or more frequently if indicators of impairment are present. If we determine that the asset becomes impaired, the carrying valueis written down to its fair value with the related impairment charge recognized in our consolidated statements of operations in the period in which theimpairment occurs.PatentsWe expense all patent-related costs in selling, general and administrative expenses as incurred.Revenue Recognition and Related Sales Allowances and AccrualsOur primary sources of revenue during the reporting periods were: (a) product revenues from Makena and Feraheme; (b) service revenues associated withthe CBR Services; and (c) license fees, collaboration and other revenues, which primarily included revenue recognized under collaboration agreements,royalties received from our license agreements, and international product revenues of Feraheme derived from our collaboration agreement with Takeda,which was terminated in 2015. Revenue is recognized when the following criteria are met:•Persuasive evidence of an arrangement exists;115Table of Contents •Delivery of product has occurred or services have been rendered;•The sales price charged is fixed or determinable; and •Collection is reasonably assured.Product RevenueWe recognize product revenues net of certain allowances and accruals in our consolidated statements of operations at the time of sale. Our contractualadjustments include provisions for returns, pricing and prompt payment discounts, as well as wholesaler distribution fees, rebates to hospitals that qualify for340B pricing and volume-based and other commercial rebates. Governmental rebates relate to our reimbursement arrangements with state Medicaidprograms. In addition, we also monitor our distribution channel to determine whether additional allowances or accruals are required based on inventory inour sales channel. Calculating these gross to net sales adjustments involves estimates and judgments based primarily on actual product sales data, forecastedcustomer buying patterns, and market research data related to utilization rates by various end-users. If we determine in future periods that our actualexperience is not indicative of our expectations, if our actual experience changes, or if other factors affect our estimates, we may be required to adjust ourallowances and accruals estimates, which would affect our net product sales in the period of the adjustment and could be significant.Our U.S. product sales, which primarily represented revenues from Makena and Feraheme for 2016, 2015 and 2014 were offset by provisions forallowances and accruals as follows (in thousands): Years Ended December 31, 2016 2015 2014Gross U.S. product sales$748,839 $561,255 $190,512Provision for U.S. product sales allowances and accruals: Contractual adjustments229,686 161,665 73,262Governmental rebates86,983 57,774 7,252Total provision for U.S. product sales allowances and accruals316,669 219,439 80,514U.S. product sales, net$432,170 $341,816 $109,998 Classification of Product Sales Allowances and AccrualsProduct sales allowances and accruals are primarily comprised of both direct and indirect fees, discounts and rebates and provisions for estimated productreturns. Direct fees, discounts and rebates are contractual fees and price adjustments payable to wholesalers, specialty distributors and other customers thatpurchase products directly from us. Indirect fees, discounts and rebates are contractual price adjustments payable to healthcare providers and organizations,such as certain physicians, clinics, hospitals, group purchasing organizations (“GPOs”), and dialysis organizations that typically do not purchase productsdirectly from us but rather from wholesalers and specialty distributors. In accordance with guidance related to accounting for fees and consideration given bya vendor to a customer, including a reseller of a vendor’s products, these fees, discounts and rebates are presumed to be a reduction of the selling price.Product sales allowances and accruals are based on definitive contractual agreements or legal requirements (such as Medicaid laws and regulations) related tothe purchase and/or utilization of the product by these entities and are recorded in the same period that the related revenue is recognized. We estimateproduct sales allowances and accruals using either historical, actual and/or other data, including estimated patient usage, applicable contractual rebate rates,contract performance by the benefit providers, other current contractual and statutory requirements, historical market data based upon experience of ourproducts and other products similar to them, specific known market events and trends such as competitive pricing and new product introductions, current andforecasted customer buying patterns and inventory levels, and the shelf life of our products. As part of this evaluation, we also review changes to federal andother legislation, changes to rebate contracts, changes in the level of discounts, and changes in product sales trends. Although allowances and accruals arerecorded at the time of product sale, certain rebates are typically paid out, on average, up to three months or longer after the sale.Allowances against receivable balances primarily relate to prompt payment discounts, provider chargebacks and certain government agency rebates andare recorded at the time of sale, resulting in a reduction in product sales revenue and the reporting of product sales receivables net of allowances. Accrualsrelated to Medicaid and provider volume rebates, wholesaler116Table of Contentsand distributor fees, GPO fees, other discounts to healthcare providers and product returns are recorded at the time of sale, resulting in a reduction in productsales and the recording of an increase in accrued expenses.DiscountsWe typically offer a 2% prompt payment discount to our customers as an incentive to remit payment in accordance with the stated terms of the invoice,generally thirty days days. Because we anticipate that those customers who are offered this discount will take advantage of the discount, we accrue 100% ofthe prompt payment discount at the time of sale, based on the gross amount of each invoice. We adjust the accrual quarterly to reflect actual experience.ChargebacksChargeback reserves represent our estimated obligations resulting from the difference between the prices at which we sell our products to wholesalers andthe sales price ultimately paid to wholesalers under fixed price contracts by third-party payers, including governmental agencies. We determine ourchargeback estimates based on actual product sales data and forecasted customer buying patterns. Actual chargeback amounts are determined at the time ofresale to the qualified healthcare provider, and we generally issue credits for such amounts within several weeks of receiving notification from the wholesaler.Estimated chargeback amounts are recorded at the time of sale, and we adjust the allowance quarterly to reflect actual experience.Distributor/Wholesaler and Group Purchasing Organization FeesFees under our arrangements with distributors and wholesalers are usually based upon units of product purchased during the prior month or quarter andare usually paid by us within several weeks of our receipt of an invoice from the wholesaler or distributor, as the case may be. Fees under our arrangementswith GPOs are usually based upon member purchases during the prior quarter and are generally billed by the GPO within 30 days after period end. Currentaccounting standards related to consideration given by a vendor to a customer, including a reseller of a vendor’s products, specify that cash considerationgiven by a vendor to a customer is presumed to be a reduction of the selling price of the vendor’s products or services and therefore should be characterizedas a reduction of product sales. Consideration should be characterized as a cost incurred if we receive, or will receive, an identifiable benefit (goods orservices) in exchange for the consideration and we can reasonably estimate the fair value of the benefit received. Because the fees we pay to wholesalers donot meet the foregoing conditions to be characterized as a cost, we have characterized these fees as a reduction of product sales and have included them incontractual adjustments or governmental rebates in the table above. We generally pay such amounts within several weeks of our receipt of an invoice fromthe distributor, wholesaler or GPO. Accordingly, we accrue the estimated fee due at the time of sale, based on the contracted price invoiced to the customer.We adjust the accrual quarterly to reflect actual experience.Product ReturnsConsistent with industry practice, we generally offer our wholesalers, specialty distributors and other customers a limited right to return our productsbased on the product’s expiration date. Currently the expiration dates for Feraheme and Makena are five years and three years, respectively. We estimateproduct returns based on the historical return patterns and known or expected changes in the marketplace. We track actual returns by individual productionlots. Returns on lots eligible for credits under our returned goods policy are monitored and compared with historical return trends and rates.We expect that wholesalers and healthcare providers will not stock significant inventory due to the cost of the product, the expense to store our products,and/or that our products are readily available for distribution. We record an estimate of returns at the time of sale. If necessary, our estimated rate of returnsmay be adjusted for actual return experience as it becomes available and for known or expected changes in the marketplace. During 2014, we reduced ourreserve for Feraheme product returns by approximately $1.8 million, primarily as a result of a lower than expected rate of product returns. The reduction ofour reserve had an impact of increasing our 2014 net income by $0.08 and $0.07 per basic and diluted share, respectively. We did not significantly adjust ourreserve for product returns during 2016 or 2015. To date, our product returns of Feraheme and Makena have been relatively limited; however, returnsexperience may change over time. We may be required to make future adjustments to our product returns estimate, which would result in a correspondingchange to our net product sales in the period of adjustment and could be significant.Governmental RebatesGovernmental rebate reserves relate to our reimbursement arrangements with state Medicaid programs. We determine our estimates for Medicaid rebates,if applicable, based on actual product sales data and our historical product claims experience. In estimating these reserves, we provide for a Medicaid rebateassociated with both those expected instances where Medicaid will117Table of Contentsact as the primary insurer as well as in those instances where we expect Medicaid will act as the secondary insurer. Rebate amounts generally are invoicedquarterly and are paid in arrears, and we expect to pay such amounts within several weeks of notification by the Medicaid or provider entity. Estimatedgovernmental rebates are recorded at the time of sale. During 2016, we revised our estimated Medicaid reserve based on actual claims received since the 2011launch of Makena, our expectations of state level utilization, and estimated rebate claims not yet submitted. This revision resulted in a $6.1 million reductionof our estimated Medicaid rebate reserve related to prior period Makena sales. During 2015, we reduced our Makena-related Medicaid and chargebackreserves, which were initially recorded at the time of the Lumara Health acquisition, by $4.0 million and $1.9 million, respectively. These measurementperiod adjustments were recorded to goodwill during 2015. We did not significantly adjust our Medicaid rebate reserve during 2014. We regularly assess ourMedicaid reserve balance and the rate at which we accrue for claims against product sales. If we determine in future periods that our actual rebate experienceis not indicative of expected claims, if actual claims experience changes, or if other factors affect estimated claims rates, we may be required to adjust ourcurrent Medicaid accumulated reserve estimate, which would affect net product sales in the period of the adjustment and could be significant.Multiple Element ArrangementsWe evaluate revenue from arrangements that have multiple elements to determine whether the components of the arrangement represent separate units ofaccounting as defined in the accounting guidance related to revenue arrangements with multiple deliverables. Under current accounting guidance,companies are required to establish the selling price of its products and services based on a separate revenue recognition process using management’s bestestimate of the selling price when there is no vendor-specific objective evidence or third-party evidence to determine the selling price of that item. If adelivered element is not considered to have standalone value, all elements of the arrangement are recognized as revenue as a single unit of accounting overthe period of performance for the last such undelivered item or services. Significant management judgment is required in determining what elementsconstitute deliverables and what deliverables or combination of deliverables should be considered units of accounting.When multiple deliverables are combined and accounted for as a single unit of accounting, we base our revenue recognition pattern on the last to bedelivered element. Revenue is recognized using either a proportional performance or straight-line method, depending on whether we can reasonably estimatethe level of effort required to complete our performance obligations under an arrangement and whether such performance obligations are provided on a best-efforts basis. To the extent we cannot reasonably estimate our performance obligations, we recognize revenue on a straight-line basis over the period weexpect to complete our performance obligations. Significant management judgment is required in determining the level of effort required under anarrangement and the period over which we are expected to complete our performance obligations under an arrangement. We may have to revise our estimatesbased on changes in the expected level of effort or the period we expect to complete our performance obligations.For multiple element arrangements, we allocate revenue to all deliverables based on their relative selling prices. We determine the selling price to beused for allocating revenue to deliverables as follows: (a) vendor specific objective evidence; (b) third-party evidence of selling price and (c) the bestestimate of the selling price. Vendor specific objective evidence generally exists only when we sell the deliverable separately and it is the price actuallycharged by us for that deliverable. Any discounts given to the customer are allocated by applying the relative selling price method.Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue in our consolidated balance sheets. Deferredrevenue associated with our CBR service revenues includes (a) amounts collected in advance of unit processing and (b) amounts associated with unearnedstorage fees collected at the beginning of the storage contract term, net of allocated discounts. Amounts not expected to be recognized within the next yearare classified as long-term deferred revenues.Service RevenueOur service revenues for the CBR Services include the following two deliverables: (a) enrollment, including the provision of a collection kit and cordblood and cord tissue unit processing, which are delivered at the beginning of the relationship (the “processing services”), with revenue for this deliverablerecognized after the collection and successful processing of the cord blood and cord tissue; and (b) the storage of newborn cord blood and cord tissue units(the “storage services”), for either an annual fee or a prepayment of 18 years or the lifetime of the newborn donor (the “lifetime option”), with revenue for thisdeliverable recognized ratably over the applicable storage period. For the lifetime option, storage fees are not charged during the lifetime of the newborndonor. However, revenue is recognized based on the average of male and female life expectancies using lifetime actuarial tables published by the SocialSecurity Administration in effect at the time of the newborn’s birth. As there are other vendors who provide processing services and storage services atseparately stated list prices, the processing118Table of Contentsservices and storage services, including the first year storage, each have standalone value to the customer, and therefore represent separate deliverables. Theselling price for the processing services is estimated based on the best estimate of selling price because we do not have vendor specific objective evidence orthird-party evidence of selling price for these elements. The selling price for the storage services is determined based on vendor specific objective evidence aswe have standalone renewals to support the selling price.License Fee, Collaboration and Other RevenuesThe terms of product development and commercialization agreements entered into between us and our collaborative licensees may include non-refundable license fees, payments based on the achievement of certain milestones and performance goals, reimbursement of certain out-of-pocket costs,including research and development expenses, payment for manufacturing services, and royalties on product sales. We recognize license fee and research anddevelopment revenue under collaborative arrangements over the term of the applicable agreements using a proportional performance model, if practical.Otherwise, we recognize such revenue on a straight-line basis. Under this model, revenue is generally recognized in an amount equal to the lesser of theamount due under the agreements or an amount based on the proportional performance to date. In cases where project costs or other performance metrics arenot estimable but there is an established contract period, revenues are recognized on a straight-line basis over the term of the relevant agreement. In caseswhere we are reimbursed for certain research and development costs associated with our collaboration agreements and where we are acting as the principal incarrying out these services, any reimbursement payments are recorded in license fee, collaboration and other revenues in our consolidated statement ofoperations to match the costs that we incur during the period in which we perform those services. Nonrefundable payments and fees are recorded as deferredrevenue upon receipt and may require deferral of revenue recognition to future periods.Our collaboration agreements may entitle us to additional payments upon the achievement of performance-based milestones. If a milestone involvessubstantive effort on our part and its achievement is not considered probable at the inception of the collaboration, we recognize the milestone considerationas revenue in the period in which the milestone is achieved only if it meets the following additional criteria:•The milestone consideration received is commensurate with either the level of effort required to achieve the milestone or the enhancement of thevalue of the item delivered as a result of a specific outcome resulting from our performance to achieve the milestone;•The milestone is related solely to our past performance; and•The milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement.There is significant judgment involved in determining whether a milestone meets all of these criteria. For milestones that do not meet the above criteriaand are therefore not considered substantive milestones, we recognize that portion of the milestone payment equal to the percentage of the performanceperiod completed at the time the milestone is achieved and the above conditions are met. The remaining portion of the milestone will be recognized over theremaining performance period using a proportional performance or straight-line method.Research and Development ExpensesResearch and development expenses include external expenses, such as costs of clinical trials, contract research and development expenses, certainmanufacturing research and development costs, regulatory filing fees, consulting and professional fees and expenses, and internal expenses, such ascompensation of employees engaged in research and development activities, the manufacture of product needed to support research and development efforts,related costs of facilities, and other general costs related to research and development. Manufacturing costs are generally expensed as incurred until a producthas received the necessary initial regulatory approval.Advertising CostsAdvertising costs are expensed as incurred and included in selling, general and administrative expenses in our consolidated statements of operations.Advertising costs, including promotional expenses, costs related to trade shows and CBR print media advertising space were $16.4 million, $8.0 million and$2.1 million for the years ended December 31, 2016, 2015 and 2014, respectively.119Table of ContentsShipping and Handling CostsWe bill customers of our CBR Services a fee for the shipping of the collection kits to CBR. Shipping and handling revenues are reported in servicesrevenues, with the associated costs in reported in costs of services.Equity-Based CompensationEquity-based compensation cost is generally measured at the estimated grant date fair value and recorded to expense over the requisite service period,which is generally the vesting period. Because equity-based compensation expense is based on awards ultimately expected to vest, we must make certainjudgments about whether employees, officers, directors, consultants and advisors will complete the requisite service period, and reduce the compensationexpense being recognized for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actualforfeitures differ from those estimates. Forfeitures are estimated based upon historical experience and adjusted for unusual events such as corporaterestructurings, which can result in higher than expected turnover and forfeitures. If factors change and we employ different assumptions in future periods, thecompensation expense that we record in the future may differ significantly from what we have recorded in the current period.We estimate the fair value of equity-based compensation involving stock options based on the Black-Scholes option pricing model. This model requiresthe input of several factors such as the expected option term, the expected risk-free interest rate over the expected option term, the expected volatility of ourstock price over the expected option term, and the expected dividend yield over the expected option term and are subject to various assumptions. The fairvalue of awards calculated using the Black-Scholes option pricing model is generally amortized on a straight-line basis over the requisite service period, andis recognized based on the proportionate amount of the requisite service period that has been rendered during each reporting period.We estimate the fair value of our restricted stock units (“RSUs”) whose vesting is contingent upon market conditions using the Monte-Carlo simulationmodel. The fair value of RSUs where vesting is contingent upon market conditions is amortized based upon the estimated derived service period. The fairvalue of RSUs granted to our employees and directors is determined based upon the quoted closing market price per share on the date of grant, adjusted forestimated forfeitures.We believe our valuation methodologies are appropriate for estimating the fair value of the equity awards we grant to our employees and directors. Ourequity award valuations are estimates and may not be reflective of actual future results or amounts ultimately realized by recipients of these grants. Theseamounts are subject to future quarterly adjustments based upon a variety of factors, which include, but are not limited to, changes in estimated forfeiture ratesand the issuance of new equity-based awards.Income TaxesDeferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax basis of assets andliabilities using future enacted rates. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of our deferredtax assets will not be realized.We account for uncertain tax positions using a “more-likely-than-not” threshold for recognizing and resolving uncertain tax positions. The evaluation ofuncertain tax positions is based on factors that include, but are not limited to, changes in tax law, the measurement of tax positions taken or expected to betaken in tax returns, the effective settlement of matters subject to audit, new audit activity, and changes in facts or circumstances related to a tax position. Weevaluate uncertain tax positions on a quarterly basis and adjust the level of the liability to reflect any subsequent changes in the relevant facts surroundingthe uncertain positions. Any changes to these estimates, based on the actual results obtained and/or a change in assumptions, could impact our income taxprovision in future periods. Interest and penalty charges, if any, related to unrecognized tax benefits would be classified as a provision for income tax in ourconsolidated statement of operations.Comprehensive Income (Loss)Our comprehensive income (loss) consists of net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) includeschanges in equity that are excluded from net income (loss), which for all periods presented in these consolidated financial statements related to unrealizedholding gains and losses on available-for-sale investments, net of tax.120Table of ContentsBasic and Diluted Net Income (Loss) per ShareWe compute basic net income (loss) per share by dividing net income (loss) by the weighted average number of common shares outstanding during therelevant period. Diluted net income (loss) per common share has been computed by dividing net income (loss) by the diluted number of common sharesoutstanding during the period. Except where the result would be antidilutive to net income (loss), diluted net income (loss) per common share would becomputed assuming the impact of the conversion of the $200.0 million of 2.5% convertible senior notes due February 15, 2019 (the “Convertible Notes”),the exercise of outstanding stock options, the vesting of restricted stock units (“RSUs”), and the exercise of warrants.We have a choice to settle the conversion obligation under the Convertible Notes in cash, shares or any combination of the two. Pursuant to certaincovenants in our six-year $350.0 million term loan facility (the “2015 Term Loan Facility”), which we entered into in 2015 to partially fund the acquisitionof CBR, we may be restricted from settling the conversion obligation in whole or in part with cash unless certain conditions in the 2015 Term Loan Facilityare satisfied. We utilize the if-converted method to reflect the impact of the conversion of the Convertible Notes. This method assumes the conversion of theConvertible Notes into shares of our common stock and reflects the elimination of interest expense related to the Convertible Notes. Prior to the acquisitionof Lumara Health in November 2014, we intended to settle the principal value of the Convertible Notes in cash and the excess conversion premium in shares.We utilized the treasury stock method to reflect the dilutive effect of the conversion premium in 2014, as if it were a freestanding written call option on ourshares prior to the November 2014 acquisition of Lumara Health. The impact of the conversion premium has been considered in the calculation of diluted netincome per share for 2014 by applying the closing price of our common stock on December 31, 2014 to calculate the number of shares issuable under theconversion premium.The dilutive effect of the warrants, stock options and RSUs has been calculated using the treasury stock method.The components of basic and diluted net income (loss) per share for 2016, 2015 and 2014 were as follows (in thousands, except per share data):Years Ended December 31,2016 2015 2014Net income (loss) - basic$(2,483) $32,779 $135,817Dilutive effect of convertible 2.5% notes— — 1,654Net income (loss) - diluted$(2,483) $32,779 $137,471 Weighted average common shares outstanding34,346 31,471 22,416Effect of dilutive securities: Warrants— 2,466 —Stock options and RSUs— 1,371 520Convertible 2.5% notes— — 2,289Shares used in calculating dilutive net income (loss) per share34,346 35,308 25,225 Net income (loss) per share: Basic$(0.07)$1.04 $6.06Diluted$(0.07)$0.93 $5.45 The following table sets forth the potential common shares issuable upon the exercise of outstanding options, the vesting of RSUs, the exercise ofwarrants (prior to consideration of the treasury stock method), and the conversion of the Convertible Notes, which were excluded from our computation ofdiluted net income (loss) per share because their inclusion would have been anti-dilutive (in thousands):121Table of ContentsYears Ended December 31,2016 2015 2014Options to purchase shares of common stock2,5901,6192,708Shares of common stock issuable upon the vesting of RSUs613167322Warrants7,382—7,382Convertible 2.5% notes7,382 7,382 —Total17,9679,16810,412 In connection with the issuance of the Convertible Notes, in February 2014, we entered into convertible bond hedges. The convertible bond hedges arenot included for purposes of calculating the number of diluted shares outstanding, as their effect would be anti-dilutive. The convertible bond hedges aregenerally expected, but not guaranteed, to reduce the potential dilution and/or offset the cash payments we are required to make upon conversion of theConvertible Notes. During 2016 and 2014, the average common stock price was below the exercise price of the warrants and during 2015, the averagecommon stock price was above the exercise price of the warrants.ReclassificationsCertain amounts in the prior period have been reclassified in order to conform to the current period presentation. In accordance with AccountingStandards Update (“ASU”) No. 2015-3, Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs, which weadopted in the first quarter of 2016, we reclassified total debt issuance costs related to our outstanding debt obligations from other long-term assets to thecarrying amount of our debt, as a direct deduction, in our consolidated balance sheets as of December 31, 2015. See Note V , “Recently Issued and ProposedAccounting Pronouncements” for additional information. C. BUSINESS COMBINATIONSAs part of our strategy to expand our product and service portfolio, in August 2015, we acquired CBR and the CBR Services and in November 2014, weacquired Lumara Health and its product Makena.CBR AcquisitionOn August 17, 2015 (the “CBR Acquisition Date”), we acquired CBR for $700.0 million in cash consideration, subject to estimated working capital,indebtedness and other adjustments. We believe CBR is a strong strategic fit for our growing business and offers a unique opportunity to reach a broaderpopulation of expectant mothers who may benefit from our product offerings in the maternal health space, including Makena. We accounted for the CBR acquisition as a business combination using the acquisition method of accounting. Under the acquisition method ofaccounting, the total purchase price of an acquisition is allocated to the net tangible and identifiable intangible assets acquired and liabilities assumed basedon their estimated fair values as of the date of acquisition. We have allocated the purchase price to the net tangible and intangible assets acquired andliabilities assumed, based on available information and various assumptions we believed were reasonable, with the remaining purchase price recorded asgoodwill.The following table summarizes the components of the total purchase price paid for CBR, as adjusted for the final net working capital, indebtedness andother adjustments (in thousands): Total AcquisitionDate Fair ValueCash consideration$700,000Estimated working capital, indebtedness and other adjustments(17,837)Purchase price paid at closing682,163Cash paid on finalization of the net working capital, indebtedness and other adjustments193Total purchase price$682,356122Table of ContentsThe following table summarizes the fair values assigned to the CBR assets acquired and liabilities assumed by us along with the resulting goodwill at theCBR Acquisition Date, as adjusted for certain measurement period adjustments recorded since the CBR Acquisition Date (in thousands): Total AcquisitionDate Fair ValueAccounts receivable$8,660Inventories3,825Prepaid and other current assets8,480Restricted cash - short-term30,752Property, plant and equipment29,401Customer relationships297,000Trade name and trademarks65,000Favorable lease asset358Deferred income tax assets5,062Other long-term assets496Accounts payable(2,853)Accrued expenses(13,770)Deferred revenues - short-term(3,100)Payable to former CBR shareholders(37,947)Deferred income tax liabilities(149,873)Other long-term liabilities(506)Total estimated identifiable net assets$240,985Goodwill441,371Total $682,356 During 2016, we recorded measurement period adjustments related to the filing of pre-acquisition federal and state income tax returns and thefinalization of other tax-related matters. These measurement period adjustments resulted in a net increase to goodwill of $0.3 million and were reflected ascurrent period adjustments during the second quarter of 2016 in accordance with the guidance in ASU 2015-16, Business Combinations (Topic 805):Simplifying the Accounting for Measurement-Period Adjustments (“ASU 2015-16”). Measurement period adjustments recorded in the fourth quarter of 2015consisted primarily of reductions to accounts receivable, inventories, prepaid and other current assets and property, plant and equipment totaling $1.9million and increases to accrued expenses and long-term liabilities totaling $0.5 million, which resulted in an increase to goodwill of $1.8 million, net of$0.6 million of deferred taxes.The gross contractual amount of accounts receivable at the CBR Acquisition Date of $11.7 million was adjusted to its fair value of $8.7 million. The fairvalue amounts for CBR’s customer relationships, trade names and trademarks were determined based on assumptions that market participants would use inpricing an asset, based on the most advantageous market for the assets (i.e., its highest and best use).We determined the fair value of the customer relationships, using an income approach, which is a valuation technique that provides an estimate of thefair value of an asset based on market participant expectations of the cash flows an asset would generate over its remaining life. Some of the more significantassumptions used in the income approach from the perspective of a market participant include the estimated net cash flows for each year for the identifiableintangible asset, the discount rate that measures the risk inherent in each cash flow stream, as well as other factors. The customer relationships will beamortized to selling, general and administrative expenses based on an economic consumption model over an expected useful life of approximately 20 years.The fair value of the trade names and trademarks was determined using the relief from royalty method, which is also an income approach. We believe thefair values assigned to the CBR customer relationships, and the trade names and trademarks are based upon reasonable estimates and assumptions givenavailable facts and circumstances as of the CBR Acquisition Date. If these assets are not successful, sales and profitability may be adversely affected in futureperiods, and as a result, the value of the assets may become impaired. The trade names and trademark intangible asset is deemed to be an indefinite-livedasset, which is not amortized but is subject to periodic assessments for impairment. See Note H, “Goodwill and Intangible Assets” for additional information.123Table of ContentsBased on the fair value adjustments primarily related to deferred revenue and identifiable intangible assets acquired, we recorded a net deferred taxliability of $144.8 million in acquisition accounting using a combined federal and state statutory income tax rate of 37.0%. The net deferred tax liabilityrepresents the $149.9 million of deferred tax liabilities recorded in acquisition accounting, primarily related to the fair value adjustments to CBR’s deferredrevenue and identifiable intangible assets, partially offset by $5.1 million of deferred tax assets acquired from CBR.We incurred approximately $11.2 million of acquisition-related costs in 2015 related to the CBR acquisition. These costs primarily represented financialadvisory fees, legal fees, due diligence and other costs and expenses.In connection with the CBR acquisition, we incurred a $6.8 million bridge loan commitment fee, which was included in other income (expense) in our2015 consolidated statement of operations and paid in the third quarter of 2015.During the post-acquisition period in 2015, CBR generated approximately $24.1 million of revenue. Separate disclosure of CBR’s earnings for the post-acquisition period in 2015 is not practicable due to the integration of CBR’s operations into our business upon acquisition.During the third quarter of 2016, we finalized the fair values assigned to the assets acquired and liabilities assumed by us at the CBR Acquisition Date.Lumara Health AcquisitionOn November 12, 2014, (the “Lumara Health Acquisition Date”), we acquired Lumara Health and its existing commercial product, Makena, for $600.0million in cash, subject to certain net working capital and other adjustments, and issued approximately 3.2 million shares of our common stock, having avalue of approximately $112.0 million at the time of closing, to the holders of common stock of Lumara Health. The acquisition of Lumara Health provided astrategic commercial entry into the maternal health business. The addition of Makena, the only FDA-approved therapy to reduce the risk of preterm birth incertain at-risk women, added a complementary commercial platform to our portfolio and transformed us into a multi-product specialty pharmaceuticalcompany.We agreed to pay additional merger consideration, up to a maximum of $350.0 million, based upon the achievement of certain net sales milestones ofMakena for the period from December 1, 2014 through December 31, 2019 as follows:•A one-time payment of $100.0 million payable upon achievement of $300.0 million in aggregate net sales in any consecutive 12-month period,commencing in the month following the Lumara Health Acquisition Date (“the First Milestone”); plus•A one-time payment of $100.0 million payable upon achievement of $400.0 million in aggregate net sales in any consecutive 12-month periodcommencing in the month following the last month in the First Milestone period (the “Second Milestone”); if the Third Milestone payment(described below) has been or is required to be made prior to achieving the Second Milestone, the Second Milestone payment shall be reduced from$100.0 million to $50.0 million; plus•A one-time payment of $50.0 million payable if aggregate net sales equal or exceed $700.0 million in any consecutive 24 calendar month period(which may include the First Milestone period) (the “Third Milestone”); however, no Third Milestone payment will be made if the SecondMilestone payment has been or is required to be made in the full amount of $100.0 million; plus•A one-time payment of $100.0 million payable upon achievement of $500.0 million in aggregate net sales in any consecutive 12-month periodcommencing in the month following the last month in the Second Milestone period (the “Fourth Milestone”); plus•A one-time payment of $50.0 million payable upon achievement of $200.0 million in aggregate net sales in each of the five (5) consecutive calendaryears from and including the 2015 calendar year to the 2019 calendar year (the “Fifth Milestone”).In the event that the conditions to more than one contingent payment are met in any calendar year, any portion of the total amount of contingentpayment due in such calendar year in excess of $100.0 million shall be deferred until the next calendar year in which less than $100.0 million in contingentpayments is due. This contingent consideration is recorded as a liability124Table of Contentsand measured at fair value based upon significant unobservable inputs. We paid the former Lumara Health security holders $100.0 million in the fourthquarter of 2016 based on our achievement of the First Milestone during the third quarter of 2016.The following table summarizes the components of the total purchase price paid for Lumara Health, as adjusted for the final net working capital andother adjustments (in thousands): Total AcquisitionDate Fair ValueCash consideration$600,000Fair value of AMAG common stock issued111,964Fair value of contingent milestone payments205,000Estimated working capital and other adjustments821Purchase price paid at closing917,785Less: Cash received on finalization of the net working capital and other adjustments(562)Cash acquired from Lumara Health(5,219)Total purchase price$912,004 At the closing, $35.0 million of the cash consideration was contributed to a separate escrow fund to secure the former Lumara Health security holders’obligations to indemnify us for certain matters, including breaches of representations and warranties, covenants included in the Lumara Health acquisitionagreement, payments made by us to dissenting stockholders, specified tax claims, excess parachute claims, and certain claims related to the Women’s HealthDivision of Lumara Health, which was divested by Lumara Health prior to the closing. As of December 31, 2016, the funds held in escrow have been fullydistributed to the former Lumara Health security holders.The fair value of the 3.2 million shares of AMAG common stock was determined based on the closing price of our common stock on the NASDAQ GlobalSelect Market (“NASDAQ”) of $34.88 per share on November 11, 2014, the closing price immediately prior to the closing of the transaction.The fair value of the contingent milestone payments was determined based on our probability-adjusted discounted cash flows estimated to be realizedfrom the net sales of Makena from December 1, 2014 through December 31, 2019. The cash flows were discounted at a rate of 5%, which we believe isreasonable given the level of certainty of the pay-out.125Table of ContentsThe following table summarizes the fair values assigned to assets acquired and liabilities assumed by us along with the resulting goodwill at the LumaraHealth Acquisition Date, as adjusted for certain measurement period adjustments for Lumara Health recorded during 2015 (in thousands): Total AcquisitionDate Fair ValueAccounts receivable$36,852Inventories30,300Prepaid and other current assets3,322Deferred income tax assets 102,355Property and equipment60Makena base technology797,100IPR&D79,100Restricted cash - long term1,997Other long-term assets3,412Accounts payable(3,807)Accrued expenses(36,561)Deferred income tax liabilities (295,676)Other long-term liabilities(4,563)Total estimated identifiable net assets$713,891Goodwill198,113Total$912,004 The measurement period adjustments recorded in 2015 consisted primarily of a $7.2 million reduction to our Makena revenue reserves and a $5.4million reduction related to net deferred tax liabilities, partially offset by a $4.5 million increase in the purchase price associated with the final settlement ofnet working capital with the former stockholders. These measurement period adjustments were reflected as current period adjustments during 2015 inaccordance with the guidance in ASU 2015-16.The gross contractual amount of accounts receivable at the Lumara Health Acquisition Date was $40.5 million. The $30.3 million fair value ofinventories included a fair value step-up adjustment of $26.1 million, which will be amortized and recognized as cost of product sales in our consolidatedstatements of operations as the related inventories are sold. We recognized $4.9 million, $11.6 million and $1.3 million of the fair value adjustment as cost ofproduct sales during the years ended December 31, 2016, 2015 and 2014, respectively. An additional $0.9 million and $1.2 million of the fair valueadjustment was recognized as research and development expense during the year ended December 31, 2016 and 2015, respectively. The remaining $6.2million is estimated to be recognized as follows: $2.1 million in 2017 and $4.1 million in 2018.The fair value amounts for the Makena base technology and IPR&D were determined based on assumptions that market participants would use in pricingan asset, based on the most advantageous market for the assets (i.e., its highest and best use). We determined the fair value of the Makena base technologyand the IPR&D using the income approach. Some of the more significant assumptions used in the income approach for these assets include the estimated netcash flows for each year for each project or product, the discount rate that measures the risk inherent in each future cash flow stream, the assessment of eachasset’s life cycle, competitive trends impacting the asset and each cash flow stream as well as other factors, including the major risks and uncertaintiesassociated with the timely and successful completion of the IPR&D projects, such as legal and regulatory risk.The fair value of the acquired IPR&D asset represents the value assigned to acquired research and development projects that, as of the Lumara HealthAcquisition Date, had not established technological feasibility and had no alternative future use, including certain programs associated with the Makenanext generation development program to extend the brand franchise beyond the February 2018 exclusivity date, such as new routes of administration, the useof new delivery technologies, as well as reformulation technologies. We believe the fair values assigned to the Makena base technology and IPR&D assetsare based upon reasonable estimates and assumptions given available facts and circumstances as of the Lumara Health Acquisition Date. If these assets are notsuccessful or successfully developed, sales and profitability may be adversely affected in future periods, and as a result, the value of the assets may becomeimpaired.126Table of ContentsBoth AMAG and Lumara Health had deferred tax assets for which full valuation allowances were provided in the pre-acquisition financial statements.However, we considered certain of the deferred tax liabilities recorded in acquisition accounting as sources of income to support realization of LumaraHealth’s deferred tax assets. We recorded a net deferred tax liability of $193.3 million in our consolidated balance sheet in acquisition accounting using acombined federal and state statutory income tax rate of 38.8%. The net deferred tax liability represents the $295.7 million of deferred tax liabilities recordedin acquisition accounting (primarily related to the fair value adjustments to Lumara Health’s inventories and identifiable intangible assets) offset by $102.4million of deferred tax assets acquired from Lumara Health which we have determined, are ‘more likely than not’ to be realized. See Note J, “Income Taxes,”for additional information.We incurred approximately $9.5 million of acquisition-related costs in 2014 related to the acquisition of Lumara Health. These costs primarilyrepresented financial advisory fees, legal fees, due diligence and other costs and expenses.During the post-acquisition period in fiscal 2014, Lumara Health generated $22.5 million of revenue from sales of Makena. Separate disclosure ofLumara Health’s earnings for the post-acquisition period in fiscal 2014 is not practicable due to the integration of Lumara Health’s operations into ourbusiness upon acquisition.During 2015, we finalized the fair values assigned to the assets acquired and liabilities assumed by us at the Lumara Health Acquisition Date.Unaudited Pro Forma Supplemental InformationThe following supplemental unaudited pro forma information presents our revenue and net income (loss) on a pro forma combined basis, including CBRand Lumara Health, assuming that the CBR acquisition occurred on January 1, 2014 and that the Lumara Health acquisition occurred on January 1, 2013. Forpurposes of preparing the following pro forma information, certain items recorded during 2015, such as the $11.2 million of acquisition-related costs, the$10.4 million loss on debt extinguishment, and $9.2 million of other one-time fees and expenses incurred in connection with the CBR acquisition financing,are excluded from 2015 and reflected in 2014. In addition, certain items recorded in 2014, such as the $153.2 million tax benefit and the $9.5 million ofacquisition-related costs incurred in connection with the acquisition of Lumara Health, are excluded from 2014 and reflected as having occurred in 2013. Thepro forma amounts do not include any expected cost savings or restructuring actions which may be achievable or may occur subsequent to the acquisition ofLumara Health or CBR, or the impact of any non-recurring activity. The following table presents the unaudited pro forma consolidated results (in thousands): Years Ended December 31, 2015 2014Pro forma combined revenues490,451 364,447Pro forma combined net income (loss)28,217 (57,739)The pro forma adjustments reflected in the pro forma combined net income (loss) in the above table primarily represent adjustments to historicalamortization of intangible assets, to historical depreciation of property, plant and equipment, and reductions to historical CBR revenues due to fair valuepurchase accounting adjustments to intangible assets, property, plant and equipment and deferred revenue. In addition, the pro forma combined net income(loss) includes increased interest expense due to the increase in term loan borrowings and the issuance of $500.0 million aggregate principal amount of7.875% Senior Notes due 2023 (the “2023 Senior Notes”) in connection with the CBR acquisition. Income taxes for all periods were adjusted accordingly.This pro forma financial information is not necessarily indicative of our consolidated operating results that would have been reported had the transactionsbeen completed as described herein, nor is such information necessarily indicative of our consolidated results for any future period.GoodwillIn connection with the CBR acquisition, we recognized $441.4 million of goodwill, primarily due to the synergies expected from combining ouroperations with CBR and to deferred tax liabilities related to fair value adjustments of intangible assets and deferred revenue. In connection with the LumaraHealth acquisition, we recognized $198.1 million of goodwill, primarily due to the net deferred tax liabilities recorded on the fair value adjustments toLumara Health’s inventories and identifiable intangible asset. The $639.5 million of goodwill resulting from the CBR and Lumara Health acquisitions is notdeductible for income tax purposes.127Table of ContentsD. INVESTMENTSAs of December 31, 2016 and 2015, our investments consisted of securities classified as available-for-sale in accordance with accounting standardswhich provide guidance related to accounting and classification of certain investments in debt and equity securities.The following is a summary of our investments as of December 31, 2016 and 2015 (in thousands): December 31, 2016 Gross Gross Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses ValueCorporate debt securities Due in one year or less$106,430 $3 $(69) $106,364Due in one to three years139,742 32 (281) 139,493U.S. treasury and government agency securities Due in one year or less1,021 — — 1,021Due in one to three years11,395 — (52) 11,343Commercial paper Due in one year or less40,560 — — 40,560Certificates of deposit Due in one year or less6,000 — — 6,000Total investments$305,148 $35 $(402) $304,781 December 31, 2015 Gross Gross Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses ValueCorporate debt securities Due in one year or less$27,964 $— $(38) $27,926Due in one to three years173,652 3 (904) 172,751Commercial paper Due in one year or less34,452 2 (5) 34,449Municipal securities Due in one year or less2,500 — — 2,500Total investments$238,568 $5 $(947) $237,626 Impairments and Unrealized Gains and Losses on InvestmentsWe did not recognize any other-than-temporary impairment losses in our consolidated statements of operations related to our securities during 2016,2015 and 2014. We considered various factors, including the length of time that each security was in an unrealized loss position and our ability and intent tohold these securities until the recovery of their amortized cost basis occurs. As of December 31, 2016, none of our investments has been in an unrealized lossposition for more than one year. Future events may occur, or additional information may become available, which may cause us to identify credit losseswhere we do not expect to receive cash flows sufficient to recover the entire amortized cost basis of a security and may necessitate the recording of futurerealized losses on securities in our portfolio. Significant losses in the estimated fair values of our investments could have a material adverse effect on ourearnings in future periods.128Table of ContentsE. FAIR VALUE MEASUREMENTSThe following tables represent the fair value hierarchy as of December 31, 2016 and 2015, for those assets and liabilities that we measure at fair value ona recurring basis (in thousands): Fair Value Measurements at December 31, 2016 Using: Total Quoted Prices inActive Markets forIdentical Assets(Level 1) Significant OtherObservable Inputs(Level 2) SignificantUnobservableInputs(Level 3)Assets: Cash equivalents$9,951 $9,951 $— $—Corporate debt securities245,857 — 245,857 —U.S. treasury and government agency securities12,364 — 12,364 —Commercial paper40,560 — 40,560 —Certificates of deposit6,000 — 6,000 —Total Assets$314,732 $9,951 $304,781 $—Liabilities: Contingent consideration - Lumara Health$145,974 $— $— $145,974Contingent consideration - MuGard2,021 — — 2,021Total Liabilities$147,995 $— $— $147,995 Fair Value Measurements at December 31, 2015 Using: Total Quoted Prices inActive Markets forIdentical Assets(Level 1) Significant OtherObservable Inputs(Level 2) SignificantUnobservableInputs(Level 3)Assets: Cash equivalents$73,676 $73,676 $— $—Corporate debt securities200,677 — 200,677 —Commercial paper34,449 — 34,449 —Municipal securities2,500 — 2,500 —Total Assets$311,302 $73,676 $237,626 $—Liabilities: Contingent consideration - Lumara Health$214,895 $— $— $214,895Contingent consideration - MuGard7,664 — — 7,664Total Liabilities$222,559 $— $— $222,559 InvestmentsOur cash equivalents are classified as Level 1 assets under the fair value hierarchy as these assets have been valued using quoted market prices in activemarkets and do not have any restrictions on redemption. Our investments are classified as Level 2 assets under the fair value hierarchy as these assets wereprimarily determined from independent pricing services, which normally derive security prices from recently reported trades for identical or similar securities,making adjustments based upon other significant observable market transactions. At the end of each reporting period, we perform quantitative andqualitative analyses of prices received from third parties to determine whether prices are reasonable estimates of fair value. After completing our analyses, wedid not adjust or override any fair value measurements provided by our pricing services as of December 31, 2016 or 2015. In addition, there were no transfersor reclassifications of any securities between Level 1 and Level 2 during 2016 or 2015.129Table of ContentsContingent considerationWe record contingent consideration related to the Lumara Health acquisition, as discussed in greater detail in Note C, “Business Combinations,” andrelated to our June 2013 license agreement for MuGard® Mucoadhesive Oral Wound Rinse (the “MuGard License Agreement”) with AbeonaTherapeutics, Inc. (“Abeona”), under which we acquired the U.S. commercial rights for the management of oral mucositis and stomatitis (the “MuGardRights”). There were no contingent consideration obligations related to the CBR acquisition.The fair value measurements of contingent consideration obligations and the related intangible assets arising from business combinations are classifiedas Level 3 assets under the fair value hierarchy as these assets have been valued using unobservable inputs. These inputs include: (a) the estimated amountand timing of projected cash flows; (b) the probability of the achievement of the factors on which the contingency is based; and (c) the risk-adjusted discountrate used to present value the probability-weighted cash flows. Significant increases or decreases in any of those inputs in isolation could result in asignificantly lower or higher fair value measurement.The following table presents a reconciliation of contingent consideration obligations related to the acquisition of Lumara Health and the MuGard Rights(in thousands):Balance as of January 1, 2015$218,702Payments made(456)Adjustments to fair value of contingent consideration4,271Other adjustments42Balance as of December 31, 2015$222,559Payments made(100,246)Adjustments to fair value of contingent consideration25,682Balance as of December 31, 2016$147,995 The $25.7 million of adjustments to the fair value of the contingent consideration liability in 2016 were due to a $31.1 million increase to the Makenacontingent consideration and a $5.4 million decrease to the MuGard contingent consideration. During the second quarter of 2016, we revised our forecast oftotal projected net sales for MuGard and reassessed the fair value of the contingent consideration liability related to the MuGard Rights. As a result, wereduced our MuGard-related contingent consideration liability by $5.6 million during the second quarter of 2016. These adjustments were included inselling, general and administrative expenses in our consolidated statements of operations. We have classified $96.8 million of the Makena contingentconsideration and $0.3 million of the MuGard contingent consideration as short-term liabilities in our consolidated balance sheet as of December 31, 2016.The fair value of the contingent milestone payments payable by us to the former stockholders of Lumara Health was determined based on ourprobability-adjusted discounted cash flows estimated to be realized from the net sales of Makena from December 1, 2014 through December 31, 2019. Thecash flows were discounted at a rate of 5.0%, which we believe is reasonable given the estimated likelihood of the pay-out. As of December 31, 2016, thetotal undiscounted milestone payment amounts we could pay in connection with the Lumara Health acquisition was $250.0 million through December 31,2019.The fair value of the contingent royalty payments payable by us to Abeona under the MuGard License Agreement was determined based on variousmarket factors, including an analysis of estimated sales using a discount rate of approximately 11% as of December 31, 2016. In addition, as of December 31,2016, we estimated that the undiscounted royalty amounts we could pay under the MuGard License Agreement, based on current projections, may range from$2.0 million to $6.0 million over the remainder of the ten year period, which commenced on June 6, 2013, the acquisition date, which is our best estimate ofthe period over which we expect the majority of the asset’s cash flows to be derived. We believe the estimated fair values of Lumara Health and the MuGard Rights are based on reasonable assumptions, however, our actual results may varysignificantly from the estimated results.DebtWe estimate the fair value of our debt obligations by using quoted market prices obtained from third-party pricing services, which is classified as a Level2 input. As of December 31, 2016, the estimated fair value of our 2023 Senior Notes, Convertible Notes and 2015 Term Loan Facility (each as defined below)was $500.0 million, $282.1 million and $336.0 million, respectively, which differed from their carrying values. See Note R, “Debt” for additional informationon our debt obligations.130Table of ContentsF. INVENTORIESOur major classes of inventories were as follows as of December 31, 2016 and 2015 (in thousands): December 31, 2016 2015Raw materials$14,382 $19,673Work in process3,924 1,985Finished goods18,952 18,987Total inventories$37,258 $40,645 Total inventories as of December 31, 2016 decreased by $3.4 million as compared to 2015 primarily due to inventory sold to customers, offset by newmanufacturing activities during the year.G. PROPERTY, PLANT AND EQUIPMENT, NETProperty, plant and equipment, net consisted of the following as of December 31, 2016 and 2015 (in thousands): December 31, 2016 2015Land$700 $700Land improvements300 300Building and improvements9,500 9,500Computer equipment and software13,866 13,193Furniture and fixtures2,401 1,725Leasehold improvements3,718 1,717Laboratory and production equipment6,449 5,683Construction in progress1,619 786 38,553 33,604Less: accumulated depreciation(14,093) (4,879)Property, plant and equipment, net$24,460 $28,725 During 2016, 2015 and 2014, depreciation expense was $9.2 million, $3.9 million and $0.5 million, respectively.131Table of ContentsH. GOODWILL AND INTANGIBLE ASSETS, NETGoodwillOur goodwill balance consisted of the following (in thousands): Balance at January 1, 2015$205,824Goodwill acquired through CBR acquisition441,075Measurement period adjustments related to Lumara Health acquisition(7,711)Balance as of December 31, 2015639,188Measurement period adjustments related to CBR acquisition296Balance as of December 31, 2016$639,484Our $639.5 million goodwill balance consisted of $198.1 million of goodwill acquired through the November 2014 Lumara Health acquisition and$441.4 million acquired through the August 2015 CBR acquisition. During 2016, the CBR goodwill increased by $0.3 million related to measurementperiod net tax adjustments. These measurement period adjustments have been reflected as current period adjustments in accordance with ASU 2015-16. As ofDecember 31, 2016, we had no accumulated impairment losses related to goodwill. Intangible AssetsAs of December 31, 2016 and 2015, our identifiable intangible assets consisted of the following (in thousands): December 31, 2016 December 31, 2015 Accumulated Accumulated Cost Amortization Impairments Net Cost Amortization NetAmortizable intangible assets: Makena base technology$797,100 $128,732 $— $668,368 $797,100 $56,540 $740,560CBR customer relationships297,000 13,590 — 283,410 297,000 1,061 295,939CBR Favorable lease358 119 239 — 358 63 295MuGard Rights16,893 1,169 15,724 — 16,893 1,016 15,877 1,111,351 143,610 15,963 951,778 1,111,351 58,680 1,052,671Indefinite-lived intangible assets: Makena IPR&D79,100 — — 79,100 79,100 — 79,100CBR trade names and trademarks65,000 — 3,700 61,300 65,000 — 65,000Total intangible assets$1,255,451 $143,610 $19,663 $1,092,178 $1,255,451 $58,680 $1,196,771As of December 31, 2016, the weighted average remaining amortization period for our finite-lived intangible assets was approximately 8.5 years.The Makena base technology and IPR&D intangible assets were acquired in November 2014 in connection with our acquisition of Lumara Health.Amortization of the Makena base technology asset is being recognized using an economic consumption model over 20 years from the acquisition date,which we believe is an appropriate amortization period due to the estimated economic lives of the product rights and related intangibles.The CBR intangible assets (the CBR customer relationships, favorable lease and trade names and trademarks) were acquired in August 2015 inconnection with our acquisition of CBR. Amortization of the CBR customer relationships is being recognized using an estimated useful life of 20 years fromthe acquisition date, which we believe is an appropriate amortization period due to the estimated economic lives of the CBR intangible assets. The favorablelease was being amortized on a straight-line basis over the remaining term of the lease. On May 4, 2016, we entered into a sublease arrangement for a portionof our CBR office space in San Bruno, California with a sublessee at a rate lower than the market rate used to determine the favorable lease intangible asset.We reevaluated the favorable lease asset based on the negotiated sublease rate, resulting in an impairment charge for the full $0.2 million net intangible assetin 2016. In addition, as part of our annual impairment test, we recorded an impairment charge of $3.7 million in the fourth quarter of 2016 related to theimpairment of a portion of the CBR trade names and trademarks indefinite-lived intangible asset based on a revised long-term revenue forecast for CBR.132Table of ContentsThe MuGard Rights were acquired from Abeona in June 2013. Amortization of the MuGard Rights was being recognized using an economicconsumption model over ten years from the acquisition date, which represented our best estimate of the period over which we expected the majority of theasset’s cash flows to be derived. Based on interactions with government payors during 2016, we determined that broader reimbursement coverage for MuGardby was unlikely and we assessed the MuGard Rights for potential impairment. From this assessment, we concluded that based on the lack of broadreimbursement and insurance coverage for MuGard and the resulting decrease in expected revenues and cash flows, the projected undiscounted cash flowswere less than the book value, indicating impairment of this intangible asset. As a result of an analysis of the fair value of the net MuGard Rights intangibleasset as compared to its recorded book value, we recognized an impairment charge for the full $15.7 million net intangible asset in the second quarter of2016. See Note C, “Business Combinations,” and Note Q, “Collaboration, License and Other Strategic Agreements,” for additional information on ourintangible assets.Total amortization expense for 2016, 2015 and 2014, was $84.9 million, $53.5 million and $5.1 million, respectively. Amortization expense for the Makenabase technology and the MuGard Rights is recorded in cost of product sales in our consolidated statements of operations. Amortization expense for the CBRrelated intangibles is recorded in selling, general and administrative expenses in our consolidated statements of operations. We expect amortization expenserelated to our finite-lived intangible assets to be as follows (in thousands):Period EstimatedAmortizationExpenseYear Ending December 31, 2017 $119,900Year Ending December 31, 2018 81,433Year Ending December 31, 2019 48,283Year Ending December 31, 2020 46,845Year Ending December 31, 2021 46,767Thereafter 608,550Total $951,778I. CURRENT AND LONG-TERM LIABILITIESAccrued ExpensesAccrued expenses consisted of the following as of December 31, 2016 and 2015 (in thousands): December 31, 2016 2015Commercial rebates, fees and returns$89,466 $45,161Professional, license, and other fees and expenses34,962 27,070Interest expense16,683 18,411Salaries, bonuses, and other compensation14,823 12,838Restructuring expense74 2,883Total accrued expenses$156,008 $106,363 Deferred RevenuesOur deferred revenue balances as of December 31, 2016 and 2015 were related to our CBR Services revenues and included: (a) amounts collected inadvance of unit processing and (b) amounts associated with unearned storage fees collected at the beginning of the storage contract term, net of allocateddiscounts.Other Long-Term LiabilitiesOther long-term liabilities at December 31, 2016 and 2015 consisted of deferred rent related to the lease of our principal executive offices in Waltham,Massachusetts. In addition, other long-term liabilities include future payments to be made to certain states in compliance with a 2011 Lumara HealthSettlement Agreement with the Department of Justice, which resolved certain claims under the qui tam provisions of the False Claims Act. 133Table of ContentsJ. INCOME TAXESFor the years ended December 31, 2016, 2015, and 2014, all of our profit or loss before income taxes was from U.S. operations. The income tax expense(benefit) consisted of the following (in thousands): Years Ended December 31, 2016 2015 2014Current: Federal$— $— $—State4,259 2,058 —Total current$4,259 $2,058 $—Deferred: Federal$9,815 $9,819 $(142,884)State(2,536) (4,812) (10,275)Total deferred$7,279 $5,007 $(153,159)Total income tax expense (benefit)$11,538 $7,065 $(153,159)The reconciliation of the statutory U.S. federal income tax rate to our effective income tax rate was as follows: Years Ended December 31, 2016 2015 2014Statutory U.S. federal tax rate35.0 % 35.0 % (34.0)%State taxes, net of federal benefit6.4 0.1 (7.9)Equity-based compensation expense34.0 0.4 10.6Contingent consideration69.9 4.7 3.1Transaction costs— 3.9 9.7Other permanent items, net21.2 3.2 3.2Tax credits(32.3) (1.7) (3.0)Write-down of acquired state net operating losses114.2 — —Valuation allowance(115.2) (28.0) (864.9)Other, net(5.8) 0.1 —Effective tax rate127.4 % 17.7 % (883.2)%For the year ended December 31, 2016, we recognized an income tax expense of $11.5 million, representing an effective tax rate of 127.4%. Thedifference between the expected statutory federal tax rate of 35.0% and the effective tax rate of 127.4% for the year ended December 31, 2016, was primarilyattributable to the impact of contingent consideration associated with Lumara Health, equity-based compensation expenses and other permanent items,including meals and entertainment expense, officers compensation and Makena-related expenses, offset by the benefit of the federal research anddevelopment and orphan drug tax credits generated during the year. The effective tax rate for the year-ended December 31, 2016 reflected the significance ofthese permanent differences in relation to the pre-tax income for the year-ended December 31, 2016. As a result of state tax planning during 2016, weanalyzed the acquired state net operating losses (“NOLs”) and determined that a significant portion were not utilizable and should be written down. Thiswrite-down was offset with a decrease in the valuation allowance as we had previously determined that it was more likely than not that these NOLs would notbe utilized.For the year ended December 31, 2015, we recognized income tax expense of $7.1 million representing an effective tax rate of 17.7%. The differencebetween the expected statutory federal tax rate of 35.0% and the 17.7% effective tax rate for 2015 was primarily attributable to the impact of a valuationallowance release related to certain deferred tax assets, partially offset by non-deductible transaction costs associated with the acquisition of CBR, and non-deductible contingent consideration expense associated with Lumara Health.We released a portion of our valuation allowance for the year ended December 31, 2014, due to taxable temporary differences available as a source ofincome as a result of the Lumara Health acquisition. As of December 31, 2014, we maintained a partial valuation allowance as we benefited only thosedeferred tax assets to the extent that existing taxable temporary differences could be used as a source of future income to realize the benefits of those deferredtax assets. During the134Table of Contentsyear ended December 31, 2015, we achieved a positive income position, and also acquired additional taxable temporary differences available as a source ofincome as a result of the CBR acquisition. Based primarily on this evidence, we concluded that as of December 31, 2015, the majority of our deferred taxassets are more likely than not to be realized.For the year ended December 31, 2014, we recognized an income tax benefit of $153.2 million representing an effective tax rate of (883.2)%. Thedifference between the statutory tax rate and the effective tax rate was attributable to a non-recurring benefit of $153.2 million for the release of a portion ofthe valuation allowance due to taxable temporary differences available as a source of income to realize the benefit of certain pre-existing AMAG deferred taxassets as a result of the Lumara Health acquisition. Excluding the impact of this item, our overall tax provision and effective tax rate would have been zero.Other factors resulting in a difference between the statutory tax rate and the effective tax rate included certain non-deductible stock compensation expenses,non-deductible transaction costs and contingent consideration associated with the acquisition of Lumara Health, and other non-deductible expenses for taxpurposes.See Note C, “Business Combinations,” for more information on the Lumara Health and CBR acquisitions.Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax basis of assets andliabilities using future enacted rates. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of the deferredtax assets will not be realized. As of December 31, 2015, we elected to early adopt new guidance issued by the FASB in November 2015 (ASU 2015-17),which simplifies the presentation of deferred income taxes by eliminating the need for entities to separate deferred income tax liabilities and assets intocurrent and noncurrent amounts in a classified statement of financial position. The components of our deferred tax assets and liabilities were as follows (inthousands): December 31, 2016 2015Assets Net operating loss carryforwards$116,275 $172,944Tax credit carryforwards9,415 6,262Deferred revenue1,811 626Equity-based compensation expense8,045 5,464Capitalized research & development18,284 25,216Reserves8,018 8,900Contingent consideration4,140 1,258Other9,769 9,636Liabilities Property, plant and equipment depreciation(2,145) (2,844)Intangible assets and inventory(367,667) (400,357)Debt instruments(1,040) (1,213)Other(542) (3,178) (195,637) (177,286)Valuation allowance(1,429) (11,859)Net deferred tax liabilities$(197,066) $(189,145)The valuation allowance decreased by approximately $10.4 million for the year ended December 31, 2016, which was primarily attributable to the write-down of the acquired Lumara Health state NOLs. As a result of state tax planning during 2016, we analyzed the acquired state NOLs and determined that asignificant portion were not utilizable and should be written down. We have considered several sources of taxable income in making our valuation allowanceassessment, including taxable income in carryback years, future reversals of existing taxable temporary differences, tax planning strategies and forecastedfuture income. At December 31, 2016, the remaining valuation allowance related primarily to our federal capital loss carryforward and our state NOLcarryforwards acquired from Lumara Health.At December 31, 2016, we had federal and state NOL carryforwards of approximately $377.6 million and $122.0 million, respectively, of which $281.1million and $19.6 million federal and state NOL carryforwards, were acquired as part of the Lumara Health transaction, respectively. Also included in thestate NOL carryforwards at December 31, 2016 were $20.1135Table of Contentsmillion of state NOL carryforwards which were acquired as part of the CBR transaction. The state NOL carryforwards acquired from Lumara Health are subjectto a full valuation allowance as it is not more likely than not that they will be realized. We also had federal capital loss carryforwards of $1.5 million to offsetfuture capital gains. At December 31, 2016, $58.3 million and $33.2 million of federal and state NOLs, respectively, related to excess equity-basedcompensation tax deductions, the benefits for which will be recorded to additional paid-in capital when recognized through a reduction of cash taxes paid.The federal and state NOLs expire at various dates through 2036. The capital loss carryforwards will expire through 2021. We have federal tax credits ofapproximately $8.6 million to offset future tax liabilities of which $1.5 million were acquired as part of the Lumara Health transaction. We have state taxcredits of $1.2 million to offset future tax liabilities. These federal and state tax credits will expire periodically through 2036 if not utilized.Utilization of our NOLs and research and development (“R&D”) credit carryforwards may be subject to a substantial annual limitation due to ownershipchange limitations that have occurred previously or that could occur in the future in accordance with Section 382 of the Internal Revenue Code of 1986(“Section 382”) as well as similar state provisions. These ownership changes may limit the amount of NOL and R&D credit carryforwards that can be utilizedannually to offset future taxable income and taxes, respectively. In general, an ownership change as defined by Section 382 results from transactionsincreasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period. Since ourformation, we have raised capital through the issuance of capital stock on several occasions. These financings, combined with the purchasing shareholders’subsequent disposition of those shares, could result in a change of control, as defined by Section 382. We conducted an analysis under Section 382 todetermine if historical changes in ownership through December 31, 2016 would limit or otherwise restrict our ability to utilize these NOL and R&D creditcarryforwards. As a result of this analysis, we do not believe there are any significant limitations on our ability to utilize these carryforwards. The NOL's andtax credits acquired from Lumara health are subject to restrictions under Section 382. These restricted NOL's and credits may be utilized subject to an annuallimitation. While we identified two ownership changes associated with the attributes acquired as part of the Lumara Health transaction and determined theseattributes are subject to an annual limitation, we do not expect the limitations to result in expiration of these attributes prior to utilization. However, futurechanges in ownership after December 31, 2016 could affect the limitation in future years and any limitation may result in expiration of a portion of the NOLor R&D credit carryforwards before utilization.Unrecognized tax benefits represent uncertain tax positions for which reserves have been established. As of December 31, 2016, we had $13.3 million ofunrecognized tax benefits, of which $13.0 million would impact the effective tax rate, if recognized. As of December 31, 2015 we had $12.7 million ofunrecognized tax benefits, of which $12.4 million would impact the effective tax rate, if recognized. We had no uncertain tax benefits recorded as ofDecember 31, 2014.A reconciliation of our changes in uncertain tax positions is as follows (in thousands): Years Ended December 31, 2016 2015 2014Uncertain tax benefits at the beginning of the year$12,695 $— $—Additions based on tax positions related to the current year300 12,695 —Additions for tax positions from prior years379 — —Subtractions for tax positions from prior years(44) — —Uncertain tax benefits at the end of the year$13,330 $12,695 $—During the year ended December 31, 2016, our unrecognized tax benefits increased by $0.6 million due primarily to tax reserves established on R&Dtax credits.During the year ended December 31, 2015, we completed studies of our historical R&D tax credits and other tax attributes, including those acquired inconnection with the Lumara Health transaction. The increase in our unrecognized tax benefits is attributable to the results of these studies, which identifieduncertain tax benefits of $12.7 million related to federal and state R&D credits and NOL carryforwards. These amounts were recorded as a reduction to ourdeferred tax assets as of December 31, 2015. A valuation allowance was recorded against these attributes at December 31, 2014, therefore there was no impactto income tax expense as a result of recording the unrecognized tax benefits during the year ended December 31, 2015.We have recorded minimal interest or penalties on unrecognized benefits since inception. We recognize both accrued interest and penalties related tounrecognized benefits in income tax expense. We do not expect our uncertain tax benefits to change significantly in the next 12 months.The statute of limitations for assessment by the Internal Revenue Service (the “IRS”) and most state tax authorities is136Table of Contentsclosed for tax years prior to December 31, 2013, although carryforward attributes that were generated prior to tax year 2013 may still be adjusted uponexamination by the IRS or state tax authorities if they either have been or will be used in a future period. We file income tax returns in the U.S. federal andvarious state jurisdictions. There are currently no federal or state audits in progress.K. ACCUMULATED OTHER COMPREHENSIVE INCOME (LOSS)The table below presents information about the effects of net income (loss) of significant amounts reclassified out of accumulated other comprehensiveincome (loss), net of tax, associated with unrealized gains (losses) on securities during 2016 and 2015 (in thousands): December 31, 2016 2015Beginning balance$(4,205) $(3,617)Other comprehensive income (loss) before reclassifications261 (4)Reclassification adjustment for gains (losses) included in net income (loss)106 (584)Ending balance$(3,838) $(4,205) L. EQUITY-BASED COMPENSATIONWe currently maintain four equity compensation plans, namely our Third Amended and Restated 2007 Equity Incentive Plan, as amended (the “2007Plan”), our Amended and Restated 2000 Stock Plan (the “2000 Plan”), the Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan(the “Lumara Health 2013 Plan”) and our 2015 Employee Stock Purchase Plan (“2015 ESPP”). All outstanding stock options granted under each of ourequity compensation plans other than our 2015 ESPP (discussed below) have an exercise price equal to the closing price of a share of our common stock onthe grant date.Our 2007 Plan was originally approved by our stockholders in November 2007, and succeeded our 2000 Plan, under which no further grants may be made.Any shares that remained available for issuance under the 2000 Plan as of the date of adoption of the 2007 Plan are included in the number of shares that maybe issued under the 2007 Plan. Any shares subject to outstanding awards granted under the 2000 Plan that expire or terminate for any reason prior to exercisewill be added to the total number of shares of our stock available for issuance under the 2007 Plan. The total number of shares available for issuance underthe 2007 Plan is 6,995,325. As of December 31, 2016, there were 1,786,672 shares remaining available for issuance under the 2007 Plan, which excludesshares subject to outstanding awards under the 2000 Plan. All outstanding options under the 2007 Plan have either a seven or ten-year term and alloutstanding options under the 2000 Plan have a ten-year term.In November 2014, we assumed the Lumara Health 2013 Plan in connection with the acquisition of Lumara Health. The total number of shares issuablepursuant to awards under this plan as of the effective date of the acquisition and after taking into account any adjustments as a result of the acquisition, was200,000 shares. As of December 31, 2016, there were 9,710 shares remaining available for issuance under the Lumara Health 2013 Plan, which are availablefor grants to certain employees, officers, directors, consultants, and advisors of AMAG and our subsidiaries who are newly-hired or who previously performedservices for Lumara Health. All outstanding options under the Lumara Health 2013 Plan have a ten-year term.The 2007 Plan and the Lumara Health 2013 Plan provides for the grant of stock options, RSUs, restricted stock, stock, stock appreciation rights and otherequity interests in our company. We generally issue common stock from previously authorized but unissued shares to satisfy option exercises and restrictedstock awards. The terms and conditions of each award are determined by our Board of Directors (the “Board”) or the Compensation Committee of our Board.The terms and conditions of each award assumed in the acquisition of Lumara Health were previously determined by Lumara Health prior to being assumedin connection with the acquisition, subject to applicable adjustments made in connection with such acquisition.In May 2015, our stockholders approved our 2015 ESPP, which authorizes the issuance of up to 200,000 shares of our common stock to eligibleemployees. The terms of the 2015 ESPP permit eligible employees to purchase shares (subject to certain plan and tax limitations) in semi-annual offeringsthrough payroll deductions of up to an annual maximum of 10% of the employee’s “compensation” as defined in the 2015 ESPP. Shares are purchased at aprice equal to 85% of the fair market value of our common stock on either the first or last business day of the offering period, whichever is lower. Plan periodsconsist of six-month periods typically commencing June 1 and ending November 30 and commencing December 1 and ending May 31. As of December 31,2016, 79,324 shares have been issued under our 2015 ESPP.137Table of ContentsDuring 2016, we also granted equity through inducement grants outside of these plans to certain employees to induce them to accept employment withus (collectively, “Inducement Grants”). The options were granted at an exercise price equal to the fair market value of a share of our common stock on therespective grant dates and will be exercisable in four equal annual installments beginning on the first anniversary of the respective grant dates. The RSUgrants will vest in three equal annual installments beginning on the first anniversary of the respective grant dates. The foregoing grants were made pursuantto inducement grants outside of our stockholder approved equity plans as permitted under the NASDAQ Stock Market listing rules. We assessed the terms ofthese awards and determined there was no possibility that we would have to settle these awards in cash and therefore, equity accounting was applied.Stock OptionsThe following table summarizes stock option activity during 2016:2007 Equity 2000 Equity 2013 Lumara Inducement Plan Plan Equity Plan Grants TotalOutstanding at December 31, 20151,963,162 14,040 96,000 830,975 2,904,177Granted581,648 — 92,400 110,000 784,048Exercised(134,455) — — (21,250) (155,705)Expired or terminated(251,533) (8,840) (54,219) (104,750) (419,342)Outstanding at December 31, 20162,158,822 5,200 134,181 814,975 3,113,178 Restricted Stock UnitsThe following table summarizes RSU activity during 2016:2007 Equity 2000 Equity 2013 Lumara Inducement Plan Plan Equity Plan Grants TotalOutstanding at December 31, 2015446,330 — 52,350 155,675 654,355Granted659,618 — 1,500 64,500 725,618Vested(209,599) — (16,749) (74,219) (300,567)Expired or terminated(122,545) — (9,407) (10,500) (142,452)Outstanding at December 31, 2016773,804 — 27,694 135,456 936,954 Equity-based compensation expenseEquity-based compensation expense for 2016, 2015 and 2014 consisted of the following (in thousands): Years Ended December 31, 2016 2015 2014Cost of product sales and services$520 $371 $122Research and development3,476 2,992 1,596Selling, general and administrative18,547 13,874 6,907Total equity-based compensation expense$22,543 $17,237 $8,625Income tax effect(6,232) (4,885) —After-tax effect of equity-based compensation expense$16,311 $12,352 $8,625 We reduce the compensation expense being recognized to account for estimated forfeitures, which we estimate based primarily on historical experience,adjusted for unusual events such as corporate restructurings, which may result in higher than expected turnover and forfeitures. Under current accountingguidance, forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.As a result of our historical net losses, there was no income tax effect on our equity-based compensation expense for 2014.138Table of ContentsWe have not recognized any excess tax benefits from equity-based compensation in additional paid-in capital because the excess tax benefits have notyet reduced cash taxes paid. Accordingly, there was no impact recorded in cash flows from financing activities or cash flows from operating activities asreported in the accompanying consolidated statements of cash flows.The following table summarizes the weighted average assumptions we utilized for purposes of valuing grants of options to our employees and non-employee directors: Years Ended December 31, 2016 2015 2014 Non-Employee Non-Employee Non-Employee Employees Directors Employees Directors Employees DirectorsRisk free interest rate (%)1.32 1.10 1.55 1.24 1.56 1.28Expected volatility (%)49 54 47 46 47 46Expected option term (years)5.00 3.00 5.00 4.00 5.00 4.00Dividend yieldnone none none none none noneRisk free interest rates utilized are based upon published U.S. Treasury yields at the date of the grant for the expected option term. During 2016, 2015and 2014, we estimated our expected stock price volatility by using the historical volatility of our own common stock price over the prior period equivalentto our expected option term, in order to better reflect expected future volatility. To compute the expected option term, we analyze historical exerciseexperience as well as expected stock option exercise patterns.The following table summarizes details regarding stock options granted under our equity incentive plans for the year ended December 31, 2016: December 31, 2016 Options Weighted AverageExercise Price Weighted AverageRemainingContractual Term Aggregate IntrinsicValue ($ in thousands)Outstanding at beginning of year2,904,177 $34.97 — $—Granted784,048 24.59 — —Exercised(155,705) 17.99 — —Expired and/or forfeited(419,342) 44.10 — —Outstanding at end of year3,113,178 $31.97 7.4 $28,113Outstanding at end of year - vested and unvested expected to vest2,915,930 $31.53 7.4 $27,038Exercisable at end of year1,536,405 $27.92 6.3 $17,928The weighted average grant date fair value of stock options granted during 2016, 2015 and 2014 was $10.63, $23.57 and $10.63, respectively. A total of822,775 stock options vested during 2016. The aggregate intrinsic value of options exercised during 2016, 2015 and 2014, excluding purchases madepursuant to our employee stock purchase plans, measured as of the exercise date, was approximately $1.5 million, $31.2 million and $5.9 million,respectively. The intrinsic value of a stock option is the amount by which the fair market value of the underlying stock on a specific date exceeds the exerciseprice of the common stock option.139Table of ContentsThe following table summarizes details regarding RSUs granted under our equity incentive plans for the year ended December 31, 2016: December 31, 2016 Restricted Stock Units Weighted Average GrantDate Fair ValueOutstanding at beginning of year654,355 $36.90Granted725,618 22.28Vested(300,567) 30.38Forfeited(142,452) 26.66Outstanding at end of year936,954 $28.78Outstanding at end of year and expected to vest781,165 $28.79The weighted average grant date fair value of RSUs granted during 2016, 2015 and 2014 was $22.28, $52.71 and $22.88, respectively. The total fairvalue of RSUs that vested during 2016, 2015 and 2014 was $9.1 million, $3.5 million and $2.7 million, respectively.At December 31, 2016, the amount of unrecorded equity-based compensation expense for both option and RSU awards, net of forfeitures, attributable tofuture periods was approximately $37.7 million. Of this amount, $21.1 million was associated with stock options and is expected to be amortized on astraight-line basis to expense over a weighted average period of approximately 2.5 years, and $16.6 million was associated with RSUs and is expected to beamortized on a straight-line basis to expense over a weighted average period of approximately 1.8 years. Such amounts will be amortized primarily toresearch and development or selling, general and administrative expense. These future estimates are subject to change based upon a variety of future events,which include, but are not limited to, changes in estimated forfeiture rates, employee turnover, and the issuance of new stock options and other equity-basedawards.M. EMPLOYEE SAVINGS PLANWe provide a 401(k) Plan to our employees by which they may defer compensation for income tax purposes under Section 401(k) of the InternalRevenue Code. Each employee may elect to defer a percentage of his or her salary up to a specified maximum. Our 401(k) Plan provides, among other things,for a company contribution of 3% of each employee’s combined salary and certain other compensation for the plan year. Salary deferred by employees andcontributions by us to the 401(k) Plan are not taxable to employees until withdrawn from the 401(k) Plan and contributions are deductible by us when made.The amount of our company contribution for the 401(k) Plan was $1.9 million, $1.8 million and $0.8 million for 2016, 2015 and 2014, respectively.N. STOCKHOLDERS’ EQUITYPreferred StockOur certificate of incorporation authorizes our Board to issue preferred stock from time to time in one or more series. The rights, preferences, restrictions,qualifications and limitations of such stock are determined by our Board. In September 2009, our Board adopted a shareholder rights plan (the “RightsAgreement”).On February 11, 2014, in connection with the pricing of the Convertible Notes, we and American Stock Transfer & Trust Company, LLC (the “RightsAgent”) entered into an amendment (the “Convertible Notes Amendment”) to the Rights Agreement. The Convertible Notes Amendment, among otherthings, provides that, notwithstanding anything in the Rights Agreement to the contrary, each of JPMorgan Chase Bank, National Association, LondonBranch, Morgan Stanley & Co. International plc and Royal Bank of Canada (together the “Call Spread Counterparties”) shall be deemed not to beneficiallyown any common shares underlying, or synthetically owned pursuant to, any warrant held by such Call Spread Counterparty, any common shares held bysuch Call Spread Counterparty (or any affiliate thereof) to hedge its exposure with respect to the convertible bond hedges and warrants, any common sharesunderlying, or synthetically owned pursuant to, any Derivative Securities (as such term is defined in the Rights Agreement), including the Convertible Notes,held, or entered into, by such Call Spread Counterparty (or any affiliate thereof) to hedge its exposure with respect to the convertible bond hedges andwarrants or any Convertible Notes held by such Call Spread Counterparty (or any affiliate thereof) in its capacity as underwriter in the notes offering.140Table of ContentsOn September 26, 2014, we adopted another amendment to our Rights Agreement (which was approved by our stockholders at our 2015 annual meetingof stockholders) to help preserve our substantial tax assets associated with NOLs and other tax benefits by deterring certain stockholders from increasing theirpercentage ownership in our stock (the “NOL Amendment”). The NOL Amendment shortened the expiration date of the Rights Agreement from September17, 2019 to March 31, 2017, decreased the exercise price of the rights from $250.00 to $80.00 in connection therewith, and made changes to the definition of“beneficial ownership,” as used in the Rights Agreement, as amended, to make it consistent with how ownership is defined under Section 382 of the InternalRevenue Code of 1986, as amended. The original Rights Agreement provided for a dividend distribution of one preferred share purchase right (a “Right”) foreach outstanding share of our common stock, which dividend was paid on September 17, 2009. Rights will separate from the common stock and will becomeexercisable upon the earlier of (a) the close of business on the 10th calendar day following the first public announcement that a person or group of affiliatedor associated persons has acquired beneficial ownership of 4.99% or more (which percentage had been 20% before the NOL Amendment) of the outstandingshares of common stock, other than as a result of repurchases of stock by us or certain inadvertent actions by a stockholder or (b) the close of business on the10th business day (or such later day as the Board may determine) following the commencement of a tender offer or exchange offer that could result, upon itsconsummation, in a person or group becoming the beneficial owner of 4.99% or more (which percentage had been 20% before the NOL Amendment) of theoutstanding shares of common stock (the earlier of such dates being herein referred to as the “Distribution Date”).The NOL Amendment provides that the Rights are not exercisable until the Distribution Date and will expire at the earliest of: (a) March 31, 2017; (b)the time at which the Rights are redeemed or exchanged; (c) the effective date of the repeal of Section 382 or any successor statute if the Board determinesthat the NOL Rights Plan is no longer necessary or desirable for the preservation of our tax benefits; (d) the first day of our taxable year to which the Boarddetermines that no tax benefits may be carried forward; or (e) September 26, 2015 if stockholder approval of the NOL Amendment had not been obtained byor on such date.There can be no assurance that the NOL Amendment will result in us being able to preserve all or any of the substantial tax assets associated with NOLsand other tax benefits.Common Stock TransactionsIn August 2015, we sold approximately 3.6 million shares of our common stock at a public offering price of $63.75 per share, resulting in net proceeds tous of approximately $218.6 million.In March 2015, we sold approximately 4.6 million shares of our common stock at a public offering price of $44.00 per share, resulting in net proceeds tous of approximately $188.8 million.At our 2015 Annual Meeting, our stockholders approved a proposal to amend our Certificate of Incorporation, as amended and restated and thencurrently in effect, to increase the number of authorized shares of our common stock from 58,750,000 shares to 117,500,000 shares (which amendment wassubsequently filed with the Secretary of State of the State of Delaware).Share Repurchase ProgramIn January 2016, we announced that our board of directors authorized a program to repurchase up to $60.0 million in shares of our common stock. Therepurchase program does not have an expiration date and may be suspended for periods or discontinued at any time. Under the program, we may purchase ourstock from time to time at the discretion of management in the open market or in privately negotiated transactions. The number of shares repurchased and thetiming of the purchases will depend on a number of factors, including share price, trading volume and general market conditions, along with working capitalrequirements, general business conditions and other factors. We may also from time to time establish a trading plan under Rule 10b5-1 of the Securities andExchange Act of 1934 to facilitate purchases of our shares under this program. During 2016, we repurchased and retired 831,744 shares of common stockunder this repurchase program for $20.0 million, at an average purchase price of $24.05 per share. O. BUSINESS SEGMENTSWe have determined that we conduct our operations in one business segment: the manufacture, development and commercialization of products andservices for use in treating various conditions, with a focus on women’s health, anemia management and cancer supportive care. Long-lived assets consistentirely of property, plant and equipment and are located in the U.S. for all periods presented.141Table of ContentsP. COMMITMENTS AND CONTINGENCIESCommitmentsOur long-term contractual obligations include commitments and estimated purchase obligations entered into in the normal course of business. Theseinclude commitments related to our facility leases, purchases of inventory and other purchases related to our products, debt obligations, and other purchaseobligations.Facility Lease ObligationsIn June 2013, we entered into a lease agreement with BP Bay Colony LLC (the “Landlord”) for the lease of certain real property located at 1100 WinterStreet, Waltham, Massachusetts (the “Waltham Premises”) for use as our principal executive offices. Beginning in September 2013, the initial term of thelease is five years and two months with one five-year extension term at our option. During 2015, we entered into several amendments to the original lease toadd additional space and to extend the term of the original lease to June 2021. In addition to base rent, we are also required to pay a proportionate share ofthe Landlord’s operating costs.The Landlord agreed to pay for certain agreed-upon improvements to the Waltham Premises and we agreed to pay for any increased costs due to changesby us to the agreed-upon plans. We record all tenant improvements paid by us as leasehold improvements and amortize these improvements over the shorterof the estimated useful life of the improvement or the remaining life of the initial lease term. Amortization of leasehold improvements is included indepreciation expense.In addition, in connection with our facility lease for the Waltham Premises, in June 2013 we delivered to the Landlord a security deposit of $0.4 millionin the form of an irrevocable letter of credit. This security deposit was increased to $0.6 million in 2015. The cash securing this letter of credit is classified onour balance sheet as of December 31, 2016 and 2015 as a long-term asset and is restricted in its use.We lease certain real property located at 1200 Bayhill Drive, San Bruno, California. The lease expires in September 2017.Facility-related rent expense, net of deferred rent amortization, for all the leased properties was $2.8 million, $1.5 million and $0.8 million for 2016,2015 and 2014, respectively.Future minimum payments under our non-cancelable facility-related leases as of December 31, 2016 are as follows (in thousands):Period Future Minimum LeasePaymentsYear Ending December 31, 2017 $2,925Year Ending December 31, 2018 2,123Year Ending December 31, 2019 2,258Year Ending December 31, 2020 2,330Year Ending December 31, 2021 1,165Total $10,801Purchase CommitmentsIn connection with our acquisition of CBR, we have certain minimum purchase commitments associated with an agreement entered into by CBR prior toour acquisition. This agreement expires in December 2018, with the remaining amount of minimum purchase commitments totaling $5.3 million as ofDecember 31, 2016.Contingent Consideration Related to Business CombinationsIn connection with our acquisition of Lumara Health in November 2014, we agreed to pay up to an additional $350.0 million, of which $100.0 millionwas paid in 2016, based on the achievement of certain sales milestones. Due to the contingent nature of these milestone payments, we cannot predict theamount or timing of such payments with certainty. See Note C, “Business Combinations,” for more information on the Lumara Health acquisition and relatedmilestone payments.142Table of ContentsContingent Regulatory and Commercial Milestone PaymentsIn July 2015, we entered into an option agreement with Velo Bio, LLC, a privately-held life-sciences company (“Velo”) that granted us an option toacquire the global rights (the “DIF Rights”) to an orphan drug candidate, digoxin immune fab (“DIF”), a poly clonal antibody in clinical development for thetreatment of severe preeclampsia in pregnant woman. If we exercise the option to acquire the DIF Rights, we will be responsible for payments totaling up to$65.0 million (including the payment of the option exercise price and the regulatory milestone payments) and up to an additional $250.0 million in salesmilestone payments based on the achievement of annual sales milestones at targets ranging from $100.0 million to $900.0 million. See Note Q,“Collaboration, License and Other Strategic Agreements,” for more information on the Velo option. We anticipate Velo will begin its Phase 2b/3a clinicalstudy in the first quarter of 2017, and as such no contingencies related to this agreement have been recorded in our consolidated financial statements as ofDecember 31, 2016.In connection with a development and license agreement (the “Antares Agreement”) with Antares Pharma, Inc. (“Antares”), we are required to payroyalties to Antares on net sales of the auto-injection system for use with hydroxyprogesterone caproate (the “Makena auto-injector”) commencing on thelaunch of the Makena auto-injector in a particular country until the Makena auto-injector is no longer sold or offered for sale in such country (the “AntaresRoyalty Term”). The royalty rates range from high single digit to low double digits and are tiered based on levels of net sales of the Makena auto-injector anddecrease after the expiration of licensed patents or where there are generic equivalents to the Makena auto-injector being sold in a particular country. Weexpect to file an sNDA for approval of the Makena auto-injector in the second quarter of 2017.Other Funding CommitmentsAs of December 31, 2016, we had several ongoing clinical studies in various clinical trial stages. Our most significant clinical trial expenditures were toclinical research organizations (“CROs”). The contracts with CROs are generally cancellable, with notice, at our option. We have recorded accrued expensesin our consolidated balance sheet of approximately $10.6 million representing expenses incurred with these organizations as of December 31, 2016, net ofany amounts prepaid to these CROs.Severance ArrangementsWe have entered into employment agreements or other arrangements with most of our executive officers and certain other employees, which provide forthe continuation of salary and certain benefits and, in certain instances, the acceleration of the vesting of certain equity awards to such individuals in theevent that the individual is terminated other than for cause, as defined in the applicable employment agreements or arrangements.Indemnification ObligationsAs permitted under Delaware law, pursuant to our certificate of incorporation, by-laws and agreements with all of our current directors, executive officers,and certain of our employees, we are obligated to indemnify such individuals for certain events or occurrences while the officer, director or employee is, orwas, serving at our request in such capacity. The maximum potential amount of future payments we could be required to make under these indemnificationobligations is not capped. Our director and officer insurance policy limits our initial exposure to $1.5 million and our policy provides significant coverage.As a result, we believe the estimated fair value of these indemnification obligations is likely to be immaterial.We are also a party to a number of other agreements entered into in the ordinary course of business, which contain typical provisions and which obligateus to indemnify the other parties to such agreements upon the occurrence of certain events. Such indemnification obligations are usually in effect from thedate of execution of the applicable agreement for a period equal to the applicable statute of limitations. Our aggregate maximum potential future liabilityunder such indemnification provisions is uncertain. Except for expenses we incurred related to the Silverstrand class action lawsuit, which was settled in2015, we have not incurred any expenses as a result of such indemnification provisions. Accordingly, we have determined that the estimated aggregate fairvalue of our potential liabilities under such indemnification provisions is not significant, and we have not recorded any liability related to suchindemnification.143Table of ContentsContingenciesLegal ProceedingsWe accrue a liability for legal contingencies when we believe that it is both probable that a liability has been incurred and that we can reasonablyestimate the amount of the loss. We review these accruals and adjust them to reflect ongoing negotiations, settlements, rulings, advice of legal counsel andother relevant information. To the extent new information is obtained and our views on the probable outcomes of claims, suits, assessments, investigations orlegal proceedings change, changes in our accrued liabilities would be recorded in the period in which such determination is made. For certain mattersreferenced below, the liability is not probable or the amount cannot be reasonably estimated and, therefore, accruals have not been made. In addition, inaccordance with the relevant authoritative guidance, for any matters in which the likelihood of material loss is at least reasonably possible, we will providedisclosure of the possible loss or range of loss. If a reasonable estimate cannot be made, however, we will provide disclosure to that effect. We expense legalcosts as they are incurred.Sandoz Patent Infringement LawsuitOn February 5, 2016, we received a Paragraph IV certification notice letter regarding an Abbreviated New Drug Application submitted to the FDA bySandoz Inc. (“Sandoz”) requesting approval to engage in commercial manufacture, use and sale of a generic version of ferumoxytol. A generic version ofFeraheme can be marketed only with the approval of the FDA of the respective application for such generic version. The Drug Price Competition and PatentTerm Restoration Act of 1984, as amended, (the “Hatch-Waxman Act”), requires an ANDA applicant whose proposed drug is a generic version of apreviously-approved drug listed in the FDA publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” also known as the “OrangeBook,” to certify to any patents listed in the Orange Book for the previously-approved drug and, in the case of a Paragraph IV certification, to notify theowner of the approved application and the relevant patent-holder. The Paragraph IV certification notice is required to contain a detailed factual and legalstatement explaining the basis for the applicant’s opinion that the proposed product does not infringe the subject patents, that such patents are invalid orunenforceable, or both. If a patent infringement suit is filed within 45 days of receipt of the Paragraph IV notice, a so-called 30-month stay is triggered thatgenerally prevents the FDA from approving the ANDA until the expiration of the 30-month stay period, conclusion of the litigation in the generic applicant’sfavor, or expiration of the patent, whichever is earlier. In its notice letter, Sandoz claims that our ferumoxytol patents are invalid, unenforceable and/or notinfringed by Sandoz’s manufacture, use, sale or offer for sale of the generic version. In March 2016, we initiated a patent infringement suit alleging thatSandoz’ ANDA filing itself constituted an act of infringement and that if it is approved, the manufacture, use, offer for sale, sale or importation of Sandoz’ferumoxytol products would infringe our patents. By the filing of this complaint, we believe 30 month stay was triggered and that the FDA is prohibited fromgranting approval of Sandoz’ application until the earliest of 30 months from the date of receipt of the notice of certification by the patent owner, theconclusion of litigation in the generic’s favor, or expiration of the patent(s). If the litigation is resolved in favor of the applicant or the challenged patentexpires during the 30 months stay period, the stay is lifted and the FDA may thereafter approve the application based on the applicable standards forapproval. On May 2, 2016, Sandoz filed a response to our patent infringement suit and the trial is scheduled for March 12, 2018. Any future unfavorableoutcome in this matter could negatively affect the magnitude and timing of future Feraheme revenues. We intend to vigorously enforce our intellectualproperty rights relating to ferumoxytol.OtherOn July 20, 2015, the Federal Trade Commission (the “FTC”) notified us that it is conducting an investigation into whether Lumara Health or itspredecessor engaged in unfair methods of competition with respect to Makena or any hydroxyprogesterone caproate product. We have fully cooperated withthe FTC and provided a thorough response to the FTC in August 2015 and are awaiting their review of our response. The FTC noted in its letter that theexistence of the investigation does not indicate that the FTC has concluded that Lumara Health or its predecessor has violated the law and we believe thatour contracts and practices comply with relevant law and policy, including the federal Drug Quality and Security Act (the “DQSA”), which was enacted inNovember 2013, and public statements from and enforcement actions by the FDA regarding its implementation of the DQSA. We have provided the FTC witha response that provides a brief overview of the DQSA for context, which we believe will be helpful, including: (a) how the statute outlined that large-scalecompounding of products that are copies or near-copies of FDA-approved drugs (like Makena) is not in the interests of public safety; (b) our belief that theDQSA has had a significant impact on the compounding of hydroxyprogesterone caproate; and (c) how our contracts with former compounders allow thosecompounders to continue to serve physicians and patients with respect to supplying medically necessary alternative/altered forms of hydroxyprogesteronecaproate.On or about April 6, 2016, we received Notice of a Lawsuit and Request to Waive Service of a Summons in a case entitled Plumbers’ Local Union No.690 Health Plan v. Actavis Group et. al. (“Plumbers’ Union”), which was filed in the Court of Common Pleas of Philadelphia County, First Judicial District ofPennsylvania and, after removal to federal court, is now144Table of Contentspending in the United States District Court for the Eastern District of Pennsylvania (Civ. Action No. 16-65-AB). Thereafter, we were also made aware of arelated complaint entitled Delaware Valley Health Care Coalition v. Actavis Group et. al. (“Delaware Valley”), which was filed with the Court of CommonPleas of Philadelphia County, First Judicial District of Pennsylvania District Court of Pennsylvania (Case ID: 160200806). The complaints name K-VPharmaceutical Company (“KV”) (Lumara Health’s predecessor company), certain of its successor entities, subsidiaries and affiliate entities (the“Subsidiaries”), along with a number of other pharmaceutical companies. We acquired Lumara Health in November 2014, a year after KV emerged frombankruptcy protection, at which time it, along with its then existing subsidiaries, became our wholly-owned subsidiary. We have not been served withprocess or waived service of summons in either case. The actions are being brought alleging unfair and deceptive trade practices with regard to certain pricingpractices that allegedly resulted in certain payers overpaying for certain of KV’s generic products. On July 21, 2016, the Plaintiff in the Plumbers’ Union casedismissed KV with prejudice to refiling and on October 6, 2016, all claims against the Subsidiaries were dismissed without prejudice. We are in discussionswith Plaintiff’s counsel to similarly dismiss all claims in the Delaware Valley case. Because the Delaware Valley case is in the earliest stages and we have notbeen served with process in this case, we are currently unable to predict the outcome or reasonably estimate the range of potential loss associated with thismatter, if any.We may periodically become subject to other legal proceedings and claims arising in connection with ongoing business activities, including claims ordisputes related to patents that have been issued or that are pending in the field of research on which we are focused. Other than the above actions, we are notaware of any material claims against us as of December 31, 2016. Q. COLLABORATION, LICENSE AND OTHER STRATEGIC AGREEMENTSOur commercial strategy includes expanding our portfolio through the in-license or acquisition of additional pharmaceutical products or companies,including revenue-generating commercial products and late-state development assets. As of December 31, 2016, we were a party to the followingcollaborations:VeloUnder our option agreement with Velo, we made an upfront payment of $10.0 million in the third quarter of 2015 for the option to acquire the DIFRights. DIF has been granted both orphan drug and fast-track review designations by the FDA for use in treating severe preeclampsia. Under the optionagreement, Velo will complete a Phase 2b/3a clinical study, which we expect to begin in the first quarter of 2017. Following the conclusion of the DIF Phase2b/3a study, we may terminate, or, for additional consideration, exercise or extend, our option to acquire the DIF Rights. If we exercise the option to acquirethe DIF Rights, we would be responsible for additional costs in pursuing FDA approval, and would be obligated to pay to Velo certain milestone paymentsand single-digit royalties based on regulatory approval and commercial sales of the product. If we exercise the option, we will be responsible for paymentstotaling up to $65.0 million (including the payment of the option exercise price and the regulatory milestone payments) and up to an additional $250.0million in sales milestone payments based on the achievement of annual sales milestones at targets ranging from $100.0 million to $900.0 million. We have determined that Velo is a variable interest entity (“VIE”) as it does not have enough equity to finance its activities without additional financialsupport. As we do not have the power to direct the activities of the VIE that most significantly affect its economic performance, which we have determined tobe the Phase 2b/3a clinical study, we are not the primary beneficiary of and do not consolidate the VIE.145Table of ContentsAntaresIn September 2014, Lumara Health entered into the Antares Agreement with Antares, which in connection with our acquisition of Lumara Health inNovember of 2014, grants us an exclusive, worldwide, royalty-bearing license, with the right to sublicense, to certain intellectual property rights, includingknow-how, patents and trademarks, to develop, use, sell, offer for sale and import and export the Makena auto-injector. In consideration for the license, tosupport joint meetings and a development strategy with the FDA, and for initial tooling and process validation, Lumara Health paid Antares an up-frontpayment in October 2014. Under the Antares Agreement, we are responsible for the clinical development and preparation, submission and maintenance of allregulatory applications in each country where we desire to market and sell the Makena auto-injector, including the U.S. We are required to pay royalties toAntares on net sales of the Makena auto-injector for the life of the Antares Royalty Term. The royalty rates range from high single digit to low double digitsand are tiered based on levels of net sales of the Makena auto-injector and decrease after the expiration of licensed patents or where there are genericequivalents to the Makena auto-injector being sold in a particular country. Antares is the exclusive supplier of the device components of the Makena auto-injector and Antares remains responsible for the manufacture and supply of the device components and assembly of the Makena auto-injector. We areresponsible for the supply of the drug to be used in the assembly of the finished auto-injector product. The development and license agreement terminates atthe end of the Antares Royalty Term, but is subject to early termination by us for convenience, by Antares if we do not submit regulatory filings in the U.S. bya certain date and by either party upon an uncured breach by or bankruptcy of the other party.AbeonaIn June 2013, we entered into the MuGard License Agreement under which Abeona granted us an exclusive, royalty-bearing license, with the right togrant sublicenses, to certain intellectual property rights, including know-how, patents and trademarks, to use, import, offer for sale, sell, manufacture andcommercialize MuGard in the U.S. and its territories (the “MuGard Territory”) for the management of oral mucositis/stomatitis (that may be caused byradiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including certain ulcers/canker sores and traumatic ulcers, such asthose caused by oral surgery or ill-fitting dentures or braces.In consideration for the license, we paid Abeona an upfront license fee of $3.3 million in June 2013. We are required to pay royalties to Abeona on netsales of MuGard until the later of (a) the expiration of the licensed patents or (b) the tenth anniversary of the first commercial sale of MuGard in the MuGardTerritory (the “MuGard Royalty Term”). These tiered, double-digit royalty rates decrease after the expiration of the licensed patents and are subject to off-setagainst certain of our expenses. After the expiration of the MuGard Royalty Term, the license shall become a fully paid-up, royalty-free and perpetual licensein the MuGard Territory.Abeona remains responsible for the manufacture of MuGard and we have entered into a quality agreement and a supply agreement under which wepurchase MuGard inventory from them. Our inventory purchases are at the price actually paid by Abeona to purchase it from a third-party plus a mark-up tocover administration, handling and overhead.Abeona is responsible for maintenance of the licensed patents at its own expense, and we retain the first right to enforce any licensed patent against third-party infringement. The MuGard License Agreement terminates at the end of the MuGard Royalty Term, but is subject to early termination by us forconvenience and by either party upon an uncured breach by or bankruptcy of the other party.R. DEBTOur outstanding debt obligations as of December 31, 2016 and December 31, 2015 consisted of the following (in thousands): December 31, 2016 20152023 Senior Notes$489,612 $488,4812015 Term Loan Facility317,546 332,6882.5% Convertible Notes179,363 170,749Total long-term debt986,521 991,918Less: current maturities21,166 17,500Long-term debt, net of current maturities$965,355 $974,418 146Table of Contents2023 Senior NotesOn August 17, 2015, in connection with the CBR acquisition, we completed a private placement of $500 million aggregate principal amount of 7.875%Senior Notes due 2023 (the “2023 Senior Notes”). The 2023 Senior Notes were issued pursuant to an Indenture, dated as of August 17, 2015 (the“Indenture”), by and among us, certain of our subsidiaries acting as guarantors of the 2023 Senior Notes and Wilmington Trust, National Association, astrustee. The Indenture contains certain customary negative covenants, which are subject to a number of limitations and exceptions. Certain of the covenantswill be suspended during any period in which the 2023 Senior Notes receive investment grade ratings.The 2023 Senior Notes, which are senior unsecured obligations of the Company, will mature on September 1, 2023 and bear interest at a rate of 7.875%per year, with interest payable semi-annually on September 1 and March 1 of each year (which began in March 2016). We may redeem some or all of the 2023Senior Notes at any time, or from time to time, on or after September 1, 2018 at the redemption prices listed in the Indenture, plus accrued and unpaid interestto, but not including, the date of redemption. In addition, prior to September 1, 2018, we may redeem up to 35% of the aggregate principal amount of the2023 Senior Notes utilizing the net cash proceeds from certain equity offerings, at a redemption price of 107.875% of the principal amount thereof, plusaccrued and unpaid interest to, but not including, the date of redemption; provided that at least 65% of the aggregate amount of the 2023 Senior Notesoriginally issued under the Indenture remain outstanding after such redemption. We may also redeem all or some of the 2023 Senior Notes at any time, orfrom time to time, prior to September 1, 2018, at a price equal to 100% of the principal amount of the 2023 Senior Notes to be redeemed, plus a “make-whole” premium plus accrued and unpaid interest, if any, to the date of redemption. Upon the occurrence of a “change of control,” as defined in theIndenture, we are required to offer to repurchase the 2023 Senior Notes at 101% of the aggregate principal amount thereof, plus any accrued and unpaidinterest to, but not including, the repurchase date. The Indenture contains customary events of default, which allow either the trustee or the holders of not lessthan 25% in aggregate principal amount of the then-outstanding 2023 Senior Notes to accelerate, or in certain cases, which automatically cause theacceleration of, the amounts due under the 2023 Senior Notes.At December 31, 2016, the principal amount of the outstanding borrowings was $500.0 million and the carrying value of the outstanding borrowings, netof issuance costs and other lender fees and expenses, was $489.6 million.2015 Term Loan FacilityOn August 17, 2015, to fund a portion of the purchase price of CBR, we entered into a credit agreement with a group of lenders, including JefferiesFinance LLC as administrative and collateral agent, that provided us with, among other things, a six-year $350.0 million term loan facility. We borrowed thefull $350.0 million available under the 2015 Term Loan Facility on August 17, 2015. The credit agreement also allows for the incurrence of incrementalloans in an amount up to $225.0 million. The unamortized original issue costs and other lender fees and expenses, including a prepayment penalty, included$6.8 million of the unamortized original issue costs and other lender fees and expenses from our then existing five-year term loan facility as a result ofaccounting guidance for the modification of debt arrangements.The 2015 Term Loan Facility bears interest, at our option, at the London Interbank Offered Rate (“LIBOR”) plus a margin of 3.75% or the prime rate plusa margin of 2.75%. The LIBOR is subject to a 1.00% floor and the prime rate is subject to a 2.00% floor. As of December 31, 2016, the stated interest rate,based on the LIBOR, was 4.75%, and the effective interest rate was 5.65%.We must repay the 2015 Term Loan Facility in installments of $4.4 million per quarter due on the last day of each quarter beginning with the quarterended December 31, 2015. The 2015 Term Loan Facility matures on August 17, 2021.The 2015 Term Loan Facility includes an annual mandatory prepayment of the debt in an amount equal to 50% of our excess cash flow (as defined in the2015 Term Loan Facility) as measured on an annual basis, beginning with the year ending December 31, 2016. As a result, as of December 31, 2016, $3.7million was estimated and reclassified from long-term debt to current portion of long-term debt in our consolidated balance sheet as the first excess paymentis expected to be made in April 2017. On or after December 31, 2016, the applicable excess cash flow percentage shall be reduced based on the total netleverage ratio as of the last day of the period. Excess cash flow is generally defined as our adjusted Earnings Before Interest, Taxes, Depreciation andAmortization (“EBITDA”) less debt service costs, unfinanced capital expenditures, unfinanced acquisition expenditures, contingent consideration paid, andcurrent income taxes as well as other adjustments specified in the credit agreement.The 2015 Term Loan Facility has a lien on substantially all of our assets, including a pledge of 100% of the equity interests in our domestic subsidiariesand a pledge of 65% of the voting equity interests and 100% of the non-voting equity interests in our direct foreign subsidiaries. The 2015 Term LoanFacility contains customary events of default and affirmative and negative covenants for transactions of this type. All obligations under the 2015 Term LoanFacility are unconditionally guaranteed by147Table of Contentssubstantially all of our direct and indirect domestic subsidiaries, with certain exceptions. These guarantees are secured by substantially all of the present andfuture property and assets of such subsidiaries, with certain exclusions.At December 31, 2016, the principal amount of the outstanding borrowings was $328.1 million and the carrying value of the outstanding borrowings, netof issuance costs and other lender fees and expenses, was $317.5 million.2.5% Convertible NotesOn February 14, 2014, we issued $200.0 million aggregate principal amount of the Convertible Notes. We received net proceeds of $193.3 million fromthe sale of the Convertible Notes, after deducting fees and expenses of $6.7 million. We used $14.1 million of the net proceeds from the sale of theConvertible Notes to pay the cost of the convertible bond hedges, as described below (after such cost was partially offset by the proceeds to us from the saleof warrants in the warrant transactions described below).The Convertible Notes are governed by the terms of an indenture between us, as issuer, and Wilmington Trust, National Association, as the trustee. TheConvertible Notes are senior unsecured obligations and bear interest at a rate of 2.5% per year, payable semi-annually in arrears on February 15 and August15 of each year. The Convertible Notes will mature on February 15, 2019, unless earlier repurchased or converted. Upon conversion of the Convertible Notes,at a holder’s election, such Convertible Notes will be convertible into cash, shares of our common stock, or a combination thereof, at our election (subject tocertain limitations in the 2015 Term Loan Facility), at a conversion rate of approximately 36.9079 shares of common stock per $1,000 principal amount ofthe Convertible Notes, which corresponds to an initial conversion price of approximately $27.09 per share of our common stock.The conversion rate is subject to adjustment from time to time upon the occurrence of certain events, including, but not limited to, the issuance of stockdividends and payment of cash dividends. At any time prior to the close of business on the business day immediately preceding May 15, 2018, holders mayconvert their Convertible Notes at their option only under the following circumstances:1)during any calendar quarter (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days(whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendarquarter is greater than or equal to 130% of the conversion price on each applicable trading day;2)during the five business day period after any five consecutive trading day period (the “measurement period”) in which the trading price per $1,000principal amount of the Convertible Notes for each trading day of the measurement period was less than 98% of the product of the last reported saleprice of our common stock and the conversion rate on each such trading day; or3)upon the occurrence of specified corporate event.On or after May 15, 2018 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convertall or any portion of their Convertible Notes, in multiples of $1,000 principal amount, at the option of the holder regardless of the foregoing circumstances.Based on the last reported sale price of our common stock during the last 30 trading days of 2016, the Convertible Notes were not convertible as ofDecember 31, 2016.In accordance with accounting guidance for debt with conversion and other options, we separately account for the liability and equity components of theConvertible Notes by allocating the proceeds between the liability component and the embedded conversion option (“equity component”) due to our abilityto settle the Convertible Notes in cash, common stock or a combination of cash and common stock, at our option (subject to certain limitations in the 2015Term Loan Facility). The carrying amount of the liability component was calculated by measuring the fair value of a similar liability that does not have anassociated convertible feature. The allocation was performed in a manner that reflected our non-convertible debt borrowing rate for similar debt. The equitycomponent of the Convertible Notes was recognized as a debt discount and represents the difference between the proceeds from the issuance of theConvertible Notes and the fair value of the liability of the Convertible Notes on their respective dates of issuance. The excess of the principal amount of theliability component over its carrying amount (“debt discount”) is amortized to interest expense using the effective interest method over five years. The equitycomponent is not remeasured as long as it continues to meet the conditions for equity classification.Our outstanding Convertible Note balances as of December 31, 2016 consisted of the following (in thousands):148Table of Contents December 31, 2016Liability component: Principal$199,998Less: debt discount and issuance costs, net(20,635)Net carrying amount$179,363 In connection with the issuance of the Convertible Notes, we incurred approximately $6.7 million of debt issuance costs, which primarily consisted ofunderwriting, legal and other professional fees, and allocated these costs to the liability and equity components based on the allocation of the proceeds. Ofthe total $6.7 million of debt issuance costs, $1.3 million was allocated to the equity component and recorded as a reduction to additional paid-in capital and$5.4 million was allocated to the liability component and is now recorded as a reduction of the Convertible Notes in our consolidated balance sheets. Theportion allocated to the liability component is amortized to interest expense using the effective interest method over five years.We determined 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 7.23% for the period from the date of issuance through December 31, 2016. As of December 31, 2016, the “if-converted value” did notexceed the remaining principal amount of the Convertible Notes.The following table sets forth total interest expense recognized related to the Convertible Notes during 2016, 2015 and 2014 (in thousands): Years Ended December 31,2016 2015 2014Contractual interest expense$5,000 $5,000 $4,375Amortization of debt issuance costs1,072 985 800Amortization of debt discount7,544 6,927 5,629Total interest expense$13,616 $12,912 $10,804As of December 31, 2016, the principal amount of the Convertible Notes was $200.0 million and the carrying value of the Convertible Notes was $179.4million.Convertible Bond Hedge and Warrant TransactionsIn connection with the pricing of the Convertible Notes and in order to reduce the potential dilution to our common stock and/or offset cash paymentsdue upon conversion of the Convertible Notes, in February 2014 we entered into convertible bond hedge transactions covering approximately 7.4 millionshares of our common stock underlying the $200.0 million aggregate principal amount of the Convertible Notes with the call spread counterparties. Theconvertible bond hedges have an exercise price of approximately $27.09 per share, subject to adjustment upon certain events, and are exercisable when and ifthe Convertible Notes are converted. If upon conversion of the Convertible Notes, the price of our common stock is above the exercise price of theconvertible bond hedges, the call spread counterparties will deliver shares of our common stock and/or cash with an aggregate value approximately equal tothe difference between the price of our common stock at the conversion date and the exercise price, multiplied by the number of shares of our common stockrelated to the convertible bond hedges being exercised. The convertible bond hedges are separate transactions entered into by us and are not part of the termsof the Convertible Notes or the warrants, discussed below. Holders of the Convertible Notes will not have any rights with respect to the convertible bondhedges. We paid $39.8 million for these convertible bond hedges and recorded this amount as a reduction to additional paid-in capital, net of tax, in 2014.In February 2014, we also entered into separate warrant transactions with each of the call spread counterparties relating to, in the aggregate,approximately 7.4 million shares of our common stock underlying the $200.0 million aggregate principal amount of the Convertible Notes. The initialexercise price of the warrants is $34.12 per share, subject to adjustment upon certain events, which is 70% above the last reported sale price of our commonstock of $20.07 on February 11, 2014. The warrants would separately have a dilutive effect to the extent that the market value per share of our common stock,as measured under the terms of the warrants, exceeds the applicable exercise price of the warrants. The warrants were issued to the call spread counterpartiespursuant to the exemption from registration set forth in Section 4(a)(2) of the Securities Act of 1933, as amended. We received $25.6 million for thesewarrants and recorded this amount to additional paid-in capital in 2014.Aside from the initial payment of $39.8 million to the call spread counterparties for the convertible bond hedges, which was partially offset by thereceipt of $25.6 million for the warrants, we are not required to make any cash payments to the call spread counterparties under the convertible bond hedgesand will not receive any proceeds if the warrants are exercised.149Table of ContentsFuture PaymentsFuture annual principal payments on our long-term debt as of December 31, 2016 were as follows (in thousands):Period Future AnnualPrincipal PaymentsYear Ending December 31, 2017 $21,166Year Ending December 31, 2018 17,500Year Ending December 31, 2019 217,498Year Ending December 31, 2020 17,500Year Ending December 31, 2021 254,459Thereafter 500,000Total $1,028,123S. RESTRUCTURINGIn connection with the CBR and Lumara Health acquisitions, we initiated restructuring programs in the third quarter of 2015 and the fourth quarter of2014, respectively, which included severance benefit expenses primarily related to certain former CBR and Lumara Health employees. As a result of theserestructurings, we recorded $0.7 million charges in 2016 as compared to $4.1 million in 2015. We expect to pay the remaining restructuring costs by the endof the first quarter of 2017.The following table outlines the components of our restructuring expenses which were included in current liabilities for 2016 and 2015 (in thousands): Years Ended December 31, 2016 2015Accrued restructuring, beginning of period$2,883 $1,953Employee severance, benefits and related costs715 3,874Payments(3,524) (2,944)Accrued restructuring, end of period$74 $2,883150Table of ContentsT. CONSOLIDATED QUARTERLY FINANCIAL DATA - UNAUDITEDThe following tables provide unaudited consolidated quarterly financial data for 2016 and 2015 (in thousands, except per share data): March 31, 2016 June 30, 2016 September 30, 2016 December 31, 2016Total revenues$109,300 $127,419 $143,782 $151,591Gross profit (a)85,474 84,563 113,092 116,349Operating expenses78,026 66,486 74,332 101,764Net income (loss)$(7,527) $(596) $16,196 $(10,557)Net income (loss) per share - basic$(0.22) $(0.02) $0.47 $(0.31)Net income (loss) per share - diluted$(0.22) $(0.02) $0.43 $(0.31) March 31, 2015 June 30, 2015 September 30, 2015 December 31, 2015Total revenues (b)$89,505 $123,884 $96,152 $108,735Gross profit (b)68,479 104,205 73,803 83,288Operating expenses (b)39,671 43,081 75,188 60,615Net income (loss) (c)$12,904 $33,258 $(20,584) $7,201Net income (loss) per share - basic$0.47 $1.09 $(0.62) $0.21Net income (loss) per share - diluted$0.39 $0.82 $(0.62) $0.20The sum of quarterly income (loss) per share totals differ from annual income (loss) per share totals due to rounding.(a)Gross profit for the second quarter of 2016 includes the impairment charge of $15.7 million relating to the MuGard Rights intangible asset.(b) In August 2015, we acquired CBR and recorded $24.1 million and $10.0 million in CBR service revenue and cost of services, respectively, in 2015and additional operating costs incurred as a result of the acquisition.(c) In August 2015, we repaid the remaining $323.0 million outstanding principal amount and recognized a $10.4 million loss on debt extinguishmentas a result of the early repayment, which we recorded in other income (expense) in our 2015 consolidated statements of operations.U. VALUATION AND QUALIFYING ACCOUNTS (IN THOUSANDS) Balance at Beginningof Period Additions (a) Deductions Chargedto Reserves Balance at End ofPeriodYear ended December 31, 2016: Allowance for doubtful accounts (a)$900 $3,209 $(948) $3,161Accounts receivable allowances (b)$10,783 $122,792 $(124,042) $9,533Rebates, fees and returns reserves$45,162 $186,941 $(142,637) $89,466Valuation allowance for deferred tax assets (c)$11,859 $632 $(11,062) $1,429Year ended December 31, 2015: Allowance for doubtful accounts (a)$— $900 $— $900Accounts receivable allowances (b)$11,618 $93,887 $(94,722) $10,783Rebates, fees and returns reserves$43,892 $120,293 $(119,023) $45,162Valuation allowance for deferred tax assets (c)$33,557 $— $(21,698) $11,859Year ended December 31, 2014: Accounts receivable allowances (b)$2,728 $60,054 $(51,164) $11,618Rebates, fees and returns reserves$4,819 $52,548 $(13,475) $43,892Valuation allowance for deferred tax assets (c)$166,416 $20,299 $(153,158) $33,557151Table of Contents(a)Additions to allowance for doubtful accounts are recorded in selling, general and administrative expenses. Additions to rebates, fees and returnsreserves are recorded as a reduction of revenues.(b)These accounts receivable allowances represent discounts and other chargebacks related to the provision for our product sales.(c)The valuation allowance for deferred tax assets includes purchase accounting adjustments and other activity related to our acquisition of LumaraHealth.V. RECENTLY ISSUED AND PROPOSED ACCOUNTING PRONOUNCEMENTSFrom time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodiesthat are adopted by us as of the specified effective date.In January 2017, the FASB issued ASU 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment (“ASU2017-04”). This new standard eliminates Step 2 from the goodwill impairment test. ASU 2017-04 requires an entity to perform its annual, or interim, goodwillimpairment test by comparing the fair value of a reporting unit with its carrying amount. An entity should recognize an impairment charge for the amount bywhich the carrying amount exceeds the reporting unit’s fair value. ASU 2017-04 still allows the option to perform a qualitative assessment for a reporting unitto determine if the quantitative impairment test is necessary. ASU 2017-04 is effective for any annual or interim goodwill impairment tests in the fiscal yearsbeginning after December 15, 2019 and must be applied prospectively. Early adoption is permitted for interim or annual goodwill impairment tests performedon testing dates after January 1, 2017. We have adopted ASU 2017-01 as of January 1, 2017, with prospective application for our interim or annual goodwillimpairment tests.In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business (“ASU 2017-01”). Thisnew standard clarifies the definition of a business and provides a screen to determine when an integrated set of assets and activities is not a business. Thescreen requires that when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a groupof similar identifiable assets, the set is not a business. ASU 2017-01 will be effective for us on January 1, 2018. However, we have adopted ASU 2017-01 as ofJanuary 1, 2017, with prospective application to any business development transaction. Depending upon individual facts and circumstances of futuretransactions, this guidance will likely result in more transactions being accounted for as asset acquisitions rather than business combinations.In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments(“ASU 2016-15”). This new standard clarifies certain aspects of the statement of cash flows, including the classification of debt prepayment or debtextinguishment costs or other debt instruments with coupon interest rates that are insignificant in relation to the effective interest rate of the borrowing,contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement ofcorporate-owned life insurance policies, distributions received from equity method investees and beneficial interests in securitization transactions. This newstandard also clarifies that an entity should determine each separately identifiable source of use within the cash receipts and payments on the basis of thenature of the underlying cash flows. In situations in which cash receipts and payments have aspects of more than one class of cash flows and cannot beseparated by source or use, the appropriate classification should depend on the activity that is likely to be the predominant source or use of cash flows for theitem. ASU 2016-15 will be effective for us on January 1, 2018. We are currently evaluating the impact of our adoption of ASU 2016-15 in our consolidatedfinancial statements.In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on FinancialInstruments (“ASU 2016-13”). The new standard requires entities to measure all expected credit losses for financial assets held at the reporting date based onhistorical experience, current conditions and reasonable and supportable forecasts. ASU 2016-13 will be effective for us for fiscal years beginning on or afterJanuary 1, 2020, including interim periods within those annual reporting periods and early adoption is permitted. We are currently evaluating the impact ofour adoption of ASU 2016-13 in our consolidated financial statements.In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based PaymentAccounting (“ASU 2016-09”). The new standard involves several aspects of the accounting for share-based payment transactions, including the income taxconsequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. ASU 2016-09 will be effective for us onJanuary 1, 2017. We are currently evaluating the impact of our adoption of ASU 2016-09 in our consolidated financial statements.152Table of ContentsIn February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”). This new standard requires entities to recognize on itsbalance sheet assets and liabilities associated with the rights and obligations created by leases with terms greater than twelve months. This new standard iseffective for annual reporting periods beginning after December 15, 2018, and interim periods within those annual periods and early adoption is permitted.We are currently evaluating the impact of ASU 2016-02 in our consolidated financial statements and we currently expect that most of our operating leasecommitments will be subject to the new standard and recognized as operating lease liabilities and right-of-use assets upon our adoption of ASU 2016-02.In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of FinancialAssets and Financial Liabilities (“ASU 2016-01”). This new standard amends certain aspects of accounting and disclosure requirements of financialinstruments, including the requirement that equity investments with readily determinable fair values be measured at fair value with changes in fair valuerecognized in our results of operations. This new standard does not apply to investments accounted for under the equity method of accounting or those thatresult in consolidation of the investee. Equity investments that do not have readily determinable fair values may be measured at fair value or at cost minusimpairment adjusted for changes in observable prices. A financial liability that is measured at fair value in accordance with the fair value option is required tobe presented separately in other comprehensive income for the portion of the total change in the fair value resulting from change in the instrument-specificcredit risk. In addition, a valuation allowance should be evaluated on deferred tax assets related to available-for-sale debt securities in combination withother deferred tax assets. ASU 2016-01 will be effective for us on January 1, 2018. The adoption of ASU 2016-01 is not expected to have a material impact onour financial position or results of operations.In September 2015, the FASB issued ASU No. 2015-16, Business Combinations (Topic 805): Simplifying the Accounting for Measurement-PeriodAdjustments (“ASU 2015-16”). ASU 2015-16 requires that an acquirer recognize adjustments to provisional amounts that are identified during themeasurement period in the reporting period in which the adjustment amounts are determined and sets forth new disclosure requirements related to theadjustments. We adopted ASU 2015-16 as of January 1, 2016. See Note C, “Business Combinations” for additional information.In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory (“ASU 2015-11”). The new standardapplies only to inventory for which cost is determined by methods other than last-in, first-out and the retail inventory method, which includes inventory thatis measured using first-in, first-out or average cost. Inventory within the scope of ASU 2015-11 is required to be measured at the lower of cost and netrealizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion,disposal, and transportation. ASU 2015-11 will be effective for us on January 1, 2017. The adoption of ASU 2015-11 is not expected to have a materialimpact on our results of operations, cash flows or financial position.In April 2015, the FASB issued ASU No. 2015-03, Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt IssuanceCosts (“ASU 2015-03”). The amendments in ASU 2015-03 require that debt issuance costs related to a recognized debt liability be presented in the balancesheet as a direct deduction from the carrying amount of that debt liability, consistent with debt discounts. In August 2015, the FASB issued ASU No. 2015-15, Interest - Imputation of Interest (Subtopic 835-30): Presentation and Subsequent Measurement of Debt Issuance Costs Associated with Line-of-CreditArrangements (“ASU 2015-15”), which allows presentation of debt issuance costs related to line-of-credit arrangements as either in accordance with theamendments in ASU 2015-03, or as an asset with subsequent amortization of the debt issuance costs ratably over the term of the arrangement. We adoptedthis guidance retrospectively in the first quarter of 2016. As a result, we presented $11.2 million of unamortized debt issuance costs as of December 31, 2015as direct deductions from the carrying amounts of the related debt liabilities. We previously included the $11.2 million of unamortized debt issuance costs in“other long-term assets” in our condensed consolidated balance sheet as of December 31, 2015.In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements - Going Concern: Disclosure of Uncertainties about anEntity’s Ability to Continue as a Going Concern (“ASU 2014-15”). ASU 2014-15 is intended to define management’s responsibility to evaluate whetherthere is substantial doubt about an organization’s ability to continue as a going concern and to provide related footnote disclosures, if required. ASU 2014-15 will be effective for annual reporting periods ending after December 15, 2016, which will be our fiscal year ending December 31, 2016, and to annual andinterim periods thereafter. We adopted ASU 2014-15 as of December 31, 2016 in our consolidated financial statements and related disclosures, which did nothave a material impact on our results of operations, cash flows or financial position.In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers, as a new Topic, Accounting Standards Codification Topic606 (“ASU 2014-09”). The new revenue recognition standard provides a five-step analysis of transactions to determine when and how revenue is recognized.The core principle is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects theconsideration to which the entity expects to be entitled in exchange for those goods or services. In March 2016, the FASB issued ASU No. 2016-08, Revenuefrom Contracts with Customer Topic 606s, Principal versus Agent Considerations, which clarifies the implementation guidance153Table of Contentson principal versus agent considerations. In April 2016, the FASB issued ASU 2016-10, Revenue from Contracts with Customers Topic 606, IdentifyingPerformance Obligations and Licensing, which clarifies certain aspects of identifying performance obligations and licensing implementation guidance. InMay 2016, the FASB issued ASU 2016-12, Revenue from Contracts with Customers Topic 606, Narrow-Scope Improvements and PracticalExpedients, related to disclosures of remaining performance obligations, as well as other amendments to guidance on collectibility, non-cash considerationand the presentation of sales and other similar taxes collected from customers. In December 2016, the FASB issued ASU No. 2016-20, Technical Correctionsand Improvements to Topic 606, Revenue from Contracts with Customers, which amends certain narrow aspects of the guidance issued in ASU 2014-09including guidance related to the disclosure of remaining performance obligations and prior-period performance obligations, as well as other amendments tothe guidance on loan guarantee fees, contract costs, refund liabilities, advertising costs and the clarification of certain examples. We are currently evaluatingthe method of adoption and the potential impact that Topic 606 may have on our financial position and results of operations. These ASUs are effective forentities for interim and annual reporting periods beginning after December 15, 2017, including interim periods within that year, which for us is the periodbeginning January 1, 2018. Early adoption is permitted any time after the original effective date. Entities have the choice to apply these ASUs eitherretrospectively to each reporting period presented or by recognizing the cumulative effect of applying these standards at the date of initial application andnot adjusting comparative information. We have not yet selected a transition method and are currently evaluating the impact of this standard in ourconsolidated financial statements.W. SUBSEQUENT EVENTSPalatin License AgreementOn January 8, 2017, we entered into a license agreement (the “Palatin License Agreement”) with Palatin Technologies, Inc. (“Palatin”) under which weacquired (a) an exclusive license in all countries of North America (the “Rekynda Territory”), with the right to grant sub-licenses, to research, develop andcommercialize Rekynda and any other products containing bremelanotide (collectively, the “Rekynda Products”), an investigational product designed to bean on-demand treatment for hypoactive sexual desire disorder in pre-menopausal women, (b) a worldwide non-exclusive license, with the right to grant sub-licenses, to manufacture the Rekynda Products, and (c) a non-exclusive license in all countries outside the Rekynda Territory, with the right to grant sub-licenses, to research, develop and manufacture (but not commercialize) the Rekynda Products. Following the satisfaction of the conditions to closing underthe Palatin License Agreement, the transaction closed on February 2, 2017.Under the terms of the Palatin License Agreement, in February 2017 we paid Palatin $60.0 million as a one-time upfront payment and will reimbursePalatin up to an aggregate amount of $25.0 million for all reasonable, documented, out-of-pocket expenses incurred by Palatin in connection with thedevelopment and regulatory activities necessary to submit a new drug application in the U.S. for Rekynda for the treatment of hypoactive sexual desiredisorder (“HSDD”) in pre-menopausal women. In addition, the Palatin License Agreement provides for future contingent payments of (a) up to $80.0 million upon achievement of certain regulatorymilestones, including FDA approval and (b) up to $300.0 million of aggregate sales milestone payments upon the achievement of certain annual net salesmilestones over the course of the license. The first sales milestone of $25.0 million will be triggered when Rekynda annual net sales exceed $250.0 million.We are also obligated to pay Palatin tiered royalties on annual net sales of the Rekynda Products, on a product-by-product basis, in the Rekynda Territoryranging from the high-single digits to the low double-digits. The royalties will expire on a product-by-product and country-by-country basis upon the latestto occur of (a) the earliest date on which there are no valid claims of Palatin patent rights covering such Rekynda Product in such country, (b) the expirationof the regulatory exclusivity period for such Rekynda Product in such country and (c) 10 years following the first commercial sale of such Rekynda Productin such country. These royalties are subject to reduction in the event that: (i) we must license additional third party intellectual property in order to develop,manufacture or commercialize a Rekynda Product or (ii) generic competition occurs with respect to a Rekynda Product in a given country, subject to anaggregate cap on such deductions of royalties otherwise payable to Palatin. After the expiration of the applicable royalties for any Rekynda Product in agiven country, the license for such Rekynda Product in such country would become a fully paid-up, royalty-free, perpetual and irrevocable license.Pending Endoceutics License AgreementOn February 13, 2017, we entered into a license agreement (the “Endoceutics License Agreement”) with Endoceutics, Inc. (“Endoceutics”) pursuant towhich Endoceutics has agreed to grant to us rights to Intrarosa, an FDA-approved product for the treatment of moderate-to-severe dyspareunia (pain duringsexual intercourse), a symptom of VVA due to menopause. The Endoceutics License Agreement grants us the right to develop and commercializepharmaceutical products containing154Table of Contentsdehydroepiandrosterone (“DHEA”), including Intrarosa, at dosage strengths of 13 mg or less per dose and formulated for intravaginal delivery, excludingany dosage strengths over 13 mg per dose and combinations with other active pharmaceutical ingredients, in the U.S. for the treatment of vulvar and vaginalatrophy (“VVA”) and female sexual dysfunction (“FSD”). The closing of the transactions contemplated by the Endoceutics License Agreement (the“Effective Date”) is subject to clearance under the Hart-Scott-Rodino Act and other customary closing conditions.Subject to the terms of the Endoceutics License Agreement, Endoceutics has agreed to conduct clinical studies for the use of Intrarosa in FSD to supportan application for regulatory approval for Intrarosa for the treatment of FSD in the U.S. We and Endoceutics have agreed to share the direct costs related tosuch studies based upon a negotiated allocation with us funding up to $20.0 million. We may, with Endoceutics’ consent (not to be unreasonably withheld,conditioned or delayed), conduct any other studies of Intrarosa for the treatment of VVA and FSD anywhere in the world for the purpose of obtaining ormaintaining regulatory approval of or commercializing Intrarosa for the treatment of VVA or FSD in the U.S. All data generated in connection with the abovedescribed studies would be owned by Endoceutics and licensed to us pursuant to the Endoceutics License Agreement.We will have the exclusive right to commercialize Intrarosa for the treatment of VVA or FSD in the U.S., subject to the terms of the Endoceutics LicenseAgreement, including having final decision making authority with respect to commercial strategy, pricing and reimbursement and other commercializationmatters. We have agreed to use commercially reasonable efforts to market, promote and otherwise commercialize Intrarosa for the treatment of VVA or FSD inthe U.S., including a commitment to a minimum marketing spend for Intrarosa in 2017. Endoceutics has the right to directly conduct, itself or through itsaffiliates or subcontractors, additional commercialization activities for Intrarosa for the treatment of VVA or FSD in the U.S., which scope of activities will beagreed to by the parties acting reasonably and in good faith, and has the right to conduct activities related generally to the field of intracinology, in eachcase, subject to our right to withhold approval in certain instances. Upon Closing, we will make an upfront payment of $50.0 million and, subject to certain conditions, will issue 600,000 shares of unregistered commonstock, to Endoceutics, 300,000 of which will be subject to a 180-day lock-up provision, and the other 300,000 of which will be subject to a one-year lock-upprovision. We have also agreed to make a payment to Endoceutics of up to $10.0 million upon the delivery of launch quantities of Intrarosa and a paymentof $10.0 million on the first anniversary of the closing. In addition, we have also agreed to pay tiered royalties to Endoceutics equal to a percentage of netsales of Intrarosa in the U.S. ranging from mid-teens (for calendar year net sales up to $150.0 million) to mid twenty percent (for any calendar year net salesthat exceed $1 billion) (such royalty rate to be dependent on the aggregate annual net sales of Intrarosa) for the commercial life of Intrarosa, with deductions(a) after the later of (i) the expiration date of the last to expire of a licensed patent containing a valid patent claim or (ii) ten years after the first commercialsale of Intrarosa for the treatment of VVA or FSD in the U.S., (b) for generic competition and (c) for third party payments. Endoceutics is also eligible toreceive certain sales milestone payments, including a first sales milestone payment of $15.0 million, which would be triggered when Intrarosa annual netU.S. sales exceed $150.0 million, and a second milestone payment of $30.0 million, which would be triggered when annual net U.S. sales exceed $300.0million. If annual net U.S. sales exceed $500.0 million, there are additional sales milestone payments totaling up to $850.0 million, which would be triggeredat various increasing sales thresholds.In connection with the Endoceutics License Agreement, we and Endoceutics have agreed to enter into an exclusive commercial supply agreement on orabout the Effective Date, pursuant to which Endoceutics, itself or through affiliates or contract manufacturers, would agree to manufacture and supplyIntrarosa to us (the “Supply Agreement”) and would be our exclusive supplier of Intrarosa in the U.S., subject to certain rights for us to manufacture andsupply Intrarosa in the event of a cessation notice or supply failure (as such terms are defined in the Supply Agreement). Under the Supply Agreement,Endoceutics would maintain at all times a second source supplier for the manufacture of DHEA and the drug product and identify and validate and transfermanufacturing intellectual property to the second source supplier within two years of the Effective Date. The Supply Agreement will remain in effect until thetermination of the Endoceutics License Agreement, unless terminated earlier by either party for an uncured material breach or insolvency of the other party,or by us if we exercise our rights to manufacture and supply Intrarosa following a cessation notice or supply failure.Under the Endoceutics License Agreement, except as permitted under the Endoceutics License Agreement or the Supply Agreement, and except for anycompounds or products affecting the melanocortin receptor pathway, including without limitation, bremelanotide (collectively, “Excluded Product”), we willnot be permitted to research, develop, manufacture, or commercialize (i) DHEA for delivery by any route of administration anywhere in world, (ii) anycompound (including DHEA) or product for use in VVA anywhere in the world, or (iii) commencing on the date of an approval of Intrarosa for the treatmentof FSD in the U.S. and continuing for the remainder of the term of the Endoceutics License Agreement, any compound (including DHEA) for use in FSD(each, a “Competing Product”). Any compound or product for use in FSD that would be a Competing Product in the United States but that (i) does notcontain DHEA and (ii) was acquired or licensed or for which the155Table of Contentsresearch, development, manufacture or commercialization of such compound or product is initiated by us or our affiliates, in each case, prior to the date of anapproval of Intrarosa for the treatment of FSD in the U.S., will be an Excluded Product and will not be subject to the exclusivity obligations under theEndoceutics License Agreement in the treatment of FSD, subject to certain restrictions in the Endoceutics License Agreement. These noncompete restrictionsare subject to certain exclusions relating to the acquisition of competing programs.The Endoceutics License Agreement expires on the date of expiration of all royalty obligations due thereunder unless earlier terminated in accordancewith the Endoceutics License Agreement. The Endoceutics License Agreement may be terminated by either Party if the Effective Date has not occurredwithin 180 days following the execution date or such date as the parties may mutually agree. The Endoceutics License Agreement may be terminated byeither Party for material breach that is either uncured after a 90-day notice period, or if such breach cannot be cured within such 90-day period, if thebreaching party does not commence appropriate and material actions to cure such breach within the notice period and continue to diligently cure such breachfor a period not to exceed 90 days, in either case, subject to tolling or determination of the arbitrators, if dispute resolution procedures are initiated within 30days of the termination notice. We have the ability to elect not to terminate the Endoceutics License Agreement in the case of a material breach, in whichcase future milestone and royalty payments owed to Endoceutics would be reduced by a negotiated percentage or by an amount determined by arbitration.Either party may terminate under certain situations relating to the bankruptcy or insolvency of the other party. We may terminate the Endoceutics LicenseAgreement for a valid business reason upon 365 days prior written notice to Endoceutics; or upon 60 days written notice in the event we reasonablydetermine in good faith, after due inquiry and after discussions with Endoceutics, that we cannot reasonably continue to develop or commercialize anyProduct as a result of a safety issue regarding the use of Intrarosa. We may also terminate the Endoceutics License Agreement upon 180 days notice if there isa change of control of AMAG and the acquiring entity (alone or with its affiliates) is engaged in a competing program (as defined in the Licensed Agreement)in the U.S. or in at least three countries within the European Union.ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE:None.ITEM 9A. CONTROLS AND PROCEDURES:Managements’ Evaluation of our Disclosure Controls and ProceduresOur principal executive officer and principal financial officer, after evaluating the effectiveness of our “disclosure controls and procedures” (as definedin the Exchange Act Rule 13a-15(e), or Rule 15d-15(e)), with the participation of our management, have each concluded that, as of December 31, 2016, theend of the period covered by this Annual Report on Form 10-K, our disclosure controls and procedures were designed and were effective to providereasonable assurance that information we are required to disclose in the reports that we file or submit under the Securities Exchange Act of 1934, as amended,is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms and that suchinformation is accumulated and communicated to management, including our principal executive officer and principal financial officer, as appropriate toallow timely decisions regarding required disclosure. It should be noted that any system of controls is designed to provide reasonable, but not absolute,assurances that the system will achieve its stated goals under all reasonably foreseeable circumstances.Management’s Annual Report on Internal Control Over Financial ReportingManagement’s Report on Internal Control over Financial Reporting is contained in Part II, Item 8 “Financial Statements and Supplementary Data” of thisAnnual Report on Form 10-K for the year ended December 31, 2016 and is incorporated herein by reference.Changes in Internal Control Over Financial Reporting There were no changes in our internal control over financial reporting (as such term is defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) thatoccurred during the three months ended December 31, 2016 that have materially affected, or that are reasonably likely to materially affect, our internalcontrol over financial reporting. 156Table of ContentsITEM 9B. OTHER INFORMATION:None.PART IIIITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE:The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which weplan to file with the Securities and Exchange Commission (the “SEC”) not later than 120 days after the close of our year ended December 31, 2016.ITEM 11. EXECUTIVE COMPENSATION:The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which weplan to file with the SEC not later than 120 days after the close of our year ended December 31, 2016.ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS:The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which weplan to file with the SEC not later than 120 days after the close of our year ended December 31, 2016.ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE:The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which weplan to file with the SEC not later than 120 days after the close of our year ended December 31, 2016.ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES:The information required under this item is incorporated herein by reference to our definitive proxy statement pursuant to Regulation 14A, which weplan to file with the SEC not later than 120 days after the close of our year ended December 31, 2016.157Table of ContentsPART IVITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES: ExhibitNumber Description2.1 Agreement and Plan of Merger, dated as of September 28, 2014, by and among Lumara Health Inc., AMAG Pharmaceuticals, Inc.,Snowbird, Inc., and Lunar Representative, LLC as the Stockholders’ Representative (incorporated herein by reference toExhibit 2.1 to the Company’s Current Report on Form 8-K filed September 29, 2014, File No. 001-10865)2.2 Stock Purchase Agreement, dated as of June 29, 2015, by and among CBR Holdco, LLC, CBR Acquisition Holdings Corp. andAMAG Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filedJune 29, 2015, File No. 001-10865)3.1, 4.1 Certificate of Incorporation of AMAG Pharmaceuticals, Inc., as restated (incorporated herein by reference to Exhibits 3.1 and4.1to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010, File No. 001-10865)3.2,4.2 Certificate of Amendment to Restated Certificate of Incorporation of AMAG Pharmaceuticals, Inc. as filed on May 21, 2015 withthe Delaware Secretary of State (incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-Kfiled May 28, 2015, File No. 001-10865)3.3, 4.3 Amended and Restated By-Laws of AMAG Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 3.1 to theCompany’s Current Report on Form 8-K filed December 17, 2015, File No. 001-10865)3.4, 4.4 Certificate of Designation of Series A Junior Participating Preferred Stock (incorporated herein by reference to Exhibits 3.1 and4.1 to the Company’s Current Report on Form 8-K filed September 4, 2009, File No. 0-14732)4.6 Specimen certificate representing AMAG Pharmaceuticals, Inc.’s Common Stock (incorporated herein by reference to Exhibit 4.3to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, File No. 001-10865)4.7 Rights Agreement, dated as of September 4, 2009 by and between AMAG Pharmaceuticals, Inc. and American Stock Transfer &Trust Company, LLC (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filedSeptember 4, 2009, File No. 0-14732)4.8 Amendment to Rights Agreement, dated as of May 10, 2012, by and between AMAG Pharmaceuticals, Inc. and American StockTransfer & Trust Company, LLC (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-Kfiled May 10, 2012, File No. 001-10865)4.9 Amendment to Rights Agreement, dated as of February 11, 2014, by and between AMAG Pharmaceuticals, Inc. and AmericanStock Transfer & Trust Company, LLC (incorporated herein by reference to Exhibit 4.4 to the Company’s Current Report onForm 8-K filed February 14, 2014, File No. 001-10865)4.10 NOL Amendment to Rights Agreement, dated as of September 26, 2014, by and between AMAG Pharmaceuticals, Inc. andAmerican Stock Transfer & Trust Company, LLC (incorporated herein by reference to Exhibit 4.1 to the Company’s CurrentReport on Form 8-K filed September 29, 2014, File No. 001-10865)4.11 Form of Rights Certificate (incorporated herein by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filedSeptember 4, 2009, File No. 0-14732)4.12 Base Indenture, dated as of February 14, 2014, by and between AMAG Pharmaceuticals, Inc. and Wilmington Trust, NationalAssociation (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed February 14,2014, File No. 001-10865)4.13 First Supplemental Indenture, dated as of February 14, 2014, by and between AMAG Pharmaceuticals, Inc. and Wilmington Trust,National Association (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filedFebruary 14, 2014, File No. 001-10865)4.14 Form of 2.50% Convertible Senior Note due 2019 (incorporated herein by reference to Exhibit 4.3 to the Company’s CurrentReport on Form 8-K filed February 14, 2014, File No. 001-10865)4.16 Indenture, dated as of August 17, 2015, by and among AMAG Pharmaceuticals, Inc., the Guarantors party thereto and WilmingtonTrust, National Association, as trustee (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form8-K filed August 17, 2015, File No. 001-10865)4.17 Form of 7.875% Senior Note due 2023 (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form8-K filed August 17, 2015, File No. 001-10865)10.1* Representative Form of Indemnification Agreement (incorporated herein by reference to Exhibit 10.2 to the Company’s AnnualReport on Form 10-K for the year ended December 31, 2009, File No. 001-10865)158Table of Contents10.2* AMAG Pharmaceuticals, Inc.’s Non-Employee Director Compensation Policy (incorporated herein by reference to Exhibit 10.1 tothe Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, File No. 001-10865)10.3* AMAG Pharmaceuticals, Inc.’s Amended and Restated 2000 Stock Plan (incorporated herein by reference to Appendix A to theCompany’s Definitive Proxy Statement on Schedule 14A filed December 14, 2005, File No. 0-14732)10.4* AMAG Pharmaceuticals, Inc.’s Third Amended and Restated 2007 Equity Incentive Plan (incorporated herein by reference toAppendix A to the Company’s Definitive Proxy Statement on Schedule 14A filed April 19, 2013, File No. 001-10865)10.5* First Amendment to the AMAG Pharmaceuticals, Inc. Third Amended and Restated 2007 Equity Incentive Plan (incorporatedherein by reference to Appendix B to the Company’s Definitive Proxy Statement on Schedule 14A filed April 16, 2015, FileNo. 001-10865)10.6* Second Amendment to the AMAG Pharmaceuticals, Inc. Third Amended and Restated 2007 Equity Incentive Plan (incorporatedherein by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A filed April 15, 2016, FileNo. 001-10865)10.7* AMAG Pharmaceuticals, Inc. 2015 Employee Stock Purchase Plan (incorporated herein by reference to Appendix C tothe Company’s Definitive Proxy Statement on Schedule 14A filed April 16, 2015, File No. 001-10865)10.8* Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (incorporated herein by reference to Exhibit 10.6 tothe Company’s Annual Report on Form 10-K for the year ended December 31, 2014, File No. 001-10865)10.9* Form of Incentive Stock Option Agreement for AMAG Pharmaceuticals, Inc. Employees under AMAG Pharmaceuticals, Inc.’sThird Amended and Restated 2007 Equity Incentive Plan and the Lumara Health Inc. Amended and Restated 2013 IncentiveCompensation Plan (incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for thequarter ended June 30, 2013, File No. 001-10865)10.10* Form of Non-Qualified Stock Option Agreement for AMAG Pharmaceuticals, Inc. Employees under AMAG Pharmaceuticals, Inc.’sThird Amended and Restated 2017 Equity Incentive Plan and the Lumara Health Inc. Amended and Restated 2013 IncentiveCompensation Plan (incorporated herein by reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q for thequarter ended June 30, 2013, File No. 001-10865)10.11* Form of Restricted Stock Unit Agreement for AMAG Pharmaceuticals, Inc. Employees under AMAG Pharmaceuticals, Inc.’s ThirdAmended and Restated 2007 Equity Incentive Plan and the Lumara Health Inc. Amended and Restated 2013 IncentiveCompensation Plan (incorporated herein by reference to Exhibit 10.11 to the Company’s Annual Report on Form 10-K for the yearended December 31, 2015, File No. 001-10865)10.12* Form of Non-Qualified Stock Option Agreement for Non-Employee Directors under AMAG Pharmaceuticals, Inc.’s Third Amendedand Restated 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.10 to the Company’s Quarterly Report onForm 10-Q for the quarter ended June 30, 2013, File No. 001-10865)10.13* Form of Restricted Stock Unit Agreement for Non-Employee Directors under AMAG Pharmaceuticals, Inc.’s Third Amended andRestated 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.1 to the Company's Quarterly Report on Form10-Q for the quarter ended June 30, 2016, File No. 001-10865)10.14* Non-Plan Restricted Stock Unit Agreement, by and between AMAG Pharmaceuticals, Inc. and William K. Heiden (incorporatedherein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed May 10, 2012, File No. 001-10865)10.15* Non-Plan Stock Option Agreement, by and between AMAG Pharmaceuticals, Inc. and William K. Heiden (incorporated herein byreference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed May 10, 2012, File No. 001-10865)10.16* Form of Non-Qualified Stock Option Agreement - Non-Plan Inducement Grant (incorporated herein by reference to Exhibit 4.3 tothe Company’s Registration Statement on Form S-8 filed August 7, 2013, File No. 333-190435)10.17* Form of Restricted Stock Unit Agreement - Non-Plan Inducement Grant (incorporated herein by reference to Exhibit 10.18 to theCompany’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865)10.18* Form of Employment Agreement between AMAG Pharmaceuticals, Inc. and each of its executive officers (other than William K.Heiden) (incorporated herein by reference to Exhibit 10.19 to the Company’s Annual Report on Form 10-K for the year endedDecember 31, 2015, File No. 001-10865)159Table of Contents10.19* Employment Agreement dated as of February 7, 2014 between AMAG Pharmaceuticals, Inc. and William K. Heiden (incorporatedherein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2014,File No. 001-10865)10.20 Lease Agreement, dated as of May 22, 2008, by and between AMAG Pharmaceuticals, Inc. and Mortimer B. Zuckerman andEdward H. Linde, trustees of 92 Hayden Avenue Trust under Declaration of Trust dated August 18, 1983. This Lease Agreementwas assigned in June 2013. (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filedMay 29, 2008, File No. 0-14732)10.21 Assignment and Assumption of Lease, dated as of June 10, 2013, by and among AMAG Pharmaceuticals, Inc., Mortimer B.Zuckerman and Edward H. Linde, trustees of 92 Hayden Avenue Trust under Declaration of Trust dated August 18, 1983 and ShireHuman Genetic Therapies, Inc. (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-Kfiled June 13, 2013, File No. 001-10865)10.22 Lease Agreement, dated as of June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONY LLC(incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed June 13, 2013, File No. 001-10865)10.23 First Amendment to Lease Agreement, dated June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONYLLC, dated March 24, 2015 (incorporated herein by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q forthe quarter ended March 31, 2015, File No. 001-10865)10.24 Second Amendment to Lease Agreement, dated June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAYCOLONY LLC, dated December 4, 2015 (incorporated herein by reference to Exhibit 10.30 to the Company’s Annual Report onForm 10-K for the year ended December 31, 2015, File No. 001-10865)10.25 Third Amendment to Lease Agreement, dated June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONYLLC, dated December 7, 2015 (incorporated herein by reference to Exhibit 10.31 to the Company’s Annual Report on Form 10-Kfor the year ended December 31, 2015, File No. 001-10865)10.26 License Agreement between AMAG Pharmaceuticals, Inc. and Abeona Therapeutics, Inc. (formerly known as PlasmaTechBiopharmaceuticals, Inc. and Access Pharmaceuticals, Inc.) dated as of June 6, 2013 (incorporated herein by reference toExhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, File No. 001-10865)(confidential treatment previously granted)10.27 Commercial Supply Agreement, dated effective as of August 29, 2012, by and between AMAG Pharmaceuticals, Inc. and Sigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarterended September 30, 2012, File No. 001-10865) (confidential treatment previously granted)10.28 Amendment No.1 to Commercial Supply Agreement, dated October 3, 2013, by and between AMAG Pharmaceuticals, Inc. andSigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.54 to the Company’s Annual Report on Form 10-K for the yearended December 31, 2013, File No. 001-10865) (confidential treatment previously granted)10.29 Amendment No. 2 to Commercial Supply Agreement, dated April 28, 2015, by and between AMAG Pharmaceuticals, Inc. andSigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for thequarter ended June 30, 2015, File No. 001-10865) (confidential treatment previously granted)10.30 Amendment No. 3 to Commercial Supply Agreement, dated October 19, 2015, by and between the Company and Sigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.36 to the Company’s Annual Report on Form 10-K for the year endedDecember 31, 2015, File No. 001-10865) (confidential treatment previously granted)10.31 Pharmaceutical Manufacturing and Supply Agreement, dated effective as of January 8, 2010, by and between AMAGPharmaceuticals, Inc. and Patheon Manufacturing Services LLC (as assignee from DSM Pharmaceuticals, Inc.) (incorporated hereinby reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, FileNo. 001-10865) (confidential treatment previously granted)10.32 Amendment No. 1 to Pharmaceutical Manufacturing and Supply Agreement, dated July 5, 2014, by and between AMAGPharmaceuticals, Inc. and Patheon Manufacturing Services LLC (as assignee from DSM Pharmaceuticals, Inc.) (incorporated hereinby reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, FileNo. 001-10865)10.33 Amendment No. 2 to Pharmaceutical Manufacturing and Supply Agreement, dated June 19, 2015, by and between AMAGPharmaceuticals, Inc. and Patheon Manufacturing Services LLC (as assignee from DPI Newco LLC as assignee from DSMPharmaceuticals, Inc.) (incorporated herein by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for thequarter ended September 30, 2015, File No. 001-10865) (confidential treatment previously granted)160Table of Contents10.34+ Amended and Restated Technical Transfer and Supply Agreement, dated as of December 19, 2016, by and between AMAGPharmaceuticals, Inc. and the Pfizer CentreOne Group of Pfizer, Inc. (Certain confidential information contained in this exhibit wasomitted by means of redacting a portion of the text and replacing it with [***]. This exhibit has been filed separately with the SECwithout any redactions pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities and Exchange Act of1934, as amended)10.35 Development and License Agreement, dated September 30, 2014, by and between Lumara Health Inc and Antares Pharma, Inc.(incorporated herein by reference to Exhibit 10.42 to the Company’s Annual Report on Form 10-K for the year endedDecember 31, 2015, File No. 001-10865) (confidential treatment previously granted)10.36 License Agreement, dated January 8, 2017, by and between AMAG Pharmaceuticals, Inc. and Palatin Technologies, Inc.,(incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed February 3, 2017, FileNo. 001-10865) (Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the textand replacing it with [***]. This exhibit has been filed separately with the SEC without any redactions pursuant to a ConfidentialTreatment Request under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended)10.37 Termination Agreement, dated December 29, 2014, by and between AMAG Pharmaceuticals, Inc. and Takeda PharmaceuticalCompany Limited (incorporated herein by reference to Exhibit 10.19 to the Company’s Annual Report on Form 10-K for the yearended December 31, 2011, File No. 001-10865) (confidential treatment previously granted)10.38 Underwriting Agreement, dated as of February 11, 2014, among AMAG Pharmaceuticals, Inc. and J.P. Morgan Securities LLC, onits own behalf and as representative of the several underwriters named in Schedule 1 thereto (incorporated herein by reference toExhibit 1.1 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)10.39 Base Call Option Transaction Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and JPMorganChase Bank, National Association, London Branch (incorporated herein by reference to Exhibit 10.1 to the Company’s CurrentReport on Form 8-K filed February 14, 2014, File No. 001-10865)10.40 Base Call Option Transaction Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and Royal Bankof Canada (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed February 14,2014, File No. 001-10865)10.41 Base Call Option Transaction Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and MorganStanley & Co. International plc (incorporated herein by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-Kfiled February 14, 2014, File No. 001-10865)10.42 Base Warrants Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and JPMorgan Chase Bank,National Association, London Branch (incorporated herein by reference to Exhibit 10.4 to the Company’s Current Report onForm 8-K filed February 14, 2014, File No. 001-10865)10.43 Amendment to Warrant Transaction, dated as of February 23, 2015, by and between AMAG Pharmaceuticals, Inc. and J.P. MorganSecurities LLC, as agent (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q forthe quarter ended March 31, 2015, File No. 001-10865)10.44 Base Warrants Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and Royal Bank of Canada(incorporated herein by reference to Exhibit 10.5 to the Company’s Current Report on Form 8-K filed February 14, 2014, FileNo. 001-10865)10.45 Base Warrants Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and Morgan Stanley & Co.International plc (incorporated herein by reference to Exhibit 10.6 to the Company’s Current Report on Form 8-K filedFebruary 14, 2014, File No. 001-10865)10.46 Additional Call Option Transaction Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. andJPMorgan Chase Bank, National Association, London Branch (incorporated herein by reference to Exhibit 10.7 to the Company’sCurrent Report on Form 8-K filed February 14, 2014, File No. 001-10865)10.47 Additional Call Option Transaction Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and RoyalBank of Canada (incorporated herein by reference to Exhibit 10.8 to the Company’s Current Report on Form 8-K filedFebruary 14, 2014, File No. 001-10865)10.48 Additional Call Option Transaction Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. andMorgan Stanley & Co. International plc (incorporated herein by reference to Exhibit 10.9 to the Company’s Current Report onForm 8-K filed February 14, 2014, File No. 001-10865)161Table of Contents10.49 Additional Warrants Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and JPMorgan ChaseBank, National Association, London Branch (incorporated herein by reference to Exhibit 10.10 to the Company’s Current Reporton Form 8-K filed February 14, 2014, File No. 001-10865)10.50 Additional Warrants Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and Royal Bank ofCanada (incorporated herein by reference to Exhibit 10.11 to the Company’s Current Report on Form 8-K filed February 14, 2014,File No. 001-10865)10.51 Additional Warrants Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and MorganStanley & Co. International plc (incorporated herein by reference to Exhibit 10.12 to the Company’s Current Report on Form 8-Kfiled February 14, 2014, File No. 001-10865)10.52 Credit Agreement, dated as of November 12, 2014, by and among AMAG Pharmaceuticals, Inc., the financial institutions andagents listed therein, and Jefferies Finance LLC (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Reporton Form 8-K filed November 12, 2014, File No. 001-10865)10.53 First Amendment to Credit Agreement, dated March 31, 2015, by and among AMAG Pharmaceuticals, Inc., the Lenders namedtherein, and Jefferies Finance LLC, as administrative agent (incorporated herein by reference to Exhibit 10.6 to the Company’sQuarterly Report on Form 10-Q for the quarter ended March 31, 2015, File No. 001-10865)10.54 Credit Agreement, dated as of August 17, 2015, by and among AMAG Pharmaceuticals, Inc., the financial institutions and agentslisted therein, and Jefferies Finance LLC (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report onForm 8-K filed August 17, 2015, File No. 001-10865)10.55 Underwriting Agreement, dated as of July 30, 2015, among AMAG Pharmaceuticals, Inc., Jefferies LLC and Barclays Capital Inc.,as representatives of the underwriters named therein (incorporated herein by reference to Exhibit 1.1 to the Company’s CurrentReport on Form 8-K filed July 31, 2015, File No. 001-10865)10.56 Underwriting Agreement, dated as of February 25, 2015, among AMAG Pharmaceuticals, Inc., J.P. Morgan Securities LLC andDeutsche Bank Securities Inc., as representatives of the underwriters named therein (incorporated herein by reference to Exhibit 1.1to the Company’s Current Report on Form 8-K filed February 26, 2015, File No. 001-10865)21.1+ Subsidiaries of AMAG Pharmaceuticals, Inc.23.1+ Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm24.1 Power of Attorney (included on the signature page(s) hereto)31.1+ Certification Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 200231.2+ Certification Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 200232.1++ Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 200232.2++ Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002101.INS+ XBRL Instance Document101.SCH+ XBRL Taxonomy Extension Schema Document101.CAL+ XBRL Taxonomy Extension Calculation Linkbase Document101.DEF+ XBRL Taxonomy Extension Definition Linkbase Document101.LAB+ XBRL Taxonomy Extension Label Linkbase Document101.PRE+ XBRL Taxonomy Extension Presentation Linkbase Document162Table of Contents+ Exhibits marked with a plus sign (“+”) are filed herewith.++ Exhibits marked with a double plus sign (“++”) are furnished herewith.* Exhibits marked with a single asterisk reference management contracts, compensatory plans or arrangements, filed in response toItem 15(a)(3) of the instructions to Form 10-K. The other exhibits listed have previously been filed with the SEC and are incorporated herein by reference, as indicated. Exhibits. We hereby file or furnish as exhibits, as the case may be, to this Form 10-K those exhibits listed in Part IV, Item 15(a)(3)above. Financial Statement Schedules. No financial statement schedules have been submitted because they are not required, notapplicable, or because the information required is included in the financial statements or the notes thereto.163Table of ContentsSIGNATURESPursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed onits behalf by the undersigned, thereunto duly authorized. AMAG PHARMACEUTICALS, INC. By:/s/ William K. Heiden William K. HeidenChief Executive Officer Date:February 17, 2017We, the undersigned officers and directors of AMAG Pharmaceuticals, Inc., hereby severally constitute and appoint William K. Heiden and EdwardMyles, and each of them singly, our true and lawful attorneys, with full power to them and each of them singly, to sign for us in our names in the capacitiesindicated below, all amendments to this report, and generally to do all things in our names and on our behalf in such capacities to enable AMAGPharmaceuticals, Inc. to comply with the provisions of the Securities Exchange Act of 1934, as amended, and all requirements of the Securities and ExchangeCommission.Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of theregistrant and in the capacities and on the dates indicated.Name Title Date /s/ William K. Heiden Chief Executive Officer (Principal Executive Officer) andDirector February 17, 2017William K. Heiden /s/ Edward Myles Senior Vice President of Finance, Chief Financial Officer andTreasurer (Principal Financial and Accounting Officer) February 17, 2017Edward Myles /s/ Barbara Deptula Director February 17, 2017Barbara Deptula /s/ John Fallon, M.D. Director February 17, 2017John Fallon, M.D. /s/ Brian P. Kelley Director February 17, 2017Brian P. Kelley /s/ Robert J. Perez Director February 17, 2017Robert J. Perez /s/ Lesley Russell, MB. Ch.B., MRCP Director February 17, 2017Lesley Russell, MB. Ch.B., MRCP /s/ Gino Santini Director February 17, 2017Gino Santini /s/ Davey S. Scoon Director February 17, 2017Davey S. Scoon /s/ James Sulat Director February 17, 2017James Sulat 164Table of Contents ExhibitNumber Description2.1 Agreement and Plan of Merger, dated as of September 28, 2014, by and among Lumara Health Inc., AMAG Pharmaceuticals, Inc.,Snowbird, Inc., and Lunar Representative, LLC as the Stockholders’ Representative (incorporated herein by reference toExhibit 2.1 to the Company’s Current Report on Form 8-K filed September 29, 2014, File No. 001-10865)2.2 Stock Purchase Agreement, dated as of June 29, 2015, by and among CBR Holdco, LLC, CBR Acquisition Holdings Corp. andAMAG Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 2.1 to the Company’s Current Report on Form 8-K filedJune 29, 2015, File No. 001-10865)3.1, 4.1 Certificate of Incorporation of AMAG Pharmaceuticals, Inc., as restated (incorporated herein by reference to Exhibits 3.1 and4.1to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2010, File No. 001-10865)3.2,4.2 Certificate of Amendment to Restated Certificate of Incorporation of AMAG Pharmaceuticals, Inc. as filed on May 21, 2015 withthe Delaware Secretary of State (incorporated herein by reference to Exhibit 3.1 to the Company’s Current Report on Form 8-Kfiled May 28, 2015, File No. 001-10865)3.3, 4.3 Amended and Restated By-Laws of AMAG Pharmaceuticals, Inc. (incorporated herein by reference to Exhibit 3.1 to theCompany’s Current Report on Form 8-K filed December 17, 2015, File No. 001-10865)3.4, 4.4 Certificate of Designation of Series A Junior Participating Preferred Stock (incorporated herein by reference to Exhibits 3.1 and4.1 to the Company’s Current Report on Form 8-K filed September 4, 2009, File No. 0-14732)4.6 Specimen certificate representing AMAG Pharmaceuticals, Inc.’s Common Stock (incorporated herein by reference to Exhibit 4.3to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2009, File No. 001-10865)4.7 Rights Agreement, dated as of September 4, 2009 by and between AMAG Pharmaceuticals, Inc. and American Stock Transfer &Trust Company, LLC (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filedSeptember 4, 2009, File No. 0-14732)4.8 Amendment to Rights Agreement, dated as of May 10, 2012, by and between AMAG Pharmaceuticals, Inc. and American StockTransfer & Trust Company, LLC (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-Kfiled May 10, 2012, File No. 001-10865)4.9 Amendment to Rights Agreement, dated as of February 11, 2014, by and between AMAG Pharmaceuticals, Inc. and AmericanStock Transfer & Trust Company, LLC (incorporated herein by reference to Exhibit 4.4 to the Company’s Current Report onForm 8-K filed February 14, 2014, File No. 001-10865)4.10 NOL Amendment to Rights Agreement, dated as of September 26, 2014, by and between AMAG Pharmaceuticals, Inc. andAmerican Stock Transfer & Trust Company, LLC (incorporated herein by reference to Exhibit 4.1 to the Company’s CurrentReport on Form 8-K filed September 29, 2014, File No. 001-10865)4.11 Form of Rights Certificate (incorporated herein by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filedSeptember 4, 2009, File No. 0-14732)4.12 Base Indenture, dated as of February 14, 2014, by and between AMAG Pharmaceuticals, Inc. and Wilmington Trust, NationalAssociation (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed February 14,2014, File No. 001-10865)4.13 First Supplemental Indenture, dated as of February 14, 2014, by and between AMAG Pharmaceuticals, Inc. and Wilmington Trust,National Association (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filedFebruary 14, 2014, File No. 001-10865)4.14 Form of 2.50% Convertible Senior Note due 2019 (incorporated herein by reference to Exhibit 4.3 to the Company’s CurrentReport on Form 8-K filed February 14, 2014, File No. 001-10865)4.16 Indenture, dated as of August 17, 2015, by and among AMAG Pharmaceuticals, Inc., the Guarantors party thereto and WilmingtonTrust, National Association, as trustee (incorporated herein by reference to Exhibit 4.1 to the Company’s Current Report on Form8-K filed August 17, 2015, File No. 001-10865)4.17 Form of 7.875% Senior Note due 2023 (incorporated herein by reference to Exhibit 4.2 to the Company’s Current Report on Form8-K filed August 17, 2015, File No. 001-10865)10.1* Representative Form of Indemnification Agreement (incorporated herein by reference to Exhibit 10.2 to the Company’s AnnualReport on Form 10-K for the year ended December 31, 2009, File No. 001-10865)165Table of Contents10.2* AMAG Pharmaceuticals, Inc.’s Non-Employee Director Compensation Policy (incorporated herein by reference to Exhibit 10.1 tothe Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, File No. 001-10865)10.3* AMAG Pharmaceuticals, Inc.’s Amended and Restated 2000 Stock Plan (incorporated herein by reference to Appendix A to theCompany’s Definitive Proxy Statement on Schedule 14A filed December 14, 2005, File No. 0-14732)10.4* AMAG Pharmaceuticals, Inc.’s Third Amended and Restated 2007 Equity Incentive Plan (incorporated herein by reference toAppendix A to the Company’s Definitive Proxy Statement on Schedule 14A filed April 19, 2013, File No. 001-10865)10.5* First Amendment to the AMAG Pharmaceuticals, Inc. Third Amended and Restated 2007 Equity Incentive Plan (incorporatedherein by reference to Appendix B to the Company’s Definitive Proxy Statement on Schedule 14A filed April 16, 2015, FileNo. 001-10865)10.6* Second Amendment to the AMAG Pharmaceuticals, Inc. Third Amended and Restated 2007 Equity Incentive Plan (incorporatedherein by reference to Appendix A to the Company’s Definitive Proxy Statement on Schedule 14A filed April 15, 2016, FileNo. 001-10865)10.7* AMAG Pharmaceuticals, Inc. 2015 Employee Stock Purchase Plan (incorporated herein by reference to Appendix C tothe Company’s Definitive Proxy Statement on Schedule 14A filed April 16, 2015, File No. 001-10865)10.8* Lumara Health Inc. Amended and Restated 2013 Incentive Compensation Plan (incorporated herein by reference to Exhibit 10.6 tothe Company’s Annual Report on Form 10-K for the year ended December 31, 2014, File No. 001-10865)10.9* Form of Incentive Stock Option Agreement for AMAG Pharmaceuticals, Inc. Employees under AMAG Pharmaceuticals, Inc.’sThird Amended and Restated 2007 Equity Incentive Plan and the Lumara Health Inc. Amended and Restated 2013 IncentiveCompensation Plan (incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for thequarter ended June 30, 2013, File No. 001-10865)10.10* Form of Non-Qualified Stock Option Agreement for AMAG Pharmaceuticals, Inc. Employees under AMAG Pharmaceuticals, Inc.’sThird Amended and Restated 2017 Equity Incentive Plan and the Lumara Health Inc. Amended and Restated 2013 IncentiveCompensation Plan (incorporated herein by reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q for thequarter ended June 30, 2013, File No. 001-10865)10.11* Form of Restricted Stock Unit Agreement for AMAG Pharmaceuticals, Inc. Employees under AMAG Pharmaceuticals, Inc.’s ThirdAmended and Restated 2007 Equity Incentive Plan and the Lumara Health Inc. Amended and Restated 2013 IncentiveCompensation Plan (incorporated herein by reference to Exhibit 10.11 to the Company’s Annual Report on Form 10-K for the yearended December 31, 2015, File No. 001-10865)10.12* Form of Non-Qualified Stock Option Agreement for Non-Employee Directors under AMAG Pharmaceuticals, Inc.’s Third Amendedand Restated 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.10 to the Company’s Quarterly Report onForm 10-Q for the quarter ended June 30, 2013, File No. 001-10865)10.13* Form of Restricted Stock Unit Agreement for Non-Employee Directors under AMAG Pharmaceuticals, Inc.’s Third Amended andRestated 2007 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.1 to the Company's Quarterly Report on Form10-Q for the quarter ended June 30, 2016, File No. 001-10865)10.14* Non-Plan Restricted Stock Unit Agreement, by and between AMAG Pharmaceuticals, Inc. and William K. Heiden (incorporatedherein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed May 10, 2012, File No. 001-10865)10.15* Non-Plan Stock Option Agreement, by and between AMAG Pharmaceuticals, Inc. and William K. Heiden (incorporated herein byreference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed May 10, 2012, File No. 001-10865)10.16* Form of Non-Qualified Stock Option Agreement - Non-Plan Inducement Grant (incorporated herein by reference to Exhibit 4.3 tothe Company’s Registration Statement on Form S-8 filed August 7, 2013, File No. 333-190435)10.17* Form of Restricted Stock Unit Agreement - Non-Plan Inducement Grant (incorporated herein by reference to Exhibit 10.18 to theCompany’s Annual Report on Form 10-K for the year ended December 31, 2015, File No. 001-10865)10.18* Form of Employment Agreement between AMAG Pharmaceuticals, Inc. and each of its executive officers (other than William K.Heiden) (incorporated herein by reference to Exhibit 10.19 to the Company’s Annual Report on Form 10-K for the year endedDecember 31, 2015, File No. 001-10865)166Table of Contents10.19* Employment Agreement dated as of February 7, 2014 between AMAG Pharmaceuticals, Inc. and William K. Heiden (incorporatedherein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2014,File No. 001-10865)10.20 Lease Agreement, dated as of May 22, 2008, by and between AMAG Pharmaceuticals, Inc. and Mortimer B. Zuckerman andEdward H. Linde, trustees of 92 Hayden Avenue Trust under Declaration of Trust dated August 18, 1983. This Lease Agreementwas assigned in June 2013. (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filedMay 29, 2008, File No. 0-14732)10.21 Assignment and Assumption of Lease, dated as of June 10, 2013, by and among AMAG Pharmaceuticals, Inc., Mortimer B.Zuckerman and Edward H. Linde, trustees of 92 Hayden Avenue Trust under Declaration of Trust dated August 18, 1983 and ShireHuman Genetic Therapies, Inc. (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-Kfiled June 13, 2013, File No. 001-10865)10.22 Lease Agreement, dated as of June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONY LLC(incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed June 13, 2013, File No. 001-10865)10.23 First Amendment to Lease Agreement, dated June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONYLLC, dated March 24, 2015 (incorporated herein by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q forthe quarter ended March 31, 2015, File No. 001-10865)10.24 Second Amendment to Lease Agreement, dated June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAYCOLONY LLC, dated December 4, 2015 (incorporated herein by reference to Exhibit 10.30 to the Company’s Annual Report onForm 10-K for the year ended December 31, 2015, File No. 001-10865)10.25 Third Amendment to Lease Agreement, dated June 10, 2013, by and between AMAG Pharmaceuticals, Inc. and BP BAY COLONYLLC, dated December 7, 2015 (incorporated herein by reference to Exhibit 10.31 to the Company’s Annual Report on Form 10-Kfor the year ended December 31, 2015, File No. 001-10865)10.26 License Agreement between AMAG Pharmaceuticals, Inc. and Abeona Therapeutics, Inc. (formerly known as PlasmaTechBiopharmaceuticals, Inc. and Access Pharmaceuticals, Inc.) dated as of June 6, 2013 (incorporated herein by reference toExhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2013, File No. 001-10865)(confidential treatment previously granted)10.27 Commercial Supply Agreement, dated effective as of August 29, 2012, by and between AMAG Pharmaceuticals, Inc. and Sigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.3 to the Company’s Quarterly Report on Form 10-Q for the quarterended September 30, 2012, File No. 001-10865) (confidential treatment previously granted)10.28 Amendment No.1 to Commercial Supply Agreement, dated October 3, 2013, by and between AMAG Pharmaceuticals, Inc. andSigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.54 to the Company’s Annual Report on Form 10-K for the yearended December 31, 2013, File No. 001-10865) (confidential treatment previously granted)10.29 Amendment No. 2 to Commercial Supply Agreement, dated April 28, 2015, by and between AMAG Pharmaceuticals, Inc. andSigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for thequarter ended June 30, 2015, File No. 001-10865) (confidential treatment previously granted)10.30 Amendment No. 3 to Commercial Supply Agreement, dated October 19, 2015, by and between the Company and Sigma-Aldrich, Inc. (incorporated herein by reference to Exhibit 10.36 to the Company’s Annual Report on Form 10-K for the year endedDecember 31, 2015, File No. 001-10865) (confidential treatment previously granted)10.31 Pharmaceutical Manufacturing and Supply Agreement, dated effective as of January 8, 2010, by and between AMAGPharmaceuticals, Inc. and Patheon Manufacturing Services LLC (as assignee from DSM Pharmaceuticals, Inc.) (incorporated hereinby reference to Exhibit 10.4 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2012, FileNo. 001-10865) (confidential treatment previously granted)10.32 Amendment No. 1 to Pharmaceutical Manufacturing and Supply Agreement, dated July 5, 2014, by and between AMAGPharmaceuticals, Inc. and Patheon Manufacturing Services LLC (as assignee from DSM Pharmaceuticals, Inc.) (incorporated hereinby reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, FileNo. 001-10865)10.33 Amendment No. 2 to Pharmaceutical Manufacturing and Supply Agreement, dated June 19, 2015, by and between AMAGPharmaceuticals, Inc. and Patheon Manufacturing Services LLC (as assignee from DPI Newco LLC as assignee from DSMPharmaceuticals, Inc.) (incorporated herein by reference to Exhibit 10.1 to the Company’s Quarterly Report on Form 10-Q for thequarter ended September 30, 2015, File No. 001-10865) (confidential treatment previously granted)167Table of Contents10.34+ Amended and Restated Technical Transfer and Supply Agreement, dated as of December 19, 2016, by and between AMAGPharmaceuticals, Inc. and the Pfizer CentreOne Group of Pfizer, Inc. (Certain confidential information contained in this exhibit wasomitted by means of redacting a portion of the text and replacing it with [***]. This exhibit has been filed separately with the SECwithout any redactions pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities and Exchange Act of1934, as amended)10.35 Development and License Agreement, dated September 30, 2014, by and between Lumara Health Inc and Antares Pharma, Inc.(incorporated herein by reference to Exhibit 10.42 to the Company’s Annual Report on Form 10-K for the year endedDecember 31, 2015, File No. 001-10865) (confidential treatment previously granted)10.36 License Agreement, dated January 8, 2017, by and between AMAG Pharmaceuticals, Inc. and Palatin Technologies, Inc.,(incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed February 3, 2017, FileNo. 001-10865) (Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the textand replacing it with [***]. This exhibit has been filed separately with the SEC without any redactions pursuant to a ConfidentialTreatment Request under Rule 24b-2 of the Securities and Exchange Act of 1934, as amended)10.37 Termination Agreement, dated December 29, 2014, by and between AMAG Pharmaceuticals, Inc. and Takeda PharmaceuticalCompany Limited (incorporated herein by reference to Exhibit 10.19 to the Company’s Annual Report on Form 10-K for the yearended December 31, 2011, File No. 001-10865) (confidential treatment previously granted)10.38 Underwriting Agreement, dated as of February 11, 2014, among AMAG Pharmaceuticals, Inc. and J.P. Morgan Securities LLC, onits own behalf and as representative of the several underwriters named in Schedule 1 thereto (incorporated herein by reference toExhibit 1.1 to the Company’s Current Report on Form 8-K filed February 14, 2014, File No. 001-10865)10.39 Base Call Option Transaction Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and JPMorganChase Bank, National Association, London Branch (incorporated herein by reference to Exhibit 10.1 to the Company’s CurrentReport on Form 8-K filed February 14, 2014, File No. 001-10865)10.40 Base Call Option Transaction Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and Royal Bankof Canada (incorporated herein by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed February 14,2014, File No. 001-10865)10.41 Base Call Option Transaction Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and MorganStanley & Co. International plc (incorporated herein by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-Kfiled February 14, 2014, File No. 001-10865)10.42 Base Warrants Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and JPMorgan Chase Bank,National Association, London Branch (incorporated herein by reference to Exhibit 10.4 to the Company’s Current Report onForm 8-K filed February 14, 2014, File No. 001-10865)10.43 Amendment to Warrant Transaction, dated as of February 23, 2015, by and between AMAG Pharmaceuticals, Inc. and J.P. MorganSecurities LLC, as agent (incorporated herein by reference to Exhibit 10.2 to the Company’s Quarterly Report on Form 10-Q forthe quarter ended March 31, 2015, File No. 001-10865)10.44 Base Warrants Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and Royal Bank of Canada(incorporated herein by reference to Exhibit 10.5 to the Company’s Current Report on Form 8-K filed February 14, 2014, FileNo. 001-10865)10.45 Base Warrants Confirmation, dated as of February 11, 2014, between AMAG Pharmaceuticals, Inc. and Morgan Stanley & Co.International plc (incorporated herein by reference to Exhibit 10.6 to the Company’s Current Report on Form 8-K filedFebruary 14, 2014, File No. 001-10865)10.46 Additional Call Option Transaction Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. andJPMorgan Chase Bank, National Association, London Branch (incorporated herein by reference to Exhibit 10.7 to the Company’sCurrent Report on Form 8-K filed February 14, 2014, File No. 001-10865)10.47 Additional Call Option Transaction Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and RoyalBank of Canada (incorporated herein by reference to Exhibit 10.8 to the Company’s Current Report on Form 8-K filedFebruary 14, 2014, File No. 001-10865)10.48 Additional Call Option Transaction Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. andMorgan Stanley & Co. International plc (incorporated herein by reference to Exhibit 10.9 to the Company’s Current Report onForm 8-K filed February 14, 2014, File No. 001-10865)168Table of Contents10.49 Additional Warrants Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and JPMorgan ChaseBank, National Association, London Branch (incorporated herein by reference to Exhibit 10.10 to the Company’s Current Reporton Form 8-K filed February 14, 2014, File No. 001-10865)10.50 Additional Warrants Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and Royal Bank ofCanada (incorporated herein by reference to Exhibit 10.11 to the Company’s Current Report on Form 8-K filed February 14, 2014,File No. 001-10865)10.51 Additional Warrants Confirmation, dated as of February 13, 2014, between AMAG Pharmaceuticals, Inc. and MorganStanley & Co. International plc (incorporated herein by reference to Exhibit 10.12 to the Company’s Current Report on Form 8-Kfiled February 14, 2014, File No. 001-10865)10.52 Credit Agreement, dated as of November 12, 2014, by and among AMAG Pharmaceuticals, Inc., the financial institutions andagents listed therein, and Jefferies Finance LLC (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Reporton Form 8-K filed November 12, 2014, File No. 001-10865)10.53 First Amendment to Credit Agreement, dated March 31, 2015, by and among AMAG Pharmaceuticals, Inc., the Lenders namedtherein, and Jefferies Finance LLC, as administrative agent (incorporated herein by reference to Exhibit 10.6 to the Company’sQuarterly Report on Form 10-Q for the quarter ended March 31, 2015, File No. 001-10865)10.54 Credit Agreement, dated as of August 17, 2015, by and among AMAG Pharmaceuticals, Inc., the financial institutions and agentslisted therein, and Jefferies Finance LLC (incorporated herein by reference to Exhibit 10.1 to the Company’s Current Report onForm 8-K filed August 17, 2015, File No. 001-10865)10.55 Underwriting Agreement, dated as of July 30, 2015, among AMAG Pharmaceuticals, Inc., Jefferies LLC and Barclays Capital Inc.,as representatives of the underwriters named therein (incorporated herein by reference to Exhibit 1.1 to the Company’s CurrentReport on Form 8-K filed July 31, 2015, File No. 001-10865)10.56 Underwriting Agreement, dated as of February 25, 2015, among AMAG Pharmaceuticals, Inc., J.P. Morgan Securities LLC andDeutsche Bank Securities Inc., as representatives of the underwriters named therein (incorporated herein by reference to Exhibit 1.1to the Company’s Current Report on Form 8-K filed February 26, 2015, File No. 001-10865)21.1+ Subsidiaries of AMAG Pharmaceuticals, Inc.23.1+ Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm24.1 Power of Attorney (included on the signature page(s) hereto)31.1+ Certification Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 200231.2+ Certification Pursuant to Rule 13a-14(a)/15d-14(a) of the Exchange Act, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 200232.1++ Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 200232.2++ Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002101.INS+ XBRL Instance Document101.SCH+ XBRL Taxonomy Extension Schema Document101.CAL+ XBRL Taxonomy Extension Calculation Linkbase Document101.DEF+ XBRL Taxonomy Extension Definition Linkbase Document101.LAB+ XBRL Taxonomy Extension Label Linkbase Document101.PRE+ XBRL Taxonomy Extension Presentation Linkbase Document+ Exhibits marked with a plus sign (“+”) are filed herewith.++ Exhibits marked with a double plus sign (“++”) are furnished herewith.* Exhibits marked with a single asterisk reference management contracts, compensatory plans or arrangements, filed in response toItem 15(a)(3) of the instructions to Form 10‑K. The other exhibits listed have previously been filed with the SEC and are incorporated herein by reference, as indicated.169CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.AMENDED AND RESTATED TECHNICAL TRANSFER AND SUPPLY AGREEMENTby and betweenPFIZER INC.andAMAG PHARMACEUTICALS, INC.Dated as of December 19, 2016CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.CONFIDENTIAL DRAFT – FOR DISCUSSION PURPOSES ONLYPage iiDevelopment & Supply Agreement (standard format)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.TABLE OF CONTENTSARTICLE 1 DEFINITIONS 2CERTAIN DEFINED TERMS2ARTICLE 2 PROJECT OVERVIEW 62.1GENERAL PRINCIPLES 62.2COMMERCIALLY REASONABLE EFFORTS 7ARTICLE 3 SERVICE FEES; SCOPE CHANGES; PROJECT MANAGEMENT 73.1TRANSFER FEES 73.2STABILITY STUDIES 73.3CHANGES IN PROJECT SCOPE 73.4STEERING COMMITTEE; PROJECT MANAGER 83.5TECHNICAL TRANSFER SUPPLIES 9ARTICLE 4 REGULATORY SUBMISSIONS; APPROVALS 94.1REGULATORY ASSISTANCE 94.2FACILITY APPROVALS 104.3ACCESS TO DRUG MASTER FILES 104.4USER FEES 104.5OWNERSHIP OF REGULATORY APPROVALS 10ARTICLE 5 PRODUCT MANUFACTURING 105.1PURCHASE AND SALE OF PRODUCTS 105.2MANUFACTURING STANDARDS; CHANGES 115.3PRE-TRANSFER APPROVAL MANUFACTURE 115.4ACTIVE PHARMACEUTICAL INGREDIENT 125.5FACILITY; DEDICATED EQUIPMENT 135.6COMPONENTS; MATERIALS 145.7PRODUCT LABELING 145.8PRODUCT TESTING AND RELEASE 155.9WASTE 175.10MISCELLANEOUS 17ARTICLE 6 FORECASTS; ORDERS; DELIVERY; INVOICING 176.1THREE YEAR PRODUCT SUPPLY FORECAST 17Page iTechnical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.6.2ROLLING FORECAST 176.3PURCHASE ORDERS 186.4PURCHASE ORDER ACCEPTANCE 186.5EXCESS QUANTITIES 186.6FORMAT OF FORECASTS AND PURCHASE ORDERS 186.7PURCHASE ORDER CHANGES; CANCELLATIONS 186.8SHORTAGE OF SUPPLY 196.9DELIVERY 196.10STORAGE FEE 196.11PRICES AND ADJUSTMENTS 206.12INVOICES; PAYMENT 206.13TAXES 206.14CONTINUOUS IMPROVEMENTS 21ARTICLE 7 QUALITY ASSURANCE 227.1QUALITY CONTROL 227.2QUALITY & TECHNICAL AGREEMENT 227.3DOCUMENTATION; BATCH RECORDS; RETENTION SAMPLES 227.4AMAG AUDITS RIGHTS 247.5REGULATORY AUTHORITY INSPECTIONS 247.6CUSTOMER REPRESENTATIVE 257.7CHANGE IN PRODUCT SPECIFICATIONS; MANUFACTURING PROCESS 257.8FAILED BATCH 257.9COMPLAINTS AND ADVERSE DRUG EXPERIENCES 277.10PRODUCT RECALLS 277.11WATER CONTENT SPECIFICATION 27ARTICLE 8 WARRANTIES; COVENANTS; INDEMNIFICATION 288.1MUTUAL REPRESENTATIONS AND WARRANTIES 288.2AMAG’S REPRESENTATIONS, WARRANTIES AND COVENANTS 288.3PFIZER’S REPRESENTATIONS, WARRANTIES AND COVENANTS 298.4INDEMNIFICATION BY AMAG 308.5INDEMNIFICATION BY PFIZER 308.6CONDITIONS OF INDEMNIFICATION 318.7NO CONSEQUENTIAL DAMAGES 31ARTICLE 9 INTELLECTUAL PROPERTY RIGHTS 319.1PFIZER INTELLECTUAL PROPERTY 319.2AMAG INTELLECTUAL PROPERTY 31Page iiTechnical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.ARTICLE 10 TERM AND TERMINATION 3210.1TERM 3210.2TERMINATION OF PROJECT 3210.3GENERAL TERMINATION RIGHTS 3310.4TERMINATION DUE TO REGULATORY CHANGES; MANUFACTURING ISSUES 3310.5CONSEQUENCES OF TERMINATION 3410.6ACCRUED OBLIGATIONS 3510.7NONEXCLUSIVE RIGHTS AND REMEDIES 3510.8SURVIVAL 35ARTICLE 11 CONFIDENTIAL INFORMATION 3611.1NONDISCLOSURE 3611.2EXCEPTIONS TO DUTY OF NONDISCLOSURE 3611.3PUBLIC ANNOUNCEMENTS 3611.4INJUNCTIVE RELIEF 36ARTICLE 12 MISCELLANEOUS 3712.1FORCE MAJEURE AND FAILURE OF SUPPLIERS. 3712.2NOTICES 3712.3GOVERNING LAW 3812.4ALTERNATIVE DISPUTE RESOLUTION 3812.5ASSIGNMENT 3812.6SEVERABILITY 3912.7MODIFICATION OF AGREEMENT; WAIVER 3912.8RELATIONSHIP OF THE PARTIES 3912.9INSURANCE 3912.10EXHIBITS 4012.11BINDING EFFECT 4012.12DEBARMENT WARRANTY 4012.13COMPLIANCE WITH LAWS 4112.14ENTIRE AGREEMENT 4112.15CONSTRUCTION 4112.16COUNTERPARTS 41EXHIBIT 1.4IEXHIBIT 1.26IIEXHIBIT 2.1IIIEXHIBIT 3.2VIIIEXHIBIT 6.10 IXEXHIBIT 7.1XPage iiiTechnical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.EXHIBIT 12.4XIPage ivTechnical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.AMENDED AND RESTATEDTECHNICAL TRANSFER AND SUPPLY AGREEMENTTHIS AMENDED AND RESTATED TECHNICAL TRANSFER AND SUPPLY AGREEMENT (this “Agreement”) ismade as of this 19th day of December, 2016 (the “Effective Date”) by and between AMAG Pharmaceuticals, Inc. (as successor ininterest to Hologic, Inc. and K-V Pharmaceutical Company, via Lumara Health, Inc.) having a principal place of business at 1100Winter Street, Waltham, Massachusetts 02451 (“AMAG”) and the Pfizer CentreOne group of Pfizer, Inc., (as successor in interest tothe One 2 One group of Hospira Worldwide, Inc.) doing business at 275 North Field Drive, Lake Forest, Illinois, 60045, (U.S.A.)(“Pfizer”).WITNESSETH:WHEREAS, under a Development and Supply Agreement dated as of 17 September 2009 (“Original Agreement”) Pfizer hasbeen manufacturing for AMAG […***…] dosage form of Hydroxyprogesterone Caproate Injection, filled and finished in a […***…]glass vial and sold under proprietary name, Makena™ ( formerly, Gestiva™);WHEREAS, pursuant to a First Amendment Agreement signed by the parties effective as of 28 March 2014 (“FirstAmendment”), Pfizer formally accepted the assignment of the Original Agreement to K-V Pharmaceutical Company and agreed toperform certain development activities for and manufacture a […***…] form of the Makena product filled and finished in a […***…]glass vial and subject to certain other terms and conditions as set forth in the First Amendment;WHEREAS, pursuant to a Second Amendment dated as of 13 April 2015 (“Second Amendment”), Pfizer acknowledged theassignment of the Original Agreement from K-V Pharmaceutical Company (via Lumara Health, Inc.) to AMAG and agreed to performcertain commercial stability studies on the […***…] form of the Product;WHEREAS, the parties have since been engaged in negotiations on a draft of a third amendment (“Draft ThirdAmendment”) under which the parties have agreed to include in the Original Agreement commercial terms and conditions regardingprices, price revisions, minimum purchase obligations and other obligations;WHEREAS, the parties have discussed the terms and conditions of a technical transfer program, under which Pfizer willtransfer the manufacture of the Makena product from its […***…] facility to its higher-containment fill-and-finish facility in […***…]; andWHEREAS, in view of the above, both parties have agreed to amend and restate in their entirety the Original Agreement, asamended by the First Amendment and the Second AmendmentCERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.in accordance with the terms and conditions as set forth below for the purposes set forth in these recitals.AGREEMENTNOW THEREFORE, in consideration of the mutual covenants and representations contained in this Agreement and for othergood and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the parties agree as follows:ARTICLE 1DEFINITIONSCertain Defined TermsAs used in this Agreement:1.1 “[…***…] Product” means the Drug in final dosage form, filled in a […***…] vial and if requested in writing by AMAG,shall include labeling and secondary packaging meeting the […***…] Product Specifications.1.2 “[…***…] Product” means the Drug in final dosage form, filled in a […***…] vial and, if requested in writing by AMAG,shall include labeling and secondary packaging meeting the Product Specifications.1.3 “Active Pharmaceutical Ingredient” or “API” means the active pharmaceutical ingredient of the Drug in bulk form thatAMAG will provide to Pfizer for incorporation into the Products, as specified in the Statement of Work.1.4 “Active Pharmaceutical Ingredient Specifications” means the detailed description and parameters of the API, as set forth onExhibit 1.4.1.5 “Adverse Drug Experience(s)” has the meaning as set forth in 21 CFR 310.305 or the substantial equivalent provisions ofother Applicable Laws.1.6 “Affiliate” means any corporation, firm, partnership or other legal entity, which directly or indirectly controls, is controlled byor is under common control with a party to this Agreement. A party will be deemed to “control” another entity if it (a) owns at leastfifty percent (50%) of the equity (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in aparticular jurisdiction) of such other entity, or (b) has the power by contract or otherwise to vote on or direct the management andpolicies of the entity.1.7 “Applicable Law” means all laws applicable to the manufacture, processing, distribution, sale and use of the Product as may beamended and in effect from time to time, including the FD&C Act and all applicable federal, state and local laws and regulations, allapplicable cGMP and all other applicable laws and regulations, of any other applicable jurisdiction.Page 2Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.Page 3Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.1.8 “Business Day” means any day of the week which is not a Saturday, Sunday or legal holiday observed by the United StatesFederal Government and the State governments of Illinois, Massachusetts, Michigan or Kansas.1.9 “Certificate of Analysis” means a document, signed by an authorized representative of Pfizer, describing the ProductSpecifications of and testing methods applied to the Product, and the results thereof. A Certificate of Analysis can also mean adocument, signed by an authorized representative of AMAG, describing the API Specifications of and testing methods applied to theAPI, and the results thereof.1.10 “Certificate of Compliance” means a document signed by an authorized representative of Pfizer attesting that a particular lot,batch or run was manufactured in accordance with cGMP, Applicable Law, and the Product Specifications. The Certificate ofCompliance may be included within the Certificate of Analysis, or separately, if required by AMAG for regulatory purposes orApplicable Law.1.11 “cGMP” means those principles and guidelines of good manufacturing practices as current Good Manufacturing Practices aredefined in the FDA rules and regulations, including the United States regulations set forth at 21 CFR Parts 210-211, as appropriate andas the same may be amended from time to time, and the corresponding requirements of any other applicable jurisdiction.1.12 “Commercial Year” means each period of twelve (12) consecutive calendar months during this Agreement beginning onJanuary 1st and ending December 31st.1.13 “Components” means the excipients, the vials and the component parts of the vials into which the Drug will be filled, and thelabeling, packaging, ancillary goods, shipping materials and other items to be procured by Pfizer from various Components supplier(s)to manufacture the Products in accordance with the Product Specifications.1.14 “Confidential Information” means any and all information disclosed hereunder in writing and identified as being confidentialor, if disclosed orally, visually or through some other media, is identified as confidential at the time of disclosure and is summarized inwriting within […***…] of such disclosure and identified as being confidential, except any portion thereof which:(a)is known to the recipient at the time of the disclosure, as evidenced by its written records or other competentevidence;(b)is disclosed to the recipient by a Third Party lawfully in possession of such information and not under anobligation of nondisclosure;(c)is or becomes patented, published or otherwise part of the public domain through no fault of the recipient;Page 4Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.(d)is developed by or for the recipient independently of Confidential Information disclosed hereunder, asevidenced by the recipient’s written records or other competent evidence; or;(e)is required by law to be disclosed by the recipient, provided, however, that the recipient gives the other partyhereto prompt notice of such legal requirement such that such other party shall have the opportunity to apply for confidential treatmentof such Confidential Information.1.15 “Drug” means the human pharmaceutical compound, Hydroxyprogesterone Caproate.1.16 “Drug Master File” or “DMF” as used in Section 4.3, means the drug master file (as such term is defined in 21 C.F.R. Part314.420) that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing,processing, packaging, and storing of drug products intended for human use.1.17 “Facility” means Pfizer's pharmaceutical manufacturing plant at […***…], or its manufacturing plant in […***…], as thecase may be.1.18 “FDA” means the United States Food and Drug Administration or any successor entity thereto.1.19 “FD&C Act” means the United States Federal Food, Drug and Cosmetic Act (21 U.S.C. 301), as amended from time to time.1.20 “Intellectual Property” or “IP” means all inventions, formulations, processes, works of authorship, and any and all rightsunder U.S. and/or foreign patents, trade secrets, know-how, copyrights, trademarks and other industrial or intangible property rights ofa similar nature and moral rights; all rights pursuant to grants and/or registrations worldwide in connection with the foregoing and allother rights with respect thereto; all rights under applications for any such grant or registration, all rights of priority under internationalconventions to make such applications and the right to control their prosecution, and all rights under amendments, continuations,divisions and continuations-in-part of such application; and all rights under corrections, reissues, patents of addition, extensions andrenewals of any such grant, registration and/or right.1.21 “Manufacturing Process” means any and all processes (or any step in any process) that is provided to Pfizer by AMAG andthat will be used to manufacture the Products, as evidenced in the batch documentation and/or development reports.1.22 “Master Batch Record” shall mean the document that defines the manufacturing methods, materials, and other procedures,directions and controls associated with the manufacture and testing of the Products, which may be amended in writing from time totime by mutual agreement of the parties.Page 5Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.1.23 “MSDS” means the Material Safety Data Sheet for the Products or the API containing such information as may be required byapplicable government agencies.1.24 “Product” means, individually, either the […***…] Product or the […***…] Product, as the context may require orcollectively, the […***…] and the […***…] Products.1.25 “Product Specifications” means those product, labeling and performance specifications for the Products filed with the relevantRegulatory Authority, including Product formulae, labeling, and materials required for the manufacture of the Product that is to bepurchased and supplied under this Agreement, as such are set forth on Exhibit 1.25, which specifications may be amended by theparties from time to time in accordance with this Agreement.1.26 “Quality & Technical Agreement” means the quality agreement, negotiated and signed by authorized representatives of theparties, that governs the essential quality obligations of them in the manufacture, testing and release of the Products hereunder. TheQuality & Technical Agreement may be amended or revised from time to time by the mutual written agreement of the parties.1.27 “Regulatory Approval” means the approval (including any supplements, amendments, pre- and post-marketing approvals),and pricing and reimbursement approvals, licenses, registrations or authorizations of any relevant Regulatory Authority, including theFDA, necessary for the manufacture, distribution, sale or use of the Product in the Territory.1.28 “Regulatory Authority” means any federal, state or local or other regulatory agency, department, bureau or othergovernmental entity (including the FDA), which is responsible for issuing approvals, licenses, registrations or authorizations necessaryfor the manufacture, import, sale and use of the Product in the Territory.1.29 “Specially Regulated Waste” means any hazardous waste, as defined by 40 CFR 261 et seq., requiring specified treatmentand disposal by rules promulgated under federal, state or other relevant laws intended to address such types of waste materials that arisefrom the manufacture of the Product.1.30 “Term” means, individually the Initial Term of this Agreement, or collectively the Initial Term and any Renewal Term, asthose defined terms are used herein.1.31 “Territory” means the United States of America, including the District of Columbia, the Commonwealth of Puerto Rico, allterritories and possessions of the United States of America, United States military bases, and any other location over which the FDAhas jurisdiction to regulate medicinal products intended for human use.1.32 “Third Party” means any party other than Pfizer or AMAG and their respective Affiliates.Page 6Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.1.33 “Waste” means all rejects, improper goods, garbage, refuse, remainder, residue, waste water or other discarded material,including solid, liquid, semisolid, or contained gaseous material that arises from the manufacture of the Product, including rejected,excess or unsuitable materials, API and Products. The term Waste does not include any Specially Regulated Waste.1.34 “Water Content Specification” means the following specification of the Product Specifications: NMT 0.20% w/w.ARTICLE 2 PROJECT OVERVIEW2.1 General PrinciplesThe parties hereby undertake to plan and execute a technical transfer project (“Project”) to transfer the manufacture of theProduct from the […***…] Facility to the […***…] Facility. The Project will include the activities and applicable timelines that areset forth on Exhibit 2.1 (“Statement of Work”). The parties will make all reasonable efforts to finalize the Statement of Work as soonas possible to enable the technical transfer activities to commence prior to the end of the […***…], with an anticipated finish date tooccur no later than the […***…].2.2 Commercially Reasonable EffortsEach party shall use all commercially reasonable efforts successfully to complete the Project. However, the partiesacknowledge and agree that neither of them can guarantee that the Project will be successful, nor warrants that a marketable productwill result from the Project.ARTICLE 3 SERVICE FEES; SCOPE CHANGES; PROJECT MANAGEMENT3.1 Transfer FeesAMAG shall pay Pfizer a […***…] technical transfer fee (the “Transfer Fee”) for its work under the Project in accordancewith the payment schedule set forth in Exhibit 2.1.3.2 Stability StudiesAs outlined in the Statement of Work, Pfizer will prepare pre-market and market-life stability batches of Products and performstability studies (“Stability Work”). The essential obligations of the parties regarding Stability Work and the charges therefor are setforth on Exhibit 3.2.3.3 Changes in Project Scope(a) Changes; Proposal In the event (i) AMAG requests that changes be made to any material aspect of the Project or theProduct Specifications, or (ii) technical difficulties requirePage 7Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.that Pfizer perform either additional work or repeat work, and such additional work is required not because of Pfizer’s fault ornegligence, or (iii) the parties mutually agree to conduct additional work related to the subject matter of this Agreement, Pfizer shallprovide AMAG with terms and conditions of any such additional, repeat or new work, including the scope of work, pricing,timeframes and responsibilities in a proposal to be mutually agreed upon in writing and signed by both parties (each, a “Proposal”).Pfizer’s pricing will reflect professional service fees quoted at a rate of […***…]. Each Proposal shall reference this Agreement, shallbe implemented as a change order, a statement of work or an amendment to this Agreement and the terms and conditions of thisAgreement shall govern and control any and all such additional, repeat or new work; provided, however, that if any provision of anyProposal conflicts with this Agreement, the terms of this Agreement shall prevail with respect to all terms except pricing terms.(b) Expansion of Territory. AMAG shall give Pfizer reasonable prior notice in the event that it desires to pursue marketingand sales activities for the Product in countries or geographic regions outside of the Territory. The parties will then determine thepreparatory work that may be required (if any) and upon agreement, Pfizer shall provide AMAG with all necessary additionaltechnical/developmental and regulatory support, including, for example, regulatory support for AMAG’s supplemental regulatoryfilings, packaging and product development, labeling, and relevant Regulatory Authority inspections. Any additionaltechnical/developmental and regulatory support for such other countries or geographic regions may be considered a change in Projectscope and the Parties will agree to the reasonable incremental costs of such additional support in accordance with Section 3.3(a). Anyadditional pre-approval inspections of the Facility that may be required by relevant Regulatory Authorities as a result shall bereimbursed in accordance with Section 7.5(b).(c) Assignment Fee. In the event that AMAG assigns or otherwise transfers substantially all of its rights and obligationsunder this Agreement to a Third party pursuant to Section 12.5, either to a commercial licensing partner or an acquirer of AMAG’sbusiness, then in each case, Pfizer will be entitled to charge AMAG an assignment fee up to an amount […***…] to cover theanticipated expenses it will incur as a result of the assignment.3.4 Steering Committee; Project Manager(a) Steering Committee. Pfizer and AMAG will jointly constitute a team (“Steering Committee”) comprised of not less thantwo (2) members from each party (or such number as the parties mutually agree). The Steering Committee will meet not less thantwice annually to address any relevant issue a party wishes to call to the attention of the Steering Committee, to review pastperformance on mutually agreed upon metrics, discuss future partnership objectives, and to oversee the relationship between AMAGand Pfizer. The Steering Committee will be considered as a working committee that will have as its goal the prompt and mutuallyagreeable resolution of any financial, technical or quality issues that may arise in order to advance and preserve a harmoniousrelationship established by and between Pfizer and AMAG. Either party may change its representatives on the Steering Committee atany time by written notice to the other party.Page 8Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.(b) Project Team; Project Manager. Promptly upon execution of this Agreement, Pfizer and AMAG shall each designatesuch of their respective employees from product development, quality assurance, manufacturing, and project management to form ateam (“Project Team”) to direct the activities to be carried out under the Statement of Work. Each party shall also designate one of itsemployees to act as its project manager (each, a “Project Manager”), who will be primarily responsible for communicating allinstructions and information concerning the Project to the members of the Project Team. The Project Team and/or the ProjectManagers shall consult periodically during the performance of the Services, through face-to-face meetings, telephone conferencesand/or videoconferences, at times to be mutually agreed upon by the Project Managers. Each party may appoint a substitute orreplacement Project Manager or a member(s) of the Project Team in the absence of its original Project Manager or original member(s)of the Project Team by notifying the other party in writing of such substitution or replacement. Neither the Project Managers nor theProject Team shall have the right to modify, amend or waive any provision of this Agreement.3.5 Technical Transfer SuppliesBased on AMAG’s final Product formulations, concentration and fill volume and the parties’ agreement to the final ProductSpecifications, Pfizer will manufacture the Products as engineering batches and stability batches (“Transfer Supplies”) at the prices setforth in the Statement of Work. The parties acknowledge that Transfer Supplies may include products utilized for technical transferpurposes only (e.g., in engineering runs, or to be used as stability testing materials), which are not intended for commercial sale in themarket, except as otherwise permitted by Applicable Law. In accordance with a schedule to be mutually agreed by the parties, AMAGshall issue its purchase order(s) for such Transfer Supplies at least […***…] before any requested delivery date. For the sake ofclarity, all relevant provisions of Articles 5, 7, 8 and 9 shall apply to the manufacture and delivery of the Transfer Supplies.ARTICLE 4 REGULATORY SUBMISSIONS; APPROVALS4.1 Regulatory AssistanceExcept as otherwise provided herein, AMAG will be solely responsible for obtaining and maintaining any RegulatoryApprovals, licences, registrations or authorizations of any relevant Regulatory Authority required for the manufacture, distribution, saleand use of the Product in the Territory.(a)General Review. In consideration of the Transfer Fees that AMAG will pay under the Statement of Work, uponAMAG’s request, Pfizer will review those portions of AMAG’s proposed regulatory submissions as relate to Pfizer’s manufacturing,packaging and quality control, quality assurance, facilities, personnel, procedures and organization before the submissions are filedwith relevant Regulatory Authorities. Pfizer will use its commercially reasonable efforts to completePage 9Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.its review of AMAG’s submissions as soon as possible, but no later than […***…] after receipt and will promptly inform AMAG ofany anticipated delays.(b)Responses to Regulatory Authorities. At AMAG’s request, Pfizer shall consult with and advise AMAG in respondingto questions from the FDA regarding AMAG’s regulatory submission for the Product, provided, however, that AMAG shall have thefinal control over such submissions. In the event that the FDA or other Regulatory Authority responds to AMAG’s regulatorysubmission that requires a response (including, for example, a technical response to an FDA finding of a deficiency, should one arise)and AMAG requests Pfizer’s review and consultation on such matter which is beyond the scope of the development services to beprovided as set forth in the Statement of Work, Pfizer shall provide AMAG with cost estimates (based on a professional services ratequoted at […***…] for any such additional review and consultation. If AMAG approves such costs in writing, AMAG shallreimburse Pfizer for such approved costs upon completion of the work and within […***…] of receipt of Pfizer’s invoice.4.2 Facility ApprovalsPfizer will secure and maintain in good order, at its sole cost and expense, such current governmental registrations, licences andpermits as are required by Regulatory Authorities in order for Pfizer to perform all of its obligations under this Agreement and tomanufacture the Products at the Facility.4.3 Access to Drug Master FilesPfizer will grant AMAG reference rights to all Drug Master Files necessary to support AMAG’s regulatory filings for theProduct. To affect this, Pfizer will execute certain letters of authorization, which will be delivered to the appropriate RegulatoryAuthorities to permit them to consult Pfizer’s DMFs in their review of AMAG’s Product regulatory submissions. Pfizer will sendcopies of such authorization letters to AMAG. Pfizer will update its DMFs annually and will inform AMAG prior to making anymodifications thereto in order to permit AMAG to amend or supplement any affected regulatory submissions and filings for Product.4.4 User FeesAMAG will pay any Regulatory Authority user fees which may become payable for the Product.4.5 Ownership of Regulatory ApprovalsThe parties agree that AMAG will be the sole and exclusive owner of all right, title and interest in and to all RegulatoryApprovals related to the API and Product and any submissions for such Regulatory Approvals. Pfizer will reasonably assist AMAG inthe preparation of all documents necessary to affect AMAG’s rights in such Regulatory Approval applications and submissions.AMAG will provide to Pfizer for its files a final copy of the CMC section of any such applicationsPage 10Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.and/or submissions for Regulatory Approval. Except as provided in Sections 3.3(a) and 7.5(b), […***…].ARTICLE 5 PRODUCT MANUFACTURING5.1 Purchase and Sale of ProductsPursuant to the terms and conditions of this Agreement and during the Term (subject to the successful completion of theProject), Pfizer shall manufacture, sell and deliver Product to AMAG, and AMAG shall purchase and take delivery of no less than […***…].5.2 Manufacturing Standards; Changes(a) Product Specifications. The Product Specifications are set forth on Exhibit 1.25. The Product Specifications may bemodified from time to time in accordance with the provisions of Section 5.2(b) and Section 7.7.(b) Changes. Pfizer will manufacture the Product in accordance with the Specifications, cGMP and all Applicable Laws, asthen in effect. The parties agree that if AMAG wishes to amend any aspect of its Manufacturing Process or the Product Specifications(“Discretionary Changes”), AMAG will provide written notice thereof to Pfizer for Pfizer’s review and approval, which approvalPfizer will not unreasonably withhold. Furthermore, each party will promptly notify the other of any new instructions or changes tothe Product Specifications that are required by any Regulatory Authority, change in Applicable Laws or other regulatoryrequirements, or by medical concerns related to the toxicity, safety and/or efficacy of the Products (“Required Changes”). The partieswill confer with respect to the best means to comply with such instructions or change requirements; provided, however, that Pfizerwill comply with any reasonable instructions issued by AMAG with respect to implementing any Required Changes. An analyticalimprovement will be considered to be a Discretionary Change unless requested or required by a Regulatory Authority, in which casesuch improvement will be considered a Required Change. All Discretionary or Required Changes will be implemented in accordancewith the change control provisions of the Quality & Technical Agreement.(c) Costs of Changes. Except as may otherwise be agreed in the Statement of Work, Pfizer will be responsible for any andall costs with respect to Required Changes that are required to bring its manufacturing operations into compliance with ApplicableLaws, and AMAG will be responsible for any and all other costs related to Required Changes affecting the Product. AnyDiscretionary Changes to the Product Specifications or the Manufacturing Process initiated by either party will be agreed to by theparties, including which party or parties will be responsible for the funding of such Discretionary Changes.5.3 Pre-Transfer Approval ManufacturePage 11Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.Pfizer agrees to manufacture and supply those quantities of Product requested in firm Purchase Orders issued by AMAG thatare necessary to validate Pfizer’s […***…] Facility, obtain Regulatory Approval(s) and build AMAG’s inventory in anticipation ofsupplying Products from the […***…] Facility (“Validation Batches”). The parties acknowledge that as Validation Batches may besold as commercial products in accordance with Applicable Law, AMAG will pay for such Validation Batches at the commercialprices set forth in Section 6.11(a) and in accordance with the terms and conditions of this Agreement, irrespective of whether theProducts ultimately receive all necessary Regulatory Approval unless the failure to receive Regulatory Approval is due the negligenceor willful misconduct of Pfizer.5.4 Active Pharmaceutical Ingredient(a) API Supply. Unless otherwise provided in the Project Statement of Work or this Agreement, the following provisions willapply to supplies of API by AMAG to Pfizer.(i) AMAG API Supply. Pfizer will manufacture the Product for AMAG from API that AMAG shall supply to Pfizer[…***…]. AMAG will supply API to Pfizer in quantities sufficient to satisfy Pfizer’s gross manufacturing requirements of the Producton lead times discussed and agreed by the Project Managers, but in no event later than […***…] prior to the scheduled start ofmanufacture. Pfizer will use the API received from AMAG only for the technical transfer or activities contemplated by this Agreementand the manufacture of Product for AMAG. AMAG will deliver the API, […***…], the relevant Facility pursuant to […***…]purchase orders that Pfizer issues to AMAG.(ii) API Documentation; Samples. With each delivery of API, AMAG will include a Certificate of Analysis, signedby an authorized individual of AMAG (or its designated API supplier) containing basic information regarding the API, including (A)the manufacturing date of the batch/lot delivered, (B) the batch/lot number, and (C) the quantity of API in such batch/lot as shipped toPfizer. AMAG will also supply a separate sample (“tailgate” sample; “satellite” sample) for each container of API supplied.(iii) Incoming Testing. Within […***…] of Pfizer’s receipt of any API supplied by AMAG, Pfizer will (A) performan identification test on the API and confirm the shipment quantity, (B) perform any other tests mutually agreed upon in writing, and(C) notify AMAG of any inaccuracies with respect to quantity or of any claim that any portion of the shipment fails the identificationor other test. In the event Pfizer notifies AMAG of any deficiency in the quantity or quality of API received, AMAG will promptlyship to Pfizer, […***…], the quantity of API necessary to complete the API shipment. In the event Pfizer notifies AMAG that the APIshipment does not conform to the Active Pharmaceutical Ingredient Specifications, AMAG will have the right to confirm such findingsat the Facility.(iv) API Dispute Resolution. If AMAG determines that such shipment of API conforms to the API Specifications, theparties will submit samples of such shipment to a mutually acceptable independent laboratory for testing. If such independentlaboratory determines that thePage 12Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.shipment conforms to the API Specifications, Pfizer will bear […***…] expenses of shipping and testing such shipment samples. IfAMAG or such independent laboratory confirms that such shipment does not meet the API Specifications, AMAG will replace, […***…] to Pfizer, the portion of the API shipment which does not conform to the API Specifications and bear […***…] expenses ofshipping and testing the shipment samples. Pfizer will dispose of any nonconforming portion of any API shipment as directed byAMAG, at AMAG’s expense.(b) Title. Notwithstanding the DDP shipping terms of Section 5.4(a)(i), AMAG will retain title to the API while it is in thePfizer facility. Pfizer will assume responsibility for the safekeeping, storage, handling and risk of loss for all shipments of APIdelivered hereunder and accepted by Pfizer, subject to the limitation in Section 5.4(c). Subject to AMAG’s ability to supply, Pfizeragrees to hold in storage […***…] at the […***…] Facility a stock of API sufficient to meet Pfizer’s manufacturing obligations ofthe Product for Purchase Orders placed by AMAG within the Firm Order Period. Notwithstanding the foregoing, the parties mayagree to different amounts of API stock to be held at the […***…] Facility during the remainder of the time that Product will bemanufactured at the […***…] Facility.(c) Loss and Replacement of API. In the event of loss or damage of any API delivered hereunder or the failure of Product tomeet Product Specifications, AMAG will supply to Pfizer replacement API according to the terms set forth in Section 5.4(a), except asotherwise provided herein. If the replacement of such API results from the negligent acts or omissions by Pfizer in the manufacture,handling or storage of Product or API, AMAG will supply to Pfizer replacement API and Pfizer will be responsible for […***…].(d) Maximum Liability. Notwithstanding any of the foregoing, in no event shall Pfizer's aggregate liability for the replacementof API exceed […***…]. This Section 5.4(d) states AMAG's sole remedy, and Pfizer's sole liability, for any loss, damage, or misuseof API. The parties acknowledge that these limitations will apply to standard batch sizes manufactured for commercial sale and that thelimitations will be reduced on a pro rata basis for batches of Transfer Supplies that are manufactured on a materially smaller scale.5.5 Facility; Dedicated Equipment(a) Facilities and Equipment. Except as provided below, Pfizer will provide, […***…], all facilities, equipment, machinery,and materials to manufacture the Product in accordance with the Product Specifications, and the professional and other labor necessaryfor the successful performance of its obligations hereunder.(b) Dedicated Equipment. At present, the parties do not anticipate the need for any specialized equipment to manufacture theProduct in accordance with cGMP and the Specifications. However, if in the future such need arises, Pfizer will advise AMAG of anyspecialized or dedicated equipment (“Dedicated Equipment”) that is required and the estimated costs associated with the purchase,installation and validation of the Dedicated Equipment. Pfizer will pay the cost of the Dedicated Equipment, subject to AMAG’s priorwritten approval of such costs, which approval will not be unreasonably withheld or conditioned. Upon such approval, Pfizer will thenpurchase, install and validate the equipment and bill AMAG for the associated costs. AMAG will make payment to Pfizer no later than[…***…] after receipt of Pfizer’s invoice. Title to the Dedicated Equipment shall be and remain in AMAG’s name. Pfizer shall (andshall cause its Affiliates to) (i) label thePage 13Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.Dedicated Equipment as the property of AMAG, (ii) use the Dedicated Equipment solely for the manufacture of the Product for and onbehalf of AMAG, (iii) keep the Dedicated Equipment free of liens, claims and encumbrances, (iv) operate the Dedicated Equipment inaccordance with the manufacturer’s instructions, and (v) maintain the Dedicated Equipment in good working condition and incompliance with cGMP and Applicable Laws. Upon the expiry or earlier termination of this Agreement, Pfizer will return or otherwisedispose of Dedicated Equipment in accordance with Section 10.5(b).5.6 Components; MaterialsUnless otherwise agreed, Pfizer will be responsible for the procurement and qualification of the Components and other rawmaterials required for the manufacture of the Product. Pfizer will procure all of the Components from suppliers that have beenapproved and qualified by Pfizer in accordance with Pfizer’s internal vendor qualification and approval processes. The partiesunderstand and agree that AMAG will have reviewed and approved the Components and Component suppliers listed in the ProductSpecifications. Under no circumstances will Pfizer have any liability to AMAG, nor will Pfizer be deemed to be in breach of thisAgreement, if Pfizer is unable to supply the Product to AMAG due to a failure of such suppliers to provide such Components to Pfizer;provided, however, that Pfizer has used commercially reasonable efforts to obtain the relevant Components from approved Componentsuppliers in accordance with AMAG’s Rolling Forecast and Purchase Orders during the Firm Order Period.5.7 Product Labeling(a) Labeling. Pfizer shall label the Product in accordance with the Product Specifications using content provided by AMAG.AMAG shall control the content and type of all labeling and packaging (and any changes or supplements thereto) for the Product andshall have the responsibility, […***…], for (i) ensuring such content is compliant with the Regulatory Approval and all ApplicableLaw, and (ii) any changes or supplements to such content, including the expense of securing any approvals required by any applicableRegulatory Authority for any such changes or supplements. Pfizer shall be responsible for obtaining such labels (and any changes orsupplements thereto) in accordance with content specified by AMAG.(b) Labeling Changes. Should AMAG request or be required to make any modifications to Product labeling and packaging,it shall submit a written change order to Pfizer containing the requested or required modifications, together with any documentationspecifying the content of the new labeling and packaging, including all necessary photo-ready art (or its substantial equivalent). Pfizershall promptly provide AMAG with a statement of charges for the work to be performed, reflecting professional service fees quoted ata rate of […***…] and its estimated timeline for implementing the changes. Upon written approval by AMAG, which approval shallnot be unreasonably withheld, Pfizer will perform all requested or required labeling and packaging work. AMAG shall pay Pfizer forthe work performed, in addition to reimbursing Pfizer for the cost of any existing labeling and packaging that has become obsolete as aresult of such changes; provided, however, that obsolescence charges do not exceed the amount of labels reasonably required byPage 14Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.Pfizer based on the first […***…] of the most recent […***…] rolling forecast provided under Section 6.2 or such other amount asmutually agreed upon in writing.(c) Bulk Product Supply. As may be specified by AMAG in AMAG’s Purchase Orders from time to time, Pfizer will labeland package quantities of the Products as unlabeled “Brite Stock” for bulk shipment to AMAG or its designated agent, in accordancewith the provisions set forth in the Quality & Technical Agreement.5.8 Product Testing and Release(a) Test Methods. Upon completion of manufacture, Pfizer will test each batch of Products for conformance with the ProductSpecifications and cGMP in accordance with agreed-upon quality control test methods set forth on Exhibit 7.1, the Quality &Technical Agreement or as otherwise requested by AMAG.(b) Documentation. After Pfizer has carried out and reviewed all testing in accordance with its quality control processes,procedures and other agreed test methods, Pfizer will provide AMAG with a Certificate of Analysis (and a Certificate of Compliance,if so required) confirming that the batch was manufactured in conformity with the applicable Product Specifications. Pfizer will alsoprovide copies of batch records and all other documents and records as required by the Quality & Technical Agreement, as well assuch samples of the batch as AMAG may reasonably request. AMAG will review all of the documentation and discuss itsobservations, if any, with Pfizer. Once all observations are resolved, and AMAG has reviewed and approved all of the documentationprovided by Pfizer, AMAG will approve the batch by providing to Pfizer its authorization to release the batch for delivery (“ReleaseAuthorization”). Pfizer will then make the batch available to AMAG at the Facility.(c) Inspection; Rejection. AMAG shall inspect, perform its quality assurance tests, and accept or reject, the correspondingbatch as conforming or non-conforming with the Product Specifications no later than […***…] from the date of AMAG’s receipt ofall documents and records required by the Quality & Technical Agreement (and if, applicable, batch samples). If AMAG rejects thebatch as being non-conforming, it shall promptly notify Pfizer. If, as a result of further review and testing, Pfizer determines that thebatch does conform to the Product Specifications or is otherwise not defective, the parties shall submit samples of such batch to amutually acceptable independent laboratory for testing, in accordance with Section 5.8(f).(d) Deemed Acceptance. Any Product that AMAG does not reject within the […***…] time period will be deemed accepted,and all claims with respect to Product not conforming with the Product Specifications will be deemed to have been waived by AMAG,except as to latent defects, as that term is defined in Section 5.8(h).(e) Product Quantity. If the quantity of Products produced in any batch manufactured and proffered for delivery to AMAG ismaterially less than the quantity specified in the applicable AMAG Purchase Order, then the parties will meet to discuss in good faithand agree to one or more remedies to resolve the shortage in a fair and equitable manner. For purposes of clarity, “materially less” shallmean a batch of Products with an abnormally high number of units either rejected or set aside at Pfizer’s determination for sampling,stability or for other reasons outside of the ordinary course of manufacturing and based on historic experience at the […***…] Facility.Page 15Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.(f) Disputes Regarding Non-Conformity; Independent Testing. Where the parties have submitted batch samples to anindependent laboratory for conformance testing, if such laboratory determines that the batch conformed to the Product Specifications,AMAG shall bear all expenses of shipping and testing such batch samples. If such laboratory confirms that such shipment did not meetthe Product Specifications, Pfizer shall replace, […***…], that portion of the batch which does not conform to the ProductSpecifications, and shall bear […***…] expenses of shipping and testing the batch samples. Any nonconforming portion of any batchshall be disposed of as directed by AMAG, at Pfizer’s expense. The independent laboratory’s results will be in writing and will be finaland binding, save for manifest error on the face of its report. Pfizer will furnish the independent laboratory with such instructionsregarding the storage, handling and potential hazards of any Product as are provided to or developed by Pfizer by or on behalf ofAMAG.(g) Replacement; Disposition of Rejected Product. Pfizer shall use all reasonable efforts to replace, […***…], that portion ofthe batch which does not conform to the Product Specifications as soon as possible, given manufacturing capacities and scheduling atthe Facility; provided, however, that AMAG provides sufficient replacement API to Pfizer in accordance with the provisions ofSection 5.4(c). Pfizer shall dispose of any rejected Products at its own cost and expense.(h) Latent Defects. Notwithstanding the acceptance provisions of Section 5.8(c) and Section 5.8(d), AMAG will have theright to reject any batch of Products that are subsequently found to be non-conforming due to latent defects. For purposes of thisSection 5.8(h), “latent defects” are any defects in the Product which are not discoverable using ordinary diligence and reasonable carein applying the quality control and test methods specified in the Quality & Technical Agreement, render the Product not conforming toProduct Specifications and are solely caused by Pfizer. The parties will consult to confirm the cause of the latent defects. If the partiesdo not agree as to whether the Product is non-conforming, they will submit samples of such Product for independent testing inaccordance with Section 5.8(f). If it is confirmed that the cause of the latent defect is attributable to Pfizer, then Pfizer will replace […***…] all such latently defective Products with Products that meet the Product Specifications, subject to the provisions of Section5.4(c) and the limitations of Section 5.4(d). All other relevant provisions of this Section 5.8 will apply to the inspection, testing andrelease of such replacement Products.5.9 WastePfizer will be responsible for the removal and disposal of all Waste resulting from Pfizer’s manufacturing of the Product,consistent with the Product’s MSDS; […***…]. Pfizer will ensure that Specially Regulated Waste is disposed only at approved sitesand through waste management handlers that have been approved in writing by AMAG. Pfizer will document the disposal anddestruction of Specially Regulated Waste in writing and provide copies of the written documentation to an authorized representative ofAMAG. AMAG will have the right, but not the obligation, to witness the actual disposal of Specially Regulated Waste. AMAG willprovide the MSDS for the API and the MSDS for the Product to Pfizer at Pfizer’s written request.5.10 MiscellaneousPage 16Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.(a) Process Rework. Pfizer will not rework or reprocess a Product unless authorized in advance by AMAG in writing andthere is a validated process for such rework or reprocessing of Product. Re-inspection does not constitute rework or reprocessing.Process rework that may become necessary as a result of AMAG’s changes will be billed separately at a reasonable fee to be mutuallyagreed between the parties in writing.(b) Sub-Lots. Should AMAG desire Pfizer to split a manufacturing lot of Product into two (2) or more sub-lots duringpackaging, Pfizer will charge a split fee of […***…] for each sub-lot packaged.ARTICLE 6 FORECASTS; ORDERS; DELIVERY; INVOICING6.1 […***…] Product Supply ForecastFor capacity planning purposes, by […***…] of each Commercial Year AMAG will provide Pfizer with a non-binding,written forecast of its estimated annual requirements of the Product during each of the next […***…] (“Annual Forecast”).6.2 Rolling ForecastDuring each calendar quarter thereafter, AMAG will provide to Pfizer a good faith, estimated rolling forecast of the quantity ofProducts that AMAG expects to order for the coming […***…] period of time (each, a “Rolling Forecast”). The first […***…] ofeach Rolling Forecast shall be considered a binding commitment upon AMAG to purchase quantities described therein and a bindingcommitment upon Pfizer to produce and deliver such quantities on the delivery dates described therein (“Firm Order Period”). Thelast […***…] of each Rolling Forecast shall be non-binding upon the Parties.6.3 Purchase OrdersAMAG shall submit each order for Product (“Purchase Order”) to Pfizer at least […***…] prior to AMAG’s requesteddelivery date. Pfizer shall use its commercially reasonable efforts to meet the delivery dates set forth in each Purchase Orders. AllPurchase Orders shall reference this Agreement and shall be governed exclusively by the terms contained herein. AMAG shall setforth in each Purchase Order (a) the quantity of Product ordered, (b) the amount of API required to fill the Purchase Order, (c) thespecified delivery date and delivery instructions, and (d) the price to be paid for the Product.6.4 Purchase Order AcceptancePfizer will confirm each Purchase Order issued in accordance with Section 6.3 […***…] after receipt and shall confirm inwriting to AMAG its acceptance of the Purchase Order, the delivery date(s), the quantity of Products ordered and the purchase price tobe paid by AMAG.Page 17Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.6.5 Excess QuantitiesPfizer will accept all Purchase Orders specifying quantities of Product up to […***…] in excess of the quantities listed in thecorresponding Firm Order Period. Pfizer will not be obligated to supply quantities of Product over and above such […***…] excessamount (“Non-Binding Excess”) but will use commercially reasonable efforts to manufacture and deliver to AMAG all or part of theNon-Binding Excess as soon as reasonably practicable.6.6 Format of Forecasts and Purchase OrdersAMAG will submit each Rolling Forecast and all Purchase Orders electronically in spreadsheet form and will specify thequantities of Products in units and the Pfizer product number (list number/inventory number).6.7 Purchase Order Changes; Cancellations(a) Changes. If AMAG requests that changes be made to any of its Purchase Orders within the Firm Order period, Pfizer willattempt to accommodate such changes within reasonable manufacturing capabilities and efficiencies. If Pfizer can accommodate suchchanges, Pfizer will advise AMAG of any costs associated therewith. If AMAG indicates in writing to Pfizer that it should proceed tomake the changes, AMAG will be deemed to have accepted the obligation to pay Pfizer for such costs. If Pfizer cannot accommodatesuch change, AMAG will nonetheless be bound to its original Purchase Orders.(b) Cancellations. If AMAG cancels any Purchase Order […***…], Pfizer will be relieved of its manufacturing obligationsrelating to such order but AMAG will not be relieved of its payment obligation unless Pfizer agrees to waive such obligation inwriting. Furthermore, if AMAG does not supply sufficient API (without providing appropriate notification to Pfizer and allowing for aperiod for both companies to evaluate the impact of such delay in API delivery) to allow Pfizer to fulfill any Purchase Order or actsimproperly in any other manner effectively to prevent Pfizer’s ability to perform, such action shall be deemed a cancellation andAMAG will remain liable for the full amount of the Purchase Order, regardless of whether Pfizer manufactures the Product or whetherAMAG takes delivery of the Product.6.8 Shortage of SupplyShortage of Supply. In the event that Pfizer is unable to manufacture the Product in accordance with AMAG’s PurchaseOrders, Pfizer shall notify AMAG as soon as possible. If the inability is not (a) caused by an event of force majeure, (b) attributable inwhole or in part to AMAG's acts or omissions or breach of its obligations under this Agreement, or (c) attributable in whole or in partto Pfizer’s Component suppliers’ acts or omissions, then Pfizer shall be solely responsible for undertaking all commercially reasonablemeasures to minimize any possible shortage of Product to AMAG as a result of its manufacturing issues. If Pfizer cannot undertakesuch measures promptly, then either party may request that the Project Managers convene a meeting to discuss possiblePage 18Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.remedial action, which may include a reduction in AMAG’s Minimum Purchase Requirements for the applicable Commercial Year.6.9 DeliveryPfizer will deliver the Product to AMAG […***…] (Incoterms 2010), the relevant Facility. […***…]. Pfizer will not deliverany Product to AMAG until (a) Pfizer has released such Product pursuant to the Specifications and the terms of the Quality &Technical Agreement, and (b) AMAG has issued to Pfizer its Release Authorization. […***…]. For any shipments outside of theUnited States, AMAG will be the exporter of record; provided, however, that Pfizer will assist AMAG, […***…], in the preparationof any required export documentation. AMAG will be responsible for all shipping validation and transportation quality control. ShouldAMAG request or require Pfizer to include electronic temperature monitoring devices (“Loggers”) with any shipping cartons of theProduct, it will comply with Pfizer’s policies on the use of and responsibilities for Loggers set forth on Exhibit 6.9.6.10 Storage Fee(a) Commercial Products. AMAG will use its commercially reasonable efforts to take delivery of all Products from theFacility no later than […***…] after the date of insurance of its Release Authorization. If AMAG anticipates that it will not be able tomeet the delivery date, it will notify Pfizer promptly that Pfizer should store the Products at the Facility on an interim basis andindicate a date certain on which it will take delivery. Pfizer will have the right to charge AMAG a storage fee of […***…] during thisinterim period. […***…].(b) Storage of Transfer Supplies. Product generated from any engineering, registration or process validation or verificationbatched will be stored […***…] at Pfizer’s […***…] Facility at controlled room temperature until FDA has granted RegulatoryApproval for the manufacture of the Products at that site.6.11 Prices and Adjustments(a) Pricing. Effective as of […***…], Pfizer shall invoice AMAG for the Products it delivers to AMAG at the Price(s) as setforth in the table below. Each invoice shall reference the Price(s) in effect on the date of Pfizer’s invoice. All pricing is firm through[…***…].ProductSizePrice Per Unit ($)Quote #Makena[…***…][…***…]10248Makena[…***…][…***…]10249Makena[…***…][…***…]10250Makena[…***…][…***…]10251(b) […***…]Page 19Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.(c) […***…](d) Comprehensive Pricing. For the avoidance of doubt, the Product pricing includes all finished and bulk packagingsupplies (i.e., labeling, packaging shipping and bulk shipping cases and pallets).6.12 Invoices; PaymentPfizer will invoice AMAG […***…]. AMAG will make payment of all amounts in Pfizer’s invoices […***…] from the dateof receipt of Pfizer’s invoice. In the event of a good faith dispute between the parties as to the amount due, AMAG will pay theundisputed amount and the parties will attempt to resolve the disputed payment within […***…].6.13 TaxesAMAG shall pay all federal, state, county or municipal sales or use tax, excise, customs charges, duties or similar charge, orany other tax assessment (other than that assessed against income), licence, fee or other charge lawfully assessed or charged on themanufacture, sale or transportation of the Product that Pfizer manufactures, sells and delivers pursuant to this Agreement. In particular,AMAG will be responsible for and pay all applicable annual establishment fees specified in the Prescription Drug User FeeAmendments to the FD&C Act, with respect to the Product. For the avoidance of doubt, AMAG shall not be required to pay any suchannual fees as relate to the Pfizer Facility, which shall be Pfizer’s sole and exclusive obligation. AMAG shall provide Pfizer withcopies of any state tax exemption form(s) if it intends to claim exemption for sales or use taxes in any state(s) where the Product is to beshipped.6.14 Continuous ImprovementsPfizer shall use reasonable commercial efforts to identify any opportunity to reduce the cost of manufacturing the Product andshall notify AMAG of such cost reduction opportunities (“Cost Reduction Program”). AMAG and Pfizer agree to confer in goodfaith to capitalize on such opportunities by sharing in the cost of implementation. Any cost savings realized from the Cost ReductionProgram shall be shared in proportion to each party’s financial contribution to such program’s development and implementation costs.ARTICLE 7 QUALITY ASSURANCE7.1 Quality ControlPfizer will apply its quality control procedures and in-plant quality control checks on the manufacture of Product for AMAGin the same manner as Pfizer applies such procedures and checks to products of similar nature manufactured for sale by Pfizer. Pfizerwill also test and release all batches of Product in accordance with the test methods described in Exhibit 7.1 to ensure that the Productsmeet the requirements of the Product Specifications and are manufactured in accordance with cGMP.Page 20Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.7.2 Quality & Technical AgreementThe parties have entered into a Quality & Technical Agreement dated June 25, 2012 and amended June 10, 2014, whichagreement shall continue to govern the quality assurance aspects of Pfizer’s manufacture of Product at its […***…] Facility.Notwithstanding the foregoing, authorized personnel of the parties must negotiate and conclude a new Quality & TechnicalAgreement as necessary for purposes of this Agreement and the Statement of Work and before any cGMP manufacture of Productcan take place at the Pfizer […***…] Facility. Upon its execution, the new Quality & Technical Agreement shall be deemed to beincorporated by reference herein.7.3 Documentation; Batch Records; Retention Samples(a) Quality Assurance Documentation. Pfizer will prepare such records documenting the technical transfer work as foreseenin the Project Statement of Work or as are otherwise reasonably requested by AMAG. Pfizer will prepare batch manufacturingrecords, which include the information relating to the manufacturing, packaging and quality operations for each lot of Product at thetime such operations occur. Pfizer will prepare all technical transfer work and batch records in accordance with Applicable Laws, theQuality & Technical Agreement, cGMP and any similar regulations of applicable Regulatory Authorities and Pfizer’s standardoperating procedures. Upon AMAG’s request, Pfizer will provide AMAG with copies of such technical transfer records and batchproduction records, including manufacturing and analytical records.(b) Document Retention. Pfizer will retain all records documenting the technical transfer work and all records relating to themanufacture of each batch of Products for not less than […***…] or for such other period as required by Applicable Law. Thereafter,Pfizer will not destroy such records without giving AMAG prior written notice and the opportunity further to store such records or tohave such records shipped to AMAG, at AMAG’s cost and expense.(c) Retention Samples. Pfizer will be responsible for storing and maintaining retention samples of each batch of Productdelivered to AMAG and associated API and other raw materials in accordance with cGMP and the Quality & Technical Agreement.7.4 AMAG Audits Rights(a) General Audit. Upon […***…] prior written notice to Pfizer, AMAG shall have the right to have representatives visitthe Facility during normal business hours to perform a quality assurance audit and inspection to review Pfizer’s records and itsproduction Facilities relating to the manufacturing, assembly and/or packaging of Product and assess its compliance with cGMP andquality assurance standards and to discuss any related issues with Pfizer’s manufacturing and management personnel. Pfizer shallprovide AMAG with copies of Pfizer’s manufacturing records (including the Master Batch Record) and other relevant documentationrelating to the Products for the purposes of assuring Product quality and compliance with agreed-upon manufacturing procedures.Such general audits shall (i) be limited to not more than […***…] designated by or representing AMAG, (ii) last for […***…], and(iii) may be conducted not more […***…]. AnyPage 21Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.auditors who are not employees of AMAG shall be required to enter into confidentiality agreements with Pfizer and AMAGcontaining terms of confidentiality at least as stringent as those set forth in Article 11.(b) For Cause Audits. AMAG shall also have the right to conduct “for-cause” audits to address significant product or safetyconcerns as discovered through Product failures related to Pfizer’s manufacture of the Product. Product failures would include issuesrelated to stability, out of specification, sterility, labeling or container integrity. AMAG shall notify Pfizer in writing in advance of theaudit and thereafter, AMAG and Pfizer shall mutually determine the timing of the audit. Each for-cause audit shall be limited to […***…] designated by or representing AMAG for […***…], except if the parties mutually agree that a longer for-cause audit period isnecessary.(c) Confidential Information in Audits. Audits by AMAG or its designees may involve the transfer of ConfidentialInformation, and any such Confidential Information shall be subject to the terms of Article 11 hereof. The results of such audits andinspections shall be considered Confidential Information under Article 11 and shall not be disclosed to Third parties, […***…],unless required by law and only then upon prior written notice to Pfizer.7.5 Regulatory Authority Inspections(a) Inspections. Pfizer also agrees to allow the FDA and any other relevant Regulatory Authority to conduct any Pre-Approval Inspection (“PAI”) or other audit they require of the […***…] Facility and Pfizer agrees to cooperate with the FDA andany other relevant Regulatory Authority in connection with such inspection. Pfizer will provide AMAG with notice of any PAI assoon as practicable. The parties shall consult regarding the nature, extent, duration of such inspection so as to determine whetherAMAG may have an interest to send its personnel or representatives to the Facility. Upon agreement, Pfizer shall allow suchrepresentatives to be present at the Facility during the FDA inspection to the extent permitted by Applicable Law.(b) Additional PAIs. In the event that AMAG has requested to expand the Territory and a Regulatory Authority other thanthe FDA requests or requires a PAI audit of the Facility in connection therewith, Pfizer will be entitled to charge a supplementaryaudit fee of […***…] per each such PAI.7.6 Customer Representative(a) In addition to the audit rights stated in Section 7.4, Pfizer shall also permit a representative of AMAG (“CustomerRepresentative”) to be present in the relevant Facility to view certain Product manufacturing steps from time-time when the Productsare being manufactured, provided that such Customer Representative (i) schedules the visit at least […***…] in advance (ii) complieswith all applicable state and federal laws prior to and during such visits, and (iii) adheres to all applicable Pfizer corporate and securitypolicies and procedures. While at the Facility, the Customer Representative must be escorted by a Pfizer employee and will haveaccess solely such areas of the Facility that are (iv) reasonably related to view the manufacturingPage 22Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.steps for the Product, (v) food-service areas, (vi) designated office space as may be allocated to the Customer Representative, (vii)public areas within the facility, or (viii) as otherwise authorized by Pfizer. AMAG acknowledges and agrees that such CustomerRepresentative visiting the Facility shall be bound by terms of confidentiality no less restrictive than those set forth in Article 11.(b) With respect to any Customer Representative, Pfizer shall provide […***…] AMAG (i) access to an on-site workspace,(ii) a conference room (if necessary for meetings), access to which shall be available per the scheduling process used by Pfizeremployees, (iii) parking facilities and toilet facilities, and (iv) reasonable access to and use of telephone, facsimile and photocopyingservices as necessary.7.7 Change in Product Specifications; Manufacturing ProcessExcept as otherwise provided in Section 5.2, and as foreseen in the technical transfer Project as set forth in the Statement ofWork detailing the technical transfer of the Product to the […***…] Facility, each of AMAG and Pfizer agrees that it will not changethe Product Specifications or any aspect of the Manufacturing Process (including change of the Components, equipment, processes orprocedures used to manufacture Product) without the prior written approval of the other party, which approval will not beunreasonably withheld, delayed, or conditioned. Upon agreement, the parties will implement all such changes in accordance with thechange control provisions of the relevant Quality & Technical Agreement.7.8 Failed BatchIn accordance with the Quality & Technical Agreement, Pfizer will investigate, and cooperate fully with AMAG ininvestigating, any batch of Product that fails to comply with cGMP or fails to meet the Product Specifications or any RegulatoryAuthority requirements. Pfizer will keep AMAG informed of the status of any investigation and, upon completion of the investigation,will provide AMAG with a final written report describing the cause of the failure and summarizing the results of the investigation.7.9 Complaints and Adverse Drug ExperiencesEach party will promptly advise the other of any complaints, notices of Adverse Drug Experience(s) or event reports, safetyissues or toxicity issues relating to the Products of which it becomes aware, and which may be the result of, or have an effect on, theProduct manufacturing operations performed by Pfizer. AMAG will be responsible for all reporting of such information to RegulatoryAuthorities. Pfizer will promptly evaluate any complaint or notice of Adverse Drug Experience(s) and reasonably assist AMAG inresponding to the same.7.10 Product Recalls(a) Recalls. In the event (i) any Regulatory Authority or other national government authority issues a request, directive ororder that the Product be recalled, (ii) a court of competentPage 23Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.jurisdiction orders such a recall, or (iii) AMAG or Pfizer reasonably determines that Product should be recalled, the parties will takeall appropriate corrective actions, and will cooperate in any governmental investigations surrounding the recall.(b) Product Replacement; Expenses. In the event that such recall results from a breach of Pfizer’s express warranties underSections 8.3(a) and 8.3(b), Pfizer will be responsible for replacing the quantity of Products that were recalled […***…]. Pfizer willuse all commercially reasonable efforts to replace such Product as soon as practicable, given scheduling at the Facility. […***…].7.11 Water Content Specification(a) Water Content Specification Failures. Both parties acknowledge that Pfizer manufactures the Product as a non-aqueoussolution in production environments that use water for injection ubiquitously. Despite all reasonable efforts that Pfizer may take atboth the […***…] Facilities to mitigate the risk for water in the Product, there remains a possibility that Pfizer will not meet thedesignated Water Content Specification of NMT 0.20% w/w. If technical difficulties arise with Water Content Specification in one (1)of more batches of Product, the parties agree that the following terms and conditions shall apply.(b) Water Content Specification Remediation. All provisions in the Agreement regarding responsibilities for re-manufacturing of failed batches, replacement of API, recalls and the like will be tolled until the parties have discussed, examined anddetermined the root cause of the failure to meet the Water Content Specification. Provided that Pfizer has used all reasonable efforts totransfer, validate and implement the remediation measures described in Section 7.11(c), below, and the parties agree that Pfizer shouldperform either additional work or repeat work to mitigate any risks relating to the Water Content Specification, Pfizer shall provideAMAG with terms and conditions of any such additional, repeat or new work, including the scope of work, pricing, timeframes andresponsibilities in a separate Proposal. In the event the root cause of the failure to meet the Water Content Specification is due to thegross negligence or wilful misconduct of Pfizer, the parties shall agree to any additional or repeat work and which party shall bear theresponsibility for such work. Pfizer’s pricing will be in accordance with the provisions of Section 3.3(a). Pfizer will then carry out thework contained in the Proposal and any necessary changes will be made to the Product Specifications and implemented in accordancewith the change control provisions of the relevant Quality & Technical Agreement. […***…].(c) Technical Transfer of Water Specification Remediation. Pfizer will ensure that it includes in the technical transferStatement of Work, all information, data, work product and results (including specifications, processes and implementation) regardingthe remediation work on the Water Specification performed at the […***…] Facility. Notwithstanding any of the foregoing, Pfizershall be required to meet the Water Content Specification, and the exceptions described herein shall not longer apply, after Pfizer hasdelivered to AMAG […***…] batches of conforming commercial Product manufactured at the […***…] Facility.Page 24Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.ARTICLE 8 WARRANTIES; COVENANTS; INDEMNIFICATION8.1 Mutual Representations and WarrantiesEach party represents, warrants and covenants to the other party that:(a) Good Standing. It is duly incorporated, validly existing and in good standing under the laws of the state in which it isincorporated;(b) Power and Authority. It has the corporate power and authority to enter into this Agreement and perform its obligationshereunder and the execution, delivery and performance of this Agreement and the performance of its obligations hereunder have beenduly authorized and approved by all necessary action and no other action on the part of it is necessary to authorize the execution,delivery and performance of this Agreement;(c) Existence of Claims. There are no suits, claims, or proceedings pending, or to its best knowledge and belief, after dueinquiry, threatened against it or any of its Affiliates in any court or by or before any governmental body or agency which would affectits ability to perform its obligations under this Agreement; and(d) No Conflicts. The performance of its obligations under this Agreement will not result in a material violation or breach ofany agreement, contract, commitment or obligation to which it is a party or by which it is bound and will not conflict with or constitutea default under its corporate charter or bylaws.8.2 AMAG’s Representations, Warranties and CovenantsAMAG represents and warrants to Pfizer that:(a) all API that AMAG provides to Pfizer will, at the time of delivery, not be adulterated or misbranded within the meaningof the FD&C Act or within the meaning of any other Applicable Law in which the definitions of adulteration and misbranding aresubstantially the same as those contained in the FD&C Act, as the FD&C Act and such laws are constituted and effective at the timeof delivery, and will not be an article which, under the provisions of Sections 404 and 505 of the Act, may not be introduced intoInterstate Commerce;(b) all API that AMAG provides to Pfizer will have been manufactured in accordance with all applicable cGMP (includingICH Q7A) and meets the API Specifications;(c) all specifications, including API Specifications and Product Specifications that AMAG provides to Pfizer will conform tothe Regulatory Approval (and any modifications or amendments thereto) that AMAG files with the FDA and other relevantRegulatory Authorities;Page 25Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.(d) it will not sell any Product into any regulatory jurisdiction unless and until it receives and/or maintains the necessaryRegulatory Approval(s); and(e) AMAG’s Intellectual Property, proprietary technology, Manufacturing Processes or other proprietary rights that AMAGprovides to Pfizer under this Agreement does not infringe any patents or know-how of a Third Party.8.3 Pfizer’s Representations, Warranties and CovenantsPfizer represents and warrants to AMAG that:(a) all Product that Pfizer delivers to AMAG hereunder will, at the time of delivery, not be adulterated or misbranded withinthe meaning of the FD&C Act or within the meaning of all Applicable Law in which the definitions of adulteration and misbrandingare substantially the same as those contained in the FD&C Act, as the FD&C Act and such laws are constituted and effective at thetime of delivery and will not be an article which may not under the provisions of Sections 404 and 505 of the FD&C Act be introducedinto interstate commerce;(b) all Product Pfizer delivers to AMAG hereunder will, at the time of delivery, be free from defects in material andworkmanship and will be manufactured (i) in accordance and conformity with the Product Specifications, and (ii) in compliance withall Applicable Laws, including those relating to the environment, food or drugs and occupational health and safety, including thoseenforced or promulgated by the FDA (including compliance with cGMP); and(c) in its performance of its obligations under this Agreement, Pfizer will not knowingly incorporate into the ManufacturingProcess any patents or know-how of a Third party for which it does not have a licence that permits it to do so and/or to be able to grantto AMAG the licences and other rights otherwise required to be granted to AMAG hereunder.(d) The foregoing warranties will not extend to any nonconformity or defect which relates to or is caused by API supplied byAMAG to Pfizer. Subject to Pfizer’s indemnity obligations in Section 8.5, the replacement provisions of Sections 5.4(c), 5.4(d), 5.8(g),5.8(h) and 7.10(b) will be AMAG’s sole and exclusive remedies for nonconforming or defective Products.(e) PFIZER MAKES NO OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS.PFIZER HEREBY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIEDWARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.8.4 Indemnification by AMAGAMAG hereby agrees to save, defend, indemnify and hold harmless Pfizer and its Affiliates and their respective officers,directors, employees, contractors, consultants and agents (each, a “Pfizer Indemnitee”) from and against any and all losses, damages,liabilities, expenses and costs,Page 26Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.including reasonable legal expense and attorneys’ fees (“Losses”), to which any Pfizer Indemnitee may become subject as a result ofany claim, demand, action or other proceeding by any Third party (a “Claim”) against a Pfizer Indemnitee arising or resulting directlyor indirectly from (a) AMAG’s breach of any representation or warranty set forth in Section 8.1 or Sections 8.2(a) - 8.2(e), (b)infringement of any Intellectual Property right of any Third party relating to the API Specifications, Product Specifications, API, Drug,Product or the Manufacturing Process, other than Pfizer’s processes used in the manufacture of the Product pursuant to this Agreement,(c) the use of or lack of safety or efficacy of the Product, or (d) any negligent or wrongful act or omission on the part of AMAG, itsemployees, agents or representatives and which relate to AMAG’s performance hereunder except, in each case, to the extent suchLosses result from the negligence or willful misconduct of any Pfizer Indemnitee or the breach by Pfizer of any express warranty orrepresentation made by Pfizer in this Agreement.8.5 Indemnification by PfizerPfizer will indemnify and hold harmless AMAG and its Affiliates and their respective officers, directors, employees,contractors, consultants and agents (each, a “AMAG Indemnitee”) from and against any and all Losses to which any AMAGIndemnitee may become subject as a result of any Claim against a AMAG Indemnitee arising or resulting, directly or indirectly, from(a) Pfizer’s breach of any representation or warranty set forth in Section 8.1 or Sections 8.3(a) and 8.3(b), (b) infringement of anyIntellectual Property right of any Third party relating to Pfizer’s manufacturing processes used in the manufacture of Product pursuantto this Agreement (excluding the API Specifications, Product Specifications, API, Drug, Product or the Manufacturing Process), or (c)any negligent or wrongful act or omission on the part of Pfizer, its employees, agents or representatives and which relate to Pfizer’sperformance hereunder except, in each case, to the extent such Losses result from the negligence or willful misconduct of any AMAGIndemnitee or the breach by AMAG of any express warranty or representation made by AMAG in this Agreement.8.6 Conditions of IndemnificationIf either party seeks indemnification from the other hereunder, it will promptly give notice to the other party of any Claim andwill cooperate fully with the other party in the investigation and defense of all such Claim. The indemnifying party will have the optionto assume the other party’s defense in any such Claim with counsel reasonably satisfactory to the other party. In the event theindemnifying party assumes such defense, the indemnified party will have the right, but not the obligation, to be represented by counselof its own selection and at its own expense. No settlement or compromise will be binding on a party hereto without its prior writtenconsent, such consent not to be unreasonably withheld.8.7 No Consequential DamagesNEITHER PARTY WILL BE LIABLE TO THE OTHER FOR INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE,EXEMPLARY OR CONSEQUENTIAL DAMAGES, LOST PROFITS, BUSINESS OR USE RESULTING FROM ANYBREACH OF THIS AGREEMENT, EVEN IFPage 27Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY THEREOF, AND REGARDLESS OF THE LEGAL OREQUITABLE THEORY (CONTRACT, TORT, OR OTHERWISE).ARTICLE 9 INTELLECTUAL PROPERTY RIGHTS9.1 Pfizer Intellectual PropertyPfizer has granted no license, express or implied, to AMAG to use Pfizer proprietary technology, know-how or otherproprietary rights (a) existing as of the Effective Date, or (b) developed by or for Pfizer on or after the Effective Date outside the scopeof any Project undertaken by Pfizer pursuant to this Agreement. Pfizer shall be the sole owner of any proprietary technology, know-how or other proprietary rights developed by or for Pfizer pursuant to any Project undertaken by Pfizer (the “Project Inventions”).However, Pfizer shall grant to AMAG, and does hereby grant to AMAG, an exclusive (even as to Pfizer), royalty-free, paid up,worldwide, perpetual license under such Project Inventions to make, have made, use, offer for sale, sell, and/or import Drug andProduct.9.2 AMAG Intellectual PropertyAMAG has granted no license, express or implied, to Pfizer to use AMAG’s proprietary technology, know-how or otherproprietary rights other than for the purposes of this Agreement.ARTICLE 10 TERM AND TERMINATION10.1 Term[…***…].10.2 […***…][…***…].10.3 General Termination RightsEither party may terminate this Agreement:(a)Bankruptcy. Immediately by providing written notice to the other party: (i) if proceedings in voluntary or involuntarybankruptcy are initiated by, on behalf of or against the other party (and, in the case of any such involuntary proceeding, not dismissed[…***…]; or (ii) if the other party is adjudicated bankrupt, files a petition under applicable insolvency laws, is dissolved or has areceiver appointed for substantially all of its property; orPage 28Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.(b)Material Breach. By giving to the other party […***…] prior written notice upon the breach of any warranty or anyother material provision of this Agreement by the other party if the breach is not cured within […***…] after written notice thereof tothe party in default; or(c)Force Majeure. Upon simple notice to the other party should the other party continue to be unable to perform itsobligations under this Agreement for a period in excess of […***…] by reason of force majeure, in accordance with Section 12.1(a).10.4 Termination in Part Due to Regulatory Changes; Manufacturing IssuesPfizer may terminate this Agreement with respect to the manufacture of the Product at the […***…] Facility:(a) Regulatory Authority Mandates. In the event that the FDA or any other Regulatory Authority issues a regulation,directive, guideline or other guidance (e.g., prohibiting or placing onerous burdens on manufacturing of hormonal or other specialtyclasses of medicinal products in the same facility where other standard pharmaceuticals are manufactured) and that materially affectsPfizer’s ability to manufacture and supply the Product or any other Pfizer products at its […***…] manufacturing plant; or(b) Manufacturing Issues. In the event that Pfizer experiences quality issues, manufacturing problems or other relatedcircumstances that (i) arise in the course of manufacturing the Product for AMAG, (ii) are beyond Pfizer’s reasonable ability to controlin the current configuration of the […***…] Facility (including cross-contamination of other lines or products, EHS-related problems;etc.), and (iii) adversely affect Pfizer’s ability to manufacture at the […***…] manufacturing plant the Product […***…].(c) Notice of Termination in Part. In such case, Pfizer shall promptly notify AMAG in writing, setting out a detaileddescription of the circumstances. The parties will consult in good faith to attempt to find a commercially reasonable solution for at least[…***…]. If the parties are not able to find such a commercially reasonable solution, Pfizer may provide notice to AMAG that it willterminate manufacture of the Product at the […***…] Facility no later than […***…] after notice, or for such shorter period if somandated by the FDA or other Regulatory Authority (“Notice Period”).(d) Manufacturing Obligations During Notice Period. During the Notice Period, AMAG shall have the right to purchase,and Pfizer the obligation to manufacture and supply, Products in accordance with the principles set forth in this Section 10.4(d). Theparties agree (i) in each […***…] period during the Notice Period, AMAG’s Purchase Orders shall not exceed the average total of[…***…] of its orders during the most recent Firm Order Period (as defined in this Agreement), and (ii) that such orders permit finaltest, release and delivery of Products no later than […***…]. Except to complete AMAG’s Purchase Orders during the NoticePeriod, Pfizer shall be not be obligated to deviate from its processes for manufacturing the Products or incur any additional costs orexpenses and shall use its best efforts to meet AMAG’s requirements.Page 29Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.(e) Termination of Obligations. In the event that Pfizer is required or permitted to give termination notice hereunder and thetechnical transfer Project is completed, validation batches of Product are successfully manufactured at the […***…] Facility and the[…***…] site PAI is issued and approved, any remaining obligations to manufacture Product at the McPherson Facility, either underthis Section 10.4 or under this Agreement, will lapse and no longer be of any effect.10.5 Consequences of TerminationExcept as provided in Section 10.4, upon expiry or termination of this Agreement for whatever reason the parties will wind-upthis Agreement and settle all outstanding issues in accordance with the principles described below.(a) Cessation of Manufacturing. Pfizer will cease all manufacturing-in-progress and other ongoing activities in an orderlymanner, unless Pfizer reasonably determines that manufacturing-in-progress or other ongoing activities must be completed in order tocomply with applicable laws and regulations.(b) Disposition of Inventory, API, Dedicated Equipment. At a time to be mutually agreed between the parties, Pfizer willreturn to AMAG, at AMAG’s option and election (i) any quantities of work-in-progress at price(s) to be mutually agreed, (ii) anyinventory of API remaining in Pfizer’s possession, and (iii) all items of Dedicated Equipment. All expenses associated with thepreparation, packing and delivery of the work-in-progress, API, and Dedicated Equipment shall be borne by AMAG, unlesstermination shall have been as a result of a material breach by Pfizer, in which case Pfizer will be responsible for such expenses. IfAMAG does not elect to take back the work-in-progress, API, or Dedicated Equipment, Pfizer have the discretion to dispose of suchitems as it deems appropriate.(c) Reimbursement for Components and Materials. In addition, AMAG will reimburse Pfizer for Pfizer’s cost of allComponents and other raw materials purchased and on hand or on order, if such Components and materials were ordered by Pfizerbased on AMAG’s Product forecasts, and Pfizer cannot reasonably use such Components and materials for other purposes. Pfizer willinvoice AMAG for all amounts due hereunder and AMAG will pay such invoice on the terms set forth in Section 6.12.(d) Return of Confidential Information. Upon expiry or earlier termination of this Agreement for any reason, each partyshall immediately return to the other all of the other party’s Confidential Information, in any form or medium disclosed by thedisclosing party. In lieu of returning all Confidential Information, each party shall have the option to destroy any ConfidentialInformation in place and/or purge it from its respective electronic information systems; provided, however, that neither party shall berequired to destroy any computer files stored securely by a party that are created during automatic system back-up. Notwithstandingthe foregoing, each party shall be allowed to retain one (1) copy of the other’s Confidential Information to ensure continuingcompliance with Article 11.10.6 Accrued ObligationsTermination of this Agreement will not relieve either party of any liability which has accrued prior to the effective date of suchtermination, nor will it prejudice either party’s right to obtainPage 30Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.performance of any obligation provided for in this Agreement, which by its express terms or context survive termination.10.7 Nonexclusive Rights and RemediesTermination is not an election of remedies. Except as otherwise provided herein, all rights and remedies of the parties providedunder this Agreement are not exclusive and are in addition to any other rights and remedies provided by law or under this Agreement.10.8 SurvivalThe terms, provisions, representations, and warranties contained in this Agreement that by their sense and context are intendedto survive the performance hereof by either or both parties will so survive the completion of performance and termination of thisAgreement, including, confidentiality obligations and the making of any and all payments due hereunder.ARTICLE 11 CONFIDENTIAL INFORMATION11.1 NondisclosureIt is contemplated that in the course of the performance of this Agreement each party may, from time to time, discloseConfidential Information to the other. Pfizer agrees that, except as expressly provided herein, it will not disclose ConfidentialInformation received from AMAG, and will not use Confidential Information disclosed to it by AMAG, for any purpose other than tofulfill Pfizer’s obligations hereunder. AMAG agrees that, except as expressly provided herein, it will not disclose ConfidentialInformation received from Pfizer, and will not use Confidential Information disclosed to it by Pfizer, for any purpose other than tofulfill AMAG’s obligations hereunder. Each party will use reasonable and customary precautions to safeguard the other party’sConfidential Information, including ensuring that it will limit the permitted disclosures of the other’s Confidential Information only tothose persons who have a “need to know” such Confidential Information and ensuring that all employees, consultants and agents whoare given access to such Confidential Information are informed of the confidential and proprietary nature of such ConfidentialInformation and have contractual or professional confidentiality and non-use obligations that are at least as restrictive as thosecontained in this Agreement.11.2 Exceptions to Duty of NondisclosureNotwithstanding the above, nothing contained in this Agreement will preclude AMAG or Pfizer from utilizing ConfidentialInformation as may be necessary in prosecuting the patent rights of AMAG pursuant to Article 9, obtaining Regulatory Approval(s),manufacturing the Product pursuant to the terms and conditions of this Agreement, or complying with Applicable Laws or court orders(provided, however, that the party disclosing such information uses reasonable efforts to seek confidential treatment of suchinformation, except as required to file and prosecute suchPage 31Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.patent applications). The obligations of the parties relating to Confidential Information will expire […***…] after the termination ofthis Agreement.11.3 Public AnnouncementsNeither party will make any public announcement concerning the transactions contemplated herein, or make any publicstatement which includes the name of the other party or any of its Affiliates, or otherwise use the name of the other party or any of itsAffiliates in any public statement or document, except as may be required by law or judicial order, without the written consent of theother party, which consent will not be unreasonably withheld. Subject to any legal or judicial disclosure obligation, any such publicannouncement proposed by a party that names the other party will first be provided in draft to the other party.11.4 Injunctive ReliefThe parties acknowledge that either party’s breach of this Article 11 may cause the other party irreparable injury for which itwould not have an adequate remedy at law. In the event of a breach, the non-breaching party may be entitled to injunctive relief inaddition to any other remedies it may have at law or in equity.ARTICLE 12 MISCELLANEOUS12.1 Force Majeure and Failure of Suppliers.(a) Force Majeure. Neither party will be considered to be in breach of this Agreement if a delay in the performance of any ofits duties or obligations hereunder (except the payment of money) has been caused by or is the result of an act of God, acts of a publicenemy, acts of terrorism, insurrections, riots, embargoes, labor disputes, including strikes, lockouts, job actions, boycotts, fires,explosions, floods, shortages of material or energy, or other unforeseeable causes beyond the control and without the fault ornegligence of the party so affected (each an event of “force majeure”). The performance of the affected party will be extended for aperiod equal to the period of such delay; provided, however, that affected party will give prompt notice to the other party of such cause,and will promptly take whatever reasonable steps are necessary to relieve the effect of such force majeure and resume compliance withthis Agreement as soon as possible. Should the event of force majeure continue for a period longer than […***…], then the party notso affected may terminate this Agreement in accordance with Section 10.3(c).(b) Transfer of Production. If Pfizer becomes subject to an event of force majeure which interferes with production ofProduct at the Facility, the parties will mutually agree on implementation of an agreed-upon action plan to transfer production ofProduct to another Pfizer manufacturing facility. The parties will, after the execution of this Agreement and at the request of eitherparty, meet to discuss and define such an action plan.Page 32Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.12.2 NoticesAll notices, requests, claims, demands and other communications between the parties will be in writing. All notices will begiven (a) by delivery in person, (b) by a nationally recognized next day courier service, (c) by first class, registered or certified mail,postage prepaid, (d) by facsimile, or (e) by PDF scanned copy sent by electronic mail to the following addresses of the respectiveparties:If to AMAG:AMAG Pharmaceuticals, Inc.1100 Winter StreetWaltham, MA 02451Attention: SVP Technical OperationsEmail: smcmillan@amagpharma.comWith a copy to:AMAG Pharmaceuticals, Inc.1100 Winter StreetWaltham, MA 02451Attention: General CounselEmail: jvittiglio@amagpharma.comIf to Pfizer:Pfizer Worldwide, Inc.275 North Field DriveLake Forest, Illinois 60045Attention: V.P. Contract ManufacturingFacsimile: (224) 212-3210Email: kevin.orfan@prizer.comWith copy to:Pfizer Inc.235 East 42nd StreetNew York, NY 10017Attention: General CounselFacsimile: (212) 309 0874Email: generalcounsel@pfizer.comNotices will be effective (w) upon receipt, if personally delivered, (x) is sent by courier, one (1) Business Day after the deliverytime promised by the nationally recognized next day courier service, (y) if delivered by facsimile or electronic mail, on first BusinessDay after the date of receipt by the transmitting person of written confirmation of successful transmission (which confirmation may beproduced by the transmitting person’s facsimile or electronic mail equipment), or (z) four (4) Business Days after being deposited in theUnited States mail, with proper postage and documentation, for first-class registered or certified mail, prepaid. A party may change itsaddress listed above by written notice to the other party.12.3 Governing LawThis Agreement will be construed, interpreted and governed by the laws of the State of New York, excluding its choice of lawprovisions. The United Nations Convention on the International Sale of Goods is hereby expressly excluded.12.4 Alternative Dispute ResolutionThe parties recognize that bona fide disputes may arise which relate to the parties’ rights and obligations under this Agreement.The parties agree that except as provided in Section 11.4, any such dispute will be resolved by alternative dispute resolution inaccordance with the procedures set forth in Exhibit 12.4.Page 33Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.12.5 AssignmentNeither party will assign this Agreement nor any part thereof without the prior written consent of the other party; provided,however, that either party may, without such consent, assign the rights and obligations of this Agreement (a) to one of its Affiliates,subsidiaries or parent corporation, and (b) in connection with the transfer, sale or divestiture of substantially all of its business to whichthis Agreement pertains or in the event of its spin-off, merger or consolidation with another company. Any permitted assignee willassume all obligations of its assignor under this Agreement. No assignment will relieve either party of responsibility for theperformance of any accrued obligation which such party then has hereunder.12.6 SeverabilityThis Agreement is subject to the restrictions, limitations, terms and conditions of all applicable governmental regulations,approvals and clearances. If any term or provision of this Agreement will for any reason be held invalid, illegal or unenforceable in anyrespect, such invalidity, illegality or unenforceability will not affect any other term or provision hereof, and this Agreement will beinterpreted and construed as if such term or provision, to the extent the same will have been held to be invalid, illegal or unenforceable,had never been contained herein.12.7 Modification of Agreement; WaiverNo waiver or modification of any of the terms of this Agreement will be valid unless in writing and signed by authorizedrepresentatives of both parties. Failure by either party to enforce any such rights under this Agreement will not be construed as awaiver of such rights, nor will a waiver by either party in one or more instances be construed as constituting a continuing waiver or asa waiver in other instances12.8 Relationship of the PartiesThe relationship of the parties under this Agreement is that of independent contractors. Nothing contained in this Agreement orthe performance of any obligations under this Agreement will create an association, partnership, joint venture, or relationship ofprincipal and agent, master and servant, or employer and employee between the parties hereto. Neither party has any express orimplied right or authority under this Agreement to assume or create any obligations or make any representations or warranties on behalfof or in the name of the other party or its Affiliates.12.9 InsuranceEach party will procure and maintain, at its own expense, for the duration of the Agreement, and for […***…] thereafter ifwritten on a claims made or occurrence reported form, the types of insurance specified below with carriers rated A- VII or better withA. M. Best or like rating agencies:Page 34Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.(a) Workers’ Compensation in accordance with applicable statutory requirements and minimum […***…] EmployersLiability and each party shall provide a waiver of subrogation in favor of the other party and its affiliate;(b) Commercial General Liability including premises operations, products & completed operations, blanket contractualliability, personal injury and advertising injury including fire legal liability for bodily injury and property damage in an amount not lessthan […***…] per occurrence and not less than […***…] in the aggregate;(c) Commercial Automobile Liability for owned, hired and non-owned motor vehicles with a combined single limit in anamount not less than […***…] each occurrence;(d) Marine Insurance covering all shipments from warehouse to warehouse as described on the bill of lading at fullreplacement cost, except as otherwise provided herein.Each party will include the other party and its Affiliates, directors, officers, employees and agents as additional insureds withrespect to Commercial General Liability (via CG20101185 or its equivalent), Commercial Automobile Liability and Excess Liabilitybut only as required by written contract. Prior to commencement of the development services, and annually thereafter, each party willfurnish to the other party certificates of insurance evidencing the insurance coverages stated above. At least […***…] written notice tothe other party shall be provided prior to any cancellation, non-renewal or material change in said coverage. In the case of cancellation,non-renewal or material change in said coverage, each party will promptly provide to the other party a new certificate of insuranceevidencing that the coverage meets the requirements in this Section 12.9. Each party, to the extent of its negligence, agrees that itsinsurance will act as primary and noncontributory from any other valid and collectible insurance maintained by the other party. Eachparty may, at its option, satisfy, in whole or in part, its obligation under this Section 12.9 through its self- insurance program. […***…]. Each party shall provide a waiver of subrogation in favor of the other party and its affiliates on all required coverages, above.All deductibles/retentions are the sole responsibility of the named insured.12.10 ExhibitsAll Exhibits referred to herein are hereby incorporated by reference.12.11 Binding EffectThis Agreement will be binding upon and inure to the benefit of each of the parties and such party’s successors and permittedassigns.12.12 Debarment WarrantyPage 35Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.Pfizer and AMAG represent and warrant that neither party uses nor will use in the future use in any capacity the services of anyperson debarred under Section (a) or (b) of 21 U.S.C. Section 335a.12.13 Compliance with LawsEach party will comply with all Applicable Laws, statutes, rules and regulations governing its performance of the terms of thisAgreement.12.14 Entire AgreementThis Agreement and the Quality & Technical Agreement, together with the Exhibits referenced and incorporated herein,constitute the entire agreement between the parties concerning the subject matter hereof and supersede all written or oral prioragreements or understandings with respect thereto. If there is any conflict, discrepancy, or inconsistency between the terms of theQuality & Technical Agreement, this Agreement or other form used by the parties, the Quality & Technical Agreement will control asregards all issues related to quality assurance; in all other cases, the Agreement will control.12.15 ConstructionIn construing this Agreement, unless expressly specified otherwise (a) references to Articles, Sections and Exhibits are toarticles, sections of, and exhibits to, this Agreement, (b) except where the context otherwise requires, use of either gender includes theother gender, and use of the singular includes the plural and vice versa, (c) headings and titles are for convenience only and do notaffect the interpretation of this Agreement, (d) any list or examples following the word “including” will be interpreted withoutlimitation to the generality of the preceding words, (e) except where the context otherwise requires, the word “or” is used in theinclusive sense, (f) all references to “dollars” or “$” herein will mean United States Dollars, and (g) each Party represents that it hasbeen represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting hereof.In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption will apply against theParty which drafted such terms and provisions. Any terms or conditions contained in an invoice that are inconsistent or in conflict withthis Agreement will be deemed not to be a part of such invoice.12.16 CounterpartsThis Agreement may be executed in any number of counterparts, each of which will be deemed an original, and all of whichtogether will constitute one and the same instrument. Signatures provided by facsimile transmission or in Adobe™ Portable DocumentFormat (PDF) sent by electronic mail will be deemed to be original signatures. Any party delivering an executed counterpart of thisAgreement by facsimile or electronic mail will also deliver an original executed counterpart, but the failure to do so will not affect thevalidity, enforceability or binding effect of this Agreement.Page 36Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.THE IMMEDIATELY FOLLOWING PAGE IS THE EXECUTION PAGEPage 37Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.IN WITNESS WHEREOF, the parties intending to be bound by the terms and conditions hereof have caused this Agreementto be signed by their duly authorized representatives as of the date first above written.PFIZER INC.AMAG PHARMACEUTICALS, INC.By: /s/ Kevin Orfan (Signature)By: /s/ William K. Heiden (Signature)Name: Kevin OrfanName: William K. HeidenTitle: Vice President Pfizer CentreOne Global Pharmaceutical ServicesChief Executive OfficerPage 38Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.EXHIBIT 1.4API SpecificationsActive Pharmaceutical Ingredient, Hydroxyprogesterone Caproate USP, SpecificationsTest MethodAcceptance CriteriaMethod of AcceptanceAppearance (Visual)[…***…]Pfizer to TestColor (Visual)[…***…]Vendor CoAVisible impurities (Visual)[…***…]Vendor CoAIdentification - IR ( USP <197K> )[…***…]Pfizer to TestAssay (UV Spectroscopy)[…***…]Vendor CoAFree Caproic Acid (USP Titrimetric Assay)[…***…]Vendor CoAMelting Point (USP <741> Class Ia)[…***…]Vendor CoARelated Substances (Ordinary Impurities)- TLC (USP <466>)[…***…]Vendor CoAResidual Solvents (Gas Chromatography) USP <467> Cyclohexane Hexane Methanol Methylene chloride […***…]Vendor CoASpecific Rotation (USP <781S>; 25°C/1% in chloroform/anhydroussubstance)[…***…]Vendor CoAWater – KF (USP <921>, Method I)[…***…]Vendor CoABioburden EP2.6.12 / USP <61> (Total Viable Aerobic Count)[…***…]Pfizer to testBacterial Endotoxin (USP <85>; Gel-Clot Limit Test)[…***…]Pfizer to testEXHIBIT 1.25Product SpecificationsAMAG and Pfizer will consult and use all reasonable efforts to prepare and complete the Product Specifications no later than […***…]after the Effective Date. Upon completion, the Product Specifications shall be attached to this Exhibit 1.25 and shall be made an integralpart of this Agreement.Exhibit Page 39Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.EXHIBIT 2.1Project Statement of Work[…***…]Exhibit Page 40Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.EXHIBIT 2.1Project Statement of Work (cont’d)[…***…]Exhibit Page 41Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.EXHIBIT 2.1Project Statement of Work (cont’d)[…***…]Exhibit Page 42Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.EXHIBIT 2.1Project Statement of Work (cont’d)[…***…]Exhibit Page 43Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.EXHIBIT 2.1Project Statement of Work (cont’d)[…***…]EXHIBIT 3.2Stability StudiesStability TestingReq.Not Req.N/AResponsibilityCostPfizerClientEngineering stability X N/ARegistration batch stabilityX X […***…]Annual Commercial Product stabilityX […***…]Total Cost:TBD[…***…]Payment:[…***…] Timing:TBD EXHIBIT 6.9Pfizer Logger PoliciesThe following policies shall apply for all shipments of Commercial Products and Development Supplies (including drug productsamples from development Batches) in which a Pfizer CentreOne customer AMAG requests or requires that electronic temperaturemonitoring devices (“Loggers”) be included in the shipment as a means of supplementary assurance of complying with the controlledroom temperature storage/shipping conditions under which the products should be maintained.It is Pfizer’s policy that if a Pfizer CentreOne Customer desires to include Loggers in shipments of tested and released CommercialProducts, the Pfizer CentreOne Customer must supply the Loggers at its own cost and responsibility.For shipments of Development Supplies or drug product samples from development Batches, it is Pfizer’s preference that the PfizerCentreOne Customer also supply the Loggers at its own cost and expense. However, as an accommodation to its Pfizer CentreOneCustomer, Pfizer is willing to provide standard, non-specialized Loggers to be included the Development Supply or drug productsample shipment as a supplementary means of assuring that the shipment has been made under controlled room temperaturestorage/shipping conditions. Pfizer procures Loggers from reputable third party vendors and relies on the representations andwarranties of these vendors for the quality and correct functioning of the Temptale devices. Although Pfizer will doExhibit Page 44Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.a preliminary check on the Loggers to ensure that they are functioning as intended before placing them in the drug product shipmentpacking and containers, it will perform no detailed testing or undertake any special calibration before use.Pfizer therefore cannot be responsible and will not be liable to any Pfizer CentreOne Customer for any and all losses, damages,liabilities, expenses and costs arising from any claim or allegation that the Loggers supplied by Pfizer have failed in their intended useduring shipment of the Development Supplies or drug product samples. The Pfizer CentreOne Customer acknowledges and agrees thatthe failure or improper functioning of the Pfizer-supplied Loggers will not give rise to any cause of action against Pfizer or serve as abasis for the Pfizer CentreOne Customer to reject the shipment of the Development Supplies or drug product samples.In addition, if Pfizer is requested to provide Loggers on accommodation, Pfizer will only supply the Temptale devices. It is the PfizerCentreOne Customer’s responsibility to have acquired the hardware and software from the Temptale manufacturer that is necessary toread the data collected by the Temptale during shipment.The Pfizer CentreOne Customer may be requested to sign a document acknowledging its understanding and acceptance of the above-stated Temptale policies.EXHIBIT 7.1Product Test MethodsIn consultation with AMAG, no later than […***…] after the Effective Date, Pfizer will use all reasonable efforts to prepare andcomplete documentation describing the procedures, methods and protocols by which the Product will be tested and released, asspecified in Section 7.1 of this Agreement. Upon completion, such documentation shall be attached to this Exhibit 7.1 and shall bemade an integral part of this Agreement.EXHIBIT 12.4Alternative Dispute ResolutionThe Parties recognize that bona fide disputes as to certain matters may arise from time to time during the term of this Agreementwhich relate to either party’s rights and/or obligations. To have such a dispute resolved by this Alternative Dispute Resolution (“ADR”)provision, a party first must send written notice of the dispute to the other party for attempted resolution by good faith negotiationsbetween their respective presidents (or their designee(s), provided any such designee has the authority to act on behalf of such party toeffectuate any such resolution) of the affected subsidiaries, divisions, or business units within […***…] days after such notice isreceived (all references to “days” in this ADR provision are to calendar days).If the matter has not been resolved within […***…] days of the notice of dispute, or if the Parties fail to meet within such […***…] days, either party may initiate an ADR proceeding as provided herein. The Parties shall have the right to be represented bycounsel in such a proceeding.Exhibit Page 45Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.1. To begin an ADR proceeding, a party shall provide written notice to the other party of the issues to be resolved by ADR. Within[…***…] days after its receipt of such notice, the other party may, by written notice to the party initiating the ADR, add additionalissues to be resolved within the same ADR.2. Within […***…] days following receipt of the original ADR notice, the Parties shall select a mutually acceptable neutral havingrequisite legal expertise and credentials (including with respect to the substantive law of the State of New York) to preside in theresolution of any disputes in this ADR proceeding. If the Parties are unable to agree on a mutually acceptable neutral within suchperiod, either party may request the President of the CPR Institute for Dispute Resolution (“CPR”), 366 Madison Avenue, 14th Floor,New York, New York 10017, to select a neutral pursuant to the following procedures:(a) The CPR shall submit to the Parties a list of not less than […***…] candidates within […***…] days after receipt of therequest, along with a Curriculum Vita for each candidate. No candidate shall be an employee, director, or shareholder of either party orany of their subsidiaries or Affiliates.(b) Such list shall include a statement of disclosure by each candidate of any circumstances likely to affect his or herimpartiality.(c) Each party shall number the candidates in order of preference (with the number one (1) signifying the greatest preference)and shall deliver the list to the CPR within […***…] days following receipt of the list of candidates. If a party believes a conflict ofinterest exists regarding any of the candidates, that party shall provide a written explanation of the conflict to the CPR along with its listshowing its order of preference for the candidates. Any party failing to return a list of preferences on time shall be deemed to have noorder of preference.(d) If the Parties collectively have identified fewer than […***…] candidates deemed to have conflicts, the CPR immediatelyshall designate as the neutral the candidate for whom the Parties collectively have indicated the greatest preference. If a tie should resultbetween two candidates, the CPR may designate either candidate. If the Parties collectively have identified […***…] or morecandidates deemed to have conflicts, the CPR shall review the explanations regarding conflicts and, in its sole discretion, may either (i)immediately designate as the neutral the candidate for whom the Parties collectively have indicated the greatest preference, or (ii) issuea new list of not less than […***…] candidates, in which case the procedures set forth in subparagraphs 2(a)-2(d) shall be repeated.3. No earlier than […***…] days or later than […***…] days after selection, the neutral shall hold a hearing to resolve each of theissues identified by the Parties. The ADR proceeding shall take place at a location agreed upon by the Parties. If the Parties cannotagree, the neutral shall designate a location other than the principal place of business of either party or any of their subsidiaries orAffiliates.4. At least […***…] days prior to the hearing, each party shall submit the following to the other party and the neutral:(a) a copy of all exhibits on which such party intends to rely in any oral or written presentation to the neutral;Exhibit Page 46Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.(b) a list of any witnesses such party intends to call at the hearing, and a short summary of the anticipated testimony of eachwitness;(c) a proposed ruling on each issue to be resolved, together with a request for a specific damage award or other remedy foreach issue. The proposed rulings and remedies shall not contain any recitation of the facts or any legal arguments and shall not exceedone (1) page per issue.(d) a brief in support of such party’s proposed rulings and remedies, provided that the brief shall not exceed forty (40) pages.This page limitation shall apply regardless of the number of issues raised in the ADR proceeding.Except as expressly set forth in subparagraphs 4(a)-4(d), no discovery shall be required or permitted by any means, includingdepositions, interrogatories, requests for admissions, or production of documents.5. The hearing shall be conducted on […***…] consecutive days and shall be governed by the following rules:(a) Each party shall be entitled to […***…] hours of hearing time to present its case. The neutral shall determine whethereach party has had the […***…] hours to which it is entitled.(b) Each party shall be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony,documents or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses shall occurimmediately after their direct testimony, and cross-examination time shall be charged against the party conducting the cross-examination.(c) The party initiating the ADR shall begin the hearing and, if it chooses to make an opening statement, shall address not onlyissues it raised but also any issues raised by the responding party. The responding party, if it chooses to make an opening statement,also shall address all issues raised in the ADR. Thereafter, the presentation of regular and rebuttal testimony and documents, otherevidence, and closing arguments shall proceed in the same sequence.(d) Except when testifying, witnesses shall be excluded from the hearing until closing arguments.(e) Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances.Affidavits prepared for purposes of the ADR hearing also shall not be admissible. As to all other matters, the neutral shall have solediscretion regarding the admissibility of any evidence.6. Within […***…] days following completion of the hearing, each party may submit to the other party and the neutral a post-hearing brief in support of its proposed rulings and remedies, provided that such brief shall not contain or discuss any new evidenceand shall not exceed […***…] pages. This page limitation shall apply regardless of the number of issues raised in the ADRproceeding.7. The neutral shall rule on each disputed issue within […***…] days following completion of the hearing. Such ruling shall adopt inits entirety the proposed ruling and remedy of one of the Parties on each disputed issue but may adopt one party’s proposed rulings andremedies on some issues and the other party’sExhibit Page 47Technical Transfer & Supply Agreement (signature version)CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[…***…]”. ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT UNDER RULE 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED.proposed rulings and remedies on other issues. The neutral shall not issue any written opinion or otherwise explain the basis of theruling or award.8. The neutral shall be paid a reasonable fee plus expenses. These fees and expenses, along with the reasonable legal fees andexpenses of the prevailing party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and anyexpenses for a hearing room, shall be paid as follows:(a) If the neutral rules in favor of one party on all disputed issues in the ADR, the losing party shall pay […***…] of suchfees and expenses.(b) If the neutral rules in favor of one party on some issues and the other party on other issues, the neutral shall issue with therulings a written determination as to how such fees and expenses shall be allocated between the Parties. The neutral shall allocate feesand expenses in a way that bears a reasonable relationship to the outcome of the ADR, with the party prevailing on more issues, or onissues of greater value or gravity, recovering a relatively larger share of its legal fees and expenses.9. The rulings of the neutral and the allocation of fees and expenses shall be binding, non-reviewable (except for an alleged act ofcorruption or fraud on the part of the arbitrator), and non-appealable, and may be entered as a final judgment in any court havingjurisdiction.10. Except as provided in paragraph 9 or as required by law, the existence of the dispute, any settlement negotiations, the ADRhearing, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed ConfidentialInformation. The neutral shall have the authority to impose sanctions for unauthorized disclosure of Confidential Information.12. The neutral may not award any form of damages or relief prohibited by Section 8.7 of the Agreement.13. The neutral shall have the authority to grant injunctive relief and other specific performance.14. The neutral shall, in rendering its decision, apply the substantive law of the State of New York, without regard to its conflict oflaws provisions.15. The hearings shall be conducted in the English language.Exhibit Page 48Technical Transfer & Supply Agreement (signature version)Exhibit 21.1AMAG Pharmaceuticals, Inc. Subsidiaries of the registrant AMAG Pharmaceuticals Canada Corporation, a Nova Scotia unlimited liability company AMAG Europe Limited, a UK private limited company AMAG Securities Corporation, a Massachusetts corporation AMAG Pharma USA, Inc., a Delaware corporation FP1096, Inc., a Pennsylvania corporation AMAG Pharmaceuticals IP Ltd., a Delaware corporation Drugtech Sárl, a Swiss company Lumara Health Services Ltd., a Missouri corporationCBR Acquisition Holdings Corp., a Delaware corporationCbr Systems, Inc., a Delaware corporation Exhibit 23.1Consent of Independent Registered Public Accounting FirmWe hereby consent to the incorporation by reference in the Registration Statements on Forms S‑3 (File Nos. 333‑202009 and 333-202252) andForms S‑8 (File Nos. 333‑82292, 333‑131656, 333‑148682, 333‑159938, 333‑168786, 333-182821, 333‑190435, 333‑197873, 333-203924 and 333-211277) of AMAG Pharmaceuticals, Inc. of our report dated February 17, 2017 relating to the financial statements and the effectiveness of internal controlover financial reporting, which appears in this Form 10‑K./s/ PricewaterhouseCoopers LLP Boston, Massachusetts February 17, 2017 Exhibit 31.1 CERTIFICATIONS I, William K. Heiden, certify that:1.I have reviewed this Annual Report on Form 10‑K of AMAG Pharmaceuticals, 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) and15d‑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 withinthose entities, 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; andd)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 likelyto materially 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, tothe registrant’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; andb)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:February 17, 2017 /s/ William K. Heiden William K. Heiden Chief Executive Officer(Principal Executive Officer)Exhibit 31.2CERTIFICATIONSI, Edward Myles, certify that:1.I have reviewed this Annual Report on Form 10‑K of AMAG Pharmaceuticals, 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) and15d‑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 withinthose entities, 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; andd)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 likelyto materially 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, tothe registrant’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; andb)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:February 17, 2017 /s/ Edward Myles Edward Myles Senior Vice President of Finance, Chief Financial Officer and Treasurer(Principal Financial Officer)Exhibit 32.1 CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES‑OXLEY ACT OF 2002In connection with the Annual Report of AMAG Pharmaceuticals, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2016 as filedwith the Securities and Exchange Commission on the date hereof (the “Report”), I, William K. Heiden, Chief Executive Officer of the Company, certify,pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my 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/ William K. Heiden William K. Heiden Chief Executive Officer (Principal Executive Officer) February 17, 2017 Exhibit 32.2CERTIFICATION PURSUANT TO18 U.S.C. SECTION 1350,AS ADOPTED PURSUANT TOSECTION 906 OF THE SARBANES‑OXLEY ACT OF 2002In connection with the Annual Report of AMAG Pharmaceuticals, Inc. (the “Company”) on Form 10-K for the year ended December 31, 2016 as filedwith the Securities and Exchange Commission on the date hereof (the “Report”), I, Edward Myles, Senior Vice President of Finance, Chief Financial Officerand Treasurer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to the best of myknowledge:(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/ Edward Myles Edward Myles Senior Vice President of Finance, Chief Financial Officer and Treasurer (Principal Financial Officer) February 17, 2017 

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