Kitov Pharma Ltd.
Annual Report 2016

Plain-text annual report

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2016 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report ________ Commission file number 001-37643 Kitov Pharmaceuticals Holdings Ltd. (Exact name of Registrant as specified in its charter) N/A (Translation of Registrant’s name into English) Israel (Jurisdiction of incorporation or organization) One Azrieli Center, Round Tower, 23rd Floor, 132 Menachem Begin Road, Tel Aviv, 6701101, Israel (Address of principal executive offices) Simcha Rock, Chief Financial Officer One Azrieli Center, Round Tower, 23rd Floor, 132 Menachem Begin Road, Tel Aviv, 6701101, Israel Tel: +972-3-933-3121; Fax: +972-153-39333121 (Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person) Securities registered or to be registered pursuant to Section 12(b) of the Act. Title of class Name of each exchange on which registered American Depositary Shares, each representing 20 Ordinary Shares (1) Ordinary Shares, no par value (2) Warrants to purchase our American Depositary Shares NASDAQ Capital Market N/A NASDAQ Capital Market (1) Evidenced by American Depositary Receipts. (2) Not for trading, but only in connection with the listing of the American Depositary Shares. Securities registered or to be registered pursuant to Section 12(g) of the Act: None (Title of Class) Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None (Title of Class) Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report: 153,237,209 Ordinary Shares, no par value (including 21 shares held in treasury) Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒ If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act 1934. Yes ☐ No ☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. 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 and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). ☒ Yes ☐ No Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Yes ☐ No ☐ Large accelerated filer☐ Accelerated filer ☐ Non-accelerated filer☐ (Do not check if a smaller reporting company) Smaller reporting company☐ Emerging growth company ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing: U.S. GAAP ☐ International Financing Reporting Standards as issued by the International Accounting Standards Board ☒ Other ☐ If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Item 17 ☐ Item 18 ☐ APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS) Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court. Yes ☐ No ☒ Yes ☐ No ☐ TABLE OF CONTENTS OPERATING AND FINANCIAL REVIEW AND PROSPECTS DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS FINANCIAL INFORMATION THE OFFER AND LISTING ADDITIONAL INFORMATION QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS ITEM 1. OFFER STATISTICS AND EXPECTED TIMETABLE ITEM 2. KEY INFORMATION ITEM 3. ITEM 4. INFORMATION ON THE COMPANY ITEM 4A. UNRESOLVED STAFF COMMENTS ITEM 5. ITEM 6. ITEM 7. ITEM 8. ITEM 9. ITEM 10. ITEM 11. ITEM 12. ITEM 13. ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS ITEM 15. ITEM 16. ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT ITEM 16B. CODE OF ETHICS ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES. ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT ITEM 16G. CORPORATE GOVERNANCE ITEM 16H. MINE SAFETY DISCLOSURE ITEM 17. ITEM 18. ITEM 19. FINANCIAL STATEMENTS FINANCIAL STATEMENTS EXHIBITS CONTROLS AND PROCEDURES [RESERVED] 5 5 5 38 68 68 76 105 115 119 122 145 146 154 154 156 157 157 157 157 158 158 158 158 161 162 162 162 Unless the context otherwise indicates or requires, all references to: ● the terms “Registrant,” “Company,” “Group”, “we,” “us,” “our,” and similar designations refer to Kitov Pharmaceuticals Holdings Ltd., together with its wholly-owned subsidiary, Kitov Pharmaceuticals, and its majority owned subsidiary, TyrNovo except where otherwise stated or where it is clear that the terms mean only Kitov Pharmaceuticals Holdings Ltd. exclusive of its subsidiaries, ● “Kitov” refers to the Registrant, together with its wholly-owned subsidiary, Kitov Pharmaceuticals, ● “Kitov Parent”, refers to the Registrant, exclusive of its subsidiaries, ● “Kitov Pharmaceuticals” refers to Kitov Pharmaceuticals Ltd., the wholly owned subsidiary of the Registrant, ● “TyrNovo” refers to TyrNovo Ltd., the majority owned subsidiary of the Registrant, ● the terms “shekels”, “Israeli shekels” and “NIS” refer to New Israeli Shekels, the lawful currency of the State of Israel, ● the terms “dollar”, “US$” or “$” refer to U.S. dollars, the lawful currency of the United States of America, ● the terms “Euro” or “€” refer to the Euro, the lawful currency of the European Union member states, ● “ordinary shares,” “our shares” and similar expressions refer to the Registrant’s Ordinary Shares, no par value per share, ● “ADS” refer to the Registrant’s American Depositary Shares, ● “public warrants” or “Series A warrants” refer to the Registrant’s warrants listed on the NASDAQ Capital Market under the symbol KTOVW, ● the “Companies Law” are to Israel’s Companies Law, 5759-1999, as amended, ● the “SEC” are to the United States Securities and Exchange Commission, ● “NASDAQ” are to the NASDAQ Capital Market, and ● the “TASE” are to the Tel Aviv Stock Exchange. 2 Glossary of Industry Terms Additionally, for convenience, the following terms used in this Annual Report Form 20-F are defined as follows: “CMC” Chemistry Manufacturing and Controls – The methods by which a drug substance and product are synthesized, purified, assayed, and packaged. “cGMP” Current Good Manufacturing Practice - minimum requirements of the FDA and other regulatory authorities for the methods, facilities, and controls used in the manufacturing, processing, and packing of a drug product that is intended for human use to ensure that the product is safe for use and has the ingredients and strength that it claims to have. “Clinical” “Drug Product” Pertaining to human studies. For the purposes of this disclosure – a drug product that has been approved by the FDA for marketing and sales within the United States. “EGFR” Epidermal growth factor receptor (EGFR; ErbB-1; HER1 in humans) is a transmembrane protein that is a receptor for “FDA” “Formulation” “Generic Product” “HTN” “IND” members of the epidermal growth factor family (EGF family) of extracellular protein ligands. United States Food and Drug Administration. All the active and inactive materials contained in a final medical product. A product developed by others than the original innovator, yet contains the same active substance as the original product both qualitatively and quantitatively. Limits of the difference from the original product within which the product may be recognized by the regulations as generic are determined separately for each product by the related regulatory authorities during the approval process. Regulatory recognition of a product as a generic product is performed through the majority of approval procedures adapted to this type of product, which differ from the approval procedures applied to a new chemical entity (NCE). Hypertension. Investigational New Drug (Application) – an application to test an experimental drug in human beings and that requires clearance by the FDA for clinical trials to be initiated. “MAPK” A mitogen-activated protein kinase (MAPK or MAP kinase) is a type of protein kinase that is specific to the amino acids serine, threonine, and tyrosine. “mTOR” A class of drugs that inhibit the mechanistic target of rapamycin (mTOR), which is a serine/threonine-specific protein kinase “NCE” “NDA” “PDX” that belongs to the family of phosphatidylinositol- 3 kinase. New Chemical Entity - a drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act. New Drug Application - an application submitted to the FDA to approve marketing a new drug. An animal model in which patient-derived tumor tissue at low passage are implanted in animals, used to conserve original tumor characteristics and to provide relevant predictive insights into clinical outcomes when evaluating new cancer therapies. “Preclinical” Drug development studies performed outside of a living organism or cell, using living cells, or appropriate animal models. The studies begin before trials in humans and assess safety, toxicity, and efficacy. Since drug development is dynamic, Preclinical studies are performed throughout the drug development lifecycle. “Pharmacokinetics” “PK” The study of the absorption, distribution, metabolism and excretion of a drug from the body; the pharmacokinetic indices provide, among other things, information on the extent and time of the patient’s exposure to the material. It is the study of how the body affects the drug. “Therapeutic effect” Measurable and meaningful change in the clinical condition of patients, resulting from the use of a certain medical drug or preparation. 3 FORWARD-LOOKING STATEMENTS Some of the statements under the sections entitled “Item 3. Key Information — D. Risk Factors,” “Item 4. Information on the Company,” “Item 5. Operating and Financial Review and Prospects” and elsewhere in this Annual Report on Form 20-F may include forward looking statements. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including “anticipates”, “believes”, “could”, “estimates”, “expects”, “intends”, “may”, “plans”, “potential”, “predicts”, “projects”, “should”, “will”, “would”, and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. In addition, the section of this Annual Report on Form 20-F entitled “Item 4. Information on the Company” contains information obtained from independent industry and other sources. You should not put undue reliance on any forward-looking statements. Unless we are required to do so under U.S. federal securities laws or other applicable laws, we do not intend to update or revise any forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: ● the initiation, timing, progress and results of our research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, as well as the extent and number of additional studies that we may be required to conduct; ● our ability to advance our therapeutic candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; ● our receipt of regulatory clarity and approvals for our therapeutic candidates and the timing of other regulatory filings and approvals; ● a delay or rejection of an NDA for one or more of our therapeutic candidates; ● the regulatory environment and changes in the health policies and regimes in the countries in which we operate including the impact of any change in regulation and legislation that could affect the pharmaceutical industry, and the difficulty of predicting actions of the FDA or any other applicable regulator of pharmaceutical products; ● the research, manufacturing, preclinical and clinical development, commercialization, and market acceptance of our therapeutic candidates; ● our ability to successfully acquire, develop or commercialize our pharmaceutical products; ● our ability to establish and maintain corporate collaborations; ● the interpretation of the properties and characteristics of our therapeutic candidates and of the results obtained with our therapeutic candidates in preclinical studies or clinical trials; ● the implementation of our business model, strategic plans for our business and therapeutic candidates; ● the scope of protection we are able to establish and maintain for intellectual property rights covering our therapeutic candidates and our ability to operate our business without infringing the intellectual property rights of others; ● estimates of our expenses, future revenues capital requirements and our needs for additional financing; ● the uncertainty surrounding an investigation by the Israel Securities Authority into our historical public disclosures and the potential impact of such investigation on the trading and price of the Registrant’s securities or on our clinical, commercial and other business relationships, or on receiving the regulatory approvals necessary in order to commercialize our products; ● the impact of competitive companies, technologies and our industry; and ● the impact of the political and security situation in Israel, the U.S. and other countries we may obtain approvals for our products on our business. You should review carefully the risks and uncertainties described under the heading “Item 3. Key Information – D. Risk Factors” in this Annual Report on Form 20-F for a discussion of these and other risks that relate to our business and investing in Kitov Parent’s ADSs and public warrants. The forward-looking statements contained in this Annual Report on Form 20-F are expressly qualified in their entirety by this cautionary statement. 4 ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS A. Directors and Senior Management PART I Not applicable B. Advisors Not applicable C. Auditors Not applicable ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE Not applicable. ITEM 3. KEY INFORMATION A. Selected Financial Data SELECTED CONSOLIDATED FINANCIAL AND OTHER DATA The following table sets forth Kitov’s selected consolidated financial data for the periods ended and as of the dates indicated. The following selected historical consolidated financial data for Kitov should be read in conjunction with “Item 5. Operational and Financial Review and Prospects” and other information provided elsewhere in this Annual Report on Form 20-F and our consolidated financial statements and related notes. The selected consolidated financial data in this section is not intended to replace the consolidated financial statements and is qualified in its entirety thereby. The selected consolidated statements of operations for the three years ended December 31, 2016, 2015 and 2014, and Kitov’s selected consolidated statements of financial position as of December 31, 2016 and 2015 have been derived from our audited consolidated financial statements included elsewhere in this Annual Report on Form 20-F. The selected consolidated statements of operations data for the year ended December 31, 2013, and the selected consolidated balance sheet data as of December 31, 2014 and 2013, have been derived from Kitov’s audited consolidated financial statements not included in this Annual Report on Form 20-F. We prepare our consolidated financial statements in accordance with IFRS as issued by the IASB. Our historical results are not necessarily indicative of results to be expected in any future periods. You should read this information together with the section of this Annual Report on Form 20-F entitled “Item 5. Operating and Financial Review and Prospects” and Kitov’s audited consolidated financial statements and related notes included elsewhere in this Annual Report on Form 20-F. Statement of Operations: Research and development expenses General and administrative expenses Stock exchange listing expense Other expenses Operating loss Financing expense, net Loss for the period Loss per ordinary share:(1) Basic and diluted Year Ended December 31, 2016 2015 2014 2013 (U.S. Dollars in thousands, except per share and weighted average shares data) 4,180 3,003 - - 7,183 4,942 12,125 2,560 1,509 - - 4,069 133 4,202 3,192 1,269 - 720 5,181 71 5,252 109 1,061 1,383 - 2,553 75 2,628 (0.11) (0.22) *(1.17) *(1.60) Weighted average number of ordinary shares used in computing basic and diluted loss per share (in thousands): 115,115 19,250 *4,482 *1,641 (1) Basic loss per ordinary share is calculated by dividing the loss attributable to shareholders by the weighted average number of ordinary shares outstanding during the period. There are no differences between basic and diluted loss per ordinary share since there are no dilutive potential ordinary shares. 5 * Unless otherwise indicated, all information contained in this Annual Report on Form 20-F gives retrospective effect to a consolidation of Kitov Parent’s share capital at a ratio of 1:13, which was effected on November 30, 2014, or the Consolidation, so that: (A) each 13 ordinary shares of Kitov Parent were consolidated into one ordinary share of Kitov Parent; and (B) each of Kitov Parent’s options (tradable and non-tradable) outstanding immediately prior to the consolidation of the share capital was adjusted by multiplying the number of ordinary shares into which such option was exercisable by 1/13 (rounded to 0.07692). Balance Sheet Data: Cash and cash equivalents Working capital (*) Total assets Total liabilities Accumulated deficit Total equity (deficit) 2016 As of December 31, 2015 2014 (U.S. Dollars, in thousands) 2013 6,758 13,625 14,914 (1,529) (26,200) 13,385 10,558 9,606 10,812 (1,383) (14,054) 9,429 1,313 773 1,759 (986) (9,852) 773 193 (946) 311 1,257 (4,600) (946) (*) Working capital is defined as current assets less current liabilities On July 11, 2013, Kitov Parent, (then known as Mainrom Line Logistics Ltd., a public shell company listed on the TASE with no assets, debt and/or liabilities) acquired the issued and outstanding shares of Kitov Pharmaceuticals. As part of the acquisition, Mainrom Line Logistics Ltd. changed its name to Kitov Pharmaceuticals Holdings Ltd. The acquisition was accounted for under IFRS as issued by the IASB, as a reverse merger, and therefore the consolidated financial statements of Kitov Parent presented in this Annual Report on Form 20-F include the financial results of Kitov Pharmaceuticals for the four years ended December 31, 2016, 2015, 2014, and 2013 and of Kitov Parent for the period from July 11, 2013 to December 31, 2016. See Item 7. Major Shareholder and Related Party Transactions – B. Related Party Transactions – Share Transfer Agreement with Kitov Pharmaceuticals” for more information. B. Capitalization and Indebtedness Not applicable. C. Reasons for the Offer and Use of Proceeds Not applicable. 6 D. Risk Factors You should carefully consider the risks we describe below, in addition to the other information set forth elsewhere in this Annual Report on Form 20- F, including Kitov’s consolidated financial statements and the related notes beginning on page F-1, which could materially affect our business, financial condition and future results. If any of the following risks actually occur, our business, financial condition and results of operations could be materially and adversely affected. In that event, the trading price of Kitov Parent’s ordinary shares, American Depositary Shares and public warrants could decline. Risks Related to Our Financial Condition and Capital Requirements We are a development stage biopharmaceutical company with a history of operating losses. We expect to incur significant additional losses in the future and may never be profitable. We are a development stage biopharmaceutical company, and we are focused on the development of innovative pharmaceutical products. Our current therapeutic candidates are in the preclinical and clinical development stages, and have not been approved for marketing and are not being sold, marketed or commercialized. Our therapeutic candidates may require additional preclinical and/or clinical trials or other testing before we can obtain regulatory approval, if we are able to obtain regulatory approval at all. We must have regulatory approval for each product that we develop before we can sell such product. We have incurred losses from commencement of our pharmaceutical research and development activities through December 31, 2016 of approximately $26.2 million as a result of research and development activities, clinical trial related activities, investment/acquisition activities, listing for trading and fund raising related activities, general administrative and other expenses. We may incur significant additional losses as we continue to focus our resources on advancing our therapeutic candidates, including those we may acquire. Our ability to generate revenue and achieve profitability depends mainly upon our ability, alone or with others, to successfully develop our therapeutic candidates and obtain the required regulatory approvals in various territories and then commercialize our therapeutic candidates. We may be unable to achieve any or all of these goals with regard to our therapeutic candidates. As a result, we may never be profitable or achieve significant or sustained revenues. Our limited operating history as a pharmaceutical research and development company makes it difficult to evaluate our business and prospects. We have a limited operating history as a pharmaceutical research and development company, and our operations to date have been limited primarily to acquiring therapeutic candidates, research and development, raising capital and recruiting scientific and management personnel and third party partners. We have not yet demonstrated an ability to commercialize or obtain regulatory approval for any of our therapeutic candidates. Consequently, any predictions about our future performance may not be accurate, and you may not be able to fully assess our ability to complete development or commercialize our therapeutic candidates, obtain regulatory approvals, or achieve market acceptance or favorable pricing for our therapeutic candidates. We will need to raise additional capital to achieve our strategic objectives of developing and commercializing additional therapeutic candidates, and our failure to raise sufficient capital would significantly impair our ability to fund our future operations, develop our therapeutic candidates, seek regulatory approval that is a prerequisite to selling any product, attract development or commercial partners and retain key personnel. Our business presently generates no revenues, and we plan to continue expending substantial funds in research and development, including CMC, preclinical and clinical trials. We plan to fund our future operations through commercialization and out-licensing of our therapeutic candidates and either debt or equity financing. However, we cannot be certain that we will be able to raise capital on commercially reasonable terms or at all, or that our actual cash requirements will not be greater than anticipated. We may have difficulty raising needed capital or securing a development or commercialization partner in the future as a result of, among other factors, our lack of revenues from commercialization of the therapeutic candidates, as well as the inherent business risks associated with our company and present and future market conditions. In addition, global and local economic and geopolitical conditions may make it more difficult for us to raise needed capital or secure a development or commercialization partner in the future and may impact our liquidity. If we are unable to obtain future financing, we may be forced to delay, reduce the scope of, or eliminate one or more of our research, development or commercialization programs related to our therapeutic candidates, any of which may have a material adverse effect on our business, financial condition and results of operations. Moreover, to the extent we are able to raise capital through the issuance of debt or equity securities, it could result in substantial dilution to existing shareholders. 7 Our long term capital requirements are uncertain and subject to numerous risks. We estimate that so long as no significant revenues are generated from our therapeutic candidates, we will need to raise substantial additional funds to acquire, develop and/or commercialize our current therapeutic candidates and any additional therapeutic candidates, as our current cash and short-term investments are not sufficient to complete the research and development of our current therapeutic candidates and any additional therapeutic candidates, and to fund our related expenses. Our long term capital requirements are expected to depend on many potential factors, including, among others: ● the regulatory path of each of our therapeutic candidates; ● our ability to successfully complete the required CMC development for our therapeutic candidates; ● our ability to successfully commercialize our therapeutic candidates, including securing commercialization agreements with third parties and favorable pricing and market share; ● the progress, success and cost of our preclinical and/or clinical trials and research and development programs; ● the costs, timing and outcome of regulatory review and obtaining regulatory approval of our therapeutic candidates and addressing regulatory and other issues that may arise post-approval; ● the costs of obtaining and enforcing our issued patents and defending intellectual property-related claims; ● the costs of developing sales, marketing and distribution channels; and ● our consumption of available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than anticipated. If we are unable to obtain approval, commercialize or out-license our therapeutic candidates or obtain future financing, we may be forced to delay, reduce the scope of, or eliminate one or more of our research and development programs related to the therapeutic candidates, which may have a material adverse effect on our business, financial condition and results of operations. Risks Related to Our Business and Regulatory Matters If we and/or our potential commercialization partners are unable to obtain FDA and/or other foreign regulatory authority approval for our therapeutic candidates, we and/or our potential commercialization partners will be unable to commercialize our therapeutic candidates. To date, we have not marketed, distributed or sold any therapeutic candidate or other product. We have entered into only one out-licensing agreement for manufacturing and distribution of our KIT-302 therapeutic candidate in South Korea, which is dependent upon achieving regulatory clearance for the therapeutic candidate in South Korea. Our therapeutic candidates are subject to extensive governmental laws, regulations and guidelines relating to development, preclinical and clinical trials, manufacturing and commercialization of drugs. We may not be able to obtain regulatory approval for any of our therapeutic candidates in a timely manner or at all. Any material delay in obtaining, or the failure to obtain, required regulatory approvals will increase our costs and materially and adversely affect our ability to generate future revenues. Any regulatory approval to market a therapeutic candidate may be subject to limitations on the indicated uses for marketing the therapeutic candidate or may impose restrictive conditions of use, including cautionary information, thereby limiting the size of the market for the therapeutic candidate. We also are, and will be, subject to numerous regulatory requirements from both the FDA and foreign state agencies that govern the conduct of preclinical and clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement. Moreover, approval by one regulatory authority does not ensure approval by other regulatory authorities in separate jurisdictions. Each jurisdiction may have different approval processes and may impose additional testing requirements for our therapeutic candidates than other jurisdictions. For example, even if the FDA grants its approval to market KIT-302 for certain indications of use, the South Korean regulatory authorities may impose additional requirements or place other limitations on the indications for use in South Korea, before our licensee and distributor in South Korea may commence manufacturing and selling KIT-302. Additionally, the FDA or other foreign regulatory bodies may change their approval policies or adopt new laws, regulations or guidelines in a manner that delays or impairs our ability to obtain the necessary regulatory approvals to commercialize our therapeutic candidates. 8 Pre-clinical, CMC, and clinical trials may involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results. We and/or our potential commercialization partners will not be able to commercialize our therapeutic candidates without completing such trials. We have limited experience in conducting and managing the CMC, preclinical and clinical trials that are required to commence commercial sales of our therapeutic candidates. CMC, preclinical and clinical trials are expensive, complex, can take many years to complete and have uncertain outcomes. We cannot predict whether we, independently or through third parties, will encounter problems with any of the completed, ongoing or planned CMC, preclinical and/or clinical trials that will cause delays, including suspension of preclinical and/or clinical trials, delays in recruiting patients into the preclinical and/or clinical trials, or delay of data analysis or release of the final report. The CMC, preclinical and clinical trials of our therapeutic candidates may take significantly longer to complete than is estimated. Failure can occur at any stage of the testing, and we may experience numerous unforeseen events during, or as a result of, the CMC, preclinical and/or clinical trial process that could delay or prevent commercialization of our current or future therapeutic candidates. In connection with the CMC, preclinical and clinical trials for our therapeutic candidates and other therapeutic candidates that we may seek to develop in the future, either on our own or through licensing or partnering agreements, we face various risks, including but not limited to: ● delays in manufacturing the drug substance and drug product for preclinical and clinical trials; ● delays in manufacturing the drug substance and drug product following NDA approval, if we receive such approval all; ● delays in securing clinical investigators or trial sites for clinical trials that must be completed for us to obtain any approval that we seek; ● delays in receiving import or other government approvals to ensure appropriate drug supply; ● delays in obtaining institutional review board (human ethics committee) and other regulatory approvals to commence a clinical trial; ● negative or inconclusive results from clinical trials; ● the FDA or other foreign regulatory authorities may disagree with the number, design, size, conduct or implementation of our clinical studies and may not approve initiation of certain clinical trials; ● an inability to monitor patients adequately during or after treatment; ● problems with investigator or patient compliance with the trial protocols; ● a therapeutic candidate may not prove safe or efficacious; ● there may be unexpected or even serious adverse events and side effects from the use of a therapeutic candidate; ● the results with respect to any therapeutic candidate may not confirm the positive results from earlier preclinical studies or clinical trials; ● the results may not meet the level of statistical significance required by the FDA or other foreign regulatory authorities; ● the results will Left only limited and/or restrictive uses, including the inclusion of warnings and contraindications, which could significantly limit the marketability and profitability of the therapeutic candidate; ● the clinical trials may be delayed or not completed due to the failure to recruit suitable candidates or if there is a lower rate of suitable candidates than anticipated or if there is a delay in recruiting suitable candidates; and ● changes to the current regulatory requirements related to clinical trials which can delay, hinder or lead to unexpected costs in connection with our receiving the applicable regulatory approvals. 9 A number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience than us, have suffered significant setbacks in advanced clinical trials, even after seeing promising results in earlier preclinical and/or clinical trials. As such, we do not know whether any clinical trials we may conduct will demonstrate adequate efficacy and safety sufficient to obtain regulatory approval to market our therapeutic candidates. If any of the preclinical and/or clinical trials of any therapeutic candidate do not produce favorable results, our ability to obtain regulatory approval for the therapeutic candidate may be adversely impacted, which will have a material adverse effect on our business, financial condition and results of operations. If we do not establish collaborations for our therapeutic candidates or otherwise raise substantial additional capital, we will likely need to alter our development and any commercialization plans. Our drug development programs and the potential commercialization of our therapeutic candidates will require additional cash to fund expenses. As such, our strategy includes selectively partnering or collaborating with multiple pharmaceutical and biotechnology companies to assist us in furthering development and potential commercialization of our therapeutic candidates, in some or all jurisdictions. While we have entered into an out-licensing agreement for manufacturing and distribution of our KIT-302 therapeutic candidate in South Korea, we may not be successful in collaborations with other third parties on acceptable terms, or at all. In addition, if we fail to negotiate and maintain suitable development or commercialization agreements, we may have to limit the size or scope of our activities or we may have to delay one or more of our development or commercialization programs. Any failure to enter into or maintain development or commercialization agreements with respect to the development, marketing and commercialization of any therapeutic candidate or failure to develop, market and commercialize such therapeutic candidate independently will have an adverse effect on our business, financial condition and results of operation. Any collaborative arrangements that we establish may not be successful or we may otherwise not realize the anticipated benefits from these collaborations. We do not control third parties with whom we have or may have collaborative arrangements, and we rely on them to achieve results which may be significant to us. In addition, any future collaboration arrangements may place the development and commercialization of our therapeutic candidates outside our control, may require us to relinquish important rights or may otherwise be on terms unfavorable to us. Our collaborative arrangements require us to rely on external consultants, advisors, and experts for assistance in several key functions, including preclinical and clinical development, manufacturing, regulatory, market research, and intellectual property. We do not control these third parties, but we rely on them to achieve results, which may be significant to us. Additionally, we are responsible for any quality or regulatory issue that a collaborator may have that affects one or more of our therapeutic candidates. Relying upon collaborative arrangements to develop and commercialize our therapeutic candidates subjects us to a number of risks, including: ● we may not be able to control the amount and timing of resources that our collaborators may devote to our therapeutic candidates; ● should a collaborator fail to comply with applicable laws, rules, or regulations when performing services for us, we could be held liable for such violations; ● our collaborators may experience financial difficulties or changes in business focus; ● our collaborators may experience quality or regulatory issues that negatively affect our therapeutic candidates; ● our collaborators may fail to secure adequate commercial supplies of our therapeutic candidates upon marketing approval, if at all; ● our collaborators may have a shortage of qualified personnel; ● we may be required to relinquish important rights, such as local trademark, marketing and distribution rights; ● business combinations or significant changes in a collaborator’s business strategy may adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement; ● under certain circumstances, a collaborator could move forward with a competing therapeutic candidate developed either independently or in collaboration with others, including our competitors; and ● collaborative arrangements are often terminated or allowed to expire, which could delay the development and may increase the cost of developing our therapeutic candidates. If any of these scenarios materialize, they could have an adverse effect on our business, financial condition or results of operations. 10 Our current business model is based largely upon the combination of drugs that have not been previously combined, as well as on new chemical entities (NCEs) that have not yet been administered to humans. Unexpected difficulties or delays in successfully developing or marketing such combination, and new drugs could have an adverse effect on our business, financial condition and results of operations. We are currently focused on the combination of drugs that have not been previously combined as well as on new chemical entities that have not yet been administered to humans. Since KIT-302 has APIs that have not previously been combined into one FDA-approved drug product or used at all in a clinical setting outside the scope of a clinical trial, and our new chemical entity NT219 has never been used in a clinical setting, we cannot be certain whether KIT-302 and/or NT 219 will be safe and efficacious. In addition, we cannot be certain that the market will consider our KIT-302 combination therapeutic candidate, our new chemical entity NT219, or any other therapeutic candidate that we may develop in the future to be superior to the current gold standard of care or to treatment with the separate drug components. Any delays in perfecting the combination, the production of the combination, or in market acceptance of the combination or new chemical entities could have an adverse effect on our business, financial condition and results of operations. In addition, as part of our strategy for growth, we may consider the acquisition of therapeutic candidates at various stages of development and in a variety of therapeutic areas. For example, on January 13, 2017, we announced that we had acquired a controlling interest in TyrNovo Ltd., a privately held Israeli developer of novel small molecules in the oncology therapeutic field. TyrNovo’s NT219 therapeutic candidate is intended to work by overcoming tumors’ cancer drug resistance and is expected to be developed to be used in combination with cancer drugs that are already approved and marketed. For more information see Item 4.B – Business Overview – NT219. We may also consider the acquisition or marketing rights of approved drug products as well. However, we may not be able to identify additional suitable acquisition candidates, complete acquisitions or integrate acquisitions successfully. In this regard, acquisitions involve numerous risks, including difficulties in the integration of the acquired therapeutic candidates and the diversion of management’s attention from other business concerns. Although we will endeavor to evaluate the risks inherent in any particular transaction, there can be no assurance that we will properly ascertain all such risks. In addition, acquisitions could result in the incurrence of substantial additional indebtedness and other expenses or in potentially dilutive issuances of equity securities. There can be no assurance that difficulties encountered with acquisitions will not have a material adverse effect on our business, financial condition and results of operations. We rely on third parties to conduct our CMC, preclinical and clinical trials, and those third parties may not perform satisfactorily, including, but not limited to, failing to meet established deadlines for the completion of such clinical trials. We do not have the ability independently to conduct CMC, preclinical or clinical trials for our product candidates, and we rely on third parties, such as contract manufacturing organizations, contract research organizations, medical institutions, contract laboratories, current and potential development or commercialization partners, clinical investigators and independent study monitors, to perform these functions. Our reliance on these third parties for development activities reduces our control over these activities. For example on March 28, 2017, we announced that due to a delay in the provision of technical documentation from an external service provider, the Company’s New Drug Application for KIT-302 for the FDA is now expected to be submitted to the FDA only during the course of Q2 2017, later than initially anticipated by the Company. Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. Although we have, in the ordinary course of business, entered into agreements with these third parties, we continue to be responsible for confirming that each of our preclinical and clinical trials is conducted in accordance with its general investigational plan and protocol. Moreover, the FDA requires us to comply with regulations and standards, commonly referred to as good laboratory, manufacturing, and clinical practices (GCP), for conducting, recording and reporting the results of preclinical and clinical trials to assure that data and reported results are credible and accurate and that the clinical trial participants are adequately protected. Regulatory authorities in other jurisdictions may have similar responsibilities and requirements. Our reliance on third parties does not relieve us of these responsibilities and requirements. 11 To date, we believe our contract manufacturing organizations, contract research organizations and other similar entities with which we are working have generally performed well. However, if these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be required to replace them. Although we believe that there are a number of other third-party contractors we could engage to continue these activities, it may result in a delay of the affected trial and additional costs. Accordingly, we may be delayed in obtaining regulatory approvals for our therapeutic candidates and may be delayed in our efforts to successfully commercialize our therapeutic candidates for targeted diseases. In addition, we rely substantially on third-party data managers for the CMC, preclinical and clinical trial data that we present to regulatory authorities in order to obtain marketing authorizations. Although we attempt to audit and control the quality of third party data, we cannot guarantee the authenticity or accuracy of such data, nor can we be certain that such data has not been fraudulently generated. There is no assurance that these third parties will pass FDA or regulatory audits, which could delay or prohibit regulatory approval. If third parties do not manufacture our therapeutic candidates in sufficient quantities, in the required timeframe, and at an acceptable cost, clinical development and commercialization of our therapeutic candidates would be delayed. We do not currently own or operate manufacturing facilities, and we rely, and expect to continue to rely, on third parties to manufacture preclinical, clinical and commercial quantities of our therapeutic candidates. Our reliance on third parties includes our reliance on them for quality assurance related to regulatory compliance. Our current and anticipated future reliance upon others for the manufacture of our therapeutic candidates may adversely affect our future profit margins, if any, and our ability to develop therapeutic candidates and commercialize any therapeutic candidates on a timely and competitive basis. We may not be able to maintain our existing or future third party manufacturing arrangements on acceptable terms, if at all. If for some reason our existing or future manufacturers do not perform as agreed or expected, or our existing or future manufacturers otherwise terminate their arrangements with us, we may be required to replace them. Although we are not substantially dependent upon our existing manufacturing agreements since we could replace them with other third party manufacturers, we may incur added costs and delays in identifying, engaging, qualifying and training any such replacements. We rely on third party contract vendors to manufacture and supply us with active pharmaceutical ingredients, or “APIs”, compliant with the International Conference of Harmonization Q7 guidance and applicable law, in the quantities we require on a timely basis. We currently do not manufacture any API ourselves. Instead, we rely on third-party vendors for the manufacture and supply of our APIs that are used to formulate our therapeutic candidates. While there are many potential API suppliers in the market, if these suppliers are incapable or unwilling to meet our current or future needs on acceptable terms or at all, we could experience delays in conducting additional clinical trials of our therapeutic candidates and incur additional costs. While there may be several alternative suppliers of API in the market, we have not conducted extensive audits and investigations into the quality or availability of their APIs. In addition we may acquire therapeutic candidates which already have long term commitments to a specific API supplier. As a result, we can provide no assurances that supply sources will not be interrupted from time to time. Changing API suppliers or finding and qualifying new API suppliers can be costly and take a significant amount of time. Many APIs require significant lead time to manufacture. There can also be challenges in maintaining similar quality or technical standards from one manufacturing batch to the next. If we are not able to find stable, reliable supplies of our APIs, we may not be able to produce enough supplies of our therapeutic candidates, which could affect our business, financial condition and results of operation. 12 We anticipate continued reliance on third-party manufacturers if we are successful in obtaining marketing approval from the FDA and other regulatory agencies for any of our therapeutic candidates. To date, our therapeutic candidates have been manufactured in relatively small quantities by third-party manufacturers. To date, our third-party manufacturers have manufactured sufficient quantities of KIT-302 for formulation development, PK studies, clinical trials, and the required large scale production in support of our NDA package that we intend to submit to the FDA for the purposes of approving KIT-302 for marketing and commercial sale in the United States. We are also in discussions with third-party manufacturers for the manufacture of cGMP-grade NT219. If the FDA or other regulatory agencies approve for marketing and commercial sale, KIT-302 and/or any other therapeutic candidate that we may develop in the future, we expect that we would continue to rely, at least initially, on third-party manufacturers to produce commercial quantities of our approved therapeutic candidates. These manufacturers may not be able to successfully increase the manufacturing capacity for any of our therapeutic candidates that may be approved in the future in a timely or economic manner, or at all. Significant scale-up of manufacturing may require additional validation studies, which the FDA must review and approve. If they are unable to successfully increase the manufacturing capacity for KIT-302 or any therapeutic candidate that we may develop in the future, or we are unable to establish alternative manufacturing capabilities, the commercial launch of any therapeutic candidates that are approved in the future may be delayed or there may be a shortage in supply. We and our third-party manufacturers are, and will be, subject to regulations of the FDA and other foreign regulatory authorities. We and our contract manufacturers are, and will be, required to adhere to laws, regulations and guidelines of the FDA and other foreign regulatory authorities setting forth cGMPs. These laws, regulations and guidelines cover all aspects of the manufacturing, testing, quality control and recordkeeping relating to our therapeutic candidates or drugs that may be approved in the future. We and our manufacturers may not be able to comply with applicable laws, regulations and guidelines. We and our manufacturers are and will be subject to unannounced inspections by the FDA, state regulators and similar foreign regulatory authorities outside the U.S. Our failure, or the failure of our third-party manufacturers, to comply with applicable laws, regulations and guidelines could result in the imposition of sanctions on us, including fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approval of our therapeutic candidates, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of our therapeutic candidates, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect regulatory approval and supplies of our therapeutic candidates and materially and adversely affect our business, financial condition and results of operations. Even if we obtain regulatory approvals, our therapeutic candidates will be subject to ongoing regulatory review. If we fail to comply with continuing U.S. and applicable foreign laws, regulations and guidelines, we could lose those approvals, and our business would be seriously harmed. Even if our therapeutic candidates receive regulatory approval, we or our potential commercialization partners, as applicable, will be subject to ongoing reporting obligations, including pharmacovigilance, and the therapeutic candidates and the manufacturing operations will be subject to continuing regulatory review, including inspections by the FDA and other foreign regulatory authorities. The results of this ongoing review may result in the withdrawal of a therapeutic candidate from the market, the interruption of the manufacturing operations or the imposition of labeling or marketing limitations. Since many more patients are exposed to drugs following their marketing approval, unanticipated adverse reactions or serious adverse reactions that were not observed in preclinical and/or clinical trials may be observed during the commercial marketing of a therapeutic candidate that may be approved in the future. 13 As we develop our therapeutic candidates or commercialize our products that may be approved in the future, we may also periodically discuss with the FDA and other regulatory authorities certain clinical, regulatory and manufacturing matters and, our views may, at times, differ from those of the FDA and other regulatory authorities. For example, the FDA may seek to regulate our combination therapeutic candidates, like KIT-302, or any product we may sell or market that consist of two or more active ingredients as combination drugs under its Combination Drug Policy. The Combination Drug Policy requires that we demonstrate that each active ingredient in a drug product contributes to the product’s claimed effect. If the FDA raises questions regarding whether available data and information provided to the FDA demonstrate the contribution of each active ingredient in such combination drug products, we may be required to provide additional data, which may require us to conduct additional preclinical studies or clinical trials. If we are required to conduct additional clinical trials or other testing of our therapeutic candidates or drug products that may be approved in the future, we may face substantial additional expenses, be delayed in obtaining marketing approval or may never obtain marketing approval for such therapeutic candidate or drug products we may sell or market. In addition, the manufacturer and the manufacturing facilities that we or our potential commercialization partners use or will use to manufacture any therapeutic candidate will be subject to periodic and unannounced review and inspection by the FDA and other foreign regulatory authorities. Later discovery of previously unknown problems with any therapeutic candidate, manufacturer or manufacturing process, or failure to comply with rules and regulatory requirements, may result in actions such as: ● restrictions on such therapeutic candidate, manufacturer or manufacturing process; ● warning letters from the FDA or other foreign regulatory authorities; ● withdrawal of the therapeutic candidate from the market; ● suspension or withdrawal of regulatory approvals; ● refusal to approve pending applications or supplements to approved applications that we or our potential commercialization partners submit; ● voluntary or mandatory recall; ● fines; ● refusal to permit the import or export of our therapeutic candidates; ● product seizure or detentions; ● injunctions or the imposition of civil or criminal penalties; or ● adverse publicity or changes to the drug’s labeling. If we, or our current or potential commercialization partners, suppliers, third party contractors or clinical investigators are slow to adapt, or are unable to adapt, to changes in existing regulatory requirements or the adoption of new regulatory requirements or policies, we or our potential commercialization partners may lose marketing approval for any of our therapeutic candidates if any of our therapeutic candidates are approved, resulting in decreased or lost revenue from milestones, product sales or royalties. Modifications to our therapeutic candidates, or to any other therapeutic candidates that we may acquire or develop in the future, are likely require new regulatory clearances or approvals before promotion or sale or may require us or our current or potential development and commercialization partners, as applicable, to recall or cease marketing these therapeutic candidates until clearances are obtained. Modifications to our therapeutic candidates, after they have been approved for marketing, if at all, or to any other therapeutic candidate that we may develop in the future, may require new regulatory clearance or approvals, and, if necessitated by a problem with a marketed product, may result in the recall or suspension of marketing of the previously approved and marketed product until clearances or approvals of the modified product are obtained. The FDA and other foreign regulatory authorities require manufacturers of approved drugs to make and document a determination of whether or not a modification requires a new approval, supplemental application or clearance. A manufacturer may determine in conformity with applicable laws, regulations and guidelines that a modification may be implemented without pre-clearance by the FDA or other foreign regulatory authorities; however, the FDA or other foreign regulatory authorities may disagree with the manufacturer’s decision. The FDA or other foreign regulatory authorities may also on their own initiative determine that a new clearance or approval is required. If the FDA or other foreign regulatory authorities require new clearances or approvals of any drug product for which we or our current or potential development and commercialization partners previously received marketing approval, we or our current or potential development and commercialization partners may be required to recall such drug product and to stop marketing the drug product as modified, which could require us or our current or potential development and commercialization partners to redesign the therapeutic candidate and cause a material adverse effect on our business, financial condition and results of operations. 14 While we have negotiated a special protocol assessment, or SPA, agreement with the FDA relating to the Phase III clinical trial protocol for KIT- 302, and have received minutes of a pre-NDA submission meeting with the FDA, this agreement and these minutes do not guarantee approval of KIT-302 or any other particular outcome from the final regulatory review of the study or the therapeutic candidate. We have reached an agreement with the FDA to conduct the Phase III clinical trial for KIT-302 pursuant to an SPA agreement. The FDA’s SPA process is designed to facilitate the FDA’s review and approval of drugs by allowing the FDA to evaluate the proposed design and size of Phase III trials that are intended to form the primary basis for determining a therapeutic candidate’s efficacy. Upon specific request by a clinical trial sponsor, the FDA will evaluate the protocol and respond to a sponsor’s questions regarding, among other things, primary efficacy endpoints, trial design and data analysis plans, within 45 days of receipt of the request. The FDA ultimately assesses whether the protocol design and planned analysis of the trial are acceptable to support regulatory approval of the therapeutic candidate with respect to its effectiveness and safety against the indication studied. All agreements and disagreements between the FDA and the sponsor regarding an SPA agreement must be clearly documented in an SPA letter or the minutes of a meeting between the sponsor and the FDA. Nevertheless, an SPA agreement does not guarantee approval of a therapeutic candidate, and approval will require that the data will convince the FDA of the safety, efficacy and need for the therapeutic candidate for each of its intended use(s). Even if the FDA agrees to the design, execution and analysis proposed in protocols reviewed under the SPA process, the FDA may revoke or alter its agreement in certain circumstances. In particular, an SPA agreement is not binding on the FDA if public health concerns emerge that were unrecognized at the time of the SPA agreement, other new scientific concerns regarding product safety or efficacy arise, the sponsor company fails to comply with the agreed upon trial protocols, or the relevant data, assumptions or information provided by the sponsor in a request for the SPA change or are found to be false or omit relevant facts. In addition, even after an SPA agreement is finalized, the SPA agreement may be modified[1], and such modification will be deemed binding on the FDA review division, except under the circumstances described above, if the FDA and the sponsor agree in writing to modify the protocol and such modification is intended to improve the study. The FDA retains significant latitude and discretion in interpreting the terms of the SPA agreement and the data and results from any study that is the subject of the SPA agreement. A revocation or alteration in our existing SPA agreement could significantly delay or prevent approval of our application. Our SPA agreement with the FDA does not ensure that KIT-302 will receive marketing approval or that the approval process will be faster than conventional regulatory procedures. Further, we cannot make assurances that the reported results of our Phase III clinical trial of KIT-302, and the minutes of a pre-NDA submission meeting with the FDA which we received in May 2016, will result in any FDA approval for KIT-302. We also cannot make assurances that the uncertainty surrounding an investigation by the Israeli Securities Authority into our historical public disclosures concerning certain aspects of our Phase III clinical trial of KIT-302, will not have an impact on the FDA approval process for KIT-302 nor what impact such might be. See “Item 8 – Financial Information – Legal Proceedings”. Further, our on-going renal clinical trial (See Item 4. Information on the Company – A. History and Development of the Company – Recent Developments – Renal Clinical Trial), whose primary efficacy endpoint is comparable to that of our Phase III Clinical Trial, may produce results that are inconsistent with those of our Phase III Clinical Trial. While we believe that our Phase III clinical trial has been completed in accordance with the SPA agreement and that the data generated met the endpoints that have been agreed in the SPA agreement to represent adequate evidence of effectiveness, and while we anticipate that we will be able to satisfactorily provide the additional information requested by the FDA as part of the minutes we received following the pre-NDA submission meeting, and we believe that the investigation by the Israeli Securities Authority will not have any material impact on the FDA approval process, and while we have no reason to believe that our renal clinical trial will produce results that are inconsistent with those of our Phase III Clinical Trial, if the FDA revokes or alters its agreement under the SPA agreement, or if the FDA interprets the data collected from the clinical trial differently than we do, or if the FDA is not satisfied with the additional information we submit to them, or if the results of our renal clinical trial are inconsistent with those of our Phase III Clinical Trial, or if the Israeli Securities Authority investigation negatively impacts the NDA review process or causes questions to be raised about the validity of the data collected from the clinical trial, the FDA may not deem the data sufficient to support an application for regulatory approval, which could materially adversely affect our business, financial condition and results of operations. 15 We depend on our ability to identify and acquire or in-license therapeutic candidates to achieve commercial success. Our therapeutic candidates, and our subsidiaries which own the rights to therapeutic candidates, were all acquired by us from third parties. We evaluate internally and with external consultants each potential therapeutic candidate. However, there can be no assurance as to our ability to accurately or consistently select therapeutic candidates that have the highest likelihood to achieve commercial success. If we cannot meet our obligations under our in-license agreement with Yissum, or if other events occur that are not within our control, we could lose our rights to our NT219 therapeutic candidate, experience delays in developing or commercializing our NT219 therapeutic candidate or incur additional costs, which could have a material adverse effect on our business, financial condition and results of operations. We acquired rights to our NT219 therapeutic candidate from Yissum Research and Development Company of the Hebrew University of Jerusalem Ltd. (“Yissum”), the Hebrew University Technology Transfer Company pursuant to a license agreement. If we do not meet our obligations under this license agreement, or if other events occur that are not within our control we could lose the rights to our NT219 therapeutic candidate, experience delays in developing or commercializing our NT219 therapeutic candidate or incur additional costs, any of which could have a material adverse effect on our business, financial condition and results of operations. In addition, Yissum is responsible under the license agreement for the filing and prosecuting certain patent applications and maintaining certain issued patents licensed to us. If Yissum does not meet its obligations in a timely manner or if other events occur that are not within Yissum’s control, which impact Yissum’s ability to prosecute certain patent applications and maintain certain issued patents licensed to us, our success of developing and commercializing theNT219 therapeutic candidate, could be jeopardized, which could have a material adverse effect on our business, financial condition and results of operations. Additionally, Yissum may decide to discontinue maintaining certain patents in certain territories for various reasons, such as a current belief that the commercial market for the therapeutic candidate will not be large or that there is a near-term patent expiration that may reduce the value of the therapeutic candidate. In the event Yissum discontinues maintaining such patents, we may not be able to enforce rights for our therapeutic candidates or protect our therapeutic candidates from competition in those territories. Our business could suffer if we are unable to attract and retain key employees or directors. The loss of the services of members of senior management or other key personnel could delay or otherwise adversely impact the successful completion of our planned CMC, preclinical and/or clinical trials or the commercialization of our therapeutic candidates or otherwise affect our ability to manage our company effectively and to carry out our business plan. We do not maintain key-man life insurance for any of our personnel. Although we have entered into employment or consultancy agreements with all of the members of our senior management team, members of our senior management team may resign at any time. High demand exists for senior management and other key personnel in the pharmaceutical industry. There can be no assurance that we will be able to continue to retain and attract such personnel. Our growth and success also depend on our ability to attract and retain additional highly qualified scientific, technical, business development, marketing, managerial and finance personnel. We experience intense competition for qualified personnel, and the existence of non-competition agreements between prospective employees and their former employers may prevent us from hiring those individuals or subject us to liability from their former employers. In addition, if we elect to independently commercialize any therapeutic candidate, we will need to expand our marketing and sales capabilities. While we attempt to provide competitive compensation packages to attract and retain key personnel, many of our competitors are likely to have greater resources and more experience than we have, making it difficult for us to compete successfully for key personnel. Compensation packages for certain of our senior office holders are subject to approval of our compensation committee and board of directors and in certain instances of our shareholders as well. We may not be able to achieve the required corporate approvals for proposed compensation packages, further making it difficult for us to compete successfully with privately owned companies in order to attract and retain key personnel. If we cannot attract and retain sufficiently qualified technical employees on acceptable terms, we may not be able to develop and commercialize competitive therapeutic candidates. Further, any failure to effectively integrate new personnel could prevent our business from successfully growing. 16 We are an international business, and we are exposed to various global and local risks that could have an adverse effect on our business. We operate our business in multiple international jurisdictions. Such operations could be affected by changes in foreign exchange rates, capital and exchange controls, expropriation and other restrictive government actions, changes in intellectual property legal protections and remedies, trade regulations and procedures and actions affecting approval, production, pricing, and marketing of, reimbursement for and access to, our products, as well as by political unrest, unstable governments and legal systems and inter-governmental disputes. Any of these changes could adversely affect our business. Kitov Parent’s subsidiary, TyrNovo, has received and may continue to receive Israeli governmental grants to assist in the funding of its research and development activities. If TyrNovo loses funding from these research and development grants, we may encounter difficulties in the funding of future research and development projects and implementing technological improvements, which would harm our operating results and may restrict the activities of our subsidiary, TyrNovo. We may encounter difficulties in securing a commercialization partner for TyrNovo’s therapeutic candidates as the grants received from the Israeli government need to be repaid from future royalties. Through December 31, 2016, Kitov Parent’s newly-acquired subsidiary, TyrNovo had obligations to the National Authority for Technological Innovation, or the Innovation Authority (formerly known as the Office of the Chief Scientist of the Ministry of Economy and Industry, or the OCS) with respect to an aggregate of approximately NIS 5.5 million with respect to grants from the OCS in connection with TyrNovo’s technology. The requirements and restrictions for such grants are found in the Encouragement of Research, Development and Technological Innovation in the Industry Law 5744-1984 (formerly known as the Law for the Encouragement of Research and Development in Industry 5744-1984), or the Innovation Law, and the regulations and guidelines thereunder. Under the Innovation Law and the regulations thereunder, royalties of 3% to 6% on the income generated from sales of products and related services developed in whole or in part under OCS programs are payable to the OCS, up to the total amount of grants received, linked to the U.S. dollar and bearing annual interest. The technologies licensed to TyrNovo by Yissum were developed, at least in part, with funds from these grants, and accordingly is obligated to pay these royalties on sales of any of its OCS funded products that achieve regulatory approval. In addition, the Government of Israel may from time to time audit sales of products which it claims incorporate technology funded via OCS programs and this may lead to additional royalties being payable on additional products. As of December 31, 2016, the maximum royalty amount that in general would be payable by TyrNovo, excluding interest, is approximately NIS 5.5 million, and as of such date TyrNovo has not paid any royalties to the OCS. We may encounter difficulties in securing a commercialization partner for TyrNovo’s therapeutic candidates due to the requirement to pay future royalties. Following the full payment of such royalties and interest, there is generally no further liability for royalty payments; however, other restrictions under the Innovation Law, described in the risk factor below under “The OCS grants TyrNovo’s technology has received for research and development expenditures restrict its ability to manufacture products and transfer (including by a way of license for R&D purposes) know-how outside of Israel and require it to satisfy specified conditions. In addition, we may encounter difficulties partnering TyrNovo’s therapeutic candidates with entities outside Israel due to certain restrictions regarding manufacturing and transferring of know-how (including by a way of license for R&D purposes) outside of Israel imposed through the Israeli Government grants”, will continue to apply even after TyrNovo has repaid the full amount of royalties on the grants. These grants have funded some of the personnel, development activities with subcontractors, and other research and development costs and expenses incurred in connection with the development of the technologies licensed to TyrNovo by Yissum. However, if these grants are not funded in their entirety or if new grants are not awarded in the future, due to, for example, OCS budget constraints or governmental policy decisions, TyrNovo’s ability to fund future research and development and implement technological improvements would be impaired, which would negatively impact our ability to develop NT219. 17 The OCS grants which TyrNovo’s technology has received for research and development expenditures restrict its ability to manufacture products and transfer (including by a way of license for R&D purposes) know-how outside of Israel and require it to satisfy specified conditions. In addition, we may encounter difficulties partnering TyrNovo’s therapeutic candidates with entities outside Israel due to certain restrictions regarding manufacturing and transferring of know-how (including by a way of license for R&D purposes) outside of Israel imposed through the Israeli Government grants. The research and development efforts underlying TyrNovo’s technology have been financed, in part, through the grants received from the OCS with respect to TyrNovo’s technology. TyrNovo, therefore, must comply with the requirements of the Innovation Law. Under the Innovation Law, TyrNovo is generally prohibited from manufacturing products developed under OCS funding outside of the State of Israel without the prior approval of the OCS and subject to payment of increased royalties, as further described in Item 4.B – Business Overview – Government Regulations and Funding. TyrNovo may not receive the required approvals for any proposed transfer of manufacturing activities. This restriction may impair TyrNovo’s ability to outsource manufacturing rights abroad. Additionally, under the Innovation Law, TyrNovo is prohibited from transferring, including by way of license for R&D purposes, the OCS-funded know-how and related intellectual property rights outside of the State of Israel, except under limited circumstances and only with the prior approval of the OCS. TyrNovo may not receive the required approvals for any proposed transfer, and even if received, TyrNovo may be required to pay the OCS a redemption fee, which may result in significant amounts, in accordance with the formulae stipulated under the Innovation Law and related regulations, while such fee will not exceed 600% of the grant amounts plus interest. Approval of the transfer of know-how to an Israeli company is required, and may be granted if the recipient abides by the provisions of applicable laws, including the restrictions on the transfer of know-how and the manufacturing rights outside of Israel and the obligation to pay royalties, and there will be an obligation to pay royalties to the OCS from the income of such sale transaction as part of the royalty payment obligation. No assurance can be given that approval to any such transfer, if requested, will be granted. These restrictions may impair our ability to perform or outsource manufacturing outside of Israel, or otherwise transfer or sell TyrNovo’s OCS funded know-how outside of Israel. It may also require TyrNovo to obtain the approval of the OCS for certain actions and transactions and pay additional royalties and other amounts to the OCS. Furthermore, the consideration available to TyrNovo’s and/or our shareholders in a transaction involving the transfer outside of Israel of know-how developed with OCS funding (such as a merger or similar transaction) may be reduced by any amounts that TyrNovo is required to pay to the OCS. If TyrNovo fails to comply with the requirements of the Innovation Law, TyrNovo may be required to refund certain grants previously received along with interest and penalties, and may become subject to criminal proceedings. The OCS is in the process of adopting rules which deal with granting of licenses to use know-how developed as a result of research financed by the OCS for R&D purposes. Such rules may have an effect on TyrNovo, with respect to the amount of payments to the OCS for the grant of sub-licenses to third parties. In addition, pursuant to Amendment No. 7, the Innovation Authority, a statutory corporation, was established on January 1, 2016 and has replaced the OCS. The Innovation Authority is authorized to change the current restrictions imposed on recipients of grants under the R&D Law with a new set of arrangements in connection with ownership obligations of know-how (including with respect to restrictions on transfer of know-how and manufacturing activities outside of Israel), as well as royalties obligations associated with approved programs. As of the date of this annual report on Form 20-F, we are unable to determine whether the Innovation Authority will promulgate new set of arrangements or adopt the arrangements which were stipulated under the R&D Law as existed prior to the amendment. Therefore, as of the date of this annual report on Form 20-F, we are unable as assess the effect, if any, of the promulgation of such arrangements on us and/or TyrNovo. 18 Risks Related to Our Industry Even if our therapeutic candidates receive regulatory approval or do not require regulatory approval, they may not become commercially viable products. Even if KIT-302, NT219, or any other therapeutic candidate that we may develop in the future, are approved for commercialization, they may not be commercially viable products. For example, if we or our potential commercialization partners receive regulatory approval to market a therapeutic candidate, approval may be subject to limitations on the indicated uses or subject to labeling or marketing restrictions which could materially and adversely affect the marketability and profitability of the therapeutic candidate. In addition, a new therapeutic candidate may appear promising at an early stage of development or after preclinical and/or clinical trials but never reach the market, or it may reach the market but not result in sufficient product sales, if any. A therapeutic candidate may not result in commercial success for various reasons, including: ● difficulty in large-scale manufacturing, including yield and quality; ● low market acceptance by physicians, healthcare payers, patients and the medical community as a result of lower demonstrated clinical safety or efficacy compared to other products, prevalence and severity of adverse side effects, or other potential disadvantages relative to alternative treatment methods; ● insufficient or unfavorable levels of reimbursement from government or third-party payers, such as insurance companies, health maintenance organizations and other health plan administrators; ● infringement on proprietary rights of others for which we or our potential commercialization partners have not received licenses; ● incompatibility with other therapeutic candidates; ● other potential advantages of alternative treatment methods and competitive forces that may make it more difficult for us to penetrate a particular market segment; ● ineffective marketing and distribution support; ● lack of significant competitive advantages over existing products on the market; ● lack of cost-effectiveness; or ● timing of market introduction of competitive products. Physicians, various other health care providers, patients, payers or the medical community in general may be unwilling to accept, utilize or recommend any of our approved therapeutic candidates. If we are unable, either on our own or through third parties, to manufacture, commercialize and market our proposed therapeutic candidates when planned, or develop commercially viable therapeutic candidates, we may not achieve any market acceptance or generate revenue. The market for our therapeutic candidates is rapidly changing and competitive, and new drug delivery mechanisms, drug delivery technologies, new drugs and new treatments which may be developed by others could impair our ability to maintain and grow our business and remain competitive. The pharmaceutical and biotechnology industry is highly competitive, and we face significant competition from many pharmaceutical, biopharmaceutical and biotechnology companies that are researching and marketing products designed to address the indications for which we are currently developing therapeutic candidates or for which we may develop therapeutic candidates in the future. There are various other companies that currently market or are in the process of developing products that address all of the indications or diseases treated by our therapeutic candidates. New drug delivery mechanisms, drug delivery technologies, new drugs and new treatments that have been developed or that are in the process of being developed by others may render our therapeutic candidates noncompetitive or obsolete, or we may be unable to keep pace with technological developments or other market factors. Some of these technologies may have an entirely different platform or means of treating the same indications as KIT- 302, NT219, or other therapeutic candidates that we may develop in the future. Technological competition from pharmaceutical and biotechnology companies, universities, governmental entities and others is intense and is expected to increase. Many of these entities have significantly greater research and development capabilities, human resources and budgets than we do, as well as substantially more marketing, manufacturing, financial and managerial resources. These entities represent significant competition for us. Acquisitions of, or investments in, competing pharmaceutical or biotechnology companies by large corporations could increase such competitors’ financial, marketing, manufacturing and other resources. 19 The potential widespread acceptance of therapies that are alternatives to ours may limit market acceptance of our formulations or therapeutic candidates, even if commercialized. Many of our targeted diseases and conditions can also be treated by other medications or drug delivery technologies. These treatments may be widely accepted in medical communities and have a longer history of use. The established use of these competitive drugs may limit the potential for our therapeutic candidates to receive widespread acceptance if commercialized. If third-party payers do not adequately reimburse customers for any of our therapeutic candidates that are approved for marketing, they might not be purchased or used, and our revenues and profits will not develop or increase. Our revenues and profits will depend heavily upon the availability of adequate reimbursement for the use of our approved therapeutic candidates, if any, from governmental or other third-party payers, both in the U.S. and in foreign markets. Reimbursement by a third-party payer may depend upon a number of factors, including the third-party payer’s determination that the use of an approved therapeutic candidate is, among others: ● a covered benefit under its health plan; ● safe, effective and medically necessary; ● appropriate for the specific patient; ● cost-effective, including compared to approved alternate therapies; and ● neither experimental nor investigational. Obtaining reimbursement approval for a therapeutic candidate from each government or other third-party payer is a time-consuming and costly process that could require us or our current or potential development and commercialization partners to provide supporting scientific, clinical and cost- effectiveness data for the use of our therapeutic candidates to each payer. Even when a payer determines that a therapeutic candidate is eligible for reimbursement, the payer may impose coverage limitations that preclude payment for some uses that are approved by the FDA or other foreign regulatory authorities. Reimbursement rates may vary according to the use of the therapeutic candidate and the clinical setting in which it used, may be based on payments allowed for lower-cost products that are already reimbursed, may be incorporated into existing payments for other products or services, and may reflect budgetary constraints or imperfections in Medicare, Medicaid or other data used to calculate these rates. In the U.S., there have been, and we expect that there will continue to be, federal and state proposals to constrain expenditures for medical products and services which may affect payments for our therapeutic candidates in the U.S. We believe that legislation that reduces reimbursement for our therapeutic candidates could adversely impact how much or under what circumstances healthcare providers will prescribe or administer our therapeutic candidates, if approved. This could materially and adversely impact our business by reducing our ability to generate revenue, raise capital, obtain additional collaborators and market our therapeutic candidates, if approved. At this stage, we are unable to estimate the extent of the direct or indirect impact of any such federal and state proposals. Further, the Centers for Medicare and Medicaid Services (CMS) frequently change product descriptors, coverage policies, product and service codes, payment methodologies and reimbursement values. Third-party payers often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, and both the CMS and other third-party payers may have sufficient market power to demand significant price reductions. 20 Legislative or regulatory reform of the healthcare system in the United States may harm our future business. On March 23, 2010, President Obama signed the “Patient Protection and Affordable Care Act” (P.L. 111-148) and on March 30, 2010, the President signed the “Health Care and Education Reconciliation Act” (P.L. 111-152), collectively commonly referred to as the “Healthcare Reform Law.” The Health Reform Law included a number of new rules regarding health insurance, the provision of health care, and conditions to reimbursement for healthcare services provided to Medicare and Medicaid patients. Through the rule making process, substantial changes have been and continue to be made to the current system for paying for healthcare in the United States, including changes made in order to extend medical benefits to tens of millions of Americans who lacked insurance coverage and to contain healthcare costs. Extending coverage to a large population could substantially change the structure of the health insurance system and the methodology for reimbursing medical services and drugs. This legislation has been one of the most comprehensive and significant reforms ever experienced by the United States in the healthcare industry, and it has significantly changed the way healthcare is financed by both governmental and private insurers. This legislation has impacted the scope of healthcare insurance and incentives for consumers and insurance companies, among others. Additionally, the Healthcare Reform Law’s provisions are designed to encourage providers to find cost savings in their clinical operations. Pharmaceuticals represent a significant portion of the cost of providing care. Through modified reimbursement rates and other incentives, the United States government is requiring that providers identify the most cost-effective services, supplies and pharmaceuticals. This environment has caused changes in the purchasing habits of providers and resulted in specific attention to the pricing negotiation, product selection and utilization review surrounding pharmaceuticals. To the extent that our therapeutic candidates are at some point reimbursable by U.S federal government programs, this attention may result in our therapeutic candidates being chosen less frequently or the pricing being substantially lowered. Some of the provisions of the Healthcare Reform Law have not yet been fully implemented and the continued effect of the legislation is difficult to predict and, at this stage, we are unable to estimate the full extent of the direct and/or indirect impact of the legislation on us. These structural changes could entail further modifications to the existing system of private payors and government programs (such as Medicare, Medicaid and state Children’s Health Insurance Program), creation of a government-sponsored healthcare insurance source, or some combination of both, as well as other changes. Restructuring the coverage of medical care in the United States could impact the reimbursement for prescribed drugs and pharmaceuticals, such as those we and our development and/or commercialization partners are currently developing. If reimbursement for our approved therapeutic candidates, if any, is substantially reduced in the future, or rebate obligations associated with them are substantially increased, our business could be materially and adversely impacted. Extending medical benefits to those who previously lacked coverage may, in the long term, result in substantial cost to the United States federal government, which may force significant additional changes to the healthcare system in the United States. Much of the funding for expanded healthcare coverage may be sought through cost savings. While some of these savings may come from realizing greater efficiencies in delivering care, improving the effectiveness of preventive care and enhancing the overall quality of care, much of the cost savings may come from reducing the cost of care and increased enforcement activities. Cost of care could be reduced by decreasing the level of reimbursement for medical services or products (including those pharmaceuticals currently being developed by us or our development and/or commercialization partners), or by restricting coverage (and, thereby, utilization) of medical services or products. In either case, a reduction in the utilization of, or reimbursement for, any therapeutic candidate for which we receive marketing approval in the future could have a materially adverse effect on our financial performance. Several States and private entities initially mounted legal challenges to the healthcare reform legislation, and they continue to litigate various aspects of the legislation. On July 26, 2012, the United States Supreme Court generally upheld the healthcare reform legislation as constitutional. However, the Supreme Court held that the legislation improperly required the States to expand their Medicaid programs to cover more individuals. As a result, the States have a choice as to whether they will expand the numbers of individuals covered by their respective State Medicaid programs. Some States have determined that they will not expand their Medicaid programs and will develop other cost saving and coverage measures to provide care to currently uninsured residents. Many of these efforts to date have included the institution of Medicaid managed care programs. The manner in which these cost saving measures are implemented could have a materially adverse effect on our financial performance. Further, the healthcare regulatory environment has seen significant changes in recent years and is still in flux. Legislative initiatives to modify or repeal the Healthcare Reform Law and judicial challenges continue, including a recent executive order issued by the recently-elected U.S. President directing government agencies and departments to minimize the economic burden of the Healthcare Reform Law to the extent permitted by law, and, notwithstanding the recent failure of the Congress to abolish much of the Healthcare Reform Law, may continue or even increase in light of the change in administrations following the most recent presidential election. We cannot predict the impact on our business of future legal challenges to the Healthcare Reform Legislation or other changes to the current laws and regulations. 21 We are subject to additional federal and state laws and regulations relating to our business, and our failure to comply with those laws could have a material adverse effect on our results of operations and financial conditions. Upon the commencement of marketing products in the United States, we will become subject to additional healthcare regulation and enforcement by the federal government and the states in which we conduct or will conduct our business. The laws that may affect our ability to operate include, but are not limited to, the following: ● the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under government healthcare programs such as the Medicare and Medicaid programs; ● the federal Anti-Inducement Law (also known as the Civil Monetary Penalties Law), which prohibits a person from offering or transferring remuneration to a Medicare or State health care program beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner or supplier of any item or service for which payment may be made, in whole or in part, by Medicare or a State health care program; ● the Ethics in Patient Referrals Act of 1989, commonly referred to as the Stark Law, which prohibits physicians from referring Medicare or Medicaid patients for certain designated health services where that physician or its family member has a financial relationship with the entity providing the designated health service, unless an exception applies; ● federal false claims laws that prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid or other government healthcare programs that are false or fraudulent; ● the so-called federal “Sunshine Act”, which requires certain pharmaceutical and medical device companies to monitor and report certain financial relationships with physicians and other healthcare providers to CMS for disclosure to the public; ● the Federal Food, Drug, and Cosmetic Act, which, among other things, strictly regulates drug product and medical device marketing, prohibits manufacturers from marketing such products for off-label use, and regulates the distribution of samples; ● federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters; and ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers. Further, the Healthcare Reform Law, among other things, amends the intent requirement of the federal anti-kickback and criminal healthcare fraud statutes. A person or entity can now be found guilty of fraud or an anti-kickback violation without actual knowledge of the statute or specific intent to violate it. In addition, the Healthcare Reform Law provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statue constitutes a false or fraudulent claim for purposes of the False Claims Act (31 U.S.C. 3729–3733). Possible sanctions for violation of these anti-kickback laws include monetary fines, civil and criminal penalties, exclusion from Medicare, Medicaid and other government programs and forfeiture of amounts collected in violation of such prohibitions. Any violations of these laws, or any action against us for violation of these laws, even if we successfully defend against it, could result in a material adverse effect on our reputation, business, results of operations and financial condition. The Healthcare Reform Law also imposes reporting requirements on certain medical devices and pharmaceutical manufacturers, among others, to make annual public disclosures of certain payments or other transfers of value to physicians and teaching hospitals and ownership or investment interests held by physicians or their immediate family members. Failure to submit required information may result in civil monetary penalties of up to an aggregate of $150,000 per year (or up to an aggregate of $1 million per year for “knowing failures”), for all payments, transfers of value or ownership or investment interests that are not reported. Manufacturers were required to begin data collection on August 1, 2013 and report such data to the CMS by March 31 each year. CMS made the data publicly available on its searchable database beginning in September 2014. 22 In addition, there has been a recent trend of increased federal and state regulation of payments made to physicians for marketing, medical directorships, and other purposes. Some states, such as California, Massachusetts and Vermont, mandate implementation of corporate compliance programs, along with the tracking and reporting of gifts, compensation and other remuneration to physicians, and some states limit or prohibit such gifts. Most recently, there has been a trend in federal and state legislation aimed at requiring pharmaceutical companies to disclose information about their production and marketing costs, and ultimately in lowering costs for drug products. Several states have introduced bills that would require disclosure of certain pricing information for prescription drugs that have no threshold amount or are above a certain annual wholesale acquisition cost, and in June 2016 Vermont became the first state to pass legislation requiring certain drug companies to disclose information relating to justification of certain price increases. The U.S. Congress has also introduced bills targeting prescription drug price transparency. Any such implementation of this type of legislation requiring publication of drug costs could materially and adversely impact our business by promoting a reduction in drug prices. As such, patients may choose to use other low-cost, established drugs or therapies. The scope and enforcement of these laws is uncertain and subject to change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations. We cannot predict the impact on our business of any changes in these laws. Federal or state regulatory authorities may challenge our current or future activities under these laws. Any such challenge could have a material adverse effect on our reputation, business, results of operations, and financial condition. Any state or federal regulatory review of us, regardless of the outcome, would be costly and time- consuming. We could be exposed to significant drug product liability claims, which could be time consuming and costly to defend, divert management attention and adversely impact our ability to obtain and maintain insurance coverage. The clinical trials that we conduct, and the testing, manufacturing, marketing and commercial sale of our therapeutic candidates, involve and will involve an inherent risk that significant liability claims may be asserted against us. We currently have a clinical trial liability policy that includes coverage for our clinical trials. Should we decide to seek additional insurance against such risks before our product sales commence, there is a risk that such insurance will be unavailable to us, or if it can be obtained at such time, that it will be available only at an unaffordable cost. Even if we obtain insurance, it may prove inadequate to cover claims or litigation costs, especially in the case of wrongful death claims. Product liability claims or other claims related to our therapeutic candidates, regardless of their outcome, could require us to spend significant time and money in litigation or to pay significant settlement amounts or judgments. Any successful product liability or other claim may prevent us from obtaining adequate liability insurance in the future on commercially desirable or reasonable terms. An inability to obtain sufficient insurance coverage at an acceptable cost or otherwise to protect against potential product liability claims could prevent or inhibit the commercialization of our products and therapeutic candidates. A product liability claim could also significantly harm our reputation and delay market acceptance of our therapeutic candidates. Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations. Our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. An economic downturn could result in a variety of risks to our business, including weakened demand for our therapeutic candidates and our inability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also strain our partners and suppliers, possibly resulting in supply disruption, or cause future customers to delay making payments for our products. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business. 23 Our business involves risks related to handling regulated substances which could severely affect our ability to conduct research and development of our therapeutic candidates. In connection with our current or potential development and commercialization partners’ research and clinical development activities, as well as the manufacture of materials and therapeutic candidates, we and our current or potential development and commercialization partners are subject to foreign, federal, state and local laws, rules, regulations and policies governing the use, generation, manufacture, storage, air emission, effluent discharge, handling and disposal of certain materials, biological specimens and wastes. We and our current or potential development and commercialization partners may be required to incur significant costs to comply with environmental and health and safety regulations in the future. Our research and clinical development, as well as the activities of our manufacturing and current or potential development and commercialization partners, both now and in the future, may involve the controlled use of hazardous materials, including but not limited to certain hazardous chemicals. We cannot completely eliminate the risk of accidental contamination or injury from these materials. In the event of such an occurrence, we could be held liable for any damages that result and any such liability could exceed our resources. Risks Related to Legal Proceedings and Intellectual Property Legal proceedings or third-party claims of intellectual property infringement and other legal challenges may require us to spend substantial time and money and could prevent us from developing or commercializing our therapeutic candidates. An adverse result in these infringements and other legal challenges could have a material adverse effect on our business, results of operations and financial condition. The development, manufacture, use, offer for sale, sale or importation of our therapeutic candidates may infringe on the claims of third-party patents or other intellectual property rights. The nature of claims contained in unpublished patent filings around the world is unknown to us, and it is not possible to know which countries patent holders may choose for the extension of their filings under the Patent Cooperation Treaty, or other mechanisms. We may also be subject to claims based on the actions of employees and consultants with respect to the usage or disclosure of intellectual property learned at other employers. The cost to us of any intellectual property litigation or other infringement proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively because of their substantially greater financial resources. Uncertainties resulting from the initiation and continuation or defense of intellectual property litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Intellectual property litigation and other proceedings may also absorb significant management time. Consequently, we are unable to guarantee that we will be able to manufacture, use, offer for sale, sell or import our therapeutic candidates in the event of an infringement action. In the event of patent infringement claims, or to avoid potential claims, we may choose or be required to seek a license from a third party and would most likely be required to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we were able to obtain a license, the rights may be non-exclusive, which could potentially limit our competitive advantage. Ultimately, we could be prevented from commercializing a therapeutic candidate or be forced to cease some aspect of our business operations if, as a result of actual or threatened patent infringement or other claims, we are unable to enter into licenses on acceptable terms. This inability to enter into licenses could harm our business significantly. From time to time, we may also be involved in various lawsuits and legal proceedings other than intellectual property infringement actions, concerning such laws as corporate and securities laws, business laws, product liability laws, and environmental laws. On December 3, 2015, we announced that we received a lawsuit and motion to approve the lawsuit as a class action lawsuit pursuant to the Class Action Lawsuits Law 5766-2006 (which was filed against us and our directors at the Tel Aviv District Court (Economic Division). The Motion asserts claims for damages to the holders of our securities listed on the TASE, arising due to the initial public offering of our securities in the U.S. during November 2015. Additionally, on February 16, 2017, we announced that four lawsuits and motions to approve the lawsuits as a class action lawsuit were filed against us and certain of our office holders at the Tel Aviv District Court (Economic Division), and served on us, with each such motion relating to the formal investigation by the Israeli Securities Authority (ISA) into our public disclosures. In addition, class actions lawsuits largely relating to the same matters were filed in the State of California and in the U.S. federal courts against us, our CEO and CFO, and in the California lawsuits, against the underwriters of our November 2015 initial public offering in the U.S.A. (collectively, “Investigation Motions”). 24 The above noted motions and class actions could result in significant legal defense costs and high punitive damage payments. Although we maintain directors’ and officers’ liability insurance, with an extension to cover the Company as well, the insurance companies may reject our claims for coverage under the policy or the coverage may not be adequate to cover future claims. Furthermore, to the extent that we may be required to indemnify our underwriters for their legal defense costs or any other damages, such indemnification would not be covered under the policy. Additionally, we may be unable to maintain our existing directors’ and officers’ liability insurance in the future at satisfactory rates or adequate amounts. With respect to the motion from December 2015, we have been advised by our attorneys that the likelihood of the Company not incurring any financial obligation as a result of such class action exceeds the likelihood that the Company will incur a financial obligation. At this preliminary stage however, we are unable, with any degree of certainty, to make any other evaluations or any other assessments with respect to the probability of success or the scope of potential exposure, if any, of any of the Investigation Motions. For more information see “Item 8 – Financial Information – Legal Proceedings”. It is difficult to foresee the results of legal actions and proceedings currently involving us or those which may arise in the future, and an adverse result in these matters could have a material adverse effect on our business, results of operations and financial condition. In addition, any legal or administrative proceedings which we are subject to could require the significant involvement of our senior management, and may divert management attention from our business and operations. We may be subject to material fines, penalties and other sanctions and other adverse consequences arising out of the Company’s ongoing Israeli Securities Authority investigation, related class action lawsuits and related matters. We operate in a complex legal and regulatory environment, and any failure or possible failure to comply with applicable laws, rules and regulations may result in civil and/or criminal legal proceedings. In Israel, the Company is currently subject to a formal investigation by the Israeli Securities Authority (the “ISA” and the “Investigation,” respectively) into its public disclosures around certain aspects of the studies related to its lead therapeutic candidate, KIT- 302. The Company has not yet been advised by the ISA of the full scope and focus of the Investigation. However, in order to provide additional information regarding the investigation to the Company’s investors and the public, the Company has had discussions with the ISA in order to obtain certain additional information which may be disclosed to the Company’s shareholders. Based on these discussions with the ISA, the Company believes that the Investigation with respect to the Company relates to the Data Monitoring Committee (“DMC”) appointed in connection with the Company’s Phase III trial of KIT-302. We cannot predict at this time the impact on us as a result of the Investigation and accordingly cannot assure you that we will not be materially and adversely affected. Responding to such an investigation is costly and involves a significant diversion of management’s attention. Such proceedings are unpredictable and may develop over lengthy periods of time. Future settlements may involve large cash penalties. The ISA has a broad range of civil and criminal penalties it may seek to impose (on the Company and/or individuals), and the Company and/or officer holders may be required to pay material fines and/or penalties. The Company and/or office holders may be subject to injunctions or limitations on future conduct, or suffer other criminal or civil penalties or adverse impacts, including additional lawsuits by private litigants. Any one or more of the foregoing could have a material adverse effect on our reputation and our business, financial condition or results of operations. For more information on the Investigation see “Item 8 – Financial Information – Legal Proceedings”. We may be unable to adequately protect or enforce our rights to intellectual property, causing us to lose valuable rights. Loss of patent rights may lead us to lose market share and potential profits. Our success depends, in part, on our ability, and the ability of our current or potential development and commercialization partners to obtain patent protection for our therapeutic candidates, maintain the confidentiality of our trade secrets and know-how, operate without infringing on the proprietary rights of others and prevent others from infringing our proprietary rights. 25 We try to protect our proprietary position by, among other things, filing U.S., European, and other patent applications related to our therapeutic candidates, inventions and improvements that may be important to the continuing development of our therapeutic candidates. Because the patent position of pharmaceutical companies involves complex legal and factual questions, we cannot predict the validity and enforceability of any patents we may obtain with certainty. Our competitors may independently develop drug delivery technologies or products similar to ours or design around or otherwise circumvent any patents that may be issued to or licensed by us. Our pending patent applications, and those that we may file in the future or those we may license from third parties may not result in patents being issued. If these patents are issued, they may not provide us with proprietary protection or competitive advantages. The degree of future protection to be afforded by our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep our competitive advantage. Patent rights are territorial; thus, the patent protection we have sought will only extend, if issued, to those countries, if any, in which we will be issued patents. Even so, the laws of certain countries do not protect our intellectual property rights to the same extent as do the laws of the U.S. and the European Union. Competitors may successfully challenge any of our patents, produce similar drugs or products that do not infringe such patents, or produce drugs in countries where we have not applied for patent protection or that do not respect such patents. Furthermore, it is not possible to know the scope of claims that will be allowed in published applications and it is also not possible to know which claims of granted patents, if any, will be deemed enforceable in a court of law. After the completion of development and registration of any future patents, third parties may still act to manufacture or market our therapeutic candidates in infringement of our patent protected rights. Such manufacture or marketing of our therapeutic candidates in infringement of any patent- protected rights is likely to cause us damage and lead to a reduction in the prices of our therapeutic candidates, thereby reducing our potential profits. We may invest a significant amount of time and expense in the development of our therapeutic candidates only to be subject to significant delay and patent litigation before they may be commercialized. In addition, due to the extensive time needed to develop, test and obtain regulatory approval for our therapeutic candidates, any patents that may be issued that protect our therapeutic candidates may expire early during commercialization. This may reduce or eliminate any market advantages that such patents may give us. Following patent expiration, we may face increased competition through the entry of generic products into the market and a subsequent decline in market share and profits. We are developing some of our therapeutic candidates in collaboration with academic and other research institutes. While we attempt to ensure that our intellectual property is protected under the terms of our collaboration agreements with such institutes, these institutes may have claims to our intellectual property. If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete against us. In addition to filing patents, we generally try to protect our trade secrets, know-how and technology by entering into confidentiality or non-disclosure agreements with parties that have access to it, such as our current or potential development and commercialization partners, employees, contractors and consultants. We also enter into agreements that purport to require the disclosure and assignment to us of the rights to the ideas, developments, discoveries and inventions of our employees, advisors, research collaborators, contractors and consultants while we employ or engage them. However, these agreements can be difficult and costly to enforce or may not provide adequate remedies. Any of these parties may breach the confidentiality agreements and willfully or unintentionally disclose our confidential information, or our competitors might learn of the information in some other way. The disclosure to, or independent development by, a competitor of any trade secret, know-how or other technology not protected by a patent could materially adversely affect any competitive advantage we may have over any such competitor. To the extent that any of our employees, advisors, research collaborators, contractors or consultants independently develop, or use independently developed, intellectual property in connection with any of our projects, disputes may arise as to the proprietary rights to this type of information. If a dispute arises with respect to any proprietary right, enforcement of our rights can be costly and unpredictable and a court may determine that the right belongs to a third party. 26 We may be subject to other patent-related litigation or proceedings that could be costly to defend and uncertain in their outcome. In addition to infringement claims against us, we may in the future become a party to other patent litigation or proceedings before regulatory agencies, including interference or re-examination proceedings filed with the U.S. Patent and Trademark Office (USPTO) or opposition proceedings in other foreign patent offices regarding intellectual property rights with respect to our therapeutic candidates, as well as other disputes regarding intellectual property rights with our current and potential development and commercialization partners, or others with whom we have contractual or other business relationships. Post-issuance oppositions are not uncommon and we and our current and potential development and commercialization partners will be required to defend these opposition procedures as a matter of course. Opposition procedures may be costly, and there is a risk that we may not prevail. Risks Related to our Operations in Israel It may be difficult to enforce a U.S. judgment against us and our officers and directors in Israel or the U.S., or to serve process on our officers and directors. We are incorporated in Israel. Most of our executive officers and directors reside outside of the U.S., and all of our assets and most of the assets of our executive officers and directors are located outside of the U.S. Therefore, a judgment obtained against us or such executive officers and our directors in the U.S., including one based on the civil liability provisions of the U.S. federal securities laws, may not be collectible in the U.S. and may not be enforced by an Israeli court. It may also be difficult for you to affect service of process on these persons in the U.S. or to assert U.S. securities law claims in original actions instituted in Israel. In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not United States law is applicable to the claim. If United States law is found to be applicable, the content of applicable United States law must be proven as a fact by expert witnesses, which can be a time consuming and costly process. Certain matters of procedure will also be governed by Israeli law. There is little binding case law in Israel that addresses the matters described above. As a result of the difficulty associated with enforcing a judgment against us in Israel, it may be impossible to collect any damages awarded by either a U.S. or foreign court. Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful shareholder claims against us and may reduce the amount of money available to us. The Companies Law and our amended and restated articles of association permit us to indemnify our directors and officers for acts performed by them in their capacity as directors and officers. The Companies Law and our amended and restated articles of association provide that a company may not exempt or indemnify a director or an office holder nor enter into an insurance contract, which would provide coverage for any monetary liability incurred as a result of (a) a breach by the director or officer of his duty of loyalty, except for insurance and indemnification where the director or officer acted in good faith and had a reasonable basis to believe that the act would not prejudice the company; (b) a breach by the director or officer of his duty of care if the breach was done intentionally or recklessly, except if the breach was solely as a result of negligence; (c) any act or omission done with the intent to derive an illegal personal benefit; or (d) any fine, civil fine, monetary sanctions, or forfeit imposed on the officer or director. See Item 6. Directors, Senior Management and Employees – C. Board Practices – Exculpation, Insurance and Indemnification of Directors and Officers. Kitov Parent has issued letters of indemnification to our directors and officers, pursuant to which we have agreed to indemnify them in advance for any liability or expense imposed on or incurred by them in connection with acts they perform in their capacity as a director or officer, subject to applicable law. The amount of the advance indemnity will not exceed 25% of Kitov Parent’s then consolidated shareholders’ equity, per its most recent consolidated annual financial statements. 27 Our indemnification obligations limit the personal liability of our directors and officers for monetary damages for breach of their duties as directors by shifting the burden of such losses and expenses to us. Although we have obtained directors’ and officers’ liability insurance, certain liabilities or expenses covered by our indemnification obligations may not be covered by such insurance or the coverage limitation amounts may be exceeded. As a result of the class action motions and lawsuits or other claims which may be filed against our directors and officers, we may need to use a significant amount of our funds to satisfy our indemnification obligations, which could severely harm our business and financial condition and limit the funds available to shareholders who may choose to bring a claim against our company. See the risk factor titled “Legal proceedings or third-party claims of intellectual property infringement and other legal challenges may require us to spend substantial time and money and could prevent us from developing or commercializing our therapeutic candidates. An adverse result in these infringements and other legal challenges could have a material adverse effect on our business, results of operations and financial conditions” under the risk factor section titled “Risks Related to Legal Proceedings and Intellectual Property”. These provisions and resultant costs may also discourage us from bringing a lawsuit against directors and officers for breaches of their duties, and may similarly discourage the filing of derivative litigation by our shareholders against the directors and officers even though such actions, if successful, might otherwise benefit our shareholders. In the event we do not satisfy the requirements for a tax-free merger of Kitov Pharmaceuticals with and into Kitov Parent, Kitov Pharmaceuticals may be subject to a material tax liability. The board of directors of each of Kitov Parent and Kitov Pharmaceuticals has approved the merger of Kitov Pharmaceuticals with and into Kitov Parent, with Kitov Parent as the surviving company. Based on our analysis, the merger satisfies the requirements for a tax-free merger under Israeli tax law, which includes amongst other requirements, which are applicable to Kitov: that the merger is being considered for business and economic purposes and that the primary goal of the merge is not tax avoidance or tax reduction; compliance with certain limitations on selling off most of each of the companies’ assets should not be sold during the period two years after the end of the tax year in which the change in the structure occurs; the merged company will continue its main business activity in the same way it did prior to the merger; and operating losses carried forward (of both the participating companies) may be deducted in the reports of the merged company, at the lower of a rate of 20% of the losses transferred each year, or up to 50% of the taxable income of the merged company. In the event the Israel Tax Authority does not agree with our analysis, Kitov Pharmaceuticals may be subject to a material tax amount on account of the sale equal to the value of its assets on the date of transfer minus the cost basis for such assets. Such a tax liability may have a material adverse effect on our financial results. We conduct our operations in Israel and therefore our results may be adversely affected by political, economic and military instability in Israel and its region. We are incorporated under the laws of the State of Israel, our principal offices are located in central Israel and some of our officers, employees, consultants and directors are residents of Israel. Accordingly, political, economic and military conditions in Israel and the surrounding region may directly affect our business. Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its Arab neighbors. Any hostilities involving Israel or the interruption or curtailment of trade within Israel or between Israel and its trading partners could adversely affect our operations and results of operations and could make it more difficult for us to raise capital. In 2008, 2012, and again in the summer of 2014, Israel was engaged in an armed conflict with Hamas, a militia group and political party operating in the Gaza Strip, and during the summer of 2006, Israel was engaged in an armed conflict with Hezbollah, a Lebanese Islamist Shiite militia group and political party. These conflicts involved missile strikes against civilian targets in various parts of Israel, and negatively affected business conditions in Israel. Political uprisings and civil resistance demonstrations in various countries in the Middle East, including Egypt, Iraq and Syria, have affected the political stability of those countries. It is not clear how this instability, will develop and how it will affect the political and security situation in the Middle East. This instability may lead to deterioration of the political relationships that exist between Israel and these countries, and have raised concerns regarding security in the region and the potential for armed conflict. The tension between Israel and Iran or extremist groups in the region, such as Hamas in Gaza and Hezbollah in Lebanon, may escalate in the future and turn violent, which could affect the Israeli economy generally and us in particular. Any armed conflicts, terrorist activities or political instability in the region could adversely affect business conditions and could harm our results of operations. Parties with whom we may do business have sometimes declined to travel to Israel during periods of heightened unrest or tension, forcing us to make alternative arrangements when necessary. The conflict situation in Israel could cause situations where medical product certifying or auditing bodies could not be able to visit manufacturing facilities of our subcontractors in Israel in order to review our certifications or clearances, thus possibly leading to temporary suspensions or even cancellations of our product clearances or certifications. The conflict situation in Israel could also result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions in such agreements. 28 Our commercial insurance does not cover losses that may occur as a result of events associated with the security situation in the Middle East. Although the Israeli government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, we cannot assure you that this government coverage will be maintained. Any losses or damages incurred by us could have a material adverse effect on our business. Any armed conflicts or political instability in the region would likely negatively affect business conditions and could harm our results of operations. Further, in the past, the State of Israel and Israeli companies have been subjected to an economic boycott. Several countries still restrict business and trade activity with the State of Israel and with Israeli companies, and additional countries may impose restrictions on doing business with Israel and Israeli companies if hostilities in the region continue or intensify. Such restrictions may seriously limit our ability to sell our products to customers in those countries. Any of the factors set forth above may have an adverse impact on our operating results, financial condition or the expansion of our business. Kitov Parent owns a majority interest in its subsidiary, TyrNovo. As a majority shareholder under the Israeli Companies Law Kitov Parent owes certain fiduciary duties to the non-controlling shareholders of TyrNovo and must share dividends and distributions with these non-controlling shareholders. In addition, in a stay of proceedings, reorganization or bankruptcy scenario, certain controlling shareholder loans may become subordinated to other obligations of TyrNovo. Kitov Parent presently owns a controlling majority stake in TyrNovo, as well as the majority of TyrNovo’s presently outstanding debt obligations. All the ordinary shares of TyrNovo that are not owned by Kitov Parent are privately held. In order to satisfy whatever fiduciary obligations Kitov Parent may have under applicable law or other governing documents to the non-controlling shareholders of TyrNovo, Kitov Parent endeavors to deal with TyrNovo at “arm’s-length.” Some transactions between Kitov Parent and TyrNovo, including any cancellation of such transactions, may require the approval of the boards of directors of TyrNovo and/or Kitov Parent, and, under certain circumstances, approval of the shareholders of TyrNovo and/or Kitov Parent by special vote and are subject to the receipt of applicable permits and approvals, and therefore Kitov Parent’s ability to control TyrNovo may be limited. For example, the current articles of association of TyrNovo require that any loans taken by TyrNovo receive unanimous consent of all shareholders present at a shareholders meeting called in order to approve such loan. The same special majority would be required in order to amend such provision in the articles of association. It is unclear if these provision apply to the Convertible Loans to be provided to TyrNovo by the Company and/or Taoz, a minority shareholder of TyrNovo, pursuant to a Binding Term Sheet between TyrNovo, Taoz and Kitov Parent which was confirmed under a final judgment entered into by the Economic Division of the Tel Aviv District Court on February 9, 2017. As such, it is presently unclear if Kitov Parent and/or Taoz can make investments into TyrNovo in the form of such Convertible Loans, nor what might be the terms of any equity investments into TyrNovo in place of such Convertible Loans. For more information on the Convertible Loans and the Court approved settlement, see Item 7. Major Shareholders and Related Party Transactions B. – Related Party Transactions – TyrNovo Ltd. In addition, any dividend or distribution from TyrNovo requires the approval of the directors of TyrNovo and may be subject to restrictions imposed other agreements to which they are party, and therefore there may be limits on the dividends or distributions Kitov Parent receives from TyrNovo and from any commercialization of NT219. In addition, in a stay of proceedings, reorganization or bankruptcy scenario, certain controlling shareholder loans may become subordinated to other obligations of the subsidiary, and Kitov Parent’s priority rights over loans it has made to TyrNovo may be pushed back in such proceedings. 29 Provisions of Israeli law and Kitov Parent’s amended and restated articles of association or TyrNovo’s articles of association may delay, prevent or otherwise impede a merger with, or an acquisition of, the Company or TyrNovo, or an acquisition of a significant portion of Kitov Parent’s or TyrNovo’s shares, which could prevent a change of control, and negatively affect the market price of Kitov Parent’s ordinary shares. Israeli corporate law regulates mergers, requires tender offers for acquisitions of shares above specified thresholds, requires special approvals for certain transactions involving directors, officers or significant shareholders and regulates other matters that may be relevant to these types of transactions. These provisions of Israeli law may delay, prevent or make difficult an acquisition of us, which could prevent a change of control and therefore depress the price of our shares, See “Item 10. Additional Information – B. Memorandum and Articles of Association – Provisions restricting change in control of our company” for more information. Furthermore, Israeli tax considerations may make potential transactions unappealing to us or to our shareholders, especially for those shareholders whose country of residence does not have a tax treaty with Israel which exempts such shareholders from Israeli tax. For example, Israeli tax law does not recognize tax-free share exchanges to the same extent as U.S. tax law. With respect to mergers, Israeli tax law allows for tax deferral in certain circumstances but makes the deferral contingent on the fulfillment of a number of conditions, including, in some cases, a holding period of two years from the date of the transaction during which sales and dispositions of shares of the participating companies are subject to certain restrictions. Moreover, with respect to certain share swap transactions, the tax deferral is limited in time, and when such time expires, the tax becomes payable even if no disposition of the shares has occurred. Kitov Parent’s amended and restated articles of association also contain provisions that could delay or prevent changes in control or changes in our management. These provisions include matters in connection with the election and removal of directors, such as Kitov Parent’s staggered board of directors, the appointment by Kitov Parent’s board of directors of additional directors to fill vacancies on the board of directors, the size of the Kitov Parent’s board of directors, the terms of office of Kitov Parent’s directors and the special majority of Kitov Parent’s voting rights required to amend such provision in its amended and restated articles of association, See “Item 6. Directors, Senior Management and Employees – C. Board Practices - Board of Directors and Officers” and “Item 10. Additional Information – B. Memorandum and Articles of Association – Provisions restricting change in control of our company” for additional information. In addition, Kitov Parent has 1,000,000,000 shares of non-voting senior preferred shares authorized, which can be issued by its board of directors, who can establish conversion, redemption, optional and other special rights, qualifications, limitations or restrictions, if any, of the non-voting senior preferred shares, without further actions by Kitov Parent’s shareholders, unless shareholder approval is otherwise required by applicable law, the rules of any exchange or other market on which its securities may then be listed or traded, its articles of association then in effect, or any other applicable rules and regulations. Furthermore, in a merger between Israeli corporations, if the non-surviving entity has more than one class of shares, the merger may need to be approved by each class of shareholders, including any classes of otherwise non-voting shares, such as the non-voting senior preferred shares authorized in Kitov Parent’s share capital. Kitov Parent’s subsidiary, TyrNovo, has obligations to the OCS with respect to grants from the OCS for certain research and development expenditures in connection with TyrNovo’s technology. The terms of these grants may require us to satisfy specified conditions in order to manufacture products and transfer technologies outside of Israel, which may impede our acquisition by, or a merger with, a foreign company. For more information, see the risk factors in connection with OCS funding found under “Risks Related to Our Financial Condition and Capital Requirements.” These and other similar provisions could delay, prevent or impede an acquisition of us or our merger with another company, or an acquisition of a significant portion of our shares, even if such an acquisition or merger would be beneficial to us or to our shareholders. See “Item 10. Additional Information – B. Memorandum and Articles of Association – Provisions Restricting Change in Control of Our Company” and “Item 10. Additional Information – E. Taxation—Israeli Tax Considerations and Government Programs” for additional information. 30 Because a certain portion of our expenses is incurred in currencies other than the U.S. dollar, our results of operations may be harmed by currency fluctuations and inflation. Our reporting and functional currency is the U.S. dollar. Most of the royalty payments from potential development and commercialization partners are expected to be payable in U.S. dollars, and we expect our revenues from future licensing agreements to be denominated mainly in U.S. dollars or in Euros. We pay a portion of our expenses in U.S. dollars; however, a portion of our expenses, related to salaries of the employees in Israel and payment to part of the service providers in Israel, are paid in NIS and in other currencies. In addition, a portion of our financial assets is held in NIS. As a result, we are exposed to currency fluctuation risks. For example, if the NIS strengthens against the U.S. dollar, our reported expenses in U.S. dollars may be higher than anticipated. In addition, if the NIS weakens against the U.S. dollar, the U.S. dollar value of our financial assets held in NIS will decline. Your obligations and responsibilities as a shareholder will be governed by Israeli law which may differ in some respects from the obligations and responsibilities of shareholders of U.S. companies. Israeli law may impose obligations and responsibilities on a shareholder of an Israeli company that are not imposed upon shareholders of corporations in the U.S. We are incorporated under Israeli law. The obligations and responsibilities of the holders of our ordinary shares are governed by our amended and restated articles of association and Israeli law. These obligations and responsibilities differ in some respects from the obligations and responsibilities of shareholders in typical U.S.-based corporations. In particular, a shareholder of an Israeli company has a duty to act in good faith toward the company and other shareholders and to refrain from abusing its power in the company, including, among other things, in voting at the general meeting of shareholders on matters such as amendments to a company’s articles of association, increases in a company’s authorized share capital, mergers and acquisitions and related party transactions requiring shareholder approval. In addition, a shareholder who knows that it possesses the power to determine the outcome of a shareholder vote or to appoint or prevent the appointment of a director or executive officer in the company has a duty of fairness toward the company. There is limited case law available to assist us in understanding the implications of these provisions that govern shareholders’ actions. These provisions may be interpreted to impose additional obligations and responsibilities on holders of our ordinary shares and/or ADSs that are not typically imposed on shareholders of U.S. corporations. Risks primarily related to our ADSs and ordinary shares and other listed securities We have identified a material weakness in our internal control over financial reporting which, if not remediated, could adversely affect our reputation, business or stock price. As described under “Item 15 - Controls and Procedures,” based on our evaluation of whether our existing internal controls over financial reporting systems are compliant with Section 404 and whether there are any material weaknesses or significant deficiencies in our existing internal controls, our management, including the chief executive officer and chief financial officer, has concluded that our disclosure controls and procedures as of the end of the period covered by this annual report, reflected a material weakness in internal control over financial reporting that would require us to enhance our procedures and systems relating to financial reporting, primarily due to the factor described below. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected on a timely basis. A deficiency was identified in our internal control over financial reporting related to the operation of the control to review the accounting for significant non-routine and complex transactions to ensure proper application of IFRS. This control did not operate effectively due to the lack of timely involvement of the qualified technical resources to perform the required management review. As a result, during the audit process, an error was detected in the accounting for equity and derivative instruments, which was corrected prior to filing our audited financial statements for 2016. 31 Although we have developed and are implementing a plan to remediate this material weakness and believe, based on our evaluation to date, that this material weakness will be remediated during 2017, we cannot assure you that this will occur within the contemplated timeframe. Moreover, we cannot assure you that we will not identify additional material weaknesses in our internal control over financial reporting in the future, nor that our disclosure controls and procedures will detect or uncover all failures of persons within the Company to disclose material information otherwise required to be set forth in our reports. If we are unable to remediate the material weakness, our ability to record, process and report financial information accurately, and to prepare financial statements within the time periods specified by the rules and forms of SEC, could be adversely affected. The occurrence of or failure to remediate the material weakness may adversely affect our reputation and business and the market price of our ordinary shares, public warrants and any other securities we may issue. We incur increased costs as a result of operating as a public company in the U.S, and our management will be required to devote substantial time to new compliance initiatives. Kitov Parent’s ADSs and public warrants have been traded on The NASDAQ Capital Market since November 20, 2015. As a public company whose securities are listed in the United States, we incur accounting, legal and other expenses that we did not incur as a public company listed on the TASE, including costs associated with our reporting requirements under the Exchange Act. We also anticipate that we will incur costs associated with corporate governance requirements, including requirements under Section 404 and other provisions of the Sarbanes-Oxley Act, as well as rules implemented by the SEC and NASDAQ, and provisions of Israeli corporate law applicable to public companies. We expect that these rules and regulations will increase our legal and financial compliance costs, introduce new costs such as investor relations and stock exchange listing fees, and will make some activities more time- consuming and costly. We are currently evaluating and monitoring developments with respect to these rules, and we cannot predict or estimate the amount of additional costs we may incur or the timing of such costs. As an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act, or JOBS Act, we may take advantage of certain temporary exemptions from various reporting requirements, including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes Oxley Act (and the rules and regulations of the SEC thereunder). When these exemptions cease to apply, we expect to incur additional expenses and devote increased management effort toward ensuring compliance with them. We cannot predict or estimate the amount of additional costs we may incur as a result of becoming a public company or the timing of such costs. Pursuant to Section 404 of the Sarbanes-Oxley Act and the related rules adopted by the SEC and the Public Company Accounting Oversight Board, starting with this annual report on Form 20-F, and each subsequent annual report thereafter that we file with the SEC, our management is required to report on the effectiveness of our internal control over financial reporting. In addition, once we no longer qualify as an “emerging growth company” under the JOBS Act and lose the ability to rely on the exemptions related thereto discussed above and depending on our status as per Rule 12b-2 of the Exchange Act, our independent registered public accounting firm may also need to attest to the effectiveness of our internal control over financial reporting under Section 404. We have only very recently commenced the process of determining whether our existing internal controls over financial reporting systems are compliant with Section 404 and whether there are any material weaknesses or significant deficiencies in our existing internal controls. This process requires the investment of substantial time and resources, including by our chief financial officer and other members of our senior management. As a result, this process may divert internal resources and take a significant amount of time and effort to complete. We cannot predict the outcome of evaluations we will conduct, and whether we will need to implement additional remedial actions in order to implement effective controls over financial reporting. The determination and any remedial actions required could result in us incurring additional costs that we did not anticipate, including the hiring of outside consultants. Irrespective of compliance with Section 404, any failure of our internal controls could have a material adverse effect on our stated results of operations and harm our reputation. As a result, we may experience higher than anticipated operating expenses, as well as higher independent auditor fees during and after the implementation of these changes. If we are unable to implement any of the required changes to our internal control over financial reporting effectively or efficiently or are required to do so earlier than anticipated, it could adversely affect our operations, financial reporting and/or results of operations and could result in an adverse opinion on internal controls from our independent auditors and cause the market price of Kitov Parent’s ordinary shares, ADSs and public warrants to decline. 32 Changes in the laws and regulations affecting public companies will result in increased costs to us as we respond to their requirements. These laws and regulations could make it more difficult or more costly for us to obtain certain types of insurance, including director and officer liability insurance, and we may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. The impact of these requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as executive officers. We cannot predict or estimate the amount or timing of additional costs we may incur in order to comply with such requirements. We may be classified as a Passive Foreign Investment Company, or PFIC, for U.S. federal income tax purposes in 2017 and may continue to be, or become, a PFIC in future years, which may have negative tax consequences for U.S. investors. We will be treated as a PFIC for U.S. federal income tax purposes in any taxable year in which either (i) at least 75% of our gross income is “passive income” or (ii) on average at least 50% of our assets by value produce passive income or are held for the production of passive income. Based on our estimated gross income, the average value of our gross assets, and the nature of our business, we believe that we may be classified as a PFIC in the current taxable year and may be treated, or may become, a PFIC in future years. If we are treated as a PFIC for any taxable year during which a U.S. investor held our ordinary shares or ADSs, certain adverse U.S. federal income tax consequences could apply to the U.S. investor. See “Item 10. Additional Information – E. Taxation– Passive Foreign Investment Company Consequences.” The market price of Kitov Parent’s ordinary shares, ADSs and public warrants is subject to fluctuation, which could result in substantial losses by investors. The stock market in general, and the market price of Kitov Parent’s ordinary shares on the TASE and its ADSs and Series A warrants on The NASDAQ Capital Market in particular, are subject to fluctuation, and changes in the price of its listed securities may be unrelated to our operating performance. The market prices of Kitov Parent’s ordinary shares on the TASE and its ADSs and public warrants on The NASDAQ Capital Market have fluctuated in the past, and we expect it will continue to do so. The market price of Kitov Parent’s ordinary shares, ADSs and public warrants are and will be subject to a number of factors, including: ● announcements of technological innovations or new therapeutic candidates by us or others; ● announcements by us of significant acquisitions, strategic partnerships, in-licensing, out-licensing, joint ventures or capital commitments; ● expiration or terminations of licenses, research contracts or other development or commercialization agreements; ● public concern as to the safety of drugs that we, our current or potential development and commercialization partners or others develop; ● the volatility of market prices for shares of biotechnology companies generally; ● success or failure of research and development projects; ● departure of key personnel; ● developments concerning intellectual property rights or regulatory approvals; ● variations in our and our competitors’ results of operations; ● changes in earnings estimates or recommendations by securities analysts, if Kitov Parent’s ordinary shares or ADSs or public warrants are covered by analysts; ● changes in government regulations or patent decisions; ● developments by our current or potential development and commercialization partners; and ● general market conditions and other factors, including factors unrelated to our operating performance. These factors and any corresponding price fluctuations may materially and adversely affect the market price of Kitov Parent’s ordinary shares and ADSs and public warrants and result in substantial losses by investors. 33 Additionally, market prices for listed securities of biotechnology and pharmaceutical companies historically have been very volatile. The market for these listed securities has from time to time experienced significant price and volume fluctuations for reasons unrelated to the operating performance of any one company. In the past, following periods of market volatility, shareholders have often instituted securities class action litigation. If we were involved in securities litigation, it could have a substantial cost and divert resources and attention of management from our business, even if we are successful. Future sales of Kitov Parent’s ordinary shares or ADSs or other warrants or convertible securities could reduce the market price of its ordinary shares and ADSs and other listed securities. As of April 25, 2017, we had an aggregate of 164,529,717 issued and outstanding ordinary shares (including 21 dormant ordinary shares held in treasury) (such number of ordinary shares would be represented by 8,226,486 of Kitov Parent’s ADSs), no non-voting senior preferred shares, 6,835,669 Series A or public warrants, representative’s warrants to purchase 157,945 of its ADSs, which were granted to the underwriters as part of Kitov Parent’s initial U.S. offering in November 2015, placement agent’s warrants to purchase 141,176 of its ADSs, which were granted to the placement agent as part of its follow-on U.S. offering in July 2016, and 11,583,883 non-tradable options to purchase 9,932,523 ordinary shares, (such number of non-tradable options and their underlying ordinary shares would be represented by 496,626 of its ADSs). We may also issue additional ordinary shares or ADSs of Kitov Parent to the remaining shareholders of TyrNovo should we seek to acquire remaining shares of TyrNovo not currently held by us. Substantial sales of Kitov Parent’s ordinary shares or ADSs or other warrants or securities convertible into ordinary shares or ADSs, or the perception that such sales may occur in the future, including sales of ordinary shares or ADSs issuable upon the exercise of options or the conversion of convertible securities, may cause the market price of Kitov Parent’s ordinary shares or ADSs or other listed securities to decline. Moreover, the issuance of shares or ADSs in connection with the future acquisition of additional shares of TyrNovo or pursuant to the conversion or exercise of options, warrants or any other convertible securities Kitov Parent and/or TyrNovo may issue will also have a dilutive effect on Kitov Parent’s shareholders, which could further reduce the price of its ordinary shares and ADSs and other listed securities on their respective exchanges. Future sales of TyrNovo’s ordinary shares or other warrants or convertible securities could dilute our holdings in TyrNovo, and reduce the value of TyrNovo reflected in our holdings of TyrNovo and also reduce the market price of Kitov Parent’s ordinary shares and ADSs and other listed securities. As of April 25, 2017, Kitov Parent held a controlling equity interest in TyrNovo representing approximately 65% of its issued and outstanding share capital. In addition we held a loan to TyrNovo of $101,157, the repayment date and other terms of such which have not been determined. In addition Kitov Parent and TyrNovo entered into a Revolving Secured Facility and Pledge Agreement on March 1, 2017, pursuant to which Kitov Parent has made loans to TyrNovo in an aggregate amount of $750,000. As part of our settlement arrangements with Taoz – Company for Management and Holdings of Companies Ltd. (“Taoz”), a minority shareholder in TyrNovo, Taoz is entitled for a certain period of time to invest up to an additional $1,750,000 in TyrNovo by way of loan which are convertible into TyrNovo equity. Furthermore, in the event that Kitov Parent increases its shareholdings in TyrNovo, through the purchase of additional shares from TyrNovo’s other current shareholders, then for a certain period of time Taoz shall have the option to purchase from Kitov Parent up to 30% of such newly acquired shares in TyrNovo. Such arrangements could serve to dilute Kitov Parent’s holdings in TyrNovo. Substantial sales of TyrNovo’s ordinary shares or other warrants or securities convertible into ordinary shares of TyrNovo, may cause the holdings of Kitov Parent in TyrNovo to be diluted, and such dilution, or the perception that such sales may occur in the future, including sales of ordinary shares of TyrNovo issuable upon the exercise of options or the conversion of convertible securities into shares of TyrNovo may cause the market price of Kitov Parent’s ordinary shares or ADSs or other listed securities to decline. As a foreign private issuer, we are permitted to follow certain home country corporate governance practices instead of applicable Securities and Exchange Commission and The NASDAQ Capital Market requirements, which may result in less protection than is accorded to investors under rules applicable to U.S domestic issuers. As a foreign private issuer, we are permitted to follow certain home country corporate governance practices instead of those otherwise required under the NASDAQ Listing Rules for U.S domestic issuers. We will follow home country practice in Israel with regard to (1) director nomination procedures, as permitted by the Companies Law, under which either our board of directors, a group of directors, or shareholder(s) holding sufficient portion of our share capital selects director nominees, subject to the terms of our amended and restated articles of association. Directors are not selected, or recommended for board of director selection, as required by the NASDAQ Listing Rules, by independent directors constituting a majority of the board’s independent directors or by a nominations committee comprised solely of independent directors, and (2) quorum requirement at shareholders’ meetings, as permitted under the Companies Law, under which and pursuant to our amended and restated articles of association, the quorum required for an ordinary meeting of shareholders consists of at least two shareholders present in person or by proxy who hold or represent at least 25% of the voting rights of our shares (and in an adjourned meeting, with some exceptions, any number of shareholders), instead of 33 1/3% of the issued share capital required under the NASDAQ Listing Rules. In addition, we will follow our home country law, instead of the NASDAQ Listing Rules, which require that we obtain shareholder approval for certain dilutive events, such as for the establishment or amendment of certain equity based compensation plans, an issuance that will result in a change of control of the company, certain transactions other than a public offering involving issuances of a 20% or more interest in the company and certain acquisitions of the stock or assets of another company. In the future we may elect to follow additional home country corporate governance practices instead of those otherwise required under the NASDAQ Listing Rules for U.S domestic issuers. Following our home country governance practices as opposed to the requirements that would otherwise apply to a U.S. company listed on The NASDAQ may provide less protection than is accorded to investors under the NASDAQ Listing Rules applicable to domestic issuers. 34 In addition, as a foreign private issuer, we will be exempt from the rules and regulations under the U.S. Securities Exchange Act of 1934, as amended or the Exchange Act, related to the furnishing and content of proxy statements, and our officers, directors and principal shareholders will be exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, we will not be required under the Exchange Act, to file annual, quarterly and current reports and financial statements with the SEC as frequently or as promptly as domestic companies whose securities are registered under the Exchange Act. As our ordinary shares are traded on the Tel Aviv Stock Exchange (“TASE”), while our ADSs and Series A warrants are traded on The NASDAQ Capital Market, we currently also report to the ISA and the TASE in accordance with the provisions of Section 35XXXIII of the Israel Securities Law, 5728-1968 and the Securities Regulations (Periodic and Immediate Reports of a Foreign Body Corporate) 5761-2000, promulgated thereunder (the “Dual-Listed Reporting Requirements”). Pursuant to the Dual-Listed Reporting Requirements, we prepare our periodic and immediate reports in accordance with U.S. securities laws and reporting requirements, as applicable to a foreign private issuer. We intend to file with the SEC, within 120 days after the end of each fiscal year ending December 31, an annual report on Form 20-F containing financial statements which will be examined and reported on, with an opinion expressed, by an independent registered public accounting firm. In accordance with the NASDAQ Listing Rules, as a foreign private issuer we are required to submit on a Form 6-K an interim balance sheet and income statement as of the end of the second quarter of each fiscal year. Furthermore, we have committed to the underwriters of our initial U.S public offering which was completed in November 2015 that for a period of three (3) years from November 25, 2015, we, at our expense, will announce its financial information for each of the first three fiscal quarters consistent with the practices of companies which are dual-listed on both the Tel Aviv Stock Exchange and a domestic U.S. securities exchange and report in accordance with the Dual-Listed Reporting Requirements; provided that the foregoing shall not apply in the event we enter into a merger transaction in which we are the non-surviving entity that would cause our ADSs and warrants to no longer be registered under the Exchange Act. The Representative of the underwriters of our initial U.S public offering which was completed in November 2015 has previously waived the announcement by us with respect to the filing of quarterly financial information, and may issue such waivers to us in the future. It is noted that recent amendments to the Israel Securities Law and regulations enacted thereunder, dispense with the requirement for the announcement of financial results for each of the first and third fiscal quarters of a calendar year for certain smaller sized TASE listed companies which report under TASE only listed reporting requirements. We believe that, were we reporting under the TASE only listed reporting requirements (and not the Dual Listed Reporting Requirements), we would qualify for such dispensation based on our company size as set forth in the regulation. In addition the SEC has recently announced that it is seeking comment for the dispensation of the requirement for the announcement of financial results for each of the first and third fiscal quarters for certain U.S. domestic issuers. Thus it remains uncertain as to how companies dual-listed on both the Tel Aviv Stock Exchange and a domestic U.S. securities exchange, and report in accordance with the in accordance with the Dual-Listed Reporting Requirements, will continue their practices with respect to the announcements of financial information for each of the first and third fiscal quarters, and it is possible that we may adopt practices for the announcement (if any) of financial information for each of the first and third fiscal quarters which are different than what we have provided in the past. The depositary for our ADSs will give us a discretionary proxy to vote our ordinary shares underlying ADSs if a holder of our ADSs does not vote at shareholders’ meetings, except in limited circumstances, which could adversely affect their interests. Under the deposit agreement for the ADSs, the depositary will give us a discretionary proxy to vote our ordinary shares underlying ADSs at shareholders’ meetings if a holder of our ADSs does not vote, unless: ● we have instructed the depositary that we do not wish a discretionary proxy to be given; ● we have informed the depositary that there is substantial opposition as to a matter to be voted on at the meeting; or ● a matter to be voted on at the meeting would have a material adverse impact on shareholders. The effect of this discretionary proxy is that a holder of our ADSs cannot prevent our ordinary shares underlying such ADSs from being voted, absent the situations described above, and it may make it more difficult for shareholders to influence the management of our company. Holders of our ordinary shares listed for trading on the TASE are not subject to this discretionary proxy. 35 We currently do not anticipate paying cash dividends, and accordingly, shareholders must rely on the appreciation in our ADSs for any return on their investment. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. Therefore, the success of an investment in our ADSs will depend upon any future appreciation in their value. There is no guarantee that our ADSs will appreciate in value or even maintain the price at which our holders have purchased their ADSs. The ability of any Israeli company to pay dividends or repurchase its shares is subject to Israeli law, and the amount of cash dividends payable may be subject to devaluation in the Israeli currency. The ability of an Israeli company to pay dividends or repurchase its shares is governed by Israeli law, which provides that distributions, including cash dividends and share repurchases, may be made only out of retained earnings as determined for statutory purposes. Since we do not have earnings, we currently do not have any ability to pay dividends or repurchase our shares. Investors in our ADSs may not receive the same distributions or dividends as those we make to the holders of our ordinary shares, and, in some limited circumstances, investors in our ADSs may not receive any value for them, if it is illegal or impractical to make them available to investors in our ADSs. The depositary for the ADSs has agreed to pay investors in our ADSs the cash dividends or other distributions it or the custodian receives on ordinary shares or other deposited securities underlying the ADSs, after deducting its fees and expenses. Investors in our ADSs will receive these distributions in proportion to the number of ordinary shares their ADSs represent. However, the depositary is not responsible if it decides that it is unlawful or impractical to make a distribution available to any holders of ADSs. For example, it would be unlawful to make a distribution to a holder of ADSs if it consists of securities that require registration under the Securities Act of 1933, as amended or the Securities Act, but that are not properly registered or distributed under an applicable exemption from registration. In addition, conversion into U.S. dollars from foreign currency that was part of a dividend which was distributed in foreign currency made in respect of deposited ordinary shares may require the approval or license of, or a filing with, any government or agency thereof, which may be unobtainable. In these cases, the depositary may determine not to distribute such property and hold it as “deposited securities” or may seek to affect a substitute dividend or distribution, including net cash proceeds from the sale of the dividends that the depositary deems an equitable and practicable substitute. We have no obligation to register under U.S. securities laws any ADSs, ordinary shares, rights or other securities received through such distributions. We also have no obligation to take any other action to permit the distribution of ADSs, ordinary shares, rights or anything else to holders of ADSs. In addition, the depositary may withhold from such dividends or distributions its fees and an amount on account of taxes or other governmental charges to the extent the depositary believes it is required to make such withholding. This means that investors in our ADSs may not receive the same distributions or dividends as those we make to the holders of our ordinary shares, and, in some limited circumstances, investors in our ADSs may not receive any value for such distributions or dividends if it is illegal or impractical for us to make them available to investors in our ADSs. These restrictions may cause a material decline in the value of the ADSs. Holders of ADSs must act through the depositary to exercise rights of shareholders of our company. Holders of our ADSs do not have the same rights as our shareholders and may only exercise the voting rights with respect to the underlying ordinary shares in accordance with the provisions of the deposit agreement for the ADSs. Under Israeli law, the minimum notice period required to convene a shareholders’ meeting is no less than 35 or 21 calendar days, depending on the proposals on the agenda for the shareholders’ meeting. When a shareholder meeting is convened, holders of our ADSs may not receive sufficient notice of the meeting to permit them to withdraw their ordinary shares to allow them to cast their vote with respect to any specific matter. In addition, the depositary and its agents may not be able to send voting instructions to holders of our ADSs or carry out their voting instructions in a timely manner. We will make all reasonable efforts to cause the depositary to extend voting rights to holders of our ADSs in a timely manner, but we cannot assure holders that they will receive the voting materials in time to ensure that they can instruct the depositary to vote the ordinary shares underlying their ADSs. Furthermore, the depositary and its agents will not be responsible for any failure to carry out any instructions to vote, for the manner in which any vote is cast or for the effect of any such vote. As a result, holders of our ADSs may not be able to exercise their right to vote and they may lack recourse if the ordinary shares underlying their ADSs are not voted as they requested. In addition, ADS holders will not be able to call a shareholders’ meeting unless they first withdraw their ordinary shares from the ADS program and convert them into the underlying ordinary shares held in the Israeli market in order to allow them to submit to us a request to call a meeting with respect to any specific matter, in accordance with the applicable provisions of the Companies Law and our amended and restated articles of association. 36 Our ordinary shares and our ADSs and Series A warrants are traded on different markets and this may result in price variations. Our ordinary shares trade on the TASE, and our ADSs and Series A warrants trade on The NASDAQ Capital Market. Trading on these markets take place in different currencies (U.S. dollars on NASDAQ and New Israeli Shekels, or NIS, on the TASE), and at different times (resulting from different time zones, different trading days and different public holidays in the U.S. and Israel). The trading prices of our securities on these two markets may differ due to these and other factors. Any decrease in the price of our securities on one of these markets could cause a decrease in the trading price of our securities on the other market. Our ADSs and Series A warrants have little prior trading history in the U.S., and present level of market activity may not be sustained, which may limit the ability of our investors to sell our ADSs in the U.S. Although our ADSs and Series A warrants have been traded on The NASDAQ Capital Market since November 20, 2015, the present level of market activity for our ADSs and Series A warrants may not be sustained. If an active market for our ADSs and Series A warrants is not sustained, it may be difficult for an investor to sell its ADSs, Series A warrants or the ADSs underlying the warrants being issued in this offering. We can issue non-voting senior preferred shares without shareholder approval, which could adversely affect the rights of holders of ordinary shares. Our amended and restated articles of association permit us to establish the rights, privileges, preferences and restrictions of future series of our non- voting senior preferred shares, which contain superior liquidation and dividend rights, and may contain other rights, including conversion, redemption, optional and other special rights, qualifications, limitations or restrictions, equivalent or superior to our ordinary shares and to issue such non-voting senior preferred shares without further approval from our shareholders. The rights of holders of our ordinary shares may suffer as a result of the rights granted to holders of non-voting senior preferred shares that we may issue in the future. In addition, we could issue non-voting senior preferred shares containing rights that prevent a change in control or merger, thereby depriving holders of our ordinary shares of an opportunity to sell their shares at a price in excess of the prevailing market price. If equity research analysts do not publish research or reports about our business or if they issue unfavorable commentary or downgrade our ADSs or Series A warrants, the price of our ADSs or Series A warrants could decline. The trading market for our ADSs and Series A warrants will rely in part on the research and reports that equity research analysts publish about us and our business. The price of our ADSs or Series A warrants could decline if such research or reports are not published or if one or more securities analysts downgrade our ADSs or Series A warrants or if those analysts issue other unfavorable commentary or cease publishing reports about us or our business. 37 We have broad discretion as to the use of the net proceeds from our November 2015 initial public offering in the U.S., and from our July 2016 follow-on public offering in the U.S., and may not use them effectively. We currently intend to use the net proceeds from our November 2015 initial public offering on NASDAQ and our July 2016 follow-on public offering to expand our clinical development program, specifically with respect to our Phase III clinical trial for our leading therapeutic candidate, KIT-302, finance the CMC activities required for submitting a New Drug Application to the FDA, perform the final PK (pharmacokinetic) trial for the selected formulation of KIT-302, finance our business development activities to enable out-licensing of our leading therapeutic candidate, KIT-302, expand our clinical development pipeline for additional drug products; and for general corporate purposes, including working capital requirements. For more information, see “Item 14 Material Modifications to the Rights of Security Holders and Use of Proceeds – E. Use of Proceeds.” In addition, we intend to continue to use the net proceeds of our July 2016 follow-on public offering to fund the possible acquisition of new therapeutic candidates and for general working capital purposes. We currently have no binding agreements or commitments to complete any transaction for the possible acquisition of new therapeutic candidates. There is no certainty that we will be able to complete any transactions for the possible acquisition of new therapeutic candidates. However, our management will have broad discretion in the application of the net proceeds from the public offerings. Our shareholders may not agree with the manner in which our management chooses to allocate the net proceeds from the public offerings. The failure by our management to apply these funds effectively could have a material adverse effect on our business, financial condition and results of operation. Pending their use, we may invest the net proceeds from the public offerings in a manner that does not produce income. We are an “emerging growth company” and the reduced disclosure requirements applicable to emerging growth companies may make our ordinary shares less attractive to investors. We are an “emerging growth company,” as defined in the JOBS Act, and we may take advantage of certain exemptions from various requirements that are applicable to other public companies that are not “emerging growth companies.” Most of such requirements relate to disclosures that we would only be required to make if we also ceased to be a foreign private issuer in the future, for example, the requirement to hold shareholder advisory votes on executive and severance compensation and executive compensation disclosure requirements for U.S. companies. However, as a foreign private issuer, we would still be required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act. We are exempt from such requirement for as long as we remain an emerging growth company, which may be up to five fiscal years after the date of this offering. We will remain an emerging growth company until the earliest of: (a) the last day of our fiscal year during which we have total annual gross revenues of at least $1.0 billion; (b) the last day of our fiscal year following the fifth anniversary of the closing of our initial U.S. offering; (c) the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt; or (d) the date on which we are deemed to be a “large accelerated filer” under the Exchange Act. When we are no longer deemed to be an emerging growth company, we will not be entitled to the exemptions provided in the JOBS Act discussed above. We cannot predict if investors will find our ordinary shares, ADSs, or warrants less attractive as a result of our reliance on exemptions under the JOBS Act. If some investors find our ordinary shares, ADS, or warrants less attractive as a result, there may be a less active trading market for our ordinary shares, ADS, and warrants and our share price may be more volatile. ITEM 4. INFORMATION ON THE COMPANY A. History and Development of the Company Kitov Parent was incorporated under the laws of the State of Israel (under a previous name) on August 12, 1968 and its ordinary shares were originally listed for trading on the TASE in 1978. Our ordinary shares are currently traded on the TASE under the symbol “KTOV”, and our ADSs and our public warrants are traded on NASDAQ under the symbols “KTOV” and “KTOVW”, respectively. In October 2012, the District Court in Lod, Israel approved the creditors arrangement in accordance with Section 350 of the Companies Law in order to effectuate the sale by Kitov Parent (then known as Mainrom Line Logistics Ltd.) of all its activities, assets, rights, obligations and liabilities to a private company held by its then controlling shareholders, and all rights of Kitov Parent’s creditors against it were extinguished. The sale was made pursuant to an arrangement between Kitov Parent and its creditors. Following such sale and a related cash distribution to Kitov Parent’s shareholders, Kitov Parent remained without any assets, debt and/or liabilities. As described in the District Court approval, in connection with the sale, on October 31, 2012, the former controlling shareholders sold control of Kitov Parent (then a shell company) to Mr. Sheer Roichman. From the completion of these transactions until the completion of the acquisition of Kitov Pharmaceuticals described below, Kitov Parent did not conduct any business activities and was a public shell company listed on the TASE with no assets, debt and/or liabilities. 38 Kitov Parent has a wholly owned Israeli subsidiary, Kitov Pharmaceuticals Ltd., which, together with Kitov Parent, is engaged in the research and development of KIT-302. Kitov Pharmaceuticals Ltd. was founded in June 2010, and pursuant to an Asset Purchase Agreement, dated October 13, 2010, between Kitov Pharmaceuticals and JPW PCH LLC, or JPW, JPW sold to Kitov Pharmaceuticals JPW’s rights and interests in and to U.S. and international patent applications relating to KIT-301 and KIT-302. Kitov Pharmaceuticals assumed all liabilities arising from ownership, use or exercise, of rights under, the patent applications. On July 11, 2013, Kitov Parent acquired Kitov Pharmaceuticals Ltd. As part of the acquisition, Mainrom Line Logistics Ltd. changed its name to Kitov Pharmaceuticals Holdings Ltd. For more information regarding this transaction, see “Item 7. Major Shareholders and Related Party Transactions – B. Related Party Transactions – Share Transfer Agreement with Kitov Pharmaceuticals”. On November 25, 2015, Kitov Parent completed an initial public offering on NASDAQ of ADSs and public warrants to purchase ADSs. The gross proceeds to us from this offering were approximately $13 million, prior to deducting underwriting discounts, commissions and other offering expenses. On January 13, 2017, we announced that we had acquired a majority equity stake in TyrNovo Ltd., a privately held developer of novel small molecules in the oncology therapeutic field. For more information see, “Item 4. Information on the Company – History and Development of the Company – Recent Developments - Acquisition of TyrNovo” below. On April 25, 2017, the boards of directors of each of Kitov Parent and Kitov Pharmaceuticals approved a merger between the two entities, with Kitov Parent remaining as the surviving entity. For more information on the proposed merger, see Item 4.C – Organizational Structure. We had no material capital expenditures for the years ended December 31, 2016, 2015, and 2014. Recent Developments Issuance of Patent by USPTO On May 12, 2016, we announced that our patent application to approve a patent relating to a drug for treating hypertension received a notice of allowance for ameliorating the elevation of blood pressure caused by a specific NSAID by the co-administration of a specific calcium channel blocker. It is possible to pursue claims to additional inventions based on the patent application by making patent filings prior to issuance of a patent on this patent application, and we have proceeded accordingly. On August 10, 2016, we announced that the United States Patent and Trademark Office (USPTO) issued patent #9,408,837 covering KIT-302. The patent, entitled “Ameliorating Drug-Induced Elevations In Blood Pressure By Adjunctive Use Of Antihypertensive Drugs,” was issued on August 9, 2016 and will have a term that can extend to February 28, 2030. We are pursuing additional claims to inventions described in U.S. Patent #9,408,837. On February 1, 2017, we announced that the USPTO issued a Notice of Allowance to us related to claims expanding the patent coverage for our lead drug candidate, KIT-302, to include oral dosage compositions containing both amlodipine and celecoxib. July 2016 Follow-on Public Offering On July 5, 2016, we completed a follow-on public offering of 2,378,823 Class A units and 1,150,589 Class B units, with each Class A unit consisting of one ADS and a public warrant and each Class B unit consisting of a non-listed, pre-funded warrant to purchase one ADS, or a pre-funded warrant, and a public warrant. Each Class A unit was sold at a negotiated price of $3.40 per unit, including the ADS issuance fee of $0.01 per ADS, and each Class B unit was sold at a negotiated price of $3.40 per unit, including the pre-funded warrant exercise price of $0.01 per full ADS and the ADS issuance fee of $0.01 per ADS. The pre-funded warrants were exercisable at any time after the date of issuance upon payment of the exercise price and the ADS issuance fee, and all of these pre-funded warrants have been exercised to-date. The gross proceeds to us from this offering were approximately $12,000,000, prior to deducting placement agent fees and other estimated offering expenses. 39 Renal Function Clinical Trial Additional data from the Phase III clinical trial of KIT-302 suggest beneficial effects on renal (kidney) function, as compared to negative effects on renal function caused by other NSAIDS. For more information, see, “Item 4. Business Overview - Our Therapeutic Candidates – Research and Development”. In addition, we have commenced conducting a clinical trial designed to validate and better quantify these potential beneficial renal effects. Any information obtained from this clinical trial is not intended to be a part of the information to be included in our new drug application that we expect to submit for the marketing clearance by the FDA of KIT-302 in Q2 2017. The trial analysis may further explain the synergistic antihypertensive effect, where the reduction in blood pressure demonstrated with KIT-302 was greater than that observed with amlodipine alone. Accordingly, we are conducting a double blind, placebo controlled, clinical trial intended statistically to demonstrate KIT-302’s effects on renal and vascular function, while providing us with data with respect to KIT-302 in addition to the data of the Phase III clinical trial, by utilizing a primary efficacy end-point in the renal function clinical trial comparable to that of the Phase III clinical trial. The trial is being performed in the U.K. in three groups of 15 to 45 patients (and a total of 105 patients), with each patient treated over a total period of two weeks. Group One is receiving a placebo, Group Two is being treated with a standard drug available in the market for treating hypertension (amlodipine besylate, one of the components of KIT-302), and Group Three is being treated with the two components of KIT-302 (celecoxib and amlodipine besylate). We expect to complete recruitment of the patients for this trial during the second calendar quarter of 2017. The renal function clinical trial for KIT-302 is being conducted in medical centers in the United Kingdom on the basis of the approval of the British Regulatory Authority (MHRA), as well as the approvals of the relevant U.K. ethics committees, which we have already received. Acquisition of TyrNovo On January 13, 2017, we announced that Kitov Parent acquired a majority equity stake in TyrNovo Ltd., a privately held developer of novel small molecules in the oncology therapeutic field, for consideration of $2 million in cash and $1.8 million equivalent of Kitov Parent’s ordinary shares based on the closing price of Kitov Parent’s shares on the TASE on January 11, 2017, or 11,292,508 ordinary shares. We may acquire additional shares in TyrNovo from all or part of TyrNovo’s additional minority shareholders for consideration consisting of Kitov Parent’s ordinary shares in such amounts as to be agreed with the shareholders. TyrNovo has developed NT219, a small molecule that we believe presents a new concept in cancer therapy by affecting two key oncology-related mechanisms, Insulin Receptor Substrates (IRS) 1 and 2, as well as the signal transducer and activator of transcription 3 (STAT3). In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects in various cancers by preventing the tumors from developing resistance to the approved drug treatments and re-sensitizing tumors to the approved drugs even after resistance is acquired. For more information regarding NT219, see, “Item 4. Business Overview - Our Therapeutic Candidates – NT219”. B. Business Overview We are a development stage biopharmaceutical company currently focused on the development of: (i) KIT-302, a combination drug for the simultaneous treatment of two clinical conditions: pain caused by osteoarthritis and hypertension (high blood pressure), which can be pre-existing or caused by the treatment for osteoarthritis; and (ii) NT219, a small molecule that uniquely targets two pathways highly involved in cancer drug resistance. 40 In the past, we had an additional combination drug in our pipeline, KIT-301, for which we had an active IND. Kitov Parent’s board of directors, following the recommendation of its science & technology committee recently determined not to continue the further development of KIT-301. In the board’s view, KIT-301 can be categorized as an inferior earlier generation combination drug, as compared to KIT-302, and taking into account the progress we have made with KIT-302’s development and in preparing our anticipated NDA, to be submitted to the FDA, for KIT-302, the board determined to remove KIT-301 from our development pipeline, and has directed management to update the FDA about such discontinuation of development of KIT-301. In addition, we may consider the acquisition of therapeutic candidates at various stages of development in various therapeutic areas or currently approved drug products. We currently have no binding agreements or commitments to complete any transaction for the possible acquisition of new therapeutic candidates or approved drug products. There is no certainty that we will be able to complete any additional transactions for the possible acquisition of new therapeutic candidates or approved drug products. We may not be able to identify suitable acquisition candidates, complete acquisitions or integrate acquisitions successfully. In this regard, acquisitions involve numerous risks, including difficulties in the integration of the acquired therapeutic candidates and the diversion of management’s attention from other business concerns. Although we will endeavor to evaluate the risks inherent in any particular transaction, there can be no assurance that we will properly ascertain all such risks. In addition, acquisitions could result in the incurrence of substantial additional indebtedness and other expenses or in potentially dilutive issuances of equity securities. There can be no assurance that difficulties encountered with acquisitions will not have a material adverse effect on our business, financial condition and results of operations. We intend to seek FDA approval for the commercialization of our therapeutic candidates, and where applicable through the Section 505(b)(2) regulatory path under the Federal Food, Drug, and Cosmetic Act of 1938, as amended. Where applicable, we also intend to seek corresponding regulatory paths for approval in other foreign jurisdictions. Our current pipeline consists of two therapeutic candidates: (i) KIT-302, which has recently successfully completed its Phase III clinical trial and which will be subject to review and approval by the FDA, upon filing a completed 505(b)(2) NDA and (ii) NT219, which is in a preclinical stage but will likely be subject to review and approval by the FDA upon filing a completed 505(b)(1) NDA, if at all. Upon and subject to receipt of the requisite approvals, we intend to commercialize our therapeutic candidates through licensing and other commercialization arrangements with pharmaceutical companies on a global and/or territorial basis. We may also evaluate, on a case by case basis, co-development and similar arrangements, as well as independent commercialization of our therapeutic candidates. Background on KIT-302 and NT219 KIT-302 is based on the generic drugs celecoxib and amlodipine besylate. Celecoxib, the active ingredient in the branded drug Celebrex®, is a known and approved-for-use drug designed primarily to relieve pain caused by osteoarthritis. Amlodipine besylate is a known and approved-for-use drug designed to reduce blood pressure. This combination is designed to simultaneously relieve pain caused by osteoarthritis and treat hypertension, which is one of the side effects of using non-steroidal anti-inflammatory drugs, or NSAIDs, for treating pain caused by osteoarthritis. In January 2017, we acquired a majority of the shares in TyrNovo, a privately held Israeli developer of novel small molecules in the oncology therapeutic field. TyrNovo has developed NT219, a small molecule that presents what we believe to be a new concept in cancer therapy by affecting two key oncology-related mechanisms, Insulin Receptor Substrates (IRS) 1 and 2, as well as the signal transducer and activator of transcription 3 (STAT3). In in-vivo pre-clinical trials in PDX models, NT219, administered concomitantly with several approved oncology drugs, displayed potent anti-tumor effects in various cancers by preventing the tumors from developing resistance to the approved drug treatments and re-sensitizing tumors to the approved drugs even after resistance is acquired. For more information regarding NT219, see, “Item 4. Business Overview - Our Therapeutic Candidates – NT219”. 41 Our competitive strengths The pharmaceutical market is characterized by large international pharmaceutical companies that develop a wide range of products, both generic and NCEs, which operate alongside smaller companies, such as ours, that develop a specific drug or a combination of drugs. Therefore, many small companies enter into agreements with such global companies during the drug development stage in order to continue the development or marketing of the drug, taking advantage of the financial, marketing and/or other resources available to such global companies. At the same time, the global companies tend to enter into agreements with smaller companies in order to save development time and resources. The global drug sector is a highly developed market with a turnover of hundreds of billions of U.S. dollars and intense competition. Most of the drugs we intend to develop have or are expected to have competing drugs or other therapies, developed at the same time by other companies and organizations. We are therefore exposed to competition in our field of operation. Although we believe our therapeutic candidates have advantages which our competitors’ products lack, there is a constant risk in the drug development field that a competing party will complete the development stages before we are able to develop our therapeutic candidates intended for the same disease. Moreover, a constant threat in our market is presented by new drugs that have already completed all the development stages and have already entered the market and are competing with the treatments and drugs previously available on the market. We believe there are several advantages to the therapeutic candidates we are developing, such as: For KIT-302: ● providing a solution to the concerns of physicians who avoid prescribing an NSAID treatment for pain caused by osteoarthritis due to its cardiovascular side effects; ● reassuring physicians who are concerned that their patients who are treated for osteoarthritis will also be treated for hypertension, which is a known side effect of NSAID treatments for pain caused by osteoarthritis. This is a particular concern, as hypertension is usually not accompanied by tangible symptoms, and therefore patients may not be aware of their condition or the need to treat it; ● using one drug that also includes an active ingredient that treats hypertension either as an existing condition or as a side effect of using other drugs, ensures that the patient receives the suitable treatment for their disease and for its side effect; ● purchasing one drug as opposed to purchasing two separate drugs may lead to financial savings for patients in the U.S. by requiring payment of just one co-payment and prescription fee as opposed to a double co-payment and prescription fee. In addition, the use of one combination drug reduces the patient’s discretion with respect to whether to purchase and use only one of the drugs and provides a comprehensive dual medical treatment in one combined drug; and ● using calcium channel blockers in our therapeutic candidates as an antihypertensive. Calcium channel blockers are not included in the FDA Safety Information Release for NSAIDs co-administered with angiotensin converting enzyme inhibitors, or ACE inhibitors, or with angiotensin II receptor antagonists. In addition to the aforementioned medical and economic advantages of KIT-302, we believe that KIT-302 has several commercial advantages, such as reduced development time compared to the development time of new chemical entities (NCEs) and decreased risk factors in the development process. These commercial advantages derive from the fact that combination drugs are based on known materials already approved for use by the FDA. The FDA offers a shortened regulatory procedure referred to as a “505(b)(2) NDA” to approve combination drugs. This procedure may be used to file a request to approve a product that relies on the results of the safety and effectiveness trials performed for the components of the combination in the past by others and not by the submitters of the request for approval. Accordingly, the approval process in a 505(b)(2) NDA is shorter and less expensive compared to the approval process for NCEs. In addition, the use of known, proven and safe components recognized by physicians and medical organizations, and the enhanced medical effect of concurrently treating and preventing hypertension, may shorten the time and decrease the costs usually required for the acceptance of the new product in the drug marketplace. 42 For NT219: NT219 is a small molecule, and small molecules typically are less expensive to develop and have less onerous CMC as compared to large proteins or antibodies. In addition, NT219 has the potentially advantageous effect of: ● overcoming drug resistance acquired by cancer; and ● working in combination with multiple approved cancer therapies. Our strategy Our goal is to become a significant player in the development of innovative chemical drugs with a clinical and commercial added value. Key elements of our strategy are to: ● develop our therapeutic candidates with clinical and commercial advantages and obtain approval thereof from the FDA and other foreign regulatory authorities; ● expand our line of therapeutic candidates through the acquisition or in-licensing of technologies, products and drugs intended to meet clinical needs, thereby utilizing the skills, knowledge and experience of our personnel to develop and enhance the value of additional products, and bring them to market efficiently; ● capitalize on the FDA’s 505(b)(2) regulatory pathway, or other pathways that simplify the road to an NDA submission, to obtain more timely and efficient approval of our formulations of previously approved products, when applicable; ● cooperate with third parties to both develop and commercialize therapeutic candidates in order to share costs and leverage the expertise of others; and ● enter into sub-license agreements with international companies for potential or future therapeutic candidates based on potential upfront and milestone payments, royalties and/or other marketing arrangements, depending on product and market conditions. Our current therapeutic candidate, “KIT-302,” and our newly-acquired therapeutic candidate, “NT219”, are described below. KIT-302: Background on Osteoarthritis and Hypertension Numerous factors influence the drug market, including the aging of the general population. As life expectancy increases, we expect that demand will increase for innovative drugs that treat diseases related to the elderly, such as osteoarthritis and hypertension. Osteoarthritis Arthritis means joint inflammation. The term is used to describe the pain, stiffness and/or swelling in the joints of the body where one or more bones are joined by ligaments. A normal joint provides a smooth surface enabling adjacent bones to move and glide on each other during normal motion. In contrast, an arthritic joint is one that may have varying degrees of inflammation and possibly destruction of the joint cartilage. These destructive changes preclude normal motion and cause pain. 43 The most common type of arthritis is called osteoarthritis and is more common with advancing age. People with osteoarthritis usually have joint pain and a decreased range of joint movement. Unlike some other forms of arthritis, osteoarthritis affects only the joints. This condition is also sometimes called degenerative joint disease. Osteoarthritis primarily affects the joint cartilage. Healthy cartilage allows bones to glide over one another and absorbs energy from the shock of physical movement. However, with osteoarthritis, the surface layer of cartilage breaks down and wears away. This allows the bony surface of the different bones under the cartilage to rub together, causing, pain, swelling, and loss of motion of the joint. Over time, affected joints may lose their normal shape. Also, bone spurs, small growths called osteophytes, may grow on the edges of the joint further impairing joint function. Thus, bits of bone or cartilage can break off and float inside the joint space, causing more pain and possible damage. Osteoarthritis in the younger population is usually caused by traumatic injuries to the joints. In contrast, in the older population it is a more of a chronic degenerative disease process. The main symptom of osteoarthritis is pain that appears gradually, worsens with exertion, and is transiently relieved by rest. The pain caused by osteoarthritis is described by patients as a deep pain or a burning sensation related to the joint tissues of the affected area. Osteoarthritis mainly affects the cartilage and disrupts the structural balance in the cartilage of the joint, causing the cartilage cells to increase production of new raw materials required to create cartilage, but concurrently produce enzymes that digest the cartilage. Osteoarthritis is one of the most common diseases worldwide causing physical disabilities in adults. According to data published in the Center for Disease Control (CDC) website, an estimated 26.9 million U.S. adults in 2005 were diagnosed with osteoarthritis, of which approximately 50% suffer from hypertension. Among individuals in the U.S., it is estimated that over 40% will eventually suffer from osteoarthritis in at least one joint. The pharmaceuticals used for treating osteoarthritis include a range of drugs. The particular choice of treatment is made according to the disease severity. These can range from acetaminophen for cases of milder severity, to diclofenac, naproxen, and celecoxib for moderate severity, up to treatment with narcotics for the most severe cases. Various non pharmacological treatments are intended to relieve the pain caused by the disease and to preserve and improve joint function. Among these treatments are changes in the patient’s life style, namely diet, physiotherapy and exercise. The objectives of these treatments are to strengthen the muscles adjacent to the joints and increase their ranges, thereby reducing body weight, and decreasing the loads on the weight carrying joints to subsequently reduce the intensity of the pain. In some cases, the conservative non pharmacological treatments are not sufficiently helpful. In such cases, patients typically request medical treatment. According to data published on the website of the Mayo Clinic in April 2013, the most common medical treatments are the use of analgesics, such as NSAIDs, which include enzyme inhibitors, such as COX-2. NSAIDs treat inflammation by inhibiting enzymes responsible for the initiation of the development of inflammation and subsequent pain. COX-2 enzyme inhibitors are non-steroidal drugs that treat inflammation by directly inhibiting COX-2, an enzyme responsible for the development of inflammation and subsequent pain but do not target the COX-1 enzyme. Targeting selectivity for COX-2 reduces the risk of peptic ulceration, and is the main advantage of celecoxib, rofecoxib and other members of this drug class over non COX-2 selective NSAIDs. After several COX-2 inhibiting drugs were approved for marketing, data from clinical trials revealed that COX-2 inhibitors caused a significant increase in heart attacks and strokes, with some drugs in the class possibly having worse risks than others. See “Business - Our Therapeutic Candidates – Competitive Treatments for Pain Caused by Osteoarthritis”. A typical osteoarthritis treatment plan with these analgesics is as follows: (i) initial treatment of minor osteoarthritis will begin with use of drugs such as acetaminophen; (ii) in the event that acetaminophen treatment is not effective, the physician will proceed to treatments using NSAIDs, which will begin using drugs such as Ibuprofen followed by naproxen and/or other NSAIDs (more than 20 types of drugs, including COX-2 enzyme inhibitors); (iii) in cases where treatment with these drugs is ineffective, the treatment will be direct injection of steroids into the affected joint; (iv) in cases where steroid injection is ineffective, treatment by injecting hyaluronic acid (HA) into the affected joint will be considered; and (v) in the event that all the aforementioned treatments fail, the patient may consider surgical replacement of the affected joint. 44 As noted above, NSAIDs, both over-the-counter and prescription are commonly taken to manage the pain of backache, osteoarthritis, rheumatoid arthritis, headache and other painful conditions. For example, according to a study commissioned by Kitov from IMS Health, the largest vendor of U.S. physician prescribing data, between April 2015 and March 2016 there were 2,428,176 prescriptions for celecoxib dispensed in the US. NICOX, a pharmaceutical company, has attempted to develop NAPROXCINOD ®, a naproxen-based drug intended to treat pain and to act as an anti-hypertensive. From 2005 to 2010, NICOX completed three Phase III clinical trials following a significant investment. However, the results of the trials did not meet the FDA’s requirements. Therefore, in May 2010, an outside advisory committee to the FDA recommended against approving the drug. As a result of this recommendation, and its own internal review, the FDA rejected the request for NDA approval. According to an announcement by NICOX in April 2012, pursuant to an appeal filed by NICOX in July 2011, a meeting was held in April 2012 between representatives of NICOX and the FDA, in which NICOX was informed that in order to gain approval of its drug, it must file a new NDA, that would include results from additional clinical trials, for the purpose of approving a specific dosage of the drug. On July 9, 2015 the FDA published a safety announcement requiring labels for prescription NSAIDs to indicate that the risk of heart attack or stroke can occur as early as the first weeks of using an NSAID and that the risk may increase with longer use of the NSAID. In effect, the current labeling, in effect since 2005, will be strengthened as a result of a review by the FDA of a variety of new safety information on prescription and over-the-counter NSAIDs, including observational studies, a large combined analysis of clinical trials, and other scientific publications. These studies were discussed at a joint meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee held in February 2014. Hypertension (High Blood Pressure) Hypertension is the most common chronic disease in the western world, affecting approximately thirty percent (30%) of the U.S. adult population, according to an article in Morbidity and Mortality Weekly Report. Untreated, hypertension can cause significant morbidity and mortality. According to its physiological definition, “hypertension” is an excessive pressure applied by the blood on the walls of the blood vessels. The term hypertension refers to excessive arterial blood pressure, which is the pressure in the arteries that propels blood to body organs. The blood pressure is created as a result of the contraction of the cardiac muscle propelling blood into the arteries, which possess a limited capacity to store the blood. Blood pressure is measured in units of mercury (Hg) millimeters (mm Hg). Diagnosing hypertension in adults requires at least two measures on two different occasions. There are two blood pressure values: ● Systolic pressure is the peak pressure in the arteries measured in the cardiac cycle, during the contraction of the heart’s left ventricle (systole); and ● Diastolic pressure is the lowest pressure point in the arteries measured when the heart’s left ventricle is relaxing and there is no contraction of the heart (diastole). In the past, hypertension was generally defined as a systolic blood pressure of greater than 140 mm Hg or a diastolic blood pressure of greater than 90 mm Hg. However, as discussed below, a recently halted NIH study may result in these designated values being set lower. The cause of hypertension in 95% of patients is unknown, and in these cases hypertension is defined as “essential hypertension”. However, some studies postulate that genetic factors and environmental factors are involved in the initial development of hypertension. These factors include high salt consumption, obesity, excessive alcohol consumption, and probably mental and behavioral factors, which may be caused by various circumstances, including working in certain professions. Extreme hypertension may lead to functional disorders, and worsening health, while the affected person does not necessarily feel it and/or is aware of it. Therefore, hypertension is often referred to as the “silent killer”. 45 The danger of hypertension is continuing damage to blood vessels in critical areas of the body, such as blood vessels in the heart, kidneys, eyes, and to the nerve tissue in the brain where any damage may cause a stroke. Moreover, damage to the blood vessels may cause blockage due to arteriosclerosis and lead to the tearing of the vessels. These complications may cause various diseases and even death. Hypertension treatment methods focus on reducing the patient’s blood pressure to normal values, thereby preventing the occurrence of complications in the long term. Even a small increase in blood pressure may cause significant cardiovascular problems. For example, it has been shown that any increase in blood pressure above a systolic value of 115 mm Hg is associated with an increased risk of suffering a cardiovascular death. This finding has been repeatedly replicated and it is now established that there is no safe level of blood pressure increase above of the “normotensive baseline value” of approximately 120 systolic and 70 diastolic. The documentation of a danger of any increase in blood pressure above a value of 120/70 was recently documented in September of 2015 in a large NIH sponsored clinical trial which enrolled over 9000 patients age 50 and older. This study also documented that patients age 50 and older with systolic blood pressures greater than 120 had a greater rate of adverse cardiovascular events than did those whose systolic blood pressure was treated to levels below 120. It has been recognized for many decades that hypertension requires treatment. This fact has been recently re-emphasized by a paper that reviewed 147 prior randomized studies of antihypertensive treatments. This meta-analysis study, concluded that the majority of the adult population with hypertension can be expected to benefit considerably from using anti-hypertension drugs. Hypertension can be treated with many different classes of medications. These include diuretics, beta blockers, alpha blockers, calcium channel blockers, ACE inhibitors, angiotensin receptor antagonists and vasodilators. In general, these medications work by either relaxing blood vessels and thereby lowering the pressure in arteries, or by assisting the body in removing fluid and thereby decreasing the pressure inside of arteries. Although drugs from each of the various classes of antihypertension medications are able to reduce blood pressure, there are marked differences in their side effects profiles. For example, the diuretics can result in kidney problems, while the beta blockers can slow the heart rate. It is therefore important for physicians carefully to select which antihypertension medications to prescribe for patients based upon the patient’s other medical problems, including what concomitant medications they are receiving. Blood pressure can undergo significant alterations when subjects are placed on various medications. For example, according to a May 2010 FDA Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee report published by the FDA, an increase of about 3.5 mm Hg was diagnosed following the use of naproxen, while the use of Celebrex causes an increase of about 2.5 mm Hg. In addition, in August 2011 the FDA issued a Safety Information release stating that co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors or with angiotensin II receptor antagonists, may result in deterioration of renal function, including possible acute renal failure, and that the antihypertensive effect of ACE inhibitors may be attenuated by NSAIDs. No such Safety Information release was issued with regard to calcium channel blockers, which is the anti-hypertensive used in our therapeutic candidates. Background on Combination Products Numerous companies worldwide have developed in recent years successful combination products comprised of a combination of two or more drugs to treat various medical conditions, where the safety and effectiveness of each of the drugs was proven separately. Combination products manufactured and sold, which are similar to our therapeutic candidate, include: ● Vimovo®, which was developed by Pozen Inc. and was approved by the FDA in May 2010. Vimovo® is a combination of naproxen and esomeprazole magnesium, marketed by AstraZeneca PLC worldwide (except in the U.S.) and by Horizon Pharma in the U.S., and is designed for treating both pain and preventing gastric ulcer. Vimovo’s® net sales in the U.S. reached $121 million in 2016, compared to net sales of $163 million in 2014. 46 ● Caduet®, a combination of Lipitor® and amlodipine, was originally developed and manufactured by Pfizer and is designated for treating both cholesterol and hypertension, with global sales of $193 million in 2015. ● Janumet®, a combination of metformin and sitagliptin, manufactured by Merck & Co. Inc. and designated to treat diabetes, with sales of $2,201 million in 2016. Combination drugs may provide improved medical treatment of patients diagnosed as suffering from two or more different diseases and also may provide convenience to patients by using a single drug instead of multiple drugs. In addition, combination drugs have significant commercial advantages deriving from maintaining and even increasing the market share of the active ingredients after their patents expire by extending the life span of the patents for the active ingredients through the use of combination drugs. Our Therapeutic Candidate Studies estimate that approximately 13.5 million patients in the U.S. alone may suffer concurrently from hypertension and chronic osteoarthritis pain in the joints, according to data published by the CDC. We are developing KIT-302 based on the generic drugs celecoxib and amlodipine besylate. Celecoxib is the active ingredient in the branded drug “Celebrex®”, a known and approved-for-use drug designed primarily to relieve pain caused by osteoarthritis. Our combination is designed simultaneously to relieve pain caused by osteoarthritis and treat hypertension, which is one of the side effects of using NSAIDs for treating pain caused by osteoarthritis. Our strategy in developing KIT-302 is based on our belief that the added anti-hypertensive drug will decrease the side effect of increased hypertension typically caused by the use of NSAIDs alone. To date, no combination drug exists that offers the combined treatment of pain caused by osteoarthritis and hypertension. We therefore believe that KIT-302 potentially holds significant advantages over the currently available drugs in the market, due to the fact that the drug treatment of osteoarthritis together with hypertension eases the burden of the treatment process for patients by providing the ability to use one drug instead of multiple drugs concurrently, thereby increasing the patients’ ease of compliance with the required treatment. KIT-302 is a fixed dosage combination product based on two known active ingredients (celecoxib and amlodipine besylate), the effectiveness and safety of which has been separately proven for each, and which is intended to enable the concurrent treatment of pain caused by osteoarthritis and hypertension. On November 7, 2013, we filed with the FDA the final statistical plan for the Phase III clinical trial protocol for KIT-302 as part of the SPA procedures. On February 20, 2014, the FDA replied and indicated that the proposed data analysis of the trial’s results that we submitted to the FDA provides a suitable solution to achieve the primary endpoint of the Phase III clinical trial and to support the final request for approval, which will be submitted. As a result of the SPA process, the FDA approved the Phase III trial design for our clinical trial, and cleared our clinical trial to begin, and on June 18, 2014, we commenced the clinical trial, as described below under “Research and Development”. The Phase III clinical trial was performed using the Adaptive Trial Design method, or ATD, in accordance with the SPA. Based on the ATD format, in the first stage of the trial 150 patients were to be recruited. Then, the decision as to whether or not to add additional patients was to be based upon a statistical calculation of the preliminary data performed by an independent statistician appointed by the Company in accordance with the protocol of the clinical trial, and in accordance with the FDA’s requested and approved method as part of the SPA, as agreed upon between the FDA and the Company. Statistical analysis of the preliminary data collected in the Phase III clinical trial was performed by the independent statisticians in accordance with the clinical trial protocol, and showed that the study met the pre-specified criteria the FDA required for stopping patient enrollment and thus proceeding to the completion of the final statistical analyses. The final statistical analyses of the data demonstrated that the Phase III study of KIT-302 met its FDA approved primary efficacy endpoint with statistical significance based upon the efficacy endpoint of less than 0.001. 47 Below is a summary of our projected timeline for the development of KIT-302: Current Status FDA Approved SPA. Phase III clinical trial completed. CMC, including stability testing, completed. PK studies completed. 2017 Submission of NDA to the FDA. Continuation of our business development activity. 2018 Anticipated FDA approval for marketing KIT-302 is based on two generic drugs (amlodipine besylate and celecoxib). Until December 2015 celecoxib was protected by patents held by Pfizer Inc. (Celebrex®). The USPTO granted Pfizer a “reissue patent” covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex®. The reissued patent extended U.S. patent protection for Celebrex® from May 30, 2014 to Dec. 2, 2015. We currently expect to receive approval from the FDA to market KIT-302 in 2018. As a result of this timing and because KIT-302 combines the treatment of osteoarthritis by celecoxib with amlodipine besylate, which treats the side effect of hypertension, we believe that KIT-302 may be an attractive alternative to the newly marketed generic versions of Celebrex®. Research and Development – KIT 302 KIT-302 is a fixed dose combination drug comprised of known and approved-for-use components, the combination of which is intended simultaneously to treat the pain caused by osteoarthritis and reduce blood pressure, thereby offsetting a side effect caused by the use of NSAIDs for osteoarthritis. Following discussions with the FDA, the FDA approved a development design in accordance with the 505(b)(2) NDA track. The FDA did not require us to perform pre-clinical trials in animal models, and therefore we are required only to conduct a single Phase III clinical trial and standard pharmacokinetic trials and bioequivalence trials. For the development of KIT-302, we performed a double blind, placebo controlled, Phase III clinical trial for testing the decrease of hypertension in patients receiving our KIT-302 therapeutic candidate. This trial was performed in the U.K. in four groups of twenty-six (26) to forty-nine (49) patients (a total of 152 patients), with each patient treated over a total period of two weeks. Group One was treated with the two components of KIT-302 (celecoxib and amlodipine besylate), Group Two was treated with a standard drug available in the market for treating hypertension (amlodipine besylate, one of the components of KIT-302), Group Three was treated with celecoxib only, and Group Four received a double placebo. The trial began in June 2014, and the final patient completed the study in November 2015. The purpose of the trial was to show that a combination of the two components of KIT-302, as demonstrated in Group One, lowered blood pressure by at least 50% as compared to the reduction in blood pressure in patients in Group Two (treatment with amlodipine besylate only). We were not required by FDA to demonstrate or measure efficacy in treatment of pain caused by osteoarthritis. Group Three and Group Four were included for control purposes and would not be considered in evaluating the primary efficacy endpoint. The trial was conducted with off-the-shelf drugs, while the combination drug was being developed in parallel by Dexcel Ltd., or Dexcel. The trial was conducted with only one dosage of amlodipine besylate (10 mg), although based on the SPA signed with the FDA, we expect that conducting a trial with this dosage only will be sufficient to seek marketing approval from the FDA for three dosages (10mg, 5 mg, and 2.5 mg), each combined with 200 mg of celecoxib. We announced the top line trial results in December 2015, showing that we successfully met the primary efficacy endpoint of the trial protocol as approved by the FDA. Data from the trial further revealed that KIT-302 tended to reduce blood pressure more than the widely used hypertension drug amlodipine besylate alone. The trial’s interim results demonstrated that the number of 152 patients treated was adequate to provide statistical validity and therefore, the results were final. These final results showed that in patients treated with amlodipine besylate only, there was a mean reduction in daytime systolic blood pressure of 8.8 mm Hg. In patients treated with KIT-302’s two components, there was a mean reduction in daytime systolic blood pressure of 10.6 mm Hg. Therefore, the primary efficacy endpoint of the study has been successfully achieved with a p value of 0.001. 48 Additional data from the trial results showed that favorable blood pressure effects of KIT-302’s two components were present in all blood pressure variables measured in the study. The data indicated that the blood pressure reduction synergy seen with combining celecoxib and amlodipine, is seen not only in the study’s primary efficacy endpoint of daytime systolic blood pressure, but was also seen from daytime diastolic blood pressure measurements and in all other blood pressure variables. After two weeks of treatment, the reduction with daytime diastolic blood pressure measurements with amlodipine alone was 5.5 mm Hg, while for patients treated with KIT-302’s components the reduction was 7.6 mm Hg. For nighttime systolic blood pressure after two weeks of treatment, the reduction with amlodipine therapy alone was 6.3 mm Hg, while for patients treated with KIT-302’s components the reduction was 10.7 mm Hg. For nighttime diastolic blood pressure after two weeks of treatment, the reduction with amlodipine besylate alone was 3.1 mm Hg, while for patients treated with KIT-302’s components the reduction was 7.2 mm Hg. Thus, the synergy in blood pressure reduction demonstrated with KIT-302’s two components was present at all times of day and with both blood pressure measures. Although celecoxib when combined with amlodipine appears to have a synergistic effect in lowering blood pressure, it appears to have the opposite effect when administered by itself. While not conclusive, we believe the medical community may take great interest in this study’s findings and its implications for pain management and hypertension. On May 12, 2016, we announced that we received the minutes from the FDA for the pre-NDA submission meeting held during April 2016. The FDA requested that the clinical study results be reviewed to check and make sure no patients suffered adverse consequences from the enhanced blood pressure reduction resulting from the synergy of celecoxib and amlodipine. We were unable to identify of any such events occurring and intend to include a detailed review in the safety section of our NDA. In addition, to further establish safety, the FDA requested a literature search related to animal studies of celecoxib and amlodipine be included in the NDA. The FDA also requested documentation of a clinical need for KIT-302, such as by identifying how many patients receive celecoxib on a chronic basis. We will provide this documentation by using computerized patient care databases. Finally, the FDA requested that the statistical calculation for the primary efficacy endpoint be performed using an alternate mathematical technique. Our statistician has already conducted this calculation and determined that the primary efficacy endpoint was successfully met with the new calculation method. The final and complete analyses, including the clinical study report, will be completed during the second quarter of 2017. We plan to file our NDA for marketing approval of KIT-302 with the FDA in Q2 2017. In addition, in connection with our Development Services Agreement with Dexcel, pursuant to which Dexcel developed the formulation for KIT-302 and is performing the subsequent stability testing and manufacturing scale-up in quantities adequate for submission of an NDA to the FDA, Dexcel performed a pilot clinical bioequivalence trial, or the Pilot PK Study, and subsequently performed final conclusive pharmacokinetic (PK) bioequivalence (BE) studies, or the Final PK Studies. The objective of these studies was to check the pharmacokinetics of the combination drug in order to show that the blood levels achieved with our combination are equivalent to those obtained with the individual components. The Pilot PK Study was performed during April and May 2015, after completion of the formulation of two prototypes of KIT-302; during June 2015, we obtained the successful results of the Pilot PK Study. The Final PK Studies, conducted under both fed and fasted conditions, using the 10 mg amlodipine component were performed between March and April 2016, and on May 10, 2016 we announced that we, together with Dexcel, had successfully completed the Final PK Studies. The Final PK Studies compared the PK of KIT-302 which is a fixed dose combination consisting of celecoxib (200 mg), indicated for osteoarthritis pain, and amlodipine (10 mg), indicated for high blood pressure, to off-the-shelf branded 200 mg celecoxib capsules and 10 mg amlodipine tablets. The results demonstrated that for both the Cmax (the maximum blood level achieved) and Area Under the Curve (the area under the concentration-time curve for drug levels), the 90% confidence intervals for both the amlodipine and celecoxib components of KIT-302 were documented to be between 80% and 125% of the values obtained with the off- the-shelf drugs, thus meeting the FDA’s standard for establishing bioequivalence. A similar PK bioequivalence study for KIT-302, containing a lower dosage (2.5 mg) of amlodipine, was completed during the third quarter of 2016, and showed similar bioequivalence results to those found in the Final PK Study. See “Item 4. Information on the Company – B. Business Overview – Development Services Agreement with Dexcel” below for more information. 49 On June 28, 2016, we announced that Dexcel had successfully completed an initial stability study for KIT-302. On December 7, 2016, we announced that Dexcel completed a study of nine pivotal batches of KIT-302 demonstrating stability for six months, which is required to submit our NDA to the FDA. The Phase III clinical trial for KIT-302 was conducted in medical centers in the United Kingdom on the basis of approvals received from the British Regulatory Authority (MHRA) and the U.K. ethics committees. It is not currently known whether the European regulatory authorities will require additional studies in order to grant their approval to market KIT-302 in Europe. Additional data from the Phase III clinical trial of KIT-302 also suggest beneficial effects on renal (kidney) function, as compared to negative effects on renal function caused by other NSAIDS. Greater reduction in plasma levels of creatinine was observed in patients in the KIT-302’s two components arm (-3.22 umol/L) compared to creatinine reduction observed in patients in the amlodipine arm (-2.55 umol/L), suggesting better renal function. In addition, peripheral edema, a known side effect of calcium channel blockers such as amlodipine, was reported in 15.6% of patients receiving amlodipine alone, but in only 8.2% of patients receiving KIT-302’s two components, suggesting that KIT-302 may protect against the amlodipine side effect of causing fluid retention by the kidneys. It is recognized that such an effect could explain at least in part, the synergistic blood pressure reducing effect of KIT-302 over therapy with amlodipine alone. Although not intended as part of the information to be included in our new drug application that we expect to submit in Q2 2017 for the marketing clearance by the FDA of KIT-302, we have commenced conducting a clinical trial designed to validate and better quantify these potential beneficial renal effects. The trial analyses may further explain the synergistic antihypertensive effect, where the reduction in blood pressure demonstrated with KIT-302’s two components was greater than that observed with amlodipine alone. Accordingly, we are conducting a double blind, placebo controlled, clinical trial intended statistically to demonstrate KIT-302’s effects on renal and vascular function, while providing us with data with respect to KIT-302 in addition to the data of the Phase III clinical trial, by utilizing a primary efficacy end-point in the renal function clinical trial comparable to that of the Phase III clinical trial. The trial is being performed in the U.K. in three groups of 15 to 45 patients (and a total of 105 patients), with each patient treated over a total period of two weeks. Group One is receiving a placebo, Group Two is being treated with a standard drug available in the market for treating hypertension (amlodipine besylate, one of the components of KIT-302), and Group Three is being treated with the two components of KIT-302 (celecoxib and amlodipine besylate). We expect to complete recruitment of the patients during the second calendar quarter of 2017 and to receive the interim results of the trial approximately up to eight weeks after completion of patient treatment. The renal function clinical trial for KIT-302 is being conducted in medical centers in the United Kingdom on the basis of the approval of the British Regulatory Authority (MHRA), as well as the approvals of the relevant U.K. ethics committees, which we have already received. On September 7, 2016, we entered into an additional Work Order with Java Clinical Research Ltd., or Java, a contract research organization based in Dublin, Ireland, under our Master Research Services Agreement with Java, the term of which was extended by such Work Order. Pursuant to the Work Order Java will manage the renal function clinical trial for KIT-302, including preparation and filing of the requests to the ethics boards and the necessary regulatory bodies of the U.K., recruiting the trial participants, employment of the primary researchers, identification and evaluation of the medical centers and their subsequent management throughout the trial period and overall management of the trial process through its completion. We also have directly engaged with third party medical centers for the performance of our renal function clinical trial being managed by Java. The Master Research Services Agreement will remain in effect until Java has provided all services through the completion of our renal function clinical trial. The parties have customary termination rights and either party may terminate the Master Research Services Agreement (or any work thereunder) upon 60 days’ notice. In addition, on July 26, 2016, we entered into a new services agreement with DABL Limited, or DABL, an Irish company based in Dublin, Ireland, in the ambulatory blood pressure monitoring technologies field, in connection with the renal function clinical trial. According to the agreement, DABL will provide protocol consultation services and coordinate the ambulatory blood pressure monitoring (ABPM) procedures and the analysis of the blood pressure tests during and after our renal function clinical trial. The services agreement will remain in effect until DABL has provided all services provided for in the agreement. However, we may terminate the agreement at any time upon 90 days’ notice, and both parties have customary termination rights. We estimate that the total cost of the agreement with Java, as well the cost of all other service providers with respect to the renal function clinical trial, will amount to approximately $1.8 million, assuming completion of the clinical trial as anticipated. 50 In order to market or sell our KIT-302 therapeutic candidate in Europe, we must apply to an applicable European country’s regulatory authorities with a request to approve KIT-302 according to the Mutual Recognition Procedure (MRP), which is a procedure applied by European Directive No. 2001/83/EC that enables access to medicinal products (drugs) in 27 countries of the European Union. The MRP approval process requires the applicant to receive approval in one of the EU countries and then apply for recognition of the other member countries to acknowledge the approval within their territory. It is not currently known whether the European regulatory authorities will require additional studies in order to grant their approval to market KIT-302 in Europe. The Company has engaged an external consultant to assist the Company in applying for regulatory approval of KIT-302 in Europe. As part of this process, the Company is scheduled to meet with regulatory authorities in Sweden and the UK in the second quarter of 2017. At that meeting, the applicability of the Company’s current data for obtaining marketing authorization in various EU countries will be discussed. Following this meeting, a plan will be finalized for obtaining regulatory approval for marketing in EU countries. Competitive Treatments for Pain Caused by Osteoarthritis The competition for KIT-302 is expected to come from the oral anti-arthritic market, or more specifically the traditional non-selective NSAIDs (such as naproxen and diclofenac), traditional NSAID/gastroprotective agent combination products or combination product packages (such as Vimovo®, Arthrotec®, Prevacid® and NapraPAC™) and the most common COX-2 inhibitor in the U.S. market, Celebrex® (including generic versions of Celebrex®). In 2016, global sales of branded celecoxib (Celebrex® by Pfizer, and Celecox® by Astellas) were $733 million and $423 million, respectively, out of which $116 million were in the US (by Pfizer) and $423 million in Japan (by Astellas). Due to the voluntary withdrawal of Vioxx® by Merck & Co. in September 2004, the FDA ordered the withdrawal of Bextra® by Pfizer and issued a Public Health Advisory in April 2005, requiring manufacturers of all prescription products containing NSAIDs to provide warnings regarding potential adverse cardiovascular events as well as life-threatening gastrointestinal events associated with the use of NSAIDs. Moreover, subsequent to an FDA advisory committee meeting in February 2005 that addressed the safety of NSAIDs, and, in particular, the cardiovascular risks of COX-2 selective NSAIDs, the FDA has indicated that long-term studies evaluating cardiovascular risk will be required to approve new NSAID products that may be used on an intermittent or chronic basis. We believe that KIT-302 has a competitive advantage over other drugs in the market because, as a COX-2 inhibitor, it has limited gastrointestinal side effects, and due to the addition of amlodipine besylate it is designed to address existing hypertension and the cardiovascular side effects of NSAIDs. License Agreement for Territory of South Korea On March 8, 2017, we announced that the Company signed a definitive License Agreement KIT-302, for the territory of South Korea, with Kuhnil Pharmaceutical Co., Ltd. (“Kuhnil”). Upon receipt of marketing authorization in South Korea, Kuhnil will have the exclusive right and license to manufacture, distribute and sell KIT-302 in South Korea. Kuhnil will be responsible for seeking regulatory approval for KIT-302 in South Korea. Under the terms of the license agreement, Kitov is entitled to receive milestone payments upon achievement of certain predefined regulatory milestones, as well as double digit royalties in a range between ten and twenty percent of net sales. The initial term of the definitive agreement with Kuhnil is for ten years from the date of first commercial sale and shall automatically renew for an additional one-year term. Commercial launch in South Korea is estimated to take place in 2019. In addition to our internal business development team, we have engaged consultants which are assisting us with finding other potential collaboration partners for KIT-302 in various markets world-wide. 51 NT219 In January 2017, we acquired a majority of the shares in TyrNovo which is developing the NT219 therapeutic candidate. NT219 is a small molecule that presents what we believe is a new concept in cancer therapy by promoting the degradation of two oncology-related checkpoints, Insulin Receptor Substrates (IRS) 1 and 2 as well as the inhibition of signal transducer and activator of transcription 3 (STAT3). In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased survival in various cancers by preventing the tumors from developing drug resistance and restoring sensitivity to the drugs after resistance is acquired. The NT219 technology has been tested in a number Patient-Derived Xenograft (PDX) models where human primary cancer cells or biopsies are taken and transplanted into mice and then used to test various cancer drugs. Below is a summary of our current projected timeline for the development of NT219: Current Status Efficacy demonstrated in various PDX models. Additional experiments ongoing. Academic collaborations established. CMC and toxicology work initiated. Background on Cancer Drug Resistance 2017 Complete CMC for preclinical studies. Begin required preclinical toxicology studies. Conduct preIND meeting with FDA. 2018 Complete cGMP manufacturing of drug for clinical trials. Complete preclinical studies. Submit IND. Initiate clinical trials. The following paragraphs are high-level summaries of the therapeutic areas we are currently investigating for NT219: Solid malignancies (e.g., pancreatic, colon and non-small cell lung cancer). According to the Journal of Oncology Practice, in 2020 roughly 1 in every 19 people worldwide will either be diagnosed with a solid tumor or be a cancer survivor. According to the American Cancer Society, lung cancers are the most common cause of cancer deaths worldwide, while pancreatic cancers are the third most common cause of cancer-related deaths in the United States. Pancreatic, colon and non-small cell lung malignancies have high mortality rates and poor five-year survival prognosis. Novel, emerging therapeutic approaches for targeting solid tumors are being developed and tested. Tumor Resistance to Cancer Therapies. Resistance to chemotherapy and to targeted therapies is a major problem facing current cancer research. The mechanisms of resistance to ‘classical’ cytotoxic chemotherapeutics and to therapies that are designed to be selective for specific target proteins share many features, such as alterations in the drug target, activation of pro-survival pathways and ineffective induction of cell death. Recent evidence suggests that among other mechanisms of resistance, inhibition of central oncological target kinases such as EGFR, MEK and mutated-BRAF could trigger feedback activation of STAT3 and IRS-to-PI3K/AKT, major survival pathways that bypass (prevent) the anti-cancer effects of various drugs. IRS. Insulin Receptor Substrate (IRS) is a junction protein that mediates various mitogenic and anti-apoptotic signals mainly from Insulin-like Growth Factor-1 Receptor (IGF1R) and Insulin Receptor (IR), but also from other oncogenes such as v-Src and ALK-fusion proteins. IRS expression is often increased in human tumors, such as prostate, pancreatic, liver, renal and ovarian cancer. Resistance to several anti-cancer therapies (e.g. inhibitors of EGFR, MEK, mutated-BRAF, mTOR, as well as chemotherapy) may be mediated by IRS up-regulation, as demonstrated in peer reviewed research articles which have been published in scientific journals. STAT3. Signal transducer and activator of transcription 3 (STAT3) plays crucial roles in several cellular processes such as cell proliferation and survival, and has been found to be aberrantly activated in many cancers. Much research has explored the leading mechanisms for regulating the STAT3 pathway and its role in promoting tumorigenesis. Evidence suggests that feedback activation of STAT3 plays a prominent role in mediating drug resistance to a broad spectrum of targeted cancer therapies and chemotherapies. 52 Mechanism of Action – NT219 The NT219 therapeutic candidate is a small molecule that we believe presents a new concept in cancer therapy by promoting the degradation of two oncology-related checkpoints, IRS1 and IRS2 as well as the inhibition of STAT3. While targeted anti-cancer drugs inhibit the “ON” signal, NT219 activates the “OFF” switch, extensively blocking major oncogenic pathways. Elimination of IRS proteins and blockage of STAT3 by NT219 could potentially prevent resistance to multiple anti-cancer drugs, extend the duration of effective drug treatment, and restore drug sensitivity in resistant tumors. IRS down-regulation can be mediated by several oncogenic pathways (MAPK, mTOR, EGFR etc). Blockade of these pathways by various drugs, could inhibit serine phosphorylation of IRS, leading to the activation of IRS to AKT survival bypass. Therefore, elimination of IRS1/2 by NT219 potentially could prevent resistance and prolong the tumor’s response to various targeted drugs, as depicted below: There have been reports in peer reviewed academic literature describing the involvement of Insulin-like Growth Factor-1 Receptor (IGF1R) up- regulation in drug-resistance. In these cases blockage of IGF1R direct substrates, IRS1/2, by NT219 could potentially overcome drug resistance. The same principal is true for STAT3. Feedback activation of STAT3 is a common cause of resistance to many targeted cancer therapies (such as the inhibitors of EGFR, MEK, HER2) and chemotherapies. Combining these cancer therapies with NT219, which disrupt this feedback mechanism, could potentially enhance cell death and delay resistance, suggesting a co-treatment strategy that may be broadly effective in oncogene-addicted tumors. Preclinical results - NT219 In pre-clinical trials, NT219, in combination with several approved cancer drugs, displayed potent anti-tumor effects and increased survival in various cancers by preventing the tumors from developing drug resistance and restoring sensitivity to the drugs after resistance is acquired. The NT219 molecule has been tested in a number Patient-Derived Xenograft (PDX) models where human primary cancer cells or biopsies are taken and transplanted into mice and then used to test various cancer drugs. NT219 has shown efficacy in various PDX models originated from non-small cell lung cancer (NSCLC), sarcoma, melanoma, pancreatic, head & neck and colon cancers. 53 Efficacy of NT219 was demonstrated in combination with three major families of oncology drugs: 1) Antibodies such as the anti-epidermal growth factor receptor (EGFR) antibody (Erbitux®); 2) Kinase Inhibitors such as blockers of EGFR (Tagrisso®, Tarceva®), MEK (Mekinist®), Mutated BRAF (Zelboraf®), and mTOR inhibitors such as Afinitor®; and 3) Chemotherapy agents such as Gemzar®, 5FU, and Oxaliplatin. Below are two examples of results obtained with NT219 in PDX models. In the head and neck cancer model treatment with NT219 in combination with Elrotinib (trade name Tarceva®, an anti EGFR drug approved for various oncology indications; left panel) resulted in overcoming drug resistance and lower volume of the tumor, compared to the treatment arm with Erlotinib alone. Similar results are depicted on the right panel where NT219 was tested in a pancreatic cancer PDX model where combination of NT219 with gemcitabine (a chemotherapy agent approved for pancreatic cancer) resulted in decreased tumor volume compared to those obtained with gemcitabine alone. The above are examples only, and do not serve as indication of the nature of the cancers that we expect NT219 to be tested on, or to eventually assist in treating. Prior to the commencement of a Phase 1 study and following a pre-IND to be conducted with the FDA, we will narrow the scope of which concomitant cancer drug or drugs NT219 will be combined in our prospective clinical trials. Competitive Oncology Drugs in Development that Target IRS1/2 or STAT3 While we are not familiar with other molecules which act as dual inhibitors of both IRS1/2 and STAT3, or lead to degradation of IRS1/2, and which are in late stage of development, there are several therapeutic candidates in development which target either upstream target of IRS1/2 as Insulin Like Growth Factor 1 Receptor (IGF1R), such as Dalotuzumab (a recombinant humanized monoclonal antibody, developed by Merck & Co for metastatic breast cancer), or target STAT3 such as Napabucasin (which is developed by Boston Biomedical and designed to inhibit cancer stem cell pathways), which are currently at Phase III clinical trial state for metastatic pancreatic and colon cancers. There are also other therapeutic candidates that target these pathways, which are mostly in early stage of development. Since we have not yet selected any final clinical indication, and no target drug has been chosen to be administrated in combination with NT219, we are at this preliminary stage unable to determine the future competitive landscape of this therapeutic candidate. 54 Intellectual Property Patents, trademarks and licenses and market exclusivity Our policy is to seek to protect our proprietary position by, among other methods, filing U.S. and foreign patent applications related to our proprietary technology, inventions and improvements that are important to the development of our business. We also rely on our trade secrets, know-how and continuing technological innovation to develop and maintain our proprietary position. We vigorously defend our intellectual property to preserve our rights and gain the benefit of our technological investments. Our business is not dependent, however, upon any single patent, trademark or contract. See “Item 3. Key Information – D. Risk Factors – Risks Related to Intellectual Property”. Kitov Kitov owns two U.S. patents and we expect to be pursuing additional international patent applications relating to our lead drug candidate, KIT-302. The following is a brief description of Kitov’s patent and trademark-related intellectual property: On August 10, 2016, we announced that the United States Patent and Trademark Office (USPTO) issued patent #9,408,837 covering KIT-302. The patent, entitled “Ameliorating Drug-Induced Elevations In Blood Pressure By Adjunctive Use Of Antihypertensive Drugs,” was issued on August 9, 2016 and is expected to have a term that can extend to February 28, 2030. The patent includes claims covering methods of ameliorating celecoxib-induced elevation of blood pressure by administering celecoxib and amlodipine separately or in combination. On February 1, 2017, we announced that the USPTO issued a Notice of Allowance to Kitov related to claims expanding the patent coverage for our lead drug candidate, KIT-302, to include oral dosage compositions containing both amlodipine and celecoxib. This patent is a divisional of the ’837 patent and is expected to have a similar patent term as that of patent #9,408,837. We anticipate that in the near future, we will be filing an international patent application, in partnership with Dexcel Ltd., which is related to pharmaceutical formulations of celecoxib and amlodipine and methods of preparing the same. We have applied to the USPTO for registered trademarks for two possible trade names for KIT-302 and have also submitted these names to the FDA for approval. TyrNovo TyrNovo’s patent and patent application portfolio includes five patent families, covering compounds that modulate protein kinase signaling and their use in treatment of protein kinase related disorders, including cancer and neurodegenerative disorders. ● Patent Family 1 was filed on December 4, 2007 (PCT filing date). The priority date is December 4, 2006. This family is directed to compounds modulating the insulin like growth factor receptor signaling and methods of using these compounds as chemotherapeutic agents for the treatment of protein kinase related disorders, in particular cancer. National phase counterparts exist in Europe (EP 2125712) and the United States (US 8,058,309), both of which are now granted with a maximum term of December 4, 2027 (not including any available patent term extension (PTE)). The European patent was validated in France, Germany, Switzerland and the United Kingdom. ● Patent Family 2 was filed on June 7, 2009 (PCT filing date). The priority date is June 5, 2008. This family is also directed to compounds modulating the insulin like growth factor receptor signaling, and methods of using these compounds as chemotherapeutic agents for the treatment of protein kinase related disorders, in particular cancer. This patent family specifically discloses and claims NT-219. National phase counterparts exist in Europe (EP 2285774), the United States (US 8,637,575) and Israel (IL 209638), all of which are now granted with a maximum term of June 7, 2029 (not including any available PTE). The European patent was validated in France, Germany, Italy, Netherlands, Spain, Switzerland, and the United Kingdom. 55 ● Patent Family 3 was filed on December 27, 2011 (PCT filing date). The priority date is December 27, 2010. This family is directed to compounds having a benzo[e][1,3]thiazin-7-one core, and methods of using these compounds as chemotherapeutic agents for the treatment of protein kinase related disorders, in particular cancer. National phase counterparts exist in Europe (EP 2658847) and the United States (US 9,073,880), both of which are now granted with a maximum term of December 27, 2031 (not including any available PTE). The European patent was validated in France, Germany, Italy, Netherlands, Spain, Switzerland, and the United Kingdom. ● Patent Family 4 was filed on July 13, 2014 (PCT filing date). The priority date is July 14, 2013. This family is directed to use of the compounds disclosed in Patent Families 1-3, for the treatment of neurodegenerative diseases, including Alzheimer’s disease. National phase applications were filed in Europe (EP 3021944), the United States (US2016/0158243) and Israel (IL 243566). All of these applications are now pending. Any patent issuing from these applications will have a maximum patent term of July 13, 2034. ● Patent Family 5 was filed on February 4, 2016 (PCT filing date). The earliest priority date is February 5, 2015. This family is directed to combinations of the compounds disclosed in Patent Families 1-3, acting as dual modulators of Insulin Receptor Substrate (IRS) and signal transducer and activator of transcription 3 (STAT3), with various targeted drug families (inhibitors of Epidermal Growth Factor Receptor (EGFR), mammalian target of rapamycin (mTOR); mitogen-activated protein kinase (MEK) or mutated B-Raf), as well as chemotherapeutic agents (Gemcitabine, 5-FU, Irinotecan and Oxaliplatin), and use of such combinations for the treatment of cancer. The combinations can be used to treat tumors that have developed resistance to these anti-cancer drugs, to prevent acquired resistance of a tumor to these drugs, or to prevent tumor recurrence following cease of treatment with these drugs. The present invention further relates to the treatment of cancer using combination therapy comprising a dual modulator of IRS and STAT3, in combination with an immunotherapy agent, and can be used to sensitize a tumor to immunotherapy. The deadline to enter the national phase is August 5, 2017. Exclusive License Agreement with Yissum. On August 15, 2013, TyrNovo entered into a license agreement with Yissum, which was subsequently amended on April 8, 2014 and March 16, 2017, pursuant to which Yissum has granted TyrNovo an exclusive, license (with the right to sublicense) for the development, use, manufacturing and commercialization of products using certain patents and know-how owned by Yissum and patent applications filed by Yissum in connection with unique inhibitors of the IGF-1R Pathway (the “Yissum License Agreement”). Under the terms of the Yissum License Agreement, Yissum shall retain the ownership of the Licensed Technology (as such term is defined therein). All rights in the results of the activities carried out by TyrNovo or third parties in the development of these products (and certain results obtained under material transfer agreements signed by TyrNovo and Yissum (the “TyrNovo MTAs”)) shall be solely owned by TyrNovo (unless an employee of the Hebrew University of Jerusalem or each of its branches is an inventor of any of the patents claiming such results, in which case they shall be owned jointly by Yissum and TyrNovo). TyrNovo has the right to grant sub-licenses to third parties in accordance with the terms set forth in the Yissum License Agreement. TyrNovo has agreed to compensate Yissum for past patent expenses in a certain amount by no later than December 31, 2018. Yissum controls the prosecution, maintenance and enforcement of all the licensed patent rights. TyrNovo has the first right but not the obligation to take action against an infringement of a licensed patent right, if TyrNovo does not do so, Yissum may undertake such action at its own expense. TyrNovo has agreed to pay Yissum a percentage of “net sales” as royalties and to pay Yissum a percentage of the income that it receives from granting sub-licenses to third parties. Additionally, in the event of an M&A prior to an IPO, TyrNovo will be required to pay Yissum a percentage of the proceeds received under such M&A. In the event of an IPO, then prior to the closing of such IPO. TyrNovo shall issue to Yissum such number of ordinary shares equal to a certain percentage of all TyrNovo shares. 56 TyrNovo is required to indemnify Yissum, the Hebrew University of Jerusalem, their directors, employees, their executive officers, consultants or representatives and any other persons acting on their behalf under the license against any liability, including product liability, damages, losses, expenses, fees and reasonable legal expenses arising out of the TyrNovo’s actions or omissions or which derive from its use, development, manufacture, marketing, sale or sublicensing of any licensed product, licensed technology, and certain information obtained under the TyrNovo MTAs, or exercise of the Yissum License Agreement, and the TyrNovo MTAs. TyrNovo has agreed to maintain, and to add Yissum as an additional insured party with respect to, clinical trials, comprehensive general liability and product liability insurance as well as an insurance policy with respect to the foregoing indemnification prior to the time when it commences clinical trials and concludes its first commercial sale. The term of the Yissum License Agreement shall expire upon the later of (i) the date of expiration in such country of the last to expire licensed patent included in the licensed technology; or (ii) the end of a period of 15 year of the first commercial sale in such country, while the license granted under the Yissum License Agreement will terminate upon the later of (unless the license has been earlier terminated or expired) (i) the date of expiration in such country of the last to expire licensed patent included in the licensed technology; (ii) the date of expiration of any exclusivity on the product granted by a regulatory or government body in such country; or (iii) the end of a period of 15 year of the first commercial sale in such country. TyrNovo has the right to terminate the Yissum License Agreement upon a prior written notice. Either party has the right to terminate the Yissum License Agreement if the other party is in material breach and has not cured such material breach within a certain amount of days as of the receipt of a written notice notifying it of such breach. Additionally, Yissum has the right to terminate the Yissum License Agreement immediately in the event that TyrNovo does not comply with its obligation (following a certain amount of months cure period) to use commercially reasonable efforts to develop and commercialize the products; if an attachment is made over the majority of TyrNovo’s assets or if execution proceedings are taken against TyrNovo and are not set aside within a certain amount of days; or if TyrNovo challenges in any forum the validity of one or more of the licensed patents. Upon termination of the Yissum License Agreement, TyrNovo shall assign to Yissum all the results obtained during the development of the product. If Yissum licenses to third parties such results, then TyrNovo shall be entitled to a percentage of the net proceeds actually received by Yissum from such third parties, up to an amount covering TyrNovo’s expenses incurred during the development of such assigned results. Market exclusivity In the branded pharmaceutical industry, the majority of a branded drug’s commercial value is usually realized during the period in which the product has market exclusivity. In the U.S. and some other countries, when market exclusivity expires and generic versions of a product are approved and marketed, there can often be very substantial and rapid declines in the branded product’s sales. The rate of this decline varies by country and by therapeutic category, and the number of generic competitor entrants to the market, among other factors; however, following patent expiration, branded products often continue to have market viability based upon the goodwill of the product name, which typically benefits from trademark protection. A brand product’s market exclusivity is generally determined by two forms of intellectual property: patent rights held by the brand company and any regulatory forms of exclusivity to which the NDA-holder is entitled. Patents are a key determinant of market exclusivity for most branded pharmaceuticals. Patents provide the brand company with the right to exclude others from practicing an invention related to the medicine. Patents may cover, among other things, the active ingredient(s), various uses of a drug product, pharmaceutical formulations, drug delivery mechanisms and processes for (or intermediates useful in) the manufacture of products, and polymorphs. Protection for individual products extends for varying periods in accordance with the expiration dates of patents in the various countries. The protection afforded, which may also vary from country to country, depends upon the type of patent, its scope of coverage and the availability of meaningful legal remedies in the country. 57 Market exclusivity is also sometimes influenced by regulatory exclusivity rights. Many developed countries provide certain non-patent incentives for the development of medicines. For example, the U.S., the European Union and Japan each provide for a minimum period of time after the approval of a new drug during which the regulatory agency may not rely upon the data of the original party who developed the drug to approve a competitor’s generic copy. Regulatory exclusivity rights are also available in certain markets as incentives for research on new indications, on orphan drugs and on medicines useful in treating pediatric patients. Regulatory exclusivity rights are independent of any patent rights and can be particularly important when a drug lacks broad patent protection. Most regulatory forms of exclusivity, however, do not prevent a competitor from gaining regulatory approval prior to the expiration of regulatory data exclusivity on the basis of the competitor’s own safety and efficacy data on its drug, even when that drug is identical to that marketed by the innovator. It is not possible to predict the length of market exclusivity for any of our branded products with certainty because of the complex interaction between patent and regulatory forms of exclusivity, and inherent uncertainties concerning patent litigation. There can be no assurance that a particular product will enjoy market exclusivity for the full period of time that we currently estimate or that the exclusivity will be limited to the estimate. Government Regulations and Funding Pharmaceutical companies are subject to extensive regulation by foreign, federal, state and local agencies, such as the FDA in the U.S., the Ministry of Health in Israel, or the various European regulatory authorities. The manufacture, distribution, marketing and sale of pharmaceutical products are subject to government regulation in the U.S. and various foreign countries. Additionally, in the U.S., we must follow rules and regulations established by the FDA requiring the presentation of data indicating that our products are safe and efficacious and are manufactured in accordance with current good manufacturing practices cGMP regulations. If we do not comply with applicable requirements, we may be fined, the government may refuse to approve our marketing applications or allow us to manufacture or market our products, and we may be criminally prosecuted. We and our manufacturers and clinical research organizations may also be subject to regulations under other foreign, federal, state and local laws, including, but not limited to, the U.S. Occupational Safety and Health Act, the Resource Conservation and Recovery Act, the Clean Air Act and import, export and customs regulations as well as the laws and regulations of other countries. As a result, pharmaceutical companies must ensure their compliance with the Foreign Corrupt Practices Act and federal healthcare fraud and abuse laws, including the False Claims Act. These regulatory requirements impact our operations and differ from one country to another, so that securing the applicable regulatory approvals of one country does not imply the approval of another country. The approval procedures involve high costs and are manpower intensive, usually extend over many years and require highly skilled and professional resources. U.S. Food and Drug Administration Approval Process The steps usually required to be taken before a new drug may be marketed in the U.S. generally include: ● completion of pre-clinical laboratory and animal testing; ● completion of required chemistry, manufacturing and controls testing; ● the submission to the FDA of an IND, the application for which must be evaluated and found acceptable by the FDA before human clinical trials may commence; ● performance of (or reference to) adequate and well-controlled human clinical trials and studies to establish the safety, pharmacokinetics and efficacy of the proposed drug for its intended use; ● submission and approval of an NDA; and ● agreement with FDA of the language on the package insert. 58 Clinical studies are conducted under protocols detailing, among other things, the objectives of the study, what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the parameters to be used in monitoring safety, and the efficacy criteria to be evaluated. A protocol for each clinical study and any subsequent protocol amendments must be submitted to the FDA as part of the IND process. In all the countries that are signatories of the Helsinki Declaration (including Israel), the prerequisite for conducting clinical trials (on human subjects) is securing the preliminary approval of the competent authorities of that country to conduct medical experiments on human subjects in compliance with the other principles established by the Helsinki Declaration. The clinical testing of a drug product candidate generally is conducted in three sequential phases prior to approval, but the phases may overlap or be combined. A fourth, or post approval, phase may include additional clinical studies. The phases are generally as follows: ● Phase I. The Phase I clinical trial is generally conducted on 8-20 healthy volunteers. Phase I clinical trials typically involve administering escalating doses of the therapeutic candidate in the healthy volunteers to assess safety, dosage tolerance, absorption, metabolism, distribution and excretion. In the case of some products for severe or life-threatening diseases, especially when the product may be too inherently toxic to ethically administer to healthy volunteers, the initial human testing is often conducted in patients; ● Phase II. The Phase II clinical trial involves administering the therapeutic candidate to a small population of sick patients to identify possible adverse events, or safety risks, and preliminary indicia of efficacy for the targeted disease or condition; ● Phase III. The Phase III clinical trial usually comprises multi-center, double-blind controlled trials in hundreds or even thousands of subjects at various sites to assess as fully as possible both the safety and effectiveness of the drug. Specifically, the Phase III clinical trial is intended to make a comparison between the therapeutic candidate and the standard therapy and/or placebo. These trials are intended to establish the overall benefit/risk profile of the product and provide an adequate basis for product labeling; and ● Phase IV. In some cases, the FDA may condition approval of an NDA for a product candidate on the sponsor’s agreement to conduct additional clinical trials after approval. In other cases, a sponsor may voluntarily conduct additional clinical trials after approval to gain more information about the drug. Such post-approval studies are typically referred to as Phase IV clinical trials. Clinical trials must be conducted in accordance with the FDA’s good clinical practices, or GCP, requirements. The FDA may order the temporary or permanent discontinuation of a clinical study at any time or impose other sanctions if it believes that the clinical study is not being conducted in accordance with FDA requirements or that the participants are being exposed to an unacceptable health risk. An institutional review board, or IRB, generally must approve the clinical trial design and patient informed consent at study sites that the IRB oversees and also may halt a study, either temporarily or permanently, for failure to comply with the IRB’s requirements, or may impose other conditions. Additionally, some clinical studies, mostly in certain types of Phase III clinical trial studies where it is required under the applicable clinical trial protocol, are overseen by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board or committee. This group recommends whether or not a trial may move forward at designated check points based on access to certain data from the study. The clinical study sponsor may also suspend or terminate a clinical trial based on evolving business objectives and/or competitive climate. As a therapeutic candidate matures through the clinical testing phases, manufacturing processes are further defined, refined, controlled, and eventually validated around the time that the Phase III clinical trial is completed. The level of control and validation required by the FDA increases as clinical studies progress. We and the third-party manufacturers on which we rely for the manufacture of our therapeutic candidates and their respective components (including the APIs) are subject to requirements that drugs be manufactured, packaged and labeled in conformity with cGMP. To comply with cGMP requirements, manufacturers must continue to spend time, money and effort to meet requirements relating to personnel, facilities, equipment, production and process, labeling and packaging, quality control, recordkeeping and other requirements. 59 Assuming completion of all required testing in accordance with all applicable regulatory requirements, detailed information on the product candidate is submitted to the FDA in the form of an NDA, requesting approval to market the product for one or more indications, together with payment of a user fee, unless waived. An NDA includes all relevant data available from pertinent nonclinical and clinical studies, including negative or ambiguous results as well as positive findings, together with detailed information on the chemistry, manufacture, controls and proposed labeling, among other things. To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the product candidate for its intended use to the satisfaction of the FDA. If an NDA submission is accepted for filing, the FDA begins an in-depth review of the NDA. Under the Prescription Drug User Fee Act, or PDUFA, the FDA’s goal is to complete its initial review and respond to the applicant within ten months of submission, unless the application relates to an unmet medical need, or is for a serious or life-threatening indication, in which case the goal may be within six months of NDA submission. However, PDUFA goal dates are not legal mandates and the FDA response often occurs several months beyond the original PDUFA goal date. Further, the review process and the target response date under PDUFA may be extended if the FDA requests or the NDA sponsor otherwise provides additional information or clarification regarding information already provided in the NDA. The NDA review process can, accordingly, be very lengthy. During its review of an NDA, the FDA may refer the application to an advisory committee for review, evaluation and recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it typically follows such recommendations. Data from clinical studies are not always conclusive and the FDA and/or any advisory committee it appoints may interpret data differently than the applicant. After the FDA evaluates the NDA and performs a pre-approval inspection, or “PAI”, on manufacturing facilities where the drug product and/or its API will be produced, the FDA will either approve commercial marketing of the therapeutic candidate with prescribing information for specific indications or issue a complete response letter indicating that the application is not ready for approval and stating the conditions that must be met in order to secure approval of the NDA. If the complete response letter requires additional data and the applicant subsequently submits that data, the FDA nevertheless may ultimately decide that the NDA does not satisfy its criteria for approval. The FDA could also approve the NDA with a Risk Evaluation and Mitigation Strategies, or REMS, plan to mitigate risks, which could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on, among other things, changes to proposed labeling, development of adequate controls and specifications, or a commitment to conduct post-marketing testing. Such post-marketing testing may include Phase IV clinical trials and surveillance to further assess and monitor the product’s safety and efficacy after approval. Regulatory approval of drug product candidates for serious or life-threatening indications may require that participants in clinical studies be followed for long periods to determine the overall survival benefit of the drug product candidate. If the FDA approves one of our therapeutic candidates, we will be required to comply with a number of post-approval regulatory requirements. We would be required to report, among other things, certain adverse reactions and production problems to the FDA, provide updated safety and efficacy information and comply with requirements concerning advertising and promotional labeling for any of our therapeutic candidates. Also, quality control and manufacturing procedures must conform to cGMP for approved drug products after our NDA is approved, if at all, and the FDA periodically inspects manufacturing facilities to assess compliance with cGMP, which imposes extensive procedural, substantive and record keeping requirements. If we seek to make certain changes to an approved product, such as certain manufacturing changes, we will need FDA review and approval before the change can be implemented. For example, if we change the manufacturer of a product or our API, the FDA may require stability or other data from the new manufacturer, and such data will take time and are costly to generate, and the delay associated with generating these data may cause interruptions in our ability to meet commercial demand, if any. While physicians may use products for indications that have not been approved by the FDA, we may not label or promote the product for an indication that has not been approved. Securing FDA approval for new indications is similar to the process for approval of the original indication and requires, among other things, submitting data from adequate and well-controlled studies that demonstrate the product’s safety and efficacy in the new indication. Even if such studies are conducted, the FDA may not approve any change in a timely fashion, or at all. 60 Section 505(b)(2) New Drug Applications We intend to submit applications for KIT-302 and any other therapeutic candidates that comprise APIs of one or more previously approved drug products that we may develop in the future via the 505(b)(2) regulatory pathway. A drug sponsor may file a 505(b)(2) NDA, instead of a “stand-alone” or “full” NDA: a 505(b)(1) NDA. Section 505(b)(2) of the Food, Drug, and Cosmetic Act, or FDC, was enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984, otherwise known as the Hatch-Waxman Amendments. Section 505(b)(2) permits the submission of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. Since the studies or clinical trials have already been successfully performed and reviewed by the FDA, the 505(b)(2) NDA can expedite the approval process. Generally, the application is typically used for drug approval to treat new indications of a previously approved drug or new formulations of previously-approved products. Some examples of products that may be allowed to follow a 505(b)(2) path to approval are drugs that have a new dosage form, strength, route of administration, formulation or indication. The Hatch-Waxman Amendments permit the applicant to rely upon certain published nonclinical or clinical studies conducted for an approved product or the FDA’s conclusions from prior review of such studies. The FDA may require companies to perform additional studies or measurements to support any changes from the approved product. The FDA may then approve the new product for all or some of the labeled indications for which the reference product has been approved, as well as for any new indication supported by the Section 505(b)(2) application. While references to nonclinical and clinical data not generated by the applicant or for which the applicant does not have a right of reference are allowed, all development, process, stability, qualification and validation data related to the manufacturing and quality of the new product must be included in an NDA submitted under Section 505(b)(2). To the extent that the Section 505(b)(2) applicant is relying on the FDA’s conclusions regarding studies conducted for an already approved product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. Specifically, the applicant must certify that: (i) the required patent information has not been filed; (ii) the listed patent has expired; (iii) the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or (iv) the listed patent is invalid or will not be infringed by the new product. The Section 505(b)(2) application also will not be approved until any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the reference product has expired. Thus, the Section 505(b) (2) applicant may invest a significant amount of time and expense in the development of its products only to be subject to significant delay and patent litigation before its products may be commercialized. Section 505(b)(1) New Drug Applications A Section 505(b)(1) NDA, known as the “full NDA,” is an application that contains full reports of investigations of safety and efficacy performed by the drug sponsor. NT219 is not a combination therapeutic candidate or a therapeutic candidate that is comprised of an API that has already undergone some or all necessary human clinical trials in another therapeutic candidate. Therefore, if NT219 is approved for human clinical trials by the FDA or any foreign regulatory agency, and shows adequate safety and efficacy data in human clinical trials, we anticipate that NT219 will require a 505(b)(1) NDA. Special Protocol Assessment The special protocol assessment, or SPA, process is designed to facilitate the FDA’s review and approval of drugs by allowing the FDA to evaluate the proposed design and size of Phase III clinical trials that are intended to form the primary basis for determining a drug product’s efficacy. Upon specific request by a clinical trial sponsor, the FDA will evaluate the protocol and respond to a sponsor’s questions regarding, among other things, primary efficacy endpoints, trial design and data analysis plans, within 45 days of receipt of the request. 61 The FDA ultimately assesses whether the protocol design and planned analysis of the trial are acceptable to support regulatory approval of the therapeutic candidate with respect to effectiveness of the indication studied. All agreements and disagreements between the FDA and the sponsor regarding an SPA must be clearly documented in an SPA letter or the minutes of a meeting between the sponsor and the FDA. Even if the FDA agrees to the design, execution and analyses proposed in protocols reviewed under the SPA process, the FDA may revoke or alter its agreement, such as under the following circumstances: ● public health concerns emerge that were unrecognized at the time of the protocol assessment, or the director of the review division determines that a substantial scientific issue essential to determining safety or efficacy has been identified after testing has begun; ● a sponsor fails to follow a protocol that was agreed upon with the FDA; or ● the relevant data, assumptions or information provided by the sponsor in a request for SPA change, are found to be false statements or misstatements, or are found to omit relevant facts. In addition, a documented SPA may be modified, and such modification will be deemed binding on the FDA review division, except under the circumstances described above, if the FDA and the sponsor agree in writing to modify the protocol and such modification is intended to improve the study. We have obtained an SPA with the FDA for our Phase III clinical trial protocol for KIT-302. FDA Guidelines on Anti-Hypertensive Drugs In March 2011, the FDA published a new draft guideline stating that drugs designed to be anti-hypertensive may include in the usage indication section of the package insert a statement that “Reduced blood pressure decreases the risk of suffering fatal and non-fatal cardiovascular events, mainly stroke and myocardial infarction”. We do not intend to prove through the Company’s clinical trials that the KIT-302 therapeutic candidate reduces the risk of suffering from the aforesaid diseases. Nevertheless, we expect that the said draft guideline will have a positive effect on the KIT-302 combination therapeutic candidate we are currently developing because the combination therapeutic candidate we are developing is intended to prevent hypertension. The FDA has informed us in writing that the package insert of the KIT-302 combination drug product may contain the statement provided in the draft guideline. European Regulatory Authorities In the event that we wish to perform trials in Europe or market or sell our KIT302 therapeutic candidate in Europe, we must apply to an applicable country’s regulatory authorities with a request to approve our therapeutic candidates according to the Mutual Recognition Procedure (MRP), which is a procedure applied by European Directive No. 2001/83/EC that enables access to medicinal products (drugs) in 27 countries of the European Union. The MRP approval process requires the applicant to receive approval in one of the EU countries and then apply for recognition of the other member countries to acknowledge the approval within their territory. It is not currently known whether the European regulatory authorities will require additional studies in order to grant their approval to market KIT-302 in Europe. Other therapeutic candidates, such as NT219, may be approved through either the MRP or through the Centralized Process in which a single application provides approval for all EU member states. The Israeli Ministry of Health Our operations are subject to permits from the Israeli Ministry of Health on two levels: First, pertaining to the import of drugs and/or raw materials, we are required to apply to the Ministry of Health for approval from its medical accessories and devices unit (AMR). 62 Second, pertaining to research and development, when we conduct trials in human, the trials will be subject to the approval of the Helsinki Committee, which acts by force of the Public Health Regulations (Trials in Human Beings), 1980 (Trials in Human Subjects Regulations) and according to the guidelines of the Helsinki declaration, or any other approval required by the Ministry of Health. According to the Trials in Human Beings Regulations, the Helsinki Committee must plan and approve every experimental process that involves human beings. The Helsinki Committee is an institutional committee that acts in the medical institution where the trial is performed and is the party that approves and supervises the entire trial process. In practice, the physician, who is the chief researcher, submits a trial protocol to the committee on behalf of the requesting party. The committee forwards its decisions regarding the requests for medical trials that were approved by the committee to the manager of the medical institute and the manager has the authority to approve the requests without additional approval of the Ministry of Health. According to the procedure for medical trials in human beings of the Ministry of Health, the Helsinki Committee will not approve performance of a medical trial, unless it is absolutely convinced that the following conditions, among others, are fulfilled: (a) the expected benefits for the participant in the medical trial and to the requesting party to Left the risk and the inconvenience involved in the medical trial to its participant; (b) the available medical and scientific information justifies the performance to the requested medical trial; (c) the medical trial is planned in a scientific manner that enables a solution to the tested question and is described in a clear, detailed and precise manner in the protocol of the medical trial, conforming with the Helsinki principles declaration; (d) the risk to the participant in the medical trial is as minimal as possible; (e) optimal monitoring and follow-up of the participant in the medical trial; (f) the initiator, the chief researcher and the medical institute are capable and undertake to allocate the resources required for adequate execution of the medical trial, including qualified personnel and required equipment; and (g) the nature of the commercial agreement with the chief researcher and the medical institute does not impair the adequate performance of the medical trial. All phases of clinical studies conducted in Israel must be conducted in accordance with the Trials in Human Subjects Regulations, including amendments and addenda thereto, the Guidelines for Clinical Trials in Human Subjects issued by the Israel Ministry of Health (the Guidelines) and the International Conference for Harmonized Tripartite Guideline for Good Clinical Practice. The regulations and the Guidelines stipulate that a medical study on humans will only be approved after the Helsinki Committee at the hospital intending to perform the study has approved the medical study and notified the relevant hospital director in writing. In addition, certain clinical studies require the approval of the Ministry of Health. The Helsinki Committee will not approve the performance of the medical study unless it is satisfied that it has advantages to the study participants and society at large that Left the risk and inconvenience for the participants and that the medical and scientific information justifies the performance of the requested medical study. The relevant hospital director, and the Ministry of Health, if applicable, also must be satisfied that the study is not contrary to the Helsinki Declaration or to other regulations. The Ministry of Health also licenses and regulates the marketing of pharmaceuticals in Israel, requiring the relevant pharmaceutical to meet internationally recognized cGMP standards. Pervasive and continuing regulation in the U.S. After a drug is approved for marketing and enters the marketplace, numerous regulatory requirements continue to apply. These include, but are not limited to: ● cGMP guidance for APIs and 21 CFR §§ 210, 211 regulations, both observed by the FDA, require manufacturers, including third party manufacturers, to follow stringent requirements for the methods, facilities and controls used in manufacturing, processing and packing of a drug product; ● labeling regulations and the FDA prohibitions against the promotion of drugs for unapproved uses (known as off-label uses), as well as requirements to provide adequate information on both risks and benefits during promotion of the drug; ● approval of product modifications or use of a drug for an indication other than approved in an NDA; ● adverse drug experience regulations, which require us to report information on adverse events during pre-market testing; ● post-market testing and surveillance requirements, including Phase IV trials, when necessary to protect the public health or to provide additional safety and effectiveness data for the drug; and ● the FDA’s recall authority, whereby it can ask, or under certain conditions order, drug manufacturers to recall from the market a product that is in violation of governing laws and regulation. After a drug receives approval, any modification in conditions of use, active ingredient(s), route of administration, dosage form, strength or bioavailability, will require a new approval, for which it may be possible to submit a 505(b)(2), accompanied by additional clinical data necessary to demonstrate the safety and effectiveness of the product with the proposed changes. Additional clinical studies may be required for proposed changes. 63 Other U.S. Healthcare Laws and Compliance Requirements For products distributed in the United States, we will also be subject to additional healthcare regulation and enforcement by the federal government and the states in which we conduct our business. Applicable federal and state healthcare laws and regulations include the following: ● The federal healthcare anti-kickback statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving, or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order, or recommendation of, any good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid; ● The Ethics in Patient Referrals Act, commonly referred to as the Stark Law, and its corresponding regulations, prohibit physicians from referring patients for designated health services (including outpatient drugs) reimbursed under the Medicare or Medicaid programs to entities with which the physicians or their immediate family members have a financial relationship or an ownership interest, subject to narrow regulatory exceptions, and prohibits those entities from submitting claims to Medicare or Medicaid for payment of items or services provided to a referred beneficiary; ● The federal False Claims Act imposes criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government claims for payment that are false or fraudulent or making a false statement to avoid, decrease, or conceal an obligation to pay money to the federal government; ● The so-called federal “Sunshine Act”, which requires certain pharmaceutical and medical device companies to monitor and report certain financial relationships with physicians and other healthcare providers to CMS for disclosure to the public; ● Health Insurance Portability and Accountability Act of 1996, imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program and also imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information. This statute also prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items, or services; and ● Analogous state laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, and some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government. 64 Reimbursement Sales of our therapeutic candidates in the United States may depend, in part, on the extent to which the costs of the therapeutic candidates will be covered by third-party payers, such as government health programs, commercial insurance and managed health care organizations. These third-party payers are increasingly challenging the prices charged for medical products and services. Additionally, the containment of health care costs has become a priority of federal and state governments, and the prices of drugs have been a focus in this effort. The United States government, state legislatures and foreign governments have shown significant interest in implementing cost-containment programs, including price controls, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our net revenue and results. If these third-party payers do not consider our therapeutic candidates to be cost-effective compared to other available therapies, they may not cover our therapeutic candidates after approval as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell our therapeutic candidates on a profitable basis. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003, (the MMA), imposed new requirements for the distribution and pricing of prescription drugs for Medicare beneficiaries and included a major expansion of the prescription drug benefit under Medicare Part D. Under Part D, Medicare beneficiaries may enroll in prescription drug plans offered by private entities which will provide coverage of outpatient prescription drugs. Part D plans include both stand-alone prescription drug benefit plans and prescription drug coverage as a supplement to Medicare Advantage plans. Unlike Medicare Parts A and B, Part D coverage is not standardized. Part D prescription drug plan sponsors are not required to pay for all covered Part D drugs, and each drug plan can develop its own drug formulary that identifies which drugs it will cover and at what tier or level. However, Part D prescription drug formularies must include drugs within each therapeutic category and class of covered Part D drugs, though not necessarily all the drugs in each category or class. Any formulary used by a Part D prescription drug plan must be developed and reviewed by a pharmacy and therapeutic committee. Government payment for some of the costs of prescription drugs may increase demand for therapeutic candidates for which we receive marketing approval. However, any negotiated prices for our therapeutic candidates covered by a Part D prescription drug plan will likely be lower than the prices we might otherwise obtain. Moreover, while the MMA applies only to drug benefits for Medicare beneficiaries, private payers often follow Medicare coverage policy and payment limitations in setting their own payment rates. Any reduction in payment that results from the MMA may result in a similar reduction in payments from non-governmental payers. On February 17, 2009, President Obama signed into law the American Recovery and Reinvestment Act of 2009. This law provides funding for the federal government to compare the effectiveness of different treatments for the same illness. A plan for the research will be developed by the Department of Health and Human Services, the Agency for Healthcare Research and Quality and the National Institutes of Health, and periodic reports on the status of the research and related expenditures will be made to Congress. Although the results of the comparative effectiveness studies are not intended to mandate coverage policies for public or private payers, it is not clear how such a result could be avoided and what if any effect the research will have on the sales of our therapeutic candidates, if any such therapeutic candidates or the condition that it is intended to treat is the subject of a study. It is also possible that comparative effectiveness research demonstrating benefits in a competitor’s product could adversely affect the sales of our therapeutic candidates. Decreases in third-party reimbursement for our therapeutic candidates or a decision by a third-party payer to not cover our therapeutic candidates could reduce physician usage of the therapeutic candidates and have a material adverse effect on our sales, results of operations and financial condition. The Patient Protection and Affordable Care Act On March 23, 2010, President Obama signed into legislation the Patient Protection and Affordable Care Act, which was subsequently amended by the Healthcare and Education Reconciliation Act (as amended, the Affordable Care Act). The Affordable Care Act resulted in sweeping changes across the health care industry. The primary goal of this comprehensive legislation was to extend health insurance coverage to currently uninsured legal U.S. residents through a combination of public program expansion and private sector health insurance reforms. To fund the expansion of insurance coverage, the Affordable Care Act contains measures designed to promote quality and cost efficiency in health care delivery and to generate budgetary savings in the Medicare and Medicaid programs. The Affordable Care Act’s provisions are designed to encourage providers to find cost savings in their clinical operations. Pharmaceuticals represent a significant portion of the cost of providing care. Through modified reimbursement rates and other incentives, the U.S. government is requiring that providers identify the most cost-effective services, supplies and pharmaceuticals. This environment has caused changes in the purchasing habits of providers and resulted in specific attention to the pricing negotiation, product selection and utilization review surrounding pharmaceuticals. This attention may result in our therapeutic candidates being chosen less frequently or the pricing being substantially lowered. Additionally, the Affordable Care Act is expected to expand and increase industry rebates for drugs covered under Medicaid programs and make changes to the coverage requirements under the Medicare Part D program. We cannot predict the impact of the Affordable Care Act on pharmaceutical companies as many of the Affordable Care Act reforms require the promulgation of detailed regulations implementing the statutory provisions which has not yet occurred. The legislation also includes significant provisions that encourage state and federal law enforcement agencies to increase activities related to preventing, detecting and prosecuting those who commit fraud, waste and abuse in federal healthcare programs, including Medicare, Medicaid and Tricare. Since the enactment of the Affordable Care Act, numerous regulations have been issued providing further guidance on its requirements. Some of the provisions of the Affordable Care Act have not yet been fully implemented, and certain provisions have been subject to judicial and Congressional challenges. The healthcare regulatory environment in the United States is still in flux, and judicial challenges and legislative initiatives to modify, limit, or repeal the Affordable Care Act continue and may increase in light of the change in administrations following the most recent United States Presidential election. Several states have decided not to expand their Medicaid programs and are seeking alternative reimbursement models to provide care to the uninsured. The manner in which these issues are resolved could materially affect the extent to which and the amount at which pharmaceuticals are reimbursed by government programs such as Medicare, Medicaid and Tricare. 65 Grants from the National Authority for Technological Innovation, or the Innovation Authority (formerly known as the Office of the Chief Scientist or the OCS). Under the Encouragement of Research, Development and Technological Innovation in the Industry Law 1984, or the Innovation Law, formerly known as The Law for the Encouragement of Industrial Research and Development, 1984, or the R&D Law, a qualifying research and development program is eligible for grants of up to 50% of the program’s research and development expenses. The recipient of the grants is required to return the grants by the payment of royalties on the revenues generated from the sale of products (and related services) developed (in all or in part) according to, or as a result of, a research and development program funded by the OCS (at rates which are determined under the Innovation Law up to the aggregate amount of the total grants received by the OCS, plus annual interest (as determined in the Innovation Law). Following the full payment of such royalties and interest, there is generally no further liability for royalty payment. Nonetheless, the restrictions under the Innovation Law (as generally specified below) will continue to apply even after repayment of the full amount of royalties payable pursuant to the grants. The pertinent obligations under the Innovation Law are as follows: ● Local Manufacturing Obligation. The terms of the grants under the Innovation Law require that a company which received OCS grants, must manufacture the products developed these grants in Israel. In general, the products may be manufactured outside Israel only if prior approval is received from the OCS and subject to payment of increased royalties cap of up to 300% of the grants, depending on the manufacturing volume that is performed outside Israel. ● Certain reporting obligations. A recipient of OCS grant is required to notify the Innovation Authority of certain events enumerated in the Innovation Law. ● Know-How transfer limitation. The Innovation Law restricts the ability to transfer know-how funded by the OCS (including by a way of license for R&D purposes) outside of Israel. Transfer of OCS funded know-how outside of Israel requires prior OCS approval and in certain circumstances is subject to payment of a redemption fee to the OCS calculated according to formulae provided under the Innovation Law (which such fee will not exceed 600% of the grants amount plus interest). Upon payment of such fee, the know-how and the manufacturing rights of the products supported by such OCS funding cease to be subject to the Innovation Law. Approval of the transfer of OCS funded know-how to another Israeli company may be granted only if the recipient abides by all the provisions of the law and related regulations, including the restrictions on the transfer of know-how and manufacturing rights outside of Israel (such transfer will include an obligation to pay royalties to the OCS from the income of such sale transaction as part of the royalty payment obligation). Approval to manufacture products outside of Israel or consent to the transfer OCS funded know-how, if requested, might not be granted or may be granted on terms that are not acceptable to us. 66 These restrictions may impair our ability to enter into agreements to perform or outsource manufacturing outside of Israel, or otherwise transfer or sell TyrNovo’s OCS funded know-how outside of Israel without the approval of the OCS. Furthermore, in the event that we, through TyrNovo, undertake a transaction involving the transfer to a non-Israeli entity of know-how developed with OCS funding pursuant to a merger or similar transaction, the consideration available to TyrNovo’s and/or our shareholders may be reduced by the amounts it is required to pay to the OCS. Any approval, if given, will generally be subject to additional financial obligations. Failure to comply with the requirements under the Innovation Law may subject TyrNovo to mandatory repayment of grants received by it (together with interest and penalties), as well as may expose TyrNovo to criminal proceedings. In addition, the Government of Israel may from time to time audit sales of products which it claims incorporate technology funded via OCS programs and this may lead to additional royalties being payable on additional products, and may subject such products to the restrictions and obligations specified hereunder. To date, TyrNovo’s technology has received grants from the OCS in a total amount of approximately NIS5.5 million. Up until the date of this Annual Report on Form 20-F, no royalties have paid in respect to the grants received by the OCS. There is no guarantee that TyrNovo will receive any further grants from the OCS or that the grants will be in the scope received in the past. On July 29, 2015, the R&D Law was amended (“Amendment No. 7”) ushering in the formation of the Innovation Authority. The Innovation Authority is authorized to change the current restrictions imposed on recipients of grants under the R&D Law with a new set of arrangements in connection with ownership obligations of know-how (including with respect to restrictions on transfer of know-how and manufacturing activities outside of Israel), as well as royalties obligations associated with approved programs. As of the date of this annual report on Form 20-F, we are unable to determine whether the Innovation Authority will promulgate new set of arrangements or adopt the arrangements which were stipulated under the R&D Law as existed prior to the amendment. Therefore, as of the date of this annual report on Form 20-F, we are unable as assess the effect, if any, of the promulgation of such arrangements on us and/or our subsidiary. It should be noted that the OCS is in the process of promulgating rules which deals with granting of licenses to use, especially for R&D purposes, know-how developed as a result of research financed by the OCS. Such rules may have an effect on TyrNovo, in respect of the amount of payments due to the Israeli government for the grant of licenses to third parties by TyrNovo. As of the date of filing of this report, we are unable to assess the effect, if any, of the promulgation of such rules on us and/or TyrNovo. C. Organizational Structure Our corporate structure consists of Kitov Pharmaceuticals Holdings Ltd., incorporated in the State of Israel, and (i) Kitov Parent’s wholly owned operating subsidiary, Kitov Pharmaceuticals Ltd., an Israeli limited corporation which was founded in June 2010 and (ii) Kitov Parent’s majority owned subsidiary TyrNovo Ltd. which it acquired in January 2017. On April 25, 2017, the boards of directors of each of Kitov Parent and Kitov Pharmaceuticals approved a merger between the two entities, with Kitov Parent remaining as the surviving entity. The respective boards of directors each determined (i) that this merger is in the best interests of the companies and their respective shareholders, (ii) that considering the financial position of the companies, no reasonable concern exists that Kitov Parent, as the absorbing and surviving company, will be unable to fulfill its obligations to its creditors, and (iii) taking into account the abovementioned, as well as the corporate management and economic benefits to the two companies resulting from completing the merger, they approved the merger. In accordance with the Companies Law, the proposed merger between Kitov Parent and Kitov Pharmaceuticals will not require shareholder approvals. The boards of directors are jointly preparing a merger proposal for submission to the Israeli Registrar of Companies. Creditor notices are being prepared as provided by the regulations promulgated under the Companies Law. Upon the request of a creditor of either entity to the proposed merger, the court may delay or prevent the merger if it concludes that there exists a reasonable concern that, as a result of the merger, the surviving company will be unable to satisfy the obligations of the target company. The court may also give instructions in order to secure the rights of creditors. In addition, the proposed merger may not be completed unless at least 50 days have passed from the date that a proposal for approval of the merger was filed with the Israeli Registrar of Companies and 30 days from April 25. 2017. We expect the merger will be completed prior to the end of the second quarter of 2017. 67 D. Property, Plant and Equipment All of our facilities are leased, and we do not own any real property. Our principal executive offices are located in the Round Tower in the Azrieli Center, Tel-Aviv, Israel. The space is in a commercial office building and has approximately 100 square meters pursuant to a 60-month lease which commenced on January 1, 2015. In addition, we sub-lease a 20 square meter office space at 11 Beit Hadfus Street, Jerusalem, Israel pursuant to a sub-lease agreement entered into on July 16, 2014 with a third party which terminates on July 31, 2017. We have no material tangible fixed assets apart from the properties described above. We believe our facilities are adequate and suitable for our current needs. ITEM 4A. UNRESOLVED STAFF COMMENTS Not applicable. ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS You should read the following discussion of our financial condition and results of operations in conjunction with the financial statements and the notes thereto included elsewhere in this Annual Report on Form 20-F. The following discussion contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Annual Report on Form 20-F, particularly those in “Item 3. Key Information – D. Risk Factors.” See also ”Special Note Regarding Forward-Looking Statements.” We are a biopharmaceutical company currently focused on the development of (i) KIT-302, a combination drug for the simultaneous treatment of two clinical conditions: pain caused by osteoarthritis and hypertension (high blood pressure), which can be pre-existing or caused by the treatment for osteoarthritis, and (ii) NT219, a small molecule that we believe presents a new concept in cancer therapy by promoting the degradation of two oncology- related checkpoints KIT-302 is based on the generic drugs celecoxib and amlodipine besylate. Celecoxib is the active ingredient of a known and approved-for-use drug designed primarily to relieve pain caused by osteoarthritis. Celecoxib is the active ingredient in the branded drug “Celebrex®”. This combination is designed to simultaneously relieve pain caused by osteoarthritis and treat hypertension, which is one of the side effects of using non-steroidal anti-inflammatory drugs, or NSAIDs, for treating pain caused by osteoarthritis. In January 2017, Kitov Parent acquired a majority of the shares in TyrNovo, a privately held Israeli developer of novel small molecules in the oncology therapeutic field. TyrNovo’s NT219 therapeutic candidate works by overcoming tumors’ cancer drug resistance and would be developed as a drug to be used in combination with other cancer drugs or treatments. The NT219 technology has been tested in a number of PDX models where human cancer cells are taken and transplanted into mice and then used to test various cancer drugs. NT219 has been tested against various classes of cancer drugs that have been recently developed as well as older standard chemotherapy. In addition, we may consider the acquisition of therapeutic candidates or existing drug products, at various stages of development in various therapeutic areas. We currently have no binding agreements or commitments to complete any transaction for the possible acquisition of new therapeutic candidates. There is no certainty that we will be able to complete any additional transactions for the possible acquisition of new therapeutic candidates. We may not be able to identify suitable acquisition candidates, complete acquisitions or integrate acquisitions successfully. In this regard, acquisitions involve numerous risks, including difficulties in the integration of the acquired therapeutic candidates and the diversion of management’s attention from other business concerns. Although we will endeavor to evaluate the risks inherent in any particular transaction, there can be no assurance that we will properly ascertain all such risks. In addition, acquisitions could result in the incurrence of substantial additional indebtedness and other expenses or in potentially dilutive issuances of equity securities. There can be no assurance that difficulties encountered with acquisitions will not have a material adverse effect on our business, financial condition and results of operations. 68 We intend to seek FDA approval for the commercialization of our therapeutic candidates, and where applicable through the Section 505(b)(2) regulatory path under the Federal Food, Drug, and Cosmetic Act of 1938, as amended. Where applicable, we also intend to seek corresponding regulatory paths for approval in other foreign jurisdictions. Our current pipeline consists of two clinical development therapeutic candidates: (i) KIT-302, which has recently successfully completed its Phase III clinical trial and which will be subject to review and approval by the FDA and (ii) NT219, which is in a preclinical stage. Upon and subject to receipt of the requisite approvals, we intend to commercialize our therapeutic candidates through licensing and other commercialization arrangements with pharmaceutical companies on a global and/or territorial basis. We may also evaluate, on a case by case basis, co- development and similar arrangements, as well as independent commercialization of our therapeutic candidates. On July 11, 2013, Kitov Parent (then known as Mainrom Line Logistics Ltd.) acquired issued and outstanding shares of Kitov Pharmaceuticals, in exchange for the issuance by Kitov Parent to Kitov Pharmaceuticals’ shareholders of ordinary shares constituting, immediately following such issuance, approximately 63.75% of the fully diluted share capital of Kitov Parent (subject to an issuance of additional ordinary shares of Kitov Parent to Kitov Pharmaceuticals’ shareholders following the attainment of a milestone in connection with our Phase III clinical trial for KIT-302, which issuance of additional shares was completed on December 24, 2015). See “Item 7. Major Shareholders and Related Party Transactions – B. Related Party Transactions – Share Transfer Agreement with Kitov Pharmaceuticals”. The acquisition was accounted for under IFRS as issued by the IASB, as a reverse merger, and therefore the consolidated financial statements of Kitov Parent presented in this Annual Report on Form 20-F include the financial results of Kitov Pharmaceuticals for the four years ended December 31, 2016, 2015, 2014, and 2013 and of Kitov Parent for the period from July 11, 2013 to December 31, 2016. On April 25, 2017, the boards of directors of each of Kitov Parent and Kitov Pharmaceuticals approved a merger between the two entities, with Kitov Parent remaining as the surviving entity. For more information on the proposed merger, see Item 4.C – Organizational Structure. History of Losses Since commencement of our pharmaceutical research and development operations, we have generated significant losses mainly in connection with the research and development of our therapeutic candidates. Such research and development activities are expected to expand over time and will require further resources if we are to be successful. As a result, we expect to continue incurring operating losses, which may be substantial over the next several years, and will need to obtain additional funds to further develop our research and development programs. As of December 31, 2016, we had an accumulated deficit of approximately $26.2 million. We plan to fund our future operations through commercialization and out-licensing of our therapeutic candidates and to raise additional capital in the future through either debt or equity financing. We believe our existing working capital will be sufficient to meet our present requirements through at least the next twelve months. Components of Statement of Operations Research and Development Expenses See “C. Research and Development, Patents and Licenses” below. General and Administrative Expenses General and administrative expenses consist primarily of compensation for directors, employees and consultants in executive and operational functions. Other significant general and administrative expenses include professional fees for outside accounting and legal services, travel costs and insurance premiums. 69 Other Expenses Other expenses represent payments made to Mr. Sheer Roichman as required by the Share Transfer Agreement. See “Item 7. Major Shareholders and Related Party Transactions – B. Related Party Transactions – Share Transfer Agreement with Kitov Pharmaceuticals”. Finance Income and Finance Expense Finance Expense comprises primarily changes in the fair value of financial liabilities as well as interest and fees in connection with loans from third parties and related parties. Finance Income comprises changes in the fair value of financial liabilities. Critical Accounting Policies and Estimates The preparation of financial statements in conformity with IFRS as issued by the IASB, requires companies to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. These estimates and judgments are subject to an inherent degree of uncertainty and actual results may differ. Our significant accounting policies are more fully described in Note 3 to our annual financial statements included elsewhere in this Annual Report on Form 20-F. Critical accounting estimates and judgments are evaluated and are based on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances, and are particularly important to the portrayal of our financial position and results of operations. Share-based compensation In accordance with IFRS 2 Share – based Payment, the grant of stock options to our employees for services rendered represents a supplementary benefit. Under IFRS 2 Share – based Payment, we estimate the fair value of these stock options at the grant date and record the value within shareholders’ equity. Fair value is determined using a standard option pricing model that takes into account the specific features of the stock option plan (net price, period of exercise, etc.), market data at the grant date (such as price, volatility, etc.) and behavioral assumptions relating to option holders. Different assumptions could result in material changes to the expense amounts recorded for these options. A. Operating Results Comparison of the Year Ended December 31, 2016 to the Year Ended December 31, 2015 Research and Development Expenses Research and development expenses for the year ended December 31, 2016 were $4.2 million, an increase of $1.6 million, or 63%, compared to $2.6 million for the year ended December 31, 2015. The increase resulted primarily from expenses for an additional PK study we conducted in 2016, expenses associated with the preparation of our New Drug Application for KIT-302, and expenses for our renal function clinical trial that commenced in 2016. General and Administrative Expenses General and administrative expenses for the year ended December 31, 2016 were $3.0 million, an increase of $1.5 million, or 99%, compared to $1.5 million for the year ended December 31, 2015. The increase resulted from an increase in salaries and related expenses, including the addition of our Vice- President of Business Development, and expenses related to Kitov Parent’s securities being listed on the NASDAQ since November 2015. Operating Loss Operating loss increased to $7.2 million during the year ended December 31, 2016 from $4.1 million during the year ended December 31, 2015 primarily due to the increases in Research and Development Expenses and General and Administrative Expenses, as described above. 70 Finance Income/Expense Finance income, net for the year ended December 31, 2016 was $77,000 and is primarily related to income from bank deposits, net of exchange rate differences. In addition, Kitov recorded a net expense of $ 5.0 million due to the net change in the fair value of derivatives. Finance expense, net for the year ended December 31, 2015 was $133,000 and was primarily related to exchange rate differences. Loss for the Period Kitov’s net loss before finance expenses due to fair value adjustments of derivative instruments (primarily Kitov Parent’s Series A Warrants traded on NASDAQ) for the year ended December 31, 2016 amounted to $7.2 million, compared with a loss of $4.1 million for the year ended December 31, 2015. In addition, a non-cash expense of $5.0 million was incurred due to the change in the fair value of derivative instruments. This change in fair value relates primarily to Kitov Parent’s Series A Warrants which included anti-dilution protection. The anti-dilution protection expired in November 2016. Comparison of the Year Ended December 31, 2015 to the Year Ended December 31, 2014 Research and Development Expenses Research and development expenses decreased to $2.560 million during the year ended December 31, 2015 from $3.192 million during the year ended December 31, 2014. This decrease was primarily due to the offset of amounts to be paid to us under the terms of our agreement with Dexcel. See “Item 10. Additional Information – C. Material Contracts – Development Services Agreement with Dexcel”. General and Administrative Expenses General and administrative expenses increased to $1.509 million during the year ended December 31, 2015 from $1.269 million during the year ended December 31, 2014. This increase was primarily due to rent expense incurred upon our move into new offices in January 2015 and additional travel expenses. Other Expenses During the year ended December 31, 2014, other expenses were NIS 2.5 million (approximately $720,000 based on the representative rate of exchange on the date of payment, March 12, 2014) due to the payment to Mr. Sheer Roichman as required by the Share Transfer Agreement. See “Item 7. Major Shareholders and Related Party Transactions – B. Related Party Transactions – Share Transfer Agreement with Kitov Pharmaceuticals”. During the year ended December 31, 2015 there were no other expenses. Operating Loss Operating loss decreased to $4.069 million during the year ended December 31, 2015 from $5.181 million during the year ended December 31, 2014 primarily due to the decrease in research and development expenses and the lack of other expenses described above. Finance Expense Net finance expense increased to $133,000 during the year ended December 31, 2015 from $71,000 during the year ended December 31, 2014 primarily resulting from a greater change in the fair value of financial liabilities associated with Kitov Parent’s series 2 warrants. 71 Loss for the Period Loss for the period decreased to $4.202 million during the year ended December 31, 2015 from $5.252 million during the year ended December 31, 2014 primarily due to the decrease in research and development expenses and the lack of other expenses described above. JOBS Act On April 5, 2012, the Jumpstart Our Business Startups Act, or the JOBS Act, was signed into law. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. This means that an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to utilize this exemption and, therefore, we will not be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. In addition, as a result of this election, our future financial statements may not be comparable to those of public companies that are not emerging growth companies and are required to comply with public company effective dates for new or revised accounting standards. Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we also elected or may elect to rely on other exemptions, including without limitation, not (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404 and (ii) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements (auditor discussion and analysis). These exemptions will apply until the earliest of (a) the last day of our fiscal year during which we have total annual gross revenues of at least $1.0 billion; (b) the last day of our fiscal year following the fifth anniversary of the closing of our initial public offering on NASDAQ on November 25, 2015; (c) the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt; or (d) the date on which we are deemed to be a “large accelerated filer” under the Exchange Act. B. Liquidity and Capital Resources Our therapeutic candidates are in the research and development stage and therefore do not generate revenues. Since commencement of our operations as a pharmaceutical research and development company, our activities have been financed by equity offerings and private loans. We have raised an aggregate of approximately NIS 4.1 million (approximately $1.137 million) from private loans (all of which have been repaid) and gross proceeds of approximately NIS 33.5 million (approximately $9.2 million based on the representative rates of exchange on the dates of the closings, March 3, 2014, September 3, 2014, and March 30, 2015) from our public offerings on the TASE, approximately $13.0 million from our initial public offering on NASDAQ in November 2015 (described below) and approximately $12.0 million for our follow-on public offering on NASDAQ in July 2016 (described below). The proceeds from the public offerings were used to repay the private loans and to fund our ongoing operations. As of December 31, 2016, we had on hand approximately $14.7 million in cash and cash equivalents, and in short term deposits. We believe that our current cash and cash equivalents are sufficient to complete the research and development of KIT-302 until its anticipated approval for marketing by the FDA in 2018 and to fund our planned research and development costs for NT219 until reaching the IND stage. Since we do not know when we will begin to generate significant revenues from our therapeutic candidates, if ever, should we decide to develop KIT-301 and any additional therapeutic candidates, we may need substantial additional funds to acquire, develop, and/or commercialize such therapeutic candidates. However, additional financing may not be available on acceptable terms, if at all. Our long term capital requirements will depend on many factors, including: ● the regulatory path of our therapeutic candidates; ● our ability to successfully commercialize our therapeutic candidates, including securing commercialization agreements with third parties and favorable pricing and market share; ● the progress, success and cost of our preclinical and/or clinical trials and research and development programs; ● the costs, timing and outcome of regulatory review and obtaining regulatory approval of our therapeutic candidates and addressing regulatory and other issues that may arise post-approval; ● the costs of obtaining and enforcing our issued patents and defending intellectual property-related claims; ● the costs of developing sales, marketing and distribution channels; and ● our consumption of available resources more rapidly than currently anticipated, resulting in the need for additional funding sooner than anticipated. 72 If we are unable to commercialize or out-license our therapeutic candidates or obtain future financing, we may be forced to delay, reduce the scope of, or eliminate one or more of our research and development programs related to the therapeutic candidates, which may have a material adverse effect on our business, financial condition and results of operations. Cash Flow Operating activities For the year ended December 31, 2016, net cash flow used in operating activities was approximately $6.3 million compared to approximately $3.3 million for the year ended December 31, 2015. The increase in net cash flow used in operating activities was due to increased Research and Development and General and Administrative expenses described above. The operating activities consisted of the conduct of PK studies for the combination drug, KIT-302, by Dexcel, expenses associated with the preparation of our New Drug Application for KIT-302, and expenses for our renal function clinical trial which commenced in 2016. We had no investment activities during the years ended December 31, 2016, 2015 and 2014, other than investment in short-term deposits. On January 13, 2017, we announced the acquisition of a majority ownership interest in TyrNovo from its majority shareholder, for consideration of $2 million in cash and $1.8 million worth of Kitov Parent’s ordinary shares based on the closing price of Kitov Parent’s ordinary shares on the TASE on January 11, 2017, or 11,292,508 ordinary shares. Financing activities For the year ended December 31, 2016, financing activities consisted of net proceeds from issuance of Class A units, each consisting of one ADS and a public warrant, and Class B units, each consisting of a pre-funded warrant, and a public warrant, on NASDAQ of approximately $12.0 million, compared to the issuance of ADSs and public warrants on NASDAQ of $10.6 million and the issuance of shares and TASE listed warrants on the TASE of $2.0 million, the repayment of loans received from related parties of $294,000, and the payment of interest of $145,000 for the year ended December 31, 2015. The proceeds from the share issuances in 2015 and 2016 were used to finance the activities related to the Phase III clinical trial for KIT-302 and the formulation of prototypes of KIT-302, as well as the acquisition of Kitov Parent’s controlling stake in TyrNovo in January 2017. As of December 31, 2016 Kitov Parent had no borrowings. As of December 31, 2016, and as of the date of this Annual Report on Form 20-F, we had no commitments for capital expenditures. C. Research and Development, Patents and Licenses Our research and development expenses consist primarily of costs of clinical trials, salaries, and consulting fees (including share-based payments), and fees paid to external service providers. We primarily use external service providers to manufacture our therapeutic candidates and to perform clinical trials with our therapeutic candidates. We charge all research and development expenses to operations as they are incurred. We expect our research and development expense to remain our primary expense in the near future as we continue to develop our therapeutic candidates. 73 From the commencement of the pharmaceutical research and development activities of Kitov Pharmaceuticals through December 31, 2016, Kitov has incurred research and development expenses of approximately $10.4 million. Set forth below is a summary of the research and development costs for the years ended December 31, 2016, 2015 and 2014. Virtually all of the costs were incurred in connection with the development of KIT-302. Total direct project costs 2016 Year Ended December 31 2015 2014 (U.S. dollars in thousands) Total 4,180 2,560 3,192 9,932 In addition to the major cost of clinical trials and CMC development, research and development expenses include consulting expenses for regulatory and project management work required for development of our therapeutic candidate portfolio. Set forth below is a summary of our research and development expenses based on the type of expenditure. Payroll expenses - related party Sub-contractors 2016 Year Ended December 31 2015 (U.S. dollars in thousands) 652 3,528 321 2,239 4,180 2,560 2014 128 3,064 3,192 In April 2014, Kitov entered into an agreement with Dexcel for the development of the drug formulation for KIT-302 and its manufacture in quantities sufficient to support the filing of an NDA with the FDA (see “Item 10. Additional Information– C. Material Contracts – Development Services Agreement with Dexcel”). We therefore began incurring costs in 2014 for the development of the drug formulation for KIT-302. Due to the inherently unpredictable nature of clinical development processes, we are unable to estimate with any certainty the costs we will incur in the continued development of our therapeutic candidates for potential commercialization. We estimate a total cost of approximately $1.3 million of research and development expenses related to the renal function clinical trial for KIT-302 and $2.8 million for pre-clinical trials related to TyrNovo’s NT219. While we are currently focused on advancing our therapeutic candidates including NT219, our future research and development expenses will depend on the success of the preclinical and clinical trials for each therapeutic candidate, as well as available resources and the ongoing assessments of each therapeutic candidate’s commercial potential. In addition, we cannot forecast with any degree of certainty which therapeutic candidates may be subject to future commercialization arrangements, when such commercialization arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements. See “Item 3. Key Information – D. Risk Factors – If we and/or our potential commercialization partners are unable to obtain FDA or other foreign regulatory authority approval for our therapeutic candidates, we and/or our potential commercialization partners will be unable to commercialize our therapeutic candidates.” As we obtain results from preclinical and/or clinical trials, we may elect to discontinue or delay development and preclinical and/or clinical trials for certain therapeutic candidates in order to focus our resources on more promising therapeutic candidates or projects. Completion of preclinical and/or clinical trials by us or our licensees may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of a therapeutic candidate. See “Item 3. Key Information – D. Risk Factors – Risks Related to Our Business and Regulatory Matters.” 74 We expect our research and development expenses to increase from current levels as we continue the advancement of our preclinical and/or clinical trials and therapeutic candidates’ development, including the development of NT219. The lengthy process of completing CMC and/or preclinical and/or clinical trials and seeking regulatory approvals for our therapeutic candidates requires substantial expenditures. Any failure or delay in completing preclinical and/or clinical trials, or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations. Due to the factors set forth above, we are not able to estimate with any certainty if and when we would recognize any net revenues from our therapeutic candidates. D. Trend Information We are a biopharmaceutical company which focuses its activities on the development of our therapeutic candidates. It is not possible for us to predict with any degree of accuracy the outcome of our research and development or commercialization efforts with regard to any of our therapeutic candidates. Our research and development expenditure is our primary expenditure, although we may incur substantial expenditure should we acquire any new therapeutic candidates. Increases or decreases in research and development expenditure are primarily attributable to the level and results of our CMC, preclinical and clinical trial activities and the amount of expenditure on those trials. E. Off-Balance Sheet Arrangements We are not party to any transactions, agreements or other contractual arrangements with unconsolidated entities whereby we have financial guarantees, subordinated retained interests, derivative instruments or other contingent arrangements that expose us to material continuing risks, contingent liabilities, or any other obligations under a variable interest in an unconsolidated entity that provides us with financing, liquidity, market risk or credit risk support. F. Tabular Disclosure of Contractual Obligations The following table summarizes Kitov’s significant contractual obligations as of December 31, 2016. Total Less than 1 year 1-3 years (U.S. dollars in thousands) (unaudited) 3-5 years Office lease obligations Obligations to R&D service providers (1) 265 1,700 70 1,700 130 65 Total 1,965 1,770 130 65 More than 5 years - - - (1) Reflects payments payable to Java Clinical Research and its sub-contractors, DABL Limited, and other service providers upon achievement of various performance milestones in accordance with current time estimates, pursuant to our service agreements with them. Kitov had no material capital expenditures for the years ended December 31, 2016, 2015 and 2014. 75 ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES A. Directors and Senior Management The following table sets forth the name, age and position of each of our executive officers, directors (and director nominees), as well as our senior employees, as of the date of this Annual Report on Form 20-F. The inclusion of any individual in this table does not necessarily imply that such individual is an officer or office holder as such terms are defined under applicable law. Name John Paul Waymack, M.D., Sc.D.(3) Isaac Israel Simcha Rock, CPA, MBA(4)(5) Steven Steinberg(1)(2) Ido Agmon, MBA(2)(3)(4) Arye Weber(1)(2)(4) Ran Tzror, CPA, MBA(4)(5) Revital Stern-Raff, CPA, MBA(1) Gil Ben-Menachem, Ph.D., MBA(3)(5) Avraham Ben-Tzvi, Adv. Hadas Reuveni, Ph.D. Age 65 38 67 56 40 68 36 43 49 46 50 Position Chairman of the Board of Directors and Chief Medical Officer Chief Executive Officer and Director Chief Financial Officer and Director Independent Director Independent Director Independent Director Independent Director Independent Director Vice President of Business Development Group Chief Legal Officer Founder and Chief Technology Officer of TyrNovo (1) Member of Kitov Parent audit committee (2) Member of Kitov Parent compensation committee (3) Member of Kitov Parent science and technology committee (4) Member of Kitov Parent investment committee (5) Director of TyrNovo John Paul Waymack, M.D., Sc.D. was one of the founders of Kitov Pharmaceuticals and has served as the chairman of Kitov Parent’s board of directors and has been responsible for the medical operations of the Company as chief medical officer since July 2013. Dr. Waymack has over 20 years of experience in the biopharma field. Dr. Waymack is a former academic transplant surgeon and a former FDA medical officer, with over twenty years of experience in drug development as a consultant to major pharmaceutical companies, including Pfizer, Roche, Pharmacia, Warner Lambert and Searle. During his 10 years of academic career, Dr. Waymack published over 100 scientific essays, mainly in the fields of prostaglandins and immunology. In addition, Dr. Waymack volunteered to the U.S. Army, where he was commissioned and served as a Major in the Medical Corp. in the position of chief of surgical studies in the U.S. Army’s Institute for Surgical Research. Dr. Waymack was also an associate professor of surgery at the University of Texas Medical Branch and at the University of Medicine and Dentistry of New Jersey. Dr. Waymack serves as a member of other boards of various healthcare corporations, both board of directors and boards of advisors, both public and private. This includes serving of the board of advisors for the publicly traded Moleculin Corporation. Isaac Israel has served as Kitov Parent’s chief executive officer and a member of the board since October 2012. Mr. Israel was the founding chief executive officer of BeeContact Ltd. (formerly TASE:BCNT), from 2001 until 2007. Since 2008 Mr. Israel has served as founding chief executive officer of Uneri Capital Ltd., a consulting firm in the capital markets field, owned by Mr. Israel, which specializes in the healthcare sector. In providing such consulting services, Mr. Israel also serves as a member of the board of directors of various healthcare corporations, both private and public, including as chairman of the board of NextGen Biomed Ltd., which is traded on the TASE. Since 2011 Mr. Israel has also provided various consulting services to Capital Point Ltd. (TASE:CPTP). Simcha Rock, CPA, MBA, has served as Kitov Parent’s chief financial officer and a member of the board since July 2013. Mr. Rock was a private equity manager at Edmond de Rothschild Private Equity Management, a firm specializing in the management of venture capital and other private equity investments funds, from February 2000 until January 2011, with responsibility for all financial, legal and administrative matters for several investment funds. Prior to 2000, Mr. Rock held financial management positions at Intel Electronics Ltd., The Jerusalem College of Technology, and JC Technologies Ltd. Mr. Rock holds a BA from Yeshiva University and an MBA from Cleveland State University. 76 Steven Steinberg, has served as a member of Kitov Parent’s board since July 13, 2016. Since January 2015, Mr. Steinberg has been the chief financial officer of Glide Talk Ltd., a technology company in the video messaging arena. From September 2013 to October 2014 he served as vice president, finance at ClientConnect Ltd., a subsidiary of Conduit Ltd., and subsequent to an acquisition, of Perion Network Ltd. a NASADQ listed company. Between August 2011 and August 2013, Mr. Steinberg acted as an independent consultant, providing start-ups and as well as mature organizations with advice in financial reporting, due diligence and business models. From December 2002 until July 2011 Mr. Steinberg was employed by Answers Corporation, a NASDAQ listed company, where he served as chief financial officer. Prior to 2002 he held a number of finance and chief financial officer roles, following a ten year period of service as an audit manager at Coopers & Lybrand (currently Price Waterhouse Coopers) in New York City. Mr. Steinberg holds a Bachelor’s Degree in Business Administration from Florida International University – School of Business Administration, and was granted a CPA license in New York State. Ido Agmon, MBA, has served as a member of Kitov Parent’s board since June 26, 2016. Since 2014, Mr. Agmon has been a manager of Aviv New- Tech (formerly Aviv Bio-Invest), a private investment fund which manages a portfolio of public Israeli & global biomed and technology companies, of which he is a co-founder, and where he is responsible for analysis and evaluation of investments in Israeli and global biomed companies. Since 2012, Mr. Agmon also has been acting as an independent consultant, providing start-ups and technology-based ventures with advice in strategic planning and fund-raising. From 2009 until 2011, Mr. Agmon served as the CEO of Meytav Technology Incubator, an Israeli-based accelerator for biotech, pharma & medtech ventures with over 20 portfolio companies. Mr. Agmon has served as a board member at a number of biomed ventures. From 2007 until 2009, he worked as the Director of Business Development in ATI incubator, a technology incubator specializing in biomed and cleantech projects, responsible for deal-flow and project evaluation. Mr. Agmon holds a Bachelor’s Degree in Business Administration & Life Sciences from Tel Aviv University, Tel Aviv, Israel, and an MBA from The Hebrew University, Jerusalem, Israel. Arye Weber, has served as a member of Kitov Parent’s board since January 23, 2017. Since 2001, Mr. Weber has been the chairman of the board and sole shareholder of Scorpio Investments Ltd., a private holding company for various investments. Between 2006 and 2009, Mr. Weber was the CEO of Alonei Meitar Ltd. a TASE listed real estate development company. Between 2004 and 2008, Mr. Weber was the chairman of the board of Inventec Investments Ltd., a TASE listed real estate development company. Between 1989 and 2002, Mr. Weber was the Manager of the Securities & Investments sector at United Mizrachi Bank, and prior to 1989 he served in various securities and investments department roles at such bank. Mr. Weber has been an external director at Capital Point Ltd., a TASE listed biotech investment company, since 2013, a director at Lapidoth Israel Oil Prospectors Corp. Ltd., a TASE listed oil and gas exploration partnership, since 2012, and a director at Sunny Communications Ltd. (formerly Scailex), a TASE listed investments company, since 2014. Mr. Weber also serves as a member of the board of directors of various privately held corporations. In the past, Mr. Weber held director positions, including, at the Tel Aviv Stock Exchange Clearing House (chairman), Bank Mizrachi Registration Company (chairman), Mashabim United Mizrachi Bank Offerings Company Ltd., Tel Aviv Stock Exchange Ltd., Maalot Israel Rating Agency, and Excellence Investment Management Company. Mr. Weber completed various courses in investments at the Tel Aviv University, and holds an M.A. in Economics and Business Studies from the University of Kharkov, U.S.S.R. (presently Ukraine). Ran Tzror, CPA, MBA has served as a member of Kitov Parent’s board since March 27, 2017. Since 2014, Mr. Tzror has been the director of S.Y Glilot Ltd., a real-estate company owned by his family. Between 2010 and 2014 he was employed by Teva Pharmaceuticals Industries Ltd. (NYSE:TEVA; TASE:TEVA) in various roles in corporate business development, the office of the CEO & President of Teva Pharmaceuticals, and as Director of the Corporate Post Merger Integration Office. Between 2007 and 2010 he was a senior associate at Somekh Chaikin Certified Public Accountants (Israel), a member firm of KPMG International. Between 2006 and 2007 he was a legal intern at the commercial division of Yigal Arnon & Co., Advocates & Notary. Mr. Tzror holds a B.A. in Accounting, Ll.B. in Law, and MBA in Financial Management from Tel-Aviv University. He also completed various courses at the Kellogg Graduate School of Management at Northwestern University in Illinois. Mr. Tzror was granted a CPA license in the State of Israel, and was also admitted as a member of the Israeli Bar Association. Revital Stern-Raff, CPA, MBA has served as a member of Kitov Parent’s board since March 2, 2017. Since 2013, Ms. Stern-Raff, has been the Chief Financial Officer of several municipal development and community association units of the City of Giv’atayim, Israel. Between 2006 and 2013, Ms. Stern- Raff held comptroller and economist positions at Ilex Medical Ltd., a publicly-traded medical diagnostic equipment company (TASE:ILX). Prior to 2006, Ms. Stern-Raff held a number of comptroller and public accounting positions. Between 2009 and 2012, Ms. Stern-Raff was an independent director at Real Imaging Holdings Ltd., a publicly traded breast cancer diagnostics company (TASE:RIMG). Ms. Stern-Raff is a licensed CPA in Israel, and holds an M.B.A. (Finance) and B.A. (Business Administration – Information Technology and Finance) from the Rishon Letzion College of Management in Israel. 77 Gil Ben-Menachem, Ph.D., MBA has served as our vice president business development since January 2016. He has over 15 years of experience in the pharmaceutical, biotechnology, and venture capital industries. He was most recently head of innovative products at Dexcel Pharma, the second largest Israeli pharmaceutical company. Dr. Ben-Menachem previously served as director of business development at Teva Pharmaceutical Industries, where he was responsible for business development efforts in connection with partnering and acquisition deals for late stage innovative drug candidates. Prior positions held by Dr. Ben-Menachem include serving as chief executive officer of OphthaliX, a company that developed drugs in the ophthalmology space, and serving as director of business development at Paramount Biosciences, a New York based merchant bank and biotechnology venture capital firm. Dr. Ben-Menachem received his Ph.D. from the Hebrew University, and MBA from the University of Maryland. He concluded his postdoctoral training in immunology and microbiology at the NIH. Avraham Ben-Tzvi, Adv., the Group’s chief legal officer, has served as the Kitov general counsel since November 2015 and was appointed as the Kitov company secretary in December 2015. Mr. Ben-Tzvi previously served as general counsel and company secretary at Medigus Ltd., a publicly traded minimally invasive endosurgical tools medical device and miniaturized imaging equipment company (NASDAQ/TASE:MDGS), from April 2014 until November 2015. Prior to that he served as an attorney at Yigal Arnon & Co. from 2009 to 2014 where, among other corporate and commercial work, he advised companies and underwriters on various offerings by Israeli companies listing in the U.S. and/or Israel and on various SEC and Israeli related securities law filings. Prior to 2009, Mr. Ben-Tzvi worked in a number of business development, corporate finance and banking roles at companies in the financial services, manufacturing and software development industries. Mr. Ben-Tzvi holds a BA in Economics from Yeshiva University in New York and an Ll.B from Sha’arei Mishpat College of Law in Hod Hasharon, Israel. Dr. Hadas Reuveni, Ph.D. is the founder and Chief Technology Officer of TyrNovo. Dr. Reuveni, a co-inventor of the TyrNovo technology, received her Ph.D., Summa Cum Laude, for anti-cancer drug discovery from the Hebrew University of Jerusalem. She has been engaged with the scientific projects in TyrNovo’s portfolio since 2005 and has nearly two decades of research and development experience in biotechnology. Dr. Reuveni founded NovoTyr Ltd. a biotech start-up company which a predecessor company to TyrNovo, developing small molecules for the treatment of cancer and neurodegenerative diseases, and where between 2005 and 2012 she served as the CEO. She also founded and served as a director and chief science officer of AngioB Ltd., a start-up company that developed GPCR-based agents for multiple indications (2006-2010). Prior to these roles, she was the director of research & development at Keryx Biopharmaceuticals (NASDAQ:KRX) on 2001-2004. Dr. Reuveni has served as a scientific consultant for Integra Holdings Ltd., Campus Bio Management Ltd. and BioLineRX (NASDAQ/TASE BLRX). B. Compensation Director Compensation We currently pay Kitov Parent’s independent directors an annual fee of NIS 24,735 (approximately $6,440) and a fee of NIS 1, 431 (approximately $373) per meeting (or a smaller amount in case they do not physically attend the meeting). During the year ended December 31, 2016, we paid Kitov Parent’s independent directors NIS 202,894 (approximately $53,500) in the aggregate. Directors’ Service Contracts There are no arrangements or understandings between us and any of our subsidiaries, on the one hand, and any of our directors, on the other hand, providing for benefits upon termination of their employment or service as directors of our company or any of our subsidiaries, except as provided in certain employment or service agreements with our executive officers who also serve as directors. 78 Executive Compensation For so long as we qualify as a foreign private issuer, we are not required to comply with the proxy rules applicable to U.S. domestic companies, including the requirement applicable to emerging growth companies to disclose the compensation of our chief executive officer and other two most highly compensated executive officers on an individual, rather than an aggregate, basis. In addition, a recent amendment to the Israeli proxy regulations governing Israeli public companies, which were promulgated under the Israeli Companies Law, requires us to disclose in the notice and proxy statement for our annual general meeting of our shareholders (or to include a reference therein to other previously furnished public disclosure) the annual compensation of our five most highly compensated office holders on an individual basis, rather than on an aggregate basis, as was previously permitted for Israeli public companies listed overseas. This disclosure may not be as extensive as that required of a U.S. domestic issuer. Under the Companies Law and Regulations, the compensation of Kitov Parent’s directors with respect their service as a director, as well as their engagement in other roles (if the director is so engaged) as well as Kitov Parent’s chief executive officer generally requires the approval of our compensation committee, the subsequent approval of the board of directors and, unless exempted under the regulations promulgated under the Companies Law, the approval of the shareholders at a general meeting. In addition the Companies Law and Regulations requires the compensation of a public company’s executive officers (other than the chief executive officer) who are not directors at the company to be approved by, first, the compensation committee, second, by the company’s board of directors and third, if such compensation arrangement is inconsistent with the company’s duly approved compensation policy, or compensation is approved prior to the approval of a new compensation policy upon expiration of the term of the previous compensation policy, or is to an executive officer who is a controlling shareholder (or certain relatives or affiliates thereof), also by the company’s shareholders. As such, the individual compensation to our directors and members of our management bodies may not necessarily be disclosed or brought for prior approval by the shareholders on an individual basis. For more information on the corporate approvals for officer compensation please see Item 6.C – Board Practices – “Compensation of Directors and Executive Officers” The aggregate compensation paid, and benefits in-kind granted to or accrued on behalf of all of Kitov’s directors and senior management for their services, in all capacities, to us during the year ended December 31, 2016, was approximately $2.1 million. As of December 31, 2016, the total amount set aside as an actuarial estimate by us to provide post-employment benefits for certain office holders was in the aggregate amount of approximately $0.2 million. We have not set aside amounts to provide post-employment benefits for the remaining office holders. We have entered into engagement agreements with each of our executive officers. All of these agreements contain customary provisions regarding noncompetition, confidentiality of information and assignment of inventions. However, the enforceability of the noncompetition provisions may be limited under applicable laws. Our directors and executive officers hold exemption and indemnification letters and a valid D&O insurance policy. For information on exemption and indemnification letters granted to our officers and directors, please see “Item 6. Directors, Senior Management and Employees - C. Board Practices - Exculpation, Insurance and Indemnification of Directors and Officers”. 79 Below is a breakdown of the annual compensation of each of Kitov’s executive officers for the year ended December 31, 2016, with respect to whom, as of the date of this Annual Report on Form 20-F, disclosure is either required in our home country, or whose compensation by us has otherwise previously been disclosed publicly on an individual basis: Name Dr. J. Paul Waymack Isaac Israel Simcha Rock Position Chairman of the Board Chief Executive Officer and Director Chief Financial Officer and Director Salary or other payments1 in (in $ thousands) Bonus payments or accruals (in $ thousands) 254 238 157 240 331 224 Share-based payment (in $ thousands)2 158 66 20 Total (in $ thousands) 652 635 401 1 Includes social benefits, such as payments to the National Insurance Institute, advanced education funds, managers’ insurance and pension funds; vacation pay; and recuperation pay as mandated by Israeli law, and car lease or vehicle use reimbursement related benefits. 2 Share based payments are measured at the fair value of the service, when available. The fair value of the Company’s share options granted to employees, directors and service providers, where fair value of service was not measurable, was estimated using the fair value of Kitov Parent’s traded warrants with similar terms, making some adjustments to reflect the specific terms of the options based on the expected duration. Consulting Agreement with Waymack Inc. (wholly owned by Dr. John Paul Waymack) In July 2013, we entered into a consulting agreement with Waymack Inc. for the services of Dr. John Paul Waymack, one of our founders, pursuant to which Dr. Waymack provides services to us as the chairman of our board of directors, and is responsible for the medical operations of the Company as chief medical officer in which capacity he reports to our board of directors. In return for Dr. Waymack’s services, as of March 2014 we paid Waymack Inc. a monthly fee of NIS 29,880 (approximately $8,690 per month based on the representative rate of exchange on June 30, 2014). Between September 2014 and December 2015, we paid Waymack Inc. a monthly fee of $14,000. Effective January 1, 2016, we are paying Waymack Inc. a monthly fee of $20,000. The service agreement may be terminated by either party upon 180 days’ advance notice to the other party. In addition to the above monthly fee Waymack Inc. is entitled to the following additional compensation: Retirement Grant. A retirement grant of six (6) times the monthly fee upon termination of Dr. Waymack’s engagement with us, provided that the termination is not due to circumstances that do not entitle an employee to severance payments under any applicable law and/or under any judicial decision of a competent tribunal. Annual Bonus. Annual bonus, which shall not exceed twelve (12) times the monthly fee, of which at least 80% is based on measurable criteria and either (i) up to 20% or (ii) up to three (3) times the monthly fee is based on non-measurable criteria under our compensation policy. Below is a description of the annual bonus based on measurable criteria: (i) a bonus in the amount of one (1) time the monthly fee for each NIS 5 million (gross) increase during the calendar year compared to the previous calendar year-end of our equity and/or asset value, taking into consideration and offsetting any relevant decrease in our equity and/or asset value which occurred in the 12 months previous to such increase; (ii) a bonus in the amount of one (1) time the monthly fee for each NIS 5 million (gross) increase in income from sales of our products in the calendar year compared to the previous calendar year; (iii) a bonus in the amount of three (3) times the monthly fee for completion of in-licensing transaction for a new product, provided however that in any event the bonus will not be paid prior to the clinical trial phase and IND approval with respect to the new product; (iv) a bonus in the amount of one (1) time the monthly fee for each NIS 10 million increase in our market value during the calendar year compared to the previous calendar year-end; (v) a bonus in the amount of six (6) times the monthly fee for each target successfully achieved in a clinical trial as of Phase II of the trial and a bonus in the amount of one (1) time the monthly fee for each target successfully achieved in a clinical trial as of Phase I; (vi) a bonus in the amount of six (6) times the monthly fee upon approval by the FDA (NDA approval) or any comparable regulatory authority in connection with our products provided however that such bonus shall not be paid for each product more than once; and (vii) a bonus in the amount of two (2) times the monthly fee after completion of registration of our securities on a U.S. stock exchange. Special bonus based on either a Merger Transaction or a Commercialization Transaction. A special bonus equal to: (i) 4% of our valuation determined in a Merger Transaction; provided that: (a) in the event that a commission is paid to third parties, the total bonus paid to Waymack Inc., any other office holders, and any third parties with respect thereto will not exceed 8% of the valuation, and the bonus paid to each such office holder shall be calculated pro rata; (b) in any event Waymack Inc. will not be entitled to a bonus based on a Merger Transaction in an amount exceeding $500,000; A “Merger Transaction” means one or more related transactions of either: (A) sale, lease, license or any transfer of all or most of our assets or securities; (B) merger so that the shareholders holding at least 50% of our issued and outstanding share capital prior to the consummation of such transaction hold less than 50% of our issued and outstanding share capital or the share capital of the surviving company following the consummation of such transaction, provided however that our valuation in such Merger Transaction is at least $25 million; 80 (ii) 4% of the cumulative revenues actually received from a Commercialization Transaction, less any payments made to third parties. The initial bonus is payable upon the receipt of at least $5 million as a result of the commercialization of our products. In the event we receive additional revenues as a result of a Commercialization Transaction exceeding such amount, Waymack Inc. will be entitled to an additional monthly bonus against revenues received by us as a result of the Commercialization Transaction in the prior month; provided that: (a) in the event that a commission is paid to third parties, the total bonus paid to Waymack Inc. and any other office holders, and any third parties with respect thereto will not exceed 10% of the total revenues, and the bonus paid to each such office holder shall be calculated pro rata; (b) in any event Waymack Inc. will not be entitled to a bonus based on a Commercialization Transaction in an amount exceeding $500,000. A “Commercialization Transaction” means the execution of a licensing and/or distribution agreement of our products with revenues of at least $5 million. Waymack Inc. will be entitled to the bonus as a result of a Commercialization Transaction only upon our receipt of at least $5 million as a result of the commercialization of our products. In the event our cash balance decreases below NIS 2 million, we may, by a resolution of the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and the board of directors, decrease and/or choose not to grant the annual bonus and/or the special bonus, provided that such resolution was made with respect to all of our office holders. Upon the increase of our cash balance above such amount, we shall grant the foregone annual bonus and/or the special bonus, as applicable. In the event of the reference of our auditors in the auditors’ opinion on our financial statements with respect to significant doubt as to our ability to continue as a “going concern,” we may, by a resolution of the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and the board of directors, decrease and/or choose not to grant the special bonus, provided that such resolution was made with respect to all of our office holders. However, upon the removal of the auditors’ “going concern” reference, we may grant the special bonus with respect to a past merger transaction. In the second quarter of 2016, each of our audit committee, board of directors and shareholders approved a grant of options under our 2016 Equity- Based Incentive Plan to Dr. Waymack for the purchase of 3,089,066 ordinary shares (the “Initial PW Grant”) (such number of ordinary shares would comprise 154,453.3 of our ADSs). Such options will vest over a period of 3 years from June 27, 2016; have an exercise price of NIS 0.7884 per ordinary share; and are exercisable for 8 years from June 27, 2016, provided, however, that no options are exercisable prior to our adoption of a revised compensation policy in accordance with the Companies Law. In addition Dr. Waymack was granted an additional 2,468,759 options following our July 2016 follow-on public offering, on the same terms and conditions of the Initial PW Grant so that the sum total of his options following such public offering reflected 3.5% of our issued and outstanding shares subsequent to the offering(the “Subsequent PW Grant”); this grant was made subject to the proviso that the economic value of the total options issued to Dr. Waymack, calculated as of the date of issuance of the Subsequent PW Grant, was not in excess of the economic value of the Initial PW Grant as of the date of the approval of our board of directors for the option grants to Dr. Waymack. Employment Agreement with Mr. Isaac Israel (previously Service Agreement with Uneri Capital Ltd.) In July 2013, we entered into a services agreement with Uneri Capital Ltd., a private company wholly owned by Mr. Isaac Israel, for the provision of part-time management services according to our needs. For such services we paid as of such date monthly payments of NIS 25,000 (approximately $7,300 per month based on the representative rate of exchange on June 30, 2014). 81 As of September 2014 we terminated the engagement with Uneri Capital and entered into an employment agreement with Mr. Isaac Israel as our chief executive officer pursuant to which we paid Mr. Israel a base salary of NIS 40,000 (approximately $10,593) per month. In addition to the above we provided Mr. Israel with a car allowance at a monthly cost of up to NIS 4,000 (approximately $1,059), management insurance policy and advanced study fund. Effective as of May 1, 2016, Mr. Israel increase the scope of his engagement with the Company to 100% from 80% and his base monthly consideration and linked benefits were increased proportionally. In addition as of May 1, 2016, Mr. Israel is engaged via a services agreement with Uneri Capital, provided, however, that there is no difference to our costs and expenses for such engagement as a service provider instead of as an employee. For such services we pay Uneri Capital as of such date monthly payments of NIS 68,867 (approximately $17,911) per month. In addition, Mr. Israel is entitled to the following additional compensation: Retirement Grant. A retirement grant of three (3) time the monthly salary equivalent (currently NIS 50,000 (approximately $13,004) per month) upon termination of Mr. Israel’s engagement with us, provided that the termination is not due to circumstances that do not entitle an employee to severance payments under any applicable law and/or under any judicial decision of a competent tribunal. Annual Bonus. Annual bonus, which shall not exceed twelve (12) times the monthly salary equivalent three (3) time the monthly salary equivalent (currently NIS 50,000 (approximately $13,004) per month) of which at least 80% is based on measurable criteria and either (i) up to 20% or (ii) up to three (3) times the monthly salary is based on non-measurable criteria under our compensation policy. The annual bonus based on measurable criteria is payable for the same events and in the same amounts as the agreement with Waymack Inc. described above, except that the bonus to Mr. Israel for each target successfully achieved in a clinical trial as of Phase I is two (2) times his monthly salary. Special bonus based on either a Merger Transaction, Fund Raise or a Commercialization Transaction. A special bonus equal to: (i) 4% of our valuation determined in a Merger Transaction payable in the same manner as the agreement with Waymack Inc. described above; (ii) NIS 200,000 for each Fund Raise, provided however, in the event that a commission is paid to third parties, the total bonus paid to Mr. Israel, any other office holders and any third parties with respect thereto will not exceed 10% of the Fund Raise amount (gross); and (iii) 4% of the cumulative revenues actually received from a Commercialization Transaction, less any payments made to third parties, payable in the same manner as the agreement with Waymack Inc. described above. A “Fund Raise” means a raise by us of each NIS 10 Million (cumulative), in any calendar year, commencing as of October 1, 2014. We may, by a resolution of the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and the board of directors, decrease and/or choose not to grant the annual bonus and/or the special bonus, in the manner described above regarding the Service Agreement with Waymack Inc. In the second quarter of 2016, each of our audit committee, board of directors and our shareholders approved a grant of options under our 2016 Equity-Based Incentive Plan to Mr. Israel for the purchase of 2,206,476 ordinary shares (such number of ordinary shares would comprise 110,323.8 of our ADSs). Such options will vest over a period of 3 years from June 27, 2016, have an exercise price of NIS 0.7884 per ordinary share, and are exercisable for 8 years from June 27, 2016, provided, however, that no options are exercisable prior to our adoption a revised compensation policy in accordance with the Companies Law. Consulting Agreement with Mr. Simcha Rock In July 2013, we entered into a consulting agreement with Mr. Rock pursuant to which Mr. Rock provides services to us as our chief financial officer. In return for Mr. Rock’s services, as of March 2014, we paid Mr. Rock a monthly fee of NIS 35,000 (approximately $10,200 per month based on the representative rate of exchange on June 30, 2014). As of September 2014, we are paying Mr. Rock NIS 50,000 (approximately $13,242) per month. The agreement may be terminated by either party upon 90 days’ prior notice to the other party. 82 In addition to the above monthly fee Mr. Rock is, as of September 1, 2014, entitled to a leased company car at a monthly cost of up to NIS 3,000 (approximately $795) and to the following additional compensation: Retirement Grant. A retirement grant of three (3) times the monthly fee upon termination of Mr. Rock’s engagement with us, provided that the termination is not due to circumstances that do not entitle an employee to severance payments under any applicable law and/or under any judicial decision of a competent tribunal. Annual Bonus. Annual bonus, which shall not exceed twelve (12) times the monthly salary equivalent (NIS 38,462 (currently approximately $10,000) per month, of which at least 80% is based on measurable criteria and either (i) up to 20% or (ii) up to three (3) times the monthly fee is based on non-measurable criteria under our compensation policy. The annual bonus based on measurable criteria is payable for the same events and in the same amounts as the agreement with Waymack Inc. described above, except that the bonus to Mr. Rock for meeting the targets of our clinical trials in a clinical trial as of Phase II is four (4) times his monthly fee and after completion of registration of our securities on a U.S. stock exchange the bonus to Mr. Rock shall be four (4) times the monthly fee and the measurable criteria for Mr. Rock includes a bonus in the amount of three (3) times the monthly fee for meeting our budget objectives. Special bonus based on either a Merger Transaction, Fund Raise or a Commercialization Transaction. A special bonus equal to: (i) 4% of our valuation determined in a Merger Transaction payable in the same manner as the agreement with Waymack Inc. described above, provided that the bonus payable to Mr. Rock based on a Merger Transaction will not exceed $350,000; (ii) NIS 100,000 for each Fund Raise, provided however, in the event that a commission is paid to third parties, the total bonus paid to Mr. Rock, any other office holders and any third parties with respect thereto will not exceed 10% of the Fund Raise amount (gross); and (iii) 4% of the cumulative revenues actually received from a Commercialization Transaction, less any payments made to third parties, payable in the same manner as the agreement with Waymack Inc. described above, provided that the bonus payable to Mr. Rock based on a Commercialization Transaction will not exceed $350,000. We may, by a resolution of the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and the board of directors, decrease and/or choose not to grant the annual bonus and/or the special bonus, in the manner described above regarding the Service Agreement with Waymack Inc. In addition, in July 2014 we granted Mr. Rock 1,188,967 non-tradable options under our 2013 Option Plan to purchase 91,455 ordinary shares. Of these options: (a) 1,011,500 options to purchase 77,805 ordinary shares will vest pro rata on a monthly basis over a period of 18 months from the date of grant and will be exercisable at an exercise price of NIS 10.40 (approximately $2.75) per ordinary share for a period of three years commencing from the date of grant of the options; and (b) 177,467 options to purchase 13,651 ordinary shares vested as of the date of the grant and are exercisable at an exercise price of NIS 10.40 (approximately $2.75) per ordinary share and will have a term of three years from the date of grant. Following the attainment of the Milestone under the Share Transfer Agreement in connection with our Phase III trial for KIT-302, we were required to grant to Mr. Rock an additional 181,089 options to purchase 13,929 ordinary shares. See “Business – Share Transfer Agreement with Kitov Pharmaceuticals”. These options will vest as of the date of grant and will be exercisable at an exercise price of NIS 10.40 (approximately $2.75) per ordinary share and will have a term of three years from the date of grant. Mr. Rock has waived the receipt of this option grant. See “Item 7. Major Shareholders and Related Party Transactions – B. Related Party Transactions – Share Transfer Agreement with Kitov Pharmaceuticals”. In the second quarter of 2016, each of our audit committee, board of directors and our shareholders approved a grant of options under our 2016 Equity-Based Incentive Plan to Mr. Rock for the purchase 661,943 ordinary shares, (such number of ordinary shares would comprise 33,097.15 of our ADSs). Such options will vest over a period of 3 years from June 27, 2016, have an exercise price of NIS 0.7884 per ordinary share, and are exercisable for 8 years from June 27, 2016, provided, however, that no options are exercisable prior to our adoption a revised compensation policy in accordance with the Companies Law. 83 C. Board Practices Board of Directors and Officers Our board of directors presently consists of eight directors. Each of Ms. Stern-Raff, Mr. Tzror, Mr. Steinberg, Mr. Agmon, and Mr. Weber qualifies as an independent director under the corporate governance standards of the NASDAQ Listing Rules and the independence requirements of Rule 10A-3 of the Exchange Act. Under the Companies Law, except as provided below, companies incorporated under the laws of the State of Israel that are “public companies,” including Israeli companies with shares listed on NASDAQ, are required to appoint at least two external directors who meet the qualification requirements set forth in the Companies Law. On July 13, 2016, our Board of Directors resolved to adopt the corporate governance exception set forth in Regulation 5D of the Israeli Companies Regulations (Relief for Public Companies with Shares Listed for Trading on a Stock Market Outside of Israel), 5760- 2000. In accordance with such Regulation, a public company with securities listed on certain foreign exchanges, including NASDAQ, that satisfies the applicable foreign country laws and regulations that apply to companies organized in that country relating to the appointment of independent directors and composition of audit and compensation committees and have no controlling shareholder are exempt from the requirement to appoint external directors or comply with the audit committee and compensation committee composition requirements under the Companies Law. In accordance with our Board’s resolution, for so long as Kitov Parent does not have a controlling shareholder as defined in Section 1 of the Companies Law, Kitov Parent intends to comply with the NASDAQ Listing Rules in connection with a majority of independent directors on the Board and in connection with the composition of each of the Audit Committee and the Compensation Committee, in lieu of such requirements set forth under the Companies Law. A majority of our Board members are independent as required by the NASDAQ Listing Rules. Furthermore, our audit committee consists of at least three independent directors, and our Compensation Committee consists of at least two independent directors. Should any person or entity become deemed to be a controlling shareholder as defined in Section 1 of the Companies Law, then in accordance with Section 248(a) of the Companies Law, we will be required to convene a special general meeting of the shareholders at the earliest possible date, the agenda of which shall include the appointment of at least two external directors. Following such appointment, all of the external directors shall be appointed to each of our audit committee and compensation committee, and at least one external director shall be appointed to each committee of the Board of Directors authorized to exercise any of the powers of the board of directors. Our directors are elected to serve are divided into three classes, with each class comprising one-third of the members of our board of directors (the “Board”) (who are not external directors, if any were appointed), (hereinafter the “first class”; the “second class”; and the “third class”). If the number of directors is not equally divisible by three, each of the first class and the second class will be comprised of a different number, the closest and lowest to one- third, while the third class will be comprised of the remaining directors (who are not external directors, if any were appointed). If the number of directors changes, the number of directors in each class will change in accordance with the aforesaid rule. At our 2017 annual general meeting of shareholders, the appointment of the directors included in the second class shall end. At our 2018 general meeting of shareholders, the appointment of the directors included in the third class shall end. At our 2019 general meeting of shareholders, the appointment of the directors included in the first class shall end. At our annual general meeting of our shareholders, the shareholders are entitled to elect directors who shall be elected for a Three-Year Term to replace the class of directors whose term in office has expired as of such annual general meeting of our shareholders, and so on ad infinitum, so that the directors who shall be elected as stated above shall enter office at the end of the annual general meeting of our shareholders at which they were elected, unless a later date for commencement of the term was decided at the time of the appointment, and shall serve for Three-Year Terms (unless their appointment will be terminated in accordance with the provisions of our amended and restated articles of association), and so that each year, the terms in office of one of the classes of directors shall expire at the annual general meeting of our shareholders for such year. A “Three-Year Term” means a term of office of a director until the third annual general meeting of our shareholders which shall be held following the date of their election as director, provided that each director shall continue to serve in office until his or her successor is duly elected and qualified, or until his or her retirement, death, resignation or removal. Our Board may appoint a director at any time to fill any vacancies until the annual meeting of our shareholders set to take place at the end of the Three-Year Term for the class of directors to which such director is so appointed by the Board, provided that the total number of the members of the Board serving at such time will not exceed the Maximum Number. The shareholders may at all times, by a Special Majority vote of the shareholders, replace or dismiss a director (in the case of replacement, only if the appointed director is not a corporation). A director to be replaced shall be given a reasonable opportunity to address the shareholders at their meeting. The tenure of a director expires pursuant to the provisions of our amended and restated articles of association and the Companies Law, upon death or if s/he becomes incompetent, unless removed from office as described above. 84 Under our amended and restated articles of association, the number of directors on our Board will be no less than four and no more than nine (including any external directors, to the extent that we may be required to appoint external directors in accordance with the Companies Law and any Regulations enacted thereunder) (“Maximum Number”). The majority of the members of the Board shall be residents of Israel, unless our center of management shall have been transferred to another country in accordance with a resolution of our Board by a majority of three quarters (75%) of the participating director votes. The number of directors may be changed, at any time and from time to time, by our shareholders with a majority of (a) 75% of the voting rights participating and voting on the matter in the applicable general meeting of our shareholders and (b) more than 47.9% of all of the voting rights in Kitov Parent as of the record date established for the applicable general meeting of our shareholders (“Special Majority”). In addition, under the Companies Law, our board of directors must determine the minimum number of directors who are required to have financial and accounting expertise. Under applicable regulations, a director with financial and accounting expertise is a director who, by reason of his or her education, professional experience and skill, has a high level of proficiency in and understanding of business accounting matters and financial statements. He or she must be able to thoroughly comprehend the financial statements of the company and initiate debate regarding the manner in which financial information is presented. In determining the number of directors required to have such expertise, the board of directors must consider, among other things, the type and size of the company and the scope and complexity of its operations. Our board of directors has determined that we require at least one director with the requisite financial and accounting expertise and that Mr. Rock (who also serves as our CFO), Mr. Steinberg, Ms. Stern-Raff, Mr. Weber and Mr. Tzror are each deemed to have such expertise. At our 2017 annual general meeting of shareholders, the terms of the directors included in the second class (Messrs. Steinberg, Agmon, Tzror) shall end. At our 2018 general meeting of shareholders, the terms of the directors included in the third class (Messrs. Israel and Rock and Ms. Stern-Raff) shall end. At our 2019 general meeting of shareholders, the terms of the directors included in the first class (Dr. Waymack and Mr. Weber) shall end. In addition to our present directors whose current terms of office are detailed above, the following persons served as directors during all or a part of 2016: Mr. Yair Katzir served as a director until March 2, 2017; Ms. Leah Bruck served as a director until January 25, 2017; Dr. Alain Zeitoun served as a director until December 16, 2016; and, Ms. Moran Sherf-Blau served as a director until September 27, 2016. Alternate Directors Our amended and restated articles of association provide, as allowed by the Companies Law, that any director may, at all times, appoint any person (which is not a corporation) by written notice to us to serve as an alternate director at a meeting of the board of directors. A person who is not qualified to be appointed as a director, a person who is already serving as a director or a person who is already serving as an alternate director for another director, may not be appointed as an alternate director, unless otherwise permitted by applicable law. A director who is already serving as a director may be appointed as an alternate director for a member of a committee of the board of directors so long as he or she is not already serving as a member of such committee, and if the alternate director is to replace an external director, he or she is required to be an external director and to have either “financial and accounting expertise” or “professional expertise,” depending on the qualifications of the external director he or she is replacing. So long as the external director’s appointment is valid, the alternate director shall be entitled to participate and vote in every meeting of the board of directors from which the appointing director is absent. Subject to the terms of appointment, the alternate director will be regarded as a director and shall have all of the authority of the director he or she is replacing. An appointing director may at any time cancel the appointment of an alternate director. The term of appointment of an alternate director will end if the appointing director notifies us in writing of the termination or cancellation of the appointment or if the appointing director’s appointment is terminated. 85 External Directors Qualifications of External Directors Under the Companies Law companies incorporated under the laws of the State of Israel that are “public companies,” including Israeli companies with shares listed on NASDAQ, are required to appoint at least two external directors who meet the qualification requirements set forth in the Companies Law. On July 13, 2016, our Board of Directors resolved to adopt the corporate governance exception set forth in Regulation 5D of the Israeli Companies Regulations (Relief for Public Companies with Shares Listed for Trading on a Stock Market Outside of Israel), 5760-2000. In accordance with such Regulation, a public company with securities listed on certain foreign exchanges, including NASDAQ, that satisfies the applicable foreign country laws and regulations that apply to companies organized in that country relating to the appointment of independent directors and composition of audit and compensation committees and have no controlling shareholder are exempt from the requirement to appoint external directors or comply with the audit committee and compensation committee composition requirements under the Companies Law. In accordance with our Board’s resolution, for so long as Kitov Parent does not have a controlling shareholder as defined in Section 1 of the Companies Law, Kitov Parent intends to comply with the NASDAQ Listing Rules in connection with a majority of independent directors on the Board and in connection with the composition of each of the Audit Committee and the Compensation Committee, in lieu of such requirements set forth under the Companies Law. A majority of our Board members are independent as required by the NASDAQ Listing Rules. Furthermore, our Audit Committee consists of at least three independent directors, and our Compensation Committee consists of at least two independent directors. Should any person or entity become deemed to be a controlling shareholder as defined in Section 1 of the Companies Law, then in accordance with Section 248(a) of the Companies Law, we will be required to convene a special general meeting of the shareholders at the earliest possible date, the agenda of which shall include the appointment of at least two external directors. Following such appointment, all of the external directors shall be appointed to each of our Audit Committee and Compensation Committee, and at least one external director shall be appointed to each committee of the Board of Directors authorized to exercise any of the powers of the board of directors. A person may not serve as an external director if the person is a relative of a controlling shareholder or if on the date of the person’s appointment or within the preceding two years the person or his or her relatives, partners, employers or anyone to whom that person is subordinate, whether directly or indirectly, or entities under the person’s control have or had any affiliation with any of ( “Affiliated Party”): (1) us; (2) any person or entity controlling us on the date of such appointment; (3) any relative of a controlling shareholder; or (4) any entity controlled, on the date of such appointment or within the preceding two years, by us or by a controlling shareholder. If there is no controlling shareholder or any shareholder holding 25% or more of voting rights in the company, a person may not serve as an external director if the person has any affiliation to the chairman of the board of directors, the general manager (chief executive officer), any shareholder holding 5% or more of the company’s shares or voting rights or the senior financial officer as of the date of the person’s appointment. The term “controlling shareholder” means a shareholder with the ability to direct the activities of the company, other than by virtue of being an office holder. A shareholder is presumed to have “control” of the company and thus to be a controlling shareholder of the company if the shareholder holds 50% or more of the “means of control” of the company. “Means of control” is defined as (1) the right to vote at a general meeting of a company or a corresponding body of another corporation; or (2) the right to appoint directors of the corporation or its general manager. For the purpose of approving transactions with controlling shareholders, the term also includes any shareholder that holds 25% or more of the voting rights of the company if the company has no shareholder that owns more than 50% of its voting rights. For purposes of determining the holding percentage stated above, two or more shareholders who have a personal interest in a transaction that is brought for the company’s approval are deemed as joint holders. The term affiliation includes: ● an employment relationship; ● a business or professional relationship maintained on a regular basis; ● control; and ● service as an office holder, excluding service as a director in a private company prior to the first offering of its shares to the public if such director was appointed as a director of the private company in order to serve as an external director following the initial public offering. 86 The term “relative” is defined as a spouse, sibling, parent, grandparent, descendant, spouse’s descendant, sibling and parent and the spouse of each of the foregoing. The term “office holder” is defined as a general manager, chief business manager, deputy general manager, vice general manager, director or manager directly subordinate to the general manager or any other person assuming the responsibilities of any of the foregoing positions, without regard to such person’s title. A person may not serve as an external director if that person or that person’s relative, partner, employer, a person to whom such person is subordinate (directly or indirectly) or any entity under the person’s control has a business or professional relationship with any entity that has an affiliation with any Affiliated Party, even if such relationship is intermittent (excluding insignificant relationships). Additionally, any person who has received compensation intermittently (excluding insignificant relationships) other than compensation permitted under the Companies Law may not continue to serve as an external director. No person can serve as an external director if the person’s position or other affairs create, or may create, a conflict of interest with the person’s responsibilities as a director or may otherwise interfere with the person’s ability to serve as a director or if such a person is an employee of the Israeli Securities Authority or of an Israeli stock exchange. If at the time an external director is appointed all current members of the board of directors, who are not controlling shareholders or relatives of controlling shareholders, are of the same gender, then the external director to be appointed must be of the other gender. In addition, a person who is a director of a company may not be elected as an external director of another company if, at that time, a director of the other company is acting as an external director of the first company. The Companies Law provides that an external director must meet certain professional qualifications or have financial and accounting expertise, and that at least one external director must have financial and accounting expertise. However, if at least one of our other directors (1) meets the independence requirements of the Exchange Act, (2) meets the standards of the NASDAQ Listing Rules for membership on the audit committee and (3) has financial and accounting expertise as defined in the Companies Law and applicable regulations, then neither of our external directors is required to possess financial and accounting expertise as long as both possess other requisite professional qualifications. The determination of whether a director possesses financial and accounting expertise is made by the board of directors. A director with financial and accounting expertise is a director who by virtue of his or her education, professional experience and skill, has a high level of proficiency in and understanding of business accounting matters and financial statements so that he or she is able to fully understand our financial statements and initiate debate regarding the manner in which the financial information is presented. The regulations promulgated under the Companies Law define an external director with requisite professional qualifications as a director who satisfies one of the following requirements: (1) the director holds an academic degree in either economics, business administration, accounting, law or public administration, (2) the director either holds an academic degree in any other field or has completed another form of higher education in the company’s primary field of business or in an area which is relevant to his or her office as an external director in the company, or (3) the director has at least five years of experience serving in any one of the following, or at least five years of cumulative experience serving in two or more of the following capacities: (a) a senior business management position in a company with a substantial scope of business, (b) a senior position in the company’s primary field of business or (c) a senior position in public administration. Except in the case of a cessation of the classification of the director as an external director following the adoption by certain companies listed on foreign stock exchanges, including NASDAQ, of the corporate governance exceptions set forth in the Regulation, as described above, until the lapse of a two- year period from the date that an external director of a company ceases to act in such capacity, the company in which such external director served, and its controlling shareholder or any entity under control of such controlling shareholder may not, directly or indirectly, grant such former external director, or his or her spouse or child, any benefit, including via (i) the appointment of such former director or his or her spouse or his child as an officer in the company or in an entity controlled by the company’s controlling shareholder, (ii) the employment of such former external director and (iii) the engagement, directly or indirectly, of such former external director as a provider of professional services for compensation, including via an entity under his or her control. With respect to a relative who is not a spouse or a child, such limitations shall only apply for one year from the date such external director ceased to be engaged in such capacity. 87 Election and Dismissal of External Directors Under Israeli law, external directors are elected by a majority vote at a shareholders’ meeting, provided that either: ● the majority of the shares that are voted at the meeting in favor of the election of the external director, excluding abstentions, include at least a majority of the votes of shareholders who are not controlling shareholders and do not have a personal interest in the appointment (excluding a personal interest that did not result from the shareholder’s relationship with the controlling shareholder); or ● the total number of shares held by non-controlling shareholders or any one on their behalf that are voted against the election of the external director does not exceed two percent of the aggregate voting rights in the company. Under Israeli law, the initial term of an external director of an Israeli public company is three years. The Companies Law provides that after an initial term of three years, external directors may be re-elected to serve in that capacity for up to two additional three year terms, provided that either: (i) (1) his or her service for each such additional term is recommended by one or more shareholders holding in aggregate at least 1% of the company’s voting rights and is approved at a shareholders meeting by a majority of the shares held by non-controlling shareholders who do not have a personal interest in the election of the external director (other than a personal interest not deriving from a relationship with a controlling shareholder) that are voted at the meeting, excluding for such purpose any abstentions, where the total number of shares held by non-controlling, disinterested shareholders voting for such reelection exceeds 2% of the aggregate voting rights in the company; and (2) the external director who has been nominated in such fashion by the shareholders is not a “linked or competing shareholder”, and does not have or has not had, on or within the two years preceding the date of such person’s appointment to serve as another term as external director, any affiliation with a linked or competing shareholder. The term “linked or competing shareholder” means the shareholder(s) who nominated the external director for reappointment or a substantial shareholder of the company holding more than 5% of the shares in the company, provided that at the time of the reappointment, such shareholder(s) of the company, the controlling shareholder of such shareholder(s) of the company, or a company under such shareholder(s) of the company’s control, has a business relationship with the company or are competitors of the company; (ii) his or her service for each such additional term is recommended by the board of directors and is approved at a shareholders meeting by the same disinterested majority required for the initial election of an external director (as described above); or (iii) the external director has proposed himself for reappointment and the reappointment was approved as provided in sub-section (i) above. The term of office for external directors for Israeli companies traded on certain foreign stock exchanges, including NASDAQ, may be further extended, indefinitely, in increments of additional three-year terms, in each case provided that, in addition to re-election in such manner described above: (1) the audit committee and subsequently the board of directors of the company confirm that, in light of the external director’s expertise and special contribution to the work of the board of directors and its committees, the re-election for such additional period is beneficial to the company; and (2) prior to the approval of the reelection of the external director, the company’s shareholders have been informed of the term previously served by such nominee and of the reasons why the board of directors and audit committee recommended the extension of such nominee’s term. An external director may be removed by the same special majority of the shareholders required for his or her election, if he or she ceases to meet the statutory qualifications for appointment or if he or she violates his or her fiduciary duty to the company. An external director may also be removed by order of an Israeli court if the court finds that the external director is permanently unable to exercise his or her office, has ceased to meet the statutory qualifications for his or her appointment, has violated his or her fiduciary duty to the company, or has been convicted by a court outside Israel of certain offenses detailed in the Companies Law. If the vacancy of an external directorship causes a company to have fewer than two external directors, the company’s board of directors is required under the Companies Law to call a special general meeting of the company’s shareholders as soon as possible to appoint such number of new external directors so that the company thereafter has two external directors. 88 Additional Provisions Relating to External Directors Under the Companies Law, each committee authorized to exercise any of the powers of the board of directors is required to include at least one external director and its audit and compensation committees are required to each include all of the external directors. An external director is entitled to compensation and reimbursement of expenses in accordance with regulations promulgated under the Companies Law and is prohibited from receiving any other compensation, directly or indirectly, in connection with serving as a director except for certain exculpation, indemnification and insurance provided by the company, as specifically allowed by the Companies Law. Audit Committee Companies Law Requirements Under the Companies Law, the board of directors of any public company must also appoint an audit committee. Except in the case of companies listed on foreign stock exchanges, including NASDAQ, which have adopted the corporate governance exceptions set forth in the Regulation, such as our company, as described under ” Qualification of External Directors”, who are exempt from the audit committee composition requirements under the Companies Law, audit committees under the Companies Law must be comprised of at least three directors, including all of the external directors. The chairman of the audit committee must be an external director. The audit committee may not include: ● the chairman of the board of directors; ● a controlling shareholder or a relative of a controlling shareholder; ● any director employed by us or by one of our controlling shareholders or by an entity controlled by our controlling shareholders (other than as a member of the board of directors); or ● any director who regularly provides services to us, to one of our controlling shareholders or to an entity controlled by our controlling shareholders. According to the Companies Law, the majority of the members of the audit committee, as well as the majority of members present at audit committee meetings, will be required to be “unaffiliated” under the Companies Law (as defined below) and the chairman of the audit committee will be required to be an external director. Any persons disqualified from serving as a member of the audit committee may not be present at the audit committee meetings, unless the chairman of the audit committee has determined that such person is required to be present at the meeting or if such person qualifies under one of the exemptions of the Companies Law. The term “unaffiliated director” is defined under the Companies Law as either an external director or an “unaffiliated director” who meets the following conditions and who is appointed or classified as such according to the Companies Law: (1) the conditions for his or her appointment as an external director (as described above) are satisfied and the audit committee approves the director having met such conditions and (2) he or she has not served as a director of the company for over nine consecutive years with any interruption of up to two years of his or her service not being deemed a disruption to the continuity of his or her service. Under the NASDAQ Listing Rules, we are required to maintain an audit committee consisting of at least three independent directors, all of whom are financially literate and one of whom has accounting or related financial management expertise. Each of the members of the audit committee is required to be “independent” as such term is defined in Rule 5605(a)(2) of the NASDAQ Listing Rules and in Rule 10A-3(b)(1) under the Exchange Act, which is different from the general test for independence of board and committee members. The independence requirements of the Exchange Act implement two basic criteria for determining independence: (1) audit committee members are barred from accepting directly or indirectly any consulting, advisory or other compensatory fee from the issuer or an affiliate of the issuer, other than in the member’s capacity as a member of the board of directors and any board committee, and (2) audit committee members may not be an “affiliated person” of the issuer or any subsidiary of the issuer apart from her or his capacity as a member of the board of directors and any board committee. The SEC has defined “affiliate” for non-investment companies as “a person that directly, or indirectly through one or more intermediaries, controls, or is controlled by, or is under common control with, the person specified.” The term “control” is intended to be consistent with the other definitions of this term under the Exchange Act as “the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person, whether through the ownership of voting securities, by contract, or otherwise.” 89 Audit Committee Role Under the Companies Law, our audit committee: ● recommends to the board of directors to recommend to our shareholders to appoint and approve the compensation of the independent registered public accounting firm engaged to audit our financial statements; ● monitors deficiencies in the management of the Company, inter alia, in consultation with the independent registered public accounting firm and internal auditor, and advises the board of directors on how to correct such deficiencies; ● decides whether to approve and recommend to the board of directors to approve engagements or transactions that require the audit committee’s approval under the Companies Law relating generally to certain related party transactions. The audit committee must pre-determine procedures for a competitive process, or other procedures, before approving related party transactions with controlling shareholders, even if such transactions are deemed by the audit committee not to be extraordinary transactions. This process is to be supervised by the audit committee, or any person authorized for such supervision, or via any other method approved by the audit committee; ● decides as to what transactions shall be considered as “extraordinary transactions” as such term is defined under the Companies Law in connection with related party transaction; ● determines the approval process for transactions that are not negligible, as well as determine which types of transactions would require the approval of the audit committee. Non-negligible transactions are defined as related party transactions with a controlling shareholder, or in which the controlling shareholder has a personal interest, even if they are deemed by the audit committee not to be extraordinary transactions but which have also been classified by the audit committee as non-negligible transactions; ● meets and receives reports from both the internal auditors and the independent registered public accounting firm dealing with matters that arise in connection with their audits; and ● regulates the Company’s rules on employee complaints, and implementing a whistleblower protection plan with respect to employee complaints of business irregularities. In accordance with the Sarbanes-Oxley Act of 2002 and the NASDAQ Listing Rules, the audit committee is also directly responsible for the appointment, compensation and performance of our independent auditors, and pre-approves audit and non-audit services to be provided by the independent auditors. In addition, the audit committee is responsible for assisting the board of directors in reviewing our annual financial statements, the adequacy of our internal controls and our compliance with legal and regulatory requirements. The audit committee also oversees our major financial risk exposures and policies for managing such potential risks, discusses with management and our independent auditor significant risks or exposure and assesses the steps management has taken to minimize such risk. Our board of directors has adopted an audit committee charter setting forth the responsibilities of the audit committee, which are consistent with the provisions of the Companies Law, rules and regulations of the SEC and the NASDAQ Listing Rules. Approval of Transactions with Related Parties The approval of the audit committee (or under certain circumstances the compensation committee) is required to effect specified actions and transactions with office holders and controlling shareholders and their relatives, or in which they have a personal interest. The audit committee may not approve an action or a transaction with a controlling shareholder or with an office holder unless at the time of approval the audit committee meets the composition requirements under the Companies Law. 90 Our audit committee consists of Ms. Revital Stern-Raff, Mr. Steven Steinberg and Mr. Arye Weber. All members of our audit committee meet the requirements for financial literacy under the applicable rules and regulations of the SEC and the NASDAQ Listing Rules. Our board of directors has determined that Ms. Stern-Raff and Mr. Steinberg are audit committee financial experts as defined by the SEC rules and have the requisite financial experience as defined by the NASDAQ Listing Rules. Compensation Committee Amendment No. 20 to the Companies Law, which became effective as of December 2012 (“Amendment No. 20”), established new regulations relating to the terms of office and employment of directors and officers in Israeli public companies and companies that have publicly issued debentures. Such companies are required to appoint a compensation committee in accordance with the guidelines set forth in the Companies Law. Except in the case of companies listed on foreign stock exchanges, including NASDAQ, which have adopted the corporate governance exceptions set forth in the Regulation, such as our company, as described under ” Qualification of External Directors”, who are exempt from the compensation committee composition requirements under the Companies Law, the compensation committee must comply with the following requirements (the “Israeli Compensation Committee Composition Requirements”): i. ii. iii. iv. v. The compensation committee must consist of at least three members; All of the external directors must serve on the committee and constitute a majority of its members; The chairman of the compensation committee must be an external director; The remaining members need not be external directors but must be directors who qualify to serve as members of the audit committee (as described above); and The provisions of the Companies Law and Regulations that govern the compensation and reimbursement terms of external directors must also apply to members of the compensation committee who are not external directors. In accordance with the Companies Law, the roles of the compensation committee are, among others, as follows: ● to recommend to the board of directors the compensation policy for directors and officers, and to recommend to the board of directors once every three years whether the compensation policy that had been approved should be extended for a period of more than three years; ● to recommend to the board of directors updates to the compensation policy, from time to time, and examine its implementation; ● to decide whether to approve the terms of office and employment of directors and officers that require approval of the compensation committee; and ● to decide whether the compensation terms of the chief executive officer of Kitov Parent which were determined pursuant to the compensation policy need not be brought for approval of the shareholders because it will harm the ability to engagement with the chief executive officer. In addition to the roles mentioned above our compensation committee will also make recommendations to our board of directors regarding the awarding of employee equity grants. Our board of directors has adopted a compensation committee charter setting forth the responsibilities of the compensation committee, which are consistent with the provisions of the Companies Law, rules and regulations of the SEC and the NASDAQ Listing Rules. Our compensation committee presently consists of Mr. Steven Steinberg, Mr. Arye Weber and Mr. Ido Agmon. 91 Under Amendment 27 to the Companies Law, which became effective as of February 17, 2016, the audit committee of an Israeli public company, which has not adopted the corporate governance exceptions set forth in the Regulation, as described above, for certain companies listed on foreign stock exchanges, and which meets the Israeli Compensation Committee Composition Requirements is permitted to act as the compensation committee of the company in lieu of having a separate committee. On March 16, 2016 our board of directors resolved to have the audit committee assume the responsibilities of the compensation committee pursuant to this new provision in the Companies Law, and our audit committee acted as our compensation committee until July 13, 2016 when our Board of Directors resolved to adopt the corporate governance exceptions set forth in the Regulation, as described above, thereby exempting us from the audit and compensation committee composition requirements under the Companies Law, provided that we comply with the with the NASDAQ Listing Rules in connection with a majority of independent directors on the Board and in connection with the composition of each of the Audit Committee and the Compensation Committee, which such Listing Rules require to be two separate committees. Compensation Policy In accordance with the provisions of Amendment No. 20, public companies must adopt a compensation policy with respect to the terms of service and employment of their directors and officers. The compensation policy must be approved by the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and board of directors, and subject to limited exceptions, by the shareholders. Shareholder approval requires one of the following: (i) the majority of shareholder votes counted at general meeting including the majority of all of the votes of those shareholders who are non-controlling shareholders and do not have a personal interest in the approval of the compensation policy, who participate at the meeting (excluding abstentions) or (ii) the total number of votes against the proposal among the shareholders mentioned in paragraph (i) does exceed two percent (2%) of the voting rights in the company. Under special circumstances, the board of directors may approve the compensation policy despite the objection of the shareholders on the condition that the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and then the board of directors decide, on the basis of detailed arguments and after discussing again the compensation policy, that approval of the compensation policy, despite the objection of the meeting of shareholders, is for the benefit of the company. On January 12, 2014, Kitov Parent’s shareholders approved Kitov Parent’s initial compensation policy (as amended by the shareholders on November 20, 2014) which was in effect for a period of three years from the date of approval, until January 12, 2017 (the “Initial Compensation Policy”). As of the date of this annual report, Kitov Parent’s shareholders have not yet approved a new compensation policy (the “Compensation Policy”). Our Compensation Committee is presently working on finalizing the new Compensation Policy. Following approval by the Board of Directors of Kitov Parent, the proposed new Compensation Policy is expected to be published by Kitov Parent before the end of the second quarter of 2017, for the approval of shareholders of Kitov Parent. Until the new Compensation Policy is approved, any approvals for amendments to any office holder compensation will need the applicable corporate approvals required for compensation which deviates from an approved compensation policy. The Initial Compensation Policy did not, and the new Compensation Policy will not, on its own, grant any rights to our directors or officers. The Initial Compensation Policy includes, and the new Compensation Policy is expected to include both long term and short term compensation elements and is to be reviewed from time to time by our compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and board, according to the requirements of the Companies Law. In general, compensation for officers will be examined while taking into consideration the following parameters, including, among others (i) education, qualifications, expertise, seniority (with us in particular, and in the officer’s profession in general), professional experience and achievements of the officer; (ii) meeting by the officer of the targets set for him, if relevant; (iii) the officer’s position, the scope of his responsibility and previous wage agreements that were signed with him; and (iv) the ratio between the total cost of the proposed engagement terms of an officer and the total cost of the wages for all of our other employees, officers and contractors, and in particular compared to the average or median wage of such employees, officers and contractors and the effect of this ratio and difference, if any, on labor relations. 92 Under the Initial Compensation Policy, we are entitled to provide a compensation package to officers which may include fixed salary (a base salary and ancillary benefits), annual cash bonus, special bonuses and share-based compensation, or any combination thereof, and additional standard benefits (“Compensation Package”). An unofficial English translation of the full text of Kitov Parent’s Initial Compensation Policy is attached as an exhibit to this Annual Report on Form 20-F. Investment Committee Our board of directors has established an investment committee in order to oversee the management and investment of the Company’s cash and cash equivalents. This committee meets on an ad hoc basis as required and is empowered to establish guidelines and policies, as well as to make decisions, with respect to managing our financial assets. Since its establishment and to date, Mr. Simcha Rock coordinates the management of the committee. The present members of the committee are Mr. Rock, Mr. Weber, Mr. Tzror and Mr. Agmon. The investment committee provides periodic updates to the Board of Directors as required under the Companies Law. Our board of directors has adopted an investment committee charter setting forth the responsibilities of the investment committee. Science and Technology Committee Our board of directors has established a science and technology committee in order to advise and assist the Board of Directors of the Company in the oversight of the Company’s research and development and technology programs. This committee shall meet on an ad hoc basis as required, but not less frequently than as established by our board of directors. The present members of the committee are Dr. Waymack, Dr. Ben-Menachem, and Mr. Agmon. The science and technology committee provides periodic updates to the Board of Directors as required under the Companies Law. Our board of directors has adopted a science and technology committee charter setting forth the responsibilities of the investment committee. Internal Auditor Under the Companies Law, the board of directors of a public company must appoint an internal auditor based on the recommendation of the audit committee. The role of the internal auditor is, among other things, to examine whether a company’s actions comply with applicable law and orderly business procedure. Under the Companies Law, the internal auditor may not be a related party or an office holder or a relative of a related party or of an office holder, nor may the internal auditor be the company’s independent auditor or the representative of the same. A “related party” is defined in the Companies Law as (i) a holder of 5% or more of the issued share capital or voting power in a company, (ii) any person or entity who has the right to designate one or more directors or to designate the chief executive officer of the company, or (iii) any person who serves as a director or as a chief executive officer of the company. Until his resignation on June 8, 2016 (for reasons not connected to the Company) our internal auditor was Mr. Pinhas Bar-Shmuel, certified public accountant (Isr.). On July 13, 2016, our Board, of Directors, following the recommendation of our Audit Committee, resolved to appoint as the Company’s new internal auditor, Mr. Yisrael Gewirtz, a partner at Fahn Kanne Control Management Ltd., a member firm of Grant Thornton International. Fiduciary Duties and Approval of Specified Related Party Transactions and Compensation under Israeli Law Fiduciary Duties of Office Holders The Companies Law imposes a duty of care and a fiduciary duty on all office holders of a company. The duty of care of an office holder is based on definition of negligence under the Israeli Torts Ordinance (New Version) 5728-1968. This duty of care requires an office holder to act with the degree of proficiency with which a reasonable office holder in the same position would have acted under the same circumstances. The duty of care includes, among other things, a duty to use reasonable means, in light of the circumstances, to obtain: ● information on the business advisability of a given action brought for his or her approval or performed by virtue of his or her position; and ● all other important information pertaining to such action. 93 The fiduciary duty incumbent on an office holder requires him or her to act in good faith and for the benefit of the company, and includes, among other things, the duty to: ● refrain from any act involving a conflict of interest between the performance of his or her duties in the company and his or her other duties or personal affairs; ● refrain from any activity that is competitive with the business of the company; ● refrain from exploiting any business opportunity of the company for the purpose of gaining a personal advantage for himself or herself or others; and ● disclose to the company any information or documents relating to the company’s affairs which the office holder received as a result of his or her position as an office holder. We may approve an act specified above which would otherwise constitute a breach of the office holder’s fiduciary duty, provided that the office holder acted in good faith, the act or its approval does not harm the company, and the office holder discloses his or her personal interest a sufficient time before the approval of such act. Any such approval is subject to the terms of the Companies Law, setting forth, among other things, the appropriate corporate bodies of the company entitled to provide such approval, and the methods of obtaining such approval. Disclosure of Personal Interests of an Office Holder and Approval of Transactions The Companies Law requires that an office holder promptly disclose to the company any personal interest that he or she may have and all related material information or documents relating to any existing or proposed transaction by the company. An interested office holder’s disclosure must be made promptly and in any event no later than the first meeting of the board of directors at which the transaction is considered. An office holder is not obliged to disclose such information if the personal interest of the office holder derives solely from the personal interest of his or her relative in a transaction that is not considered an extraordinary transaction. Under the Companies Law, once an office holder has complied with the above disclosure requirement, a company may approve a transaction between the company and the office holder or a third party in which the office holder has a personal interest. However, a company may not approve a transaction or action that is not to the company’s benefit. Under the Companies Law, unless the articles of association of a company provide otherwise, a transaction with an office holder or with a third party in which the office holder has a personal interest, which is not an extraordinary transaction, requires approval by the board of directors. The Companies Law provides that such a transaction, which is not an extraordinary transaction, may be approved by the board of directors or a committee of the board of directors or any other entity (which has no personal interest in the transaction) authorized by the board of directors. Our amended and restated articles of association provide that transactions in which officers have a personal interest but not extraordinary transactions can be approved by our chief executive officer and chief financial officer (unless they have the personal interest; in which case it will be one of our directors instead of such interested officer). If the transaction considered is an extraordinary transaction with an office holder or third party in which the office holder has a personal interest, then audit committee approval is required prior to approval by the board of directors. For the approval of compensation arrangements with directors and executive officers, see “Item 6. Directors, Senior Management and Employees – B. Compensation .” Any persons who have a personal interest in the approval of a transaction that is brought before a meeting of the board of directors or the audit committee may not be present at the meeting or vote on the matter. However, if the chairman of the board of directors or the chairman of the audit committee has determined that the presence of an office holder with a personal interest is required, such office holder may be present at the meeting for the purpose of presenting the matter. Notwithstanding the foregoing, a director who has a personal interest may be present at the meeting and vote on the matter if a majority of the directors or members of the audit committee have a personal interest in the approval of such transaction. If a majority of the directors at a board of directors meeting have a personal interest in the transaction, such transaction also requires approval of the shareholders of the company. 94 A “personal interest” is defined under the Companies Law as the personal interest of a person in an action or in a transaction of the company, including the personal interest of such person’s relative or the interest of any other corporate body in which the person or such person’s relative is a director or general manager, a 5% shareholder or holds 5% or more of the voting rights, or has the right to appoint at least one director or the general manager, but excluding a personal interest stemming solely from the fact of holding shares in the company. A personal interest also includes (1) a personal interest of a person who votes according to a proxy of another person, including in the event that the other person has no personal interest, and (2) a personal interest of a person who gave a proxy to another person to vote on his or her behalf regardless of whether the discretion of how to vote lies with the person voting or not. An “extraordinary transaction” is defined under the Companies Law as any of the following: ● a transaction other than in the ordinary course of business; ● a transaction that is not on market terms; or ● a transaction that may have a material impact on the company’s profitability, assets or liabilities. Disclosure of Personal Interests of a Controlling Shareholder and Approval of Transactions The Companies Law also requires that a controlling shareholder promptly disclose to the company any personal interest that he or she may have and all related material information or documents relating to any existing or proposed transaction by the company. A controlling shareholder’s disclosure must be made promptly and in any event no later than the first meeting of the board of directors at which the transaction is considered. Extraordinary transactions with a controlling shareholder or in which a controlling shareholder has a personal interest, including a private placement in which a controlling shareholder has a personal interest, and the terms of engagement of the company, directly or indirectly, with a controlling shareholder or a controlling shareholder’s relative (including through a corporation controlled by a controlling shareholder), regarding the company’s receipt of services from the controlling shareholder, and if such controlling shareholder is also an office holder of the company, regarding his or her terms of employment, require the approval of each of (i) the audit committee or the compensation committee with respect to the terms of the engagement of the company, (ii) the board of directors and (iii) the shareholders, in that order. In addition, the shareholder approval must fulfill one of the following requirements: ● a majority of the shares held by shareholders who have no personal interest in the transaction and are voting at the meeting must be voted in favor of approving the transaction, excluding abstentions; or ● the shares voted by shareholders who have no personal interest in the transaction who vote against the transaction represent no more than 2% of the voting rights in the company. In addition, any extraordinary transaction with a controlling shareholder or in which a controlling shareholder has a personal interest with a term of more than three years requires the abovementioned approval every three years, however, such transactions not involving the receipt of services or compensation can be approved for a longer term, provided that the audit committee determines that such longer term is reasonable under the circumstances. The Companies Law requires that every shareholder that participates, in person, by proxy or by voting instrument, in a vote regarding a transaction with a controlling shareholder or in which such has a personal interest, must indicate in advance or in the ballot whether or not that shareholder has a personal interest in the vote in question. Failure to so indicate will result in the invalidation of that shareholder’s vote. For more information regarding exemptions from shareholder approval for extraordinary transactions with a controlling shareholder, see “Item 10 – Additional Information – B. Memorandum and Articles of Association – Board of Directors.” 95 Compensation of Directors and Executive Officers Directors. Under Amendment No. 20, the compensation of our directors with respect their service as a director, as well as their engagement in other roles (if the director is so engaged) requires the approval of our compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law), the subsequent approval of the board of directors and, unless exempted under the regulations promulgated under the Companies Law, the approval of the shareholders at a general meeting. If the compensation of a director is inconsistent with our duly approved compensation policy, or compensation is approved prior to the approval of a new compensation policy upon expiration of the term of the previous compensation policy, then, provided that those provisions that must be included in the compensation policy according to the Companies Law have been considered by the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and board of directors, shareholder approval will also be required, as follows: ● at least a majority of the shares held by all shareholders who are not controlling shareholders and do not have a personal interest in such matter, present and voting at such meeting, are voted in favor of the compensation package, excluding abstentions; or ● the total number of shares of non-controlling shareholders and shareholders who do not have a personal interest in such matter voting against the compensation package does not exceed 2% of the aggregate voting rights in the company. If the amounts of cash compensation to be paid to each independent director will be the same as that which is paid to our other independent directors, and will not be in excess of the maximum amounts set forth under Regulations 4, 5 and 7 of the Companies Regulations (Rules Concerning Compensation and Expenses for an External Director), 5760-2000, then the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and board of directors may determine that payment of such compensation is an engagement which does not require the approval of our shareholders pursuant to the leniencies set forth in Regulation 1A(2) under the Companies Regulations (Relief Regulations Regarding Transactions with Interested Parties, 5760-2000 (hereinafter: the “Relief Regulations”). Executive Officers Other Than the Chief Executive Officer. The Companies Law requires the compensation of a public company’s executive officers (other than the chief executive officer) who are not directors at the company to be approved by, first, the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law), second, by the company’s board of directors and third, if such compensation arrangement is inconsistent with the company’s duly approved compensation policy, or compensation is approved prior to the approval of a new compensation policy upon expiration of the term of the previous compensation policy, the company’s shareholders (by a special majority vote as discussed above with respect to the approval of director compensation). However, if the shareholders of the company do not approve a compensation arrangement with an executive officer that is inconsistent with the company’s stated compensation policy, the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and board of directors may override the shareholders’ decision if each of the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and the board of directors provide detailed reasons for their decision. Non-material amendments to the compensation of a public company’s executive officers (other than the chief executive officer) may be approved by the chief executive officer of the company if the company’s compensation policy has established that such amendments within the parameters established in the compensation policy may be approved by the chief executive officer, and the compensation is consistent with the company’s compensation policy. Chief Executive Officer. The compensation paid to a public company’s chief executive officer who is not a director at the company is required to be approved by, first, the company’s compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law); second, the company’s board of directors, and, unless exempted under the regulations promulgated under the Companies Law, by the company’s shareholders (by a special majority vote as discussed above with respect to the approval of director compensation). However, if the shareholders of the company do not approve the compensation arrangement with the chief executive officer who is not a director at the company, the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and board of directors may override the shareholders’ decision if each of the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and the board of directors provide a detailed report for their decision. The renewal or extension of the engagement with a public company’s chief executive officer need not be approved by the shareholders of the company if the terms and conditions of such renewal or extension are no more beneficial than the previous engagement or there is no substantial difference in the terms and conditions under the circumstances, and the terms and conditions of such renewal or extension are in accordance with the company’s compensation policy. 96 The compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and board of directors approval should be in accordance with the company’s duly approved compensation policy; however, in special circumstances, they may approve compensation terms of a chief executive officer that are inconsistent with such policy provided that they have considered those provisions that must be included in the compensation policy according to the Companies Law and that shareholder approval was obtained (by a special majority vote as discussed above with respect to the approval of director compensation). The compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) may waive the shareholder approval requirement with regards to the approval of the initial engagement terms of a candidate for the chief executive officer position, if they determine that the compensation arrangement is consistent with the company’s stated compensation policy, and that the chief executive officer did not have a prior business relationship with the company or a controlling shareholder of the company and that subjecting the approval of the engagement to a shareholder vote would impede the company’s ability to employ the chief executive officer candidate. The engagement with a public company’s office holder need not be approved by the shareholders of the company with respect to the period from the commencement of the engagement until the next shareholder meeting convened by the company, if the terms and conditions of such engagement were approved by the compensation committee (or audit committee acting in lieu of the compensation company) and the board of directors of the company, the terms and conditions of such engagement are in accordance with the company’s compensation policy approved in accordance with Section 267A of the Companies Law, and if the terms and conditions of such engagement are no more beneficial than the terms and conditions of the person previously serving in such role or there is no substantial difference in the terms and conditions of the previous engagement versus the new one under the circumstances, including the scope of engagement. Duties of Shareholders Under the Companies Law, a shareholder has a duty to refrain from abusing its power in the company and to act in good faith and in an acceptable manner in exercising its rights and performing its obligations to the company and other shareholders, including, among other things, when voting at meetings of shareholders on the following matters: ● an amendment to the articles of association; ● an increase in the company’s authorized share capital; ● a merger; and ● the approval of related party transactions and acts of office holders that require shareholder approval. A shareholder also has a general duty to refrain from discriminating against other shareholders. The remedies generally available upon a breach of contract will also apply to a breach of the shareholder duties mentioned above, and in the event of discrimination against other shareholders, additional remedies are available to the injured shareholder. In addition, any controlling shareholder, any shareholder that knows that its vote can determine the outcome of a shareholder vote and any shareholder that, under a company’s articles of association, has the power to appoint or prevent the appointment of an office holder, or any other power with respect to a company, is under a duty to act with fairness towards the company. The Companies Law does not describe the substance of this duty except to state that the remedies generally available upon a breach of contract will also apply in the event of a breach of the duty to act with fairness, taking the shareholder’s position in the company into account. 97 Exculpation, Insurance and Indemnification of Directors and Officers Under the Companies Law, a company may not exculpate an office holder from liability for a breach of a fiduciary duty. An Israeli company may exculpate an office holder in advance from liability to the company, in whole or in part, for damages caused to the company as a result of a breach of duty of care but only if a provision authorizing such exculpation is included in its articles of association. Our amended and restated articles of association include such a provision. The company may not exculpate in advance a director from liability arising out of a prohibited dividend or distribution to shareholders. Under the Companies Law and the Securities Law, 5738 – 1968 (“Securities Law”) a company may indemnify an office holder in respect of the following liabilities, payments and expenses incurred for acts performed by him or her as an office holder, either in advance of an event or following an event, provided its articles of association include a provision authorizing such indemnification: ● a monetary liability incurred by or imposed on him or her in favor of another person pursuant to a judgment, including a settlement or arbitrator’s award approved by a court. However, if an undertaking to indemnify an office holder with respect to such liability is provided in advance, then such an undertaking must be limited to events which, in the opinion of the board of directors, can be foreseen based on the company’s activities when the undertaking to indemnify is given, and to an amount or according to criteria determined by the board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned foreseen events and amount or criteria; ● reasonable litigation expenses, including reasonable attorneys’ fees, incurred by the office holder as a result of an investigation or proceeding instituted against him or her by an authority authorized to conduct such investigation or proceeding, provided that (i) no indictment was filed against such office holder as a result of such investigation or proceeding; and (ii) no financial liability was imposed upon him or her as a substitute for the criminal proceeding as a result of such investigation or proceeding or, if such financial liability was imposed, it was imposed with respect to an offense that does not require proof of criminal intent or in connection with a monetary sanction; ● a monetary liability imposed on him or her in favor of a payment for a breach offended at an Administrative Procedure (as defined below) as set forth in Section 52(54)(a)(1)(a) to the Securities Law; ● expenses associated with an Administrative Procedure conducted regarding an office holder, including reasonable litigation expenses and reasonable attorneys’ fees; and ● reasonable litigation expenses, including attorneys’ fees, incurred by the office holder or imposed by a court in proceedings instituted against him or her by the company, on its behalf, or by a third party, or in connection with criminal proceedings in which the office holder was acquitted, or as a result of a conviction for an offense that does not require proof of criminal intent. An “Administrative Procedure” is defined as a procedure pursuant to chapters H3 (Monetary Sanction by the Israeli Securities Authority), H4 (Administrative Enforcement Procedures of the Administrative Enforcement Committee) or I1 (Arrangement to prevent Procedures or Interruption of procedures subject to conditions) to the Securities Law. Under the Companies Law and the Securities Law, a company may insure an office holder against the following liabilities incurred for acts performed by him or her as an office holder if and to the extent provided in the company’s articles of association: ● a breach of a fiduciary duty to the company, provided that the office holder acted in good faith and had a reasonable basis to believe that the act would not harm the company; ● a breach of duty of care to the company or to a third party, to the extent such a breach arises out of the negligent conduct of the office holder; ● a monetary liability imposed on the office holder in favor of a third party; ● a monetary liability imposed on the office holder in favor of an injured party at an Administrative Procedure pursuant to Section 52(54)(a)(1)(a) of the Securities Law; and ● expenses incurred by an office holder in connection with an Administrative Procedure, including reasonable litigation expenses and reasonable attorneys’ fees. 98 Under the Companies Law, a company may not indemnify, exculpate or insure an office holder against any of the following: ● a breach of fiduciary duty, except for indemnification and insurance for a breach of the fiduciary duty to the company to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company; ● a breach of duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office holder; ● an act or omission committed with intent to derive illegal personal benefit; or ● a fine or forfeit levied against the office holder. Under the Companies Law, exculpation, indemnification and insurance of office holders must be approved by the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and the board of directors and, with respect to directors or controlling shareholders, their relatives and third parties in which such controlling shareholders have a personal interest, also by the shareholders. The compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and board of directors may approve the inclusion of each director under the coverage of our directors and officers insurance policy without the need for shareholder approval, if they determine that, pursuant to the leniencies set forth in Regulation 1B1 of the Relief Regulations, the provision of such insurance coverage to the directors under our directors and officers insurance policy is being granted on market terms, and with no material adverse effect on our profits, assets or obligations, and is consistent with our Compensation Policy which was approved by our shareholders in accordance with the Companies Law, and is the same as the coverage provided to all of our other directors. The compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and board of directors may approve the issuance to directors of our standard letters of waiver of liability and indemnification, immediately, as of the date of their respective appointments as directors, with the approval by our shareholders being deferred to the next general meeting of our shareholders following such approval, if they determine that, pursuant to the leniencies set forth in Regulation 1B4 of the Relief Regulations, that the letters which we issue to the appointed directors are consistent with our Compensation Policy which was approved by our shareholders in accordance with the Companies Law, and are no more beneficial to the Appointed Directors as such letters previously issued to our other directors. Our amended and restated articles of association permit us to exculpate, indemnify and insure our office holders to the fullest extent permitted or to be permitted by law. Our office holders are currently covered by a directors’ and officers’ liability insurance policy. We have entered into agreements with each of our current office holders exculpating them from a breach of their duty of care to us to the fullest extent permitted by law, subject to limited exceptions, and undertaking to indemnify them to the fullest extent permitted by law, subject to limited exceptions, including with respect to liabilities resulting from our Registration Statements on Form F-1 filed in connection with our initial public offering in the U.S. during November 2015 and in connection with our July 2016 public offering, to the extent that these liabilities are not covered by insurance. This indemnification is limited to events determined as foreseeable by the board of directors based on our activities, and to an amount or according to criteria determined by the board of directors as reasonable under the circumstances. The maximum aggregate amount of indemnification that we may pay to our office holders based on such indemnification agreement is with respect to all permitted indemnification, including in connection with a public offering of our securities, an amount equal to 25% of our shareholders’ equity on a consolidated basis, based on our most recent financial statements made publicly available before the date on which the indemnification payment was made. Such indemnification amounts are in addition to any insurance amounts. Each office holder who agrees to receive this letter of indemnification also gives his approval to the termination of all previous letters of indemnification that we have provided to him or her in the past, if any. 99 On February 7, 2017, we announced that the Israeli Securities Authority began a formal investigation (the “ISA Investigation”) into, amongst other matters, our public disclosures around our lead drug candidate, KIT-302. For more information on the ISA Investigation see “Item 8. Financial Information – A. Financial Statements and Other Financial Information – Legal Proceedings”. Mr. Isaac Israel, Kitov’s CEO, was detained for questioning and subsequently released on the same day, under certain limited restrictive terms established by a court, as per, what the Company’s outside attorneys have advised us is, standard practice in such Israeli Securities Authority investigations and enforcement proceedings. On February 9, 2017, the Board of Directors of Kitov Parent, resolved to approve the payment of one hundred thousand NIS (NIS 100,000), as needed, for the benefit of Mr. Israel, for the purpose of placing a bond required in order to secure Mr. Israel’s return from overseas travel required in the performance of his duties as CEO of Kitov Parent. The resolution was adopted, inter alia, in accordance with the letter of indemnification between Kitov Parent and Mr. Israel presently in effect, and in accordance with Israeli applicable law. To date, Mr. Israel has not yet traveled out of Israel under a bond placed by Kitov Parent. We expect to indemnify our officers and directors for obligations, including the deductibles for our directors and officers liability insurance policy, they may be required to pay and costs and expenses they may incur related to the ISA Investigation referred to above and the 2015 Motion, the 2017 Motions and U.S. Class Actions described in Item 8. Financial Information – A. Financial Statements and Other Financial Information – Legal Proceedings, pursuant to the letters of indemnification issued to our directors and officers. Kitov Parent’s audit committee and board of directors determined that Kitov Parent would indemnify and undertakes in advance to indemnify the officers provided with letters of indemnity (the "Indemnity Letters"). The Indemnity Letters also received the approval of the shareholders of Kitov Parent. According to the Indemnity Letters the total accumulative sum of indemnification paid by Kitov Parent to all the officers in Kitov Parent according to the Indemnity Letter that were issued by Kitov Parent will not exceed a sum equal to 25% of Kitov Parent’s equity attributed to Kitov Parent’s shareholders according to its latest audited or reviewed consolidated financial statements, as the case may be, as of the date of indemnification. The payment of the indemnity sum will not prejudice the Officers right to receive insurance coverage benefits. Once Kitov Parent has paid indemnity sums to its Officers at the maximum indemnity sum, Kitov Parent will not bear additional indemnity sums unless the payment of these additional sums is approved by authorized corporate bodies according to the law applicable at the time of payment of the additional indemnity sums, and subject to an amendment in Kitov Parent’s articles of association, if such is required by applicable law at such time. Insofar as indemnifications for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling the registrant pursuant to the foregoing provisions, the registrant has been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable. To our knowledge, other than with respect to the 2015 Motion, the 2017 Motions, the U.S. Class Actions, and the ISA Investigation, which are all described further in “Item 8. Financial Information – A. Financial Statements and Other Financial Information – Legal Proceedings”, there is no pending litigation or proceeding against any of our office holders as to which indemnification is being, or may be sought, nor are we aware of any other pending or threatened litigation or proceeding that may result in claims for indemnification by any office holder. D. Employees As of December 31, 2016, we had: (i) four consultants and service providers providing management and financial services, including our chief executive officer, chief financial officer and our chairman of the board, who also fulfills duties and responsibilities of chief medical officer; (ii) one employee serving as our vice president of business development; (iii) one employee providing in-house legal services (iv) one employee serving as our office administrator; and (v) two consultants providing research and development services. As of December 31, 2015 and 2014, we had: (i) four consultants and service providers providing management and financial services, including our chief financial officer and our chairman of the board, who also fulfills duties and responsibilities of chief medical officer; (ii) one employee serving as our chief executive officer; (iii) one employee providing in-house legal services; and (iv) four consultants providing research and development services. 100 While none of our employees is party to a collective bargaining agreement, in Israel we are subject to certain labor statutes and national labor court precedent rulings, as well as to certain provisions of the collective bargaining agreements between the Histadrut (General Federation of Labor in Israel) and the Coordination Bureau of Economic Organizations including the Industrialists' Associations. These provisions of collective bargaining agreements are applicable to our Israeli employees by virtue of extension orders issued in accordance with relevant labor laws by the Israeli Ministry of Labor and Welfare, and which apply such agreement provisions to our employees even though they are not directly part of a union that has signed a collective bargaining agreement. The laws and labor court rulings that apply to our employees principally concern the minimum wage laws, procedures for dismissing employees, determination of severance pay, leaves of absence (such as annual vacation or maternity leave), sick pay and other conditions for employment. The extension orders which apply to our employees principally concern the requirement for length of the work day and workweek, mandatory contributions to a pension fund, annual recreation allowance, travel expenses payment and other conditions of employment. We generally provide our employees with benefits and working conditions beyond the required minimums. Israeli law generally requires severance pay, which may be funded by managers' insurance and/or a pension fund described below, upon the retirement or death of an employee or termination of employment without cause (as defined in the law). Furthermore, Israeli employees and employers are required to pay predetermined sums to the National Insurance Institute, which is similar to the United States Social Security Administration. Such amounts also include payments for national health insurance. A general practice also followed by us is the contribution of funds on behalf of most of our employees either to a fund known as managers' insurance, to a pension fund or to a combination of both. We have never experienced labor-related work stoppages or strikes and believe that our relations with our employees are satisfactory. E. Share Ownership The following table sets forth information with respect to the beneficial ownership of Kitov Parent’s ordinary shares as of April 25, 2017 by: ● each of our directors, executive officers and senior management and employees individually; and ● all of our executive officers, directors, and senior management and employees as a group. The beneficial ownership of Kitov Parent’s ordinary shares in this table is determined in accordance with the rules of the SEC. Under these rules, a person is deemed to be a beneficial owner of a security if that person has or shares voting power, which includes the power to vote or to direct the voting of the security, or investment power, which includes the power to dispose of or to direct the disposition of the security. For purposes of the table below, we deem ordinary shares of Kitov Parent issuable pursuant to options or warrants that are currently exercisable or exercisable within 60 days of April 25, 2017, if any, to be outstanding and to be beneficially owned by the person holding the options or warrants for the purposes of computing the percentage ownership of that person, but we do not treat them as outstanding for the purpose of computing the percentage ownership of any other person. The percentage of ordinary shares beneficially owned is based on 164,529,696 ordinary shares of Kitov Parent’s issued and outstanding as of April 25, 2017 (not including 21 shares held in treasury). 101 Name of Beneficial Owner Directors John Paul Waymack(1) Isaac Israel(2) Simcha Rock(3) Steven Steinberg Ido Agmon Arye Weber Ran Tzror Revital Stern-Raff Senior Management and Employees Gil Ben-Menachem(4) Avraham Ben-Tzvi(5) Hadas Reuveni(6) Ordinary Shares Beneficially Owned Number Percentage 3,214,969 15,385 99,148 0 0 0 0 0 * * 0 1.92% *% *% *% *% *% *% *% *% *% *% Total (directors, senior management and employees) 3,478,794 2.08% * Less than 1% (1) (2) (3) (4) (5) Includes 2,184,431 ordinary shares held directly by JPW PCH LLC, a Virginia limited liability company, owned 51% by Dr. John Paul Waymack, and 30,538 ordinary shares held directly by Dr. John Paul Waymack, and Series A warrants to purchase 50,000 ADS (representing 1,000,000 of our ordinary shares), that are currently exercisable, which are held by Dr. Waymack and some of his immediate family members who are minors. The number of shares set forth in the table as beneficially owned by Dr. Waymack, does not include 1,389,456 ordinary shares issuable upon exercise of outstanding options, which, while vested on a time-based vesting basis, are as of April 25, 2017 not necessarily exercisable within 60 days due to the required fulfillment of certain other contingencies and clawback provisions April 25, 2017 under the terms of the grants. Dr. John Paul Waymack may be deemed to beneficially own all of the shares held directly by JPW PCH LLC. To the best of our knowledge, and as informed to us by Dr. John Paul Waymack, Dr. Waymack has irrevocably assigned to an unaffiliated minority shareholder of JPW PCH LLC, any of the decision making with respect to any acquisitions or dispositions by JPW PCH LLC of any of our securities. The number of shares set forth in the table as beneficially owned by Mr. Israel, does not include 551,619 ordinary shares issuable upon exercise of outstanding options currently exercisable, which, while vested on a time-based vesting basis, are as of April 25, 2017 not necessarily exercisable within 60 days due to the required fulfillment of certain other contingencies and clawback provisions under the terms of the grants. Includes 91,455 ordinary shares issuable upon exercise of outstanding options currently exercisable. The exercise price of these options is NIS 10.40 per share and the options expire in July 2017. The number of shares set forth in the table as beneficially owned by Mr. Rock, does not include 165,486 ordinary shares issuable upon exercise of outstanding options currently exercisable, which, while vested on a time-based vesting basis, are as of April 25, 2017 not necessarily exercisable within 60 days due to the required fulfillment of certain other contingencies and clawback provisions under the terms of the grants. Includes ordinary shares issuable upon exercise of outstanding options currently exercisable comprising less than 1% of Kitov Parent’s ordinary shares. Includes ordinary shares as well as ordinary shares issuable upon exercise of outstanding options currently exercisable comprising less than 1% of Kitov Parent’s ordinary shares. 2016 Equity-Based Incentive Plan On April 18, 2016, we adopted the Kitov Pharmaceutical Holdings Ltd. 2016 Equity-Based Incentive Plan, or the 2016 Equity Incentive Plan. The 2016 Equity Incentive Plan provides for the granting to our directors, officers, employees and consultants and to the directors, officers, employees and consultants of our subsidiaries and affiliates, of equity-based incentive awards, including, amongst others, options, restricted share units (RSUs), restricted shares, with either ordinary shares of Kitov Parent or Company ADSs underlying the applicable award. The 2016 Equity Incentive Plan provides for awards to be granted at the determination of Kitov Parent’s board of directors (who is entitled to delegate its powers under the 2016 Equity Incentive Plan to the compensation committee or audit committee of Kitov Parent’s board of directors) in accordance with applicable laws. The exercise price and vesting period of awards are determined by Kitov Parent’s board of directors. The initial number of ordinary shares reserved for the grant of awards under the 2016 Equity Incentive Plan is 12,000,000 ordinary shares, or the equivalent number of ADSs representing such number of Kitov Parent’s ordinary shares (presently, at the ratio of 20 ordinary shares to 1 ADS, such number is equal to 600,000 ADSs). Kitov Parent’s board of directors may, subject to any other approvals required under any applicable law, increase or decrease the number of ordinary shares to be reserved under the 2016 Equity Incentive Plan. As of April 25, 2017 there were non-tradable options exercisable into 9,750,130 ordinary shares issuable upon the exercise of outstanding options under the 2016 Equity Incentive Plan (such number of ordinary shares would comprise 487,507 of Kitov Parent’s ADSs). 102 The 2016 Equity Incentive Plan will be effective until the earliest of (a) its cancellation by the board of directors of Kitov Parent and (b) April 18, 2026. Nevertheless, awards granted prior to the 2016 Equity Incentive Plan’s expiration date, whether vested or not vested up to that date, will remain effective and will not expire prior to their expiration date as set forth in the notice of grant of award (but in any event not in excess of 10 (ten) years from the allocation date). Upon termination of engagement with the Company for any reason, other than in the event of death or for cause, all unvested options will expire and all vested options at time of termination will generally be exercisable within up to twelve (12) months after the date of such termination, unless otherwise determined by the board of directors (or the committee, as applicable), subject to the terms of the 2016 Equity Incentive Plan and the governing award agreement. If we terminate a grantee for cause (as defined in the 2016 Equity Incentive Plan) the grantee’s right to exercise all vested and unvested options granted to him will expire immediately, unless otherwise determined by the board of directors (or the committee, as applicable). Upon termination of engagement with the Company due to death, all the vested options at the time of termination will be exercisable by the grantee’s heirs or estate, for one (1) year from the date of death, unless otherwise determined by the board of directors (or the committee, as applicable), subject to the terms of the 2016 Equity Incentive Plan and the governing award agreement. The 2016 Equity Incentive Plan enables us to grant awards through one of the following Israeli tax programs, at our discretion and subject to the applicable legal limitations: (a) according to section 102 of the Israeli Income Tax Ordinance, through a program with a trustee that is appointed by us, (b) according to section 102 of the Israeli Income Tax Ordinance, without a trustee, or (c) according to the provisions of section 3(9) in the Israeli Income Tax Ordinance. The 2016 Equity Incentive Plan also enables us to grant options as Incentive Stock Options for U.S. tax purposes. The 2016 Equity Incentive Plan includes directives for protecting the option holders during the exercise period with respect to distribution of bonus stock, issue of rights, splitting or consolidating our share capital and dividend distribution. We will be entitled at our sole discretion, to change the terms of the 2016 Equity Incentive Plan and/or replace it and/or terminate it regarding future grants at any time, as we deem appropriate. It is also clarified that we will be entitled to change the terms of 2016 Equity Incentive Plan regarding grants that were granted to the grantees, provided that the terms of the options which were already granted will not be changed in a way that may materially impair the rights of the grantees, without the consent of award grantees holding a majority in interest of the awards so affected, and in the event that such consent is obtained, all awards so affected shall be deemed amended, and the holders thereof shall be bound, as set forth in such consent. Kitov Parent’ board of directors will determine, at its sole discretion, if a certain change may materially impair the rights of the grantee. In May 2016, Kitov Parent received from the Securities Authority of the State of Israel an exemption from prospectus requirements pursuant to the prevailing laws of the State of Israel, with respect to the offering of any securities of Kitov Parent issuable pursuant to the 2016 Equity Incentive Plan, In accordance with the terms of such exemption, in lieu of Kitov Parent filing an outline of offering in connection with the 2016 Equity Incentive Plan, Kitov Parent will provide without charge to each award grantee in Israel, upon the oral or written request of such person, Hebrew translations of the Registration Statement on Form S-8 filed in connection with the 2016 Equity Incentive Plan and the 2016 Equity Incentive Plan. Administration of the 2016 Equity Incentive Plan The 2016 Equity Incentive Plan is administered by Kitov Parent’s board of directors, regarding the granting of awards and the terms of award grants, including exercise price, method of payment, vesting schedule, acceleration of vesting and the other matters necessary in the administration of such plans. Awards granted under the 2016 Equity Incentive Plan to eligible Israeli employees, officers and directors and which are granted under Section 102 of the Israel Income Tax Ordinance pursuant to which the awards or the ordinary shares (or ADSs in accordance with a ruling from the Israel Tax Authority dated June 19, 2016, or Tax Ruling) issued upon their exercise must be allocated or issued to a trustee and be held in trust for two years from the date upon which such awards were granted in order to benefit from the provisions of Section 102. Under Section 102, any tax payable by an grantee from the grant or exercise of the awards is deferred until the transfer of the awards or ordinary shares (or ADSs; in accordance with the Tax Ruling) by the trustee to the grantee or upon the sale of the awards or ordinary shares (or ADSs in accordance with the Tax Ruling), and gains may qualify to be taxed as capital gains at a rate equal to 25%, subject to compliance with specified conditions. 103 2013 Option Plan On November 27, 2013, Kitov Parent adopted the 2013 Kitov Pharmaceutical Holdings Ltd. Stock Option Allocation Plan, or the 2013 Option Plan. The 2013 Option Plan provides for the granting of options to our directors, officers, employees and consultants and to the directors, officers, employees and consultants of our subsidiaries and affiliates. The 2013 Option Plan provides for options to be granted at the determination of Kitov Parent’s board of directors (who is entitled to delegate its powers under the 2013 Option Plan to Kitov Parent’s compensation committee) in accordance with applicable laws. The exercise price and vesting period are determined by Company’s board of directors. As of April 25, 2017, there were 1,833,753 non-tradable options exercisable into 182,393 ordinary shares issuable upon the exercise of outstanding options under the 2013 Option Plan. The 2013 Option Plan will be effective until the earliest of (a) its cancellation by Kitov Parent’s board of directors and (b) October 31, 2023. Nevertheless, options granted up to the 2013 Option Plan’s expiration date, whether vested or not vested up to that date, will remain effective and will not expire prior to their expiration date (within 10 (ten) years from the allocation date). Upon termination of employment for any reason, other than in the event of death or for cause, all unvested options will expire and all vested options at time of termination will generally be exercisable for 90 days following termination, subject to the terms of the 2013 Option Plan and the governing option agreement. If we terminate a grantee for cause (as defined in the 2013 Option Plan) the grantee’s right to exercise all vested and unvested the options granted to him will expire immediately. Upon termination of employment due to death, all the vested options at the time of termination will be exercisable by the grantee’s heirs or estate, for twelve (12) months from the latest of: (i) death or (ii) option expiration date, subject to the terms of the 2013 Option Plan and the governing option agreement. The 2013 Option Plan enables us to grant options through one of the following tax programs, at our discretion and subject to the applicable legal limitations: (a) according to section 102 of the Israeli Income Tax Ordinance, through a program with a trustee that is appointed by us or (b) according to the provisions of section 3(i) in the Israeli Income Tax Ordinance. The 2013 Option Plan includes directives for protecting the option holders during the exercise period with respect to distribution of bonus stock, issue of rights, splitting or consolidating our share capital and dividend distribution. We will be entitled at our sole discretion, to change the terms of the 2013 Option Plan and/or replace it and/or terminate it regarding future grants at any time, as we deem appropriate. It is also clarified that we will be entitled to change the terms of 2013 Option Plan regarding grants that were granted to the grantees, provided that the terms of the options which were already granted will not be changed in a way that may materially impair the rights of the grantees, without the consent of the grantees. Kitov Parent’s board of directors will determine, at its sole discretion, if a certain change may materially impair the rights of the grantee. Without limiting the foregoing, in every case of a material event whereby (i) Kitov Parent will become a private company with shares no longer be traded on a stock exchange; (ii) there occurs a restructuring, including merger transaction in which Kitov Parent is not the surviving corporation or as a result of which there is a change in control; (iii) there occurs an arrangement between Kitov Parent and its creditors and/or shareholders and/or option holders; (iv) there occurs the sale of all or a substantial part of Kitov Parent’s assets; or (v) there occurs a liquidation of Kitov Parent, Kitov Parent’s board of directors, in its sole discretion, may adjust and change the terms of the options according to the plan for all the grantees or to certain grantees, in its sole discretion, including by (i) accelerating the vesting period of unvested options and (ii) replacing vested options with securities of the purchaser or any party related to the purchaser or other compensation to the grantee. Unless otherwise determined by the board of directors, non-vested options will expire soon before the material event or will be exercised, according to the decision of the board of directors. The board of directors will have the right to require the grantees to exercise all the vested options, soon before the occurrence of the material event and any option that will not be exercised will expire and will be devoid of any value. 104 Administration of Our 2013 Option Plan Our 2013 Option Plan is administered by Kitov Parent’s board of directors, regarding the granting of options and the terms of option grants, including exercise price, method of payment, vesting schedule, acceleration of vesting and the other matters necessary in the administration of these plans. Options granted under the 2013 Option Plan to eligible Israeli employees, officers and directors are granted under Section 102 of the Israel Income Tax Ordinance pursuant to which the options or the ordinary shares issued upon their exercise must be allocated or issued to a trustee and be held in trust for two years from the date upon which such options were granted in order to benefit from the provisions of Section 102. Under Section 102, any tax payable by an employee from the grant or exercise of the options is deferred until the transfer of the options or ordinary shares by the trustee to the employee or upon the sale of the options or ordinary shares, and gains may qualify to be taxed as capital gains at a rate equal to 25%, subject to compliance with specified conditions. Form S-8 registration statements On May 20, 2016 Kitov Parent filed a registration statement on Form S-8 under the Securities Act to register 12,000,000 ordinary shares of Kitov Parent issued or reserved to be issued under our 2016 Equity Incentive Plan. We intend to file one or more additional registration statements on Form S-8 under the Securities Act to register ordinary shares of Kitov Parent issued or reserved to be issued under the 2016 Equity Incentive Plan. The registration statements on Form S-8 become effective automatically upon filing. Ordinary shares issued upon exercise of a share option or other award and registered pursuant to the Form S-8 registration statement will, subject to vesting provisions and Rule 144 volume limitations applicable to our affiliates, be available for sale in the open market immediately unless they are subject to the 180-day lock-up or, if subject to the lock-up, immediately after the 180-day lock-up period expires. ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS A. Major Shareholders The following table sets forth information with respect to the beneficial ownership of Kitov Parent’s ordinary shares as of April 25, 2017 by each person or entity known by us to own beneficially more than 5% of Kitov Parent’s outstanding ordinary shares. The beneficial ownership of Kitov Parent’s ordinary shares in this table is determined in accordance with the rules of the SEC. Under these rules, a person is deemed to be a beneficial owner of a security if that person has or shares voting power, which includes the power to vote or to direct the voting of the security, or investment power, which includes the power to dispose of or to direct the disposition of the security. For purposes of the table below, we deem ordinary shares issuable pursuant to options or warrants that are currently exercisable or exercisable within 60 days of April 25, 2017, if any, to be outstanding and to be beneficially owned by the person holding the options or warrants for the purposes of computing the percentage ownership of that person, but we do not treat them as outstanding for the purpose of computing the percentage ownership of any other person. The percentage of ordinary shares beneficially owned is based on 164,529,696 ordinary shares (not including 21 shares held in treasury). The data presented is based on information provided to us by the holders, or disclosed in public regulatory filings in the U.S. or Israel, in accordance with the applicable law. None of our shareholders has different voting rights from other shareholders. To the best of our knowledge, we are not owned or controlled, directly or indirectly, by another corporation or by any foreign government. We are not aware of any arrangement that may, at a subsequent date, result in a change of control of our company. Unless otherwise noted below, all references to “ordinary shares” refers to ordinary shares of Kitov Parent. 105 Name of Beneficial Owner 5% or greater shareholders Shares Beneficially Owned Number Percentage Goldman Hirsh Partners Ltd./Dr. Gil Pogozelich (1) 11,292,508 6.8% (1) On January 13, 2017, we issued 11,292,508 ordinary shares to Katzenell Dimant Trustees Ltd. as trustee holding such shares in escrow on behalf of us and Goldman Hirsh Partners Ltd. (GHP), a privately owned Israeli company. The ordinary shares were issued as part of the consideration paid to GHP for the sale to us of its holdings in TyrNovo Ltd. The ordinary shares were issued on a private placement basis in Israel pursuant to exemptions from the prospectus requirements under applicable Israeli securities laws and from the registration requirements of the United States Securities Act of 1933, as amended. GHP has signed a Shareholder’s Undertaking in connection with the ordinary shares containing, amongst other matters, a prohibition on transfer of such ordinary shares until January 13, 2018 and certain standstill limitations. GHP agreed to vote its ordinary shares, subject to certain exceptions relating to significant corporate transactions, in accordance with the recommendation of our board of directors and in favor of persons nominated and recommended to serve as directors by the board, and has granted us a proxy to ensure GHP’s compliance with such voting undertakings. It is our understanding, to the best of our knowledge, that GHP is controlled by Dr. Gil Pogozelich, an Israeli citizen and resident. Except as indicated in footnotes to this table, we believe that the shareholders named in this table have sole voting and investment power with respect to all shares shown to be beneficially owned by them, based on information provided to us by such shareholders. Changes in Percentage Ownership by Major Shareholders Goldman Hirsch Partners Ltd. On January 12, 2017, Kitov Parent acquired a controlling equity stake in TyrNovo Ltd. from Goldman Hirsch Partners Ltd. (GHP), its majority shareholder, for consideration of USD 2 million in cash and 11,292,508 ordinary shares of Kitov Parent, equivalent to USD 1.8 million based on the closing price of Kitov Parent’s ordinary shares on the TASE on January 11, 2017. At closing of the transaction, on January 13, 2017 Kitov Parent issued 11,292,508 ordinary shares to Katzenell Dimant Trustees Ltd. as trustee holding such shares in escrow on behalf of Kitov Parent and GHP. The ordinary shares were issued on a private placement basis in Israel pursuant to exemptions from the prospectus requirements under applicable Israeli securities laws and from the registration requirements of the United States Securities Act of 1933, as amended. GHP has signed a Shareholder’s Undertaking in connection with the ordinary shares containing, amongst other matters, a prohibition on transfer of such ordinary shares until January 13, 2018 and certain standstill limitations. Pursuant to such undertaking, GHP has agreed to vote its ordinary shares, subject to certain exceptions relating to significant corporate transactions, in accordance with the recommendation of our board of directors and in favor of persons nominated and recommended to serve as directors by the board, and has granted Kitov Parent a proxy to ensure GHP’s compliance with such voting undertakings. Mr. Sheer Roichman / Haiku Capital Ltd. As reported on the Schedules 13G filed on June 1, 2016 by Mr. Sheer Roichman and Haiku Capital Ltd., a company wholly-owned by Mr. Roichman, as of such date Haiku Capital beneficially owned 221,020 ordinary shares and held options issued by us to Haiku Capital representing the right to purchase 400,000 ordinary shares, and Mr. Sheer Roichman beneficially owned 2,473,780 ordinary shares. 106 As reported on the Schedules 13G previously filed by Mr. Sheer Roichman and Haiku Capital, Mr. Roichman acquired beneficial ownership of 7,506,060 of our ordinary shares via the acquisition in our November 2015 initial public offering in the U.S. by Haiku Capital of ADSs representing such number of ordinary shares. At such time Haiku Capital also purchased public warrants representing the right to purchase 375,303 American Depositary Shares representing 7,506,060 of our Ordinary Shares, which are not currently exercisable. Subsequent to our initial U.S. public offering, Mr. Roichman acquired beneficial ownership of an additional 3,330,901 of our ordinary shares via open market purchases (of our ordinary shares on the TASE and our ADSs on NASDAQ) by Mr. Roichman directly (2,664,060 ordinary shares comprising such additional holdings) and by Haiku Capital (666,841 ordinary shares comprising such additional holdings). Prior to the initial U.S. public offering Haiku Capital owned options currently exercisable representing the right to purchase 400,000 of our ordinary shares. To the best of our knowledge, other than these 400,000 options, Mr. Roichman had no beneficial ownership over any other of our securities immediately prior to the initial U.S. public offering. Prior to the Share Transfer Agreement with Kitov Pharmaceuticals dated July 11, 2013, Mr. Roichman and Haiku Capital were the controlling shareholders of Kitov Parent (then called Mainrom Line Logistics Ltd.). At the closing of the Share Transfer Agreement with Kitov Pharmaceuticals dated July 11, 2013, Mr. Roichman was the beneficial owner of 3,083,983 of Kitov Parent’s ordinary shares (prior to a 1-for-13 reverse stock split of our outstanding share capital, which we completed in November 2014) which represented 12.07% of the issued and outstanding share capital at such time. After a series of off-exchange transactions as well as direct sales on the TASE, Mr. Roichman ceased to be a significant shareholder of Kitov Parent in April 2014. Dr. John Paul Waymack Immediately prior to our initial U.S. public offering, Dr. John Paul Waymack had beneficial ownership of 1,111,721 of Kitov Parent’s ordinary shares which represented 8.58% of its issued and outstanding share capital at the time. Such amount included 1,081,183 ordinary shares held directly by JPW PCH LLC, a Virginia limited liability company, owned 51% by Dr. John Paul Waymack and 30,538 ordinary shares held directly by Dr. John Paul Waymack. Dr. John Paul Waymack may be deemed to beneficially own all of the shares held directly by JPW PCH LLC. In December 2015, we issued 1,103,248 of Kitov Parent’s ordinary shares to JPW PCH LLC, as a result of the attainment of the milestone in connection with our Phase III clinical trial for KIT-302. (see “Item 7. Major Shareholders and Related Party Transactions – B. Related Party Transactions – Share Transfer Agreement with Kitov Pharmaceuticals"). Dr. Waymack’s holdings were reduced below 5% of Kitov Parent’s issued and outstanding share capital as a result of our initial U.S. public offering. Dexcel Ltd. Immediately prior to our initial U.S. public offering, Dexcel Ltd. a private company wholly owned by Dexon Holdings Ltd. which is a private company wholly owned by Mr. Dan Oren who may be deemed to beneficially own all of the shares held directly by Dexcel Ltd., was known to us to have owned 755,294 of our ordinary shares which represented 5.83% of our issued and outstanding share capital at the time. These shares were issued to Dexcel Ltd. pursuant to the achievement of milestones under our Development Services Agreement with Dexcel Ltd. 157,783 ordinary shares were issued at the first tranche. Upon completion of a milestone the second tranche of 597,511 ordinary shares was issued in May 2015. Dexcel Ltd.’s holdings were reduced below 5% of our issued and outstanding share capital as a result of our initial U.S. public offering in November 2015. Record Holders As of the date of this Annual Report on Form 20-F, there were (i) three shareholders of record of our ordinary shares, one of which was a U.S. entity holding 0.4% of our ordinary shares and two of which were Israeli entities holding 99.6% of our ordinary shares; and (ii) one holder of record for the public warrants which was a U.S. entity. As of April 20, 2017, there were 4,257,157 ADSs outstanding (equivalent to 85,143,140 ordinary shares, or approximately 51.75% of our total issued and outstanding ordinary shares), which were held by 62 holders of record as recorded on the records of Depositary Trust Corporation and our ADS Depositary, The Bank of New York Mellon. The number of record holders is not representative of the number of beneficial holders of our ADSs, ordinary shares, and our warrants because many of the ADSs, ordinary shares and our warrants are held by brokers or other nominees. Other than with respect to certain restricted shares or ADS containing a legend, the shares for a publicly traded company such as ours, which is listed on the TASE (and with ADSs listed on the NASDAQ), are generally recorded in the name of our Israeli share registrar, Registration Company of United Mizrahi Bank Ltd. or in the name of our ADS Depositary, The Bank of New York Mellon. 107 B. Related Party Transactions TyrNovo Ltd. On January 13, 2017, Kitov Parent completed its acquisition of a controlling interest in TyrNovo, from GHP. Pursuant to the terms of the transaction, including such adjustments to the terms and conditions which were finalized between the parties subsequent to the closing, Kitov Parent issued GHP 11,292,508 of its ordinary shares (the “Consideration Shares”) and will pay GHP aggregate cash proceeds of $2 million (the “Cash Consideration”) in exchange for 9,570 ordinary shares in TyrNovo and the assignment to Kitov Parent of a loan in the amount of $101,157 made by GHP to TyrNovo, (the “Completed TyrNovo Acquisition”). $800,000 of the Cash Consideration was paid to GHP (or to other third parties on behalf of GHP) on January 13, 2017. An additional $1,032,843 of the Cash Consideration was paid to GHP (or to other third parties on behalf of GHP) in April 2017. The remaining $167,157 of the Cash Consideration is being held back by Kitov Parent pending the fulfillment of certain conditions as agreed to between Kitov Parent and GHP. As part of the Completed TyrNovo Transaction, and following the arrangements for the payment of the additional Cash Consideration in April 2017, Kitov Parent agreed with GHP that it also acquired a loan to TyrNovo of $101,157 from GHP. The repayment date and other terms of such acquired loan have not been determined. All of the Consideration Shares are being held in escrow in order to ensure the fulfillment of certain post-closing undertakings and to satisfy indemnification claims and other liabilities the Company may become subject to as a result of the Completed TyrNovo Acquisition. Kitov Parent announced that it may acquire additional equity stakes in TyrNovo from TyrNovo’s minority shareholders, which include employees and consultants of TyrNovo, in exchange for additional ordinary shares of Kitov Parent, in amounts to be determined with such shareholders. Concurrent with the closing of the Completed TyrNovo Acquisition, on January 13, 2017 GHP resigned from its position as sole director of TyrNovo Ltd. On January 13, 2017, GHP signed a Shareholder’s Undertaking in connection with the ordinary shares of Kitov Parent held by GHP containing, amongst other matters, a prohibition on transfer of such ordinary shares until January 13, 2018 and certain standstill limitations. GHP has agreed to vote its ordinary shares, subject to certain exceptions relating to significant corporate transactions, in accordance with the recommendation of Kitov Parent’s board of directors and in favor of persons nominated and recommended to serve as directors by the board, and has granted Kitov Parent a proxy to ensure GHP’s compliance with such voting undertakings. On January 16, 2017, in connection with the Completed TyrNovo Acquisition, Mr. Simcha Rock, Kitov Parent’s chief financial officer, was appointed as a director of TyrNovo Ltd. On January 19, 2017, the Tel Aviv District Court (Economic Division) issued a temporary interlocutory injunction (the “Injunction”), in response to a motion filed on January 19, 2017 by Taoz – Company for Management and Holdings of Companies Ltd. (“Taoz”), a shareholder owning 534 shares (then representing approximately 3.12%) of TyrNovo (hereinafter, the “Motion”). The Motion was filed ex parte against Kitov Parent, TyrNovo, GHP and Katzenell Dimant Trustees Ltd., the escrow agent with respect to the Consideration Shares which are required to be held in escrow subsequent to closing in accordance with the terms of the Completed TyrNovo Acquisition. Taoz filed the Motion, alleging certain rights as a minority shareholder in TyrNovo and contractual rights with GHP pursuant to a non-binding term sheet executed on July 11, 2016 by and among Taoz, TyrNovo, and GHP. In the Injunction, the Court enjoined Kitov Parent and GHP from continuing with any actions to complete the Completed TyrNovo Acquisition, but only to the extent that the Completed TyrNovo Transaction had not yet closed. The Court rejected the Motion with respect to all the additional temporary interlocutory injunctive relief sought by Taoz. On February 9, 2017, Kitov Parent, TyrNovo and Taoz entered into a settlement arrangement in connection with the Motion, which was approved by the Board of Directors of Kitov Parent, pursuant to which the following agreements were signed: 1) A Waiver and Release Agreement among Kitov Parent, TyrNovo and Taoz pursuant to which the parties agreed, amongst other matters, to: i. Taoz’s consent to dismiss with prejudice any and all proceedings against Kitov Parent and TyrNovo in connection with the Motion; 108 ii. mutual settlement with respect to court costs; iii. a grant by Taoz of an irrevocable waiver and release to Kitov Parent and TyrNovo, as well as their respective affiliated parties for any and all damages Taoz may, now or in the future, have against them in connection with the Completed TyrNovo Acquisition; and iv. an irrevocable waiver by Kitov Parent to Taoz for any claims and/or demands it may, now or in the future, have against Taoz and/or any director of TyrNovo nominated by Taoz, for any acts or omissions by TyrNovo during the period of time preceding the execution of Waiver and Release Agreement. 2) A Binding Term Sheet between TyrNovo, Taoz and Kitov Parent pursuant to which the parties agreed, amongst other matters, i. ii. that Taoz is entitled to be issued an additional 77 ordinary shares of TyrNovo, representing 0.4% of the issued and outstanding share capital of TyrNovo immediately following this issuance, within thirty (30) days from February 9, 2017; that Taoz shall have the right during a period commencing upon February 9, 2017 and ending upon the earlier of: (1) the lapse of 60 days from the day on which TyrNovo notifies Taoz in writing, of a notice by the board of TyrNovo (a “Milestone Notice”) stating that a U.S. FDA approval to commence a Phase I clinical trial has been obtained, or; (2) 30 months from February 9, 2017, to invest an additional US$750,000 (the “Deferred Investment”) to be provided to TyrNovo by way of a convertible loan; the principal amount of the convertible loan shall bear interest at a rate per annum of LIBOR + 6% in the event of US$ loans, and Prime + 6% in the event of NIS loans, compounded annually, from the date on which Taoz made the loan and until the date of conversion or repayment thereof; repayment of the loan amount shall be made, unless automatically converted prior to the Repayment Date, upon the earliest of: (a) 6 months following the date of the publication by TyrNovo of the official results of the Phase I clinical trials; (b) 36 months from the date of first transfer to TyrNovo by Taoz of the funding under the Convertible Loan; (c) immediately prior to an Exit Event (defined as either a qualified initial public offering of TyrNovo or the consummation of a merger or sale of all or substantially all of TyrNovo’s assets or share capital); or (d) an Event of Default (as defined in the Binding Term Sheet); the earliest of the events detailed above are referred to as the "Repayment Date"; in the event that prior to the Repayment Date TyrNovo shall raise additional funds in an amount of not less than US$1,000,000 in consideration for shares of TyrNovo from an investor who is not, on February 9, 2017, a shareholder in TyrNovo (the "Next Financing Round"), then, immediately prior to the Next Financing Round, the loan amount shall automatically convert into ordinary shares of TyrNovo at a price per share which shall be the lower of (i) a price per share reflecting a 30% discount off the price per share paid in the Next Financing Round by the investor and (ii) a price per TyrNovo share reflecting a TyrNovo company valuation of $13,500,000 divided by the number of issued and outstanding shares of TyrNovo as of February 9, 2017; during the period commencing 14 days before the Repayment Date and ending 7 days before the Repayment Date, provided that the loan amount was not converted automatically as set forth above, the lender may, at its election, convert the loan amount into ordinary shares of TyrNovo at a loan conversion price equal to a price per TyrNovo share reflecting a TyrNovo company valuation of $13,500,000 divided by the number of issued and outstanding shares of TyrNovo as of February 9, 2017; iii. that upon issuance of preferred shares by TyrNovo in the future, each of Taoz and/or Kitov Parent shall have the right, only upon the first time that TyrNovo issues such preferred shares, to notify TyrNovo that it wishes to convert all ordinary TyrNovo shares issued to Taoz under the Binding Term Sheet and the TyrNovo ordinary shares held by Kitov Parent in an amount not exceeding twice the number of TyrNovo shares initially acquired by Taoz, or converted by Taoz by virtue of the conversion as set forth in clause ii. above, into such preferred shares, provided that the preference with respect to each preferred share of Taoz and Kitov Parent shall be equal to the actual purchase price for which these TyrNovo shares were issued; 109 iv. v. to an option granted to Taoz to invest in TyrNovo in an amount of up to US$1,000,000 for TyrNovo ordinary shares, pursuant to a convertible loan which may be exercised until the earlier of (1) the lapse of 30 months from February 9, 2017; (2) an Exit Event or (3) the lapse of 60 days following TyrNovo’s Milestone Notice; to the grant to Taoz of certain director appointment rights with respect to the board of directors of TyrNovo until the earlier of (1) such time in which the option set forth in item (iv) above is exercised or expired and is no longer exercisable and the shares in TyrNovo held by Taoz constitute less than 8.9% of the issued and outstanding share capital of TyrNovo (including a mechanism for calculating the conversion of any convertible loans for the purposes of this threshold); and (2) immediately prior to an Exit Event; vi. that until an Exit Event, the grant to Taoz of registration rights for its TyrNovo shares upon grant by TyrNovo in the future of registration rights to any of its shareholders with respect to securities of TyrNovo, under the same terms and conditions, and in accordance with the same registration rights agreement(s), that such right was granted to such other shareholder(s) of TyrNovo; and vii. that until an Exit Event, and notwithstanding the higher threshold set forth under TyrNovo’s Articles of Association currently in effect, Taoz shall have the right to purchase its pro rata share of Additional Securities (as defined in the Binding Term Sheet) that TyrNovo may, from time to time, propose to sell and issue. 3) A Shareholders Agreement between Kitov Parent and Taoz, including, amongst others, the following matters: i. ii. iii. an undertaking by Kitov Parent to finance any future working capital requirement of TyrNovo, up to an amount of $1,000,000, of which the amount of $750,000 shall be provided to TyrNovo no later than 30 days from February 9, 2017, and $250,000 pursuant to a business plan to be approved by the Board of Directors of TyrNovo no later than May 9, 2017, and such financing by Kitov Parent shall be provided by way of Convertible Loan (as defined in the Binding Term Sheet); in the event that the Milestone (as defined in the Binding Term Sheet) is achieved, and Taoz did not invest the Deferred Investment then Kitov Parent shall have the right, for a period of 60 days, to acquire all of the Taoz's holdings in TyrNovo at a price per share of US$476.48; in the event that Kitov Parent increases its shareholdings in TyrNovo, through the purchase of additional shares from TyrNovo’s then current shareholders, by more than 1,500 shares of TyrNovo until February 9, 2018, then Taoz shall have the option within 14 days of the notification by Kitov Parent of such purchases to purchase up to 30% of such newly acquired shares in TyrNovo, and if it does so elect, Taoz shall be obligated to purchase from Kitov Parent, within a period of 12 months of delivery to Kitov Parent of the notice of such election, such shares so elected to acquire at the New Shares PPS (as defined below); and, in the event Taoz fails to purchase such shares it so elected to acquire from Kitov Parent, Taoz shall immediately transfer to Kitov Parent, as liquidated damages, for no consideration to be paid by Kitov Parent, such number of securities equal to 20% of the amount of the shares it so elected to acquire from Kitov Parent and which Taoz has failed to purchase, out of the shares in TyrNovo then held by Taoz; the "New Shares PPS" shall mean, (1) in the event that the newly acquired TyrNovo shares are purchased by Kitov Parent, in whole or in part, in consideration for shares of Kitov Parent, then during a period of six months from the acquisition date by Kitov Parent, an amount, in cash equal to US$350 per TyrNovo share, and during a period commencing as of the lapse of six months and until the lapse of 12 months from the acquisition date by Kitov Parent, an amount, in cash equal to US$403 per TyrNovo share, and (2) in the event that all the newly acquired TyrNovo shares are purchased by Kitov Parent for cash consideration only, then an amount, in cash, equal to 104% of the price per TyrNovo share actually paid by Kitov Parent as consideration for such TyrNovo shares; 110 iv. until an Exit Event, Taoz shall have a right of first refusal with respect to any transfer by Kitov Parent (or a permitted transferee thereof) of its shares in TyrNovo up to its Pro Rata Share (as defined in the Binding Term Sheet); v. until an Exit Event, in the event that Taoz did not purchase the offered shares under the right of first refusal as set forth above, Taoz shall have a right to participate in such transfer, by selling up to its Pro Rata Share of the TyrNovo shares proposed to be sold by Kitov Parent, on the same terms and conditions, for receipt of the same type of consideration, provided that such transfer is completed by Kitov Parent; vi. until the earliest of (1) the lapse of 30 months from February 9, 2017; (2) the execution of investment agreements by TyrNovo with an external non-affiliated investor (other than Kitov Parent or company controlled by Kitov Parent), according to which TyrNovo shall issue 10% or more of its issued share capital immediately prior to such issuance, (3) immediately prior to an Exit Event, or (4) the lapse of 60 days following TyrNovo's Milestone Notice, Kitov Parent shall not make any transfer of shares in TyrNovo, except for up to 15% of the issued share capital of TyrNovo or a transfer to a Permitted Transferee (as defined in the agreement); and vii. Kitov Parent provides to Taoz a put option to sell to Kitov Parent up to 50% of the TyrNovo shares issued to Taoz through its investments in TyrNovo as set forth in the Binding Term Sheet, or of any shares actually acquired by Taoz from Kitov Parent in accordance with item (iii) above, exercisable during a period of 90 days from the publication by TyrNovo of the results of the Phase I clinical trials, for a price per TyrNovo share equal to US$1,600, which subject to receipt by Kitov Parent of an exercise notice from Taoz, such price shall be paid, 40 days after the delivery of the exercise notice, and subject to all required regulatory and corporate approvals, in (1) ordinary shares of Kitov Parent, at a price per share value (for each Kitov Parent share) equal to the higher of (a) NIS 1.824 (subject to adjustments due to stock split and combination) and (b) the average price of the shares of Kitov Parent at the closing of trade on the Tel Aviv Stock Exchange during a period of 30 days following the lapse of the exercise period, or, at Kitov Parent’ sole discretion, (2) in cash; upon the expiration of the 90 day exercise period, the put option, if not exercised by Taoz, shall expire and no longer be valid. GHP and Taoz also reached a settlement agreement in connection with the claims of Taoz towards GHP (and its affiliates). On February 9, 2017, the Court entered a final judgement confirming the settlement arrangements amongst Taoz, TyrNovo and Kitov Parent, as well as between Taoz and GHP (and its affiliates). On February 13, 2017, Kitov Parent appointed Dr. Gil Ben-Menachem, its Vice President of Business Development as a director of TyrNovo. Kitov Parent and TyrNovo entered into a Revolving Secured Facility and Pledge Agreement on March 1, 2017, pursuant to which Kitov Parent has made loans to TyrNovo in an aggregate amount of $750,000. The loans were made on various dates between February 15, 2017 and March 8, 2017. The principal balance of, and any accrued and unpaid interest on and fees in relation to, the loans were repayable in full by TyrNovo on March 31, 2017 (the “Maturity Date”). The shareholders of TyrNovo approved an extension of the Maturity Date to April 30, 2017. Interest accrued on the loans at the rate of Libor + 6% (six percent) per annum, compounded annually, and paid on the last business day of each calendar year of the term, or on the Maturity Date if occurring prior to the last business day of a calendar year of the term. As security for the payment in full of its loans and accrued interest and performance of its other undertakings, TyrNovo granted to Kitov Parent a security interest in all of TyrNovo’s right, title and interest for the benefit of Kitov Parent, in certain assets and rights of TyrNovo. On April 25, 2017, Kitov Parent appointed Mr. Ran Tzror, one of its independent directors, as a director of TyrNovo. 111 An affiliate of GHP had historically provided certain management, accounting, business development and other ancillary services to TyrNovo. Upon closing of the sale of GHP’s holdings in TyrNovo to Kitov Parent, TyrNovo terminated this arrangement with GHP’s affiliate. Kitov Parent now provides applicable services to TyrNovo and expects that a formal arm’s length transaction services agreement between Kitov Parent and TyrNovo, setting out the terms and conditions of these arrangements, will be finalized in the near future. Consulting Agreement with Lior Tamar Investments Ltd. In August 2014, we entered into a consulting agreement with Lior Tamar Investments Ltd., or Lior Tamar, a privately held Israeli company, pursuant to which Lior Tamar provides us with various services, including introduction to Israeli investors, facilitating meetings and introductions to underwriters, assistance in locating business cooperation opportunities, and consultation with respect to raising debt and bonds. In consideration for these services, we paid Lior Tamar a monthly fee of $9,500, and 2.5% of all amounts actually raised and received by us from third parties, excluding amounts received from interested parties. However, Lior Tamar waived its rights to receive 2.5% of the amounts raised in the November 2015 offering on NASDAQ in exchange for a flat fee of $245,000 in consideration of Lior Tamar’s services in connection with advising us on matters related to that offering. Lior Tamar did not serve as a finder, in any way, in connection with that offering. Lior Tamar waived its rights to receive 2.5% of the amounts to be raised in our follow-on offering on NASDAQ in July 2016 in exchange for a flat fee of $300,000 in consideration of Lior Tamar’s services in connection with advising us on matters related to that offering. Lior Tamar did not serve as a finder, in any way, in connection with that offering. The agreement was terminable by either party upon 60 days’ notice, and Lior Tamar was entitled to payment for any fund raising that closes during the 90 day period following termination of the agreement. On July 27, 2016 we entered into an amendment to the consulting agreement with Lior Tamar, pursuant to which we now pay Lior Tamar a monthly fee of $12,500 (commencing as of December 2015), and 33.5% of all amounts actually raised and received by us from third parties in capital markets transactions, excluding amounts received by the Company in certain events, including, amongst others, amounts received from interested parties, and amounts in excess of $25,000,000 which are received by the Company pursuant to a funding event as defined in the consulting agreement. In addition we paid Lior Tamar a one-time amendment signing bonus of $50,000. In the event that, with respect to any contemplated funding event, we shall not be permitted to pay and/or Lior Tamar shall not be permitted to receive, 3.5% of all amounts actually raised and received by us from third parties in a particular capital markets transaction, whether for reasons of law, regulation, commercial arrangements of the Company in connection with the transaction, or otherwise, then Lior Tamar shall provide us with a timely waiver of the such consideration to be received by Lior Tamar in connection with such transaction. Upon delivery of such waiver Lior Tamar shall be entitled to receive alternative consideration in connection with such transaction, which accomplishes, to the extent possible, the original business purpose of the waived consideration in a compliant, valid and enforceable manner. The agreement may be terminated by either party for any reason at any time by furnishing the other party with a notice of termination 60 days prior to such notice of termination having effect, and Lior Tamar is entitled to payment for any fund raising that closes during the 90 day period following termination of the agreement; provided, however, that during the period between July 1, 2016 and December 31, 2018, the advance notice period shall be six months prior to any notice of termination having effect, and during the period of time when this extended notice period is in effect, Lior Tamar is entitled to payment for any fund raising that closes during the 30 day period following termination of the agreement. A company under the control of Isaac Israel, our chief executive officer and member of our board of directors, provides consulting services to Capital Point Ltd. by having Mr. Israel acting as a director at certain companies in which Capital Point Ltd. has made investments. Capital Point Ltd. is a public company traded on the TASE, which is co-managed by certain individuals known to us to be the principals of Lior Tamar Investments Ltd. In addition, Mr. Arye Weber, one of our independent directors, serves as an External Director on the board of directors of Capital Point Ltd., as well as on Capital Point Ltd.’s audit and compensation committees. The Company’s audit committee and board of directors approved this consulting agreement with Lior Tamar, as well as the amendment thereto, in accordance with the requirements of the Companies Law. 112 August 2015 Loan Agreement On August 12, 2015 we entered into a loan agreement with certain lenders, pursuant to which the lenders extended us a loan, or the August Loan, in the aggregate amount of $430,000, or the Principal Amount. Haiku Capital Ltd., who at the time was not a related party, becoming such only as a result of our initial U.S. offering in November 2015, provided us $100,000 of the August Loan. In addition, we received an option, or the Additional Financing Option, at any time until the earliest of (i) completion of our initial public offering in the United States, or a U.S. offering; (ii) the completion of a public offering on the Tel Aviv Stock Exchange, or TASE, of our securities, or an Israeli Offering; or (iii) December 31, 2015, to require that each lender advance an additional principal amount equal to the Principal Amount advanced by such lender and up to an additional aggregate of $430,000, or the Additional Principal Amount, and the Additional Principal Amount together with the Principal Amount, the Loan Amount. Such Additional Principal Amount, if any, shall have the same terms and conditions as the Principal Amount. Haiku Capital Ltd. committed to $100,000 of such Additional Principal Amount. The Principal Amount and the Additional Principal Amount did not bear interest and were not linked to any index. We did not exercise the option for the Additional Principal Amount. Each lender in the August Loan placed an order to purchase ADSs and warrants in the U.S. offering in an amount equal to or greater than such lender's Loan Amount. As such, and as we completed a U.S. Offering, we were required to repay the Loan Amount to each lender and also to pay each lender an allocation fee equal to 33% of the lender’s Principal Amount advanced by such lender. The payments occurred in December 2015 following the completion of our U.S. offering. Share Transfer Agreement with Kitov Pharmaceuticals On July 11, 2013, pursuant to a Share Transfer Agreement dated April 2, 2013 between Kitov Parent, Kitov Pharmaceuticals, Dr. Morris Laster and JPW PCH LLC (Kitov Pharmaceutical’s shareholders at the time), and the controlling shareholder in Kitov Pharmaceuticals at such time, Mr. Sheer Roichman and Haiku Capital Ltd. (a private company wholly owned by Mr. Roichman), Kitov Parent (then called Mainrom Line Logistics Ltd.) acquired the shares of Kitov Pharmaceuticals in exchange for the issuance of 1,351,478 ordinary shares to Kitov Pharmaceutical’s shareholders, representing at the time 63.75% of the fully diluted share capital of Kitov Parent. In addition, pursuant to the agreement, Kitov Parent issued to the former shareholders of Kitov Pharmaceutical a right to purchase an additional 1,379,060 ordinary shares of Kitov Parent if within 28 months from the completion of the acquisition, or November 11, 2015, we complete our Phase III clinical trial and the data analyses have demonstrated that the reduction in blood pressure in the group treated with KIT-302 was at least half of that achieved with amlodipine monotherapy, known as the Milestone. In addition, under the terms of the Share Transfer Agreement, Mr. Roichman was entitled to receive various sums from the funds raised by us from public and private financings. This amount was paid in full by us in March 2014. At the closing of the Share Transfer Agreement, Kitov Pharmaceutical’s shareholders transferred 100% of Kitov Pharmaceuticals share capital on a fully diluted basis to us, as follows: (i) 80% of the share capital directly to us and (ii) 20% of the share capital to a trustee, to hold such shares for our sole benefit until the earlier of the occurrence of: (A) the Milestone referred to above or (B) 28 months from the closing of the Share Transfer Agreement, or November 11, 2015. On November 11, 2015 the 20% share capital held by the trustee was transferred to us, resulting in our holding 100% of the share capital of Kitov Pharmaceuticals. Furthermore, in December 2015, we issued an additional 1,379,060 of our ordinary shares to the former shareholders of Kitov Pharmaceuticals Ltd. as a result of the attainment of the Milestone, including the issuance of 1,103,248 Ordinary Shares of Kitov Parent to JPW PCH LLC, a Virginia limited liability company, owned 51% by Dr. John Paul Waymack, the chairman of the board of directors. Pursuant to the agreement, Kitov Parent granted to its external consultants, Lior Tamar Investments Ltd., held by Mr. Shay Itzhak Lior and Mr. Yossi Tamar, options to acquire 1,194,616 ordinary shares of Kitov Parent and agreed to grant to Mr. Simcha Rock, our current chief financial officer and a director, options to acquire 1,370,056 ordinary shares of Kitov Parent, subject to the adoption of an option plan (of this amount, 181,089 of the options to be granted to Mr. Rock are subject to Kitov Parent attaining the milestone referred to above and 1,011,500 options are subject to fund raising by Kitov Parent in the amount of NIS 1,000,000). At closing, Mr. Sheer Roichman granted Kitov Parent a loan in the amount of NIS 500,000, free of interest and linkage. Kitov Parent was to repay the loan to the lender on the date on which it and/or Kitov Pharmaceuticals will raise after the transaction, an amount of no less than NIS 500,000. In the event that the loan was not paid when due, Mr. Roichman would be entitled to convert the loan to securities of Kitov Parent at a conversion price reflecting a 30% discount to the average price of Kitov Parent's shares during 30 trading days preceding the date on which Mr. Roichman notified Kitov Parent of his intention to convert the loan. This loan was repaid in March 2014. 113 As part of the agreement, Mr. Roichman agreed that in the event Kitov Parent issues its shares to the public and receives early commitments to purchase its securities in an amount of no less than NIS 500,000, Mr. Roichman will participate in the offering by placing an order for Kitov Parent shares in an amount of no less than NIS 750,000. If the offering to the public will include the grant of options to acquire Kitov Parent shares for a cash payment, Mr. Roichman will place orders for Kitov Parent's securities offered to the public in an amount of NIS 750,000 minus the exercise price of the offered options which he will acquire (in the event that all orders placed by Mr. Roichman under the public offering will be fully received). It is noted, that insofar as the amount of the loan made by Mr. Roichman to Kitov Parent referred to above is not repaid on issuance date, Mr. Roichman will only pay the exercise price to Kitov Parent in exchange for the purchased options on the option exercise date insofar as he elects to exercise the options, and the purchase price will be offset against repayment of the loan. This requirement was satisfied at the time of Kitov Parent's March 2014 offering of ordinary shares on the Tel Aviv Stock Exchange. In addition, under the terms of the agreement, Mr. Roichman is entitled to receive out of all the funds that will be raised by Kitov Parent from public and private financings, including through convertible loans, in one or more transactions and including funds invested by Mr. Roichman himself the following sums: (a) 10% of the amounts invested up to a total cumulative sum of NIS 9 million and (b) 25% of the invested amounts exceeding NIS 9 million, up to a cumulative amount of NIS 2.5 million, also called the maximum remuneration sum, plus VAT if required. This amount was paid by Kitov Parent in March 2014. As part of the agreement, the parties agreed that all the loans granted to Kitov Parent and/or to Kitov Pharmaceuticals by Mr. Roichman and/or by controlling stakeholders of Kitov Pharmaceuticals, as the case may be, up to the closing, except the loan made by Mr. Roichman to Kitov Parent on the closing date, will be repaid to Mr. Roichman and/or to the controlling stakeholders of Kitov Pharmaceuticals on a pro rata basis according to their relative share in the debts of Kitov Parent, subject to payment of the maximum remuneration sum referred to above. Upon closing of the transaction, Dr. Paul Waymack, Dr. Morris Laster and Mr. Simcha Rock were appointed to the board of directors of Kitov Parent, replacing Mr. Erez Goldstmidt, Mr. Hedan Orenstein and Mr. Oren Giditz, who resigned. Kitov Parent repaid all obligations to Mr. Sheer Roichman under the agreement and satisfied all of its obligations under the agreement to pay the maximum remuneration sum by the payment of NIS 2.5 million at such time as Kitov Parent completed its approximately NIS 17.2 million financing in March 2014 pursuant to a prospectus published and approved by the Israel Securities Authority. Loans from Mr. Sheer Roichman From November 2013 to February 2014, Kitov Parent received loans in the aggregate amount of NIS 990,000 (approximately $285,000 based on the representative rate of exchange on December 31, 2013) pursuant to a loan agreement with several lenders, including Mr. Sheer Roichman and third parties. The loans did not bear interest and were not linked to the CPI. However, we paid to the lenders a credit allocation commission in the amount of approximately NIS 330,000 (approximately $95,000 based on the representative rate of exchange on December 31, 2013), payable to the lenders together with the principal of the loan on the loan repayment date. The entire loan and commission have been repaid according to its terms. Other Related Party Agreements We have entered into agreements with our executive officers and key employees. See “Item 6. Directors, Senior Management and Employees – B. Compensation”. For information on exemption and indemnification letters granted to our officers and directors, please see “Item 6. Directors, Senior Management and Employees - C. Board Practices - Exculpation, Insurance and Indemnification of Directors and Officers.” C. Interests of Experts and Counsel Not applicable. 114 ITEM 8. FINANCIAL INFORMATION A. Consolidated Statements and Other Financial Information See Item 18 Legal Proceedings From time to time, we may become party to legal proceedings and claims in the ordinary course of business, or otherwise. 2015 Motion to Approve a Class Action in Israel On December 3, 2015, we announced that we received a lawsuit and motion to approve the lawsuit as a class action lawsuit pursuant to the Class Action Lawsuits Law 5766-2006 (the “2015 Motion”) which was filed against us and our directors at the Tel Aviv District Court (Economic Division). The 2015 Motion is with respect to asserted claims for damages to the holders of our securities listed on the Tel Aviv Stock Exchange, arising due to the public offering of our initial public offering of our securities in the U.S. during November 2015. In the 2015 Motion it was claimed that the class the petitioners are seeking to represent, namely, anyone holding our shares at the start of trading on November 22, 2015 exclusive of the respondents and/or anyone acting on their behalf and/or any affiliates thereof and excluding anyone whose rights to our shares derive from ADS certificates issued in the U.S to such extent as derived therefrom; and any holders of our Series 2 TASE listed warrants as of the start of trading on November 22, 2015, exclusive of the respondents and/or anyone acting on their behalf and/or any affiliates thereof (Purported Class). The total amount claimed from all defendants, if the 2015 Motion is certified as a class action, as set forth in the motion is approximately NIS 16.4 million. In addition to this amount, the petitioners in the motion are seeking remedies in order to redress discrimination against the Purported Class owing to the dilution caused by the public offering, including the possibility that the Purported Class should be awarded from Kitov Parent amounts reflecting the losses of the Purported Class from a possible price increase in the shares of Kitov Parent following the announcement of the Phase III clinical trial results. Under applicable Israeli law, a motion to approve a lawsuit as a class action initially needs to be approved as such by the court. Only after such approval is granted by the court, will the court proceed to the second stage of hearing the underlying claims of the class action lawsuit. We announced that we reject the claims asserted in the 2015 Motion. We have delivered our response to the court in accordance with applicable law, and a preliminary hearing was held by the court on September 12, 2016. At such hearing the court determined that certain claims of the petitioners in connection with alleged personal interests by affiliates of Kitov Parent in connection with the public offering of our initial public offering of our securities in the U.S. during November 2015 are not part of the grounds for the 2015 Motion and no remedies shall be sought by the petitioners in connection therewith. The court set a schedule for the submission by the petitioners of a motion for discovery, and any responses to such motion. An additional preliminary hearing was held on February 7, 2017. At that hearing the court ruled on the scope of the petitioners’ motion for discovery, and pursuant to such ruling Kitov Parent delivered to the petitioners (subject to signing confidentiality undertakings) certain protocols of the board of directors of Kitov Parent. Pursuant to the filing of one of the 2017 Motions to Approve a Class Action in Israel by the same attorneys for the plaintiffs in the 2015 Motion, Kitov Parent and other respondents in the 2015 Motion filed a motion to narrow the scope of court's ruling on the petitioners’ motion for discovery, and the petitioners filed a motion to declare that Kitov Parent did not comply with the court's ruling on the petitioners’ motion for discovery and therefor is in contempt of the court. Furthermore, petitioners filed a motion for the dismissal of the further motion to narrow the scope of court's ruling on the petitioners’ motion for discovery. On March 30, 2017 the court ordered the parties to negotiate on the matter in order to try and reach a procedural agreement, and scheduled an additional preliminary hearing for May 4, 2017. 115 On November 8, 2016, a shareholder of Kitov Parent submitted a request to the court in connection with the 2015 Motion to be excluded from the Purported Class and claiming to have independent causes of action and claims of approximately NIS 1 million (the “Petition to Exclude”). We responded to the court as required, and, amongst other arguments, we noted that pursuant to the Class Action Lawsuits Law 5766-2006 and the Regulations enacted thereunder, at the current stage of the court proceedings with respect to the Motion, such shareholder cannot petition to be excluded from the Purported Class. The court ordered the shareholder to respond to our response and he has done so. The shareholder has not submitted any independent lawsuit against us, and we are of the view that such shareholder’s claims are identical to the asserted claims for damages in the Motion. We have been advised by our attorneys that the likelihood of Kitov Parent not incurring any financial obligation as a result of the class action (including the 2015 Motion and the Petition to Exclude) exceeds the likelihood that Kitov Parent will incur a financial obligation. At this preliminary stage however, we are unable, with any degree of certainty, to make any other evaluations or any other assessments with respect to the 2015 Motion's probability of success or the scope of potential exposure, if any. ISA Investigation On February 7, 2017, we announced that Kitov Parent is currently being investigated by the Israeli Securities Authority (the “ISA” and the “Investigation,” or “ISA Investigation” respectively). We have not yet been advised by the ISA of the full scope and focus of the Investigation. However, as previously disclosed by us on May 1, 2017, we have had discussions with the ISA regarding the Investigation, and are able to provide additional information to our investors and other stakeholders, with regard to the nature of the ISA’s concerns with respect to Kitov Parent. Based on these discussions with the ISA, we understand that the Investigation with respect to Kitov Parent relates to the Data Monitoring Committee ("DMC") that was appointed in connection with our Phase III clinical trial of KIT-302. In connection with the clinical trial, we appointed an independent statistician and an orthopedist to serve as our DMC in order to review the preliminary results of the initial patient group, with respect to determining if it would be necessary to increase the number of patients to be enrolled in the clinical trial in order to demonstrate statistical validity required to meet the primary endpoint of the clinical trial. This DMC's responsibilities and reporting procedures were detailed in a document that was distributed to all the team members involved in the clinical trial, including the members of the DMC (the "Procedure"). According to this Procedure, a group of external independent statisticians was to receive the preliminary clinical trial results and analyze the standard deviations. The Procedure provided that the independent statisticians would send the analyzed standard deviations to both of the DMC members, who would then review the analysis, and determine whether or not the primary efficacy endpoint was met (i.e. they were to look at the statistician's printout and see if the lower limit of the 95% confidence interval for the KIT-302 drug exceed 50% of the value for amlodipine). It is our understanding that the ISA is investigating the circumstances surrounding the actual dissemination of the statistical analysis to the members of the DMC, and whether or not this led to any misleading disclosures in any of the Company's public filings. We believe that the ISA’s concerns with respect to the DMC are misguided and not consistent with industry accepted U.S. Food and Drug Administration (“FDA”) regulatory requirements, nor with the procedures for the conduct of clinical trials for the purposes of New Drug Application submissions to the FDA. In addition, we strongly dispute the legal ramifications of any possible concerns of the ISA with respect to our disclosures in these matters. We firmly believe that (i) the information relating to the circumstances surrounding the actual dissemination of the statistical analysis to the members of this DMC is not material; and (ii) that such information was not material at the time of the Company’s announcement of the final clinical trial results. This matter had no impact whatsoever on the validity of the statistical analysis of the KIT-302 Phase III clinical trial data, which met its primary efficacy endpoint with statistical significance. Furthermore, we believe that the ISA is not the regulatory body authorized to evaluate the materiality of events and the completeness of public disclosures made by us in compliance with United States federal securities laws. The process actually undertaken by us in connection with such clinical trial results, fully complied with the requirements of the FDA, and the Medicines and Healthcare products Regulatory Agency (“MHRA”) and the human ethics committee agreed-to protocol for the Phase III clinical trial of KIT- 302 (“Clinical Trial Protocol”). Some clinical studies, mostly in certain types of Phase III clinical trial studies where it is required under the applicable clinical trial protocol, are overseen by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety monitoring board or committee. This group recommends whether or not a trial may move forward at designated check points based on access to certain data from the study. The clinical study sponsor may also suspend or terminate a clinical trial based on evolving business objectives and/or competitive climate. According to the KIT-302 Phase III Clinical Trial Protocol approved by the above-mentioned regulatory authorities, no data monitoring committee or data safety monitoring board or committee was required at all, and the committee we named “DMC”, had no authority or power to modify or otherwise alter the conduct of the clinical trial, and was not tasked with usual data safety monitoring board or committee responsibilities related to a clinical trial. 116 In accordance with the Clinical Trial Protocol, which had been approved by the FDA, the decision as to whether or not to add additional patients, or to stop patient enrollment, was based solely upon the statistical analysis of the preliminary data performed by an independent statistician (who was also a member of our “DMC”). The statistical analysis of the preliminary data collected in the Phase III clinical trial definitively showed that the study met the pre- specified criteria the FDA required for stopping patient enrollment and completing the final statistical analyses. The statistical analyses of the efficacy data collected in the Phase III clinical trial of KIT-302 resulted in a p-value of less than 0.001, clearly demonstrating that the Phase III clinical trial met its primary efficacy endpoint with statistical significance (any p-value less than 0.05 would have been adequate by statistical standards for proving efficacy). The Investigation is still ongoing, and our officers are fully cooperating with the ISA in its Investigation. Kitov Parent’s board of directors has expressed its full support of Company management. The Company, its officers and board of directors look forward to the conclusion of this Investigation in the most expeditious manner possible. The information in connection with the Investigation disclosed above, and elsewhere herein this Annual Report on Form 20-F, may not necessarily reflect the full scope or focus of the Investigation, or the entirety of any allegations being investigated and/or which may ultimately be raised by the ISA against the Company and/or any of its officers or affiliates. At this preliminary stage, we are still unable, with any degree of certainty, to make any other evaluations or any other assessments with respect to the ISA Investigation or the scope of potential exposure, if any. 2017 Motions to Approve a Class Action in Israel On February 16, 2017, we announced that four lawsuits and motions to approve the lawsuits as a class action lawsuit were filed against us and certain of our office holders at the Tel Aviv District Court (Economic Division), and served on us, with each such motion relating to the ISA Investigation into our public disclosures around certain aspects of the studies related to our lead drug candidate, KIT-302 (the “2017 Motions”). The first motion was filed against us, our executive directors and certain of our former directors, by the law offices of Tadmor & Co. and Prof. Yuval Levy & Co. acting on behalf of one of our shareholders, Mr. Kobi Koren, who is requesting to act as representative of all shareholders of record from December 10, 2015 until February 6, 2017. The plaintiff alleges, among other things, that we included misleading information in our public filings, which caused the class for which the plaintiff is seeking recognition an aggregate loss of NIS 25,545,206 (approximately US$ 6,818,000). The second motion was filed against us, our executive directors and certain of our present and former directors, by the law offices of Yanay & Co. acting on behalf of Mr. Ilan Vainreb, Ms. Merav Shir, Mr. Dimitry Braverman and Mr. Tzhaci Tal Gaon, our shareholders, who are requesting to act as representatives of all our shareholders on February 6, 2017, the date the ISA's investigation was reported, excluding the respondents named in the motion. The plaintiffs allege, among other things, that we included misleading information in our public filings which caused the class for which the plaintiffs are seeking recognition an aggregate loss of NIS 36,525,592.51 (approximately US$ 9,748,000). The third motion was filed against us, our executive directors and certain of our former directors, and our former internal auditor, by the law offices of Redei-Gadot acting on behalf of Messrs. Reuven Hay Refua and Binyamin Gabay, our shareholder, who are requesting to act as representatives of all shareholders of record from December 15, 2015 until February 6, 2017, excluding the respondents in the motion. The plaintiffs allege, among other things, that we included misleading information in our public filings which caused the class for which the plaintiffs are seeking recognition, an aggregate loss of NIS 33,235,000 (approximately US$8,870,000). This motion has since been withdrawn in response to the Petition for Dismissal (see below). 117 The fourth motion was filed against us, our executive directors and certain of our present and former directors, by the law offices of Kalai, Rosen & Co. acting on behalf of by Messrs. Yoram Chayut and Gur Tzemach, our shareholders, who are requesting to act as representatives of all shareholders of record from December 10, 2015 until February 6, 2017. The plaintiffs allege, among other things, that we included misleading information in our public filings which caused the class for which the plaintiffs are seeking recognition, an aggregate loss of NIS 29,094,290 (approximately US$ 7,765,000). The petitioners this motion have petitioned the court to dismiss the other 3 of the 2017 Motions (“Petition for Dismissal”). The court granted the petitioners in the other 3 of the 2017 Motions, as well as the Company and the other defendants, until March 28, 2017 to respond to Petition for Dismissal. The Company and the other defendants filed its response to the Petition for Dismissal on March 28, 2017. In addition on March 28, 2017, the Company and the defendants in all of the 2017 Motions submitted a request to the court to extend the deadline for responding to any of the 2017 Motions until 90 days subsequent to the decision by the court in the Petition for Dismissal. In a court decision from March 30, 2017, the court advised the plaintiff parties to try and reach a procedural agreement regarding the combination of the motions, and all relevant deadlines for responding were extended until a subsequent decision to be made. In a court decision from April 3, 2017, after all responses to the Petition for Dismissal were filed, the court again decided that the plaintiffs should try to reach a procedural agreement regarding the combination of the motions and update the court in the matter until May 3, 2017. This latter decision also stated that the respondents (including the Company) may be party to any such procedural agreement. Under applicable Israeli law, a motion to approve a lawsuit as a class action initially needs to be approved as such by the court. Only after such approval is granted by the court, will the court proceed to the second stage of hearing the underlying claims of the class action lawsuit. The court may also determine to combine the 2017 Motions, based on, among other things, considering the underlying facts and circumstances of each motion. Our management rejects the claims in all of the aforesaid 2017 Motions. At this preliminary stage we are unable, with any degree of certainty, to make any evaluations or any assessments with respect to the 2017 Motions as to the probability of success or the scope of potential exposure, if any. U.S. Class Actions On February 7, 2017, an individual who allegedly acquired Kitov Parent’s securities, individually and on behalf of a putative class of investors who purchased or otherwise acquired Kitov Parent’s securities, filed a lawsuit in the United States District Court for the Southern District of New York against Kitov Parent, its CEO and CFO, alleging violations of U.S. federal securities laws and seeking unspecified damages and other relief based on, among other things, Kitov Parent allegedly including misleading information in its public filings. Our time to respond to the Complaint is to be determined. An initial pretrial conference is scheduled for May 18, 2017. On February 10, 2017, an individual who allegedly acquired Kitov Parent’s securities, individually and on behalf of a putative class of investors who purchased or otherwise acquired Kitov Parent’s securities, filed a lawsuit in the Superior Court of the State of California for the County of San Mateo against Kitov Parent, its CEO and CFO, and the underwriters of Kitov Parent’s initial public offering, alleging violations of U.S. federal securities laws and seeking unspecified damages and other relief based on, among other things, Kitov Parent allegedly including misleading information in its public filings. On March 20, 2017, an individual who allegedly acquired Kitov Parent’s securities, individually and on behalf of a putative class of investors who purchased or otherwise acquired Kitov Parent’s securities, filed a lawsuit in the Superior Court of the State of California for the County of San Mateo against Kitov Parent, its CEO and CFO, and the underwriters of Kitov Parent’s initial public offering, alleging violations of U.S. federal securities laws and seeking unspecified damages and other relief based on, among other things, Kitov Parent allegedly including misleading information in its public filings. On April 6, 2017, the Superior Court of the State of California for the County of San Mateo entered an order consolidating the two California putative class actions. On April 13, 2017, the court entered a case management order requiring the plaintiffs to file and serve an amended consolidated complaint on or before June 5, 2017. The case management order requires Kitov Parent and the other defendants to file and serve their answers or other responses to the amended consolidated complaint on or before July 20, 2017. The court has scheduled an initial case management conference for October 11, 2017. 118 Our management rejects the claims in all of the aforesaid class actions lawsuits in the United States of America (the “U.S. Class Actions”). At this preliminary stage we are unable, with any degree of certainty, to make any evaluations or any assessments with respect to the U.S. Class Actions as to the probability of success or the scope of potential exposure, if any. Other than the 2015 Motion, the ISA Investigation, the 2017 Motions and the U.S. Class Actions, we are not currently a party to any significant legal or arbitration proceedings involving any third party, including governmental proceedings pending or known to be contemplated, which may have, or have had in the recent past, significant effects on the company’s financial position or profitability. Dividend Policy We anticipate that, for the foreseeable future, we will retain any future earnings to support operations and to finance the growth and development of our business. Therefore, we do not expect to pay cash dividends for at least the next several years. We did not declare dividends during the three most recent fiscal years. The distribution of dividends may also be limited by the Companies Law, which permits the distribution of dividends only out of retained earnings or earnings derived over the two most recent fiscal years, whichever is higher, provided that there is no reasonable concern that payment of a dividend will prevent a company from satisfying its existing and foreseeable obligations as they become due. Our amended and restated articles of association provide that dividends will be paid at the discretion of, and upon resolution by, our board of directors, subject to the provision of the Companies Law. B. Significant Changes Except as otherwise disclosed in this Annual Report on Form 20-F, no significant change has occurred since December 31, 2016. ITEM 9. THE OFFER AND LISTING A. Offer and Listing Details Our ordinary shares are currently traded on the TASE under the symbol “KTOV”. Our ADSs and public warrants are currently traded on NASDAQ under the symbols “KTOV” and “KTOVW”, respectively. The following table sets forth, for the periods indicated, the reported high and low closing sales prices of our ADSs on NASDAQ. Most Recent Six Months April 2017 March 2017 February 2017 January 2017 December 2016 November 2016 Quarterly First Quarter 2017 Fourth Quarter 2016 Third Quarter 2016 Second Quarter 2016 First Quarter 2016 Fourth Quarter 2015 (commencing November 20) Annual 2017 (through April 30) 2016 2015 (commencing November 20) 119 $ U.S. Price Per ADS High Low 2.04 2.16 2.88 3.35 3.51 3.75 3.35 4.32 3.62 6.68 4.60 4.47 3.35 6.68 4.47 1.85 1.93 1.69 2.70 2.93 3.12 1.69 2.93 2.77 3.11 2.33 2.43 1.69 2.33 2.43 The following table sets forth, for the periods indicated, the reported high and low closing sales prices of the public warrants traded on NASDAQ. Most Recent Six Months April 2017 March 2017 February 2017 January 2017 December 2016 November 2016 Quarterly First Quarter 2017 Fourth Quarter 2016 Third Quarter 2016 Second Quarter 2016 First Quarter 2016 Fourth Quarter 2015 (commencing November 20) Annual 2017 (through April 30) 2016 2015 (commencing November 20) 120 $ U.S. Price Per Public Warrant High Low 0.55 0.58 0.99 1.36 1.47 1.68 1.36 2.38 1.10 2.50 1.10 0.75 1.36 2.5 0.70 0.45 0.45 0.40 0.96 1.07 1.30 0.40 1.07 0.73 0.76 0.50 0.49 0.40 0.50 0.53 The following table sets forth, for the periods indicated, the reported high and low closing sales prices of our ordinary shares on the TASE in NIS and U.S. dollars. U.S. dollar per ordinary share amounts are calculated using the U.S. dollar representative rate of exchange on the date to which the high or low market price is applicable, as reported by the Bank of Israel. Most Recent Six Months April 2017 March 2017 February 2017 January 2017 December 2016 November 2016 October 2016 Quarterly First Quarter 2017 Fourth Quarter 2016 Third Quarter 2016 Second Quarter 2016 First Quarter 2016 Fourth Quarter 2015 Third Quarter 2015 Second Quarter 2015 First Quarter 2015 Annual 2016 2015 2014 2013 2012 NIS * Price Per Ordinary Share $ U.S. * Price Per Ordinary Share High Low High Low 0.38 0.41 0.55 0.64 0.68 0.69 0.74 0.64 0.74 0.66 1.29 0.92 2.07 1.82 1.84 4.13 1.29 4.13 18.06 33.27 9.31 0.35 0.36 0.33 0.53 0.58 0.61 0.66 0.33 0.58 0.54 0.62 0.46 0.50 1.19 1.38 1.51 0.46 0.50 1.34 3.04 3.29 0.11 0.11 0.09 0.17 0.18 0.18 0.20 0.17 0.20 0.18 0.34 0.24 0.54 0.48 0.47 1.05 0.34 1.05 5.16 9.41 2.43 0.10 0.10 0.15 0.14 0.15 0.16 0.17 0.09 0.15 0.14 0.16 0.12 0.13 0.31 0.35 0.38 0.12 0.13 0.34 0.83 0.83 * Price adjusted due to the distribution of dividends in October 2012 in connection with the sale by Kitov Parent (then known as Mainrom Line Logistics Ltd.) of all of its activities, assets, rights, obligations and liabilities to a private company held by its then controlling shareholders. On April 28, 2017 the last reported sale price of our ADSs on NASDAQ was $1.88 per ADS, the last reported sale price of the public warrants on NASDAQ was $0.45 per public warrant. On April 30, 2017 the last reported sale price of our ordinary shares on the TASE was NIS 0.354 per share, or $0.10 per share (based on the representative U.S. dollar – NIS rate of exchange of 3.619 on April 30, 2017). B. Plan of Distribution Not applicable. C. Markets Our ordinary shares are listed and traded on the TASE under the symbol KTOV. Our ADSs and our public warrants are currently traded on NASDAQ under the symbols “KTOV” and “KTOVW”, respectively. D. Selling Shareholders Not applicable. E. Dilution Not applicable. F. Expenses of the Issue Not applicable. 121 ITEM 10. ADDITIONAL INFORMATION A. Share Capital Not applicable. B. Memorandum and Articles of Association Securities Registers Our registration company for our shares is Registration Company of United Mizrahi Bank Ltd, and its address is 7 Jabotinsky St., Ramat Gan, Israel. Our transfer agent and registrar for our ADSs is the depositary for our ADRs, Bank of New York Mellon, and its address is 101 Barclay Street, New York, NY. Objects and Purposes According to our memorandum of association and our amended and restated articles of association, we are permitted to engage in any legal business. Our registration number with the Israeli Registrar of Companies is Public Company number 520031238. Ordinary Shares The following is a description of our ordinary shares. Our authorized share capital is 5,000,000,000 ordinary shares, with no par value, and 1,000,000,000 non-voting senior preferred shares, with no par value, divided into 5 classes of 200,000,000 preferred shares in each class. The above amounts include 21 dormant ordinary shares held in treasury. The ordinary shares do not have preemptive rights, preferred rights or any other right to purchase our securities. Neither our amended and restated articles of association nor the laws of the State of Israel restrict the ownership or voting of ordinary shares by non-residents of Israel, except under certain circumstances for ownership by nationals of certain countries that are, or have been, in a state of war with Israel. Transfer of Shares. Our fully paid ordinary shares may generally be freely transferred under our amended and restated articles of association, unless the transfer is restricted or prohibited by applicable law or the rules of the stock exchange on which the shares are traded. Notices. Under the Companies Law, and regulations promulgated thereunder, and our amended and restated articles of association, we are required to publish notices on our website, at least 21 days’ prior notice of a shareholders’ meeting. However, under regulations promulgated under the Companies Law, we are required to publish notices on our website at least 35 calendar days prior any shareholders’ meeting in which the agenda includes matters which may be voted on by voting instruments. Regulations under the Companies Law exempt companies whose shares are listed for trading both on a stock exchange in and outside of Israel, from some provisions of the Companies Law. These regulations exempt us from some of the requirements of the Israeli proxy regulations, under certain circumstances. According to the Companies Law and the regulations promulgated thereunder, as applicable to Kitov Parent, for purposes of determining the shareholders entitled to notice and to vote at such meeting, the board of directors may fix the record date not more than 40 nor less than four calendar days prior to the date of the meeting, provided that an announcement regarding the general meeting shall be given prior to the record date. 122 Election of Directors. Under our amended and restated articles of association, the number of directors on our Board will be no less than four and no more than nine (including any external directors, to the extent that we may be required to appoint external directors in accordance with the Companies Law and any Regulations enacted thereunder) (“Maximum Number”). The majority of the members of the Board shall be residents of Israel, unless our center of management shall have been transferred to another country in accordance with a resolution of our Board by a majority of three quarters (75%) of the participating director votes. The number of directors may be changed, at any time and from time to time, by our shareholders with a majority of (a) 75% of the voting rights participating and voting on the matter in the applicable general meeting of our shareholders and (b) more than 47.9% of all of the voting rights in Kitov Parent as of the record date established for the applicable general meeting of our shareholders (“Special Majority”). For more information, please see “Item 6 – Directors, Senior Management and Employees – C. Board Practices.” Dividend and Liquidation Rights. Subject to preferences that may be applicable to any then outstanding preferred shares, our profits, in respect of which a resolution was passed to distribute them as dividend or bonus shares, shall be paid pro rata to the amount of shares held by the shareholders. In the event of our liquidation, the liquidator may, with the general meeting’s approval, and subject to any preferences that may be applicable to any then outstanding preferred shares, distribute parts of our property in specie among the shareholders and he or she may, with similar approval, deposit any part of our property with trustees in favor of the shareholders as the liquidator, with the approval mentioned above, deems fit. Voting, Shareholders’ Meetings and Resolutions. Holders of ordinary shares are entitled to one vote for each ordinary share held on all matters submitted to a vote of shareholders. The quorum required for an ordinary meeting of shareholders consists of at least two shareholders present, in person or by proxy, or who has sent us a voting instrument indicating the way in which he or she is voting, who hold or represent, in the aggregate, at least 25% of the voting rights of our outstanding share capital. A meeting adjourned for lack of a quorum is adjourned to the same day in the following week at the same time and place or any time and place as prescribed by the board of directors in notice to the shareholders. At the reconvened meeting one shareholder at least, present in person or by proxy constitutes a quorum except where such meeting was called at the demand of shareholders. With the agreement of a meeting at which a quorum is present, the chairman may, and on the demand of the meeting he must, adjourn the meeting from time to time and from place to place, as the meeting resolves. Annual general meetings of our shareholders are to be held once every year within a period of not more than 15 months after the last preceding annual general shareholders’ meeting. Our board of directors may call special general meetings of shareholders. The Companies Law provides that a special general meeting of shareholders may be called by the board of directors or by a request of two directors or 25% of the directors in office, whichever is the lower, or by shareholders holding at least 5% of our issued share capital and at least 1% of the voting rights, or of shareholders holding at least 5% of our voting rights, subject to the provisions set forth in our amended and restated articles of association. An ordinary resolution requires approval by the holders of a majority of the voting rights present, in person or by proxy, at the meeting and voting on the resolution. Allotment of Shares. Our board of directors has the power to allot or to issue shares to any person, with restrictions and condition as it deems fit. Preferred Shares Pursuant to Israel’s securities laws, a company whose ordinary shares are registered for trade on the TASE may not have more than one class of shares for a period of one year following initial registration of the company on the TASE. After a period of one year, it is permitted to issue preferred shares if the preference of those shares is limited to a preference in the distribution of dividends and these preferred shares have no voting rights, and if such issuance is otherwise in accordance with any then applicable TASE regulations or directives with respect to the issuance of preferred shares by a company whose ordinary shares are listed on the TASE. We presently do not have any issued and outstanding preferred shares. On December 5, 2016, our shareholders approved the amendment to our amended and restated articles of association, as well as to our memorandum of association, for the addition to Kitov Parent’s registered share capital of 1,000,000,000 non-voting senior preferred shares, with no par value, divided into 5 classes of 200,000,000 preferred shares in each class (the “Preferred Shares”). 123 Pursuant to our amended and restated articles of association, our board of directors is authorized to fix, by resolution of the board of directors, (i) the number of issued Preferred Shares (subject to the maximum number of Preferred Shares authorized in such class), (ii) the designation of such class of Preferred Shares, and (iii) the conversion, redemption, optional and other special rights, qualifications, limitations or restrictions, if any, of the shares of such class of Preferred Shares. Consequently, the issuance of Preferred Shares would be available for issuance without further actions by Kitov Parent’s shareholders, unless shareholder approval is required by Israeli law, the rules of any exchange or other market on which Kitov Parent’s securities may then be listed or traded, Kitov Parent’s articles of association then in effect, or any other applicable rules and regulations. For so long as we are also listed on the TASE, the issuance of any Preferred Shares will also be subject to the requirements of any TASE regulations or directives governing the issuance of preferred shares by companies whose ordinary shares are listed on the TASE. The TASE has not yet issued any directives in connection with the issuance of preferred shares by a company whose ordinary shares are listed on TASE, other than a recently issued temporary directive which is currently scheduled to expire in November 2017. Subject to the actual terms of issuance determined by our Board of Directors for any Preferred Shares when issued, our Preferred Shares may be convertible into our ordinary shares or another series of Preferred Shares. Each such series of Preferred Shares shall have such number of shares, designations, preferences, voting powers, qualifications, and special or relative rights or privileges as shall be determined by the board of directors, which may include, among others, dividend rights, voting rights, liquidation preferences, conversion rights and preemptive rights, rights, qualifications, limitations and/or restrictions determined by our board of directors in accordance with our articles of association in effect at the time of any such issuance, including, but not limited to, some or all of the following: (i) the number of Preferred Shares constituting that series and the distinctive designation of that series, which number may be increased or decreased (but not below the number of Preferred Shares then outstanding) from time to time by action of the board of directors; (ii) the dividend rate and the manner and frequency of payment of dividends on the Preferred Shares of that series, whether dividends will be cumulative, and, if so, from which date; (iii) subject to applicable law, whether that series will have voting rights, in addition to any voting rights provided by law, and, if so, the terms of such voting rights; (iv) the terms and conditions of any conversion privilege of the series, including provision for adjustment of the conversion rate in such events as the board of directors may determine; (iv) whether or not the shares of that series will be redeemable, and, if so, the terms and conditions of such redemption; (vi) whether that series will have a sinking fund for the redemption or purchase of Preferred Shares of that series, and, if so, the terms and amount of such sinking fund; (vii) whether or not the Preferred Shares of the series will have priority over or be on a parity with or be junior to the Preferred Shares of any other series or class in any respect; (viii) the rights of the Preferred Shares of that series in the event of voluntary or involuntary liquidation, dissolution or winding up of the corporation, and the relative rights or priority, if any, of payment of Preferred Shares of that series; and any other relative rights, preferences and limitations of that series. Issuance of Preferred Shares by our board of directors may result in such shares having dividend or liquidation preferences senior to the rights of the holders of our ordinary shares and, Preferred Shares which are convertible into our ordinary shares could potentially dilute the voting rights of the holders of our ordinary shares. Once designated by our board of directors, and offered hereby, each series of Preferred Shares may have specific financial and other terms that will be described in a prospectus supplement. The description of the Preferred Shares that is set forth in any prospectus supplement is not complete without reference to the documents that govern the Preferred Shares. All Preferred Shares offered hereby will, when issued, be fully paid and nonassessable, including Preferred Shares issued upon the exercise of Preferred Share warrants or subscription rights, if any. Each Preferred Share shall be entitled to receive upon distribution, and in preference to our ordinary shares, (i) dividends in excess of the general dividends issued to all shareholders including holders of Ordinary Shares, and/or (ii) amounts paid in a distribution of our surplus assets on winding up, in an amount equal to the original issue price for such Preferred Shares as set forth in Kitov Parent’s share registry (adjusted for share combinations or subdivisions or other recapitalizations of Kitov Parent’s shares), and less the amount of any dividend previously paid in preference, all pro rata to the number of Kitov Parent’s Preferred Shares of each specific class of Preferred Shares issued and outstanding at such time, without having regard to any premium paid or discount thereon, and all subject to the provisions hereof. 124 Furthermore, and after payment of the Preferred Shares’ dividend preferences or liquidation preferences as aforesaid, each Preferred Share in Kitov Parent’s capital shall be entitled to receive upon distribution, (i) a general dividend issued to all Shareholders, (ii) bonus shares, and (iii) amounts paid in a distribution of Kitov Parent’s surplus assets on winding up, all pro rata to the number of Kitov Parent’s Shares (Ordinary Shares and Preferred Shares) issued and outstanding at such time, without having regard to any premium paid thereon or discount, and all subject to the provisions hereof. All Preferred Shares shall be non-voting shares and shall not vest the holder thereof with any right to participate in Kitov Parent’s general meetings, to receive notice thereof and/or to vote thereat. Without limitation to the above, the Preferred Shares shall not confer upon the holders thereof any voting rights or any right to appoint directors or any other right with respect to general meetings, including without limitation, attending, voting at or requesting to convene, such general meetings or proposing matters for the agenda of such general meetings, except as expressly set forth below or as otherwise specifically provided by Israeli law. So long as any Preferred Shares are outstanding, the provisions of the section below titled “Modification of class rights”, and the provisions of this section shall apply, such that the adoption of a resolution, by a regular majority in voting power of the Preferred Shares who are present, entitled to vote thereon (if any) and voting thereon, voting together as a single class, given in person or by proxy or by an authorized proxy holder, at a meeting of holders of Preferred Shares shall be necessary for effecting or validating: (i) (ii) (iii) Authorization of Senior Shares. Any amendment or alteration of the Memorandum of Association or Articles of Association of Kitov Parent so as to authorize or create, or increase the authorized amount of, any class or series of shares to be so authorized, created or increased after the initial issuance of any class of Preferred Shares, the terms of which expressly provide that such class or series will rank senior to the outstanding class or classes of Preferred Shares as to dividend rights and distribution rights upon the liquidation, winding up or dissolution of Kitov Parent (collectively, “Senior Shares”); Amendment of the Preferred Shares. Any amendment, alteration or repeal of any provision of the Articles of Association so as to adversely affect the special rights, preferences, privileges or voting powers of the Preferred Shares; and Share Exchanges, Reclassifications, Mergers and Consolidations. Any consummation of a binding share exchange or reclassification involving the Preferred Shares, or of a merger or consolidation of Kitov Parent with or into another entity, unless in each case (x) the Preferred Shares remain outstanding or, in the case of any such merger or consolidation with respect to which Kitov Parent is not the surviving or resulting entity (or the Preferred Shares are otherwise exchanged or reclassified), are converted or reclassified into or exchanged for preferred shares of the surviving or resulting entity or its ultimate parent, and (y) such Preferred Shares that remain outstanding or such preferred shares, as the case may be, have rights, preferences, privileges and voting powers of the surviving or resulting entity or its ultimate parent that, taken as a whole, are not materially less favorable to the holders thereof than the rights, preferences, privileges and voting powers, taken as a whole, of the Preferred Shares immediately prior to the consummation of such transaction; 125 provided, however, that (A) for all purposes of this section, (1) any increase in the amount of Kitov Parent’s authorized Ordinary Shares or Preferred Shares or the issuance of any additional Ordinary Shares or Preferred Shares or (2) the authorization or creation of any class or series of shares established after the initial issuance of any class of Preferred Shares, the terms of which do not expressly provide that such class or series ranks senior to or on a parity with the previously issued and outstanding Preferred Shares as to dividend rights and distribution rights upon any liquidation, winding up or dissolution of Kitov Parent (collectively, “Junior Shares”); or the authorization or creation of any class or series of shares established after the initial issuance of any class of Preferred Shares the terms of which expressly provide that such class or series will rank on a parity with the previously issued and outstanding Preferred Shares as to dividend rights and distribution rights upon any liquidation, winding up or dissolution of Kitov Parent (collectively, “Parity Shares”); and, any increase in the amount of authorized but unissued shares of such class or series of Parity Shares or Junior Shares or the issuance of additional shares of such class or series of Parity Shares or Junior Shares, will be deemed not to adversely affect (or to otherwise cause to be materially less favorable) the rights, preferences, privileges or voting powers of the previously issued and outstanding Preferred Shares and shall not require the consent or the adoption of a resolution by the holders of the previously issued and outstanding Preferred Shares; (B) in the event of a binding share exchange or reclassification involving the Preferred Shares, or of a merger or consolidation of Kitov Parent with or into another entity, as described above in which the provisions of sub-section (b) (iii)(x) and (y) above are complied with, the consent or the adoption of a resolution by the holders of the previously issued Preferred Shares shall not be required in order to effect, validate or approve such share exchange, reclassification, merger or consolidation; and (C) to the extent that, notwithstanding the provisions of immediately preceding clauses (A) and (B), the consent or approval of the holders of Preferred Shares, voting together as a single class, is nonetheless required by applicable law or the Articles of Association in such circumstances, or such consent or approval is otherwise required by applicable law or the Articles of Association with respect to any matter that is not set forth in the provisions of items (i)-(iii) of this section above, such approval or consent may be given by the adoption of a resolution, by a simple majority of the voting power of the Preferred Shares who are present, entitled to vote thereon (if any) and voting thereon, voting together as a single class, given in person or by proxy or by an authorized person, at a meeting of holders of Preferred Shares and the legal quorum for any such meeting shall be as set forth above with respect to meeting of holders of our Ordinary Shares. The rules and procedures for calling and conducting any meeting of the holders of Preferred Shares (including, without limitation, the fixing of a record date in connection therewith), the solicitation and use of proxies at such a meeting, the obtaining of written consents and any other procedural aspect or matter with regard to such a meeting or such consents shall be governed by any rules the Board of Directors, in its discretion, may adopt from time to time, which rules and procedures shall conform to the requirements of our amended and restated articles of association (including the provisions set forth above), applicable law and, if applicable, the rules of any national securities exchange or other trading facility on which the Preferred Shares are listed or traded at the time. Although our board of directors has no intention at the present time of doing so, it could authorize the issuance of a series of Preferred Shares that could, depending on the terms of such series, impede the completion of a merger, tender offer, change of control or other takeover attempt. Board of Directors Under our amended and restated articles of association, resolutions by the board of directors shall be decided by a majority of votes of the directors present, or participating, in the case of voting by media, and voting, each director having one vote. In the event of a tie, the chairman of the board does not hold a casting vote. Under the Companies Law, except as provided below, companies incorporated under the laws of the State of Israel that are “public companies,” including Israeli companies with shares listed on NASDAQ, are required to appoint at least two external directors who meet the qualification requirements set forth in the Companies Law. On July 13, 2016, our Board of Directors resolved to adopt the corporate governance exception set forth in Regulation 5D of the Israeli Companies Regulations (Relief for Public Companies with Shares Listed for Trading on a Stock Market Outside of Israel), 5760-2000. In accordance with such Regulation, a public company with securities listed on certain foreign exchanges, including NASDAQ, that satisfies the applicable foreign country laws and regulations that apply to companies organized in that country relating to the appointment of independent directors and composition of audit and compensation committees and have no controlling shareholder are exempt from the requirement to appoint external directors or comply with the audit committee and compensation committee composition requirements under the Companies Law. In accordance with our Board’s resolution, for so long as Kitov Parent does not have a controlling shareholder as defined in Section 1 of the Companies Law, Kitov Parent intends to comply with the NASDAQ Listing Rules in connection with a majority of independent directors on the Board and in connection with the composition of each of the Audit Committee and the Compensation Committee, in lieu of such requirements set forth under the Companies Law. A majority of our Board members are independent as required by the NASDAQ Listing Rules. Furthermore, our Audit Committee consists of at least three independent directors, and our Compensation Committee consists of at least two independent directors. Should any person or entity become deemed to be a controlling shareholder as defined in Section 1 of the Companies Law, then in accordance with Section 248(a) of the Companies Law, we will be required to convene a special general meeting of the shareholders at the earliest possible date, the agenda of which shall include the appointment of at least two external directors. Following such appointment, all of the external directors shall be appointed to each of our Audit Committee and Compensation Committee, and at least one external director shall be appointed to each committee of the Board of Directors authorized to exercise any of the powers of the board of directors. 126 The Companies Law requires that certain transactions, actions and arrangements be approved as provided for in a company’s articles of association and in certain circumstances by the audit committee or the compensation committee and by the board of directors itself. Those transactions that require such approval pursuant to a company’s articles of association must be approved by its board of directors. In certain circumstances, audit committee and shareholder approval is also required. The vote required by the audit committee and the board of directors for approval of such matters, in each case, is a majority of the directors participating in a duly convened meeting. Under the Companies Law, except as to certain companies listed on foreign stock exchanges, including NASDAQ, as described above, the audit committee is to be comprised of at least three members appointed by the board of directors, which members must include all of the external directors. The majority of members of the audit committee must be independent directors (as defined in the Companies Law), and the chairman of the audit committee must be an external director. The Companies Law requires that a member of the board of directors or senior management of the company promptly and, in any event, not later than the first board meeting at which the transaction is discussed, disclose any personal interest that he or she may have, either directly or by way of any corporation in which he or she is, directly or indirectly, a 5% or greater shareholder, director or general manager or in which he or she has the right to appoint at least one director or the general manager, as well as all related material information known to him or her, in connection with any existing or proposed transaction by the company. In addition, if the transaction is an extraordinary transaction, (that is, a transaction other than in the ordinary course of business, otherwise than on market terms, or is likely to have a material impact on the company’s profitability, assets or liabilities), the member of the board of directors or senior management must also disclose any personal interest held by his or her spouse, siblings, parents, grandparents, descendants, spouse’s descendants, siblings and parents, and the spouses of any of the foregoing. Once the member of the board of directors or senior management complies with the above disclosure requirement, a company may approve the transaction in accordance with the provisions of its articles of association. Under the provisions of the Companies Law, whoever has a personal interest in a matter, which is considered at a meeting of the board of directors or the audit committee, may not be present at this meeting or vote on this matter, unless it is not an extraordinary transaction as defined in the Companies Law. However, if the chairman of the board of directors or the chairman of the audit committee has determined that the presence of an office holder with a personal interest is required for the presentation of a matter, such officer holder may be present at the meeting. Notwithstanding the foregoing, if the majority of the directors have a personal interest in a matter, they shall be allowed to participate and vote on this matter, but the approval of the transaction by the shareholders in the general meeting is required. Our amended and restated articles of association provide that, subject to the Companies Law, all actions executed in good faith by the board of directors or by a committee thereof or by any person acting as a director or a member of a committee of the board of directors, will be deemed to be valid even if, after their execution, it is discovered that there was a flaw in the appointment of these persons or that any one of these persons was disqualified from serving at his or her office. Our amended and restated articles of association provide that, subject to the provisions of the Companies Law, the board of directors may appoint board of directors’ committees. The committees of the board of directors shall report to the board of directors their resolutions or recommendations on a regular basis, as shall be prescribed by the board of directors. The board of directors may cancel the resolution of a committee that has been appointed by it; however, such cancellation shall not affect the validity of any resolution of a committee, pursuant to which we acted, vis-à-vis another person, who was not aware of the cancellation thereof. Decisions or recommendations of the committee of the board which require the approval of the board of directors will be brought to the directors’ attention a reasonable time prior to the discussion at the board of directors. 127 According to the Companies Law, a contract of a company with its directors, regarding their conditions of service, including the grant to them of exemption from liability from certain actions, insurance, and indemnification as well as the company’s contract with its directors on conditions of their employment, in other capacities, generally requires the approval of the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law), the board of directors, and the shareholders. Under the Companies Regulations (Relief from Related Party Transactions), 5760-2000, promulgated under the Companies Law, as amended, certain extraordinary transactions between a public company and its controlling shareholder(s) do not require shareholder approval. Such extraordinary transactions must be approved by both the board of directors and the audit committee and (i) must involve the extension of an existing transaction that was duly approved and does not involve any significant change in the terms of the existing transaction or the change is solely for the benefit of the company; (ii) is solely for the benefit of the company; (iii) is with the controlling shareholder or another person in which the controlling shareholder has an interest and the transaction is in accordance with the terms of a framework agreement that was duly approved; (iv) is with the controlling shareholder or another person in which the controlling shareholder has an interest, the purpose of which is a transaction of theirs with a third party or a joint proposal to enter into a transaction with a third party, and the terms of the transaction that apply to the controlling shareholder are not significantly different from the terms that apply to the controlling shareholder or an entity controlled by him or her (while taking into account the extent of their respective involvement in the transaction); (v) is among companies controlled by the controlling shareholder, or between the public company and the controlling shareholder or another person in which the controlling shareholder has a personal interest, and the transaction is on market terms, within the ordinary course of business and does not harm the company; or (vi) on the date of approval of the extraordinary transaction by the board of directors and audit committee, the shareholders who do not have personal interest in the approval of the said transactions do not hold more than 2% of the voting rights in the company. In addition, under such regulations, directors’ compensation and employment arrangements in a public company do not require the approval of the shareholders if both the compensation committee (or the audit committee acting in lieu of a compensation committee pursuant to the Companies Law) and the board of directors agree that such arrangements are solely for the benefit of the company. Employment and compensation arrangements for an office holder that is a controlling shareholder of a public company, or the provision of directors and officers insurance for the chief executive officer, do not require shareholder approval if certain criteria are met. The Board, following the prior determination of the Audit Committee or Compensation Committee, as applicable, may also determine that the compensation being offered to certain office holders (including directors) is an engagement which, pursuant to the leniencies set forth in the Relief Regulations, can be entered into by a company immediately, with the approval by the shareholders being deferred to the next shareholder meeting to be called by the Company, is such compensation is consistent with compensation policy of the company which was approved by the shareholders of the company in accordance with the Companies Law, and are no more beneficial to the recipient as such similar compensation previously granted to other holders of the same office. Private Placements Under the Companies Law, if (i) as a result of a private placement a person would become a controlling shareholder or (ii) a private placement will entitle investors to receive 20% or more of the voting rights of a company as calculated before the private placement, and all or part of the private placement consideration is not in cash or in public traded securities or is not in market terms and if as a result of the private placement the holdings of a substantial shareholder shall increase or as a result of it a person shall become a substantial shareholder, then in either case, the allotment must be approved by the board of directors and by the shareholders of the company. A “substantial shareholder” in connection with a private placement as set forth above, is defined as a shareholder who holds five percent or more of the company’s outstanding share capital or voting rights, and which assumes the exercise of all of the securities convertible into shares either held by that person prior to such private placement or offered to such person under the private placement. In order for the private placement to be on “market terms” the board of directors has to determine, on the base of detailed explanation, that the private placement is on market terms, unless proven otherwise. Otherwise, under the Companies Law and the regulations promulgated thereunder, a private placement of securities does not require approval at a general meeting of the shareholders of a company; provided however, that in other special circumstances, such as a private placement completed in lieu of a special tender offer, or a private placement under circumstances which qualifies as a related party transaction requiring shareholder approval, approval at a general meeting of the shareholders of a company is then also required. A Registered Direct Offering in the United States is generally considered a private placement under the Companies Law. 128 Access to corporate records Under the Companies Law, shareholders are provided access to minutes of our general meetings, our shareholders register and principal shareholders register, our amended and restated articles of association, our financial statements and any document that we are required by law to file publicly with the Israeli Companies Registrar or the Israel Securities Authority. In addition, shareholders may request to be provided with any document related to an action or transaction requiring shareholder approval under the related party transaction provisions of the Companies Law. We may deny this request if we believe it has not been made in good faith or if such denial is necessary to protect our interest or protect a trade secret or patent. Modification of class rights Under the Companies Law and our amended and restated articles of association, the rights attached to any class of share, such as voting, liquidation and dividend rights, may be amended by adoption of a resolution by the holders of a majority of the shares of that class present at a separate class meeting, or otherwise in accordance with the rights attached to such class of shares, as set forth in our amended and restated articles of association. The enlargement of an existing class of shares or the issuance of additional shares thereof, shall not be deemed to modify the rights attached to the previously issued shares of such class or of any other class, unless otherwise provided by the terms of the shares. Provisions Restricting Change in Control of Our Company As described below, certain provisions of the Companies Law and/or our amended and restated articles of association may have an effect of delaying, deferring or preventing a change in control. Full Tender Offer A person wishing to acquire shares of an Israeli public company and who would as a result hold over 90% of the target company’s issued and outstanding share capital is required by the Companies Law to make a tender offer to all of the company’s shareholders for the purchase of all of the issued and outstanding shares of the company. A person wishing to acquire shares of an Israeli public company and who would as a result hold over 90% of the issued and outstanding share capital of a certain class of shares is required to make a tender offer to all of the shareholders who hold shares of the same class for the purchase of all of the issued and outstanding shares of the same class. If the shareholders who do not respond to or accept the offer hold less than 5% of the issued and outstanding share capital of the company or of the applicable class of the shares, and more than half of the shareholders who do not have a personal interest in the offer accept the offer, all of the shares that the acquirer offered to purchase will be transferred to the acquirer by operation of law. However, a tender offer will be accepted if the shareholders who do not accept it hold less than 2% of the issued and outstanding share capital of the company or of the applicable class of the shares. Upon a successful completion of such a full tender offer, any shareholder that was an offeree in such tender offer, whether such shareholder accepted the tender offer or not, may, within six months from the date of acceptance of the tender offer, petition the Israeli court to determine whether the tender offer was for less than fair value and that the fair value should be paid as determined by the court. However, under certain conditions, the offeror may determine in the terms of the tender offer that an offeree who accepted the offer will not be entitled to petition the Israeli court as described above. 129 If the shareholders who did not respond or accept the tender offer hold at least 5% of the issued and outstanding share capital of the company or of the applicable class, the acquirer may not acquire shares of the company that will increase its holdings to more than 90% of the company’s issued and outstanding share capital or of the applicable class from shareholders who accepted the tender offer. The description above regarding a full tender offer shall also apply, with necessary changes, when a full tender offer is accepted and the offeror has also offered to acquire all of the company’s securities. Special Tender Offer The Companies Law provides that an acquisition of shares of an Israeli public company must be made by means of a special tender offer if as a result of the acquisition the purchaser would become a holder of at least 25% of the voting rights in the company. This rule does not apply if there is already another holder of at least 25% of the voting rights in the company. Similarly, the Companies Law provides that an acquisition of shares in a public company must be made by means of a special tender offer if as a result of the acquisition the purchaser would become a holder of more than 45% of the voting rights in the company, if there is no other shareholder of the company who holds more than 45% of the voting rights in the company. These requirements do not apply if the acquisition (i) occurs in the context of a private offering, on the condition that the shareholders’ meeting approved the acquisition as a private offering whose purpose is to give the acquirer at least 25% of the voting rights in the company if there is no person who holds at least 25% of the voting rights in the company, or as a private offering whose purpose is to give the acquirer 45% of the voting rights in the company, if there is no person who holds 45% of the voting rights in the company; (ii) was from a shareholder holding at least 25% of the voting rights in the company and resulted in the acquirer becoming a holder of at least 25% of the voting rights in the company; or (iii) was from a holder of more than 45% of the voting rights in the company and resulted in the acquirer becoming a holder of more than 45% of the voting rights in the company. The special tender offer may be consummated only if (i) at least 5% of the voting power attached to the company’s outstanding shares will be acquired by the offeror and (ii) the special tender offer is accepted by a majority of the votes of those offerees who gave notice of their position in respect of the offer; in counting the votes of offerees, the votes of a holder in control of the offeror, a person who has personal interest in acceptance of the special tender offer, a holder of at least 25% of the voting rights in the company, or any person acting on their or on the offeror’s behalf, including their relatives or companies under their control, are not taken into account. In the event that a special tender offer is made, a company’s board of directors is required to express its opinion on the advisability of the offer or shall abstain from expressing any opinion if it is unable to do so, provided that it gives the reasons for its abstention. An office holder in a target company who, in his or her capacity as an office holder, performs an action the purpose of which is to cause the failure of an existing or foreseeable special tender offer or is to impair the chances of its acceptance, is liable to the potential purchaser and shareholders for damages resulting from his or her acts, unless such office holder acted in good faith and had reasonable grounds to believe he or she was acting for the benefit of the company. However, office holders of the target company may negotiate with the potential purchaser in order to improve the terms of the special tender offer, and may further negotiate with third parties in order to obtain a competing offer. If a special tender offer was accepted by a majority of the shareholders who announced their stand on such offer, then shareholders who did not respond to the special offer or had objected to the special tender offer may accept the offer within four days of the last day set for the acceptance of the offer. In the event that a special tender offer is accepted, then the purchaser or any person or entity controlling it and any corporation controlled by them shall refrain from making a subsequent tender offer for the purchase of shares of the target company and may not execute a merger with the target company for a period of one year from the date of the offer, unless the purchaser or such person or entity undertook to effect such an offer or merger in the initial special tender offer. 130 Under the Companies Regulations (Relief for Public Companies whose Shared are Traded on Exchanges Outside of Israel), 5760-2000 (the “Foreign Listing Relief Regulations”), the above requirements for a special tender offer do not apply in instances whereby according to the laws of the foreign jurisdiction there are limitations regarding the acquisition of a controlling interest in the company of any specified portion or the acquisition of a controlling interest of any specified portion necessitates an offer by the potential acquirer of a controlling interest to acquire shares from amongst the publicly traded shares. The Israeli Securities Authority is of the view that US securities laws and exchange regulations of various exchanges do not purport to limit the acquisition of controlling interests in a company, do not require the potential acquirer of a controlling interest to make an offer to acquire shares from the public, and as such Israeli companies that are publicly traded in the United States of America cannot benefit from the special tender offer waiver pursuant to the Foreign Listing Relief Regulations and are thus subject to the general provisions of the Companies Law which require a special tender offer as outlined above. Merger The Companies Law permits merger transactions if approved by each party’s board of directors and, unless certain requirements described under the Companies Law are met, a majority of each party’s shareholders, by a majority of each party’s shares that are voted on the proposed merger at a shareholders’ meeting. The board of directors of a merging company is required pursuant to the Companies Law to discuss and determine whether in its opinion there exists a reasonable concern that, as a result of a proposed merger, the surviving company will not be able to satisfy its obligations towards its creditors, taking into account the financial condition of the merging companies. If the board of directors has determined that such a concern exists, it may not approve a proposed merger. Following the approval of the board of directors of each of the merging companies, the boards of directors must jointly prepare a merger proposal for submission to the Israeli Registrar of Companies. For purposes of the shareholder vote, unless a court rules otherwise, the merger will not be deemed approved if a majority of the shares voting at the shareholders’ meeting (excluding abstentions) that are held by parties other than the other party to the merger, any person who holds 25% or more of the means of control (See “Management – Audit Committee – Approval of Transactions with Related Parties” for a definition of means of control) of the other party to the merger or any one on their behalf including their relatives (See “Item 6. Directors, Senior Management and Employees - C. Board Practices - External Directors – Qualifications of External Directors” for a definition of relatives) or corporations controlled by any of them, vote against the merger. In addition, if the non-surviving entity of the merger has more than one class of shares, the merger must be approved by each class of shareholders, and such separate class voting may also include any classes of otherwise non-voting shares. If the transaction would have been approved but for the separate approval of each class of shares or the exclusion of the votes of certain shareholders as provided above, a court may still rule that the company has approved the merger upon the request of holders of at least 25% of the voting rights of a company, if the court holds that the merger is fair and reasonable, taking into account the appraisal of the merging companies’ value and the consideration offered to the shareholders. Under the Companies Law, each merging company must send a copy of the proposed merger plan to its secured creditors. Unsecured creditors are entitled to receive notice of the merger, as provided by the regulations promulgated under the Companies Law. Upon the request of a creditor of either party to the proposed merger, the court may delay or prevent the merger if it concludes that there exists a reasonable concern that, as a result of the merger, the surviving company will be unable to satisfy the obligations of the target company. The court may also give instructions in order to secure the rights of creditors. In addition, a merger may not be completed unless at least 50 days have passed from the date that a proposal for approval of the merger was filed with the Israeli Registrar of Companies and 30 days from the date that shareholder approval of both merging companies was obtained. 131 On April 25, 2017, the boards of directors of each of Kitov Parent and Kitov Pharmaceuticals approved a merger between the two entities, with Kitov Parent remaining as the surviving entity. See Item 4.C – Organizational Structure for more information on this merger, which we expect to be completed prior to the end of the second quarter of 2017. Tax Issues Israeli tax law treats some acquisitions, such as stock-for-stock exchanges between an Israeli company and a foreign company, less favorably than U.S. tax laws treat them. For example, Israeli tax law may, under certain circumstances, subject a shareholder who exchanges his ordinary shares for shares in another corporation to taxation prior to the sale of the shares received in such stock-for-stock swap. Amended and Restated Articles of Association Our amended and restated articles of association contain provisions that could delay or prevent changes in control or changes in our management. These provisions include the following: ● no cumulative voting in the election of directors, which limits the ability of minority shareholders to elect director candidates; ● the right of our board of directors to elect a director to fill a vacancy, which may prevent shareholders from being able to fill vacancies on our board of directors; ● a majority of the members of our board of directors are required to be residents of Israel, unless our center of management has been transferred to another country by a decision of our board of directors resolved by a supermajority of three-quarters of the participating votes at such board of directors meeting; ● the size of our board of directors shall be no more than nine (including any external directors required under applicable law); ● the directors, except for our external directors, are divided into three classes, as nearly equal in number as possible.; and, at each annual general meeting, the term of one class of directors expires, and the directors of such class are re-nominated to serve an additional three year term that expires at the annual general meeting held in the third year following such election, with this process continues indefinitely; and ● the provisions in our amended and restated articles of association governing the number of directors, the election and removal of directors, the division of the board of directors into classes, and the establishment of the center of management may only be changed by the shareholders with a majority of (a) 75% of the voting rights participating and voting on the matter in the applicable general meeting and (b) more than 47.9% of all of the voting rights in Kitov Parent as of the record date established for the applicable general meeting. Changes in Our Capital The general meeting may, by a simple majority vote of the shareholders attending the general meeting: ● increase Kitov Parent’s registered share capital by the creation of new shares from the existing class or a new class, as determined by the general meeting; ● cancel any registered share capital which have not been taken or agreed to be taken by any person; ● consolidate and divide all or any of its share capital into shares of larger nominal value than its existing shares; ● subdivide Kitov Parent’s existing shares or any of them, Kitov Parent’s share capital or any of it, into shares of smaller nominal value than is fixed; ● reduce Kitov Parent’s share capital and any fund reserved for capital redemption in any manner, and with and subject to any incident authorized, and consent required, by the Companies Law; and ● reduce shares from the issued and outstanding share capital of Kitov Parent, in such manner that those shares shall be cancelled and any nominal par value paid for those shares will be registered at Kitov Parent’s books as capital fund, which shall be deemed as a premium paid on those shares which shall remain in the issued and outstanding share capital of Kitov Parent. 132 C. Material Contracts Clinical Trial Services Agreements – Phase III Clinical Trial Master Research Services Agreement with Java Clinical Research Ltd. On February 9, 2014, we entered into a Master Research Services Agreement with Java Clinical Research Ltd., or Java, a contract research organization based in Dublin, Ireland. According to the terms of the agreement, Java will manage the Phase III clinical trial for KIT-302, including preparation and filing of the requests to the ethics boards and the necessary regulatory bodies of the European Union, recruiting the tested subjects, employment of the primary researchers, identification and evaluation of the medical centers and their subsequent management throughout the trial period and overall management of the trial process through its completion. We engaged with third party medical centers for the performance of our Phase III clinical trial through Java. The total cost of the agreement with Java, including the cost of all service providers with which we have engaged through Java, with respect to the Phase III clinical trial amounted to approximately $2.5 million. The Master Research Services Agreement was intended to remain in effect until Java provided all services through the completion of our Phase III trial of KIT-302. Services Agreement with DABL Limited On August 2, 2013, we entered into a services agreement with DABL Limited, or DABL, an Irish company based in Dublin, Ireland, in the ambulatory blood pressure monitoring technologies field. According to the agreement, DABL will provide protocol consultation services and coordinate the ambulatory blood pressure monitoring (ABPM) procedures and the analysis of the blood pressure tests during and after our Phase III trial of KIT-302. DABL’s technology enables the collection of data from hundreds of blood pressure tests during the day on each patient during the clinical trials as opposed to the traditional individual tests that yield many fewer results for statistical analysis during the same time frame. The above services agreement was intended to be in effect until DABL provided all services including the statistical analysis of results the blood pressure tests following our Phase III trial of KIT-302. Clinical Trial Services Agreements - Renal Function Clinical Trial Work Order with Java On September 7, 2016 we entered into an additional Work Order with Java, under the Master Research Services Agreement the term of which was extended by such Work Order, pursuant to which Java will manage the renal function clinical trial for KIT-302, including preparation and filing of the requests to the ethics boards and the necessary regulatory bodies of the U.K., recruiting the trial participants, employment of the primary researchers, identification and evaluation of the medical centers and their subsequent management throughout the trial period and overall management of the trial process through its completion. We also have directly engaged with third party medical centers for the performance of our renal function clinical trial being managed by Java. The Master Research Services Agreement will remain in effect until Java has provided all services through the completion of our renal function clinical trial. The parties have customary termination rights and either party may terminate the Master Research Services Agreement (or any work thereunder) upon 60 days’ notice. 133 Service Agreement with DABL On July 26, 2016 we entered into a new services agreement with DABL in connection with the renal function clinical trial. According to the agreement, DABL will provide protocol consultation services and coordinate the ambulatory blood pressure monitoring (ABPM) procedures and the analysis of the blood pressure tests during and after our renal function clinical trial. The services agreement will remain in effect until DABL has provided all services provided for in the agreement. However, we may terminate the agreement at any time upon 90 days’ notice, and both parties have customary termination rights. We estimate that the total cost of the agreement with Java, as well the cost of all other service providers with respect to the renal function clinical trial, will amount to approximately $1.3 million, assuming completion of the clinical trial as anticipated. Development Services Agreement with Dexcel On April 1, 2014, we entered into a Development Services Agreement with Dexcel Ltd., or Dexcel, a global pharmaceutical company, which has been involved in the manufacture and marketing of more than 55 branded and generic products. The agreement provides for Dexcel to develop the formulation for KIT-302 and the subsequent stability testing and manufacturing scale-up in quantities adequate for submission of an NDA to the FDA. Dexcel’s services include performing compatibility testing of APIs with excipients, screening to find at least two prototypes and identifying analytical methods for product analysis. We agreed to bear the cost of the APIs as well as other materials or means required for Dexcel to perform the services under the agreement. In exchange for these services, we will pay Dexcel: (i) $2 million in cash in four equal installments ($500,000 which was paid upon execution of the agreement, $500,000 which was paid upon attainment of the second milestone in May 2015, $500,000 that was paid in May 2016 as a result of the attainment of the fifth milestone, and the remaining $500,000 to be paid by the end of July 2016 based on the remaining milestone during the development and manufacturing period); and (ii) in our ordinary shares having an aggregate value of $1.5 million issued in three equal installments (the first issuance of 157,783 ordinary shares was made upon execution of the agreement, the second issuance of 597,511 ordinary shares was made upon attainment of the second milestone in May 2015, and the final issuance of 3,009,888 ordinary shares was made on June 19, 2016 in connection with the attainment of the fifth milestone ). In addition, in exchange for a right of first negotiation with regard to future global marketing rights for KIT-302 and for an option to negotiate the future commercial manufacture of KIT-302 Dexcel agreed to pay us $500,000 in two equal installments based on milestones during the development and manufacturing period (of which the first payment of $250,000 was made in May 2015 upon the attainment of the second development milestone, and the remaining $250,000 was paid in May 2016 as a result of the attainment of the fifth development milestone). Under the terms of the agreement, in the event we intend to enter into negotiations with any third party to enter into a commercial marketing or licensing agreement for the product, we are obligated to notify Dexcel of our intention to do so, and Dexcel has the right, within 21 days, to notify us whether it wishes to negotiate with us on mutually agreeable and commercially reasonable terms for the rights, in which case we are required to negotiate exclusively with Dexcel in good faith in an attempt to reach a mutual agreement with 60 days. If Dexcel does not so notify us, or if upon expiration of this 60 day period the parties are unable to agree in good faith upon its terms and conditions, we will be free to enter into a commercial agreement with any party on any terms we determine. We have formally notified Dexcel that we intend to enter into negotiations with third parties to enter into a commercial marketing or licensing agreement for the KIT-302 product. Dexcel has not notified us within the requisite 21 days whether or not it wishes to negotiate with us on mutually agreeable and commercially reasonable terms for these rights. As such, we believe that we are free to enter into a commercial agreement with any party on any terms we determine. On June 9, 2015 we, together with Dexcel, successfully completed the performance of a pilot pharmacokinetic clinical trial, or Pilot PK Study, which commenced on March 31, 2015 in Ichilov Medical Center in Tel Aviv. The objective of the Pilot PK Study was to demonstrate that the concentration of KIT- 302 in the blood of the subjects is comparable to the concentrations observed in the administration of the two existing, approved drugs (celecoxib and amlodipine besylate, which are the active components of KIT-302). For the purpose of this Pilot PK Study, Dexcel manufactured two prototypes of the KIT- 302 final formulation, based on the two existing approved drugs. 134 On May 10, 2016 we announced that we, together with Dexcel, had successfully completed a final conclusive pharmacokinetic (PK) bioequivalence (BE) study, or the Final PK Study. The objective of this study was to check the pharmacokinetics of the combination drug produced in a manufacturing setting in order to show that the blood levels achieved with our combination are the same as those obtained with the individual components. The Final PK Study compared the PK of KIT-302 which is a fixed dose combination consisting of celecoxib (200 mg), indicated for osteoarthritis pain, and amlodipine (10 mg), indicated for high blood pressure, to off-the-shelf branded 200 mg celecoxib capsules and 10 mg amlodipine tablets. A similar PK bioequivalence study for KIT-302, containing a lower dosage (2.5 mg) of amlodipine, was completed during the third quarter of 2016, and showed similar bioequivalence results to those found in the Final PK Study. On June 19, 2016, we entered into an amendment with Dexcel with respect to the conduct of this additional study, for which we will pay Dexcel approximately $200,000. On June 28, 2016 we announced that Dexcel has successfully completed an initial stability study for KIT-302. Additional stability studies required for the NDA are ongoing. According to the Development Services Agreement with Dexcel, any new intellectual property rights resulting from the development made by Dexcel which are applicable to manufacture, research, development, making of, use, sale, production commercialization and distribution of KIT-302 shall be jointly and equally owned (50%/50%) by Dexcel and Kitov. We anticipate that in the near future, we will be filing an international patent application, in partnership with Dexcel, which is related to pharmaceutical formulations of celecoxib and amlodipine and methods of preparing the same. Under the Development Services Agreement, Dexcel granted Kitov and Kitov granted Dexcel each a fully-paid, non-exclusive, perpetual world-wide license to the jointly and equally owned new intellectual property rights. Accordingly, we expect that there will be no royalty payments due to Dexcel for our use of this jointly and equally owned new intellectual property rights. The Development Services Agreement will remain in effect until Dexcel has provided all services through the completion of manufacturing scale-up in quantities adequate for submission of an NDA to the FDA as well as stability testing. However, the parties have customary termination rights and either party may terminate the agreement upon 90 days’ notice. Other Agreements For a description of other agreements, please see "Item 3. Major Shareholders and Related Party Transactions – D. Risk Factors – Risks Related to Our Business and Regulatory Matters", "Item 4. Information on the Company – B. Business Overview – Services and License Agreements", "Item 4. Information on the Company – B. Business Overview – Intellectual Property", "Item 4. Information on the Company- B. Business Overview - Intellectual Property - Exclusive License Agreement with Yissum", "Item 5. Operating and Financial Review and Prospects – B. Liquidity and Capital Resources", "Item 7. Major Shareholders and Related Party Transactions – A. Major Shareholders – Changes in Percentage Ownership by Major Shareholders", "Item 7. Major Shareholders and Related Party Transactions – B. Related Party Transactions – TyrNovo Ltd.", "Item 7. Major Shareholders and Related Party Transactions – B. Related Party Transactions" – August 2015 Loan Agreements", "Item 7. Major Shareholders and Related Party Transactions – B. Related Party Transactions – Consulting Agreement with Lior Tamar Investments Ltd.", "Item 7. Major Shareholders and Related Party Transactions – B. Related Party Transactions – Share Transfer Agreement with Kitov Pharmaceuticals". For information on exemption and indemnification letters granted to our officers and directors, please see “Item 6 – Directors, Senior Management and Employees – C. Board Practices – Exemption, Insurance and Indemnification of Directors and Officers.” D. Exchange Controls Exchange Controls There are currently no material Israeli currency control restrictions on payments of dividends or other distributions with respect to our securities or the proceeds from the sale of our securities, except under certain circumstances, for shareholders who are subjects of countries that are, or have been, in a state of war with Israel or otherwise as set forth in this section and under “Item 10E. Additional Information — Taxation.” However, legislation remains in effect pursuant to which currency controls can be imposed by administrative action at any time. Israeli residents have an obligation to file reports with the Bank of Israel regarding certain transactions. 135 E. Taxation The following description is not intended to constitute a complete analysis of all tax consequences relating to the acquisition, ownership and disposition of our ordinary shares, ADSs or warrants (the “Shares”). You should consult your own tax advisor concerning the tax consequences of your particular situation, as well as any tax consequences that may arise under the laws of any state, local, foreign or other taxing jurisdiction. Israeli Tax Considerations and Government Programs The following is a summary of the material Israeli tax laws applicable to us, and some Israeli Government programs benefiting us. This section also contains a discussion of some Israeli tax consequences to persons owning our Shares. This summary does not discuss all the aspects of Israeli tax law that may be relevant to a particular investor in light of his or her personal investment circumstances or to some types of investors subject to special treatment under Israeli law. Examples of this kind of investor include traders in securities or persons that own, directly or indirectly, 10% or more of our outstanding voting capital, all of whom are subject to special tax regimes not covered in this discussion. Some parts of this discussion are based on a new tax legislation which has not been subject to judicial or administrative interpretation. The discussion should not be construed as legal or professional tax advice and does not cover all possible tax considerations. SHAREHOLDERS ARE URGED TO CONSULT THEIR OWN TAX ADVISORS AS TO THE ISRAELI OR OTHER TAX CONSEQUENCES OF THE PURCHASE, OWNERSHIP AND DISPOSITION OF OUR SHARES, INCLUDING, IN PARTICULAR, THE EFFECT OF ANY FOREIGN, STATE OR LOCAL TAXES. General Corporate Tax Structure in Israel Israeli resident companies are generally subject to corporate tax, currently at the rate of 24% for 2017 of a company’s taxable income (to be reduced to 23% in 2018 and thereafter). The corporate tax rate for the tax years 2015 and 2016 was 26.5% and 25% respectively. However, the effective tax rate payable by a company that derives income from a Preferred Enterprise may be considerably less. Capital gains derived by an Israeli resident company are subject to tax at the prevailing corporate tax rate. Under Israeli tax legislation, a corporation will be considered as an “Israeli resident company” if it meets one of the following: (i) it was incorporated in Israel; or (ii) the control and management of its business are exercised in Israel. Taxation of Our Shareholders Capital Gains Capital gain tax is imposed on the disposal of capital assets by an Israeli resident, and on the disposal of such assets by a non- Israel resident if those assets are either (i) located in Israel; (ii) are shares or a right to a share in an Israeli resident corporation, or (iii) represent, directly or indirectly, rights to assets located in Israel. The Israeli Income Tax Ordinance of 1961 (New Version) (the “Ordinance”) distinguishes between “Real Gain” and the “Inflationary Surplus.” Real Gain is the excess of the total capital gain over Inflationary Surplus computed generally on the basis of the increase in the Israeli CPI between the date of purchase and the date of disposal. In general, the capital gain accrued by individuals on the sale of our Shares will be taxed at the rate of 25%. However, if the individual shareholder is a “Controlling Shareholder” (i.e., a person who holds, directly or indirectly, alone or together with another, 10% or more of one of the Israeli resident company’s means of control) at the time of sale or at any time during the preceding 12 months period, such gain will be taxed at the rate of 30%. The real capital gain derived by corporations will be generally subject to a corporate tax rate of 25% in 2016 and 24% in 2017. 136 Individual and corporate shareholder dealing in securities in Israel are taxed at the tax rates applicable to business income – 25% for corporations in 2016 and 24% in 2017 and a marginal tax rate of up to 48% and 47% for an individual in 2016 and in 2017 and thereafter, respectively, plus a 2% excess tax in 2016 and 3% in 2017 and thereafter, which is levied on individuals whose taxable income in Israel exceeds NIS 810,720 in 2016 and 640,000 in 2017 and thereafter (linked to the Israeli consumer price index) Notwithstanding the foregoing, capital gain derived from the sale of our Shares by a non-Israeli shareholder may be exempt under the Ordinance from Israeli taxation provided that the following cumulative conditions are met: (i) the shares were purchased upon or after the registration of the securities on the stock exchange (this condition shall not apply to shares purchased on or after January 1, 2009), (ii) the seller does not have a permanent establishment in Israel to which the derived capital gain is attributed, (iii) if the seller is a corporation, no more than 25% of its means of control are held, directly and indirectly, by an Israeli resident shareholders, and (iv) if the seller is a corporation, there is no Israeli Resident that is entitled to 25% or more of the revenues or profits of the corporation directly or indirectly. In addition, the sale of shares may be exempt from Israeli capital gain tax under the provisions of an applicable tax treaty. For example, the U.S.-Israel Double Tax Treaty exempts U.S. resident from Israeli capital gain tax in connection with such sale, provided (i) the U.S. resident owned, directly or indirectly, less than 10% of an Israeli resident company’s voting power at any time within the 12 month period preceding such sale; (ii) the seller, being an individual, is present in Israel for a period or periods of less than 183 days at the taxable year; and (iii) the capital gain from the sale was not derived through a permanent establishment of the U.S. resident in Israel. Either the purchaser, the Israeli stockbrokers or financial institution through which the shares are held is obliged, subject to the above mentioned exemptions, to withhold tax upon the sale of securities from the real capital gain at the rate of 25% in respect of a corporation and/or an individual. At the sale of securities traded on a stock exchange a detailed return, including a computation of the tax due, must be filed and an advanced payment must be paid on January 31 and June 30 of every tax year in respect of sales of securities made within the previous six months. However, if all tax due was withheld at source according to applicable provisions of the Ordinance and regulations promulgated thereunder the aforementioned return need not be filed and no advance payment must be paid. Capital gain is also reportable on the annual income tax return. Dividends A distribution of dividend by our company from income attributed to a Preferred Enterprise will generally be subject to withholding tax in Israel at the following tax rates: Israeli resident individuals - 20% with respect to dividends to be distributed as of 2014; Israeli resident companies – 0% for a Preferred Enterprise; Non-Israeli residents – 20% with respect to dividends to be distributed as of 2014, subject to a reduced rate under the provisions of any applicable double tax treaty, subject to an approval from the Israeli Tax Authorities. A distribution of dividends from income, which is not attributed to a Preferred Enterprise to an Israeli resident individual, will generally be subject to income tax at a rate of 25%. However, a 30% tax rate will apply if the dividend recipient is a “Controlling Shareholder” (as defined above) at the time of distribution or at any time during the preceding 12 months period. If the recipient of the dividend is an Israeli resident corporation, such dividend will be exempt from income tax provided the income from which such dividend is distributed was derived or accrued within Israel. The Ordinance provides that a non-Israeli resident (either individual or corporation) is generally subject to an Israeli income tax on the receipt of dividends at the rate of 25% (30% if the dividends recipient is a “Controlling Shareholder” (as defined above), at the time of distribution or at any time during the preceding 12 months period); those rates are subject to a reduced tax rate under the provisions of an applicable double tax treaty. Thus, under the U.S.- Israel Double Tax Treaty the following rates will apply in respect of dividends distributed by an Israeli resident company to a U.S. resident: (i) if the U.S. resident is a corporation which holds during that portion of the taxable year which precedes the date of payment of the dividend and during the whole of its prior taxable year (if any), at least 10% of the outstanding shares of the voting stock of the Israeli resident paying corporation and not more than 25% of the gross income of the Israeli resident paying corporation for such prior taxable year (if any) consists of certain type of interest or dividends (other than dividend or interest received from subsidiary corporations, 50 percent or more of the outstanding shares of the voting stock of which is owned by the paying corporation at the time such dividends or interest is received) – the tax rate is 12.5%, (ii) if both the conditions mentioned in section (i) above are met and the dividend is paid from an Israeli resident company’s income which was entitled to a reduced tax rate applicable to a Preferred Enterprise as defined in the Israel’s Encouragement of Capital Investments Law (1959) – the tax rate is 15% and (iii) in all other cases, the tax rate is 25%. The aforementioned rates under the Israel U.S. Double Tax Treaty will not apply if the dividend income was derived through a permanent establishment of the U.S. resident in Israel. 137 A non-Israeli resident who receives dividends from which tax was withheld is generally exempt from the obligation to file tax returns in Israel with respect to such income, provided that (i) such income was not generated from business conducted in Israel by the taxpayer, and (ii) the taxpayer has no other taxable sources of income in Israel with respect to which a tax return is required to be filed. Financial institutions through which shareholders typically hold securities are generally required, subject to any of the foregoing exemptions, reduced tax rates and the demonstration of a shareholder regarding his, her or its foreign residency, to withhold tax upon the distribution of dividend at the rate of 25%, so long as the shares are registered with a Nominee Company (for corporations and individuals). Foreign Exchange Regulations Non-residents of Israel who hold our Shares are able to receive any dividends, and any amounts payable upon the dissolution, liquidation and winding up of our affairs, repayable in non-Israeli currency at the rate of exchange prevailing at the time of conversion. However, Israeli income tax is generally required to have been paid or withheld on these amounts. In addition, the statutory framework for the potential imposition of currency exchange control has not been eliminated, and may be restored at any time by administrative action. Estate and Gift Tax Israeli law presently does not impose estate or gift taxes. U.S. Federal Income Tax Considerations The following is a description of certain U.S. federal income tax consequences relating to the acquisition, ownership and disposition of our ADSs and warrants by a holder. This description addresses only the U.S. federal income tax consequences to holders that are initial purchasers of our ADSs and warrants pursuant to this offering and that will hold such ADSs and warrants as capital assets. This description does not address tax considerations applicable to holders that may be subject to special tax rules, including, without limitation: ● banks, financial institutions or insurance companies; ● real estate investment trusts, regulated investment companies or grantor trusts; ● dealers or traders in securities, commodities or currencies; ● tax exempt entities or organizations; ● certain former citizens or residents of the United States; ● persons that received our ADSs or warrants as compensation for the performance of services; ● persons that will hold our ADSs or warrants as part of a “hedging,” “integrated” or “conversion” transaction or as a position in a “straddle” for U.S. federal income tax purposes; ● partnerships (including entities classified as partnerships for U.S. federal income tax purposes) or other pass-through entities, or holders that will hold our ADSs or warrants through such an entity; ● U.S. Holders (as defined below) whose “functional currency” is not the U.S. dollar; or ● holders that own directly, indirectly or through attribution 10% or more of the voting power or value of our shares. 138 Moreover, this description does not address the U.S. federal estate, gift, or alternative minimum tax consequences, or any U.S. state, local or non- U.S. tax consequences of the acquisition, ownership and disposition of our ADSs and warrants. This description is based on the U.S. Internal Revenue Code of 1986, as amended, or the Code, existing, proposed and temporary U.S. Treasury Regulations promulgated thereunder and administrative and judicial interpretations thereof, in each case as in effect and available on the date hereof. All the foregoing is subject to change, which change could apply retroactively and could affect the tax consequences described below. There can be no assurances that the U.S. Internal Revenue Service, or IRS, will not take a different position concerning the tax consequences of the acquisition, ownership and disposition of our ADSs and warrants or that such a position would not be sustained. Holders should consult their own tax advisers concerning the U.S. federal, state, local and foreign tax consequences of acquiring, owning and disposing of our ADSs and warrants in their particular circumstances. For purposes of this description, the term “U.S. Holder” means a beneficial owner of our ADSs or warrants that, for U.S. federal income tax purposes, is (i) a citizen or resident of the United States, (ii) a corporation (or entity treated as a corporation for U.S. federal income tax purposes) created or organized in or under the laws of the United States, any state thereof, or the District of Columbia, (iii) an estate the income of which is subject to U.S. federal income tax regardless of its source or (iv) a trust (x) with respect to which a court within the United States is able to exercise primary supervision over its administration and one or more U.S. persons have the authority to control all of its substantial decisions or (y) that has elected to be treated as a domestic trust for U.S. federal income tax purposes. A “Non-U.S. Holder” is a beneficial owner of our ADSs or warrants that is neither a U.S. Holder nor a partnership (or other entity treated as a partnership for U.S. federal income tax purposes). If a partnership (or any other entity treated as a partnership for U.S. federal income tax purposes) holds our ADSs and warrants, the U.S. federal income tax consequences relating to an investment in our ADSs and warrants will depend in part upon the status of the partner and the activities of the partnership. Such a partner or partnership should consult its tax advisor regarding the U.S. federal income tax consequences of acquiring, owning and disposing of our ADSs and warrants in its particular circumstances. In general, if you hold ADSs, you will be treated as the holder of the underlying ordinary shares represented by those ADSs for U.S. federal income tax purposes. Accordingly, gain or loss generally will not be recognized if you exchange ADSs for the underlying ordinary shares represented by those ADSs. Persons considering an investment in our ADSs or warrants should consult their own tax advisors as to the particular tax consequences applicable to them relating to the acquisition, ownership and disposition of our ADSs and warrants, including the applicability of U.S. federal, state and local tax laws and non-U.S. tax laws. Taxation of Dividends and Other Distributions on Our ADSs Subject to the discussion below under “Passive Foreign Investment Company Consequences,” if you are a U.S. Holder, the gross amount of any distribution made to you with respect to our ADSs before reduction for any Israeli taxes withheld therefrom, generally will be includible in your income as dividend income to the extent such distribution is paid out of our current or accumulated earnings and profits as determined under U.S. federal income tax principles. Non-corporate U.S. Holders may qualify for the lower rates of taxation with respect to dividends on ADSs applicable to long-term capital gains (i.e., gains from the sale of capital assets held for more than one year), provided that certain conditions are met, including certain holding period requirements and the absence of certain risk reduction transactions. Moreover, such lower rate of taxation shall not apply if we are a PFIC for the taxable year in which it pays a dividend, or was a PFIC for the preceding taxable year. However, such dividends will not be eligible for the dividends received deduction generally allowed to corporate U.S. Holders. To the extent that the amount of any distribution by us exceeds our current and accumulated earnings and profits as determined under U.S. federal income tax principles, it will be treated first as a tax-free return of your adjusted tax basis in our ADSs and thereafter as either long-term or short-term capital gain depending upon whether the U.S. Holder has held our ADSs for more than one year as of the time such distribution is received. 139 If you are a U.S. Holder, dividends paid to you with respect to our ADSs will be foreign source income for foreign tax credit purposes. Subject to certain conditions and limitations, Israeli tax withheld on dividends may be deducted from your taxable income or credited against your U.S. federal income tax liability. The limitation on foreign taxes eligible for credit is calculated separately with respect to specific classes of income. For this purpose, dividends generally constitute “passive category income,” or, in the case of certain U.S. Holders, “general category income.” A foreign tax credit for foreign taxes imposed on distributions may be denied if you do not satisfy certain minimum holding period requirements. The rules relating to the determination of the foreign tax credit are complex, and you should consult your tax advisor to determine whether and to what extent you will be entitled to this credit. The amount of a distribution paid to a U.S. Holder in a foreign currency will be the dollar value of the foreign currency calculated by reference to the spot exchange rate on the day the U.S. Holder receives the distribution, regardless of whether the foreign currency is converted into U.S. dollars at that time. Any foreign currency gain or loss a U.S. Holder realizes on a subsequent conversion of foreign currency into U.S. dollars will be U.S. source ordinary income or loss. If dividends received in foreign currency are converted into U.S. dollars on the day they are received, a U.S. Holder generally should not be required to recognize foreign currency gain or loss in respect of the dividend. Subject to certain limitations, including the Medicare tax, discussed below, “qualified dividend income” received by a non-corporate U.S. Holder should be subject to tax at a preferential maximum tax rate of 20 percent. Distributions taxable as dividends paid on the our ADSs should qualify for the preferential 20 percent rate provided that either: (i) we are entitled to benefits under the income tax treaty between the United States and Israel (the “Treaty”) or (ii) our ADSs will be treated as readily tradable on an established securities market in the United States and certain other requirements are met. We believe that we will be entitled to benefits under the Treaty and that our ADSs will become readily tradable on an established securities market in the United States, and therefore any dividend distributions with respect to our ADSs should be “qualified dividends” eligible for the preferential tax rate. However, no assurance can be given that our ADSs will be treated as readily tradable. The preferential rate does not apply unless certain holding period requirements are satisfied. With respect to our ADSs, the U.S. Holder must have held such ADSs for at least 61 days during the 121-day period beginning 60 days before the ex- dividend date. The preferential rate also does not apply to dividends received from a passive foreign investment company (or classified as a passive foreign investment company in the preceding taxable year) or in respect of certain hedged positions or in certain other situations. The legislation enacting the preferential tax rate on qualified dividends contains special rules for computing the foreign tax credit limitation of a taxpayer who receives dividends subject to the preferential tax rate. U.S. Holders of our ADSs should consult their own tax advisors regarding the effect of these rules in their particular circumstances. Subject to the discussion below under “Backup Withholding Tax and Information Reporting Requirements,” if you are a Non-U.S. Holder, you generally will not be subject to U.S. federal income (or withholding) tax on dividends received by you on your ADSs, unless: ● you conduct a trade or business in the U.S. and such income is effectively connected with that trade or business (and, if required by an applicable income tax treaty, the dividends are attributable to a permanent establishment or fixed base that such holder maintains in the U.S.); or ● you are an individual and have been present in the U.S. for 183 days or more in the taxable year of such sale or exchange and certain other conditions are met. Sale, Exchange or Other Disposition of Our ADSs and Warrants Subject to the discussion below under “Passive Foreign Investment Company Consequences,” if you are a U.S. Holder, you generally will recognize gain or loss on the sale, exchange or other disposition of our ADSs and warrants equal to the difference between the amount realized on such sale, exchange or other disposition and your adjusted tax basis in our ADSs and warrants, and such gain or loss will be capital gain or loss. The adjusted tax basis in an ADS and warrant generally will be equal to the cost of such ADS and warrant. If you are a non-corporate U.S. Holder, capital gain from the sale, exchange or other disposition of an ADS or warrant is generally eligible for a preferential rate of taxation applicable to capital gains, if your holding period determined at the time of such sale, exchange or other disposition for such ADS or warrant exceeds one year (i.e., such gain is long-term capital gain). The deductibility of capital losses is subject to limitations. Any such gain or loss generally will be treated as U.S. source income or loss for foreign tax credit limitation purposes. A foreign tax credit for foreign taxes imposed on capital gains may be denied if you do not satisfy certain minimum holding period requirements. The rules relating to the determination of the foreign tax credit are complex, and it is possible that the ability of a U.S. Holder to claim a foreign tax credit for any such Israeli tax will be limited. You should consult your tax advisor to determine whether, and to what extent, you will be entitled to this credit. 140 Subject to the discussion below under “Backup Withholding Tax and Information Reporting Requirements,” if you are a Non-U.S. Holder, you generally will not be subject to U.S. federal income or withholding tax on any gain realized on the sale or exchange of such ADSs and warrants unless: ● such gain is effectively connected with your conduct of a trade or business in the United States (and, if required by an applicable income tax treaty, the gain is attributable to a permanent establishment or fixed base that you maintain in the United States); or ● you are an individual and have been present in the United States for 183 days or more in the taxable year of such sale or exchange and certain other conditions are met. Passive Foreign Investment Company Consequences We may be classified as a Passive Foreign Investment Company (PFIC). If we were to be so classified in any taxable year, a U.S. Holder would be subject to special rules generally intended to reduce or eliminate any benefits from the deferral of U.S. federal income tax that a U.S. Holder could derive from investing in a non-U.S. company that does not distribute all of its earnings on a current basis. A non-U.S. corporation will be classified as a PFIC for federal income tax purposes in any taxable year in which, after applying certain look-through rules with respect to the income and assets of subsidiaries, either: ● at least 75% of its gross income is “passive income”; or ● at least 50% of the average quarterly value of its total gross assets (which may be determined in part by the market value of our ADSs and warrants, which is subject to change) is attributable to assets that produce “passive income” or are held for the production of passive income. Passive income for this purpose generally includes dividends, interest, royalties, rents, gains from commodities and securities transactions, the excess of gains over losses from the disposition of assets which produce passive income, and includes amounts derived by reason of the temporary investment of funds raised in offerings of our ADSs and warrants. If a non-U.S. corporation owns directly or indirectly at least 25% by value of the stock of another corporation, the non-U.S. corporation is treated for purposes of the PFIC tests as owning its proportionate share of the assets of the other corporation and as receiving directly its proportionate share of the other corporation’s income. If we are classified as a PFIC in any year with respect to which a U.S. Holder owns our ADSs or warrants, we will generally continue to be treated as a PFIC with respect to such U.S. Holder in all succeeding years during which the U.S. Holder owns our ADSs or warrants, regardless of whether we continue to meet the tests described above. Because PFIC status is based on our income, assets and activities for the entire taxable year, it is not possible to determine whether we will be characterized as a PFIC for the 2017 taxable year until after the close of the year. Moreover, we must determine our PFIC status annually based on tests which are factual in nature, and our status in future years will depend on our income, assets and activities in those years. In addition, our status as a PFIC may depend on how quickly we utilize the cash proceeds from this offering in our business. There can be no assurance that we will not be considered a PFIC for any taxable year. 141 If we are a PFIC, and you are a U.S. Holder, then unless you make one of the elections described below, a special tax regime will apply to both (a) any “excess distribution” by us to you (generally, your ratable portion of distributions in any year which are greater than 125% of the average annual distribution received by you in the shorter of the three preceding years or your holding period for our ADSs or warrants) and (b) any gain realized on the sale or other disposition of the ADSs or warrants. Under this regime, any excess distribution and realized gain will be treated as ordinary income and will be subject to tax as if (i) the excess distribution or gain had been realized ratably over your holding period, (ii) the amount deemed realized in each year had been subject to tax in each year of that holding period at the highest marginal rate for such year (other than income allocated to the current period or any taxable period before we became a PFIC, which would be subject to tax, at the U.S. Holder’s regular ordinary income rate for the current year and would not be subject to the interest change discussed below), and (iii) the interest charge generally applicable to underpayments of tax had been imposed on the taxes deemed to have been payable in those years. In addition, dividend distributions made to you will not qualify for the lower rates of taxation applicable to long- term capital gains discussed above under “Distributions.” Certain elections may be available that would result in an alternative treatment (such as mark-to- market treatment) of our ADSs or warrants. If a U.S. Holder makes the mark-to-market election, then, in lieu of being subject to the tax and interest charge rules discussed above, the U.S. Holder generally will recognize as ordinary income any excess of the fair market value of the ADSs or warrants at the end of each taxable year over their adjusted tax basis, and will recognize an ordinary loss in respect of any excess of the adjusted tax basis of the ADSs or warrants over their fair market value at the end of the taxable year (but only to the extent of the net amount of income previously included as a result of the mark-to-market election). If a U.S. Holder makes the election, the U.S. Holder’s tax basis in its ADSs or warrants will be adjusted to reflect these income or loss amounts. Any gain recognized on the sale or other disposition of ADSs or warrants in a year when we are a PFIC will be treated as ordinary income and any loss will be treated as an ordinary loss (but only to the extent of the net amount of income previously included as a result of the mark-to-market election). The mark-to-market election is available only if we are a PFIC and our ADSs or warrants are “regularly traded” on a “qualified exchange.” Our ADSs and warrants will be treated as “regularly traded” in any calendar year in which more than a de minimis quantity of our ADSs and warrants are traded on a qualified exchange on at least 15 days during each calendar quarter. The NASDAQ is a qualified exchange for this purpose. Because a mark-to-market election cannot be made for any lower-tier PFICs that we may own, a U.S. Holder may continue to be subject to the tax and interest charge rules discussed above with respect to such holder’s indirect interest in any investments held by us that are treated as an equity interest in a PFIC for U.S. federal income tax purposes, including stock in any of our subsidiaries that are treated as PFICs. If a U.S. Holder makes a mark-to market election, it will be effective for the taxable year for which the election is made and all subsequent taxable years unless our ADSs or warrants are no longer regularly traded on a qualified exchange or the IRS consents to the revocation of the election. We do not intend to provide the information necessary for U.S. Holders to make qualified electing fund elections if we are classified as a PFIC. U.S. Holders should consult their tax advisors to determine whether any of these elections would be available and if so, what the consequences of the alternative treatments would be in their particular circumstances. If we are determined to be a PFIC, the general tax treatment for U.S. Holders described in this section would apply to indirect distributions and gains deemed to be realized by U.S. Holders in respect of any of our subsidiaries that also may be determined to be PFICs. If a U.S. Holder owns ADSs or warrants during any year in which we are a PFIC, the U.S. Holder generally will be required to file an IRS Form 8621 (Information Return by a Shareholder of a Passive Foreign Investment Company or Qualified Electing Fund) with respect to us, generally with the U.S. Holder’s federal income tax return for that year. U.S. Holders should consult their tax advisors regarding whether we are a PFIC and the potential application of the PFIC rules. 142 Medicare Tax Certain U.S. Holders that are individuals, estates or trusts are subject to a 3.8% tax on all or a portion of their “net investment income,” which may include all or a portion of their dividend income and net gains from the disposition of ADSs and warrants. Each U.S. Holder that is an individual, estate or trust is urged to consult its tax advisors regarding the applicability of the Medicare tax to its income and gains in respect of its investment in our ADSs and warrants. Certain Reporting Requirements with Respect to Payments of Offer Price U.S. Holders paying more than $100,000 for our ADSs and warrants generally may be required to file IRS Form 926 reporting the payment of the Offer Price for our ADSs and warrants to us. Substantial penalties may be imposed upon a U.S. Holder that fails to comply. Each U.S. Holder should consult its own tax advisor as to the possible obligation to file IRS Form 926. Backup Withholding Tax and Information Reporting Requirements U.S. backup withholding tax and information reporting requirements may apply to certain payments to certain holders of our ADSs and warrants. Information reporting generally will apply to payments of dividends on our ADSs, and to proceeds from the sale or redemption of our ADSs and warrants made within the United States, or by a U.S. payer or U.S. middleman, to a holder of our ADSs and warrants, other than an exempt recipient (including a payee that is not a U.S. person that provides an appropriate certification and certain other persons). A payer may be required to withhold backup withholding tax from any payments of dividends on our ADSs, or the proceeds from the sale or redemption of our ADSs and warrants within the United States, or by a U.S. payer or U.S. middleman, to a holder, other than an exempt recipient, if such holder fails to furnish its correct taxpayer identification number or otherwise fails to comply with, or establish an exemption from, such backup withholding tax requirements. Any amounts withheld under the backup withholding rules will be allowed as a credit against the beneficial owner’s U.S. federal income tax liability, if any, and any excess amounts withheld under the backup withholding rules may be refunded, provided that the required information is timely furnished to the IRS. Foreign Asset Reporting Certain U.S. Holders who are individuals are required to report information relating to an interest in our ADSs and warrants, subject to certain exceptions (including an exception for shares held in accounts maintained by financial institutions) by filing IRS Form 8938 (Statement of Specified Foreign Financial Assets) with their federal income tax return. U.S. Holders are urged to consult their tax advisors regarding their information reporting obligations, if any, with respect to their ownership and disposition of our ADSs and warrants. THE DISCUSSION ABOVE IS A GENERAL SUMMARY. IT DOES NOT COVER ALL TAX MATTERS THAT MAY BE OF IMPORTANCE TO A PROSPECTIVE INVESTOR. EACH PROSPECTIVE INVESTOR IS URGED TO CONSULT ITS OWN TAX ADVISOR ABOUT THE TAX CONSEQUENCES TO IT OF AN INVESTMENT IN OUR ADSs AND WARRANTS IN LIGHT OF THE INVESTOR’S OWN CIRCUMSTANCES. F. Dividends and Paying Agents Not applicable. G. Statement by Experts Not applicable. H. Documents on Display We are required to file reports and other information with the SEC under the Exchange Act and the regulations thereunder applicable to foreign private issuers. 143 You may read and copy our Annual Report on Form 20-F, including the related exhibits and schedules, and any document we file with the SEC without charge at the SEC’s public reference room at 100 F Street, N.E., Room 1580, Washington, D.C. 20549. You may also obtain copies of the documents at prescribed rates by writing to the Public Reference Section of the SEC at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC- 0330 for further information on the public reference room. The SEC also maintains an Internet site that contains reports and other information regarding issuers that file electronically with the SEC. Our filings with the SEC are also available to the public through this web site at http://www.sec.gov. These SEC filings are also available to the public on (i) the Israel Securities Authority’s Magna website at www.magna.isa.gov.il, (ii) the Tel Aviv Stock Exchange website at http://www.maya.tase.co.il, and (iii) from commercial document retrieval services. In addition, since Parent’s ordinary shares are traded on the TASE, in the past we filed Hebrew language periodic and immediate reports with, and furnished information to, the TASE and the Israel Securities Authority, or the ISA, as required under Chapter F of the Israel Securities Law, 1968. In accordance with Section 35XXXIII of the Israel Securities Law, and pursuant to the prior approvals of our securities holders to change to reporting in accordance with the U.S. securities laws and regulations, we presently report to ISA and the TASE in accordance with the Securities Regulations (Periodic and Immediate Reports of a Foreign Body Corporate) 5761-2000, promulgated thereunder (the “Dual-Listed Reporting Requirements”). Pursuant to the Dual- Listed Reporting Requirements, we prepare our periodic and immediate reports in accordance with U.S. securities laws and reporting requirements. Our major shareholders are required to make applicable ownership disclosures in accordance with U.S. securities laws and reporting requirements. We generally initially file or furnish our reports, as applicable, to the SEC. We then submit copies of the SEC filings and submissions to ISA and TASE, including any filings made by our major shareholders with respect to their holdings in Kitov Parent, in accordance with the Dual-Listed Reporting Requirements. Such copies can be retrieved electronically through the websites for listed company reports of ISA (www.magna.isa.gov.il) and TASE (www.maya.tase.co.il). As a foreign private issuer, we will be exempt from the rules under the Exchange Act relating to the furnishing and content of proxy statements, and our officers, directors and principal shareholders will be exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. As permitted under the Companies Law, and the Notice Regulations which were enacted pursuant to such law, and as set forth in Parent’s amended and restated articles of association, Kitov Parent is not required to physically deliver a notice of a shareholders meeting, a proxy statement or a voting slip. Kitov Parent prepares notices of general meetings of its shareholders, as well as the accompanying proxy statements, voting slips and voting instruction forms, (collectively, the “Proxy Materials”) in accordance with applicable laws, rules and regulations and disclosure requirements in the State of Israel, as such are applicable to a company whose shares are traded on both the TASE and the NASDAQ, and which reports to the SEC as a foreign private issuer and to ISA and the TASE in accordance with the Dual-Listed Reporting Requirements. Our Proxy Materials may not necessarily be mailed to our beneficial shareholders in Israel, or to our beneficial ADS holders in the U.S. We will furnish to the SEC on Form 6-K the forms of our Proxy Materials, and they will be made available to the public on the SEC’s website at www.sec.gov. We will also submit the Proxy Materials to ISA and TASE and they will be made available to the public on their respective websites for listed company reports: www.magna.isa.gov.il and www.maya.tase.co.il. We will also include the Proxy Materials on our corporate website, to the extent required under the Companies Law and the applicable regulations enacted thereunder governing publication of notices of general meetings of our shareholders and the distribution of the Proxy Materials. The circulation of by us of any Proxy Materials should not be taken as an admission that we are subject to the proxy rules under the Exchange Act. 144 In addition, we will not be required under the Exchange Act to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. However, we intend to file with the SEC, within 120 days after the end of each fiscal year ending December 31, an annual report on Form 20-F containing financial statements which will be examined and reported on, with an opinion expressed, by an independent registered public accounting firm. In accordance with the NASDAQ Listing Rules, as a foreign private issuer we are required to submit on a Form 6-K an interim balance sheet and income statement as of the end of the second quarter of each fiscal year. Furthermore, we have committed to the underwriters of our initial U.S public offering which was completed in November 2015 that for a period of three (3) years from November 25, 2015, the Company, at its expense, will announce its financial information for each of the first three fiscal quarters consistent with the practices of companies which are dual-listed on both the TASE and a domestic U.S. securities exchange and report in accordance with the Dual-Listed Reporting Requirements; provided that the foregoing shall not apply in the event the Company enters into a merger transaction in which the Company is the non- surviving entity that would cause our ADSs and warrants to no longer be registered under the Exchange Act. We will furnish this periodic information with the SEC under cover of Form 6-K. The Representative of the underwriters of our initial U.S public offering which was completed in November 2015 has previously waived any announcement by us with respect to the filing of quarterly financial information, and may issue such waivers to us in the future. It is noted that recent amendments to the Israel Securities Law and Regulations enacted thereunder, dispense with the requirement for the announcement of financial results for each of the first and third fiscal quarters of a calendar year for certain smaller sized TASE listed companies which report under TASE only listed reporting requirements. We believe that, were we reporting under the TASE only listed reporting requirements (and not the Dual Listed Reporting Requirements), we would qualify for such dispensation based on our company size as set forth in the regulation. In addition the SEC has recently announced that it is seeking comment for the dispensation of the requirement for the announcement of financial results for each of the first and third fiscal quarters for certain U.S. domestic issuers. Thus it remains uncertain as to how companies dual-listed on both the TASE and a domestic U.S. securities exchange, and report in accordance with the Dual-Listed Reporting Requirements, will continue their practices with respect to the announcements of financial information for each of the first and third fiscal quarters, and it is possible that we may adopt practices for the announcement (if any) of financial information for each of the first and third fiscal quarters which are different than what we have provided in the past. Any statements in this Annual Report on Form 20-F about any of our agreements, contracts or other documents is not necessarily complete. If the agreement, contract or document is filed as an exhibit to the Annual Report on Form 20-F the agreement, contract or document is deemed to modify the description contained in this annual report. We urge you to review the exhibits themselves for a complete description of the contract or document. The Company maintains a corporate website at www.kitovpharma.com. TyrNovo also maintains a website at www.tyrnovo.co.il. Information contained on, or that can be accessed through, our websites does not constitute a part of this Annual Report on Form 20-F. We have included our website addresses in this Annual Report on Form 20-F solely as inactive textual references. We intend to post on our websites any materials required to be posted on such website under applicable corporate or securities laws and regulations, including posting on the Company website any notices of general meetings of Kitov Parent’s shareholders. I. Subsidiary Information Not applicable. ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Market risk is the risk of loss related to changes in market prices, including interest rates and foreign exchange rates, of financial instruments that may adversely impact our financial position, results of operations or cash flows. Our overall risk management program focuses on the unpredictability of financial markets and seeks to minimize potential adverse effects on our financial performance. Risk of Interest Rate Fluctuation and Credit Exposure Risk We do not anticipate undertaking any significant long-term borrowings. At present, our credit and interest risk arises from cash and cash equivalents, deposits with banks as well as accounts receivable. A substantial portion of our liquid instruments is invested in short-term deposits with Bank Leumi le- Israel Ltd., a major Israeli banking institution. We estimate that because the liquid instruments are invested mainly for the short-term and with highly-rated institutions, the credit and interest risk associated with these balances is immaterial. The primary objective of our investment activities is to preserve principal while maximizing the income we receive from our investments without significantly increasing risk and loss. Our investments are exposed to market risk due to fluctuations in interest rates, which may affect our interest income and the fair market value of our investments. We manage this exposure by performing ongoing evaluations of our investments. Equity Price Risk We are not exposed to equity securities price risk because we have never invested in equity securities. 145 Foreign Currency Exchange Risk Our foreign currency exposures give rise to market risk associated with exchange rate movements of the U.S. dollar, our functional and reporting currency, mainly against the NIS and other currencies. Although the U.S. dollar is our functional currency and reporting currency, a portion of our expenses are denominated in NIS. Our NIS expenses consist principally of payments to employees or service providers and short term investments in currencies other than the U.S. dollar. We anticipate that a sizable portion of our expenses will continue to be denominated in currencies other than the U.S. dollar. If the U.S. dollar fluctuates significantly against the NIS it may have a negative impact on our results of operations. We manage our foreign exchange risk by aligning the currencies for holding short term investments with the currencies of expected expenses, based on our expected cash flows. Portfolio diversification is performed based on risk level limits that we set. To date, we have not engaged in hedging transactions. In the future, we may enter into currency hedging transactions to decrease the risk of financial exposure from fluctuations in the exchange rates of our principal operating currencies. These measures, however, may not adequately protect us from the material adverse effects of such fluctuations. (A) Set forth below is a sensitivity test to possible changes in U.S. dollars/NIS exchange rate as of December 31, 2016: Sensitive instrument Cash Accounts receivable Accounts payable Other payables Post employment benefit liabilities Total income (loss) Income (loss) from change in exchange rate (U.S. dollars in thousands) Value (U.S. dollars in thousands) Income (loss) from change in exchange rate (U.S. dollars in thousands) Down 2% Down 5% Up 5% (35) (4) 8 14 2 (15) (85) (9) 20 33 6 (35) 1,777 189 (424) (695) (125) 722 85 9 (20) (33) (6) 35 Up 2% 35 4 (8) (14) (2) 15 (B) As of the date of this Annual Report on Form 20-F, our interest rate risk exposure is in respect to bank deposits, which expose us to risk due to change in fair value interest rates. As of December 31, 2016 we had interest bearing bank deposits of $8.3 million, bearing interest in the range of 1.58%-2.7% depending upon the nature of the deposit scheme. ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES A. Debt Securities Not applicable. B. Warrants and Rights Not applicable. C. Other Securities Not applicable. 146 D. American Depositary Shares The Bank of New York Mellon, as depositary, will register and deliver American Depositary Shares, also referred to as ADSs. Each ADS will represent 20 shares (or a right to receive 20 shares) deposited with a local bank in Israel, as custodian for the depositary in Israel. Each ADS will also represent any other securities, cash or other property which may be held by the depositary. The depositary’s office at which the ADSs will be administered is located at 101 Barclay Street, New York, New York 10286. The Bank of New York Mellon’s principal executive office is located at One Wall Street, New York, New York 10286. You may hold ADSs either (A) directly (i) by having an American Depositary Receipt, also referred to as an ADR, which is a certificate evidencing a specific number of ADSs, registered in your name, or (ii) by having uncertificated ADSs registered in your name, or (B) indirectly by holding a security entitlement in ADSs through your broker or other financial institution that is a direct or indirect participant in The Depository Trust Company, also called DTC. If you hold ADSs directly, you are a registered ADS holder, also referred to as an ADS holder. This description assumes you are an ADS holder. If you hold the ADSs indirectly, you must rely on the procedures of your broker or other financial institution to assert the rights of ADS holders described in this section. You should consult with your broker or financial institution to find out what those procedures are. Registered holders of uncertificated ADSs will receive statements from the depositary confirming their holdings. As an ADS holder, we will not treat you as one of our shareholders and you will not have shareholder rights. Israeli law governs shareholder rights. The depositary will be the holder of the shares underlying your ADSs. As a registered holder of ADSs, you will have ADS holder rights. A deposit agreement among us, the depositary, ADS holders and all other persons indirectly or beneficially holding ADSs sets out ADS holder rights as well as the rights and obligations of the depositary. New York law governs the deposit agreement and the ADSs. The following is a summary of the material provisions of the deposit agreement. For more complete information, you should read the entire deposit agreement and the form of ADR, attached as exhibits to this Annual Report on Form 20-F. Dividends and Other Distributions How will you receive dividends and other distributions on the shares? The depositary has agreed to pay or distribute to ADS holders the cash dividends or other distributions it or the custodian receives on shares or other deposited securities, upon payment or deduction of its fees and expenses. You will receive these distributions in proportion to the number of shares your ADSs represent. Cash. The depositary will convert any cash dividend or other cash distribution we pay on the shares into U.S. dollars, if it can do so on a reasonable basis and can transfer the U.S. dollars to the United States. If that is not possible or if any government approval is needed and cannot be obtained, the deposit agreement allows the depositary to distribute the foreign currency only to those ADS holders to whom it is possible to do so. It will hold the foreign currency it cannot convert for the account of the ADS holders who have not been paid. It will not invest the foreign currency and it will not be liable for any interest. Before making a distribution, any withholding taxes, or other governmental charges that must be paid will be deducted. See “Item 10. Additional Information – E. Taxation - Taxation of our Shareholders" for more detail. It will distribute only whole U.S. dollars and cents and will round fractional cents to the nearest whole cent. If the exchange rates fluctuate during a time when the depositary cannot convert the foreign currency, you may lose some of the value of the distribution. 147 Shares. The depositary may distribute additional ADSs representing any shares we distribute as a dividend or free distribution. The depositary will only distribute whole ADSs. It will sell shares which would require it to deliver a fraction of an ADS (or ADSs representing those shares) and distribute the net proceeds in the same way as it does with cash. If the depositary does not distribute additional ADSs, the outstanding ADSs will also represent the new shares. The depositary may sell a portion of the distributed shares (or ADSs representing those shares) sufficient to pay its fees and expenses in connection with that distribution. Rights to purchase additional shares. If we offer holders of our securities any rights to subscribe for additional shares or any other rights, the depositary may (i) exercise those rights on behalf of ADS holders, (ii) distribute those rights to ADS holders or (iii) sell those rights and distribute the net proceeds to ADS holders, in each case after deduction or upon payment of its fees and expenses. To the extent the depositary does not do any of those things, it will allow the rights to lapse. In that case, you will receive no value for them. The depositary will exercise or distribute rights only if we ask it to and provide satisfactory assurances to the depositary that it is legal to do so. If the depositary will exercise rights, it will purchase the securities to which the rights relate and distribute those securities or, in the case of shares, new ADSs representing the new shares, to subscribing ADS holders, but only if ADS holders have paid the exercise price to the depositary. U.S. securities laws may restrict the ability of the depositary to distribute rights or ADSs or other securities issued on exercise of rights to all or certain ADS holders, and the securities distributed may be subject to restrictions on transfer. Other Distributions. The depositary will send to ADS holders anything else we distribute on deposited securities by any means it thinks is legal, fair and practical. If it cannot make the distribution in that way, the depositary has a choice. It may decide to sell what we distributed and distribute the net proceeds, in the same way as it does with cash. Or, it may decide to hold what we distributed, in which case ADSs will also represent the newly distributed property. However, the depositary is not required to distribute any securities (other than ADSs) to ADS holders unless it receives satisfactory evidence from us that it is legal to make that distribution. The depositary may sell a portion of the distributed securities or property sufficient to pay its fees and expenses in connection with that distribution. U.S. securities laws may restrict the ability of the depositary to distribute securities to all or certain ADS holders, and the securities distributed may be subject to restrictions on transfer. The depositary is not responsible if it decides that it is unlawful or impractical to make a distribution available to any ADS holders. We have no obligation to register ADSs, shares, rights or other securities under the Securities Act. We also have no obligation to take any other action to permit the distribution of ADSs, shares, rights or anything else to ADS holders. This means that you may not receive the distributions we make on our shares or any value for them if it is illegal or impractical for us to make them available to you. Deposit, Withdrawal and Cancellation How are ADSs issued? The depositary will deliver ADSs if you or your broker deposits shares or evidence of rights to receive shares with the custodian. Upon payment of its fees and expenses and of any taxes or charges, such as stamp taxes or stock transfer taxes or fees, the depositary will register the appropriate number of ADSs in the names you request and will deliver the ADSs to or upon the order of the person or persons that made the deposit. How can ADS holders withdraw the deposited securities? You may surrender your ADSs for the purpose of withdrawal at the depositary’s office. Upon payment of its fees and expenses and of any taxes or charges, such as stamp taxes or stock transfer taxes or fees, the depositary will deliver the shares and any other deposited securities underlying the ADSs to the ADS holder or a person the ADS holder designates at the office of the custodian. Or, at your request, risk and expense, the depositary will deliver the deposited securities at its office, if feasible. The depositary may charge you a fee and its expenses for instructing the custodian regarding delivery of deposited securities. 148 How do ADS holders interchange between certificated ADSs and uncertificated ADSs? You may surrender your ADR to the depositary for the purpose of exchanging your ADR for uncertificated ADSs. The depositary will cancel that ADR and will send to the ADS holder a statement confirming that the ADS holder is the registered holder of uncertificated ADSs. Alternatively, upon receipt by the depositary of a proper instruction from a registered holder of uncertificated ADSs requesting the exchange of uncertificated ADSs for certificated ADSs, the depositary will execute and deliver to the ADS holder an ADR evidencing those ADSs. Voting Rights How do you vote? ADS holders may instruct the depositary how to vote the number of deposited shares their ADSs represent. If we request the depositary to solicit your voting instructions (and we are not required to do so), the depositary will notify you of a shareholders’ meeting and send or make voting materials available to you. Those materials will describe the matters to be voted on and explain how ADS holders may instruct the depositary how to vote. For instructions to be valid, they must reach the depositary by a date set by the depositary. The depositary will try, as far as practical, subject to the laws of Israel and the provisions of our amended and restated articles of association or similar documents, to vote or to have its agents vote the shares or other deposited securities as instructed by ADS holders. If we do not request the depositary to solicit your voting instructions, you can still send voting instructions, and, in that case, the depositary may try to vote as you instruct, but it is not required to do so. Except by instructing the depositary as described above, you won’t be able to exercise voting rights unless you surrender your ADSs and withdraw the shares. However, you may not know about the meeting enough in advance to withdraw the shares. In any event, the depositary will not exercise any discretion in voting deposited securities and it will only vote or attempt to vote as instructed by the holder of the ADSs or as described in the following sentence. If we asked the depositary to solicit your instructions at least 30 days before the meeting date but the depositary does not receive voting instructions from you by the specified date, it will consider you to have authorized and directed it to give a discretionary proxy to a person designated by us to vote the number of deposited securities represented by your ADSs. The depositary will give a discretionary proxy in those circumstances to vote on all questions at to be voted upon unless we notify the depositary that: ● we do not wish to receive a discretionary proxy; ● there is substantial shareholder opposition to the particular question; or ● the particular question would have an adverse impact on our shareholders. We are required to notify the depositary if one of the conditions specified above exists. We cannot assure you that you will receive the voting materials in time to ensure that you can instruct the depositary to vote your shares. In addition, the depositary and its agents are not responsible for failing to carry out voting instructions or for the manner of carrying out voting instructions. This means that you may not be able to exercise voting rights and there may be nothing you can do if your shares are not voted as you requested. In order to give you a reasonable opportunity to instruct the depositary as to the exercise of voting rights relating to deposited securities, if we request the depositary to act, we agree to give the depositary notice of any such meeting and details concerning the matters to be voted upon at least 30 days in advance of the meeting date. 149 Fees and Expenses Persons depositing or withdrawing shares or ADS holders must pay: For: $5.00 (or less) per 100 ADSs (or portion of 100 ADSs) Issuance of ADSs, including issuances resulting from a distribution of shares or rights or other property Cancellation of ADSs for the purpose of withdrawal, including if the deposit agreement terminates $.05 (or less) per ADS Any cash distribution to ADS holders A fee equivalent to the fee that would be payable if securities distributed to you had been shares and the shares had been deposited for issuance of ADSs Distribution of securities distributed to holders of deposited securities (including rights) that are distributed by the depositary to ADS holders $.05 (or less) per ADS per calendar year Depositary services Registration or transfer fees Expenses of the depositary Transfer and registration of shares on our share register to or from the name of the depositary or its agent when you deposit or withdraw shares Cable, telex and facsimile transmissions (when expressly provided in the deposit agreement) converting foreign currency to U.S. dollars Taxes and other governmental charges the depositary or the custodian has to pay on any ADSs or shares underlying ADSs, such as stock transfer taxes, stamp duty or withholding taxes As necessary Any charges incurred by the depositary or its agents for servicing the deposited securities As necessary The depositary collects its fees for delivery and surrender of ADSs directly from investors depositing shares or surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by deduction from cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for them. The depositary may collect any of its fees by deduction from any cash distribution payable (or by selling a portion of securities or other property distributable) to ADS holders that are obligated to pay those fees. The depositary may generally refuse to provide fee-attracting services until its fees for those services are paid. From time to time, the depositary may make payments to us to reimburse us for costs and expenses generally arising out of establishment and maintenance of the ADS program, waive fees and expenses for services provided to us by the depositary or share revenue from the fees collected from ADS holders. In performing its duties under the deposit agreement, the depositary may use brokers, dealers, foreign currency or other service providers that are owned by or affiliated with the depositary and that may earn or share fees, spreads or commissions. The depositary may convert foreign currency itself or through any of its affiliates and, in those cases, acts as principal for its own account and not as an agent, fiduciary or broker on behalf of any other person and earns revenue, including, without limitation, fees and spreads that it will retain for its own account. The spread is the difference between the exchange rate assigned to the currency conversion made under the deposit agreement and the rate that the depositary or its affiliate receives in an offsetting foreign currency trade. The depositary makes no representation that the exchange rate used or obtained in any currency conversion under the deposit agreement will be the most favorable rate that could be obtained at the time or as to the method by which that rate will be determined, subject to its obligations under the deposit agreement. 150 Payment of Taxes You will be responsible for any taxes or other governmental charges payable on your ADSs or on the deposited securities represented by any of your ADSs. The depositary may refuse to register any transfer of your ADSs or allow you to withdraw the deposited securities represented by your ADSs until those taxes or other charges are paid. It may apply payments owed to you or sell deposited securities represented by your ADSs to pay any taxes owed and you will remain liable for any deficiency. If the depositary sells deposited securities, it will, if appropriate, reduce the number of ADSs to reflect the sale and pay to ADS holders any proceeds, or send to ADS holders any property, remaining after it has paid the taxes. Amendment and Termination How may the deposit agreement be amended? We may agree with the depositary to amend the deposit agreement and the ADRs without your consent for any reason. If an amendment adds or increases fees or charges, except for taxes and other governmental charges or expenses of the depositary for registration fees, facsimile costs, delivery charges or similar items, or prejudices a substantial right of ADS holders, it will not become effective for outstanding ADSs until 30 days after the depositary notifies ADS holders of the amendment. At the time an amendment becomes effective, you are considered, by continuing to hold your ADSs, to agree to the amendment and to be bound by the ADRs and the deposit agreement as amended. How may the deposit agreement be terminated? The depositary will initiate termination of the deposit agreement if we instruct it to do so. The depositary may initiate termination of the deposit agreement if ● 60 days have passed since the depositary told us it wants to resign but a successor depositary has not been appointed and accepted its appointment; ● we delist our shares from an exchange on which they were listed and do not list the shares on another exchange; ● we appear to be insolvent or enter insolvency proceedings ● all or substantially all the value of the deposited securities has been distributed either in cash or in the form of securities; ● there are no deposited securities underlying the ADSs or the underlying deposited securities have become apparently worthless; or ● there has been a replacement of deposited securities. If the deposit agreement will terminate, the depositary will notify ADS holders at least 90 days before the termination date. At any time after the termination date, the depositary may sell the deposited securities. After that, the depositary will hold the money it received on the sale, as well as any other cash it is holding under the deposit agreement, unsegregated and without liability for interest, for the prorata benefit of the ADS holders that have not surrendered their ADSs. Normally, the depositary will sell as soon as practicable after the termination date. After the termination date and before the depositary sells, ADS holders can still surrender their ADSs and receive delivery of deposited securities, except that the depositary may refuse to accept a surrender for the purpose of withdrawing deposited securities if it would interfere with the selling process. The depositary may refuse to accept a surrender for the purpose of withdrawing sale proceeds until all the deposited securities have been sold. The depositary will continue to collect distributions on deposited securities, but, after the termination date, the depositary is not required to register any transfer of ADSs or distribute any dividends or other distributions on deposited securities to the ADSs holder (until they surrender their ADSs) or give any notices or perform any other duties under the deposit agreement except as described in this paragraph. 151 Limitations on Obligations and Liability Limits on our Obligations and the Obligations of the Depositary; Limits on Liability to Holders of ADSs The deposit agreement expressly limits our obligations and the obligations of the depositary. It also limits our liability and the liability of the depositary. We and the depositary: ● are only obligated to take the actions specifically set forth in the deposit agreement without negligence or bad faith; ● are not liable if we are or it is prevented or delayed by law or circumstances beyond our or its control from performing our or its obligations under the deposit agreement; ● are not liable if we or it exercises discretion permitted under the deposit agreement; ● are not liable for the inability of any holder of ADSs to benefit from any distribution on deposited securities that is not made available to holders of ADSs under the terms of the deposit agreement, or for any special, consequential or punitive damages for any breach of the terms of the deposit agreement; ● have no obligation to become involved in a lawsuit or other proceeding related to the ADSs or the deposit agreement on your behalf or on behalf of any other person; ● are not liable for the acts or omissions of any securities depository, clearing agency or settlement system; and ● may rely upon any documents we believe or it believes in good faith to be genuine and to have been signed or presented by the proper person. In the deposit agreement, we and the depositary agree to indemnify each other under certain circumstances. Requirements for Depositary Actions Before the depositary will deliver or register a transfer of ADSs, make a distribution on ADSs, or permit withdrawal of shares, the depositary may require: ● payment of stock transfer or other taxes or other governmental charges and transfer or registration fees charged by third parties for the transfer of any shares or other deposited securities; ● satisfactory proof of the identity and genuineness of any signature or other information it deems necessary; and ● compliance with regulations it may establish, from time to time, consistent with the deposit agreement, including presentation of transfer documents. The depositary may refuse to deliver ADSs or register transfers of ADSs when the transfer books of the depositary or our transfer books are closed or at any time if the depositary or we think it advisable to do so. Your Right to Receive the Shares Underlying your ADSs ADS holders have the right to cancel their ADSs and withdraw the underlying shares at any time except: ● when temporary delays arise because: (i) the depositary has closed its transfer books or we have closed our transfer books; (ii) the transfer of shares is blocked to permit voting at a shareholders' meeting; or (iii) we are paying a dividend on our shares; ● when you owe money to pay fees, taxes and similar charges; or ● when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of shares or other deposited securities. This right of withdrawal may not be limited by any other provision of the deposit agreement. 152 Series A Warrants The following summary of certain terms and provisions of the outstanding Series A warrants is not complete and is subject to, and qualified in its entirety by the provisions of the Warrant Agent Agreement and form of Warrant Certificate, which is filed as an exhibit to the registration statement filed with the SEC on Form F-1 (Registration No. 333-207117) on November 18, 2015, as amended by the Letter Amendment to Warrant Agent Agreement which is filed as an exhibit to our Report on Form 6-K submitted to the SEC on June 29, 2016, as subsequently amended and supplemented. Prospective investors should carefully review the terms and provisions set forth in the Warrant Agent Agreement and form of Warrant Certificate, as amended. Series A warrants are administered by the Bank of New York Mellon, as warrant agent. Exercisability. The Series A warrants are exercisable immediately upon issuance and at any time up to November 25, 2020. The Series A warrants will be exercisable, at the option of each holder, in whole or in part by delivering to us a duly executed exercise notice accompanied by payment in full for the number of ADSs purchased upon such exercise (except in the case of a cashless exercise as discussed below), together with the ADS issuance fee of $0.05 per ADS and other applicable charges and taxes. Unless otherwise specified in the Series A warrant, the holder will not have the right to exercise the Series A warrants, in whole or in part, if the holder (together with its affiliates) would beneficially own in excess of 4.99% of the number of our ordinary shares outstanding immediately after giving effect to the exercise, as such percentage is determined in accordance with the terms of the Series A warrants. Cashless Exercise. In the event that a registration statement covering ordinary shares underlying the Series A warrants is not effective, and an exemption from registration is not available for the resale of such ordinary shares underlying the Series A warrants, the holder may, in its sole discretion, exercise Series A warrants and, in lieu of making the cash payment otherwise contemplated to be made to us upon such exercise in payment of the aggregate exercise price, elect instead to receive upon such exercise the net number of ADSs determined according to the formula set forth in the Warrant Agent Agreement. The issuance fee of $0.05 per ADS, as well as other applicable charges and taxes, are due and payable upon any cashless exercise. Exercise Price. The exercise price per ADS purchasable upon exercise of the Series A warrants is equal to $3.78 per full ADS (which may be adjusted as set forth below). In addition to the exercise price per ADS, the $0.05 issuance fee per ADS and other applicable charges and taxes are due and payable upon exercise. Adjustment Provisions. The exercise price and the number of ADSs issuable upon exercise are subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock subdivisions and combinations, reclassifications or similar events affecting our ADSs or ordinary shares. Transferability. Subject to applicable laws, the Series A warrants may be transferred at the option of the holders upon surrender of the Series A warrants to the warrant agent, together with the appropriate instruments of transfer. Warrant Agent and Exchange Listing. The Series A warrants will be issued in registered form under the Warrant Agent Agreement between us and the warrant agent. Fundamental Transaction. If, at any time while the Series A warrants are outstanding, (1) we consolidate or merge with or into another person, (2) we sell, lease, license, assign, transfer, convey or otherwise dispose of all or substantially all of our assets, (3) any purchase offer, tender offer or exchange offer (whether by us or another person) is completed pursuant to which holders of our ordinary shares are permitted to sell, tender or exchange their ordinary shares for other securities, cash or property and has been accepted by the holders of 50% or more of our outstanding shares of ordinary shares, (4) we effect any reclassification or recapitalization of our ADSs or ordinary shares or any compulsory share exchange pursuant to which our ordinary shares are converted into or exchanged for other securities, cash or property, or (5) we consummate a stock or share purchase agreement or other business combination with another person whereby such other person acquires more than 50% of our outstanding ordinary shares, each, a “Fundamental Transaction”, then upon any subsequent exercise of the Series A warrants, the holders thereof will have the right to receive the same amount and kind of securities, cash or property as it would have been entitled to receive upon the occurrence of such Fundamental Transaction if it had been, immediately prior to such Fundamental Transaction, the holder of the number of ADSs then issuable upon exercise of the Series A warrant, and any additional consideration payable as part of the Fundamental Transaction. Rights as a Shareholder. Except as otherwise provided in the Warrant Agent Agreement or by virtue of such holder’s ownership of ADSs or ordinary shares, the holder of Series A warrants does not have rights or privileges of a holder of ADSs or ordinary shares, including any voting rights, until the holder exercises the Series A warrants. 153 ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES Not applicable PART II ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS A. Below is a summary of the changes to our articles of association effected by the recent adoption of our English language amended and restated articles of association on March 2, 2016, replacing our previous Hebrew language articles of association which were in effect until March 2, 2016, as well as certain additional amendments to our memorandum of association and our amended and restated articles of association which were approved by our shareholders at the 2016 Annual General Meeting of the Shareholders held on December 5, 2016. ● An addition to the charitable donations clause to allow us to issue securities to charity. ● 75% of the participating directors at a vote of the board of directors will be required to determine that our center of management will be outside of Israel. ● The addition of a clause permitting the board of directors to issue redeemable securities. ● The addition of the chief executive officer and Company secretary to the authored signatories on share certificates. ● Share transfer instruments can be approved by our management instead of needing full board of directors approval. ● The addition of a provision stating that the board of directors can decline to approve transfers if not allowed under law, TASE rules or otherwise. ● The addition and revision of miscellaneous technical provisions governing submission of proof or ownership and proxies for shareholder meetings. ● Shareholder meetings shall be held in Israel unless our center of management has been changed as set forth in the amended and restated articles of association. ● Revised so that if the chairman of the board of directors is not present for a shareholder meeting then the chief executive officer or company secretary, or someone appointed by either of them, shall be chair of a shareholder meeting, before submitting the chair selection matter to those present at the shareholders meeting. ● Reduction in the maximum number of directors from 12 to 9. ● A majority of directors shall be Israeli residents unless our center of management has been changed as set forth in the amended and restated articles of association. ● Directors shall be appointed for three year terms with one third of the board of director member’s terms expiring every year ● Changing the director appointment provisions in the amended and restated articles of association will be subject to a special majority of 75% of the votes cast at a shareholders meeting and which majority comprises at least 47.9% of Kitov Parent’s voting rights. 154 ● Removal of the provision requiring external directors (this matter will now be subject to the requirements of the Companies Law and Regulations). ● Establishes that the audit committee of the board of directors is delegated with authority to approve the compensation of auditors as long as our securities are traded in U.S. markets. ● Shorten time period for receiving unclaimed dividends from 7 years to 3 years. ● Added provision that notices to shareholders may be publicized as specified by law (i.e. not only newspaper ads). ● Transactions in which officers have a personal interest but not extraordinary transactions can be approved by chief executive officer and chief financial officer (unless they have the personal interest; in which case it will be a director instead), as opposed the default provision in the Companies Law which requires full board of directors approval unless the articles of association state otherwise. ● The increase of Kitov Parent’s registered Ordinary Share capital to 5,000,000,000 Ordinary Shares of no par value each. ● The addition to Kitov Parent’s registered share capital of 1,000,000,000 preferred shares, with no par value in 5 classes of 200,000,0000 preferred shares in each class (the "Preferred Shares"), and the authorization of our Board of Directors to fix, by resolution of the Board of Directors, (i) the number of issued Preferred Shares (subject to the maximum number of Preferred Shares authorized in such class), (ii) the designation of such class of Preferred Shares, and (iii) the conversion, redemption, optional and other special rights, qualifications, limitations or restrictions, if any, of the shares of such class of Preferred Shares, without further actions by our shareholders, unless shareholder approval is otherwise required for any particular reason by virtue of Israeli law, the rules of any exchange or other market on which our securities may then be listed or traded, our Articles of Association then in effect, or any other applicable rules and regulations. ● The organizational supervisor for our internal auditor will be our general manager, and the annual or periodic work plan shall be presented to our Audit Committee of the Board of Directors for its review and approval. ● Our Board may issue shares which shall be dormant upon issue. ● The provisions in the amended and restated articles of association concerning insurance coverage for directors and officers, waiver of liability and indemnification are prospective in nature and will incorporate any future revisions to applicable law governing such matters. B. C. D. E. Not Applicable Not Applicable Not Applicable Use of Proceeds. Initial Public Offering The effective date of the registration statement (File no. 333-207117) for our initial U.S public offering of our ADSs and warrants, was November 20, 2015. The offering with respect to our ADSs and warrants commenced on November 20, 2015 and was closed on November 25, 2015. Rodman & Renshaw, a unit of H.C. Wainwright & Co., and Joseph Gunnar & Co., LLC were joint bookrunning managers for the offering, We registered 3,158,900 American Depository Shares (ADSs), each representing 20 of our ordinary shares, and public warrants to purchase up to 3,158,900 ADSs, and granted the underwriters a 45-day option to purchase up to an additional 473,835 ADSs and/or warrants to purchase an additional 473,835 ADSs to cover over-allotments, if any, at the public offering price of $4.12 per ADS and $.01 per public warrant. The over-allotment was partially exercised by the underwriters for 220,074 warrants on November 25, 2015. As of April 2017, we have used approximately $4.5 million of the net proceeds of this offering for research and development activities, approximately $0.6 million to repay the August Loans, approximately $2.0million for the acquisition of TyrNovo, and approximately $3.5 million for general corporate purposes. None of the net proceeds of the offering used for research and development activities; repayment of indebtedness; working capital; and any other purposes for which at least $100,000 has been used, was paid directly or indirectly to any director, officer, general partner of ours or to their associates, persons owning ten percent or more of any class of our equity securities, or to any of our affiliates, except for (i) payments in connection with the $100,000 Principal Amount of the August Loans held by Haiku Capital Ltd., which, together with Mr. Sheer Roichman (who is deemed to beneficially own the shares held by Haiku Capital), became a holder of more than ten percent of our issued an outstanding share capital as a result of the acquisition of such holdings via participation in the offering; and (ii) ordinary course payments of ongoing compensation (including bonuses) paid to our directors and executive officers for their services in accordance with the terms and conditions of their agreements with the Company. 155 ITEM 15. CONTROLS AND PROCEDURES (a) Disclosure Controls and Procedures We have performed an evaluation of the effectiveness of our disclosure controls and procedures that are designed to ensure that the material financial and non-financial information required to be disclosed to the SEC is recorded, processed, summarized and reported timely. Based on our evaluation, our management, including the chief executive officer and chief financial officer, has concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this report, were ineffective as described in (b) below. (b) Management’s Annual Report on Internal Control over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rule 13a-15(f) promulgated under the Exchange Act. Our internal control system was designed to provide reasonable assurance to our management and board of directors regarding the reliability of financial reporting and the preparation and fair presentation of published financial statements for external purposes in accordance with generally accepted accounting principles. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation and may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with policies or procedures may deteriorate. Our management, including the chief executive officer and chief financial officer, conducted an evaluation, pursuant to Rule 13a-15(c) promulgated under the Exchange Act, of the effectiveness, as of the end of the period covered by this Annual Report, of its internal control over financial reporting based on the framework in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013). Based on the results of this evaluation, management concluded that as at December 31, 2016 our internal control over financial reporting was not effective due to the material weakness in internal controls described below. A deficiency was identified in our internal control over financial reporting related to the operation of the control to review the accounting for significant non-routine and complex transactions to ensure proper application of IFRS. This control did not operate effectively due to the lack of timely involvement of the qualified technical resources to perform the required management review. As a result, during the audit process, an error was detected in the accounting for equity and derivative instruments, which was corrected prior to filing our audited financial statements for 2016. We have undertaken remedial measures by broadening the role of our external financial expert with expertise in IFRS, to allow for stronger oversight in this area. Under the supervision and with the participation of our senior management, including our principal executive officer and principal financial officer, we plan to design enhanced processes and controls to address any other issues that might be identified through our on-going review of our internal control processes and will continue to undertake any needed remedial measures to make improvements in our internal control. Notwithstanding the foregoing, there can be no assurance that our controls and procedures will detect or uncover all failures in our controls over measurement and disclosure in our financial statements or detect instances of fraud, if any. 156 (c) Attestation Report of Registered Public Accounting Firm This annual report does not include an attestation report of the Company’s registered public accounting firm due to a transition period established by the rules of the Securities and Exchange Commission for newly public companies. (d) Changes in Internal Controls over Financial Reporting There were no changes in our internal control over financial reporting that occurred during the year ended December 31, 2016 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. ITEM 16. [RESERVED] ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT Our board of directors has determined that Mr. Steinberg and Ms. Stern-Raff are audit committee financial experts as defined by the SEC rules and have the requisite financial experience as defined by the NASDAQ Listing Rules. Mr. Weber, Mr. Agmon, Mr. Steinberg, Ms. Stern-Raff and Mr. Tzror qualify as independent directors under the corporate governance standards of the NASDAQ Listing Rules and the independence requirements of Rule 10A-3 of the Exchange Act. ITEM 16B. CODE OF ETHICS Our Board of Directors adopted a Code of Business Conduct and Ethics (the “Code”) that applies to all our employees, including without limitation our chief executive officer, chief financial officer and controller. A copy of the Code may be viewed on our website at www.kitovpharma.com. It is our intention for the code of ethics to remain accessible on our website for as long as we remain subject to the requirements of this Item and choose to comply with this Item by posting the Code on our website. Information contained on, or that can be accessed through, our website does not constitute a part of this Annual Report on Form 20-F and is not incorporated by reference herein. Other than technical, administrative or other non-substantive amendments, there have been no changes to our code of ethics since our most recent Annual Report Form 20-F. ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES Under the Companies Law, the board of directors is required to report to the annual general meeting the compensation paid to the auditors. The following table sets forth the approximate total compensation that was paid by the Company and its subsidiaries to the Company’s independent auditors, Somekh Chaikin, Certified Public Accountants (Israel), a member of KPMG International, for each of the years ended December 31: Audit fees(1) Audit-related fees(2) Tax (3) Total (in thousands of U.S. dollars) 2016 2015 51 33 3 87 42 83 8 133 (1) “Audit fees” include fees for services performed in connection with the Company’s annual audit, certain procedures regarding the Company’s interim financial results, consultation concerning financial accounting and reporting standards. (2) “Audit-related fees” relate to assurance and associated services that are traditionally performed by the independent auditor, including fees related to our public offerings and registration statements. (3) These fees relate to services provided regarding tax compliance and review of tax returns. 100% of the audit related services, tax and other fees described in the table above were approved by the audit committee in accordance with paragraph (c)(7)(i)(C) of Rule 2-01 of Regulation S-X. 157 Audit committee's pre-approval policies and procedures Under the Companies Law and our amended and restated articles of association, our shareholders are authorized to appoint our independent auditors. Under the Companies Law and our amended and restated articles of association, the shareholders may appoint our independent auditors to hold office for a longer period of time that will not extend beyond the end of the third annual meeting following that at which the auditor was appointed. At our 2014 annual general meeting of the shareholders, our shareholders appointed Somekh Chaikin, Certified Public Accountants (Israel), a member of KPMG International, as the independent public accountants of the Company for such longer period of time not to extend beyond the 2017 annual general meeting at which time the appointment of an auditor will be presented to the shareholders once again. Under the Companies Law and our amended and restated articles of association, the board of directors is authorized to determine the independent auditor’s remuneration. In addition, the NASDAQ Listing Rules require that a listed company’s audit committee approve the re-appointment and remuneration of the independent auditor. Our amended and restated articles of association include a provision which states that for so long as our securities are listed for trading on an exchange in the United States of America, such authority of the board of directors to set the remuneration of the auditor for audit activity and/or for additional services to us not being audit-related, will be deemed to have been delegated by the board of directors to the audit committee of the board of directors. This policy, which is designed to assure that such engagements do not impair the independence of our auditors, requires pre-approval from the audit committee on an annual basis for the various audit and non-audit services that may be performed by our auditors. Our audit committee is not permitted to approve the engagement of our auditors for any services that would be inconsistent with maintaining the auditor's independence or that are not permitted by applicable law. ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES. Not applicable. ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS. Not applicable ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT. Not applicable ITEM 16G.CORPORATE GOVERNANCE Home Country Practices As a foreign private issuer, we are permitted to follow Israeli corporate governance practices instead of NASDAQ Listing Rules, provided that we disclose which requirements we are not following and the equivalent Israeli requirement. We intend to rely on this “foreign private issuer exemption” with respect to the following items: ● Distribution of annual and quarterly reports to shareholders. Under Israeli law, as a public company whose shares are traded on the TASE, we are not required to distribute annual and quarterly reports directly to shareholders and the generally accepted business practice in Israel is not to distribute such reports to shareholders but to make such reports publicly available through the website of the Israeli Securities Authority and the TASE. In addition, we make our audited financial statements available to our shareholders at our offices. 158 ● Independent Directors. Israeli law generally does not require that a majority of our board members be independent as required by the NASDAQ Listing Rules. In addition, Israeli law does not require, nor do our independent directors conduct, regularly scheduled meetings at which only our independent directors are present. We are required, however, to ensure that all members of our audit committee are “independent” under the applicable NASDAQ and SEC criteria for independence. On July 13, 2016, our Board of Directors resolved to adopt the corporate governance exceptions set forth in Regulation 5D of the Israeli Companies Regulations (Relief for Public Companies with Shares Listed for Trading on a Stock Market Outside of Israel), 5760-2000. In accordance with our Board’s resolution, for so long as Kitov Parent does not have a controlling shareholder as defined in Section 1 the Companies Law, Kitov Parent intends to comply with the NASDAQ Listing Rules in connection with a majority of independent directors on the Board and in connection with the composition of each of the Audit Committee in under the Companies Law. As such, our board of directors does not include two directors classified as external directors in accordance with the Israeli Companies Law, but such corporate governance exceptions do require that a majority of our board members be independent as required by the NASDAQ Listing Rules. ● Audit Committee. While our board of directors has adopted an audit committee charter, neither applicable Israeli laws, nor our amended and restated articles of association, require that we adopt and file an audit committee charter. Consistent with Israeli law, the independent auditors are elected at a meeting of shareholders instead of being appointed by the audit committee. ● Compensation Committee and Compensation of Officers. Under NASDAQ Listing Rules, Kitov Parent must establish a compensation committee and adopt a formal written compensation committee charter addressing the scope of the compensation committee's responsibilities, including structure, processes and membership requirements, among others. While our board of directors has adopted a compensation committee charter, neither applicable Israeli laws, nor our amended and restated articles of association, require that we adopt and file a compensation committee charter. Additionally, we comply with the requirements set forth under the Companies Law, pursuant to which transactions with office holders of Kitov Parent regarding their terms of office and employment, and transactions with a controlling shareholder in Kitov Parent regarding his or her employment and/or his or her terms of office with the Company, may require the approval of the compensation committee, the board of directors and under certain circumstances the shareholders, either in accordance with our previously approved compensation policy or, in special circumstances in deviation therefrom, taking into account certain considerations set forth in the Companies Law. The requirements for shareholder approval of any office holder compensation, and the relevant majority or special majority for such approval, are all as set forth in the Companies Law. Thus, we will seek shareholder approval for all corporate actions with respect to office holder compensation requiring such approval under the requirements of the Companies Law, including seeking prior approval of the shareholders for the compensation policy and for certain office holder compensation, rather than seeking approval for such corporate actions in accordance with NASDAQ Listing Rules. ● Shareholder Approval. We seek shareholder approval for all corporate actions requiring such approval in accordance with the requirements of the Companies Law, which are different from the shareholder approval requirements under the NASDAQ Listing Rules, including NASDAQ Listing Rule 5635. The NASDAQ Listing Rules require that we obtain shareholder approval for certain dilutive events, such as for the establishment or amendment of certain equity-based compensation plans and arrangements, issuances that will result in a change of control of a company, certain transactions other than a public offering involving issuances of 20% or more of the shares or voting power in a company, and certain acquisitions of the stock or assets of another company involving issuances of 20% or more of the shares or voting power in a company or if any director, officer or holder of 5% or more of the shares or voting power of the company has a 5% or greater interest in the company or assets to be acquired or consideration to be paid and the transaction could result in an increase in the outstanding common shares or voting power by 5% or more. 159 Under the Companies Law, shareholder approval is required for any transaction, including any grant of equity-based compensation, to a director or a controlling shareholder, but is not generally required to establish or amend an equity based compensation plan. Similarly, shareholder approval is required for a private placement that is deemed a “extraordinary private placement” or that involves a director or controlling shareholder. A “extraordinary private placement” is a private placement in which a company issues securities representing 20% or more of its voting rights prior to the issuance and the consideration received pursuant to such issuance is not comprised, in whole or in part, solely of cash or securities registered for trade on an exchange or which is not made pursuant to market conditions, and as a result of which the shareholdings of a 5% holder of the shares or voting rights of the company increases or as a result of which a person will become a holder of 5% of the shares or voting rights of the company or a controlling shareholder after the issuance. We will attempt to seek shareholder approval for our stock option or equity-based compensation plans (and the relevant annexes thereto) to the extent required in order to ensure they are tax qualified for any employees in the U.S. or who are U.S. citizens. However, even if such approval is not received, then the stock option or equity-based compensation plans will continue to be in effect, but we will be unable to grant to our U.S. resident and/or citizen employees options that qualify as Incentive Stock Options for U.S. federal tax purpose. Our stock option or other equity-based compensation plans are also available to our non-U.S. employees, and provide features necessary to comply with applicable non-U.S. tax laws. ● Approval of Related Party Transactions. All related party transactions are approved in accordance with the requirements and procedures for approval of interested party acts and transactions, set forth in sections 268 to 275 of the Companies Law, and the regulations promulgated thereunder, which require the approval of the audit committee, the compensation committee, the board of directors and shareholders, as may be applicable, for specified transactions, rather than approval by the audit committee or other independent body of our Board of Directors as required under the NASDAQ Listing Rules. ● Meetings of Shareholders: Annual Meetings; Proxy Solicitations; Quorum. The NASDAQ Listing Rules require that each company listing common stock, and their equivalents, hold an annual meeting of shareholders within one year of the end of each fiscal year, and that at such meeting, shareholders must be afforded the opportunity to discuss company affairs with management and, if required by the Company's governing documents, to elect directors. They further require that each company shall solicit proxies and provide proxy statements for all meetings of shareholders and shall provide copies of such proxy solicitation to NASDAQ. Under the NASDAQ Listing rules, the quorum required for an ordinary meeting of shareholders consists of 33 1/3% of the issued share capital. We will follow our home country practices with respect to the above as follows: ● Annual Meetings. As permitted under the Companies Law and Regulations enacted pursuant to such law, and as set forth in our amended and restated articles of association, we are required to hold an annual meeting each year and provided that it is no later than 15 months from the prior annual meeting. At the annual meeting we are required to elect directors (other than external directors, if such are required to be elected) and to present the annual financial statements and annual report, as well as presenting the fees paid to our auditors. 160 ● Proxy Solicitations. As permitted under the Companies Law and Regulations enacted pursuant to such law, and as set forth in our amended and restated articles of association, we are not required to physically deliver a notice of a shareholders meeting and a proxy statement. We will prepare notices of general meeting of our shareholders, as well as the accompanying proxy statement and voting instruction forms, (collectively, the “Proxy Materials”) in accordance with applicable rules, regulations and disclosure requirements in the State of Israel, as such are applicable to a Company whose shares are traded on both the TASE and the NASDAQ. Our Proxy Materials may not necessarily be mailed to beneficial shareholders in Israel, nor to beneficial ADS holders in the U.S. Forms of the Proxy Materials will be furnished to the SEC on Form 6-K, and will be available to the public on the SEC’s website at http://www.sec.gov. The proxy materials will also be filed with the Israeli Securities Authority and TASE and available on the websites: www.magna.isa.gov.il or www.maya.tase.co.il. The Proxy Materials will also be made available on the Company’s corporate website at www.kitovpharma.com, as required under the Companies Law and Regulations governing distribution of the Proxy Materials. ● Quorum. As permitted under the Companies Law, pursuant to our amended and restated articles of association, the quorum required for an ordinary meeting of our shareholders consists of at least two shareholders present in person or by proxy who hold or represent at least 25% of the voting rights of our shares (and in an adjourned meeting, with some exceptions, any number of shareholders), instead of 33 1/3% of the issued share capital required under the NASDAQ Listing Rules. ● Nominations Committee and Nominations of our Directors. Our directors are not selected, nor recommended for board of director selection, by independent directors constituting a majority of the board’s independent directors or by a nominations committee comprised solely of independent directors as required by the NASDAQ Listing Rules. With the exception of external directors (if any are required to be elected) and any directors elected by our Board of Directors due to vacancy, our directors are elected by a general or special meeting of our shareholders. The nominations for directors, which are presented to our shareholders, are generally made by our directors, but nominations may be made by one or more of our shareholders as provided in our amended and restated articles of association, under the Companies Law or in an agreement between us and our shareholders. GHP has entered into a Shareholder’s Undertaking with Kitov Parent pursuant to which it has agreed to vote its ordinary shares, subject to certain exceptions relating to significant corporate transactions, in accordance with the recommendation of Kitov Parent’s board of directors and in favor of persons nominated and recommended to serve as directors by the board, and has granted Kitov Parent an proxy to ensure its compliance with such voting undertakings. Other than such Shareholder’s Undertaking, currently there is no other agreement between us and any shareholder regarding the nomination or appointment of directors. In accordance with our amended and restated articles of association, under the Companies Law, any one or more shareholders holding, in the aggregate such portions of our outstanding voting power, as set forth in our amended and restated articles of association may nominate one or more persons for election as directors at a general meeting by delivering a written notice of such shareholder’s intent to make such nomination or nominations to our registered office. Each such notice must set forth all of the details and information as required to be provided by our amended and restated articles of association. ● Nominations Committee Charter or Board Resolution. Under NASDAQ Listing Rules, U.S. domestic listed companies, must adopt a formal written charter or board resolution, as applicable, addressing the nominations process and such related matters as may be required under the federal securities laws. We do not have such a formal written charter or board resolution. Otherwise, we intend to comply with the rules generally applicable to U.S. domestic companies listed on NASDAQ. We may in the future decide to use the foreign private issuer exemption with respect to some or all of the other NASDAQ Listing Rules related to corporate governance. We also intend to comply with Israeli corporate governance requirements set forth in the Companies Law and Regulations enacted pursuant to such law which are applicable to public companies. Disclosure of Compensation of Executive Officers For so long as we qualify as a foreign private issuer, we are not required to comply with the proxy rules applicable to U.S. domestic companies, including the requirement applicable to emerging growth companies to disclose the compensation of our chief executive officer and other two most highly compensated executive officers on an individual, rather than an aggregate, basis. Nevertheless, a recent amendment to the Israeli proxy regulations governing Israeli public companies which were promulgated under the Israeli Companies Law requires us to disclose in the notice and proxy statement for our annual general meeting of our shareholders (or to include a reference therein to other previously furnished public disclosure) the annual compensation of our five most highly compensated office holders on an individual basis, rather than on an aggregate basis, as was previously permitted for Israeli public companies listed overseas. This disclosure may not be as extensive as that required of a U.S. domestic issuer. ITEM 16H. MINE SAFETY DISCLOSURE Not applicable 161 ITEM 17. FINANCIAL STATEMENTS The Registrant has responded to Item 18 in lieu of responding to this Item. ITEM 18. FINANCIAL STATEMENTS PART III See the consolidated financial statements as of December 31, 2016 and 2015 and for the three-year period ended December 31, 2016 of Kitov Pharmaceuticals Holdings Ltd., and the report thereon dated March 27, 2017 of Somekh Chaikin, independent registered public accounting firm, a Member Firm of KPMG International, beginning on page F-1. ITEM 19. EXHIBITS The exhibits filed with or incorporated into this Annual Report on Form 20-F are listed in the index of exhibits below: Exhibit Number 1.1 1.2 1.3 2.1 2.2 2.3 2.4 2.5 2.6 Exhibit Description Memorandum of Association of the Registrant (included as Exhibit 99.2 to our Form 6-k furnished to the Securities and Exchange Commission on December 6, 2016, and incorporated herein by reference). Amended and Restated Articles of Association of the Registrant (included as Exhibit 99.2 to our Form 6-k furnished to the Securities and Exchange Commission on December 6, 2016, and incorporated herein by reference). Certificate of Company Name Change (unofficial English translations from Hebrew) (included as part of Exhibit 3.1 to our Registration Statement on Form F-1 as filed with the Securities and Exchange Commission on September 24, 2015, and incorporated herein by reference). Form of Deposit Agreement among the Registrant, the Bank of New York Mellon, as Depositary, and all Owners and Holders from time to time of American Depositary Shares issued hereunder (included as Exhibit 4.1 to our Registration Statement on Form F-1 as filed with the Securities and Exchange Commission on September 24, 2015, and incorporated herein by reference). Form of Warrant Agent Agreement (included as Exhibit 4.2 to our Registration Statement on Form F-1/A as filed with the Securities and Exchange Commission on November 18, 2015, and incorporated herein by reference). Form of American Depositary Receipt (included in Exhibit 2.1). Form of Underwriters' Warrant, (included as Exhibit 4.4 to our Registration Statement on Form F-1/A as filed with the Securities and Exchange Commission on November 18, 2015, and incorporated herein by reference). Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.5 to the Registrant’s Registration Statement on Form F-1 as filed with the Securities and Exchange Commission on June 27, 2016). Form of Letter Amendment to Warrant Agent Agreement with respect to Series A warrants (incorporated by reference to Exhibit 4.1 to the Registrant’s Form 6-K furnished to the Securities and Exchange Commission on June 29, 2016) 162 2.7 2.8 2.9 2.10 4.1* 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 Form of Pre-Funded Series B Warrant Agreement (incorporated by reference to Exhibit 4.4 to the Registrant’s Registration Statement on Form F-1 as filed with the Securities and Exchange Commission on June 27, 2016). Stock Purchase Agreement, dated January 12, 2017, by and between the Registrant and Goldman Hirsh Partners Ltd. Shareholder’s Undertaking by Goldman Hirsh Partners Ltd. dated January 13, 2017. Flow of Funds Agreement, dated April 9, 2017, by and between the Registrant and Goldman Hirsh Partners Ltd. Development Services Agreement, dated as of April 1, 2014, by and between Kitov Pharmaceuticals Ltd. and Dexcel Ltd. (included as Exhibit 10.1 to our Registration Statement on Form F-1 as filed with the Securities and Exchange Commission on September 24, 2015, and incorporated herein by reference). Master Research Services Agreement, dated February 4, 2014, between Kitov Pharmaceuticals Ltd.t and Java Clinical Research Limited (included as Exhibit 10.2 to our Registration Statement on Form F-1 filed with the Securities and Exchange Commission on September 24, 2015, and incorporated herein by reference). Change Order Forms under Master Research Services Agreement between Kitov Pharmaceuticals Ltd. and Java Clinical Research Limited dated March 26, 2014, September 22, 2014, and April 2, 2015 (included as Exhibit 10.3 to our Registration Statement on Form F-1 as filed with the Securities and Exchange Commission on September 24, 2015, and incorporated herein by reference). Work Order No. 2 under Master Research Services Agreement between Kitov Pharmaceuticals Ltd. and Java Clinical Research Limited dated September 7, 2016 (incorporated by reference to Exhibit 10.4 to the Registrant’s Post-Effective Amendment No. 2 to Registration Statement on Form F-1 on Form F-3 as filed with the Securities and Exchange Commission on December 12, 2016). Share Transfer Agreement, dated as of April 2, 2013, Kitov Pharmaceuticals Holdings Ltd. (then known as Mainron Line Logisitics Ltd.), Kitov Pharmaceuticals Ltd., the shareholders of Kitov Pharmaceuticals, Sheer Roichman and Haiku Capital Ltd. (included as Exhibit 10.4 to our Registration Statement on Form F-1 filed with the Securities and Exchange Commission on September 24, 2015, and incorporated herein by reference). Form of Letter of Exemption adopted on July 2013 (unofficial English translation from Hebrew) (included as Exhibit 10.5 to our Registration Statement on Form F-1 filed with the Securities and Exchange Commission on September 24, 2015, and incorporated herein by reference). Form of Letter of Indemnity adopted on July 2013 (unofficial English translation from Hebrew) (included as Exhibit 10.6 to our Registration Statement on Form F-1 as filed with the Securities and Exchange Commission on September 24, 2015, and incorporated herein by reference). 2013 Stock Option Plan, as amended (unofficial English translation from Hebrew (included as Exhibit 10.7 to our Registration Statement on Form F-1 filed with the Securities and Exchange Commission on September 24, 2015, and incorporated herein by reference). Kitov Pharmaceuticals Holdings Ltd. 2016 Equity-Based Incentive Plan (included as Exhibit 99.1 to our Registration Statement on Form S-8 filed with the Securities and Exchange Commission on May 19, 2016, and incorporated herein by reference) 4.10 Loan Agreement, dated August 12, 2015 between Kitov Pharmaceuticals Holdings Ltd. and certain lenders (included as Exhibit 10.8 to our Registration Statement on Form F-1 filed with the Securities and Exchange Commission on September 24, 2015, and incorporated herein by reference). 4.11 Kitov Pharmaceuticals Holdings Ltd. 2014 Office Holders' Compensation Policy (unofficial translation to English from Hebrew original) (included as Exhibit 4.9 to our Annual Report for 2015 on Form 20-F filed with the Securities and Exchange Commission on March 18, 2016, and incorporated herein by reference). Form of Underwriting Agreement (included as Exhibit 1.1 to our Registration Statement on Form F-1/A filed with the Securities and Exchange Commission on November 18, 2015, and incorporated herein by reference). Form of Share Purchase Agreement between Kitov Pharmaceuticals Holdings Ltd. and the purchasers (incorporated by reference to Exhibit 1.1 to the Registrant’s Form 6-K furnished to the Securities and Exchange Commission on June 29, 2016) License Agreement, dated as of August 15, 2013, by and between Yissum Research Development Company of The Hebrew University of Jerusalem, Ltd. and Tyrnovo Ltd. First Amendment to License Agreement, dated as of April 8, 2014, by and between Yissum Research Development Company of The Hebrew University of Jerusalem, Ltd. and Tyrnovo Ltd. Second Amendment to License Agreement, dated as of March 16, 2017, by and between Yissum Research Development Company of The Hebrew University of Jerusalem, Ltd. and Tyrnovo Ltd. Binding Term Sheet by and amongst Kitov Pharmaceuticals Holdings Ltd., TyrNovo Ltd. and Taoz – Company for Management and Holdings of Companies Ltd. approved by the Economic Division of the Tel Aviv District Court on February 9, 2017 Amendment to the Binding Term Sheet by and amongst Kitov Pharmaceuticals Holdings Ltd., TyrNovo Ltd. and Taoz – Company for Management and Holdings of Companies Ltd. approved by the Economic Division of the Tel Aviv District Court on February 9, 2017 (unofficial English translations from Hebrew) TyrNovo Ltd. Shareholders Agreement by and between Kitov Pharmaceuticals Holdings Ltd. and Taoz – Company for Management and Holdings of Companies Ltd. approved by the Economic Division of the Tel Aviv District Court on February 9, 2017 List of subsidiaries of the Registrant. Certification by Chief Executive Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002. Certification by Chief Financial Officer pursuant to section 302 of the Sarbanes-Oxley Act of 2002. Certification by Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Certification by Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 4.12 4.13 4.14† 4.15† 4.16† 4.17 4.18 4.19 8.1 12.1 12.2 13.1 13.2 * Confidential treatment granted with respect to portions of this Exhibit. † Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. 163 The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this Annual Report on Form 20-F on its behalf. SIGNATURES KITOV PHARMACEUTICALS HOLDINGS LTD. By: By: /s/ Isaac Israel Name: Isaac Israel Title: Chief Executive Officer /s/ Simcha Rock Name: Simcha Rock Title: Chief Financial Officer May 1, 2017 164 Kitov Pharmaceuticals Holdings Ltd. Consolidated Financial Statements As of December 31, 2016 Contents Auditors’ Report Consolidated Financial Statements as of December 31, 2016 Consolidated Statements of Financial Position Consolidated Statements of Operations and other Comprehensive Income Consolidated Statements of Changes in Equity Consolidated Statements of Cash Flows Notes to the Consolidated Financial Statements F-1 Page F-2 F-3 F-4 F-5 - F-6 F-7 F-8 - F-24 Report of Independent Registered Public Accounting Firm The Board of Directors and Shareholders Kitov Pharmaceuticals Holdings Ltd. We have audited the accompanying consolidated statements of financial position of Kitov Pharmaceuticals Holdings Ltd and its subsidiary (hereinafter – “the Company”) as of December 31, 2016 and 2015, and the related consolidated statements of operations, changes in equity (deficit) and cash flows for each of the years in the three-year period ended December 31, 2016. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. Our audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2016 and 2015, and the results of their operations and their cash flows for each of the years in the three-year period ended December 31, 2016, in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board. We draw attention to Note 11F to the financial statements. There is an ongoing activity conducted by the Israel Securities Authority to investigate allegations that the Company did not disclose certain information to the public. In addition, numerous lawsuits and motions have been filed against the Company and certain of its office holders. The ultimate outcome of these matters cannot presently be determined, and no provision for any liability that may result has been made in the financial statements. Our opinion is not modified in respect of this matter. /s/ Somekh Chaikin Somekh Chaikin Certified Public Accountants (Isr.) Member firm of KPMG International Tel-Aviv, Israel March 27, 2017 F-2 Consolidated Statements of Financial Position Assets Cash and cash equivalents Short term deposits Other receivables Total current assets Fixed assets, net Total assets Liabilities Accounts payable Other payables Derivative instruments Total current liabilities Non-current liabilities Post employment benefit liabilities Equity Share capital, no par value Share premium Receipts on account of warrants Capital reserve for share-based payments Capital reserve from transactions with related parties Accumulated loss Total equity Total liabilities and equity Kitov Pharmaceuticals Holdings Ltd. December 31 December 31 2016 2015 Note USD thousands USD thousands 4,18 18 5 7 8 17 8 8 9 6,758 7,899 241 10,558 - 246 14,898 10,804 16 8 14,914 10,812 515 758 - 353 704 141 1,273 1,198 256 185 - 30,826 7,415 583 761 (26,200) 13,385 - 22,159 27 536 761 (14,054) 9,429 14,914 10,812 The accompanying notes are an integral part of these consolidated financial statements. F-3 Consolidated Statements of Operations and Other Comprehensive Income Kitov Pharmaceuticals Holdings Ltd. Note 12 13 14 15 15 15 Research and development expenses General and administrative expenses Other expenses Operating Loss Net change in fair value of derivatives Finance expense Finance income Finance expenses, net Loss for the year Other comprehensive loss Items that will not be classified to profit or loss Remeasurement of defined benefit liability Total comprehensive loss for the year Loss per share data Basic and diluted loss per share – USD Number of shares used in calculating basic and diluted loss per share 2014 2016 2015 USD thousands USD thousands USD thousands 3,192 1,269 720 5,181 2,560 1,509 - 4,069 4,180 3,003 - 7,183 5,019 61 (138) 4,942 (94) 227 - 133 (274) 345 - 71 12,125 4,202 5,252 21 - - 12,146 4,202 5,252 0.11 115,114,946 0.22 19,250,340 1.17 4,481,684 The accompanying notes are an integral part of these consolidated financial statements F-4 Consolidated Statements of Changes in Equity Kitov Pharmaceuticals Holdings Ltd. Share Capital Share premium Receipts on account of warrants Capital reserve for share- based payments Capital reserve from transactions with related parties Accumulated loss Total For the year ended December 31, 2016: Balance as of January 1, 2016 Comprehensive loss for the year: Loss for the year Other comprehensive loss Total comprehensive loss for the year Transactions with owners of the company: Issuance of American Depository Shares (ADSs) on the NASDAQ, net of issuance costs Issuance of warrants, net of issuance costs Share issuance due to a strategic cooperation agreement (see note 11) Share-based payments Transfer of derivative instrument from liability to equity Exercise of warrants (series A) Exercise of warrants (series B) Total transactions with owners of the company - 22,159 27 536 761 (14,054) 9,429 - - - - - - - - - - - 5,222 - - 2,517 - - - - - - - - - - 500 103 - 302 2,540 8,667 - - (250) 297 7,388 (2,517) 7,388 - - 47 - - - - - - - - - (12,125) (21) (12,146) (12,125) (21) (12,146) - - - - - - - 5,222 2,517 250 400 7,388 302 23 16,102 Balance as of December 31, 2016 - 30,826 7,415 583 761 (26,200) 13,385 Share Capital Share premium Receipts on account of warrants Capital reserve for share- based payments Capital reserve from transactions with related parties Accumulated loss Total For the year ended December 31, 2015: Balance as of January 1, 2015 Loss for the year Issuance of shares, net of issuance costs Exercise and expiration of warrants (series 1) Share issuance due to a strategic cooperation agreement (see note 11) Share-based payments Exercise of warrants (series 2) Issuance of American Depository Shares (ADSs) on the NASDAQ, net of issuance costs Issuance of warrants, net of issuance costs Balance as of December 31, 2015 - - - - - - - 9,104 - 1,821 201 500 - 2 - - 10,531 - - 22,159 200 - - (200) - - - - 27 27 560 - - - (83) 59 - - - 761 - - - (9,852) (4,202) - - 773 (4,202) 1,821 1 417 59 2 - - - - - 10,531 27 - - - - - 536 761 (14,054) 9,429 The accompanying notes are an integral part of these consolidated financial statements. F-5 Consolidated Statements of Changes in Equity Kitov Pharmaceuticals Holdings Ltd. Share Capital Share premium Receipts on account of warrants Capital reserve for share- based payments Capital reserve from transactions with related parties Accumulated loss Total For the year ended December 31, 2014: Balance as of January 1, 2014 Loss for the year Issuance of shares, net of issuance costs Issuance of warrants in a rights offering Share issuance due to a strategic cooperation agreement (see note 11) Share-based payments Options exercised Capital reserve from transactions with related parties Return of funds to a related party Balance as of December 31, 2014 - - - - - - - - - - 2,654 - 6,200 (200) 327 - 123 - - - - 200 - - - - - 141 - 57 - 333 88 (59) - - 859 - - - - - - 43 (141) (4,600) (5,252) - - (946) (5,252) 6,257 - - - - - - 660 88 64 43 (141) 773 9,104 200 560 761 (9,852) The accompanying notes are an integral part of these consolidated financial statements. F-6 Consolidated Statements of Cash Flows for the year ended December 31, Cash flows from operating activities: Loss for the year Adjustments: Depreciation Finance expense, net Share-based payments Expenses in regard to a strategic cooperation agreement (see note 11) Non-remunerable services provided by related parties Changes in assets and liabilities: Changes in other receivables Changes in accounts payable Changes in other payables Changes in post employment benefit liabilities Net cash used in operating activities Cash flows from investing activities: Increase in short term deposits Acquisition of fixed assets Net cash used in investing activities Cash flows from financing activities: Repayment of loans from related parties Loans received from third parties Repayment of loans from third parties Proceeds from issuance of shares and ADSs Share and ADS issuance expenses paid Proceeds from issuance of warrants Warrants issuance expenses paid Receipts from warrant exercise Interest received Interest paid Net cash provided by financing activities: Net increase (decrease) in cash Cash at the beginning of the year Effect of translation adjustments on cash Cash at end of the year Kitov Pharmaceuticals Holdings Ltd. 2016 2015 USD thousands 2014 (12,125) (4,202) (5,252) 2 4,942 400 250 - 1 133 59 417 - - 71 88 660 37 (6,531) (3,592) (4,396) - (138) 357 50 269 (6,262) (7,899) (10) (7,909) - - - 6,287 (1,065) 5, 713 (968) 325 138 (6) 10,424 (3,747) 10,558 (53) 6,758 197 (152) 54 185 284 (3,308) - (9) (9) (294) - - 14,942 (2,059) 190 (10) 2 - (145) 12,632 9,315 1,313 (70) 10,558 (375) 453 (208) - (130) (4,526) - - - (622) 132 (246) 6,848 (571) 349 (25) 57 - (100) 5,822 1,296 193 (176) 1,313 The accompanying notes are an integral part of these consolidated financial statements F-7 Kitov Pharmaceuticals Holdings Ltd. Notes to the Consolidated Financial Statements Note 1 - General Reporting entity Kitov Pharmaceuticals Holdings Ltd. (hereinafter: “the Company”) is an Israeli company, that was incorporated in Israel as a private company in August 1968, and has been listed for trading on the Tel Aviv Stock Exchange since September 1978. In October 2012, the Company disposed of all of its previous operations, and in July, 2013, the Company acquired shares of Kitov Pharmaceuticals Ltd. (hereinafter: “Kitov”) from its shareholders, in exchange for the Company’s shares (hereinafter: “the Acquisition”). The Company’s securities (American Depository Shares (“ADS”) as well as Series A warrants) were listed for trading on the NASDAQ in November 2015. Each ADS represents 20 ordinary shares with no par value. Each warrant enables the purchase of 1 ADS. The Company’s address is One Azrieli Center, Round Tower, 132 Menachem Begin Road, Tel Aviv 6701101 Israel. The Company together with Kitov are referred to, in these financial statements, as “the Group”. As of the date of the financial statements, the Group is engaged, through Kitov, in the development of combination drugs that treat two clinical conditions simultaneously, pain caused by osteoarthritis and hypertension. Since incorporation through December 31, 2016, the Company has incurred losses and negative cash flows from operations mainly attributed to its development efforts and has an accumulated deficit of USD 26.2 million. The Company has financed its operations mainly through private and public financing rounds. In November 2015 and July 2016, the Company raised a total of USD 20.5 million net, which management believes will allow the Company to complete its current development plans. At present, the Company has no revenue and may require additional funding for future plans. Note 2 - Basis of Preparation of the Financial Statements A. Statement of compliance with International Financial Reporting Standards The Company has prepared the financial statements in accordance with International Financial Reporting Standards (hereinafter: “IFRS”), as issued by the International Accounting Standard Board (“IASB”). These financial statements have been approved by the board of directors on March 27, 2017. B. Functional and presentation currency These financial statements are presented in US dollars (USD), which is the Group’s functional currency, rounded to the nearest one thousand, unless otherwise noted. The USD is the currency that represents the principal economic environment in which the Group operates. C. Use of estimates and judgment The preparation of financial statements in conformity with IFRS requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. Management prepares the estimates on the basis of past experience, various facts, external circumstances, and reasonable assumptions according to the pertinent circumstances of each estimate. F-8 Notes to the Consolidated Financial Statements Note 2 - Basis of Preparation of the Financial Statements (continued) Kitov Pharmaceuticals Holdings Ltd. The preparation of accounting estimates used in the preparation of the Group’s financial statements requires management of the Company to make assumptions regarding circumstances and events that involve considerable uncertainty. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. D. Fair value determination of share-based payments In preparing these financial statements, the Group is required to determine the fair value of share-based payment arrangements. The Group uses observable market data as far as possible. Further information about the assumptions made in measuring fair value of share based payments, is included in note 9. E. Exchange rates and linkage bases Balances in foreign currency or linked thereto are included in the financial statements at the representative exchange rates, as published by the Bank of Israel, which were prevailing as of the statement of financial position date. Data on exchange rates are as follows: Date of financial statements: December 31, 2016 December 31, 2015 December 31, 2014 Changes in exchange rates for the Year ended: December 31, 2016 December 31, 2015 December 31, 2014 Note 3 - Significant Accounting Policies Representative exchange rate of $ (NIS/$ 1) % 3.845 3.902 3.889 (1.5) 0.3 12.0 The accounting policies set out below have been consistently applied for all periods presented in these consolidated financial statements A. Subsidiary A subsidiary is an entity controlled by the Company. The Company controls an entity when it is exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power over the entity. The financial statements of the subsidiary are included in the consolidated financial statements from the date that control commences until the date that control is lost. F-9 Notes to the Consolidated Financial Statements Note 3 - Significant Accounting Policies (continued) B. Foreign currency transactions Kitov Pharmaceuticals Holdings Ltd. Transactions in foreign currency are translated to the functional currency of Group companies at exchange rates as of the transaction dates. Monetary assets and liabilities denominated in foreign currency as of the reporting date are translated into the functional currency at the exchange rate as of the said date. Exchange rate differences with respect to monetary items are the differences between the amortized cost in the functional currency as of the start of the year, adjusted for the effective interest during the year, and the amortized cost in foreign currency, translated at the exchange rate as of the end of the year. Non-monetary items denominated in foreign currency and measured at historical cost, are translated using the exchange rate as of the transaction date. Exchange rate differences arising from translation into the functional currency are recognized on the statement of operations as financial expenses. C. Derivative and Non-derivative financial instruments 1. Non-Derivative financial instruments a. Non-derivative financial assets Non-derivative financial assets include: cash and cash equivalents, short term deposits and other receivables. Cash and cash equivalents include cash balances available for immediate use and call deposits. Cash equivalents include short-term highly liquid investments (with original maturities of three months or less) that are readily convertible into known amounts of cash and are exposed to insignificant risks of change in value. b. Non-derivative financial liabilities Non-derivative financial liabilities include: accounts payables and other accounts payable. Initial recognition of financial liabilities The Group initially recognizes debt instruments issued as they are created. Other financial liabilities are initially recognized on the trade date on which the Group becomes party to contractual terms of the instrument. Financial liabilities are initially recognized at fair value less any attributable transaction costs. Subsequent to initial recognition, financial liabilities are measured at amortized cost using the effective interest method. Transaction costs directly attributable to an expected issuance of an instrument that will be classified as a financial liability are recognized as an asset as part of deferred expenses in the statement of financial position. These transaction costs are deducted from the financial liability upon their initial recognition, or are amortized as financing expenses in the statement of operations when the issuance is no longer expected to occur. De-recognition of financial liabilities Financial liabilities are de-recognized upon expiration of the Group’s liability, as set forth in the agreement, or when disccharged or cancelled. F-10 Notes to the Consolidated Financial Statements Note 3 - Significant Accounting Policies (continued) 2. Derivative financial liabilities Kitov Pharmaceuticals Holdings Ltd. The Group holds derivative financial instruments that do not serve hedging purposes, including separable embedded derivatives. Measurement of derivative financial instruments Derivatives are recognized initially at fair value; attributable transaction costs are recognized in profit or loss as incurred. Subsequent to initial recognition, derivatives are measured at fair value, and changes therein are accounted for as described below. The changes in fair value of these derivatives are recognized in profit or loss, as financing income or expense. Included in this accounting treatment are changes in the fair value of the conversion component of NIS-linked warrants that do not have a fixed exercise price. The fair value of these derivatives is based on market price, and classified as level 1. D. Intangible assets – research and development costs Expenditure on research activities, undertaken with the prospect of gaining new scientific or technical knowledge and understanding, is recognized in profit or loss when incurred. Development activities involve a plan or design for the production of new or substantially improved products and processes. Development expenditure is capitalized only if development costs can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, and the Group has the intention and sufficient resources to complete development and to use or sell the asset. The expenditure capitalized in respect of development activities includes the cost of materials, direct labor and overhead costs that are directly attributable to preparing the asset for its intended use, and capitalized borrowing costs. Other development expenditure is recognized in profit or loss as incurred. In subsequent periods, any capitalized development expenditure is measured at cost less accumulated amortization and accumulated impairment losses. As the Company has not met the criteria mentioned above, all development costs are currently recognized in profit and loss as expense. E. Loss per share The Group presents loss per share data for its ordinary share capital. Loss per share is calculated by dividing the loss attributable to holders of ordinary shares, by the weighted average number of ordinary shares outstanding during the period. F. Transactions with controlling shareholder Assets and liabilities included in a transaction with a controlling shareholder are measured at fair value on the date of the transaction. As the transaction is on the equity level, the Company includes the difference between the fair value and the consideration from the transaction in its equity. F-11 Notes to the Consolidated Financial Statements Note 3 - Significant Accounting Policies (continued) G. Share-based payment transactions Kitov Pharmaceuticals Holdings Ltd. The fair value of share-based payment grants to employees and officers is recognized as payroll expense, against equity, over the period in which eligibility for such grant is earned. The amount charged as share-based payment grants expense is contingent on vesting conditions, which are service or performance conditions and is adjusted to reflect the number of grants expected to vest. As for share-based payment grants contingent on non-vesting conditions, or on vesting conditions which are performance conditions connected to market conditions, the Company accounts for these conditions when estimating the fair value of such grants; therefore the Company recognizes an expense with respect to these grants, regardless of fulfillment of these conditions. H. Financing income and expense Finance income comprises changes in the fair value of the financial liability through profit and loss, and income from short term deposits. Finance expenses include loss from exchange rate differences. Interest expense is recognized, using the effective interest method. In the statements of cash flows, interest received and interest paid are presented as part of cash flows from financing activities I. Equity Incremental costs directly attributable to an expected issuance of an instrument that will be classified as equity are recognized as an asset in deferred expenses in the statement of financial position. The costs are deducted from the equity upon the initial recognition of the equity instruments, or are expensed as financing expenses in the statement of operations when the issuance is no longer expected to take place. J. Issuance of units of securities The consideration received from the issuance of units of securities is attributed initially to financial liabilities that are measured each period at fair value through profit or loss, and then to financial liabilities that are measured only upon initial recognition at fair value. The remaining amount is the value of the equity component. Direct issuance costs are attributed to the specific securities in respect of which they were incurred, whereas joint issuance costs are attributed to the securities on a proportionate basis according to the allocation of the consideration from the issuance of the units, as described above. K. Employee benefits The Group has a number of post-employment benefit plans. The plans are usually financed by deposits with insurance companies or with funds managed by a trustee, and they are classified as defined contribution plans and as defined benefit plans. A defined contribution plan is a post-employment benefit plan under which an entity pays fixed contributions into a separate entity and has no legal or constructive obligation to pay further amounts. Obligations for contributions to defined contribution pension plans are recognized as an expense in profit or loss in the periods during which related services are rendered by employees. F-12 Notes to the Consolidated Financial Statements Note 3 - Significant Accounting Policies (continued) Other long-term employee benefits The Group’s net obligation in respect of long-term employee benefits other than pension plans is the amount of future benefit that employees have earned in return for their service in the current and prior periods; that benefit is discounted to determine its present value, and the fair value of any related assets is deducted Kitov Pharmaceuticals Holdings Ltd. Note 4 - Cash and Cash Equivalents Balance in USD Balance in other currencies Total cash Note 5 - Other Receivables Government authorities – mainly VAT Prepaid expenses Total receivables Note 6 - Subsidiary As of December 31 2015 2016 USD thousands 4,980 1,778 6,758 10,199 359 10,558 As of December 31 2015 2016 USD thousands 151 90 241 124 122 246 The following is condensed information regarding the subsidiary directly held by the Company: Incorporated and operates in Israel Group’s ownership equity Company’s direct ownership of equity Amounts provided by the Company to the subsidiary Guarantees USD thousands Loans Total investment in subsidiary Kitov Pharmaceuticals Ltd. Israel 100% 100% 13,157 - (13,918) F-13 Notes to the Consolidated Financial Statements Note 7- Other Payables Due to related parties (note 10) Accrued expenses Payroll related payables Note 8 - Equity A. The Company’s share capital Ordinary shares, no par value Class A preferred shares, no par value Class B preferred shares, no par value Class C preferred shares, no par value Class D preferred shares, no par value Class E preferred shares, no par value B. Changes in share capital during the year Kitov Pharmaceuticals Holdings Ltd. As of December 31 2015 2016 USD thousands 548 76 134 758 549 123 32 704 As of December 31, 2016 As of December 31, 2015 Authorized Number of shares thousand Issued and paid-in Authorized Issued and paid-in 5,000,000 2,000 2,000 2,000 2,000 2,000 153,237 - - - - - 500,000 77,756 - - - - - - - - - - For the year ended December 31 Number of shares thousand 2015 2016 2014 Issued as at January 1 Issuance of ADSs Issuance of shares Share issuance deriving from a strategic cooperation agreement (see note 11) Share issuance due to meeting of milestone Share based payments Exercise of warrants Exercise of options Issued as at December 31 F-14 77,756 47,576 - 3,010 - 669 24,226 - 5,972 63,178 6,388 597 1,379 - 242 - 2,011 - 3,760 158 - - 43 153,237 77,756 5,972 Notes to the Consolidated Financial Statements Note 8 - Equity (continued) C. Financing rounds during the year Kitov Pharmaceuticals Holdings Ltd. 1. In July 2016, in a public offering on the NASDAQ, the Company raised USD 12 million (approximately $10.0 million net of placement agent fees and other offering related expenses). In the public offering the Company issued securities as follows: (i) 2,378,823 Class A units - comprised of 2,378,823 ADSs and 2,378,823 Series A warrants to purchase 2,378,823 ADSs, and (ii) 1,150,589 Class B units - comprised of 1,150,589 prefunded Series B warrants to purchase 1,150,589 ADSs and 1,150,589 Series A warrants to purchase 1,150,589 ADSs. The July 2016 public offering was completed at a price of USD 3.40 per unit. Each Series A warrant is exercisable through November 25, 2020 for an exercise price of USD 3.78, as adjusted following the July 2016 offering. All of the Series B warrants had been exercised by August 31, 2016 for an exercise price of USD 0.01 per ADS. In addition, the Company granted representatives of the placement agent non-traded warrants to purchase up to 141,176 ADSs for an exercise price of USD 4.08. 2. In November 2015, in a public offering on the NASDAQ, the Company raised USD 13.0 million, (approximately USD 10.6 million after deduction of underwriters’ commissions and public offering related expenses). On November 20, 2015, the Company’s ADSs and warrants commenced trading on the NASDAQ under the symbols KTOV and KTOVW, respectively. The public offering was completed on November 25, 2015. In the November 2015 public offering the Company issued 3,158,900 ADSs and 3,158,900 Series A warrants to purchase 3,158,900 ADSs. Each ADS represents 20 ordinary shares with no par value. Each warrant enables the purchase of 1 ADS. The public offering was completed at a price of USD 4.13 for a unit of 1 ADS and 1 warrant. Each warrant is exercisable for a period of 5 years for an initial exercise price of USD 4.13, which has since been adjusted to USD 3.78 (see note C.1. above). In addition, the Company granted the underwriters the right to sell within 45 days up to 473,835 ADSs and/or 473,835 Series A warrants at the same terms as the public offering (of which the underwriters exercised the right to sell 220,074 warrants). The Company also granted the underwriters non-traded warrants to purchase up to 157,945 ADSs for an exercise price of USD 4.956. D. Other equity transactions during the year 1. During the year, the Company issued 669,100 shares to service providers for services granted. The fair value of the shares was measured at the fair value of the services, and amounted to USD 103 thousand. 2. In May 2016 the Company issued 3,009,888 shares to Dexcel Ltd. following meeting a milestone in accordance with the agreement between the Company and Dexcel Ltd. The fair value of the shares was USD 500 thousand. 3. During the year the Company issued 1,214,340 shares derived from the exercise of Series A warrants, for proceeds of USD 302 thousand. F-15 Notes to the Consolidated Financial Statements Note 9 - Share-based Payment Arrangements Kitov Pharmaceuticals Holdings Ltd. A. In February 2015, the Company’s board of directors decided to grant 44,786 options to two consultants in return for their services. The options are exercisable into 44,786 shares for an exercise price of NIS 4.00 for a period of 24 months. The options vested immediately on the grant date, May 14, 2015. The fair value of these options at the date of granting was measured at USD 31 thousand. In May 2016 and June 2016, the Company granted 7,281,370 options to the chairman of board of directors, chief executive officer, chief financial officer, senior employees and a service provider. Each option may be exercised into one ordinary share, at an exercise price of NIS 0.7884 ($0.205) per share over a vesting period of 3 years. The exercise period is 8 years from date of issuance provided, however that with respect to 5,957,485 thousand of the options granted to directors of the Company, no options are exercisable prior to the Company’s adoption of a revised compensation policy in accordance with the Companies Law. In June 2016, the Company approved the future grant of options to the chairman of the board of directors in order to maintain a number of options reflecting a certain percentage of holdings in the Company, subject to certain conditions as determined by the board of directors. Accordingly, an additional 2,468,759 options were granted. The fair value of these options at the date of the grant was measured at USD 680 thousand. B. Other share based payment arrangements See note 11 with regard to share based payments to a strategic cooperation service provider, and note 8D with regards to share based payments to service providers. C. The number and weighted average exercise prices (in NIS) of share options are as follows: Weighted average exercise price 2015 2016 2014 Outstanding at January 1 Expired during the year Exercised during the year Granted during the year Outstanding at December 31 Exercisable at December 31 0.81 0.81 - 0.79 0.83 0.96 0.78 0.80 - 4.00 0.81 0.83 2016 3,510,729 0.46 2,865,943 - - 0.21 9,750,129 0.80 0.78 10,394,915 2,269,808 0.54 Number of options 2015 3,872,359 406,416 - 44,786 3,510,729 3,285,729 2014 1,819,475 - 567,949 2,620,833 3,872,359 2,977,068 The options outstanding at December 31, 2016 had an exercise price in the range of NIS 0.79 – NIS 4 (2015 - NIS 0.65 – NIS 4), and weighted average contractual life of 7.7 years (2015 – 2.9 years). F-16 Notes to the Consolidated Financial Statements Note 9 - Share-based Payment Arrangements (continued) D. Options to service providers were measured at the fair value of the service, when available. The fair value of the Company’s share options granted to employees, directors and service providers, where fair value of service was not measurable, was estimated using the fair value of the traded warrants with similar terms, making some adjustments to reflect the specific terms of the options based on the expected duration. For 2014 grants, the fair value was estimated using the Black Scholes model. The following assumptions were used: Kitov Pharmaceuticals Holdings Ltd. Share Price - NIS Warrant price - USD Expected volatility (%) Expected duration (years) Dividend yield (%) Risk free rate interest rate (%) E. Expenses recognized in the financial statements: 2016 2015 2014 0.21-0.26 1.07-1.42 - 4-8 0 N/A - - - - - - 0.52 - 0.60 - 56 -115 4-10 0 0.75 - 3 2016 For the year ended December 31 2015 USD thousands 2014 Total share-based expense recognized 400 59 88 Note 10 - Transactions and Balances with Related Parties A. Related party balances are included in the balance sheet under the following items: Other payables Post-employment benefit liabilities B. The statement of operations includes amounts referring to transactions with related parties, as follows: As of December 31 2015 2016 USD thousands 548 227 549 185 General and administrative expenses Research and development expenses Interest and linkage expenses 781 652 - 552 321 - 477 - 6 F-17 2016 For the year ended December 31 2015 USD thousands 2014 Notes to the Consolidated Financial Statements Note 10 - Transactions and Balances with Related Parties (continued) Kitov Pharmaceuticals Holdings Ltd. C. The statement of changes in equity for the years ended December 31, 2016 and 2015 includes amounts referring to transactions with related parties of USD 363 thousand and USD 526 thousand, respectively, which are included in the issuance costs of the ADSs. See also note 11C. D. Service agreements with related parties 1. Agreement for consulting services with a company owned by Dr. Paul Waymack, commencing January 2016 is USD 20 thousand monthly. 2. Agreement with Mr. Simcha Rock for his full time services to the Company as the Company’s CFO. The monthly payment is NIS 50 thousand (USD 13 thousand). 3. Up until May 2016, Mr. Israel’s basic salary was NIS 40 thousand per month (USD 10 thousand) and linked to the Consumer Price Index. Since May 2016 Mr. Israel is employed as a service provider. The monthly payment is NIS 68 thousand (USD 18 thousand). In addition, Dr. Waymack, Mr. Rock, and Mr. Israel are entitled to annual and special bonuses, as well as retirement grants see Note 11.C and D. E. The Company made payments to key management: 2016 For the year ended December 31 2015 USD thousands 2014 Short - term employee benefits Post-employment benefits Share based payments Note 11 - Commitments and contingent liabilities 1,336 25 244 1,605 1,207 185 7 1,399 443 - 47 490 A. In April 2014, the Company signed a strategic cooperation agreement with Dexcel Ltd. (hereinafter: “Dexcel”), including for formulation development services for the drug KIT-302 (hereinafter: “the drug”), the right to negotiate the commercial manufacture of the drug, and the right to negotiate the marketing of the drug. In consideration for the services provided by Dexcel, the Company paid USD 2 million in 4 equal USD 0.5 million payments, and USD 1.5 million worth of shares in 3 tranches of USD 0.5 million each. The first tranche of 157,783 shares was issued at a price of NIS 11.05 per share, the second tranche of 597,511 shares was issued in May 2015 at a price of NIS 3.359 per share, and the final tranche of 3,009,888 shares was issued in June 2016 at a price per share of NIS 0.63. Dexcel paid the Company USD 0.5 million in 2 payments upon completion of milestones, for the right to negotiate the global marketing rights and the commercial manufacturing of the drug. The first payment was received in May 2015, and the second payment was paid in June 2016. Payments made to Dexcel, net of receipts from Dexcel, were charged to research and development expenses based on milestones achieved. F-18 Notes to the Consolidated Financial Statements Note 11 - Commitments and contingent liabilities (continued) Kitov Pharmaceuticals Holdings Ltd. The intellectual property (hereinafter -“IP”) owned by the Company prior to this agreement will continue to be owned by the Company. Dexcel was granted the right to use the Company’s IP for the purpose of development of the drug. Any IP developed in the process of the drug’s development and manufacturing will be owned jointly by the Company and Dexcel, and the Company and Dexcel will give each other the right to use this IP. In addition, any IP developed by Dexcel in the process of the drug’s development and manufacturing, and which is not under the joint IP, will be owned by Dexcel, and Dexcel will give the Company the right to use it in connection with the drug. B. The Company has an annual commitment under a lease agreement for its office premises of approximately NIS 240 thousand per year (approximately USD 62 thousand) through the end of 2019. C. The Company’s Chairman of the Board, Chief Executive Officer, and Chief Financial Officer are entitled to annual and special bonuses under the terms of their employment and consulting agreements. These bonuses will become due upon the achievement of certain milestones, including fund raising, merger transactions, and agreements for the commercialization of the Company’s products. These financial statements include bonuses in the amount of USD 848 thousand for the year ended December 31, 2016, and USD 599 thousand for the year ended December 31, 2015, of which USD 363 thousand and USD 526 thousand, respectively, are included in the statement of changes in equity as part of issuance costs of ADSs, see note 17. D. The Company’s Chairman of the Board, Chief Executive Officer, and Chief Financial Officer are entitled to retirement grants under the terms of their employment and consulting agreements. These grants are measured based on the time of service and their monthly pay. These financial statements include a liability due to these grants of USD 256 thousand and USD 185 thousand, as of December 31, 2016 and 2015. E. In December 2015, a lawsuit and a motion to approve such lawsuit as a class action was filed against the Company and its directors by shareholders who were holding the Company’s Tel Aviv Stock Exchange listed securities before the offering mentioned in note 8C5, claiming damages for the purported class in the motion totaling NIS 16.4 million (USD 4.3 million) due to the said offering. The Company has delivered its response to the court in accordance with applicable law, and a preliminary hearing was held by the court on September 12, 2016. At that hearing the court determined that certain claims of the petitioners in connection with alleged personal interests by affiliates of the Company in connection with the public offering of our initial public offering of our securities in the U.S. during November 2015 are not part of the grounds for the Motion and no remedies shall be sought by the petitioners in connection therewith. The court set a schedule for the submission by the petitioners of a motion for discovery, and any responses to such motion. An additional preliminary hearing was held on February 7, 2017. At that hearing the court ruled on the scope of the petitioners’ motion for discovery, and pursuant to such ruling the Company delivered to the petitioners (subject to signing confidentiality undertakings) certain protocols of the board of directors of the Company. An additional preliminary hearing was scheduled for April 27, 2017. On November 8, 2016, a shareholder of the Company submitted a request to the court in connection with the Motion to be excluded from the Purported Class and claiming to have independent causes of action and claims of approximately NIS 1 million (the “Petition to Exclude”). The Company responded to the court as required, and, amongst other arguments, the Company noted that pursuant to the Class Action Lawsuits Law 5766-2006 and the Regulations enacted thereunder, at the current stage of the court proceedings with respect to the Motion, such shareholder cannot petition to be excluded from the Purported Class. The court ordered the shareholder to respond to its response and he has done so. The shareholder has not submitted any independent lawsuit against the Company, and the Company is of the view that such shareholder’s claims are identical to the asserted claims for damages in the Motion. F-19 Notes to the Consolidated Financial Statements Note 11 - Commitments and contingent liabilities (continued) Kitov Pharmaceuticals Holdings Ltd. The Company’s management rejects the claims asserted in the Motion as well as in the Petition to Exclude, and, in consultation with its legal advisors, believes that the likelihood of the company not incurring any financial obligation as a result of this class action exceeds the likelihood that the company will incur a financial obligation. Therefore, no provision for this matter was recorded in these financial statements. F. In February 2017 the Company announced that the Israeli Securities Authority has begun a formal investigation into, amongst other matters, the Company’s public disclosures in connection with the Data Monitoring Committee (DMC) appointed in connection with the Company’s Phase III trial of KIT-302, the results of which were announced in December 2015, and what information regarding the DMC was disclosed publicly by Kitov. A DMC is generally an external independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing, and in the case of the KIT-302 Phase III clinical trial was established in order to analyze the preliminary results of the initial patient group enrolled in the clinical trial and determine the number of additional patients, if any, that Kitov might have needed to recruit in order to demonstrate statistical validity, and to meet the primary end point of the clinical trial. In February 2017, four lawsuits and motions to approve the lawsuits as a class action lawsuit (each, a “Motion”), were filed against the Company and certain of its office holders at the Tel Aviv District Court (Economic Division), and served on the Company, with each Motion relating to the above noted formal investigation by the Israeli Securities Authority (ISA) into the Company’s public disclosures. The Motions were filed against the Company and various former and present officers of the Company, on behalf of shareholders of the Company who are requesting to act as representative of all shareholders of record during various periods of time from December 10, 2015 until February 6, 2017. The plaintiffs in the various Motions allege, among other things, that the Company included misleading information in its public filings, which caused the class for which the plaintiffs are seeking recognition an aggregate loss ranging between NIS 25,545,206 (approximately US$ 6,818,000) and NIS 36,525,592 (approximately US$ 9,748,000). The petitioners in one of the above noted Motions has motioned to the court to dismiss the other 3 Motions. The court has granted the petitioners in the other 3 Motions, as well as the Company and the other defendants, until March 28, 2017 to respond to this motion to dismiss the other 3 Motions. On February 7, 2017, a holder the Company’s securities listed on the NASDAQ filed in the United States District Court (Southern District of New York), a federal securities class action against the Company, its CEO and CFO, seeking unspecified damages and relief in connection with, amongst other things, damages alleged to have occurred due to the purchasers of the Company’s securities in the Company’s initial public offering in the USA on November 20, 2015, as well as in open market purchases, as a result of the Company allegedly including misleading information in its public filings. This lawsuit was served on the Company’s agent for service in the USA on March 22, 2017. An initial pretrial conference has been scheduled by the court for March 30, 2017. On February 10, 2017, a holder the Company’s securities listed on the NASDAQ filed in the Superior Court of the State of California, a securities class action against the Company, its CEO and CFO and the underwriters in the Company’s initial public offering in the USA on November 20, 2015, seeking unspecified damages and relief in connection with, amongst other things, damages alleged to have occurred due to the purchasers of the Company’s securities in such public offering as a result of the Company allegedly including misleading information in its public filings. This lawsuit was served on the Company’s agent for service in the USA on March 3, 2017. A case management conference has been scheduled by the court for June 9, 2017. F-20 Kitov Pharmaceuticals Holdings Ltd. Notes to the Consolidated Financial Statements Note 11 - Commitments and contingent liabilities (continued) On March 20, 2017, a holder the Company’s securities listed on the NASDAQ filed in the Superior Court of the State of California, a securities class action against the Company, its CEO and CFO and the underwriters in the Company’s initial public offering in the USA on November 20, 2015, seeking unspecified damages and relief in connection with, amongst other things, damages alleged to have occurred due to the purchasers of the Company’s securities in such public offering as a result of the Company allegedly including misleading information in its public filings. This lawsuit has not yet been served on the Company’s agent for service in the USA. A case management conference has been scheduled by the court for July 26, 2017. The Company’s management rejects the claims in all of the aforesaid Motions and class action lawsuits. At this preliminary stage the Company is unable, with any degree of certainty, to make any evaluations or any assessments with respect to the Motions’ and/or lawsuits in the U.S.A. and in Israel as to the probability of success or the scope of potential exposure, if any. Therefore, no provision for this matter was recorded in these financial statements. Note 12 - Research and Development Expenses Research and development expenses include consulting expenses for development of drug formulation and for non-clinical, clinical, regulatory and project management work required for the Company’s drug portfolio. Note 13 - General and Administrative Expenses 2016 For the year ended December 31 2015 USD thousands 2014 Employee and officer compensation including share-based payment, see also Note 9) Professional consulting Board member remuneration and insurance Rent and office maintenance Travel Car expenses Depreciation Other 1,252 1,143 155 94 99 42 2 216 541 728 67 95 13 27 1 37 523 532 54 52 - - 108 3,003 1,509 1,269 F-21 Notes to the Consolidated Financial Statements Note 14 - Other Expense As part of the Acquisition, Haiku, a wholly owned company of the controlling shareholder at the time of the transaction, was eligible to receive, out of all funds raised by the Company in one or multiple transactions, an amount of up to NIS 2,500 thousand. Following the share issuance described in Note 8C1, an amount of NIS 2,500 thousand (USD 720 thousand) was paid to Haiku. This amount was recorded as other expenses in 2014. Kitov Pharmaceuticals Holdings Ltd. Note 15 - Finance Expense (Income) Change in fair value of derivatives Expenses * Income Net change in fair value of derivatives 2016 For the year ended December 31 2015 USD thousands 2014 5,160 (141) 5,019 - (94) (94) - (274) (274) * This expense related to the fair value adjustments of the Series A warrants. The warrants include an anti-dilution provision whereby the exercise price of the Series A warrants are subject to “weighted average” ratchet anti-dilution provision, so that upon future issuance of the Company’s ADSs or an equivalent number of ordinary shares, subject to specified exceptions, at a price less than the exercise price then in effect, the exercise price will be reduced. The ratchet expired on November 25, 2016. 2016 For the year ended December 31 2015 USD thousands 2014 Finance expense Fees and interest expense Loss from exchange rate differences, net Credit allocation fee ** Warrant issuance costs 6 55 - - 61 3 79 141 4 227 21 216 83 25 345 ** In August 2015 the Company entered into loan agreements with several third parties (the “Lenders”) pursuant to which, they extended the Company loans of USD 430 thousand. The loans were repaid in November 2015 with an addition of credit allocation fees in the amount of $141 thousand. Finance income Interest income from short term deposits 138 - - F-22 2016 For the year ended December 31 2015 USD thousands 2014 Kitov Pharmaceuticals Holdings Ltd. Notes to the Consolidated Financial Statements Note 16 - Taxes on Income A. Corporate tax rate The tax rate applicable to the Company for 2016 is 25%. The tax rate in 2017 is expected to be 24%. B. The Company and its subsidiary incurred losses in 2016, as well as carry-forward losses from previous years, which are not expected to be utilized in the foreseeable future. Therefore the Group companies did not record current taxes or deferred taxes. The carry-forward loss for tax purposes for the Company and its subsidiary, and the unrecognized deferred taxes from research and development expenses, amounts to USD 13.2 million as of December 31, 2016 (2015 – USD 9 million, 2014 – USD 5 million). C. The Company’s 2012 tax assessment is deemed finalized, pursuant to section 145 of the Income Tax Ordinance. The subsidiary’s 2011 tax assessment is deemed finalized, pursuant to section 145 of the Income Tax Ordinance. Note 17 - Employee benefits A. Employee benefits include post-employment benefits and short term benefits. Post-employment benefits are part of key management compensation – see note 10 on related and interested parties. Balances include: Short-term benefits Post-employment benefits B. Post-employment benefit plans – defined contribution plan December 31. 2016 USD thousands 2015 USD thousands 670 256 556 185 The Company has a defined contribution plan in respect of the Company’s liability in respect of its employees who are subject to Section 14 of the Severance Pay Law – 1963. Year ended December 31 2015 USD thousands 2016 USD thousands 2014 USD thousands Amount recognized as general and administrative expense in respect of defined contribution plan 39 25 3 F-23 Kitov Pharmaceuticals Holdings Ltd. Notes to the Consolidated Financial Statements Note 18 - Financial Instruments Cash and cash equivalents and short term deposits The Group held cash and cash equivalents and short term deposits of USD 14,657 thousand at December 31, 2016 (2015 – USD 10,558). These are held with banks, which are rated A2, based on Moody’s Rating Agency ratings. The short term deposits, mainly in USD, bear fixed interest ranging between 1.58% - 2.7%. The carrying amount of cash and cash equivalents and short term deposits approximate their fair value. Note 19 - Subsequent Events On January 12, 2017 the Company acquired a controlling equity stake in TyrNovo Ltd. from its majority shareholder, for consideration of USD 2 million in cash and 11,292,508 ordinary shares of Kitov, equivalent to USD 1.8 million based on the closing price of the Company’s shares on the TASE on January 11, 2017. TyrNovo, a privately held developer of novel small molecules in the immuno-oncology therapeutic field, is developing NT219, a small molecule that has demonstrated the potential to overcome resistance to multiple anti-cancer drugs. It presents a new concept in cancer therapy by promoting the degradation signal proteins, Insulin Receptor Substrates (IRS) 1 and 2 as well as the inhibition of signal transducer and activator of transcription 3 (STAT3), extensively blocking major oncogenic pathways, which are highly involved in anti-cancer drug resistance. On February 9, 2017, the Company, TyrNovo and Taoz entered into a settlement arrangement in response to a motion filed on January 19, 2017 by Taoz - Company for Management and Holdings of Companies Ltd., a shareholder owning approximately 3% of TyrNovo. Among other terms, these agreements include an undertaking by the Company to finance any future working capital requirement of TyrNovo, up to an amount of USD 1 million, provided by way of Convertible Loan. As of March 20, 2017 the Company had placed loans of USD 750,000. F-24 STOCK PURCHASE AGREEMENT Exhibit 2.8 This Stock Purchase Agreement (this “Agreement”) is entered into as of January 12, 2017, by and among Kitov Pharmaceuticals Holdings Ltd., an Israeli publicly traded corporation (“Parent”), on behalf of itself and, if Parent is not the buyer hereunder, also on behalf of an as yet undetermined Affiliated party of Parent which shall join this Agreement subsequent to the Closing (“Buyer”), and Goldman Hirsh Partners Ltd. (the “Seller”) which is a stockholder of Tyrovo Ltd., an Israeli private corporation (the “Company”). Parent, Buyer and Seller are sometimes referred to individually herein as a “Party” and collectively as the “Parties.” RECITALS A. Seller owns beneficially and of record 9,570 issued and outstanding shares of capital stock of the Company, (the “Shares”). B. This Agreement contemplates a transaction, in which Buyer will purchase from Seller, and Seller will sell to Buyer, the Shares in return for the cash and equity based consideration and other obligations set forth below and in the agreements and undertakings annexed hereto. NOW, THEREFORE, in consideration of the premises and the mutual promises herein made, and in consideration of the agreements, representations, warranties and covenants herein contained, the Parties agree as follows. ARTICLE 1 DEFINITIONS 1.1 For purposes of this Agreement, the following terms have the meanings specified: “Acquisition Transaction” means any transaction or series of transactions involving: (a) the sale, license or disposition of all or a material portion of any of the Company’s business, properties or assets, other than sales in the Ordinary Course of Business; (b) the issuance, disposition or acquisition of: (i) any shares or other equity security of any of the Company (other than pursuant to the exercise of outstanding options or warrants in according with their terms); (ii) any option, call, warrant or right (whether or not immediately exercisable) to acquire any shares, unit or other equity security of any of the Company; or (iii) any security, instrument or obligation that is or may become convertible into or exchangeable for any shares, unit or other equity security of any of the Company; (c) any merger, consolidation, business combination, reorganization or similar transaction involving any of the Company; (d) any engagement of all or substantially all of the Service Providers, consultants and contractors of the Company; or (e) any joint venture or other strategic investment in or involving the Company (other than an ongoing commercial or strategic relationship in the ordinary course of business). 1 “Affiliate” means any Person that directly or indirectly controls, is controlled by, or is in common control with, any other Person. For purposes of the preceding sentence, “control’ means possession, directly or indirectly, of the power to direct or cause direction of management and policies through ownership of voting securities, contract, voting trust or otherwise. “CERCLA” means the Comprehensive Environmental Response, Compensation, and Liability Act of 1980, as amended. “Code” means the Internal Revenue Code of 1986, as amended. “Confidential Information” means all information of a confidential or proprietary nature (whether or not specifically labeled or identified as “confidential”), in any form or medium, of the Company, Buyer or Parent or its customers, suppliers, distributors or other business relations, including all information concerning finances, customer information, supplier information, products, services, prices, organizational structure and internal practices, forecasts, sales and other financial results, records and budgets, and business, marketing, development, sales and other commercial strategies, unpatented inventions, ideas, methods and discoveries, trade secrets, know-how, unpublished patent applications and other confidential intellectual property, designs, specifications, documentation, components, source code, object code, schematics, drawings, protocols and processes. “Damages” means all penalties, fines, costs, Liabilities, obligations, Taxes, losses, expenses and fees, including court costs and reasonable attorneys’ fees and expenses. “Environmental Laws” means any Israeli, US federal, state, or local statute, law, ordinance, code, order, injunction, decree, ruling or regulations which regulate or control pollution or protection of the environment, including laws relating to emissions, discharges or releases of Hazardous Substances into ambient air, surface water, ground water or lands or relating to the treatment, storage, disposal, transport or handling of Hazardous Substances. “Escrow Agent” means an independent third party escrow agent mutually acceptable to the Buyer and the Seller. “Escrow Agreement” means the Escrow Agreement, dated as of the Closing Date among the Seller, Seller Trustee, Parent, Buyer and the Escrow Agent, in the form attached hereto as Exhibit A. “Escrow Amount” means (i) $1,200,000 of the Cash Consideration; and, (ii) all of the Consideration Shares. “Escrow Fund” means, at any given time after the Closing, the Escrow Amount, as such amount may be decreased as provided in this Agreement. “Excess Company Closing Liabilities Amount” means any portion of the Company Closing Liabilities in excess of $380,000. 2 “Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder. "Expiration Date" a date which is 12 months from Closing date. “FDA” means the United States Food and Drug Administration. “Fundamental Representations” means, any of the representations, warranties and/or covenants contained in: (i) the entire ARTICLE 3; (ii) Sections 4.1 through 4.3, 4.7 through 4.9, 4.11, 4.14, and 4.18; and, (iii) Sections 5.1through 5.5, 5.7, 5.13, 5.15, and 5.16. “GAAP” means either U.S. or Israeli generally accepted accounting principles, or International Financial Reporting Standards, consistently applied. “Governing Documents” means, as to any Person, the articles of incorporation or certificate of incorporation and code of regulations and/or bylaws (if such Person is a corporation); the partnership agreement and partnership certificate (if such Person is a partnership); or the articles of organization and operating agreement (if such Person is a limited liability company); and other documents relating to and establishing or governing the existence and legal operation of such Person, of any type or nature, each as amended to date. “Government Approval” means any (a) necessary filings, notifications, registrations, applications, declarations and submissions in connection with the transactions contemplated under the Transaction Documents, as required under any applicable Law and (b) consents, Permits or Orders from a Governmental Authority required to be obtained or made by the Seller or the Buyer or any of their respective Affiliates to execute, deliver and perform their respective obligations under the Transaction Documents and consummate the transactions contemplated thereunder. “Governmental Authority” means any court, tribunal, arbitrator, authority, agency, commission, bureau, board, department, official, body or other instrumentality of the United States, Israel, or any foreign country, or any domestic or foreign state, province, county, city, other political subdivision or any other similar body or organization exercising governmental or quasi-governmental power or authority, including Regulatory Agencies. “Hazardous Substances” means any hazardous substance or hazardous waste, whether solid, semi-solid, liquid or gaseous, which are regulated, listed or controlled as such under any Environmental Laws. 3 “Indebtedness” means without duplication: (a) all obligations (including the principal amount thereof or, if applicable, the accreted amount thereof and the amount of accrued and unpaid interest thereon) of the Company, whether or not represented by bonds, debentures, notes or other securities (whether or not convertible into any other security), for the repayment of money borrowed, whether owing to banks or other financial institutions, on equipment leases or otherwise; (b) all deferred indebtedness of the Company for the payment of the purchase price of property or assets purchased (other than accounts payable incurred in the Ordinary Course of Business); (c) all obligations of the Company to pay rent or other amounts under a lease which is required to be classified as a capital lease on the face of a balance sheet prepared in accordance with GAAP (applied on a basis consistent with the basis on which the Audited Financial Statements were prepared and in accordance with the Company’s historic past practice); (d) all outstanding reimbursement obligations of the Company with respect to letters of credit, bankers’ acceptances or similar facilities issued for the account of the Company; (e) all obligations of the Company under any interest rate swap agreement, forward rate agreement, interest rate cap or collar agreement or other financial agreement or arrangement entered into for the purpose of limiting or managing interest rate risks; (f) all obligations secured by any Security Interest existing on property owned by the Company, whether or not indebtedness secured thereby will have been assumed; (g) all guaranties, endorsements, assumptions and other contingent obligations of the Company in respect of, or to purchase or to otherwise acquire, indebtedness of others; (h) all premiums, penalties, fees, expenses, breakage costs and change of control payments required to be paid or offered in respect of any of the foregoing on prepayment, as a result of the consummation of the transactions contemplated by the Agreement or in connection with any lender consent; and (i) all obligations of the Company, whether interest bearing or otherwise, owed to any security holder of the Company and/or any Affiliate of any security holder of the Company. “Intellectual Property” means, collectively, in the United States, Israel and all other countries or jurisdictions, (a) all inventions (whether patentable or unpatentable and whether or not reduced to practice), all improvements thereto, and all Patents, design rights and industrial designs (b) all Trademarks, all goodwill associated therewith, and all applications, registrations, and renewals in connection therewith, (c) all moral rights, copyrights and other rights in any work of authorship, compilation, derivative work or mask work and all applications, registrations, and renewals in connection therewith, (d) all Patents, (e) all trade secrets and confidential information (including confidential ideas, research and development, know-how, methods, formulas, compositions, manufacturing and production processes and techniques, technical and other data, designs, drawings, specifications, customer and supplier lists, pricing and cost information, and business and marketing plans and proposals), (f) Software, (g) works of authorship (whether or not copyrightable), copyrights and registrations and applications therefor, and all renewals, extensions, restorations and reversions thereof, including website content, product artwork, promotion and marketing materials, (h) all other proprietary or intellectual property rights, (i) all copies and tangible embodiments of any of the foregoing (in whatever form or medium), (j) the exclusive right to display, perform, reproduce, make, use, sell, distribute, import, export and create derivative works or improvements based on any of the foregoing and (k) all income, royalties, damages and payments related to any of the foregoing (including damages and payments for past, present or future infringements, misappropriations or other conflicts with any intellectual property), and the right to sue and recover for past, present or future infringements, misappropriations or other conflict with any intellectual property. “Israeli Securities Laws” means the Israeli Securities Law, 5728-1968, the rules and regulations promulgated under thereunder, and any listing rules and regulations of the TASE. 4 “Knowledge” means, when referring to the “knowledge” of the Seller, or any similar phrase or qualification based on knowledge of the Seller, (a) the actual knowledge of any Service Provider, employee, officer or person serving on the ultimate governing body (i.e., director of a corporation, manager of a limited liability company or other equivalent role) of the Company; and (b) the knowledge that any such Party referenced in clause (a) above, as a prudent business person, would have obtained after making due inquiry with respect to the particular matter in question. “Law” means the common law of any state or other jurisdiction, or any provision of any foreign, federal, state or local law, statute, code, rule, regulation, Order, certification standard, accreditation standard, Permit, judgment, regulatory code of practice, statutory guidance, injunction, decree or other decision of any court or other tribunal or Governmental Authority, including any Information Privacy and Security Law. “Liabilities” means any Indebtedness, liabilities, demands, commitments or obligations of any nature whatsoever, whether accrued or unaccrued, absolute or contingent, direct or indirect, asserted or unasserted, fixed or unfixed, known or unknown, choate or inchoate, perfected or unperfected, liquidated or unliquidated, secured or unsecured, or otherwise, whether due or to become due, whether arising out of any Contract or tort and whether or not the same would be required by GAAP to be stated in financial statements or disclosed in the notes thereto. “Liens” means all liens, security interests, claims, mortgages, deeds of trust, preemptive rights, leases, charges, options, rights of first refusal, easements, proxies, voting trusts or agreements, transfer restrictions, pledges, assessments, covenants, warrants, rights, calls, commitments or other contract rights, burdens and other encumbrances of every kind, including restrictions on voting or use. “Losses” means any and all Liabilities, losses, damages, judgments, awards, settlements, royalties, diminution in value, interest, penalties, fines, Taxes, demands, Proceedings, claims, deficiencies, costs and expenses of any kind (including reasonable fees and expenses of attorneys, accountants and other experts paid in connection with the investigation or defense of any of the foregoing or any Proceeding relating to any of the foregoing). “Material Adverse Effect” means any change, event, effect, claim, circumstance or matter (each, an “Effect”) that (considered together with all other Effects) is, or could reasonably be expected to be or to become, materially adverse to: (a) the business, condition, assets, capitalization, Intellectual Property, Liabilities, operations, results of operations or financial performance of the Company taken as a whole; (b) Buyer’s right to own, or to freely dispose of (subject to any limitations on transfer in existence as of the date of the Closing and disclosed herein by the Seller), or to receive dividends or other distributions with respect to, the shares of the Company; or (c) the ability of the Company or the Seller to perform any of their material covenants or obligations under this Agreement or under any other contract or instrument executed, delivered or entered into in connection with any of the transactions contemplated by this Agreement such that any such inability to perform would impair the ability of Seller to consummate the transactions contemplated hereby. “Ordinary Course of Business” means the ordinary course of business consistent with past custom and practice of the Company. 5 “Order” means any order, judgment, ruling, injunction, award, stipulation, assessment, decree or writ, whether preliminary or final, of any Governmental Authority. “Patents” means all patent disclosures, patent applications and patents and all registrations, continuations, continuations-in-part, divisionals, re- examinations, renewals, extensions and reissues and counterparts thereof of the United States and all countries and jurisdictions foreign thereto and all reissues, reexamined patents, divisions, continuations, continuations-in-part, revisions, and extensions thereof. “Person” means any individual, sole proprietorship, partnership, limited liability company, joint venture, trust, unincorporated association, corporation, firm or other entity or any Governmental Authority. “Personal Information” means any information subject to applicable Law or Orders relating to privacy or data protection, including information included in the definition of “Information” under the Israeli Privacy Protection Law, 1981, and applicable Israeli judicial precedent or guidelines or directives issued by the Israeli Law, Information and Technology Authority defining such term; any “personal data,” as defined by the European Union Data Protection Directive and any national Law implementing such directive, a natural person’s name, street address, telephone number, age, e-mail address, unique device or browser identifier, photograph, cultural or social identity, social security number, driver’s license number, alien registration number, passport number, medical history, or customer or account number, private affairs, personality, personal status, persistent identifier, device identifier or any other piece of information that allows the identification of a natural person, which will include “personal health information,” and “personal financial information” each as defined by applicable Law. “Post-Closing Parent Corporate Governance Agreements” means the individual agreements to be entered into at Closing by Seller with Parent covering corporate governance arrangements, including relationships between shareholders and/or management and other shareholder and corporate governance matters in the form attached hereto as Exhibit B. “Privacy Policy” means each external or internal, past or present privacy policy of the Company, including any policy relating to: (a) the privacy of users of any website or mobile application of the Company; (b) the collection, use, storage, disclosure, and transfer of any User Data or Personal Information; and (c) any employee information. “Products” means the products of the Company as of the Closing all set forth on Exhibit C attached hereto. “Proceeding” means any suit, action, cause of action, litigation, hearing, inquiry, examination, demand, proceeding, controversy, complaint, appeal, notice of violation, citation, summons, subpoena, arbitration, mediation, dispute, claim, investigation or audit of any nature whether civil, criminal, administrative, regulatory or otherwise and whether at Law or in equity. “Related Party” means each officer or director of the applicable Person and its Affiliates, each family member of any director or officer of the applicable Person and its Affiliates, each trust for the benefit of any of the foregoing, and each Affiliate of any of the foregoing. 6 “Security Interest” means any mortgage, pledge, lien, encumbrance, charge or other security interest, other than (a) mechanic’s and similar liens, (b) liens for Taxes not yet due and payable or for Taxes that the taxpayer is contesting in good faith through appropriate proceedings, (c) purchase money liens and liens securing rental payments under capital lease arrangements, and (d) other liens arising in the Ordinary Course of Business and not incurred in connection with the borrowing of money. “Securities Act” means the United States Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder. “Securities Laws” means the Securities Act, the Exchange Act and the Israeli Securities Laws. “Service Provider” means each director, officer, employee, manager, independent contractor, consultant, leased employee, or other service provider of the applicable Person. “Yissum” means Yissum Research Development Company of the Hebrew University of Jerusalem Ltd. “Yissum License” means that certain License Agreement between Yissum and the Company dated August 12, 2013. “Software” means all Internet domain names and websites, (including top level domain names and global top level domain names) and social media identifiers, handles and tags, computer software and firmware (including source code, executable code, data, databases, user interfaces and related documentation). “Subsidiary” means, with respect to any Person, any corporation, limited liability company, partnership, association or business entity of which a majority of the total voting power or control of such entity is at the time owned or controlled, directly or indirectly, by that Person or one or more of the other Subsidiaries of that Person or a combination thereof. “TASE” means the Tel Aviv Stock Exchange. “Tax” means any and all multi-national, U.S. Israeli, federal, state, local, or foreign income, gross receipts, franchise, estimated, alternative minimum, add-on minimum, sales, use, transfer, registration, value added, excise, natural resources, entertainment, amusement, severance, stamp, occupation, premium, windfall profit, environmental, customs, duties, real property, personal property, ad valorem, capital stock, social security, unemployment, disability, payroll, license, employee or other withholding, composite, healthcare (whether or not considered a tax under applicable Law), escheat or unclaimed property (whether or not considered a tax under applicable Law) or other tax, of any kind whatsoever, including any interest inflation indexation, linkage differentials, penalties or additions to Tax, any penalties resulting from any failure to file or timely file a Tax Return, or additional amounts in respect of the foregoing; the foregoing will include any transferee or secondary liability for a Tax and any liability assumed by agreement or arising as a result of being (or ceasing to be) a member of any Affiliated Group (or being included (or required to be included) in any Tax Return relating thereto). 7 “Tax Returns” means returns, declarations, reports, notices, forms, claims for refund, information returns or other documents (including any related or supporting schedules, statements or information) filed or required to be filed with any Governmental Authority, or maintained by any Person, or required to be maintained by any Person, in connection with the determination, assessment or collection of any Tax of any Party or the administration of any Laws, regulations or administrative requirements relating to any Tax. “Third Party Fee” means $250,000 + VAT paid to Lior Tamar Investments Ltd. (the “Seller Agent”) by, or on behalf of, the Seller. “Trademarks” means, in the United States and all countries and jurisdictions foreign thereto, registered trademarks, registered service marks, trademark and service mark applications, unregistered trademarks and service marks, registered trade names and unregistered trade names, corporate names, fictitious names, registered trade dress and unregistered trade dress, logos, slogans, Internet domain names, rights in telephone numbers, and other indicia of source, origin, endorsement, sponsorship or certification, together with all translations, adaptations, derivations, combinations and renewals thereof. “Transaction Documents” means (i) this Agreement and all exhibits and schedules hereto, and (ii) any other documents or agreements executed in connection with the transactions contemplated hereunder and all exhibits and schedules thereto, (collectively, the “the Ancillary Agreements”). “Treasury Regulations” means the Treasury Regulations promulgated under the Code. “User Data” means any Personal Information and other data or information (including all non-Personal Information) collected by or on behalf of the Seller from users of any website or mobile application of the Seller, whether collected while online or off-line. “U.S.” or “United States” means the United States of America. ARTICLE 2 PURCHASE AND SALE OF SHARES 2.1 Basic Transaction. On and subject to the terms and conditions of this Agreement, at the Closing, Buyer shall purchase from the Seller, and the Seller shall sell, assign, transfer and deliver to Buyer, all of such Seller’s Shares for the consideration specified in this Article 2, free and clear of any and all Security Interests. The Shares to be sold, assigned and transferred pursuant to this Article 2 represent, as of the date hereof, in the aggregate 55.97% of the issued and outstanding shares of the capital stock of the Company, as well as on a fully diluted basis. 8 2.2 Purchase Price. In consideration of the transfer of the Shares and the other obligations set forth in this Agreement, the aggregate purchase price to be paid by the Parent on behalf of the Buyer for the Shares at a valuation of approximately $397.07 per Share (and in aggregate approximately $3,800,000 for all of the Shares), which will consist of: (a) payment to Seller by or on behalf of Buyer of an amount of cash equal in the aggregate to the sum of $2,000,000 (the “Cash Consideration”), and (b) the issuance by Parent to Escrow Agent on behalf of Seller, of 11,292,508 of Parent’s Ordinary Shares of no par value each, representing a value in aggregate of approximately $1,800,000 calculated based on a price of NIS 0.614 per Ordinary share at the representative NIS/USD exchange rate for January 11, 2017 of 3.852, (the “Consideration Shares”, and together with the Cash Consideration, the “Consideration”). At Closing, subject to fulfilment of the Conditions Precedent detailed in Article 6 to full satisfaction of the Buyer or Parent, an Affiliate of Buyer shall deliver: (a) the Cash Consideration, after deduction of the cash portion of the Escrow Amount and the Closing Portion of Third Party Fee, payable in cash by wire transfer of immediately available funds, which shall be disbursed to such bank account(s) as Seller shall designate in writing to Parent prior to the Closing; (b) the Cash Consideration portion of the Escrow Amount into the Escrow Fund; (c) evidence that the Consideration Shares have been duly issued by Parent and that such Consideration Shares have been delivered to the Escrow Agent; and (d) an amount of $100,000 + VAT out of the Cash Consideration paid to Seller Agent on behalf of the Seller for part of the Third Party Fee (the "Closing Portion of Third Party Fee"). 2.3 The Closing. The closing of the transactions contemplated by this Agreement (the “Closing”) shall take place remotely through the electronic exchange of closing documents and physical delivery of any certificates representing the Shares or Consideration Shares, and completed no later than 13:00 p.m. Israel time on January 13, 2017 (or at such other time and location mutually agreeable to the Parties) (the “Closing Date”). 2.4 Deliveries at the Closing. At the Closing, in addition to the fulfillment of any of the conditions required of any Party as set forth in ARTICLE 6 and ARTICLE 7: (A) Seller will deliver to Buyer or an Affiliate thereof: (a) a validly executed stock power in the form attached hereto as Schedule 2.4a(1) signed by the Seller and a share certificate covering the Shares issued in the name of the Buyer or of an Affiliate of the Buyer as trustee for the Buyer and the Shares transferred from the Seller to the Buyer or an Affiliate of the Buyer as trustee for the Buyer, and the registration of the Buyer or an Affiliate of the Buyer as trustee for the Buyer as the shareholder owning the Shares in the shareholder register of the Company, and deliver to the Buyer or an Affiliate of the Buyer as trustee for the Buyer such shareholder register, signed by a duly authorized Company officer, in the form attached hereto as Schedule 2.4a(2); (b) validly executed copy of a unanimous written resolution of the Company's Board of Directors, substantially in the form of Schedule 2.4b approving: (1) the sale and transfer of the Shares as set forth herein this Agreement; and (2) the appointment of the Buyer's directors, as detailed in Section 5.7; (c) resignation and release letter by the directors nominated by the Seller effective at Closing and a duly executed and binding copy of the Seller Directors POA as set forth in Section 5.7; (d) a certificate duly executed by the Seller and an officer of the Company nominated by the Seller in a form attached herein as Schedule 2.4d; (e) the Closing Balance Sheet; and (f) the Post Closing Parent Corporate Governance Agreement signed by the Seller; and (B) Buyer or an Affiliate thereof will deliver to Seller; (a) a certificate duly executed by the Buyer or an Affiliate thereof and containing the representation and warranty of Buyer or an Affiliate thereof that the conditions set forth in Sections 7.1 through 7.3, and 7.5 through 7.6 have been duly satisfied; (b) confirmation from the Buyer or an Affiliate thereof that the Escrow Amount has been deposited with the Escrow Agent in accordance with the terms of the Escrow Agreement; and (c) the Consideration as specified in Section 2.2. 9 ARTICLE 3 REPRESENTATIONS AND WARRANTIES CONCERNING THE TRANSACTION 3.1 Representations and Warranties of Seller. The Seller hereby represents and warrants to Buyer and Parent as follows: (a) Capacity and Authorization of Seller. The Seller is duly organized, validly existing and in good standing under the Laws of the jurisdiction of its formation, which jurisdiction is Israel, and has all requisite power and authority to own, lease and operate its assets, properties and business and to carry on its business as now being conducted. Complete and correct copies of the charter documents, bylaws, articles of association or similar organizational documents, of the Seller and all amendments thereto have been made available to the Buyer or an Affiliate thereof. The Seller is not in violation of any of the provisions of its charter documents, bylaws, articles of association or similar organizational documents. The minute books and resolutions of the Seller previously made available to the Buyer or an Affiliate thereof contain true, complete and accurate records of all meetings and accurately reflect in all material respects all corporate action of the equity holders and board of directors (including committees thereof) of such Seller. The Seller has all requisite power and authority to execute, deliver and perform its obligations under this Agreement and each of the Ancillary Agreements to which it is a party and to consummate the transactions contemplated hereby and thereby. The execution and delivery of this Agreement and the Ancillary Agreements to which the Seller is party, the performance by the Seller of its obligations hereunder and thereunder and the consummation by the Seller of the transactions contemplated hereby and thereby have been duly authorized. This Agreement has been, and the Ancillary Agreements to which the Seller is party will be, duly executed and delivered by the Seller and constitute the legal, valid and binding obligation of the Seller, enforceable against it in accordance with its respective terms, except as enforcement may be limited by applicable bankruptcy, insolvency, reorganization, moratorium and other similar Laws affecting the rights of creditors generally and the availability of equitable remedies. The Seller has not granted to any Person any power of attorney in respect of it or relating to the conduct of its business. The Seller has never approved, or commenced any proceeding or made any election contemplating, the dissolution or liquidation of the Seller or the winding up or cessation of its business. (b) Noncontravention. Neither the execution and the delivery of this Agreement, and the other agreements contemplated hereby, nor the consummation of the transactions contemplated hereby and thereby, will materially (i) violate any statute, regulation, rule, injunction, judgment, order, decree, ruling, charge or other restriction of any government, governmental agency or court to which the Seller is subject or its Governing Documents, or (ii) conflict with, result in a breach of, constitute a default under, result in the acceleration of, create in any party the right to accelerate, terminate, modify, or cancel, or require any notice under any agreement, contract, lease, license or instrument to which the Seller is a party or by which the Seller is bound or to which any of the Seller’s assets is subject. 10 (c) Brokers’ Fees. Other than the Third Party Fee, the Seller does not have any Liability or obligation to pay any finder’s fees or commissions to any broker, finder, or agent with respect to the transactions contemplated by this Agreement for which Buyer or the Company or any respective Affiliate thereof are or could become liable or obligated. (d) Shares. Seller holds of record and owns beneficially the Shares, free and clear of any restrictions on transfer (other than restrictions under the Securities Laws), Security Interests, options, warrants and purchase rights, and on the Closing Date will have full and unrestricted power to sell, assign, transfer and deliver such Shares. (e) Absence of Litigation. Seller is not a party to any, and there are no pending or, to the Knowledge of Seller, threatened proceedings, against Seller challenging the validity of the transactions contemplated by this Agreement which, if determined adversely, would prevent the consummation of the transactions contemplated by this Agreement. (f) Investment Representations. Seller hereby acknowledges that the Consideration Shares have not been registered under the Securities Laws and that they are being offered and sold pursuant to exemptions from registration contained in the Securities Laws based in part upon its representations and warranties contained in this Agreement. Accordingly, Seller hereby represents and warrants as follows: (i) Economic Risk. Seller is capable of evaluating the merits and risks of its investment in Parent and has the capacity to protect its own interests. Any interest in the Consideration Shares may not be sold, pledged or otherwise transferred or hypothecated unless the Consideration Shares are registered pursuant to the Securities Laws, or an exemption from such registration is available under the Securities Laws, and in the absence of such registration or exemption, the holder must bear the economic risk of this investment indefinitely. It understands that there is no assurance that any exemption from registration under the Securities Laws will be available and that, even if available, such exemption may not allow the transfer all or any portion of the Consideration Shares under the circumstances, in the amounts or at the times the holder might propose. (ii) Acquisition for Own Account. The Seller is acquiring the Consideration Shares for its own account for investment only, and not with a view towards their distribution or resale, without prejudice, however, to its right, at all times, to sell or otherwise dispose of all or any part of such securities pursuant to an effective registration statement under the Securities Laws or under an exemption from such registration and in compliance with applicable securities Laws. protect its own interests in connection with the transactions contemplated in this Agreement. (iii) Protecting Its Interest. By reason of its, or of its management’s (if any), business or financial experience, Seller has the capacity to 11 (iv) General Solicitation. The Consideration Shares are not being purchased as a result of any advertisement, article, notice or other communication regarding the Consideration Shares published in any newspaper, magazine or similar media or broadcast over television or radio or presented at any seminar or any other general solicitation or general advertisement. (v) Parent’s Information. No offering memorandum or similar disclosure document has been prepared in connection with the offer of the Consideration Shares, and Seller has had the opportunity to review the Transaction Documents (including all exhibits and schedules thereto) and the Parent’s reports filed publicly with the SEC and/or TASE and has been afforded (i) the opportunity to ask such questions as it has deemed necessary of, and to receive answers from, representatives of the Parent concerning the terms and conditions of the offering of the Consideration Shares and the merits and risks of investing in the Consideration Shares; (ii) access to publicly disclosed information about the Parent and its financial condition, results of operations, business, properties, management and prospects sufficient to enable it to evaluate its investment; and (iii) the opportunity to obtain such additional information that the Parent possesses or can acquire without unreasonable effort or expense, that it may legally disclose (and if not so able to disclose, has provided a legal reason for such non-disclosure) and that is necessary to make an informed investment decision with respect to the investment in the Parent. The only representations and warranties being given by the Parent are contained in this Agreement. No broker or agent of the Parent has provided any information or advice with respect to the Consideration Shares nor is such information or advice necessary or desired. Seller has had an opportunity to discuss Parent’s business, management and financial affairs with directors, officers and management of Parent and to ask them questions and receive answers from them regarding the terms and conditions of an investment in Parent’s equity. (vi) Rule 144. Seller acknowledges that it is aware that Rule 144 under the Securities Act which allows for the public resale of restricted and control securities, as the case may be, if a number of conditions are met, may not necessarily be available with respect to the Consideration Shares and, in any event, is available only if certain conditions are satisfied, and that any sale of the Consideration Shares that might be made in reliance upon Rule 144 may only be made in accordance with the terms and conditions of such rule and that a copy of Rule 144 will be delivered to Seller upon request. (vii) Regulation S Exemption. Seller understands that the Consideration Shares are being offered and sold to Seller in reliance on an exemption from the registration requirements of United States federal and state securities laws under Regulation S promulgated under the Securities Act, and that the Parent is relying upon the truth and accuracy of the representations, warranties, agreements, acknowledgments and understandings of the Seller set forth herein in order to determine the applicability of such exemptions and the suitability of the Seller to acquire the Consideration Shares. In this regard, Seller represents, warrants and agrees that: (a) Seller is not a U.S. Person (as defined in Regulation S) and is not an affiliate (as defined in Rule 501(b) under the 1933 Act) of the Parent and is not acquiring the Consideration Shares for the account or benefit of a U.S. Person. 12 (b) At the time of the origination of contact concerning the issuance of the Consideration Shares and the date of the execution and delivery of this Agreement, Seller was outside of the United States. (c) Seller will not, during any ‘distribution compliance period’ under Regulation S, if applicable (the “Restricted Period”), offer, sell, pledge or otherwise transfer the Consideration Shares in the United States, or to a U.S. Person for the account or for the benefit of a U.S. Person, or otherwise in a manner that is not in compliance with Regulation S. (d) Seller will, after expiration of the Restricted Period, offer, sell, pledge or otherwise transfer the Consideration Shares only pursuant to registration under the Securities Act or an available exemption therefrom and, in accordance with all applicable state and foreign securities laws. (e) Neither Seller nor or any person acting on Seller’s behalf has engaged, nor will engage, in any directed selling efforts to a U.S. Person with respect to the Consideration Shares, and Seller and any person acting on Seller’s behalf have complied and will comply with any applicable “offering restrictions” requirements of Regulation S under the Securities Act. (f) The issuance of the Consideration Shares contemplated by this Agreement have not been pre-arranged with a buyer located in the United States or with a U.S. Person, and are not part of a plan or scheme to evade the registration requirements of the Securities Act. (g) Neither Seller nor any person acting on Seller’s behalf has undertaken or carried out any activity for the purpose of, or that could reasonably be expected to have the effect of, conditioning the market in the United States, its territories or possessions, for any of the Consideration Shares. Seller agrees not to cause any advertisement of the Consideration Shares to be published in any newspaper or periodical or posted in any public place and not to issue any circular relating to the Consideration Shares. (viii) Compliance with Laws. Any resale of the Consideration Shares during a ‘distribution compliance period’, if applicable, as defined in Rule 902(f) to Regulation S shall only be made in compliance with exemptions from registration afforded by Regulation S. Further, any such sale of the Consideration Shares in any jurisdiction outside of the United States will be made in compliance with the securities laws of such jurisdiction. Seller will not offer to sell or sell the Consideration Shares in any jurisdiction unless Seller obtains all required consents, if any. (ix) Israeli Securities Law. Seller affirms that it is a “Qualified Investor” listed under the First Schedule of the Israeli Securities Law 5728-1968, purchasing for itself, namely that it is a venture capital fund, defined as an entity primarily involved in investments in companies which, at the time of investment, (i) are primarily engaged in research and development or manufacture of new technological products or processes and (ii) involve above-average risk, and undertakes that it will provide the Parent with appropriate documentation to such effect, as required under applicable Israeli law and regulation. Seller further acknowledges, warrants and undertakes that no action will be taken in Israel that would permit the offering of the Consideration Shares or the distribution of any prospectus or other offering document to the public in Israel, and that the Consideration Shares were and are issued by way of a private placement and that the Consideration Shares are subject to the resale restrictions under Section 15C of the Israel Securities Law and Section 5 of the Israeli Securities Regulations (Details Regarding Sections 15A-15C of the Securities Law-1968) - 2000. 13 (x) No Voting Agreements. Other than the applicable Post Closing Parent Corporate Governance Agreement to be entered into at Closing by Seller, at the time the Consideration Shares are offered, and as of the date hereof, and at the Closing, Seller is not, and will not be, a party to any agreement or arrangement, whether written or oral, with Parent, any of the Parent's officers or shareholders or a corporation in which the Parent's officers or shareholders are an Interested Party (as defined in the Israeli Companies Law, 5759-1999), regulating the management of the Parent, the shareholders' rights in the Parent, the transfer of shares in the Parent, including any voting agreements, shareholder agreements or any other similar agreement even if its title is different or has any other relations or agreements with any of the Parent’s shareholders, directors or officers. (xi) No Governmental Review. It understands that no Israeli or United States federal or state agency or any other government or governmental agency has passed on or made any recommendation or endorsement of the Consideration Shares or the fairness or suitability of the investment in the Consideration Shares nor have such authorities passed upon or endorsed the merits of the offering of the Consideration Shares. (xii) Restricted Securities. It understands that the Consideration Shares, are characterized as “restricted securities” under the U.S. federal securities laws inasmuch as they are being issued by the Parent in a transaction not involving a public offering and that under such laws and applicable regulations such securities may be resold without registration in the United States of America under the Securities Act only, and in Israel under Israeli Securities Laws only in certain limited circumstances. It understands and acknowledges that: (i) the Consideration Shares are being offered and sold without registration under the Securities Laws in a private placement that is exempt from the registration provisions of the Securities Laws and (ii) the availability of such exemption depends in part on, and the Buyer and Parent will rely upon the accuracy and truthfulness of, the foregoing representations and it hereby consents to such reliance. of the Buyer or Parent in connection with the purchase of the Consideration Shares constitutes legal, tax or investment advice. (xiii) Independent Advice. It understands that nothing in this Agreement or any other materials presented to it by or on behalf 14 imprinted with the following legend (in addition to any legend required under applicable state or foreign securities laws): (xiv) The Seller further acknowledges and understands that the certificate evidencing the Consideration Shares may be “THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED WITH THE SECURITIES AND EXCHANGE COMMISSION OR THE SECURITIES COMMISSION OF ANY STATE AND HAVE BEEN ACQUIRED PURSUANT TO AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “ACT”). THESE SECURITIES HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH A VIEW TO DISTRIBUTION OR RESALE, AND MAY NOT BE SOLD, MORTGAGED, PLEDGED, HYPOTHECATED OR OTHERWISE TRANSFERRED EXCEPT IN ACCORDANCE THEREWITH, PURSUANT TO AN EFFECTIVE REGISTRATION UNDER THE ACT OR PURSUANT TO AN AVAILABLE EXEMPTION FROM REGISTRATION UNDER THE ACT, OR OUTSIDE THE UNITED STATES IN ACCORDANCE WITH RULE 904 OF REGULATION S UNDER THE ACT, IN EACH CASE IN ACCORDANCE WITH ALL APPLICABLE STATE SECURITIES LAWS AND THE SECURITIES LAWS OF OTHER JURISDICTIONS. THE ISSUER OF THESE SECURITIES MAY REQUIRE AN OPINION OF COUNSEL IN FORM AND SUBSTANCE SATISFACTORY TO THE ISSUER TO THE EFFECT THAT ANY PROPOSED TRANSFER OR RESALE IS EITHER IN COMPLIANCE WITH THE ACT AND ANY APPLICABLE STATE SECURITIES LAWS AND THE SECURITIES LAWS OF OTHER JURISDICTIONS. IN ADDITION, NO HEDGING TRANSACTION MAY BE CONDUCTED WITH RESPECT TO THESE SECURITIES UNLESS SUCH TRANSACTIONS ARE IN COMPLIANCE WITH THE ACT.” (g) Seller Information. The information relating to Seller that is provided by Seller, or any director, officer, employee, agent or representative thereof, for inclusion in any document filed with or furnished to the SEC, or otherwise submitted to any other Regulatory Agency, in connection with the transactions contemplated by the Transaction Documents, will not at the time that such information is provided by any such Person as aforesaid contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances in which they are made, not misleading. (h) Waiver. Any waiver and consent attached herein as Schedule 3.1(h) whereby each relevant shareholder of the Company waives all pre- emption rights and any other participation right it may have in connection with the transactions contemplated hereby, including, with respect to sale and transfer of the Shares and any rights of first refusal, tag-along or other similar rights it may have in connection with the sale and transfer of the Shares are duly authorized and validly executed by the signatory thereto. No other waiver, consent or process is required in order for the transactions contemplated hereby to be in full force and effect. (i) Governing Documents; Records. All actions taken and all transactions entered into by the Company which required the approval or consent of its board of directors or shareholders have been duly approved by all necessary action of the board of directors and shareholders of the Company. There has been no violation of any of the provisions of the Governing Documents of the Company, and the Company has not taken any action that is inconsistent in any material respect with any resolution adopted by the Company’s shareholders or board of directors (or similar body). All minutes, resolutions and other corporate records and documents of the Company, for the period from its founding through the date hereof, which were requested to be provided to Parent by Seller (collectively, the “Corporate Records”) have been provided to Parent, such Corporate Records are complete, true and correct and include all minutes of all meetings and all resolutions of the directors (and any committees of such directors) and shareholders of the Company as at the date hereof, and at the Closing Date will contain the minutes of all meetings and all resolutions of the directors (and any committees of such directors) and shareholders of the Company. 15 (j) Seller acknowledges that the Third Party Fee defined in Section 2.2 which is due from Seller to such third party will be paid by Buyer or an Affiliate thereof on behalf of the Seller solely and out of the Cash Consideration as set forth in section 2.2. 3.2 Representations and Warranties of Buyer and Parent. Parent and Buyer represent and warrant to Seller as follows: (a) Organization of Buyer. Parent is a corporation duly organized, validly existing and in good standing under the laws of the State of Israel. Buyer is, or upon formation will be, a corporation duly organized, validly existing and in good standing under the applicable laws of its jurisdiction of incorporation. (b) Authorization of Buyer. Parent and Buyer, as applicable, has or will have the requisite power and authority to execute and deliver this Agreement, and the other agreements contemplated herein, and to perform its obligations hereunder and thereunder. This Agreement, and the other agreements contemplated herein, have been or will be duly authorized by all requisite action of Parent and Buyer, as applicable, and constitutes, and upon execution the other agreements contemplated herein will constitute, the valid and legally binding obligations of Parent and Buyer, as applicable, enforceable in accordance with their terms and conditions, except (i) as enforcement may be limited by general principles of equity or rules governing specific performance, injunctive relief and other equitable remedies, whether applied in a court of law or a court of equity, and (ii) as enforcement may be limited by bankruptcy, insolvency, moratorium, relief of debtors or other similar laws affecting creditors’ rights and remedies generally. (c) Noncontravention. Neither the execution and delivery of this Agreement, and the other agreements contemplated hereby, nor the consummation of the transactions contemplated hereby and thereby, will materially (i) violate any statute, regulation, rule, injunction, judgment, order, decree, ruling, charge or other restriction of any government, governmental agency or court to which Buyer and Parent, as applicable, is subject or any provision of its Governing Documents, or (ii) conflict with, result in a breach of, constitute a default under, result in the acceleration of, create in any party the right to accelerate, terminate, modify or cancel, or require any notice under any material agreement, contract, lease, license or instrument to which Parent or Buyer is a party or by which it is bound or to which any of its assets is subject. 16 (d) Brokers’ Fees. Neither Buyer nor Parent nor any of their respective Affiliates have any Liability or obligation to pay any finder’s fees or commissions to any broker, finder or agent with respect to the transactions contemplated by this Agreement for which Seller could become liable or obligated. (e) Investment Representations. (i) Parent acknowledges, and Buyer shall acknowledge, that the Shares have not been registered for offer or sale under any Securities Laws, and are not listed for trading on any stock exchange, stock quotation service or other stock market. It is understood that the Shares are being sold by Seller in reliance on exemptions from the registration requirements of any applicable Securities Laws, and may not be sold, transferred or otherwise disposed of unless subsequently registered under applicable Securities Laws or unless an exemption from registration is available. (ii) Without derogating from the representations made by the Seller hereunder, Buyer or its Affiliate acting on its behalf has such knowledge and experience in financial and business matters in general and with respect to businesses of a nature similar to the business of the Company so as to be capable of evaluating the merits and risks of, and making an informed business decision with regard to, the acquisition of the Shares. (iii) Buyer shall be acquiring the Shares solely for its own account and not with a view to or for resale in connection with any distribution or public offering thereof, within the meaning of applicable securities laws and regulations. ARTICLE 4 REPRESENTATIONS AND WARRANTIES CONCERNING THE COMPANY The Seller represents and warrants to Buyer and Parent as follows: 4.1 Organization and Corporate Power. The Company is a corporation duly incorporated, validly existing and in good standing under the laws of the State of Israel. The Company has the requisite corporate power and authority to carry on the businesses in which it is engaged and to own and use its properties as they are now owned and used, and perform its obligations under all contracts and agreements to which it is party or by which it is bound. Schedule 4.1 accurately sets forth the names of the members of the board of directors (or similar body) of the Company and its corporate officers. The Seller has provided to Buyer or its Affiliate acting on its behalf true and correct copies of the Governing Documents of the Company. The Company is not in violation of any of the provisions of its Governing Documents. The minute books and resolutions of the Company previously made available to the Buyer or an Affiliate thereof contain true, complete and accurate records of all meetings and accurately reflect in all material respects all corporate action of the equity holders and board of directors (including committees thereof) of the Company. The execution and delivery of this Agreement and the Ancillary Agreements to which the Seller is party, the performance by the Seller of its obligations hereunder and thereunder and the consummation by the Seller of the transactions contemplated hereby and thereby have been duly authorized. The Company has not granted to any Person any power of attorney in respect of it or relating to the conduct of its business. The Company has never approved, or commenced any proceeding or made any election contemplating, the dissolution or liquidation of the Company or the winding up or cessation of its business. 17 4.2 Capitalization. The authorized as well as the issued and outstanding capital of the Company as of the date hereof is as set forth on Schedule 4.2. All Shares are duly authorized, validly issued, fully paid and non-assessable, and are held of record and owned beneficially by Seller as set forth in Schedule 4.2, and none of the Shares are subject to preemptive rights, repurchase option, forfeiture provision or restriction on transfer created by statute (other than restrictions on transfer imposed by virtue of applicable securities laws), the Governing Documents, or any agreement to which the Company or the Seller is a party or by which it is bound. Except as set forth in Schedule 4.2, there are no outstanding or authorized options, warrants, purchase rights, subscription rights, conversion rights, exchange rights or other contracts or commitments that require the Company to issue, sell or otherwise cause to become outstanding any of its capital stock. Except as set forth in Schedule 4.2, the Company has no obligation of any kind to issue any additional Shares to any Person. 4.3 Subsidiaries. The Company does not have and, did not at any time previously have, any subsidiary (defined as an entity of which the Company owns directly or indirectly more than 50% of the outstanding securities entitled generally to vote for the election of directors or equivalent managing persons) and does not hold and, did not at any time previously hold, any material direct or indirect beneficial interest in any other corporation, partnership, joint venture or other entity or enterprise. 4.4 Noncontravention. Except as set forth in Schedule 4.4, neither the execution and delivery of this Agreement, nor the consummation of the transactions contemplated hereby, will (a) violate any statute, regulation, rule, injunction, judgment, order, decree, ruling, charge or other restriction of any government, governmental agency or court to which the Company is subject or any provision of the Governing Documents of the Company, or (b) conflict with, result in a breach of, or constitute a default under any Material Contract. Except as set forth in Schedule 4.4, the Company is not required to give any notice to, make any filing with, or obtain any authorization, consent or approval of any Governmental Authority in order for the Parties to consummate the transactions contemplated by this Agreement. 4.5 Governing Documents; Records. All actions taken and all transactions entered into by the Company which required the approval or consent of its board of directors or shareholders have been duly approved by all necessary action of the board of directors and shareholders of the Company. There has been no violation of any of the provisions of the Governing Documents, and the Company has not taken any action that is inconsistent in any material respect with any resolution adopted by the Company’s shareholders or board of directors (or similar body). 18 4.6 Brokers’ Fees. Other than as set forth on Schedule 4.6, the Company has no Liability or obligation to pay any finder’s fees or commissions to any broker, finder or agent with respect to the transactions contemplated by this Agreement. 4.7 Financial Statements. Attached hereto as Schedule 4.7 are the audited balance sheets and statements of income, stockholders’ equity and cash flows of the Company as of and for the calendar years ended December 31, 2014 and December 31, 2015 (the “2015 Financial Statements” or the “Financial Statements”). The audited 2015 Financial Statements, including the notes thereto, have been prepared based upon the Company’s books and records and are in accordance with GAAP, and fairly present the financial condition of the Company in all material respects as of the dates stated and the results of operations of the Company for such period. 4.8 No Liabilities. The Company does not have any accrued, contingent or other Liabilities of any nature, either matured or unmatured (whether or not required to be reflected in financial statements in accordance with GAAP, and whether due or to become due), except for (i) the Liabilities identified in Schedule 4.8(i), which are correct as of the date hereof “Company Closing Liabilities”), and (ii) any and all Exit Fees and/or Historical Patent Costs (each as defined in the Yissum License) which are or may become due and payable to Yissum under the Yissum License as a result of the completion of the transactions contemplated hereunder, and which are reflected in Schedule 4.8(ii). (b) Indebtedness. There is no Indebtedness of the Company for borrowed money. (c) No Guarantee of Indebtedness. The Company does not have any outstanding guarantees for debt or other obligations of any other Person. (d) Insider Receivables. There is no Indebtedness owed to the Company by any Service Provider, employee, officer, director or shareholder, other than expense reimbursements in the Ordinary Course of Business. 4.9 Subsequent Events. Since the December 31, 2015: (a) the Company has operated in the Ordinary Course of Business, and as of the date hereof, there have been no events, series of events or the lack of occurrence thereof which, singularly or in the aggregate, could reasonably be expected to have a Material Adverse Effect on the business or financial condition of the Company, taken as a whole; and (b) there has not been any material loss, damage or destruction to, or any material interruption in the use of, any of the Company’s material assets (whether or not covered by insurance). 19 4.10 Legal Compliance. (a) The Company has all material governmental permits, licenses, registrations, certificates and other governmental authorizations (the “Permits”) necessary for the Company to conduct is businesses as presently conducted. (b) The Company is in compliance in all material respects with all applicable laws, statutes, rules, regulations, codes, plans, injunctions, judgments, orders, decrees, rulings and charges thereunder of Governmental Authorities (collectively, the “Applicable Laws”). 4.11 Tax Matters. Except as set forth on Schedule 4.11: (a) The Company has filed or caused to be filed all material Tax Returns required to be filed with respect to the Company with respect to all past years through calendar year 2015. All such Tax Returns at the time of filing complied with all applicable Tax laws in all material respects. All Taxes owed by the Company shown on any Tax Return have been timely and properly paid or, to the extent not yet due for payment, have been adequately accrued on the books and records of the Company. All Taxes required to be withheld by the Company have been properly and timely withheld and remitted. The Company is not currently the beneficiary of any extension of time within which to file any Tax Return. There are no Security Interests on the assets of the Company that arose in connection with any failure or alleged failure to pay any Tax. (b) There is no dispute or claim concerning any Tax Liability of the Company (i) claimed or raised by any Taxing authority in writing, or (ii) as to which Seller has Knowledge based upon personal contact with any agent of such authority. (c) The Company has not waived any statute of limitations in respect of Taxes or agreed to any extension of time with respect to a Tax assessment or deficiency. (d) No Tax Return of the Company is currently being audited and the Company has not received notice of any pending audit. 4.12 Real Property. The Company does not own nor lease any real property. 4.13 Title to Assets. The Company has good title to, or a valid leasehold interest in, all material tangible, personal property assets (i) used regularly in the conduct of its businesses, and (ii) located on the premises of the Company, shown on the Audited Financial Statements or acquired after December 31, 2015, including all fixtures, furniture, equipment, and machinery (collectively, the “Fixed Assets”), and such Fixed Assets are subject to no material liens, mortgages, pledges, encumbrances or charges, except for properties and assets disposed of in the Ordinary Course of Business, or leased assets of third parties subject to a valid leasehold interest with a corresponding collateral securitization filing as set forth on Schedule 4.13, or such other exceptions which are not material in character, amount or extent and do not materially detract from the value of or interfere with the use of the tangible assets subject thereto or affected thereby. To the Knowledge of Seller, all Fixed Assets are in good operating condition (subject to normal wear and tear. 20 4.14 Intellectual Property. (a) Except as set forth on Schedule 4.14, the Company owns or possesses all rights to use all Intellectual Property necessary to the operation of its businesses as presently conducted and such present use does not conflict with the lawful rights of others in any material respect. The Company has not received written or oral notice of any claim against it involving any conflict or claim of conflict relating to the Intellectual Property of the Company and, to the Knowledge of Seller, there is no basis for any such claim or conflict. The Company has taken all reasonably necessary action to maintain and protect each item of Intellectual Property that it owns or uses. (b) Except as set forth on Schedule 4.14, the Company has never assigned or otherwise transferred ownership of, or agreed to assign or otherwise transfer ownership of, any Intellectual Property necessary to the operation of its businesses as presently conducted to any other Person. (c) Each Person who is or was an employee or other Service Provider of the Company and/or who is or was involved in the creation or development of any Intellectual Property, including prior to incorporation of the Company, has signed a valid and enforceable agreement containing an irrevocable assignment to the Company, of all Intellectual Property Rights and Intellectual Property created or developed in the course of that Person’s work with the relevant entity, as well as confidentiality provisions protecting the Intellectual Property Rights and Intellectual Property of the Company, as applicable. (d) Except as set forth on Schedule 4.14 no funding, facilities or personnel of any Governmental Authority or any public or private university, college, or other educational or research institution, was used, directly or indirectly, to create or develop, in whole or in part, any of the Intellectual Property of the Company. (e) Except as set forth on Schedule 4.14, the Company is not currently nor has it ever been a member or promoter of, or a contributor to, any industry standards body or similar organization that could require or obligate the Company to grant or offer to any other Person any license or right to any of the Intellectual Property of the Company. (f) The Company is not bound by, and none of the Intellectual Property owned by the Company is subject to, any contract or agreement containing any covenant or other provision (other than any restrictions that may be imposed by Applicable Law) that in any way limits or restricts the ability of the Company to use, exploit, assert, or enforce any of the Intellectual Property owned by the Company anywhere in the world. (g) Except as set forth on Schedule 4.14, no Person has infringed, misappropriated, or otherwise violated, and no Person is currently infringing, misappropriating or otherwise violating, any of the Intellectual Property of the Company in any material respect. (h) The Company has never infringed (directly, contributorily, by inducement or otherwise), misappropriated or otherwise violated any intellectual property right of any other Person; (ii) no infringement, misappropriation or similar claim or legal proceeding is pending or has been threatened against the Company or against any other Person who may be entitled to be indemnified, defended, held harmless or reimbursed by the Company with respect to such claim or legal proceeding; and (iii) the Company has never received any notice or other communication (in writing or otherwise) relating to any actual, alleged or suspected infringement, misappropriation or violation of any intellectual property right of another Person. 21 (i) Yissum License. Other than as set forth on Schedule 4.14 (i), the Yissum License has not been amended since August 12, 2013, and is in full force and effect. To the Knowledge of the Seller, the Company has never received any notice or other communication (in writing or otherwise) from Yissum with respect to a conflict or claim of conflict relating the Yissum License, or which could lead to termination of the Yissum License. The Company is not and has not been in the past in breach of the License Agreements which may lead to termination of the Yissum License and there is currently no cause for termination of the Agreement. 4.15 Personal Information; IT Security (a) The Company has not received a complaint or been the subject of any Proceeding regarding its collection, use or disclosure of Personal Information or its privacy or data security policies, practices or activities. To the Seller’s Knowledge, all information technology systems and computers of the Company (and all parts thereof), are free of (i) any critical defects, and (ii) any disabling codes or instructions and any “back door,” “time bomb,” “Trojan horse,” “worm,” “drop dead device,” “virus” or other software routines or hardware components that permit unauthorized access or the unauthorized disruption, impairment, disablement or erasure of such information technology systems, computers or Intellectual Property (or any parts thereof) or data or other software of users (“Contaminants”). The Company takes and has taken commercially reasonable steps, and implements and have implemented commercially reasonable procedures, intended to ensure that information technology systems used in connection with the operation of the businesses of the Company are free from Contaminants and safeguard the security of such information technology systems. The Company has commercially reasonable disaster recovery plans, procedures and facilities for its businesses, and takes and has taken commercially reasonable steps to safeguard the information technology systems and computers used in the operation of businesses. Except as set forth on Schedule 4.15 there have been no unauthorized intrusions or breaches of the security of such information technology systems and computers. The Company has adequate security measures in place to protect Personal Information in its possession, custody or control, and the Company has not experienced any breach of security or unauthorized access by any third party to Personal Information in the Company’s possession, custody or control. For purposes hereof, information in the Company’s possession, custody or control includes information stored for the Company by any Service Provider or vendor. Section 4.15 of the Disclosure Schedules identifies and describes each distinct electronic or other database, including location, containing Personal Information maintained by or for the Company at any time (the “Databases”), the types of Personal Information in each Database, the means by which the Personal Information was collected, the security and retention policies that have been adopted and maintained with respect to each Database, the geographical location(s) of each Database, and whether each Database has been registered with any Governmental Authority. To the Seller’s Knowledge, no breach or violation of any such Privacy Policy or security policy has occurred or is threatened, and to the Seller’s Knowledge, there has been no Loss, unauthorized or illegal use of or access to any of the data or information in any of the Databases. Except as set forth on Schedule 4.15, no Person has provided any notice, made any claim or initiated any Proceeding or, to the Knowledge of the Seller, commenced any Proceeding with respect to actual or alleged Loss, damage or unauthorized access, collection, use, storage, handling, retention, destruction, disclosure, modification, processing or other misuse of any User Data or Personal Information or with respect to any violation of a Law pertaining to privacy, security, data protection, User Data or Personal Information, including any Laws, and, to the Knowledge of the Seller, there is no reasonable basis for any such notice, claim or Proceeding. There are no outstanding information, enforcement, Proceeding, deregistrations or transfer prohibition notices or any other nature of notice or audit request under applicable Laws currently outstanding against the Company, or any outstanding appeal against such notices nor, to the Knowledge of the Company, are there any circumstances which give rise to the giving of any such notices. Except as provided on Schedule 4.15 there are no unsatisfied access requests in respect of User Data held by the Company or any outstanding applications for rectification or erasure of User Data. The Company has implemented and maintains commercially reasonable safeguards to ensure that User Data or Personal Information is protected against Loss, damage and unauthorized access, use, modification, or other misuse. 22 (b) The Company has all necessary authority to receive, access, use and disclose the Personal Information in the Company’s possession or under its control in connection with the operation of its businesses. The Company has at all times made all disclosures to, and obtained any necessary consents and authorizations from, users, customers, employees, Service Providers, contractors and other applicable Persons required by applicable legal requirements relating to privacy, security or data protection and has filed any required registrations (the details of which are correct, proper and suitable for the purposes for which the Company process the Personal Information which is the subject of them) with the applicable data protection authority, including any consents or authorizations necessary to operate the businesses of the Company. (c) No breach or violation of any such security policy has occurred or is threatened, and there has been no Loss, unauthorized or illegal use of or access to any of the data or information in any of the Databases. No Person has provided any notice, made any claim or initiated any Proceeding or, to the Knowledge of the Seller, commenced any claim or Proceeding with respect to actual or alleged Loss, damage or unauthorized access, use, disclosure, modification, or other misuse of any Personal Information or with respect to any violation of a legal requirement pertaining to privacy, security, data protection, or Personal Information and, to the Seller’s Knowledge, there is no reasonable basis for any such notice, claim or Proceeding. There are no outstanding information, enforcement, deregistration or transfer prohibition notices or any other nature of notice or audit request under applicable Laws currently outstanding against the Seller, or any outstanding appeal against such notices nor, to the Knowledge of the Seller, are there any circumstances which may give rise to the giving of any such notices. There are no unsatisfied access requests in respect of Personal Information held by the Company nor any outstanding applications for rectification or erasure of Personal Information. 23 4.16 Contracts. (a) Schedule 4.16 lists the following contracts and other agreements (other than those of a type disclosed in another Schedule) to which the Company is a party: (i) each contract, agreement or commitment in respect of the sale of products or the performance of services, or for the purchase or lease of inventories, equipment, raw materials, supplies, services or utilities which (i) involves payments or receipts by the Company of $25,000 or more and is not terminable by the Company at any time upon notice of 90 days or less, or (ii) is not to be fully performed within six months from the date of this Agreement; (ii) any material agreement for the lease of personal property to or from any Person providing for lease payments in excess of $25,000 per annum; (iii) each partnership, joint venture or similar agreement; (iv) indebtedness for or related to borrowed money, or any capitalized lease obligation, in excess of $50,000 or under which it has imposed a Security Interest on any of its assets, tangible or intangible; (v) any material agreement with the Seller or any other shareholder of the Company; (vi) any deferred compensation, severance, indemnification, or other plan or arrangement for the benefit of its Service Providers; (vii) any collective bargaining agreement; (viii) any agreement under which the Company has advanced or loaned money to Service Providers outside the Ordinary Course of Business; (ix) any agreement pursuant to which the Company has been appointed an exclusive partner, reseller or distributor, or pursuant to which either entity has appointed another Person as an exclusive partner, reseller, or distributor; (x) any supply agreement that is with the Company’s top 10 suppliers by spending calculated on an annual basis as of December 31, 2015; (xi) any agreement (A) imposing any restriction on the right or ability of the Company to (1) compete with any other Person; or (2) develop or distribute any technology or Products; or (B) imposing exclusive arrangements on the Company to acquire any product or other asset or any services from a single source; (xii) any agreement relating to the acquisition, transfer, use, development, sharing or license of any Intellectual Property of the Company y and licenses for any non-customized software that is not: (1) so licensed solely in executable or object code form pursuant to a nonexclusive, internal use software license; and (2) generally available on standard terms for less than $1,000 per copy, seat or user, as applicable; 24 (xiii) any agreement constituting or relating to any (A) prime contract, subcontract, letter contract, purchase order or delivery order executed or submitted to or on behalf of any Governmental Authority or any prime contractor or higher-tier subcontractor, or under which any Governmental Authority or any such prime contractor or subcontractor otherwise has or may acquire any right or interest, or (B) quotation, bid or proposal submitted to any Governmental Authority or any proposed prime contractor or higher-tier subcontractor of any Governmental Authority; and (xiv) any other agreement that was entered into outside the Ordinary Course of Business or was inconsistent with the past practices of the Company, since December 31, 2015. The contracts and agreements in the respective categories described in clauses (i) through (xiv) above are referred to in this Agreement as “Material Contracts.” (b) The Company has made available to Buyer accurate and complete copies of all Material Contracts, including all amendments thereto. Each Material Contract is valid and in full force and effect and is enforceable by the Company, in accordance with its terms, subject to: (i) laws of general application relating to bankruptcy, insolvency and the relief of debtors; and (ii) rules of law governing specific performance, injunctive relief and other equitable remedies. (c) Except as set forth on Schedule 4.16, neither the Company, nor the Seller nor, to the Knowledge of Seller, any other Person which is a party thereto has violated or breached in any material respect, or committed any material default under, any Material Contract. No event has occurred, and no circumstance or condition exists, that (with or without notice or lapse of time) will, or could reasonably be expected to: (A) result in a material violation or breach of any of the provisions of any such Material Contract; (B) give any Person the right to declare a default or exercise any remedy under any such Material Contract; (C) give any Person the right to accelerate the maturity or performance of any such Material Contract; or (D) give any Person the right to cancel, terminate or modify any Material Contract. (d) The Company has not received any notice or other communication regarding any actual or possible violation or breach of, or default under, any Material Contract, nor has it waived any of its material rights under any Material Contract. 4.17 Insurance. Schedule 4.17 sets forth the following information with respect to each insurance policy to which the Company is a party, a named insured, or otherwise the beneficiary of coverage: (a) the name of the insurer, the name of the policyholder and the name (or group designation) of each covered insured; and (b) the policy number and the period of coverage. With respect to each such insurance policy, no claim for coverage by the Company has been denied. The Company has not received any written notice of cancellation or termination with respect to any insurance policy. All premiums due and payable with respect to the insurance policies of the Company set forth in Schedule 4.17 have been fully paid and all such insurance policies are valid and enforceable policies. 25 4.18 Litigation. There is no claim, litigation, action, arbitration, suit, or judicial proceeding pending or, to the Knowledge of Seller, threatened in writing, against the Company, at law or equity, before any Governmental Authority. 4.19 Labor and Employment Matters. (a) The Company is in compliance in all respects with all Applicable Laws respecting employment and employment practices and terms and conditions of employment. Neither the Company or, to the Knowledge of the Seller, any of its respective Service Providers, representatives or employees has committed any unfair labor practices in connection with the operation of the businesses of the Company, and there is no pending or, to the Knowledge of the Seller, threatened in writing charge or complaint against the Company by any Governmental Authority. (b) No union representation exists respecting the employees or other Service Providers of the Company and, to the Knowledge of Seller, no union organizing activities are taking place. (c) To the Knowledge of Seller, no organizational effort is currently being made or threatened on behalf of any labor union with respect to the employees or other Service Providers of the Company. There is no pending or, to the Knowledge of the Seller, threatened labor dispute, strike or work stoppage against the Company. 4.20 Employee Benefits. (a) Schedule 4.20 lists each non-qualified deferred compensation plan, qualified defined contribution retirement plan, qualified defined benefit retirement plan or other material fringe benefit plan or program that the Company maintains or to which the Company contributes (“Benefit Plans”). (b) Except as set forth on Schedule 4.20, the execution and delivery of this Agreement and the consummation of the transactions contemplated hereby in and of itself, will not (A) require the Company to make a larger contribution to, or pay greater benefits or provide other rights under, any Benefit Plan than it otherwise would, or (B) create or give rise to any additional vested rights or service credits under any Benefit Plan, in either case whether or not some other subsequent action or event would be required to cause such payment or provision to be triggered. 26 (c) Schedule 4.20 sets forth as of the date hereof true and correct information concerning (i) all severance and change of control plans or arrangements for the benefit of present Service Providers, directors or officers (or other equivalent positions) or employees of the Company and any former Service Providers, directors or officers (or other equivalent positions) or employees of the Company if any such plans or arrangements provide for any continuing obligations of the Company, (ii) all employment agreements with any present director or officer (or other equivalent position) of the Company and any former directors or officers (or other equivalent positions) of the Company if any such agreements provide for any continuing obligations of the Company, (iii) any Person who has accepted an offer of employment made by the Company but whose employment has not yet started and of any outstanding offer of employment made to any Person by the Company providing for annual cost to the Company in excess of $25,000, and (iv) all non-competition agreements with the Company executed by directors or officers (or other equivalent positions) of the Company since the beginning of 2013. (d) With respect to the Benefit Plans, individually and in the aggregate, there are no funded benefit obligations for which contributions have not been made and there are no unfunded benefit obligations which have not been accounted for by reserves, or otherwise properly reflected in accordance with GAAP, on the Audited Financial Statements. 4.21 Environment. (a) The Company is in compliance with all Environmental Laws, except for any noncompliance that is not reasonably expected to have a material adverse effect on the business or financial condition of the Company, taken as a whole. (b) There is no outstanding action, suit, proceeding, charge, complaint, claim, demand or notice that has been filed or commenced against the Company alleging a failure to comply with Environmental Laws. (c) The Company has not received notice that it is a potentially responsible party for corrective action under CERCLA or any other similar Environmental Laws. 4.22 Compliance with Laws and Permits; Clinical and Regulatory Matters. (a) The Company holds and has at all times held and complied with, and immediately following the Closing the Company will hold and be in compliance with, all Permits necessary for the conduct, ownership, use, occupancy or operation of the businesses of the Company. Without derogating from the foregoing, the Company and its Service Providers and employees and agents hold all Permits, from the FDA and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of Company’s products (any such Governmental Authority, a “Regulatory Agency”), including all authorizations required under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”) and the regulations of the FDA promulgated thereunder, and the Public Health Service Act of 1944, as amended (the “PHSA”). Such Permits are valid and in full force and effect in all material respects. As of the date hereof, the Company has not received any written notice from any Governmental Entity (a) alleging any actual or possible violation of or failure to comply with any term or requirement of any such Permit, or (b) regarding any actual or possible revocation, withdrawal, suspension, cancellation, termination or modification of any such Permit. 27 (b) With respect to the businesses of the Company, (i) the Company is in compliance with all applicable laws regarding registration, license, certification for each site at which the Company’s products are tested, manufactured, labeled, sold, or distributed; (ii) the Company has exported any of its products or business knowledge in compliance in all material respects with applicable law; (iii) all of the studies and tests in relation to the Products conducted by or on behalf of Company were, or are being, conducted in all material respects in accordance with applicable Laws of the jurisdiction where conducted at the time such studies and test were conducted and in accordance with the prevailing scientific standards applicable to the conduct of such studies and activities; (iv) all manufacturing operations performed by or on behalf of the Company have been and are being conducted in all material respects in compliance with the Quality Systems Regulations of the FDA; (v) all required pre-clinical toxicology studies and non-clinical laboratory studies sponsored by or on behalf of Company, or otherwise conducted with respect to Products under development have been, or are being, conducted in compliance with the FDA's Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices in the United States; (vi) each clinical trial conducted by or on behalf of Company with respect to Products was, or is being, conducted in accordance with its clinical trial protocol, and in compliance in all material respects with all applicable Laws, including Good Clinical Practices, Informed Consent and all other applicable requirements contained in 21 CFR Parts 312, 50, 54, 56 and 11 and Company has filed all required notices (and made available to Buyer copies thereof) of adverse drug or product experiences, injuries or deaths relating to clinical trials conducted by or on behalf of Company with respect to such Products; and (vii) the Company is in compliance with all applicable reporting requirements for all Permits identified on Section 4.22 of the Disclosure Schedules, including applicable adverse event reporting requirements in and outside of the United States under applicable Law. The Company is in compliance with all FDA and similar state and local laws applicable to the maintenance, compilation and filing of reports with regard to the Products. Schedule 4.22(b) sets forth a list of all adverse event reports related to the Products. All of the complaint review and analysis reports of the Companythrough the date hereof, including information regarding complaints by product and root cause analysis of closed complaints, were made available to Buyer and such reports are correct in all material respects. (c) Neither the Company nor anyone acting on behalf of Company has received any written notice or other written communication from any Governmental Authority (i) contesting the clearance or approval of, the uses of or the labeling and promotion of the Products, or (ii) otherwise alleging any violation of any laws by the Seller. (k) There have been no recalls, field notifications or seizures ordered or adverse regulatory actions taken (or, to the Knowledge of the Seller, threatened) by the FDA or any other Governmental Authority with respect to the Products, including any facilities where any such products are produced, processed, packaged or stored and the Company has not within the last three years, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall of any product or provided post-sale warnings regarding any product. In addition, there have been no claims or actions asserted, are pending or, to the Knowledge of the Seller, threatened against the Company with respect to the performance of the Products or injuries or other adverse events arising from the use of the Company product or any warranty claims in respect thereof. 28 (l) All filings with and submissions to the FDA and any corollary entity in any other jurisdiction made by the Company with regard to the Company’s products, whether oral, written or electronically delivered, were true, accurate and complete as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete as of the date hereof, and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. (m) Neither Company, nor to Seller’s Knowledge, any Service Provider, director, officer, employee, agent or representative thereof, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto, or for any other Regulatory Agency to invoke any similar policy. Neither Company, nor to Seller’s Knowledge, any Service Provider, director, officer, employee, agent or representative thereof, has engaged in any activity prohibited under U.S. federal, state or foreign criminal or civil health care Laws (including the U.S. federal Anti-Kickback Statute, Stark Law, False Claims Act, Health Insurance Portability and Accountability Act, in each case, as amended, and any comparable state Laws), or the regulations promulgated pursuant to such Laws (each, a “Health Care Law”). There is no civil, criminal, administrative or other proceeding, notice or demand pending, received or, to Seller’s Knowledge, threatened against Company that relates to an alleged violation of any Health Care Law. Neither Company, nor to Seller’s Knowledge, any Service Provider, director, officer, employee, agent or representative thereof, has been convicted of any crime or engaged in any conduct for which debarment or exclusion is mandated by 21 U.S.C. sec. 335a(a), 42 U.S.C. sec. 1320a-7(a) or any similar Law or authorized by 21 U.S.C. sec. 335a(b), 42 U.S.C. sec. 1320a-7(b) or any similar Law. There are no consent decrees (including plea agreements) or similar actions to which Seller, or to Seller’s Knowledge, any Service Provider, director, officer, employee, agent or representative thereof, are bound or which relate to the Products. (n) Company has complied in all material respects with all applicable statutes, rules, regulations, decrees, writs and orders of the FDA and any other Regulatory Agency with respect to the labeling, storing, testing, development, manufacture, packaging and distribution of the Products. (o) To the Seller’s Knowledge, no data generated by or on behalf of Company with respect to any Product is the subject of any action, either pending or threatened, by any Regulatory Agency relating to the truthfulness or scientific adequacy of such data. (p) Neither Company, nor to Seller’s Knowledge, any Service Provider, director, officer, employee, agent or representative thereof, has received any notice that the FDA or any other Regulatory Agency or clinical investigator has initiated, or threatened to initiate, any action to suspend any clinical trial, or otherwise restrict the pre-clinical research or clinical study of any Product or any drug product being developed based on any Intellectual Property of the Company, or to recall, suspend or otherwise restrict the development or manufacture of any Company product. 29 (q) Company has not received written notice of, or is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any Products. To Seller’s Knowledge, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such action. (r) Company has made available to Buyer true, correct and complete copies of any and all applications, approvals, licenses, written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA or other Regulatory Agency, including any documents received from the FDA and any other Regulatory Agency that indicate or suggest lack of compliance with the regulatory requirements of the FDA or such other Regulatory Agency. Company has made available to Buyer true, correct and complete copies of all material correspondence to or from the FDA or other Regulatory Agency, minutes of meetings, written reports of phone conversations, visits or other contact with the FDA or other Regulatory Agency, and all other documents concerning communications to or from the FDA or other Regulatory Agency, or prepared by the FDA or other Regulatory Agency or which bear in any way on Seller’s compliance with regulatory requirements of the FDA or any other Regulatory Agency, or on the approval of any Products. 4.23 Certain Business Relationships with Company. Except as described in Schedule 4.23, no Seller or its Affiliates or any Related Party thereof, (a) owns any material asset, tangible or intangible, which is used in the business of Company, (b) is owed money by or owes money to the Company, (c) has entered into, or has had any direct or indirect financial interest in, any contract, transaction or business dealing involving the Company, (d) is competing, directly or indirectly, with the Company, (e) is a member, manager, director, officer or employee of, or consultant to, or owns, directly or indirectly, any interest in, any vendor, supplier or customer of the Company, or is in any way associated with or involved in the business of the Company (except in his or her official capacity as a Service Provider, director, officer or employee of the Company, as the case may be), (f) has any interest in or has filed any application with respect to any Intellectual Property, which arises out of or relates to the Company or its businesses, (g) has any claim or right against the Company (other than rights to receive compensation for, or expense reimbursement in connection with, services performed as an Service Provider, employee or director) or (h) is party to any transactions, contracts or understandings with Company that would be considered a “transaction” under Item 404 of Regulation S-K under the Securities Act if Company were to be subject to such regulation. 4.24 Product Liability. The Company has not given or made any warranties to third Persons with respect to any products developed by it, except for the warranties imposed by the provisions of the Material Contracts as listed on Schedule 4.16 and Applicable Laws. The Seller has no Knowledge of any present claim against the Company not fully covered by insurance for clinical trial liability or product liability on account of any express or implied warranty. 30 4.25 Anti-Corruption Compliance. The Company has not (and none of the Company’s officers or directors, agents, Service Providers or any other Person acting on behalf the Company has), directly or indirectly: (a) taken any action which would cause it to be in violation of the U.S. Foreign Corrupt Practices Act of 1977, as amended, or any rules or regulations thereunder, or any similar anti-corruption or anti-bribery legal requirements applicable to the Company in any jurisdiction; (b) used any corporate funds for unlawful contributions, gifts, entertainment or other unlawful expenses relating to political activity; (c) made, offered or authorized any unlawful payment to foreign or domestic government officials or employees, whether directly or indirectly; or (d) made, offered or authorized any bribe, rebate, payoff, influence payment, kickback or other similar unlawful payment, whether directly or indirectly. No Service Provider, officer or director of Company has bribed another Person intending to obtain or retain business or an advantage in the conduct of business for the Company and the Company has in place adequate procedures designed to prevent any Service Provider or any officer or director of Company from undertaking any such conduct. 4.26 Export Control Legal Requirements (a) The Company has complied with all applicable export and re-export control Laws (“Export Controls”), including the Export Administration Regulations maintained by the U.S. Department of Commerce, trade and economic sanctions maintained by the U.S. Treasury Department’s Office of Foreign Assets Control, and the International Traffic in Arms Regulations maintained by the U.S. Department of State and any applicable anti- boycott compliance regulations. The Company has not directly or indirectly sold, exported, re-exported, transferred, diverted, or otherwise disposed of any products, software, or technology (including products derived from or based on such technology) to any destination, entity, or Person prohibited by Laws of the United States, Israel, or any other country, without obtaining prior authorization from the competent Governmental Authority as required by those Laws. The Company is in compliance with all applicable U.S., Israel, and foreign import Laws (“Import Restrictions”), including Title 19 of the U.S. Code and Title 19 of the Code of Federal Regulations. (b) Except as authorized, the Company has not released or disclosed controlled technical data, technology, biological or chemical materials to any foreign national whether in the United States, Israel, or abroad. (c) No Proceeding is pending or threatened, concerning or relating to any export or import activity of the Company. No voluntary self- disclosures have been filed by or for the Company with respect to possible violations of Export Controls and Import Restrictions. (d) The Seller has no Knowledge of any fact or circumstance that could result in any Liability of the Company for violation of Export Control and Import Restrictions. (e) The Company has maintained all records required to be maintained in their possession as required under the Export Control and Import Restrictions. 31 4.27 Full Disclosure This Agreement (including the Schedules and any closing deliverables) does not as of the date hereof, and will not as of the Closing: (i) contain any representation, warranty or information that is false or misleading with respect to any material fact; or (ii) omit to state any material fact necessary in order to make the representations, warranties and information contained and to be contained herein and therein (in the light of the circumstances under which such representations, warranties and information were or will be made or provided) not false or misleading. The Seller has no Knowledge of any information or other fact that is or may become materially adverse to the business, condition, assets, capitalization, Intellectual Property, Liabilities, operations, results of operations, financial performance or prospects of the Company that has not been set forth in this Agreement or in the Schedules. ARTICLE 5 COVENANTS 5.1 Access and Investigation. During the period from the date of this Agreement and continuing until the earlier of the termination of this Agreement pursuant to Article 8 or the Closing (the “Pre-Closing Period”), the Company and the Seller shall: (a) provide Buyer or an Affiliate acting on its behalf and Buyer’s representatives with reasonable access during normal business hours to the Company’s personnel and assets and to all existing books, records, Tax Returns, work papers and other documents and information relating to the Company; and (b) provide Buyer or an Affiliate acting on its behalf and Buyer’s representatives with copies of such existing books, records, Tax Returns, work papers and other documents and information relating to the Company, and with such additional financial, operating and other data and information regarding the Company, as Buyer or an Affiliate acting on its behalf may reasonably request. During the Pre-Closing Period, Buyer or an Affiliate acting on its behalf may make inquiries of Persons having business relationships with the Company, and the Company and its representatives shall help facilitate (and shall cooperate fully with Buyer or an Affiliate acting on its behalf in connection with) such inquiries. 5.2 Operation of the Business of the Company. During the Pre-Closing Period, the Company and the Seller shall: (i) conduct Company’s business in the ordinary course and use its reasonable best efforts to maintain its business, assets and Service Provider,; (ii) not issue or agree to issue any additional shares or any other voting security or any rights to acquire any such additional shares or voting security; (iii) not engage in any additional borrowings, loans or capital leases; (iv) not change the terms of compensation of Service Provider, of the Company; (v) not authorize or consummate any dividends or distributions or sale of assets or payment of management fees to Seller or others, or any consolidation, merger, sale of any of its assets or purchase of capital assets or purchase of all or substantially all of the assets other entity, or any other extraordinary corporate transaction; and (vi) not change any of its methods of accounting or accounting practices in any material respect or in respect of Taxes, nor make or change any Tax election or enter into a Tax related agreement, nor commence or settle any legal action, nor enter into any material transaction or take any other material action outside the Ordinary Course of Business or inconsistent with its past practices. Notwithstanding the foregoing, the Company may take any action described in clauses (i) through (vi) above if: (A) Buyer or an Affiliate acting on its behalf gives its prior written consent to the taking of such action by the Company; or (B) such action is expressly contemplated by this Agreement. 32 5.3 Payments to Yissum pursuant to the Yissum License. The Seller confirms that (i) Seller and/or the Company, as applicable, has notified Yissum of the transactions contemplated by this Agreement which are an Exit Event, to the satisfaction of Yissum with respect to any prior notification requirements set forth in the Yissum License; (ii) following the Closing, Seller shall promptly pay Yissum out of the Cash Consideration any and all Exit Fees which may become due and payable to Yissum under the Yissum License as a result of the completion of the transactions contemplated hereunder; and, (iii) Seller undertakes to receive from Yissum by no later than 30 days following the Closing, an agreement to defer the payment by the Company of the Historical Patents Costs until no earlier than December 31, 2018; and, in absence of such agreement by Yissum, Seller shall promptly pay Yissum out of the Cash Consideration any and all Historical Patent Costs which may become due and payable to Yissum under the Yissum License as a result of the completion of the transactions contemplated hereunder. Any defined terms in this sub-section not defined in this Agreement are as defined in the Yissum License. 5.4 Notification. (a) Notification. During the Pre-Closing Period, the Seller or the Company shall promptly notify Parent in writing of: (i) the discovery by Seller or the Company of any event, condition, fact or circumstance that occurred or existed on or prior to the date of this Agreement and that caused or constitutes a breach of or an inaccuracy in any representation or warranty made by the Seller in this Agreement; (ii) any event, condition, fact or circumstance that occurs, arises or exists after the date of this Agreement and that would cause or constitute a breach of or an inaccuracy in any representation or warranty made by the Seller in this Agreement if: (A) such representation or warranty had been made as of the time of the occurrence, existence or discovery of such event, condition, fact or circumstance; or (B) such event, condition, fact or circumstance had occurred, arisen or existed on or prior to the date of this Agreement; (iii) any breach of any covenant or obligation of the Company or the Seller; and (iv) any event, condition, fact or circumstance that would make the timely satisfaction of any of the conditions set forth in Article 6 impossible or unlikely. (b) Updates. If any event, condition, fact or circumstance that is required to be disclosed pursuant to Section 5.4(a) requires any material change in any Schedule attached hereto either by itself or together with other events, conditions, facts or circumstances, or if any such event, condition, fact or circumstance either by itself or together with other events, conditions, facts or circumstances, would require such a material change assuming the Schedule were dated as of the date of the occurrence, existence of discovery of such event, condition, fact or circumstance, then the Seller shall promptly inform the Parent in writing of such update and shall use its reasonable best efforts to deliver to Buyer or an Affiliate acting on its behalf and Parent an updated Schedule specifying such change. Any such update, if agreed to in writing by the Buyer or an Affiliate acting on its behalf and Parent, shall be deemed to supplement or amend the relevant Schedule for the purpose of: (i) determining the accuracy of any of the representations and warranties made by the Seller in this Agreement; and (ii) determining whether any of the conditions set forth in ARTICLE 6 have been satisfied. 33 5.5 No Negotiation. During the Pre-Closing Period, the Seller and the Company shall not, and shall ensure that each of the Company, and the Seller does not: (a) solicit or encourage the initiation or submission of any expression of interest, inquiry, proposal or offer from any Person (other than Buyer) relating to a possible Acquisition Transaction; (b) participate in any discussions or negotiations or enter into any agreement, understanding or arrangement with, or provide any non-public information to, any Person (other than Buyer or its Representatives) relating to or in connection with a possible Acquisition Transaction; or (c) entertain or accept any proposal or offer from any Person (other than Buyer), relating to a possible Acquisition Transaction. The Company and the Seller shall promptly notify Parent of any inquiry, indication of interest, proposal or offer relating to a possible Acquisition Transaction that is received by any of the Seller or the Company during the Pre-Closing Period (including the identity of the Person making or submitting such inquiry, indication of interest, proposal or offer, and the terms thereof). 5.6 Filings and Consents. (a) Filings. Each party shall use commercially reasonable efforts to file, as soon as practicable after the date of this Agreement, all notices, reports and other documents required to be filed by such party with any Governmental Authority with respect to the transactions contemplated by this Agreement, and to submit promptly any additional information requested by any such Governmental Authority. (b) Efforts. Subject to Section 5.6(c), each party hereto shall use commercially reasonable efforts to take, or cause to be taken, all actions necessary to consummate and make effective the transactions contemplated by this Agreement. Without limiting the generality of the foregoing, but subject to Section 5.6(c), each party to this Agreement: (i) shall make all filings (if any) and give all notices (if any) required to be made and given by such party in connection with the transactions contemplated by this Agreement; and (ii) shall use commercially reasonable efforts to obtain each consent (if any) required to be obtained (pursuant to any Applicable Law or contract, or otherwise) by such party in connection with the transactions contemplated by this Agreement. (c) Limitations. Notwithstanding anything to the contrary contained in Section 5.6(b) or elsewhere in this Agreement, Buyer and Parent shall not have any obligation under this Agreement: (i) to divest or agree to divest (or cause any of its Affiliates or the Company to divest or agree to divest) any of its respective businesses, product lines or assets, or to take or agree to take (or cause any of its Affiliates or the Company to take or agree to take) any other action or to agree (or cause any of its Affiliates or the Company to agree) to any limitation or restriction on any of its respective businesses, product lines or assets; or (ii) to contest any legal proceeding relating to the transactions contemplated by this Agreement. 5.7 Resignation of Directors. The Seller shall (and shall cause the Company to) use commercially reasonable efforts to obtain and deliver to Parent at or prior to the Closing the resignation of the directors of the Company listed on Schedule 5.74.1 hereto, effective as of the later of the Closing and the date Parent causes such director to be replaced (it being understood that such resignations shall not constitute a termination of employment by such director). In addition, at the Closing, the Seller shall deliver to Parent an irrevocable power of attorney with respect to Seller’s rights to appoint directors at the Company in accordance with the Governing Documents of the Company (the “Seller Directors POA”). 34 5.8 Ancillary Agreements. As soon as possible following the date hereof and in any event prior to the Closing, the Seller shall execute and deliver and shall cause the Company to execute and deliver to Buyer or an Affiliate acting on its behalf and/or Parent, as applicable, all agreements and documents set forth in Article 6 to be executed by the Company and such Seller. 5.9 Reasonable Efforts. Prior to the Closing: (a) the Seller shall (and shall cause the Company to) use all reasonable efforts to cause the conditions set forth in Article 6 to be satisfied on a timely basis; and (b) Buyer or an Affiliate acting on its behalf and Parent shall use all reasonable efforts to cause the conditions set forth in Article 6 to be satisfied on a timely basis. 5.10 Closing Balance Sheet. At Closing, the Company shall deliver to Parent a consolidated balance sheet of the Company as of each of December 31, 2016 and the Closing Date, satisfactory to the Parent and prepared in accordance with GAAP based upon the Company’s books and records in accordance with the Company’s accounting policies and procedures consistently applied,, in accordance with the Company’s historic past practice, and which fairly present the consolidated financial condition of the Company in all material respects as of the dates stated (the “Closing Balance Sheet”). 5.11 Communications with Employees. Prior to the Closing Date, the Seller shall not (and the Seller shall ensure that none of its respective representatives, the Company or any of the Company’s representatives) communicate with Service Provider, of the Company (which are not Seller) regarding post-Closing employment or other forms of engagement matters with Buyer or any subsidiary or Affiliate of Buyer, including post-Closing employee benefit plans and compensation, without the prior written approval of Buyer. Concurrent with the execution of this Agreement, Buyer shall provide the Company with written information to provide to the Company’s Service Provider, regarding the transition. 5.12 Litigation Support. If and for so long as any Party is actively contesting or defending against any action, suit, proceeding, hearing, investigation, charge, complaint, claim or demand in connection with (a) any transaction contemplated under this Agreement, or (b) any fact, situation, circumstance, status, condition, activity, practice, plan, occurrence, event, incident, action, failure to act or transaction on or prior to the Closing Date involving the Company, including, but not limited to any such matters arising out of a Party’s defense of any matter subject to indemnification under Article 10 as permitted pursuant to such Article 10, each of the other Parties shall cooperate with such Party and such Party’s counsel in the defense or contest, make available their personnel, and provide such testimony and access to their books and records as shall be necessary in connection with the defense or contest, all at the sole cost and expense of the contesting or defending Party (unless the contesting or defending Party is entitled to indemnification therefor under Article 10). 35 5.13 Audited Financial Statements of Company. Following the Closing, the Company shall prepare and deliver to Parent by no later than March 1, 2017, those historical audited financial statements relating to the Company, including notes thereto, as Parent is required or otherwise intends to file with the SEC pursuant to the Exchange Act and/or the Securities Act, including as of and for the year ended December 31, 2016, (the “Company Financial Statements”), which Company Financial Statements shall fairly and accurately present in all material aspects the financial position of the Company. Following the Closing, the Company shall provide Parent all such information as is reasonably necessary to enable Parent to prepare and file with the SEC any pro forma financial statements of the Parent consolidated with the Company which may be required to be filed by Parent pursuant to the Exchange Act and/or the Securities Act. 5.14 Listing of Consideration Shares. Parent shall use commercially reasonable efforts to cause the Consideration Shares to be approved for listing on the Tel Aviv Stock Exchange as soon as possible prior to or following the Closing. 5.15 Restrictive Covenants (a) Public Announcements; Confidentiality. From and after the date of this Agreement: (i) Seller hereby covenants with and undertakes to Buyer and Parent that the Company and Seller shall not (and the Company and Seller shall ensure that its representatives, the Company and the Company’s representatives do not) issue any press release or make any public statement (other than to any Service Provider of the Company on a need to know basis) regarding (or otherwise disclose to any Person the existence or terms of) this Agreement or any of the other transactions or documents contemplated by this Agreement, without Buyer’s (or an Affiliate acting on its behalf) prior written consent. (ii) The Seller agrees that at all times after the date of this Agreement the Seller shall keep strictly confidential all Confidential Information relating to the Company, the Parent and the Buyer, and their respective Affiliates, including the Intellectual Property of the Company. (iii) Notwithstanding anything to the contrary in this Agreement, in case any Confidential Information or other information concerning the Parties hereto or the transactions contemplated hereunder is information that may be considered "material non-public information" pursuant to the securities laws and regulations governing Parent and the securities exchanges on which its shares are traded – the Seller hereby undertakes not to make any unlawful use of such information, including by way of effecting a transaction in a security of Parent while the information or any part thereof is in the Seller's or Company’s possession. The Seller represents that it is aware, and will advise the Company, and its respective representatives. Service Providers, directors, officers, employees, consultants and agents who are informed of the matters that are the subject of this Agreement, of the restrictions imposed by the applicable securities laws on the purchase or sale of securities by any person who has received material, non-public information regarding a company with publicly traded securities, as well as the restrictions making it unlawful to communicate such information to any other person when it is reasonably foreseeable that such other person is likely to purchase or sell securities in reliance upon such information. 36 (iv) Notwithstanding that which is stated in elsewhere in this Agreement, to the extent that Parent is required under any applicable securities law, or by the applicable rules of any stock exchange on which Parent lists its securities, to deliver any notice to a stock exchange or relevant securities regulatory authority and/or issue any press release or public announcement with respect to the commercial relationship between the Parties hereto and/or this Agreement, including the filing of a copy of this Agreement or any schedules, exhibits or annexes thereof, as may be required by law, it shall be permitted to issue such release, make such announcement, or file such filing. (a) Non-Competition. The Seller covenants and agrees that, during the period beginning on the Closing Date and ending on the fifth anniversary of the Closing Date (the “Restricted Period”), it and its Affiliates will not, directly or indirectly, engage or participate in any manner (as an owner, equity holder, financing source, director, manager, officer, employee, agent, representative, consultant, Service Provider or otherwise) in any business that is or may reasonably be considered to be competitive with any business engaged in by the Company, the Buyer or Parent or any of their respective Affiliates, anywhere in the world. Notwithstanding the foregoing, nothing contained in this Section 5.15(a) 5.15 will prohibit the Seller or its Affiliates from the passive ownership of less than 5% of any class of stock listed on a national securities exchange or traded in the over-the-counter market. (b) Non-Solicitation of Business Relationships. Without limiting the generality of the provisions of Section 5.15(a) 5.15 above, the Seller covenants and agrees that during the Restricted Period it and its Affiliates will not, directly or indirectly, solicit, induce or advise or participate in any manner (as an owner, equity holder, financing source, director, manager, officer, employee, agent, representative, consultant, Service Provider or otherwise) in any business that solicits, induces or advises, any Person that is or was a customer, supplier or other business relation of the Company at any time during the 48 month period prior to the Closing Date for purposes of diverting such Person’s business from the Buyer or any of its Affiliates or providing any goods or services which are or may reasonably be considered to be competitive with those provided by the Company, Buyer or Parent or any of their respective Affiliates. (c) Non-Solicitation of Employees and Contractors. The Seller covenants and agrees that during the Restricted Period it and its Affiliates will not, directly or indirectly, solicit, induce, employ or engage, or participate in any manner (as an owner, equity holder, financing source, director, manager, officer, employee, agent, representative, consultant, Service Provider or otherwise) in any business that solicits, induces, employs or engages, any individual that served as a Service Provider or independent contractor to the Company, Buyer or Parent or any of their respective Affiliates at any time during the 12 month period prior to the Closing Date, or otherwise seek to influence or alter any such individual’s relationship with the Company, Buyer or Parent or any of their respective Affiliates. 37 (d) Non-Disparagement. The Seller covenant and agree that it and its Affiliates will not, directly or indirectly, make, cause to be made or condone the making of any statement or other communication, written or otherwise, that could constitute disparagement or criticism of, or that could otherwise be considered to be derogatory or detrimental to, or otherwise reflect adversely on, harm the reputation of, or encourage any adverse action against the Company, Buyer or Parent or any of their respective Affiliates or Service Providers. (e) Acknowledgements; Remedies. The Seller acknowledges and agrees that (i) the covenants and agreements set forth in this Section 5.15 were a material inducement to the Buyer and Parent to enter into this Agreement and to perform their obligations hereunder, (ii) the Buyer, Parent and their respective stakeholders would not obtain the benefit of the bargain set forth in this Agreement as specifically negotiated by the Parties if the Seller or any of its Affiliates breached any provision of this Section 5.15, (iii) any breach of any provision of this Section 5.15 by the Seller or any of its respective Affiliates would result in a significant loss of goodwill by the Buyer, Parent and the Company, (iv) the Consideration is sufficient consideration to make the covenants and agreements set forth herein enforceable, (v) the length of time, scope and geographic coverage of the covenants set forth in this Section 5.15 is reasonable given the benefits the Seller will directly or indirectly receive hereunder, and (vi) The Seller will not challenge the reasonableness of the time, scope, geographic coverage or other provisions of this Section 5.15(a) 5.15 in any Proceeding, regardless of who initiates such Proceeding. The Seller agree that in the event of any actual or threatened breach by the Seller or any of its respective Affiliates of any of the provisions contained in this Section 5.15(a) 5.15, the Buyer will be entitled to injunctive and other equitable relief without (A) posting any bond or other security, (B) proving actual damages and (C) showing that monetary damages are an inadequate remedy. Nothing contained herein will be construed as prohibiting the Buyer or Parent or any of their respective Affiliates from pursuing any other remedies available to it for such breach or threatened breach, including the recovery of any damages that it is able to prove. The Seller will cause each of its Affiliates to comply with this Section 5.15, and will be liable for any breach by any of its Affiliates of this Section 5.15(a) 5.15. In the event of a breach or violation by the Seller or any of its respective Affiliates of this Section 5.15(a) 5.15, the Restricted Period with respect to the Seller will be extended by a period of time equal to the period of time during which such Person violates the terms of this Section 5.15(a)5.15. 5.16 Lock-Up (a) Agreement to Lock-Up. Seller hereby agrees that it will not, without the prior written consent of the Buyer, during the period commencing on the date of the issuance of each of the Consideration Shares (such date, the “Issue Date”) and ending on the date that is twelve months after the Issue Date, lend, offer, pledge, sell, contract to sell, sell any option or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase, or otherwise transfer or dispose of, directly or indirectly, any of the applicable Shares or enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the applicable Shares (each of the foregoing, a “Transaction”). Seller further agrees to execute such agreements as may be reasonably requested by Parent that are consistent with this Section 5.16 or that are necessary to give further effect hereto, including the execution of any agreements that are necessary to give further effect hereto with respect to any permitted transferee of the Consideration Shares (in whole or in part), including the form of individual agreement to be entered into at Closing by Seller with Parent covering corporate governance arrangements, including the Post-Closing Parent Corporate Governance Agreement. 38 (b) Stop Transfer Instructions. In order to enforce the foregoing covenant, Seller further agrees that the Parent may impose stop-transfer instructions with respect to the applicable Shares and/or any of Parent’s American Depositary Shares which may be issued to represent such Shares, until the end of such restricted period. 5.17 Excess Post-Closing Company Liabilities. Following the Closing, the Seller shall be entitled to negotiate, in consultation with Buyer or an Affiliate thereof acting on Buyer’s behalf, with any Persons which are due any Company Closing Liabilities, in order to reduce the obligations of the Company with respect to such Company Closing Liabilities. Following the completion of such negotiations, which in any event shall not extend past the Initial Escrow Fund Release Date, any remaining outstanding Company Closing Liabilities which are in excess of the Excess Company Closing Liabilities Amount shall be on account of the Seller (the “Excess Post-Closing Company Liabilities”). 5.18 General. If at any time after the Closing any further action is necessary to carry out the purposes of this Agreement, each of the Parties will take such further action (including the execution and delivery of such further instruments and documents) as any other Party reasonably may request. ARTICLE 6 CONDITIONS PRECEDENT TO OBLIGATIONS OF BUYER The obligations of Buyer or an Affiliate acting on its behalf to cause the transactions contemplated by this Agreement to be consummated are subject to the satisfaction (or waiver by Buyer or an Affiliate acting on its behalf), at or prior to the Closing, of each of the following conditions: 6.1 Accuracy of Representations. Each of the representations and warranties of the Seller and/or any Affiliate of the above which is a party to a Transaction Document containing such representations and warranties (whether as original party, transferee or by joinder agreement) contained in a Transaction Document or any schedule, certificate or other document delivered pursuant thereto or in connection with the transactions contemplated thereby that are subject to materiality or similar qualifications or exceptions will be true and correct in all respects on and as of the date of this Agreement and as of the Closing as if made at and as of the Closing (other than such representations and warranties that are made as of a specified date, which representations and warranties will be true and correct in all respects as of such date), and each of the representations and warranties of the Seller and/or any Affiliate of the above which is a party to a Transaction Document containing such representations and warranties (whether as original party, transferee or by joinder agreement) contained in a Transaction Document or any schedule, certificate or other document delivered pursuant thereto or in connection with the transactions contemplated thereby that are not subject to materiality or similar qualifications or exceptions will be true and correct in all material respects on and as of the date hereof and as of the Closing as if made at and as of the Closing (other than such representations and warranties that are made as of a specified date, which representations and warranties will be true and correct in all material respects as of such date). 39 6.2 Performance of Covenants. Each of the covenants and obligations of the Seller, or the Company are required to comply with or to perform at or prior to the Closing shall have been complied with and performed in all material respects. 6.3 Governmental and Other Consents. (a) Governmental Consents. All filings with, notices to and other consents of any Governmental Authority required to be made or obtained on or prior to the Closing Date in connection with the transactions contemplated by this Agreement shall have been made or obtained and shall be in full force and effect and any waiting period under any applicable antitrust or competition law, regulation or other Applicable Law shall have expired or been terminated. (b) TASE Consent. The authorization of the TASE for the listing of the Consideration Shares. (c) Other Consents. Buyer or an Affiliate acting on its behalf shall have received evidence satisfactory to Buyer or an Affiliate acting on its behalf that all consents identified in Schedule 6.3 (b) (c) shall have been obtained and shall be in full force and effect, and all other material consents of third parties (other than governmental authorities) required to be obtained in connection with the transactions contemplated by this Agreement shall have been obtained and shall be in full force and effect. 6.4 No Material Adverse Effect. Since the date of this Agreement, there shall not have occurred any Material Adverse Effect. 6.5 Deliverables. The Seller shall have delivered to Buyer or an Affiliate acting on its behalf each of the deliverables detailed in Section 2.4 above. 6.6 No Restraints. No temporary restraining order, preliminary or permanent injunction or cease and desist or other order preventing the consummation of the transactions contemplated by this Agreement, or imposing fines, assessments, costs, liabilities or penalties in respect thereof, shall have been issued by any court of competent jurisdiction or Governmental Authority and remain in effect, and there shall not be any legal requirement enacted or deemed applicable to the transactions contemplated by this Agreement that makes consummation of such transactions illegal. 40 6.7 Employee Matters. The Seller and the Company shall have confirmed that with respect to each of the Company Service Providers listed on Schedule 6.7, such Service Provider remains engaged by the Company, as applicable, and none of such Service Providers as aforesaid shall have expressed an intention or interest (whether formally or informally) in, or taken any action toward, terminating his or her engagement with the Company, Buyer or an Affiliate thereof before or after the Closing. The Company shall have accrued in full all any compensation, wage, bonus, commission, vacation pay and other employment and/or service related benefits accrued through the Closing. 6.8 No Legal Proceedings. No Governmental Authority and no other Person shall have commenced or threatened (or made any determination) to commence any legal proceeding: (a) challenging any of the transactions contemplated by this Agreement or seeking the recovery of damages in connection with any of the transactions contemplated by this Agreement; (b) seeking to prohibit or limit the exercise by Buyer or an Affiliate acting on its behalf of any material right pertaining to its ownership of the Shares; (c) seeking to materially restrict or condition, or that may have the effect of preventing, delaying, making illegal or otherwise interfering with, the transactions contemplated by this Agreement; or (d) seeking to compel any of the Company, Buyer or any Affiliate of Buyer to dispose of or hold separate any material assets as a result of the transactions contemplated by this Agreement. ARTICLE 7 CONDITIONS PRECEDENT TO OBLIGATIONS OF SELLER The obligations of Seller to consummate the transactions contemplated by this Agreement are subject to the satisfaction (or waiver by the Seller), at or prior to the Closing, of the following conditions: 7.1 Accuracy of Representations. Each of the representations and warranties of the Buyer or Parent, as applicable, contained in the Transaction Documents or any schedule, certificate or other document delivered pursuant thereto or in connection with the transactions contemplated thereby that are subject to materiality or similar qualifications or exceptions will be true and correct in all respects on and as of the date of this Agreement and as of the Closing as if made at and as of the Closing (other than such representations and warranties that are made as of a specified date, which representations and warranties will be true and correct in all respects as of such date), and each of the representations and warranties of the Buyer contained in the Transaction Documents or any schedule, certificate or other document delivered pursuant thereto or in connection with the transactions contemplated thereby that are not subject to materiality or similar qualifications or exceptions will be true and correct in all material respects on and as of the date hereof and as of the Closing as if made at and as of the Closing (other than such representations and warranties that are made as of a specified date, which representations and warranties will be true and correct in all material respects as of such date). 7.2 Performance of Covenants. Each of the covenants and obligations that Buyer or an Affiliate acting on its behalf or Parent is required to comply with or to perform at or prior to the Closing shall have been complied with and performed in all material respects. 41 7.3 The Consideration. The Seller shall have received: (a) the Cash Consideration (minus the Escrow Amount and the Third Party Fee); (b) the Consideration Shares represented by Parent share certificates and an updated Parent share register duly endorsed or with duly executed stock power representing each of the Consideration Shares and deliverable to the Escrow Agent, as applicable. 7.4 No Restraints. No temporary restraining order, preliminary or permanent injunction or cease and desist or other order preventing the consummation of the transactions contemplated by this Agreement, or imposing fines, assessments, costs, liabilities or penalties in respect thereof, shall have been issued by any court of competent jurisdiction or Governmental Authority and remain in effect, and there shall not be any legal requirement enacted or deemed applicable to the transactions contemplated by this Agreement that makes consummation of such transactions illegal. 7.5 No Legal Proceedings. No Governmental Authority and no other Person shall have commenced or threatened (or made any determination) to commence any legal proceeding: (a) challenging any of the transactions contemplated by this Agreement or seeking the recovery of damages in connection with any of the transactions contemplated by this Agreement; (b) seeking to prohibit or limit the exercise by Seller of any material right pertaining to its ownership of the Consideration Shares; or (c) seeking to materially restrict or condition, or that may have the effect of preventing, delaying, making illegal or otherwise interfering with, the transactions contemplated by this Agreement. ARTICLE 8 TERMINATION 8.1 Termination Events. This Agreement may be terminated prior to the Closing: (a) by the mutual written consent of Buyer or an Affiliate acting on its behalf and Seller; (b) by any Party hereto if the Closing has not taken place on or before 13:00 a.m. (Israel time) on January 13, 2017, unless such Party is in breach of any of the provisions of this Agreement; (c) by either Buyer or an Affiliate acting on its behalf or the Seller if: (i) a court of competent jurisdiction or other Governmental Authority shall have issued a final and nonappealable order, decree or ruling, or shall have taken any other action, having the effect of permanently restraining, enjoining or otherwise prohibiting the transactions contemplated by this Agreement; or (ii) there shall be any legal requirement enacted, promulgated, issued or deemed applicable to the transactions contemplated by this Agreement by any Governmental Authority that would make consummation of such transactions illegal; 42 (d) by Buyer or an Affiliate acting on its behalf if: (i) any of the representations and warranties of the Seller contained in this Agreement shall be inaccurate as of the date of this Agreement, or shall have become inaccurate as of a date subsequent to the date of this Agreement, such that the condition set forth in Section 6.1 would not be satisfied; (ii) any of the covenants and obligations which the Seller or the Company are required to comply with or to perform as set forth in this Agreement shall have been breached such that the condition set forth in Section 6.2 would not be satisfied; or (iii) a Material Adverse Effect shall have occurred and the change or effect resulting therefrom continues in effect such that the condition set forth in Section 6.4 would not be satisfied; provided, however, that, for purposes of clauses “(i)” and “(ii)” only, if an inaccuracy in any of the representations and warranties of the Seller as of a date subsequent to the date of this Agreement or a breach of a covenant or obligations by the Seller or the Company) is curable by the Company, or the Seller through the use of reasonable efforts before 13:00 p.m. (Israel time) on January 13, 2017 after Buyer or an Affiliate acting on its behalf notifies the Seller in writing of the existence of such inaccuracy or breach (the “Seller Cure Period”), then Buyer may not terminate this Agreement under this Section 8.1(d) as a result of such inaccuracy or breach prior to the expiration of the Seller Cure Period, provided that the Company, the Seller, during the Seller Cure Period, continue to exercise reasonable efforts to cure such inaccuracy or breach (it being understood that Buyer may not terminate this Agreement pursuant to this Section 8.1(d) with respect to such inaccuracy or breach if such inaccuracy or breach is cured prior to the expiration of the Seller Cure Period); or (e) by the Seller if: (i) any of Buyer’s or Parent’s representations and warranties contained in this Agreement shall be inaccurate as of the date of this Agreement, or shall have become inaccurate as of a date subsequent to the date of this Agreement, such that the condition set forth in Section 7.1 would not be satisfied; or (ii) if any of Buyer’s or Parent’s covenants contained in this Agreement shall have been breached such that the condition set forth in Section 6.4 would not be satisfied; provided, however, that if an inaccuracy in any of Buyer’s or Parent’s representations and warranties as of a date subsequent to the date of this Agreement or a breach of a covenant by Buyer or Parent is curable by Buyer or Parent through the use of reasonable efforts before 13:00 p.m. (Israel time) on January 13, 2017 after the Seller notifies Parent in writing of the existence of such inaccuracy or breach (the “Buyer Cure Period”), then the Seller may not terminate this Agreement under this Section 8.1(e) as a result of such inaccuracy or breach prior to the expiration of the Buyer Cure Period, provided Buyer or an Affiliate acting on its behalf or Parent, as applicable, during the Buyer Cure Period, continues to exercise reasonable efforts to cure such inaccuracy or breach (it being understood that the Seller may not terminate this Agreement pursuant to this Section 8.1(e) with respect to such inaccuracy or breach if such inaccuracy or breach is cured prior to the expiration of the Buyer Cure Period). 8.2 Termination Procedures. If Buyer or an Affiliate acting on its behalf wishes to terminate this Agreement pursuant to Section 8.1, Parent shall deliver to the Seller a written notice stating that Buyer is terminating this Agreement and setting forth a brief description of the basis on which Buyer is terminating this Agreement. If the Seller wishes to terminate this Agreement pursuant to Section 8.1, the Seller shall deliver to Parent a written notice stating that the Seller is terminating this Agreement and setting forth a brief description of the basis on which the Seller is terminating this Agreement. 43 8.3 Effect of Termination. If this Agreement is terminated pursuant to Section 8.1, all further obligations of the Parties shall terminate, other than those obligations which by their nature are meant to survive termination of this Agreement. Nothing in the foregoing shall be construed as restricting any Party from terminating this Agreement for breach by the other Party as provided by Applicable Law or impair the right of any Party to obtain such remedies as may be available to it in law or equity with respect to such a breach by any other Party. ARTICLE 9 [RESERVED] ARTICLE 10 INDEMNIFICATION 10.1 Survival of Representations, Etc. Subject to the limitations in this Article 10, all covenants, agreements, representations and warranties made by Seller and Buyer pursuant to this Agreement shall be deemed to have survived the Closing and shall remain effective, subject to the provisions of Section 10.5. 10.2 Indemnification Provisions for Benefit of Buyer and Parent. Subject to the limitations in this Article 10, following the Closing, the Seller shall indemnify and save and hold Buyer and Parent and their Affiliates and their respective equity holders, officers, directors, managers, employees, attorneys, accountants, consultants, financial advisors and other agents (“Buyer Indemnified Parties”) harmless from and against any Damages suffered or incurred by any Buyer Indemnified Party (provided that Seller shall be limited in his or its respective obligations hereunder by the other limitations set forth in this Article 10) arising out of or resulting from: (a) a breach of any representation or warranty made by Seller in this Agreement; or (b) the failure of Seller or Company duly to perform or observe any covenant or agreement in this Agreement required on the part of Seller or Company to be performed or observed before the Closing Date; or (c) the failure of Seller duly to perform or observe any covenant or agreement in this Agreement required on the part of Seller to be performed or observed after the Closing Date. 44 10.3 Indemnification Provisions for Benefit of Seller. Following the Closing, Buyer shall indemnify, and save and hold harmless the Seller, its Affiliates and their respective equity holders, officers, directors, managers, employees, attorneys, accountants, consultants, financial advisors and other agents (“Seller Indemnified Parties”) from and against any Damages suffered or incurred by any one or more of them arising out of or resulting from: (a) a breach of any representation or warranty made by Buyer or Parent in this Agreement; or (b) the failure of Buyer or Parent duly to perform or observe any covenant or agreement in this Agreement required on the part of Buyer or Parent to be performed or observed before or after the Closing Date. 10.4 Exclusive Remedy. This Article 10 constitutes the Buyer’s, Parent’s and Seller’s sole and exclusive remedy for any and all Damages or other claims (excluding any actions for specific performance) relating to or arising from this Agreement, any of the agreements, documents and instruments executed and delivered in connection herewith or the transactions contemplated by any of the foregoing. Neither of Buyer, Parent nor Seller may avoid such limitation on Liability by seeking damages for breach of contract, tort, cost recovery or contribution pursuant to any other theory of Liability, other than claims based on fraud or intentional misrepresentation or willful misconduct. 10.5 Damage to Buyer. The Parties acknowledge and agree that, if the Company suffers, incurs or otherwise becomes subject to any Damages as a result of or in connection with any inaccuracy in or breach of any representation, warranty, covenant or obligation, then (without limiting any of the rights of Company as an indemnitee), Buyer shall also be deemed, by virtue of its ownership of the Shares, to have incurred Damages as a result of and in connection with such inaccuracy or breach. 10.6 Term. (a) Any rights of a Buyer Indemnified Party to indemnification under this Agreement (including under Section 10.2) shall apply only to those claims written notice of which shall have been delivered by Buyer or an Affiliate acting on its behalf to Seller on or before twenty four (24) months from the date hereof (such period on or before twenty (24) months from the date hereof, the “Survival Period”), except that such indemnification obligations with respect to breaches of any representation or warranty in the case of fraud or criminal activity, will survive the Closing and continue indefinitely. (b) Any rights of any Seller Indemnified Party to indemnification under this Agreement (including under Section 10.3) shall apply only to those claims written notice of which shall have been delivered by Seller to Buyer on or before the end of the Survival Period, except that such indemnification obligations with respect to breaches of any representation or warranty in the case of fraud or criminal activity, will survive the Closing and continue indefinitely. (c) Notwithstanding anything in this Article 10 to the contrary, the covenants of the Parties shall survive according to their respective terms. 10.7 Indemnification Limitations. Any right of an Indemnified Party to indemnification under this Agreement shall not apply to any claim until the aggregate of all such claims which have become final totals at least $100,000 (the “Indemnity Basket”), in which event such indemnity shall apply to all such claims which become final, but only to the extent of the amount in excess of the Indemnity Basket. 45 10.8 Indemnification Procedure (a) In the event that any Person entitled to indemnification under this Agreement (an “Indemnified Party”) receives notice of the assertion of any claim or of the commencement of any Proceeding by any Person who is not a Party or an Affiliate of a Party (a “Third Party Claim”) against such Indemnified Party, with respect to which a Party is or may be required to provide indemnification under this Agreement (an “Indemnifying Party”), the Indemnified Party will give written notice regarding such Third Party Claim to the Indemnifying Party within 30 days after learning of such Third Party Claim, provided that the failure to so notify an Indemnifying Party will not relieve the Indemnifying Party of its obligations under this ARTICLE 10.8 except to the extent (and only to the extent) that the Indemnifying is materially prejudiced by reason of such failure, and will not relieve such Indemnifying Party from any other obligation that it may have to an Indemnified Party other than under this ARTICLE 10. (b) The Indemnifying Party will be entitled to participate in the defense of such Third Party Claim at such Indemnifying Party’s expense (which expenses will not be applied against any indemnity limitation herein). The Indemnifying Party at its option will be entitled to assume the defense thereof (subject to the limitations set forth below) by (i) delivering written notice to the Indemnified Party of its election to assume the defense of such Third Party Claim within 15 days of receipt of notice from the Indemnified Party, (ii) appointing a nationally recognized and reputable counsel reasonably acceptable to the Indemnified Party to be the lead counsel in connection with such defense and (iii) entering into a written agreement with the Indemnified Party that the Indemnifying Party is unconditionally obligated to pay and satisfy any Losses which may arise with respect to such Third Party Claim and provides evidence of its ability to satisfy such obligation, in each case, in form and substance reasonably satisfactory to the Indemnified Party. If the Indemnifying Party does not expressly elect to assume the defense of such Third Party Claim within the time period and otherwise in accordance with the preceding sentence, the Indemnified Party will have the sole right to assume the defense of and to settle such Third Party Claim. (c) If the Indemnifying Party has assumed the defense of a Third Party Claim in accordance with the terms hereof, the Indemnified Party will be entitled to participate in the defense of such claim and to employ counsel of its choice for such purpose, and the fees and expenses of such separate counsel will be borne by the Indemnified Party other than any fees and expenses of such separate counsel (i) that are incurred prior to the date the Indemnifying Party assumes control of such defense, (ii) if the Indemnified Party reasonably will have concluded (upon advice of its counsel) that there may be one or more legal defenses available to such Indemnified Party that are not available to the Indemnifying Party, or (iii) if the Indemnifying Party may have different, conflicting, or adverse legal positions or interests from the Indemnified Party with respect to such Third Party Claim. 46 (d) Notwithstanding anything to the contrary contained herein, the Indemnifying Party will not be entitled to assume the defense of a Third Party Claim (and the Indemnified Party will be entitled to maintain or assume control of the defense of such Third Party Claim) if (i) the Third Party Claim relates to or involves any criminal or quasi criminal Proceeding, (ii) the Indemnified Party reasonably believes an adverse determination with respect to the Third Party Claim would be detrimental to or injure the Indemnified Party’s reputation or future business prospects, (iii) the Third Party Claim seeks an injunction or other equitable relief against the Indemnified Party, (iv) the Indemnified Party reasonably believes that the Losses relating to the claim could exceed the maximum amount that such Indemnified Party would then be entitled to recover under this ARTICLE 10, (v) the Third Party Claim involves Taxes, (vi) there exists or would, or could reasonably be expected to, exist a conflict of interest that would make it inappropriate in the judgment of the Indemnified Party for the same counsel to represent both the Indemnified Party and the Indemnifying Party, (vii) the Indemnified Party elects to pursue one or more defenses or counterclaims available to it that are inconsistent with one or more of those that are being pursued by the Indemnifying Party in respect of such Third-Party Claim or any litigation relating thereto, (viii) the Third Party Claim involves a material customer or material supplier of the Indemnified Party, or (ix) the Indemnifying Party fails to vigorously defend the Third Party Claim. (e) If the Indemnifying Party will assume the defense of any Third Party Claim, the Indemnifying Party will obtain the prior written consent of the Indemnified Party before entering into any settlement of, consenting to the entry of any judgment with respect to or ceasing to defend such Third Party Claim. (f) The indemnification required hereunder in respect of a Third Party Claim will be made by prompt payment by the Indemnifying Party of the amount of actual Losses in connection therewith, as and when bills are received by the Indemnifying Party or within 10 days following the Indemnifying Party’s receipt of notice that Losses have been incurred. (g) Notwithstanding the provisions of Section 11.13, each Indemnifying Party hereby consents to the nonexclusive jurisdiction of any court in which a Proceeding in respect of a Third Party Claim is brought against any Indemnified Party for purposes of any claim that an Indemnified Party may have under this Agreement with respect to such Proceeding or the matters alleged therein and agrees that process may be served on each Indemnifying Party with respect to such claim anywhere. (h) The Indemnifying Party will not be entitled to require that any Proceeding be made or brought against any other Person before a Proceeding is brought or claim is made against it hereunder by the Indemnified Party. (i) In the event any Indemnified Party has a claim against any Indemnifying Party hereunder that does not involve a Third Party Claim being asserted against or sought to be collected from such Indemnified Party, the Indemnified Party will deliver notice of such claim with reasonable promptness to the Indemnifying Party, provided that the failure to so notify an Indemnifying Party will not relieve the Indemnifying Party of its obligations under this ARTICLE 10 except to the extent (and only to the extent) that the Indemnifying Party is materially prejudiced by reason of such failure, and will not relieve such Indemnifying Party from any other obligation that it may have to an Indemnified Party other than under this ARTICLE 10. If the Indemnifying Party does not notify the Indemnified Party within 10 days following its receipt of such notice that the Indemnifying Party disputes its Liability to the Indemnified Party hereunder, such claim specified by the Indemnified Party in such notice will be conclusively deemed a Liability of the Indemnifying Party hereunder and the Indemnifying Party will pay the amount of such Liability to the Indemnified Party on demand. 47 (j) If the Indemnifying Party agrees that it has an indemnification obligation under this ARTICLE 10 but asserts that it is obligated to pay a lesser amount than that claimed by the Indemnified Party, the Indemnifying Party will pay such lesser amount promptly to the Indemnified Party, without prejudice to or waiver of the Indemnified Party’s claim for the difference. 10.9 Materiality Qualifiers. Notwithstanding anything to the contrary contained herein, for purposes of determining (a) whether a breach of a representation or warranty exists for purposes of this Agreement or any schedule, certificate or other document delivered pursuant hereto or thereto, (b) the amount of Losses arising from such a breach for which Indemnified Parties are entitled to indemnification under this Agreement and (c) whether the Basket Amount has been exceeded, each such representation and warranty will be read without giving effect to any qualification that is based on materiality, including the words “material,” “material adverse effect,” “in any material respect” and other uses of the word “material” or words of similar meaning (and will be treated as if such words were deleted from such representation or warranty). 10.10 Investigation. Notwithstanding anything to the contrary contained herein, if the transactions contemplated hereby are consummated, the Buyer Indemnified Parties t expressly reserve the right to seek indemnity or other remedy for any Losses arising out of or relating to any breach of any representation, warranty or covenant contained herein, notwithstanding (a) any investigation by, disclosure to or Knowledge of the Buyer or Parent or any of their respective Affiliates or the directors, officers, employees, consultants, financial advisors, counsel, accountants and other agents of the Buyer or Parent or any of their respective Affiliates in respect of any fact or circumstances that reveals the occurrence of any such breach, whether before or after the execution and delivery hereof, or (b) the Buyer’s waiver of any condition to the Closing or participation in the Closing. 10.11 Satisfaction of Indemnification Claims. For any claim for indemnification under ARTICLE 10, the Buyer Indemnified Parties will first seek satisfaction of such indemnification claim from the Escrow Fund until such amounts have been distributed to the Seller or have been exhausted, before seeking indemnification directly from the Seller, provided that, for any claims for indemnification under ARTICLE 10 with respect to a breach of a Fundamental Representation, the Buyer Indemnified Parties will have the right (but not the obligation) to seek satisfaction of such claim directly from the Seller. If any amount owed under this ARTICLE 10 is not paid within 10 days of the Indemnifying Parties and the Indemnified Parties agreeing such amount is due or upon a final adjudication determined by a court of competent jurisdiction that such amount is due (either, a “Final Determination”), the Buyer may, in its sole discretion, in addition to all other remedies it may have, recover some or all of such amount by setting off such amount against any amounts then due and payable by the Buyer or any of its Affiliates to the Seller or any of its Affiliates under the Transaction Documents or any other agreement with the Seller. In each case, the exercise of such right to cancel or set off will not constitute a breach of any Buyer Indemnified Party’s obligations under the Transaction Documents or any other agreement with the Seller, and the exercise or failure to exercise such right to cancel or set off will not constitute an election of remedies or limit any Party in any manner in the enforcement of any other remedies that may be available to such Party. 48 10.12 Waiver of Contribution. The Seller hereby irrevocably waives and releases any right of contribution, subrogation or any similar right against any Buyer Indemnified Party in respect of matters that are or may become the subject of claims for indemnification hereunder and any indemnification payments that the Seller may, at any time, be required to make to any Indemnified Party pursuant to this Agreement. 10.13 Tax Treatment of Payments. All indemnification payments made pursuant to this Agreement will be treated by the Buyer, the Seller and its respective Affiliates, to the extent permitted by Law, as an adjustment to the Purchase Price for Income Tax purposes. 10.14 Release of Escrow Fund. (a) On the fifth Business Day following satisfaction by Seller and/or Company, as applicable, of all of their respective obligations under both of Section 5.3 and Section 5.13 (the “Initial Escrow Fund Release Date”), the Escrow Agent will release to the Seller the amount of any remaining Cash Consideration in the Escrow Fund, minus: (i) the aggregate amount of all Excess Company Post-Closing Liabilities, which shall be transferred by Escrow Agent to the Buyer or an Affiliate acting on its behalf; (ii) the aggregate amount (as determined by the Buyer, or an Affiliate acting on its behalf, in its commercially reasonable discretion) reasonably necessary to serve as security for any unresolved indemnification claims with respect to a breach of any Fundamental Representation, or a breach of any representation, warranty or covenant in the case of fraud or criminal activity, previously made by a Buyer- related Indemnified Party based on the facts and circumstances existing at the time (a “Withheld Indemnity Amount”); and (iii) any remaining portion of the Third Party Fee represented by any Cash Consideration remaining in the Escrow Account which is in excess of any Excess Company Post-Closing Liabilities and any Withheld Indemnity Amount, which shall be paid to Seller Agent on behalf of the Seller for all or part of the remaining portion of the Third Party Fee. (b) On the fifth Business Day following the Expiration Date, the Escrow Agent will release to the Seller the amount of any remaining value of the Escrow Fund, minus (i) the aggregate amount (as determined by the Buyer, or an Affiliate acting on its behalf, in its commercially reasonable discretion) reasonably necessary to serve as security for any unresolved indemnification claims with respect to a breach of any Fundamental Representation, or a breach of any representation, warranty or covenant in the case of fraud or criminal activity, previously made by a Buyer-related Indemnified Party based on the facts and circumstances existing at the time; and, (ii) any remaining portion of the Third Party Fee remaining in the Escrow Account which is in excess of any Withheld Indemnity Amount, which shall be paid to Seller Agent on behalf of the Seller for all or part of the remaining portion of the Third Party Fee. 49 ARTICLE 11 MISCELLANEOUS 11.1 Entire Agreement. This Agreement and all Schedules, exhibits, annexes or other attachments hereto or thereto, and the certificates, documents, instruments and writings that are delivered pursuant hereto or thereto, constitutes the entire agreement and understanding of the Parties in respect of the subject matter hereof and supersedes all prior understandings, agreements, undertakings or representations by or among the Parties, written or oral, to the extent they relate in any way to the subject matter hereof. 11.2 No Third Party Beneficiaries. Other than as otherwise explicitly set forth herein, there are no third party beneficiaries having rights under or with respect to this Agreement. For avoidance of doubt it is hereby clarified that neither the Company nor Yissum, (and none of their respective officers or directors, agents, Service Providers or any other Person acting on their behalf), nor any shareholder of the Company which is not a Seller hereunder, are third party beneficiaries of this Agreement. 11.3 Assignment; Binding Effect. No Party other than Buyer or an Affiliate acting on its behalf or the Parent, as applicable, may assign either this Agreement or any of its rights, interests or obligations hereunder without the prior written approval of the other Parties, and any such assignment by a Party without prior written approval of the other Parties will be deemed invalid and not binding on such other Parties. Notwithstanding anything herein to the contrary, Buyer or an Affiliate acting on its behalf or Parent may assign or transfer any of its rights, privileges, or obligations set forth in, arising under, or created by this Agreement to any Affiliate, provided that Buyer and Parent remain obligated hereunder. All of the terms, agreements, covenants, representations, warranties and conditions of this Agreement are binding upon, inure to the benefit of and are enforceable by, the Parties and their respective successors and permitted assigns. 11.4 Notices. All notices, requests, demands, claims, and other communications hereunder shall be in writing. Any notice, request, demand, claim or other communication hereunder shall be deemed duly delivered, given and received (a) if delivered by hand, when delivered; (b) if sent via facsimile transmission before 10:00 a.m. (Israel time) on any Business Day, when receipt is confirmed; (c) if sent via facsimile transmission on a day other than a Business Day and receipt is confirmed, or if sent after 10:00 a.m. (Israel time) on any Business Day and receipt is confirmed, on the Business Day following the date on which receipt is confirmed; (d) if sent by registered, certified or first class international mail, then ten Business Days after being sent; and (e) if sent by overnight delivery via a national courier service, one Business Day after being sent domestically and three Business Days if being delivered internationally, in each case to the address or facsimile telephone number set forth beneath the name of such party below: If to Seller: Goldman Hirsh Partners Ltd. Abba Even 1, Herzliya Pituach, Israel Attention: Gil Pogozelich Fax: 972-9-7711805 email: gil@goldman-hirsh.com 50 If to Buyer or Parent: Kitov Pharmaceuticals Holdings Ltd. One Azrieli Center, Round Tower, Floor 23 132 Menachem Begin Rd., Tel Aviv 6701101 Israel Attention: Avraham Ben-Tzvi, Adv. – Company Secretary Fax: +972-153-39311321 email: avraham@kitovpharma.com Any Party may send any notice, request, demand, claim, or other communication hereunder to the intended recipient at the address set forth above using any other means (including personal delivery, expedited or air courier, messenger service, telecopy, ordinary mail, or electronic mail), but no such notice, request, demand, claim or other communication shall be deemed to have been duly given unless and until it actually is received by the intended recipient. Any Party may change the address to which notices, requests, demands, claims and other communications hereunder are to be delivered by giving the other Parties notice in the manner herein set forth. 11.5 Headings. The article and section headings contained in this Agreement are inserted for convenience only and will not affect in any way the meaning or interpretation of this Agreement. 11.6 Governing Law. This Agreement will be governed by and construed in accordance with the laws of the State of Israel, without giving effect to any choice of law principles. 11.7 Amendment; Extensions; Waivers. No amendment, modification, waiver, replacement, termination or cancellation of any provision of this Agreement will be valid, unless the same is in writing and signed by Buyer or an Affiliate acting on its behalf, Parent and the Seller; and any such waiver shall not be applicable or have any effect except in the specific instance in which it is given. Neither the failure nor any delay on the part of any Party to exercise any power, right, privilege or remedy under this Agreement will operate as a waiver thereof; and no single or partial exercise of any such power, right, privilege or remedy shall preclude any other or further exercise thereof or of any other power, right, privilege or remedy. 11.8 Severability. The provisions of this Agreement will be deemed severable and the invalidity, unlawfulness or unenforceability of any provision will not affect the validity or enforceability of the other provisions hereof, and the remainder of this Agreement, and the application of such provision to Persons or circumstances other than those as to which it is determined to be invalid, unlawful, or unenforceable, shall not be impaired or otherwise affected and shall continue to be valid and enforceable to the fullest extent permitted by law so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to any Party. Upon such determination that any term or other provision is invalid, illegal or incapable of being enforced, the Parties shall negotiate in good faith to modify this Agreement so as to effect the original intent of the Parties as closely as possible in an acceptable manner in order that the transactions contemplated hereby are consummated as originally contemplated to the greatest extent possible. 51 11.9 Expenses. Except as otherwise expressly provided in this Agreement, including as set forth in Article 10, each Party will bear its own costs and expenses incurred in connection with the preparation, execution and performance of this Agreement and the transactions contemplated by this Agreement, including all fees and expenses of agents, representatives, financial advisors, legal counsel and accountants; provided however, and for avoidance of doubt it is clarified that the Company’s costs and expenses incurred in connection with the preparation, execution and performance of this Agreement and the transactions contemplated by this Agreement, including all fees and expenses of agents, representatives, financial advisors, legal counsel, accountants or any other Person who performed services for or on behalf of the Company, or who is otherwise entitled to any compensation from any of the aforegoing, in connection with this Agreement, any of the transactions contemplated by this Agreement or otherwise, for the period prior and up to and including the Closing, shall be borne by the Seller and any such amounts will have either been paid in full by, or accrued for the account of, the Seller prior to the Closing, as evidenced by documentation acceptable to the Buyer. 11.10 Counterparts; Effectiveness. This Agreement may be executed in one or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument. This Agreement may be executed by exchange of signatures by facsimile or electronic scan. This Agreement will become effective when one or more counterparts have been signed by each Party and delivered to the other Parties. 11.11 Construction. This Agreement has been freely and fairly negotiated among the Parties. If an ambiguity or question of intent or interpretation arises, this Agreement will be construed as if drafted jointly by the Parties and no presumption or burden of proof will arise favoring or disfavoring any Party because of the authorship of any provision of this Agreement, and the parties hereto agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting party shall not be applied in the construction or interpretation of this Agreement. Any reference to any law will be deemed also to refer to such law as amended and all rules and regulations promulgated thereunder, unless the context requires otherwise. Any reference to dollars or $ shall mean United States dollars. The words “include,” “includes,” and “including” and variations thereof, shall not be deemed to be terms of limitation, but rather will be deemed to be followed by “without limitation.” The use of the word “or” shall not be exclusive. Pronouns in masculine, feminine and neuter genders will be construed to include any other gender, and words in the singular form will be construed to include the plural and vice versa, unless the context otherwise requires. The words “this Agreement,” “herein,” “hereof,” “hereby,” “hereunder,” and words of similar import refer to this Agreement as a whole (including any Exhibits, Annexes, Appendices and Schedules which are deemed part of this Agreement, and included in any references to such term), and not to any particular subdivision unless expressly so limited. References to Sections, Exhibits, Annexes, Appendices and Schedules refer respectively, unless otherwise noted to Sections of this Agreement and the Exhibits, Annexes, Appendices and Schedules attached hereto. 52 11.12 Schedules. The Parties will be deemed to have knowledge of the contents of the Schedules to this Agreement, and any matter that is disclosed in a Schedule to this Agreement shall be deemed to have been included in such other Schedule if the applicability of such disclosure to any other applicable representation, warranty or covenant would be reasonably apparent on its face to a Person reviewing the Schedules, not withstanding the omission of an appropriate cross reference thereto. The Parties acknowledge and agree that the disclosure by Seller of any matter in the Schedules shall not be deemed to constitute an acknowledgment by Seller that the matter is required to be disclosed by the terms of this Agreement or that the matter is material. 11.13 Dispute Resolution. Should there be a dispute between the Parties relating to or arising from this Agreement or any of the agreements, documents and instruments executed and delivered in connection herewith or the transactions contemplated by any of the foregoing, and if the dispute cannot be settled through direct discussions, the Parties agree that any unresolved controversy or claim arising out of or in any way relating to this Agreement and the transactions contemplated hereby shall be submitted to the exclusive jurisdiction of the applicable courts of the State of Israel in the Tel Aviv District. The Parties hereby agree not to assert, by way of motion, as a defense, or otherwise in any such suit, action or proceeding that the suit, action or proceeding is brought in an inconvenient forum, that the venue of the suit, action or proceeding is improper or that this Agreement or the subject matter thereof may not be enforced by such courts. [SIGNATURE PAGE FOLLOWS] 53 IN WITNESS WHEREOF, the Parties have executed this Agreement on the date first above written. PARENT: KITOV PHARMACEUTICALS HOLDINGS LTD. /s/ Simcha Rock By: Name: Simcha Rock Title: CFO BUYER: KITOV PHARMACEUTICALS HOLDINGS LTD; solely on behalf of Buyer pending Buyer’s execution of a joinder to this Agreement. /s/ Simcha Rock By: Name: Simcha Rock Title: CFO SELLER: GOLDMAN HIRSH PARTNERS LTD /s/ Dr. Gil S. Pogozelich By: Name: Dr. Gil S. Pogozelich Title: CEO 54 SHAREHOLDER UNDERTAKING AND AGREEMENT Exhibit 2.9 This SHAREHOLDER UNDERTAKING AND AGREEMENT (this “Undertaking”), dated as of January 13, 2017, is entered into by and among and Kitov Pharmaceuticals Holdings Ltd., an Israeli public company (“Company”) and Goldman Hirsh Partners Ltd. (the “Shareholder”). RECITALS A. The Company and the Shareholder are parties to a Share Purchase Agreement dated as of January 12, 2017 (the “SPA”), pursuant to which the Buyer will acquire the Shares from Seller in exchange for the Consideration (each defined term above as defined in the SPA); B. Pursuant to the SPA, at the Closing (as defined in the SPA), the Company shall issue to the Shareholder, 11,292,508 Consideration Shares, representing approximately 6.86% (the “Initial Percentage”) of the total outstanding share capital of the Company as of immediately following the Closing; C. The purpose of this Undertaking is to set forth in writing the undertakings by the Shareholder relating to the ownership of the Shares (as defined below) by the Shareholder and certain other matters; D. Execution and delivery of this Undertaking by the Shareholder is a condition to the obligation of the Buyer and Company to consummate the transactions contemplated by the SPA; and E. The Shareholder represents and warrants that (i) the Ordinary Share Equivalents Beneficially Owned by the Shareholder and its Group Members, as a group, are as set forth in Exhibit A attached hereto; (ii) such Shareholder has the full legal capacity, power and authority to execute and deliver this Undertaking and to perform its obligations contemplated hereby; and (iii) such Shareholder and/or any of its Group Members is not a party to any shareholders agreement, voting arrangement or any other arrangement with respect to its holdings in the Company and all the Ordinary Share Equivalents Beneficially Owned by the Shareholder and its Group Members, as a group, held by the Shareholder and its Group Members, as a group, are not subject to any voting arrangement or any other arrangement which would contradict such Shareholder's obligations under this Undertaking. 1 In consideration of the foregoing and the mutual representations, warranties, covenants and agreements contained herein and in the SPA, as well as other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, the Shareholder undertakes, and the Parties agree, as follows: UNDERTAKING AND AGREEMENT Section 1.1 Certain Defined Terms. For purposes of this Undertaking: ARTICLE I DEFINITIONS “Activist Investor” means, as of any date, any Person that has, directly or indirectly through its publicly disclosed Affiliates, whether individually or as a member of a publicly disclosed Group, within the two-year period immediately preceding such date, and in each case with respect to the Company, any of its Subsidiaries or any of its or their equity securities (i) publicly made, engaged in or been a participant (as defined in Instruction 3 to Item 4 of Schedule 14A under the Exchange Act) in any “solicitation” of “proxies” (as such terms are defined in Regulation 14A as promulgated by the SEC and assuming for this purpose that the Company was subject to the proxy rules under Section 14 of the Exchange Act) or in the submission of position statements (as such term is used in the Israeli Companies Law) (including, in each case, similar concepts under Israeli or any other applicable law), to vote any equity securities of the Company or any of its Subsidiaries, including in connection with a proposed change in Control or other extraordinary or fundamental transaction involving the Company or any of its Subsidiaries, or a public proposal for the election or replacement of any directors of the Company or any of its Subsidiaries, not approved by the board of directors of the Company or such Subsidiary prior to first public disclosure thereof, (ii) publicly called, or publicly sought to call, a meeting of shareholders of the Company or any of its Subsidiaries or publicly initiated any shareholder proposal or meeting agenda item for action by shareholders of the Company or any of its Subsidiaries (including through action by written consent), in each case not approved by the board of directors of the Company or such Subsidiary prior to first public disclosure thereof, (iii) commenced a “tender offer” (as such term is used in Regulation 14D under the Exchange Act or in the Israeli Companies Law) to acquire equity securities of the Company or any of its Subsidiaries that was not approved (at or before the time of commencement) by the board of directors of the Company or such Subsidiary, (iv) otherwise publicly acted, alone or in concert with others, to seek to Control or influence the board of directors of the Company or shareholders of the Company or any of its Subsidiaries (provided that this clause (iv) is not intended to apply to the activities of any member of the board of directors of the Company or such Subsidiary, with respect to the Company or such Subsidiary, taken in good faith solely in his or her capacity as a director of the Company or such Subsidiary), (v) otherwise acted, alone or in concert with others or upon the recommendation of proxy advisory firms or in accordance with established internal proxy voting guidelines, to vote against any recommendations of the board of directors board of directors of the Company or influence the shareholders of the Company or any of its Subsidiaries with respect to any meeting agenda item for action by shareholders of the Company or any of its Subsidiaries, or (vi) publicly disclosed any intention, plan, arrangement or other Contract to do any of the foregoing. “ADS” means American Depositary Shares representing Ordinary Shares, each ADS as of the date hereof representing twenty Ordinary Shares. “Affiliate” (including, with a correlative meaning, “affiliated”) means, when used with respect to a specified Person, a Person that directly or indirectly, through one or more intermediaries, Controls, is Controlled by or is under common Control with such specified Person. 2 “Beneficially Own”, “Beneficial Owner” and “Beneficial Ownership” mean, with respect to any securities, having “beneficial ownership” of such securities for purposes of Rule 13d-3 or 13d-5 under the Exchange Act (as in effect on the date of this Undertaking). In addition, a Person shall be deemed to be the Beneficial Owner of, and shall be deemed to Beneficially Own and have Beneficial Ownership of, any securities which are the subject of, or the reference securities for, or that underlie, any Derivative Instrument of such Person, with the number of securities Beneficially Owned being the notional or other number of securities specified in the documentation evidencing the Derivative Instrument as being subject to be acquired upon the exercise or settlement of such Derivative Instrument or as the basis upon which the value or settlement amount of such Derivative Instrument is to be calculated in whole or in part or, if no such number of securities is specified in such documentation, as determined by the Board in its sole discretion to be the number of securities to which the Derivative Instrument relates. “Board” means the board of directors of the Company. “Business Day” means a day that is not a Friday, Saturday, or a statutory or civic holiday in Tel Aviv, Israel or any other day on which banks in Tel Aviv, Israel are required or authorized to be closed. “Company Competitor” means any Person competing with the Company with respect to any of its products. “Contract” means any contract, agreement, instrument, undertaking, indenture, commitment, loan, license, settlement, consent, note or other legally binding obligation (whether or not in writing). “Control”, “Controlled” and “Controlling” mean, when used with respect to any specified Person, the power to vote at least 25% of the voting power of a Person, or the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities or other interests, by Contract or otherwise, and the terms “Controlled by” and “under common Control with” shall be construed accordingly. “Current Directors” means the directors serving on the Board as of the date of this Undertaking. “Depositary” means the depositary with respect to the ADSs, which as of the date hereof is BNY Mellon. “Derivative Instrument” means any and all derivative securities (as defined under Rule 16a-1 under the Exchange Act) that increase in value as the value of any Equity Securities of the Company increases, including a long convertible security, a long call option and a short put option position, in each case, regardless of whether (a) such derivative security conveys any voting rights in any Equity Security, (b) such derivative security is required to be, or is capable of being, settled through delivery of any Equity Security or (c) other transactions hedge the value of such derivative security. “Equity Right” means, with respect to any Person, any security (including any preferred share, capital note, debt security or hybrid debt- equity security) or obligation convertible into or exercisable or exchangeable for, or giving any Person any right to subscribe for or acquire, or any options, calls, warrants, restricted shares, restricted shares units, deferred share awards, share units, “phantom” awards, dividend equivalents, participations, interests, rights or commitments relating to, or any share appreciation right or other instrument the value of which is determined in whole or in part by reference to the market price or value of, shares of capital stock or earnings of such Person. 3 “Equity Securities” means (a) Ordinary Shares, ADSs, preferred shares or other capital stock or equity interests or equity-linked interests of the Company and (b) Equity Rights that are directly or indirectly exercisable or exchangeable for or convertible into Ordinary Shares, ADSs, preferred shares or other capital stock or equity interests or equity-linked interests of the Company. “Exchange Act” means the United States Securities Exchange Act of 1934 and the rules and regulations promulgated thereunder. “Governmental Authority” means any (a) nation, region, state, county, city, town, village, district or other jurisdiction, (b) federal, state, local, municipal, foreign or other government, (c) department, agency or instrumentality of a federal, state, local, municipal, foreign or other government, including any state-owned or state controlled instrumentality of a foreign or other government, (d) governmental or quasi-governmental entity of any nature (including any governmental agency, branch, department or other entity and any court or other tribunal), (e) international or multinational organization formed by states, governments or other international organizations, (f) organization that is designated by executive order pursuant to Section 1 of the United States International Organizations Immunities Act (22 U.S.C. 288 of 1945), as amended, and the rules and regulations promulgated thereunder or (g) other body (including any industry or self-regulating body) exercising, or entitled to exercise, any administrative, executive, judicial, legislative, police or regulatory authority or power of any nature. “Group” has the meaning assigned to such term in Section 13(d)(3) of the Exchange Act. “Group Member” means, with respect to any specified Person, any Affiliate of the specified Person that is, directly or indirectly, Controlled by the specified Person and includes any Person with respect to which the specified Person is a direct or indirect Subsidiary. “Hedging Arrangement” means any transaction or arrangement, including through the creation, purchase or sale of any security, including any security-based swap, swap, cash-settled option, forward sale agreement, exchangeable note, total return swap or other derivative, in each case, the effect of which is to hedge the risk of owning Equity Securities. “Incumbent Directors” means (a) the Current Directors, (b) new directors nominated or appointed by a majority of the Current Directors and (c) other directors nominated or appointed by a majority of the Current Directors and other Incumbent Directors. “Israeli Companies Law” means the Israeli Companies Law, 5759-1999, as amended from time to time, including regulations thereunder and successor provisions and regulations thereto. “Israeli Securities Laws” means the Israeli Securities Law, 5728-1968, the rules and regulations promulgated under thereunder, and any listing rules and regulations of the TASE. “Law” means any supranational, international, national, federal, state, provincial, local or similar law (including common law), statute, code, order, ordinance, rule, regulation, treaty (including any tax treaty), license, permit, authorization, approval, consent, decree, injunction, binding judicial or administrative interpretation or other requirement, in each case enacted, promulgated issued or entered by a Governmental Authority. 4 “Lock-Up Period” means, with respect to: (a) the Consideration Shares, the 12-month period commencing on the date of issuance of such Consideration Shares, and (b) any other Shares, the 12-month period commencing on the date of issuance or acquisition of such Shares. “Ordinary Shares” means the ordinary shares of the Company, no par value. “Ordinary Share Equivalents” means (i) in the case of an Ordinary Share, one Ordinary Share or (ii) in the case of an ADS, the number of Ordinary Shares represented by such ADS. For purposes of calculating the number of Ordinary Share Equivalents outstanding, Ordinary Shares underlying ADSs shall not be counted separately as being outstanding (i.e., such Ordinary Shares shall be counted only once). “Party” means a party to this Undertaking. “Permitted Transferee” means the Shareholder and any direct or indirect wholly owned Subsidiary of the Shareholder; provided that if any such transferee of Shares ceases to be a direct or indirect wholly owned Subsidiary of the Shareholder, (a) such transferee shall, and the Shareholder shall procure that such transferee shall, immediately Transfer back the transferred Shares to the applicable transferor, or, if such transferor by that time is no longer a Permitted Transferee, to the Shareholder, as if such Transfer of such Shares had not taken place ab initio, and (b) the Company shall no longer, and shall instruct its transfer agent, Israeli registration company, the Depositary and other third parties to no longer, record or recognize such Transfer of such Shares on the shareholders’ register of the Company and/or the register of ADS holders of the Depositary. “Person” means any individual, sole proprietorship, partnership, limited liability company, joint venture, trust, unincorporated association, corporation, firm or other entity or group (as defined in the Exchange Act) or any Governmental Authority. “Prohibited Transferee” means (a) any Company Competitor, (or (b) any Person who after such Transfer, would Beneficially Own more than 5% of the Voting Securities and to the knowledge of the Shareholder, after due inquiry on the date of the applicable Transfer, would report its ownership position on Schedule 13D (or successor form). “Representatives” means, as to any Person, its Affiliates and its and their respective directors, officers, managers, employees, agents, attorneys, accountants, financial advisors and other advisors or representatives. “Rule 144” means Rule 144 promulgated by the SEC pursuant to the Securities Act, as such Rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the SEC having substantially the same effect as such Rule. “Rule 415” means Rule 415 promulgated by the SEC pursuant to the Securities Act, as such Rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the SEC having substantially the same effect as such Rule. “SEC” means the United States Securities and Exchange Commission. “Securities Act” means the Securities Act of 1933 and the rules and regulations promulgated thereunder. 5 “Securities Laws” means the Securities Act, the Exchange Act and the Israeli Securities Laws. “Share Percentage Cap” means the Initial Share Percentage; provided that (a) immediately following any Transfer of Shares by the Shareholder (other than to a Permitted Transferee), the Share Percentage Cap shall be reduced to a percentage equal to (i) the aggregate number of Ordinary Share Equivalents Beneficially Owned by the Shareholder and its Group Members immediately following such Transfer of Shares (excluding any Ordinary Share Equivalents for which Beneficial Ownership was acquired in violation of this Undertaking prior to such Transfer), divided by (ii) the aggregate number of Ordinary Share Equivalents outstanding immediately following such Transfer of Shares; (b) the Share Percentage Cap shall in no event be less than 1%; and (c) to the extent that any Shares that are deemed to have been Transferred pursuant to any Hedging Arrangement are subsequently returned or released to the Shareholder by a counterparty with respect to such Hedging Arrangement (including as a result of the Shareholder electing cash settlement of such Hedging Arrangement), such Shares shall be treated as if they had not been Transferred by the Shareholder for purposes of this Undertaking and the Share Percentage Cap shall be adjusted accordingly. “Shares” means (a) the Consideration Shares and (b) any Equity Securities issued or issuable with respect to the Consideration Shares on or after the date of this Undertaking by way of a share dividend or share split or in connection with a combination of shares, recapitalization, merger, consolidation or other reorganization and (d) any other Equity Securities held by the Shareholder or any of its Affiliates. “Standstill Level” means, as of any date, a number of Ordinary Share Equivalents equal to (a) the Share Percentage Cap, multiplied by (b) the number of Ordinary Shares outstanding on such date. “Standstill Period” means the period beginning on the date hereof and ending on the first Business Day on which the Shareholder and its Group Members, together with the other former shareholders of Tyrnovo Ltd. which were issued any Consideration Shares pursuant to such Person’s applicable SPA, and their respective Group Members collectively Beneficially Own a number of Ordinary Share Equivalents less than 1% of the then issued and outstanding Ordinary Shares; provided that for purposes of Section 4.1(a) only, “Standstill Period” shall mean the period beginning on the date hereof and ending on the first Business Day on which none of the Shareholder or its Group Members Beneficially Own any Ordinary Shares or ADSs. “Subsidiary” means, with respect to any Person, any corporation, limited liability company, partnership, association or business entity of which a majority of the total voting power or control of such entity is at the time owned or controlled, directly or indirectly, by that Person or one or more of the other Subsidiaries of that Person or a combination thereof. “TASE” means the Tel Aviv Stock Exchange. “Voting Securities” means the Ordinary Share Equivalents and any other securities of the Company entitled to vote at any general meeting of the Company. 6 ARTICLE II TRANSFER RESTRICTIONS Section 2.1 Restrictions on Transfer. The right of the Shareholder and its Affiliates to directly or indirectly, in any single transaction or series of related transactions, sell, assign, pledge, hypothecate or otherwise transfer (or enter into any Contract or other obligation regarding the future sale, assignment, pledge or transfer of) Beneficial Ownership of (each, a “Transfer”) any Shares is subject to the restrictions set forth in this Article II, and no Transfer of Shares by the Shareholder or any of its Affiliates may be effected except in compliance with this Article II. Any attempted Transfer in violation of this Undertaking shall be of no effect and null and void, regardless of whether the purported transferee has any actual or constructive knowledge of the Transfer restrictions set forth in this Undertaking, and shall not be recorded on the stock transfer books of the Company or the Depositary or any local custodian or transfer agent. the applicable Lock-Up Period without the prior written consent of the Company, other than: (a) The Shareholder shall not directly or indirectly, in any single transaction or series of related transactions, Transfer any Shares during (i) a Transfer of Shares in response to a tender or exchange offer by any Person that has been approved or recommended by the Board (provided a majority of directors at the time of such approval or recommendation are Incumbent Directors) or a Transfer of Shares permitted by Section 2.1(e); (ii) a Transfer of Shares to the Company or a Subsidiary of the Company; (iii) a Transfer of Shares to a Permitted Transferee, so long as such Permitted Transferee, to the extent it has not already done so, executes a customary joinder to this Undertaking, in form and substance reasonably acceptable to the Company, in which such Permitted Transferee agrees to be bound by the terms of this Undertaking as if such Permitted Transferee was an original party hereto; (iv) a Transfer of Shares as a result of any acquisition of outstanding stock of Shareholder (by merger, consolidation or otherwise) or any sale of all or substantially all of the assets of Shareholder; provided that any such Transfer that would result in any Person becoming the ultimate parent entity of the Shareholder (such that the Shareholder is a direct or indirect Subsidiary of another Person or all or substantially all of the Shareholder’s assets have been acquired by another Person) shall be subject to Section 5.6; provided, in each case, that any such Transfer is made in accordance with all applicable Laws. (b) Following the Lock-Up Period of any Shares, the Shareholder shall be entitled to Transfer the applicable Shares in its sole discretion, subject to Section 2.1(d) and provided that the Shareholder shall not directly or indirectly, in any single transaction or series of related transactions, Transfer any Shares: (i) other than in accordance with all applicable Laws and the other terms and conditions of this Undertaking; or (ii) to any Prohibited Transferee (except in a Permitted Transfer). 7 The Shareholder shall not be deemed to have breached its obligations under Section 2.1(b)(ii) as it relates to Prohibited Transferees with respect to the Transfer of Shares to any Person so long as the Shareholder acts in good faith, based on generally available public information and the advice of its financial advisors, to determine whether such Person is a Prohibited Transferee. accordance with applicable Law: (c) “Permitted Transfer” means, in each case, following the expiration of the Lock-Up Period and so long as such Transfer is in (i) a Transfer of Shares in accordance with Section 2.1(a); (ii) a Transfer of Shares effected through a “brokers’ transaction” as defined in Rule 144(g) executed on a securities exchange or over- the-counter market by a securities broker-dealer acting as agent for the Shareholder (so long as such Transfer is not directed by the Shareholder to be made to a particular counterparty or counterparties and the Shareholder reasonably believes, after due inquiry, as of the date of such Transfer, that the Transfer executed by such broker-dealer is not or will not be to a Prohibited Transferee); (iii) a Transfer of Shares to a counterparty (other than a Prohibited Transferee) in connection with a Hedging Arrangement, including any related Transfer of Shares or other Equity Securities by any such counterparty to any other Person (so long as such Transfer by such counterparty is not at the express direction of the Shareholder and the Shareholder reasonably believes, after due inquiry, as of the date of such Transfer, that the Transfer by such counterparty is not or will not be to a Prohibited Transferee); or (iv) a Transfer of Shares permitted by Section 2.1(e). (d) Notwithstanding anything to the contrary contained herein but subject to Section 2.1(e), the Shareholder shall not Transfer, or cause or permit the Transfer of, any Shares in connection with any “tender offer” (as such term is used in Regulation 14D under the Exchange Act or Chapters Two and Three of Part VIII of the Israeli Companies Law) or any merger or merger-type transaction, which is either not approved or recommended by the Board or approved or recommended by the Board when a majority of directors at the time of such approval or recommendation are not Incumbent Directors. (e) Notwithstanding anything to the contrary herein, nothing in this Undertaking will prohibit the Shareholder from agreeing to, and from Transferring, or causing or permitting the Transfer of, any Shares in connection with, any “special tender offer” under Chapter Two of Part VIII of the Israeli Companies Law with respect to which the Board comprising a majority of directors who are Incumbent Directors has determined not to express or make a recommendation (whether in favor or against). for purposes of this Undertaking and shall be subject to the provisions of this Section 2.1. (f) The entry by the Shareholder into a Hedging Arrangement with respect to any Shares shall be deemed to be a Transfer of such Shares 8 Section 3.1 Voting Undertakings. ARTICLE III VOTING AND PROXIES (a) During any Lock Up Period with respect to any number of Ordinary Share Equivalents Beneficially Owned by the Shareholder and its Group Members, as a group, and, subsequent to such Lock Up Period for so long as the aggregate number of Ordinary Share Equivalents Beneficially Owned by the Shareholder and its Group Members, as a group, together with the other former shareholders of Tyrnovo Ltd. which were issued any Consideration Shares pursuant to such Person’s applicable SPA, and their respective Group Members, is greater than or equal to 1% of the then issued and outstanding Ordinary Shares (hereinafter, the “Voting Undertaking Period”), the Shareholder shall cause all of the Voting Securities Beneficially Owned by it or any of its Group Members or over which it or any of its Group Members has voting control to be voted, (i) in favor of all those persons nominated and recommended to serve as directors of the Company by the Board and/or any applicable committee thereof (provided a majority of directors on the Board and/or such committee at the time of such approval or recommendation are Incumbent Directors), (ii) with respect to any matter relating to remuneration of directors, directors’ insurance or indemnification or release from liability of directors, in favor of the proposal recommended by the Board following the prior recommendation by any applicable statutory independent committee thereof (provided a majority of directors on the Board and/or such committee at the time of such approval or recommendation are Incumbent Directors); provided, however, that in the event such matter relating to remuneration of directors, directors’ insurance or indemnification or release from liability of directors is a matter in which all of the Incumbent Directors (including any on the applicable statutory independent committee of the Board approving such matter) have a personal interest, then in a manner which is proportionally consistent with the votes received by the Company on behalf of any Ordinary Shares not Beneficially Owned by the Shareholder or any of its Group Members (excluding the votes of any Activist Investors and/or any discretionary proxies which may have been received by the Company), and (iii) with respect to any other action, proposal or matter to be voted on by the shareholders of the Company (including through action by written consent), in accordance with the recommendation of the Board or any applicable committee thereof (so long as a majority of directors on the Board and/or such committee at the time of such recommendation are Incumbent Directors); provided, however, that the undertakings in sub-clauses (ii) and (iii) above shall not apply to matters which require the declaration of a personal interest and/or affiliation with a controlling shareholder as defined in, and in accordance with, the Israeli Companies Law (the “Voting Undertaking”). Notwithstanding the foregoing, the Shareholder and its Group Members shall be free to vote at their discretion in connection with any proposal submitted for a vote of the shareholders of the Company in respect of (A) the issuance of Equity Securities in connection with any merger, consolidation or business combination of the Company, (B) any merger, consolidation or business combination of the Company or (C) the sale of all or substantially all the assets of the Company, except in each of clause (A), (B) and (C) where such proposal has not been approved or recommended by the Board or has been approved or recommended by the Board when a majority of directors at the time of such approval or recommendation are not Incumbent Directors, in which event the Voting Undertaking shall apply. 9 (b) During any Voting Undertaking Period, with respect to any matter that the Shareholder is required to vote on in accordance with Section 3.1(a), the Shareholder shall cause each Voting Security owned by it or over which it has voting control to be voted by completing the proxy forms distributed by the Company or the voting instructions distributed by the Depositary, as applicable, and not by any other means. The Shareholder shall deliver the completed proxy form to the Company or the completed voting instruction form to the Depositary (with a copy sent to the Company Secretary), as applicable, no later than five (5) Business Days prior to the date of such general meeting of the Company. Upon the written request of the Company, the Shareholder hereby agrees to take such further action or execute such other instruments as may be reasonably necessary to effectuate the intent of this Section 3.1(b). Section 3.2 Irrevocable Proxy. (a) By execution of this Undertaking, Shareholder does hereby appoint Company, or any duly authorized agent thereof, with full power of substitution and resubstitution, as Shareholder’s true and lawful attorney and irrevocable proxy, to the fullest extent of the Shareholder’s rights with respect to each Voting Security owned by it or over which it has voting control, solely with respect to any matter that the Shareholder is required to vote on in accordance with Section 3.1(a) hereof, and for which matters such Shareholder is not required to provide a declaration of a personal interest and/or affiliation with a controlling shareholder as defined in, and in accordance with, the Israeli Companies Law, if the Shareholder is unable or unwilling to perform his, her or its obligations under this Undertaking (the “Proxy”). Shareholder intends this Proxy to be irrevocable and coupled with an interest hereunder until the end of the term of this Undertaking (as set forth in Section 5.3 hereof). (b) Without prejudice to that which is set forth in Section 4.7 to the Deposit Agreement dated November 25, 2015 by and amongst the Depositary, the Company, and owners and holders of ADSs, as amended, and as may be amended in the future, the Shareholder hereby expressly and irrevocably revokes any, (i) proxies previously granted with respect to each Voting Security owned by it or over which it has voting control and represents that none of such previously-granted proxies are irrevocable, and/or, (ii) until the end of the term of this Undertaking (as set forth in Section 5.3 hereof), any proxies it may grant with respect to each Voting Security owned by it or over which it has voting control which are not in accordance with the terms and conditions of this Undertaking and any such proxies shall be deemed void ab initio, and to any such extent as such may not be deemed void ab initio under any applicable legal doctrine, such shall nonetheless be deemed superseded and replaced by the Proxy, which shall be deemed to have been issued later than any other such proxy. Section 3.3 Control Block Limitations (a) To such extent that the Voting Undertaking and/or the Proxy shall, on its own, or aggregated under applicable law with one or more voting undertakings, proxies, voting agreements or any other such instruments (“Voting Instruments”) which were duly entered into by the parties to such instruments, be deemed to create a “controlling block” necessitating a “special tender offer” under Chapter Two of Part VIII of the Israeli Companies Law (“Control Block”), and without prejudice, however, to any of the Shareholder’s other obligations pursuant to this Undertaking with respect to each Voting Security owned by it or over which it has voting control, the Voting Undertaking and/or the Proxy shall immediately be deemed null and void, but only with respect to the minimal number of Voting Securities as shall be necessary to have the effect that the Voting Securities to which such Voting Undertaking and/or Proxy continues to apply will not be above the applicable threshold in the Israeli Companies Law which causes the creation of such a Control Block, all as determined by the Company in its sole and absolute discretion. 10 (b) In the event that the entry into any Voting Instruments by the Shareholder is in breach of this Undertaking, or in breach of any other agreement between the parties to such Voting Instrument(s) and the Company, the Shareholder does hereby appoint Company, or any duly authorized agent thereof, with full power of substitution and resubstitution, as Shareholder’s true and lawful attorney and irrevocable proxy, to the fullest extent of the Shareholder’s rights with respect to such Voting Instrument, to take any action, at Shareholder’s expense, to terminate or invalidate such Voting Instrument it order to prevent the creation of such a Control Block. ARTICLE IV STANDSTILL Section 4.1 Restrictions. During the Standstill Period, the Shareholder shall not, directly or indirectly, and shall cause its Representatives (to the extent acting on behalf of the Shareholder) and Group Members not, directly or indirectly, to, without the prior written consent of, or waiver by, the Company: (a) subject to Section 4.2, acquire, offer or seek to acquire, agree to acquire or make a proposal (including any private proposal to the Company or the Board) to acquire, by purchase or otherwise (including through the acquisition of Beneficial Ownership), any securities (including any Equity Securities or Voting Securities) or Derivative Instruments, or direct or indirect rights to acquire any securities (including any Equity Securities or Voting Securities) or Derivative Instruments, of the Company or any Subsidiary or Affiliate of the Company or any successor to or Person in Control of the Company, or any securities (including any Equity Securities or Voting Securities) or indebtedness convertible into or exchangeable for any such securities or indebtedness; provided that the Shareholder may acquire, offer or seek to acquire, agree to acquire or make a proposal to acquire Ordinary Share Equivalents (and any securities (including any Equity Securities or Voting Securities) convertible into or exchangeable for Ordinary Share Equivalents) and Derivative Instruments with respect to Ordinary Share Equivalents, if, immediately following such acquisition, the collective Beneficial Ownership of Ordinary Share Equivalents of the Shareholder and its Group Members, as a group, would not exceed the Standstill Level; Subsidiaries, taken as a whole; (b) offer, or seek to acquire, or participate in any acquisition of a majority of the consolidated assets of the Company and its (c) conduct, fund or otherwise become a participant in any “tender offer” (as such term is used in Regulation 14D under the Exchange Act or Chapters Two and Three of Part VIII the Israeli Companies Law) or in any merger or merger type transaction, involving Equity Securities, Voting Securities or any securities convertible into, or exercisable or exchangeable for, Equity Securities or Voting Securities, in each case either not approved by the Board or approved by the Board when a majority of directors at the time of such approval or recommendation are not Incumbent Directors; (d) otherwise act in concert with others to seek to control or influence the Board or shareholders of the Company or its Subsidiaries or Affiliates; provided that nothing in this clause (d) shall preclude the Shareholder or its Representatives from engaging in discussions with the Company or its Representatives; 11 (e) make or join or become a participant (as defined in Instruction 3 to Item 4 of Schedule 14A under the Exchange Act) in (or in any way knowingly encourage) any “solicitation” of “proxies” (as such terms are defined in Regulation 14A as promulgated by the SEC and assuming for this purpose that the Company was subject to the proxy rules under Section 14 of the Exchange Act) (including, in each case, similar concepts under Israeli law, including submission of positions statements), or consent to vote any Voting Securities or any of the voting securities of any Subsidiaries or Affiliates of the Company (including through action by written consent), or otherwise knowingly advise or influence any Person with respect to the voting of any securities of the Company or its Subsidiaries or Affiliates; (f) make any public announcement with respect to, or solicit or submit a proposal for, or offer, seek, propose or indicate an interest in (with or without conditions) any merger or merger type transaction, including, but not limited to, a merger pursuant to Chapter One of Part VIII or Chapter Three of Part IX of the Israeli Companies Law, consolidation, business combination, “tender offer” (as such term is used in Regulation 14D under the Exchange Act or Chapters Two and Three of Part VIII of the Israeli Companies Law), recapitalization, reorganization, purchase or license of a material portion of the assets, properties, securities or indebtedness of the Company or any Subsidiary or Affiliate of the Company, or other similar extraordinary transaction involving the Company, any Subsidiary of the Company or any of its securities or indebtedness, or enter into any discussions, negotiations, arrangements, understandings or agreements (whether written or oral) with any other Person regarding any of the foregoing; (g) call or seek to call a meeting of shareholders of the Company or initiate any shareholder proposal or meeting agenda item for action of the Company’s shareholders, or seek election or appointment to or to place a representative on the Board or seek the removal of any director from the Board; (h) form, join, become a member or in any way participate in a Group (other than with the Shareholder, any of its Group Members or any counterparty (other than a Prohibited Transferee) in connection with a Hedging Arrangement that complies with Section 2.1(c)(iii)) with respect to the securities of the Company or any of its Subsidiaries or Affiliates; (i) deposit any Voting Securities in a voting trust or similar Contract or subject any Voting Securities to any voting agreement, pooling arrangement or similar arrangement or Contract, or grant any proxy with respect to any Voting Securities (in each case, other than (i) with the Shareholder or any of its wholly owned Subsidiaries, (ii) as part of a Hedging Arrangement that complies with Section 2.1(c)(iii) or (iii) in accordance with Section 3.1); other Representatives to make any proposal or disclose any plan on its or their behalf, inconsistent with the foregoing restrictions; (j) make any proposal or disclose any plan, or cause or authorize any of its and their directors, officers, employees, agents, advisors and 12 (k) knowingly take any action or cause or authorize any of its and their directors, officers, employees, agents, advisors and other Representatives to take any action on its or their behalf, that would reasonably be expected to require the Company or any of its Subsidiaries or Affiliates to publicly disclose any of the foregoing actions or the possibility of a business combination, merger or other type of transaction or matter described in this Section 4.1; (l) knowingly advise, assist, arrange or otherwise enter into any discussions or arrangements with any third party with respect to any of the foregoing; or legal action or otherwise). (m) directly or indirectly, contest the validity of, any provision of this Section 4.1 (including this subclause) or Section 3.1 (whether by Section 4.2 Exclusions. The prohibition in Section 4.1(a) shall not apply to the activities of the Shareholder or any of its Group Members in connection with: (a) acquisitions made as a result of a stock split, stock dividend, reorganization, recapitalization, reclassification, combination, exchange of shares or other like change approved or recommended by the Board (provided a majority of directors at the time of such approval or recommendation are Incumbent Directors); or (b) acquisitions made in connection with a transaction or series of related transactions in which the Shareholder or any of its Group Members acquires a previously unaffiliated business entity that Beneficially Owns Equity Securities, Voting Securities or Derivative Instruments, or any securities convertible into, or exercisable or exchangeable for, Equity Securities, Voting Securities or Derivative Instruments, at the time of the consummation of such acquisition, provided that in connection with any such acquisition, the Shareholder or such applicable Group Member, as the case may be, either (A) causes such entity to divest the Equity Securities, Voting Securities or Derivative Instruments, or any securities convertible into, or exercisable or exchangeable for, Equity Securities, Voting Securities or Derivative Instruments, Beneficially Owned by the acquired entity within a period of one hundred twenty (120) calendar days after the date of the consummation of such acquisition, or (B) divests the Equity Securities, Voting Securities or Derivative Instruments, or any other securities convertible into, or exercisable or exchangeable for, Equity Securities, Voting Securities or Derivative Instruments, Beneficially Owned by the Shareholder and its Affiliates, in an amount so that the Shareholder and its Affiliates, together with such acquired business entity, shall not, acting alone or as part of a Group, directly or indirectly, Beneficially Own a number of Ordinary Share Equivalents in excess of the Standstill Level following such acquisition, and prior to the disposition thereof, such Ordinary Share Equivalents or other Voting Securities remain subject to the terms of this Undertaking in all respects, or (C) causes such entity to execute a customary joinder to this Undertaking, in form and substance reasonably acceptable to the Company, in which such entity agrees to be bound by the terms of this Undertaking as if such entity was an original party hereto. 13 ARTICLE V MISCELLANEOUS Section 5.1 Notices. All notices and other communications made pursuant to or under this Undertaking will be in writing and will be deemed to have been duly given or made (a) when personally delivered, (b) when transmitted by facsimile or electronic mail if such transmission occurs on a Business Day before 5:00 p.m. (recipient local time), or the next succeeding Business Day if such transmission occurs at any other time, (c) three Business Days after deposit with a nationally recognized international overnight courier service, or (d) ten Business Days after the mailing if sent or by registered or certified international mail, postage prepaid, return receipt requested. All notices and other communications under this Undertaking will be delivered to the addresses set forth below, or such other address as such Party may have given to the other Parties by notice pursuant to this Section 5.1: If to the Shareholder: Goldman Hirsh Partners Ltd. Abba Even 1, Herzliya Pituach, Israel Attention: Gil Pogozelich Fax: 972-9-7711805 email: gil@goldman-hirsh.com If to the Company: Kitov Pharmaceuticals Holdings Ltd. One Azrieli Center, Round Tower, 23rd Floor 132 Menachem Begin Road Email: avraham@kitovpharma.com Attention: Avraham Ben-Tzvi, Adv. Section 5.2 Expenses. Except as otherwise provided herein, all fees and expenses incurred in connection with or related to the transactions contemplated hereby will be paid by the Party incurring such fees or expenses. In the event of termination of this Undertaking, the obligation of each Party to pay its own expenses will be subject to any rights of such Party arising from a breach of this Undertaking by the other. Section 5.3 Term. Notwithstanding anything contained herein to the contrary, this Undertaking shall terminate, and all rights and obligations hereunder shall cease, on the date upon which the Shareholder together with the other former shareholders of Tyrnovo Ltd. which were issued any Consideration Shares pursuant to such Person’s applicable SPA, and their respective Group Members, no longer Beneficially Owns Shares representing in the aggregate at least 1% of the issued and outstanding Ordinary Shares, provided that in no event shall this Undertaking terminate prior to expiration of the last Lock-Up Period. Section 5.4 Entire Undertaking. This Undertaking constitutes the entire agreement of the Parties relating to the subject matter hereof and thereof and supersedes all prior and contemporaneous agreements, negotiations, correspondence, undertakings and communications of the Parties, oral or written, with respect to the subject matter hereof. Section 5.6 Successors. This Undertaking will be binding upon the Parties and their respective successors, permitted assigns, executors and legal representatives. Without limiting ARTICLE II hereof in any way, the Shareholder agrees that this Undertaking and the obligations hereunder shall attach to the Shares from the date hereof through the term of this Undertaking (pursuant to Section 5.3) and shall be binding upon any person to which legal or beneficial ownership of the Shares shall pass, whether by operation of law or otherwise, including the Shareholder’s heirs, guardians, administrators or successors, and the Shareholder further agrees to take all actions necessary to effectuate the foregoing. 14 Section 5.7 Assignments. All the provisions of this Undertaking by or for the benefit of the Shareholder or of the Company shall bind and inure to the benefit of their respective successors and permitted assigns Nothing in this Undertaking will limit the ability of the Company to assign its rights or obligations hereunder in connection with a merger, consolidation, combination, reorganization or similar transaction or the transfer, sale, lease, conveyance or disposition of all or substantially all of its assets. The Shareholder will not enter into any transaction pursuant to which any Person would become its ultimate parent entity (such that the Shareholder is a direct or indirect Subsidiary of another Person or all or substantially all of the Shareholder’s assets have been acquired by another Person) without causing such Person to assume all of the Shareholder’s obligations under this Undertaking effective as of the consummation of such transaction. Any attempted assignment in violation of this Section 5.6 will be void ab initio. Section 5.8 Amendment; Waiver. This Undertaking will not be amended, modified or waived in any manner without the consent in writing duly executed and delivered by the Company as authorized to do so by the Board when a majority of directors at the time of such authorization are Incumbent Directors. No failure or delay of any Party to exercise any right or remedy given to such Party under this Undertaking and no custom or practice of the Parties in variance with the terms hereof, will constitute a waiver of any Party’s right to demand exact compliance with the terms hereof. Any written waiver will be limited to those items specifically waived therein and will not be deemed to waive any future breaches or violations or other non-specified breaches or violations unless, and to the extent, expressly set forth therein. Section 5.9 Severability. If any term or provision of this Undertaking is held invalid, illegal or unenforceable in any respect under any applicable Law, the validity, legality and enforceability of all other terms and provisions of this Undertaking will not in any way be affected or impaired. If the final judgment of a court of competent jurisdiction or other Governmental Authority declares that any term or provision hereof is invalid, illegal or unenforceable, the Parties agree that the court making such determination will have the power to reduce the scope, duration, area or applicability of the term or provision, to delete specific words or phrases, or to replace any invalid, illegal or unenforceable term or provision with a term or provision that is valid, legal and enforceable and that comes closest to expressing the intention of the invalid, illegal or unenforceable term or provision. Section 5.10 No Ownership Interest. Nothing contained in this Undertaking shall be deemed to vest in the Company any direct or indirect ownership or incidence of ownership of or with respect to any Ordinary Share Equivalents Beneficially Owned by the Shareholder or its Group Members. All rights, ownership and economic benefits of and relating to any Ordinary Share Equivalents Beneficially Owned by the Shareholder or its Group Members shall remain vested in and belong to the Shareholder or the applicable Group Member, and the Company does not have authority to manage, direct, superintend, restrict, regulate, govern, or administer any of the policies or operations of the Shareholder or its Group Members or exercise any power or authority to direct Shareholder or any of its Group Members in the voting of any of the Ordinary Share Equivalents Beneficially Owned by the Shareholder or its Group Members, except as otherwise provided herein. Section 5.11 Governing Law. This Undertaking will be construed and enforced in accordance with, and will be governed exclusively by, the internal Laws of the State of Israel, without giving effect to any Law or rule that would cause the Laws of any jurisdiction other than the State of Israel to be applied. 15 Section 5.12 Exclusive Jurisdiction. The Economic Division of the competent courts of Tel-Aviv, Israel shall have exclusive jurisdiction in all matters relating to any dispute arising out of or relating to this Undertaking, or the breach thereof, to the exclusion of any other jurisdiction. Each of the Parties (a) irrevocably consents to the exclusive jurisdiction and venue of the court as set forth above, (b) agrees that process may be served upon them in any manner authorized by the court for such persons, (c) waives the defense of an inconvenient forum and covenants not to assert or plead any objection which they might otherwise have to such jurisdiction, venue and such process, and (d) agrees that a final judgment in such proceeding shall be final, binding and enforceable in any court of competent jurisdiction. Without prejudice to any of the provisions set forth in Section 5.12 below each Party agrees not to commence any legal proceedings subject to this Section 5.11 except in such courts. Section 5.13 Specific Performance. The Shareholder agrees that irreparable damage would occur in the event that any of the provisions of this Undertaking were not performed in accordance with their specific terms or were otherwise breached. Accordingly, the Company will be entitled to enforce specifically the provisions of this Undertaking, including obtaining an injunction or injunctions to prevent breaches or threatened breaches of this Undertaking, in any court designated to resolve disputes concerning this Undertaking (or, if such court lacks subject matter jurisdiction, in any appropriate court of competent jurisdiction), this being in addition to any other remedy to which the Company is entitled at Law or in equity. The Shareholder further agrees not to assert and waives (a) any defense in any action for specific performance that a remedy at Law would be adequate and (b) any requirement under any Law to post security or provide indemnity as a prerequisite to obtaining equitable relief. Section 5.14 Other Remedies. Except to the extent set forth otherwise in this Undertaking, all remedies under this Undertaking expressly conferred upon the Company will be deemed cumulative with and not exclusive of any other remedy conferred hereby, or by Law or in equity upon the Company, and the exercise by the Company of any one remedy will not preclude the exercise of any other remedy. Section 5.15 Rules of Construction. The following rules of construction will govern the interpretation of this Undertaking: (a) all references to Articles, Sections or Schedules are to Articles, Sections or Schedules in this Undertaking, unless otherwise stated explicitly; accounting principles in the United States; (b) each accounting term not otherwise defined in this Undertaking has the meaning assigned to it in accordance with generally accepted (c) unless the context otherwise requires, words in the singular or plural include the singular and plural, and pronouns stated in either the masculine, the feminine or neuter gender will include the masculine, feminine and neuter; words “but not limited to”; (d) whenever the words “include,” “includes” or “including” are used in this Undertaking they will be deemed to be followed by the (e) the word “extent” in the phrase “to the extent” will mean the degree to which a subject or other thing extends, and such phrase will not simply mean “if”; 16 (f) references to any statute, rule, regulation or form (including in the definition thereof) will be deemed to include references to such statute, rule, regulation or form as amended, modified, supplemented or replaced from time to time (and, in the case of any statute, include any rules and regulations promulgated under such statute), and all references to any section of any statute, rule, regulation or form include any successor to such section; (g) time is of the essence with regard to all dates and time periods set forth or referred to in this Undertaking; not affect the construction or interpretation of any of its provisions; (h) the subject headings of Articles and Sections of this Undertaking are included for purposes of convenience of reference only and will Schedules and Exhibits hereto, (ii) the term “any” means “any and all” and (iii) the term “or” will not be exclusive and will mean “and/or”; (i) (i) the terms “hereof”, “herein”, “hereby”, “hereto”, and derivative or similar words refer to this entire Undertaking, including the (j) (i) references to “days” means calendar days unless Business Days are expressly specified, (ii) references to “NIS” mean New Israeli Shekels and (iii) references to “$” mean U.S. dollars; (k) the term “foreign” will mean non-U.S.; and (l) the Parties have participated jointly in the negotiation and drafting of this Undertaking; in the event an ambiguity or question of intent or interpretation arises, this Undertaking will be construed as if drafted jointly by the Parties, and no presumption or burden of proof will arise favoring or disfavoring any Party by virtue of the authorship of any of the provisions hereof and the language used will be deemed to be the language chosen by the Parties to express their mutual intent. Section 5.16 Counterparts; Deliveries. This Undertaking may be executed simultaneously in counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument. This Undertaking and any amendments hereto or thereto, to the extent signed and delivered by means of electronic transmission of .pdf files or other image files via e-mail, cloud-based transfer or file transfer protocol, or use of a facsimile machine, will be treated in all manners and respects and for all purposes as an original agreement or instrument and will be considered to have the same binding legal effect as if it were the original signed version thereof delivered in person. No party to any such agreement or instrument will raise the use of electronic transmission or a facsimile machine to deliver a signature or the fact that any signature or agreement or instrument was transmitted or communicated through the use of electronic transmission or a facsimile machine as a defense to the formation or enforceability of a contract, and each such party forever waives any such defense. [The remainder of this page is intentionally left blank.] 17 IN WITNESS WHEREOF, the Parties have executed this Undertaking as of the date first written above. SHAREHOLDER: /s/ Gil Pogozelich Goldman Hirsh Partners Ltd. Abba Even 1, Herzliya Pituach, Israel Attention: Gil Pogozelich Fax: 972-9-7711805 email: gil@goldman-hirsh.com ACCEPTED AND AGREED KITOV PHARMACEUTICALS HOLDINGS LTD. /s/ Simcha Rock By: Name: Simcha Rock CFO Its: 18 Flow of Funds Agreement Exhibit 2.10 THIS FLOW OF FUNDS AGREEMENT (this “Agreement”) is made and entered into as of April 9, 2017, by and among Goldman Hirsh Partners Ltd. (the “Seller”), and Kitov Pharmaceuticals Holdings Ltd. an Israeli publicly traded corporation or its Affiliated party (the "Buyer"), (each of the Seller, and the Buyer shall also be referred to as a “Party”, and collectively as the “Parties”). WHEREAS, the Seller and the Buyer have entered into a Stock Purchase Agreement (the “Purchase Agreement” or the "SPA") dated January 12, 2017 for the purchase of shares of the Seller in Tyrnovo Ltd (the "Company"); and WHEREAS, according to Section 2.2 to the Purchase Agreement, the Buyer was required to deposit the Cash Consideration portion of the Escrow Amount in an Escrow Fund; and WHEREAS, the Seller and the Buyer wish to determine the manner in which the Cash Consideration shall be transferred to the Seller ; and NOW, THEREFORE, in consideration of the mutual promises and covenants set forth herein, the Parties hereby agree as follows: (Unless otherwise specifically defined hereunder, any capitalized term used herein shall have the definition allocated to it in the Purchase Agreement) 1. Buyer and Seller agree and confirm that the Cash Consideration has been, and shall be, paid as follows: 1.1. An amount of US$800,000 was paid at the Closing of the Purchase Agreement according to the provisions thereof: US$117,000 (VAT Included) were paid to Lior Tamar Investment Ltd.; and 683,000US$ were paid to the Seller and payment of such respective amounts to each of Lior Tamar Investments Ltd. and the Seller is hereby confirmed by Seller. 1.2. An amount of US$76,050 was paid by the Buyer to Taoz– Company for Management and Holdings of Companies Ltd., on behalf of the Seller, on March 15, 2017. 1.3. An additional amount of US$906,793 shall be paid according to the provisions and subject to the conditions of section 2 below. 1.4. An additional amount of US$ 217,157 shall be paid according to the provisions and subject to the conditions of section 3 below. 2. Within 3 business days from the date of signing this Agreement, Buyer shall transfer to the Seller, or to third parties as set forth below on his behalf, amounts as follows: 2.1. An amount of US$ 175,500 (VAT included) to Lior Tamar Investments Ltd., the Seller Agent, on behalf of Seller, by wire transfer, to the bank account detailed in Exhibit 2.1. 2.2. An amount equal to US$234,000 (VAT included) as the Exit Fee amount as set forth in the Yissum Exit Fee Letter, to Yissum, on behalf of Seller, by wire transfer, to the bank account detailed in the Yissum Exit Fee Letter. It is agreed between the Parties that an additional amount of US$ 46,800 (VAT included) will be released to the Seller within 3 business days after the Seller will deliver to the Buyer a letter from Yissum, duly executed by Yissum, regarding the Exit Fee, in the form attached hereto as Exhibit 2.2 (“Yissum Exit Fee Letter”). 2.3. An amount equal to US$ 97,058 (before VAT, if any) to the Seller, by wire transfer, to the bank account detailed in Exhibit 2.4 will be released to the Seller within 1 business day after the Seller will deliver to the Buyer a letter from Yissum (“Yissum”), duly executed by Yissum, regarding the postponement of payment of historical patent costs in the form attached hereto as Exhibit 2.3 (“Postponement Letter”). 2.4. An amount equal to US$ 101,157 (the "Refunded Loan Repayment Amount") to the Company, on behalf of Seller, as refund to the Company of amounts paid to the Seller on February 2017 as repayment of a loan from the Seller to the Company. Subject to such refund of the Refunded Loan Repayment Amount, such right of the Seller for repayment by the Company of the Refunded Loan Repayment Amount, is hereby irrevocably Assigned to the Buyer. 2.5. An amount equal to US- $252,278 to the Seller, by wire transfer, to the bank account detailed in Exhibit 2.4 3. With respect to each payment set forth below, if relevant, subject to the condition set forth with respect to such payment below, then, an amount of up to US$ 217,157 (the “Aggregate Remaining Cash Consideration”) shall be paid by the Buyer (and which for avoidance of doubt, and notwithstanding that which is stated otherwise in the Purchase Agreement, such Aggregate Remaining Cash Consideration shall not be deposited in an Escrow Fund) at the earlier of (i) the lapse of 24 months from the date hereof or (ii) with respect to each payment set forth below, such time set forth below with respect to such payment, if applicable: 3.1. Within 3 business days from delivery by the Seller to the Buyer of a written confirmation from the Tax Authorities (Pre ruling), that there is no tax due with respect to shares issued to Dr. Hadas Reuveni, the Buyer shall pay an amount of US$ 100,000 to the Seller. In the event that during a period of 24 months, from the date hereof, a written requirement or a written claim by the Tax Authorities (“Tax Claim”) was received by TyrNovo and/or either of the Parties and/or Dr. Hadas Reuveni (“Receiving Party”), then the Receiving Party shall provide prompt notice of such Tax Claim to the Seller and shall make best efforts to enable the Seller to appeal the Tax Claim. Any peremptory Tax Claim shall be paid by the Buyer after giving the Seller an advanced written notice of such payment, and deducted from the amount of US$ 100,000 mentioned hereabove. Any payment under dispute with the Tax Authorities shall remain with the Buyer and not paid to the Seller until the appeal of the Tax Claim becomes peremptory. For avoidance of doubt it is clarified that the Seller is not obligated to apply to the Tax Authorities for the Ruling. It is agreed that the Buyer is entitled, at its sole and absolute discretion, to apply to the Tax Authorities at Buyer's expense. In such case, the Buyer shall notify the Seller with a written advanced notice before turning to the Tax Authorities, without such prior notice constituting a right of the Seller to prevent such application by the Buyer. 3.2. Within 3 business days from delivery by the Seller to the Buyer of a written confirmation from a CPA that all payments and/or withholding amounts due to the Israel National Insurance Institute or Israeli Income Tax Authority, and any employee pension, manager’s insurance with regard to the employment of Dr. Hadas Reuveni and Dr. Lena Kupershmidt for any periods of employment ended on December 31, 2016, the Buyer shall pay an amount of US$ 50,000 to the Seller. 3.3. An amount of US$ 67,157 which shall be paid by the Buyer to the Seller at the lapse of 12 months from the date hereof Provided that no Additional Liabilities will be revealed. For the purpose of this Agreement, “Additional Labilities” shall mean any amount that any Buyer Indemnified Parties are entitled to as indemnification pursuant to the provisions of the Purchase Agreement. 2 4. Seller confirms that the Company has paid the Seller and entities related to the Seller all amounts due to them from the Company as detailed in the schedule of Company Closing Liabilities (as defined in Section 4.8 to the Purchase Agreement) and the Seller and related entities have no further claim against the Company for payments arising on account of loans and or services provided by the Seller to the Company. 5. The Buyer shall not be required to deposit the Cash Consideration portion of the Escrow Amount or any part thereof in an Escrow Fund. 6. This Agreement will not be amended, modified or waived in any manner without the consent in writing duly executed and delivered by each Party hereto, or any third party beneficiary hereof. No failure or delay of any Party hereto, or any third party beneficiary hereof to exercise any right or remedy given to such party under this Agreement and no custom or practice of such parties in variance with the terms hereof, will constitute a waiver of any party’s right to demand exact compliance with the terms hereof. Any written waiver will be limited to those items specifically waived therein and will not be deemed to waive any future breaches or violations or other non-specified breaches or violations unless, and to the extent, expressly set forth therein. 7. The provisions of this Agreement will be deemed severable and the invalidity, unlawfulness or unenforceability of any provision will not affect the validity or enforceability of the other provisions hereof, and the remainder of this Agreement, and the application of such provision to persons or circumstances other than those as to which it is determined to be invalid, unlawful, or unenforceable, shall not be impaired or otherwise affected and shall continue to be valid and enforceable to the fullest extent permitted by law so long as the economic or legal substance of the transactions contemplated hereby is not affected in any manner materially adverse to any Party or other person. If the final judgment of a court of competent jurisdiction or other Governmental Authority declares that any term or provision hereof is invalid, illegal or unenforceable, the Parties agree that the court making such determination will have the power to reduce the scope, duration, area or applicability of the term or provision, to delete specific words or phrases, or to replace any invalid, illegal or unenforceable term or provision with a term or provision that is valid, legal and enforceable and that comes closest to expressing the intention of the invalid, illegal or unenforceable term or provision. 8. This Agreement will be construed and enforced in accordance with, and will be governed exclusively by, the internal laws of the State of Israel, without giving effect to any Law or rule that would cause the Laws of any jurisdiction other than the State of Israel to be applied. The competent courts of Tel- Aviv, Israel shall have exclusive jurisdiction in all matters relating to any dispute arising out of or relating to this Agreement, or the breach thereof, to the exclusion of any other jurisdiction. 9. The Parties have participated jointly in the negotiation and drafting of this Agreement; in the event an ambiguity or question of intent or interpretation arises, this Agreement will be construed as if drafted jointly by the Parties, and no presumption or burden of proof will arise favoring or disfavoring any Party by virtue of the authorship of any of the provisions hereof and the language used will be deemed to be the language chosen by the Parties to express their mutual intent. 10. This Agreement may be executed simultaneously in counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument. This Agreement and any amendments hereto or thereto, to the extent signed and delivered by means of electronic transmission of .pdf files or other image files via e-mail, cloud-based transfer or file transfer protocol, or use of a facsimile machine, will be treated in all manners and respects and for all purposes as an original agreement or instrument and will be considered to have the same binding legal effect as if it were the original signed version thereof delivered in person. No party to any such agreement or instrument will raise the use of electronic transmission or a facsimile machine to deliver a signature or the fact that any signature or agreement or instrument was transmitted or communicated through the use of electronic transmission or a facsimile machine as a defense to the formation or enforceability of a contract, and each such party forever waives any such defense. 3 IN WITNESS WHEREOF the parties have signed this Agreement as of the date first hereinabove set forth. KITOV PHARMACEUTICALS HOLDINGS LTD. By: Title: /s/ Isaac Israel and /s/ Simcha Rock CEO CFO Address One Azrieli Center, Round Tower, 23rd Floor 132 Menachem Begin Road Tel Aviv 6701101, Israel Telephone: +972-3-9333121 Mobile: +972-54-8679966 Fax: +972-153-39311321 GOLDMAN HIRSH PARTNERS LTD. /s/ By: Title: Address Abba Even 1, Herzliya Pituach, Israel Attention: Gil Pogozelich Fax: 972-9-7711805 email:gil@goldman-hirsh.com 4 THE SYMBOL “[****]” DENOTES PLACES WHERE PORTIONS OF THIS DOCUMENT HAVE BEEN OMIITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. SUCH MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION Exhibit 4.14 This License Agreement (“Agreement”) is made in Jerusalem this 15 day of August, 2013, by and between: LICENSE AGREEMENT YISSUM RESEARCH DEVELOPMENT COMPANY OF THE HEBREW UNIVERSITY OF JERUSALEM, LTD., of Hi Tech Park, Edmond J. Safra Campus, Givat Ram, Jerusalem 91390, Israel (“Yissum”) of the one part; and TYRNOVO LTD. (or any other name approved by the Israeli registrar of companies), a company in formation (the “Company”), represented until its registration by GOLDMAN HIRSH PARTNERS LTD. of 6 Hahoshlim St. Herzliya Pituach 46723, Israel (“GHP”), of the second part; (each of Yissum and the Company, a “Party”, and collectively the “Parties”) WHEREAS: WHEREAS: WHEREAS: WHEREAS: Prof. Alexander Levitzki of the Hebrew University of Jerusalem (the “Researcher”) and Dr. Hadas Reuveni, then an employee of Novotyr Therapeutics Ltd. (“NovoTyr”) and/or certain other members of the Researcher’s team at the Hebrew University of Jerusalem (together the “Inventors”) developed technology with respect to unique inhibitors of the IGF-1R pathway as more fully described in the patent applications listed in Appendix A1 hereto; (collectively, the “Existing Portfolio of Patent Applications”); and the Inventors and NovoTyr have assigned all their rights and title to all of the Appendix A1 Existing Portfolio of Patent Applications and the inventions claimed therein to Yissum; and Yissum owns the Existing Portfolio of Patent Applications; and the rights and title of scientists of the Hebrew University of Jerusalem in and to all inventions, know-how and the results of research created by them vest solely with Yissum; and the Company has represented to Yissum that either by itself or through third parties, it has the financial capacity and the strategic commitment to facilitate the development, production, marketing and distribution of products as contemplated in this agreement; and the Company wishes to obtain a license from Yissum for the development and commercialization of the inventions claimed in all or part of the Existing Patent Applications as defined in Section 1.4.5 below and the Know-How (as defined in Section 1.4.10 below), at the Company’s discretion; and WHEREAS: Yissum agrees to grant the Company such a license, all in accordance with the terms and conditions of this Agreement. NOW THEREFORE THE PARTIES DO HEREBY AGREE AS FOLLOWS: 1. Interpretation and Definitions 1.1. 1.2. The preamble and appendices to this Agreement constitute an integral part hereof and shall be read jointly with its terms and conditions. In this Agreement, unless otherwise required or indicated by the context, the singular shall include the plural and vice-versa, the masculine gender shall include the female gender, “including” or “includes” shall mean including, without limiting the generality of any description preceding such terms and the use of the term “or” shall mean “and/or”, any reference to the term “sale” shall include the sale, lease, rental, or other disposal of any Product and any reference to “the date of execution of this Agreement” shall mean the date of the last signature of this Agreement by the Parties. 1.3. The headings of the Sections in this Agreement are for the sake of convenience only and shall not serve in the interpretation of the Agreement. 1.4. In this Agreement, the following capitalized terms shall have the meanings appearing alongside them, unless provided otherwise: 1.4.1. 1.4.2. 1.4.3. “Affiliate” shall mean any person, organization or other legal entity which controls, or is controlled by, or is under common control with, the Company. “Control” shall mean the holding of more than fifty percent (50%) of (i) the equity or (ii) the voting rights or (iii) the right to elect or appoint directors. “Development Plan” shall mean the written plan and timetable for the development and the commercialization of Products, including specific development milestones, prepared by the Company and approved by Yissum, a copy of which shall be attached to this Agreement as Appendix B, within three (3) months of the date of execution of this Agreement, as amended from time to time. “Development Results” shall mean the results of activities carried out by the Company or by third parties (other than the Researcher and his team) at the direction of the Company pursuant to the Development Plan or otherwise in fulfillment of the Company’s obligations hereunder (including its development obligations under Section 5 below), including, any invention, patent or patent application, product, material, method, discovery, composition, process, technique, know-how, data, information or other result which do not form part of the Licensed Technology, and further including any governmental or regulatory filing submitted, or approval, license, registration, or authorization obtained, by the Company, an Affiliate or Sublicensee in respect of the Products, as well as any other information, data, material, results, devices and know-how arising from the performance of the Development Plan. 1.4.4. “Effective Date” shall mean the date upon which NovoTyr Shareholders Approval (as defined in Section 2.2 below) is received. 1.4.5. “Existing Patent Applications” shall mean: (i) the patent applications currently listed in Appendix A2, provided that patent family 3711 (Yissum reference no.) or patent family 3712 (Yissum reference no.) may be deleted therefrom by written request of the Company to be notified to Yissum within one hundred and twenty (120) days of the execution of this Agreement; and (ii) other patent applications from the Existing Portfolio of Patent Applications selected by the Company, within its sole discretion, and notified to Yissum in writing within one hundred and twenty (120) days from the date of execution of this Agreement, which shall be added to Appendix A2 hereto. 1.4.6. “Exit Event” shall mean, (i) a transaction or series of transactions, which result in; (a) the sale, assignment, transfer or other disposition of all or a majority of the assets of the Company; or (b) the sale, assignment, transfer or other disposition of all or majority of the share capital of the Company as a result of which there is a change of “control” within the meaning of such term in Section 1.4.1 above; or (ii) an initial public share offering of the Company (an “IPO”). 2 1.4.7. “Exit Fee” shall mean the amount payable to Yissum in accordance with Section 7.3, below. 1.4.8. “Exit Proceeds” shall mean any consideration, monetary or otherwise, including shares and other securities or goods, actually received by the Company or the Original Shareholders (as applicable), directly or indirectly in the framework, or as a result, of an Exit Event as referred to in 1.4.6 above, it being agreed that any non-monetary consideration shall be valued at its fair market value as determined by mutual agreement between the Parties and failing such agreement, according to the assessment of an independent appraiser to be selected by the Parties. 1.4.9. “First Commercial Sale” shall mean the first sale of a Product by the Company, an Affiliate or a Sublicensee after the receipt of any required regulatory approval to market and sell such Product, excluding trials, evaluations or testing arrangements. 1.4.10. “Know-How” shall mean all proprietary, non-public tangible or intangible information, techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, ancillary materials, results, devices, or know-how developed by the Inventors (including the Researcher), prior to the OCS Approval, directly related to the subject matter claimed in the Existing Patent Applications, and belonging to Yissum and described generally in Appendix A3. 1.4.11. “License” shall have the meaning ascribed thereto in Section 3.1 below. 1.4.12. “Licensed Patents” shall mean (a) the Existing Patent Applications, and any patent application that claims priority therefrom; as well as (b) all divisions, continuations, continuations-in-part, re-examinations, reissues, renewals, registrations, confirmations, substitutions, or extensions, including European Supplementary Protection Certificates (“SPCs”), and “Orphan Drug” status (within the meaning of such term under the US Orphan Drug Act) and/or any other similar statutory protection, and any provisional applications, national, regional, PCT or similar applications, and any and all patents issuing from, and patentable inventions, methods, processes, and other subject matter disclosed or claimed in, any or all of the foregoing. 1.4.13. “Licensed Technology” shall mean the Know-How and the Licensed Patents. 1.4.14. “Net Sales” shall mean: (i) (ii) the gross sales price invoiced for sales of Products by the Company, an Affiliate or Sublicensee to a third party; or the fair market value of non-monetary consideration received in connection with such sales as mutually agreed by the Parties, and failing such agreement, according to the assessment of an independent appraiser to be selected by the Parties; after deduction of: (i) bona fide discounts to the extent actually taken by third parties, provided however, that where any discount is based on sales of a bundled set of products that includes the Product, the discount shall be allocated to the Product on a pro rata basis based on the sales value (i.e., the unit average selling price multiplied by the unit volume) of the Product relative to the sales value contributed by the other constituent products in the bundled set, with respect to such sale; (ii) sales taxes, excise, customs, VAT and sales taxes or other taxes (except income tax) imposed on such sales; (iii) any cash backs, returns, refunds or similar repayment or return credits (by credit note) actually made after the relevant invoice was issued; (iii) royalties paid to the OCS; and (iv) transport and insurance charges; provided that such deductions are directly related to the sale of the applicable Products, and were awarded within the regular running of the business of the Company, Affiliate or Sublicensee. 3 In the event of sales made through a distributor, reseller or marketing agent who does not pay a fixed, final amount for such sales, the sales made by such distributor, resellers or marketing agent shall be deemed gross sales for the purposes of this Agreement. In the event of sales or deductions not made at “arms length”, then for the purpose of calculation of Royalties (as defined below) to Yissum, Net Sales shall be determined by mutual agreement between the Parties and failing such agreement, according to the assessment of an independent appraiser to be selected by the Parties. With respect to sales by the Company, its Affiliate, or Sublicensee as applicable, to any Affiliate or Sublicensee, as the case may be, the term, “Net Sales” shall mean only the amount received by such Affiliate or Sublicensee on resale to a third party purchaser after deduction of the items specified above, to the extent applicable. 1.4.15. “NovoTyr Shareholders Approval” shall have the meaning ascribed thereto in Section 2.2 below. 1.4.16. “OCS” shall mean the Office of the Chief Scientist of the Ministry of Economics. 1.4.17. “OCS Approval” shall have the meaning ascribed thereto in Section 2.2 below. 1.4.18. “Original Shareholders” shall mean GHP or any of its permitted transferees or assigns (as defined in the governing corporate agreements pursuant to which GHP received its shares in the Company). 1.4.19. “Product” shall mean any product, process, or service that (a) uses the Licensed Technology; or (b) the sale of which, in the absence of the license granted to the Company in this Agreement, would infringe one or more of the Licensed Patents. 1.4.20. “Royalties” shall have the meaning ascribed thereto in Section 7.1 below. 1.4.21. “Subcontracting Agreement” shall mean (i) a bona fide subcontracting agreement pursuant to which a contractor is engaged for the purpose of manufacturing or developing any of the Products (or part thereof) on the Company’s behalf, for monetary consideration; or (ii) a bona fide arms-length research agreement, pursuant to which an academic or research institution is engaged for the purpose of performing research, on the Company’s behalf, for the development of any of the Products (or part thereof), provided that in no event shall the consideration (if any) therefor comprise any Products; and the term “Subcontractor” shall be construed accordingly. 1.4.22. “Sublicense” shall mean any grant by the Company or its Affiliates of any of the rights granted under this Agreement or any part thereof; including the right to develop, manufacture, market, sell or distribute the Licensed Technology or any Product, for which grant the recipient of the Sublicense is required to pay the grantor of the Sublicense, excluding a Subcontracting Agreement. 4 1.4.23. “Sublicense Consideration” shall mean any proceeds or consideration or benefit of any kind whatsoever, whether monetary or otherwise, that the Company or an Affiliate may receive from a Sublicensee as a direct or indirect result of the grant of a Sublicense and/or pursuant thereto or an option to obtain such Sublicense, except amounts received by the Company which constitute royalties based on Net Sales by Sublicensees in respect of which the Company is required to pay Royalties to Yissum. 1.4.24. “Sublicense Fees” shall have the meaning ascribed thereto in Section 7.2 below. 1.4.25. “Sublicensee” shall mean any third party to whom the Company or an Affiliate shall grant a Sublicense or option to obtain such Sublicense. For the sake of clarity, Sublicensee shall include any other third party (other than a Subcontractor) to whom such rights shall be transferred or assigned, or who may assume control thereof by operation of law or otherwise. 1.4.26. “Territory” shall mean worldwide. 1.4.27. “University” shall mean the Hebrew University of Jerusalem and each of its branches. 2. Conditions Precedent 2.1. 2.2. The Company acknowledges that it is aware that (i) Yissum and NovoTyr executed a license agreement dated September 19, 2005 (as amended from time to time) (the “License Agreement”); (i) the Licensed Technology (or part thereof) was developed and/or generated by the Inventors in the framework of an incubator project approved by the OCS for implementation by NovoTyr within the incubator program of Meytav Technological Incubator Ltd.; (ii) on March 19, 2013 Yissum notified NovoTyr in writing of the termination of the License Agreement for breach by NovoTyr of certain of the terms thereof and required NovoTyr to assign and transfer to Yissum all right, title and interest of NovoTyr in and to the Licensed Patents and the Know-How (to the extent of NovoTyr’s ownership of any rights therein), pursuant to the terms of the License Agreement; (iii) the assignment and transfer of NovoTyr’s right, title and interest in and to the Licensed Patents and Know-How to Yissum as aforesaid is subject to the approval and requirements of the OCS; and (iv) on August 4, 2013 Yissum and NovoTyr entered into an IP Agreement pursuant to which, inter alia, NovoTyr irrevocably assigned and transferred all its right, title and interest in and to the Licensed Patents and the Know-How to Yissum, subject to the approval and requirements of the OCS (the “IP Agreement”). The Parties agree that this Agreement, shall be conditional upon: (i) the execution by all of the shareholders of NovoTyr of a resolution approving the execution of the IP Agreement and, therefore, the assignment and transfer of the Licensed Patents and Know-How to Yissum pursuant thereto (“NovoTyr Shareholders Approval”), provided however that the grant of the License by Yissum to the Company pursuant to Section 3 below and the Company’s right to grant Sublicenses under Section 6 below shall be further conditional upon the receipt by Yissum of the approval of the OCS to the assignment and transfer to Yissum of the Licensed Patents and Know-How as aforesaid in accordance with terms and conditions that are reasonably acceptable to Yissum (“OCS Approval”); (the receipt of NovoTyr Shareholders Approval and OCS Approval, respectively, the “Conditions Precedent”). 5 2.3. 2.4. 2.5. 2.6. 2.7. Yissum undertakes to use diligent efforts to cause the Conditions Precedent to be fulfilled as soon as possible. Yissum represents and warrants that it has made available to the Company all the relevant information in its possession in connection with such Conditions Precedent (including all material facts that in Yissum’s reasonable opinion are likely to prevent or otherwise adversely affect their fulfillment) and that, subject to Section 2.7 below, until the OCS Approval is received, Yissum shall inform the Company about any such material information as soon as possible but no later than ten (10) days after becoming aware thereof. The Company shall cooperate with Yissum and shall make reasonable commercially efforts to assist Yissum with respect to obtaining OCS Approval, including the signature of documents and undertakings (if any) required by the OCS. The date upon which the NovoTyr Shareholders Approval has been received, shall be deemed the Effective Date. In the event that both of the Conditions Precedent are not fulfilled by the first anniversary of the date of execution of this Agreement, either Party shall have the right to terminate this Agreement by written notice to the other Party (effective immediately). In such case, this Agreement shall be of no force or effect, and no Party shall have any claim against the other Party arising from this Agreement or any discussions or negotiations by the Parties in respect of this Agreement or the termination thereof as aforesaid. The said period for the fulfillment of the Conditions Precedent may be extended by written agreement of the Parties. It is understood, however, that Yissum shall not unreasonably refuse any request by the Company for an extension of such period (including additional requests for further extensions). It is agreed further that: (i) Yissum shall only be entitled to refuse a request by the Company for extensions of such period upon grounds relating to such Conditions Precedent (including the non-fulfillment thereof); and (ii) Yissum shall not be entitled to refuse a request by the Company for extensions of such period if the fulfillment of the Conditions Precedent is likely to occur during the relevant extension period requested by the Company, provided that each such extension period requested by the Company shall not exceed nine (9) months. 3. The License 3.1. 3.2. Subject to the full performance by the Company of its obligations in accordance with this Agreement, Yissum hereby grants the Company an exclusive license (with the right to grant sublicenses in accordance with Section 6 below) to make commercial use of the Licensed Technology, in order to commercialize, exploit, develop, have developed, manufacture, have manufactured market, import, export, distribute, offer to sell, or sell Products, all within the Territory only, subject to and in accordance with the terms and conditions of this Agreement (the “License”). Notwithstanding the provisions of Section 3.1 above, Yissum, on behalf of the University, shall retain the right to make, use and practice the Licensed Technology for the University’s own internal research, educational and pre-clinical purposes, subject to the confidentiality obligations undertaken herein by Yissum. 6 4. Term of the License The License shall expire, if not earlier terminated pursuant to the provisions of this Agreement, on a country-by-country basis, upon the later of: (i) the date of expiration in such country of the last to expire Licensed Patent included in the Licensed Technology; (ii) the date of expiration of any exclusivity on the Product granted by a regulatory or government body in such country; or (iii) the end of a period of fifteen (15) years from the date of the First Commercial Sale in such country. Should the periods referred to in Subsections (i) or (ii) expire in a particular country prior to the period referred to in Subsection (iii), above, the license in that country or those countries shall be deemed an exclusive license to the Know-How during such post-expiration period. Upon the expiration of the later of the periods set forth in Subsections (i) through (iii) above (and provided that the License has not been terminated prior thereto), the Company shall have a perpetual fully-paid, royalty-free non-exclusive license to the Know-How. 5. Development and Commercialization 5.1. 5.2. 5.3. 5.4. 5.5. 5.6. The Company undertakes, at its own expense, to use commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with a the Development Plan prepared by the Company and approved by Yissum, a copy of which shall be attached to this Agreement as Appendix B within three (3) months of the date of execution of this Agreement. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth above, upon Yissum’s prior written approval. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results. The Company shall (i) provide Yissum with periodic written reports (“Development Reports”) not less than annually, on its product development progress or efforts to commercialize under the Development Plan within sixty (60) days after December 31 of each calendar year. These progress reports shall include progress on research and development, status of applications for regulatory approvals, manufacturing, sublicensing, marketing, importing, and sales during the preceding calendar year, as well as plans for the present calendar year. If reported progress in respect of a Product differs materially from that anticipated in its Development Plan or a preceding Development Plan, the Company shall explain, in its Development Report, the reason therefor and prepare a modified Development Plan for Yissum’s review. The Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the performance of the Company hereunder. The Company shall pursue the development and registration of all commercially reasonable indications or uses of the Product. Upon completion of the development of any Product, the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. In the event the Company does not use commercially reasonable efforts to commercialize any Product, unless such delay is due to (i) the requirements of a regulatory or other governmental authority; (ii) force majeure in accordance with Section 18.8 below; or (iii) agreed revisions in the timelines in the amended Development Plan, Yissum shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and shall allow the Company up to twelve (12) months to cure such failure of diligence (the “Cure Period”). The Company’s failure to cure such failure to Yissum’s reasonable satisfaction within the Cure Period shall be considered a material breach of this Agreement and Yissum shall be entitle to terminate this Agreement, including the License, immediately. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, including the Law of Encouragement of Industrial Research and Development, 1984 as amended or supplemented from time to time and all regulations promulgated thereunder (the “R&D Law”) and all the rules and regulations of the OCS (to the extent applicable), and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder. 5.7. The Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number units of any Product developed and/or manufactured under this Agreement, for academic research purposes only. 7 6. Sublicenses 6.1. The Company shall be entitled to grant Sublicenses under the License, without obtaining Yissum’s prior approval provided that: 6.2. 6.3. 6.4. 6.5. 6.6. 6.7. (a) each Sublicense shall be granted in a bona fide arms-length commercial transaction pursuant to a written agreement; and (b) the Sublicense shall comply with the terms and conditions set forth in this Section 5 below. Any Sublicense shall be dependent on the validity of the License and shall terminate upon termination of the License. The Company shall ensure that any Sublicense shall include material terms that require the Sublicensee to comply with the terms of this Agreement, the breach of which terms shall be a material breach resulting in termination of the Sublicense. In such an event, the Company undertakes to take all reasonable steps to enforce such terms upon the Sublicensee, including the termination of the Sublicense. In all cases, the Company shall immediately notify Yissum of any breach of the material terms of a Sublicense, and shall copy Yissum on all correspondence with regard to such breach. Furthermore, in the context of any Sublicense, the Company will obtain an agreement from the relevant Sublicensee (i) that such Sublicensee may only use the Licensed Technology and any related information received from the Company in connection with the further development and/or commercialization of a Product pursuant to the terms of the sublicense agreement, and will keep same confidential, and (ii) naming Yissum as a third party beneficiary with the right to directly enforce the use and confidentiality provisions described in sub- section (i) above. The Company shall require each Sublicensee to provide it with regular written royalty reports that include at least the detail that the Company is required to provide pursuant to Section 8.2 below. Any act or omission of the Sublicensee which is not promptly remedied by the Company or the Sublicensee and which would have constituted a breach of this Agreement by the Company had it been an act or omission of the Company, and which the Company has not made best efforts to promptly cure, including termination of the Sublicense, shall constitute a breach of this Agreement by the Company. For the avoidance of any doubt it is hereby declared that under no circumstance whatsoever shall a Sublicensee be entitled to assign such Sublicense or further Sublicense the License or any part thereof. The Company shall provide Yissum with (a) a copy of the term sheet (if any) signed with any prospective Sublicensee as soon as practicable after signature thereof; and (b) the then latest draft of the Sublicense no later than ten (10) days prior to the anticipated date of signature thereof. In addition the Company shall provide Yissum with an executed copy of the Sublicense and of any amendments thereto within fourteen (14) days of its execution. 6.8. The Company shall not be entitled to grant any rights whatsoever in respect of the Licensed Technology or the Product to any third party, including without limitation rights of distribution/distributorship, except by means of a Sublicense. 8 7. License Consideration In consideration for the grant of the License, the Company shall pay Yissum the following consideration during the term of the License as set forth in Section 4 above: 7.1. 7.2. 7.3. Royalties at a rate of [****] percent ([****]%) of Net Sales (the “Royalties”). Sublicense fees at a rate of [****] percent ([****]%) of Sublicense Consideration (“Sublicense Fees”). Yissum shall be entitled to receive from the Company an Exit Fee as follows: 7.3.1. 7.3.2. 7.3.3. Sale of Company Shares or Assets Prior to the Company’s IPO. In the event of an Exit Event as referred to in Section 1.4.5(i) above the Exit Proceeds of which are equal to or less than [****] (USD [****]) US Dollar, the Company or the Original Shareholders (as applicable) shall transfer to Yissum [****] percent ([****]%) of such Exit Proceeds; or in the event of an Exit Event the Exit Proceeds of which are higher than [****] (USD [****]) US Dollar, the Company or the Original Shareholders (as applicable) shall transfer to Yissum the greater of (a) [****] percent ([****]%) of such Exit Proceeds; or (b) [****] US dollars (US $[****]) at the time of the said Exit Event; or Company IPO. If the Exit Event is an IPO, then, immediately prior to the closing of the IPO, the Company shall issue to Yissum such number of ordinary shares of the Company equal to [****] percent ([****]%) of all of the shares of the Company. The Original Shareholders or the Company (as applicable) and Yissum shall bear their own tax burden. The Company shall give Yissum written notice of an Exit Event not later than seven (7) days prior to the occurrence thereof, setting out the relevant details of the Exit Event. If the Exit Event is an IPO, the Company shall also provide a capitalization table reflecting the issued share capital of the Company on a fully diluted basis prior to the IPO and all other information required for the calculation of equity consideration to which Yissum is entitled as aforesaid, and appropriate supporting documentation. The shares to which Yissum is entitled as provided above shall be issued to Yissum immediately prior to and subject to the occurrence of the IPO. In the case of any other Exit Event (other than an IPO) the Exit Fees due to Yissum shall be paid to Yissum within fourteen (14) days of the actual receipt by the Company or the Original Shareholders (as applicable) of the Exit Proceeds upon the occurrence of such Exit Event, such payment to be accompanied by a written report certified as being correct by the chief financial officer of the Company, detailing the total Exit Proceeds and the Exit Fee due to Yissum. In addition, in the case of an Exit Event, the Company shall provide Yissum with a copy of the relevant documents relating to the Exit Event within fourteen (14) days of the execution thereof, and in the event that the Company is required to do so, Yissum shall execute any additional customary non-disclosure undertaking. 7.3.4. For the avoidance of doubt, the Company’s failure to pay the Exit Fee as set forth in Sections 7.3.1 and 7.3.2, above, shall be a material breach of this Agreement that, if not cured by the Company within the time allotted for the cure of material breaches in Section 15.2.2, below, will result in the termination of this Agreement and the License granted herein. 9 8. Reports and Accounting 8.1. 8.2. 8.3. 8.4. The Company shall give Yissum written notice of any Sublicense Consideration received or First Commercial Sale made within thirty (30) days of such event. One (1) month after the end of each calendar quarter commencing from the earlier of (i) the First Commercial Sale; or (ii) the grant of a Sublicense or receipt of Sublicense Consideration, the Company shall furnish Yissum with a quarterly report (“Periodic Report”), certified as being correct by the chief financial officer of the Company, detailing the total sales and Net Sales effected during the preceding quarter, the total Sublicense Consideration received during the preceding quarter and the total Royalties and Sublicense Fees due to Yissum in respect of that period. Once the events set forth in sub-section (i) or (ii), above, have occurred, Periodic Reports shall be provided to Yissum whether or not Royalties and Sublicense Fees are payable for a particular calendar quarter. The Periodic Reports shall contain full particulars of all sales made by the Company, Affiliates or Sublicensees and of all Sublicense Consideration received, including a breakdown of the number and type of Products sold, discounts, returns, the country and currency in which the sales were made, invoice dates and all other data enabling the Royalties and Sublicense Fees payable to be calculated accurately. On the date prescribed for the submission of each Periodic Report, the Company shall pay the Royalties and Sublicense Fees due to Yissum for the reported period. All payments under this Agreement shall be computed and paid in US dollars, using the appropriate foreign exchange rate reported in the Wall Street Journal on the last working day of the calendar quarter. Payment of value added tax – or of any analogous foreign tax, charge or levy (if charged), applicable to the payment to Yissum of the consideration as detailed in Section 7 above shall be borne by the Company and added to each payment in accordance with the statutory rate in force at such time. Withholding of any taxes will apply in accordance with the applicable law. Payments may be made by check or by wire transfer to the following account: Bank Name: Hapoalim (12) Branch Name: Zion Square (783) Account Number: 142-155557 Swift Code: Poalilit The Company shall keep, and shall require its Affiliates and Sublicensees to keep, full and correct books of account in accordance with Generally Accepted Accounting Principles as required by international accounting standards enabling the Royalties and Sublicense Fees to be calculated accurately. Starting from the first calendar year after the First Commercial Sale, or the first grant of a Sublicense, whichever occurs first, an annual report, authorized by a certified public accountant, shall be submitted to Yissum within ninety (90) days of the end of each calendar year, detailing Net Sales and Sublicense Consideration, Royalties and Sublicense Fees, both due and paid (the “Annual Reports”). The Annual Reports shall also include the Company’s sales and royalty forecasts for the following calendar year, if available. The Company shall, and shall require and make its best efforts to cause its Affiliates and Sublicensees to, retain such books of account for five (5) years after the end of each calendar year during the period of this Agreement, and, if this Agreement is terminated for any reason whatsoever, for five (5) years after the end of the calendar year in which such termination becomes effective. 10 8.5. 8.6. Yissum will either (i) allow the Company a credit against future Royalties or Sublicense Fees to be paid for Royalties or Sublicense Fees previously paid on account of Net Sales or Sublicense Considerations, as appropriate, that were reported as bad debts in the Company’s annual audited financial statements; or (ii) if such bad debts are recorded by the Company in its annual audited financial statement after the Company’s obligation to pay Royalties and/or Sublicense Fees has ceased, Yissum shall repay any Royalties or Sublicense Fees received on account of Net Sales and/or Sublicense Fees that were reported as bad debts by the Company. Yissum shall be entitled (at its sole expense) to appoint not more than two (2) representatives who must be independent certified public accountants or such other professionals as appropriate (the “Representatives”) to inspect during normal business hours the Company’s and its Affiliates’ and Sublicensee’s books of account, records and other relevant documentation to the extent relevant or necessary for the sole purpose of verifying the performance of the Company’s payment obligations under this Agreement, the calculation of amounts due to Yissum under this Agreement and of all financial information provided in the Periodic Reports, provided that Yissum shall coordinate such inspection with the Company, Affiliate or Sublicensee (as the case may be) in advance and limit such audits to no more than two (2) each calendar year. In addition, Yissum may require that the Company, through the Representatives, inspect during normal business hours the books of account, records and other relevant documentation of any Sublicensees, to the extent relevant or necessary for the sole purpose of verifying the performance of the Company’s payment obligations under this Agreement, the calculation of amounts due to Yissum under this Agreement and of all financial information provided in the Periodic Reports, and the Company shall cause such inspection to be performed. The Parties shall reconcile any underpayment or overpayment within thirty (30) days after the Representatives deliver the results of the audit. Any underpayment shall be subject to interest in accordance with the terms of Section 8.7, below. In the event that any inspection as aforesaid reveals any underpayment by the Company to Yissum in respect of any year of the Agreement in an amount exceeding five percent (5%) of the amount actually paid by the Company to Yissum in respect of such year, then the Company shall, in addition, pay the cost of such inspection. 8.7. Any sum of money due Yissum which is not duly paid on time shall bear interest from the due date of payment until the actual date of payment at the rate of annual LIBOR plus four percent (4%) per annum accumulated on a monthly basis. 9. Ownership 9.1 9.2 Subject to the Company’s rights pursuant to the License, all right, title and interest in and to the Licensed Technology shall be solely owned by Yissum, and the Company shall hold and make use of the rights granted pursuant to the License solely in accordance with the terms of this Agreement. All rights in the Development Results shall be solely owned by the Company, and any patents arising therefrom shall be registered in the name of the Company only, except to the extent that an employee of the University, including, the Researcher, is properly considered an inventor of a patentable invention arising from the Development Results, in which case such ownership shall be held jointly by the Company and Yissum, as appropriate (“Joint Patents”). Any such Joint Patents shall be registered in the name of both the Company and Yissum. 11 10. Patents 1.1. 10.2. 10.3. 10.4. 10.5. 10.6. The Company shall reimburse Yissum for all previous documented expenses and costs relating to the registration and maintenance of the Licensed Patents (listed in Appendix A2), which are detailed in Appendix C hereto (the “Historical Patent Costs”) upon the earlier of: (i) the date of expiry of a period of a period of four (4) years after the date of execution of this Agreement; (ii) the date of occurrence of an Exit Event in respect of which the Exit Proceeds are [****] (US $[****]) or more; or (iii) the date upon which the Company enters into a Sublicense pursuant to which the Company is entitled to receive an upfront payment of at least [****] (US $[****]). Yissum, in consultation with the Company, shall be responsible for the filing, prosecution and maintenance of the Licensed Patents in the Territory, at the Company’s expense (the “Ongoing Patent Costs”), such Ongoing Patent Costs to be calculated with effect from the date of execution of this Agreement. Each application and every patent registration shall be made and registered in the name of Yissum or, should the law of the relevant jurisdiction so require, in the name of the relevant inventors and then assigned to Yissum and shall be deemed part of the Licensed Technology. The Company agrees to have Yissum’s patent counsel directly bill the Company for such expenses and shall directly pay such bills in accordance with patent counsel’s directions. It is agreed that the Company shall bear the Ongoing Patent Costs in respect of the filing, prosecution and maintenance of all of the patent applications in the Existing Portfolio of Patent Applications until the earlier of (i) the selection by the Company and notification to Yissum of the additional patent applications which shall be added to Appendix A2 pursuant to Section 1.4.5 above; or (ii) the expiry of a period of one hundred and twenty (120) days after the date of execution of this Agreement. Save for the patent applications listed in Appendix A2, Yissum shall be entitled to deal with the patent applications in the Existing Portfolio of Patent Applications as it deems fit, including abandoning any of the said patent applications. Subject to the above, the Parties shall consult and make every effort to reach agreement in all respects relating to the manner of making applications for and registering the patents, including the time of making the applications, the countries where applications will be made and all other particulars relating to the registration and maintenance of the Licensed Patents. Notwithstanding the foregoing, Yissum reserves the sole right to make all final decisions with respect to the preparation, filing, prosecution and maintenance of such patent applications and patents. The Parties shall assist each other in all respects relating to the preparation of documents for the registration of any patent or any patent- related right upon the request of the other Party. Both Parties shall take all appropriate action in order to assist the other to extend the duration of a Licensed Patent or obtain any other extension obtainable under law, to maximize the scope of the protection afforded by the Licensed Patents. In the event that the Company is approached by a patent examiner or attorney in connection with any matter that is the subject matter of this Agreement, it shall give Yissum immediate notice of such approach. The Company shall only reply to such approaches after consultation with Yissum and subject to its consent. The Company, shall mark, and shall make its best efforts to cause its Affiliates and Sublicensees to mark, all Products covered by one or more of the Licensed Patents with patent numbers (or the legend “patent pending”) applicable to such Product. The Company shall make its best efforts to ensure that its Sublicensee complies with the provisions of this Section. 12 If at any time during the term of this Agreement the Company decides that it is undesirable, as to one or more countries, to file, prosecute or maintain any patents or patent applications within the Licensed Patents, it shall give at least ninety (90) days written notice thereof to Yissum, and upon the expiration of the ninety (90) day notice period (or such longer period specified in the Company’s notice) the Company shall be released from its obligations to bear the expenses to be incurred thereafter as to such patent(s) or patent application(s). As of such time, such patent(s) or application(s) shall be removed from the Licensed Technology regarding such countries and Yissum shall be free to grant rights in and to such patent(s) or patent application(s) in such countries to third parties, without further notice or obligation to the Company, and the Company shall have no rights whatsoever to exploit such patent(s) or patent application(s) or the Know-How related thereto. 10.7. 10.8. Upon the execution of this Agreement, the Company shall execute a letter of assignment concerning its interest in any Joint Patents that will provide that such interest will be irrevocably assigned to Yissum in the event that the Company is declared bankrupt, is voluntarily or involuntarily dissolved, or otherwise ceases operations. The foregoing does not constitute an obligation or warranty (express or implied) on the part of Yissum that any patent or patent registration application will indeed be made or registered or be registerable in respect of the Licensed Technology or any part thereof, nor shall it constitute an obligation or warranty, express or implied on the part of Yissum that a registered patent will be valid or afford any protection. For the avoidance of doubt, nothing in this Agreement constitutes a representation or warranty, express or implied, on the part of Yissum regarding the validity of or the protection afforded by any of the patents or patent registration applications detailed in Appendix A or regarding the commercial exploitability or any other value of the Licensed Technology or that the Licensed Technology will not infringe the rights of any third party, and Yissum hereby expresses that it has made no examination as to the validity of the Licensed Patents. 11. Patent Rights Protection 11.1. 11.2. The Company and Yissum shall each inform the other promptly in writing of any alleged infringements by a third party of the Licensed Patents in the Territory, together with any available written evidence of such alleged infringement. The Company, its Affiliate or Sublicensee shall have the first right in its own name and at its own expense to initiate any legal action and enforce the Licensed Patents against any infringement of such Licensed Patents (including but not limited to infringement by means of the filing of an Abbreviated New Drug Application with a certification under 21 U.S.C. 355(j)(2)(A)(vii)(IV)). Before the Company, its Affiliate or its Sublicensee commences an action with respect to any infringement, the Company shall give careful consideration to the views of Yissum in making its decision whether or not to initiate any legal action and, if relevant, make these views known to its Affiliate or Sublicensee. The Company shall, or, if relevant, shall make its best efforts to ensure that its Affiliate or Sublicensee shall, continuously keep Yissum apprised of all developments in the action and shall continuously provide Yissum with full information and copies of all documents relevant to the proceedings, including, all documents filed with the courts by the parties to the legal action(s) and all correspondence with the other parties to the proceedings, and shall seek Yissum’s input and approval on any substantive submissions or positions taken in the litigation regarding the scope, validity or enforceability of the Licensed Patents. 13 If Yissum shall determine that the legal actions taken by the Company may adversely affect Yissum’s rights hereunder, Yissum at its own expense shall be entitled to appoint its own counsel to represent it in such litigation, unless, according to assessment of an independent appraiser to be selected by the Parties who shall be an attorney with at least ten (10) years of experience in intellectual property licensing or litigation in the life sciences, there is a conflict of interests in which case the Company shall reimburse Yissum the reasonable expenses of such legal representation and independent appraiser determines that there is no conflict of interest, the expenses of such appraiser shall be borne by Yissum. If the Company, its Affiliate or its Sublicensee elects to commence an action as described above and Yissum is a legally indispensable party to such action (being the registered owner of the infringed patent rights), Yissum, at the Company’s expense, may be joined as a co-plaintiff, provided that all the following conditions shall be fulfilled: (a) the Company shall continuously provide Yissum with full information and copies of all documents relevant to the proceedings, including, all documents filed with the courts by the parties to the legal action(s) and all correspondence with the other parties to the proceedings, as well as all drafts of written submissions relating to such legal action that are sent to the Company for review, and all Yissum’s reasonable comments in respect thereof will be taken into account; (b) any out of pocket expenses incurred by the Company or Yissum in connection with such action(s), including all legal and litigation related fees and expenses, all out of pocket expenses for external assistance required to comply with any discovery or other motions and any costs or amounts awarded to the counterparties in such action(s) shall be borne by the Company; (c) if Yissum shall determine that a conflict of interest exists between the Company and Yissum, Yissum shall be entitled, at its own expense, to appoint its own counsel to represent it in such litigation and the Company shall make reasonable efforts to ensure that such counsel chosen by Yissum is fully informed and receives all material necessary to adequately participate in such action; and (d) the Company shall bear all costs, expenses and awards incurred by or awarded against Yissum, with respect to any action filed against Yissum alleging that an action initiated by the Company pursuant to the terms of this Section 11 was anticompetitive, malicious, or otherwise brought for an improper purpose, whether by a counterparty to such aforementioned action or by any third party. If Yissum is not required by law to be joined as a co-plaintiff, Yissum, to the extent permitted by law, and at its own cost, may elect to join the action as a co-plaintiff at its own initiative and shall jointly control the action with the Company, its Affiliate or its Sublicensee. Irrespective of whether Yissum joins any such action as described above it shall provide reasonable cooperation to the Company, its Affiliate or its Sublicensee. The Company shall reimburse Yissum for any costs it incurs as part of an action brought pursuant to this Section where Yissum has not elected to join the action as a co-plaintiff at its own initiative. 11.3. If the Company, its Affiliate or its Sublicensee does not bring an action against an alleged infringer pursuant to Section 11.2, above, or has not commenced negotiations with said infringer for discontinuance of said infringement within one hundred and eighty (180) days after learning of said infringement, Yissum shall have the right, but not the obligation, to bring an action for such infringement at its own expense, and retain all proceeds from such action. If the Company has commenced negotiations with said infringer for the discontinuance of said infringement within such one hundred and eighty (180) day period, the Company shall have an additional period of ninety (90) days from the end of the first one hundred and eighty (180) day period to conclude its negotiations before Yissum may bring an action for said infringement. 14 11.4. 11.5. 11.6. 11.7. No settlement, consent judgment or other voluntary disposition of an infringement suit may be entered without the consent of Yissum, which consent shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt and notwithstanding anything to the contrary herein, should Yissum bring an action as set forth in Section 11.3, above, it shall have the right to settle such action by licensing the Licensed Technology, or part of it, to the alleged infringer. Any award or settlement payment resulting from an action initiated by the Company pursuant to this Section 11 shall be utilized, first to effect reimbursement of documented out-of-pocket expenses incurred by both Parties in relation to such legal action, and thereafter shall be paid to the Company and shall be deemed Sublicense Consideration received under this Agreement, in respect of which Sublicense Fees shall be due to Yissum. If either Party commences an action and then decides to abandon it, such Party will give timely notice to the other Party. The other Party may continue the prosecution of the suit after both Parties agree on the sharing of expenses. The Company shall use its diligent efforts at its own expense to defend any action, claim or demand made by any entity against the Company or Yissum in connection with rights in the Licensed Technology or the Licensed Patents relating thereto. Each Party shall notify the other immediately upon learning of any such action, claim or demand as aforesaid. 12. Confidentiality 12.1. 12.2. 12.3. Each Party undertakes that during the term of this Agreement and for a period of five (5) years subsequent thereto, it shall maintain full and absolute confidentiality, and shall also be liable for its officers or employees or representatives maintaining absolute confidentiality, with respect to all information, details and data which is in or comes to its knowledge or that of its officers, employees, representatives or any person acting on its behalf directly or indirectly relating to the Licensed Technology, the Company, Yissum, the University, and their employees and the Researcher. Each Party undertakes not to convey or disclose anything in connection with the foregoing to any entity without the prior written permission of the disclosing Party. The obligation contained in this Section shall not apply to information which (i) is in the public domain as of the date of this Agreement or hereafter comes into the public domain through no fault of the receiving Party, its officers, employees, representatives or persons acting on its behalf; (ii) recipient can demonstrate by its written records that it rightfully had such information in its possession prior to disclosure of thereof by discloser to recipient; (iii) recipient rightfully obtains from a third party, who to the best of recipient’s knowledge has the right to transfer or disclose it, without default or breach of an obligation of confidentiality or nondisclosure; (iv) is independently developed by the recipient without use of discloser’s Confidential Information as can be demonstrated by documentary evidence; or (v) is disclosed pursuant to the order or requirement of a court, administrative agency, or other governmental body. Notwithstanding the above, either Party may disclose details and information to its officers, employees, representatives or persons acting on its behalf, Affiliates and Sublicensees, as necessary for the performance of its obligations pursuant to this Agreement, provided that it procures that such parties execute a confidentiality agreement substantially similar in content to this Section 12. Each Party shall be responsible and liable to the other for any breach by its personnel or, in the case of the Company only, any Sublicensee, of such undertakings of confidentiality as if such breach were a breach by the Party itself. 12.4. Yissum shall procure that the Researchers and any other person connected with it with regard to the License execute a confidentiality agreement substantially similar in content to this Section 12. 15 12.5. As a precondition to any Sublicense, the Company shall ensure that the Sublicensee procures that the Sublicensee’s officers, employees, representatives or persons acting on the Sublicensee’s behalf are bound by a written confidentiality agreement substantially similar in content to this Section 12. 12.6. Without prejudice to the foregoing, the Company shall not mention the name of the University, Yissum or the Researcher, unless required by law, in any manner or for any purpose in connection with this Agreement, or any matter relating to the Licensed Technology, without obtaining the prior written consent of Yissum. Notwithstanding the foregoing, the Company shall be entitled to identify the Licensed Technology as having been developed by the Researcher and the other Inventors and licensed from Yissum. 12.7. Neither Party shall issue any press release or other media statement regarding the execution, existence or terms of this Agreement or any developments of the Licensed Technology without the prior written approval of the other Party. 12.8. The provisions of this Section shall be subject to permitted publications pursuant to Section 13, below. 13. Publications 13.1. 13.2. 13.3. Yissum shall ensure that no publications in writing, in scientific journals or orally at scientific conventions relating to the Licensed Technology, the Development Plan, the Development Results or the Product, which are subject to the terms and conditions of this Agreement, are published by it or its Researcher or other Inventors, without first seeking the consent of the Company. The Company undertakes to reply to any such request for publication by Yissum within thirty (30) days of its receipt of a request in connection with the publication of articles in scientific journals, and within seven (7) days of its receipt of a request in connection with article abstracts. The Company may only decline such an application upon reasonable grounds, which shall be fully detailed in writing. Should the Company decide to object to publication as provided in sub-section 13.2, publication shall be postponed for a period of not more than three (3) months from the date the publication was sent to the Company to enable the filing of patent applications or the removal of the Company’s confidential information. 13.4. The provisions of this Section shall not prejudice any other right, which Yissum has pursuant to this Agreement or at law. 13.5. For the avoidance of doubt, the provisions of this Section in connection with the prohibition against publication shall not apply to internal publication made in the University for the Researcher and University employees provided that such persons are subject to written obligations of confidentiality substantially similar to those set forth in Section 12. 16 14. Liability and Indemnity 14.1. 14.2. 14.3. TO THE EXTENT PERMITTED BY THE APPLICABLE LAW, YISSUM MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, WITH RESPECT TO THE LICENSED TECHNOLOGY. IN PARTICULAR, YISSUM MAKES NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE LICENSED TECHNOLOGY WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER RIGHTS OF ANY THIRD PARTY. IN ADDITION, NOTHING IN THIS AGREEMENT MAY BE DEEMED A REPRESENTATION OR WARRANTY BY YISSUM AS TO THE VALIDITY OF ANY OF THE PATENTS OR THEIR REGISTRABILITY OR OF THE ACCURACY, SAFETY, EFFICACY, OR USEFULNESS, FOR ANY PURPOSE, OF THE LICENSED TECHNOLOGY. YISSUM HAS NO OBLIGATION, EXPRESS OR IMPLIED, TO SUPERVISE, MONITOR, REVIEW OR OTHERWISE ASSUME RESPONSIBILITY FOR THE PRODUCTION, MANUFACTURE, TESTING, MARKETING OR SALE OF ANY PRODUCT OR SERVICE. NEITHER YISSUM NOR THE RESEARCHER, NOR THE UNIVERSITY, NOR THE DIRECTORS, OFFICERS AND EMPLOYEES OF YISSUM AND/OR OF THE UNIVERSITY SHALL HAVE ANY LIABILITY WHATSOEVER TO THE COMPANY OR TO ANY THIRD PARTY FOR OR ON ACCOUNT OF ANY INJURY, LOSS, OR DAMAGE, OF ANY KIND OR NATURE WHETHER DIRECT OR INDIRECT, SUSTAINED BY THE COMPANY OR BY ANY THIRD PARTY, FOR ANY DAMAGE ASSESSED OR ASSERTED AGAINST THE COMPANY, OR FOR ANY OTHER LIABILITY INCURRED BY OR IMPOSED UPON THE COMPANY OR ANY OTHER PERSON OR ENTITY, DIRECTLY OR INDIRECTLY ARISING OUT OF OR IN CONNECTION WITH OR RESULTING FROM (i) THE PRODUCTION, MANUFACTURE, USE, PRACTICE, LEASE, OR SALE OF ANY PRODUCT OR SERVICE; (ii) THE USE OF THE LICENSED TECHNOLOGY; OR (iii) ANY ADVERTISING OR OTHER PROMOTIONAL ACTIVITIES WITH RESPECT TO ANY OF THE FOREGOING. IN NO EVENT SHALL YISSUM, THE RESEARCHER, THE UNIVERSITY, OR THE DIRECTORS, OFFICERS AND EMPLOYEES OF YISSUM AND/OR OF THE UNIVERSITY BE LIABLE TO THE COMPANY OR ANY OF ITS AFFILIATES OR TO ANY THIRD PARTY FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING, LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY THE COMPANY OR ITS AFFILIATES OR ANY THIRD PARTY, WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE OR TORT, OR OTHERWISE, ARISING OUT OF THIS AGREEMENT. The Company shall be liable for any loss, injury or damage whatsoever caused directly or indirectly to or suffered by its employees or to any person acting on its behalf or to the employees of Yissum or the University or to any person acting on their behalf, or to the Inventors, or to any third party by reason of the Company’s acts or omissions pursuant to this Agreement or by reason of any use made of the Licensed Technology, the Development Results or any Product or exercise of the License. The Company undertakes to compensate, indemnify, defend and hold harmless Yissum, the University, and any person acting on their behalf and any of their directors, officers, employees, consultants or representatives and the Inventors (herein referred to jointly and severally as “Indemnitees”) against any claim, investigation or liability including, without limitation, product liability, damage, loss, costs and expenses, including legal costs, attorneys’ fees and litigation expenses, incurred by or imposed upon the Indemnitees by reason of its acts or omissions or which derive from its use, development, manufacture, marketing, sale or sublicensing of any Product or Licensed Technology or exercise of the License. Yissum shall (i) as soon as practicable notify the Company of any claim (in any event, within fourteen (14) days after Yissum becomes aware of the claim), (ii) authorize and allow the Company to have sole control of the defense and settlement of the claim, provided that any settlement that may impose any obligations on any of the Indemnitees or an admission of liability by any of the Indemnitees shall require Yissum’s prior written consent which shall not be unreasonably withheld or delayed; and (iii) provide any information and cooperation reasonably requested by the Company, at the Company’s sole expense. The failure by Yissum to comply with subsections (i) or (iii) above shall not affect the Company’s indemnification obligations set forth in this Section 14.3 above, except to the extent that such failure has an irreparably harmful affect on, or otherwise jeopardizes the defense by the Company of such claim. The Company shall keep Yissum informed of the status and progress of such claim, the defense thereof and/or settlement negotiations with respect thereto. Without derogating from the foregoing, Yissum shall be entitled to participate in the defense of any claim as aforesaid with its own counsel at its own expense. 17 The Company shall ensure that its Sublicensees shall provide undertakings of indemnification which shall also be given also in favor of, and shall be actionable by Yissum, the University, and any director, officer or employee of Yissum or of the University, and by the Researcher and the other Inventors. 14.4. During the term of this Agreement, the Company or its Affiliate shall procure and maintain, or require that its Sublicensee procure and maintain, with no cost to Yissum, comprehensive general liability insurance in amounts as are industry standard for similar circumstances. Such comprehensive general liability insurance shall provide contractual liability coverage for the Company’s indemnification under this Agreement and in particular as stated above in Section 14.3 above. Beginning at the time any Product shall be commercially distributed or sold by the Company, an Affiliate or a Sublicensee, but in any event no later than the First Commercial Sale, the Company, its Affiliates or Sublicensee (if applicable) shall procure and maintain at their own cost and expense, in addition to the above general liability insurance, product liability insurance, in amounts that are standard in the industry for similar products. The insurance coverage required under this Section shall not be construed to create a limit of the Company’s liability with respect to its indemnification under this Agreement. The Company shall cause Yissum to be named as an additional insured without any right of subrogation against Yissum in all such insurance policies. 14.5. 14.6. The Company shall provide Yissum with written evidence of such insurance upon request. The Company shall provide Yissum with written notice at least fifteen (15) days prior to the cancellation, non-renewal or material change in such insurance. If the Company does not obtain replacement insurance providing comparable coverage within such fifteen (15) day period, Yissum shall have the right to terminate this Agreement effective at the end of such fifteen (15) day period without notice or any additional waiting periods. The Company shall maintain, at its own expense, liability insurance as set forth in Section 14.4, above, beyond the expiration or termination of this Agreement as long as a Product relating to or developed pursuant to this Agreement is being commercially distributed or sold by the Company, an Affiliate or a Sublicensee, and thereafter as required by applicable laws. 15. Termination of the Agreement 15.1. Unless otherwise agreed by the Parties in writing, this Agreement shall terminate upon the occurrence of the later of the following: (i) the date of expiry of the last of the Licensed Patents; or (ii) the date of expiry of a period of fifteen (15) years from the date of the last First Commercial Sale of the Product in the Territory. 15.2. Without prejudice to the Parties’ rights pursuant to this Agreement or at law, either Party may terminate this Agreement by written notice to the other in any of the following cases: 15.2.1. immediately upon such written notice, if: (i) the other Party passes a resolution for voluntary winding up or a winding up application is made against it and not set aside within sixty (60) days; or (ii) a receiver or liquidator is appointed for the other Party; or (iii) the other Party enters into winding up or insolvency or bankruptcy proceedings. Each of the Parties undertakes to notify the other within seven (7) days if any of the abovementioned events occur; or 18 15.2.2. upon breach of this Agreement, where such breach has not been remedied within thirty (30) days from the breaching Party’s receipt of written notice from the non-breaching Party requiring such remedy, except in the event of failure to use commercially reasonable efforts to commercialize any Product, which shall be governed by the provisions of Section 5.5 above. 15.3. In addition to the above, and without prejudice to Yissum’s rights pursuant to this Agreement or at law, Yissum shall be entitled to terminate this Agreement immediately upon written notice to the Company in the following circumstances: 15.3.1. a breach of Section 5.5 above, where such breach has not been cured as provided for in Section 5.5. 15.3.2. if an attachment is made over the Company’s assets or if execution proceedings are taken against the Company and the same are not set aside within thirty (30) days of the date the attachment is made or the execution proceedings are taken. 15.3.3. uncured lapse of insurance coverage under section 14.4, above; 15.3.4. failure to defend against third party claims as required under Section 11, above; or 15.3.5. a claim by the Company, made in any forum, claiming that one or more of the Licensed Patents are invalid or unenforceable 15.4. In addition to the above, the Company shall be entitled to terminate this Agreement for any reason at any time, upon sixty (60) days prior written notice to Yissum (effective immediately), provided that in the event of such termination by the Company, the Company hereby irrevocably undertakes that, neither the Company nor any of its Affiliates (whether directly or indirectly) shall develop or manufacture any product that contains an active ingredient that is chemically identical or similar to the active ingredient in a Product for a period of three (3) years after the effective date of such termination. 15.5. Upon termination of this Agreement for any reason other than the expiration of its term, the License shall terminate, the Licensed Technology and all rights included therein shall revert to Yissum, and Yissum shall be free to enter into agreements with any other third parties for the granting of a license or to deal in any other manner with such right as it shall see fit at its sole discretion. The Company shall return or transfer to Yissum, within fourteen (14) days of termination of the License, all material, in soft or hard copy, relating to the Licensed Technology or Products connected with the License, and it may not make any further use thereof. In case of termination as set out herein, the Company will not be entitled to any reimbursement of any amount paid to Yissum under this Agreement. Yissum shall be entitled to conduct an audit in order to ascertain compliance with this provision and the Company agrees to allow during the Company’s regular business hours access to Yissum or its representatives for this purpose. 19 15.6. Upon the termination of the Agreement for any reason other than the expiration of its term or due to or the uncured breach by Yissum (as set forth in section 15.2.2, above), the Company shall transfer and assign to Yissum all of the Development Results and any information and documents, in whatever form, relating thereto, including any data, results, regulatory information (including applications, registrations, licenses, authorizations, approvals and all clinical studies, tests, and manufacturing batch records relating to a Product, and all data contained in any of the foregoing) and files that relate to the Licensed Technology or the Product(s), provided that if any or all such Development Results are developed using any funds received from the OCS, such transfer and assignment shall be subject to the applicable terms and conditions of the R&D Law (as defined in Section 5.6 above) and the applicable rules and regulations of the OCS and the execution by Yissum of the relevant undertakings (if any) required by the OCS. Subject to the foregoing, the Company shall fully cooperate with Yissum to effect such transfer and assignment and shall execute any document and perform any acts required to do so. 15.7. Notwithstanding the foregoing, neither the termination of this Agreement for any reason nor the expiration of the License shall release the Company from its obligation to carry out any financial or other obligation which it was liable to perform prior to the Agreement’s termination or the License’s expiration. In addition, Sections 7, 8, 9, 12, 14, 15, 16, 17 and 19 shall survive the termination of this Agreement to the extent required to effectuate the intent of the Parties as reflected in this Agreement. 16. Law The provisions of this Agreement and everything concerning the relationship between the Parties in accordance with this Agreement shall be governed by Israeli law and jurisdiction shall be granted only to the appropriate court in Jerusalem, except that Yissum may bring suit against the Company in any other jurisdiction outside the State of Israel in which the Company has assets or a place of business. 17. Arbitration 17.1. 17.2. 17.3. Notwithstanding and in addition to the provisions of Section 16, above, all differences of opinion and disputes arising between the Parties in connection with the Agreement or its interpretation or its performance or breach, shall be referred for the decision of a single arbitrator, whose identity shall be determined by mutual consent of the parties. Should the Parties not reach agreement as to the identity of the arbitrator within 14 days of request by either Party for the appointment of an arbitrator, the arbitrator shall be appointed by the Chairman of the Jerusalem District Committee of the Israel Bar Association on the application of either of the Parties. The arbitration shall be held in Israel. The proceedings before and all documents submitted to such arbitrator shall be in the English language. The arbitrator shall not be bound by the civil procedure regulations and laws of evidence but shall base his/her decision on the substantive law of Israel and shall give grounds for his/her decision. The arbitrator shall be empowered to grant temporary injunctions and orders, which shall be enforceable in foreign jurisdictions, in accordance with Section 16, above. 17.4. The decision of the arbitrator shall be final and binding upon the Parties, and shall be enforceable in foreign jurisdictions. 17.5. The execution of this Agreement shall constitute the execution of an Arbitration Agreement. 20 18. Miscellaneous 18.1. 18.2. 18.3. 18.4. Relationship of the Parties. It is hereby agreed and declared between the Parties that they shall act in all respects relating to this Agreement as independent contractors and there neither is nor shall there be any employer-employee or principal-agent relationship or partnership relationship between the Company (or any of its employees) and Yissum. Each Party will be responsible for payment of all salaries and taxes and social welfare benefits and any other payments of any kind in respect of its employees and officers, regardless of the location of the performance of their duties, or the source of the directions for the performance thereof. Assignment. The Parties may not transfer or assign, or encumber or endorse their rights, obligations or duties or any of them pursuant to this Agreement to another, without the prior written consent of the Party, which consent shall not be unreasonably denied, conditioned or delayed. No waiver. The failure or delay of a Party to the Agreement to claim the performance of an obligation of the other Party shall not be deemed a waiver of the performance of such obligation or of any future obligations of a similar nature. Representation by Legal Counsel. Each Party represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in drafting this Agreement. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption shall exist or be implied against the Party which drafted such terms and provisions. 18.5. Legal Costs. Each Party shall bear its own legal expenses involved in the making of this Agreement. 18.6. 18.7. 18.8. Agreements with Researcher/University Employee. The Company shall disclose to Yissum any existing agreement or arrangement of any kind with the Researcher, any representative of the Researcher, and shall not enter into any such agreement or arrangement without the prior written consent of Yissum. Without derogating from the foregoing, should the Company choose to (i) retain the services of the Researcher or any other employee of the University in connection with the License; or (b) grant any benefit, including, any cash payments or securities of any kind, to the Researcher or any other employee of the University, it shall do so only through a written agreement executed between the Company and Yissum. Any such agreement will require, among other things, that any intellectual property rights generated under such agreement will be governed by the terms of this Agreement. Notwithstanding the foregoing, any inventions that any University students may make while working as and, in the capacity of, a Company employee shall be owned by the Company. Taxes. Monetary amounts mentioned in this Agreement do not include value added tax (VAT). Unless otherwise provided herein, each Party shall be solely responsible for and bear and pay any sales, use, service, income or other tax, applicable to it under the law, levied or incurred on account of this Agreement or the activities hereunder or the consummation thereof. Force Majeure. Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached the Agreement for failure or delay in fulfilling or performing any term of this Agreement to the extent, and for so long as, such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party and without fault of such Party, including fires, earthquakes, floods, embargoes, wars, acts of war (whether war is declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority or other party provided that the nonperforming Party uses commercially reasonable efforts to avoid or remove such causes of nonperformance and continues performance under this Agreement with reasonable dispatch whenever such causes are removed. The Party affected by such circumstances shall promptly notify the other Party in writing when such circumstances cause a delay or failure in performance and when they cease to do so. 21 18.9. Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original. 18.10. Binding Effect. This Agreement shall be binding upon the Parties upon the receipt of NovoTyr Shareholders Approval and shall enter into force and become effective as of the Effective Date, save for the grant of the License by Yissum to the Company pursuant to Section 3 above and the Company’s right to grant Sublicenses under Section 6 above which shall enter into force and become effective upon the receipt of OCS Approval pursuant to Section 2 above. 18.11. Entire Agreement. This Agreement constitutes the full and complete agreement between the Parties and supersedes any and all agreements or understandings, whether written or oral, concerning the subject matter of this Agreement, and may only be amended by a document signed by both Parties. 18.12. Formation of Company; Ratification of Agreement. In the event that the Company is not incorporated and/or fails to ratify this Agreement by signing this Agreement in the place indicated below, within a period of thirty (30) days after the Effective Date, then Yissum shall be entitled, upon seven (7) days prior written notice to GHP (which shall be deemed to have been served if delivered or sent to the address of GHP as set out on the first page of this Agreement, in accordance with the provisions of Section 19 below) to terminate this Agreement, without derogating from Yissum’s rights hereunder or by law to any other or additional relief. 19. Notices All notices and communications pursuant to this Agreement shall be made in writing and sent by facsimile or by registered mail or served personally at the following addresses: To Yissum at: Yissum Research Development Company of the Hebrew University of Jerusalem Ltd. P.O. Box 39135, Jerusalem 91390 Israel Facsimile: 972-2-6586689 Email: bob.trachtenberg@yissum.co.il To the Company at c/o Goldman Hirsh Partners Ltd. 6 Hahoshlim St. Herzliya Pituach 46723 Israel Facsimile: 972-776935601 Email: gil@goldman-hirsh.com or such other address furnished in writing by one Party to the other. Any notice served personally shall be deemed to have been received on the day of service, any notice sent by registered mail as aforesaid shall be deemed to have been received seven (7) days after being posted by prepaid registered mail. Any notice sent by facsimile or electronic mail shall be deemed to have been received by the next business day after receipt of confirmation of transmission (provided that any notice terminating this Agreement which is sent by electronic mail shall be followed by a notice sent in any other manner provided herein). [Signature page follows] 22 IN WITNESS WHEREOF THE PARTIES HAVE SET THEIR HANDS YISSUM By: /s/ Yaacov Michlin Name: Yaacov Michlin Title: CEO Date: Aug. 15, 2013 THE COMPANY (Represented by GHB) By: /s/ Goldman Hirsh Partners Ltd. Name: Gil Pogozelich Title: Date: We, _____________________________, hereby ratify this Agreement and confirm that _____________________________is bound by the provisions of this Agreement and that all references herein to “the Company” are references only to ___________________________. THE COMPANY By: /s/ Name: Title: Date: I the undersigned, Prof. Alexander Levitzki, have reviewed, am familiar with and agree to all of the above terms and conditions. I hereby undertake to cooperate fully with Yissum in order to ensure its ability to fulfill its obligations hereunder, as set forth herein. /s/ Prof. Alexander Levitzki Prof. Alexander Levitzki Aug.12, 2013 Date signed 23 Appendix A A1 - Existing Portfolio of Patent Applications Family: 3711 Title: NOVEL PROTEIN KINASE MODULATORS AND THERAPEUTIC USES THEREOF (NT-157) Inventor Ben-David Iris Levitzki Alexander SASSON Revital STEINER Lilach WEISSBERG Avi Reuveni Hadas Patent ID Status Country Date Number Date Number Date Number Application Publication Patent 3711-00 3711-01 3711-02 Expired Exhausted Granted US PCT US 04/12/200660/872,511 04/12/2007PCT/IL2007/0014 04/12/200712/517,278 12/06/2008WO2008/068751 04/03/2010US2010/0056635 15/11/2011 8,058,309 Family: 3712 Title: NOVEL MODULATORS OF PROTEIN KINASE SIGNALING Inventor Levitzki Alexander LUCASSEN Andre C. B SASSON Revital Reuveni Hadas 24 Patent ID Status Country Date Number 3712-00 Expired US 05/06/200861/058,943 Application Publication Date Number Patent Date Number 3712-01 Exhausted PCT 07/06/2009PCT/IL2009/000568 10/12/2009 3712-02 3712-03 3712-04 Allowed US Published Europe Filed Israel 07/06/200912/995,669 07/06/2009 07/06/2009 05/05/2011 9758026 23/02/2011 209638 Family: [****] Title: [****][****][****][****][****][****][****] WO 2009/147682 US 2011/0105618 A1 2285774 Inventor [****] [****] Patent ID Status Country Date Number [****] [****] [****] [****][****] Application Publication Date Number Patent Date Number Family: 3745 Title: COMPOUNDS WHICH MODULATE PROTEIN KINASE SIGNALING Inventor Levitzki Alexander Reuveni Hadas Patent ID Status Country Date Number 3745-01 Expired US 06/07/201161/504,722 Application Publication Date Number Patent Date Number 3745-02 3745-03 NP Entry PCT Filed US 27/12/2011PCT/IL2011/050078 27/06/201313/976,876 25 WO 2012/090204 A1 05/07/2012 NP to be entered in US and EP Family: 3787 Title: COMBINATIONS FOR TREATING CANCER Inventor Reuveni Hadas Levitzki Alexander Patent ID Status Country Date Number 3787-00 Expired US 01/03/201161/447,733 Application 3787-01 Published PCT 01/03/2012PCT/IL2012/000098 Publication Date Number Patent Date Number 07/09/2012 WO 2012/117396A1 Family: 3946 Title: IGF-1R SIGNALING PATHWAY INHIBITORS USEFUL IN THE TREATMENT OF NEURODEGENERATIVE DISEASES Inventor Cohen Ehud Reuveni Hadas Levitzki Alexander Patent ID Status Country Filed 3946-01 US Application Date Number 14/07/201361/846,014 Publication Date Number Patent Date Number 26 Family: 3711 Title: NOVEL PROTEIN KINASE MODULATORS AND THERAPEUTIC USES THEREOF (NT-157) A2 - Existing Patents Inventor Ben-David Iris Levitzki Alexander SASSON Revital STEINER Lilach WEISSBERG Avi Reuveni Hadas Patent ID Status Country Date Number Date Number Date Number Application Publication Patent 3711-00 3711-01 3711-02 ** Expired US Exhausted PCT Granted US 04/12/200660/872,511 04/12/2007PCT/IL2007/0014 04/12/200712/517,278 Family: 3712 Title: NOVEL MODULATORS OF PROTEIN KINASE SIGNALING 12/06/2008WO2008/068751 04/03/2010US2010/0056635 15/11/2011 8,058,309 Inventor Levitzki Alexander LUCASSEN Andre C. B SASSON Revital Reuveni Hadas Patent ID Status Country Date Number Application Publication Date Number Patent Date Number 3712-00 3712-01 3712-02 3712-03 3712-04 ** Expired US Exhausted PCT Allowed US Published Europe Filed Israel 05/06/200861/058,943 07/06/2009PCT/IL2009/000568 07/06/200912/995,669 07/06/2009 07/06/2009 10/12/2009WO 2009/147682 05/05/2011US 2011/0105618 A1 2285774 9758026 23/02/2011 209638 27 Family: 3745 Title: COMPOUNDS WHICH MODULATE PROTEIN KINASE SIGNALING Inventor Levitzki Alexander Reuveni Hadas Patent ID 3745-01 3745-02 3745-03 Status Country Expired US NP Entry Filed US PCT Application Date Number 06/07/201161/504,722 27/12/2011PCT/IL2011/050078 27/06/201313/976,876 Publication Date Number Patent Date Number 05/07/2012WO 2012/090204 A1 NP to be entered in US and EP ** NOTE: (i) Either patent family 3711 (Yissum reference no.) or patent family 3712 (Yissum reference no.) may be deleted from this Appendix A2 by written request of the Company to be notified to Yissum within 120 days of the execution of this Agreement pursuant to clause 1.4.5 of this Agreement; (ii) other patent applications selected by the Company from the Existing Portfolio of Patent Applications (Appendix A1) and notified to Yissum in writing thereof within 120 days of the execution of this Agreement pursuant to clause 1.4.5 of this Agreement shall be added to this Appendix. 28 1. The compounds developed are inhibitors of the IGF1R/IRS1-2 pathway as well as inhibitors of Stat3 signaling. We have additional data derived from large number of cancer cell lines in tissue culture and in a number of in vivo animal models targeting metastatic melanoma, metastatic prostate cancer, colon cancer and multiple myeloma. A3 - Know-How 2. In vivo data on of NT compounds with Chemotherapy (Taxol). 3. [****] 4. [****] 5. Inhibition of the STAT-3 phosphorylation which is involved in anti-cancer immunomodulation , anti-matastatic, anti-angiogenic, anti-proliferative. 6. [****] 7. Toxicity, safety, solubility, pharmacodinamic and phramcokinetic data related to the NT compounds. 8. The use of cell-free kinase assay developed at Prof. Levitzki’s lab utilizing full length IGF1R purified from mammalian cells to discover unique allosteric inhibitors of this receptor. YISSUM By: Name: Title: Date: THE COMPANY By: Name: Title: Date: 29 YISSUM By: Name: Title: Date: Appendix B The Development Plan [To be attached per Section 1.4.2] THE COMPANY By: Name: Title: Date: 30 Appendix C Historical Patent Costs 3711 - Novel Protein Kinase Modulators and Therapeutic uses Thereof (NT-157) 3712 - Novel Modulators of Protein Kinase Signaling (NT-219) [****] 3745 – Compounds Which Modulate Protein Kinas Signaling 3787 – Combinations for Treating Cancer 3946 - Signaling Pathway Inhibitors Useful in the Treatment of Neurodegenerative Diseases Total: 31 $ $ $ $ $ $ $ 41,323 27,806 1,280 11,358 10,831 4,460 97,058 Exhibit 4.15 Execution version THE SYMBOL “[****]” DENOTES PLACES WHERE PORTIONS OF THIS DOCUMENT HAVE BEEN OMIITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. SUCH MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION FIRST AMENDMENT TO LICENSE AGREEMENT This First Amendment to License Agreement (“First Amendment”) is effective as of 8 April, 2014 (the “Effective Date”), by and between, YISSUM RESEARCH DEVELOPMENT COMPANY OF THE HEBREW UNIVERSITY OF JERUSALEM LTD., of Hi Tech Park, Edmond J Safra Campus, Givat Ram, Jerusalem 91390 Israel, (“Yissum”) of the one part; and TYRNOVO LTD., of 8 Abba Eban Ave. Herzliya Pituach 46723, Israel, (the “Company”), of the second part; (each a “Party” and jointly, the “Parties”). WHEREAS, Yissum and the Company signed a License Agreement dated 15 August 2013 (the “License Agreement”) pursuant and subject to the terms and conditions of which, Yissum granted the Company an exclusive worldwide license to make commercial use of the Licensed Technology in order to commercialize, exploit, develop, have developed, manufacture, have manufactured, market, import, export, distribute, offer to sell, or sell Products; and WHEREAS, the Parties confirm that the first Condition Precedent (being receipt of NovoTyr Shareholders Approval) has been fulfilled and the Effective Date of the License Agreement is the date of signature thereof (i.e. 15 August 2013); and WHEREAS, Yissum is a party, by virtue of an assignment to Yissum by NovoTyr Therapeutics Ltd., (“NovoTyr”), to: (i) a Material Transfer Agreement with The University of British Columbia (“UBC”) effective as of 27 November 2011, a copy of which is attached hereto as Annex A1 (the “UBC MTA”); (ii) a Material Transfer Agreement with The University of Texas M.D. Anderson Cancer Center (“MD Anderson”) effective as of 28 February 2011, as amended by an Amending Agreement effective as of 11 July 2011, a copy of which is attached hereto as Annex A2 (the “MD Anderson MTA”); (iii) a Material Transfer Agreement with The Regents of the University of Michigan (“UM”) effective as of 23 September 2009, a copy of which is attached hereto as Annex A3 (the “UM MTA”) and (iv) a Material Transfer Agreement with Hadassah Medical Organization (“HMO”) effective as of 1 January 2010, a copy of which is attached hereto as Annex A4 (the “HMO MTA”), pursuant to which each of UBC, MD Anderson, UM and HMO, respectively were provided certain materials as described in Annex B hereto (the “Research Materials”) for the purpose of conducting academic research as more fully described in the UBC MTA, the MD Anderson MTA, and the UM MTA respectively (together, the “U.S. MTAs”) and in the HMO MTA; and WHEREAS, pursuant to a Material Transfer Agreement among Yissum, Dr. Ehud Cohen, a researcher at the Hebrew University of Jerusalem (“Dr. Cohen”) and NovoTyr, effective as of 1 January 2010 (the “Dr. Cohen MTA”), which was terminated by mutual agreement on 15 January 2014, Dr. Cohen conducted certain academic research at the Hebrew University of Jerusalem with respect to certain of the Research Materials and shall continue to conduct such academic research with respect to such materials as contemplated in Section 3.2 of the License Agreement; and -1- WHEREAS, pursuant to a Material Transfer Agreement among the Company, Bar Ilan Research and Development Company Ltd. (“BIRAD”) and Prof. Izhak Haviv, a researcher at Bar Ilan University (“Prof. Haviv”), effective as of 12 February 2014 (the “BIRAD MTA”), a copy of which is attached as Annex C, the Company shall provide BIRAD and Prof. Haviv with the Research Materials for the purpose of conducting certain services as more fully described in the BIRAD MTA and Yissum consented to the provision of the Research Materials to and use thereof by BIRAD and Prof. Haviv for the said purpose, all subject to the terms and conditions of the BIRAD MTA; and WHEREAS, it is acknowledged that: (i) the Research Materials provided to UBC, MD Anderson, UM, HMO and Yissum by NovoTyr and to be provided to BIRAD and Prof. Haviv by the Company as aforesaid constitute Licensed Technology and/or fall within the scope of the License granted to the Company under the License Agreement; and (ii) other materials may be provided to UBC and/or MD Anderson under the U.S. MTAs and/or to BIRAD under the BIRAD MTA and/or Dr. Cohen may use other materials for academic research at the Hebrew University of Jerusalem which may constitute Licensed Technology and/or fall within the scope of the License as aforesaid, which shall be added to Annex B (such other materials, collectively, the “Other Materials”); and WHEREAS, the Company agrees to the continued use of such materials pursuant to the U.S. MTAs and the the HMO MTA and further agrees to abide by the terms and conditions thereof said MTAs; and WHEREAS, subject to the receipt of OCS Approval (as such term is defined in the License Agreement) and the written consent of UBC, MD Anderson, UM and HMO, respectively, the Parties agree that Yissum shall assign to the Company each of the U.S. MTAs and the HMO MTA (as applicable); and WHEREAS, in view of the foregoing, the Parties wish to amend the License Agreement as set out below, NOW THEREFORE, the Parties hereby agree as follows: 1. 2. Capitalized terms in this First Amendment shall bear the meaning ascribed to such terms in the License Agreement unless the context otherwise requires. The Preamble and all Annexes hereto shall constitute an integral part hereof. -2- 3. The License granted under the License Agreement shall also apply to Yissum’s rights in the following, which shall be licensed to the Company “as is” and shall be included within the definition of Licensed Technology in the License Agreement: (i) all data, inventions, information, findings and other results generated, discovered and/or arising from the use of the Research Materials and/or Other Materials provided to UBC, MD Anderson, UM, HMO which are owned by Yissum (collectively, the “NovoTyr MTA Results”) arising prior to the receipt of the OCS Approval, provided that in the case of Inventions (as defined in the MD Anderson MTA) directly relating to NT 157 and/or other materials and/or other Inventions which are jointly owned by Yissum and MD Anderson, the license granted to the Company shall be non-exclusive only; and (ii) all Inventions (as defined in the BIRAD MTA) generated, discovered, reduced to practice and/or arising from Bar Ilan University’s and/or Prof. Haviv’s and/or Prof. Haviv’s research team’s use of the Research Materials (collectively, the “BIRAD Results”) arising prior to the receipt of the OCS Approval; and (iii) all inventions, ideas, information, findings and/or other results from the use of the Research Materials under the Dr. Cohen MTA directly related to the Licensed Technology, which are generally described in Annex D hereto (collectively, the “Existing HUJI Results”); and (iv) any inventions, ideas, information, findings or other results that are generated, discovered and/or arise from any future use of the Research Materials and/or Other Materials by Dr. Cohen for academic research at the Hebrew University of Jerusalem, and are directly related to the Licensed Technology, of which Yissum has been notified (collectively, the “Future HUJI Results”); all subject to Section 4 below and subject to the rights that each of UBC, MD Anderson, UM, HMO and/or BIRAD has under each of the U.S. MTAs, the HMO MTA, and the BIRAD MTA respectively and to any restrictions contained therein. 4. Without derogating from the foregoing, it is hereby agreed that: all references to the Development Results in the License Agreement shall also refer to: (a) all BIRAD Results arising following the receipt of the OCS Approval; and (b) all NovoTyr MTA Results arising following the receipt of the OCS Approval, subject to the assignment by Yissum to the Company of each of the U.S. MTAs and the HMO MTA with the written consent of UBC, MD Anderson, UM and HMO, respectively, as aforesaid. In the event that any of the U.S. MTAs and/or the HMO MTA are not assigned to the Company for any reason, all NovoTyr MTA Results arising under the relevant U.S. MTA(s) and/or the HMO MTA (which is not assigned as aforesaid) following the receipt of the OCS Approval shall be included within the License and, therefore, within the definition of Licensed Technology in the License Agreement. -3- 5. 6. 7. Without derogating from the indemnification obligations of the Company pursuant to Section 14.3 of the License Agreement, the Company undertakes to compensate, indemnify, defend and hold harmless the Indemnitees (as defined in Section 14.3) against any claim, investigation or liability including, without limitation, product liability, damage, loss, costs and expenses, including legal costs, attorneys’ fees and litigation expenses, incurred by or imposed upon the Indemnitees directly or indirectly arising from or in connection with any or all of the U.S. MTAs and/or the HMO MTA and/or the use, development, manufacture, marketing, sale or sublicensing by the Company, any Affiliate or any Sublicensee of any the NovoTyr MTA Results, the BIRAD Results, the Existing HUJI Results and the Future HUJI Results. This First Amendment shall be read together with the License Agreement, and save for the changes contained herein, all the terms and conditions contained in the License Agreement remain unchanged, and in full force and effect. This First Amendment together with the License Agreement (as amended hereby) constitute the entire agreement between the Parties in respect of the subject matter hereof, and supersede all prior agreements or understandings between the Parties relating to the subject matter hereof, and this First Amendment may be amended only by a written document signed by the authorized representatives of both Parties. [signature page follows] -4- IN WITNESS WHEREOF, the Parties have caused this First Amendment to be executed effective as of the date first above written. YISSUM RESEARCH DEVELOPMENT COMPANY OF THE HEBREW UNIVERSITY OF JERUSALEM LTD. Signature: /s/ Yaacov Michlin Name: Title: Date: Yaacov Michlin CEO Signature: /s/ Ariela Merkel Name: Title: Ariela Markel VP Licensing, Biothecnology TYRNOVO LTD. Signature: /s/ Trynovo Ltd. Name: Title: Date: Gil Pogozelich Chairman May 29, 2014 I the undersigned, Dr. Ehud Cohen, have reviewed, am familiar with and agree to all of the above terms and conditions. I hereby undertake to cooperate fully with Yissum in order to ensure its ability to fulfill its obligations hereunder, as set forth herein. /s/ Dr. Ehud Cohen Annexes: Annex A1 – the UBC MTA Annex A2 – the MD Anderson MTA Annex A3 – the UM MTA Annex A4 – the HMO MTA Annex B – the Research Materials Annex C – the BIRAD MTA Annex D – the Existing HUJI Results Date signed -5- Annex A Attached: Annexes A(1); A(2); A(3) and A(4) -6- MATERIAL TRANSFER AGREEMENT THIS MATERIAL TRANSFER AGREEMENT (this “Agreement”), effective as of 27 November, 2011, is made and entered into by and between NovoTyr Therapeutics Ltd., a company duly incorporated under the laws of Israel, of P.O.B. 408, Kiryat Shmona 11013, Israel (“the Company”), and The University of British Columbia, a non-profit state related organization operating under the University Act of British Columbia, CANADA of 103-6190 Agronomy Road, Vancouver, British Columbia, Canada (“Recipient Institution”), at which Prof. Dr. Michael Cox, is a researcher (“the Scientist”) (together, Recipient Institution and the Scientist will be known as the “Recipient”). WHEREAS, the Company, the Recipient and the Scientist wish the Recipient and the Scientist to receive one or more samples of the Company’s proprietary materials (such Company materials and any derivatives and modifications thereof, hereinafter, collectively, “the Materials”) and confidential information relating to the Materials of the Company, its business or technology (the “Confidential Information”) for the sole purpose of conducting academic research and testing with respect thereto (“the Purpose”). NOW THEREFORE, the parties hereby agree as follows: 1. 2. 3. 4. The Company shall supply certain Materials to Recipient for use by the Scientist as aforesaid in the Preamble hereto and may disclose Confidential Information to Recipient in relation thereto. All Confidential Information must be clearly identified in writing as “Confidential” either at the time of disclosure or within thirty (30) days thereafter. Recipient may use the Materials and the Confidential Information solely for the Purpose. Recipient shall not use the Materials, the Confidential Information or any substance that is replicated or derived therefrom for any commercial or profit-generating purpose, or in the conduct of research that is subject to consulting, licensing or other similar legal or commercial obligations to another institution, corporation, or business entity. Recipient shall use the Material only at Recipient Institution and only in the Scientist’s laboratory under the direction of the Scientist or of others working under his direct supervision. Recipient shall not transfer the Material to any other person (including, any other person within Recipient Institution) without the Company’s prior written consent, and shall prohibit access thereto by unauthorized third parties. Recipient shall, and shall cause the Scientist to store and use the Materials and any written copies of Confidential Information in a safe place and in a safe manner. Recipient represents to the Company that: (i) Recipient and the Scientist are regularly engaged in conducting laboratory studies and have all the required authorizations, approvals, registrations, licenses, and permits and are entitled to perform such experimental work at the Scientist’s laboratory at Recipient Institution; (ii) Recipient is entitled under all applicable laws, rules and regulations to use the Materials according to this Agreement; (iii) Recipient has adequate training and facilities to study the Materials according to this Agreement and the Scientist will directly supervise the use thereof hereunder. -7- Recipient undertakes that (a) Recipient Institution shall, and shall cause the Scientist to use the Materials in accordance with all applicable laws and regulations and in accordance with all applicable guidelines and ethical principles; and (ii) Recipient shall use the Materials under suitable containment conditions and the Materials will under no circumstances be administered to humans. Recipient confirms to the best of its knowledge (after making due enquiry) to the Company that it is not a party to any agreement with a third party: (i) that would be in conflict with the obligations undertaken by Recipient under this Agreement; (ii) that would prevent Recipient from carrying on research with the Materials; or (iii) that would be in conflict with the rights of the Company under this Agreement. The Materials and the Confidential Information will be held strictly confidential and Recipient shall treat and/or protect the Material and the Confidential Information with the same degree of care that it maintains and protects the confidential information of Recipient, but in any event, no less than a reasonable degree of care. Recipient shall not disclose the Materials and the Confidential Information to any third party, unless published in accordance to section 11; or unless such disclosure is required by law or court order, in which case, the Company will be promptly informed thereof by Recipient Institution or the Scientist (as the case may be) so that the Company may seek a protective order or other remedy. In any event, Recipient shall disclose only that portion of the Confidential Information that is legally required to be disclosed. Notwithstanding the aforegoing, the Confidential Information shall not include any information in respect of which it can be shown by written evidence that: (i) at the time of first disclosure, the information was already in the possession of Recipient Institution or the Scientist; or (ii) the information is in the public domain at the time of disclosure or becomes part of the public domain thereafter without Recipient Institution or the Scientist or other scientists or employees of Recipient Institution being responsible therefor; (iii) the information has been received on a non-confidential basis from a third party that is not bound by a confidentiality obligation; or (iv) is independently developed by employees, agents or consultants of the Recipient who had no knowledge of or access to the Company’s Confidential Information as evidenced by the Recipient’s written records. The Materials and the Confidential Information are and shall remain the exclusive property of the Company and, upon termination of this Agreement or otherwise at the Company’s request, Recipient shall, in accordance with the Company’s instructions, either return to the Company or dispose of in accordance with the applicable laws and regulations, all Materials and written Confidential Information, and any copies and derivatives thereof. 5. 6. 7. -8- 8. 9. 10. 11. The Company shall own all right, title and interest in and to: (i) any, inventions, techniques, compositions, compounds, substances, formulations, improvements, applications, information, and findings relating to the Materials that are generated, discovered, reduced to practice and/or arise from Recipient’s use of the Materials (collectively, “Inventions”); and (ii) all patents, copyrights, know-how trademarks and other intellectual property in and/or covering the Inventions. All Inventions shall be promptly disclosed to the Company and upon the Company’s request, Recipient shall execute and deliver to the Company any document or instrument (including, deeds of assignment) and shall take all further acts reasonably required to transfer and/or assign all right, title and interest in and to the Inventions to the Company. Without derogating from the aforegoing, in the event that any Invention is generated, discovered or reduced to practice by the Scientist and/or any other scientist or employee of Recipient Institution as aforesaid, the Company agrees to name the Scientist and/or such other scientist or employee as inventors of such Invention in any patent application filed in respect thereof. For the purpose of this Agreement, the Inventions shall be deemed to be “Confidential Information”, all without derogating from the right of Recipient to publish the results of the Purpose subject to and in accordance with the provisions of section 11 below. Notwithstanding anything to the contrary in this Agreement, the Company hereby grants to Recipient a non-exclusive license to all Inventions for research and scholarly purposes exclusively. Except as otherwise expressly provided in this Agreement (for the Purpose), nothing contained in this Agreement shall be construed as granting Recipient Institution or the Scientist any ownership, license or other rights, express or implied, in or to any of the Materials, or Confidential Information or in or to any patents, trademarks or other intellectual property rights relating to the Materials and/or the Inventions. Recipient shall keep the Company informed with regard to the use of the Materials hereunder and shall provide the Company, at Company’s written request and upon completion or termination of this Agreement, with a written copy of all data generated therefrom. The data may be used by the Company for its internal evaluation. Notwithstanding the aforegoing, Recipient grants to the Company full access to any primary data relating to the Materials as well as the right to include the data in any patent applications and regulatory filings and in any Publication as defined in section 11 below. In the event Recipient wishes to publish results of the Purpose, in scientific journals, manuscripts or at scientific meetings (each, a “Publication”), the release or publication of any such Publication shall be subject to the prior review of the Company. Each Publication will adequately acknowledge and appropriately reflect the contribution of the researchers and/or employees of each of the Company and Recipient and/or the source of the information included therein, in accordance with customary scientific practice. Recipient shall provide the Company with a copy of the contemplated Publication at least 45 (forty-five) calendar days prior to submission thereof for publication or presentation at scientific meetings (“Review Period”). The Company shall have the right to: (i) provide comments to the proposed Publication which comments shall be discussed by the Recipient Institution and/or the Scientist (as the case may be) and the Company in good faith and in a timely manner and be incorporated into the Publication accordingly, provided that the Scientist shall have final authority to determine the scope and content of any publication; or (ii) to object thereto because it contains Confidential Information or any patentable subject matter for which patent protection should be sought (prior to publication). Upon the Company’s written request such Confidential Information shall be deleted from such publication, provided that such deletion does not alter the integrity of results, and that Recipient is allowed to publish the results of the Purpose, subject to the terms of this section 11. In the event that any patentable subject matter is identified by Company within the Review Period, Recipient shall delay publication for a maximum of 90 (ninety) additional days to allow the Company an opportunity to file the required patent applications. -9- 12. The Materials are provided to Recipient without any warranties, whether express or implied, including, without limitation, warranties of merchantability or fitness for a particular purpose. Without derogating from the aforegoing, the Company makes no representation or warranty, express or implied, that use of the Materials will not infringe any patent or other proprietary rights of a third party. RECIPIENT MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE DATA, INVENTIONS OR OTHER RESULTS ARISING FROM THE PURPOSE OR WITH RESPECT TO ANY CONFIDENTIAL INFORMATION IT MAY DISCLOSE TO THE COMPANY. RECIPIENT SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTY OF NON-INFRINGEMENT OR MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND WILL IN NO EVENT BE LIABLE FOR ANY LOSS, WHETHER DIRECT, CONSEQUENTIAL, INCIDENTAL, OR SPECIAL OR OTHER SIMILAR OR LIKE DAMAGES ARISING FROM ANY DEFECT, ERROR OR FAILURE TO PERFORM, EVEN IF RECIPIENT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THE COMPANY ACKNOWLEDGES THAT THE PURPOSE IS OF AN EXPERIMENTAL AND EXPLORATORY NATURE, THAT NO PARTICULAR RESULTS CAN BE GUARANTEED, AND THAT IT HAS BEEN ADVISED BY RECIPIENT TO UNDERTAKE ITS OWN DUE DILIGENCE WITH RESPECT TO ALL MATTERS ARISING FROM THIS AGREEMENT. The conduct of any testing or research by Recipient Institution (or the Scientist or any other scientists or employees of Recipient Institution) with respect to the Materials shall be its sole risk and responsibility and the Company will not be liable for any consequences thereof. The Materials are to be used and handled with caution and prudence in any experimental work, since not all characteristics of the Materials are necessarily known. The Company and the directors, officers, employees, agents and consultants of the Company shall not be liable for any claims, demands, liabilities, costs, losses, damages or expenses (including legal costs and attorneys’ fees) that directly or indirectly arise out of or result from the use, application, storage or disposal of the Materials and/or Confidential Information by Recipient Institution, the Scientist or any other scientists or employees of Recipient Institution (hereinafter, collectively, “Liabilities”), except to the extent that such Liabilities are finally proven to have resulted directly from the Company’s gross negligence or willful misconduct. The Company hereby indemnifies, holds harmless and defends the Recipient, its Board of Governors, directors, officers, employees, faculty, students, invitees, and agents against any and all claims (including all reasonable legal fees and disbursements incurred) arising out of the use by the Company of any Inventions, or any data or other results arising from the Purpose including, any damages or losses arising from or out of same, howsoever the same may arise, except for claims arising out of gross negligence or willful misconduct by Recipient’s researchers. -10- 13. Since a breach by Recipient of any of the undertakings contained herein may result in irreparable and continuing damage to the Company for which there may be no adequate remedy at law, the Company shall be entitled, upon appropriate proof, to injunctive relief and/or a decree for specific performance, and such other relief as may be proper (including monetary damages, if appropriate). 14. 14.1. Without derogating from the parties’ rights hereunder or by law to any other or additional relief, it is agreed that the Company may terminate this Agreement at any time by serving a written notice to such effect on Recipient. 14.2. The termination of this Agreement for any reason shall not relieve a party of any of its respective obligations which shall have accrued prior to such termination. 14.3. The provisions of sections 6-9 (inclusive), 11-14 (inclusive) and section 21 shall survive any termination of this Agreement. 15. 16. 17. 18. 19. The Preamble and Schedules hereto form an integral part of this Agreement. In this Agreement “including”, “includes” means including, without limiting the generality of any description preceding such terms. This Agreement constitutes the entire agreement between the parties hereto in respect of the subject-matter hereof, and supersedes all prior agreements or understandings between the parties relating to the subject-matter hereof and this Agreement may be amended only by a written document signed by the parties hereto. In the event any provision of this Agreement is held by a court or other tribunal of competent jurisdiction to be illegal, invalid or unenforceable, such provisions shall be limited or eliminated to the minimum extent necessary so that this Agreement shall otherwise remain in full force and effect. Neither party shall be entitled to assign this Agreement or any or all of its rights, or obligations under this Agreement or arising therefrom, without the prior written consent of the other party. Notwithstanding the foregoing, the Company shall be entitled to assign this Agreement to a third party that acquires all of the business to which the Purpose relates, provided that written notice thereof is given to Recipient Institution and the assignee agrees to be bound by all the terms and conditions of this Agreement as though such assignee had been a party in the first instance. No waiver by any party hereto, whether express or implied, of its rights under any provision of this Agreement shall constitute a waiver of such party’s rights under such provisions at any other time or a waiver of such party’s rights under any other provision of this Agreement. No failure by any party hereto to take any action against any breach of this Agreement or default by another party hereto shall constitute a waiver of the former party’s rights to enforce any provision of this Agreement or to take action against such breach or default or any subsequent breach or default by such other party. -11- 20. 21. The provisions of this Agreement are severable and, in the event that any one or more of the provisions or part of a provision contained in this Agreement shall, for any reason, be held by any court of competent jurisdiction to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision or part of a provision of this Agreement; but such provision shall be modified as set out below and the balance of this Agreement shall be interpreted as if such provision were so modified. The parties shall negotiate in good faith in order to agree on the terms of an alternative provision which complies with applicable law and achieves, to the greatest extent possible, the same effect as would have been achieved by the invalid, illegal or unenforceable provision. Any notice or other communication required to be given by the parties under this Agreement shall be in writing and shall be deemed to have been given (a) if personally delivered, when actually delivered; or (b) if sent by facsimile, the next business day after receipt of confirmation or transmission, or (c) 14 (fourteen) days after being mailed by registered or certified mail, postage prepaid (for the purposes of proving such service, it being sufficient to prove that such notice was properly addressed and posted to the respective addresses set forth below, or such other address or addresses as is subsequently specified in writing pursuant to this section 21): If to the Company: Novotyr Therapeutics Ltd. P.O.B. 408 Kiryat Shmona 11013 Israel Attention: CEO Facsimile:+972-4-681-8806 With a copy to: Adv. Yael Baratz Baratz & Co. 1 Azrieli Center, Round Tower 18th floor, Tel-Aviv 67021, Israel Facsimile: +972-3-6960986 If to Recipient and the Scientist: University-Industry Liaison Office The University of British Columbia 103-6190 Agronomy Road, Vancouver, British Columbia V6T 1Z3, CANADA Attention: Dr. Mario A Kasapi, Associate Director, SRG Facsimile: 604-822-8589 -12- With a copy to Scientist: Michael E. Cox Associate Professor, Dept, of Urologic Sciences The University of British Columbia The Vancouver Prostate Centre 2660 Oak St. Jack Bell Research Centre Vancouver, BC Canada V6H 3Z6 Fax 604-875-5654 22. 23. This Agreement may be executed in any number of counterparts (including counterparts transmitted by facsimile), each of which shall be deemed to be an original, but all of which taken together shall be deemed to constitute one and the same instrument. Each party agrees to execute, acknowledge and deliver such further documents and instruments and to do any other acts, from time to time, as may be reasonably necessary, to effectuate the purposes of this Agreement. 24. The parties hereto acknowledge that the Scientist is a member of the Board of Directors of the Company. [Signature page follows] -13- IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date set out below. [Signature page of Material Transfer Agreement] NovoTyr Therapeutics Ltd. Signature: /s/ Hadas Reuveni Name: Title: Date: Hadas Reuveni CEO Dec. 27, 2011 Read and Acknowledged by the Scientist Prof. Michael E. Cox Signature: /s/ Prof. Michael E. Cox Date: Dec. 6, 2011 The University of British Columbia Signature: /s/ Mario A. Kasapi Name: Mario A. Kasapi Title: Date: Associate Director Dec. 5, 2011 -14- MATERIAL TRANSFER AGREEMENT THIS MATERIAL TRANSFER AGREEMENT (this “Agreement”), effective as of February 28, 2011, is made and entered into by and between NovoTyr Therapeutics Ltd., a company duly incorporated under the laws of Israel, of P.O.B. 408, Kiryat Shmona 11013, Israel (the “Company”), and The University of Texas M. D. Anderson Cancer Center (the “Recipient”) a member institution of The University of Texas System. The Company and Recipient are referred to individually as “Party”, or collectively as the “Parties”. WHEREAS, the Company and the Recipient wish the Recipient to receive one or more samples of the Company’s proprietary materials, NT 157 and other materials provided by the Company to Recipient under this Agreement, such Company materials and any derivatives and progeny thereof, hereinafter, collectively, (the “Materials”) and confidential information of the Company relating to the Materials, its business or technology provided to Recipient (the “Confidential Information”) for the purpose of conducting academic research relating to NT 157 and as further described in Exhibit A (the “Purpose”). The research will be conducted by Recipient under the supervision of Dr. Menashe Bar Eli, Ph.D. (the “Scientist”). NOW THEREFORE, the Parties hereby agree as follows: 1. 2. 3. The Company shall supply certain Materials to Recipient as aforesaid in the Preamble hereto and may disclose Confidential Information to Recipient and/or the Scientist in relation thereto. The Recipient may use the Materials and the Confidential Information solely for the Purpose. The Parties agree to negotiate in good faith any proposed modifications to the Purpose, as described in Exhibit A, during the term of this Agreement, if any such modifications are requested by either Party. Without the Company’s prior written consent and subject to Recipient’s rights in inventions as set forth in Section 8 hereunder, neither Recipient nor the Scientist shall use the Materials or the Confidential Information or any substance that is replicated therefrom for any commercial or profit-generating purpose, or in the conduct of research that is subject to consulting, licensing or other similar legal or commercial obligations to another institution, corporation, or business entity, except for any rights retained by the United States Government under applicable laws and regulations to the extent that any agency of the United States funds the research. Recipient shall use the Material only at Recipient’s organization and only in the Scientist’s laboratory under the direction of the Scientist or of others working under his direct supervision. Recipient shall not transfer the Material to any other person (including, any other person within Recipient’s organization) without the Company’s prior written consent, and shall use reasonable efforts to prohibit access thereto by unauthorized third parties. Recipient shall store and use the Materials and any written copies of Confidential Information in a safe place and in a safe manner. -15- 4. 5. 6. Recipient represents to the Company that: (i) Recipient and the Scientist are regularly engaged in conducting laboratory studies and have all the required authorizations, approvals, registrations, licenses, and permits and are entitled to perform such experimental work in vitro and/or in vivo at the Scientist’s laboratory in Recipient’s organization. Recipient and the Scientist are entitled under all applicable laws, rules and regulations to perform the said research. Recipient and the Scientist have adequate training and facilities to study the Materials and will directly supervise the said research; (ii) Recipient and the Scientist shall use the Materials in accordance with all applicable laws and regulations and in accordance with all applicable guidelines and ethical principles; (iii) Recipient and the Scientist shall use the Materials solely for in vitro and in vivo investigations under suitable containment conditions and the Materials will not under any circumstances be administered to humans. Recipient further represents to the Company that, to the best of its knowledge, after making reasonable inquiry with respect thereto, Recipient is not a party to any agreement with a third party: (i) that would be in conflict with the obligations undertaken by Recipient under this Agreement; (ii) that would prevent Recipient from carrying on research and development activities and studies with the Materials; or (iii) that would be in conflict with the rights of the Company under this Agreement. The Materials and the Confidential Information will be held confidential and Recipient shall treat and/or protect the Material and the Confidential Information with the same degree of care that it maintains and protect the confidential information of Recipient of a similar nature, but in any event, no less than a reasonable degree of care. Neither Recipient nor the Scientist shall disclose the Materials (subject to Recipient’s right to publish in accordance with Section 11 hereunder) and the Confidential Information to any third party, except for members of the Recipient’s scientific or institutional review boards, provided, however, that such persons are obligated to maintain the confidentiality of such information consistent with the terms of this Agreement, unless such disclosure is required by law, regulation or court order, in which case, the Company will be promptly informed thereof by Recipient or the Scientist (as the case may be), to the extent reasonably possible, so that the Company may seek a protective order or other remedy. In any event, Recipient and the Scientist shall disclose only that portion of the Confidential Information that is legally required to be disclosed. Notwithstanding the aforegoing, the Confidential Information shall not include any information in respect of which it can be shown by written evidence that: (i) at the time of first disclosure, the information was already in the possession of Recipient or the Scientist; or (ii) the information is in the public domain at the time of disclosure or becomes part of the public domain thereafter through no wrongful act of, or breach of these confidential obligations by Recipient or the Scientist; or (iii) the information has been received on a non-confidential basis from a third party that is not bound by a confidentiality obligation; or (iv) is independently developed by Recipient or the Scientist without use of the Confidential Information. -16- 7. 8. The Materials and the Confidential Information are and shall remain the exclusive property of the Company and, upon termination of this Agreement or otherwise at the Company’s request, Recipient shall, in accordance with the Company’s instructions, either return to the Company or dispose of in accordance with the applicable laws and regulations, all unused Materials and written Confidential Information, and any copies and derivatives thereof, except that Recipient may retain and maintain copies of Confidential Information for purposes of observing compliance with this Agreement, for regulatory compliance purposes, for purposes of publishing research in accordance with Section 11, and for its own internal research and academic purposes. Recipient’s confidentiality obligations with respect to the Confidential information shall survive for a period of five (5) years following termination or expiration of this Agreement. Recipient will promptly disclose to the Company any ideas, inventions, techniques, compositions, compounds, substances, formulations, improvements, and applications conceived of and reduced to practice during the conduct of the Purpose and/or arising from the performance of the Purpose and/or using the Materials (“Inventions”) after notification of any such Inventions is received by Recipient’s Office of Technology Commercialization. Inventions directly related to NT 157 and/or other Materials shall be owned jointly by Recipient and Company. Ownership of all other Inventions (“Other Inventions”) will be determined by inventorship which will be determined in accordance with applicable patent laws. In the case of any non-patentable ideas, inventions, techniques, compositions, compounds, substances, formulations, improvements, and applications, inventorship will be determined under such principles by treating the aforegoing as if they were patentable. Recipient hereby grants Company a worldwide, non-exclusive, royalty-free license with the right to sublicense, to any Inventions in which Recipient has an ownership interest. In addition, Recipient, consistent with the Recipient’s patent policy, hereby offers to Company the first option to negotiate an exclusive worldwide, transferable, sublicensable and perpetual license for Recipient’s rights in Inventions. Company may exercise its option by submitting a written request to Recipient at any time within three (3) months following the disclosure of the Invention to Company (such period, the “Option Term”). If Company timely exercises its option and notifies Recipient of its desire to enter into a license agreement, the Parties will negotiate, in good faith, a license agreement within a period not to exceed three (3) months from Company’s notification to Recipient of its desire to enter into a license agreement, or such other period of time to which the Parties mutually agree. Company shall be responsible for (in consultation with Recipient) and shall finance the patent activities, provided that if Company decides that it does not wish to file any patent application, or to continue to prosecute any patent application and/or maintain any patent in any country, Company shall notify Recipient thereof in writing and Recipient shall be entitled (but not be obligated) to do so at its expense, without derogating from any rights of Company as provided herein. The consideration payable in respect of such license shall be mutually agreed by the Parties and shall be commercially reasonable, to be negotiated in good faith. However, if the Parties are engaged in meaningful negotiations, the aforementioned time periods shall be extended by the Parties by such period as may reasonably be requested by either of the Parties. Any dispute between the Parties relating to any of the terms of the license (except, for the removal of doubt, any of the terms specifically agreed by the Parties in this Section 8) shall be referred to a senior executive at Recipient and the chief executive officer of Company in order to reach an amicable solution regarding such dispute, at the written request of either of the Parties. Should an amicable solution not be achieved by the forementioned representatives, within thirty (30) days after referral as aforesaid, such dispute shall be submitted to the Texas Attorney General for determination, whose decision shall be final and binding upon the Parties. If Company fails to exercise its option with respect to an Invention within the applicable Option Term or if Recipient and Company are unable to agree upon the terms of a license during the good faith negotiations and the Parties agree in writing not to continue the negotiation process and/or to refer such dispute to the forementioned representatives or to the Texas Attorney General for determination as provided above, Company’s right to obtain a license hereunder will cease. However, if Company does not obtain an exclusive license to any Invention, then in accordance with applicable law, Recipient shall be entitled to grant an equivalent non-exclusive, royalty-free license to such Invention to any person requesting a license to such Invention. Company owns and will continue to own any existing ideas, inventions, techniques, compositions, compounds, substances, formulations, improvements, applications, information, findings and other results of whatsoever nature relating to NT 157. Recipient does not claim any rights to any Company owned patent applications, patents, trademarks and any other intellectual property or any new intellectual property generated by Company under this Agreement (collectively, “Company’s Existing IP”). Except as otherwise expressly provided in this Agreement (for the Purpose), nothing contained in this Agreement shall be construed as granting Recipient or the Scientist any ownership, license or other rights, express or implied, in or to any of the Materials, Confidential Information or to any patents, trademarks or other intellectual property rights owned by the Company. -17- 9. Recipient shall keep the Company informed with regard to the use of the Materials hereunder and shall provide the Company, at regular intervals and promptly upon completion or termination of this Agreement, with a written copy of all data and findings generated therefrom (the “Results”) in confidence. Company shall own all Results, subject to Recipient’s right to publish such Results pursuant to Section 11 and to use such Results for its own internal research and academic purposes before publication, and for any purpose after publication. All non-patentable Results that merely confirm or validate the Company’s Existing IP and/or results generated by the Company (“Non-Patentable Results”) may be used and/or disclosed by the Company without restriction. Subject to Section 11, the Company shall keep all other Results (i.e. excluding Non-Patentable Results) confidential until the earlier of (i) publication or other public presentation of such Results pursuant to Section 11, (ii) filing and publishing of a patent application in respect thereof, or (iii) twelve (12) months after the conclusion of the Research, whereafter, subject to Recipient’s publication rights, such Results may be used by the Company without restriction. 10. 10.1. 10.2. 10.3. 10.4. In the event either Party wishes to publish information relating to any Inventions or Results, in scientific journals, manuscripts or at scientific meetings (each, a “Publication”), the release or publication of any such Publication shall be subject to the provisions of this Section 10 below. Each Publication will adequately acknowledge and appropriately reflect the contribution of the researchers and/or employees of each of the Company and Recipient and/or the source of the information included therein, in accordance with customary scientific practice. The Parties acknowledge that the Research is collaborative, and that an independent, joint publication is anticipated to be authored by Dr. Alex Levitzki of the Hebrew University of Jerusalem (“Dr. Levitzki”) and the Scientist and the timing and contents of the publication will be determined by the mutual agreement of Dr Levitzki and the Scientist, subject to the provisions of Section 10.5 below. Therefore, the Parties agree not to independently publish the Results and/or Inventions before a joint publication as aforesaid; provided, however, that if no joint publication has been submitted for publication after twelve (12) months from the completion of the Research, the Parties reserve the right to independently publish the Results and/or Inventions, with due regard to the protection of the other Party’s confidential information and subject to the provisions of Section 10.5 below. Notwithstanding the foregoing, the Party wishing to publish shall provide the other Party with a copy of the contemplated Publication at least forty- five (45) days prior to submission thereof for publication or presentation at scientific meetings (“Review Period”) and the other Party shall have the right to review and comment upon the publication in order to protect the providing Party’s confidential information, it being agreed that such comments shall be reasonably considered for inclusion in the Publication and that any confidential information of the providing Party (other than any Results or Inventions) shall be deleted from such publication, at such Party’s request. Upon request, the publication will be delayed up to ninety (90) additional days to enable the providing Party to secure adequate intellectual property protection of property of providing Party that would be affected by said publication. 11. The Materials are provided to Recipient without any warranties, whether express or implied, including, without limitation, warranties of merchantability or fitness for a particular purpose. Without derogating from the aforegoing, the Company makes no representation or warranty, express or implied, that use of the Materials will not infringe any patent or other proprietary rights of a third party. Notwithstanding the foregoing, the Company represents that to the best of its knowledge, the Company has not received any written notice of any claims that the use of the Material infringes any patent, patent application, trade secret, or other property or proprietary rights of any third party. -18- 12. The conduct of any research by Recipient (or the Scientist or any other scientists or employees of Recipient) with respect to the Materials shall be its sole risk and responsibility and the Company will not be liable for any consequences thereof. The Materials are to be used and handled with caution and prudence in any experimental work, since not all characteristics of the Materials are necessarily known. The Company and the directors, officers, employees, agents and consultants of the Company (hereinafter, collectively, “the Indemnitees”) shall not be liable for any claims, demands, liabilities, costs, losses, damages or expenses (including legal costs and attorneys’ fees) that directly or indirectly arise out of or result from the use, application, storage or disposal of the Materials and/or Confidential Information by Recipient, the Scientist or any other scientists or employees of Recipient (hereinafter, collectively, “Liabilities”), except to the extent that such Liabilities are finally held by a court of competent jurisdiction have resulted directly from the negligence or willful misconduct of the Company and the directors, officers, employees, agents and consultants of the Company. In the event that any of the Indemnitees should suffer any Liabilities as aforesaid or shall be requested to pay any person or entity any amount whatsoever as compensation for any Liabilities as aforesaid, then to the extent authorized by the Constitution and laws of the State of Texas, Recipient shall indemnify and hold harmless such Indemnitees from and against such Liabilities, except to the extent that such Liabilities are finally held by a court of competent jurisdiction to have resulted directly from the negligence or willful misconduct of the Company and the directors, officers, employees, agents and consultants of the Company, as aforesaid. 13. Since a breach by Recipient of any of the undertakings contained herein may result in irreparable and continuing damage to the Company for which there may be no adequate remedy at law, subject to the laws of the State of Texas, the Company shall be entitled, upon appropriate proof, to seek injunctive relief and/or a decree for specific performance, and such other relief as may be proper (including monetary damages, if appropriate). 14. 14.1. Without derogating from the Parties’ rights hereunder or by law to any other or additional relief, it is agreed that the either Party may terminate this Agreement at any time by serving a written notice to such effect on the other Party. 14.2. The termination of this Agreement for any reason shall not relieve a Party of any of its respective obligations which shall have accrued prior to such termination. 14.3. The provisions of Sections 6 to 9 (inclusive), 11-14 (inclusive) and Sections 20 and 21 shall survive any termination of this Agreement. 15. 16. The Preamble and Exhibits hereto form an integral part of this Agreement. In this Agreement “including”, “includes” means including, without limiting the generality of any description preceding such terms. This Agreement constitutes the entire agreement between the Parties in respect of the subject-matter hereof, and supersedes all prior agreements or understandings between the Parties relating to the subject-matter hereof and this Agreement may be amended only by a written document signed by the Parties. -19- 17. 18. 19. 20. 21. Neither Party shall be entitled to assign this Agreement or any or all of its rights, or obligations under this Agreement or arising therefrom, without the prior written consent of the other Party. Notwithstanding the foregoing, the Company shall be entitled to assign this Agreement to a third party that acquires all of the business to which the Purpose relates with written notice provided to Recipient. No waiver by any Party, whether express or implied, of its rights under any provision of this Agreement shall constitute a waiver of such Party’s rights under such provisions at any other time or a waiver of such Party’s rights under any other provision of this Agreement. No failure by any Party to take any action against any breach of this Agreement or default by another Party hereto shall constitute a waiver of the former Party’s rights to enforce any provision of this Agreement or to take action against such breach or default or any subsequent breach or default by such other Party. The provisions of this Agreement are severable and, in the event that any one or more of the provisions or part of a provision contained in this Agreement shall, for any reason, be held by any court of competent jurisdiction to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision or part of a provision of this Agreement; but such provision shall be modified as set out below and the balance of this Agreement shall be interpreted as if such provision were so modified. The Parties shall negotiate in good faith in order to agree on the terms of an alternative provision which complies with applicable law and achieves, to the greatest extent possible, the same effect as would have been achieved by the invalid, illegal or unenforceable provision. This Agreement shall be governed in all respects by the laws of Texas, without giving effect to its principles of conflicts of law that direct that the laws of another jurisdiction apply. Any notice or other communication required to be given by the Parties under this Agreement shall be in writing and shall be deemed to have been given (a) if personally delivered, when actually delivered; or (b) if sent by facsimile, the next business day after receipt of confirmation of transmission, or (c) 7 (seven) days after being mailed by registered or certified mail, postage prepaid (for the purposes of proving such service, it being sufficient to prove that such notice was properly addressed and posted to the respective addresses set forth below, or such other address or addresses as is subsequently specified in writing pursuant to this Section 21): If to the Company: P.O.B. 408 Kiryat Shmona 11013 Israel Attention: CEO Facsimile: Fax: +972-4-681-8806 -20- With a copy to: (which shall not constitute the grant of notice hereunder) Adv. Yael Baratz; and/or Adv. Marcella Druck Eytan Baratz & Co. 1 Azrieli Center, Round Tower 18th floor, Tel-Aviv 67021, Israel Facsimile: +972-3-6960986 If to Recipient and the Scientist: i. Notice should be given to: The University of Texas M. D. Anderson Cancer Center 1020 Holcombe Boulevard Legal Services, Suite 1550 Attn: Chief Legal Officer Houston, TX 77030 Phone: (713) 745-6633; Facsimile: (713) 745-6029 ii. A copy of the notice should be given to: The University of Texas M. D. Anderson Cancer Center 1100 Holcombe Boulevard, Suite FCT8.5038 Office of Research Administration Attn: Executive Director, Research Administration Houston, TX 77030 Phone: (713) 792-3220; Facsimile: (713) 794-4535 iii. A copy of the notice may be given to the Scientist. 22. 23. 24. 25. This Agreement may be executed in any number of counterparts (including counterparts transmitted by facsimile or electronic mail in pdf format), each of which shall be deemed to be an original, but all of which taken together shall be deemed to constitute one and the same instrument. Notwithstanding any other provision of this Agreement, it is understood that the Parties are subject to, and shall comply with, United States laws, regulations, and governmental requirements and restrictions controlling the export of technology, technical data, computer software, laboratory prototypes, and other commodities, information and items, including without limitation, the Arms Export Control Act, the Export Administration Act of 1979, relevant executive orders, and United States Treasury Department embargo and sanctions regulations, all as amended from time to time (“Restrictions”) and that the Parties’ obligations hereunder are contingent on compliance with applicable Restrictions. English is the official language of this Agreement. Accordingly, all notices, documents and communications relating to the Agreement, and all dispute resolution proceedings arising under this Agreement must be, in their entirety, in English. Recipient is an agency of the State of Texas and under the constitution and laws of the State of Texas possesses certain rights and privileges, is subject to certain limitations and restrictions, and only has such authority as is granted to it under the constitution and laws of the State of Texas. Notwithstanding any provision hereof, nothing in this Agreement is intended to be, nor will it be construed to be, a waiver of the sovereign immunity of the State of Texas or a prospective waiver or restriction of any of the rights, remedies, claims, and privileges of the State of Texas. Moreover, notwithstanding the generality or specificity of any provision hereof, the provisions of this Agreement as they pertain to Recipient are enforceable only to the extent authorized by the constitution and laws of the State of Texas; accordingly, to the extent any provision hereof conflicts with the constitution or laws of the State of Texas or exceeds the right, power or authority of Recipient to agree to such provision, then that provision will not be enforceable against Recipient or the State of Texas. -21- IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed as of the date set out below. NovoTyr Therapeutics Ltd. Signature: /s/ Ofer Edelman Name: Title: Ofer Edelman CFO Signature: /s/ Hadas Reuveni Name: Title: Date: Hadas reuveni CEO June 19, 2011 The University of Texas M. D. Anderson Cancer Center Accepted and Agreed: Signature: /s/ Wesley Harrott Name: Wesley Harrott Title: Date: Executive Director, ResearchAdministration June 16, 2011 Read and Understood: Menashe Bar Eli, Ph.D. Signature: /s/ Menashe Bar Eli, Ph.D. Date: June 15, 2011 -22- Research Plan of Menashe Bar Eli and Alexander Levitzki EXHIBIT A Based on NovoTyr’s results showing efficacy of NT157 in both SC and metastatic models of human melanoma A375 in nude mice, and synergic effect of NT157 with both Dacarbazine, an approved drug for melanoma, and B-Raf inhibitors, MDA will examine in its models: I. The inhibitory activity of NT157 in two in-vivo models of human melanoma in mice: - Metastasis in lungs following iv injection of human melanoma cells - Growth of sc xenograft tumors and IHC of the tumors following cease of treatment. IHC staining will be performed for p-IGFR1, p- IRS1, p-STAT3 and CD31. The combined effect of NT157 and Plexxicon B-Raf inhibitors in-tissue culture and in animal models. To that end, melanoma cell lines with and without B-RAF V600E mutation will be utilized. The inhibitory activity of NT157 on cell lines in which B-Raf is mutated and cell lines derived from Plexxicon 4032 resistant patients [****]. Five human melanoma cell lines harboring V600E mutation and selected to be resistant to PLX-4032 will be used for these studies. II. III. -23- MATERIAL TRANSFER AGREEMENT THIS MATERIAL TRANSFER AGREEMENT (this “Agreement”), effective as of September 23, 2009, is made and entered into by and between NovoTyr Therapeutics Ltd., a company duly incorporated under the laws of Israel, of P.O.B. 408, Kiryat Shmona 11013, Israel (“the Company”), the Regents of the University of Michigan, a non-profit state related organization of Ann Arbor, MI 48109, Michigan, USA (“Recipient”), on behalf of their employee, Dr. Luke Peterson, a researcher at the Recipient (“the Scientist”). WHEREAS, the Company and Recipient wish the Recipient to receive one or more samples of the Company’s proprietary materials (such Company materials and any derivatives and modifications thereof, hereinafter, collectively, “the Materials”) and certain proprietary and confidential information regarding the Company, its business or technology disclosed in written, or tangible form or, if disclosed orally or in non-tangible form, is confirmed in writing within twenty (20) working days of disclosure (the “Confidential Information”), it being agreed, however, that any information regarding the Materials disclosed to Recipient, whether in written, oral or any other form shall be deemed to be Confidential Information, regardless of whether or not identified as such, for the purpose of conducting academic research and testing with respect to the Materials (“the Purpose”). NOW THEREFORE, the parties hereby agree as follows: 1. 2. 3. 4. The Company shall supply certain Materials to Recipient as aforesaid in the Preamble hereto and may disclose Confidential Information to Recipient in relation thereto. Scientist, on behalf of Recipient, and the Recipient may use the Materials and the Confidential Information solely for the Purpose. Recipient, including the Scientist, shall not use the Materials, the Confidential Information or any substance that is replicated or derived therefrom for any commercial or profit-generating purpose, or in the conduct of research that is subject to consulting, licensing or other similar legal or commercial obligations to another institution, corporation, or business entity. Recipient shall use the Material only at Recipient’s organization and only in the Scientist’s laboratory under the direction of the Scientist or of others working under his direct supervision. Recipient, including the Scientist, shall not transfer the Material to any other person (including, any other person within Recipient’s organization) without the Company’s prior written consent, and shall prohibit access thereto by unauthorized third parties. Recipient shall store and use the Materials and any written copies of Confidential Information in a safe place and in a safe manner. Recipient represents and warrants to the Company that: (i) Recipient, and the Scientist, are regularly engaged in conducting laboratory studies and have all the required authorizations, approvals, registrations, licenses, and permits and are entitled to perform such experimental work at the Scientist’s laboratory in Recipient’s organization. Recipient is entitled under all applicable laws, rules and regulations to use the Materials according to this Agreement. Recipient, including the Scientist, has adequate training and facilities to study the Materials according to this Agreement and will directly supervise the use thereof hereunder; (ii) Recipient shall use the Materials in accordance with all applicable laws and regulations and in accordance with all applicable guidelines and ethical principles; (iii) Recipient shall use the Materials under suitable containment conditions and will under no circumstances be administered to humans. -24- 5. 6. 7. Recipient further represents and warrants to the Company that neither it nor the Scientist is a party to any agreement with a third party: (i) that would impair or have an adverse effect on its ability to comply with the obligations undertaken by Recipient under this Agreement; (ii) that would prevent Recipient from carrying on research and development activities and studies with the Materials or (iii) that would impair or have an adverse effect on the rights of the Company under this Agreement. The Materials and the Confidential Information will be held strictly confidential and Recipient shall treat and/or protect the Material and the Confidential Information with the same degree of care that it maintains and protects the confidential information of Recipient, but in any event, no less than a reasonable degree of care. Recipient shall not disclose the Materials and the Confidential Information to any third party, unless such disclosure is required by law or court order, in which case, the Company will be promptly informed thereof by Recipient so that the Company may seek a protective order or other remedy. In any event, Recipient shall disclose only that portion of the Confidential Information that is legally required to be disclosed. Notwithstanding the aforegoing, the Confidential Information shall not include any information in respect of which it can be shown by written evidence that: (i) at the time of first disclosure, the information was already in the possession of Recipient or the Scientist; or (ii) the information is in the public domain at the time of disclosure or becomes part of the public domain thereafter without breach of this Agreement; (iii) the information has been received on a non-confidential basis from a third party that is not bound by a confidentiality obligation; or (iv) information that is independently generated by Recipient without reference to Confidential Information. The Recipient undertake to limit access to Confidential Information solely to its employees on a strict need-to-know policy and the Recipient shall obligate such employees, including the Scientist, to observe the confidentiality obligations imposed hereunder. The Materials and the Confidential Information are and shall remain the exclusive property of the Company and, upon termination of this Agreement or otherwise at the Company’s request, Recipient shall, in accordance with the Company’s instructions, either return to the Company or dispose of in accordance with the applicable laws and regulations, all Materials and written Confidential Information, and any copies thereof. -25- 8. 9. 10. 11. The Company shall own all right, title and interest in and to: (i) any ideas, inventions, techniques, compositions, compounds, substances, formulations, improvements, applications, information, findings and other results of whatsoever nature regarding the Materials that are generated, discovered, reduced to practice as a result of Recipient’s and/or the Scientist’s use of the Materials (collectively, “Inventions”); and (ii) all patents and/or other intellectual property covering the Inventions; provided, that Recipient shall have a non-exclusive, royalty-free license to use such Inventions solely for internal research and educational purposes. All Inventions shall be promptly disclosed to the Company and upon the Company’s request, Recipient, including the Scientist, shall execute and deliver to the Company any document or instrument (including, deeds of assignment) and shall take all further acts reasonably required to transfer and/or assign all right, title and interest in and to the Inventions to the Company and/or to perfect the Company’s title therein. Without derogating from the aforegoing, in the event that any Invention is generated, discovered or reduced to practice by the Scientist and/or any other scientist or employee of Recipient as aforesaid, the Company agrees to name the Scientist and/or such other scientist or employee as inventors of such Invention in any patent application filed in respect thereof. For the purposes of this Agreement, the Inventions shall be deemed to be “Confidential Information”, unless and until published or otherwise disclosed subject to and in accordance with the provision of section 11 below. Except as otherwise expressly provided in this Agreement (for the Purpose), nothing contained in this Agreement shall be construed as granting Recipient or the Scientist any ownership, license or other rights, express or implied, in or to any of the Materials, or Confidential Information (including, for the removal of doubt, the Inventions) or in or to any patents, trademarks or other intellectual property rights relating to the Materials and/or the Inventions. Recipient acting through the Scientist shall keep the Company informed with regard to the use of the Materials hereunder and shall provide the Company, at regular intervals and promptly upon completion or termination of this Agreement, with a written copy of all data generated therefrom. The data may be used by the Company without restriction. Recipient grants to the Company full access to any primary data relating to the Materials as well as the right to include the data in any patent applications and regulatory filings. In the event Recipient and/or the Scientist wishes to publish information relating to any Inventions or other results generated, discovered or reduced to practice as aforesaid, in scientific journals, manuscripts or at scientific meetings (each, a “Publication”), the release or publication of any such Publication shall be subject to the prior written review by the Company and to compliance with the provisions of this section 11 below. Each Publication will adequately acknowledge and appropriately reflect the contribution of the researchers and/or employees of each of the Company and Recipient and/or the source of the information included therein, in accordance with customary scientific practice. Recipient and/or the Scientist, (as the case may be) shall provide the Company with a copy of the contemplated Publication at least 45 (forty five) days prior to submission thereof for publication or presentation at scientific meetings. The Company shall have the right, at its sole discretion, to either (i) provide comments to the proposed Publication which comments shall be discussed by Recipient and/or the Scientist (as the case may be) and the Company, in good faith and in a timely manner and be incorporated into the said publication accordingly and/or request that any Confidential Information be deleted prior to publication in which case such Confidential Information shall be deleted by Recipient as aforesaid; or (ii) to delay publication for a period not to exceed 90 (ninety) days as a result of information in the proposed Publication for which patent protection should be sought (prior to publication). 12. The Materials are provided to Recipient without any warranties, whether express or implied, including, without limitation, warranties of merchantability or fitness for a particular purpose. Without derogating from the aforegoing, the Company makes no representation or warranty, express or implied, that use of the Materials will not infringe any patent or other proprietary rights of a third party. -26- 13. The conduct of any testing or research by Recipient (or the Scientist or any other scientists or employees of Recipient) with respect to the Materials shall be its sole risk and responsibility and the Company will not be liable for any consequences thereof. The Materials are to be used and handled with caution and prudence in any experimental work, since not all characteristics of the Materials are necessarily known. The Company and the directors, officers, employees, agents and consultants of the Company (hereinafter, collectively, “the Indemnitees”) shall not be liable for any claims, demands, liabilities, costs, losses, damages or expenses (including legal costs and attorneys’ fees) that directly or indirectly arise out of or result from the use, application, storage or disposal of the Materials and/or Confidential Information by Recipient, the Scientist or any other scientists or employees of Recipient (hereinafter, collectively, “Liabilities”), except to the extent that such Liabilities are finally proven to have resulted directly from the Company’s gross negligence or willful misconduct. In the event that any of the Indemnitees should suffer any Liabilities as aforesaid or shall be requested to pay any person or entity any amount whatsoever as compensation for any Liabilities as aforesaid, then to the extent permitted by law Recipient shall indemnify and hold harmless such Indemnitees from and against such Liabilities, except to the extent that such Liabilities are finally proven to have resulted directly from the Company’s gross negligence or willful misconduct, as aforesaid. 14. Since a breach by Recipient and/or the Scientist of any of the undertakings contained herein may result in irreparable and continuing damage to the Company for which there may be no adequate remedy at law, the Company shall be entitled, upon appropriate proof, to seek injunctive relief and/or a decree for specific performance, and such other relief as may be proper (including monetary damages, if appropriate). 15. 15.1. Without derogating from the parties’ rights hereunder or by law to any other or additional relief, it is agreed that the Company may terminate this Agreement at any time by serving a written notice to such effect on Recipient and the Scientist. 15.2. The termination of this Agreement for any reason shall not relieve a party of any of its respective obligations which shall have accrued prior to such termination. 15.3. The provisions of sections 6-9 (inclusive), 11-15 (inclusive) and sections 22 and 23 shall survive any termination of this Agreement. 16. The Preamble and Schedules hereto form an integral part of this Agreement. In this Agreement “including”, “includes” means including, without limiting the generality of any description preceding such terms. -27- 17. 18. 19. 20. 21. This Agreement constitutes the entire agreement between the parties hereto in respect of the subject-matter hereof, and supersedes all prior agreements or understandings between the parties relating to the subject-matter hereof and this Agreement may be amended only by a written document signed by the parties hereto. In the event any provision of this Agreement is held by a court or other tribunal of competent jurisdiction to be illegal, invalid or unenforceable, such provisions shall be limited or eliminated to the minimum extent necessary so that this Agreement shall otherwise remain in full force and effect. Neither party shall be entitled to assign this Agreement or any or all of its rights, or obligations under this Agreement or arising therefrom, without the prior written consent of the other party. Notwithstanding the foregoing, the Company shall be entitled to assign this Agreement to a third party that acquires all of Company’s business, to which this Agreement relates. No waiver by any party hereto, whether express or implied, of its rights under any provision of this Agreement shall constitute a waiver of such party’s rights under such provisions at any other time or a waiver of such party’s rights under any other provision of this Agreement. No failure by any party hereto to take any action against any breach of this Agreement or default by another party hereto shall constitute a waiver of the former party’s rights to enforce any provision of this Agreement or to take action against such breach or default or any subsequent breach or default by such other party. The provisions of this Agreement are severable and, in the event that any one or more of the provisions or part of a provision contained in this Agreement shall, for any reason, be held by any court of competent jurisdiction to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision or part of a provision of this Agreement; but such provision shall be modified as set out below and the balance of this Agreement shall be interpreted as if such provision were so modified. The parties shall negotiate in good faith in order to agree on the terms of an alternative provision which complies with applicable law and achieves, to the greatest extent possible, the same effect as would have been achieved by the invalid, illegal or unenforceable provision. 22. This Agreement shall be governed in all respects by the laws of the State of New York. -28- 23. Any notice or other communication required to be given by the parties under this Agreement shall be in writing and shall be deemed to have been given 1 (one) business day after delivery (including by way of personal delivery and/or delivery by courier); or if sent by facsimile, the next business day after receipt of confirmation of transmission to the respective addresses set forth below, or such other address or addresses as is subsequently specified in writing pursuant to this section 23): If to the Company: Novotyr Therapeutics Ltd. P.O.B. 408 Kiryat Shmona 11013 Israel Attention: CEO Facsimile:+972-4-681-8806 With a copy to: Adv. Yael Baratz Baratz, Horn & Co. 1 Azrieli Center, Round Tower 18th floor, Tel-Aviv 67021, Israel Facsimile: +972-3-6960986 If to Recipient and the Scientist: University of Michigan Division of Research Development and Administration 3003 South State Street, Room 1072 Ann Arbor, MI 48109-1274 Michigan, USA Attention: Elaine Brock Facsimile: 734-763-4053 With a copy to: Dr. Luke Peterson Department of Internal Medicine-Hematology/Oncology 1200 Domino Farms, Lobby J Ann Arbor, MI 48109-5750 24. 25. This Agreement may be executed in any number of counterparts (including counterparts transmitted by facsimile), each of which shall be deemed to be an original, but all of which taken together shall be deemed to constitute one and the same instrument. Each party agrees to execute, acknowledge and deliver such further documents and instruments and to do any other acts, from time to time, as may be reasonably necessary, to effectuate the purposes of this Agreement. [Remainder of page intentionally left blank] -29- IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date set out below. Novotyr Therapeutics Ltd. Signature: /s/ Hadas Reuveni Name: Hadas Reuveni Title: CEO Signature: /s/ Noam Lavtman Name: Title: Date: Noam Lavtman Director Oct. 29, 2009 Declaration by Scientist The Regents of the University of Michigan Signature: /s/ Elaine L. Brock Name: Title: Date: Elaine L. Brock Sr. Assoc. Director Div of Research Dev. & Admin. Oct. 16, 2009 I, the undersigned, Dr. Luke Peterson, hereby confirm that I have read the above Agreement and in my capacity as employee of the Recipient’s organization, I agree to abide by the terms of the above Agreement and shall refrain from any act or omission that may constitute a breach of the Agreement. Dr. Luke Peterson Signature: /s/ Dr. Luke Peterson Date: Oct. 12, 2009 -30- MATERIAL TRANSFER AGREEMENT THIS MATERIAL TRANSFER AGREEMENT (this “Agreement”), effective as of January 1st, 2010, is made and entered into by and between Novotyr Therapeutics Ltd., a company duly incorporated under the laws of Israel, of P.O.B. 408, Kiryat Shmona 11013, Israel (“the Company”), Hadassah Medical Organization, a non-profit organization (“Recipient”), and Dr. Michal Lotem, a researcher at the Recipient (“the Scientist”). WHEREAS, the Company, the Recipient and the Scientist wish the Recipient and the Scientist to receive samples of the Company’s proprietary materials described in Appendix A hereto (such Company materials and any derivatives and modifications thereof, hereinafter, collectively, “the Materials”) and confidential information relating to the Materials of the Company, its business or technology (the “Confidential Information”) for the purpose of conducting certain academic research and testing with respect thereto as more fully described in the research plan attached hereto as Appendix B (“the Research Plan” and “the Purpose”, respectively). NOW THEREFORE, the parties hereby agree as follows: 1. 2. 3. The Company shall supply the Materials to the Recipient and the Scientist as aforesaid in the Preamble hereto and may disclose Confidential Information to Recipient and/or the Scientist in relation thereto. The Company shall pay the Recipient a sum of NIS 50,000 (fifty thousand New Israel Sheqels), including overhead and all taxes (if any), for the performance of the Research Plan, against submission by the Recipient to the Company of an invoice (“cheshbon”) from the Recipient. Each of the Recipient and the Scientist may use the Materials and the Confidential Information solely for the Purpose. Neither Recipient nor the Scientist shall use the Materials, the Confidential Information or any substance that is replicated or derived therefrom for any commercial or profit- generating purpose, or in the conduct of research that is subject to consulting, licensing or other similar legal or commercial obligations to another institution, corporation, or business entity. Recipient shall use the Material only at Recipient’s organization and only in the Scientist’s laboratory under the direction of the Scientist or of others working under his direct supervision. Neither Recipient nor the Scientist shall transfer the Material to any other person (including, any other person within Recipient’s organization) without the Company’s prior written consent, and shall prohibit access thereto by unauthorized third parties. Recipient and the Scientist shall store and use the Materials and any written copies of Confidential Information in a safe place and in a safe manner. -31- 4. 5. 6. 7. Each of Recipient and the Scientist represents and warrants to the Company that: (i) Recipient and the Scientist are regularly engaged in conducting laboratory studies and have all the required authorizations, approvals, registrations, licenses, and permits and are entitled to perform such experimental work at the Scientist’s laboratory in Recipient’s organization. Recipient and the Scientist are entitled under all applicable laws, rules and regulations to use the Materials according to this Agreement. Recipient and the Scientist have adequate training and facilities to study the Materials according to this Agreement and will directly supervise the use thereof hereunder; (ii) Recipient and the Scientist shall use the Materials in accordance with all applicable laws and regulations and in accordance with all applicable guidelines and ethical principles; (iii) Recipient and the Scientist shall use the Materials under suitable containment conditions and will under no circumstances be administered to humans. Each of Recipient and the Scientist further represent and warrant to the Company that they are not a party to any agreement with a third party: (i) that would be in conflict with the obligations undertaken by Recipient and the Scientist under this Agreement; (ii) that would prevent Recipient and the Scientist from carrying on research and development activities and studies with the Materials; or (iii) that would be in conflict with the rights of the Company under this Agreement. The Materials and the Confidential Information will be held strictly confidential and each of Recipient and the Scientist shall treat and/or protect the Material and the Confidential Information with the same degree of care that they maintain and protect the confidential information of Recipient, but in any event, no less than a reasonable degree of care. Neither Recipient nor the Scientist shall disclose the Materials and the Confidential Information to any third party, unless such disclosure is required by law or court order, in which case, the Company will be promptly informed thereof by Recipient or the Scientist (as the case may be) so that the Company may seek a protective order or other remedy. In any event, Recipient and the Scientist shall disclose only that portion of the Confidential Information that is legally required to be disclosed. Notwithstanding the aforegoing, the Confidential Information shall not include any information in respect of which it can be shown by written evidence that: (i) at the time of first disclosure, the information was already in the possession of Recipient or the Scientist; or (ii) the information is in the public domain at the time of disclosure or becomes part of the public domain thereafter without Recipient or the Scientist or other scientists or employees of Recipient being responsible therefor; or (iii) the information has been received on a non-confidential basis from a third party that is not bound by a confidentiality obligation. The Materials and the Confidential Information are and shall remain the exclusive property of the Company and, upon termination of this Agreement or otherwise at the Company’s request, Recipient and the Scientist shall, in accordance with the Company’s instructions, either return to the Company or dispose of in accordance with the applicable laws and regulations, all Materials and written Confidential Information, and any copies and derivatives thereof. -32- 8. 9. 10. 11. The Company shall own all right, title and interest in and to: (i) any ideas, inventions, techniques, compositions, compounds, substances, formulations, improvements, applications, information, findings and other results of whatsoever nature directly relating to the Materials that are generated, discovered, reduced to practice and/or arise from Recipient’s and/or the Scientist’s use of the Materials in the performance of the Research Plan (collectively, “Inventions”); and (ii) all patents, copyrights, know-how trademarks and other intellectual property in and/or covering the Inventions. All Inventions shall be promptly disclosed to the Company and upon the Company’s request, Recipient and the Scientist shall execute and deliver to the Company any document or instrument (including, deeds of assignment) and shall take all further acts reasonably required to transfer and/or assign all right, title and interest in and to the Inventions and related intellectual property to the Company and/or to perfect the Company’s title therein. Without derogating from the aforegoing, in the event that any Invention is generated, discovered or reduced to practice by the Scientist and/or any other scientist or employee of Recipient as aforesaid, the Company agrees to name the Scientist and/or such other scientist or employee as inventors of such Invention in any patent application filed in respect thereof. For the purposes of this Agreement, the Inventions shall be deemed to be “Confidential Information”. Except as otherwise expressly provided in this Agreement (for the Purpose), nothing contained in this Agreement shall be construed as granting Recipient or the Scientist any ownership, license or other rights, express or implied, in or to any of the Materials, or Confidential Information (including, for the removal of doubt, the Inventions) or in or to any patents, trademarks or other intellectual property rights relating to the Materials and/or the Inventions. Recipient and the Scientist shall keep the Company informed with regard to the use of the Materials hereunder and shall provide the Company, at regular intervals and promptly upon completion or termination of this Agreement, with a written copy of all data generated therefrom. The data may be used by the Company without restriction. Recipient and the Scientist grant to the Company full access to any primary data relating to the Materials as well as the right to include the data in any patent applications and regulatory filings. In the event Recipient and/or the Scientist wishes to publish information relating to any Inventions generated, discovered or reduced to practice as aforesaid, in scientific journals, manuscripts or at scientific meetings (each, a “Publication”), the release or publication of any such Publication shall be subject to the prior written consent of the Company. Each Publication will adequately acknowledge and appropriately reflect the contribution of the researchers and/or employees of each of the Company and Recipient and/or the source of the information included therein, in accordance with customary scientific practice. Recipient or the Scientist (as the case may be) shall provide the Company with a copy of the contemplated Publication at least 60 (sixty) days prior to submission thereof for publication or presentation at scientific meetings. The Company shall have the right to: (i) provide comments to the proposed Publication which comments shall be discussed by the Recipient and/or the Scientist (as the case may be) and the Company in good faith and in a timely manner and be incorporated into the Publication accordingly; or (ii) to object thereto because it contains Confidential Information or other information of the Company for which patent protection should be sought (prior to publication), or should be held confidential. Upon the Company’s written request such Confidential Information or other information as aforesaid shall be deleted from such publication. -33- 12. 13. The Materials are provided to Recipient and the Scientist without any warranties, whether express or implied, including, without limitation, warranties of merchantability or fitness for a particular purpose. Without derogating from the aforegoing, the Company makes no representation or warranty, express or implied, that use of the Materials will not infringe any patent or other proprietary rights of a third party. The conduct of any testing or research by Recipient (or the Scientist or any other scientists or employees of Recipient) with respect to the Materials shall be its sole risk and responsibility and the Company will not be liable for any consequences thereof. The Materials are to be used and handled with caution and prudence in any experimental work, since not all characteristics of the Materials are necessarily known. The Company and the directors, officers, employees, agents and consultants of the Company (hereinafter, collectively, “the Indemnitees”) shall not be liable for any claims, demands, liabilities, costs, losses, damages or expenses (including legal costs and attorneys’ fees) that directly or indirectly arise out of or result from the use, application, storage or disposal of the Materials and/or Confidential Information by Recipient, the Scientist or any other scientists or employees of Recipient (hereinafter, collectively, “Liabilities”), except to the extent that such Liabilities are finally proven to have resulted directly from the Company’s gross negligence or willful misconduct. In the event that any of the Indemnitees should suffer any Liabilities as aforesaid or shall be requested to pay any person or entity any amount whatsoever as compensation for any Liabilities as aforesaid, then Recipient shall indemnify and hold harmless such Indemnitees from and against such Liabilities, except to the extent that such Liabilities are finally proven to have resulted directly from the Company’s gross negligence or willful misconduct, as aforesaid. 14. Since a breach by Recipient and/or the Scientist of any of the undertakings contained herein may result in irreparable and continuing damage to the Company for which there may be no adequate remedy at law, the Company shall be entitled, upon appropriate proof, to injunctive relief and/or a decree for specific performance, and such other relief as may be proper (including monetary damages, if appropriate). 15. 15.1. Without derogating from the parties’ rights hereunder or by law to any other or additional relief, it is agreed that the Company may terminate this Agreement at any time by serving a written notice to such effect on Recipient and the Scientist. 15.2. The termination of this Agreement for any reason shall not relieve a party of any of its respective obligations which shall have accrued prior to such termination. 15.3. The provisions of sections 6-9 (inclusive), 11-15 (inclusive) and sections 22 and 23 shall survive any termination of this Agreement. -34- 16. 17. 18. 19. 20. 21. The Preamble and Schedules hereto form an integral part of this Agreement. In this Agreement “including”, “includes” means including, without limiting the generality of any description preceding such terms. This Agreement constitutes the entire agreement between the parties hereto in respect of the subject-matter hereof, and supersedes all prior agreements or understandings between the parties relating to the subject-matter hereof and this Agreement may be amended only by a written document signed by the parties hereto. In the event any provision of this Agreement is held by a court or other tribunal of competent jurisdiction to be illegal, invalid or unenforceable, such provisions shall be limited or eliminated to the minimum extent necessary so that this Agreement shall otherwise remain in full force and effect. Neither party shall be entitled to assign this Agreement or any or all of its rights, or obligations under this Agreement or arising therefrom, without the prior written consent of the other party. Notwithstanding the foregoing, the Company shall be entitled to assign this Agreement to a third party that acquires all of the business to which the Purpose relates. No waiver by any party hereto, whether express or implied, of its rights under any provision of this Agreement shall constitute a waiver of such party’s rights under such provisions at any other time or a waiver of such party’s rights under any other provision of this Agreement. No failure by any party hereto to take any action against any breach of this Agreement or default by another party hereto shall constitute a waiver of the former party’s rights to enforce any provision of this Agreement or to take action against such breach or default or any subsequent breach or default by such other party. The provisions of this Agreement are severable and, in the event that any one or more of the provisions or part of a provision contained in this Agreement shall, for any reason, be held by any court of competent jurisdiction to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision or part of a provision of this Agreement; but such provision shall be modified as set out below and the balance of this Agreement shall be interpreted as if such provision were so modified. The parties shall negotiate in good faith in order to agree on the terms of an alternative provision which complies with applicable law and achieves, to the greatest extent possible, the same effect as would have been achieved by the invalid, illegal or unenforceable provision. 22. This Agreement shall be governed in all respects by the laws of Israel, without giving effect to its principles of conflicts of law that direct that the laws of another jurisdiction apply and the Parties hereto hereby submit to the exclusive jurisdiction of the competent courts in Tel-Aviv- Jaffa, Israel. -35- 23. Any notice or other communication required to be given by the parties under this Agreement shall be in writing and shall be deemed to have been given (a) if personally delivered, when actually delivered; or (b) if sent by facsimile, the next business day after receipt of confirmation or transmission, or (c) 7 (seven) days after being mailed by registered or certified mail, postage prepaid (for the purposes of proving such service, it being sufficient to prove that such notice was properly addressed and posted to the respective addresses set forth below, or such other address or addresses as is subsequently specified in writing pursuant to this clause 23): If to the Company: Novotyr Therapeutics Ltd. P.O.B. 408 Kiryat Shmona 11013 Israel Attention: CEO Facsimile: +972-4-681-8806 With a copy to: Adv. Yael Baratz Baratz & Co. 1 Azrieli Center, Round Tower 18th floor, Tel-Aviv 67021, Israel Facsimile: +972-3-6960986 If to Recipient and the Scientist: Hadassah Medical Organization POBox 12000 Jerusalem, Israel 91120 Attention: Dr. Arik Tzukert Facsimile: 972-2-643-4701 24. 25. This Agreement may be executed in any number of counterparts (including counterparts transmitted by facsimile), each of which shall be deemed to be an original, but all of which taken together shall be deemed to constitute one and the same instrument. Each party agrees to execute, acknowledge and deliver such further documents and instruments and to do any other acts, from time to time, as may be reasonably necessary, to effectuate the purposes of this Agreement. 26. The parties hereto acknowledge that the Scientist is a member of the Board of Directors of the Company. -36- IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date set out below. Novotyr Therapeutics Ltd. Signature: /s/ Hadas Reuveni Name: Title: Date: Hadas Reuveni CEO 24.2.2010 Dr. Michal Lotem Signature: /s/ Dr. Michal Lotem Date: Feb. 28 , 2010 Hadassah Medical Organization Signature: /s/ Dr. Arik Tzukert Name: Title: Date: Dr. Arik Tzukert Director, R&D Divison 24.2.2010 -37- Annex B THE RESEARCH MATERIALS NT157, NT219, NT700 and NT701were provided to MD Anderson and Yissum. UBC received NT157 but will also receive NT219. UM received NT157, NT219, NT205 and as a control molecule NT155. HMO received NT157. BIRAD will receive NT219, NT157, NT701, NT700 and may receive other molecules in the future. -38- Annex C BIRAD MTA -39- MATERIAL TRANSFER AGREEMENT THIS MATERIAL TRANSFER AGREEMENT (this “Agreement”), effective as of February 12, 2014, (the: “Effective Date”) is made and entered into by and between TyrNovo Ltd., a company duly incorporated under the laws of Israel, of 8 Abba Eban Ave., Herzliya Pituach, 4672526 Israel, (“the Company”), Bar Ilan Research and Development Company Ltd. (“BIRAD”), a company formed under the law of Israel and the technology commercialization subsidiary of Bar Ilan University (“Recipient Institution”), and Prof. Izhak Haviv, a researcher at the Recipient Institution (“the Scientist”) (the Recipient Institution and the Scientist, together, “Recipient”) ; and WHEREAS, Company and Yissum Research Development Company of the Hebrew University of Jerusalem Ltd. (“Yissum”) signed a License Agreement on 15 August 2013, with respect to, among others, the materials described in Appendix A to this Agreement to be provided to Recipient under this Agreement (the “Yissum Materials” and the “License Agreement”, respectively);and WHEREAS, the Company and Hadassah Medical Organization (“Hadassah”) have signed on 24 day of November, 2013 an MTA, attached to this Agreement as Appendix B (the: “Hadassah MTA”), under which the Company received from Hadassah, subject to the Hadassah MTA terms and conditions, the materials described in Appendix C to this Agreement to be provided to Recipient under this Agreement (the: “Hadassah Materials”); and WHEREAS, the Company is the proprietary owner of certain materials described in Appendix D to this Agreement and possesses all rights, title and interest vested therein (the: “Company’s Materials” and together with the Hadassah Materials and the Yissum Materials- the: “Materials”); and WHEREAS, the Company and BIRAD wish Recipient to receive one or more samples of the Materials and certain Confidential Information relating to the Materials of the Company for the sole purpose of enabling BIRAD to cause the performance by Recipient of certain services with respect thereto in accordance with the Services Agreement between Company and BIRAD dated February 12, 2014 (“Services Agreement”) and workplan attached hereto as Appendix E (“the Purpose”). NOW THEREFORE, the parties hereby agree as follows: 1. The Company shall supply certain Materials to Recipient as aforesaid in the Preamble hereto and may disclose Confidential Information to Recipient in relation thereto. “Confidential Information” means information relating to the Company Materials disclosed by or on behalf of the Company to the Scientist and/or to BIRAD that is either marked as confidential or (if disclosed orally) is reduced to a written summary marked as confidential and delivered to the Scientist within 30 days of disclosure, except to the extent such information: (i) was known to Recipient or any of its personnel at the time it was disclosed, as evidenced by written records at the time of disclosure; (ii) is at the time of disclosure or later becomes publicly known under circumstances involving no breach of this Agreement; (iii) is lawfully and in good faith made available to Recipient or any of its personnel by a third party who is not subject to obligations of confidentiality to the Company with respect to such information; or (iv) is independently developed by personnel of Recipient without the use of or reference to Confidential Information, as demonstrated by documentary evidence. -40- 2. 3. 4. 5. Recipient may use the Materials and the Confidential Information solely for the Purpose. Recipient shall not use the Materials, the Confidential Information or any substance that is replicated or derived therefrom for any commercial or profit-generating purpose, or in the conduct of research that is subject to consulting, licensing or other similar legal or commercial obligations to another institution, corporation, or business entity. Transfer of the Materials to Recipient under this Agreement shall not restrict Company from transferring the Materials to any other organizations or from using the Materials in any other manner. Recipient shall not transfer the Materials to any other third party without Company’s prior written consent. Recipient shall use the Materials only at Recipient Institution and only in the Scientist’s laboratory under the direction of the Scientist or of others working under his direct supervision. Neither Recipient Institution nor the Scientist shall transfer the Materials to any other person (including, any other person within Recipient Institution without the Company’s prior written consent), other than to members of the Scientist Research Team (as defined below) . and shall prohibit access thereto by unauthorized third parties. Recipient shall store and use the Materials and any written copies of Confidential Information in a safe place and in a safe manner. BIRAD and the Scientist represent and warrant to the Company that: (i) Recipient Institution and the Scientist are regularly engaged in conducting laboratory studies and have all the required authorizations, approvals, registrations, licenses, and permits required for the Purpose and are entitled to perform such experimental work at the Scientist’s laboratory at Recipient Institution. Recipient is entitled under all applicable laws, rules and regulations to use the Materials according to this Agreement; Recipient has adequate training and facilities to study the Materials according to this Agreement and Scientist will directly supervise the use thereof hereunder; (ii) Recipient shall use the Materials in accordance with all applicable laws and regulations and in accordance with all applicable guidelines and ethical principles; (iii) Recipient shall use the Materials under suitable containment conditions and will under no circumstances be administered to humans. BIRAD and the Scientist further represent and warrant to the Company that neither Recipient Institution nor the Scientist is a party to any agreement with a third party: (i) that would be in conflict with the obligations undertaken by BIRAD and/or Recipient under this Agreement; (ii) that would prevent BIRAD and Recipient from performing the contemplated services with the Materials; or (iii) that would be in conflict with the rights of the Company under this Agreement. -41- 6. 7. 8. 9. 10. Company represents and warrants to BIRAD that it has Hadassah’s permission to provide Hadassah Materials to Recipient and to the best of its knowledge and subject to the confirmation by Yissum with respect to the Yissum Materials set forth at the end of this Agreement, Company has all necessary rights and permissions needed to provide Company Materials and Yissum Materials to Recipient all for the purposes of performing the work contemplated under this Agreement. The Confidential Information will be held strictly confidential and each of Recipient Institution and the Scientist shall treat and/or protect the Confidential Information with the same degree of care that they maintain and protect the confidential information of Recipient, but in any event, no less than a reasonable degree of care. Recipient Institution and Scientist may disclose Confidential Information only to members of the Scientist’s research team who have a “need to know” such information and only to the extent necessary in order to perform the Services (“Scientist’s Research Team”). Scientist undertakes to ensure that each member of the Scientist’s Research Team shall be bound by written agreements including confidentiality obligations at least as restrictive as those provided in this Agreement. Recipient shall remain responsible, vis-à-vis the Company, for any actions of Scientist’s Research Team that if taken by Recipient, would constitute a breach of its confidentiality obligations under this Agreement. Neither Recipient Institution nor the Scientist shall disclose the Confidential Information to any third party, unless such disclosure is required by law or court order, in which case, the Company will be promptly informed thereof by BIRAD or the Scientist (as the case may be) so that the Company may seek a protective order or other remedy. In any event, Recipient shall disclose only that portion of the Confidential Information that is legally required to be disclosed. The Materials and the Confidential Information are and shall remain the exclusive property of the Company (and/or of Hadassah, if applicable, according to the Hadassah MTA, and/or of Yissum, if applicable, as provided below) and, upon termination of this Agreement or otherwise at the Company’s request, BIRAD shall cause Recipient, in accordance with the Company’s instructions, either return to the Company or dispose of in accordance with the applicable laws and regulations, all Materials and written Confidential Information, and any copies and derivatives thereof, except that Recipient may retain one copy of any such Confidential Information in its confidential files solely for purposes of monitoring Recipient’s obligations under this Agreement. It is hereby clarified that the Yissum Materials and all Confidential Information relating thereto are and shall remain the exclusive property of Yissum. Yissum shall own all right, title and interest in and to: (i) the Yissum Materials and (ii) Inventions (as defined below) made prior to the OCS Approval (as such term is defined in the License Agreement) and (iii) all patents, copyrights, know-how, trademarks and other intellectual property in and/or covering such Inventions, in each case solely to the extent the claims are directed at such Inventions. Company shall own all right, title and interest in and to (i) Inventions arising following to the OCS Approval and (ii) all patents, copyrights, know- how, trademarks and other intellectual property in and/or covering such Inventions, in each case solely to the extent the claims are directed at such Inventions. In the event that OCS Approval is not obtained for any reason, all right, title and interest in and to the Inventions irrespective of when such Inventions arise, and all patents, copyrights, know-how, trademarks and other intellectual property in and/or covering the Inventions, to the extent the claims are directed at such Inventions, shall be owned exclusively by Yissum. “Invention” means any inventions, techniques, compositions, compounds, substances, formulations, improvements, applications, information and findings with respect to the Yissum Materials or their use (including progeny and derivatives of the Yissum Material) that are generated, discovered, reduced to practice and/or arise from Recipient Institution’s and/or the Scientist’s and/or the Scientist’s Research Team’s use of the Yissum Materials. Except as otherwise expressly provided in this Agreement (for the Purpose), nothing contained in this Agreement shall be construed as granting BIRAD, Recipient Institution or the Scientist any ownership, license or other rights, express or implied, in or to any of the Materials, or Confidential Information or in or to any patents, trademarks or other intellectual property rights relating to the Materials. In the event Recipient Institution and/or the Scientist wishes to publish information relating to any Inventions generated, discovered or reduced to practice as aforesaid, in scientific journals, manuscripts or at scientific meetings (each, a “Publication”), the release or publication of any such Publication shall be subject to the prior written consent of the Company. Each Publication will adequately acknowledge and appropriately reflect the contribution of the researchers and/or employees of each of the Company, Recipient Institution and Hadassah and/or the Hebrew University of Jerusalem, as applicable, and/or the source of the information included therein, in accordance with customary scientific practice. Recipient Institution or the Scientist (as the case may be) shall provide the Company with a copy of the contemplated Publication at least 60 (sixty) days prior to submission thereof for publication or presentation at scientific meetings. The Company shall have the right to: (i) provide comments to the proposed Publication which comments shall be discussed by the Recipient Institution and/or the Scientist (as the case may be) and the Company in good faith and in a timely manner and be incorporated into the Publication accordingly; and/or (ii) to object thereto because it contains Confidential Information or other information of the Company for which patent protection should be sought (prior to publication), or should be held confidential. Upon the Company’s written request such Confidential Information or other information as aforesaid shall be deleted from such publication. 11. Except for the warranties set forth in Section 6, the Materials are provided to Recipient without any warranties, whether express or implied, including, without limitation, warranties of merchantability or fitness for a particular purpose. The Materials are provided “AS IS”. Without derogating from the aforegoing, the Company makes no representation or warranty, express or implied that use of the Materials will not infringe any patent or other proprietary rights of a third party. -42- 12. 13. 15. 17. 18. The conduct of any testing or research by Recipient Institution or the Scientist or any other scientists or employees of Recipient Institution with respect to the Materials shall be its sole risk and responsibility and the Company will not be liable for any consequences thereof, except for any liability resulting from the breach of the representations and warranties set forth in Section 6. The Materials are to be used and handled with caution and prudence in any experimental work, since not all characteristics of the Materials are necessarily known. Since a breach by Recipient Institution and/or the Scientist of any of the undertakings contained herein may result in irreparable and continuing damage to the Company for which there may be no adequate remedy at law, the Company shall be entitled, upon appropriate proof, to seek injunctive relief and/or a decree for specific performance, and such other relief as may be proper (including monetary damages, if appropriate). 14. 14.1. This Agreement shall enter into effect as of the Effective Date set forth above, and shall continue in full force until completion of the work plan (Appendix E) or until terminated in accordance to this Agreement. 14.2. Without derogating from the parties’ rights hereunder or by law to any other or additional relief, it is agreed that the Company may terminate this Agreement at any time by serving a written notice to such effect on BIRAD. 14.3. The termination of this Agreement for any reason shall not relieve a party of any of its respective obligations which shall have accrued prior to such termination. 14.4. The provisions of sections 7-9 (inclusive), 11-15 (inclusive) and sections 21 and 22 shall survive any termination of this Agreement. The Preamble and Schedules hereto form an integral part of this Agreement. In this Agreement “including”, “includes” means including, without limiting the generality of any description preceding such terms. This Agreement constitutes the entire agreement between the parties hereto in respect of the subject-matter hereof, and supersedes all prior agreements or understandings between the parties relating to the subject-matter hereof and this Agreement may be amended only by a written document signed by the parties hereto. None of the parties shall be entitled to assign this Agreement or any or all of its rights, or obligations under this Agreement or arising therefrom, without the prior written consent of the other parties. Notwithstanding the foregoing, the Company shall be entitled to assign this Agreement to a third party that acquires all or substantially all of the shares, assets or business of the Company without the need to obtain BIRAD’s or Scientist’s prior written consent. -43- 19. 20. 21. 22. 23. 24. No waiver by any party hereto, whether express or implied, of its rights under any provision of this Agreement shall constitute a waiver of such party’s rights under such provisions at any other time or a waiver of such party’s rights under any other provision of this Agreement. No failure by any party hereto to take any action against any breach of this Agreement or default by another party hereto shall constitute a waiver of the former party’s rights to enforce any provision of this Agreement or to take action against such breach or default or any subsequent breach or default by such other party. The provisions of this Agreement are severable and, in the event that any one or more of the provisions or part of a provision contained in this Agreement shall, for any reason, be held by any court of competent jurisdiction to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision or part of a provision of this Agreement; but such provision shall be modified as set out below and the balance of this Agreement shall be interpreted as if such provision were so modified. The parties shall negotiate in good faith in order to agree on the terms of an alternative provision which complies with applicable law and achieves, to the greatest extent possible, the same effect as would have been achieved by the invalid, illegal or unenforceable provision. This Agreement shall be governed in all respects by the laws of Israel, without giving effect to its principles of conflicts of law that direct that the laws of another jurisdiction apply and the Parties hereto hereby submit to the exclusive jurisdiction of the competent courts in Tel-Aviv- Jaffa, Israel. Any notice or other communication required to be given by the parties under this Agreement shall be in writing and shall be deemed to have been given (a) if personally delivered, when actually delivered; or (b) if sent by facsimile or by electronic mail, the next business day after receipt of confirmation of transmission (provided that any notice terminating this Agreement which is sent by electronic mail shall be followed by a notice sent in any other manner provided herein), or (c) 7 (seven) days after being mailed by registered or certified mail, postage prepaid (for the purposes of proving such service, it being sufficient to prove that such notice was properly addressed and posted to the respective addresses set forth below, or such other address or addresses as is subsequently specified in writing pursuant to this section 22): If to the Company: TyrNovo Ltd. 8 Abba Eban Ave. POB 12454 (Goldman-Hirsh Partners) Herzliya Pituach, 4672526 Israel Attention: CEO Facsimile: 097711805 If to BIRAD: Bar Ilan Research and Development Foundation Ltd. Bar Ilan University Ramat Gan Attention: Frances Shalit. PhD. Facsimile: 035353088 This Agreement may be executed in any number of counterparts (including counterparts transmitted by facsimile or by electronic mail in PDF format), each of which shall be deemed to be an original, but all of which taken together shall be deemed to constitute one and the same instrument. Each party agrees to execute, acknowledge and deliver such further documents and instruments and to do any other acts, from time to time, as may be reasonably necessary, to effectuate the purposes of this Agreement. [Signature page to follow] -44- IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date set out below. [Signature page of Material Transfer Agreement] TyrNovo Ltd. Signature: /s/ Hadas Reuveni Name: Title: Date: Hadas Reuveni CEO Feb 6, 2014 Prof. Izhak Haviv Signature: /s/ Prof. Izhak Haviv Date: Feb. 6, 2014 BIRAD Bar Ilan Research and Development Foundation Ltd. Signature: /s/ Orli Tori Name: Title: Date: Orli Tori CEO Feb. 12, 2014 Declaration We, the undersigned, Yissum Research Development Company of the Hebrew University of Jerusalem Ltd., confirm that we have reviewed the above Agreement and consent to the terms and conditions thereof to the extent relating to the Yissum Materials and related Confidential Information, and hereby authorize the transfer of the Yissum Materials and related Confidential Information by the Company to the Recipient and the disclosure and use thereof as expressly provided in the above Agreement, all subject to and in accordance with the terms and conditions of the above Agreement and this Declaration. Neither Yissum nor the Hebrew University of Jerusalem Ltd. (“HUJ”) gives any representations or warranties of any nature whatsoever with respect to the Yissum Materials and any related Confidential Information provided to BIRAD and none of Yissum, HUJ, nor any of their affiliates, employees, researchers or agents shall be liable for any claims, losses, damages or expenses arising out of or in connection with the use, application, storage or disposal of any of the Yissum Materials and/or related Confidential Information. Yissum Research Development Company of the Hebrew University of Jerusalem Ltd. Signature: /s/ Ariela Markel Name: Title: Date: Ariela Markel VP Licensing, Biotechnology Feb. 10, 2014 Appendices: Appendix A – Yissum Materials Appendix B – Hadassah MTA Appendix C – Hadassah Materials Appendix D – Company’s Materials Appendix E – Research Program -45- NT219 NT157 NT701 (for in vitro assay) NT700 (for in vitro assay) Cell lines described in the Hadassah MTAs TN0210-0215, TN0710-0715 Appendix A – Yissum Materials Appendix B – Hadassah MTA Appendix C – Hadassah Materials Appendix D – Company’s Materials Appendix E – Research Program 1. תוירקיע תומישמ – ובונריט הדובע תינכות: ל (דשה/הלחשה/תינומרעה/סגה יעמה ינטרס ,המוטסלבוילג) םילוחמ םיפסונ םינטרס תושיגרו םילוחמ המונלמ יאת תושיגר תקירס-NT219, NT157 (תופסונ תורזגנל תילנויצפואו – Company’s Materials) םיביגמ-אל לומ םיביגמ תרדגהו: א. תלוכי קדביתו ,התואנ תורידהבו ריבס בצקב םיחתפתמ םילודיגה וב לדומ תלבקל םירבכעב ולתשוי תואמגודה לכ NT219 תחימצ בצק תא בכעל שדוחל םילוח 8-כ – (ביצקתה הנבנ ויפ לע) יופצ הקידב בצק .(תרוקיב וא לופיט תצובקל םירבכע 2) תוליעפ ייוסינ לש הקירסב םילודיגה. ב. קדבית ,םיאת תורושכ ולבקתיש ,םילוחמ המונלמ יאת תושיגר in-vitro .תיברתב הקידבל םיאת ושרפוי היספויבכ וקפוסיש םילודיגהמ .זוכיר יולת ןפואב יכרע תלבקל תזרוזמ הקירס :הרטמ IC50 ו-IC90, לש היצניבמוקה תוליעי תניחבו NT219 ו-NT701 תורשואמ תופורת םע. תוליעפ תחכוה NT219 הצובקל םירבכע 8) תרחבנה היצקידניאב) + IHC יוסינ ףוסב ל דואמ שלח וביגה וא ללכ וביגה אלש םילודיגה) הדימעה היסולכואה רותיא-NT219) ,תימונג הניחבמ םידימעה םילודיגל םיביגמה םילודיגה תאוושהו שמשל םייושעש םייגולויב םירקרמ תרדגהל inclusion/exclusion criteria לש תפדעומ היצניבמוק תרדגהל וא ,ינילקה ןויסינב NT219 תרשואמ הפורת םע. םידחוימ םיתוריש: א. PamGene – ב לופיט בקע הקלדה וא יוביכ תורבועש תוזאניק רותיא-NT219 ל תויתבוגת יוזיחל) םירקרמויב רותיאל ,םיביגמ אל לומ םיביגמב- NT219 תפדעומ תופורת תיצניבמוק רותיאלו (תודימע ינונגנמו. תוירפסב שומיש shRNA ל הבוגתה לע םיעיפשמה םינובלח לש היצדילאו וא רותיאל-NT219, ליעל ורכזוהש תורטמל. ב. 4. םיפתושמ םירמאמ םוסריפל רקחמ ינוויכ תמלשה. -46- 2. NT219 Dose Response Study 3. Annex D EXISTING HUJI RESULTS The Existing HUJI Results are summarized in a publication in Aging Cell on November 2013 entitled “A novel inhibitor of the insulin/IGF signaling pathway protects from age-onset, neurodegeneration-linked proteotoxicity” and are described in patent application entitled “IGF-1R Signaling Pathway Inhibitors Useful in the Treatment of Neurogenerative Diseases” (Yissum code: 3946). -47- Execution version Exhibit 4.16 THE SYMBOL "[****]" DENOTES PLACES WHERE PORTIONS OF THIS DOCUMENT HAVE BEEN OMIITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. SUCH MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION SECOND AMENDMENT TO LICENSE AGREEMENT This Second Amendment to License Agreement (“Second Amendment”) is effective as of 16 March 2017 (the “Effective Date”), by and between, YISSUM RESEARCH DEVELOPMENT COMPANY OF THE HEBREW UNIVERSITY OF JERUSALEM LTD., of Hi Tech Park, Edmond J Safra Campus, Givat Ram, Jerusalem 91390 Israel, (“Yissum”) of the one part; and TYRNOVO LTD., of One Azrieli Center, Round Tower, 23rd Floor, 132 Menachem Begin Road, Tel Aviv, 6701101, Israel, (the “Company”), of the second part; (each a “Party” and jointly, the “Parties”). WHEREAS, Yissum and the Company are parties to a License Agreement dated 15 August 2013, as amended by the First Amendment to License Agreement effective as of 8 April 2014, (the License Agreement, as amended, the “License Agreement”); and WHEREAS, the Company entered into a Services Agreement with Bar Ilan Research and Development Company Ltd. (“BIRAD”) dated 12 February 2014 and, following the execution of this Second Amendment, the Company intends to enter into an Amended and Restated Service Agreement with BIRAD which shall amend, supersede and replace the said Services Agreement (such Amended and Restated Service Agreement, the “BIRAD Services Agreement”); and WHEREAS, the Parties wish to amend the License Agreement as set out below, NOW THEREFORE, the Parties hereby agree as follows: 1. 2. Capitalized terms in this Second Amendment shall bear the meaning ascribed to such terms in the License Agreement unless the context otherwise requires. The Preamble hereto shall constitute an integral part hereof. The definition of Development Results (Section 1.4.3 of the License Agreement) is hereby deleted in its entirety and replaced by the following: “1.4.3. “Development Results” shall mean the results of activities carried out by the Company or by third parties (other than the Researcher and his team) at the direction of the Company pursuant to the Development Plan or otherwise in fulfillment of the Company’s obligations hereunder (including its development obligations under Section 5 below), including, any invention, patent or patent application, product, material, method, discovery, composition, process, technique, know-how, data, information or other result which do not form part of the Licensed Technology, and further including any governmental or regulatory filing submitted, or approval, license, registration, or authorization obtained, by the Company, an Affiliate or Sublicensee in respect of the Products, as well as any other information, data, material, results, devices and know-how arising from the performance of the Development Plan, and shall be deemed to include all Materials Results (as defined below), but excluding any invention, know-how or other results that are not related, or connected to the Licensed Technology and/or the Products in any manner whatsoever. 1 The term “Materials Results” shall mean any and all compositions, materials, data and other results with respect to (i) NT219, NT157, NT701 and NT700 as more fully described in the Licensed Patents or any progeny or derivatives thereof (the “Materials”) and/or chemical analogs of Materials, including with respect to new applications or uses thereof (whether alone or in combination with other compounds); and/or (ii) biomarkers and/or target proteins identified through the use of the Materials, in each case that are obtained or arrived at by Prof. Izhak Haviv, Prof. Salamon Stemmer of Rabin Medical Center and/or students, researchers, and technicians working under the direction of either of them at Bar Ilan University and/or Rabin Medical Center, as applicable, in the performance of the services under the BIRAD Services Agreement.” 3. Section 1.4.5 of the License Agreement is hereby deleted in its entirety and replaced by the following: “1.4.5. “Existing Patent Applications” shall mean the patent applications listed in Appendix A2 hereto.” Appendix A2 is attached hereto as Exhibit 1A. 4. 5. 6. Appendix B (The Development Plan) of the License Agreement is hereby deleted in its entirety and replaced by a new Appendix B which is attached hereto as Exhibit 1B. The definition of “Licensed Technology” in Section 1.4.13 of the License Agreement is hereby deleted in its entirety and replaced by the following: “1.4.13. “Licensed Technology” – shall mean the Know-How, the Licensed Patents and the NovoTyr Results.” The definition of “NovoTyr Shareholders Approval” in Section 1.4.15 of the License Agreement is hereby deleted in its entirety and the following new definition is hereby added in place thereof: “1.4.15. “NovoTyr Results” – shall mean any proprietary, non-public know-how, data, information or other results which were transferred and assigned by NovoTyr to Yissum and belonging to Yissum, as set forth in Appendix A3(a).” The NovoTyr Results are described in Exhibit 2 hereto which shall be attached to the License Agreement as Appendix A3(a). 7. The following provision is hereby added at the end of the definition of Net Sales (Section 1.4.14 of the License Agreement): “It is agreed that the sales price invoiced or received for the sale of Products by the Company to its Affiliate(s), or by the Company to its Sublicensee(s) shall not constitute Net Sales.” 2 8. The definition of Products (Section 1.4.19 of the License Agreement) is hereby deleted in its entirety and replaced by the following: “1.4.19. “Product” shall mean any product, process, or service that (a) uses the Licensed Technology and/or the Development Results (or any part of the foregoing); or (b) the sale of which, in the absence of the license granted to the Company in this Agreement, would infringe one or more of the Licensed Patents.” 9. The definition of Sublicense Consideration (Section 1.4.23 of the License Agreement) is hereby deleted in its entirety and replaced by the following: “1.4.23. “Sublicense Consideration” shall mean any proceeds or consideration or benefit of any kind whatsoever, whether monetary or otherwise, including securities and options to buy securities, that the Company or an Affiliate may receive from a Sublicensee, as a direct or indirect result of the grant of a Sublicense to a Sublicensee and/or pursuant thereto or an option to obtain such Sublicense, except: (i) amounts received by the Company which constitute royalties based on Net Sales by Sublicensees, in respect of which the Company is required to pay Royalties to Yissum; and (ii) amounts expressly dedicated to, and actually expended upon the research and development of Products to be performed by the Company for the relevant Sublicensee, provided that: (a) any such amounts constitute research and/or development funding only and not payment for Products nor other type of grant or benefit; (b) such research and/or development activities are performed pursuant to a defined research and development program and budget agreed with such Sublicensee, a copy of which is provided to Yissum; and (c) the Company submits to Yissum a written expense report confirmed by the Company’s chief financial officer demonstrating that such amounts have actually been expended and/or incurred by the Company in the conduct of such research and/or development activities in accordance with such research and development program and budget, and that the expenses actually incurred as aforesaid include reasonable overhead costs, it being agreed, that any amounts received by the Company as aforesaid, but not expended and/or incurred as set out above, shall be deemed to be Sublicense Consideration. It is hereby further agreed that if the Sublicense Consideration comprises securities or options to purchase securities, Yissum shall receive the portion of such Sublicense Consideration to which it is entitled under this Agreement in the form of securities or options to purchase such securities (as the case may be), under the same terms as the Company receives its Sublicense Consideration from the Sublicensee, it being understood and agreed, however, that any VAT payable (if any in connection with the grant and/or exercise of such options and the sale and/or release of securities issued upon exercise of these options and/or any other options-related event or act (of Yissum or the Company), shall be borne solely by the Sublicensee issuing these options to Yissum, and such Sublicensee will be solely liable for the payment of such VAT. 3 10. Section 5.5 of the License Agreement is hereby deleted in its entirety and replaced by the following: “5.5. In the event the Company does not use commercially reasonable efforts to commercialize any Product, unless such delay is due to (i) the requirement of any regulatory or other governmental authority; (ii) force majeure in accordance with section 18.8 below; or (iii) agreed revisions in the timelines in the amended Development Plan, Yissum shall notify the Company in writing of the Company's failure to meet its obligation of diligence and shall allow the Company at least twelve (12) month to cure such failure of diligence (the “Cure Period”). In the event that the Company fails to cure such failure of diligence to Yissum’s reasonable satisfaction within the Cure Period, Yissum shall be entitled to terminate this Agreement, including the License, by written notice to the Company (effective immediately), it being agreed, however, that such failure to cure as aforesaid shall not be considered a material breach of this Agreement.” 11. Section 7.1 of the License Agreement is hereby deleted in its entirety and replaced by the following: “7.1. Royalties at the rate of [****] percent ([****]%) of Net Sales (the “Royalties”). In the event that the Company pays BIRAD royalties pursuant to the BIRAD Services Agreement on Net Sales of Products which were developed (in whole or in part) using Materials Results, or any part thereof, then the percentage set forth above shall be reduced from [****] percent ([****]%) to [****]percent ([****]%).” 12. Section 10.1 of the License Agreement is hereby deleted in its entirety and replaced by the following: “10.1. The Company shall reimburse Yissum for all previous documented expenses and costs relating to the registration and maintenance of the Licensed Patents (listed in Appendix A2), which are detailed in Appendix C hereto (the “Historical Patent Costs”) by no later than 31 December 2018.” 13. Section 12.6 of the License Agreement is hereby deleted in its entirety and replaced by the following: “12.6. Without prejudice to the foregoing, the Company shall not mention the name of the University, Yissum or the Researcher, in any manner or for any purpose in connection with this Agreement, or any matter relating to the Licensed Technology, without obtaining the prior written consent of Yissum, except that the Company may make routine disclosures to government agencies, any disclosures by the Company, or an affiliate thereof, to the extent required in the fulfillment of any reporting requirements to competent authorities under applicable security laws and/or by any applicable securities exchange or other disclosures as required by law, or disclosures in response to any due diligence enquiry relating to the Company, subject to the execution of a customary non-disclosure agreement. Notwithstanding the foregoing, the Company shall be entitled to identify the Licensed Technology as having been developed by the Researcher and the other Inventors and licensed from Yissum.” 14. Section 12.7 of the License Agreement is hereby deleted in its entirety and replaced by the following: “12.7. Neither Party shall issue any press release or other media statement regarding the execution, existence or terms of this Agreement or in connection with the Licensed Technologywithout the prior written approval of the other Party, which shall not be withheld unreasonably; provided that such approval shall not be required where disclosure is required in the fulfillment of any reporting requirements by the Company, or an affiliate thereof, to competent authorities under applicable security laws and/or by any applicable securities exchange or as otherwise required by law.” 4 15. The following new limitation of liability provision shall be added at the end of Section 14.1 of the License Agreement: “EXCEPT FOR ANY LIABILITY UNDER SECTION 12 (CONFIDENTIALITY), SECTIONS 14.2 AND 14.3 ABOVE (LIABILITY AND INDEMNITY) AND/OR ANY LIABILITY ARISING FROM THE MISAPPROPRIATION OF ANY INTELLECTUAL PROPERTY OF YISSUM AND/OR THE UNIVERSITY, NEITHER THE COMPANY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE TO YISSUM, THE RESEARCHER, THE UNIVERSITY, OR THE REPRESENTATIVES OF YISSUM AND/OR THE UNIVERSITY OR TO ANY THIRD PARTY FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING, LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY ANY OF THE FOREGOING OR THIRD PARTY, WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE OR TORT, OR OTHERWISE, ARISING OUT OF THIS AGREEMENT.” 16. Sections 14.4, 14.5 and 14.6 of the License Agreement shall be deleted in their entirety and replaced by the following: “14.4. The Company or its Affiliate shall procure and maintain, or require that its Sublicensee procure and maintain, at no cost to Yissum, the following policies of insurance: (i) comprehensive clinical trials liability insurance in amounts commensurate with accepted commercial practice and the minimum coverage requirements prescribed by applicable laws and regulations and/or the relevant regulatory authority in the country in which such clinical trials are conducted and/or the relevant clinical trial site, during the period that any Product is being tested in clinical trials prior to commercial sale; and (ii) comprehensive general liability insurance in reasonable amounts and on reasonable terms in the circumstances, having regard, in particular, to the nature of the relevant Product(s) and accepted practice in the relevant industry, during the period that such Product(s) is/are being commercially distributed or sold by the Company, an Affiliate or a Sublicensee, and thereafter as required by applicable law. Such comprehensive general liability insurance shall provide contractual liability coverage for the Company’s indemnification under this Agreement and in particular as stated above in Section 14.3 above. 14.5. Without derogating from the foregoing, beginning at the time any Product shall be commercially distributed or sold by the Company, an Affiliate or a Sublicensee, but in any event no later than the First Commercial Sale, the Company, its Affiliates or Sublicensee (if applicable) shall procure and maintain at their own cost and expense, in addition to the above general liability insurance, product liability insurance, in amounts that are standard in the industry for similar products. 5 14.6. The named insured under any insurance policy for clinical trials shall be the Company, the Researcher, Yissum and the University and the beneficiaries thereof shall include also the respective employees, officers and directors of Yissum and the University. The named insured under any insurance policy for product liability shall be the Company, Yissum and the University. The policy or policies so issued shall include a “cross-liability” provision pursuant to which the insurance is deemed to be separate insurance for each named insured (without right of subrogation as against any of the insured under the policy, or any of their representatives, employees, officers, directors). 14.7. The Company hereby undertakes to comply punctually with all obligations imposed upon it under such policies, including, the obligation to pay in full and punctually all premiums and other payments due under such policies. The Company will provide Yissum upon request with written evidence of such insurance. The Company shall provide the Yissum with at least thirty (30) days’ written notice prior to the cancellation, non-renewal or material change in such insurance. 14.8. The insurance requirements above shall not be construed to create a limit of the Company’s liability with respect to its indemnification obligations under this Section 14.” 17. Section 15.3 of the License Agreement is hereby deleted in its entirety and replaced by the following: “15.3. In addition to the above, and without prejudice to Yissum’s rights pursuant to this Agreement or at law, Yissum shall be entitled to terminate this Agreement immediately upon written notice to the Company in the following circumstances: 15.3.1. pursuant to Section 5.5; 15.3.2. if an attachment is made over the majority of the Company’s assets or if execution proceedings are taken against the Company and the same are not set aside within ninety (90) days of the date the attachment is made or the execution proceedings are taken; or 15.3.3. a claim by the Company, made in any forum, claiming that one or more of the Licensed Patents are invalid or unenforceable.” 18. The following new Section is hereby added after Section 15.6 of the License Agreement and the current Section 15.7 shall be renumbered Section 15.8: “15.7. In the event that any or all of the Development Results assigned to Yissum as set forth in above shall be licensed or otherwise transferred to a third party and shall generate any income to Yissum, then subject to the Company having complied and continuing to comply with the obligations under this Agreement which remain in existence following termination of the License as aforesaid, Yissum shall pay to the Company [****] percent ([****] %) of the Net Proceeds actually received by Yissum in respect of such license, until such time as the Company shall have received, in aggregate, an amount equal to the amount of the documented expenses of any kind (internal (e.g. salaries) and out-of-pocket) actually incurred by the Company in order to generate and/or develop the Development Results, less any amounts actually received or receivable by the Company from third parties in connection with the Development Results prior to the transfer and assignment of the Development Results to Yissum, as reflected in the Company's audited financial statements (the “Development Reimbursement”). 6 The Company will allow Yissum a credit against Development Reimbursements to be paid in the future, of any Development Reimbursements previously paid on account of Net Proceeds that were reported as bad debts in Yissum's annual audited financial statements or, if there are no future Development Reimbursements to be made by Yissum and to the extent possible, return the amount of Development Reimbursements paid to the Company on account of Net Proceeds that were reported as bad debts in Yissum's annual audited financial statements. Yissum shall pay to the Company amounts, if any, payable under this Section 15.7, within ninety (90) days of receipt of the relevant Net Proceeds. For the purpose of this Section, “Net Proceeds” means royalties, license fees any other monetary proceeds or consideration of any kind, actually received by Yissum in respect of such license (or an option to obtain such license) with a third party (excluding funds for research or development at the University or payments for the supply of services) after the deduction of all costs, fees, and expenses incurred by Yissum in connection with such license (including, patent costs, and all attorneys fees and expenses and other costs and expenses in connection with the negotiation and conclusion of such license). ” 19. 20. 21. 22. In the event of termination of the License (in whole or in part, such as termination with respect to a particular country), any existing agreements that contain a Sublicense of, or other grant of right with respect to, the Licensed Technology shall terminate to the extent of such Sublicense or other grant of right; provided, however, that, for each Sublicensee, upon termination of the Sublicense agreement with such Sublicensee, if the Sublicensee is not then in breach of such Sublicense agreement with the Company such that the Company would have the right to terminate such Sublicense or Yissum would have the right to terminate this Agreement as a consequence thereof pursuant to the terms of this Agreement, Yissum shall be obligated, at the request of such Sublicensee, to enter into a new agreement with such Sublicensee on substantially the same terms as those contained in such Sublicense agreement, and provided further that such terms shall be amended, if necessary, to the extent required to ensure that such Sublicense agreement does not impose any obligations or liabilities on Yissum which are not included in this Agreement. Upon the execution of this Second Amendment, the Company shall execute the letter of assignment attached hereto as Exhibit 3 concerning its interest in any Joint Patents and Development Results that will provide that such interest will be irrevocably assigned to Yissum in the event that the License Agreement is terminated for any reason whatsoever other than the expiration of its term or due to an uncontested uncured breach by Yissum. This Second Amendment shall be read together with the License Agreement, and save for the changes contained herein, all the terms and conditions contained in the License Agreement remain unchanged, and in full force and effect. This Second Amendment together with the License Agreement (as amended hereby) constitute the entire agreement between the Parties in respect of the subject matter hereof, and supersede all prior agreements or understandings between the Parties relating to the subject matter hereof, and this Second Amendment may be amended only by a written document signed by the authorized representatives of both Parties. Following the execution of this Second Amendment, the Parties undertake and commit to work together in good faith in order to prepare an Amended and Restated License Agreement which shall incorporate the License Agreement as amended hereby in one agreement. [signature page follows] 7 IN WITNESS WHEREOF, the Parties have caused this Second Amendment to be executed effective as of the date first above written. YISSUM RESEARCH DEVELOPMENT COMPANY OF THE HEBREW UNIVERSITY OF JERUSALEM LTD. Signature: Name: Title: Collaborations Signature: Name: Title: Date: /s/ Itzik Goldwaser, PhD Itzik Goldwaser VP, Head of Research Collaborations /s/ Ariela Markel Ariela Markel VP Licensing, Biotechnology March 16, 2017 TYRNOVO LTD. Signature:/s/ Hadas Reuveni Name: Title: Hadas Reuveni Founder & CTO Signature:/s/ Simcha Rock Name: Title: Date: Simcha Rock Director April 20, 2017 I the undersigned, Prof. Alexander Levitzki, have reviewed, am familiar with and agree to all of the above terms and conditions. I hereby undertake to cooperate fully with Yissum in order to ensure its ability to fulfill its obligations hereunder, as set forth herein. /s/ Alex Levitzki Prof. Alexander Levitzki April 20, 2017 Date signed Exhibit 1A - Appendix A2 to License Agreement – Existing Patent Applications Exhibit 1B – Appendix B to License Agreement – Development Plan Exhibit 2 - Appendix A3(a) to License Agreement – NovoTyr Results Exhibit 3 - TyrNovo Assignment Letter 8 Exhibit 1A Existing Patent Applications Family: 3711 Title: NOVEL PROTEIN KINASE MODULATORS AND THERAPEUTIC USES THEREOF (NT-157) Inventor University Faculty Department Ben-David Iris Levitzki Alexander SASSON Revital STEINER Lilach WEISSBERG Avi Reuveni Hadas HUJI Faculty of Science The Alexander Silberman Institute for Life Sciences Patent ID Status Application Country Date Number Publication Date Number Date Number Patent 3711-00 3711-01 3711-02 3711-03 3711-04 3711-05 3711-06 3711-07 3711-08 3711-09 3711-10 Expired US Exhausted PCT Granted US Granted Europe Australia (Oceania) Abandoned Abandoned Canada Abandoned China Abandoned India Abandoned Israel Abandoned Japan (Asia) Abandoned US 60/872,511 04/12/2006 04/12/2007 PCT/IL2007/0014 12/517,278 04/12/2007 07827467.7 04/12/2007 2007330333 04/12/2007 2,671,632 04/12/2007 04/12/2007 200780050587.5 04/12/2007 3739/DELNP/2009 199097 04/12/2007 2009-539869 04/12/2007 13/293,546 11/10/2011 12/06/2008 WO2008/068751 04/03/2010 US2010/0056635 2125712 02/12/2009 15/11/2011 8,058,309 2125712 15/02/2010 CN101652345 31/10/2012 15/04/2010 P2010-511694A Family: 3712 Title: NOVEL MODULATORS OF PROTEIN KINASE SIGNALING 9 Inventor University Faculty Department Levitzki Alexander LUCASSEN Andre C. B SASSON Revital Reuveni Hadas HUJI Faculty of Science The Alexander Silberman Institute for Life Sciences Patent ID Status Country Date Number Application Publication Date Number Date Number Patent 3712-00 Expired US 05/06/2008 61/058,943 3712-01 Exhausted PCT 07/06/2009 PCT/IL2009/000568 10/12/2009 2009/147682 WO Granted Granted Granted Abandoned US Europe Israel Canada 07/06/2009 07/06/2009 07/06/2009 07/06/2009 12/995,669 09758026.0 209638 2,758,016 [****] Title: [****][****][****][****][****][****][****][****] US 2011/0105618 05/05/2011 23/02/2011 A1 2285774 28/01/2014 8,637,575 25/02/2015 2285774 209638 01/10/2016 Inventor University Faculty Department [****] [****][****] [****][****][****] [****][****][****] [****] 3712-02 3712-03 3712-04 3712-05 Family: [****] [****] Patent ID Status Application Country Date Number Publication Date Number Date Number Patent [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] [****] Family: 3745 Title: COMPOUNDS WHICH MODULATE PROTEIN KINASE SIGNALING Inventor University Faculty Department Levitzki Alexander Reuveni Hadas HUJI Faculty of Science The Alexander Silberman Institute for Life Sciences 10 Patent ID Status Country Date Number Date Number Date Number Application Publication Patent 3745-00 3745-01 Expired Expired US US 27/12/2010 06/07/2011 61/427,220 61/504,722 3745-02 Exhausted PCT 27/12/2011 PCT/IL2011/050078 05/07/2012 3745-03 3745-04 Granted Granted US Europe 27/12/2011 27/12/2011 13/976,876 11813909.6 17/10/2013 Family: 3787 Title: COMBINATIONS FOR TREATING CANCER Inventor University Faculty Department WO 2012/090204 A1 US 2013/0274251 A1. 07/07/2015 9,073,880 23/12/2015 2658847 Reuveni Hadas Levitzki Alexander HUJI Faculty of Science The Alexander Silberman Institute for Life Sciences Patent ID Status Country Date Number Application Publication Date Number Patent Date Number 3787-00 Expired US 01/03/2011 61/447,733 3787-01 Abandoned PCT 01/03/2012 PCT/IL2012/000098 07/09/2012 2012/117396A1 WO Family: 3946 Title: IGF-1R SIGNALING PATHWAY INHIBITORS USEFUL IN THE TREATMENT OF NEURODEGENERATIVE DISEASES Inventor University Faculty Department Ben-Sasson Shmuel Cohen Ehud Reuveni Hadas Levitzki Alexander HUJI HUJI HUJI Faculty of Medicine Faculty of Medicine Experimental medicine and cancer research Biochemistry Faculty of Science The Alexander Silberman Institute for Life Sciences Patent ID Status Application Country Date Number Publication Date Number Patent Date Number 3946-00 3946-01 3946-02 3946-03 3946-04 Expired Expired NP-Entry Filed Filed US US PCT Europe Israel 61/664,786 27/06/2012 14/07/2013 61/846,014 13/07/2014 PCT/IB2014/063071 14825966.6 13/07/2014 243566 13/07/2014 3946-05 Examination US 13/07/2014 14/904,787 09/06/2016 A1 US2016/0158243 11 Exibit 1B Development Plan [****] 12 Exhibit 2 Appendix A3(a) to License Agreement – NovoTyr Results 1. The compounds developed are inhibitors of the IGF1R/IRS1-2 pathway as well as inhibitors of STAT-3 signaling. We have additional data derived from large number of cancer cell lines in tissue culture and in a number of in vivo animal models targeting metastatic melanoma, metastatic prostate cancer, colon cancer and multiple myeloma. In vivo data on the NT compounds with Chemotherapy (Taxol) [****]. [****]. Inhibition of the STAT-3 phosphorilation which is involved in anti-cancer immunomodulation, anti-metastatic, anti-angiogenic, anti-proliferative. [****]. 2. 3. 4. 5. 6. 7. Toxicity, safety,solubilty, pharmacodinamic and pharmacokinetic data related to the NT compounds. 13 EXHIBIT 3 ASSIGNMENT LETTER ASSIGNMENT AGREEMENT Made as a Deed This ASSIGNMENT AGREEMENT (the “Agreement”) is made this 16 day of March, 2017, by and between Yissum Research Development Company of the Hebrew University of Jerusalem Ltd., Hi-Tech Park, Edmond J. Safra Campus, Givat Ram, Jerusalem, Israel on the one hand (“Yissum”) and TyrNovo Ltd. of One Azrieli Center, Round Tower, 23rd Floor, 132 Menachem Begin Road, Tel Aviv, 6701101, Israel, on the other hand (the “Company”). Yissum and the Company shall be referred each as a “Party”, and together as the “Parties”. WHEREAS, Yissum and the Company are parties to a License Agreement dated 15 August 2013, as amended by the First Amendment to License Agreement effective as of 8 April 2014, and the Second Amendment to License Agreement effective as of __ February 2017 (the above License Agreement, as amended, the “License Agreement”); according to which the Company received, among other things, a License to the Licensed Patents; WHEREAS, pursuant to the License Agreement, certain inventions have been or shall/may be registered jointly in the name of Yissum and the Company and shall be regarded as Joint Patents; and WHEREAS, the Parties have agreed that, upon the occurrence of the Trigger Event (as defined below), the Company shall assign and transfer to Yissum its title and ownership in and to the Joint Patents and all Development Results and thereafter Yissum shall become the sole and exclusive owner of such Joint Patents and Development Results; all in accordance with the terms and conditions of this Agreement; NOW THEREFORE THE PARTIES DO HEREBY AGREE AS FOLLOWS: 1. Preamble 1.1 The recitals hereto constitute an integral part hereof. 1.2 The headings of the sections in this Agreement are for the sake of convenience only and shall not serve in the interpretation of the Agreement. 1.3 All capitalized terms not defined herein shall have the meaning ascribed to such terms in the License Agreement. 1.4 In this Agreement the following expressions shall have the meanings appearing alongside them, unless the context otherwise requires: “Intellectual Property Rights” shall mean any and all rights relating to intellectual property, including without limitation, all inventions, patents and patent applications, including all re-issuances, continuations, continuations-in-part, divisions, revisions, extensions and re-examinations thereof. “Effective Date” shall mean the date of occurrence of the Trigger Event. “Trigger Event” shall mean the termination of the License Agreement for any reason whatsoever, other than the expiration of its term or due to an uncontested breach by Yissum. 14 2. Assignment of Joint Patents and Development Results. 2.1 Upon the Effective Date, the Company shall assign, convey and transfer to Yissum, its successors and assigns, the entire right, title and interest in and to any Joint Patent(s) and Development Results, including all Intellectual Property Rights therein, and all rights and benefits under any applicable law, treaty or convention. 2.2 Subsequent to an assignment pursuant to this Agreement, the Company or its successors, legal representatives or assigns shall notify Yissum, its successors, legal representatives and assigns, of any facts known to it regarding said Joint Patents and Development Results, testify in any legal proceeding, sign all lawful papers, execute all divisional, continuing, reissue and foreign applications, make all rightful oaths, and generally do everything possible to assist Yissum, its successors, legal representatives and assigns, to obtain and enforce proper protection, full ownership and rights of use for said Joint Patents and Development Results in all countries. 2.3 In the event the Company, its successors, legal representatives or assigns fail to execute and deliver such documents and instruments promptly upon Yissum’s request, Yissum is hereby authorized and appointed attorney-in-fact of and for the Company to make, execute and deliver any and all such documents and instruments. 3. Governing Law and Jurisdiction. The provisions of this Agreement and everything concerning the relationship between the Parties in accordance with this Agreement shall be governed by the laws of the State of Israel and exclusive jurisdiction shall be granted to the appropriate courts in Jerusalem, Israel. 4. Miscellaneous. This Agreement supersedes any prior understanding, agreement, practice or contract, oral or written, between the Parties with respect to the matters covered by this Agreement. This Agreement may not be modified except by written instrument signed by all Parties hereto. This Agreement may be executed in counterparts, each of which shall be deemed an original, but which together shall constitute one and the same instrument. This Agreement shall be binding upon the Parties’ heirs, executors, administrators, successors, and assigns. The invalidity of any provision of this Agreement shall not result in the invalidity of the entire Agreement. AS WITNESS THE HANDS OF THE PARTIES: TyrNovo Ltd. One Azrieli Center, Round Tower, 23rd Floor, 132 Menachem Begin Road, Tel Aviv, 6701101, Israel /s/ Hadas Reuveni By: Name: Hadas Reuveni Title: CEO /s/ Shimca Rock By: Name: Shimca Rock Title: CEO Date: April 23, 2017 Yissum Research Development Company of the Hebrew University of Jerusalem Ltd. Hi-Tech Park, Edmond J. Safra Campus, Givat Ram, P.O.B 39135, Jerusalem 91390, Israel /s/ Ariela Markel By: Name: Ariela Markel Title: VP Lisencing, Biothecnology /s/ Itzik Goldwaser By: Name: Itzik Goldwaser Title: Head of Research Collaboration Date: March 16, 2017 15 Company: Kitov Investors: Exhibit 4.17 BINDING TERM SHEET DATED FEBRUARY 9, 2017 Tyrnovo Ltd., (the “Company”). Kitov Pharmaceuticals Holdings Ltd. an Israeli publicly traded corporation (“Parent”), on behalf of itself and, if Parent is not the buyer of the shares previously held by Goldman Hirsh Partners Ltd., also on behalf of an as yet undetermined Affiliated party of Parent (“Kitov”) which shall , upon execution thereof by it, be deemed a Party to this Agreement Ab Initio. The transfer of shares of the Company from Kitov to an Affiliated party thereof, as set forth above, shall be subject to the same preconditions applicable to a transfer to a Permitted Transferee, set forth hereunder. Taoz – Company for Management and Holdings of Companies Ltd, (the “Investor”). The Investor shall be entitled to transfer its rights hereunder and any shares of the Company purchased by the Investor hereunder, to a limited partnership in which the Investor is the holder of control (as such term is defined in the Securities Law, 5728-1968) of the general partner of such partnership (the “LP”) or a Permitted Transferee (as defined hereunder) so long as such Permitted Transferee or LP shall execute in writing a joinder to this Binding Term Sheet pursuant to which such transferee agrees to be bound by the terms of this Binding Term Sheet as if an original party hereto. The Investment: Up to US$ 1,000,000 (the “Aggregate Amount”). Out of the Aggregate Amount, an amount of US$250,000 (the “Initial Investment”) was invested in the Company by the Investor prior to the date hereof and in consideration for such investment the Investor was issued 534 Ordinary Shares. The parties agree that the Investor is entitled to be issued additional 77 Ordinary Shares (“Additional Shares”) which shall be issued by the Company within thirty (30) days from the signing of this Binding Term Sheet. In event that the Additional Shares were not issued within such thirty (30) day period Tyrnovo shall pay the Investor, as sole remedy, an amount of US$50,000 within 30 days thereafter. The Investor shall have the right during the Deferred Investment Period (defined below) to invest the remaining US$ 750,000 (the “Deferred Investment”) The Deferred Investment Period shall mean a period commencing upon the date hereof and ending upon the earlier of: (1) the lapse of 60 days from the day in which the Company notifies the Investor in writing, that the Milestone was achieved (the “Company’s Milestone Notice”), or; (2) 30 months from the date hereof. Upon exercise of the right to invest the Deferred Investment, such amount will be provided to the Company by way of a Convertible Loan. For the purpose hereof, “Milestone” shall mean a notice by the Board of the Company to the Investor stating that an FDA approval to commence a Phase I clinical trial has been obtained. For the purpose hereof, “Convertible Loan” shall mean a loan by the Investor, to the Company, which shall be granted under the terms further detailed in Annex A attached hereto. 1 Securities: Ordinary Shares of par value NIS 0.01 each (the “Ordinary Shares”). Option for Additional Investment Investor’s Director: Upon issuance of preferred shares by the Company in the future, each of the Taoz and/or Kitov shall have the right, only upon the first time that the company issues such shares, to notify the Company that it wishes to convert all Ordinary Shares issued to the Investor under the Initial Investment, Deferred Investment and the Option (with respect to the Taoz) and the shares held by Kitov in an amount not exceeding twice the number of shares converted by Taoz as set forth above (with respect to Kitov) into such preferred shares, provided that the preference with respect to each preferred share of Taoz and Kitov shall be equal to the actual Purchase Price for which these shares were issued. Such right of Taoz and Kitov shall be exercisable for a period of 30 days from the date in which the Company notified to each of Taoz and Kitov, in writing, of such issuance of preferred shares by the Company. The Investor will be granted an option to invest in the Company an amount of up to US$ 1,000,000 in consideration for Ordinary Shares, as a Convertible Loan (as defined above) (the “Option”). The Option may be exercised until the earlier of (i) the lapse of 30 months from the date hereof; (ii) ii) immediately prior to a Qualified Initial Public Offering (“IPO”),; or (iii) immediately prior to the consummation of a merger or sale of all or substantially all of the Company’s assets or share capital excluding such sale to Kitov (“M&A Transaction”, and together with an IPO, an “Exit Event”) ”); or (iv) the lapse of 60 days following the Company’s Milestone Notice. During the Director Appointment Right Period - the Investor shall be entitled to appoint one (1) (the “DAR Number”)representative to serve as a member of the board of directors of the Company, which appointment right shall automatically terminate upon the lapse of the Director Appointment Right Period. Any directors appointed by the Investor shall execute a declaration to the Company stating their eligibility to serve as a director. If, at any time during the Director Appointment Right Period, Kitov increases its number of members appointed on its behalf on the board of directors of the Company to four or more, the DAR Number shall be increased to two (2). If the number of the Kitov Directors is reduced, the number of directors which the Investor shall have the right to appoint under the above shall be reduced accordingly to half of the number of the Kitov Directors actually serving on the board of directors of the Company rounded down to the nearest whole number, provided that in no event shall the number of Investor’s directors during the Director Appointment Right Period shall decrease from 1 director. For the purpose hereof, the “Director Appointment Right Period” shall mean a period commencing on the date hereof and ending upon the earlier of (i) such time in which the Option was exercised or expired and is no longer exercisable and the shares in the Company held by the Investor constitute less than 8.9% of the issued and outstanding share capital of the Company; and, (ii) immediately prior to an Exit Event. 2 If the Investor has loaned to the Company Convertible Loans, that are convertible into shares of the Company (assuming the Fixed Conversion Price as defined in Annex A) but were no yet converted, it shall be deemed, solely for the purposes of calculating the 8.9% holdings threshold of the Investor in the Company for determining the continuation in force of the Director Appointment Right Period, and only as long as such loan was not previously repaid, as if the Investor has converted the Convertible Loan/s into such number of the Company's shares, according to the Fixed Conversion Price Annex A, which will be calculated together with the Investor's other shareholdings in the Company at the time of any such determination as above. The Parties shall cause the Company to amend the Articles of Association of the Company to accommodate the agreement under this Section. Information Rights; Access Rights: Until the closing of an Exit Event, the Investor shall have the right to receive, following Investor’s reasonable request, (i) annual audited financial statements,; and (ii) until the later of (1) the lapse of the Director Appointment Right Period and (2) the lapse of a 30-month period from the date hereof, an annual budget and such other information concerning the Company as may be reasonably required by the Investor semiannual management report disclosing scientific, clinical, business development, IP, and regulatory activities of the past quarter and plans for the upcoming year. Registration Rights: Pre-Emptive Rights: Any information, to which Investor shall have access to, shall be subject to absence of conflict of interest of such Investor, and subject to Investor entering into a confidentiality and non-disclosure agreement with the Company and acceptable to the Company. Each of the Parties undertakes to cause the board of directors of the Company to convene once every calendar quarter in order to keep the directors of the Company duly informed of the status of the Company, its activities, developments and plans. Until the closing of an Exit Event, upon grant by the Company in the future of registration rights to any of its shareholders with respect to securities of the Company, Investor shall have the right, only upon the first time that the Company grants such rights, to notify the Company that it wishes to receive such registration rights under the same terms and conditions, and in accordance with the same registration rights agreement(s), that such right was granted to such other shareholder(s) of the Company. Such right of the Investor shall be exercisable for a period of 30 days from the date in which the Company notified the Investor, in writing, of such grant of registration rights by the Company Until an Exit Event, and notwithstanding the threshold set forth under Article 43.3 of the Company’s Articles of Association in effect on the date of this Term Sheet, the Investor shall have the right to purchase its Pro Rata Share of Additional Securities (as defined below) that the Company may, from time to time, propose to sell and issue. “Pro Rata Share” shall mean the ratio of (X) the number of outstanding Ordinary Shares owned by the Investor prior to the issuances of Additional Securities, to (Y) the total number of outstanding shares of the Company prior to the issuances of Additional Securities. 3 “Additional Securities” shall mean all shares or rights convertible into shares of the Company (“Securities”) after the date hereof, other than: (A) Securities issued to employees, directors, consultants or contractors of the Company or any of its subsidiaries, pursuant to a share purchase/option plan approved by the Board; (B) Securities issued as part of stock splits, bonus shares, stock dividends or like transactions; (C) Securities issued upon exercise or conversion of rights convertible into shares (D) Securities issued to an investor which is defined by the board of directors as a strategic investor (collectively “Excluded Issuances”). Strategic Investor shall mean an Investor who has a material value to the Company, such material value is: (a) beyond the funds directly invested by such Investor, and (b) in the field of operation of the Company. In the event that the Company proposes to issue Additional Securities, it shall give the Investor written notice (the “Rights Notice”), describing the type of Additional Securities, the number of such Additional Securities to be offered, and the price upon which the Company proposes to issue the same. Investor shall have ten (10) business days after receipt of the Rights Notice to agree to purchase up to its Pro Rata Share of such Additional Securities, at the price and upon the terms specified in the Rights Notice by giving written notice to the Company and stating therein the quantity of Additional Securities to be purchased. Failure to timely agree to purchase Additional Securities, in whole or in part, shall be deemed as a decision not to purchase any of the Additional Securities. Permitted Transferee For the purpose hereof, “Permitted Transferee” shall include: With respect to the Investor: Any Party or member of the Investor’s controlling shareholder’s immediate family (the “Family Members”) and/or any incorporated entities which are fully owned by all or each individual Family Members. With respect to all Shareholders: (i) a transferee by inheritance; (ii) the Shareholder’s immediate family members, (iii) an entity controlled by, controlling, or under common control with a Shareholder or any Permitted Transferee, or (iv) a trust created solely for benefit of a Shareholder or a Permitted Transferee. So long as such Permitted Transferee shall execute in writing a joinder to this Binding Term Sheet pursuant to which such transferee agrees to be bound by the terms of this Binding Term Sheet as if an original party hereto. Service Agreements: The Company and the parties shall negotiate at arm’s length, with respect to the provision of professional services to the Company under terms and conditions to be subject to approval of the board of directors of the Company. Legal Fees: Upon the execution of this Binding Term Sheet, the Company will disburse to Investor its legal expenses for concluding the Initial Investment in the amount of $7,500, and further pay to Investor an additional amount of $7,500 for its legal expenses in concluding this Binding Term Sheet. The foregoing amounts are exclusive of VAT, which will be added to each amount so paid. Governing Law; Jurisdiction: This Binding Term Sheet, shall be governed by the laws of the State of Israel and any dispute arising in connection therewith shall be submitted to the sole and exclusive jurisdiction of the courts in Tel Aviv, Israel. Binding Agreement; This Binding Term Sheet shall constitute a binding agreement between the parties hereto on the matters detailed herein. This Term Sheet is not intended to be an agreement for the benefit of any third party. A breach by either Party of this Agreement, which is not remedied within 30 days from non-breaching party’s written notice (“Material Breach”), shall automatically terminate this Binding Term Sheet. Notices All notices, requests, demands, claims, and other communications hereunder shall be in writing and made in accordance with the Notice provisions set forth under the Company’s Articles of Association then in effect. [SIGNATURE PAGE FOLLOWS] 5 Agreed and Accepted on: February 9, 2017. THE COMPANY: __________________________________________ TYRNOVO LTD. By: /s/_____________________________________ Title: ______________________________________ THE INVESTOR: __________________________________________ TAOZ – COMPANY FOR MANAGEMENT AND HOLDINGS OF COMPANIES LTD. By: /s/_____________________________________ Title: ______________________________________ KITOV: __________________________________________ KITOV PHARMACEUTICALS HOLDINGS LTD. an Israeli publicly traded corporation (“Parent”), on behalf of itself and, if Parent is not the buyer of the shares previously held by Goldman Hirsh Partners Ltd., also on behalf of an as yet undetermined Affiliated party of Parent (“Kitov”) which shall upon execution thereof by it, be deemed a Party to this Agreement Ab Initio By: /s/ _____________________________________ Title: ______________________________________ 6 1. Interest. Annex A The Convertible Loan principal amount shall bear interest at a rate per annum of LIBOR + 6% in the event of US$ loans, and Prime + 6% in the event of NIS loans, compounded annually, from the date on which the Investor transferred the Deferred Investment to the Company (“Convertible Loan Principal Amount”), and until the date of conversion or repayment thereof, as set forth below (the “Interest” and together with the Convertible Loan Principal Amount, the “Loan Amount”). 2. Repayment. Repayment of the Loan Amount shall be made, unless automatically converted prior to the Repayment Date, upon the earliest of: (a) 6 months following the date of the publication by the Company of the official results of the Phase I clinical trials (b) 36 months from the date of first transfer to the Company by Investor of the funding under the Convertible Loan (c) immediately prior to an Exit Event or; (d) an Event of Default (as defined below) (the earliest of the events detailed in sections 2 (a) - (d) shall be referred hereafter as the “Repayment Date”). 3. Conversion of the Loan Amount 3.1. Automatic Conversion. In the event that prior to the Repayment Date (the “Qualified Period”) the Company shall raise additional funds in an amount of not less than US$ 1,000,000 in consideration for shares of the Company from an investor who is not, on the date hereof, a shareholder in the Company (the “Next Financing Round”), then, immediately prior to the Next Financing Round, the Loan Amount shall automatically convert into ordinary shares of the Company at a price per share which shall be the lower of (i) a price per share reflecting a 30% discount off the price per share paid in the Next Financing Round by the investor and (ii) US$ 775 (the “Automatic Conversion Event”). 3.2. Optional Conversion. During the period commencing 14 days before the Repayment Date and ending 7 days before the Repayment Date (the “Optional Conversion Period”), provided that the Loan Amount was not converted according to the provisions of section 3.1 prior thereto, Lender may, at its election, convert the Loan Amount into ordinary shares of the Company at a Loan Conversion Price equal to US$ 595 per share (the “Fixed Conversion Price”). The Company shall inform the Investor in writing, at least 10 days in advance, of the commencement date of the Optional Conversion Period. Any delay in delivery of such notice shall extend the Optional Conversion Period in the same delay period. The Optional Conversion shall be subject to receipt by the Company, during the Optional Conversion Period, of a notice in writing from the Investor of such Conversion. 4. Event of Default The Loan Amount, to the extent not earlier converted as set forth in Section 3 above, shall immediately become due and payable upon any of the following events: (i) the execution by the Company of a general assignment for the benefit of creditors; (ii) the filing by or against the Company, by any person other than the lender of the Convertible Loan, of any petition in bankruptcy or any petition for relief under the provisions of any law for the relief of debtors, and the continuation of such petition without dismissal for a period of one hundred and twenty (120) days or more; (iii) the appointment of a receiver or trustee to take possession of a material portion of the property or assets of the Company and the continuation of such appointment without dismissal for a period of one hundred and twenty (120) days or more; (iv) the commencement by the Company of any liquidation proceedings or the adoption of a winding up resolution by the Company; (v) the commencement by third parties of any liquidation proceedings, which have not been terminated within one hundred and twenty (120) days thereafter; or (vi) a court of competent jurisdiction making an order deferring the commencement and/or prosecution of proceedings against the Company(“םיכילה תאפקה”) .. 7 AMENDMENT TO BINDING TERM SHEET DATED FEBRUARY 9, 2017 [UNOFFICIAL TRANSLATION FROM HEBREW TO ENGLISH] Exhibit 4.18 The agreements attached to this email are agreed upon by the Parties thereto as the final drafts thereof. Annex A to the document entitled “Binding Term Sheet” is amended as follows: The amount $775 in Section 3.1 and the amount $595 in Section 3.2 of Annex A, will be replaced by such number which is equal to US$ 13,500,000 divided by the issued and outstanding share capital of the Company as of today’s date of this Agreement (February 9th 2017). The amendment is agreed upon by all Parties. /s/ Ran Streichman For: TAOZ – COMPANY FOR MANAGEMENT AND HOLDINGS OF COMPANIES LTD. /s/ Ran Diamant, Adv. For: KITOV PHARMACEUTICALS HOLDINGS LTD. & TYRNOVO LTD. Shareholders Agreement Exhibit 4.19 This Shareholders Agreement (the “Agreement”) is entered into effective as of February 9, 2017, by and between Kitov Pharmaceuticals Holdings Ltd. an Israeli publicly traded corporation (“Parent”), on behalf of itself and, if Parent is not the buyer of the shares previously held by GHP (as defined hereunder), also on behalf of an as yet undetermined Affiliated party of Parent which shall, upon execution thereof by it, be deemed a Party to this Agreement Ab Initio (“Kitov”) and Taoz – Company for Management of Companies Ltd. (“Taoz”); each of Kitov and Taoz a “Party” and collectively the “Parties”. WHEREAS, in view of the recent developments, in connection with Kitov's acquisition of control in Tyrnovo Ltd. (hereinafter: the "Company"), and the proceedings in the Tel Aviv District Court (Economics Division) commenced by Taoz in connection with that certain Term Sheet executed by and among Taoz, the Company and the former controlling shareholder of the Company, Goldman Hirsh Partners Ltd. (hereinafter: "GHP") on July 11, 2016 (hereinafter: "Investment Agreement"); and WHEREAS, Kitov and Taoz wish to mutually end the proceedings between Taoz on one hand and Kitov and the Company on the other in connection with the Investment Agreement; WHEREAS, Kitov, Taoz and the Company have entered into that certain Binding Term Sheet dated February 1, 2017 (the “Binding Term Sheet”) setting forth the arrangements for, among other matters, investments by Taoz into the Company, and that certain Waiver and Release Agreement dated February 9, 2017 setting forth the arrangements for, among other matters, mutual waivers and releases in connection with the Investment Agreement; and WHEREAS, the Parties have reached additional understandings relating to their relationship as shareholders of the Company; NOW THEREFORE, the Parties hereto agree as follows: 1. Both the Company and Kitov acknowledge the initial investment made by Taoz in the Company, prior to Kitov's acquisition of the Company's shares from GHP, in the amount of $250,000, in exchange for which 534 Ordinary Shares of the Company were issued to Taoz (hereinafter: the "First Investment"). 2. Finance by Kitov. Kitov hereby undertakes to finance any future working capital requirement of the Company, up to an amount of $1,000,000, of which the amount of $750,000 shall be provided to the Company no later than 30 days from the execution of this Agreement and $250,000 pursuant with a business plan to be approved by the Board of Directors of the Company no later than three (3) months following the execution of this Agreement. Such financing by Kitov shall be provided by way of Convertible Loan (as defined in the Binding Term Sheet). Each Party undertakes to cause the Board to adopt an agreed business plan within the indicated period. 1 of 11 3. The transfer of shares of the Company from Kitov to an Affiliated party thereof, as set forth in the preamble to this Agreement shall be subject to the same preconditions applicable to a transfer to a Permitted Transferee, as set forth in the Binding Term Sheet. 4. In event that the Milestone (as defined in the Binding Term Sheet) was achieved, however Taoz did not invest the Deferred Investment (as defined in the Binding Term Sheet) then Kitov shall have the right, for a period of 60 days, to acquire all of the Taoz’s holdings in the Company at a price per share of US$ 476.48. 5. Participation in Increase of Shareholdings. In the event that Kitov increases its shareholdings in the Company, through the purchase of additional shares from the Company's current shareholders, by more than 1,500 shares of the Company (hereinafter: "Newly Acquired Shares") during a period of 12 months from the date hereof, then, Kitov shall notify Taoz once every calendar month of any purchases consummated by it during the previous calendar month (the “Kitov NAS Notice”) and Taoz shall notify Kitov, within 14 days of receipt of the Kitov NAS Notice (the “Taoz DNAS Notice”), if it wishes to purchase part of the Newly Acquired Shares, up to 30% of the Newly Acquired Shares, and the amount of Newly Acquired Shares, up to 30% of the Newly Acquired Shares, that it wishes to purchase (the “Designated Newly Acquired Shares”). Taoz shall be obligated to purchase, within a period of 12 months of delivery of the Taoz DNAS Notice as set forth above, (the “DNAS Acquisition Deadline Date”), the Designated Newly Acquired Shares from Kitov at the New Shares PPS (defined below). In event that Taoz failed to purchase the Designated Newly Acquired Shares by the DNAS Acquisition Deadline Date (a “Taoz DNAS Acquisition Failure”), Taoz shall immediately transfer to Kitov, as liquidated damages and not a penalty, and as the sole remedy for such Taoz DNAS Acquisition Failure, for no consideration to be paid by Kitov, such number of securities equal to 20% of the amount of shares included in the Designated Newly Acquired Shares which Taoz has failed to purchase, out of the shares held by Taoz (the “Taoz Forfeited Securities”). 2 of 11 By execution of this Agreement, Taoz does hereby appoint Kitov, or any duly authorized agent thereof, with full power of substitution and resubstitution, in the event of a Taoz DNAS Acquisition Failure, as Taoz’s true and lawful attorney and irrevocable proxy, to the fullest extent of the Taoz’s rights with respect to each Taoz Forfeited Security owned by it or over which it has control, if Taoz is unable or unwilling to perform its obligations with respect to the transfer of the Taoz Forefeited Securities (the “Proxy”). Taoz intends this Proxy to be irrevocable and coupled with an interest hereunder and shall terminate at the earlier of: (i) the end of the term of this Agreement; or (ii) upon the consummation of the acquisition of the Designated Newly Acquired Shares by Taoz as set forth above. Taoz hereby expressly and irrevocably revokes any, (i) proxies previously granted with respect to each Taoz Forfeited Security owned by it or over which it has control and represents that none of such previously-granted proxies are irrevocable, and/or, (ii) until the end of the term of this Agreement, any proxies it may grant with respect to each Taoz Forfeited Security owned by it or over which it has control which are not in accordance with the terms and conditions of this Agreement and any such proxies shall be deemed void ab initio, and to any such extent as such may not be deemed void ab initio under any applicable legal doctrine, such shall nonetheless be deemed superseded and replaced by the Proxy, which shall be deemed to have been issued later than any other such proxy. The “New Shares PPS” shall mean, (1) in the event that the Newly Acquired Shares are purchased by Kitov, in whole or in part, in consideration for shares of Kitov, then during a period of six months from the Acquisition Date, an amount, in cash equal to US$ 350 per share, and during a period commencing as of the lapse of six months and until the lapse of 12 months from the Acquisition Date, an amount, in cash equal to US$ 403 per share. (2) in the event that all the Newly Acquired Shares are purchased by Kitov for cash consideration only, then an amount, in cash, equal to 104% of the price per share actually paid by Kitov as consideration for such Newly Acquired Shares. In such case Kitov shall furnish Taoz with the purchase agreements executed with the former shareholders outlining the terms of purchase. . 6. Right of First Refusal: Until an Exit Event, Taoz shall have a right of first refusal with respect to any transfer by Kitov (or a Permitted Transferee thereof) (the “Offeror”) of its shares in the Company, of any or all of its shares, in such quantities and under such terms and conditions as follows: 6.1. Kitov shall send to Taoz a written notice detailing the number of shares intended to be transferred or sold (the “Offered Shares”), the price and the other terms of the transfer or sale (the “Offer”). Taoz shall have a right to purchase only up to its Pro Rata Share (as defined in the Binding Term Sheet) of the Offered Shares by sending Kitov a written notice (the “Notice of Reply”) within a period of ten (10) business days after receipt of Offer, and under the terms of the Offer. If the Taoz does not accept in the abovementioned manner, then Taoz shall be regarded as having given a notice of refusal to purchase the Offered Shares or any part thereof. 3 of 11 6.2. The Notice of Reply shall constitute an agreement for the sale and purchase of the Pro Rata Share of the Offered Shares at the price and conditions, and by delivery of the same type consideration, as specified in the Offer. 6.3. Notwithstanding the foregoing, the right of first refusal as set forth above shall not apply with respect to a Transfer to a Permitted Transferee ("רבענ רתומ") as defined in the Binding Term Sheet, so long as such Permitted Transferee shall execute in writing a joinder to this Agreement pursuant to which such transferee agrees to be bound by the terms of this Agreement as if an original party hereto. 7. Co-Sale: Until an Exit Event, in the event that Taoz did not purchase the Offered Shares under the Right of First Refusal as set forth above, Taoz shall have a right, exercisable upon written notice to Kitov within ten (10) business days after the receipt of the Offer, to participate in such transfer, by selling up to its Pro Rata Share out of the Offered Shares, on the same terms and conditions, for receipt of the same type of consideration, of the Offer (provided that such transfer is completed by Kitov). If Taoz does not accept in the abovementioned manner, then Taoz shall be regarded as having given a notice of refusal to participate in the sale of the Offered Shares or any part thereof. Notwithstanding the foregoing, the Co-Sale right as set forth above shall not apply with respect to a Transfer to a Permitted Transferee ("רתומ רבענ") as defined above. 8. No-Sale: Until the earlier of (i) the lapse of 30 months from the date hereof; (ii) the execution of investment agreements by the Company with external non-affiliated investor (other than Kitov or a Company controlled by Kitov), according to which the Company shall issue 10% or more of its issued share capital immediately prior to such issuance, , (iii) immediately prior to a Qualified Initial Public Offering ("IPO"), (iv) immediately prior to the consummation of a merger or sale of all or substantially all of the Company's assets or share capital (“M&A Transaction”, and together with an IPO, an “Exit Event”), or (v) the lapse of 60 days following the Company’s Milestone Notice, Kitov shall not make any transfer, except for: (i) up to 15% of the issued share capital of the Company or (ii) transfer to a Permitted Transferee. 9. Put Option. Kitov hereby provides to Taoz an option to sell to Kitov up to 50% of the shares issued to Taoz through the Initial Investment, Deferred Investment and the Option (as such terms are defined in the Binding Term Sheet) and any Designated Newly Acquired Shares actually acquired by Taoz, exercisable during a period of 90 days from the publication by the Company of the results of the Phase I clinical trials (the “Exercise Period”), for a price per share equal to US$1,600 (the “Exercise Price”). Subject to receipt by Kitov of an exercise notice from Taoz, the Exercise Price s hall be paid, 40 days after the delivery of the exercise notice, and subject to all required regulatory and corporate approvals including, without limitation the approval of the Tel Aviv Stock Exchange, in (1) ordinary shares of Kitov Pharmaceuticals Holdings Ltd., at a price per share value (for each Kitov share) equal to the higher of (i) of NIS 1.824 (subject to adjustments due to stock split and combination) and (ii) the average price of the shares of Kitov at the closing of trade on the Tel Aviv Stock Exchange during a period of 30 days following the lapse of the Exercise Period, or, according to Kitov’s sole discretion, (2) in cash. Upon the expiration of the Exercise Period, the Put Option, if not exercised by Taoz, shall expire and no longer be valid. The exercise of the Put Option shall be executed by providing Kitov with written notice of the Taoz's decision to sell all its shares under the Put Option. 4 of 11 10. Confidentiality Each party to this Agreement possesses Confidential Information (as defined below); and, each party in possession of Confidential Information (the "Disclosing Party") may disclose some of its Confidential Information to the other party (the "Receiving Party") during the term of this Agreement; and the Parties hereto agree as follows: 10.1. Notwithstanding any termination of this Agreement, the Receiving Party’s undertakings with respect to the Confidential Information (as defined below) shall remain valid and binding for a period of five (5) years after the termination of this Agreement. 10.2. For purposes of this Agreement: "Confidential Information" shall mean and include: 10.2.1. Trade Secrets and Technical Information (as hereinafter defined) and other information of the Disclosing Party of a confidential and/or proprietary nature or which could reasonably be expected to be confidential, whether written or oral, received by the Receiving Party from the Disclosing Party or to which the Receiving Party has access, and which relate to the business, technology, products, marketing and/or activities of the Disclosing Party, including but not limited to all copies, excerpts, modifications, translations, enhancements and adaptations of all the foregoing, whether made by the Receiving Party or otherwise,; "Trade Secrets" shall include, but not be limited to, technical and/or business information embodied in all drawings, designs, technical manuals, plans, proposals, marketing and sales plans, customer lists, financial information, costs, pricing information and product application data, owned or developed by the Disclosing Party; "Technical Information" shall mean all technical information, including but not limited to source code, object code, documentation, manuals, product plans, technical know-how, technical data, performance data, product specifications and other information of a technical nature whether or not contained or incorporated in drawings, photographs, memoranda, operational documents, models, prototypes, designs, quality control and test charts, manuals and methods; or 5 of 11 10.3. 10.4. 10.2.2. any information which is marked "confidential", or bears a marking of like import, or which the Disclosing Party states in writing at the time of transmittal to, or receipt by, the Receiving Party is to be considered confidential. Such writing shall be sufficiently specific to enable the Receiving Party to identify the information considered to be confidential by the Disclosing Party. For avoidance of doubt it is clarified that this Agreement as well as any discussions held in connection with the Agreement, and any proposed terms and conditions with respect thereto, are deemed Confidential Information under this Agreement. The Receiving Party shall (a) use the Confidential Information solely to the extent necessary for the purposes of this Agreement and shall not use the Confidential Information for any other purpose; (b) not disclose, communicate, divulge, disseminate or make available any Confidential Information to any entity or person other than as set forth herein this Agreement and shall restrict disclosure of the confidential Information to those of its officers, directors, employees, agents, accountants, attorneys, consultants or other professional advisors (collectively “Representatives”) who are bound by a written instrument to maintain the confidentiality and non-use of the Confidential Information in similar manner as provided by this Agreement; and (c) disclose the Confidential Information to its Representatives only to the extent it is strictly necessary for each such Representative to perform such duties for the Receiving Party. The Receiving Party shall take all reasonable steps, which may be necessary in order to enforce any undertaking by such Representatives with respect to the confidentiality, non-use or nondisclosure obligation by any such person in connection with the Confidential Information. Receiving Party is aware that Confidential Information not expressly approved for release hereunder may be deemed "Inside Information" under Israeli and/or US securities laws, and any use or disclosure thereof may be deemed a criminal offense in one or more jurisdictions. Receiving Party undertakes (i) not to make any unlawful use of Confidential Information, and, (ii) that while in possession of Confidential Information which is considered Inside Information, neither Receiving Party, nor any of its Representatives, while in possession of Confidential Information, shall directly or indirectly buy, sell, trade the securities of the Disclosing Party, and shall not advise any other entity with respect to the foregoing. Receiving Party is aware that any such activities may be deemed "Insider Trading" under Israeli and/or US securities laws, and any use or disclosure thereof may be deemed a criminal offense in one or more jurisdictions. Receiving Party represents that it is aware of, and will advise any of its Representatives, of the restrictions imposed by the applicable securities laws and regulations on the purchase or sale of securities by any person who has received non- public information regarding a company with publicly traded securities, as well as the restrictions making it unlawful to communicate such information to any other person when it is reasonably foreseeable that such other person is likely to purchase or sell securities in reliance upon such information. 6 of 11 10.5. Information shall not be deemed confidential, and the Receiving Party shall have no obligation with respect to any such information, which the Receiving Party can evidence, to the Disclosing Party by appropriate written and dated documentation: 10.5.1. is already known to the Receiving Party at or prior to the Effective Date; or 10.5.2. is or becomes publicly known through no wrongful act of the Receiving Party; or 10.5.3. is independently developed by the Receiving Party or is rightfully received by the Receiving Party from a third party without restriction and without breach of this Agreement; or 10.5.4. is approved for release by written authorization of the Disclosing Party. 10.6. 10.7. Any Confidential Information is and shall always remain the exclusive property of the Disclosing Party, and the Receiving Party hereby acknowledges the right, title and interest of the Disclosing Party in and to the Confidential Information. The Receiving Party will not at any time infringe, contest, dispute or question such right, title or interest nor aid others in doing so directly or indirectly. The Receiving Party shall use the same standard of care it uses to protect its own Confidential Information to avoid disclosure to, or misuse of by, any third party of any of the Disclosing Party’s Confidential Information for the duration of this Agreement and for a period of five (5) years from the date of the termination of this Agreement. In the event that the Receiving Party or any of its Representatives becomes legally compelled to disclose any of the Confidential Information, the Receiving Party shall provide the Disclosing Party with prompt written notice of such requirement, so that the Disclosing Party may seek a protective order or other appropriate remedy. In the event that such protective order or other remedy is not obtained, the Receiving Party will furnish only that minimum portion of the Confidential Information which the Receiving Party is advised by written opinion of its legal counsel is legally required, and shall exercise all commercially reasonable efforts to obtain assurances that confidential treatment will be accorded such disclosure. Neither party under this Agreement shall publicly announce or disclose the existence of this Agreement, or its contents, any discussions relating thereto, or the discussions of the purposes of this Agreement, without the prior written consent of the other party or except as may be required by law or by applicable rules of any stock exchange or quotation system on which such Party or its affiliates lists or trades securities. 7 of 11 10.8. All the Disclosing Party’s Confidential Information and all tangible forms of such information, including, but not limited to, business information, data, documents, drawings, specifications, prototypes, and software received hereunder by the Receiving Party from the Disclosing Party shall remain the property of the Disclosing Party. Upon written request by the Disclosing Party, the Receiving Party shall return to the Disclosing Party all tangible forms of the Disclosing Party Confidential Information, including any and all copies thereof, provided however, that the Receiving Party may keep one (1) copy of any Confidential Information for archival purposes only and such copy shall remain subject to the confidentiality obligations hereunder. 10.9. Neither this Agreement nor any disclosure of Confidential Information may be construed as: (i) granting any right, warranty, or license by implication or otherwise under any patent, copyright, know-how or design rights, or other form of protection of industrial or intellectual property; or (ii) obligating the Disclosing Party to furnish to the Receiving Party or any of its Representatives any Confidential Information. 11. Notices All notices and other communications made pursuant to or under this Agreement will be in writing and will be deemed to have been duly given or made (a) when personally delivered, (b) when transmitted by facsimile or electronic mail if such transmission occurs on a Business Day before 5:00 p.m. (recipient local time), or the next succeeding Business Day if such transmission occurs at any other time, (c) three Business Days after deposit with a nationally recognized international overnight courier service, or (d) ten Business Days after the mailing if sent or by registered or certified international mail, postage prepaid, return receipt requested. All notices and other communications under this Agreement will be delivered to the addresses set forth below, or such other address as such Party may have given to the other Parties by notice pursuant to this Section 11: If to Taoz: ____________________________________________ _____________________________________________ If to Kitov: Kitov Pharmaceuticals Holdings Ltd. One Azrieli Center, Round Tower, 23rd Floor 132 Menachem Begin Road Email: avraham@kitovpharma.com Attention: Avraham Ben-Tzvi, Adv. 8 of 11 12. Expenses. Except as otherwise provided herein, all fees and expenses incurred in connection with or related to the transactions contemplated hereby will be paid by the Party incurring such fees or expenses. In the event of termination of this Agreement, the obligation of each Party to pay its own expenses will be subject to any rights of such Party arising from a breach of this Agreement by the other. 13. Entire Agreement. This Agreement, and the Binding Term Sheet, constitute the entire agreement of the Parties relating to the subject matter hereof and thereof and supersedes all prior and contemporaneous agreements, negotiations, correspondence, Agreements and communications of the Parties, oral or written, with respect to the subject matter hereof. 14. Amendment; Waiver. This Agreement will not be amended, modified or waived in any manner without the consent in writing duly executed and delivered by each Party hereto. No failure or delay of any Party to exercise any right or remedy given to such Party under this Agreement and no custom or practice of the Parties in variance with the terms hereof, will constitute a waiver of any Party’s right to demand exact compliance with the terms hereof. Any written waiver will be limited to those items specifically waived therein and will not be deemed to waive any future breaches or violations or other non-specified breaches or violations unless, and to the extent, expressly set forth therein. 15. Severability. If any term or provision of this Agreement is held invalid, illegal or unenforceable in any respect under any applicable Law, the validity, legality and enforceability of all other terms and provisions of this Agreement will not in any way be affected or impaired. If the final judgment of a court of competent jurisdiction or other Governmental Authority declares that any term or provision hereof is invalid, illegal or unenforceable, the Parties agree that the court making such determination will have the power to reduce the scope, duration, area or applicability of the term or provision, to delete specific words or phrases, or to replace any invalid, illegal or unenforceable term or provision with a term or provision that is valid, legal and enforceable and that comes closest to expressing the intention of the invalid, illegal or unenforceable term or provision. 16. Governing Law. This Agreement will be construed and enforced in accordance with, and will be governed exclusively by, the internal Laws of the State of Israel, without giving effect to any Law or rule that would cause the Laws of any jurisdiction other than the State of Israel to be applied. 17. Exclusive Jurisdiction. The competent courts of Tel-Aviv, Israel shall have exclusive jurisdiction in all matters relating to any dispute arising out of or relating to this Agreement, or the breach thereof, to the exclusion of any other jurisdiction. Each of the Parties (a) irrevocably consents to the exclusive jurisdiction and venue of the court as set forth above, (b) agrees that process may be served upon them in any manner authorized by the court for such persons, (c) waives the defense of an inconvenient forum and covenants not to assert or plead any objection which they might otherwise have to such jurisdiction, venue and such process, and (d) agrees that a final judgment in such proceeding shall be final, binding and enforceable in any court of competent jurisdiction. 9 of 11 18. Rules of Construction The following rules of construction will govern the interpretation of this Agreement: 18.1. all references to Articles, Sections or Schedules are to Articles, Sections or Schedules in this Agreement, unless otherwise stated explicitly; 18.2. 18.3. 18.4. 18.5. 18.6. each accounting term not otherwise defined in this Agreement has the meaning assigned to it in accordance with generally accepted accounting principles in the State of Israel; unless the context otherwise requires, words in the singular or plural include the singular and plural, and pronouns stated in either the masculine, the feminine or neuter gender will include the masculine, feminine and neuter; whenever the words “include,” “includes” or “including” are used in this Agreement they will be deemed to be followed by the words “but not limited to”; the word “extent” in the phrase “to the extent” will mean the degree to which a subject or other thing extends, and such phrase will not simply mean “if”; references to any statute, rule, regulation or form (including in the definition thereof) will be deemed to include references to such statute, rule, regulation or form as amended, modified, supplemented or replaced from time to time (and, in the case of any statute, include any rules and regulations promulgated under such statute), and all references to any section of any statute, rule, regulation or form include any successor to such section; 18.7. time is of the essence with regard to all dates and time periods set forth or referred to in this Agreement; 18.8. 18.9. the subject headings of Articles and Sections of this Agreement are included for purposes of convenience of reference only and will not affect the construction or interpretation of any of its provisions; (i) the terms “hereof”, “herein”, “hereby”, “hereto”, and derivative or similar words refer to this entire Agreement, including the Schedules and Exhibits hereto, (ii) the term “any” means “any and all” and (iii) the term “or” will not be exclusive and will mean “and/or”; 18.10. (i) references to “days” means calendar days unless Business Days are expressly specified, (ii) references to “NIS” mean New Israeli Shekels and (iii) references to “$” mean U.S. dollars; 18.11. the Parties have participated jointly in the negotiation and drafting of this Agreement; in the event an ambiguity or question of intent or interpretation arises, this Agreement will be construed as if drafted jointly by the Parties, and no presumption or burden of proof will arise favoring or disfavoring any Party by virtue of the authorship of any of the provisions hereof and the language used will be deemed to be the language chosen by the Parties to express their mutual intent. 19. Counterparts; Deliveries. This Agreement may be executed simultaneously in counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument. This Agreement and any amendments hereto or thereto, to the extent signed and delivered by means of electronic transmission of .pdf files or other image files via e-mail, cloud-based transfer or file transfer protocol, or use of a facsimile machine, will be treated in all manners and respects and for all purposes as an original agreement or instrument and will be considered to have the same binding legal effect as if it were the original signed version thereof delivered in person. No party to any such agreement or instrument will raise the use of electronic transmission or a facsimile machine to deliver a signature or the fact that any signature or agreement or instrument was transmitted or communicated through the use of electronic transmission or a facsimile machine as a defense to the formation or enforceability of a contract, and each such party forever waives any such defense. [SIGNATURE PAGE FOLLOWS] 10 of 11 IN WITNESS WHEREOF, the Parties have executed this Agreement on the date first above written. __________________________________________ TAOZ – COMPANY FOR MANAGEMENT AND HOLDINGS OF COMPANIES LTD. By: Title: __________________________________________ KITOV PHARMACEUTICALS HOLDINGS LTD. an Israeli publicly traded corporation (“Parent”), on behalf of itself and, if Parent is not the buyer of the shares previously held by Goldman Hirsh Partners Ltd., also on behalf of an as yet undetermined Affiliated party of Parent (“Kitov”) which shall, upon execution hereof by it, be deemed a Party to this Agreement Ab Initio. By: Title: 11 of 11 The following table sets forth the name and jurisdiction of incorporation of our subsidiaries as of the date hereof. Kitov Pharmaceuticals Holdings Ltd. Name of Subsidiary Kitov Pharmaceuticals Ltd.* Tyrnovo Ltd. Exhibit 8.1 Jurisdiction of Incorporation Israel Israel *On April 25, 2017, the boards of directors of each of Kitov Pharmaceuticals Holdings Ltd. and Kitov Pharmaceuticals Ltd. approved a merger between the two entities, with Kitov Pharmaceuticals Holdings Ltd.remaining as the surviving entity. For more information on the proposed merger, see Item 4.C – Organizational Structure in the Annual Report for 2016 on Form 20-F in which this is Exhibit is included. CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER UNDER SECTION 302 OF THE SARBANES-OXLEY ACT Exhibit 12.1 I, Isaac Israel, certify that: 1. I have reviewed this annual report on Form 20-F of Kitov Pharmaceuticals Holdings Ltd.; 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 the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report; 4. The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d- 15(f)) for the company 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 company, including its consolidated subsidiaries, is made known to us by others within those 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 our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; c. Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d. Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and 5. The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’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 are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting. Date: May 1, 2017 /s/ Isaac Israel Isaac Israel Chief Executive Officer CERTIFICATION OF THE CHIEF FINANCIAL OFFICER UNDER SECTION 302 OF THE SARBANES-OXLEY ACT Exhibit 12.2 I, Simcha Rock, certify that: 1. I have reviewed this annual report on Form 20-F of Kitov Pharmaceuticals Holdings Ltd.; 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 the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report; 4. The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d- 15(f)) for the company 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 company, including its consolidated subsidiaries, is made known to us by others within those 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 our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; c. Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and d. Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and 5. The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’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 are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting. Date: May 1, 2017 /s/ Simcha Rock Simcha Rock Chief Financial Officer CERTIFICATION OF CHIEF EXECUTIVE OFFICER UNDER SECTION 906 OF THE SARBANES-OXLEY ACT Pursuant to 18 U.S.C. Section 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Kitov Pharmaceuticals Holdings Ltd. (the “Company”) hereby certifies, to such officer’s knowledge that: 1. The accompanying Annual Report on Form 20-F of the Company for the year ended December 31, 2016 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and 2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. Exhibit 13.1 Date: May 1, 2017 /s/ Isaac Israel Isaac Israel Chief Executive Officer The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. Section 1350, and is not being filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference to any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. CERTIFICATION OF CHIEF FINANCIAL OFFICER UNDER SECTION 906 OF THE SARBANES-OXLEY ACT Pursuant to 18 U.S.C. Section 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of Kitov Pharmaceuticals Holdings Ltd. (the “Company”) hereby certifies, to such officer’s knowledge that: 1. The accompanying Annual Report on Form 20-F of the Company for the year ended December 31, 2016 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and 2. The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. Exhibit 13.2 Date: May 1, 2017 /s/ Simcha Rock Simcha Rock Chief Financial Officer The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. Section 1350, and is not being filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference to any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. 

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