Exhibit 10.1

A request for confidential treatment has been made with respect to portions of the following document that are marked with [*CONFIDENTIAL*]. The redacted portions have been filed separately with the SEC.

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

DATED AS OF AUGUST 5, 2016

BY AND BETWEEN

MEI PHARMA, INC.

AND

HELSINN HEALTHCARE SA

A request for confidential treatment has been made with respect to portions of the following document that are marked with [*CONFIDENTIAL*]. The redacted portions have been filed separately with the SEC.

A request for confidential treatment has been made with respect to portions of the following document that are marked with [*CONFIDENTIAL*]. The redacted portions have been filed separately with the SEC.

A request for confidential treatment has been made with respect to portions of the following document that are marked with [*CONFIDENTIAL*]. The redacted portions have been filed separately with the SEC.

A request for confidential treatment has been made with respect to portions of the following document that are marked with [*CONFIDENTIAL*]. The redacted portions have been filed separately with the SEC.

SCHEDULES :

Schedule 1.14 : Certain Patents

Schedule 1.40 : Licensor Know-How

Schedule 1.41 : Licensor Patents

Schedule 1.46 : On-Going Agreements

Schedule 1.64 : S*BIO Agreement

Schedule 2.5 : Technology Transfer Plan

Schedule 4.3.2 : Essential Development Elements

Schedule 7.1 : Existing Product and Compound Available for Transfer to Licensee

Schedule 7.3 : Existing Product and Compound to be Retained by Licensor

A request for confidential treatment has been made with respect to portions of the following document that are marked with [*CONFIDENTIAL*]. The redacted portions have been filed separately with the SEC.

LICENSE, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

This License, Development and Commercialization Agreement (this “Agreement” ), dated as of August 5, 2016 (the “Effective Date” ), is made by and between MEI Pharma, Inc., a Delaware corporation having an office at 11975 El Camino Real, Suite 101, San Diego, CA 92130 ( “Licensor” ), and Helsinn Healthcare SA, a Swiss corporation having its registered office at Via Pian Scairolo 9, 6912 Pazzallo-Lugano, Switzerland ( “Licensee” ). Licensor and Licensee are sometimes referred to herein individually as a “Party” and collectively as the “Parties” .

RECITALS

W HEREAS , Licensor has developed the Compound (as defined below);

W HEREAS , Licensee is interested in further developing and commercializing the Compound; and

W HEREAS , Licensor wishes to grant a license to Licensee under certain intellectual property rights related to the Compound to develop, manufacture and commercialize the Compound and Product (as defined below), and Licensee wishes to take such license, in each case in accordance with the terms and conditions set forth below; and

W HEREAS , the Parties entered into a Mutual Confidential Disclosure Agreement on December 16, 2015 ( “Prior CDA” ) to facilitate the discussion and evaluation of a possible transaction between the Parties.

N OW T HEREFORE , in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, and for other good and valuable consideration, receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

As used in this Agreement, the following initially capitalized terms shall have the meanings set forth in this ARTICLE 1 or as otherwise defined elsewhere in this Agreement:

1.1 “ Affiliate ” means with respect to any person, any other person directly or indirectly controlling, controlled by, or under common control with such person; provided, that, for purposes of this definition, “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”), as used with respect to any person, means (i) 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 by contract or otherwise, or (ii) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities of such person. For purposes of this Section 1.1, “person” means an individual, corporation, partnership, limited partnership, limited liability company, limited liability partnership, syndicate, person (including a “person” as defined in Section 13(d)(3) of the

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Securities Exchange Act of 1934, as amended, together with the rules and regulations promulgated thereunder), trust, association, entity or government or political subdivision, agency or instrumentality of a government.

1.2 “ Applicable Law ” means any applicable United States federal, state or local or foreign or multinational law, statute, standard, ordinance, code, rule, regulation, resolution or promulgation, or any order, writ, judgment, injunction, decree, stipulation, ruling, determination or award entered by or with any Governmental Authority, or any license, franchise, permit or similar right granted under any of the foregoing, or any similar provision having the force or effect of law. For the avoidance of doubt, any specific references to any Applicable Law or any portion thereof, shall be deemed to include all then-current amendments thereto or any replacement or successor law, statute, standard, ordinance, code, rule, regulation, resolution, order, writ, judgment, injunction, decree, stipulation, ruling, or determination thereto.

1.3 “ Azacitidine ” means that certain compound referred to as azacitidine with the IUPAC name 4-Amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1 H )-one, including any [*CONFIDENTIAL*] .

1.4 [*CONFIDENTIAL*] .

1.5 “ Baseline Quarter Net Sales ” means, on a country-by-country basis, the average cumulative Net Sales of the Product in such country during the [*CONFIDENTIAL*] consecutive [*CONFIDENTIAL*] that immediately precede the Calendar Quarter during which a Generic Product with respect to the Product is first commercially sold in such country. For example, if a Generic Product with respect to the Product is commercially sold in the U.S. for the first time on [*CONFIDENTIAL*] , then the Baseline Quarter Net Sales with respect to the U.S. are the cumulative Net Sales of the Product in the U.S. during the [*CONFIDENTIAL*] Calendar Quarters of [*CONFIDENTIAL*] divided by [*CONFIDENTIAL*] .

1.6 “ Business Day ” means a day other than a Saturday, Sunday, or bank or other public holiday in California and/or in the Canton of Ticino.

1.7 “ Calendar Quarter ” means each three (3) month period commencing January 1, April 1, July 1 or October 1 of any year; provided, however, that (a) the first Calendar Quarter of the Term shall extend from the Effective Date to the end of the first full Calendar Quarter thereafter, and (b) the last Calendar Quarter of the Term shall end upon the expiration or termination of this Agreement.

1.8 “ Calendar Year ” means the period beginning on the 1st of January and ending on the 31st of December of the same year; provided, however, that (a) the first Calendar Year of the Term shall commence on the Effective Date and end on December 31 of the same year and (b) the last Calendar Year of the Term shall commence on January 1 of the Calendar Year in which this Agreement terminates or expires and end on the date of termination or expiration of this Agreement.

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1.9 “ Change of Control ” means (a) a merger or consolidation of Licensor with a Third Party that results in the voting securities of Licensor outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent at least fifty percent (50%) of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger or consolidation, (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the direct or indirect beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of Licensor, or (c) the sale or other transfer to a Third Party of all or substantially all of Licensor’s and its Affiliates’ assets.

1.10 “ Clinical Trial ” means a clinical trial, including any phase I trial, phase II trial, phase III trial, or phase IV trial (including any non-interventional studies, safety studies, investigator initiated clinical trial trials, and epidemiological studies), as the case may be, and as any such trial is defined by an applicable Regulatory Authority to obtain information regarding a product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of such product.

1.11 “ Collaboration Patent ” means any Patent Covering (i) any Invention relating to the Compound and/or Product that is conceived, reduced to practice or otherwise developed through, based on or derived from work carried out after the Effective Date under this Agreement, including in the performance of the On-Going Agreements or in connection with the On-Going Studies or the POC Study or (ii) any improvement, addition, refinement, modification, development, discovery or invention that references, is based on or is derived from the data contained in that certain document titled [*CONFIDENTIAL*] , which was provided by Licensee to Licensor prior to the Effective Date, or any data that replicates or recreates such data. For clarity, Collaboration Patents are a subset of Licensee Patents.

1.12 “ Commercialize ” means, with respect to (a) a Royalty Product, to promote, market, distribute, sell (and offer for sale or contract to sell), import, export, or otherwise commercially exploit or provide product support for the Royalty Product and to conduct activities, other than Development or Manufacturing, in preparation for conducting the foregoing activities, including activities to produce commercialization support data and to secure and maintain market access and reimbursement, and (b) the Compound, to distribute, sell (and offer for sale or contract to sell), import or export the Compound, and to conduct activities, other than Development or Manufacturing, in preparation for conducting the foregoing activities. “ Commercializing ” and “ Commercialization ” shall have correlative meanings. For the avoidance of doubt, Commercialization does not include Development and Manufacturing.

1.13 “ Commercially Reasonable Efforts ” means, with respect to the efforts and resources to be expended by a Party with respect to the Compound and Product hereunder, the level of efforts and resources consistent with the efforts and resources a pharmaceutical company of similar size and situation in the exercise of its reasonable business judgment typically devotes to its own product candidates of similar market potential, at a similar stage in development or product lifecycle, taking also into account the stage of development or product lifecycle of other products in such Party’s portfolio candidates, issues of safety and efficacy, product profile, the

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proprietary position of the Compound and Product, cost of goods, the competitiveness of the marketplace, the regulatory structure involved, the likelihood of regulatory approval, the anticipated or actual profitability of the applicable product, and other technical, legal, scientific and medical considerations.

1.14 “ Compound ” means (i) that certain compound referred to as pracinostat, with the IUPAC name (2 E )-3-(2-Butyl-1-(2-(diethylamino)ethyl)-1 H -benzo[ d ]imidazol-5-yl)- N -hydroxyacrylamide ( “ Pracinostat ” ), and (ii) [*CONFIDENTIAL*] ; provided, that the Parties acknowledge and agree that “Compound” does not include anything that is covered or claimed by any of those Patents included in Schedule 1.14 .

1.15 “ Control ” and “ Controlled by ” means, with respect to any Know-How, Invention, Patent, technology, copyright, trademark or other intellectual property right, the possession by a Party or its Affiliates (whether by ownership, license grant or other means) of the legal right to grant the right to access or use, or to grant a license or a sublicense to, such Know-How, Invention, Patent right, technology, copyright, trademark or other intellectual property right as provided for herein without violating the proprietary rights of any Third Party or any terms of any agreement or other arrangement between such Party (or any of its Affiliates) and any Third Party.

1.16 “ Cover ” , “ Covered ” or “ Covering ” means, with respect to a Patent, that, in the absence of a license granted to a Person under a Valid Claim included in such Patent, the manufacture, use, practice, distribution or sale of the subject matter of such Patent by such Person would infringe, or contribute to or induce the infringement of, such Valid Claim, or with respect to a Patent application, as if such Valid Claim was contained in an issued Patent.

1.17 “ Develop ” means to research, develop, analyze, test and conduct preclinical trials, Clinical Trials, any preclinical/clinical/CMC commitments following Regulatory Approval) and all other regulatory trials, for the Compound or a Royalty Product, as well as any and all activities pertaining to manufacturing development, formulation development, including new indications, new formulations and all other activities, including regulatory activities, related to securing and maintaining Regulatory Approval, for the Compound or a Royalty Product. “ Developing ” and “ Development ” shall have correlative meanings.

1.18 “ Development Activities ” means those Development activities undertaken by or on behalf of Licensee with respect to the Compound or a Royalty Product.

1.19 “ Dollar ” or “ $ ” means the legal tender of the United States of America.

1.20 “ Executive Officer ” means, with respect to each Party, an appropriate executive officer as indicated by each such Party.

1.21 “ FDA ” means the United States Food and Drug Administration and any successor Regulatory Authority having substantially the same function.

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1.22 “ FD&C Act ” means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder.

1.23 “ First Commercial Sale ” means, with respect to any country, the first shipment of the Product by or on behalf of Licensee or its Affiliate or its Sublicensee to a Third Party in such country for end use or consumption of the Product in such country after Regulatory Approval of the Product in such country or, if earlier, the invoicing of a Third Party for such shipment. Sales or transfers of reasonable quantities of the Product for Clinical Trial purposes, or for compassionate or similar use, shall not be considered a First Commercial Sale.

1.24 “ Force Majeure ” means any circumstances whatsoever which are not within the reasonable control of the Party affected thereby, potentially including an act of God, war, act of terrorism, insurrection, riot, strike or labor dispute, shortage of materials, fire, explosion, flood, government requisition or allocation, breakdown of or damage to plant, equipment or facilities, interruption or delay in transportation, fuel supplies or electrical power, embargo, boycott, order or act of civil or military authority.

1.25 “ Generic Product ” means, with respect to a country, any pharmaceutical product that is distributed by a Third Party (that is not licensed or otherwise permitted by Licensee or its Affiliates or its Sublicensees) in such country (i) under a Regulatory Approval approved by a Regulatory Authority in reliance, in whole or in part, on the Regulatory Approval for the Product, including any product authorized for sale (a) [*CONFIDENTIAL*] , (b) [*CONFIDENTIAL*] , or (c) [*CONFIDENTIAL*] , and (ii) which product (a) contains the same active pharmaceutical ingredient(s) as the Product, (b) [*CONFIDENTIAL*] and (c) [*CONFIDENTIAL*] .

1.26 “ Good Clinical Practices ” or “ GCP ” means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable, (i) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ( “ ICH ” ) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products, (ii) the Declaration of Helsinki (1964) as last amended at the 64 ^th World Medical Association in October 2013 and any further amendments or clarifications thereto, (iii) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (iv) the equivalent Applicable Law in any relevant country, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

1.27 “ Good Laboratory Practices ” or “ GLP ” means the then-current standards, practices and procedures promulgated or endorsed by (a) the European Commission Directive 2004/10/EC relating to the application of the principles of good laboratory practices as well as “The rules governing medicinal products in the European Union,” Volume 3, Scientific

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guidelines for medicinal products for human use (ex - OECD principles of GLP), (b) the FDA as defined in 21 C.F.R. Part 58, and (c) the equivalent Applicable Law in any relevant country, each as may be amended and applicable from time to time.

1.28 “ Good Manufacturing Practices ” or “ GMP ” means all applicable Good Manufacturing Practices including, as applicable, (i) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Sections 210, 211, 601 and 610, (ii) the principles detailed in the ICH Q7 guidelines, and (iii) the equivalent Applicable Law in any relevant country, each as may be amended and applicable from time to time.

1.29 “ GxPs ” means each of GCP, GLP and GMP as and to the extent applicable.

1.30 “ Government Official ” means: (i) any official, officer, employee, representative, or anyone acting in an official capacity on behalf of: (a) any government or any department or agency thereof; (b) any public international organization (such as the United Nations, the International Monetary Fund, the International Red Cross, or the World Health Organization), or any department, agency, or institution thereof; or (c) any government-owned or controlled company, institution, or other entity, including a government-owned hospital or university; (ii) any political party or party official; and (iii) any candidate for political office.

1.31 “ Governmental Authority ” means any United States federal, state or local, or any foreign, government or political subdivision thereof, or any multinational organization or authority, or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof), or any governmental arbitrator or arbitral body. For clarity, any Regulatory Authority shall be a Governmental Authority.

1.32 “ IND ” means an investigational new drug application, clinical trial authorization or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.

1.33 “ Invention ” means any improvement, addition, refinement, modification, development, discovery or invention, whether or not patentable, that is conceived, reduced to practice or otherwise developed by either Party, or by both Parties, under this Agreement.

1.34 “ Joint Invention ” means any Invention conceived, reduced to practice or otherwise developed by one (1) or more employees or contractors of Licensee and one (1) or more employees or contractors of Licensor.

1.35 “ Know-How ” means all secret and substantial technical, scientific, regulatory and other information, results, knowledge, techniques, in whatever form and whether or not confidential, patented or patentable, including Inventions, invention disclosures, discoveries, plans, processes, practices, methods, knowledge, trade secrets, know-how, instructions, skill, experience, ideas, concepts, data (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, safety, quality control, and preclinical and clinical data),

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formulae, formulations, compositions, specifications, marketing, pricing, distribution, cost, sales and manufacturing data or descriptions. Know-How does not include any Patent claiming any of the foregoing.

1.36 “ Licensed Field ” means all uses and indications in human and animal health.

1.37 “ Licensee Know-How ” means any and all Know-How, whether or not patented or patentable, to the extent Controlled by, or on behalf of, Licensee or its Affiliates following the Effective Date or at any time thereafter during the Term (other than the Licensor Know-How) that is specifically related to the Development, Manufacture, Commercialization or other use of the Compound or Product.

1.38 “ Licensee Patent ” means any Patent, including any Collaboration Patent, that (i) claims a priority date after the Effective Date, (ii) is Controlled by Licensee (or its Affiliates) during the Term (other than the Licensor Patents) and (iii) contains one or more claims Covering the Compound and/or Product (including the Development, Manufacturing or Commercialization of the Compound and/or Product).

1.39 “ Licensee Technology ” means Licensee Know-How and Licensee Patents.

1.40 “ Licensor Know-How ” means any and all Know-How, whether or not patented or patentable, to the extent Controlled by, or on behalf of, Licensor or its Affiliates as of the Effective Date or at any time during the Term that is necessary in connection with the Development, Manufacture, Commercialization or other use of the Compound or Product as contemplated herein. Licensor Know-How Controlled by Licensor as of the Effective Date is either outlined in Schedule 1.40 or will be included by Licensor in the transfer under the Technology Transfer Plan. Notwithstanding the foregoing, “Licensor Know-How” does not include any Know-How that is owned or in-licensed by a Third Party described in the definition of “Change of Control” or such Third Party’s Affiliates (a) prior to the closing of such Change of Control, except to the extent that any such Know-How was Controlled by Licensor or any of its Affiliates prior to such Change of Control, or (b) after such Change of Control (other than arising from (i) Licensor’s or any of its Affiliates’ performance of activities hereunder or (ii) the use of any Licensor Technology or Licensee Technology).

1.41 “Licensor Patent” means (i) the Patents set forth on Schedule 1.41 , including patents issuing from any patent application set forth on Schedule 1.41 (ii) [ *CONFIDENTIAL*] , (iii) all provisional applications, substitutions, continuations, continuations-in-part, divisionals, renewals, patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including patent term adjustments, Patent Term Extensions, supplementary protection certificates or the equivalent thereof, and foreign counterparts of any of the foregoing, and (iv) [*CONFIDENTIAL*] . For the sake of clarity, the term “Licensor Patent” shall not be construed to include any Collaboration Patent or any Patent that Covers (or otherwise claims) a Joint Invention. Notwithstanding the foregoing, “Licensor Patent” does not include [*CONFIDENTIAL*].

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1.42 “ Licensor Technology ” means Licensor Know-How and Licensor Patents.

1.43 “ Manufacture ” or “ Manufacturing ” or “ Manufactured ” means, with respect to the Compound and Product, the receipt, handling and storage of active pharmaceutical ingredients, drug substance or drug product and other materials, the manufacturing, processing, Packaging and Labeling, holding (including storage), quality assurance and quality control testing (including release) of the Compound and Product (other than quality assurance and quality control related to development of the manufacturing process, which activities shall be considered Development activities) and shipping of the Compound and Product.

1.44 “ Marketing Authorization Application ” or “ MAA ” means an application to the appropriate Regulatory Authority for approval to market and sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

1.45 “ Net Sales ” means, with respect to a Royalty Product ( [*CONFIDENTIAL*] ), the gross amount invoiced for sales of a Royalty Product by Licensee or its Sublicensees to Third Parties (other than Third Parties that are also Affiliates or Sublicensees of Licensee), less the following deductions from such gross amounts to the extent attributable to such Royalty Product and to the extent actually incurred, allowed, accrued or specifically allocated:

(a) trade, cash and quantity discounts actually given;

(b) price reductions or rebates, retroactive or otherwise, or charge backs actually granted or paid to Governmental Authorities, group purchasing organizations, Third Party payors (including managed health care organizations) or trade customers;

(c) amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns;

(d) reasonable and customary freight, shipping insurance and other transportation charges directly related to the sale of the Royalty Product separately stated on the invoice to the Third Party;

(e) fees for any services provided by wholesalers and warehousing chains related to the distribution of such Royalty Product; and

(f) sales, value-added, excise taxes, tariffs and duties, and other taxes and government charges directly related to the sale, to the extent that such items are included in the gross invoice price of the Royalty Product and actually borne by Licensee or its Sublicensees without reimbursement from any Third Party (other than Third Parties that are also Affiliates or Sublicensees of Licensees) (but not including taxes assessed against the income derived from such sale);

all as determined in accordance with generally accepted accounting principles in the U.S. ( “GAAP” ) on a basis consistent with Licensee’s or its Sublicensee’s, as applicable, annual audited financial statements.

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The transfer of a Royalty Product between or among Licensee and its Affiliates or Sublicensees for resale (which resale will give rise to Net Sales), use in a Clinical Trial or use as a free marketing sample, will not be considered a sale.

Upon the sale or other disposal of a Royalty Product, such sale, disposal or use will be deemed to constitute a sale with the consideration for the sale being the consideration for the relevant transaction and constituting Net Sales hereunder, or if the consideration is not a monetary amount, a sale will be deemed to have occurred for a price assessed on the value of whatever consideration has been provided in exchange for the sale. Disposal of a Royalty Product for or use of a Royalty Product in Clinical Trials or as free samples will not give rise to any deemed sale under this definition. Such amounts will be determined from the books and records of Licensee and its Sublicensees maintained in accordance with GAAP or corresponding accounting standards in any other jurisdiction, consistently applied throughout the organization.

In no event shall any particular amount of deduction identified above be deducted more than once in calculating Net Sales ( i.e. , no “double counting” of deductions).

1.46 “ On-Going Agreements ” means certain agreements and specific work orders entered into by Licensor with Third Parties as of the Effective Date with respect to the Compound and/or the Product, as such agreements and work orders are listed in Schedule  1.46 .

1.47 “ On-Going Studies ” means, collectively, (i) those Clinical Trials involving the Compound internally designated by Licensor as [*CONFIDENTIAL*] respectively, and (ii) that certain Clinical Trial [*CONFIDENTIAL*] , with clinicaltrial.gov identifier [*CONFIDENTIAL*] .

1.48 “ Patents ”  means any and all (i) issued patents, (ii) pending patent applications, including all provisional applications, substitutions, continuations, continuations-in-part, divisionals and renewals, and all patents granted thereon, (iii) patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including patent term adjustments, Patent Term Extensions, supplementary protection certificates or the equivalent thereof, (iv) inventor’s certificates, (v) other forms of government-issued rights substantially similar to any of the foregoing, and (vi) United States and foreign counterparts of any of the foregoing.

1.49 “ Patent Term Extension ” means any term extensions, supplementary protection certificates and equivalents thereof offering Patent protection beyond the initial term with respect to any issued Patents.

1.50 “ Person ” means any individual, firm, corporation, partnership, limited liability company, trust, business trust, joint venture, Governmental Authority, association or other entity.

1.51 “ POC Study ” means a Clinical Trial of the Product for the Second Indication.

1.52 “ Pre-Marketing ” means all sales and marketing and medical affairs activities undertaken prior to and in preparation for the launch of the Product. Pre-Marketing shall include

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market research, key opinion leader development, advisory boards, medical education, disease-related public relations, health care economic studies, sales force training and other pre-launch activities prior to the First Commercial Sale of the Product in a given country or other regulatory jurisdiction.

1.53 “ Pricing Approval ” means, with respect to any country where a Governmental Authority authorizes reimbursement or access, or approves or determines pricing, for pharmaceutical products, receipt of such reimbursement or access authorization or pricing approval or determination (as the case may be).

1.54 “ Product ” means any pharmaceutical product, containing the Compound, whether or not as the sole active ingredient, and in any dosage, form or formulation ready for dispensing to or consumption by an end-user. For clarity, (i) the Compound in drug substance form (as opposed to the drug dosage form) shall constitute the Compound, but not the Product, and (ii) the term “Product” shall not be construed to include any proprietary compounds of Licensor or any of its Affiliates other than the Compound.

1.55 “ Product Complaint ” means any written, verbal or electronic expression of dissatisfaction regarding Product sold by or on behalf of Licensee or its Sublicensees, including reports of actual or suspected product tampering, contamination, mislabeling or inclusion of improper ingredients.

1.56 “ Promotional Materials ” means all written, printed, video or graphic advertising, promotional, educational and communication materials (other than the Product labels and package inserts) for marketing, advertising and promoting of the Product, for use (i) by a Sales Representative or (ii) in advertisements, web sites or direct mail pieces.

1.57 “ Qualified Sublicensee ” means (a) any Affiliate of Licensee that is headquartered and incorporated in the United States, or (b) a reputable Third Party that has (i) the capability to effectively market, distribute and sell the Product in [*CONFIDENTIAL*] [*CONFIDENTIAL*] through a dedicated sales force, (ii) has a strategic focus [*CONFIDENTIAL*] , and (iii) has been actively commercializing products [*CONFIDENTIAL*] in [*CONFIDENTIAL*] for at least the [*CONFIDENTIAL*] preceding the execution of a sublicense agreement with Licensee.

1.58 “ Regulatory Approval ” means, with respect to any pharmaceutical product in any regulatory jurisdiction for a given indication, approval from the applicable Regulatory Authority permitting the distribution, use and sale of such pharmaceutical product in such regulatory jurisdiction for such indication in accordance with Applicable Law.

1.59 “ Regulatory Authority ” means, in a particular country or regulatory jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval and/or Pricing Approval of a pharmaceutical product in such country or regulatory jurisdiction.

1.60 “ Regulatory Data ” means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other

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documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product (including any applicable Drug Master Files ( “DMFs” ), Chemistry, Manufacturing and Control ( “CMC” ) data, or similar documentation).

1.61 “ Regulatory Materials ” means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority that are necessary in order to Develop, Manufacture, obtain marketing authorization, market, sell or otherwise Commercialize the Product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, MAAs, presentations, responses, and applications for other Regulatory Approvals.

1.62 “ Royalty Product ” means (i) the Product or (ii) [*CONFIDENTIAL*] .

1.63 “ Royalty Term ” means, on a country-by-country basis, the following:

1.63.1 with respect to each Tier 1 Country, the period of time beginning on the First Commercial Sale of the Product in such country and ending upon the later of (i) the date of expiration of the last to expire Licensor Patent or Collaboration Patent containing a Valid Claim Covering the Commercialization, Manufacturing or use, but where the only remaining Valid Claim Covers a method of use, only a use in an indication that is approved and included in Promotional Materials used by Licensee or its Sublicensees in the applicable jurisdiction, of the Compound or Product in such country, (ii) fifteen (15) years from First Commercial Sale of the Product in such country, or (iii) the date of expiration of data exclusivity as conferred by a competent Regulatory Authority for the Product in such country; and

1.63.2 with respect to each Tier 2 Country, the period of time beginning on the First Commercial Sale of the Product in such country and ending after fifteen (15) years from First Commercial Sale of the Product in such country.

1.64 “ S*BIO Agreement ” means the Asset Purchase Agreement between S*BIO Pte Ltd. ( “ S*BIO ” ) and Licensor, dated as of August 7, 2012, in the form attached hereto in Schedule 1.64 , as may be amended from time-to-time only in accordance with Section 10.2.14.

1.65 “ Sales Representative ” means an individual who is employed by a Party and who performs details and other promotional efforts with respect to the Product.

1.66 “ Second Indication ” means the use of the Product in combination with Azacitidine for the treatment of intermediate and/or high risk and/or very high risk myelodysplastic syndrome (MDS).

1.67 “ Target Indication ” means the use of the Product in combination with Azacitidine for the treatment of patients with diagnosed acute myeloid leukemia (AML) who are “unfit” for intensive chemotherapy. The Parties acknowledge and agree that “unfit” will be construed broadly to include all synonyms thereof and analogous concepts with respect thereto, including “unsuited” and “not able” to receive intensive chemotherapy.

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1.68 “ Territory ” means all countries worldwide.

1.69 “ Third Indication ” means any indication other than the Target Indication or the Second Indication.

1.70 “ Third Party ” means any Person other than Licensor, Licensee or their respective Affiliates.

1.71 “Tier 1 Country” means any of the following countries: [*CONFIDENTIAL*].

1.72 “ Tier 2 Country ” means any country in the Territory other than a Tier 1 Country.

1.73 “ United States ” or “ U.S. ” means the United States of America and its possessions and territories.

1.74 “ Valid Claim ” with respect to any country, means (i) a claim of an issued and unexpired Patent in such country which has not been revoked, held unenforceable, unpatentable or invalid by an administrative agency, court or other governmental agency of a competent jurisdiction in a final and non-appealable decision (or decision unappealed within the time allowed for appeal), and which has not been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise and (ii) a claim in a pending Patent application that is being prosecuted in good faith and has not been pending for more than [*CONFIDENTIAL*] from the first office action date with respect to such Patent application (for clarity, a Patent application pending longer than such [*CONFIDENTIAL*] period would become a Valid Claim after such period upon the issuance of the relevant Patent).

1.75 Additional Definitions. The following terms have the meanings set forth in the corresponding Sections of this Agreement:

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ARTICLE 2

LICENSES

2.1 License Grants.

2.1.1 Grant to Licensee.  Subject to the terms and conditions of this Agreement, Licensor hereby grants to Licensee during the Term an exclusive (even as to Licensor, but subject to the sentence in this Section 2.1.1 beginning with “For clarity”), payment-bearing license with the right to sublicense only in accordance with Section 2.3.2, under and with respect to the Licensor Technology, to, directly or indirectly, Develop, Manufacture and Commercialize the Compound and Product in and for the Licensed Field throughout the Territory. For clarity, but without limiting the scope of the preceding sentence, (i) Licensor shall have the right to use the Licensor Technology for the sole and limited purposes of performing its obligations under this Agreement, and (ii) Licensee and its Affiliates shall not promote, market, distribute or sell the Compound to end-users, but may sell (including related distribution, importing and exporting) or otherwise supply the Compound to Affiliates and/or Sublicensees and/or Third Party manufacturers for further Manufacturing into Product for sale to end-users.

2.1.2 Grant to Licensor.  Subject to the terms and conditions of this Agreement, Licensee hereby grants to Licensor during the Term a non- exclusive, royalty free license, with the right to sublicense ( [*CONFIDENTIAL*] ), under and with respect to the Licensee Technology, for the sole and limited purposes of performing its obligations under this Agreement.

2.2 Additional Licensing Provisions.

2.2.1 Negative Covenant.   Licensee covenants that it will not use or practice any of Licensor’s rights to and under the Licensor Patents or other intellectual property rights licensed (or sublicensed, as applicable) to it under this ARTICLE 2, except for the purposes expressly permitted in the applicable license grant.

2.2.2 Freedom to Operate.  In addition to the exclusive license granted under Section 2.1.1, Licensor hereby grants to Licensee a non-exclusive license under [*CONFIDENTIAL*] that are (i) Controlled by Licensor or its Affiliates during the Term and (ii) necessary to Develop, Manufacture and Commercialize the Compound and the Product in the Licensed Field in the Territory.

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2.2.3 No Implied Licenses; Retained Rights.  Except as explicitly set forth in this Agreement, Licensor does not grant any license, express or implied, under its intellectual property rights to Licensee, whether by implication, estoppel or otherwise.

2.3 Performance by Affiliates and Sublicensees.

2.3.1 Performance by Affiliates.  The Parties recognize that each may perform some or all of its obligations under this Agreement through Affiliates; provided, however, that each Party shall remain responsible for the performance by its Affiliates and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Each Party hereby expressly waives any requirement that the other Party exhausts any right, power or remedy, or proceed against an Affiliate, for any obligation or performance hereunder prior to proceeding directly against such Party with respect to such obligation or performance. Wherever in this Agreement the Parties delegate responsibility to Affiliates, the Parties agree that such entities may not amend the terms of this Agreement or act contrary to its terms in any way. Notwithstanding the foregoing, or anything to the contrary herein, an Affiliate of Licensee shall not have the right to promote, market or sell the Product to end users unless such Affiliate is a Sublicensee under and in accordance with Section 2.3.2; provided, that, Licensee’s Affiliates may sell (including related distribution, exporting and importing of) Compound and Product to other Affiliates of Licensee and Sublicensees (and, for clarity, which sales are not Net Sales).

2.3.2 Sublicensees.  Licensee shall have the right (but not the obligation) to sublicense those rights granted to it under Section 2.1.1 and Section 2.2.2 to (i) any Affiliate or Third Party outside of the United States, without the prior written consent of Licensor, (ii) a Qualified Sublicensee [*CONFIDENTIAL*] , without the prior written consent of Licensor, and (iii) any other Third Parties [*CONFIDENTIAL*] , with Licensor’s prior written consent, not to be unreasonably withheld or delayed (each of (i) through (iii), a “ Sublicensee ” ), which sublicenses may include the right of such Sublicensees to grant further sublicenses on terms consistent with this Section 2.3.2 (and any such sub-sublicensees, regardless of the number of tiers, shall be a “Sublicensee”). Each sublicense granted by Licensee or its Sublicensees shall be consistent with the terms and conditions of this Agreement. Licensee shall provide Licensor notice of each sublicense promptly after the execution, and prior to any public disclosure, thereof identifying the Sublicensee, the countries involved and whether such Sublicensee is being granted the right(s) to Develop, Manufacture and/or Commercialize the Compound and/or Product. Licensee shall remain responsible for the performance or non-performance of all of its obligations under this Agreement by any Sublicensees as if such actions or inactions were being taken, or omitted, directly by Licensee and, accordingly, Licensee shall have such cure rights, if any, as are provided to Licensee hereunder in connection with any such actions or inactions as may constitute a breach of this Agreement. Without limiting Licensee’s obligations under this Agreement, Licensee shall enforce the terms of each relevant sublicense agreement as Licensee will deem appropriate in the best interest of the Product. Licensee hereby expressly waives any requirement that Licensor exhaust any right, power or remedy, or proceed against a subcontractor, for any obligation or performance hereunder prior to proceeding directly against Licensee. For the avoidance of doubt, and notwithstanding the grant of any sublicense

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with respect to any one or more countries, Licensee will remain directly responsible for all amounts owed to Licensor under this Agreement.

2.4 [*CONFIDENTIAL*].

2.5 Technology Transfer.  In accordance with the transfer plan set forth on Schedule 2.5 hereto (the “ Technology Transfer Plan ” ), Licensor shall transfer to Licensee, and Licensee shall accept, the Licensor Know-How, Regulatory Materials, Regulatory Data and other technical information that is described in the Technology Transfer Plan and other, if any, Licensor Know-How, Regulatory Materials and Regulatory Data Controlled by Licensor as of the Effective Date, to permit and enable Licensee or its Affiliates to Develop and Manufacture the Compound and the Product pursuant to the terms of this Agreement. The implementation and transfer of information and materials pursuant to this Section 2.5 shall be conducted through electronic, email and teleconference consultation between the Parties as set forth in the Technology Transfer Plan. Without limiting the foregoing, subject to the availability of Licensor’s personnel, Licensor shall provide reasonable assistance to Licensee, upon Licensee’s reasonable request therefor, for a period not to exceed [*CONFIDENTIAL*] following the Effective Date, in interpreting and understanding the Licensor Know-How to facilitate the effective adoption thereof. In addition, Licensor shall, [*CONFIDENTIAL*].  For clarity, in the event that [*CONFIDENTIAL*] , then [*CONFIDENTIAL*].  In addition to the foregoing transfer obligations, the Parties will take such steps as are necessary for Licensor to continue conducting the On-Going Studies and the POC Study under the IND(s) transferred to Licensee. Licensee may only use the Regulatory Materials and Regulatory Data provided by Licensor hereunder in accordance with the rights granted to Licensee under Section 2.1.1.

2.6 Access to Raw Data.  If reasonably required by Licensee and not previously provided, Licensor shall, upon reasonable notice from Licensee, provide Licensee with an opportunity to review and use any original documentation and raw data related to the Compound and/or the Product that is in Licensor’s or its Affiliates’ Control on the Effective Date or at the time of Licensee’s request; provided, that the foregoing obligation to provide any such raw data shall not include raw data that was generated prior to Licensor coming to Control the Compound and Product and that was never in Licensor’s possession (the “ External Data ” ). If Licensee or Licensor becomes aware of the existence of such External Data after the Effective Date, then upon request by Licensee, Licensor shall provide reasonable assistance to Licensee in locating and acquiring access to such External Data from the entity in possession of such External Data. For clarity, Licensor shall have no obligation under this Section 2.6 to generate any new documentation, raw data or analysis thereof.

2.7 Ongoing Agreements.

2.7.1 Licensor shall comply with the relevant terms and conditions of the Ongoing Agreements and shall use Commercially Reasonable Efforts to complete, or cause the completion of, the activities provided for in each Ongoing Agreement (i.e., the completion of the activities under the specific work orders identified in Schedule 1.46 ) as expeditiously as possible. Licensor shall regularly discuss with Licensee and shall keep Licensee informed regarding

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relevant activities under each Ongoing Agreement as reasonably requested by Licensee. Licensee shall also be entitled to [*CONFIDENTIAL*] with the Third Party counter-parties to the Ongoing Agreements and will [*CONFIDENTIAL*] of any such [*CONFIDENTIAL*] . In case of any disagreement between the Parties with respect to any such activity, [*CONFIDENTIAL*] shall have the right to make the final decision; provided, that [*CONFIDENTIAL*] cannot exercise its decision-making authority in any way that (i) would cause [*CONFIDENTIAL*] to be in breach of [*CONFIDENTIAL*] or (ii) would impose upon [*CONFIDENTIAL*] any additional obligations (e.g., in terms of employee allocation) without [*CONFIDENTIAL*] prior written consent. All fees and payments incurred by Licensor in connection with the Ongoing Agreements shall be borne by Licensee and shall be reimbursed upon presentation by Licensor of the relevant invoice accompanied by appropriate written evidence of the expenses incurred, provided however that Licensee shall not be obliged to reimburse any amount that (i) was not contemplated in the relevant Ongoing Agreement, and (ii) was not previously authorized in writing by Licensee (provided, further, that, the Parties acknowledge and agree that all amounts in connection with activities planned or ongoing under the Ongoing Agreements as of the Effective Date and already disclosed to Licensee prior to the Effective Date have been previously authorized by Licensee). Licensee may request changes to an Ongoing Agreement and Licensor will use Commercially Reasonable Efforts to cause any such change to be implemented under the applicable Ongoing Agreement, subject to Licensee’s payment of all documented fees and payments incurred by Licensor in connection with such change.

2.7.2 All results, information, and data arising out of the activities conducted under the Ongoing Agreements shall be timely communicated to Licensee and put at Licensee’s disposal for use by Licensee in accordance with the terms and conditions of this Agreement.

2.8 Improvements.   Subject to the terms and conditions of this Agreement, Licensee shall have the right to develop and carry out, directly or indirectly, and to license to its Affiliates and Third Parties, whatever improvement, addition, refinement, modification or development, whether patentable or not, it deems fit with respect to the Compound and the Product.

2.8.1 Licensee will be the exclusive owner of any and all Inventions generated with regard to the Compound and/or the Product which are conceived, reduced to practice or otherwise developed by Licensee and/or any of its Affiliates or Sublicensees or any employee, agent or other person acting on behalf of Licensee, and of any resulting Patent (which shall be a Licensee Patent).

2.8.2 Licensee will be the sole owner of all Joint Inventions generated with regard to the Compound and/or the Product. Licensor may be listed as inventor so as to establish joint inventorship in the case of any relevant Patent or Collaboration Patent claiming a Joint Invention, which shall in any event constitute a Licensee Patent. For clarity, the Parties hereby acknowledge and agree that Licensor shall have no right to conduct any activities with respect to the Compound and the Product after the Effective Date, except as expressly provided

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for under this Agreement, including activities in connection with the Ongoing Studies, the POC Study and the Ongoing Agreements.

2.8.3 For clarity, [*CONFIDENTIAL*] shall at any time have the right to decide whether to file any application for a [*CONFIDENTIAL*] Patent, including any [*CONFIDENTIAL*] Patent, as well as to maintain, prosecute and enforce any such [*CONFIDENTIAL*] Patent (including [*CONFIDENTIAL*] Patent) in any country of the Territory at its sole discretion, and [*CONFIDENTIAL*] shall use Commercially Reasonable Efforts to support and/or assist, bearing exclusively [*CONFIDENTIAL*] own internal costs, as may be reasonably required by [*CONFIDENTIAL*] in connection therewith.

2.8.4 [*CONFIDENTIAL*] hereby assigns to [*CONFIDENTIAL*] all right, title and interest that it or its Affiliates or their respective employees or contractors may have in and to the [*CONFIDENTIAL*] Patents, together with the right to sue for past, present, and future infringement thereof. With respect to agreements executed after the Effective Date, if any, [*CONFIDENTIAL*] shall require that all of its and its Affiliates’ employees and contractors conducting any activities with respect to the Compound or Product execute a written agreement with [*CONFIDENTIAL*] pursuant to which (i) such employees and contractors assign to [*CONFIDENTIAL*] all of their right, title and interest that they may have with respect to any Invention pertaining to the Compound or Product, and (ii) agree to maintain the confidentiality of all such Inventions on terms consistent with the provisions of ARTICLE 12.

ARTICLE 3

GOVERNANCE

3.1 Joint Steering Committee.  Promptly following the Effective Date, Licensee and Licensor will establish a joint steering committee ( “ JSC ” ), consisting of six (6) people, with three (3) representatives appointed by Licensor and three (3) representatives appointed by Licensee. The JSC will be chaired by one of Licensee’s representatives. The role of the JSC shall be advisory in nature, with the main purpose of serving as a forum for the sharing of information and facilitating communications between the Parties regarding Development Activities and Commercialization.

3.2 Meetings and Minutes.

3.2.1 The JSC shall meet at least quarterly for the first two (2) Calendar Years, and thereafter twice per Calendar Year, or as often as needed and as agreed by the Parties, with each Party bearing its own costs and expenses for organization and participation. Meetings may be in-person, or by telephone conference call, or internet meeting, as determined by the JSC members for each meeting. Employees or consultants of a Party who are not representatives of the Parties on the JSC may attend JSC meetings; provided, however, that such attendees are bound by obligations of confidentiality and non-disclosure consistent with ARTICLE 12.

3.2.2 Licensee will be responsible for preparing reasonably detailed written minutes of all JSC meetings that reflect material decisions made and action items identified at such meetings. Definitive minutes of all JSC meetings shall be finalized no later

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than ten (10) Business Days after the meeting to which the minutes pertain. If at any time during the preparation and finalization of the meeting minutes, the Parties do not agree on any issue with respect to the minutes, such issue shall be recorded in the finalized minutes for said meeting.

3.3 Decision Making.

3.3.1 Without prejudice to the provisions of Section 3.3.2 below, the JSC shall attempt to make decisions by consensus of the representatives present, with each Party having a single vote irrespective of the number of representatives of such Party in attendance or by a written resolution signed by at least one (1) representative appointed by each Party.

3.3.2 If the JSC cannot, or does not, reach consensus on an issue which has been discussed during a meeting of the JSC, within five (5) Business Days after the matter has first been discussed by the JSC, or any shorter term which is required by specific circumstances, then such issue will first be referred to the respective Executive Officers of the Parties to try to reach a mutually acceptable resolution. In the event that the Executive Officers of each Party are unable to resolve such dispute in good faith within five (5) Business Days, and provided that the Executive Officers have discussed such matter, then [*CONFIDENTIAL*] shall have the sole authority to decide such matter; provided that any final determination made by [*CONFIDENTIAL*] under this Section 3.3.2 shall (i) be consistent with the terms of this Agreement (and shall not amend this Agreement) and (ii) not require [*CONFIDENTIAL*] to conduct any activities or bear any additional expense without the [*CONFIDENTIAL*] prior written consent. For the avoidance of any doubt, it is hereby expressly agreed that Licensee shall have the right to decide on all steps to be taken in connection with the Development and/or the Commercialization of the Product; provided, that all such Development and/or Commercialization shall be conducted in accordance with the terms and conditions of this Agreement.

ARTICLE 4

DEVELOPMENT

4.1 Development Progress Updates.  At the end of each [*CONFIDENTIAL*] , Licensee shall provide Licensor with a report regarding the progress of Development Activities during the previous [*CONFIDENTIAL*] . Without limiting the foregoing, reasonably prior to each meeting of the JSC, each Party shall provide the other Party with a written summary regarding material Development activities that it has directly or indirectly conducted, if any, since the previous JSC meeting, and shall provide copies of any specific information that the other Party may reasonably request with respect such summary.

4.2 Overview of Development. Subject to the terms and conditions of this Agreement, Licensee shall be responsible for the Development of the Product as set forth herein. Licensee shall use Commercially Reasonable Efforts to perform Development Activities for the Product to achieve the development milestones set forth in Section 8.2.

4.3 Development Plan.

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4.3.1 Licensee shall (i) use Commercially Reasonable Efforts to carry out Development Activities (other than those constituting Essential Development Elements) pursuant to a development plan (as amended from time to time pursuant to this Section 4.3, the “ Development Plan ” ) in accordance with the tentative time frames indicated in the Development Plan and (ii) carry out the Essential Development Elements pursuant to the Development Plan in accordance with the tentative time frames indicated in the Development Plan. Subject to Section 4.3.2, the Development Plan shall be provided by Licensee to Licensor and the JSC within [*CONFIDENTIAL*] of the Effective Date.

4.3.2 The Development Plan shall in any and all events be consistent with Schedule 4.3.2 (the subject matter of such Schedule, “ Essential Development Elements ” ). In addition, the Development Plan shall include CMC activities, preclinical studies and Clinical Trials necessary for obtaining and maintaining Regulatory Approval, with respect to the Product and the projected timeline for completing such Development Activities. Licensee may update the Development Plan from time-to-time to reflect any material changes, reprioritizations of, or additions to the Development Plan. Such updated Development Plan shall be discussed in the following JSC meeting and Licensee will consider (but will [*CONFIDENTIAL*] ) any comments provided by the JSC in good faith. Once Licensee has considered, and to the extent applicable, incorporated any comments by the JSC, it shall provide Licensor with a copy of such amended Development Plan. Notwithstanding anything to the contrary in this Agreement, the Development Plan shall continue to include the Essential Development Elements, except to the extent that Licensor grants its consent to the modification of any Essential Development Element, which consent shall not be unreasonably withheld or delayed.

4.3.3 Licensee shall conduct the Development Activities in accordance with sound and ethical business and scientific practices, and in compliance with all Applicable Law, including GCPs and GLPs, and also including all applicable data privacy and data protection laws. In addition, Licensee shall not use in any capacity, in connection with its Development of the Compound or Product hereunder, any Person who has been debarred pursuant to Section 306 of the FD&C Act (or similar Applicable Law outside of the U.S.), or who is the subject of a conviction described in such section, and Licensee shall inform Licensor in writing immediately if it or any Person who is performing services for Licensee hereunder is debarred or is the subject of a conviction described in Section 306 (or similar Applicable Law outside of the U.S.), or if any action, suit, claim, investigation or legal administrative proceeding is pending or, to Licensee’s knowledge, is threatened, relating to the debarment of Licensee or any Person used in any capacity by Licensee in connection with its Development of the Compound or Product hereunder.

4.4 Development Costs.   As between the Parties, Licensee shall be solely responsible for one hundred percent (100%) of all Development costs incurred by or on behalf of Licensee or its Affiliates or Sublicensees, with respect to any Development Activities, except to the extent otherwise set forth in the Technology Transfer Plan and excluding, for clarity, Development Activities with respect to the On-Going Studies and the activities set forth at Section 4.7 with respect to the POC Study for the Second Indication.

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4.5 Records, Reports and Information.

4.5.1 General.   Each Party shall maintain current and accurate records (in sufficient detail and in good scientific manner appropriate for regulatory and patent purposes) of all work conducted by it or on its behalf (including, with respect to Licensee, work conducted by its Affiliates and Sublicensees in accordance with Section 2.3) under the Development Plan or in connection with the On-Going Studies, the On-Going Agreements and the POC Study in full compliance with GxPs and any and all Applicable Laws.

4.5.2 Access to Records.   [*CONFIDENTIAL*] shall have the right to review all records in connection with the [*CONFIDENTIAL*] , the activities performed under [*CONFIDENTIAL*] , and the [*CONFIDENTIAL*] Controlled by [*CONFIDENTIAL*] upon written request and the Parties’ reasonable agreement regarding an appropriate time for such audit.

4.6 On-Going Studies.   Licensor will use Commercially Reasonable Efforts to conduct, or have conducted, and finalize the On-Going Studies as soon as reasonably possible. Licensor has conducted and shall conduct the Ongoing Studies in accordance with sound and ethical business and scientific practices, and in compliance with all Applicable Law, including GCPs and GLPs, and also including all applicable data privacy and data protection laws. In addition, Licensor has not used and shall not use in any capacity, in connection with the Ongoing Studies, any Person who has been debarred pursuant to Section 306 of the FD&C Act (or similar Applicable Law outside of the U.S.), or who is the subject of a conviction described in such section, and Licensor shall inform Licensee in writing immediately if it or any Person who is performing services for Licensor hereunder is debarred or is the subject of a conviction described in Section 306 (or similar Applicable Law outside of the U.S.), or if any action, suit, claim, investigation or legal administrative proceeding is pending or, to Licensor’s knowledge, is threatened, relating to the debarment of Licensor or any Person used in any capacity by Licensee in connection with the On-Going Studies. Licensee shall have the right to review and comment on the clinical study report and/or appendices of the On-Going Studies.

4.7 POC Study for the Second Indication.

4.7.1 Promptly following the Effective Date, the Parties shall discuss and seek agreement in good faith on the protocol for the performance of the POC Study, the contract research organization to be engaged and the relevant budget for such POC Study. Licensor shall be responsible for performance of the POC Study in accordance with Applicable Laws and subject to Section 4.6 applied mutatis mutandis with respect to the POC Study; provided, that, in the event that the external costs associated with the POC Study exceed USD [*CONFIDENTIAL*] , then the Parties shall confer and shall seek an agreement in good faith following the procedure described at Section 3.3.2, provided however that in case that the Parties are unable to find such an agreement then none of the Parties will have a casting vote and the POC Study will be discontinued (subject to compliance with any Applicable Laws and regulatory requirements).

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4.7.2 The Parties shall on a regular basis exchange information and updates on the POC Study through meetings of the JSC, including by way of Licensor’s reporting obligations under Section 4.1.

4.7.3 Licensee will reimburse Licensor for [*CONFIDENTIAL*] of all documented external costs and expenses incurred by Licensor in connection with the POC Study, up to USD [*CONFIDENTIAL*] . Licensor shall invoice Licensee from time-to-time in connection with such amounts, and Licensee shall pay such invoices within [*CONFIDENTIAL*] of receipt of an invoice therefor.

4.7.4 For clarity, following completion of the POC Study, Licensee will be free to decide whether or not to pursue the further Development of the Product for the Second Indication (and to [*CONFIDENTIAL*] any relevant [*CONFIDENTIAL*] ) and any and all subsequent activities will be governed by the terms and conditions of this Agreement.

ARTICLE 5

REGULATORY

5.1 Regulatory Filings and Regulatory Approvals.

5.1.1 General Responsibilities; Ownership of Regulatory Approvals.  Subject to Section 2.5, Licensee or its nominee shall be responsible for the preparation of all Regulatory Materials necessary or desirable for obtaining and maintaining the Regulatory Approvals for the Compound (to the extent necessary) and Product (including in connection with Patient Information Leaflets, labeling and packaging for the Product) and Licensee shall, directly or through any of its nominees, submit such Regulatory Materials, as applicable, to the applicable Governmental Authorities.

5.1.2 Pricing Approvals.  To the extent that a given country or regulatory jurisdiction requires Pricing Approval for sale of the Product, Licensee shall (to the extent permitted by Applicable Laws), directly and/or through any of its nominees, be solely responsible for (and shall use Commercially Reasonable Efforts toward) obtaining and maintaining Pricing Approvals in all such countries and regulatory jurisdictions.

5.1.3 Cost of Regulatory Activities.  Subject to Section 2.5, all regulatory costs incurred in connection with the preparation of Regulatory Materials, and obtaining of Regulatory Approvals, for the Compound and Product shall be borne solely by Licensee. Licensee shall be responsible for all regulatory costs involved in the maintenance of all Regulatory Approvals for the Compound and Product.

5.1.4 Reporting and Review.  Starting from the date of the first MAA submission in any country of the Territory, Licensee shall send Licensor a report every two Calendar Quarters setting forth all MAAs and Regulatory Approvals that have been submitted for approval or received approval for, in each case with respect to the Product (and whether submitted or received by or on behalf of Licensee or its Affiliate or Sublicensee); provided, that, in any event, Licensee shall notify Licensor within five (5) Business Days regarding its or its

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Affiliate’s or Sublicensee’s receipt of Regulatory Approval for the Product and an indication in each of the United States, Japan, China, the United Kingdom, Spain, Italy, Germany or France.

5.2 Pharmacovigilance and Medical Inquiries.

5.2.1 Pharmacovigilance.   Subject to Section 2.5 and the Parties’ transition of the global safety database (including relevant information related to adverse events) on timing agreed by the Parties, Licensee shall be responsible for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product (whether or not Regulatory Approval has been achieved), in each case in accordance with Applicable Law and this Agreement (and Licensee shall ensure that, in the Development and Commercialization of the Product, it will record, investigate, summarize, notify, report and review all adverse events in accordance with Applicable Law). While the On-Going Agreements, On-Going Studies and the POC Study continue, Licensor shall be responsible for the collection and transmission to Licensee of information related to adverse events associated with the Product arising from such On-Going Agreements, On-Going Studies and POC Study as required by Applicable Laws and the Parties will work together in good faith to ensure that each has access to such safety data as is required by Applicable Law and in order enable each Party to satisfy any regulatory requirements.

5.2.2 Medical Inquiries for the Product.  Following the Effective Date, subject to Section 5.1.1, Licensee shall be responsible for handling all medical questions or inquiries in each country, including all Product Complaints, with regard to Product sold by or on behalf of Licensee (or any of its Sublicensees), in each case in accordance with Applicable Law and this Agreement.

5.3 Regulatory Authority Communications Received by a Party.

5.3.1 General.   Each Party shall use Commercially Reasonable Efforts to promptly inform the other Party of notification of any action by, or notification or other information that it receives (directly or indirectly) from, any Regulatory Authority that (i) raises any material concerns regarding the safety or efficacy of the Product or Compound, (ii) indicates a potential material liability of either Party to Third Parties in connection with the Product or Compound, (iii) is reasonably likely to lead to a recall, market withdrawal or market notification with respect to the Product or Compound, or (iv) relates to expedited and periodic reports of adverse events with respect to the Product or Compound, or Product Complaints, and which may have an adverse impact on Regulatory Approval or the continued Commercialization of the Product or Compound. Licensee shall be solely responsible for responding to any such communications relating to the Product, and the Parties shall reasonably cooperate with and assist each other in complying with regulatory obligations. Each Party shall also promptly provide the other Party with a copy of all material correspondence received from a Regulatory Authority specifically regarding the matters referred to above to the extent reasonably requested by such other Party.

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5.3.2 Disclosures.   In addition to its obligations under this Agreement, each Party shall use Commercially Reasonable Efforts to promptly disclose to the other Party the following regulatory information:

(a) All material information pertaining to material actions taken by Regulatory Authorities, in connection with the Product or Compound, including notice of initiation by Regulatory Authorities of investigations, inspections, detentions, seizures or injunctions concerning the Product or Compound, notice of violation letter (i.e., an untitled letter), warning letter, service of process or other material inquiry.

(b) All material information pertaining to notices from Regulatory Authorities, regarding non-compliance with Applicable Law in connection with the Product or Compound as soon as reasonably possible.

5.4 Recall, Withdrawal, or Market Notification of Product.  In the event that (i) any Governmental Authority threatens or initiates any action to recall or withdraw the Product from the market, or to cause a market notification (e.g., by requiring the issuance of a “Dear Doctor” letter) or (ii) Licensee makes the determination to initiate any action to recall or withdraw the Product from the market, or to cause a market notification, Licensee shall notify Licensor of such communication or determination, as applicable, promptly and without delay after receipt or determination, as applicable, thereof. Licensee shall determine whether to initiate any recall, withdrawal or market notification of the Product. Licensee shall at all times utilize a batch tracing system which will enable the Parties to identify, on a prompt basis, customers who have been supplied with Product of any particular batch, and to recall such batch of Product from such customers as set forth in this Section 5.4. All costs and expenses associated with implementing a recall, withdrawal or market notification with respect to the Product shall be borne by Licensee.

ARTICLE 6

COMMERCIALIZATION

6.1 Commercialization.   During the Term, Licensee shall be solely responsible for Commercializing the Compound and Product, which Commercialization shall be in accordance with this Agreement and with all Applicable Laws. As between the Parties, Licensee shall be responsible for one hundred percent (100%) of the expenses (including Pre-Marketing and other Commercialization expenses) incurred by or on behalf of Licensee or its Sublicensees in connection with the Commercialization of the Compound and Product, including any expenses incurred by or on behalf of Licensee or its Affiliates in connection with selling (including related exporting and importing of) Compound and Product in unfinished form to other Affiliates of Licensee and Sublicensees. Without limiting the foregoing, Licensee shall use Commercially Reasonable Efforts to Commercialize the Product throughout the Territory.

6.2 Commercialization Progress Updates.   Licensee shall regularly inform and update Licensor on the status of its and its Sublicensees Pre-Marketing and Commercialization of the Product. Such updates and information, and any relevant discussion on the status of such Pre-Marketing and Commercialization shall be made in the course of meetings of the JSC

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starting from the date indicated above, and Licensee will consider (but will not be obliged to follow) any comments provided by the JSC in good faith.

6.3 Licensee’s Performance.

6.3.1 Specific Commercialization Obligations.  Without limiting the generality of the provisions of Section 6.1, in connection with the Commercialization of the Compound and Product by or on behalf of Licensee hereunder:

(a) Licensee shall (i) use Commercially Reasonable Efforts to Commercialize the Product for the Target Indication throughout the Territory and to maximize the commercial potential for the Product and (ii) not sell or distribute the Product in the [*CONFIDENTIAL*] in such a manner as to decrease the revenue attributable to the Product in the interest of benefiting another product being sold or distributed by or on behalf of Licensee.

(b) Licensee shall not utilize deceptive, misleading or unethical business practice in connection with the Commercialization of the Compound or Product hereunder.

(c) Licensee shall be solely responsible, directly or through its Affiliates or Sublicensees, as applicable in accordance with such activities as Affiliates or Sublicensees may conduct in accordance with the terms of this Agreement, for (i) receiving, accepting and filling orders for the Compound and Product, (ii) handling all returns of the Compound and Product, (iii) controlling invoicing, order processing and collection of accounts receivable for the sales of the Compound and Product, and (iv) distributing and managing inventory of the Compound and Product.

6.3.2 Compliance.  Licensee shall not use in any capacity, in connection with its Commercialization of the Compound or Product hereunder, any Person who has been debarred pursuant to Section 306 of the FD&C Act (or similar Applicable Law outside of the U.S.), or who is the subject of a conviction described in such section, and Licensee shall inform Licensor in writing immediately if it or any Person who is performing services for Licensee hereunder is debarred or is the subject of a conviction described in Section 306 (or similar Applicable Law outside of the U.S.), or if any action, suit, claim, investigation or legal administrative proceeding is pending or, to Licensee’s knowledge, is threatened, relating to the debarment of Licensee or any Person used in any capacity by Licensee in connection with its Commercialization of the Compound or Product hereunder.

6.4 Promotional Materials.

6.4.1 Creation of Promotional Materials.  Licensee will create, directly or through its Sublicensees or other nominees, and develop Promotional Materials for the Product in accordance with the Regulatory Approvals and Applicable Law.

6.4.2 No Inclusion of Licensor Logos on Packaging and Promotional Materials.   Notwithstanding anything to the contrary herein, Licensee shall not use any Licensor

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trademark, names, logos or housemark in connection with any Promotional Materials or the Product without Licensor’s prior written consent, which consent shall not be withheld or delayed in the event that Applicable Laws requires the use of any such Licensor marks.

6.4.3 Licensee Ownership of Promotional Materials.  Licensee shall own all right, title and interest in and to any Promotional Materials created by or on behalf of Licensee hereunder relating to the Product including copyrights, but excluding trademarks, names, logos and other marks Controlled by Licensor or its Affiliates.

6.5 Product Trademarks and Product Trade Dress.

6.5.1 Product Trademark.  Licensee shall Commercialize the Product under the trademark and the trade dress selected by Licensee (the “ Product Trademark ” and the “ Product Trade Dress ” , respectively).

6.5.2 Use and Ownership of Product Trademarks and Product Trade Dress.  All uses of the Product Trademark and Product Trade Dress by Licensee, its Affiliates and Sublicensees to identify and/or in connection with the Commercialization of the Product shall be in accordance with Regulatory Approvals and all Applicable Law. Licensee shall own and retain all rights to the Product Trademark and Product Trade Dress (in each case, together with all goodwill associated therewith). Licensee shall also own rights to any internet domain names incorporating the Product Trademark or any variation or part of such trademark as its URL address.

6.5.3 Maintenance of Product Trademark.  During the Term, Licensee will use Commercially Reasonable Efforts to establish, maintain and enforce the Product Trademarks as it deems appropriate in connection with the Commercialization of the Product, and will bear all costs and expenses relating thereto.

6.6 Commercialization Data.  Licensee shall own all marketing and sales data and information resulting from its Commercialization of the Product during the Term (the “ Commercialization Data ” ), including promotional materials, marketing strategies and market research data.

ARTICLE 7

SUPPLY

7.1 Transfer of Existing Materials.  Within [*CONFIDENTIAL*] of the Effective Date, Licensor shall provide a one-time supply of Product and Compound to Licensee, without further consideration by Licensee to Licensor, other than that set forth in Section 8.1 below, up to the amounts and in the forms set forth on Schedule 7.1 , which Licensee agrees to accept on an as-is basis. Licensor shall make available to Licensee the Product and Compound up to the amounts and in the forms specified on Schedule  7.1 with appropriate documentation (i.e., appropriate certificates of analysis or compliance, as applicable) following receipt of a written request therefor from Licensee that specifies the quantities and forms desired. The Product and Compound shall be made available to Licensee EXW (as defined in INCOTERMS 2010) at the

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warehouse locations specified in Schedule 7.1 . For clarity, Licensee shall bear all costs related to shipping, taxes, and acceptance testing associated with such supply. In the event that Licensee does not provide such a written request, or if there are any quantities of Compound or Product remaining after such [*CONFIDENTIAL*] period, and subject to Section 7.3 below, Licensor will destroy any such remaining quantities and will inform Licensee of such destruction.

7.2 Subsequent Supply; Packaging and Labeling; Certain Other Manufacturing Activities. Licensee or its designated Third Party shall be responsible (at its sole cost and expense) for all Product and Compound supply (other than Product and Compound supplied by Licensor under Section 7.1) and all final product labeling and packaging (whether in commercial or clinical packaging presentation), including insertion of materials such as patient inserts, patient medication guides, professional inserts and any other written, printed or graphic materials accompanying the Product and considered to be part of the finished Product packaging and labeling, and handling, storage, quality control, quality assurance, testing and release (collectively, “ Packaging and Labeling ” ). For clarity, Licensee’s Packaging and Labeling responsibilities apply to the Product and Compound supplied by Licensor under Section 7.1. Licensee or its designated Third Party shall ensure that all such Packaging and Labeling complies with Applicable Laws, GMPs and the Regulatory Approvals for the Product. To the extent that a Third Party is involved in Packaging and Labeling or other activities described in this Section 7.2, Licensee shall be wholly responsible for, and bear one hundred percent (100%) of the costs related to, qualifying such Third Party to perform such activities.

7.3 MEI Supplies. Notwithstanding Sections 2.5 and 7.1, the Parties acknowledge and agree that Licensor will retain those quantities of Compound and Product as are set forth on Schedule 7.3 in connection with Licensor’s obligations to perform the Ongoing Studies and to complete activities under the Ongoing Agreements. In addition, the Parties shall work together in good faith to ensure that Licensor is allocated and receives a sufficient quantity of Compound and Product to perform the POC Study from the supply generated under those certain On-Going Agreements identified on Schedule 1.46 with agreement identifiers [*CONFIDENTIAL*] .

ARTICLE 8

PAYMENTS

8.1 Upfront Payments. Licensee shall pay to Licensor by wire transfer of immediately available funds, into an account designated in writing by Licensor, an amount equal to (i) fifteen million dollars ($15,000,000), within ten (10) Business Days of the Effective Date, and (ii) five million dollars ($5,000,000), within ten (10) Business Days of the earlier of (a) the date when Licensee (or its Affiliate, Sublicensee or other nominee) becomes aware of the first dosing of a patient with the Product in the Clinical Trial internally designated by Licensor as MEI 009 or (b) March 1, 2017 (together, clauses (i) and (ii), the “ Upfront Payment ” ). The Upfront Payment shall be (i) non-refundable and non-creditable against any other payments due hereunder and (ii) inclusive of the consideration for the Compound and Product supply to be made by Licensor to Licensee pursuant to Section 7.1 above.

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8.2 Milestone Payments.   Licensee shall pay to Licensor the milestone payments described in this Section 8.2 following achievement (and only upon the first occurrence) of the corresponding milestone event. Licensee shall promptly notify Licensor in writing of, but in no event later than [*CONFIDENTIAL*] after, the achievement of each such milestone event (each, a “ Milestone Notification Notice ” ). Licensee shall pay the applicable milestone payment by wire transfer of immediately available funds into an account designated by Licensor within [*CONFIDENTIAL*] days after the achievement (and only upon the first occurrence) of the applicable milestone event; provided, however, that in no event shall a failure to deliver a Milestone Notification Notice relieve Licensee of its obligation to pay Licensor the milestone payments described in this Section 8.2. Each such milestone payment is nonrefundable and non-creditable against any other payments due hereunder.

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8.3 Royalty Payments.

8.3.1 Product.  On a country-by-country basis during the Royalty Term applicable to such country, Licensee shall pay to Licensor in accordance with Section 8.5 the following royalties on Net Sales of the Product, subject to Sections 8.3.3 and 8.3.4:

(a) Royalties for Net Sales of Product (i) [*CONFIDENTIAL*] or (ii) directly Commercialized by Licensee or its Affiliates shall be payable at the following rates:

(b) For Net Sales of Product [*CONFIDENTIAL*] and not directly Commercialized by Licensee or its Affiliates in Tier 1 Countries: [*CONFIDENTIAL*] of Net Sales of Product in each such country.

(c) For Net Sales of Product [*CONFIDENTIAL*] and not directly Commercialized by Licensee or its Affiliates in Tier 2 Countries: [*CONFIDENTIAL*] of Net Sales of Product in each such country.

For example purposes only, if aggregate annual global Net Sales equal [*CONFIDENTIAL*] , with [*CONFIDENTIAL*] of such sales [*CONFIDENTIAL*] and Tier 1 Countries where Licensee or its Affiliates are directly Commercializing the Product, then Licensor would receive total royalties for that year equal to [*CONFIDENTIAL*] , calculated as follows:

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(1) Sales [*CONFIDENTIAL*] and Tier 1 Countries where Licensee or its Affiliates are directly Commercializing the Product:  [*CONFIDENTIAL*]; PLUS

(2) sales in Tier 1 Countries ( [*CONFIDENTIAL*] ) where Licensee and its Affiliates are not directly Commercializing:  [*CONFIDENTIAL*].

8.3.2 Royalties in connection with [*CONFIDENTIAL*].

(a) On such timing as the Parties may agree in good faith, Licensee shall engage a Third Party expert selected by Licensee, and reasonably acceptable to Licensor, to evaluate, at Licensee’s sole expense, the [*CONFIDENTIAL*] by Licensee (or its Sublicensees) of [*CONFIDENTIAL*] . Licensee shall share such expert’s determination with Licensor.

(b) Regardless of such expert’s determination, Licensee shall have the right to decide at its discretion whether or not to [*CONFIDENTIAL*] (including direct Commercialization or through its Affiliates, Sublicensees or other nominees). If Licensee’s decision is positive, then (i) the licenses granted to Licensee in Sections 2.1.1 and 2.2.2 under the Licensor Technology shall, to the extent applicable, automatically be expanded from just the Product to also include [*CONFIDENTIAL*] , and (ii) Licensee shall pay to Licensor during the Royalty Term a royalty on Net Sales [*CONFIDENTIAL*] at a rate of [*CONFIDENTIAL*] where such sales are [*CONFIDENTIAL*] . Notwithstanding any other provision of this Agreement, the Parties acknowledge and agree that for purposes of calculating the royalties due under this Section 8.3.2(b), in each country in which Licensee or its Affiliate or Sublicensee is [*CONFIDENTIAL*] royalties will be payable [*CONFIDENTIAL*] . For example, if Licensee or its Sublicensee is [*CONFIDENTIAL*] in a given country, and such Person(s) sells [*CONFIDENTIAL*], then there will be deemed to be [*CONFIDENTIAL*] that are subject to royalty payments under this Section 8.3.2(b).

8.3.3 Royalty Reductions in the United States and Countries Where Licensee or its Affiliates are Directly Commercializing the Product.   On a country-by-country basis, if at any time during the Royalty Term in the United States or any country where Licensee and its Affiliates are directly Commercializing the Product a Generic Product is commercially sold and remains on the market in such country for a period of [*CONFIDENTIAL*] , then the royalty rate applicable for such country shall be reduced, starting [*CONFIDENTIAL*] from the day when the Generic Product is commercially sold, by [*CONFIDENTIAL*] . Such [*CONFIDENTIAL*] application shall be accomplished by way of the Parties calculating the overall amount of overpaid royalties based on such [*CONFIDENTIAL*] reduction, and Licensee shall have the right to offset any such amount against further payments to be paid to Licensor under this Agreement; provided, that when applying any such offset Licensee shall advise Licensor thereof in writing, including the amount of such offset remaining. Thereafter,

(a) for so long as such Generic Product remains on the market in such country, if the cumulative Net Sales in such country during a Calendar Quarter are equal to or exceed [*CONFIDENTIAL*] , but are less than [*CONFIDENTIAL*] , of the Baseline Quarter

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Net Sales, then the royalty rate will be further reduced by [*CONFIDENTIAL*] in addition to the [*CONFIDENTIAL*] reduction mentioned at Section 8.3.3 above; or

(b) for so long as such Generic Product remains on the market in such country, if the cumulative Net Sales in such country during a Calendar Quarter are less than [*CONFIDENTIAL*] , of the Baseline Quarter Net Sales, then the royalty rate will be further reduced by [*CONFIDENTIAL*] in addition to the [*CONFIDENTIAL*] reduction mentioned at Section 8.3.3.

8.3.4 Royalty Reductions in Countries Where Licensee or its Affiliates are not Directly Commercializing the Product (other than the United States).   On a country-by-country basis, if at any time during the Royalty Term with respect to any country where Licensee or its Affiliates are not directly Commercializing the Product (other than the United States), a Generic Product is commercially sold and remains on the market in such country for a period of [*CONFIDENTIAL*] , then the royalty rate applicable for such country shall be reduced, starting [*CONFIDENTIAL*] from the day when the Generic Product is commercially sold, by [*CONFIDENTIAL*] . Such [*CONFIDENTIAL*] application shall be accomplished by way of the Parties calculating the overall amount of overpaid royalties based on the such [*CONFIDENTIAL*] reduction, and Licensee shall have the right to offset any such amount against further payments to be paid to Licensor under this Agreement; provided, that when applying any such offset Licensee shall advise Licensor thereof in writing, including the amount of such offset remaining. Thereafter, and for so long as such Generic Products remain on the market, if cumulative Net Sales in such country during a Calendar Quarter are less than [*CONFIDENTIAL*] of the Baseline Quarter Net Sales, then the royalty rate will be reduced to [*CONFIDENTIAL*] .

8.3.5 Royalty Minimum.   Notwithstanding the foregoing Sections 8.3.3 and 8.3.4, or Sections 9.2(c), 9.2(d) and 9.3(c)(iii), on a country-by-country basis and for the shorter of (i) the Royalty Term in each such country or (ii) [*CONFIDENTIAL*] , in no event shall the royalties payable by Licensee to Licensor be reduced to less than [*CONFIDENTIAL*] of Net Sales in such country.

8.4 Royalties due under the S*BIO Agreement.   [*CONFIDENTIAL*] shall be responsible for any payments due to S*BIO in connection with Development, Manufacture, and Commercialization of the Product, including payments associated with Net Sales of any given Product in any country. Throughout the Term, Licensor agrees to comply with its obligations under the S*BIO Agreement to the extent necessary to preserve Licensee’s rights with respect to the Compound and the Product in the Territory under this Agreement, and not take any action that would result in the loss of [*CONFIDENTIAL*] rights held by Licensor thereunder.

8.5 Royalty Payments and Reports.   Licensee shall calculate all Royalty Payments payable to Licensor pursuant to Section 8.3 with respect to Net Sales at the end of each Calendar Quarter, which amounts shall be converted to Dollars at such time in accordance with Section 8.7. Licensee shall pay to Licensor the royalty payment due for Net Sales during a given Calendar Quarter within [*CONFIDENTIAL*] after the end of such Calendar Quarter;

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provided, that, Licensee may make such payments through any of its Affiliates; provided, further, that, and notwithstanding Section 8.6, in the event that payment through any such Affiliate results in any given tax (or incremental tax increase) that would not have been payable had Licensee not made such payment through such Affiliate, then Licensee shall be solely responsible for such tax (or incremental tax increase). Licensee shall also provide Licensor with a good faith estimate of all Net Sales and the Royalty Payments due in connection therewith within [*CONFIDENTIAL*] following the end of each Calendar Quarter, provided however that this will not create any liability on Licensee in connection with any inaccuracy which may be included in such estimate. Each royalty payment due shall be accompanied by (i) a statement of the amount of gross sales of each Royalty Product, (a) as a whole and (b) on a country-by-country basis during the applicable Calendar Quarter (including such amounts expressed in local currency and as converted to Dollars), (ii) an itemized calculation of Net Sales (a) as a whole and (b) on a country-by-country basis, showing for both (a) and (b) deductions provided for in the definition of “Net Sales” during such Calendar Quarter, and (iii) a statement of the prices and the number of units of Royalty Products sold. Licensee shall be responsible for the proper accounting of Net Sales by or on behalf of its Sublicensees.

8.6 Taxes and Withholding.

8.6.1 VAT.  The Parties agree to cooperate with one another and use reasonable efforts to ensure that any value added tax or similar payment ( “ VAT ” ) in respect of any payments made by Licensee to Licensor under this Agreement does not represent an unnecessary cost in respect of payments made under this Agreement; provided, that the Parties further agree that as of the Effective Date it is not anticipated that VAT will apply in connection with payments under this Agreement. For purposes of clarity, all sums payable under this Agreement shall be exclusive of VAT. In the event that any VAT is owing in any jurisdiction in respect of any such payment, Licensee shall pay such VAT, and (i) if such VAT is owing as a result of any action by Licensee, including any assignment or sublicense (including assignment to, or payment hereunder by, a Licensee-related entity or Affiliate), or any failure on the part of Licensee or its Affiliates to comply with applicable tax laws or filing or record retention requirements, that has the effect of modifying the tax treatment of the Parties hereto, then the payment in respect of which such VAT is owing shall be made without deduction for or on account of such VAT to ensure that Licensor receives a sum equal to the sum which it would have received had such VAT not been due or (ii) otherwise, such payment shall be made after deduction of such VAT. In the event that any deducted VAT is later recovered by Licensee, Licensee shall promptly reimburse Licensor for the deducted amount. For the sake of clarity, any increase in payments to Licensor under this Section 8.6.1 shall reflect only the incremental increase in VAT directly resulting from clause (i) above. In the event that any VAT is owing in any jurisdiction in respect of any such payment, Licensor will provide to Licensee tax invoices showing the correct amount of VAT in respect of such payments hereunder.

8.6.2 Withholding Tax Matters. If Licensee is required to make a payment to Licensor subject to a deduction of tax or withholding tax, the sum payable by Licensee (in respect of which such deduction or withholding is required to be made) shall be made to Licensor after deduction of the amount required to be so deducted or withheld, which

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deducted or withheld amount shall be remitted to the appropriate Governmental Authority in accordance with Applicable Laws. Any such withholding taxes required under Applicable Laws to be paid or withheld shall be an expense of, and borne solely by Licensor, subject to Section 8.6.1, and the obligation of Licensee to assume the responsibility of such expense in the event that such expense arises as a result of any action by Licensee.

8.6.3 Tax Cooperation. To the extent Licensee is required to deduct and withhold taxes on any payments to Licensor, Licensee shall pay the amounts of such taxes to the proper Governmental Authority in a timely manner and promptly transmit to Licensor an official tax certificate or other evidence of such withholding reasonably sufficient to enable Licensor to claim such payments of taxes. Licensor shall provide to Licensee any tax forms that may be reasonably necessary in order for Licensee not to withhold tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. Licensor shall use reasonable efforts to provide any such tax forms to Licensee at least thirty (30) days prior to the due date for any payments for which the Licensor desires that Licensee apply a reduced withholding rate. Each Party shall provide the other with reasonable assistance to enable the recovery or reduction, as permitted by Applicable Laws, of withholding taxes, VAT, or similar obligations resulting from payments made under this Agreement, such recovery to be for the benefit of the Party bearing such withholding tax or VAT.

8.7 Currency Conversion.   All payments hereunder shall be made in United States Dollars. For the purpose of calculating any sums due under, or otherwise reimbursable pursuant to, this Agreement (including the calculation of Net Sales expressed in currencies other than Dollars), any amount expressed in a foreign currency shall be converted into Dollars in a manner consistent with Licensee’s normal practices used to prepare its audited financial statements for external reporting purposes, in accordance with GAAP, consistently applied, or by using the Wall Street Journal or Reuters, at Licensee’s discretion.

8.8 Late Payments.   Any amount required to be paid by Licensee hereunder which is not paid on the date due shall accrue interest from the date due at the rate of the one-month London Interbank Offered Rate ( “ LIBOR ” ) as quoted in the Wall Street Journal (or if it no longer exists, similarly authoritative source) plus four hundred (400) basis points; provided, however, that in no event shall such rate exceed the maximum legal annual interest rate. The payment of such interest shall not limit Licensor from exercising any other rights it may have as a consequence of the lateness of any payment. Such interest shall be computed on the basis of a year of three hundred sixty (360) days for the actual number of days payment is delinquent.

8.9 Records; Audits.  Licensee shall keep full, true and accurate records and books of account containing all particulars that may be necessary for the purpose of confirming the accuracy of, and calculating, as applicable, all royalty payments and other amounts due to Licensor hereunder (including records of Net Sales), during the Term and for two (2) years thereafter or such longer period as required by Applicable Laws. Licensor shall have a right to request one audit of Licensee in each Calendar Year throughout the Term in order to confirm the accuracy of the foregoing (an “ Audit ” ); provided, that, such one audit per Calendar Year limitation shall not apply in the event of any subsequent “for cause” audit. Upon the written

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request by Licensor to Audit Licensee, Licensor shall have the right to engage an independent, internationally recognized accounting firm reasonably acceptable to Licensee and which will be subject to appropriate written obligations of confidentiality, to perform a review as is reasonably necessary to enable such accounting firm to calculate or otherwise confirm the accuracy of any of the foregoing for the Calendar Year(s) requested by Licensor. Licensee, shall make personnel reasonably available during regular business hours to answer queries on all such books and records required for the purpose of the Audit. The accountants shall deliver a copy of their findings to each of the Parties within ten (10) Business Days of the completion of the review, and, in the absence of fraud or manifest error, the findings of such accountant shall be final and binding on each of the Parties. Any underpayments by Licensee shall be paid to Licensor within five (5) Business Days of notification of the results of such Audit. Any overpayments made by Licensee shall be refunded by Licensor within five (5) Business Days of notification of the results of such Audit. The cost of the accountants shall be the responsibility of Licensor unless the accountants’ calculation shows that the actual royalties payable, Net Sales and/or any other applicable amount Audited hereunder (in the aggregate with respect to the entire period audited) to be different, by more than [*CONFIDENTIAL*] , than the amounts as paid and reported by Licensee for the period subject to the Audit, in which case Licensee shall bear the costs of the accountants. Any information obtained during such audit shall be treated as Confidential Information. In the event that Licensor has a good faith basis, which shall be shared with Licensee, for believing that a Sublicensee of Licensee is not accurately reporting Net Sales (and thus that Licensee is not making appropriate royalty payments hereunder), then at Licensor’s request, Licensee shall enforce its audit rights with respect to any such Sublicensee and Licensee shall report back to Licensor regarding the outcome of any such audit.

ARTICLE 9

PROSECUTION, MAINTENANCE AND ENFORCEMENT OF LICENSOR PATENTS

9.1 Licensor Patents.

9.1.1 Licensor Responsibility and Ownership of Intellectual Property.   Licensor shall prosecute, maintain and, subject to Section 9.4, extend the Licensor Patents, including conducting any interferences, reexaminations, reissues, opposition proceedings, or request for patent term extension relating thereto, at its sole cost and expense. Licensor shall provide Licensee with an updated Schedule 1.41 on an annual basis or more frequently upon Licensee’s reasonable request.

9.1.2 Licensee’s Cooperation.   At Licensor’s request, Licensee shall reasonably cooperate with the prosecution of the Licensor Patents. Licensor shall give Licensee the opportunity to discuss and comment on the matter, it being understood that Licensor shall have the right to ultimately decide on all steps to be taken, and shall be solely responsible, for the maintenance, prosecution or extension of the Licensor Patents.

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9.1.3 Discontinuation of Prosecution or Maintenance of the Licensor Patents. If, during the Term, Licensor decides to no longer prosecute or maintain any Licensor Patent, Licensor shall notify Licensee in writing of such decision as soon as possible (but in no event less than [*CONFIDENTIAL*] ) prior to any filing or payment due date, or any other date that requires action, in connection with such Licensor Patent and Licensee shall thereupon have the right, but not the obligation, to assume responsibility for the filing, prosecution or maintenance thereof in the name of Licensor and at Licensee’s cost and expense. If Licensee elects to exercise such right, Licensor shall execute such assignments and other documents and perform such acts at Licensee’s reasonable expense as may be reasonably necessary to allow Licensee to file, maintain and prosecute such Patents in Licensee’s name, and such Patents shall cease to be Licensor Patents and thereafter shall be deemed Licensee Patents for all purposes of this Agreement (including, for clarity, for the purpose of Section 1.63.1 above). Licensor will use good faith efforts to make available to Licensee its authorized attorneys, agents or representatives, or such of its employees as are reasonably necessary to assist Licensee in exercising its rights described under this Section 9.1.3. Licensor will sign, or will have signed, all legal documents as are reasonably necessary to enable Licensee to prosecute and maintain such Patents.

9.1.4 Patents listed in Schedule 1.14 . Licensor hereby assigns and transfers to Licensee the Patents listed in Schedule 1.14 . Promptly following the Effective Date, the Parties shall execute and file as appropriate such assignment and other documents as may be required to fully and effectively vest all rights, title, and interests in and to such Patents in Licensee.

9.2 Infringement by Compound or Product.

(a) Each of the Parties shall promptly, but in any event no later than ten (10) Business Days after receipt of notice thereof, notify the other Party in writing in the event of any notice or claim by a Third Party of alleged patent or other intellectual property infringement by Licensee or its Affiliates or Sublicensees with respect to the manufacture, use, sale, offer for sale or importation of the Compound or Product (each, an “ Infringement Claim ” ). With respect to any Infringement Claim, the Parties shall attempt to negotiate in good faith an amicable resolution with respect thereto with the appropriate Third Party. If the Parties cannot settle such Infringement Claim with the appropriate Third Parties within fifteen (15) Business Days after the receipt of the notice pursuant to this Section, then, (i) Section 9.2(c) shall first apply, and (ii) if no agreement is entered pursuant to Section 9.2(c), then Licensee shall have the right and obligation to defend any such suit or action and, and the Parties shall reasonably cooperate in the defense of such suit or action, each bearing its own expenses, subject to Section 9.2(d).

(b) Neither Licensor nor Licensee shall take a position in connection with an Infringement Claim, including defense, settlement or compromise of any such suit or action without the consent of the other Party (which consent shall not be unreasonably withheld) if the position, including defenses or settlement or compromise, would have a material adverse impact on the other Party (in which case the consent of such other Party shall be required). For

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purposes of this Section 9.2(b), any settlement in connection with an Infringement Claim that would involve the waiver of rights (including the rights to receive payments) of such other Party shall be deemed a material adverse impact and shall require the consent of such other Party, such consent not to be unreasonably withheld.

(c) If necessary to avoid infringement of intellectual property owned or controlled by a Third Party through the Manufacture, use or Commercialization of the Compound or the Product (as the Product and/or Compound (i) are described and/or claimed in the Licensor Patents and (ii) are being Developed and Manufactured by or on behalf of Licensor as of the Effective Date) for the Target Indication or Second Indication in the Territory, Licensee and Licensor shall use Commercially Reasonable Efforts to obtain a license for Licensee under the Third Party’s intellectual property right. In particular, Licensor shall have the first right to negotiate and acquire rights to such intellectual property through a license or otherwise (including pursuant to any settlement agreement); provided, that, if Licensor declines to exercise such right, Licensor shall promptly inform Licensee thereof and Licensee shall have the right to conduct such negotiations and acquire such rights and to deduct, subject to Section 8.3.5, any and all payments made to any Third Party under this Section 9.2(c) against any [*CONFIDENTIAL*] to be made by Licensee to Licensor under this Agreement, provided, however, that in no event shall such offset reduce any payment to be made to Licensor hereunder by more than [*CONFIDENTIAL*] of the amount otherwise payable.

(d) Licensee shall, subject to Section 8.3.5, have the right to offset against [*CONFIDENTIAL*] to be made by Licensee to Licensor under this Agreement [*CONFIDENTIAL*] of all costs and expenses (for clarity, not including any settlement costs or damages) incurred in defending any suit or action by a Third Party that claims that the use, Manufacture or Commercialization of the Compound and/or the Product (as the Compound and/or the Product (i) are described and/or claimed in the Licensor Patents and (ii) are being Developed and Manufactured by or on behalf of Licensor as of the Effective Date) infringes any issued patent claim in a Third Party’s Patent covering the use of the Compound or of the Product in the Target Indication or Second Indication.

9.3 Infringement or Invalidation Actions by Third Parties.

(a) Notice. If either Party becomes aware, or otherwise receives notice, of any patent nullity, invalidity or unenforceability actions, any declaratory judgment actions, or any alleged or threatened infringement, in each case, of or involving any Licensor Patents, including, any claims arising under the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98-417), as amended, or its equivalent in a country other than the United States it will promptly (but in any case no later than five (5) Business Days from becoming aware of any such action) notify in writing the other Party thereof.

(b) Enforcement of Patents.

(i) Licensee Action. Licensee shall have the first right to initiate a suit or take other appropriate action it believes is required against any Third Party with respect to infringement or misappropriation of the Licensor Technology, after having conferred

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with Licensor. Licensee shall have the right to be assisted by and cooperate with its local Affiliates and/or Sublicensees if this is deemed useful or appropriate by Licensee in the interest of an effective enforcement of rights.

(ii) Licensor Action. If Licensee fails to institute such litigation or otherwise take steps to remedy the applicable infringement within thirty (30) days of the date that Licensee becomes aware of such action or infringement (including by way of the Licensor providing notice thereof pursuant to Section 9.3(a)), then Licensor will have the right (but not the obligation), at its own expense, to bring any such suit, action or proceeding by counsel of its own choice.

(c) Cooperation; Costs; Damages.

(i) If one Party brings any suit, action or proceeding under Section 9.3(b), the other Party agrees to be joined as party plaintiff if necessary to prosecute the suit, action or proceeding and to give the first Party authority to file, prosecute and control the suit, action or proceeding; provided, however, that neither Party will be required to transfer any right, title or interest in or to any property to the other Party or any other party to confer standing on a Party hereunder, and provided further that such other Party shall in any case have the right to be represented by its own counsel at its cost and expense.

(ii) The Party not pursuing the suit, action or proceeding hereunder will provide reasonable assistance to the other Party, including by executing any and all reasonably necessary documents as may be required to bring such suit, action or proceeding, providing access to relevant documents and other evidence and making its employees available, subject to the other Party’s reimbursement of any reasonable external costs incurred by the non-enforcing or defending Party in providing such assistance.

(iii) The Party initiating the suit, action or proceeding under Section 9.3(b) shall assume and pay all costs and expenses related thereto, including fees and expenses of counsel selected by it and shall have control over the suit, action or proceeding; provided, that (A) in the case of any such suit, action or proceeding [*CONFIDENTIAL*] , then the other Party shall reimburse to the Party initiating the action [*CONFIDENTIAL*] , or (B) in the case of any such suit, action or proceeding in countries other than [*CONFIDENTIAL*] , then the other Party shall reimburse to the Party initiating the action [*CONFIDENTIAL*] of all documented external fees, costs and expenses incurred in connection with such suit, action or proceeding, such reimbursement payment to be made on a quarterly basis within [*CONFIDENTIAL*] of submission by the Party initiating the suit of the relevant invoice and accompanying documentation, provided however that if Licensee is the Party initiating the action, then Licensor’s reimbursement of [*CONFIDENTIAL*] or [*CONFIDENTIAL*] , as applicable, of all reasonable, documented external fees, costs and expenses incurred in connection with such suit, action or proceeding shall be effected by Licensee deducting such amounts from [*CONFIDENTIAL*] otherwise payable to Licensor hereunder in connection with Net Sales, or [*CONFIDENTIAL*], in the country in which such action under this Section 9.3 is pursued (and subject to Section 8.3.5). [*CONFIDENTIAL*].

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(iv) The Party controlling an action shall not, without the prior written consent of the non-controlling Party (which shall not be unreasonably withheld), enter into any compromise or settlement relating to any claim, suit or action that it brought under Section 9.3 that admits the invalidity or unenforceability of any Licensor Patent, or requires the non-controlling Party to pay any sum of money, or otherwise adversely affects the rights of the non-controlling Party hereunder (including the rights to receive payments), provided however that this sub-section (iv) shall not apply in the event Licensor has exercised its right to [*CONFIDENTIAL*] .

(v) Any settlements, damages or other monetary awards (a “ Recovery ” ) recovered pursuant to a suit, action or proceeding brought pursuant to this Section 9.3 will be allocated between the Parties pro rata based on the respective costs and expenses incurred by each Party with respect thereto; provided, that, Licensor shall not share in any such Recovery if Licensor has [*CONFIDENTIAL*] .

9.4 Patent Term Extensions.   Licensee and Licensor shall cooperate in good faith throughout the Territory in filing for and obtaining patent term extensions and supplementary or complementary protection certificates, if available, in respect of the Licensor Patents. Such cooperation may include: (i) advising each other in a timely manner of any action by any Regulatory or other competent Governmental Authority that is pertinent to any such extension; (ii) reasonably supplying each other with all information in its control pertaining to the extension of any such Licensor Patent; (iii) cooperating with each other to prepare and execute in due time all supporting documents required in connection with the extension of any such Licensor Patent; and (iv) keeping the other Party timely informed and updated on the relevant procedures in connection with such extension.

9.5 Patent Marking.  Licensee shall mark the Product marketed and sold by Licensee (or its Sublicensees) hereunder with appropriate patent numbers or indicia in accordance with Applicable Laws.

9.6 Patent Challenge.  Licensor will be permitted to terminate this Agreement upon written notice to Licensee, effective upon receipt, if Licensee or any of its Sublicensees or Affiliates, directly or indirectly, (i) initiate or request an interference or opposition proceeding with respect to, (ii) make, file or maintain any claim, demand, lawsuit or cause of action to challenge the validity or enforceability of, or (iii) oppose any extension of, or the grant of a supplementary protection certificate with respect to, any Licensor Patent.

ARTICLE 10

REPRESENTATIONS, WARRANTIES AND COVENANTS; COMPLIANCE

10.1 Mutual Representations and Warranties.  Each Party hereby represents and warrants to the other Party as follows, as of the Effective Date:

10.1.1 Corporate Existence and Power.  It is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and

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operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including the right to grant the licenses granted by it hereunder.

10.1.2 Authority and Binding Agreement.   (i) It has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder, and (iii) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms, except as enforcement may be affected by bankruptcy, insolvency or other similar laws and by general principles of equity.

10.1.3 No Conflicts.  The execution, delivery and performance of this Agreement by it do not (i) conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound or (ii) violate any Applicable Law.

10.1.4 All Consents and Approvals Obtained.  Except with respect to Regulatory Approvals for the Development, Manufacturing or Commercialization of the Product or as otherwise described in this Agreement, (i) all necessary consents, approvals and authorizations of, and (ii) all notices to, and filings by such Party with, all Governmental Authorities and other Persons required to be obtained or provided by such Party as of the Effective Date in connection with the execution, delivery and performance of this Agreement have been obtained and provided, except for those approvals, if any, not required at the time of execution of this Agreement.

10.2 Additional Representations, Warranties and Covenants of Licensor.  Licensor hereby represents and warrants as of the Effective Date and, to the extent applicable, covenants, to Licensee that:

10.2.1 Licensor has not filed any Marketing Authorization Applications with a Governmental Authority for the sale of the Product.

10.2.2 Licensor is the owner of the Licensor Patents and owner or licensee of the Licensor Know-How and has full right and power to grant the licenses set forth in ARTICLE 2, free and clear of any adverse assignment, grant, restriction on use or other encumbrances inconsistent with such grant, in the manner, for the duration of and to the extent set forth in this Agreement, except such non-exclusive rights as have been granted to Third Parties solely to perform their obligations to Licensor under the On-Going Agreements or in connection with the performance of the On-Going Studies or POC Study.

10.2.3 Licensor has complied with all Applicable Laws in all material respects, including any disclosure requirements, in connection with the filing, prosecution and maintenance of the Licensor Patents owned by Licensor.

10.2.4 Neither Licensor nor, to the knowledge of Licensor, its subcontractors, has received written notice of any action, suit, investigation or proceedings

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pending before or threatened by any Governmental Authority with respect to the Compound and/or the Product.

10.2.5 To the best of Licensor’s knowledge, the use and practice of the Licensor Technology and the Development, Manufacture, and Commercialization of the Compound and Product (as the Product and Compound (i) are described and/or claimed in the Licensor Patents and (ii) are being Developed and Manufactured by or on behalf of Licensor as of the Effective Date) do not infringe the intellectual property rights of any Third Party, and no Third Party has made any assertion in writing to the contrary.

10.2.6 To Licensor’s knowledge, (i) no Third Party is infringing any Licensor Patents], and (ii) [no Third Party has challenged the scope, duration, validity, enforceability, priority, or Licensor’s right to use or license any Licensor Patent.

10.2.7 Other than the Licensor Patents and Licensor Know-How, (i) none of Licensor nor any of its Affiliates nor employees owns or holds any rights with respect to any Patent or Know-How that is necessary for, or would be infringed by, the Development, Manufacture or Commercialization of the Compound or Royalty Products, and (ii) none of Licensor’s subcontractors owns or holds any rights with respect to any issued Patent that is necessary for, or would be infringed by, the Development, Manufacture or Commercialization of the Compound or Product (as the Product and Compound (x) are described and/or claimed in the Licensor Patents and (y) are being Developed and Manufactured by or on behalf of Licensor as of the Effective Date).

10.2.8 Except with respect to Licensor Know-How that was generated prior to Licensor coming to Control the Compound and Product and that was never in Licensor’s possession ( “ External Know-How ” ), all Licensor Know-How existing as of the Effective Date has been made available to Licensee, or will be made available to Licensee in accordance with the Technology Transfer Plan, and, to Licensor’s best knowledge, is free from any material inaccuracies. If Licensee or Licensor becomes aware of the existence of such External Know-How after the Effective Date, then upon request by Licensee, Licensor shall provide reasonable assistance to Licensee in locating and acquiring access to such External Know-How from the entity in possession of such External Know-How.

10.2.9 None of the Confidential Information relating to Licensor Know-How has been disclosed to any Third Party other than under written confidentiality and non-use commitments.

10.2.10 To the best of the knowledge of Licensor, all raw data developed by or on behalf of Licensor or its Affiliates and supporting Licensor Know-How or otherwise relating to the Compound or the Product are available and free from any material inaccuracies.

10.2.11 To Licensor’s best knowledge, none of the materials and documents provided to Licensee in the course of Licensee’s due diligence preceding execution of this Agreement contained any untrue statement of material fact.

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10.2.12 Licensor has informed Licensee of any pre-clinical or clinical data or information concerning the Compound and/or the Product and that to the knowledge of Licensor reasonably suggests that there may exist quality, toxicity, safety and/or efficacy concerns which may materially impair the safety of the Compound and/or the Product.

10.2.13 Licensor has conducted all Development of the Compound and the Product prior to the Effective Date in accordance with sound and ethical business and scientific practices, and in compliance with all Applicable Law, including GCPs and GLPs, and also including all applicable data privacy and data protection laws. In addition, Licensor has not used in any capacity, in connection with the Development of the Compound and the Product prior to the Effective Date, any Person who has been debarred pursuant to Section 306 of the FD&C Act (or similar Applicable Law outside of the U.S.), or who has been the subject of a conviction described in such section, and Licensor shall inform Licensee in writing immediately if it or any Person who has performed any such Development is debarred or is the subject of a conviction described in Section 306 (or similar Applicable Law outside of the U.S.), or if any action, suit, claim, investigation or legal administrative proceeding is pending or, to Licensor’s knowledge, is threatened, relating to the debarment of Licensor or any Person used in any capacity by Licensee in connection with such Development.

10.2.14 Licensor has received no notice from S*BIO that it is in breach of any of its obligations under the S*BIO Agreement, and, as of the Effective Date, Licensor is not aware of any breach of the S*BIO Agreement nor of any other circumstance on which Licensor might cease to hold and enjoy the rights granted to it with respect to Licensor Technology under the S*BIO Agreement, and Licensor shall not amend, modify or waive any of its rights under the S*BIO Agreement in a manner that would have an adverse effect on the interests of Licensee hereunder without the prior written consent of Licensee.

10.2.15 Other than as has been made available to Licensee via [*CONFIDENTIAL*] , and with the sole exceptions of that certain agreement in negotiation with [*CONFIDENTIAL*] and that certain [*CONFIDENTIAL*] , there are no binding contracts or agreements to which Licensor is a Party, other than the S*BIO Agreement and the On-Going Agreements, [*CONFIDENTIAL*] .

10.3 Additional Representations, Warranties and Covenants of Licensee.   Licensee hereby represents and warrants as of the Effective Date and, to the extent applicable, covenants, to Licensor that:

10.3.1 Licensee’s compensation programs for its Sales Representatives do not, and will not, provide financial incentives for the promotion, sales, and marketing of the Product in violation of any Applicable Laws or any professional requirements.

10.3.2 Licensee’s medical, regulatory and legal teams will review all training materials and programs prior to use by Licensee to ensure that all training materials and programs are in accordance with the Regulatory Approvals and Applicable Laws.

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10.3.3 Licensee and its Affiliates Control no Know-How or Patents that Cover or are otherwise necessary for the Development, Manufacture, use or Commercialization of the Compound or Royalty Products.

10.4 Anti-Sandbagging; Disclaimer.  Neither Party shall bring any claim or pursue any remedy against the other Party for breach of any of such other Party’s representations or warranties under this ARTICLE 10 to the extent that the first Party had knowledge that such other Party was in breach of such representations or warranties as of the Effective Date. Subject to the representations and warranties set forth in Sections 10.1 and 10.2 above, Licensee understands that the Compound and Product are the subject of ongoing clinical research and development and that Licensor cannot ensure the safety or usefulness of the Compound or Product or that the Compound or Product will receive Regulatory Approvals. In addition, Licensor makes no warranties except as set forth in this ARTICLE 10 concerning the Licensor Technology.

10.5 No Other Representations or Warranties. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

10.6 Compliance.

10.6.1 Compliance with Anti-Corruption Laws.  In connection with this Agreement, each of the Parties represents, warrants and covenants that it has complied and will comply with all Applicable Laws, including those Applicable Laws (and industry codes) dealing with government procurement, conflicts of interest, corruption or bribery, including, if applicable, the U.S. Foreign Corrupt Practices Act of 1977, as amended, and any laws enacted to implement the Organisation of Economic Cooperation and Development Convention on Combating Bribery of Foreign Officials in International Business Transactions.

10.6.2 Prohibited Conduct.  In connection with this Agreement, each of the Parties represents, warrants and covenants that it has not made, offered, given, promised to give, or authorized, and will not make, offer, give, promise to give, or authorize, any bribe, kickback, payment or transfer of anything of value, directly or indirectly, to any person or to any Government Official for the purpose of: (i) improperly influencing any act or decision of the person or Government Official; (ii) inducing the person or Government Official to do or omit to do an act in violation of a lawful or otherwise required duty; (iii) securing any improper advantage; or (iv) inducing the person or Government Official to improperly influence the act or decision of any organization, including any government or government instrumentality, in order to assist Licensee or Licensor in obtaining or retaining business.

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10.6.3 Compliance by Licensor.  Licensor shall use Commercially Reasonable Efforts, prior to Licensee filing for the first Regulatory Approval for the Product, to adopt or make conforming changes to its comprehensive compliance program so as to be in compliance with the United States Department of Health and Human Services Office of Inspector General (OIG)’s April 2003 publication “Compliance Program Guidance for Pharmaceutical Research and Manufacturers, Code on Interactions with Health Care Professionals” and with the Conduct of Clinical Trials”.

ARTICLE 11

INDEMNIFICATION

11.1 Indemnification by Licensor.   Licensor hereby agrees to save, indemnify, defend and hold Licensee, its Affiliates, and their respective directors, officers, agents and employees harmless from and against any and all losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses) (collectively, “ Losses ” ) arising in connection with any and all charges, complaints, actions, suits, proceedings, hearings, investigations, claims, demands, judgments, orders, decrees, stipulations or injunctions by a Third Party (each a “ Claim ” ) to the extent resulting or otherwise arising from (i) any breach by Licensor of any of its representations, warranties, covenants or obligations pursuant to this Agreement or (ii) the negligence or willful misconduct by Licensor or its Affiliates, sublicensees or subcontractors or their respective officers, directors, employees, agents or consultants in performing any obligations under this Agreement or under any other agreement which may have an impact on the Licensor Technology, the Compound, or Royalty Products, except to the extent such Losses as are caused by instructions provided by Licensee and implemented by Licensor.

11.2 Indemnification by Licensee.   Licensee hereby agrees to save, indemnify, defend and hold Licensor, its Affiliates, and their respective directors, agents and employees harmless from and against any and all Losses arising in connection with any and all Claims to the extent resulting or otherwise arising from (i) any breach by Licensee of any of its representations, warranties, covenants or obligations pursuant to this Agreement, (ii) the negligence or willful misconduct by Licensee (or its Affiliates, Sublicensees, subcontractors, wholesalers or distributors) or their respective officers, directors, employees, agents or consultants in performing any obligations under this Agreement or under any other agreement which may have an impact on the Licensor Technology, the Compound, or Royalty Products, or (iii) the Development, Manufacturing, or Commercialization of the Compound or a Royalty Product hereunder (including, for clarity, any product liability Losses resulting therefrom) by Licensee (or its Affiliates, Sublicensees, subcontractors, wholesalers or distributors) or their respective officers, directors, employees, agents or consultants.

11.3 Indemnification Procedures.

11.3.1 A Party believing that it is entitled to indemnification under, as applicable, Section 11.1 or Section 11.2 (an “ Indemnified Party ” ) shall give prompt written notification to the other Party (the “ Indemnifying Party ” ) of the commencement of any Claim for which indemnification may be sought or, if earlier, upon the assertion of any such Claim by a

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Third Party (it being understood and agreed, however, that the failure by an Indemnified Party to give notice of a Claim as provided in this Section 11.3.1 shall not relieve the Indemnifying Party of its indemnification obligation under this Agreement except and only to the extent that such Indemnifying Party is actually materially prejudiced as a result of such failure to give notice). Within thirty (30) days after delivery of such notification, the Indemnifying Party may, upon written notice thereof to the Indemnified Party, assume control of the defense of such Claim with counsel reasonably satisfactory to the Indemnified Party. If a Party believes that a Claim presented to it for indemnification is one as to which the Party seeking indemnification is not entitled to indemnification under, as applicable, Section 11.1 or Section 11.2, it shall so notify the Party seeking indemnification.

11.3.2 If the Indemnifying Party elects to assume the defense of such Claim, the Indemnified Party may participate in such defense at its own expense; provided, that if the interests of the Indemnified Party and the Indemnifying Party with respect to such Claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under Applicable Law, ethical rules or equitable principles, the Indemnifying Party shall be responsible for the reasonable fees and expenses of counsel to the Indemnified Party solely in connection therewith.

11.3.3 The Indemnifying Party shall keep the Indemnified Party advised of the status of such Claim and the defense thereof and shall consider recommendations made by the Indemnified Party with respect thereto.

11.3.4 The Indemnified Party shall not agree to any settlement of such Claim without the prior written consent of the Indemnifying Party, which shall not be unreasonably withheld. The Indemnifying Party shall not agree to any settlement of such Claim or consent to any judgment in respect thereof that does not include a complete and unconditional release of the Indemnified Party from all liability with respect thereto or that imposes any liability or obligation on the Indemnified Party or adversely affects the Indemnified Party without the prior written consent of the Indemnified Party, which shall not be unreasonably withheld.

11.3.5 For clarity, neither Party shall have any indemnification obligation pursuant to Section 11.1 or Section 11.2 to the extent the applicable Claim results or otherwise arises from the breach of this Agreement, negligence, or willful misconduct of the other Party or its Affiliates, sublicensees or subcontractors or their respective officers, directors, employees, agents or consultants.

11.4 Limitation of Liability.   NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY LOST PROFITS, OR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.4 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER

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SECTION 11.1 or 11.2 WITH RESPECT TO AMOUNTS OWED TO A THIRD PARTY, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 12.

11.5 Insurance.  Each Party shall procure and maintain insurance, including, as applicable, clinical trials insurance and product liability insurance, adequate to cover its obligations hereunder and which is consistent with normal business practices of prudent companies similarly situated at all times during which the Compound or Product is being clinically tested in human subjects or commercially distributed or sold by or on behalf of such Party pursuant to this Agreement. Without limiting the foregoing:

(a) each Party shall procure and maintain clinical trials insurance coverage, which prior to the First Commercial Sale of the Product, shall be in accordance with the minimum requirements by Applicable Law and industry standards in each country where the clinical trials are carried out; and

(b) Licensee shall procure and maintain product liability insurance coverage, which upon First Commercial Sale of the Product, shall in no event be less than [*CONFIDENTIAL*] per loss occurrence and [*CONFIDENTIAL*] in the aggregate.

It is understood that such insurance shall not be construed to create a limit of a Party’s liability with respect to its indemnification obligations under this ARTICLE 11. Each Party shall provide the other Party with written evidence of such insurance prior to commencement of this Agreement and upon expiration of any one (1) coverage. Each Party shall provide the other Party with written notice at least thirty (30) days prior to the cancellation, nonrenewal or material change in such insurance or self - insurance which materially adversely affects the rights of the other Party hereunder.

ARTICLE 12

CONFIDENTIALITY

12.1 Confidential Information.

12.1.1 The Parties agree that during the Term, and for a period of [*CONFIDENTIAL*] years thereafter, a Party receiving Confidential Information of the other Party will (X) maintain in confidence such Confidential Information to the same extent such Party maintains its own proprietary information of similar kind and value, and, in any event, no less than a reasonable standard of care, (Y) not disclose such Confidential Information to any Third Party without the prior written consent of the other Party, except as otherwise expressly permitted below and, in the case of Licensee, except as necessary or useful for a proper and full performance of its rights and obligations hereunder, and (Z) not use such Confidential Information for any purpose except those permitted by this Agreement. As used herein, “ Confidential Information ” means all Know-How and other information and materials received by either Party from the other Party or its Affiliates pursuant to this Agreement. The foregoing obligations and the other obligations set forth in this Section 12.1 shall not apply with respect to any portion of such Confidential Information which:

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(a) is publicly disclosed by the disclosing Party, either before or after it becomes known to the receiving Party;

(b) was known to the receiving Party or any or its Affiliates, without any obligation to keep it confidential, prior to when it was received from the disclosing Party;

(c) is subsequently disclosed to the receiving Party or any of its Affiliates by a Third Party that is lawfully in possession thereof without obligation to keep it confidential;

(d) has been published by a Third Party or otherwise enters the public domain through no fault of the receiving Party or any of its Affiliates in breach of this Agreement; or

(e) has been independently developed or acquired by the receiving Party or any of its Affiliates without the aid, application or use of the disclosing Party’s Confidential Information.

Notwithstanding clauses (a) through (e) above, both Parties shall be bound to the obligations of this Article 12 (as the receiving Party hereunder) with respect to all Licensor Know-How to the extent such Licensor Know-How (i) was confidential prior to the Effective Date and (ii) specifically relates to the Compound or Product.

12.1.2 The receiving Party shall have the right to disclose any Confidential Information provided by the other Party hereunder if, in the reasonable opinion of the receiving Party’s legal counsel, such disclosure is necessary to comply with the terms and conditions of this Agreement, or the requirements of any law or rule imposed by the U.S. Securities and Exchange Commission or any securities exchange or other Applicable Law, but only to the extent of such necessity or requirements; and no such disclosure shall cause any such information to cease to be Confidential Information hereunder, except to the extent such disclosure results in a public disclosure of such information. Where reasonably possible, the receiving Party shall notify the disclosing Party of the receiving Party’s intent to make such disclosure of Confidential Information pursuant to the preceding sentence sufficiently prior to making such disclosure so as to allow the disclosing Party adequate time to take whatever action the disclosing Party may deem to be appropriate to protect the confidentiality of the Confidential Information.

12.1.3 Except as set forth above, each Party agrees that it shall provide or permit access to Confidential Information of the other Party only to (i) the receiving Party’s attorneys, independent accountants and financial advisors for the sole purpose of enabling such attorneys, independent accountants and financial advisors to provide advice to the receiving Party and (ii) the receiving Party’s Affiliates, directors, officers, employees, consultants, advisors and permitted subcontractors, sublicensees and subdistributors, and to the directors, officers, employees, consultants, advisors and permitted subcontractors, sublicensees, subdistributors and other Third Parties, who have a need to know such Confidential Information to assist the receiving Party with the activities contemplated or required of it by this Agreement; provided

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that in each case the Person to whom Confidential Information is being disclosed is subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and nonuse of the receiving Party pursuant to this Section 12.1; and provided further, that each Party shall remain responsible for any failure by its attorneys, independent accountants and financial advisors, Affiliates, and its and its Affiliates’ respective directors, officers, employees, consultants, advisors and permitted subcontractors, sublicensees and subdistributors, to treat such Confidential Information as required under this Section 12.1.

For clarity, either Party may disclose without any limitation such Party’s U.S. federal income tax treatment and the U.S. federal income tax structure of the transactions relating to such Party that are based on or derived from this Agreement, as well as all materials of any kind (including opinions, other tax analyses, or a complete copy of this Agreement and any amendments thereto) relating to such tax treatment or tax structure, except to the extent that nondisclosure of such matters is reasonably necessary in order to comply with applicable securities laws.

12.1.4 Each Party acknowledges that a Party in breach of any of its obligations under this Section 12.1 may cause the non-breaching Party irreparable harm, for which monetary damages will be an inadequate remedy. Therefore, notwithstanding anything to the contrary in this Agreement in the event of any such breach, the non-breaching Party shall be entitled, in addition to any other remedy available to it under this Agreement, at law or in equity, to seek injunctive relief, including an accounting for profits, specific performance of the terms hereof and other equitable relief for such breach, without the posting of bond or other security.

12.2 Publicity. Any press releases or other public statements or disclosures regarding the subject matter of this Agreement shall be subject to the express prior written consent of each of the Parties, which consent shall not be unreasonably withheld or delayed; provided that a disclosure shall be permitted without the other Party’s consent to the extent that it does not contain information beyond that included in a prior disclosure approved in writing by both Parties. Notwithstanding the foregoing, any disclosure which is required by Applicable Law or the rules of the U.S. Securities and Exchange Commission or any securities exchange, as reasonably advised by the disclosing Party’s counsel, may be made without the prior consent of the other Party, although, prior to making any such legally required disclosure, the Party making such disclosure shall give the other Party prompt notice and an opportunity to comment on the proposed disclosure.

12.3 Securities Filings.  In the event Licensee proposes to file with the U.S. Securities and Exchange Commission or the securities regulators of any state or other jurisdiction under the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, or any other applicable securities law a registration statement or any other disclosure document which describes or refers to this Agreement, including filing a copy of this Agreement itself, Licensee shall notify Licensor of such intention and shall provide Licensor with a copy of relevant portions of the proposed filing not less than three (3) Business Days prior to such filing (or such shorter period of time as may be required in the circumstances, and any revisions to such portions of the proposed filing a reasonable time prior to the filing thereof), and shall use

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reasonable efforts to obtain confidential treatment of any information concerning Licensor that Licensor requests be kept confidential, consistent with Licensee’s disclosure obligations under applicable securities laws. Licensor may, at its discretion, file with the U.S. Securities and Exchange Commission or the securities regulators of any state or other jurisdiction under the Securities Act of 1933, as amended, the Securities Exchange Act of 1934, as amended, or any other applicable securities law a registration statement or any other disclosure document which describes or refers to this Agreement, including filing a copy of this Agreement itself. Licensor shall provide Licensee with a copy of relevant portions of the proposed filing reasonably in advance of making such filing, and shall use Commercially Reasonable Efforts to obtain confidential treatment of any information concerning Licensee that Licensee reasonably requests be kept confidential, consistent with Licensor’s disclosure obligations under applicable securities laws. For clarity, in no event shall Licensor be obligated to delay or withhold such a filing in order to comply with the foregoing sentence if such compliance would result in Licensor being in violation of any Applicable Law.

12.4 Publications.

12.4.1 Licensee shall be free at all times to make publications or presentations with regard to the Compound and/or the Product, as it shall deem appropriate for the effective management of the Development and Commercialization of the Compound and Product throughout the Territory; provided, that Licensee shall (a) provide Licensor every [*CONFIDENTIAL*] throughout the Term with a publication strategy plan and (b) a copy of said publications or material presentations intended to be given to a public international audience for Licensor’s information reasonably prior to the public disclosure thereof.

12.4.2 The Parties acknowledge and agree that certain Third Parties counterparties to the agreements included in the Licensor’s data room prior to the Effective Date may have been granted publication rights related to the Compound and Product, and publications by such Persons in compliance with the provisions of the relevant agreements shall be permitted; provided, that Licensor shall advise Licensee reasonably prior to the public disclosure thereof regarding any anticipated publications by such Persons.

12.5 Use of Names.  Except as otherwise set forth in this Agreement, neither Party shall use the name of the other Party in relation to this transaction in any public announcement, press release or other public document without the written consent of such other Party, which consent shall not be unreasonably withheld; provided, however, that subject to Section 12.2, either Party may use the name of the other Party in any document filed with any Regulatory Authority or Governmental Authority, including the Securities and Exchange Commission.

12.6 Unauthorized Disclosure of Confidential Information.   Each Party shall have a response plan in place for any disclosure of Confidential Information that is not authorized or otherwise permitted under this Agreement. Such plan shall include considerations of, among other things, notification, remediation and retrieval. In the event that a Party becomes aware of an unauthorized disclosure of Confidential Information, then such Party shall notify the other Party promptly in writing.

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12.7 Survival.  The obligations and prohibitions contained in this ARTICLE 12 as they apply to Confidential Information shall survive the expiration or termination of this Agreement for a period of [*CONFIDENTIAL*] years.

12.8 Prior CDA.   The Parties acknowledge and agree that any and all information exchanged or otherwise disclosed, and discussions, between themselves prior to the Effective Date shall remain subject, to the extent applicable, to the terms and conditions of the Prior CDA. Information exchanged or otherwise disclosed, and discussions, between the Parties following the Effective Date under or related to this Agreement or its subject matter shall be subject to the terms and conditions of this Agreement and not the Prior CDA. Furthermore, the Parties hereby acknowledge and agree that this Agreement constitutes an amendment to the Prior CDA (which satisfies the requirements of Section 13 of the Prior CDA), which amendment provides for the Parties to be able to mutually agree to terminate the Prior CDA immediately, and the Parties hereby agree that, without limiting the provisions thereof that survive termination thereof, the Prior CDA shall be deemed terminated as of the Effective Date.

ARTICLE 13

TERM AND TERMINATION

13.1 Term.  This Agreement shall become effective on the Effective Date and, unless earlier terminated pursuant to this ARTICLE 13, shall remain in effect on a country-by-country basis until the expiration of the Royalty Term applicable to such country as set forth at Section 1.63 of this Agreement (the “ Term ” ).

13.2 Termination for Breach.

13.2.1 Either Party may, without prejudice to any other remedies available to it at law or in equity, terminate this Agreement upon written notice to the other Party in the event that the other Party (the “ Breaching Party ” ) shall have materially breached this Agreement. The Breaching Party shall have ninety (90) days (thirty (30) days in the event of non-payment) after written notice thereof was provided to the Breaching Party by the non-breaching Party to remedy such default; provided, however, that if such breach is capable of being cured but cannot be cured within such cure period and the breaching Party initiates actions to cure such breach within such period and thereafter diligently pursues such actions, the breaching Party shall have an additional ninety (90) days (for a total of one hundred eighty (180) days) to cure such breach (except in the event of non-payment, in which such case no additional time period shall apply). Unless the Breaching Party has cured any such breach or default prior to the expiration of such applicable cure period, such termination shall become effective upon receipt of the written notice of termination by the Breaching Party to be given within ten (10) days of the end of such period.

13.2.2 In the event of an uncured material breach by Licensor giving Licensee the right to terminate this Agreement under Section 13.2.1, then as an alternative to its right to terminate this Agreement as described above, Licensee may in its discretion elect to continue this Agreement and to exercise its rights pursuant to Section 15.1.2 to refer the measure of its damages to determination pursuant to arbitration, which arbitration may determine a one-

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time payment or going-forward reduction in payments as an appropriate remedy for the material breach giving rise to such right to terminate.

13.2.3 Notwithstanding the foregoing, in the event that Licensor’s material breach compromises the fundamental purpose of this Agreement and the ability of Licensee to continue the Development, Manufacture and Commercialization of the Compound and/or Product, and Licensee has no alternative but to terminate this Agreement, then in such case Licensee shall receive from Licensor appropriate payments (as determined pursuant to Article 15.13 below) to compensate Licensee for losses or damages, if any, suffered as a result of such material breach and termination of this Agreement (including as a result of Third Parties’ actions in connection therewith).

13.3 Claims for damages . Without limitation of any other remedy available hereunder, nothing in this Agreement shall limit a Party’s right to bring a claim for damages in the event of a breach of this Agreement by the other Party.

13.4 Termination as a Result of Bankruptcy.  Each Party shall have the right to terminate this Agreement upon written notice as a result of the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other Party; provided that such termination shall be effective only if such proceeding is not dismissed within ninety (90) days after the filing thereof.

13.5 Discontinuation by Licensee.   Notwithstanding any other provision of this Agreement, Licensee shall at any time have the right to discontinue the Development of the Compound and Product and relinquish all the rights and the licenses granted to it under this Agreement and terminate this Agreement by giving thirty (30) days advance written notice to Licensor, in the event that in Licensee’s reasonable judgment after diligent consideration and consultation with Licensor, it is not reasonably viable for Licensee to carry out further Development of the Compound and Product.

ARTICLE 14

EFFECTS OF EXPIRATION OR TERMINATION

14.1 Licenses upon Expiration.   Upon the expiration (but not termination) of this Agreement, in its entirety, or with respect to any given country(ies), Licensee’s license under Section 2.1.1 shall survive and become a [*CONFIDENTIAL*] , exclusive license not requiring any [*CONFIDENTIAL*] under this Agreement.

14.2 Effects of Termination for Cause by Licensee.  Upon the termination of this Agreement by Licensee pursuant to Sections 13.2 or 13.3,

(a) Licensee shall have the rights described in Section 13.2.2;

(b) all rights and licenses granted to Licensee hereunder shall immediately terminate and be of no further force and effect and Licensee shall cease Developing,

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Commercializing, Manufacturing and Packaging and Labeling the Product in and for all applicable countries; and

(c) at Licensor’s request, the Parties shall negotiate in good faith a license agreement pursuant to which (i) Licensor would be granted rights under and to Licensee Technology and (ii) Licensee would transfer to Licensor all of Licensee’s right, title and interest in and to any and all regulatory filings, Regulatory Approvals and other Regulatory Materials Controlled by Licensee for the Product, for consideration consistent with then-prevailing market conditions, on customary terms and conditions. In the event that the Parties cannot finalize such an agreement within sixty (60) days of commencing negotiations with respect thereto, the agreement shall be referred for resolution pursuant to Section 15.13 applied mutatis mutandis to such agreement.

14.3 Effects of Other Terminations.  Upon the termination of this Agreement other than by Licensee pursuant to Sections 13.2 or 13.3,

(a) except to the extent that may be required in connection with the activities described at Section 14.4 below, all rights and licenses granted to Licensee hereunder shall immediately terminate and be of no further force and effect and Licensee shall cease Developing, Commercializing, Manufacturing and Packaging and Labeling the Product in and for all applicable countries;

(b) effective on the date of such termination, Licensee hereby grants to Licensor an exclusive, irrevocable, perpetual, royalty-free and fully paid-up, license, with the right to sublicense (subject however to the provisions of Section 14.4 below), under and with respect to the Licensee Technology to Develop, Manufacture and Commercialize the Compound and Product;

(c) Licensee will assign to Licensor all of Licensee’s right, title and interest in and to any (i) Promotional Materials, (ii) copyrights and trademarks (including the Product Trademarks and Product Trade Dress), including any goodwill associated therewith, and any registrations and design patents for the foregoing, and (iii) any internet domain name registrations for such trademarks and slogans, all to the extent solely related to the Product; provided, however, in the event Licensor exercises such right to have assigned such Promotional Materials, Licensee shall grant, and hereby does grant, a royalty-free right and license to any housemarks, trademarks, names and logos of Licensee contained therein for a period of [*CONFIDENTIAL*] for the sole and exclusive purpose of using such assigned Promotional Materials in connection with the Commercialization of the Product, after which Licensor shall immediately cease using any materials bearing such housemarks, trademarks, name and logo of Licensee;

(d) subject to Section 14.4, Licensee will assign to Licensor, at Licensor’s sole discretion and direction and to the extent permissible under each respective agreement, all of Licensee’s right, title and interest in and to any agreements (or portions thereof) between Licensee and Third Parties that relate to the Development or Manufacture of the Product;

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(e) Licensee will assign to Licensor, at Licensor’s sole discretion and direction, the management and continued performance of any clinical trials for the Product ongoing hereunder as of the effective date of such termination in respect of which Licensor shall assume full financial responsibility from and after the effective date of such termination; and

(f) Licensee will transfer to Licensor all of Licensee’s right, title and interest in and to any and all Development Data, Commercialization Data, regulatory filings, Regulatory Approvals and other Regulatory Materials Controlled by Licensee for the Product, and material embodiments thereof to the extent specifically related to the Compound and Product. Such transfer, including the transfer of relevant Licensee Know-How, will be undertaken in accordance with a transition plan to be reasonably agreed to by the Parties acting in good faith.

Licensee shall also cause its Affiliates to transfer and assign to Licensor all of such Affiliates’ right, title and interest in and to the foregoing items set forth in this Section 14.3

14.4 Rights of Licensee’s Sublicensees Upon Termination and Supply Obligations.

14.4.1 In the event of termination of this Agreement by Licensor pursuant to Section 13.2 for Licensee’s uncured material breach, Licensee’s Third Party Sublicensees’ (as opposed to its Affiliates) rights in the Compound and the Product shall survive and Licensee’s rights as [*CONFIDENTIAL*] shall be [*CONFIDENTIAL*] free of charge and shall become direct licenses from Licensor to the Sublicensees; provided, however, that, such direct license shall be regulated by either (a) [*CONFIDENTIAL*] or (b) another mutually agreed agreement between Licensor and such Sublicensee; provided, further, that, for a period of [*CONFIDENTIAL*] following the termination of this Agreement by Licensor pursuant to Section 13.2 for Licensee’s uncured material breach, Licensee shall continue to provide such support services to its Sublicensees as it was providing under its sublicense agreements. Notwithstanding the foregoing, this Section 14.4.1 shall not apply to any Sublicensee (i) whose actions or omissions caused this Agreement to be terminated or who was otherwise in breach of this Agreement or the relevant sublicense agreement at the time of termination, or (ii) that is also an Affiliate of Licensee. If Licensor steps-in to directly license one or more Sublicensees under this Section 14.4.1, then upon Licensor’s request and expense Licensee shall provide management services in relation to overseeing the activities of any such Sublicensee(s) pursuant to an agreement that the Parties will negotiate in good faith.

14.4.2 Licensee undertakes, upon Licensor’s reasonable request, to manufacture and supply the Compound and/or the Product, directly or through its nominee, in accordance with Licensor’s and/or the Sublicensees’ reasonable requirements for a period and at a price to be reasonably agreed upon in good faith between the Parties, and Licensor hereby grants to Licensee all rights with respect to the Licensor Technology as may be necessary in order for Licensee to perform such manufacture and supply.

14.5 Accrued Rights.  Expiration or termination this Agreement for any reason will be without prejudice to any rights that will have accrued to the benefit of a Party prior to the effective date of such expiration or termination. Such expiration or termination will not relieve a

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Party from obligations that are expressly indicated to survive the expiration or termination of this Agreement.

14.6 Survival.  Notwithstanding anything to the contrary contained herein, the following provisions shall survive any expiration or termination of this Agreement: ARTICLES: 1 (to the extent necessary to give effect to other surviving provisions, 6.4.3, 6.5.2, 6.6, 8 (with respect to amounts due or accrued prior to the expiration or termination of this Agreement), 11 (except for Section 11.5), 12 (for the period set forth in Sections 12.1.1 and 12.7, provided, that, the paragraph at the end of Section 12.1.1 and immediately above Section 12.1.2 shall have no further force or effect), 13.3, 14 (to the extent applicable) and 15. Except as set forth in this ARTICLE 14 or otherwise expressly set forth herein, upon expiration or termination of this Agreement all other rights and obligations of the Parties shall cease.

14.7 Rights in Bankruptcy.  All rights and licenses of whatever type and nature granted under or pursuant to this Agreement by Licensor and Licensee are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code, and any equivalent law in the United States or any other country. The Parties agree that each Party, solely in its capacity as licensee of certain rights under this Agreement, hereby retains and has the right, but not the obligation, to exercise any or all of its rights and elections under the U.S. Bankruptcy Code and any equivalent law. This Section 14.7 is without prejudice to any rights that a Party may have under the Bankruptcy Code or other applicable law. The Parties further agree that, in the event of the commencement of a bankruptcy case by or against a Party (such Party, the “ Bankrupt Party ” ) under the U.S. Bankruptcy Code, (a) the other Party (the “ Non-Bankrupt Party ”) shall be entitled to a complete duplicate of (or complete access to, as appropriate) all intellectual property licensed to the Non-Bankrupt Party hereunder and all embodiments of such intellectual property, which, if not already in the Non-Bankrupt Party’s possession, shall be promptly delivered to it (x) upon any such commencement of a bankruptcy case and upon the Non-Bankrupt Party’s written request therefore, unless the Bankrupt Party assumes this Agreement pursuant to Section 365 of the Bankruptcy Code or otherwise elects to continue to perform all of its obligations under this Agreement or (y) if not delivered under clause (x), following the rejection of this Agreement by the Bankrupt Party under Section 365 of the Bankruptcy Code and upon the Non-Bankrupt Party’s written request therefore and (b) the Bankrupt Party shall not interfere with the Non-Bankrupt Party’s rights to such intellectual property and all embodiments of such intellectual property, and shall use Commercially Reasonable Efforts to assist and not interfere with the Non-Bankrupt Party in obtaining such intellectual property and all embodiments of such intellectual property from all other entities. The “embodiments” of intellectual property include all tangible, intangible, electronic or other embodiments of rights and licenses hereunder, including all compounds and products embodying intellectual property, Product, filings with Regulatory Authorities and related rights and Licensor Know-How in the case that Licensor is the Bankrupt Party and Licensee Know-How in the case Licensee is the Bankrupt Party.

ARTICLE 15

MISCELLANEOUS

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15.1 Disputes.

15.1.1 The Parties recognize that, from time to time, disputes, controversies or claims may arise which stem from or are related to a Party’s respective rights or obligations under this Agreement or a Party’s actual or alleged breach of this Agreement (a “ Dispute ” ). It is the desire of the Parties to establish procedures to facilitate the resolution of Disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to arbitration or litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Section 15.1.1 if and when a Dispute arises under this Agreement. If the Parties are unable to resolve any Dispute within [*CONFIDENTIAL*] after such Dispute is submitted to it, either Party may, by written notice to the other Party, have such dispute referred to the Parties’ designated Executive Officers or their delegates for attempted resolution. In the event the designated Executive Officers or their delegates are not able to resolve such dispute within such [*CONFIDENTIAL*] period after receipt of written notice, then each Party is free to pursue any remedy at law or in equity available to such Party; provided, that Section 15.1.2 shall apply in the event of a Dispute related to Section 13.2.2.

15.1.2 If Licensee elects to exercise its rights under Section 13.2.2, it shall submit the question of Licensee’s damages to be finally settled by arbitration administered in accordance with the procedural rules of the American Arbitration Association (the “ AAA ” ) in effect at the time of submission, as modified by this Section 15.1.2. The arbitration will be governed by the Laws of the State of New York. The arbitration will be heard and determined by three (3) arbitrators who are retired judges or attorneys with at least twenty (20) years of relevant experience in the pharmaceutical and biotechnology industry, each of whom will be impartial and independent and will not have worked for or on behalf of either Party for at least five (5) years. Each Party will appoint one (1) arbitrator and the third arbitrator will be selected by the two (2) Party-appointed arbitrators, or, failing agreement within thirty (30) days following appointment of the second arbitrator, by the AAA. Such arbitration will take place in New York, New York. The arbitration award so given will, absent manifest error, be a final and binding determination, will be fully enforceable in any court of competent jurisdiction, and will not include any damages expressly prohibited by Section 11.4. Licensor will pay the fees, costs and expenses for the arbitrator it chooses, Licensee will pay the fees, costs and expenses for the arbitrator it chooses, and the Parties will share payment for the third arbitrator. Except in a proceeding to enforce the results of the arbitration or as otherwise required by Applicable Laws or securities exchange, neither Party nor any arbitrator may disclose the existence, content or results of any arbitration hereunder without the prior written consent of both Parties.

15.2 Entire Agreement; Amendment.   This Agreement, together with the Schedules hereto (but excluding Schedule  1.64 , i.e., the S*BIO Agreement), contains the entire understanding of the Parties with respect to the subject matter hereof. Any other express or implied agreements and understandings, negotiations, writings and commitments, either oral or written, in respect to the subject matter hereof are superseded by the terms of this Agreement. The Schedules and Exhibits to this Agreement are incorporated herein by reference and shall be deemed a part of this Agreement. This Agreement may be amended, or any term hereof

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modified, only by a written instrument duly executed by authorized representatives of each of the Parties.

15.3 Force Majeure.   No Party shall be liable for any failure to perform, or be considered in breach of, its obligations under this Agreement (other than obligations to make payments of money) to the extent such performance has been delayed, interfered with or prevented by an event of Force Majeure, and the obligations of such Party under this Agreement (other than obligations to make payments of money) whose performance is affected by Force Majeure shall be suspended for so long as its performance remains affected by the event of Force Majeure. Any Party that experiences an event of Force Majeure shall provide prompt notice of such event to the other Party, including an estimate of the likely period of time during which its performance will be affected, and shall use reasonable efforts to remove the condition constituting Force Majeure. In the event of a prolonged condition of Force Majeure that makes it unreasonable to continue to perform other activities then being performed by the Parties and their Affiliates pursuant to this Agreement, the Parties shall consult directly or through the appropriate Committees and may appropriately scale back their respective activities in order to avoid waste or inappropriate usage of resources under the circumstances, and neither Party shall be liable for any such reasonable scale back, or be considered in breach of its obligations under this Agreement (other than obligations to make payments of money to the other Party) as a result of such reasonable scale back.

15.4 Notices.   Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement and shall be deemed to have been sufficiently given for all purposes if mailed by first class certified or registered mail, postage prepaid (which notice shall be effective five (5) Business Days after such mailing); express delivery service (which notice shall be effective on the first Business Day after delivery to such service); or personally delivered to the appropriate addresses (which notice shall be effective upon delivery to such addresses) set forth below or to such other addresses or numbers for a Party as such Party may inform the other Party by giving five (5) Business Days’ prior written notice:

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15.5 Maintenance of Records.   Each Party shall keep and maintain all records required by Applicable Law or regulation (including records for intellectual property protection purposes) with respect to its activities hereunder pertaining to the Compound and Product and shall make copies of such records available to the other Party as required herein. Each Party must maintain such records for the greater of [*CONFIDENTIAL*] or the time period required by Applicable Law.

15.6 Assignment.  Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed, except that a Party may make such an assignment or transfer without the other Party’s written consent to any of its Affiliates or to a successor to substantially all of the business of such Party to which this Agreement relates, whether in a merger, sale of stock, sale of assets or other transaction, provided that such Affiliate, permitted successor or assignee of rights and/or obligations hereunder assumes, in writing to the other Party, performance of such rights and/or obligations in accordance with the terms and conditions of this Agreement. Any assignment or transfer, or attempted assignment or transfer, by either Party in violation of the terms of this Section 15.6 shall be null and void and of no legal effect. This Agreement shall be binding on, and inure to the benefit of, each Party, its successors and permitted assigns.

15.7 Offset Rights.  Except as expressly permitted in this Agreement, neither Party may, at any time or for any reason, offset any payments due to the other Party or its Affiliates under this Agreement.

15.8 Severability.  If any one (1) or more of the provisions of this Agreement is held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is taken, such provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.

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15.9 Cumulative Remedies.  No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under Applicable Law.

15.10 Ambiguities; No Presumption.  Each of the Parties acknowledges and agrees that this Agreement has been diligently reviewed by and negotiated by and between them, that in such negotiations each of them has been represented by competent counsel and that the final agreement contained herein, including the language whereby it has been expressed, represents the joint efforts of the Parties hereto and their counsel. Accordingly, in interpreting this Agreement or any provision hereof, no presumption shall apply against any Party hereto as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.

15.11 Headings.  The headings for each ARTICLE and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular ARTICLE or Section.

15.12 Interpretation.  Except where the context expressly requires otherwise, (a) the use of any gender herein shall be deemed to encompass references to either or both genders, and the use of the singular shall be deemed to include the plural (and vice versa), (b) the words “include”, “includes” and “including” shall be deemed to be followed by the phrase “without limitation”, (c) the word “will” shall be construed to have the same meaning and effect as the word “shall”, (d) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (e) any reference herein to any person shall be construed to include the person’s successors and assigns, (f) the words “herein”, “hereof” and “hereunder”, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (g) all references herein to ARTICLES, Sections, or Schedules shall be construed to refer to ARTICLES, Sections, or Schedules of this Agreement, and references to this Agreement include all Schedules hereto, (h) the word “notice” means notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement, (i) provisions that require that a Party, the Parties or any committee hereunder “agree”, “consent” or “approve” or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding electronic mail and instant messaging), (j) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof, and (k) the terms “or” and “and/or” shall be interpreted in the inclusive sense commonly associated with the term “and/or”.

15.13 Governing Law; Equitable Relief; and Jurisdiction.

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15.13.1 Governing Law.   This Agreement shall be governed by and construed in accordance with the internal laws of the State of New York applicable to agreements made and to be performed entirely within such state, without regard to the conflicts of law principles of such state, other than Section 5-1401 of the New York General Obligations Applicable Law; provided that any matters relating to the construction or effect of any patent will be governed by the patent laws of the United States. This Agreement was prepared in the English language, which language shall govern the interpretation of, and any dispute regarding, the terms of this Agreement.

15.13.2 Equitable Relief.  Notwithstanding anything in this Agreement to the contrary, each Party shall have the right to seek injunctive or other equitable relief from a court of competent jurisdiction pursuant to Section 15.13.3 that may be necessary to avoid irreparable harm or to maintain the status quo.

15.13.3 Jurisdiction.  Without limiting the provisions of Section 15.1, each Party (a) irrevocably submits to the exclusive jurisdiction of the United States District Court for the Southern District of New York and the Supreme Court of the State of New York, New York County (collectively, the “ Courts ” ), for purposes of any action, suit or other proceeding arising out of this Agreement, (b) agrees not to raise any objection at any time to the laying or maintaining of the venue of any such action, suit or proceeding in any of such Courts, and (c) irrevocably waives any claim that such action, suit or other proceeding has been brought in an inconvenient forum and further irrevocably waives the right to object, with respect to such action, suit or other proceeding, that such Courts do not have any jurisdiction over such Party. Each Party further agrees that service or any process, summons, notice or document by U.S. registered mail to such Party’s notice address provided for in this Agreement shall be effective service of process for any action, suit or proceeding in New York with respect to any matters to which it has submitted to jurisdiction in this Section 15.13.3. Notwithstanding the forgoing, nothing contained in this Agreement will deny any Party the right to seek injunctive relief or other equitable relief from a court of competent jurisdiction applying the laws of the court in the context of a bona fide emergency or prospective irreparable harm, and such an action may be filed and maintained notwithstanding any other ongoing proceeding.

15.14 No Waiver.  Any delay in enforcing a Party’s rights under this Agreement or any waiver as to a particular default or other matter shall not constitute a waiver of such Party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written and signed waiver relating to a particular matter for a particular period of time.

15.15 No Third Party Beneficiaries.  No person or entity other than Licensee, Licensor and their respective Affiliates, successors and permitted assignees hereunder, shall be deemed an intended beneficiary hereunder or have any right to enforce any obligation of this Agreement.

15.16 Independent Contractors.  It is expressly agreed that Licensee and Licensor shall be independent contractors and that the relationship between Licensee and Licensor shall not constitute a partnership, joint venture or agency. Neither Licensee nor Licensor shall have the authority to make any statements, representations, or commitments of any kind, or to take

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any action, which shall be binding on the other Party, without the prior written consent of such other Party.

15.17 Counterparts; Facsimile Signatures.  This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument. This Agreement may be executed by delivery of electronically scanned copies of original signatures delivered by facsimile or electronic mail, and such signatures shall be deemed to bind each Party as if they were original signatures.

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I N W ITNESS W HEREOF , the Parties have executed this Agreement by their duly authorized representatives as of the date first written above.

Signature Page to License, Development and Commercialization Agreement

A request for confidential treatment has been made with respect to portions of the following document that are marked with [*CONFIDENTIAL*]. The redacted portions have been filed separately with the SEC.

Schedule 1.14 : Certain Patents

A request for confidential treatment has been made with respect to portions of the following document that are marked with [*CONFIDENTIAL*]. The redacted portions have been filed separately with the SEC.

A request for confidential treatment has been made with respect to portions of the following document that are marked with [*CONFIDENTIAL*]. The redacted portions have been filed separately with the SEC.

A request for confidential treatment has been made with respect to portions of the following document that are marked with [*CONFIDENTIAL*]. The redacted portions have been filed separately with the SEC.