Exhibit 10.1

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

COLLABORATION AND LICENSE AGREEMENT

BY AND BETWEEN

TESARO, INC.

AND

JANSSEN BIOTECH, INC.

TABLE OF CONTENTS

LIST OF EXHIBITS

COLLABORATION AND LICENSE AGREEMENT

THIS COLLABORATION AND LICENSE AGREEMENT (“Agreement”) is entered into as of April 5, 2016 (the “Effective Date”), by and between JANSSEN BIOTECH, INC., a Pennsylvania corporation, having its principal place of business at 800/850 Ridgeview Drive, Horsham, PA 19044 (hereinafter “Company”) and TESARO, INC., a Delaware corporation having its principal place of business at 1000 Winter Street, Suite 3300, Waltham, MA 02451 (“TESARO”).  Company and TESARO are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.

WHEREAS, TESARO is currently developing a small molecule poly ADP ribose polymerase (PARP) inhibitor, Niraparib, for certain cancer indications (including breast cancer and ovarian cancer); 

WHEREAS, Company desires to obtain, and TESARO desires to grant to Company, a worldwide (excluding Japan), exclusive license to develop and commercialize Niraparib for prostate cancer indications, subject to the terms and conditions of this Agreement; and

WHEREAS, TESARO and Company desire to collaborate with respect to the development, manufacture and commercialization of Niraparib as set forth in this Agreement.

NOW, THEREFORE, in consideration of the foregoing and the premises and conditions set forth herein, the Parties agree as follows: 

ARTICLE 1
DEFINITIONS 

1.1“Acquirer” means any Third Party that is an acquirer in any Change of Control transaction and any of such Third Party’s Affiliates.

1.2“Affiliate” means, with respect to a particular Person and a particular time, another Person that controls, is controlled by or is under common control with such first Person at any such time during the Term.  For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under the common control with”) means the actual power, either directly or indirectly through one or more intermediaries, to direct or cause the direction of the management and policies of a Person, whether by the ownership of fifty percent (50%) or more of the voting stock of such Person, by contract, or otherwise. 

1.3“Affordable Basis” means making a product available to patients at the lowest cost possible.  For clarification, Affordable Basis is satisfied if a Party sells such product for no more than [***].  In determining Affordable Basis, the Parties recognize that, to the extent that a Party engages a Third Party in the commercialization of a product on an Affordable Basis, such Third Party shall be entitled to [***]; provided that the applicable Party uses Commercially Reasonable Efforts to minimize such Third Party profits.

1.4“Alliance Manager” means the person appointed by each Party from within its respective organization to coordinate and facilitate the communication, interaction and cooperation of the Parties pursuant to this Agreement.

1.5“ANDA” means an abbreviated new drug application submitted to the FDA pursuant to 21 U.S.C. § 355(j), and all amendments and supplements thereto

1.6“Applicable Law” means all applicable statutes, ordinances, regulations, rules or orders of any kind whatsoever of any Governmental Authority, including the FFDCA, 21 U.S.C. §301 et seq., U.S. Patent Act (35 U.S.C. §1 et seq.), Federal False Claims Act (31 U.S.C. §3729 et seq.), the Anti-Kickback Statute (42 U.S.C. §1320a-7b et seq.), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the EU member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use and related guidance, Directive 95/46/EC on the protection of individuals with regard to the processing of  personal data and on the free movement of such data, the related national implementing laws and regulations of the EU member states, provisions of the national laws and industry and professionals codes of EU member states governing anti-bribery and anti-kickback practices, all as amended from time to time, together with any rules, regulations, and compliance guidance promulgated thereunder.

1.7“AstraZeneca” means AstraZeneca UK Limited or any assignee of such entity under the AstraZeneca License Agreements.

1.8“AstraZeneca License Agreements” means, collectively, (a) the Patent License Agreement, dated October 4, 2012, between TESARO and AstraZeneca, relating to certain intellectual property licensed to AstraZeneca by the Institute of Cancer Research (the “AstraZeneca-ICR License Agreement”), and (b) the Patent License Agreement, dated October 4, 2012, between TESARO and AstraZeneca, relating to certain intellectual property licensed to AstraZeneca by the University of Sheffield (the “AstraZeneca-Sheffield License Agreement”), in each case ((a) and (b)), including all amendments thereto.

1.9“AstraZeneca Patents” means the “Licensed Patents” as such term is defined in each of the AstraZeneca License Agreements.

1.10“Business Day” means a day other than Saturday, Sunday or any other day on which banking institutions in New York, New York are closed for business. 

1.11“Calendar Quarter” means a financial quarter based on the Johnson & Johnson Universal Calendar; provided,  however, that the first Calendar Quarter for the first Calendar Year extends from the Effective Date to the end of the then-current Calendar Quarter and the last

Calendar Quarter extends from the first day of such Calendar Quarter until the effective date of the termination or expiration of this Agreement.

1.12“Calendar Year” means a year based on the Johnson & Johnson Universal Calendar for that year.  The last Calendar Year of the Term begins on the first day of the Johnson & Johnson Universal Calendar Year for the year during which termination or expiration of this Agreement will occur, and the last day of such Calendar Year will be the effective date of such termination or expiration. 

1.13“Centralized Approval Procedure” means, to the extent compulsory or permitted for the Marketing Approval of a pharmaceutical product in Iceland, Liechtenstein, Norway or any country in the European Union, the procedure administrated by the EMA which results in a single Marketing Approval granted by the European Commission (excluding any pricing or reimbursement approval) that is valid in all countries in the European Union and following recognition, Iceland, Liechtenstein and Norway.

1.14“Change of Control” shall occur if: (a) any Third Party acquires directly or indirectly the beneficial ownership of any voting security of a Party, or if the percentage ownership of such person or entity in the voting securities of a Party is increased through stock redemption, cancellation or other recapitalization, and immediately after such acquisition or increase such Third Party is, directly or indirectly, the beneficial owner of voting securities representing more than fifty percent (50%) of the total voting power of all of the then outstanding voting securities of a Party; (b) a merger, consolidation, recapitalization or reorganization of a Party is consummated, other than any such transaction, which would result in stockholders or equity holders of such Party immediately prior to such transaction, owning, directly or indirectly, at least fifty percent (50%) of the outstanding securities of the surviving entity (or its parent entity) immediately following such transaction; (c) the stockholders or equity holders of a Party approve a plan of complete liquidation of such Party, or an agreement for the sale or disposition by such Party of all or substantially all of such Party’s assets, other than pursuant to a transaction described above or to an Affiliate; (d) individuals who, as of the date hereof, constitute the Board of Directors of a Party (the “Incumbent Board”) cease for any reason to constitute at least a majority of the Board of Directors of such Party (provided,  however, that any individual becoming a director subsequent to the date hereof whose election, or nomination for election by such Party’s shareholders, was recommended or approved by a vote of at least a majority of the directors then comprising the Incumbent Board shall be considered as though such individual were a member of the Incumbent Board); or (e) the sale or transfer to a Third Party of all or substantially all of such Party’s assets is effected. 

1.15“Clinical Data” means any and all data (anonymized, to the extent required by Applicable Law or relevant contracts) generated from any Clinical Trial, or from testing or analysis of subjects or samples from a Clinical Trial (e.g., in vitro testing of tissue samples from subjects enrolled in a Clinical Trial), including raw data, any top-line results reports, and the final clinical study report from such Clinical Trial. 

1.16“Clinical Trials” means a Phase 1 Trial, Phase 2 Trial, Phase 2/3 Trial, Phase 3 Trial or Phase 4 Trial, as applicable.

1.17“CMC Development” means the Development activities related to the composition, manufacture, and specification of the drug substance and the drug product intended to assure the proper identification, quality, purity and strength of the drug, including, but not limited to: test method development and stability testing, process development, drug substance development, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development.

1.18“Co-Packaged Product” means any product containing, in a single package or container and intended for coordinated sale or use, two (2) or more separate products as components, one (1) of which is a Product and the other one (1) or more are for preventative, therapeutic, or diagnostic use.

1.19“Combination Product” means any Product containing as a single formulation, two or more active pharmaceutical ingredients (each, an “API”) as components, including (i) a Compound and (ii) one or more other APIs.    

1.20“Combination Use” means the use of a Single Agent Product in combination with at least one other product that is not a Product for the diagnosis, treatment or prevention of any indication, where such Single Agent Product and other product are packaged and sold separately.

1.21“Commercialization” means any activities directed to marketing, promoting and/or Distributing a pharmaceutical product.  When used as a verb, “Commercialize” means to engage in Commercialization activities.

1.22“Commercially Reasonable Efforts” means, with respect to the efforts and resources to be expended, or activities to be undertaken, by a Party or its Affiliate with respect to any objective or activity to be undertaken hereunder, reasonable efforts and resources intended in good faith to accomplish such objective or activity as such Party would normally use to accomplish a similar objective or activity under similar circumstances, it being understood and agreed that, with respect to the Development, Manufacture, seeking and obtaining Marketing Approval, or Commercialization of a Compound or Product, such efforts and resources shall be consistent with those efforts and resources normally used by a Party under similar circumstances for similar compounds or products to which it has similar rights, which compound or product, as applicable, is at a similar stage in its development or product life and is of similar market potential, taking into account all commercial, scientific, economic and other factors (not including payments due to a Party hereunder), including:  (a) issues of efficacy, safety, and expected and actual approved labeling; (b) the expected and actual competitiveness of alternative products sold by Third Parties in the marketplace; (c) the expected and actual product profile of the Compound or Product; (d) the expected and actual patent and other proprietary position of the Compound or Product; (e) the likelihood of Marketing Approval of the Product given the regulatory structure involved, including the likelihood of obtaining regulatory exclusivity; (f) the ability to formulate and Develop Combination Products; and (g) the market penetration, actual

profitability and the return on investment potential of the Product, including pricing and reimbursement status achieved or likely to be achieved and expected and actual Third Party costs.  Additionally, neither Party shall take into account the Alliance Payments, royalties or milestone payments due to the other Party under this Agreement in connection with its use of Commercially Reasonable Efforts.  To the extent that the performance of a Party’s obligations hereunder is adversely affected by the other Party’s failure to perform its obligations hereunder, the impact of such performance failure will be taken into account in determining whether such first Party has used Commercially Reasonable Efforts to perform its affected obligations. 

1.23“Company Field” means the diagnosis, treatment or prevention of prostate cancer in humans. 

1.24“Company Know-How” means any Know-How Controlled by Company or its Affiliates during the Term that is used by Company or any of its Affiliates or (sub)licensees to Exploit the Compounds or Single Agent Products in the Company Field in the Company Territory, but excluding any such Know-How to the extent that it (a) is used to Exploit a Compound due to its incorporation or use as part of a Combination Product, and (b) is not necessary or useful for the Exploitation of Compounds as Single Agent Products.  

1.25“Company Net Sales” means, with respect to any Product sold by Company or any of its Affiliates, licensees or sublicensees, the gross amounts invoiced on sales of such Product by Company or any of its Affiliates, licensees or sublicensees to a Third Party purchaser in an arms-length transaction, less the following customary deductions, determined in accordance with GAAP and internal policies and actually taken, paid, accrued or allocated based on good faith estimates:

(a)        trade, cash and/or quantity discounts, allowances, and credits, excluding commissions for commercialization;

(b)        excise taxes, use taxes, tariffs, sales taxes and customs duties, and/or other government taxes imposed on the sale of Product (including VAT, but only to the extent that such VAT taxes are not reimbursable or refundable), specifically excluding, for clarity, any income taxes assessed against the income arising from such sale;

(c)        outbound freight, shipment and insurance costs to the extent included in the price and separately itemized on the invoice price;

(d)        [***], cash rebates payable to, or the impact of reimbursement caps established by, a governmental authority (or agent thereof) pursuant to governmental regulations by reason of any national or local health insurance program or similar program, including government levied fees as a result of healthcare reform policies;

(e)        retroactive price reductions, credits or allowances actually granted upon rejections or returns of Product, including for recalls or damaged goods, or billing errors and reserves for returns;

(f)        rebates, chargebacks, administrative fees and discounts (or equivalent thereof) payable to managed health care organizations, group purchasing organizations, pharmacy benefit managers (or equivalent thereof), specialty pharmacy providers, federal, state/provincial, local or other governments, or their agencies or purchasers, reimbursers, or trade customers;

(g)        amounts payable to patients through co-pay assistance cards or similar forms of rebate directly related to the prescribing of the Product; and

(h)        any invoiced amounts which are not collected by Company or its Affiliates, including bad debts.

All aforementioned deductions shall only be allowable to the extent they are commercially reasonable and shall be determined, on a country-by-country basis, as incurred in the ordinary course of business in type and amount consistent with Company’s, its Affiliate’s, or Third Party licensee’s or sublicensee’s (as the case may be) business practices consistently applied across its product lines and accounting standards and verifiable based on Company’s and its Affiliates’ sales reporting system. 

Sales of a Product by and between Company and its Affiliates, licensees or sublicensees are not sales to Third Parties and shall be excluded from Net Sales calculations for all purposes so long as such Product is subsequently resold to a Third Party end user.  Sales of a Product on an Affordable Basis in Developing Countries shall be excluded from Net Sales calculations for purposes of royalty calculations under ARTICLE 8.  Any disposition of a Product as free samples, donations, patient assistance, test marketing programs or other similar programs or studies where such Product is supplied free of charge shall not be subject to royalties. 

Notwithstanding the foregoing, but subject to Section 3.1(e), with respect to any Combination Product that is sold by Company or any of its Affiliates, licensees or sublicensees, the Net Sales of such Combination Product for the determination of royalties of Combination Products will be calculated by multiplying the Net Sales of such Combination Product (calculated as set forth above) by the fraction 1/A, where A is the total number of separate active pharmaceutical ingredients included in such Combination Product.

1.26“Company Parent” means Johnson & Johnson, a New Jersey corporation.

1.27“Company Patents” means all Patents Controlled by Company or its Affiliates during the Term that are necessary to Exploit Compounds or the Single Agent Products in the Company Field in the Company Territory, but excluding any such Patent to the extent that it (a) Covers such Compound due to its incorporation or use as part of a Combination Product and (b) is not necessary or useful for the Exploitation of Compounds as Single Agent Products.

1.28“Company Technology” means, collectively, the Company Patents and the Company Know-How.

1.29“Company Territory” means worldwide, excluding Japan.

1.30“Compound” means (a) the Initial Compound; (b) the compound licensed to TESARO under the Merck License Agreement and known as MK-2512; or (c) with respect to both (a) and (b), any pharmaceutically acceptable salt, polymorph, crystal form, prodrug or solvate thereof.

1.31“Conducting Party” means the Party that is (or the Party whose Affiliate, licensee or sublicensee is) conducting a Clinical Trial of a Product.

1.32“Confidential Information” means, subject to ARTICLE 11, (a) all non-public or proprietary information disclosed by a Party to the other Party under this Agreement, which may include Know-How; and (b) all other non-public or proprietary information (including Know-How) that is expressly deemed in this Agreement to be Confidential Information of such Party whether or not disclosed by such Party or any of its Affiliates to the other Party or any of its Affiliates; in each case ((a) and (b)) without regard as to whether any of the foregoing is marked “confidential” or “proprietary,” or disclosed in oral, written, graphic, or electronic form.  Confidential Information shall include: (a) the terms and conditions of this Agreement; and (b) Confidential Information disclosed by either Party pursuant to the Mutual Non-Disclosure Agreement dated December 29, 2015, between TESARO and Janssen Research & Development LLC, an Affiliate of Company (the “Prior CDA”). 

1.33“Control” or “Controlled” means, with respect to any Know-How, Patent, Trademark or other intellectual property right, possession by a Party or[***] any of its Affiliates, of the ability (without taking into account any rights granted by one Party to the other Party under the terms of this Agreement) to grant access, a license or a sublicense to such Know-How, Patent, Trademark or other intellectual property right without violating the terms of any agreement or other arrangement with, or necessitating the consent of, any Third Party, but with respect to TESARO excluding any Know-How, Patent, Trademark or other intellectual property right that comes into the Control of TESARO pursuant to a Change of Control of TESARO, except to the extent and only to the extent that, such Know-How, Patent, Trademark or other intellectual property right is (a)  made, conceived or reduced to practice by the Acquirer following a Change of Control through the use of, or reference to, any Know-How, Patent, Trademark or other intellectual property right Controlled by TESARO prior to the Change of Control and the failure of Company to have access to such intellectual property right would prevent Company from exercising its rights under Section 3.1 to Exploit Compounds and Products, as they existed immediately prior to the Change of Control; or (b) actually used by TESARO or its Affiliates, or the Acquirer, to Exploit the Compounds or Products following the consummation of such Change of Control.  For clarity, “Control” of a compound by a Party shall mean that such Party Controls Know-How, Patents or other intellectual property rights with respect to such compound.

1.34“Cover” or “Covering” means, with respect to a product, technology, process or method, that, in the absence of ownership of or a license granted under a Valid Claim, the practice or

Exploitation of such product, technology, process or method would infringe such Valid Claim (or, in the case of a Valid Claim that has not yet issued, would infringe such Valid Claim if it were to issue).

1.35“CPR” means the International Institute for Conflict Prevention & Resolution or any successor organization having substantially the same function.

1.36“Critical Observation” means a significant and meaningful GMP deviation or deficiency that requires immediate remediation.

1.37“Currency Hedge Rate” means the Johnson & Johnson currency hedge rate[***]. The Johnson & Johnson currency hedge rate is calculated [***]. 

1.38“Developing Countries” means those countries defined by the World Bank as either “low income countries” or “lower middle income economies” as of the Effective Date.  If, during the Term, countries reported by the World Bank are moved in or out of these designations, the Parties will discuss in good faith the royalty reduction treatment for such countries.

1.39“Development” means all research and non-clinical and clinical drug development activities and processes, including toxicology, pharmacology, project management and other non-clinical efforts, statistical analysis, formulation development, delivery system development, statistical analysis, CMC Development, the performance of Clinical Trials (including the Manufacturing of Compound or Product for use in Clinical Trials) and other activities, reasonably necessary to obtain or maintain Marketing Approval of a pharmaceutical product.  When used as a verb, “Develop” means to engage in Development activities.

1.40“Distribution” means offering to sell, selling, distributing, exporting, transporting and other activities associated with the foregoing activities with respect to the distribution of a pharmaceutical product, including inventory management and control, storage, warehousing and distribution, invoicing, collection of sales proceeds, booking of sales, preparation of sales records and reports, customer relations and services and handling of returns.  When used as a verb, “Distribute” means to engage in Distribution activities.

1.41“DMF Equivalent”  means (a) a Drug Master File (as defined in 21 CFR 314.420) with respect to the U.S.; (b) Module 3 of the Common Technical Document with respect to countries in the EU; or (c) any equivalent of any of the foregoing with respect to any country outside the U.S. or EU.

1.42“Drug Approval Application” means an MAA or NDA.

1.43“EMA” means the European Medicines Agency or any successor agency(ies) or authority having substantially the same function.

1.44“European Commission” means the executive body of the European Union that is responsible, among other things, for granting marketing authorization for medicinal products through the Centralized Approval Procedure.

1.45“European Union” or “EU” means the European Union member states as then-currently constituted; provided,  however, that the EU shall always be deemed to include the Major EU Countries.  As of the Effective Date, the European Union member states are Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.

1.46“Executive Officers” means (a) with respect to Company, either (i) prior to the first Marketing Approval of any Product in the Company Field in the Company Territory, the Global Head of Research and Development (or his or her designee), and (ii) following the first Marketing Approval of any Product in the Company Field in the Company Territory, the President of U.S. oncology commercial operations (or his or her designee), and (b) with respect to TESARO, the Chief Executive Officer (or his or her designee).

1.47“Exploitation” means research, use, practice, Development, Manufacture or Commercialization.  When used as a verb, to “Exploit” means to engage in Exploitation activities.

1.48“FDA” means the U.S. Food and Drug Administration and any successor agency(ies) or authority having substantially the same function.

1.49“FFDCA” means the U.S. Federal Food, Drug, and Cosmetic Act (21 U.S.C. §301 et seq.), as amended from time to time.

1.50“Field” means, (a) with respect to Company and its Affiliates and (sub)licensees, the Company Field, and (b) with respect to TESARO and its Affiliates and (sub)licensees, the TESARO Field.  References to a “Party’s Field” shall be interpreted accordingly.

1.51“First Commercial Sale” means, on a Product-by-Product and country-by-country basis, the first sale for monetary value of such Product under this Agreement by a Party, its Affiliates, licensees or sublicensees to an end user for use, consumption or resale of such Product in such country in the Company Field after Marketing Approval of such Product in the Company Field has been obtained in such country, where such sale results in a Net Sale.  Sale of a Product under this Agreement by a Party to an Affiliate of such Party or a licensee or sublicensee of such Party shall not constitute a First Commercial Sale unless such Affiliate, licensee or sublicensee is the end user of such Product.  For the avoidance of doubt, the sale of Product for clinical study purposes, early access programs (such as to provide patients with a Product prior to Marketing Approval pursuant to treatment INDs or protocols, named patient programs or compassionate use programs) or any similar uses shall not constitute a First Commercial Sale. 

1.52“Fixed Dose Combination Product” or “FDC” means any Product containing, as a single formulation, two or more APIs as components, including (a) a Compound and (ii) one or more other APIs.  For clarity, an FDC is a “Combination Product” hereunder.

1.53“Force Majeure” means any event beyond the reasonable control of the affected Party, which may include embargoes; war or acts of war, including terrorism; insurrections, riots, or civil unrest; strikes, lockouts or other labor disturbances; epidemics, fire, floods, earthquakes or other acts of nature; acts, omissions or delays in acting by any Governmental Authority (other than delays incident to the ordinary course of drug development); and failure of plant or machinery.

1.54“GAAP” means generally accepted accounting principles in the U.S., consistently applied.

1.55“Generic Approval” means, with respect to a pharmaceutical product for which Marketing Approval has been granted in any country or jurisdiction, a subsequent Marketing Approval for another pharmaceutical product in such country or any other country that is granted based upon: (a) reference to an existing Marketing Approval for such pharmaceutical product (or any of its APIs), or to any Regulatory Documentation or Clinical Data underlying such existing Marketing Approval but not including pursuant to a Right of Reference granted under this Agreement; and (b) in the U.S., that pharmaceutical product is approved with an “A” rating under an ANDA, or outside of the U.S., that pharmaceutical product is similarly approved.    

1.56“Generic Version” means, with respect to a given pharmaceutical product and a given country or jurisdiction, a version of such pharmaceutical product that: (a) contains the same active pharmaceutical ingredient(s) as such pharmaceutical product (and no other active pharmaceutical ingredient(s)); (b) has the same indication; (c) has the same dosage form and strength; (d) is approved for marketing or sale in such country or jurisdiction pursuant to a Generic Approval; and (e) is sold by a Third Party in such country pursuant to such Generic Approval.

1.57“Good Clinical Practices” or “GCP” means the then-current standards, practices and procedures promulgated or endorsed by the FDA as set forth in 21 C.F.R. Parts 50, 54 and 56 (or any successor statute or regulation), and in the guideline adopted by the International Conference on Harmonization (“ICH”), titled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance” (or any successor document), including related regulatory requirements imposed by the FDA and comparable regulatory standards, practices and procedures promulgated by the European Commission or other Regulatory Authority, as they may be updated from time to time.

1.58“Good Laboratory Practices” or “GLP” means the then-current standards, practices and procedures promulgated or endorsed by the FDA as set forth in 21 C.F.R. Part 58 (or any successor statute or regulation), including related regulatory requirements imposed by the FDA and comparable regulatory standards, practices and procedures promulgated by the European

Commission or other Regulatory Authority, as they may be updated from time to time, including applicable guidelines promulgated under the ICH.

1.59“Good Manufacturing Practices” or “GMP” means the then-current good manufacturing practices required by the FFDCA, as amended, and the regulations promulgated thereunder by the FDA at 21 C.F.R. Parts 210 and 211, for the manufacture and testing of pharmaceutical materials, and comparable Applicable Law related to the manufacture and testing of pharmaceutical materials in jurisdictions outside the U.S., including the quality guideline promulgated by the ICH designated ICH Q7A, titled “Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients” and the regulations promulgated thereunder, in each case as they may be updated from time to time.

1.60“Governmental Authority” means any multi-national, supra-national, federal, state, local, municipal or other government authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).

1.61“IND” means (a) an Investigational New Drug application as defined in the FFDCA and applicable regulations promulgated thereunder by the FDA, including 21 C.F.R. Part 312; or (b) a Clinical Trial authorization application or other documentation filed with a Regulatory Authority in any other country or jurisdiction outside the U.S., the filing or becoming effective of which (in the case of (a) or (b)) is necessary to commence or conduct clinical testing of a pharmaceutical product in humans in such country or jurisdiction. 

1.62“Indication” means a discrete clinically recognized form of a disease in the Company Field.   For purposes of this Agreement, treatment of different subpopulations within a population of patients treated for a particular cancer type/indication or different lines of treatment for the same cancer type/indication shall also be treated as separate Indications (e.g., front-line treatment, relapsed refractory treatment and maintenance treatment of the same disease shall be considered different Indications).

1.63“Initial Compound” means the compound known as Niraparib, as further described in Exhibit 1.63. 

1.64“Initial Indications” means [***].

1.65“Initial Product” means the Single Agent Product Developed by TESARO prior to the Effective Date that contains the Initial Compound as its sole active pharmaceutical ingredient. 

1.66“International Public Organization” means any of the organizations listed in 8 C.F.R. § 316.20, as amended from time to time.

1.67“Invention” means any invention, discovery or development, whether or not patentable, made, conceived or reduced to practice under this Agreement, whether made, conceived or

reduced to practice solely by, or on behalf of, TESARO, Company, the Parties jointly, or any Affiliate of the same.

1.68“JAA” means any anti-androgen compound Controlled by Company or any of its Affiliates during the Term or a product containing such compound as a sole active pharmaceutical ingredient, as the context requires.  For clarity, the term “JAA” does not include any FDC or other Combination Product containing a JAA as a component.

1.69“Johnson & Johnson Universal Calendar” means the universal calendar system used by Company Parent and its Affiliates for internal and external reporting purposes (a copy of which for the year 2016 is attached hereto as Exhibit 1.69 and a copy of which prior to the beginning of each such year for succeeding years shall be provided to TESARO). 

1.70“Know-How” means information, inventions, discoveries, formulations, formulas, practices, procedures, processes, methods, knowledge, know-how, trade secrets, technology, techniques, designs, drawings, correspondence, computer programs, documents, apparatus, results, strategies, Regulatory Documentation, information and submissions pertaining to, or made in association with, filings with any Governmental Authority, data (including pharmacological, toxicological, non-clinical data, Clinical Data, analytical and quality control data, manufacturing data and descriptions, market data, financial data or descriptions), devices, assays, chemical formulations, specifications, material, product samples and other samples, physical, chemical and biological materials, and the like, in written, electronic, oral or other tangible or intangible form, whether or not patentable.

1.71“Knowledge” means, as applied to a Party, that such Party shall be deemed to have knowledge of a particular fact or other matter to the extent that a reasonably prudent person with primary responsibility for the applicable subject matter (whether an officer or employee of such Party) knew or should have known of such fact or other matter.

1.72“[***]” means [***].

1.73“[***]” means [***].

1.74“Major EU Countries” means, collectively, France, Germany, Italy, Spain, and the United Kingdom (whether or not such countries are EU member states).

1.75“Major Markets” mean the U.S., Canada and the Major EU Countries.

1.76“[***]” means [***].

1.77“Manufacture” means all activities and processes related to the manufacturing of a pharmaceutical product, or any ingredient thereof, including labeling, packaging, in-process and finished product testing, release of such pharmaceutical product or any component or ingredient thereof, performance of quality assurance activities related to manufacturing and release of such pharmaceutical product, and the performance of ongoing stability tests and regulatory activities

related to any of the foregoing.  Where the context so requires, Manufacture shall also include obtaining product from contract manufacturers subject to the terms and conditions of this Agreement.  When used as a verb, to “Manufacture” means to engage in Manufacturing activities.

1.78“Manufacturing Costs” means [***].  Costs included will be consistent with the activities outlined in Section 1.77 (the “Manufacture” definition).

1.79“Marketing Approval”  means, with respect to a pharmaceutical product and any country or jurisdiction, any and all: (a) Regulatory Approvals that are necessary to market or sell such pharmaceutical product in such country or jurisdiction, including approval of a Drug Approval Application; and (b) pricing and reimbursement approvals that are necessary to obtain before initiating Commercialization of such pharmaceutical product in such country or jurisdiction.  For purposes of illustration with respect to the Major EU Countries, the following pricing and reimbursement approvals are examples of those described in clause (b): in France, publication of the reimbursed price level in the official journal and registration on a reimbursement list by or on behalf of Comité Economique des Produits de Santé or Haute Autorité de Santé (or a successor agency); in Italy, publication of reimbursement in the Government’s Official Gazette (by Agenzia Italiana del Farmaco or a successor agency); in Germany, execution of contract with the head association of sick funds (GKV-Spitzenverband, Gesetzlichen Krankenversicherung, or a successor agency); in Spain, authorization by La Comisión Interministerial de Precios de los Medicamentos or La Comisión Nacional para el Uso Racional de los Medicamentos (or a successor agency) for national patient access to reimbursement by or on behalf of a Governmental Authority; and in the United Kingdom, a recommendation by the National Institute for Health and Care Excellence (or a successor agency) to obtain mandatory funding to enable broad market access.    

1.80“Marketing Authorization Application” or “MAA” means an application for authorization to market and/or sell a drug product submitted to a Regulatory Authority in any country or jurisdiction other than the U.S., and amendments and supplements thereto, including, with respect to the European Union, a marketing authorization application filed with the EMA pursuant to the Centralized Approval Procedure or with the applicable Regulatory Authority of a country in the European Economic Area with respect to the decentralized procedure, mutual recognition or any national approval procedure.

1.81“Merck” means Merck Sharp & Dohme Corp. or any assignee of such entity under the Merck License Agreement.

1.82“Merck Know-How” has the meaning set forth in the Merck License Agreement.

1.83“Merck License Agreement” means the License Agreement, dated May 22, 2012, between Merck and TESARO, including all amendments thereto.

1.84“Merck Patents” means the “Compound Patent Rights” as such term is defined in the Merck License Agreement.

1.85“Merck Term” means the “Term” of the Merck License Agreement as such term is defined in the Merck License Agreement.

1.86“Merger Control Laws” means all U.S. federal and state, and any foreign, statutes, rules, regulations, orders, administrative and judicial doctrines, and other Applicable Law, relating to antitrust or competition matters, or that are designed or intended to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade or lessening of competition.

1.87“Monotherapy Use” means the use of one Single Agent Product alone for the diagnosis, treatment or prevention of any indication.

1.88“NDA” means a new drug application submitted to the FDA pursuant to Section 505(b) of the FFDCA, 21 U.S.C. § 355(b), and all amendments and supplements thereto.

1.89“Net Sales” means (a) with respect to any Product sold by Company or any of its Affiliates, licensees or sublicensees, Company Net Sales and (b) with respect to any Product sold by TESARO or any of its Affiliates, licensees or sublicensees, TESARO Net Sales. 

1.90“Orange Book” means, as applicable, the most recent and electronic editions of the Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

1.91“Other TESARO Patents” means TESARO Patents other than the Merck Patents and the AstraZeneca Patents.

1.92“Pass-through Third Party Royalties” means the Pass-through Merck Royalty, the Pass-through AstraZeneca-ICR Royalty and the Pass-through AstraZeneca-Sheffield Royalty.

1.93“Patents” means all: (a) patents, including any utility or design patent; (b) patent applications, including provisionals, substitutions, divisionals, continuations, continuations in-part or renewals; (c) patents of addition, restorations, extensions, supplementary protection certificates, registration or confirmation patents, patents resulting from post-grant proceedings, re-issues and re-examinations; (d) other patents or patent applications claiming priority directly or indirectly to (i) any such specified patent or patent application specified in (a) through (c), or (ii) any patent or patent application from which a patent or patent application specified in (a) through (c) claim direct or indirect priority; (e) inventor’s certificates; and (f) other rights issued from a Governmental Authority similar to any of the foregoing; in each case of (a) through (f), irrespective of whether such patent, patent application or other right arises in the U.S. or any other country or jurisdiction.

1.94“Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision, department or agency of a government.

1.95“Phase 1 Trial” means a clinical trial of a pharmaceutical product that (a) (i) is a first-in-humans trial on subjects who are patients, (ii) is for the purposes of establishing initial safety, tolerability, pharmacokinetic and pharmacodynamic data for such product, (iii) exposes subjects to such product and (iv) is designed to provide the sponsor of the clinical trial with sufficient data about such product to initiate a Phase 2 Trial; or (b) meets the definition in 21 C.F.R. §312.21(a) or any of its foreign equivalents. 

1.96“Phase 2 Trial” means a clinical trial of a pharmaceutical product (a) with the endpoint of evaluating its effectiveness for a particular indication or indications, its short term tolerance and safety, as well as its pharmacokinetic and pharmacodynamic data in patients with the indications under study and is not intended to be pivotal to support Marketing Approval for such product; or (b) that meets the definition in 21 C.F.R. §312.21(b) or any of its foreign equivalents.

1.97“Phase 2/3 Trial” means a Phase 2 Trial involving a sufficient number of subjects that, prior to commencement of the trial or at any other defined point in the trial, satisfies both of the following ((a) and (b)):

(a)        such trial is designed to (i) establish that the applicable pharmaceutical product is safe and efficacious for its intended use, and (ii) define and determine warnings, precautions, and adverse reactions that are associated with the pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Marketing Approval for such Product or a similar clinical study prescribed by the FDA; and

(b)        such trial is or becomes a registration trial sufficient for filing an application for a Marketing Approval the applicable pharmaceutical product in the U.S., as evidenced by (i) an agreement with or statement from the FDA on a Special Protocol Assessment or equivalent, or (ii) other guidance or minutes issued by the FDA, for such registration trial.

1.98“Phase 3 Trial” means a clinical trial of a pharmaceutical product (a) on a sufficient number of patients, which trial (i) is designed to establish that such product is safe and efficacious for its intended use, (ii) is designed to define warnings, precautions and adverse reactions that are associated with such product in the dosage range to be prescribed, and (iii) is pivotal to support Marketing Approval for such product; or (b) that meets the definition in 21 C.F.R. §312.21(c) or any of its foreign equivalents.

1.99“Phase 4 Trial” means a clinical trial of a pharmaceutical product, possibly including pharmacokinetic studies, which trial (a) is not required to be completed prior to obtaining Marketing Approval for an indication; and (b) either (i) is required by the applicable Regulatory Authority as mandatory to be conducted on or after the Marketing Approval of an indication, or (ii) is conducted voluntarily to enhance scientific knowledge of such product (e.g., providing additional drug profile, safety data or marketing support information, or supporting expansion of product labeling).

1.100“Product” means any pharmaceutical product, including all forms, presentations, strengths, doses and formulations (including any method of delivery), containing a Compound alone or in combination with other APIs.  For the sake of clarity, all forms, presentations, doses and formulations of a pharmaceutical product containing a Compound shall be considered the same Product for purposes of this Agreement, so long as each form, presentation, dose and formulation contains the same Compound and same other APIs (and no other Compounds or other APIs).

1.101“Regulatory Approval” means any and all approvals, licenses (including import licenses), registrations or authorizations from any Regulatory Authority that are required under Applicable Law or reasonably necessary to Exploit a pharmaceutical product in any country or jurisdiction for one or more uses, and all amendments and supplements thereto. 

1.102“Regulatory Authority” means any applicable Governmental Authority with authority over the Exploitation of a pharmaceutical product in a country or jurisdiction, including (a) in the U.S., the FDA; and (b) in the European Union, the EMA and the European Commission.

1.103“Regulatory Documentation” means, with respect to the Compounds and Products, (a) all applications for Regulatory Approval of any Compound or Product, including Drug Approval Applications; (b) all Regulatory Approvals for any Compound or Product, including INDs and Marketing Approvals; (c) all supporting documents created for, referenced in, submitted to or received from an applicable Regulatory Authority relating to any of the applications or Regulatory Approvals described in clauses (a) or (b), including DMF Equivalents, annual reports, advertising and promotion documents required to be submitted to Regulatory Authorities, adverse event files, complaint files and Manufacturing records; (d) all correspondence made to, made with, or received from any Regulatory Authority (including written correspondence and minutes from meetings, discussions or conferences) relating to any of the foregoing applications, Regulatory Approvals or documents described in clauses (a), (b) or (c), in each case ((a), (b), (c) and (d)), including all Know-How included therein.

1.104“Right of Reference” shall have the meaning set forth in 21 C.F.R. §314.3(b) or equivalents thereto under Applicable Law in countries or jurisdictions outside the U.S.

1.105“Royalty Term” means, on a Product-by-Product and country-by-country basis, the time period beginning with the First Commercial Sale of such Product in such country (or, if earlier with respect to a Prostate-Approved Single Agent Product, the first sale or other transfer of such Product in such country for a use described in clause (B) or (C) of the definition of “Prostate-Approved Single Agent Product” where such sale or transfer results in a Net Sale) and continuing until the later of:  (a) the expiration of the last Valid Claim of a TESARO Patent that Covers such Product in such country; or (b) ten (10) years from the First Commercial Sale of such Product in such country.

1.106“Single Agent Product” means (a) any Product that contains a Compound as its sole API and (b) any Product that is deemed to be a Single Agent Product pursuant to Section 3.1(e). 

1.107“Supplemental Application” means, with respect to any pharmaceutical product for which a Drug Approval Application has been approved by the applicable Regulatory Authority, an application to supplement or amend such Drug Approval Application to expand the approved label for such pharmaceutical product to include use of such pharmaceutical product for an additional indication. 

1.108“Tax” or “Taxes” means any taxes, levies, imposts, duties, charges, assessments or fees of any nature (including any interest thereon).

1.109“Technology Transfer Costs” means internal and external costs incurred by TESARO for the transfer of copies of all tangible embodiments of Know-How necessary for Company’s establishment of Manufacturing capabilities for Compound API as described in the API Supply Agreement.  With respect to internal costs, FTEs will be invoiced at an annual rate of $[***]  per FTE (i.e., an hourly rate of $[***] per FTE, assuming [***] working days per year and an 8 hour workday).  For the avoidance of doubt, Technology Transfer Costs exclude expenses for travel and time spent in general planning meetings.  A quarterly budget for TESARO consulting services related to technology transfer will be established and agreed to by the Parties in accordance with the API Supply Agreement.  All Technology Transfer Costs will be invoiced according to Section 8.13.

1.110“Territory” means, (i) with respect to Company and its Affiliates and (sub)licensees, the Company Territory, and (ii) with respect to TESARO and its Affiliates and (sub)licensees, the TESARO Territory.  References to a “Party’s Territory” shall be interpreted accordingly.

1.111“TESARO Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31, for so long as this Agreement is in effect; provided,  however, that the first TESARO Calendar Quarter for the first TESARO Calendar Year extends from the Effective Date to the end of the then-current TESARO Calendar Quarter and the last TESARO Calendar Quarter extends from the first day of such TESARO Calendar Quarter until the effective date of the termination or expiration of this Agreement. 

1.112“TESARO Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31, for so long as this Agreement is in effect.  The last TESARO Calendar Year of the Term begins on January 1 for the year during which termination or expiration of this Agreement will occur, and the last day of such TESARO Calendar Year will be the effective date of such termination or expiration.

1.113“TESARO Field” means (a) with respect to Japan, all uses, including the diagnosis, treatment or prevention of any disease in humans, and (b) with respect to any country or jurisdiction outside Japan, all uses outside of the Company Field.   

1.114“TESARO Know-How” means all Know-How Controlled by TESARO during the Term that is necessary or useful to Exploit the Compounds or Products in the Company Field in the Company Territory.

1.115“TESARO License Agreements” means (a) the Merck License Agreement, and (b) the AstraZeneca License Agreements. 

1.116“TESARO Net Sales” means with respect to any Product, the gross amounts invoiced and included as current period sales of such Product by TESARO or any of its Affiliates or (sub)licensees to a Third Party purchaser in an arm’s-length transaction, less the following customary deductions, to the extent they are actually taken, paid, accrued or allocated based on good faith estimates, all determined in accordance with GAAP and internal policies, consistently applied: 

(a)        trade and quantity discounts other than early payment cash discounts;

(b)        returns, rebates, chargebacks and other allowances;

(c)        retroactive price reductions that are actually allowed or granted;

(d)        sales commissions paid to Third Party distributors and/or selling agents;

(e)        deductions to gross invoice price of Product imposed by Regulatory Authorities or other governmental entities;

(f)        the standard inventory cost of devices or delivery systems used for dispensing or administering Product; and

(g)        a fixed amount equal to three percent (3%) of the amount invoiced to cover bad debt, early payment cash discounts, transportation and insurance and custom duties. 

1.117“TESARO Patents” means all Patents Controlled by TESARO during the Term that are necessary or useful to Exploit the Compounds or Products in the Company Field in the Company Territory.  TESARO Patents include, as of the Effective Date, those Patents set forth in Exhibit 1.117, the Merck Patents and AstraZeneca Patents.    

1.118“TESARO Technology” means, collectively, the TESARO Patents and the TESARO Know-How.

1.119“TESARO Territory” means worldwide.

1.120“Third Party” means any Person other than (a) Company, (b) TESARO or (c) an Affiliate of either of Company or TESARO.

1.121“Third Party Royalties” means royalties required to be paid by TESARO or its Affiliates on Product sales to Third Parties. 

1.122“Trademark” means any word, name, symbol, colour, designation, slogan, catch phrase or device or any combination thereof used or intended to be used in commerce and indicating the

source for a product or service, including any domain name, trademark, trade dress, brand mark, trade name, brand name, logo or business symbol, any registrations of any of the foregoing or any pending applications therefor.

1.123“U.S.” means the United States of America, including its territories and possessions.

1.124“Valid Claim” means either: (a) a claim of an issued and unexpired Patent, to the extent such claim has not been revoked, held invalid or unenforceable by a patent office, court or other Governmental Authority of competent jurisdiction in a final order, from which no further appeal can be taken, and which claim has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise; or (b) a claim of a patent application that has not been pending for more than seven (7) years from the date of its first priority patent application filing anywhere in the world and that has not been revoked, cancelled, withdrawn, held invalid or abandoned. 

Additional Definitions.  Each of the following definitions is set forth in the Section of this Agreement indicated below:

ARTICLE 2

GOVERNANCE

2.1Joint Steering Committee.    

(a)        Formation and Purpose.    The Parties agree to establish and convene a joint steering committee (the “JSC”) within ninety (90) days after the Effective Date.  The JSC shall consist of representatives from each Party as further described in Section 2.6(a) and operate in accordance with this Section 2.1 and Section 2.6. The purpose of the JSC shall be to serve as a forum for discussing, monitoring and sharing information with respect to the Parties’ Exploitation of the Compounds and Products in the Company Field in the Company Territory and in the TESARO Field in the TESARO Territory, and to resolve any Deadlocked Committee Matter pursuant to Section 2.1(d).  Notwithstanding the foregoing or anything else contained herein to the contrary, Exploitation of the Compounds or Products by or on behalf of TESARO, in each case, (i) for Combination Products, Co-Packaged Products or Combination Use in the TESARO Field in the TESARO Territory or (ii) in Japan, shall not be subject to the oversight or authority of the JSC or any other Joint Committee; provided, that the foregoing shall not limit the provisions of ARTICLE 7 with respect to the allocation of Single Agent Products or Compound API in the event of an anticipated or actual shortage or any provisions of this Agreement expressly requiring TESARO to provide to a Joint Committee or Company any reports, plans or other information regarding Exploitation of Compounds or Products by or on behalf of TESARO, except to the extent Combination Products, Co-Packaged Products or Combination Use in the TESARO Field are expressly excluded from such provisions.

(b)        Responsibilities of the JSC.    The JSC shall: 

(i)discuss and monitor Development, regulatory, Manufacturing, medical affairs and Commercialization activities with respect to the Compounds

and Products in the Company Field in the Company Territory and in the TESARO Field in the TESARO Territory consistent with this Agreement;

(ii)review summaries of results and progress of the Development under the TESARO Development Plan and Company Development Plan presented or submitted by the Parties in accordance with Section 4.2(h), including periodic reviews of data, results and analyses from the Development activities conducted under the TESARO Development Plan or Company Development Plan (including clinical, regulatory and safety data, results, reports and analyses);

(iii)establish working groups or committees as necessary or appropriate and agreed to by the JSC, and delegate tasks within its authority to further discuss and share information with respect to the Development and Commercialization of the Compounds and Products in the Company Field in the Company Territory and in the TESARO Field in the TESARO Territory;

(iv)resolve Deadlocked Committee Matters to the extent authorized by Section 2.1(d); and

(v)perform other obligations specifically delegated to it and permitted under this Agreement.

(c)JSC Decisions and Actions.  The JSC shall not have any formal decision-making authority, except with respect to the resolution of Deadlocked Committee Matters as described in Section 2.1(d).  Actions to be taken and decisions to be made by the JSC with respect to such matters shall be taken or made by unanimous agreement, with each Party’s JSC representatives collectively having one (1) vote. 

(d)Escalation Procedures for Deadlocked Committee Matters.  Either Party may refer a matter that is expressly designated in Section 2.2(c), 2.3(c), 2.5(c), 7.4(c) or 7.7 as a “Deadlocked Committee Matter” to the JSC for attempted resolution.  For clarity, no matter, dispute or failure of a Joint Committee to reach unanimous agreement with respect to any matter, other than those expressly designated as Deadlocked Committee Matters in the foregoing Sections shall be subject to the Escalation Procedures or resolution as a Deadlocked Committee Matter hereunder.  If the JSC does not reach unanimous agreement on any Deadlocked Committee Matter within thirty (30) Business Days from the date that the matter is first presented to the JSC, such matter shall be resolved as follows, which shall be the exclusive mechanism for resolving Deadlocked Committee Matters:

(i)Either Party may, by written notice to the other, have such Deadlocked Committee Matter referred to the Executive Officers for resolution.  The Executive Officers shall meet promptly to discuss such Deadlocked

Committee Matter and seek in good faith to determine a resolution.  If the Executive Officers do not agree upon a resolution in a timely manner, which shall in no case be more than thirty (30) calendar days after the Deadlocked Committee Matter was referred to them, then such Deadlocked Committee Matter shall be resolved in accordance with Section 2.1(d)(ii) and the relevant provision of this Agreement pursuant to which such Deadlocked Committee Matter was referred to the JSC.  The procedures set forth in this Section 2.1(d)(i) are referred to as the “Escalation Procedures.”

(ii)If another provision of this Agreement expressly designates a matter as a Deadlocked Committee Matter and provides: (A) for a resolution methodology or a specific final resolution with respect to such Deadlocked Committee Matter in the event mutual agreement is not reached other than final decision-making authority of a Party (e.g., resolution by an independent Third Party accountant, or the status quo prevails), then such resolution methodology or specific final resolution shall be binding on the Parties; or (B) that one of the Parties has final decision-making authority with respect to such Deadlocked Committee Matter in the event mutual agreement is not reached, then the decision of the Party with final decision-making authority on such matter shall be final and binding on the Parties subject to the limitations set forth in Section 2.1(d)(iii). 

(iii)Notwithstanding anything to the contrary in this Agreement, neither Party may exercise its final decision-making authority with respect to a Deadlocked Committee Matter to: (1) amend this Agreement or a Party’s rights or obligations under this Agreement; (2) determine that either Party has fulfilled or breached a Party’s obligations under this Agreement; (3) make any decision that expressly requires TESARO’s or Company’s approval or agreement or the approval or agreement of both Parties under this Agreement; (4) resolve any dispute regarding whether a Milestone Event has been achieved, the amount of any royalties or other payments owed by one Party to the other Party, or the Net Sales of a Product allocable to an Indication; (5) resolve any dispute regarding whether a matter is a Deadlocked Committee Matter or subject to TESARO or Company final decision-making under this Agreement, or whether a matter is a Dispute hereunder; (6) cause either Party to violate Applicable Law or regulatory requirements; or (7) cause the other Party to violate or not be in compliance with its own health care compliance policies and procedures of general application, consistently applied by such Party and its Affiliates, or any corporate integrity agreement to which such Party is subject.

(iv)Except as expressly provided in this Agreement with respect to the Deadlocked Committee Matters, no matter, decision, or action of the Parties shall require the agreement, approval or consent of a Joint Committee. 

(v)If another provision of this Agreement expressly provides for the Parties to engage a Third Party accounting firm to resolve a Deadlocked Committee Matter, the following terms shall apply:

(1)        The Parties shall mutually select and engage an independent Third Party accounting firm that has no auditing or other financial relationship with either Party or any of its Affiliates.

(2)        Such accounting firm shall, as soon as reasonably practicable after such firm is engaged, deliver a report to each Party with its analysis and determination of such Deadlocked Committee Matter. 

(3)        The costs of such firm’s services shall be shared equally by the Parties (for clarity, subject to Section 8.11 in the event of any audit conducted thereunder).

(e)General Performance.  If either Party reasonably believes that the other Party intends to take any action relating to any Compound or Product that would reasonably be expected to materially and adversely affect such Party’s Development or Commercialization of the Compounds or Products in its Field in its Territory, then such Party may so notify the other Party; provided,  however, that this Section 2.1(e) shall not apply with respect to any Deadlocked Committee Matter or any matter that a Joint Committee is expressly authorized to determine, approve or resolve under this Agreement.  If a Party receives a notice pursuant to this Section 2.1(e) and it has not yet taken the action identified therein, such Party shall use commercially reasonable efforts to refrain from taking such action until the Parties have attempted to resolve the notifying Party’s concerns in accordance with this Section 2.1(e).  The Parties shall meet promptly thereafter (and, in any event, within ten (10) Business Days thereafter) to discuss the concerns raised in such notice and shall use good faith efforts to agree upon a mutually acceptable resolution to such concerns within thirty (30) calendar days after receipt of the notice.  If the Parties do not agree upon a resolution within such thirty (30) day period, either Party may, by written notice to the other, have the matter referred to the Executive Officers for resolution.  The Executive Officers shall meet promptly to discuss such matter and to seek in good faith to determine a mutually acceptable resolution.  If the Executive Officers do not agree upon a resolution in a timely manner, which shall in no case be more than ten (10) calendar days after the matter was referred to them, then the final decision regarding the taking, or refraining from taking, the applicable action will be made by the Party proposing

to take such action, or, if either Party has the sole right under this Agreement to take such action, the Party with the sole right to take the action.  For the avoidance of doubt, if a Party has the right to take an action under this Agreement, it shall not be a breach of this Agreement if such Party takes such action prior to the conclusion of the process contemplated by this Section 2.1(e); provided, that (i) it is reasonably necessary for such Party to take such action, and (ii) such Party sought in good faith to reach mutual agreement on the matter. 

2.2Joint Development Committee.    

(a)Formation and Purpose.    The Parties agree to establish and convene a joint development committee (the “JDC”) within ninety (90) days after the Effective Date.  The JDC shall consist of representatives from each Party as further described in Section 2.6(a) and operate in accordance with this Section 2.2 and Section 2.6. The purpose of the JDC shall be to serve as a forum for discussing, monitoring and sharing information with respect to the Parties’ Development of, and regulatory activities related to, the Compounds and Products in the Company Field in the Company Territory and in the TESARO Field in the TESARO Territory, and to determine, approve or resolve matters with respect to such Development and regulatory activities that the JDC is expressly authorized under Section 2.2(c) to determine, approve or resolve under this Agreement.

(b)Responsibilities of the JDC.    The JDC shall: 

(i)discuss and monitor Development and regulatory activities with respect to the Compounds and Products in the Company Field in the Company Territory and in the TESARO Field in the TESARO Territory;

(ii)review and discuss the Development Plans submitted by the Parties in accordance with Section 4.2(c), and discuss any concerns raised by either Party with respect to such Development Plans in accordance with Section 4.2(c);

(iii)discuss any Objection with respect to a Clinical Trial that is referred to the JDC pursuant to Section 4.2(d);

(iv)discuss the logistics of sharing Know-How pursuant to Section 4.2(f) and sharing safety data and Regulatory Documentation pursuant to Section 5.5;

(v)to the extent requested by a Party pursuant to Section 4.2(f), discuss issues related to the Development of the Compounds or Products;

(vi)review summaries of results and progress of the Development under the TESARO Development Plan and Company Development Plan, including

periodic reviews of data, results and analyses from the Development activities conducted pursuant under the TESARO Development Plan or Company Development Plan (including clinical, regulatory and safety data, results, reports and analyses) provided by the Parties pursuant to Section 4.2(h);

(vii)review and discuss the Registration Plans submitted by the Parties in accordance with Section 5.2(c), and discuss any concerns raised by either Party with respect to the Registration Plans in accordance with Section 5.2(c);

(viii)review and discuss the Parties’ medical affairs plans with respect to the Products in the Company Field in the Company Territory and in the TESARO Field in the TESARO Territory (e.g. field-based medical education activities and grant-based medical education programs) in accordance with Section 5.8;

(ix)discuss any Phase 4 Trials of the Products;

(x)consult with the Joint Manufacturing Committee with respect to clinical supply manufacturing in accordance with Section 7.4(b);

(xi)discuss a publication strategy with respect to the Compounds and Products and the review of such publications, in accordance with Section 11.9;

(xii)establish working groups or committees as necessary or appropriate and agreed to by the JDC, and delegate tasks within its authority to further discuss and share information with respect to the Development of the Compounds and Products in the Company Field in the Company Territory and in the TESARO Field in the TESARO Territory, such as a quality subcommittee and separate clinical quality subcommittees for purposes of overseeing the conduct of Clinical Trials in accordance with GLP, GCP and the PVA; and

(xiii)perform other obligations specifically delegated to it and permitted under Section 2.2(c) or another provision of this Agreement.

(c)JDC Decisions and Actions.  The JDC shall not have any formal decision-making authority, except with respect to the following matters: 

(i)The JDC shall determine whether any Drug Approval Application for a Monotherapy Use in the Company Field submitted by Company to the JDC in accordance with Section 5.3(b)(iv)  satisfies the appropriate efficacy and safety criteria outlined in the applicable protocol and notify Company of the results of such review.  If the JDC does not reach unanimous agreement

on such matter within thirty (30) Business Days from the date that the matter is first presented to the JDC, such matter will be a Deadlocked Committee Matter.  Either Party may refer such matter to the JSC for attempted resolution pursuant to the Escalation Procedures.  If the matter is not resolved pursuant to the Escalation Procedures, TESARO shall have final decision-making authority with respect to such Deadlocked Committee Matter.

(ii)The JDC shall determine which portions of a Drug Approval Application for Combination Use or a Combination Product, in each case, in the Company Field in the Company Territory are subject to review and comment by the Parties pursuant to Sections 5.3(c)(iii) and 5.3(d)(iii).  If the JDC does not reach unanimous agreement on such matter within thirty (30) Business Days from the date that the matter is first presented to the JDC, such matter will be a Deadlocked Committee Matter.   Either Party may refer such matter to the JSC for attempted resolution pursuant to the Escalation Procedures.  If the matter is not resolved pursuant to the Escalation Procedures, the Party submitting such Drug Approval Application shall have final decision-making authority with respect to such Deadlocked Committee Matter.  For clarity, this Section 2.2(c)(ii) does not apply to Combination Use or Combination Products in the TESARO Field in the TESARO Territory.

Actions to be taken and decisions to be made by the JDC with respect to such matters shall be taken or made by unanimous agreement, with each Party’s JDC representatives collectively having one (1) vote.  If the JDC does not reach unanimous agreement on an action or decision with respect to any Deadlocked Committee Matter within thirty (30) Business Days from the date that the matter is first presented to the JDC, such Deadlocked Committee Matter shall be referred to the JSC or otherwise subject to resolution in accordance with Section 2.1(d).

2.3Joint Commercialization Committee.    

(a)Formation and Purpose.    The Parties agree to establish and convene a joint commercialization committee (the “JCC”) within ninety (90) days after the Effective Date.  The JCC shall consist of representatives from each Party as further described in Section 2.6(a) and operate in accordance with this Section 2.3 and Section 2.6. The purpose of the JCC shall be to serve as a forum for discussing, monitoring and sharing information with respect to the Parties’ Commercialization of the Compounds and Products in the Company Field in the Company Territory and in the TESARO Field in the TESARO Territory, to seek alignment between the Parties with respect to certain aspects of such Commercialization and to determine, approve or resolve matters with respect to

such Commercialization that the JCC is expressly authorized under Section 2.3(c) to determine, approve or resolve under this Agreement.

(b)Responsibilities of the JCC.    The JCC shall: 

(i)discuss and monitor the Commercialization of the Products in the Company Field in the Company Territory and in the TESARO Field in the TESARO Territory, including promotional activities with respect thereto, to the extent permissible under Applicable Law;

(ii)discuss and seek to reach alignment with respect to key aspects of the Distribution of Single Agent Products in accordance with Section 6.2(c)(i);

(iii)review and discuss Pricing Terms with respect to the Products to the extent provided under Section 6.2(d);

(iv)review and discuss the commercialization plans submitted by the Parties, and seek to reach alignment on key Commercialization issues relating to the Products, in accordance with Section 6.2(e);

(v)discuss and seek to reach alignment with respect to recommendations of the JFC on certain matters as described in Exhibit 8.3, or in the event the JFC fails to reach unanimous agreement with respect to any such matters;  and

(vi)perform other obligations specifically delegated to it and permitted under Section 2.3(c) or another provision of this Agreement.

(c)JCC Decisions and Actions.  The JCC shall not have any formal decision-making authority, except with respect to the following matters:

(i)The JCC shall determine procedures for TESARO’s regulatory compliance review and approval of Company’s Promotional Materials in accordance with Section 6.8.  If the JCC does not reach unanimous agreement on such matter within thirty (30) Business Days from the date that the matter is first presented to the JCC, such matter will be a Deadlocked Committee Matter.  Either Party may refer such matter to the JSC for attempted resolution pursuant to the Escalation Procedures.  If the matter is not resolved pursuant to the Escalation Procedures, TESARO shall have final decision-making authority with respect to such Deadlocked Committee Matter.

(ii)The JCC shall approve a Major Market Net Sales Allocation Methodology and Residual Allocation Methodologies based on recommendations from

the JFC in accordance with Exhibit 8.3.  If the JCC does not reach unanimous agreement on such matter within thirty (30) Business Days from the date that the matter is first presented to the JCC, such matter will be a Deadlocked Committee Matter.   Either Party may refer such matter to the JSC for attempted resolution pursuant to the Escalation Procedures.  If the matter is not resolved pursuant to the Escalation Procedures, the Parties shall mutually select and engage an independent Third Party accounting firm to resolve such Deadlocked Committee Matter pursuant to Section 2.1(d)(v).

(iii)The JCC shall determine which countries outside the Major Markets will be included as Other Included Countries in accordance with Exhibit 8.3.  If the JCC does not reach unanimous agreement on such matter within thirty (30) Business Days from the date that the matter is first presented to the JCC, such matter will be a Deadlocked Committee Matter.  Either Party may refer such matter to the JSC for attempted resolution pursuant to the Escalation Procedures.  If the matter is not resolved pursuant to the Escalation Procedures, the proposed change to the list of Other Included Countries will not be made.

(iv)The JCC shall reassess the Major Market Net Sales Allocation Methodology and its data sources on an annual basis, and approve required changes to such methodology, in accordance with Exhibit 8.3.  If the JCC does not reach unanimous agreement on such matter within thirty (30) Business Days from the date that the matter is first presented to the JCC, such matter will be a Deadlocked Committee Matter.  Either Party may refer such matter to the JSC for attempted resolution pursuant to the Escalation Procedures.  If the matter is not resolved pursuant to the Escalation Procedures, [***].

(v)The JCC shall reassess the use of the Major Market Net Sales Allocation Methodology in the Other Included Countries on an annual basis, and determine whether additional countries should be included as Other Included Countries, in accordance with Exhibit 8.3.  If the JCC does not reach unanimous agreement on such matter within thirty (30) Business Days from the date that the matter is first presented to the JCC, such matter will be a Deadlocked Committee Matter.  Either Party may refer such matter to the JSC for attempted resolution pursuant to the Escalation Procedures.  If the matter is not resolved pursuant to the Escalation Procedures, no change will be made to such use or list of Other Included Countries for such year.

(vi)The JCC shall determine the Distribution costs and prostate commercialization and other related costs incurred by TESARO to be

deducted from TESARO Prostate-Approved Single Agent Product Net Sales for purposes of calculating Alliance Payments pursuant to Exhibit 8.3.  If the JCC does not reach unanimous agreement on such matter within thirty (30) Business Days from the date that the matter is first presented to the JCC, such matter will be a Deadlocked Committee Matter.  Either Party may refer such matter to the JSC for attempted resolution pursuant to the Escalation Procedures.  If the matter is not resolved pursuant to the Escalation Procedures, the Parties shall mutually select and engage an independent Third Party accounting firm to resolve such Deadlocked Committee Matter pursuant to Section 2.1(d)(v).

Actions to be taken and decisions to be made by the JCC with respect to such matters shall be taken or made by unanimous agreement, with each Party’s JCC representatives collectively having one (1) vote.  If the JCC does not reach unanimous agreement on a Deadlocked Committee Matter within thirty (30) Business Days from the date that the matter is first presented to the JCC, such Deadlocked Committee Matter shall be referred to the JSC or otherwise subject to resolution in accordance with Section 2.1(d).

2.4Joint Manufacturing Committee.  The Parties shall establish a joint manufacturing and supply chain committee (the “JMC”) in accordance with Section 7.4.    

2.5Joint Finance Committee.

(a)Formation and Purpose.    The Parties agree to establish and convene a joint finance committee (the “JFC”) within ninety (90) days after the Effective Date.  The JFC shall consist of individuals from each Party with reasonable expertise in the areas of accounting, cost allocation, budgeting and financial reporting as further described in Section 2.6(a) and operate in accordance with this Section 2.5 and Section 2.6.  The JFC shall be a forum for discussing, monitoring, sharing information and seeking to reach alignment regarding the conduct of the accounting, reporting, reconciliation and other related finance and accounting activities set forth in this Agreement, and to determine, approve or resolve matters with respect to such finance and accounting activities that the JFC is expressly authorized under Section 2.5(c) to determine, approve or resolve under this Agreement.

(b)Responsibilities of the JFC.    The JFC shall:

(i)discuss and seek to make unanimous recommendations to the JCC on certain matters as described in Exhibit 8.3;

(ii)if the Major Market Net Sales Allocation Methodology, Residual Allocation Methodology, list of Other Included Countries or any other decision described in Exhibit 8.3 is not resolved prior to launch of a

Prostate-Approved Single Agent Product in a particular country, develop and seek to agree upon an interim methodology to allow each Party to appropriately record and report its financial position and contributions as necessary at quarter or year-end with respect to sales of such Prostate-Approved Single Agent Product in such country in accordance with Exhibit8.3;

(iii)upon the request of either Party, review and discuss the allocation of rebates payable to federal, state/provincial, local or other governments, or their agencies, with respect to sales of a Prostate-Approved Single Agent Product in a country in accordance with Section 3.2 of Exhibit 8.3; and

(iv)perform other obligations specifically delegated to it and permitted under Section 2.5(c) or another provision of this Agreement.

(c)JFC Decisions and Actions.  The JFC shall not have any formal decision-making authority, except with respect to the following matters:

(i)The JFC shall develop and approve procedures for quarterly reporting of actual results, and review and discussion of potential discrepancies, quarterly reconciliation, reasonable forecasting, and other finance and accounting matters in accordance with Section 8.3(b).  If the JFC does not reach unanimous agreement on any such matter within thirty (30) Business Days from the date that the matter is first presented to the JFC, such matter will be a Deadlocked Committee Matter.  Either Party may refer such matter to the JSC for attempted resolution pursuant to the Escalation Procedures.  If the matter is not resolved pursuant to the Escalation Procedures, each Party may, in good faith, select its own reasonable procedures for such reporting not otherwise inconsistent with this Agreement or applicable Third Party license agreements. 

(ii)The JFC shall determine the timing for delivery of the Annual Alliance Payment Forecast in accordance with Section 8.3(e).  If the JFC does not reach unanimous agreement on such determination within thirty (30) Business Days from the date that the matter is first presented to the JFC, such forecast shall be delivered by November 1 of each year.

(iii)The JFC shall determine whether any additional information should be included in the Annual Alliance Payment Forecast in accordance with Section 8.3(e).  If the JFC does not reach unanimous agreement on any such matter within thirty (30) Business Days from the date that the matter is first presented to the JFC, such matter will be a Deadlocked Committee Matter.  Either Party may refer such matter to the JSC for attempted resolution pursuant to the Escalation Procedures.  If the matter is not resolved pursuant to the Escalation Procedures, TESARO shall not be required to provide such additional information.

(iv)The JFC shall develop and approve a process for the Parties to agree upon the estimated Alliance Payments for a TESARO Calendar Quarter before the close of such TESARO Calendar Quarter in accordance with Section 8.3(e).  If the JFC does not reach unanimous agreement on such matter within thirty (30) Business Days from the date that the matter is first presented to the JFC, such matter will be a Deadlocked Committee Matter.  Either Party may refer such matter to the JSC for attempted resolution pursuant to the Escalation Procedures.  If the matter is not

resolved pursuant to the Escalation Procedures, TESARO shall have final decision-making authority with respect to such Deadlocked Committee Matter.

(v)The JFC shall determine the timing for delivery of the Annual Royalty Payment Forecast in accordance with Section 8.4(c).  If the JFC does not reach unanimous agreement on such determination within thirty (30) Business Days from the date that the matter is first presented to the JFC, such forecast shall be delivered by November 1 of the year prior to the year covered by such forecast.

(vi)The JFC shall determine whether any additional information should be included in the Annual Royalty Payment Forecast in accordance with Section 8.4(c).  If the JFC does not reach unanimous agreement on such matter within thirty (30) Business Days from the date that the matter is first presented to the JFC, such matter will be a Deadlocked Committee Matter.  Either Party may refer such matter to the JSC for attempted resolution pursuant to the Escalation Procedures.  If the matter is not resolved pursuant to the Escalation Procedures, neither Party shall be required to provide any such additional information; provided, that the foregoing shall not limit the Parties express obligations with respect to the Annual Royalty Payment Forecast under Section 8.4(c).

(vii)The JFC shall review and approve any proposed reallocations and adjustments of Net Sales of Prostate-Approved Single Agent Products in accordance with Section 3.3 of Exhibit 8.3.  If the JCC does not reach unanimous agreement on such matter within thirty (30) Business Days from the date that the matter is first presented to the JCC, such matter will be a Deadlocked Committee Matter.   Either Party may refer such matter to the JSC for attempted resolution pursuant to the Escalation Procedures.  If the matter is not resolved pursuant to the Escalation Procedures, the Parties shall mutually select and engage an independent Third Party accounting firm to resolve such Deadlocked Committee Matter pursuant to Section 2.1(d)(v).  

Actions to be taken and decisions to be made by the JFC shall be taken or made by unanimous agreement, with each Party’s JFC representatives collectively having one (1) vote.  If the JFC does not reach unanimous agreement on an action or decision with respect to any such matter to be recommended to the JCC within thirty (30) Business Days from the date that the matter is first presented to the JFC or within the time period otherwise expressly provided in this Agreement, such action or decision shall be referred to the JCC for its consideration.  If the JFC does not reach unanimous agreement on a Deadlocked Committee Matter within thirty (30) Business Days from the date that the matter is first presented to the JFC, such Deadlocked Committee Matter shall be referred to the JSC or otherwise subject to resolution in accordance with Section 2.1(d).

2.6Committee Membership and Operations.    

(a)Membership. Each of the JSC, JDC, JCC, JMC and JFC (each, a “Joint Committee”) shall consist of up to six (6) representatives, one-half of which shall be appointed by Company and one-half of which shall be appointed by TESARO.  Each Joint Committee may elect to vary the number of representatives from time to time, provided that each Joint Committee shall maintain an equal number of representatives from each Party.  Each representative shall have the appropriate level of experience in the subject area of the applicable Joint Committee, and at least one (1) representative shall have sufficient seniority within the applicable Party’s organization to have the necessary decision-making authority in order for such Joint Committee to fulfill its responsibilities.  Either Party may designate substitutes for its Joint Committee representatives if one (1) or more of such Party’s designated representatives is unable to be present at a meeting.  A Party may replace any of its Joint Committee representatives by written notice to the other Party specifying the prior representative(s) and their replacement(s).  Each Joint Committee representative shall be bound by confidentiality and non-use obligations at least as restrictive as those set forth in this Agreement to, and shall be an employee of, the Party that it represents or one of such Party’s Affiliates.

(b)Joint Committee Chairperson.    Each Joint Committee will have a chairperson, to be designated by Company.  The chairperson shall be responsible for calling and convening meetings of its Joint Committee (provided, the chairperson shall call meetings at the reasonable request of TESARO or any of its representatives in accordance with Section 2.6(c)), but shall have no special authority over the other members of its Joint Committee.  The chairperson of each Joint Committee (or its designee) shall: (i) prepare and circulate an agenda reasonably in advance of each upcoming meeting of such Joint Committee (provided that any agenda shall be mutually agreed by the committee members); and (ii) prepare and issue minutes of each meeting of such Joint Committee within thirty (30) days thereafter.  Each representative on each Joint Committee may, prior to any meeting, submit to the chairperson materials to be circulated to each member of the Joint Committee

together with the meeting agenda or otherwise.  The minutes for each Joint Committee meeting shall not be finalized until each representative on such Joint Committee reviews and approves such minutes, provided that any minutes from a Joint Committee meeting shall be deemed approved unless a representative on such Joint Committee objects to the accuracy of such minutes within fifteen (15) days after circulation by the chairperson of such Joint Committee. 

(c)Meetings. 

(i)Timing and Frequency.  Promptly following its formation, each Joint Committee will hold an in-person meeting to establish its operating procedures consistent with this Agreement.  After its initial meeting, the JSC shall meet at least twice per year during the Term and each other Joint Committee shall meet at least once every Calendar Quarter during the Term or as frequently as agreed by the Parties.  Additional meetings of a Joint Committee may be held with the consent of each Party (such consent not to be unreasonably withheld, delayed or conditioned), as required under this Agreement or to discuss any Deadlocked Committee Matter referred to such Joint Committee in accordance with this Agreement.  In the case of any matter or deadlock referred to a Joint Committee, such meeting shall be held within ten (10) Business Days following referral to such Joint Committee, or as soon as reasonably possible thereafter.    

(ii)Meeting Procedures.  Meetings of a Joint Committee shall be effective only if a majority of representatives on such Joint Committee of each Party are present or participating, including at least one (1) representative of each Party.  Other than the initial meeting, each Joint Committee may meet either (x) in person at either Party’s facilities (alternating between facilities of each Party unless otherwise agreed) or at such locations as the Parties may otherwise agree, at least twice every Calendar Year; or (y) by audio or video teleconference.  Each Party shall be responsible for all of its own expenses incurred in connection with its representatives’ participation in each Joint Committee meeting, including all travel and lodging.  All other Third Party expenses incurred by a Joint Committee for one of its meeting, such as expenses associated with off-site meetings, shall be shared equally by the Parties.

(iii)Non-Member Participation.  Additional non-members of a Joint Committee having relevant experience may be invited to participate in a meeting of such Joint Committee, provided that such participants shall have no voting rights or powers.  Non-member participants of a Party or its Affiliates shall be allowed to attend a meeting of a Joint Committee only if: (x) the other Party’s representatives on such Joint Committee have consented to the attendance (such consent not to be unreasonably

withheld, delayed or conditioned); and (y) such non-member participant is subject to confidentiality and non-use obligations at least as restrictive as those set forth in this Agreement. 

2.7Additional Subcommittees.  Each Joint Committee may establish subcommittees to perform any responsibilities assigned to such Joint Committee under this Agreement; provided, that no subcommittee shall (a) have any decision-making authority, or (b) be delegated any matter that is or could become a Deadlocked Committee Matter.  The purpose, scope and procedures of any such subcommittee shall be agreed in writing by the Joint Committee that establishes such subcommittee.  Unless otherwise agreed by the Parties, any such subcommittee shall consist of an equal number of representatives appointed by Company and TESARO, or their respective representatives on the applicable Joint Committee, and the number of representatives on any such subcommittee may be varied from time to time by the applicable Joint Committee or by mutual agreement of the Parties, subject to the foregoing. 

2.8Authority.  The Parties agree that it shall be conclusively presumed that, unless otherwise explicitly stated, each voting member of each Joint Committee and subcommittee has the authority and approval of such member’s respective senior management in casting his or her vote.  Each Joint Committee and subcommittee shall each have only the powers expressly assigned to it in this ARTICLE 2 or elsewhere in this Agreement, and shall not have any power to amend, modify or waive compliance with this Agreement.  Notwithstanding anything else contained herein to the contrary, except as expressly provided in this Agreement with respect to the Deadlocked Committee Matters, no matter, decision, or action of the Parties shall require the agreement, approval or consent of a Joint Committee or any subcommittee thereof. 

2.9Alliance Managers.  Promptly following the Effective Date, each Party shall designate in writing an Alliance Manager to serve as the primary point of contact for the Parties regarding all collaboration activities contemplated under this Agreement.  Each Alliance Manager shall facilitate communication and coordination of the Parties’ activities under this Agreement relating to the Compounds and the Products.  The Alliance Managers shall be allowed to attend, as a non-voting observer, meetings of each Joint Committee and subcommittee of which the Alliance Manager is not a member.

2.10Compliance with Merger Control Laws.  It is the intent of the Parties to at all times during the Term comply with applicable Merger Control Laws.  If at any time during the Term, either Party in good faith reasonably determines upon the advice of counsel that the performance by either Party of its obligations under this Agreement or this Article 2, including with respect to the sharing of information, would violate applicable Merger Control Laws, then the Parties shall negotiate in good faith to agree upon mutually acceptable alternative arrangements that comply with applicable Merger Control Laws, including, if reasonably requested by a Party, arranging for information deliverable to a Party hereunder to be delivered to a mutually agreed Third Party. 

ARTICLE 3

LICENSES

3.1Licenses to Company.    

(a)License to Company.  Subject to the terms and conditions of this Agreement, TESARO hereby grants to Company a royalty-bearing, non-transferable (except to the extent permitted under Section 15.4) license, with the right to grant sublicenses as provided in Section 3.1(c), under the TESARO Technology and TESARO Trademarks, which license shall be non-exclusive with respect to the Merck Know-How and exclusive (even as to TESARO, except to the extent necessary for TESARO to perform its obligations under this Agreement, including Sections 5.2(d), 6.2(c) and 6.2(d)) with respect to any TESARO Technology (other than the Merck Know-How) and the TESARO Trademarks, to Exploit the Compounds and Products in the Company Field in the Company Territory.  The foregoing license grant by TESARO does not include any grant of rights under the TESARO Technology or TESARO Trademarks to Exploit any active pharmaceutical compound that is not a Compound, other than, to the extent applicable, any API(s) Controlled by TESARO (if any) that are included in a Product that is deemed to be a Single Agent Product pursuant to Section 3.1(e).    

(b)Rights under Merck Patents [***].    Notwithstanding the definition of “Company Field” or anything to the contrary contained herein, Company acknowledges and agrees that (i) the license granted to TESARO under the Merck License Agreement does not include the right or license under the Merck Patents or the Merck Know-How to Exploit the Compounds or Products for the diagnosis of any indication in humans, and therefore the foregoing license grant by TESARO to Company hereunder does not include a sublicense under the Merck Patents or the Merck Know-How to Exploit the Compounds or Products for the diagnosis of any indication in humans[***].

(c)Sublicensing. Company shall have the right to grant sublicenses of the rights granted to Company under this Section 3.1 to its Affiliates and Third Parties through multiple tiers provided that: 

(i)Company has provided at least five (5) Business Days’ prior written notice to TESARO of any sublicense; provided, that sublicenses granted solely in connection with Development (but not Commercialization), such as licenses to contract manufacturers (other than any contract manufacturer engaged by TESARO or its Affiliates), contract research organizations or clinical study sites, shall not require any notice to TESARO; and

(ii)each such sublicense shall (1) refer to and be subordinate to this Agreement, (2) be consistent in all material respects with the terms and conditions of this Agreement and the TESARO License Agreements, and

(3) include Section 10.4 and the provisions of the Merck License Agreement set forth on Exhibit 10.4.

Company shall use reasonable efforts to procure the prompt performance by any sublicensee of the terms of each such sublicense agreement and ensure that any sublicensee will comply with the applicable terms and conditions of this Agreement.  Company shall be liable for all acts and omissions of any sublicensee and shall indemnify TESARO against all Losses incurred or suffered by TESARO, or for which TESARO may become liable, arising out of any act or omission of any sublicensee, pursuant to Section 14.1.  The grant of any sublicense will not relieve Company of its obligations under this Agreement, except to the extent such obligations are satisfactorily performed by such sublicensee.  Notwithstanding Section 3.1(c)(i) above, Company shall provide to TESARO copies of each sublicense with a Third Party that grants such Third Party the right to directly Develop or Commercialize the Compounds or Products in the Company Field in any country or jurisdiction in the Company Territory within five (5) days after execution thereof; provided that Company shall have the right to reasonably redact commercially sensitive information from such copies.  Information regarding the scope of the license grants, territory or term of each such sublicense and the identity of the Third Party shall not be considered commercially sensitive. 

(d)Exclusivity.  During the period commencing on the Effective Date and ending on the [***] anniversary of the Effective Date (the “Exclusivity Period”), neither TESARO nor any of its Affiliates shall, directly or indirectly: (i) [***], except to the extent necessary to perform TESARO’s obligations under this Agreement or the TESARO License Agreements; (ii) [***], except to the extent necessary to perform TESARO’s obligations under this Agreement; (iii) [***]; or (iv) collaborate with, license, enable or otherwise authorize or grant any rights to any Third Party to conduct any of the activities described in clause (i), (ii) or (iii) of this Section 3.1(d), or enter into any agreement, amendment to an existing agreement or option to do any of the same; or (v) [***].  Notwithstanding anything to the contrary herein, the restrictions in this Section 3.1(d) are subject to the terms of [***]. 

(e)Products containing Non-Cancer APIs.  If either Party or its Affiliates desires to Develop or Commercialize, directly or indirectly, any Product that contains a Compound and at least one other API that is not intended to treat cancer (e.g., [***]) it shall notify the other Party in writing.  If such Product includes another API intended to treat cancer (e.g., a JAA), such Product shall be deemed to be a “Combination Product” for purposes of this Agreement.  If such Product does not include another API intended to treat cancer, such Product shall be deemed to be a “Single Agent Product” for purposes of this Agreement.  Following receipt of such notice, the Parties shall negotiate in good faith and attempt to agree upon an

adjustment to the calculation of Net Sales of any such Product in the Company Field, in each case, that fairly reflects the value of the Compound included in such Product and the other API(s) included in such Product.  If the Parties fail to reach Agreement on such an adjustment prior to the First Commercial Sale of any such Product anywhere in the Company Territory, then such Net Sales shall be calculated in accordance with Section 1.116 or Section 1.25, as applicable; provided, that such failure may be referred to the dispute resolution process under ARTICLE 13 as a Dispute hereunder, and the resolution of such Dispute shall include a retroactive reconciliation back to the date of such First Commercial Sale, as appropriate.  For the avoidance of doubt, this Section 3.1(e) does not apply to any Combination Product Developed or Commercialized, directly or indirectly, by TESARO in the TESARO Field or to any Product Developed or Commercialized, directly or indirectly, by TESARO solely in Japan.

(f)Co-Packaged Products.  Company shall not Exploit any Compound or Product as a component of any Co-Packaged Product unless and until the Parties amend this Agreement to set forth (i) terms and conditions applicable to pricing of Co-Packaged Products and (ii) any other terms and conditions applicable to Commercialization of Co-Packaged Products that the Parties agree should be different from the terms and conditions relating to Commercialization of other Products.  [***]  If Company desires to Exploit any Compound or Product as a component of Co-Packaged Products in the Company Field and the Company Territory, then the Parties will negotiate in good faith to execute such amendment as soon as reasonably practicable.  For the avoidance of doubt, [***]. 

3.2License to TESARO. 

(a)License to TESARO.  Subject to the terms and conditions of this Agreement, Company hereby grants to TESARO a non-exclusive, fully-paid, royalty-free, non-transferable (except in accordance with Section[***]  15.4), license, with the right to grant sublicenses as provided in Section 3.2(b), under the Company Technology to Exploit the Compounds and Single Agent Products in the TESARO Field (but not including prostate cancer in humans) in the Company Territory.  The foregoing license grant by Company does not include (x) any grant of rights under the Company Technology to Exploit any active pharmaceutical compound that is not a Compound other than, to the extent applicable, any API(s) Controlled by Company (if any) that are included in a Product that is deemed to be a Single Agent Product pursuant to Section 3.1(e),  (y) any grant of rights under the Company Technology to Exploit any Compound or Product in Japan in the Company Field or (z) any grant of rights under the Company Technology to Exploit any Compound or Product in Japan in the TESARO Field.  If requested by TESARO, Company shall grant to TESARO a non-exclusive, royalty-bearing, non-transferable (except in accordance with Section[***]  15.4), license, with the right to grant sublicenses as provided in Section 3.2(b), under the Company

Technology to Exploit Products in Japan on commercially reasonable terms to be negotiated in good faith and mutually agreed upon by the Parties (such agreement not to be unreasonably withheld, conditioned or delayed).  If the Parties do not reach agreement on such terms within ninety (90) days after TESARO’s request for such a license, the Parties shall select and agree upon a mutually acceptable independent Third Party expert who is neutral, disinterested and impartial, and has experience relevant to such licenses.  Each Party may make written and oral submissions of its position to such expert.  Such expert shall, no later than ten (10) Business Days after the last submission, select one of the Party’s positions as his or her final decision, and shall not have the authority to modify either Party’s position or render any substantive decision other than to select the position of either TESARO or Company.  A basis of such selection would be fair compensation to Company for the value of Company Technology as applied to any or all Products in Japan.  The Parties agree that the decision of such expert shall be binding on each of them.     

(b)Sublicensing.  TESARO shall have the right to grant sublicenses of the rights granted by Company under Section 3.2(a) to its Affiliates and Third Parties through multiple tiers.  Each such sublicense shall refer to and be subordinate to this Agreement, and shall be consistent in all material respects with the terms and conditions of this Agreement.  TESARO shall remain responsible for the performance of this Agreement and the performance of its sublicensees hereunder.  TESARO shall provide to Company copies of each sublicense with a Third Party that grants such Third Party the right to directly Develop or Commercialize a Compound or Single Agent Product in the TESARO Field in any country or jurisdiction in the TESARO Territory, provided that TESARO shall have the right to redact commercially sensitive information from such copies.  Information regarding the scope of the license grants, territory or term of each such sublicense and the identity of the Third Party shall not be considered commercially sensitive. 

3.3[***]  

3.4Retained Rights.    Except as exclusively licensed to Company under this Agreement and otherwise subject to Section 3.1(d), TESARO retains all rights under the TESARO Technology and TESARO Trademarks: (a) to Exploit any Compound alone as the sole active pharmaceutical ingredient or in combination with other active pharmaceutical ingredients, including in a co-packaged or co-formulated product, in the TESARO Field and throughout the TESARO Territory, whether or not expressly stated herein; and (b) to Exploit any Compound in combination with one or more other active pharmaceutical ingredients in the TESARO Field, in each case ((a) and (b)), without the consent of Company or any Joint Committee.

3.5No Implied Licenses.  All licenses and rights are granted only as expressly provided in this

Agreement and no license or other right is or shall be created or granted under this Agreement by implication, estoppel, or otherwise.  All rights not expressly granted by a Party under this Agreement are reserved by such Party and may not be used by the other Party for any purpose.

3.6[***] 

ARTICLE 4

DEVELOPMENT    

4.1General.  Prior to the Effective Date, TESARO commenced Development of the Initial Product for certain indications in the TESARO Field, including breast cancer and ovarian cancer.  During the Term, Company shall have the right to Develop the Compounds, Single Agent Products and Combination Products in the Company Field in the Company Territory, and TESARO shall retain the right to Develop the Compounds, Single Agent Products and Combination Products in the TESARO Field in the TESARO Territory, in each case subject to the terms and conditions of this Agreement.  Certain aspects of the Parties’ Development of the Compounds and Products shall be communicated through the JDC, as further described in ARTICLE 2 and this ARTICLE 4, but neither Party’s Development activities and decisions require the approval, consent or agreement of the JDC, JSC, any other Joint Committee, subcommittee, or the other Party except as expressly provided in this Agreement.

4.2Development Activities

(a)Company Development Activities.  Except as expressly provided in this Agreement, Company shall be solely responsible for and have sole authority with respect to, at its own expense, all Development of the Compounds, Single Agent Products and Combination Products in the Company Field in the Company Territory, including Development for Monotherapy Use or Combination Use in the Company Field in the Company Territory.  Company shall conduct such Development in accordance with the Company Development Plan, which may be updated from time to time by Company in accordance with Section 4.2(c). 

(b)TESARO Development Activities.  Except as expressly provided in this Agreement, TESARO shall be solely responsible for and have sole authority with respect to, at its own expense, all Development of the Compounds, Single Agent Products and Combination Products in the TESARO Field in the TESARO Territory, including Development for Monotherapy Use or Combination Use in the TESARO Field in the TESARO Territory.   

(c)Communication of Development Activities.  A summary of all ongoing and planned Phase 2 Trials and Phase 3 Trials of Products in the TESARO Field in the TESARO Territory is attached hereto as Exhibit 4.2(c) (the “TESARO Development Plan”), and a summary of Company’s planned Clinical Trials of the Products in the Company Field in the Company Territory will be delivered to TESARO within [***] after the Effective Date (the “Company Development

Plan” and, together with the TESARO Development Plan, the “Development Plans”).  Each Party shall update its Development Plan twice per year for so long as such Party (or any of its Affiliates or (sub)licensees) is conducting Development of the Products, and shall deliver such updated Development Plan to the JDC for review and discussion; provided, that one of such updated Development Plans shall be delivered no later than [***] after the start of each Calendar Year.  In addition to such updates, each Party may amend its Development Plan at any time, and shall deliver such amended Development Plan to the JDC for review and discussion at its next regularly scheduled meeting.  For clarity, approval of a Party’s Development Plan by the JDC, JSC or other Party shall not be required.  Each updated and amended Development Plan shall contain sufficient details regarding the Development activities described therein for (a) the other Party to assess potential adverse effects of such Development activities on the other Party’s ongoing or planned Development activities with respect to the Products, to the extent that such information is available and (b) TESARO to prepare the Third Party Development Reports in accordance with Section 4.2(h).  If either Party reasonably believes that any activity set forth in the other Party’s Development Plan could adversely affect any of its ongoing or planned Development activities with respect to the Products, such Party shall so notify the other Party, stating the basis for its belief, and the JDC shall meet to discuss such concerns.

(d)Right to Object to Clinical Trials.  Neither Party, nor any of its Affiliates, licensees or sublicensees, shall conduct or have conducted on its behalf a Clinical Trial of a Product unless such Party first provides the other Party with an opportunity to review and, if permitted below, to object to such Clinical Trial as follows:

(i)The Conducting Party shall provide the draft protocol (or, if not available, a detailed description of the proposed protocol and trial design) and investigator’s brochure for such Clinical Trial to the other Party (the “Reviewing Party”) at least [***] before the first submission of the protocol to an institutional review board or ethics committee.    

(ii)The Reviewing Party may, but is not obligated to, provide comments on the draft protocol and investigator’s brochure for such Clinical Trial to the Conducting Party no later than [***] after receipt of such draft protocol and investigator’s brochure.  The Conducting Party shall reasonably consider such comments in good faith.

(iii)In addition, the Reviewing Party may notify the Conducting Party that it objects to the design for such Clinical Trial (such notice, an “Objection”) no later than [***] after receipt of the draft protocol and investigator’s brochure on one or more of the following grounds:

(1)if Company is the Reviewing Party, Company reasonably determines in good faith that the proposed Clinical Trial would result in a safety or tolerability finding that would raise material concerns regarding the clinical benefit of any Product in the Company Field; or

(2)if TESARO is the Reviewing Party, TESARO reasonably determines in good faith that the proposed Clinical Trial would result in a safety or tolerability finding that would raise material concerns regarding the clinical benefit of any Product in the TESARO Field.

(iv)Any notice of an Objection shall include specific proposals relating to the design of the Clinical Trial in order to address and overcome the ground(s) for Objection, and the Parties shall promptly discuss such proposals in good faith.  If the Parties do not agree on the proposals raised in an Objection within [***] of the date of such notice, the Conducting Party may conduct the proposed Clinical Trial in accordance with such draft protocol and investigator’s brochure.

(v)If the Conducting Party intends to materially change a protocol or investigator’s brochure for a Clinical Trial of a Product after providing a draft of such protocol or investigator’s brochure to the Reviewing Party, such Clinical Trial shall be subject again to the procedures set forth above in this Section 4.2(d), unless such material change is required or recommended by a Regulatory Authority, institutional review board or ethics committee, in which case, the Conducting Party shall only be required to provide as much notice as is reasonably practicable prior to implementing such change and the Reviewing Party shall have no right to raise an Objection thereto; provided, that the review of material changes contemplated by this Section 4.2(d)(v) shall not require the Conducting Party to terminate or suspend any ongoing Clinical Trial. 

(e)Clinical Trial Registries.  Each Party shall be responsible, in accordance with Applicable Law, for registering each Clinical Trial of a Product that such Party conducts in the appropriate clinical trial registry and posting the results of such Clinical Trial.    

(f)Sharing of Development Know-How.    

(i)Within [***] after the Effective Date, TESARO shall provide Company with electronic copies of the INDs relating to Development of the Initial Compound and Initial Product set forth on Exhibit 4.2(f).     

(ii)Following the Effective Date: (A) within thirty (30) days after Company’s reasonable request (provided, that such requests may not be more frequent than once per Calendar Quarter with respect to any given Product after the first [***] of Development of such Product by Company), TESARO shall provide to Company any TESARO Know-How relating to the Development of the Compounds and Products that is necessary or useful for Company to Develop the Compounds or Products in the Company Field in the Company Territory, including any such Know-How relating to the Development of diagnostics with respect to the Compounds or Products (it being understood and acknowledged by Company that TESARO is not granting rights to Company that it does not Control under the Merck License Agreement or AstraZeneca License Agreements, including any rights relating to the Development of diagnostics with respect to the Compounds or Products)); (B) the Conducting Party, with respect to any Clinical Trial, shall provide the other Party with any safety data resulting from such Clinical Trial in accordance with the PVA or as otherwise determined by the Parties; and (C) the Conducting Party with respect to any Clinical Trial shall provide the other Party with a copy of the final clinical study report from such Clinical Trial promptly following completion thereof.  The Parties shall discuss the logistics of sharing Know-How pursuant to this Section 4.2(f)(ii) through the JDC.  In the event Company reasonably determines that any TESARO Know-How that is Controlled by TESARO pursuant to the Merck License Agreement or any AstraZeneca License Agreement is necessary to seek Marketing Approval of a Product in the Company Field, TESARO will use reasonable efforts to obtain such TESARO Know-How from Merck or AstraZeneca, as the case may be, if TESARO is not in possession of such TESARO Know-How.     Notwithstanding anything to the contrary in this Agreement, a Party that is required to provide any Know-How pursuant to this Section 4.2(f)(ii) may, prior to providing such Know-How to the other Party, redact any [***] “Redactable Information”).

(iii)Each Party shall promptly disclose to the other Party in writing any other issue related to the Development of the Compounds or Products that could reasonably impact the other Party’s ongoing or planned Development activities with respect to the Compounds or Products.  Such disclosure shall contain sufficient details regarding the issue described therein for the other Party to assess the impact of such issue on the other Party’s ongoing or planned Development activities with respect to the Compounds or Products.  If requested by a Party following such disclosure, the JDC shall meet to discuss the issue. 

(g)Ownership of Development Information and Results.  Company shall own all Clinical Data and other Know-How generated under Clinical Trials of and other

Development of the Compounds and Products in the Company Field in the Company Territory.  TESARO shall own all Clinical Data and other Know-How generated under Clinical Trials of and other Development of the Compounds and Products in the TESARO Field in the TESARO Territory.

(h)Development Reports.  Twice each Calendar Year, each Party shall provide to the other Party in writing (and verbally to the JDC) a report detailing such Party’s efforts and progress during the six (6) months prior to such date, as applicable, to Develop the Compounds and Products in such Party’s Field and Territory.  Each such report shall describe material Development activities completed since the last report, including the object and parameters of the Development, when initiated, when completed and a summary of all material results; provided,  however, that neither Party shall be required to include any Redactable Information in such report.  TESARO may use the information contained in the reports provided by Company pursuant to this Section 4.2(h) to prepare a development report with respect to the Compounds and Products in the format, and with the same level of detail, as the report attached hereto as Exhibit 4.2(h) (a “Third Party Development Report”). TESARO may disclose such Third Party Development Report to Merck and AstraZeneca to the extent necessary for TESARO to satisfy its obligations under Sections 3.02(b) and 3.03 of the Merck License Agreement and Section 4 of the AstraZeneca License Agreements. Prior to disclosing a Third Party Development Report to Merck or AstraZeneca, TESARO shall provide a draft of such Third Party Development Report to Company for review and, upon Company’s request, TESARO shall redact from such Third Party Development Report any Redactable Information.  TESARO acknowledges and agrees that the Third Party Development Report shall be sufficient to satisfy its obligations to provide reports with respect to the Development of the Compounds and Products by Company under Sections 3.02(b) and 3.03 of the Merck License Agreement and Section 4 of the AstraZeneca License Agreements.

4.3Development Diligence Obligations. 

(a)Company shall use Commercially Reasonable Efforts to Develop, and to seek Marketing Approval for, [***] and shall continue to use such efforts until Marketing Approval is obtained for [***].  For clarity, but without limiting the foregoing, in no event shall Company be obligated to Develop or seek Regulatory Approval for [***]. 

(b)Without limitation of Section 4.3(a), if in connection with its exercise of Commercially Reasonable Efforts, Company determines to cease Development of any Product(s) for any Initial Indication prior to the achievement of the Development Milestone(s) or any Regulatory Milestone(s) associated with such ceased Development, then Company shall promptly notify TESARO in writing

and present such decision to the JDC at its next regular planned meeting for discussion and explanation.  If Company determines, in its sole discretion and consistent with its obligation of Commercially Reasonable Efforts, to recommence the ceased Development or commence new Development for the Initial Indication or commence Development of any Product(s) for an Indication that is not an Initial Indication (in each case, such Indication, a “Notice Indication”), then Company shall promptly notify TESARO of such decision in writing.  Upon delivery of such notice, if the Development Milestone(s) or any Regulatory Milestone(s) associated with the ceased Development of the Initial Indication have not yet been achieved, then such Development Milestone(s) and Regulatory Milestone(s) shall be deemed to be amended to continue or replace the ceased Development of the Initial Indication with the Development of the Notice Indication. 

4.4Compliance with Law.   The Parties will, and will cause their Affiliates and Third Party subcontractors to, comply with Applicable Law in performing Development activities with respect to the Compounds and Products, including those pertaining to the use of laboratory animals, GLP, GMP or GCP, as appropriate.  

4.5Records.  The Parties will, and will cause their Affiliates and Third Party subcontractors to, maintain complete and accurate records of all work conducted in performing Development activities with respect to the Compounds and Products, and all results, data, Inventions and Know-How made during the performance of such Development. Subject to a Party’s agreements with Third Parties (provided that such agreements are entered into in accordance with this Agreement and such Party has notified the other Party of the existence of such agreements), each Party shall have unrestricted access to all results, data, Inventions and Know-How Controlled by such Party or its Affiliates related to any Compound or Product (not including Combination Products in the TESARO Field) to ensure data integrity, traceability, acceptability, quality and operational compliance with all Applicable Law; provided,  however, that neither Party shall have access to the other Party’s Redactable Information.  Such records shall contain sufficient detail and be in good scientific and, as appropriate, GLP, GCP, and GMP manner suitable for patent preparation and filing and regulatory purposes.  The Parties will maintain or cause to be maintained such records with respect to the Compounds and each such Product for a period at least five (5) years after receipt of Marketing Approval of any Product in an ICH region and until there are no pending or contemplated Drug Approval Applications or Regulatory Approvals in an ICH region or at least five years have elapsed since the formal discontinuation of clinical Development of such Product; provided,  however, that such records shall be retained for a longer period if required by the applicable Regulatory Authority.  If either Party plans to destroy or discard any of such records after the retention period has expired, such Party will notify the other Party in writing.  The Parties will then discuss and decide whether to send the records to an offsite storage facility, to the other Party, or another alternative as agreed to by the Parties.

4.6Subcontracting.  Each Party may subcontract the performance of any Development activities conducted in accordance with this Agreement to any of its Affiliates or any Third

Party, provided that such Party shall oversee the performance of any subcontracted activities in a manner that would be reasonably expected to result in their successful and timely completion and shall remain responsible for the performance of such subcontracted activities in accordance with this Agreement.  Each Party agrees to use reasonable efforts to include in any contract or other written arrangement with each of its subcontractors a clause permitting the other Party to exercise its right to inspect any facilities at which the subcontractor conducts Development activities with respect to the Compounds or Products (not including Combination Products in the TESARO Field) under Section 4.7.

4.7Audits.  With respect to any facility or site at which either Party conducts Development with respect to the Compounds or Products (including, where commercially reasonable and permitted under the applicable agreement between such Party and its subcontractor, such subcontractor’s facilities or sites, but not including Combination Products in the TESARO Field), the other Party will have the right, exercisable no more than once per Calendar Year (or more often, but not more than quarterly, if there are material compliance issues), upon reasonable written notice and during normal business hours, to inspect such site and facility and any records relating thereto, at its expense, in each case only to the extent reasonably necessary to verify such Party’s or its subcontractors compliance with the terms of this Agreement relating to GMP, GLP and GCP that could reasonably affect the inspecting Party’s Development or Commercialization of Compounds or Products in its Field.  Such inspection shall be subject to the confidentiality provisions of this Agreement.  In the event that, during such an inspection visit, the inspected facilities are found to be non-compliant with one or more GMP, GLP, GCP standards, the inspecting Party shall so notify the inspected Party of such non-compliance and the inspected Party shall submit a proposed recovery/corrective action plan to the other Party within sixty (60) days after the other Party’s notification to Conducting Party of such non-compliance.  The foregoing inspection rights shall only be exercised by a Party to the extent necessary for that Party to Exploit its rights hereunder. 

ARTICLE 5

REGULATORY RESPONSIBILITIES

5.1General.  During the Term, Company shall have the right to obtain and maintain Regulatory Approvals for the Single Agent Products and Combination Products in the Company Field in the Company Territory and shall otherwise have the regulatory responsibilities for Products in the Company Field in the Company Territory as set forth in this ARTICLE 5; provided,  however, that TESARO shall have the right to obtain and maintain Marketing Approval for Monotherapy Use of the Single Agent Products in the Company Field in the Company Territory on the terms set forth in this ARTICLE 5. TESARO shall retain the right to obtain and maintain Regulatory Approvals for the Single Agent Products and Combination Products in the TESARO Field in the TESARO Territory, subject to the terms and conditions of this Agreement.  Certain aspects of the Parties’ regulatory activities with respect to the Products shall be communicated through the JDC as expressly described in ARTICLE 2 and this ARTICLE 5, but neither Party’s regulatory activities and decisions require the approval, consent

or agreement of the JDC, JSC, any other Joint Committee, subcommittee, or the other Party except as expressly provided in this Agreement.

5.2Regulatory Activities – General. 

(a)Company Regulatory Activities.  Company shall have the sole right and authority, at its own expense but subject to TESARO’s rights under Section 5.3(b) to file for, obtain and maintain Marketing Approval of the Single Agent Products for Monotherapy Use in the Company Field, to: (i) develop and implement the overall regulatory strategy with respect to obtaining Marketing Approval of the Products in the Company Field in the Company Territory, including Marketing Approval of the Single Agent Products for Combination Use in the Company Field in the Company Territory; (ii) prepare, obtain and maintain all Regulatory Documentation with respect to Products in the Company Field in the Company Territory; and (iii) subject to Sections 5.7 and 5.9, conduct communications with the relevant Regulatory Authorities with respect to the Compounds and Products in the Company Field in the Company Territory.  Regulatory Documentation shall include, for the purposes of this ARTICLE 5, all INDs, Drug Approval Applications and Marketing Approvals.

(b)TESARO Regulatory Activities.  TESARO shall have the sole right and authority, at its own expense, to: (i) develop and implement the overall regulatory strategy with respect to obtaining Marketing Approval of the Products in the TESARO Field in the TESARO Territory; (ii) prepare, obtain, and maintain all Regulatory Documentation to the Products in the TESARO Field in the TESARO Territory; (iii) subject to Sections 5.7 and 5.9, conduct communications with the relevant Regulatory Authorities with respect to those Products in the TESARO Field in the TESARO Territory; and (iv) subject to Section 5.2(a)(ii) and 5.3(b), file for, obtain and maintain Marketing Approval for the Single Agent Product for Monotherapy Use in the Company Field in the Company Territory. 

(c)Communication of Regulatory Activities.  At least [***] prior to filing a first Drug Approval Application for a Single Agent Product in the TESARO Field in any country or jurisdiction in the TESARO Territory, TESARO shall use reasonable efforts to deliver to the JDC a summary of its planned activities with respect to obtaining Marketing Approval for the Single Agent Products in the TESARO Field throughout the TESARO Territory (the “TESARO Registration Plan”).  At least [***] prior to filing a first Drug Approval Application for a Product in the Company Field in any country or jurisdiction in the Company Territory, Company shall use reasonable efforts to deliver to the JDC a summary of its planned activities with respect to obtaining Marketing Approval for the Products in the Company Field throughout the Company Territory (the “Company Registration Plan” and, together with the TESARO Registration Plan, the “Registration Plans”).  Each Party shall update its Registration Plan

once per Calendar Quarter for so long as such Party (or any of its Affiliates or (sub)licensees) is seeking Marketing Approval for the Products, and shall deliver such updated Registration Plan to the JDC for review and discussion (but not approval).  For clarity, approval of a Party’s Registration Plan by the JDC or other Party shall not be required; provided that the Registration Plan shall be consistent with the rights of that Party.  Each Registration Plan shall contain: (i) a list of each country and jurisdiction in which the applicable Party plans to file a Drug Approval Application for each Product; (ii) for each country and jurisdiction described in clause (i), (A) the expected timing of submission of the Drug Approval Application, (B) the expected approval date of the Drug Approval Application, (C) the proposed indication(s) for which approval will be sought, and (D) the anticipated date of First Commercial Sale of such Product in such country and jurisdiction (or first commercial sale with respect to Single Agent Products in the TESARO Field).  If, following delivery of any Registration Plan by a Party, the other Party reasonably believes that any activity set forth in such Registration Plan could adversely affect any of its ongoing or planned Development or regulatory activities with respect to the Products, such Party shall so notify the other Party and the JDC shall meet to discuss such concerns.

(d)Regulatory Updates.  Company shall promptly provide TESARO with notice of the granting of any Marketing Approval of a Product obtained by Company, and TESARO shall promptly provide Company with notice of the granting of any Marketing Approval of a Single Agent Product obtained by TESARO.  TESARO may disclose information to Merck and AstraZeneca with respect to Company’s regulatory activities with respect to the Products in the Company Field in the Company Territory consistent with the level of detail set forth in the Third Party Development Reports, to the extent necessary for TESARO to comply with its reporting requirements under Section 4.01(f) of the Merck License Agreement and Section 4 of each of the AstraZeneca License Agreements.  Notwithstanding the foregoing, prior to disclosing such information to Merck or AstraZeneca, TESARO shall provide a draft of such disclosure to Company for review and, upon Company’s request, TESARO shall redact from such disclosure any Redactable Information.  TESARO acknowledges and agrees that the information that TESARO is permitted to disclose to Merck and AstraZeneca pursuant to this Section 5.2(d) shall be sufficient to satisfy its obligations to provide information under Section 4.01(f) of the Merck License Agreement and Section 4 of each of the AstraZeneca License Agreements.

5.3INDs and Marketing Approvals.    

(a)INDs.    

(i)Prior to the Effective Date, TESARO filed the following INDs with respect to the Initial Product: IND 100,996 (Ovarian) and IND 117,580

(Breast).  Following the Effective Date, TESARO shall continue to maintain such INDs to the extent required for Company to initiate and conduct the Clinical Trials set forth in the Company Development Plan. 

(ii)Following the Effective Date, Company shall prepare, file and maintain all INDs for the Products that are required for Company to conduct the Clinical Trials set forth in the Company Development Plan, including any Clinical Trials of a Single Agent Product in combination with any other any pharmaceutical product and any Clinical Trials of a Combination Product.

(b)Marketing Approvals – Single Agent Products for Monotherapy Use.    

(i)  TESARO shall have the sole right and authority to prepare, obtain and maintain all Drug Approval Applications and Marketing Approvals for any Monotherapy Use in the TESARO Field in the TESARO Territory.

(ii)  Company shall have the sole right and authority to prepare all Drug Approval Applications for any Monotherapy Use in the Company Field in the Company Territory.  TESARO shall have the first right, and Company shall have the second right, to submit any such Drug Approval Application to a Regulatory Authority in any country or jurisdiction in the Company Field, and to obtain and maintain the resulting Marketing Approval, in accordance with the terms set forth in the remainder of this Section 5.3(b). 

(iii)If Company desires to submit a Drug Approval Application for a Monotherapy Use in the Company Field to a Regulatory Authority in any country or jurisdiction in the Company Territory, Company shall so notify TESARO no later than [***] prior to the date on which Company desires to submit such Drug Approval Application to such Regulatory Authority.  Within [***] after receipt of such notice, TESARO shall deliver a written notice to Company (such notice, a “Monotherapy Registration & Distribution Notice”) stating: (x) whether or not TESARO will submit such Drug Approval Application, and obtain and maintain the resulting Marketing Approval on behalf of the Company in accordance with Section 5.3(b)(iii); (y) whether or not TESARO has submitted a Drug Approval Application for, or obtained Marketing Approval of, the corresponding Monotherapy Use in the TESARO Field in the applicable country or jurisdiction; and (z) whether or not TESARO will Distribute the applicable Single Agent Product in the applicable country or jurisdiction in accordance with Section 6.2(c). 

(iv)  In the event that TESARO delivers a Monotherapy Registration & Distribution Notice stating that TESARO will submit the applicable Drug Approval Application for a Monotherapy Use in the Company Field, and

obtain and maintain the resulting Marketing Approval, in the applicable country or jurisdiction in the Company Territory, then the provisions of this Section 5.3(b)(iv)  shall apply with respect to such Drug Approval Application and Marketing Approval.    

(1)No later than [***] prior to the date on which Company desires to submit such Drug Approval Application to the applicable Regulatory Authority, Company shall submit such Drug Approval Application to the JDC for review.  Within [***] following submission of a such Drug Approval Application to the JDC the JDC shall review such Drug Approval Application to reasonably determine whether it satisfies the appropriate efficacy and safety criteria outlined in the applicable protocol and notify Company of the results of such review. 

(2)If a notice given by the JDC in accordance with clause (1) above indicates that the applicable Drug Approval Application does not satisfy the appropriate efficacy and safety criteria outlined in the applicable protocol, then TESARO shall have no obligation to submit such Drug Approval Application to the applicable Regulatory Authority unless and until Company revises such Drug Approval Application to satisfy the appropriate efficacy and safety criteria outlined in the applicable protocol.

(3)If a notice given by the JDC in accordance with clause (1) above indicates that the applicable Drug Approval Application satisfies the appropriate efficacy and safety criteria outlined in the applicable protocol, then TESARO shall submit such Drug Approval Application to the applicable Regulatory Authority in the applicable country or jurisdiction in the Company Field upon the request of Company; provided,  however, that (x) if TESARO previously submitted a Drug Approval Application for the corresponding Monotherapy Use in the TESARO Field in such country or jurisdiction, then TESARO shall not be obligated to submit Company’s Drug Approval Application until TESARO’s Drug Approval Application is approved or finally rejected by the applicable Regulatory Authority and (y) if Marketing Approval for the corresponding Monotherapy Use in the TESARO Field has been previously granted in such country or jurisdiction, such Drug Approval Application in the Company Field shall be submitted as a Supplemental Application to such Marketing Approval.  TESARO shall pay any filing fees required to submit any Drug Approval Application or Supplemental Application, as applicable, or to

obtain or maintain the resulting Marketing Approval, to such Regulatory Authority and shall either seek reimbursement of such filing fees from Company pursuant to Section 8.13 or deduct such filing fees from the TESARO Prostate-Approved Single Agent Product Net Sales as part of calculating Alliance Payments in accordance with Exhibit 8.3.   

(4)Upon TESARO’s submission of a Drug Approval Application or Supplemental Application to a Regulatory Authority in accordance with clause (3) above, TESARO shall, and hereby does, appoint Company as its authorized agent to assume primary responsibility with respect to such Drug Approval Application or Supplemental Application, as applicable (and the resulting Marketing Approval) and all associated communications with such Regulatory Authority; provided that Company complies with all Applicable Laws in connection with such communications and keeps TESARO informed of all associated communications in accordance with Section 5.4(b).  In furtherance of the foregoing, at Company’s request prior to the filing of such Drug Approval Application or Supplemental Application, as applicable, TESARO shall execute a letter, in a mutually agreed form, appointing Company as authorized agent to assume primary responsibility with respect to such Drug Approval Application or Supplemental Application, as applicable, and the Parties shall submit such letter to the applicable Regulatory Authority.   

(5)If the applicable Regulatory Authority approves a Drug Approval Application or Supplemental Application submitted by TESARO in accordance with clause (3) above, then, subject to Company’s rights under clause (4) above, TESARO shall be the holder of the resulting Marketing Approval in the Company Field and, if applicable, shall remain as the holder of the corresponding Marketing Approval in the TESARO Field.  Except with respect to a Change of Control, TESARO shall not, sell, transfer or assign any such Drug Approval Application, Supplemental Application or Marketing Approval with respect to the Company Field (or grant any Third Party any rights relating to such Marketing Approval) without Company’s prior written consent, such consent not to be unreasonably withheld.  If TESARO desires to withdraw or to cease to maintain any such Marketing Approval, TESARO shall so notify Company at least [***] prior to the date upon which TESARO intends to withdraw or cease to maintain such Marketing Approval and, upon Company’s request prior to the expiration of such [***], TESARO shall assign

such Marketing Approval to Company and shall take all actions necessary to effectuate such assignment, and the Parties shall negotiate in good faith and agree upon any modifications to this Agreement necessary to enable Company to maintain such Marketing Approval. 

(v)  In the event that (A) TESARO delivers a Monotherapy Registration & Distribution Notice stating that it will not submit the applicable Drug Approval Application for a Monotherapy Use in the Company Field in a country or jurisdiction in the Company Territory, and obtain and maintain the resulting Marketing Approval or (B) TESARO fails to deliver a Monotherapy Registration & Distribution Notice within [***] after Company notifies TESARO of its desire to submit a Drug Approval Application for a Monotherapy Use in the Company Field in a country or jurisdiction in the Company Territory, then, in each case ((A) and (B)), the provisions of this Section 5.3(b)(v) shall apply with respect to such Drug Approval Application and Marketing Approval. 

(1)Prior to submitting such Drug Approval Application to the applicable Regulatory Authority in such country or jurisdiction, Company shall provide TESARO with a draft of such Drug Approval Application, and TESARO may provide comments on such Drug Approval Application, which Company shall consider in good faith; provided,  however, that Company may redact any Redactable Information prior to providing such draft to TESARO. 

(2)Following TESARO’s review of a Drug Approval Application in accordance with clause (1) above, Company may submit such Drug Approval Application to the applicable Regulatory Authority at any time and shall promptly notify TESARO after such submission.  Company shall pay any filing fees required to submit such Drug Approval Application to such Regulatory Authority or to obtain or maintain the resulting Marketing Approval.  Company shall be solely responsible for all communications with such Regulatory Authority with respect to such Drug Approval Application; provided that Company shall keep TESARO informed of all associated communications in accordance with Section 5.4(b).

(3)If the applicable Regulatory Authority approves a Drug Approval Application submitted by Company in accordance with clause (2) above, Company shall be the holder of the resulting Marketing Approval. 

(vi)     If at any time Company is the holder of any Marketing Approval for Monotherapy Use in the Company Field, upon TESARO’s request at any time after the grant of such Marketing Approval, Company shall assign and transfer such Marketing Approval to TESARO and shall take all actions necessary to effectuate such assignment and transfer, and the provisions of clauses (3) (with respect to fees), (4) and (5) of Section 5.3(b)(iv) shall thereafter apply to such Marketing Approval. 

(c)Marketing Approvals – Single Agent Products for Combination Use. 

(i)TESARO shall have the sole right and authority to prepare, obtain and maintain all Drug Approval Applications and Marketing Approvals for any Combination Use in the TESARO Field in the TESARO Territory. 

(ii)Company shall have the sole right and authority to prepare, obtain and maintain all Drug Approval Applications and Marketing Approvals for any Combination Use in the Company Field in the Company Territory; provided,  however, Company may, in its sole discretion, seek Marketing Approval for such Combination Use using a Supplemental Application to a Marketing Approval for Monotherapy Use in the Company Field, in which case the corresponding provisions of Section 5.3(b) shall apply (substituting “Combination Use in the Company Field” for “Monotherapy Use in the Company Field” in the provisions thereof) with respect to the preparation, submission and maintenance of such Supplemental Application and the resulting Marketing Approval.  For clarity, Company is not granting any rights to TESARO under this Agreement with respect to any such Combination Use.    

(iii)Prior to submitting any Drug Approval Application for a Combination Use in the Company Field in the Company Territory (and, in any event, at least [***] in advance of submission) in accordance with this Section 5.3(c), a Party shall provide the other Party with a draft of relevant portions of the Drug Approval Application as determined by the JDC, and the other Party may provide comments on any portions of such Drug Approval Application that relate to a Compound, which the submitting Party shall consider in good faith; provided, however, that, prior to submitting such draft to the other Party, the submitting Party may redact any Redactable Information from such Drug Approval Application.

(d)Marketing Approvals – Combination Products.

(i)Subject to Sections 3.1(d) and 3.4, TESARO shall have the sole right and authority to prepare, obtain and maintain all Drug Approval Applications and Marketing Approvals for any Combination Product in the TESARO Field in the TESARO Territory.

(ii)Company shall have the sole right and authority to prepare, obtain and maintain all Drug Approval Applications and Marketing Approvals for the Combination Products in the Company Field in the Company Territory.  For clarity, Company is not granting any rights to TESARO under this Agreement with respect to any such Combination Product.  

(iii)Prior to submitting any Drug Approval Application for a Combination Product in the Company Field in the Company Territory (and, in any event, at least [***] in advance of submission) in accordance with this Section 5.3(d)(iii), Company shall provide TESARO with a draft of relevant portions of the Drug Approval Application as determined by the JDC, and TESARO may provide comments on any portions of such Drug Approval Application that relate to a Compound, which Company shall consider in good faith; provided,  however, that, prior to providing such drafts to TESARO, Company may redact any Redactable Information.

5.4Interactions with Regulatory Authorities.

(a)Regulatory Meetings.  Where Applicable Law so permits, each Party shall have the right to have two (2) representatives participate in all material meetings, conferences and discussions between the other Party and the applicable Regulatory Authority with respect to any Compound or Product (provided that such representatives shall not be actively involved in seeking Regulatory Approval for a product other than a Product in any indication that will be discussed at such meeting, conference or discussion); provided,  however, that [***].  Each Party shall provide the other Party with reasonable advance notice (and, in any event, at least five (5) Business Days advance notice) of all such meetings, conferences and discussions and all copies of all relevant information with respect to such meetings, conferences and discussions; provided,  however, that, prior to providing such information to the other Party, the providing Party may redact any Redactable Information. 

(b)Regulatory Correspondence.  Each Party shall provide the other Party with drafts of any material Regulatory Documentation related to a Party’s Development or Commercialization of a Product (excluding Drug Approval Applications and Supplemental Applications, which are governed by Sections 5.3(b), 5.3(c) and 5.3(d)) that such Party plans to submit to any Regulatory Authority reasonably in advance of submission (and, in any event, at least five (5) Business Days in advance of submission, if practicable, and otherwise, with as much notice as practicable), and the other Party may provide comments on such Regulatory Documentation, which the submitting Party shall consider in good faith; provided,  however, that the submitting Party may, prior to providing such Regulatory Documentation to the other Party, redact any Redactable Information.  Notwithstanding anything to the contrary in this Agreement, in no event shall

Company be obligated to provide TESARO with any DMF Equivalents with respect to any Combination Product Developed by Company.  For clarity, this Section 5.4(b) shall apply with respect to any proposed changes to the label for a Product (other than proposed label changes set forth in a Supplemental Application submitted in accordance with Section 5.3(b)(i)  or 5.3(c)(ii)). 

(c)Post-Marketing Commitments.  Each Party shall perform all activities necessary to satisfy any post-marketing requirements imposed by a Regulatory Authority with respect to a Single Agent Product in such Party’s Field, in accordance with the timelines established by such Regulatory Authority.

5.5Sharing of Regulatory Documentation.    

(a)Initial Transfer of Regulatory Documentation.  Within [***] after the Effective Date, TESARO shall deliver to Company electronic copies (unless otherwise required by Applicable Law) of all Regulatory Documentation relating to the Initial Compound and Initial Product set forth on Exhibit 5.5(a).   

(b)Sharing of Safety Data.  Upon a Party’s request or as required under the PVA, each Party shall provide the other Party with any safety data relating to the Compounds or Products that is necessary for such other Party to prepare, obtain or maintain any Regulatory Approval that such Party has a right or obligation to prepare, obtain or maintain pursuant to this ARTICLE 5.  The Parties shall discuss the logistics of sharing safety data pursuant to this Section 5.5(b) through the JDC.    

(c)Ongoing Sharing of Regulatory Documentation.  Upon a Party’s reasonable request, each Party shall provide the other Party with copies of any Regulatory Documentation or Know-How Controlled by such Party that relates to a Compound or Product, to the extent that such Regulatory Documentation or Know-How is required or reasonably expected to be required for the other Party to prepare, obtain or maintain any Regulatory Approval for a Compound or Product that such other Party has a right or obligation to prepare, obtain or maintain under this ARTICLE 5.  The Parties shall discuss the logistics of sharing Regulatory Documentation pursuant to this Section 5.5(c) through the JDC.  Notwithstanding anything to the contrary in this Agreement, a Party that is required to provide Regulatory Documentation or Know-How pursuant to this Section 5.5(c) may, prior to providing such Regulatory Documentation or Know-How to the other Party, redact any Redactable Information. Notwithstanding anything to the contrary in this Agreement, in no event shall Company be obligated to provide TESARO with any DMF Equivalents with respect to any Combination Product Developed by Company.

5.6Rights of Reference. 

(a)Rights of Reference Granted to Company.  Subject to the terms and conditions of this Agreement, TESARO (on behalf of itself and its Affiliates) hereby grants to Company a non-exclusive Right of Reference (with the right to grant further Rights of Reference to any of Company’s Affiliates, sublicensees or Third Party distributors that will hold the Marketing Approval for any Product in the Company Field in any country or jurisdiction in the Company Territory) to any Regulatory Documentation Controlled by TESARO (including the IND for the Single Agent Product filed by Merck prior to the Effective Date and the corresponding Phase 1 Clinical Trial data) that is required or reasonably expected to be required to obtain or maintain any Regulatory Approval of a Compound or Product in the Company Field in the Company Territory that Company is permitted to obtain or maintain under Section 5.2(a) or Section 5.3 (such Regulatory Documentation, the “TESARO Regulatory Documentation”), for the sole purpose of preparing, obtaining and maintaining such Regulatory Approval.  Company shall notify TESARO of any additional right of reference granted by Company in accordance with this Section 5.6(a), and shall obtain from the referee an undertaking that it shall comply with applicable provisions of this Agreement and Applicable Law with respect thereto.

(b)Rights of Reference Granted to TESARO.  Subject to the terms and conditions of this Agreement, Company (on behalf of itself and its Affiliates) hereby grants to TESARO a non-exclusive Right of Reference (with the right to grant further Rights of Reference to any of TESARO’s Affiliates, (sub)licensees or Third Party distributors that will hold the Marketing Approval for any Single Agent Product in the TESARO Field in any country or jurisdiction in the TESARO Territory) to any Regulatory Documentation Controlled by Company that is required or reasonably expected to be required to obtain or maintain any Regulatory Approval of a Compound or Product that TESARO is permitted to obtain or maintain under Section 5.2(b) or Section 5.3 (the “Company Regulatory Documentation”), for the sole purpose of preparing, obtaining and maintaining such Regulatory Approval; provided,  however, that such Right of Reference shall not apply to the following, (i) any DMF equivalent for a Combination Product, (ii) any portion of any Company Regulatory Documentation that includes CMC information with respect to a Combination Product or (iii) any portion of any Company Regulatory Documentation that relates to any compound that is not a Compound or any product that is not a Product.  TESARO shall notify Company of any additional right of reference granted by TESARO in accordance with this Section 5.6(b), and shall obtain from the referee an undertaking that it shall comply with applicable provisions of this Agreement and Applicable Law with respect thereto.

(c)Documentation.  If requested by a Party, the other Party shall provide any signed statement that authorizes any Right of Reference granted to such Party under this

Section 5.6 that is required by Applicable Law or the Regulatory Authority in the applicable country or jurisdiction.  In the event that any Affiliate, licensee, sublicensee or Third Party distributor of a Party holds any Regulatory Documentation to which the other Party is granted a Right of Reference under this Section 5.6, such Party will cause such Affiliate, licensee, sublicensee or Third Party distributor to grant a Right of Reference to the other Party to the same extent that such Party is required to grant such Right of Reference under this Section 5.6.

(d)Access.  The Rights of Reference granted pursuant to this Section 5.6 shall include the right to access all Know-How included or referenced in the applicable Regulatory Documentation; provided,  however, that such right of access shall not apply to any Know-How that is Redactable Information.

5.7Adverse Event Reporting and Safety Data Exchange.

(a)Company Responsibilities. Company will maintain the global safety database, safety monitoring, pharmacovigilance surveillance, compliance and filing of all required safety reports to all Regulatory Authorities in the Company Territory with respect to any Combination Product (including any FDC) Developed by Company in the Company Field and, to the extent required by Applicable Law, any Combination Use of a Single Agent Product solely in the Company Field, including annual safety reports, throughout the Development and Commercialization of such Combination Product or combination regimen, as applicable.

(b)TESARO Responsibilities. TESARO will maintain the global safety database, safety monitoring, pharmacovigilance surveillance, compliance and filing of all required safety reports to all Regulatory Authorities in the Company Territory and TESARO Territory with respect to each Single Agent Product (other than with respect to any Combination Use in the Company Field for which Company is responsible pursuant to Section 5.7(a)) and with respect to any Combination Product Developed by TESARO in the TESARO Field, including annual safety reports, throughout the Development and Commercialization of such Single Agent Product or Combination Product, as applicable. 

(c)Safety Information Exchange; Pharmacovigilance Agreement.  The Parties shall cooperate to develop methods or procedures for sharing information relating to the clinical experiences with respect to the Products in accordance with safety reporting requirements of the respective Regulatory Authorities and as necessary to comply with Applicable Law.    Specific details regarding the management of safety data (including adverse events reports) related to the Development and Commercialization of the Products will be delineated in a separate global pharmacovigilance agreement (the “PVA”).  The Parties shall agree upon the

terms of the PVA no later than the anticipated date of the First Commercial Sale or clinical activity with respect to any Product in the Company Field in the Company Territory.  In the event of any conflicts or inconsistencies between the PVA and this Agreement, the terms of the PVA shall take precedence for matters relating to pharmacovigilance.    

5.8Medical Affairs.  The Parties shall review and discuss medical affairs activities with respect to the Products (including the matters described in this Section 5.8 and investigator initiated studies, cooperative group studies, early access programs, HECOR studies, RWE and company-sponsored medical affairs studies) through the JDC (or, if created by the JDC, a joint medical affairs subcommittee).

(a)Medical Science Liaisons.  Each Party shall determine independently how and if to utilize and deploy its medical science liaisons for activities relating to the Products in the Company Territory, provided that any arrangements a Party makes with its medical science liaisons are subject to the provisions of Sections 5.8(b) and 5.8(c).

(b)Responses to Medical Inquiries.    

(i)Each Party shall apply its standard guidelines and procedures for determining and providing appropriate responses to medical inquiries for which it is responsible according to this Section 5.8(b).  Each Party shall ensure that any such response procedures and standard response documents comply with Applicable Law. 

(ii)Company shall be responsible for dealing with medical inquiries about the Products in the Company Field in the Company Territory.  TESARO shall refer any medical inquiries that it receives about the Products in the Company Field in the Company Territory to Company or such Persons as Company may designate from time to time.

(iii)TESARO shall be responsible for dealing with medical inquiries about the Products in the TESARO Field in the TESARO Territory.  Company shall refer any medical inquiries that it receives about the Products in the TESARO Field in the TESARO Territory or such Persons as TESARO may designate from time to time. 

(iv)Each Party shall provide the other Party, on a recurring basis, with access to current medical affairs communications and training materials, including anticipated questions and answers, relating to the Products and as used by such Party’s medical affairs personnel in the Company Territory.  Each Party will conduct training of its medical affairs personnel on the use of such materials and on following the procedures of such training materials.  Company may respond to any medical inquiries about the Products in the TESARO Field in the Company Territory strictly in accordance with the information contained in the medical affairs communications materials provided by TESARO.  TESARO may respond to any medical inquiries about

the Products in the Company Field in the Company Territory strictly in accordance with the information contained in the medical affairs communications materials provided by Company.  Any medical inquiry seeking or requiring information not contained in such materials shall be referred by the receiving Party to the other Party or such Persons as the other Party may designate from time to time.

(c)Conferences and Symposia.  Except for any Third Party medical education activities (e.g., accredited CME programs) over which a Party has no control or influence beyond providing funding or as otherwise agreed by the Parties: (i) Company shall not, and shall ensure that its Affiliates do not, participate in or sponsor any formal presentation or panel or medical booths with respect to any Product in the TESARO Field at any conference or symposia, or provide any information with respect to any Product in the TESARO Field at any conference or symposia, without the prior consent of TESARO; and (ii) TESARO shall not, and shall ensure that its Affiliates do not, participate in or sponsor any formal presentation or panel or medical booths with respect to any Product in the Company Field at any conference or symposia, or provide any information with respect to any Product in the Company Field at any conference or symposia, without the prior consent of Company. 

5.9Recalls and Voluntary Withdrawals.

(a)Notification.  Each Party shall notify the other Party in writing promptly following its determination that any event, incident or circumstance related to safety issues or regulatory concerns has occurred that is reasonably likely to result in the need for a recall, market suspension or market withdrawal of a Product, and shall include in such notice (a “Potential Recall Notice”) the reasoning behind such determination and any supporting facts.  Such Potential Recall Notice shall be given no later than five (5) Business Days after such determination is made; provided,  however, that if any Regulatory Authority (i) threatens or initiates any action to remove a Product from the market in any country or (ii) requires a Party, or any of its Affiliates or (sub)licensees, to distribute a “Dear Doctor” letter or its equivalent regarding the use of a Product in such Party’s Field, then, in either case ((i) or (ii)), the Potential Recall Notice shall be given within one (1) Business Day after such Party becomes aware of the action, threat or requirement (as applicable).  TESARO shall be permitted to disclose any Potential Recall Notice delivered by Company to Merck to extent necessary to satisfy its obligations under Section 4.01(g) of the Merck License Agreement.

(b)Decision-Making.  If the Party that receives a Potential Recall Notice does not agree with the determination or recommendation of the other Party that the recommended recall, market suspension or market withdrawal of the applicable Product is advisable or necessary, then the Parties shall promptly meet to discuss whether to conduct such recall, market suspension or market withdrawal.  If the Parties do not reach agreement on whether to conduct such recall, market suspension or market withdrawal within five (5) Business Days after a Potential Recall Notice is given, then: (i) if such Product is a Single Agent Product or a Combination Product Developed by TESARO in the TESARO Field, TESARO shall have the final decision-making authority with respect to such recall, market suspension or market withdrawal; and (ii) if such Product is a Combination Product Developed by Company in the Company Field, Company shall have the final decision-making authority with respect to such recall, market suspension or market withdrawal.  Notwithstanding the foregoing, the Parties shall abide by any decision of the applicable Regulatory Authority with respect to any recall, market suspension or market withdrawal of a Product and, in the event TESARO notifies Company that it believes a recall, market suspension or market withdrawal of a Combination Product Developed by Company in the Company Field should occur due to safety concerns regarding the Compound included therein, then TESARO shall have the final decision-making authority with respect to such recall, market suspension or market withdrawal.    

(c)Recall Procedure and Recall Expenses.  TESARO shall be responsible for implementing, directing and administering (including communicating with Regulatory Authorities with respect to) any recall, market suspension or market withdrawal of a Single Agent Product or a Combination Product Developed by TESARO in the TESARO Field that is determined to be advisable or necessary in accordance with Section 5.9(b) at its own expense, provided that Company shall, upon the request of TESARO, provide any reasonable assistance in implementing or administering such recall, market suspension or market withdrawal.  Company shall be responsible for implementing, directing and administering (including communicating with Regulatory Authorities with respect to) any recall, market suspension or market withdrawal of a Combination Product Developed by Company in the Company Field that is determined to be advisable or necessary in accordance with Section 5.9(b) at its own expense, provided that TESARO shall, upon the request of Company, provide any reasonable assistance in implementing or administering such recall, market suspension or market withdrawal. 

(d)Recall Records.  Each Party shall maintain records of all sales of the Products to direct accounts sufficient to administer a recall until the later of: (a) the third (3rd) anniversary of the last day of the Term; (b) the third (3rd) anniversary of the last sale of any Product; (c) the last expiration date of the last Product sold by or on behalf of such Party; or (d) the expiration of any period as may be required under any Applicable Law.

(e)Public Statements regarding Recalls.  TESARO shall be solely responsible for making all public statements in respect of any recall, market suspension or market withdrawal of any Single Agent Product or any Combination Product Developed by TESARO in the TESARO Field.  Before issuing any such public statement that contains the name of or that could reasonably be construed to refer to Company or any of its Affiliates, TESARO shall provide Company with a copy of such public statement and reasonably consider the comments of Company.  TESARO shall comply with any request by Company to remove any of its Confidential Information (except to the extent such information is required by Applicable Law to be disclosed).  Company shall be solely responsible for making all public statements in respect of any recall, market suspension or market withdrawal of any Combination Product Developed by Company in the Company Field.  Before issuing any such public statement that contains the name of or that could reasonably be construed to refer to TESARO or any of its Affiliates, Company shall provide TESARO with a copy of such public statement and reasonably consider the comments of TESARO.  Company shall comply with any request by Company to remove any of its Confidential Information (except to the extent such information is required by Applicable Law to be disclosed).  The provisions of Section 11.5 shall not apply to a public statement made under this Section 5.9(e).

5.10Subcontracting.  Each Party may subcontract the performance of any activities conducted in accordance with this ARTICLE 5 to any of its Affiliates or any Third Party, provided that such Party shall oversee the performance of any subcontracted activities in a manner that would be reasonably expected to result in their successful and timely completion and shall remain responsible for the performance of such subcontracted activities in accordance with this Agreement.

ARTICLE 6

COMMERCIALIZATION

6.1General.  During the Term, Company shall have the right to Commercialize the Products in the Company Field in the Company Territory, and TESARO shall retain the right to Commercialize the Products in the TESARO Field in the TESARO Territory, in each case subject to the term and conditions of this ARTICLE 6.  Certain aspects of the Parties’ Commercialization of the Products shall be subject be communicated through the JCC, as expressly described in ARTICLE 2 and this ARTICLE 6, to the extent permitted by Applicable Law, but neither Party’s Commercialization activities and decisions require the approval, consent or agreement of the JCC, JSC, any other Joint Committee, subcommittee, or the other Party except as expressly provided in this Agreement.

6.2Commercialization Activities. 

(a)Company Commercialization Activities – In General.  Subject to Sections 6.2(c) and 6.2(d), Company shall be solely responsible for and have sole authority

with respect to, at its own expense, all aspects of the Commercialization of the Products in the Company Field in the Company Territory, including all Fixed Dose Combination Products Developed by Company in the Company Field.     

(b)TESARO Commercialization Activities – In General.   TESARO shall be solely responsible for and have sole authority with respect to, at its own expense, all aspects of the Commercialization of the Products in the TESARO Field in the TESARO Territory. 

(c)Distribution Activities.    

(i)Notwithstanding anything to the contrary in this Agreement, TESARO shall be solely responsible for and have sole authority with respect to all aspects of the Distribution of Single Agent Products in the TESARO Field in the TESARO Territory and in the Company Field in the Company Territory.  Company hereby grants TESARO, and TESARO hereby accepts, the exclusive authority and responsibility to Distribute each Single Agent Product in the Company Field in each country or jurisdiction where such Single Agent Product has received Marketing Approval for Monotherapy Use in the Company Field during the Term.  Notwithstanding the foregoing, Company shall have the right and authority to Distribute a Single Agent Product in the Company Field in a country or jurisdiction to the extent permitted under Section 6.4.  The JCC shall discuss and seek to reach alignment with respect to key aspects of Distribution of a Single Agent Product in countries or jurisdictions where such Single Agent Product has received Marketing Approval for Monotherapy Use in both the TESARO Field and Company Field. 

(ii)Company shall be solely responsible for and have sole authority with respect to, at its own expense, all aspects of the Distribution of the Combination Products in the Company Field in the Company Territory.

(iii)In the event that a Party receives any orders for a Product in a country or jurisdiction where the other Party is responsible for Distributing, or that the other Party is responsible for Distributing, such Party shall refer such orders to the distributing Party. 

(iv)TESARO shall prepare and maintain complete and accurate written records and accounts with respect to Distribution activities conducted pursuant to this Section 6.2(c) in conformity with Applicable Law and TESARO’s standard practices, provided that in no case shall such records be maintained for less than three (3) years following the Calendar Year to which such records pertain (or any longer period required by Applicable Law).

(d)Pricing Matters.  

(i)Subject to Section 6.2(d)(iv), TESARO shall be solely responsible for and shall have final decision-making authority with respect to all decisions regarding the prices charged and discounts, rebates and other sale and reimbursement terms and conditions (collectively, “Pricing Terms”) for the Single Agent Products in the Company Field in the Company Territory.    

(ii)TESARO shall be solely responsible for and shall have final decision-making authority with respect to all decisions regarding Pricing Terms for the Products in the TESARO Field in the TESARO Territory.

(iii)Company shall be solely responsible for and shall have final decision-making authority with respect to all decisions regarding Pricing Terms for the Combination Products in the Company Field in the Company Territory. 

(iv)[***]    

(e)Commercialization Plans.  Each Party shall submit to the JCC a high-level summary of its commercialization plans for Products on an annual basis.  Each such summary shall include the following topics: Product labeling, contracted services, brand vision and lifecycle management, package design and configuration, positioning and messaging, branding and Trademarks.  The JCC shall review and discuss such commercialization plans, and seek to reach alignment with respect to key Commercialization issues related to the Products reflected in such plans, such as Product labeling, strategic branding elements, brand security, brand integrity, customer targeting, product positioning and promotional programs (e.g. speaker programs and payer activities).  For clarity, approval of a Party’s commercialization plan by the other Party, the JCC or JSC shall not be required. 

6.3Commercialization Diligence Obligations.

(a)Following receipt of Marketing Approval for a Product in the Company Field in any country in the Company Territory, Company shall use Commercially Reasonable Efforts to Commercialize such Product in the Company Field in the Company Territory; provided,  however, that in no event shall Company be obligated to use Commercially Reasonable Efforts to Commercialize more than one Product in any given country in the Company Territory.

(b)Following Company’s receipt of Marketing Approval for a Single Agent Product for Monotherapy Use in any Indication in the Company Field in a country or jurisdiction where such Single Agent Product has received Marketing Approval