COLLABORATION AND LICENSE AGREEMENT

THIS COLLABORATION AND LICENSE AGREEMENT dated the 21st day of May, 2003 (the “Execution Date”) is by and between TULARIK INC., a corporation organized and existing under the laws of the State of Delaware and having its principal office at 1120 Veterans Blvd., South San Francisco, California 94080 (“Tularik”), and AMGEN INC., a corporation organized and existing under the laws of the State of Delaware and having its principal office at One Amgen Center Drive, Thousand Oaks, California 91329-1799 (“Amgen”).

INTRODUCTION

WHEREAS, Tularik and Amgen are each in the business of discovering, developing and commercializing pharmaceutical products.

WHEREAS, Tularik and Amgen are interested in collaborating: (i) in the identification and validation of targets for use in the discovery of molecules potentially useful to prevent or treat cancer; and (ii) in the discovery, development and commercialization of molecules for use in the prevention or treatment of certain cancers.

WHEREAS, on the Execution Date, Tularik and Amgen are entering into a Stock Purchase Agreement, pursuant to which Amgen shall purchase shares of Tularik common stock at certain designated times.

NOW, THEREFORE, Tularik and Amgen agree as follows:

ARTICLE 1

DEFINITIONS

When used in this Agreement, each of the following terms shall have the meanings set forth in this Article 1:

1.1Active” means with respect to a Molecule, that such Molecule [**] Scientifically-Qualified Target in a manner that meets requirements established by the Joint Research Committee, as confirmed by such committee on a Molecule-by-Molecule basis.

1.2Affiliate” means any corporation, company, partnership, joint venture and/or firm that controls, is controlled by, or is under common control with a specified person or entity. For purposes of this Section 1.2, “control” shall be presumed to exist if one of the following conditions is met: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares having the right to vote for the election of directors, and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest with the power to direct the management and policies of such non-corporate entities. The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership


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permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such owner has the power to direct the management and policies of such entity.

1.3 “Amgen Background Materials” means any compounds, targets, assays, antibodies or other materials that are (a) necessary or useful for the conduct of the Research Program, (b) Controlled by Amgen, (c) utilized in the Research Program (but only to the extent so utilized) and (d) either in Amgen’s or any of its Affiliates’ possession as of the Execution Date or are discovered or acquired by Amgen and/or any of its Affiliates during the Research Program Term but outside of the conduct of the Research Program.

1.4Amgen Background Technology” means any inventions, information, methods, know how, trade secrets or data that (a) are Controlled by Amgen, (b) relate to [**] or are necessary or useful for the performance of the Research Program, (c) are utilized in the Research Program (but only to the extent so utilized) and (d) either are in Amgen’s or any of its Affiliates’ possession as of the Execution Date or are discovered or acquired by Amgen and/or any of its Affiliates during the Research Program Term but outside of the conduct of the Research Program.

1.5Amgen Development Compound” means [**] a Pre-Clinical Compound that is so designated in accordance with Section 3.1.4, a Back-Up Compound therefor selected in accordance with Section 3.5 and any other Molecule that is made in the course of: (a) performing medicinal chemistry on, (b) optimizing or (c) performing molecular biological or other modifications of, such Pre-Clinical Compound or Back-Up Compound, together with any and all [**].

1.6Amgen Development Product” or “AD Product” means a product containing an Amgen Development Compound as an active ingredient.

1.7Annual Research Plan” means the plan to be developed by the Joint Research Committee for each Contract Year, to be updated as necessary during each Contract Year, setting forth, among other things, a master plan for the Research Program during the Research Program Term and the matters described in Section 2.6 below.

1.8Antibody” means a polyclonal or monoclonal antibody, whether multiple or single chain, recombinant or naturally occurring, whole or fragment, and any constructs thereof, as well as nucleotide sequences encoding such antibody.

1.9 “Background Materials” means the Amgen Background Materials and the Tularik Background Materials.

1.10Background Technology” means the Amgen Background Technology and the Tularik Background Technology.

1.11Business Day” means a day other than a Saturday or Sunday on which banking institutions in California are open for business.


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1.12Cancer Field” means the prevention, control and/or treatment in humans of cancer; provided that [**].

1.13[**] Target” means a Scientifically-Qualified Target that is selected by Amgen as a [**] Target pursuant to Section 2.7.3.

1.14[**] Target” means a Scientifically-Qualified Target that is selected by Amgen as a [**] Target pursuant to Section 2.7.3.

1.15Commercialization” or “Commercialize” means any and all activities directed to pre-launch and launch of products, marketing, promoting, distributing, offering for sale and selling a product, importing a product for sale, conducting Commercial Phase IIIB Studies and Phase IV Studies, and manufacturing for commercial sale (except for scale-up activities, which shall be Development activities). When used as a verb, “Commercialize” means to engage in Commercialization.

1.16Confidential Information” means all proprietary documents, technology, know-how or other information (whether or not patentable) regarding a Party’s technology, research or development efforts, products, business or objectives. Any information or documents disclosed by a Party to the other Party pursuant to the Non-Disclosure Agreement between the Parties [**] shall be deemed the disclosing Party’s Confidential Information under this Agreement and shall be subject to the provisions of Article 10. For clarity, any information of a Party disclosed at a meeting of the Joint Research Committee, the Niche Indication Commercialization Committee or the Joint Steering Committee (or any subcommittees or project teams of the foregoing) or disclosed through an audit report shall constitute Confidential Information of a Party unless otherwise specified.

1.17Contract Year” means (a) with respect to the first Contract Year, the period beginning on the Effective Date and ending on December 31, 2003 (the “First Contract Year”), and (b) with respect to each subsequent Contract Year, the twelve (12) month period beginning on the day following the end of the First Contract Year and each succeeding twelve (12) month period thereafter during the Research Program Term (except that the last Contract Year shall end on the anniversary of the Effective Date immediately following the effective date of any termination or expiration of this Agreement). Each Contract Year (other than the First and last Contract Year) shall be divided into four (4) “Contract Quarters” comprised of successive three (3) month periods. In the First Contract Year, the first Contract Quarter shall end on the first day following the Effective Date that is the last day of a calendar quarter, and in the last Contract Year, the last Contract Quarter shall end on the anniversary of the Effective Date immediately following the effective date of any termination or expiration of this Agreement.

1.18Control” or “Controlled” means with respect to any (a) material, document, item of information, method, data or other know-how or (b) intellectual property right, the possession (whether by ownership or license, other than by a license granted pursuant to this Agreement) by a Party or its Affiliates of the ability to grant to the other Party access, ownership, a license and/or a sublicense as provided herein under such item or right without violating the terms of any


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agreement or other arrangement with any Third Party as of the time such Party would first be required hereunder to grant the other Party such access, ownership, license, or sublicense.

1.19Covering,” “Cover” or “Covered” means, with respect to a Patent Right, that, but for rights granted to a Party under such Patent Right, the practice by such Party of an invention claimed in such Patent Right would infringe a Valid Claim included in such Patent Right, or in the case of a Patent Right that is a patent application, would infringe a Valid Claim in such patent application if it were to issue as a patent.

1.20 “[**]” means that certain license agreement entered into by [**], pursuant to which [**].

1.21Detail” means a face-to-face sales call made to an individual medical professional with prescribing authority or a small group of such professionals during which an Amgen Development Product is discussed with such professional(s).

1.22Development” or “Develop” means, with respect to a Molecule that has achieved Pre-Clinical Status, preclinical and clinical drug development activities, including, among other things: test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, development-stage manufacturing, quality assurance/quality control procedure development and performance with respect to clinical materials, statistical analysis and report writing, clinical studies, regulatory affairs, product approval and product registration (including pricing approvals). When used as a verb, “Develop” means to engage in Development. Development shall include a Development Phase IIIB Study. For the purposes of this Agreement, Commercial Phase IIIB Studies or Phase IV Studies shall constitute Commercialization.

1.23 “[**] Target” means a Target for which there is reasonable evidence [**].

1.24Effective Date” means the HSR Clearance Date (as defined in Section 15.2.4) or, if the Parties mutually agree that an HSR Filing is not required, June 15, 2003.

1.25 “Extended Research Period” means, on a Program Target-by-Program Target basis, the period commencing on the date on which Tularik grants a license to Amgen with respect to a particular Program Target under Section 2.16 and expiring on [**].

1.26FDA” means the United States Food and Drug Administration, or a successor agency thereto.

1.27First Commercial Sale” means, for each Amgen Development Product or Tularik Development Product, on a country-by-country basis, the first shipment of an Amgen Development Product or Tularik Development Product, as the case may be, to a Third Party by Amgen or Tularik, or their Affiliates or sublicensees, in a country in the Territory after Regulatory Approval has been achieved for such Amgen Development Product or Tularik Development Product in such country. Sales for test marketing, sampling and promotional uses, clinical trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale.


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1.28FTE” means a full-time equivalent person year (consisting of a total of 1,760 hours per year) of scientific, technical or managerial work on or related to the Research Program or of work on or related to the Development or Commercialization of a Program Compound, Pre-Clinical Compound, Amgen Development Compound or Amgen Development Product.

1.29 “Good Clinical Practices” or “GCP” means the standards, practices and procedures set forth in the guidelines entitled “Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance,” including related regulatory requirements imposed by the FDA, any successor agency and, as applicable, the equivalent thereof in jurisdictions outside the United States, as updated from time to time.

1.30 “Good Laboratory Practices” or “GLP” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, and comparable regulatory standards in jurisdictions outside the United States.

1.31 “Good Manufacturing Practices” or “GMP” means the then-current good manufacturing practices required by the FDA as set forth in the U.S. Federal Food, Drug, and Cosmetic Act, as amended, and the regulations promulgated thereunder, for the manufacturing and testing of pharmaceutical materials, and any other equivalent laws or regulations applicable to the manufacturing and testing of pharmaceutical materials in jurisdictions outside the United States.

1.32IND” means (a) (i) an Investigational New Drug Application, as defined in the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder, that is required to be filed with the FDA before beginning clinical testing of a pharmaceutical product in human subjects, or any successor application or procedure and (ii) any foreign counterpart of a U.S. Investigational New Drug Application, and (b) all supplements and amendments that may be filed with respect to the foregoing.

1.33Joint Steering Committee” means a committee comprised of an appropriate number of representatives of Tularik and Amgen to plan and oversee the activities contemplated by this Agreement and resolve disputes under this Agreement as set forth in Article 12.

1.34Laws” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign.

1.35Lead Compound” means (a) a Program Compound that meets the Lead Selection Criteria and has been selected by the Joint Research Committee during the Research Program for chemical optimization or for the commencement of molecular biological or other modification thereof and/or other Pre-Clinical Research Evaluation in order to synthesize and identify Pre-Clinical Compounds, or (b) a Program Compound that has been [**].


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1.36 “Lead Selection Criteria” means the criteria agreed to by the Joint Research Committee pursuant to Section 2.4.1 that a Program Compound must satisfy in order to be selected as a Lead Compound.

1.37Lead Status” means the status that may be designated [**] for a Molecule that is biologically active against [**].

1.38 “Molecule” means any biologically active molecule including but not limited to [**].

1.39NDA” means (a) (i) a New Drug Application or Biologics License Application submitted to the FDA, or any successor application or procedure, and (ii) any foreign counterpart of a U.S. New Drug Application or Biologics License Application, and (b) all supplements and amendments, including supplemental New Drug Applications or Biologics License Applications (and any foreign counterparts), that may be filed with respect to the foregoing.

1.40 “Net Sales” shall mean the gross sales price of the applicable Royalty-Bearing Product, in finished product form, invoiced by a Party, its Affiliates or sublicensees from sales to arms’-length Third Party end users, less, to the extent such amounts are included in the invoiced sales price, taxes, shipping costs (including freight and insurance) and duties and other governmental charges paid for and separately identified on the invoice. Additionally, the following amounts will be subtracted from the gross invoiced sales price to calculate Net Sales: (a) [**] discounts actually allowed; (b) [**] rejection or return of goods; (c) [**] amounts paid or credited to a wholesaler, purchaser, Third Party payor or other contractee as a result of [**]; (d) rebates paid or credited to any governmental agency (or branch thereof) or to any Third Party payor, administrator or contractee; and (e) discounts mandated by, or granted in response to, [**]. For purposes of the definition of Net Sales, a Third Party shall not be considered a sublicensee if it is granted only the right to sell the product (e.g., a wholesaler) and if the Party, its Affiliates or sublicensee records the sales of a Royalty-Bearing Product upon transfer to such Third Party.

1.41Niche Indication Commercialization” means activities solely relating to the Commercialization of an Amgen Development Product as to which Tularik exercises its option pursuant to Section 6.2 with respect to Niche Indications in the United States [**]. For clarity, Niche Indication Commercialization is not intended to include activities that are primarily directed outside of the United States [**].

1.42Niche Indications” means those indications within the Cancer Field that have projected peak year sales levels [**].

1.43Option Fee” means the amount Amgen must pay to Tularik to exercise the Option, which shall vary as a function of the point at which Amgen exercises the Option, on a Molecule-by-Molecule basis, as follows: (a) [**]; or (b) [**].

1.44Party” means Amgen or Tularik; “Parties” mean Amgen and Tularik.

1.45Patent Rights” means all existing patents and patent applications and all patent applications hereafter filed and patents hereafter issued, including without limitation any


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continuations, continuations-in-part, divisions, provisionals or any substitute applications, any patent issued with respect to any such patent applications, any reissue, reexamination, renewal or extension (including any supplemental protection certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all foreign counterparts of any of the foregoing.

1.46Phase I Study” means a clinical study in subjects to evaluate the pharmacokinetic and pharmacodynamic properties, maximum tolerated dose, dosing interval and absorption, distribution, metabolism and excretion (ADME) of a candidate drug.

1.47Phase IIA Study” means a clinical study intended for dose exploration, dose response, duration of effect, kinetic/dynamic relationship and preliminary efficacy and safety study of a candidate drug in the target patient population.

1.48Phase IIB Study” means a controlled dose ranging clinical study to evaluate further the efficacy and safety of a candidate drug in the target patient population and to define the optimal dosing regimen.

1.49Phase IIIA Study” means a controlled clinical study to confirm with statistical significance the efficacy and safety of a candidate drug in larger, targeted patient populations, performed to obtain Regulatory Approval of a product.

1.50Phase IIIB Study” means a clinical study intended to enhance the profile of a product for a non-approved indication that is not required or pivotal for initial Regulatory Approval of a product. A “Development Phase IIIB Study” means a Phase IIIB Study commenced prior to the completion of Phase IIIA Studies required for Regulatory Approval for the first indication for an Amgen Development Product. A “Commercial Phase IIIB Study” means a Phase IIIB Study commenced after the completion of Phase IIIA Studies required for Regulatory Approval for the first indication for an Amgen Development Product but before receipt of initial Regulatory Approval in the country in which such trial is being conducted.

1.51Phase IV Study” means a clinical study of a product initiated in a country after receipt of initial Regulatory Approval for such product in such country.

1.52 “Pre-Clinical Candidate Status” or “Pre-Clinical Status” means the status that is (a) assigned by Amgen to a Program Compound, and for which the results of Pre-Clinical Research Evaluation activities support the commencement of GLP toxicology studies, or (b) designated by Tularik for a Molecule that is [**].

1.53 “Pre-Clinical Compound” means a Program Compound (a) that has achieved Pre-Clinical Status in the Research Program, as determined in accordance with Section 3.1, or (b) that has been designated by Amgen as a Pre-Clinical Compound [**].

1.54Pre-Clinical Research Evaluation” means any and all of the activities relating to the qualification of a Molecule for Pre-Clinical Status, including, but not limited to, medicinal chemistry, chemical optimization or molecular biological or other modification activities, as the


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case may be, and pre-clinical activities, up to those occurring immediately prior to the commencement of GLP toxicology studies.

1.55Program Compound” means a Molecule that (a)(i) is in a Party’s or any of its Affiliates’ possession as of the Execution Date, or is [**] by a Party or any of its Affiliates during the Research Program Term but [**] the Research Program, (ii) is [**] a Program Target and (iii) is selected by the Joint Research Committee for Pre-Clinical Research Evaluation in the conduct of the Research Program; or (b) is [**] a Program Target; or (c) is otherwise designated a Program Compound by the Joint Research Committee; or (d) is identified as Active against a Program Target during the Extended Research Period by Amgen and/or its sublicensees, Affiliates or Third Party subcontractors, whether such compound was a Program Compound existing when Amgen elected to extend the Research Program Term for such Program Target, or is otherwise created, Controlled, obtained or synthesized by or for Amgen during the Extended Research Period; provided however that in no event shall [**] Program Compound unless such designation is affirmatively agreed to by the Joint Research Committee.

1.56Program Intellectual Property” means Program Patent Rights, Program Material and Program Technology. For clarity, Program Intellectual Property excludes Background Technology and Background Materials.

1.57Program Material” means (i) any Scientifically-Qualified Targets (including Program Targets), (ii) any Program Compounds and (iii) any material first identified or discovered in the conduct of the Research Program, including, without limitation, biological materials or chemical compounds such as tissue samples, molecules, reagents and materials useful to perform screens.

1.58Program Patent Rights” means any Patent Rights that are Controlled by one or both Parties and that Cover any Program Technology or Program Materials. Notwithstanding the foregoing, Program Patent Rights excludes any Patent Rights relating to [**].

1.59Program Target” means [**] that the Joint Research Committee has selected as a Program Target and for which the Joint Research Committee has committed to initiate activities in the Research Program that relate to (a) [**], (b) drug discovery or similar activities using such Target or (c) such other activities related to the validation or use of the Target in the Cancer Field as are determined appropriate by the Joint Research Committee and identified in the Annual Research Plan.

1.60Program Technology” means any invention, information, methods, know how, trade secrets or data that (a) is Controlled by a Party or jointly by the Parties and (b) is first invented or discovered in the conduct of the Research Program. For clarity, Program Technology excludes Program Materials, Background Materials, Background Technology and [**].

1.61Regulatory Approval” means any and all approvals (including any applicable governmental price and reimbursement approvals), licenses, registrations, or authorizations of any federal, national, multinational, state, provincial or local regulatory agency, department,


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bureau or other governmental entity that are necessary for the manufacture, use, storage, import, transport, promotion, marketing and sale of a product in a country or group of countries.

1.62 “Regulatory Filings” means, collectively, INDs, NDAs, drug master files and applications for designation of a product as an “Orphan Product(s)” under the Orphan Drug Act, or any other similar filings (including any foreign equivalents), including any related correspondence and discussions as may be required or requested by the FDA or equivalent foreign governmental authority(ies), for the clinical testing, manufacture or sale of a product.

1.63Research Program” means the collaborative research program to be conducted by the Parties in accordance with the Annual Research Plan and this Agreement. For clarity, activities conducted pursuant to Sections 2.7.7 and 2.7.9 shall not be part of the Research Program.

1.64Royalty-Bearing Product” means an Amgen Development Product or a Tularik Development Product.

1.65Royalty-Paying Party” means, with respect to a Royalty-Bearing Product, the Party obligated to pay royalties to the other Party under any of the provisions of Section 8.5.

1.66Scientifically-Qualified Target” or “SQT” means a Target (a) that is [**], and (b) that [**]. On an ongoing basis, new oncogene-encoded protein targets will become Scientifically-Qualified Targets as they meet the objective criteria established by the Joint Research Committee. For clarity, a Target shall not be deemed as failing to meet the criteria established by the Joint Research Committee to become an SQT if the Joint Research Committee reasonably determines that there is insufficient information to make an informed decision.

1.67Significant Pharmaceutical Enterprise” means (a) a company (other than Amgen or an Amgen Affiliate) that, together with its Affiliates, had worldwide annual revenues from the sale of pharmaceutical products in excess of [**] during its most recently completed fiscal year and (b) any Affiliates of such company.

1.68Small Molecule” means a compound that [**] other than (a) [**], (b) [**]or (c) [**].

1.69Stock Purchase Agreement” means the Stock Purchase Agreement entered into by the Parties on the Execution Date.

1.70Target” means, subject to Section 2.7.1, any [**] encoded by [**] (a) (i) whose [**] or (ii) that is [**] or (b) that is brought to the Joint Research Committee by Amgen for consideration as a Scientifically-Qualified Target. All Targets shall be listed on the Research Program Target List, as amended by the Joint Research Committee from time to time.

1.71Territory” means all the countries of the world.

1.72Third Party” means any person or entity other than a Party or any of its Affiliates.


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1.73 “Tularik Background Materials” means any compounds, targets, assays, antibodies or other materials that are (a) necessary or useful for the conduct of the Research Program, (b) Controlled by Tularik, (c) utilized in the Research Program (but only to the extent so utilized) and (d) either in Tularik’s or any of its Affiliates’ possession as of the Execution Date or are discovered or acquired by Tularik and/or any of its Affiliates during the Research Program Term but outside of the conduct of the Research Program.

1.74Tularik Background Technology” means any inventions, information, methods, know how, trade secrets or data that (a) are Controlled by Tularik, (b) relate to [**] or are necessary or useful for the performance of the Research Program, (c) are utilized in the Research Program (but only to the extent so utilized) and (d) either are in Tularik’s or any of its Affiliates’ possession as of the Execution Date or are discovered or acquired by Tularik and/or any of its Affiliates during the Research Program Term but outside of the conduct of the Research Program. For clarity, Tularik Background Technology excludes any inventions, information, methods, know how, trade secrets or data relating to [**].

1.75Tularik Development Compound” or “TDC” means (a) a Pre-Clinical Compound that becomes a Tularik Development Compound under Section 3.1.4(b) or any other Molecule made in the course of performing medicinal chemistry on, optimizing or performing molecular biological or other modifications of such Pre-Clinical Compound or (b) a former Pre-Clinical Compound, a Back-Up Compound therefor and any other Molecule made in the course of: (1) performing medicinal chemistry on, (ii) optimizing or (iii) performing molecular biological or other modifications of, such Pre-Clinical Compound or Back-Up Compound therefor, that reverts to Tularik pursuant to Section 3.3 and that Tularik Develops in accordance with Section 3.4, together with any and all [**].

1.76Tularik Development Product” or “TD Product” means a product containing a Tularik Development Compound as an active ingredient.

1.77Tularik Exclusive Compound” or “TEC” means a Molecule that Tularik develops with biological activity against a Tularik Exclusive Target in accordance with Section 2.7.7.

1.78Tularik Exclusive Product” means a product containing a Tularik Exclusive Compound as an active ingredient.

1.79Tularik Exclusive Target” means a Scientifically-Qualified Target that is selected by Tularik as a Tularik Exclusive Target pursuant to Section 2.7.3.

1.80Tularik Target” means (a) any and all Targets that are [**], or that have been [**] that are not deemed to be an SQT prior to the end of the Research Program Term, (b) any and all Scientifically-Qualified Targets that are not selected as [**] Targets, [**] Targets or Tularik Exclusive Targets in accordance with Section 2.7.3, (c) any and all [**] Targets for which the relevant option period has expired as set forth in Section 2.7.6 without such [**] Target being selected as a [**] Target during such option period, (d) any and all [**] Targets that are not selected as Program Targets prior to the expiration of the Research Program Term, (e) any and


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all Program Targets that have not been used for [**] prior to the expiration of the Research Program Term or (f) any and all Scientifically-Qualified Targets, [**] Targets, [**] Targets or Program Targets regarding which, at any time during the Research Program Term or during the Extended Research Period, as applicable, either (i) Amgen notifies Tularik that it desires not to participate in further validation or drug discovery activities with respect to such Target or (ii) Amgen fails to exercise commercially reasonable efforts in undertaking the research activities assigned to it with respect to such Target pursuant to the Annual Research Plan, and its rights terminate thereto pursuant to Section 11.3.3. When such a Target becomes a Tularik Target, such Target shall no longer be deemed a Scientifically-Qualified Target, [**] Target, [**] Target or Program Target, as the case may be.

1.81 “Tularik Target Product” means a product that contains, as an active ingredient, a Molecule with biological activity against a Tularik Target that Tularik develops in accordance with Section 2.7.9 or Section 3.4.

1.82 “Valid Claim” means a claim (a) of any issued, unexpired patent that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, and that has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise or (b) of any patent application that shall not have been cancelled, withdrawn, abandoned or been pending in: (i) the United States for more than [**] years from its earliest priority date claimed; or (ii) any country or region outside the United States for more than [**] years from its earliest priority date claimed.

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

DEFINITION


  SECTION

Acceptance Period

  2.16.1

Amgen Indemnified Parties

  14.1.2

Amgen Third Party Payments

  8.5.1(c)

Back-Up Compounds

  3.5.1

[**]

   

Commercial Phase IIIB Study

  1.50

Compete

  6.2

Development Failure

  3.3

Development Phase IIIB Study

  1.50

DOJ

  15.2.1

First Contract Year

  1.17

FTC

  15.2.2

HSR Act

  15.2.3

HSR Clearance Date

  15.2.4

HSR Filing

  15.2.5

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Initial Scientifically-Qualified Targets

  2.7.2

Joint Program Inventions

  9.1.2(b)

Joint Research Committee

  2.2.1

Joint Research Project Team

  2.2.1

Negotiation Period

  2.16.1

Niche Indication Commercialization Committee

  6.4.2

Notice of Discontinuance

  3.3

Offer

  2.16.1

Option

  2.7.9(d)

Patent Prosecution

  9.2.1

Pre-Clinical Data Package

  3.1.1

Pre-Clinical Notification Period

  3.1.3

Program Compound Inventions

  9.1.2(a)

Program Inventions

  9.1.2(b)

Research Program Target List

  2.7.1(b)

Research Program Term

  2.1.2

Reversion Date

  4.3

ROFR

  2.16.2

ROFR Acceptance Period

  2.16.2

Sole Program Inventions

  9.1.2(b)

Target Exclusivity Notice

  2.16.1

TEC Expression of Interest

  2.7.7(c)

TEC Notification

  2.7.7(a)

TEC Response Period

  2.7.7(b)

TEC Right of First Negotiation

  2.7.7

Third Party Opportunity

  2.9.1

Tularik Indemnified Parties

  14.1.1

Tularik Target Expression of Interest

  2.7.9(d)(iii)

Tularik Target Notification

  2.7.9(d)(i)

Tularik Target Response Period

  2.7.9(d)(ii)

Tularik Third Party Payments

  8.5.2

ARTICLE 2

RESEARCH PROGRAM

2.1 GENERAL.

2.1.1 Objectives.

(a) The Parties shall collaborate in carrying out the Research Program as set forth in the then-current Annual Research Plan, with the global objectives, consistent with the resources allocated to such activities under the Annual Research Plan, of (i) [**] Program Targets; (ii) [**] Program Targets; and (iii) [**]. For clarity, the objectives set forth above are not intended to limit either Party’s obligations in accordance with Section 2.4.1 nor are they


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intended to limit the JRC’s discretion to select Program Targets without regard to the proportion of Program Targets suitable for development of Antibodies relative to those suitable for development of Small Molecules.

(b) It is anticipated that, during [**] the Research Program Term, there will be [**] by the Joint Research Committee.

(c) It is intended that Tularik shall be primarily responsible for the identification of Targets. It is further intended that, to the extent practicable, both Parties will participate in the full range of activities to be conducted in the Research Program, including without limitation Target validation, assay configuration, high throughput screening and Pre-Clinical Research Evaluation of Program Compounds, all of the foregoing subject to the Parties’ respective capabilities and capacities to perform such activities.

(d) It is intended that Amgen shall be solely responsible for generating, or having generated, Antibodies (including humanization of Antibodies, as appropriate) against Program Targets.

(e) It is intended that the Research Program will be conducted as a unified collaborative effort with activities by the Parties carried out at each Party’s respective facilities as outlined in the Annual Research Plan.

(f) It is also acknowledged that, during the Research Program Term and outside of the Research Program, the Parties will each be conducting broader target identification and validation, assay configuration, high throughput screening, chemical optimization and modification and preclinical activities with respect to Molecules that are not primarily biologically active against the Targets.

(g) It is also intended, notwithstanding subsection (f) above, that, during the Research Program Term, the Parties shall collaborate in making available for the Research Program (i) Small Molecule chemical libraries, and (ii) Antibodies or other Molecules, if any, that have been raised or are Active against Program Targets, in each case that are Controlled by the Parties and as set forth in the then-current Annual Research Plan, with the global objectives of maximizing the quantity and quality of the Pre-Clinical Compounds with potential utility in the Cancer Field consistent with the resources allocated to such activities under the Annual Research Plan; provided however that neither Party shall be obligated to [**]. Each Party shall, under the Annual Research Plan, [**].

2.1.2 Research Program Term. The term of the Research Program (the “Research Program Term”) shall commence on the Effective Date and end on the fifth anniversary of the Effective Date, unless extended for one or more additional twelve (12) month periods upon the written consent of both Parties as permitted under Section 2.15.


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2.2 JOINT RESEARCH COMMITTEE.

2.2.1 Formation And Membership. As soon as practicable after the Execution Date, Amgen and Tularik shall establish a Joint Research Committee (the “Joint Research Committee”) comprised of [**] representatives designated by Amgen and [**] representatives designated by Tularik, each of whom shall have experience and seniority sufficient to enable him or her to make decisions on behalf of the Party he or she represents; provided that Amgen and Tularik may designate an appropriate number of additional representatives from time to time. From time to time during the Research Program Term, the Joint Research Committee shall establish one or more Joint Research Project Teams (each, a “Joint Research Project Team”) to implement various aspects of the Annual Research Plan. Such teams shall be governed in the same manner and subject to the relevant requirements as set forth herein for the Joint Research Committee. The Joint Research Committee shall not have the power to amend or waive compliance with this Agreement.

2.2.2 Administrative Matters. The Joint Research Committee shall appoint a chairperson from among its members, which shall rotate semi-annually between the representatives from Tularik and the representatives from Amgen. The chairperson shall be responsible for calling meetings of the Joint Research Committee and for leading the meetings. A Joint Research Committee member of the Party hosting a meeting of the Joint Research Committee shall serve as secretary of that meeting. The secretary of the meeting shall prepare and distribute to all members of the Joint Research Committee minutes of the meeting sufficiently in advance of the next meeting to allow adequate review and comment prior to the meeting. Such minutes shall provide a description in reasonable detail of the discussions at such meeting and a list of any actions, decisions or determinations approved by the Joint Research Committee. Minutes of each Joint Research Committee meeting shall be approved or disapproved and revised as necessary, prior to the next meeting. Final minutes of each meeting shall be distributed to the members of the Joint Research Committee by the chairperson for that meeting.

2.2.3 Decision Making. Decisions of the Joint Research Committee (and each Joint Research Project Team) shall be made by unanimous consent of Amgen and Tularik, with each Party having one vote, provided that if the Joint Research Committee cannot reach unanimous agreement, [**]. If a Joint Research Project Team is unable to reach unanimous agreement on any matter, such matter shall be referred to the Joint Research Committee.

2.2.4 Meetings.

(a) The Joint Research Committee shall meet at least four (4) times per Contract Year (except that proportionately fewer meetings shall be held in a Contract Year with fewer than twelve (12) months). Such meetings shall be held at such times and places as are mutually agreed upon by the Joint Research Committee and shall be conducted in person; provided, however, that the first meeting of the Joint Research Committee shall occur within [**] of the Effective Date. Each Party shall be responsible for its own expenses incurred in connection with attendance by its personnel at any meeting of the Joint Research Committee. By


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approval of the chairperson, such approval not to be unreasonably withheld, representatives may participate in any meeting of the Joint Research Committee by means of telephone conference or similar communications mode by means of which all persons participating in the meeting can hear each other.

(b) Each Party shall use commercially reasonable efforts to cause its representatives to attend the meetings of the Joint Research Committee in person. If a Party’s representative is unable to attend a meeting, such Party may designate an alternate representative to attend such meeting in place of the absent representative. In addition, each Party may, at its discretion, invite additional employees, and, with the consent of the other Party, consultants or scientific advisors, to attend the meetings of the Joint Research Committee, provided that all such employees, consultants, and scientific advisors shall have an obligation to treat all information and materials disclosed at such meetings as confidential.

(c) Either Party may also convene a special meeting of the Joint Research Committee for the purpose of resolving disputes or for the purpose of reviewing (or making) a decision pertaining to the designation of a Target as a Scientifically-Qualified Target or a Program Target by providing [**] written notice to the other Party.

2.2.5 Responsibilities. The Joint Research Committee shall be responsible for, among other things:

(a) overseeing the Research Program;

(b) providing a forum for consensual decision making as to the Research Program activities;

(c) reviewing recommendations from and advising the Joint Research Project Teams;

(d) reviewing needs in areas not included in the Research Program, but that are necessary to support projects in the Research Program;

(e) preparing and approving each Annual Research Plan for each Contract Year after the First Contract Year;

(f) appointing one or more Joint Research Project Teams, as may be appropriate, to implement the Annual Research Plan;

(g) monitoring the Parties’ compliance with their respective obligations under the Annual Research Plan, including the accomplishment of key objectives and the devotion of an appropriate number of FTEs to the Research Program;

(h) reviewing and approving any amendments to the Annual Research Plan and evaluating any substantive departures by either Party from the Annual Research Plan;


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(i) evaluating any [**] into the Research Program;

(j) determining whether a Target is a Scientifically-Qualified Target;

(k) selecting those [**] Targets that the Parties wish to designate as Program Targets;

(l) selecting (i) Program Compounds, (ii) Lead Compounds and (iii) Back-Up Compounds for Pre-Clinical Compounds;

(m) determining those research projects that will be pursued in the Research Program and those that will be discontinued;

(n) proposing Program Compounds for consideration by Amgen as Pre-Clinical Compounds;

(o) monitoring reports submitted by the Parties pursuant to the Annual Research Plan; and

(p) reviewing and commenting upon (but not approving) the patent filing strategies of the Parties as provided in Article 9.

2.2.6 Pipeline Review. Promptly following the Effective Date, the Joint Research Committee shall convene to review Tularik’s pre-Pre-Clinical Status pipelines of Program Compound candidates to determine those that shall be accepted into the Research Program. Tularik shall identify all [**] relating to Tularik’s pre-Pre-Clinical Status pipelines of Program Compound candidates that the Joint Research Committee identifies as desirable for inclusion in the Research Program.

2.3 JOINT RESEARCH PROJECT TEAMS.

2.3.1 Formation Of Joint Research Project Teams. Within [**] after the Joint Research Committee establishes a Joint Research Project Team, each Party shall designate its initial representatives for such team. Either Party may change its designees for any Joint Research Project Team at any time upon written notice to the other Party.

2.3.2 Responsibilities. The Joint Research Project Teams shall be responsible for, among other things:

(a) implementing aspects of the Annual Research Plan assigned to such Joint Research Project Team by the Joint Research Committee;

(b) recommending [**] Targets for designation as Program Targets;

(c) recommending to the Joint Research Committee those research projects that should be pursued in the Research Program and those that should be discontinued; and


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(d) recommending to the Joint Research Committee Program Compounds for qualification for Pre-Clinical Status.

2.3.3 Special Meeting. Either Party may convene a special meeting of the appropriate Joint Research Project Team for the purpose of reviewing (or making) a recommendation concerning whether a Program Compound has qualified for Pre-Clinical Status by providing [**] written notice to the other Party.

2.4 CONDUCT OF THE RESEARCH PROGRAM.

2.4.1 The Joint Research Committee shall adopt project progression guidelines, including criteria for designating Scientifically-Qualified Targets and selection of Lead and Back-Up Compounds for the Research Program. The Parties shall conduct the Research Program in good scientific manner in accordance with such project progression guidelines and in compliance with applicable Laws. Each Party shall use commercially reasonable efforts to conduct the activities of the Research Program that are assigned to it in the Annual Research Plan.

2.4.2 A Party shall not use any Molecule for screening under the Research Program that is part of a research program or under development by such Party (either alone or with a Third Party) outside of the Research Program, or is subject to any previously granted and currently in effect license granted by a Party to a Third Party that would preclude the Development or Commercialization hereunder of a product containing such Molecule. If such previously granted license is amended, terminates or expires during the Research Program Term such that the preclusion is no longer effective, such Molecule shall be made a part of the Research Program. If a Molecule is [**].

2.4.3 Tularik shall devote to the Research Program activities the number of FTEs being funded by Amgen pursuant to Section 8.2 and make out-of-pocket expenditures as are reasonably necessary to support the research efforts of such FTEs over the course of the Research Program. Over the course of the Research Program Term, Amgen shall devote to the satisfaction of all of its obligations and the exercise of all of its rights under this Agreement [**], at a minimum, a number of FTEs that are substantially equal to the number of FTEs Tularik is required to dedicate over the course of the Research Program pursuant to Section 8.2 and will make out-of-pocket expenditures reasonably necessary to support the efforts of such FTEs and to accomplish the tasks set forth in the Annual Research Plan over the course of the Research Program. All FTE utilization under the Research Program shall either be expressly provided for in the Annual Research Plan or approved by the Joint Research Committee. Except for funding of the Research Program paid to Tularik by Amgen pursuant to Section 8.2, each Party (i) shall be responsible for the procurement and documentation of testing and related activities to demonstrate the appropriate quality of all materials provided by it that are used in the Research Program (e.g., that such materials will be manufactured in accordance with GMPs, if applicable), and for providing appropriate equipment and facilities to conduct its responsibilities under the Research Program, and (ii) shall bear its own costs and expenses in conducting its activities under the Research Plan, including without limitation, costs and expenses of materials, labor,


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equipment and overhead costs, and storage, handling, transportation and disposal of chemical synthesis by-products generated by it during the performance of the Research Program.

2.4.4 Each Party shall submit periodic reports to the Joint Research Committee, as may be required by the Annual Research Plan, detailing its activities under the Research Program. The Joint Research Committee shall use such periodic reports to monitor the Parties’ respective FTE contributions to the Research Program.

2.4.5 Each Party may request from the other a written certification by the [**], as the case may be, verifying the number of FTEs provided by such Party pursuant to Section 2.4.3. Upon a Party’s receipt of a written request for such certification, such Party shall promptly provide to the requesting Party such certification.

2.4.6 Each Party shall identify one (1) of its representatives to serve as a program director with responsibility for overseeing that Party’s day-to-day activities relating to the Research Program and to serve as a contact person for coordinating Research Program activities between the Parties.

2.5 DISCLOSURE OF [**].

2.5.1 The Parties acknowledge that certain materials, and data and information relating thereto, Controlled by a Party may include [**], and that the use of such [**] in the Research Program, and the Development and Commercialization of products resulting from the use of such [**], may result (1) [**], (2) [**] or (3) [**].

2.5.2 Each Party acknowledges its obligation to inform the other Party of [**] relating to any Program Technology, Background Technology, Program Materials or Background Materials that it provides to the Research Program, and to inform the other Party of any known intellectual property Controlled by a Third Party and not licensed to a Party or otherwise available under the Research Program that the disclosing Party reasonably believes may be necessary for the practice or use of the Program Technology, Background Technology, Program Materials or Background Materials under the Research Program. Notwithstanding the foregoing, if a Party is precluded from disclosing certain information related to such a [**] because of obligations of confidentiality owed to a Third Party with respect thereto, such Party shall not be obligated hereunder to disclose such information; provided however that such Party will, at a minimum, provide to the other Party [**]. With respect to any proposed Scientifically-Qualified Target, all [**] related thereto shall be identified and described in reasonable detail in writing by the Party that Controls such target to the Joint Research Committee at such time as such target is proposed for inclusion in the Research Program as an SQT.

2.5.3 The [**] shall be considered for all Program Technology, Background Technology, Program Materials or Background Materials prior to the inclusion of such technology or materials in the Research Program. The Joint Research Committee will decide whether to include any [**] will be included. By way of example, proposed Scientifically-Qualified Targets will only be permitted into the Research Program after the Joint Research


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Committee has evaluated the nature and scope of the [**]. If the Joint Research Committee decides to include [**] in the Research Program, Amgen shall be obligated to pay all fees, milestones, royalties and any other payments due to Third Parties under such [**] with respect to Amgen Development Products, subject to Section 8.5.4.

2.6 ANNUAL RESEARCH PLAN.

2.6.1 The Joint Research Committee shall prepare and approve the Annual Research Plan for every Contract Year (other than the First Contract Year) at least [**] prior to the commencement of such Contract Year. The Annual Research Plan for the First Contract Year shall be prepared and approved by the Joint Research Committee within [**] after the Execution Date.

2.6.2 The Joint Research Committee shall update and amend, as appropriate, the then-current Annual Research Plan from time to time.

2.6.3 Each Annual Research Plan shall contain the specific research objectives to be achieved during the relevant Contract Year, the specific activities to be performed under the Research Program during such year and the timeline for performing such activities, and shall designate which Party shall be responsible for performing each of such activities.

2.6.4 Each Annual Research Plan shall be consistent with the other terms and conditions of this Agreement, including without limitation the objectives set forth in Section 2.1.1, and each Annual Research Plan for Contract Years after the First Contract Year shall be substantially the same in form, including the items itemized in, the Annual Research Plan for the First Contract Year.

2.7 TARGETS.

2.7.1 Identification And Validation Of Targets. During the Research Program Term and consistent with the Annual Research Plan, Tularik shall use commercially reasonable efforts to identify Targets, and each Party shall use commercially reasonable efforts to validate Targets and to discover and develop novel anti-cancer agents that modulate certain Targets previously identified by Tularik or those Targets identified and validated in the Research Program as being Scientifically-Qualified Targets and that are later selected as Program Targets, using the technologies, data and materials specified in such Annual Research Plan.

(a) In Exhibit B, Tularik has disclosed to Amgen all targets that it has identified that satisfy the definition of a “Target” under this Agreement as of the Execution Date. During the Research Program Term, Tularik shall also disclose to the Joint Research Committee each target that it identifies that could reasonably qualify as a Target within [**] of identifying such potential Target. Notwithstanding the foregoing, Tularik shall not be required to make available to the Research Program a Target that Tularik identifies under the Research Program if such Target was (i) identified by Tularik by [**] or (ii) [**]. In either of the foregoing cases, such Target shall not be a Target for the purposes of this Agreement. Tularik shall provide


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sufficient information for the Joint Research Committee to make an informed decision whether a potential target qualifies as a “Target” for purposes of the Research Program.

(b) Following such disclosure, the Joint Research Committee will then decide whether to make such potential target a Target. Each potential target that the Joint Research Committee determines qualifies as a “Target” shall be listed on the “Research Program Target List” set forth in Exhibit B, as amended by the Joint Research Committee from time to time. The Research Program Target List as of the Execution Date is attached hereto as Exhibit B. If the Joint Research Committee does not add the potential target to the Research Program Target List within [**] of presentment by Tularik, such potential target shall be outside the scope of the Research Program. For clarity, such potential target shall not be a Tularik Target.

(c) Promptly after a Target is added to the Research Program Target List, Tularik shall provide all information and material relating to the potential utility of such Target in the Cancer Field (as well as in other fields, if available).

(d) Amgen shall have the right, but not the obligation, to [**]. All such Targets shall be added to the Research Program Target List.

(e) If Tularik conducts any activities under the Research Program with respect to a Target on the Research Program Target List or that are otherwise approved by the Joint Research Committee or required under the Annual Research Plan, [**]. In addition, if any such Target would not otherwise qualify to be a Program Target hereunder, then [**].

2.7.2 Scientifically-Qualified Targets. At the first meeting of the Joint Research Committee following the Effective Date, the Joint Research Committee shall agree on objective criteria for determining whether a Target is a Scientifically-Qualified Target. Such criteria may include the criteria specified in Section 1.66. In addition, at the first meeting of the Joint Research Committee following the Effective Date, the Joint Research Committee will determine which of the Targets listed on Exhibit B are Scientifically-Qualified Targets (such Targets shall be referred to as the “Initial Scientifically-Qualified Targets”). On an ongoing basis during the Research Program Term, the Joint Research Committee shall determine, within [**] of disclosure of a Target by Tularik hereunder, whether such Target disclosed by Tularik is a Scientifically-Qualified Target based on the objective criteria established by the Joint Research Committee. If the Joint Research Committee does not designate a Target disclosed by Tularik as a Scientifically-Qualified Target (i) in the case of a Target identified by Tularik listed on Exhibit B on the Execution Date, within [**] or (ii) in the case of a Target disclosed by Tularik after the Execution Date, within [**] of the date of such disclosure, [**]. On an ongoing basis during the Research Program Term, the Joint Research Committee shall determine, within [**] of disclosure of a Target by Amgen as permitted under Section 2.7.1, whether such Target disclosed by Amgen is a Scientifically-Qualified Target based on the objective criteria established by the Joint Research Committee. If the Joint Research Committee does not designate a Target disclosed by Amgen as a Scientifically-Qualified Target, such Target shall [**].


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2.7.3 Target Selection. Subject to Section 2.7.4, the Parties will select, from among the universe of Scientifically-Qualified Targets, certain Scientifically-Qualified Targets to become [**] Targets, [**] Targets or Tularik Exclusive Targets in accordance with the procedures set forth in this Section 2.7.3.

(a) Within [**] of the Effective Date, from the universe of Initial Scientifically-Qualified Targets, Amgen shall select up to [**] Targets as either [**] Targets or [**] Targets. Tularik shall then have the opportunity to select [**] Initial Scientifically-Qualified Target not so previously selected by Amgen as a Tularik Exclusive Target. The Parties shall continue alternating [**] selections [**] until all the Initial Scientifically-Qualified Targets have been either selected or passed on by the Parties, as the case may be. Those Initial Scientifically-Qualified Targets that are not selected as [**] Targets, [**] Targets, or Tularik Exclusive Targets under this Section 2.7.3(a) shall cease to be Initial Scientifically-Qualified Targets and thereafter shall be deemed Tularik Targets.

(b) Thereafter, at each quarterly meeting of the Joint Research Committee during the Research Program Term, the Parties will select, from among the Targets designated as Scientifically-Qualified Targets at the prior quarterly meeting of the Joint Research Committee, those Scientifically-Qualified Targets that are to become [**] Targets, [**] Targets or Tularik Exclusive Targets in the manner described in Section 2.7.3(a). Subject to the provisions of Section 2.7.4, for [**] Scientifically-Qualified Targets selected by Amgen as either [**] Targets or [**] Targets, Tularik shall [**] Scientifically-Qualified Target to become an additional Tularik Exclusive Target. If Tularik [**], then Amgen shall have the right to [**] at such quarterly meeting in the course of selecting further [**] Targets or [**] Targets at such meeting. If neither Party selects an SQT as a [**] Target, [**] Target or Tularik Exclusive Target when such SQT is available for selection at a quarterly meeting of the Joint Research Committee, such Target will be deemed a Tularik Target. Each quarterly meeting at which these designations shall be made shall be scheduled approximately [**] from the previous quarterly meeting.

(c) Scientifically-Qualified Targets that are not selected as [**] Targets, [**] Targets or Tularik Exclusive Targets and that have not otherwise become Tularik Targets prior to the end of the Research Program Term shall be deemed Tularik Targets.

2.7.4 Target Maximums. The maximum number of Scientifically-Qualified Targets that can be designated by Amgen as [**] Targets (including those [**] Targets that subsequently become Program Targets and [**] Targets that are converted to [**] Targets under Section 2.7.6) during the Research Program Term is [**]. The maximum number of Scientifically-Qualified Targets that can be designated by Amgen as [**] Targets during the Research Program Term is [**]; provided, however, that if a [**] Target is subsequently converted by Amgen to a [**] Target under Section 2.7.6, [**]. The maximum number of Scientifically-Qualified Targets that can be designated by Tularik as Tularik Exclusive Targets during the Research Program Term is [**].

2.7.5 [**] Targets. Tularik shall not have the right to select [**] Targets as Tularik Exclusive Targets during the period of the Research Program Term that such Scientifically-


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Qualified Targets are [**] Targets. Notwithstanding the foregoing, unless and until a [**] Target is designated as a Program Target by the Joint Research Committee, Amgen shall not have the right to [**] without Tularik’s prior written consent. However, Tularik shall have the right to [**].

2.7.6 [**] Targets.

(a) During the option period set forth in this Section 2.7.6, and subject to Section 2.7.4, Amgen shall have the option to convert [**] Targets into [**] Targets (i.e., Tularik shall not have the right to select such [**] Targets as Tularik Exclusive Targets). The option period with respect to each [**] Target shall be as follows: (a) if such Target was an Initial Scientifically-Qualified Target, [**] from the date on which such Target was selected as a [**] Target; and (b) if such Target was not an Initial Scientifically-Qualified Target, [**] from the date on which such Target was selected as a [**] Target. If Amgen wishes to exercise its option to convert a particular [**] Target into a [**] Target, Amgen shall deliver written notice of such fact to Tularik prior to the expiration of the applicable option period. Effective upon [**], and provided that Amgen has not already reached the maximum limit of [**] Targets under Section 2.7.4, the applicable Target shall cease to be a [**] Target and shall thereafter be deemed a [**] Target. If Amgen does not exercise its option to convert a [**] Target to a [**] Target prior to the expiration of the option period for such Target, then such Target shall, as of the date on which the option period for such Target expires, cease to be a [**] Target and shall thereafter be deemed a Tularik Target.

(b) Amgen shall not have the right to [**] without Tularik’s prior written consent. However, Tularik shall have the right to [**]. Amgen shall have the right to [**]. Amgen shall have the right to use all Program Technology and all Program Materials with respect to carrying out its activities with Program Targets in the course of practicing the licenses granted to it in Article 7, subject to Tularik’s rights with respect to Tularik Targets, Tularik Development Compounds, Tularik Development Products, Tularik Target Products, Tularik Exclusive Compounds and Tularik Exclusive Products provided in this Agreement.

2.7.7 Tularik Exclusive Targets. Amgen shall not have the right to select Tularik Exclusive Targets as [**] Targets or [**] Targets. Tularik shall have the non-exclusive, subject to Section 2.8.2(f), right pursuant to Section 7.2, at Tularik’s cost, (i) outside of the Research Program to use such Tularik Exclusive Target to research and develop Molecules biologically active against such Tularik Exclusive Target for use both inside and outside of the Cancer Field and (ii) to Commercialize any resulting Tularik Exclusive Products, without any obligation to Amgen. Notwithstanding the foregoing, if Tularik intends to research, develop or commercialize a Tularik Exclusive Compound or a Tularik Exclusive Product in collaboration with a Third Party (or to grant a license to a Third Party to do any of the foregoing), Tularik shall provide Amgen with the opportunity to negotiate terms under which Amgen would collaborate in or obtain a license for undertaking such activities (a “TEC Right of First Negotiation”), provided that a TEC Right of First Negotiation shall not apply to [**]. On a Tularik Exclusive Target-by-Tularik Exclusive Target basis, for [**] Amgen or its Affiliates are not permitted to undertake the activities set forth in Section 2.8.1(a) with respect to a Tularik Exclusive Target (as set forth


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in Section 2.8.2(f)), Tularik shall not (a) engage in discussions or enter into negotiations regarding any such collaboration with a Third Party with respect to any such Tularik Exclusive Target and/or any Tularik Exclusive Compound or Tularik Exclusive Product with respect to such Tularik Exclusive Target that is subject to the TEC Right of First Negotiation or (b) enter into any agreements with a Third Party relating thereto. The TEC Right of First Negotiation shall operate as follows:

(a) Tularik shall promptly notify Amgen in writing (the “TEC Notification”) of its intention to seek a collaborator or licensee for the research, development and/or Commercialization of the relevant Tularik Exclusive Compound or Tularik Exclusive Product and shall provide to Amgen a reasonably detailed written description of such proposed collaboration or license, together with any data, results materials or information related to such Tularik Exclusive Compound or Tularik Exclusive Product that has not previously been provided to Amgen.

(b) Within [**] of its receipt of the TEC Notification (the “TEC Response Period”), Amgen shall notify Tularik of its interest, if any, in initiating discussions regarding such proposed collaboration or license.

(c) In the event that Amgen notifies Tularik prior to the termination of the TEC Response Period that it has an interest in participating in such proposed collaboration or in obtaining such license (a “TEC Expression of Interest”), then the Parties shall negotiate in good faith for a period of up to [**] from the date of Tularik’s receipt of the TEC Expression of Interest in an effort to reach a definitive agreement regarding such collaboration or license.

(d) For the duration of [**], Tularik may discuss with a Third Party the general outline of such collaboration or license; provided, however, that Tularik shall not negotiate such collaboration with a Third Party, enter into any agreements with such Third Party or propose terms to such Third Party on which Tularik would be willing to consummate such collaboration or license.

(e) In the event that the Parties reach a definitive agreement with respect to such Tularik Exclusive Compound or Tularik Exclusive Product pursuant to subsection (c), such Tularik Exclusive Compound or Tularik Exclusive Product shall no longer be designated a Tularik Exclusive Compound or Tularik Exclusive Product and the rights and obligations of the Parties with respect to such antibody, compound or product shall be governed by the terms of such definitive agreement and not this Agreement.

(f) In the event that (i) Amgen fails to notify Tularik prior to the termination of the TEC Response Period that it is interested in collaborating or obtaining a license with Tularik with respect to such Tularik Exclusive Compound or Tularik Exclusive Product, (ii) Amgen notifies Tularik prior to the termination of the TEC Response Period that it has no interest in such collaboration or license or (iii) Amgen timely provides Tularik with a TEC Expression of Interest but the Parties fail to reach a definitive agreement within [**] period specified in subsection (c), then Tularik shall be free to enter into a collaboration or license with


23


a Third Party with respect to such Tularik Exclusive Compound or Tularik Exclusive Product; provided, however, that Tularik may not enter into any collaboration or license with a Third Party [**].

2.7.8 Program Targets.

(a) Once Amgen has designated an SQT as a [**] Target, the Joint Research Committee will periodically consider whether it wishes to use such [**] Target for identification of Molecules [**] and, among other things, conduct the activities set forth in the definition of “Program Target.” If the Joint Research Committee wishes to so use such [**] Target and conduct such activities, then the Joint Research Committee shall designate such [**] Target as a Program Target and the Joint Research Committee will prepare and approve an amendment to the Annual Research Plan to reflect the activities to be undertaken by the Parties with respect to such Program Target.

(b) For each Program Target, each Party will use commercially reasonable efforts to conduct activities assigned to it under the amended Annual Research Plan to identify Program Compounds Active against such Program Target and to continue to identify Lead Compounds and Pre-Clinical Compounds from any such Program Compounds. From time to time, the JRC may select Program Compounds that meet the Lead Selection Criteria as Lead Compounds. The Parties shall not conduct any [**] unless and until the JRC selects such Program Compound as a Lead Compound.

2.7.9 Tularik Targets.

(a) Subject to the rights of Amgen set forth in this Section 2.7.9, Amgen shall not have the right to select Tularik Targets as [**] Targets or [**] Targets. Tularik shall have the exclusive right pursuant to Section 7.2, at Tularik’s cost (i) outside of the Research Program to use such Tularik Target to research and Develop Molecules biologically active against such Tularik Target, for use [**] and (ii) to Commercialize any resulting Tularik Target Product, subject to Section 2.7.9(b).

(b) Tularik shall have the right to use all Program Technology relating to Tularik Targets (if any) and all Program Materials relating to Tularik Targets (if any), excluding Program Compounds; provided, however, that Tularik may use those Program Compounds that [**]. For each Program Target, Amgen shall designate [**]. For clarity, the licenses granted under Sections 7.2.1(b), 7.2.2 and 7.2.3 are specifically subject to the provisions of this Section 2.7.9(b).

(c) As soon as reasonably practicable after a Target becomes a Tularik Target, Amgen shall provide Tularik with any Program Technology and any Program Material in its Control as may be available to Tularik as specified in subsection (b).

(d) Notwithstanding the foregoing, if Tularik intends to research, Develop or Commercialize a Molecule identified through the use of a Tularik Target, Tularik shall provide


24


Amgen with an option, at the times and subject to the conditions specified in this Section 2.7.9(d), to convert such Molecule into an Amgen Development Compound (the “Option”). Such Option shall operate as follows:

(i) Tularik shall promptly notify Amgen in writing of the achievement, with respect to a Molecule identified through the use of a Tularik Target, of each of the following milestones: (A) Lead Status; and (B) Pre-Clinical Status (either, a “Tularik Target Notification”). The Tularik Target Notification shall include the amount of the Option Fee and information regarding such achievement reasonably sufficient to allow Amgen to make an informed decision whether to exercise the Option.

(ii) Within [**] of its receipt of a Tularik Target Notification (the “Tularik Target Response Period”), Amgen shall notify Tularik of its interest, if any, in exercising the Option with respect to the relevant Molecule.

(iii) In the event that Amgen notifies Tularik in writing prior to the termination of the relevant Tularik Target Response Period that it has an interest in exercising the Option with respect to the relevant Molecule (a “Tularik Target Expression of Interest”), then:

(A) Amgen shall pay Tularik the applicable Option Fee within [**] of such notification; and

(B) The relevant Molecule that is the subject of the Tularik Target Expression of Interest shall become an Amgen Development Compound.

(iv) In the event that for any Molecule that has reached Pre-Clinical Status (A) Amgen fails to notify Tularik in writing prior to the expiration of the applicable Tularik Target Response Period that it is interested in exercising the Option with respect to such Molecule or (B) Amgen notifies Tularik in writing prior to the expiration of the applicable Tularik Target Response Period that it has no interest in exercising the Option with respect to such Molecule, then Tularik shall be free to enter into a collaboration or license with a Third Party with respect to such Molecule at any time following such Tularik Target Response Period with no further obligation to Amgen.

2.8 EXCLUSIVITY.

2.8.1 General.

(a) During the Research Program Term, and subject to the exceptions set forth in Section 2.8.2 and the permitted activities set forth in Section 2.8.3, neither Party nor its Affiliates shall, either alone or in collaboration with a Third Party, engage in any activity, the goal of which is:

(i) the identification or validation of any [**]; or


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(ii) the discovery and Pre-Clinical Research Evaluation of Molecules intended for use [**], in each case except pursuant to the Research Program.

(b) During the Research Program Term, [**]. During the Extended Research Period [**]. For clarity, subject to Section 2.7.9(b), (i) [**], and (ii) [**] license or otherwise enable a Third Party to take such actions.

(c) Tularik agrees that during the Research Program Term neither Tularik nor its Affiliates will use outside of the Research Program any of the patent rights licensed to them under the [**].

2.8.2 Exceptions. Provided that the other Party’s Background Technology or Background Materials are not disclosed or used in such activities (unless such use is approved in advance in writing by such Party), the prohibitions set forth in Section 2.8.1(a) are not intended to apply to any activity directed to the identification or validation of Targets or the discovery and Pre-Clinical Research Evaluation of Molecules,

(a) where such activity is undertaken in fulfillment of an obligation of a Party pursuant to an agreement existing as of the Execution Date, and as identified with respect to Tularik in Exhibit A;

(b) where such activity is undertaken with respect to any assets Controlled by Amgen as of the Execution Date;

(c) where such activity is undertaken in fulfillment of an obligation of a Party pursuant to an agreement with an academic, research or other non-commercial institution, which agreement provides that such Party shall be granted the right (or the option to obtain the right), with the right to grant sublicenses to the other Party, to use any targets, Molecules and related know-how for research, Development and Commercialization under this Agreement;

(d) where a Party’s involvement in such activity results from such Party’s acquisition of or by a Third Party (by merger or otherwise), which Third Party, prior to such acquisition or merger, was already engaged in such activity, provided that such Party does not [**]; and further provided that no Program Technology or Program Materials are disclosed to the Third Party; and provided further that to the extent any other technology Controlled by the Party in the form of [**] are disclosed to such Third Party, the Party that made the disclosure shall undertake in writing that it will use its best efforts to prevent the Third Party from using such technology or data in any activities prohibited by Section 2.8.1;

(e) where such activity is undertaken by Tularik with respect to a Tularik Target, a Tularik Exclusive Target, a Tularik Target Compound, a Tularik Target Product, a Tularik Exclusive Compound, a Tularik Exclusive Product, a Target against which a Tularik Development Compound is Active, a Tularik Development Compound or a Tularik Development Product to the extent permitted by the provisions of this Agreement;

(f) where such activity is undertaken [**]; or


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(g) where such activity is undertaken with respect to a Third Party Opportunity, pursuant to the relevant provisions of Section 2.9.

2.8.3 Other Permitted Activities. For purposes of clarity, provided that the other Party’s Background Technology or Background Materials are not disclosed or used in such activities (unless approved in advance in writing by such Party), activities that are not prevented by the prohibitions set forth in Section 2.8.1 include, without limitation, the following:

(a) either Party may, outside of the conduct of the Research Program, engage in target identification and validation activities and/or drug discovery or pre-clinical evaluation, development or commercialization of a Molecule [**];

(b) either Party may, outside of the conduct of the Research Program, engage in Pre-Clinical Research Evaluation, Development or Commercialization of a Molecule for use [**], provided that such Molecule, (i) is in-licensed from a Third Party, (ii) has achieved the equivalent of Pre-Clinical Status at the time of such in-licensing and (iii) is not generally known or known by such Party to exert its action through a Program Target; or

(c) Amgen may, outside of the conduct of the Research Program, engage in Pre-Clinical Research Evaluation, Development or Commercialization of a Molecule for use [**], provided that such Molecule has achieved the equivalent of Pre-Clinical Status as of the Effective Date.

2.8.4 Scope Of Restrictions. The Parties agree that, given the high costs and significant risks involved in discovering and developing pharmaceutical products, and given that the Parties will be exchanging Confidential Information in order to perform the Research Program, the exclusive relationship between them regarding the Research Program and the Cancer Field, which is reflected herein, is a fair and efficient means to reach a satisfactory conclusion from their cooperative efforts.

2.9 THIRD PARTY OPPORTUNITIES.

2.9.1 In the event that a Party is presented with an opportunity to collaborate with a Third Party (a “Third Party Opportunity”) with respect to the discovery and/or Pre-Clinical Research Evaluation of one or more Molecules for use [**], then such Party may pursue such Third Party Opportunity, but only in the manner provided in this Section 2.9. Such Party shall present the Third Party Opportunity, including all material terms and conditions relating thereto, to the Joint Research Committee for the Joint Research Committee’s consideration for inclusion in the Research Program.

2.9.2 The Joint Research Committee shall have [**] from the date on which a Third Party Opportunity is presented to it to decide whether to pursue such Third Party Opportunity. In the event that the Joint Research Committee elects to pursue such Third Party Opportunity, then the Parties shall negotiate with the Third Party that presented such Third Party Opportunity in a good faith effort to reach an agreement with the Third Party whereby the Third Party


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Opportunity can be included in the Research Program. In the event that the Parties and the Third Party that presented such Third Party Opportunity reach an agreement to include such Third Party Opportunity in the Research Program, then:

(a) the Third Party Opportunity shall be included in the Research Program; and

(b) the Annual Research Plan shall be appropriately amended to include, without limitation, provisions for the sharing by the Parties of the costs associated with the Third Party Opportunity.

2.9.3 In the event that the Joint Research Committee does not elect to pursue such Third Party Opportunity or the Parties fail, despite a good faith effort, to reach agreement with the Third Party that presented such Third Party Opportunity to include the Third Party Opportunity in the Research Program, then the Party that was initially presented with such Third Party Opportunity shall have the right to pursue such Third Party Opportunity outside of the conduct of the Research Program, unless the Target that is the subject of such Third Party Opportunity is a Scientifically-Qualified Target (other than a Tularik Exclusive Target, subject to Section 2.8.2(f)) and/or a Tularik Target, or the Molecule or Molecules that are the subject of such Third Party Opportunity are generally known or is known by such Party to exert its action through a Scientifically-Qualified Target (other than a Tularik Exclusive Target, subject to Section 2.8.2(f)) and/or a Tularik Target. Notwithstanding the foregoing, [**].

2.10 RESEARCH PROGRAM RECORDS.

2.10.1 All work conducted by each Party in the course of the Research Program shall be completely and accurately recorded, in reasonable detail and in good scientific manner, in separate laboratory notebooks. On reasonable notice, and at reasonable intervals, each Party shall have the right to inspect and copy all such records of the other Party reflecting Program Technology or work done under the Research Program, to the extent reasonably required to carry out its respective obligations and to exercise its respective rights hereunder. Notwithstanding the definition of “Confidential Information,” all such records shall constitute Confidential Information of the Party owning such records. The Parties acknowledge and agree that neither Party guarantees the success of the Research Program tasks undertaken hereunder.

2.10.2 In order to protect the Parties’ Patent Rights under U.S. law in any inventions conceived or reduced to practice during or as a result of the Research Program, each Party agrees to maintain a policy that requires its employees to record and maintain all data and information developed during the Research Program in such a manner as to enable the Parties to use such records to establish the earliest date of invention and/or diligence to reduction to practice. At a minimum, the policy shall require such individuals to record all inventions generated by them in standard laboratory notebooks or other suitable means that are dated and corroborated by non-inventors on a regular, contemporaneous basis.


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2.11 DISCLOSURE OF RESEARCH PROGRAM RESULTS. Subject to restrictions imposed by a Party’s confidentiality obligations to any Third Party with respect to [**], each Party will disclose to the other all Program Technology that is discovered, invented or made by such Party during the course of the Research Program and that is useful in or relates to the Research Program, including, without limitation, information regarding potential Scientifically-Qualified Targets, Molecules identified in the Research Program through the use of Program Targets, activities of such Molecules, derivatives and results of in vitro and in vivo studies, assay techniques and new assays. Such Program Technology will be promptly disclosed to the other Party, with meaningful discoveries or advances being communicated as promptly as practicable after such information is obtained or its significance is appreciated. Upon written request, each Party will provide the other with copies of the raw data generated in the course of the Research Program, if reasonably necessary to the other Party’s work under the Research Program. Any information disclosed pursuant to this Section 2.11 may be used by the other Party solely for the purposes of the Research Program or as otherwise expressly permitted in this Agreement. For clarity, nothing in this Section 2.11 shall be deemed to require a Party to disclose to the other Party the actual sequence of any Target being pursued in the Research Program unless and until such Target is designated as a Scientifically-Qualified Target.

2.12 MATERIAL TRANSFER. In order to facilitate the Research Program, either Party may provide to the other Party certain Program Materials and Background Materials Controlled by the supplying Party (other than under this Agreement) for use by the other Party in furtherance of the Research Program. All such Program Materials shall be considered the Confidential Information of both Parties and shall be subject to the restrictions in Article 10. All Background Materials shall be considered the Confidential Information of the supplying Party and shall be subject to the restrictions in Article 10. Except as otherwise provided under this Agreement, all such Program Materials and Background Materials delivered to the other Party shall remain the sole property of the supplying Party, shall be used only in furtherance of the Research Program and solely under the control of the other Party and its Affiliates, shall not be used or delivered to or for the benefit of any Third Party without the prior written consent of the supplying Party and shall not be used in research or testing involving human subjects. The Program Materials and Background Materials supplied under this Section 2.12 must be used with prudence and appropriate caution in any experimental work, since not all of their characteristics may be known. THE PROGRAM MATERIALS AND BACKGROUND MATERIALS ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE MATERIALS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.

2.13 LIABILITY. Subject to Section 14.1, in connection with conduct of the Research Program, each Party shall be responsible for, and hereby assumes, any and all risks of personal injury or property damage attributable to the negligent acts or omissions of that Party or its Affiliates, and their respective directors, officers, employees and agents.


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2.14 USE OF SUBCONTRACTORS OR AFFILIATES. Either Party may perform some of its obligations under the Research Program through one or more subcontractors or Affiliates; provided that (a) none of the rights of the other Party hereunder are diminished or otherwise adversely affected as a result of such subcontracting or use of Affiliates, (b) such Party obtains the written approval of the other Party prior to engaging any subcontractor, which approval shall not be unreasonably withheld or delayed and (c) the subcontractor or Affiliate undertakes in writing obligations of confidentiality and non-use regarding the other Party’s Confidential Information that are substantially the same as those undertaken by Amgen and Tularik pursuant to Article 10 hereof. In the event a Party performs one or more of its obligations under the Research Program through a subcontractor or Affiliate, then such Party shall at all times be responsible for the performance of such subcontractor or Affiliate. For the avoidance of doubt, it is understood that an Affiliate of a Party shall not be deemed to be a subcontractor of such Party as a result of the delegation of any duties to the Affiliate, and it is understood that the provisions of Section 2.14 do not apply to contracts for [**].

2.15 EXTENSION OF RESEARCH PROGRAM TERM. The Parties acknowledge that they may find it to be mutually beneficial to extend the Research Program Term. Consequently, the Parties hereby agree to negotiate in good faith, at least six (6) months prior to the expiration of the original Research Program Term (or any mutually agreed extension thereof), whether or not to extend the Research Program Term on terms and conditions that are mutually acceptable to the Parties. Should the Parties choose to extend their collaborative work during the Research Program Term (which shall not include any election by Amgen under Section 2.16), they may choose to limit the scope of such extension to ongoing collaboration with respect to particular Targets, Molecules or products, or otherwise, and shall agree on appropriate modifications to this Agreement to provide for such activities.

2.16 EXTENDED RESEARCH PERIOD.

2.16.1 At any time prior to [**], Amgen shall have the right to provide written notice to Tularik (such notice, the “Target Exclusivity Notice”), on a Program Target-by-Program Target basis, that it desires to obtain an exclusive license under Tularik’s rights to the Program Intellectual Property, the Tularik Background Technology and the Tularik Background Materials to (a) [**]. For a period of [**] from the date on which Tularik receives the Target Exclusivity Notice (the “Negotiation Period”), Tularik shall have the right to negotiate with a Third Party the terms under which such Third Party would obtain an exclusive license to perform the activities described in (a) and (b). Upon the expiration of the Negotiation Period, Tularik shall offer to Amgen the opportunity to obtain such license upon the terms offered by such Third Party (the “Offer”). Amgen shall have [**] from its receipt of such Offer to unqualifiedly accept or decline such Offer in writing (such period, the “Acceptance Period”). If Tularik has provided an Offer to Amgen, and if Amgen fails to respond prior to the expiration of the Acceptance Period, it shall be deemed to have declined such Offer, and Tularik shall have no further obligation to grant to Amgen such a license. If Tularik has not provided an Offer to Amgen (i.e., no Third Party has offered terms for such a license to such a Target within the Negotiation Period), then Amgen shall have the right to pay Tularik [**] to obtain a license as described in (a) and (b). If Amgen accepts such Offer prior to the expiration of the Acceptance Period, or Amgen notifies Tularik in


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writing within the Acceptance Period that Amgen is prepared to make the lump sum payment, as applicable, then, subject to Amgen’s prompt payment of and compliance with the terms of the Offer or prompt payment of such lump sum, as applicable, Tularik shall automatically be deemed to grant to Amgen the license set forth in Section 7.1.1 with respect to such Target during the Extended Research Period.

2.16.2 If at any time prior to the [**], Tularik desires to grant to a Third Party an exclusive license to a Program Target prior to the time Amgen provides a Target Exclusivity Notice, Amgen shall have a first right of refusal with respect to such Program Target upon the terms offered by any such Third Party (the “ROFR”). Tularik shall promptly notify Amgen if Tularik intends to grant such a license to a Third Party. Amgen shall have [**] from its receipt of such notice from Tularik to unqualifiedly accept or decline such terms in writing (the “ROFR Acceptance Period”). If Amgen fails to respond to the ROFR prior to the expiration of the ROFR Acceptance Period, it shall be deemed to have declined such ROFR, and Tularik shall have no further obligation to grant to Amgen such a license. If Amgen accepts such ROFR prior to the expiration of the ROFR Acceptance Period, then, subject to Amgen’s payment of and compliance with the terms of the ROFR, Tularik shall automatically be deemed to grant to Amgen the license set forth in Section 7.1.1 with respect to such Target during the Extended Research Period.

2.16.3 If Amgen exercises its rights under Section 2.16.1 or 2.16.2 to extend the license set forth in Section 7.1.1 with respect to one or more Program Targets, then either (i) [**].

2.17 EXPIRATION OF RESEARCH PROGRAM TERM. Upon expiration of the Research Program Term (including any extensions thereof in accordance with Section 2.15), the following Sections of this Article 2 shall survive in full force and effect: 2.7.7, 2.7.9, 2.10, 2.11, 2.12, 2.13, 2.16 and 2.17.

ARTICLE 3

DEVELOPMENT PROGRAM

3.1 PRE-CLINICAL COMPOUNDS.

3.1.1 The Joint Research Committee shall notify Amgen in writing when a Joint Research Project Team has recommended a Program Compound for Pre-Clinical Status. Such notification shall (1) identify the Program Compound with specificity, (2) identify the related Program Target and (3) identify the Back-Up Compounds for such Program Compound in accordance with Section 3.5.1. Such notification shall be accompanied by any pertinent data, information, results and materials relating to the foregoing available to the Joint Research Committee (the “Pre-Clinical Data Package”).

3.1.2 If Amgen reasonably determines that the Pre-Clinical Data Package is complete, it shall approve the Pre-Clinical Data Package and such Program Compound shall be deemed to have achieved Pre-Clinical Status. If Amgen reasonably determines that the Pre-Clinical Data


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Package is not complete, i.e., it is insufficient to make a determination whether to Develop and Commercialize such Pre-Clinical Compound, it shall promptly, but in no event later than [**] following receipt of the Pre-Clinical Data Package, notify the Joint Research Committee and specifically identify any additional data, information, results or materials that should be provided.

3.1.3 Amgen shall, as soon as possible, but in all cases within [**] after Amgen has approved the Pre-Clinical Data Package as complete (the “Pre-Clinical Notification Period”), provide the Joint Research Committee with written notification of its interest in Developing such Pre-Clinical Compound. If Amgen fails to provide such written notification within the Pre-Clinical Notification Period, Amgen shall be deemed not to be interested in Developing such Pre-Clinical Compound.

3.1.4 Upon the expiration of the Pre-Clinical Notification Period with respect to a particular Pre-Clinical Compound, the Joint Research Committee shall designate such Pre-Clinical Compound as an Amgen Development Compound or Tularik Development Compound, as applicable, in accordance with this Section 3.1.4.

(a) Amgen Development Compound. If Amgen provided written notification to the Joint Research Committee of its interest in Developing a Pre-Clinical Compound within the Pre-Clinical Notification Period, then such Pre-Clinical Compound shall thereafter be Developed by Amgen as an Amgen Development Compound subject to the terms of this Agreement.

(b) Tularik Development Compound. If Amgen either (a) failed to provide to the Joint Research Committee written notification of its interest in Developing a Pre-Clinical Compound within the Pre-Clinical Notification Period or (b) notified the Joint Research Committee in writing that it is not interested in Developing a Pre-Clinical Compound, then in each case, and subject to the provisions of Section 3.4, such Pre-Clinical Compound may thereafter be Developed by Tularik as a Tularik Development Compound, subject to the terms of this Agreement.

3.2 DEVELOPMENT ACTIVITIES. Amgen shall have sole right and responsibility for all aspects of Developing Amgen Development Compounds and obtaining Regulatory Approval of such Amgen Development Compounds, including making all strategic and tactical decisions with respect thereto, undertaking all necessary Development and establishing the methods and means by which it performs such activities under this Agreement, and shall use commercially reasonable efforts in doing so. Furthermore, Amgen agrees to conduct such Development activities in compliance with all Laws that are applicable to the particular stage of Development of each Amgen Development Compound, including without limitation, GLP, GCP and GMP. Notwithstanding the above, [**].

3.3 DISCONTINUED DEVELOPMENT. In the event that Amgen undertakes the Development of at least one Amgen Development Compound or Amgen Development Product Active against a given Program Target and thereafter Amgen (a) notifies Tularik of its election not to continue


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to Develop any of such Amgen Development Compounds and Amgen Development Products Active against a given Program Target or to conduct Pre-Clinical Research Evaluation of its Back-Up Compounds for such Amgen Development Compounds or Amgen Development Products (a “Notice of Discontinuance”) or (b) fails to exercise commercially reasonable efforts in undertaking such Development and Pre-Clinical Research Evaluation and does not cure such failure within [**] after receipt of written notice from Tularik asserting such failure (such uncured failure, a “Development Failure”), then all Amgen Development Compounds and Amgen Development Products Active against such Program Target (including all Back-Up Compounds designated therefor) shall thereafter be deemed Tularik Development Compounds or Tularik Development Products, respectively (and not Amgen Development Compounds or Amgen Development Products). Tularik shall have the right, subject to the provisions of Section 3.4, to continue the Development of such TD Compounds or TD Products and Pre-Clinical Research Evaluation of the Back-Up Compounds therefor in accordance with Section 3.4; provided however, that [**].

3.4 TULARIK DEVELOPMENT OF TD PRODUCTS AND TULARIK TARGET PRODUCTS.

3.4.1 General. In undertaking the development of a Tularik Development Compound, TD Product or Tularik Target Product, Tularik shall do so at its own expense and, other than as provided in this Section 3.4, independent of Amgen; provided that Tularik shall provide Amgen with an annual report concerning the status of the Development of each Tularik Development Compound, TD Product or Tularik Target Product.

3.4.2 Reverted Targets, Molecules and Products. The Parties will cooperate to the extent practicable and at Tularik’s expense (subject to the provisions of this Section 3.4.2) to transition to Tularik a Pre-Clinical Compound, an Amgen Development Compound or an Amgen Development Product [**] that becomes a Tularik Development Compound, TD Product or Tularik Target Product, as the case may be, under Section 3.3, Section 3.1.4(b) or Article 11 or otherwise under this Agreement. In addition, if a Program Target ceases to be a Program Target and instead becomes a Tularik Target because such Target is as described in Section 1.80(e) or (f), then in each case (i) rights to all Amgen Development Compounds and AD Products, if any, with respect to such Target shall revert to Tularik and in the event no Amgen Development Compounds and AD Products exist that are Active against such Program Target at the time such Program Target becomes a Tularik Target, then Tularik shall have the right to select from existing Program Compounds, if any, a Program Compound as a Tularik Target Product [**], (ii) all products containing any of such Amgen Development Compounds (or Program Compound(s)) as an active ingredient shall be Tularik Target Products and (iii) all AD Products with respect to such Target shall be Tularik Target Products. Tularik shall have the right to synthesize Molecules biologically active against Tularik Targets after such Targets become Tularik Targets. Tularik shall have the right to create or synthesize additional back-up compounds for Tularik Development Compounds as back-up compounds therefor after Pre-Clinical Compounds become Tularik Development Compounds under Section 3.1.4(b), which back-up compounds shall themselves be Tularik Development Compounds. The Parties will cooperate to the extent practicable and at Tularik’s expense (subject to the provisions of this Section 3.4.2) to transition to Tularik all Amgen Development Compounds, AD Products and


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Back-Up Compounds, if any, with respect to a Program Target that subsequently becomes a Tularik Target in order to enable Tularik to Develop and Commercialize such Molecules and AD Products as Tularik Target Products, but in no event [**]. Amgen shall not transfer and Tularik shall have no right to use any Amgen Background Technology or Amgen Background Materials in conjunction with any of such Targets, Molecules or products that revert to Tularik hereunder.

3.4.3 Ongoing Studies. At Tularik’s option and expense, Amgen shall complete all clinical studies of Amgen Development Compounds and AD Products that have reverted to Tularik under Section 3.3 or Section 3.4.2 that were initiated prior to Tularik’s receipt of a Notice of Discontinuance, the occurrence of a Development Failure or the date on which a Program Target became a Tularik Target, as the case may be; provided however, that [**].

3.4.4 Regulatory Requirements. The Parties will cooperate to ensure that Tularik, at its sole expense, has reasonable access and rights of reference to all Regulatory Approvals obtained by Amgen prior to the date on which Amgen Development Compounds and AD Products reverted to Tularik under Section 3.3 or Section 3.4.2 that are relevant to all such Molecules and products as shall be reasonably necessary to enable Tularik to continue the Development and Commercialization of such Molecules and products, as the case may be, as Tularik Development Compounds, TD Products or Tularik Target Products in a manner consistent with Article 4. Such access and rights of reference shall be provided by license under the applicable Regulatory Approvals, transfer of the applicable Regulatory Approvals, a letter granting a right of reference with respect to the applicable Regulatory Approvals or such other action as shall be mutually agreed by the Parties. Additionally, Amgen shall provide other assistance and documentation with respect to such Molecules and products as reasonably necessary to enable Tularik to comply with FDA and other regulatory requirements with respect thereto.

3.4.5 Information Transfer. [**] Amgen will transfer all material, data, information or results obtained in the course of its research and Development of Program Compounds, Amgen Development Compounds, AD Products and related Back-Up Compounds [**] such Molecules and products reverted to Tularik under Section 3.1.4, 3.3 or 3.4.2, only to the extent as shall be reasonably necessary for Tularik to continue the Development of and to Commercialize such Molecules and products as Tularik Development Compounds, TD Products or Tularik Target Products.

3.4.6 Manufacture Of Clinical Supply; Manufacturing Information. Notwithstanding anything to the contrary in this Agreement, if Amgen elects to continue manufacturing pursuant to Section 4.3(ii), then Amgen shall have no obligation, for any reason or under any circumstance, to provide Tularik or its Affiliates, licensees or sublicensees with any information concerning Amgen’s commercial manufacturing facility or any information (such as information contained in the Chemistry Manufacturing Control section of Amgen’s Regulatory Filings) pertaining to the manufacture of such Tularik Development Compound or TD Product.


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3.5 BACK-UP COMPOUNDS.

3.5.1 When a Program Compound is nominated for Pre-Clinical Status, Amgen shall have the right to identify other Program Compounds that shall serve as back-up compounds reserved for development as AD Products if such Program Compound Development is discontinued (“Back-Up Compounds”). Back-Up Compounds shall be identified by Amgen in the course of the Research Program, Extended Research Program or the Development of such Program Compound from time to time, based on back-up selection criteria agreed upon by the Joint Research Committee pursuant to 2.4.1. Amgen may select [**] from the Program Compounds created or synthesized during the Research Program. For clarity, Amgen shall have the right to create or synthesize any number of back-up compounds that are not themselves Program Compounds for such Amgen Development Compounds, which shall themselves be Amgen Development Compounds.

3.5.2 Upon the designation of a Pre-Clinical Compound as an Amgen Development Compound or the reversion of an Amgen Development Compound to become a Tularik Development Compound under Section 3.3, the rights of Tularik or Amgen, respectively, to such Pre-Clinical Compound shall include rights to all Back-Up Compounds for such Molecule.

3.6 DEVELOPMENT OF TULARIK EXCLUSIVE COMPOUNDS AND TULARIK EXCLUSIVE PRODUCTS. Subject to Amgen’s TEC Right of First Negotiation under Section 2.7.7, Tularik shall have the exclusive right, at its own expense, to undertake the development of Tularik Exclusive Compounds and Tularik Exclusive Products.

3.7 USE OF SUBCONTRACTORS. Amgen shall have the right to perform some of its obligations regarding the Development of Amgen Development Compounds or Amgen Development Products, including without limitation any activities under Article 5, through one or more subcontractors. In the event Amgen performs one or more of its obligations regarding the Development of Amgen Development Compounds through the use of a subcontractor, Amgen shall at all times be responsible for the performance of such subcontractor. For the avoidance of doubt, it is understood that an Affiliate of Amgen shall not be deemed to be a subcontractor of Amgen.

ARTICLE 4

MANUFACTURE AND SUPPLY

4.1 CLINICAL SUPPLY. Amgen shall have sole right and responsibility for manufacturing or having manufactured quantities of Amgen Development Compounds and Amgen Development Product necessary for pre-clinical and clinical studies throughout the Territory.

4.2 COMMERCIAL SUPPLY. Amgen shall have sole right and responsibility for manufacturing or having manufactured the Amgen Development Compound (as the active ingredient), and Amgen Development Products for commercial sale throughout the Territory.


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4.3 SUPPLY OF TD PRODUCTS. If Amgen is manufacturing clinical or commercial supplies of an Amgen Development Compound or AD Product at the time such Molecule or product becomes a Tularik Development Compound or Tularik Development Product under Section 3.3 or Section 3.4.2 or under Article 11, and Tularik requests Amgen to Supply such Molecule(s) to Tularik, then Amgen, at its sole discretion, may either (i) [**], or (ii) [**].

4.4 SUPPLY OF TD PRODUCTS AND TULARIK EXCLUSIVE PRODUCTS. Except as otherwise provided in Section 4.3, Tularik shall be