EX-10.3

EX-10.3 3 grts-ex10_3.htm EX-10.3 EX-10.3

Certain identified information has been omitted from this Exhibit 10.3 because it is both (i) not material and (ii) would likely cause competitive harm to the Company, if publicly disclosed. Double asterisks [**] denote omissions.

Exhibit 10.3

COLLABORATION, Option AND LICENSE AGREEMENT

by and between

gilead sciences, Inc.

and

Gritstone oncology, inc.

TABLE OF CONTENTS


Article I DEFINITIONS AND INTERPRETATION		1
Article II COLLABORATION AND OPTION		25
2.1.	Research and Development Activities	25
2.2.	Gilead Composition	27
2.3.	Materials Transfer	27
2.4.	Option	27
Article III LICENSES; EXCLUSIVITY		30
3.1.	Licenses to Gilead	30
3.2.	License to Gritstone	33
3.3.	Subcontracting	34
3.4.	No Other Rights; Retained Rights	34
3.5.	Exclusivity	34
3.6.	Change of Control	37
Article IV GOVERNANCE		38
4.1.	Joint Steering Committee	38
4.2.	Dispute Resolution	39
4.3.	Alliance Managers	39
4.4.	Ad-Hoc Committees	40
4.5.	Costs of Governance	40
Article V TECHNOLOGY TRANSFERS		40
5.1.	Disclosure of Know-How	40
5.2.	Consultation and Assistance	42
Article VI DEVELOPMENT AND REGULATORY MATTERS		42
6.1.	Development	42
6.2.	Development Reports	42
6.3.	Regulatory	42
6.4.	Development Diligence	44
6.5.	Pharmacovigilance	44
6.6.	Compliance	44
6.7.	Regulatory Notices	45
Article VII MANUFACTURING		45
7.1.	Supply Agreement	45
7.2.	Manufacturing	45
7.3.	Manufacturing Know-How and Assistance	45
7.4.	Manufacturing Technology Transfer	45
7.5.	Future Manufacturing Improvements	46
7.6.	Gritstone Operational Documentation	46
7.7.	Transfer Limitation	47
Article VIII COMMERCIALIZATION		47
8.1.	Commercialization	47
8.2.	Commercialization Diligence	47
Article IX FINANCIAL PROVISIONS		47
9.1.	Upfront Payment	47
9.2.	Equity Investment	47
9.3.	Option Exercise Fee	47
9.4.	Milestone Payments	47
9.5.	Royalty Payments	49
9.6.	Royalty Reductions	49


9.7.	Third Party Obligations	50
9.8.	Cumulative Effect of Reductions	53
9.9.	No Projections	54
9.10.	Non-Refundable and Non-Creditable Payments	54
Article X REPORTS AND PAYMENT TERMS		54
10.1.	Reports; Payment Terms	54
10.2.	Currency	55
10.3.	Blocked Currency	55
10.4.	Taxes; Withholding	56
10.5.	Records and Audit Rights	56
Article XI INTELLECTUAL PROPERTY RIGHTS		57
11.1.	Inventorship	57
11.2.	Ownership	57
11.3.	Prosecution and Maintenance	58
11.4.	Enforcement	59
11.5.	Defense	61
11.6.	Recovery.	62
11.7.	Trademarks	62
11.8.	Product Listings	62
11.9.	Patent Term Extensions	62
Article XII CONFIDENTIALITY		63
12.1.	Nondisclosure	63
12.2.	Exceptions	64
12.3.	Authorized Disclosure	64
12.4.	Terms of this Agreement	66
12.5.	Securities Filings; Disclosure under Applicable Law	66
12.6.	Publicity	66
12.7.	Publications	66
Article XIII TERM AND TERMINATION		67
13.1.	Term	67
13.2.	Termination for Material Breach	67
13.3.	Termination for Insolvency	68
13.4.	Termination by Gilead for Convenience	68
13.5.	[**].	68
13.6.	Rights in Bankruptcy	69
Article XIV EFFECT OF TERMINATION		70
14.1.	Termination by Gilead for Convenience or by Gritstone for Material Breach or Insolvency of Gilead or Expiration Without Option Exercise	70
14.2.	Termination by Gilead for Material Breach by or Insolvency of Gritstone	71
14.3.	Alternative to Termination.	72
14.4.	Surviving Provisions	72
Article XV REPRESENTATIONS, WARRANTIES, AND COVENANTS		75
15.1.	Representations and Warranties by Each Party	75
15.2.	Representations and Warranties by Gritstone as of the Effective Date	75
15.3.	Representations and Warranties by Gritstone as of the Disclosure Letter Date	79
15.4.	Covenants.	80
15.5.	Additional Covenants of Gritstone	81
15.6.	Limitation on Scope of Representations, Warranties and Covenants	82
15.7.	Disclaimer	83


Article XVI INDEMNIFICATION; LIABILITY		83
16.1.	Indemnification by Gritstone	83
16.2.	Indemnification by Gilead	84
16.3.	Indemnification Procedure	84
16.4.	Mitigation of Loss	85
16.5.	Limitation of Liability	85
16.6.	Insurance	86
Article XVII GENERAL PROVISIONS		87
17.1.	Assignment	87
17.2.	Extension to Affiliates	87
17.3.	Severability	87
17.4.	Governing Law and Waiver of Jury Trial	87
17.5.	Dispute Resolution; Rules of Arbitration	88
17.6.	Force Majeure	89
17.7.	Waivers and Amendments	90
17.8.	Relationship of the Parties	90
17.9.	Notices	90
17.10.	Further Assurances	91
17.11.	Compliance with Law	91
17.12.	Parties in Interest; No Third Party Beneficiary Rights	91
17.13.	English Language	91
17.14.	Expenses	91
17.15.	Interpretation	91
17.16.	Entire Agreement	92
17.17.	Counterparts	92
17.18.	Cumulative Remedies	92

iii

LIST OF SCHEDULES

Schedules


Schedule 1.29	ChAdV and SAM Platform Technology
Schedule 1.66	EDGE™ Machine-Learning Platform Technology
Schedule 1.71	Excluded Technology
Schedule 1.122	Existing In-License Agreements
Schedule 1.153	[**]
Schedule 2.1.2(a)	R&D Plan
Schedule 2.1.2(b)	Gritstone R&D Budget
Schedule 3.1.4	Future In-License Agreement [**]
Schedule 3.5.4	Selected Provisions of Gritstone-[**] Arrangement
Schedule 5.1	[**]
Schedule 6.2	Form of Development Report
Schedule 7.4	[**]
Schedule 9.2	Stock Purchase Agreement
Schedule 11.10	[**]-Related Provisions of Third Party Agreements
Schedule 12.6.2	Press Release
Schedule 15.2	Disclosure Schedule
Schedule 15.2.1	Licensed Patents
Schedule 15.3	Disclosure Schedule as of the Bringdown Letter Date
Schedule 15.3.1	Licensed Patents as of the Bringdown Letter Date

COLLABORATION, option AND LICENSE AGREEMENT

This COLLABORATION, OPTION AND LICENSE AGREEMENT (this “Agreement”) is made as of January 29, 2021 (the “Effective Date”), by and between Gilead Sciences, Inc., a Delaware corporation having an office at 333 Lakeside Drive, Foster City, CA 94404 (“Gilead”) and Gritstone Oncology, Inc., a Delaware corporation having an office at 5959 Horton Street, Suite 300, Emeryville, California 94608 (“Gritstone”). Gilead and Gritstone are each referred to individually as a “Party” and together as the “Parties.”

RECITALS

WHEREAS, Gilead is a pharmaceutical company with expertise in the development and commercialization of pharmaceutical and biological products;

WHEREAS, Gritstone is a biotechnology company focused on discovering and developing therapeutics using its platform technology;

WHEREAS, Gilead and Gritstone wish to collaborate with respect to certain development and manufacturing process development activities with respect to a potential vaccine product using or incorporating the Licensed Technology for the Field of Use (each, as defined below); and

WHEREAS, Gilead wishes to obtain, and Gritstone wishes to grant, an exclusive option to a license under the Licensed Technology (as defined below) and, following the exercise by Gilead of such option, Gilead will have the right to perform further development, manufacturing, commercialization or Exploitation of products incorporating a Vaccine (each, as defined below), in each case in the Field of Use, subject to the terms and conditions set forth herein.

NOW, THEREFORE, in consideration of the foregoing and the mutual agreements set forth below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

Article I
DEFINITIONS AND INTERPRETATION

Unless the context otherwise requires, the terms in this Agreement with initial letters capitalized will have the meanings set forth below, or the meaning as designated in the indicated places throughout this Agreement.

1.1. “ACA” means the Patient Protection and Affordable Care Act.

1.2. “Accounting Standards” means U.S. generally accepted accounting principles, consistently applied.

1.3. “Acquired Person” has the meaning set forth in Section 1.33.

1.4. “Acquiring Person” means, collectively, the Person referenced as the acquirer of the Acquired Person or the Acquired Person’s securities or assets in the definition of Change of Control and such Person’s Affiliates, other than the Acquired Person in the definition of Change of Control and such Acquired Person’s Affiliates, determined immediately prior to the closing of such Change of Control.

1.5. “Action” means any claim, action, suit, arbitration, inquiry, audit, proceeding or investigation by or before, or otherwise involving, any Governmental Authority.

1.6. “Affiliate” means, with respect to a Person, any entity or person that controls, is controlled by, or is under common control with that Person, but solely during the period in which such entity or person controls, is controlled by, or is under common control with that Person. For the purpose of this Section 1.6 only, “control” or “controlled” means, (a) direct or indirect, ownership of more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors in the case of a corporation or more than fifty percent (50%) of the equity interest in the case of any other type of legal entity; (b) status as a general partner in any partnership; or (c) any other arrangement whereby the entity or person appoints or has the right to appoint (other than through the ownership of voting securities) a majority of the members of the board of directors or equivalent governing body of a corporation or other entity or has the ability to cause the direction of the management or policies of a corporation or other entity; provided, however, in the case of this clause (c), no person or entity will be deemed to be an Affiliate of such Person solely by virtue of such person’s or entity’s direct or indirect ownership of any securities of such Person. The Parties acknowledge that in the case of entities organized under the laws of certain countries where the maximum percentage ownership permitted by Applicable Law for a foreign investor is less than fifty percent (50%), such lower percentage will be substituted in clause (a) of the preceding sentence; provided, that such foreign investor has the power to direct the management and policies of such entity.

1.7. “Agreement” has the meaning set forth in the preamble of this Agreement.

1.8. “Agreement Payments” has the meaning set forth in Section 10.4.1.

1.9. “Alliance Manager” has the meaning set forth in Section 4.3.

1.10. “Antitrust Filing” has the meaning set forth in Section 2.4.3(a).

1.11. “Antitrust Law” means any Applicable Law that is designed to prohibit, restrict or regulate actions having the purpose or effect of monopolization, lessening of competition or restraint of trade, including the HSR Act.

1.12. “Applicable Law” means all applicable laws, statutes, rules, regulations, treaties (including tax treaties), orders, judgments or ordinances having the effect of law of any national, multinational, federal, state, provincial, county, city or other political subdivision, including, to the extent applicable, GCP, GLP and GMP, as well as all applicable data protection and privacy laws, rules and regulations, in each case that may be in effect from time to time during the Term, including, to the extent applicable, the United States Department of Health and Human Services privacy rules under the Health Insurance Portability and Accountability Act and the Health Information Technology for Economic and Clinical Health Act and the EU General Data Protection Regulation (Regulation (EU) 2016/679).

1.13. “[**]” has the meaning set forth in Section [**].

1.14. “Audited Party” has the meaning set forth in Section 10.5.2.

1.15. “Auditing Party” has the meaning set forth in Section 10.5.2.

1.16. “Auditor” has the meaning set forth in Section 10.5.2.

1.17. “Biosimilar Application” has the meaning set forth in Section 11.4.2(f).

1.18. “Biosimilar Product” means, with respect to a Product that has Regulatory Approval in the country or jurisdiction in question, a biological medicine or biological product for human use which: (a) is highly similar to such Product; (b) has no clinically meaningful differences from such Product as determined by Applicable Laws or any applicable Regulatory Authority; and (c) is approved for use (i) in the U.S., as biosimilar (as defined in the ACA) to such Product pursuant to an abbreviated regulatory approval process established under the ACA in 42 U.S.C. § 262(k) as such regulations may be amended from time to time, or a successor regulatory classification, (ii) in the EU, as a similar biological medicinal product pursuant to Directive 2001/83/EC or Regulation (EC) No 726/2004 (as applicable) as such regulations may be amended from time to time, or a successor regulatory classification, or (iii) in any other country or jurisdiction, pursuant to an equivalent regime in such country or jurisdiction.

1.19. “BLA” means a Biologics License Application filed with the FDA in the United States with respect to a Product, as defined in 42 U.S.C. § 262(a) and Title 21 of the U.S. Code of Federal Regulations, Section 601.2 et seq.

1.20. “[**]” has the meaning set forth in Section [**].

1.21. “[**]” has the meaning set forth in Section [**].

1.22. “Breaching Party” has the meaning set forth in Section 13.2.1.

1.23. “Brief” has the meaning set forth in Section 17.5.4.

1.24. “Business Day” means a day other than: (a) Saturday or Sunday; (b) any other day on which commercial banks located in San Francisco, California are obligated by Applicable Laws or executive order to close; (c) the Sunday through Saturday containing July 4th; or (d) December 26 through December 31.

1.25. “Calendar Quarter” means each successive period of three (3) calendar months commencing on January 1, April 1, July 1, and October 1, except that the first Calendar Quarter of the Term will commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1, or October 1 after the Effective Date, and the last Calendar Quarter will end on the last day of the Term.

1.26. “Calendar Year” means each successive period of twelve (12) calendar months commencing on January 1 and ending on December 31, except that the first Calendar Year of the Term will commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term will commence on January 1 of the year in which the Term ends and end on the last day of the Term.

1.27. “Cassette” means HIV Antigen sequences that may additionally include [**].

1.28. “ChAdV” means a chimpanzee adenovirus vector.

1.29. “ChAdV and SAM Platform Technology” means [**].

1.30. “Challenge” has the meaning set forth in Section 13.5.

1.31. “Challenge Notice” has the meaning set forth in Section 13.5.

1.32. “Challenging Party” has the meaning set forth in Section 13.5.

1.33. “Change of Control” means, with respect to a Person (an “Acquired Person”), the occurrence of any of the following events from and after the Effective Date: (a) any Person or group of Persons becomes the beneficial owner (directly or indirectly) of more than fifty percent (50%) of the voting shares of such Acquired Person; (b) such Acquired Person consolidates with or merges into or with another Person pursuant to a transaction in which more than fifty percent (50%) of the voting shares of the acquiring or resulting entity outstanding immediately after such consolidation or merger is not held by the holders of the outstanding voting shares of such Acquired Person immediately preceding such consolidation or merger; or (c) such Acquired Person sells or transfers to a Person other than an Affiliate of such Acquired Person all or substantially all of such Acquired Person’s assets. Notwithstanding the foregoing, the following will not constitute a Change of Control: (i) a sale of capital stock to underwriters in an underwritten public offering of a Party’s capital stock solely for the purpose of financing, (ii) the acquisition of securities of the Acquired Person by any Person or group of Persons that acquires the Acquired Person’s securities in a transaction or series of related transactions the primary purpose of which is to obtain financing for the Acquired Person through the issuance of equity securities, (iii) a transaction solely to change the domicile of a Party; or (iv) a transaction or series of related transactions involving solely the Acquired Person and one or more Affiliates of the Acquired Person.

1.34. “Claims” has the meaning set forth in Section 16.1.

1.35. “Clinical Trial” means any human clinical trial of a pharmaceutical or biological product.

1.36. “CMC” means chemistry, manufacturing, and controls portion of a Regulatory Filing.

1.37. “CMO” means a Third Party contract manufacturer.

1.38. “Code” has the meaning set forth in Section 13.3.

1.39. “Collaboration IP” means, collectively, all Collaboration Know-How and Collaboration Patents.

1.40. “Collaboration Know-How” means, subject to Section 11.10.1, any and all Know-How that is conceived, discovered or otherwise made by or on behalf of either Party or their respective Affiliates in the course of performing activities under this Agreement during the Term, whether solely or jointly with the other Party or any Third Party(ies); provided, for clarity, that Collaboration Know-How excludes (a) Know-How that is [**] and (b) Know-How that is [**], except that this clause (b) shall not exclude Know-How that is (i) [**] or (ii) [**].

1.41. “Collaboration Patents” means, subject to Section 11.10.1, any Patent Right of a Party or any of its Affiliates that claims any Collaboration Know-How.

1.42. “Combination Product” means any Product, in any dosage strength, formulation, or method of administration, that includes: (a) a Vaccine; and (b) one (1) or more [**] (each in clause (b), an “Other Product”), whether in fixed dose combination, co-formulated, co-packaged, or otherwise sold together for one (1) price; provided, however, that in the case of any Product that includes [**], an “Other Product” is deemed to exclude [**]. For clarity, Combination Products include [**].

1.43. “Commercialize” means any and all activities directed to the commercialization of a product, including marketing; detailing; promotion; distributing; order processing; handling returns and recalls; booking sales; administering and commercially selling such product; importing, exporting and transporting such product for commercial sale; and seeking Pricing Approval of a product (if applicable),

whether before or after Regulatory Approval has been obtained, as well all regulatory compliance with respect to the foregoing. For clarity, “Commercialization” does not include: (a) Manufacturing; or (b) any Clinical Trials and other trials commenced after Regulatory Approval. When used as a verb, “Commercialize” means to engage in Commercialization.

1.44. “Commercially Reasonable Efforts” means, with respect to a particular activity, Product and Party, that [**].

1.45. “Competing Infringement” has the meaning set forth in Section 11.4.1.

1.46. “Competing Product” has the meaning set forth in Section 3.5.2.

1.47. “Compulsory License” means, with respect to a Product in a country or territory, a license, or rights granted to a Third Party by a governmental agency within such country or territory to sell or offer for sale such Product in such country or territory under any Patent Right or Know-How owned or controlled by either Party or its Affiliates, without direct or indirect authorization from such Party or its Affiliates.

1.48. “Compulsory Licensee” means a Third Party granted a Compulsory License.

1.49. “Confidential Information” means, with respect to a Party, all confidential and proprietary information, including chemical or biological materials, chemical structures, nucleic acid or amino acid sequences, Commercialization plans, correspondence, customer lists, data, Development plans, formulae, improvements, Inventions, Know-How, processes, Regulatory Materials, reports, strategies, techniques or other confidential or proprietary business, scientific or technical information, in each case, that are disclosed by or on behalf of such Party to the other Party in connection with this Agreement, whether prior to, on or after the Effective Date, regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other Party by or on behalf of the disclosing Party in oral, written, visual, graphic or electronic form. Without limitation to the foregoing, (a) Gritstone Collaboration IP shall be deemed Confidential Information of Gritstone, and Gritstone shall be deemed the disclosing Party and Gilead shall be deemed the receiving Party with respect thereto; (b) Gilead Collaboration IP shall be deemed the Confidential Information of Gilead, and Gilead shall be deemed the disclosing Party and Gritstone shall be deemed the receiving Party with respect thereto; and (c) Joint Collaboration IP shall be deemed Confidential Information of both Parties, and both Parties shall be deemed the disclosing Party and the receiving Party with respect thereto.

1.50. “Control” or “Controlled” means with respect to (a) any Patent Rights, Know-How, other intellectual property right, Regulatory Materials or Confidential Information, the ability of a Party or its Affiliates, as applicable (whether through ownership or license (other than a license granted in this Agreement)) to grant to the other Party or its Affiliates the licenses or sublicenses as provided herein and to otherwise disclose such Know-How, intellectual property right, Regulatory Materials or Confidential Information to the other Party as provided herein, and (b) any right of reference, the ability of a Party or its Affiliates to grant such right of reference as provided herein in each case ((a) and (b)), to the extent not in violation of the terms of any then-existing agreement with any Third Party at the time such Party or its Affiliates, as applicable, (x) in the case of clause (a), would be required hereunder to grant the other Party or its Affiliates such license or sublicenses as provided herein or to otherwise disclose such Know-How, intellectual property right, Regulatory Materials or Confidential Information to the other Party or its Affiliates or (y) in the case of clause (b), would be required to grant the other Party or its Affiliates such right of reference. Notwithstanding the foregoing, a Party and its Affiliates will be deemed not to “Control” any intellectual property rights or rights of reference that are owned or in-licensed by a Third Party (or any

Affiliates of such Third Party in existence prior to the Change of Control, other than such Party or its Affiliates) that becomes an Affiliate of such Party (or that merges or consolidates with such Party) after the Effective Date as a result of a Change of Control of such Party unless (a) prior to the consummation of such Change of Control, such Party or any of its Affiliates also Controlled such Patent Right, Know-How, other intellectual property right, Regulatory Materials or right of reference; or (b) after the consummation of such Change of Control, such Party or any of its Affiliates uses, develops or invents any such Patent Right, Know-How, other intellectual property right, Regulatory Materials or right of reference in the performance of its obligations or exercise of its rights under this Agreement (for clarity, other than in the case of Gritstone or any of its Affiliates or sublicensees pursuant to the license granted in Section 3.2.2), in each of which cases ((a) and (b)), such Patent Right, Know-How, other intellectual property right, Regulatory Materials or right of reference will be deemed to be “Controlled” by such Party for purposes of this Agreement.

1.51. “Cover” means, with reference to a Valid Claim and a product, that the making, using, offering to sell, selling, importing or exporting of such product would infringe such Valid Claim in the country in which such activity occurs without a license thereto (or ownership thereof).

1.52. “Cure Period” has the meaning set forth in Section 13.2.1.

1.53. “[**]” has the meaning set forth in Section [**].

1.54. “Default” means: (a) any breach, violation or default; (b) the existence of circumstances or the occurrence of an event that with the passage of time or the giving of notice or both would constitute a breach, violation or default; or (c) the existence of circumstances or the occurrence of an event that, with or without the passage of time or the giving of notice or both, would give rise to a right of termination, renegotiation, acceleration or material change of terms.

1.55. “Develop” or “Development” means clinical drug development activities and other development activities with respect to a product, including Clinical Trials, test method development and stability testing; toxicology; formulation; qualification; validation; statistical analysis and report writing; the preparation and submission of INDs and MAAs; regulatory affairs with respect to the foregoing and all other activities necessary or useful or otherwise requested or required by a Regulatory Authority or as a condition or in support of obtaining or maintaining a Regulatory Approval. For clarity, “Development” does not include Research or Manufacturing. When used as a verb, “Develop” means to engage in Development.

1.56. “Development Milestone Events” has the meaning set forth in Section 9.4.1.

1.57. “Development Milestone Payments” has the meaning set forth in Section 9.4.1.

1.58. “Disclosing Party” has the meaning set forth in Section 12.1.

1.59. “Disclosure Letter” has the meaning set forth in Section 2.4.2.

1.60. “Disclosure Letter Date” has the meaning set forth in Section 2.4.2.

1.61. “Dispute” has the meaning set forth in Section 17.5.1.

1.62. “Divestment Period” has the meaning set forth in Section 3.5.2.

1.63. “DOJ” has the meaning set forth in Section 2.4.3(a).

1.64. “Dollars” or “$” means the legal tender of the United States.

1.65. “Drug Master File” has the meaning set forth in Section 6.3.2.

1.66. “EDGE™ Machine-Learning Platform Technology” means the [**].

1.67. “Effective Date” has the meaning set forth in the preamble of this Agreement.

1.68. “EMA” means the European Medicines Agency, or any successor agency or authority thereto with comparable responsibilities.

1.69. “Encumbrance” means any claim, charge, equitable interest, hypothecation, lien, mortgage, pledge, assignment to a Third Party, power of sale, right of pre-emption, or security interest of any kind.

1.70. “European Union” or “EU” means all of the European Union member states as of the Effective Date.

1.71. “Excluded Technology” means [**].

1.72. “Existing CDA” means the Mutual Confidential Disclosure Agreement between the Parties, dated May 5, 2017.

1.73. “Existing In-License Agreement” has the meaning set forth in Section 1.122.

1.74. “Exploit” means to make, have made, import, export, distribute, use, have used, sell, have sold, or offer for sale, including to Research, Develop, Manufacture, perform or have performed medical affairs, Commercialize, register, modify, enhance, improve, or otherwise exploit. “Exploitation” and “Exploiting” will be construed accordingly.

1.75. “FDA” means the United States Food and Drug Administration, or any successor agency or authority thereto with comparable responsibilities.

1.76. “FDA Debarment List” means the list of firms or persons debarred pursuant to Sections 306(a) or 306(b) of the Federal Food, Drug, and Cosmetic Act (the “FDCA”) (21 U.S.C. § 335(a)).

1.77. “FDCA” has the meaning set forth in Section 1.76.

1.78. “Field of Use” means all uses in the field of HIV, including treatment, cure, diagnosis, or prevention thereof and, for clarity, acquired immunodeficiency syndrome; provided that, with respect to any Licensed Technology for which Gilead receives a sublicense under (a) the [**], the “Field of Use” will be limited to [**], (b) [**], (c) [**]; (d) [**] or (e) [**].

1.79. “First Commercial Sale” means, on a Product-by-Product and country-by-country basis, the first sale of such Product in such country for use or consumption by the general public (following receipt of all Regulatory Approvals that are required in order to sell such Product in such country) and for which any of Gilead or its Affiliates or Sublicensees has invoiced sales of Products in the Territory; provided, however, that the following will not constitute a First Commercial Sale: (a) any sale to an Affiliate or Sublicensee, unless such Affiliate or Sublicensee is the last Person in the distribution chain of the Product; (b) any use of such Product in Clinical Trials or non-clinical development activities with respect to such Product by or on behalf of a Party; or (c) [**].

1.80. “Force Majeure” has the meaning set forth in Section 17.6.

1.81. “Foundational Licensed Patent” means any [**].

1.82. “FPFD” means the administration of the first dose of a Product to the first patient (or healthy volunteer, as relevant) while such patient or healthy volunteer is participating in a Clinical Trial.

1.83. “FTC” has the meaning set forth in Section 2.4.3(a).

1.84. “FTE” means [**] hours per year. Any person who devotes less than [**] hours per year on the activities under the R&D Plan will be treated as an FTE on a pro-rata basis, based upon the actual number of hours worked by such person on such activities, divided by [**]. Overtime, and work on weekends, holidays, and the like will not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution. For the avoidance of doubt, no individual shall count as more than one (1) FTE for any year.

1.85. “Future Core In-License Agreement” means a Gritstone In-License Agreement other than an Existing In-License Agreement pursuant to which Gritstone in-licenses, or otherwise acquires, Control of Patent Rights, Know-How or other intellectual property rights [**].

1.86. “Future Gritstone Product-Related Agreement” means an agreement, other than a Future Core In-License Agreement, entered into by Gritstone or any of its Affiliates and one or more Third Party(ies) after the Effective Date that (a) [**], or (b) [**], in each case (a) and (b), [**]; provided that [**].

1.87. “Future Gritstone Product-Related [**]” means a Future Gritstone Product-Related Agreement, excluding any Future Gritstone Product-Related [**].

1.88. “Future Gritstone Product-Related [**]” means (i) a Future Gritstone Product-Related Agreement described in clause (a) of the definition of Future Gritstone Product-Related Agreement or (ii) [**], including, for clarity, [**].

1.89. “[**]” means any issued Patent Rights that (a) are Controlled by Gritstone or any of its Affiliates [**], and (b) would be [**] (for clarity, other than [**], excluding [**].

1.90. “[**]” means any [**] that is Controlled by Gritstone or any of its Affiliates [**].

1.91. “Future Gritstone Product-Related Agreement Sublicense” has the meaning set forth in Section 9.7.2(c)(ii).

1.92. “Future Other In-License Agreement” means a Gritstone In-License Agreement other than an Existing In-License Agreement, a Future Core In-License Agreement or a Future Gritstone Product-Related Agreement Sublicense.

1.93. “GCP” means the then-current standards, practices and procedures concerning Clinical Trials promulgated or endorsed by a Regulatory Authority of competent jurisdiction, as such regulations may be amended from time to time, including: (a) for the United States, as set forth in 21 C.F.R. Parts 11, 50, 54, 56, and 312, and guidance for industry, including “Guidance for Industry E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1),” including related regulatory requirements imposed by the FDA; (b) for the European Union, as set forth in Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 and Commission Directive 2005/28/EC of 8 April 2005; (c) as set forth in ICH

Guideline for Good Clinical Practice E6(R2); and (d) analogous Applicable Laws of an applicable Regulatory Authority of competent jurisdiction.

1.94. “Generic Version” means, with respect to a Product, a product (including a “biogeneric,” “follow-on biologic,” “follow-on biological medicine or product,” “follow-on protein product,” “similar biological medicine or product,” or “biosimilar product”) that: (a) within the U.S., is “biosimilar” or “interchangeable,” with respect to such Product as evaluated by the FDA or otherwise determined by Applicable Law; or (b) in the ROW, is determined by the applicable Regulatory Authority or by Applicable Law to be “similar,” “interchangeable,” “bioequivalent,” or “biosimilar” to such Product. For clarity, with respect to a Product, a Biosimilar Product will constitute a Generic Version of such Product.

1.95. “[**]” means [**], or any successor or permitted assignee under [**].

1.96. “[**]” means that certain [**] between [**] and as may be further amended from time to time in accordance with its terms and Section 15.5.7.

1.97. “[**]” means that certain [**].

1.98. “Gilead” has the meaning set forth in the preamble of this Agreement.

1.99. “Gilead Background IP” means any and all Patent Rights, Know-How and other intellectual property rights: (a) in existence and owned or otherwise controlled by Gilead or its Affiliates as of the Effective Date; or (b) invented, conceived, discovered or otherwise made outside of this Agreement and owned or otherwise controlled by Gilead or its Affiliates after the Effective Date, but during the Term.

1.100. “Gilead Collaboration IP” means, collectively, the Gilead Collaboration Know-How and the Gilead Collaboration Patents.

1.101. “Gilead Collaboration Know-How” means any Collaboration Know-How other than (a) Gritstone Collaboration Know-How; or (b) Joint Collaboration Know-How.

1.102. “Gilead Collaboration Patents” means any Collaboration Patents other than (a) Gritstone Collaboration Patents; or (b) Joint Collaboration Patents.

1.103. “Gilead Composition” means any HIV Antigen [**] provided by or on behalf of Gilead under the Agreement, and any nucleic acid encoding such HIV Antigen [**], including [**].

1.104. “Gilead Indemnitee” has the meaning set forth in Section 16.1.

1.105. “Gilead Licensed Know-How” means any Know-How Controlled by Gilead or any of its Affiliates as of the Effective Date or during the Term, other than Joint Collaboration Know-How, that is (a) [**] for Gritstone to conduct any Gritstone R&D Activities or any of its activities under the Supply Agreement, in each case in accordance with this Agreement or the Supply Agreement, as applicable; and (b) either (i) [**] by Gilead to Gritstone [**] for use in such activities, (ii) relate to Gilead Compositions or Gilead Materials transferred by Gilead to Gritstone under this Agreement, or (iii) constituting Gilead Collaboration Know-How [**].

1.106. “Gilead Licensed Patents” means any Patent Right Controlled by Gilead or any of its Affiliates as of the Effective Date or during the Term, other than Joint Collaboration Patents, that (a) claims any Gilead Licensed Know-How; or (b) is otherwise [**] for Gritstone to conduct any Gritstone R&D

Activities or any of its activities under the Supply Agreement, in each case in accordance with this Agreement or the Supply Agreement, as applicable.

1.107. “Gilead Licensed Technology” means all Gilead Licensed Know-How, Gilead Licensed Patents and any Materials Controlled by Gilead or any of its Affiliates as of the Effective Date or during the Term that are provided to Gritstone for use in the performance of the Gritstone R&D Activities or Gritstone’s activities under the Supply Agreement.

1.108. “Gilead Materials” has the meaning set forth in Section 2.3.

1.109. “Gilead R&D Activities” has the meaning set forth in Section 2.1.1.

1.110. “GLP” means the then-current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, as such regulations may be amended from time to time, and analogous Applicable Laws of an applicable Regulatory Authority and all additional Regulatory Authority documents or regulations that replace, amend, modify, supplant or complement any of the foregoing.

1.111. “GMP” means the then-current standards, practices and procedures concerning Good Manufacturing Practice promulgated or endorsed by a Regulatory Authority of competent jurisdiction, including: (a) section 501(a)(2)(B) of the United States Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(B)); (b) relevant United States regulations in Title 21 of the United States Code of Federal Regulations (including Parts 11, 210, 211, 600, and 610); (c) EU Commission Directive 2003/94/EC; (d) the European Community Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, in Volume 4 of the European Commission’s Rules Governing Medicinal Products in the European Union; (e) ICH Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; (f) analogous Applicable Laws of an applicable Regulatory Authority at the time of Manufacture; and (g) all additional Regulatory Authority documents, regulations, policies, guidances, or guidelines, that replace, amend, modify, supplant, or complement any of the foregoing.

1.112. “GMP Supply Product” has the meaning set forth in the Supply Agreement.

1.113. “Good Faith Efforts” means, with respect to a stated goal of a Party, that such Party will use good faith efforts to achieve such goal; provided that [**].

1.114. “Governmental Authority” means any: (a) federal, state, local, municipal, foreign or other government; (b) governmental or quasi-governmental authority of any nature (including any agency, board, body, branch, bureau, commission, council, department, entity, governmental division, instrumentality, office, officer, official, organization, representative, subdivision, unit and any court or other tribunal); (c) multinational governmental organization or body; or (d) entity or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature (including any arbiter).

1.115. “Gritstone” has the meaning set forth in the preamble of this Agreement.

1.116. “[**]” means that certain [**] by and between Gritstone, on the one hand, and [**], on the other hand, dated as of [**] and as may be further amended from time to time in accordance with Section 15.5.12.

1.117. “Gritstone Background IP” means any and all Patent Rights, Know-How and other intellectual property rights: (a) in existence and owned or otherwise Controlled by Gritstone or its Affiliates

as of the Effective Date; or (b) invented, conceived, discovered or otherwise made outside of this Agreement and owned or otherwise Controlled by Gritstone or its Affiliates after the Effective Date, but during the Term, in each case ((a) and (b)) that is necessary or reasonably useful to Exploit the Product in the Field of Use in the Territory.

1.118. “Gritstone Background Patent” means any Patent Right within the Gritstone Background IP.

1.119. “Gritstone Collaboration IP” means collectively, the Gritstone Collaboration Know-How and Gritstone Collaboration Patents.

1.120. “Gritstone Collaboration Know-How” means, subject to Section 11.10.1, any Know-How within the Collaboration Know-How that:

1.120.1. is conceived, discovered or otherwise made [**]; or

1.120.2. is conceived, discovered or otherwise made [**].

1.121. “Gritstone Collaboration Patents” means, subject to Section 11.10.1, any Collaboration Patents that:

1.121.1. are invented [**]; or

1.121.2. are invented [**];

1.121.3. provided that [**], all Patent Rights within [**] will be considered Gritstone Collaboration Patents for purposes of Sections [**].

1.122. “Gritstone In-License Agreement” means any contract or agreement with a Third Party (a) (i) pursuant to which Gritstone in-licenses, or otherwise acquires, Control of Patent Rights, Know-How or other intellectual property rights that constitute Licensed Technology for purposes of this Agreement that is set forth on Schedule 1.122 as of the Effective Date or (ii) that becomes an Existing In-License Agreements pursuant to Section 3.1.4(h) as of the date such agreement becomes an Existing In-License Agreement (each, ((i) and (ii)), an “Existing In-License Agreement”); or (b) that becomes a Gritstone In-License Agreement pursuant to Section 9.7.2 as of the date such agreement becomes a Gritstone In-License Agreement.

1.123. “Gritstone Indemnitee” has the meaning set forth in Section 16.2.

1.124. “Gritstone Materials” has the meaning set forth in Section 2.3.

1.125. “Gritstone Operational Documentation” means documents and information specifically related to the internal practices, policies, operating procedures, equipment and systems used by or on behalf of Gritstone or any of its Affiliates in carrying out its operations and activities, including all such documents and information maintained to comply with Applicable Law, which are (a) generally applicable to Gritstone’s operations, facilities or equipment (e.g., with respect to calibration and environmental monitoring); and (b) [**].

1.126. “Gritstone Other Agent” mean an Other Agent that is owned or exclusively licensed by Gritstone.

1.127. “Gritstone Platform Technologies” means the ChAdV and SAM Platform Technology and the LNP Platform Technology.

1.128. “Gritstone Product Patents” has the meaning set forth in Section 11.3.1(c).

1.129. “Gritstone Product-Related Agreement Selected Improvement IP” has the meaning set forth in Section 9.7.2(b)(ii).

1.130. “Gritstone R&D Activities” has the meaning set forth in Section 2.1.1.

1.131. “Gritstone R&D Budget” has the meaning set forth in Section 2.1.2.

1.132. “Gritstone Reimbursable Costs” has the meaning set forth in Section 10.1.3.

1.133. “HIV” means human immunodeficiency virus.

1.134. “HIV Antigen” means any [**], intended to stimulate an HIV specific immune response in humans.

1.135. “HSR Act” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (15 U.S.C. § 18a).

1.136. “ICC Rules” has the meaning set forth in Section 17.5.3.

1.137. “IND” means an investigational new drug application (including any amendment or supplement thereto) submitted to the FDA pursuant to U.S. 21 C.F.R. Part 312, including any amendments thereto. References herein to IND will include, to the extent applicable, any comparable filing(s) outside the U.S. for the investigation of any product in any other country or group of countries (such as a clinical trial application in the EU).

1.138. “Indemnification Claim Notice” has the meaning set forth in Section 16.3.1.

1.139. “Indemnified Party” has the meaning set forth in Section 16.3.1.

1.140. “Indemnifying Party” has the meaning set forth in Section 16.3.1.

1.141. “Indemnitee” means a Gilead Indemnitee or a Gritstone Indemnitee, as the context requires.

1.142. “Infringement” has the meaning set forth in Section 11.4.1.

1.143. “Infringement Action” has the meaning set forth in Section 11.4.2(a).

1.144. “Initial Outside Date” has the meaning set forth in Section 2.4.3(c).

1.145. “Initiating Party” has the meaning set forth in Section 11.4.2(e).

1.146. “Invention” means any invention or discovery that is created, conceived or reduced to practice.

1.147. “Joint Collaboration IP” means, collectively, the Joint Collaboration Know-How and Joint Collaboration Patents.

1.148. “Joint Collaboration Know-How” means any Know-How within the Collaboration Know-How that (a) relates to [**]; (b) is not related to [**]; and (c) is conceived, discovered or otherwise made [**] jointly by or on behalf of Gritstone or any of its Affiliates, on the one hand, and by or on behalf of Gilead or any of its Affiliates, on the other hand.

1.149. “Joint Collaboration Patents” means any Collaboration Patents that (a) relate to any [**]; (b) are not related to any [**]; and (c) claim Joint Collaboration Know-How.

1.150. “Joint Steering Committee” or “JSC” has the meaning set forth in Section 4.1.1.

1.151. “JSC Co-Chair” has the meaning set forth in Section 4.1.2.

1.152. “Know-How” means algorithms, data, Inventions, methods (including methods of use or administration or dosing), practices, results, software, techniques, technology and trade secrets, including analytical and quality control data, analytical methods (including applicable reference standards), assays, batch records, chemical structures and formulation information, compositions of matter, formulae, manufacturing data and information, pharmacological, toxicological and clinical test data and results, processes, reports, research data, research tools, sequences, standard operating procedures and information of a scientific or technical nature, in each case, whether patentable or not, and, in each case, tangible manifestations thereof, excluding any Regulatory Materials and Gritstone Operational Documentation.

1.153. “Knowledge” means, with respect to Gritstone, [**]; provided that with respect to the “Knowledge” of [**].

1.154. “Licensed Gritstone Background Know-How” means any Licensed Know-How within the Gritstone Background IP, excluding, for clarity, any Collaboration Know-How.

1.155. “Licensed Gritstone Background Patent” means any Licensed Patent within the Gritstone Background IP, excluding, for clarity, any Collaboration Patent.

1.156. “Licensed Gritstone Background Technology” means any and all Licensed Gritstone Background Know-How and Licensed Gritstone Background Patents.

1.157. “Licensed Know-How” means any and all Know-How Controlled by Gritstone or any of its Affiliates [**] (including Gritstone Collaboration Know-How, but excluding Joint Collaboration Know-How) which is [**] to Exploit any Product in the Field of Use in the Territory, but excluding any Know-How within the Excluded Technology. For clarity, Licensed Know-How excludes any Licensed Patents.

1.158. “Licensed Patent” means any Patent Right Controlled by Gritstone or any of its Affiliates [**] (including Gritstone Collaboration Patents, but excluding Joint Collaboration Patents) which is [**] to Exploit any Product in the Field of Use in the Territory, but excluding any Patent Rights within the Excluded Technology.

1.159. “Licensed Technology” means, collectively, all Licensed Patents and Licensed Know-How.

1.160. “[**]” means that certain [**] between Gritstone and [**].

1.161. “LNP” means lipid nanoparticle technology.

1.162. “LNP Platform Technology” means the [**].

1.163. “Losses” has the meaning set forth in Section 16.1.

1.164. “MAA” means a BLA, a marketing authorization application submitted to the EMA or to the competent Regulatory Authority of a member state of the EU or any equivalent filing in a country or regulatory jurisdiction other than the U.S. or EU with the applicable Regulatory Authority, and all amendments and supplements thereto, to obtain marketing approval for a pharmaceutical or biological product, in a country or in a group of countries.

1.165. “Major European Market” means each of France, Germany, Italy, Spain and the United Kingdom.

1.166. “Manufacture” means all activities related to the manufacturing of a product or any component or ingredient thereof, including the production, manufacture, having manufactured, processing, filling, finishing, packaging, labeling, shipping and holding of product or any intermediate thereof, including process development, process qualification and validation, scale-up, commercial manufacture and analytic development, product characterization, stability testing, quality assurance and quality control. For clarity, “Manufacture” does not include Research, Development, or Commercialization.

1.167. “Manufacturing Technology Transfer” has the meaning set forth in Section 7.4.

1.168. “Material Breach” means a breach of this Agreement which is material to the rights and obligations of the Parties and the transactions contemplated by this Agreement, taken as a whole.

1.169. “Material Manufacturing Improvement” means a [**] that is Controlled by Gritstone or any of its Affiliates with respect to the Manufacturing process for a [**], including [**].

1.170. “Material Platform Improvement” means a [**] that is Controlled by Gritstone or any of its Affiliates with respect to the Gritstone Platform Technology, including [**].

1.171. “Materials” has the meaning set forth in Section 2.3.

1.172. “Milestone Payments” has the meaning set forth in Section 9.4.2.

1.173. “Milestones” means the Development Milestone Events and Sales Milestone Events.

1.174. “Net Receipts” means [**].

1.175. “Net Sales” means [**]:

[**].

With respect to [**], the following will apply:

[**].

1.176. “New License Agreement” has the meaning set forth in Section 14.1.6.

1.177. “Non-Breaching Party” has the meaning set forth in Section 13.2.1.

1.178. “Non-Challenging Party” has the meaning set forth in Section 13.5.

1.179. “Non-Prosecuting Party” has the meaning set forth in Section 11.3.2.

1.180. “Notice of Possible Option Exercise” has the meaning set forth in Section 2.4.2.

1.181. “Option” has the meaning set forth in Section 2.4.1.

1.182. “Option Effective Date” has the meaning set forth in Section 2.4.3(b).

1.183. “Option Exercise Date” has the meaning set forth in Section 2.4.1.

1.184. “Option Exercise Fee” has the meaning set forth in Section 9.3.

1.185. “Option Exercise Notice” has the meaning set forth in Section 2.4.1.

1.186. “Option Term” has the meaning set forth in Section 2.4.1.

1.187. “Other Agent” means an active agent, other than an HIV Antigen, including [**].

1.188. “Other Product” has the meaning set forth in Section 1.42.

1.189. “Outside Date” has the meaning set forth in Section 2.4.3(c).

1.190. “Owned Licensed Gritstone Background Technology” means any and all Licensed Gritstone Background Technology owned by Gritstone.

1.191. “Owned Licensed Technology” means any and all Licensed Technology owned by Gritstone.

1.192. “Party” and “Parties” has the meaning set forth in the preamble of this Agreement.

1.193. “Patent Rights” means all rights, title, and interests in and to: (a) all national, regional, and international patents and patent applications filed in any country of the world, including provisional patent applications and all supplementary protection certificates; (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority to any of the foregoing, including any continuation, continuation-in-part, divisional, provisional, converted provisional and continued prosecution application, or any substitute application; (c) any patent issued with respect to or in the future issued from any such patent applications, including utility models, petty patents, design patents, and certificates of invention; and (d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, reexaminations, and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications.

1.194. “Patent Term Extensions” means any patent term extension, supplementary protection certificate or similar extension.

1.195. “Payee” means a Party receiving a payment under this Agreement.

1.196. “Payor” means a Party owing or making a payment under this Agreement.

1.197. “Per Product Annual Net Sales” has the meaning set forth in Section 9.4.2.

1.198. “Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, Governmental Authority or any other entity not specifically listed herein.

1.199. “Pharmacovigilance Agreement” has the meaning set forth in Section 6.5.

1.200. “Phase 1 Clinical Trial” means a Clinical Trial that provides for the first introduction into humans of a pharmaceutical or biological product conducted in normal volunteers or patients to get information on product safety, tolerability, immunogenicity, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the foreign equivalent thereof).

1.201. “Phase 1b Clinical Trial” means a Phase 1 Clinical Trial in the target patient population that is designed to establish safety and immunogenicity, which may also be designed to establish an initial indication of efficacy.

1.202. “Phase 3 Clinical Trial” means a Clinical Trial of a pharmaceutical or biologic product on a sufficient number of patients, which trial the FDA permits to be conducted under an open IND and is designed to: (a) establish that the pharmaceutical or biologic product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the pharmaceutical or biologic product in the dosage range to be prescribed; and (c) together with other results, support an MAA to a Regulatory Authority for the pharmaceutical or biologic product, and that satisfies the requirements of U.S. federal regulation 21 C.F.R. § 312.21(c) and its successor regulation or equivalents in other jurisdictions.

1.203. “Pivotal Clinical Trial” means any (a) Phase 3 Clinical Trial; or (b) other Clinical Trial of a pharmaceutical or biologic product on a sufficient number of patients, the results of which, together with prior data and information concerning such product, are intended to be or otherwise are sufficient, without any additional Clinical Trial to meet the evidentiary standard for demonstrating the safety, purity, efficacy, and potency of such product established by a Regulatory Authority in any particular jurisdiction and that is intended to support, or otherwise supports, the filing of an MAA to a Regulatory Authority in such jurisdiction (including any bridging study). Notwithstanding any provision to the contrary set forth in this Agreement, treatment of patients as part of an expanded access program, compassionate sales or use program (including named patient program or single patient program), or an indigent program, in each case, will not be included in determining whether or not a Clinical Trial is a Pivotal Clinical Trial or whether a patient has been dosed thereunder.

1.204. “[**] Agreement” means [**] Agreement between the Parties, [**].

1.205. “Pricing Approval” means any approval, agreement, determination or decision establishing prices that can be charged to consumers for a pharmaceutical or biological product or that will be reimbursed by Governmental Authorities for a pharmaceutical or biological product, in each case, in a country where Governmental Authorities approve or determine pricing for pharmaceutical or biological products for reimbursement or otherwise.

1.206. “Product” means any product that contains, incorporates or otherwise includes a Vaccine, in any form, dosage strength or formulation for any method of administration [**] and does not include any

(i) [**]; or (ii) [**]. All Products that [**], will be considered the same Product for purposes of this Agreement. For clarity, a Product may constitute a Combination Product.

1.207. “Product Mark” has the meaning set forth in Section 11.7.

1.208. “Product-Specific Third Party IP” has the meaning set forth in Section 9.7.1.

1.209. “Prosecuting Party” has the meaning set forth in Section 11.3.2.

1.210. “Prosecution and Maintenance” or “Prosecute and Maintain” means, with respect to a Patent Right, the preparation, filing, prosecution and maintenance of such Patent Right, as well as re-examinations, reissues, and appeals with respect to such Patent Right, together with the initiation or defense of interferences, oppositions, inter partes review, derivations, re-examinations, post-grant proceedings and other similar proceedings (or other defense proceedings with respect to such Patent Right, but excluding the defense of challenges to such Patent Right as a counterclaim in an infringement proceeding) with respect to the particular Patent Right, and any appeals therefrom. For clarification, “Prosecution and Maintenance” or “Prosecute and Maintain” will not include any other enforcement actions taken with respect to a Patent Right.

1.211. “Publication” has the meaning set forth in Section 12.7.

1.212. “Publishing Party” has the meaning set forth in Section 12.7.

1.213. “Qualifying Use of Gritstone Platform Technology” has the meaning set forth in Section 9.7.2(d).

1.214. “R&D Plan” means the plan set forth on Schedule 2.1.2(a), as may be updated from time to time pursuant to Section 2.1.2.

1.215. “R&D Program” means all activities conducted solely or jointly by the Parties during the Option Term pursuant to the R&D Plan.

1.216. “R&D Team Review Meeting” has the meaning set forth in Section 5.1.2(a).

1.217. “Receiving Party” has the meaning set forth in Section 12.1.

1.218. “Regulatory Approval” means all approvals, licenses and authorizations of the applicable Regulatory Authority necessary for the marketing and sale of a pharmaceutical or biological product for a particular indication in a country or region (including separate Pricing Approvals, as applicable), and, as applicable, including the approvals by the applicable Regulatory Authority of any expansion or modification of the label for such indication.

1.219. “Regulatory Authority” means any national or supranational Governmental Authority, including the FDA, the EMA or any health regulatory authority in any country or region that is a counterpart to the foregoing agencies, in each case, that holds responsibility for development and commercialization of, and the granting of Regulatory Approval for, a pharmaceutical or biological product in such country or region.

1.220. “Regulatory Exclusivity” means the ability to exclude Third Parties from obtaining Regulatory Approval or Commercializing a Product in a country, either through data exclusivity rights (including as described in 42 U.S.C. § 351(k)), orphan-drug exclusivity, pediatric exclusivity (including as

described in 42 U.S.C. § 351(m)) or such other rights conferred by Applicable Laws or a Regulatory Authority in such country or jurisdiction, in each case, other than through Patent Rights.

1.221. “Regulatory Filings” means any submission to a Regulatory Authority of any appropriate regulatory application, including any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto. For the avoidance of doubt, Regulatory Filings will include any IND or MAA.

1.222. “Regulatory Materials” means Regulatory Filings, submissions, notifications, communications, correspondence, registrations, marketing approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to develop, manufacture, market, sell or otherwise commercialize a Product in a particular country or jurisdiction, including INDs, BLAs, and other applications for marketing approval.

1.223. “Research” means activities related to the characterization, design, discovery, generation, identification, non-clinical or pre-clinical studies, pre-clinical development, analytical and process development, optimization, production, or profiling of vaccine candidates or products. For clarity, “Research” does not include Development or Manufacturing. When used as a verb, “Research” means to engage in Research.

1.224. “Response” has the meaning set forth in Section 17.5.4.

1.225. “Reviewing Party” has the meaning set forth in Section 12.7.

1.226. “ROW” means all countries and territories of the world in the Territory other than the U.S.

1.227. “Royalties” has the meaning set forth in Section 9.5.1.

1.228. “Royalty Floor” has the meaning set forth in Section 9.8.1.

1.229. “Royalty Term” has the meaning set forth in Section 9.5.2.

1.230. “Sales Milestone Events” has the meaning set forth in Section 9.4.2.

1.231. “Sales Milestone Payments” has the meaning set forth in Section 9.4.2.

1.232. “SAM” means a self-amplifying mRNA system.

1.233. “Securities Regulator” has the meaning set forth in Section 12.3.1(a).

1.234. “Selected Collaboration IP” means any [**] that relates to (i) [**] or (ii) [**].

1.235. “Selected Collaboration Patents” means any Patent Right within the Selected Collaboration IP.

1.236. “Selected Dispute” has the meaning set forth in Section 17.5.1.

1.237. “Selected Licensed Data” has the meaning set forth in Section 5.1.2(b).

1.238. “Selling Party” means Gilead, its Affiliates, or its Sublicensees, in each case, expressly excluding distributors.

1.239. “Senior Officers” means, with respect to Gilead, its Chief Medical Officer or his or her designee, and, with respect to Gritstone, its Chief Executive Officer or his or her designee.

1.240. “[**]” means a [**] agreement between such Third Party and a Party, any of its Affiliates, or any of its or their respective licensees or sublicensees, which agreement was entered into in connection with [**] regarding such Third Party’s ability to Exploit [**] in one or more countries [**] owned or controlled by such Party or its Affiliates; provided that no such Third Party shall be deemed a [**].

1.241. “Stock Purchase Agreement” has the meaning set forth in Section 9.2.

1.242. “Subcontractor” means a Third Party contractor engaged by a Party to perform certain obligations or exercise certain rights of such Party under this Agreement (for clarity, not including the performance of any obligations or exercise of any rights of Gritstone, its Affiliates or its or their sublicensees under Section 3.2.2) on a fee-for-service basis (including contract research organizations, Third Parties acting as distributors, or CMOs), which Third Party is not otherwise granted licenses or other rights to Exploit Products.

1.243. “Sublicensees” means any Third Party to whom a Party, any of its Affiliates or any of its Sublicensees grants a sublicense of its rights hereunder to Exploit Products, provided that [**], Sublicensees shall not include Subcontractors.

1.244. “Supply Agreement” has the meaning set forth in Section 7.1.

1.245. “Supply Product” has the meaning set forth in the Supply Agreement.

1.246. “Taxes” has the meaning set forth in Section 10.4.1.

1.247. “Term” has the meaning set forth in Section 13.1.

1.248. “Terminated Product” means, with respect to: (a) the termination of this Agreement with respect to a Product, the Product subject to such termination; (b) the termination of this Agreement with respect to a country in the Territory, all Products in the country in the Territory subject to such termination; and (c) the termination of this Agreement in its entirety, all Products in all countries in the Territory.

1.249. “Territory” means all countries and territories of the world.

1.250. “Third Party” means any Person other than a Party or an Affiliate of a Party.

1.251. “Third Party Acquisition” has the meaning set forth in Section 3.5.2.

1.252. “Third Party Agreement-Governed Intellectual Property Rights” has the meaning set forth in Section 11.10.2(a).

1.253. “Third Party Infringement” has the meaning set forth in Section 11.5.1.

1.254. “Third Party Payment” means any amount paid or required to be paid by Gritstone pursuant to any Gritstone In-License Agreement.

1.255. “Transfer Taxes” has the meaning set forth in Section 10.4.1.

1.256. “Transferrable Manufacturing Improvement” means [**].

1.257. “Transferrable Platform Improvement” means [**].

1.258. “Transition Period” has the meaning set forth in Section 7.4.

1.259. “[**]” means that certain [**], as may be amended from time to time in accordance with its terms and Section 15.5.7.

1.260. “[**]” means that certain [**] between Gritstone [**], and as may be further amended from time to time in accordance with its terms.

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

1.262. “Vaccine” means any vaccine developed under this Agreement, which vaccine (i) was developed from or otherwise uses the Gritstone Platform Technologies; and (ii) incorporates a ChAdV vector or a SAM vector, with or without LNP, that expresses one or more HIV Antigens; provided that such vaccine will not include any (1) [**] or (2) [**]. For clarity, [**].

1.263. “Valid Claim” means a claim in: (a) an issued and unexpired patent which has not been revoked or held unenforceable or invalid by a decision of a court, patent office, or other governmental agency of competent jurisdiction from which no appeal can be or has been taken within the time allowed for appeal, and which has not been disclaimed, donated to the public or admitted to be invalid or unenforceable through reissue, re-examination, disclaimer, or otherwise; or (b) an [**].

Article II
Collaboration and Option

2.1. Research and Development Activities.

2.1.1. Each Party’s Responsibilities. Gilead will be responsible for conducting all activities assigned to it under the R&D Plan, including conducting a [**] Clinical Trial of a Vaccine and, at Gilead’s sole discretion, (a) one or more [**]; and (b) [**] (such activities, collectively, the “Gilead R&D Activities”). Gritstone will be responsible for performing all activities assigned to it under the R&D Plan, including conducting any [**] activities provided in such plan (such activities, the “Gritstone R&D Activities”). Gritstone will perform, or have performed, all Gritstone R&D Activities in accordance with the R&D Plan and this Agreement. Gritstone will not perform any activities with respect to a Product other than in accordance with the R&D Plan or the Supply Agreement. If the Gritstone R&D Activities have not been completed prior to Gilead’s delivery of an Option Exercise Notice pursuant to Section 2.4.1, at Gilead’s request, Gritstone will continue performing all remaining Gritstone R&D Activities in accordance with the R&D Plan and this Agreement and the license granted to Gritstone under Section 3.2.1 will survive until completion of the remaining Gritstone R&D Activities or until Gilead otherwise requests that Gritstone stop performing such remaining Gritstone R&D Activities. Gilead will reimburse Gritstone for the Gritstone Reimbursable Costs incurred by Gritstone in performing or having performed [**] in accordance with the Gritstone R&D Budget. Gritstone shall promptly inform Gilead upon Gritstone determining that it is likely to overspend or underspend by more than [**]. On a [**] for such [**] shall be deemed Gritstone Reimbursable Costs and reimbursed by Gilead [**].

2.1.2. R&D Plan and Gritstone R&D Budget. The initial draft of the R&D Plan agreed to by the Parties is attached hereto on Schedule 2.1.2(a). From time to time during the Option Term, and on [**], the JSC will review the then-current R&D Plan for potential amendments. Each Party’s JSC

representatives will consider in good faith all such amendments proposed by the other Party’s JSC representatives. Any proposed amendments to the R&D Plan will become effective only upon approval by the JSC, and subject to Section 4.2. The R&D Plan will be consistent with the terms of this Agreement and will form a part of this Agreement. In the event of an inconsistency between the R&D Plan and this Agreement, the terms of this Agreement will prevail. The R&D Plan will be deemed the Confidential Information of each Party. In addition, attached as Schedule 2.1.2(b) is a written budget for the Gritstone R&D Activities, which budget includes [**] (collectively, clause (a) and (b), the “Gritstone R&D Budget”).

2.1.3. Records. Each Party will prepare and maintain complete and accurate written records of all activities performed as well as results and data obtained pursuant to the R&D Plan, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes. In addition to the reporting obligations set forth herein, upon reasonable request of Gilead, Gritstone will grant Gilead and its Affiliates reasonable access to [**] that is generated in the course of performance of the R&D Program in a format (e.g., remote web-access secured by end-user identity and authentication solutions or by other means providing a comparable, sufficient level of data security) reasonably acceptable to both Parties. Gilead and its Affiliates will also have the right, at reasonable intervals and upon reasonable notice to Gritstone, to [**]. All such records in their disclosed form will be deemed the Confidential Information of each Party (without affecting the ownership of or confidentiality and non-use obligations related to the information therein).

2.1.4. Reporting. Each Party will keep the other Party reasonably informed on the status, progress and results of its activities under the R&D Plan through the regularly-scheduled JSC meetings described in Section 4.1.3. At least [**] before each regularly-scheduled JSC meeting, each Party will submit to the JSC a written summary (in the form of a slide deck or as otherwise reasonably determined by such Party) of the status, progress and results of its activities under the R&D Plan since its prior report. The JSC will review and discuss the status, progress and results of the R&D Program. In addition, Gritstone will provide Gilead with a final written report within [**] following the completion of its activities under the R&D Plan, which report will summarize the activities undertaken and all accomplishments achieved under the R&D Plan. All such summaries and reports in their disclosed form will be deemed the Confidential Information of each Party (without affecting the ownership of or confidentiality and non-use obligations related to the information therein).

2.2. Gilead Composition.

2.2.1. Provision of Gilead Compositions. Gilead will provide Gritstone with Gilead Compositions consisting of HIV Antigens or otherwise as Gilead believes to be reasonably necessary for Gritstone to conduct its activities under the R&D Plan or the Supply Agreement, in each case as set forth in the R&D Plan. All such Gilead Compositions will remain at all times the property of Gilead. No such Gilead Compositions, or any derivatives, analogs, modifications or components thereof, may be transferred, delivered or disclosed to any Third Party other than a Third Party identified for such purpose in the R&D Plan without the prior written approval of Gilead. Gritstone and its Affiliates may only use, and will only permit the use by any permitted Third Party of, such Gilead Compositions provided to Gritstone as contemplated under the R&D Plan or the Supply Agreement and for no other purpose. Gritstone will not, and Gritstone will cause its Affiliates and permitted Third Party transferees to not, distribute or release any such Gilead Compositions to any Person other than Gritstone’s or Gritstone Affiliate’s or permitted Third Party’s laboratory personnel under the direct supervision of Gritstone or a Gritstone Affiliate. Gilead will have no obligation to provide to Gritstone additional Gilead Compositions beyond those consisting of HIV Antigens described in the R&D Plan or the Supply Agreement. Gritstone will not use, and will ensure that its Affiliates and permitted Third Party transferees (each as applicable) do not use, any such Gilead

Compositions in connection with any Research, Development, Manufacturing or other activities that are subject to consulting or licensing obligations to any Third Party. Gritstone will use, and will ensure that its Affiliates and permitted Third Party transferees (each as applicable) use, such Gilead Compositions in compliance with all Applicable Law.

2.2.2. No Warranties. GRITSTONE UNDERSTANDS THAT ALL GILEAD COMPOSITIONS ARE SUPPLIED ON AN “AS IS” AND “WHERE IS” BASIS. GRITSTONE ACKNOWLEDGES THAT GILEAD COMPOSITIONS ARE EXPERIMENTAL IN NATURE AND MAY HAVE UNKNOWN HAZARDOUS CHARACTERISTICS, THAT GRITSTONE IS AWARE OF THE RISKS OF WORKING WITH EXPERIMENTAL MATERIAL AND THAT GRITSTONE WILL STRICTLY ADHERE TO PROPER LABORATORY PROCEDURES FOR HANDLING MATERIAL WITH UNKNOWN HAZARDS AND ANY OTHER INSTRUCTIONS PROVIDED BY GILEAD WITH RESPECT TO SUCH GILEAD COMPOSITIONS. THE GILEAD COMPOSITIONS WILL NOT BE USED IN HUMANS BY OR ON BEHALF OF GRITSTONE OR ITS AFFILIATES.

2.3. Materials Transfer. In addition to any Gilead Compositions transferred pursuant to Section 2.2, during the Option Term, Gilead or Gritstone may also transfer to Gritstone or Gilead, as applicable, or its respective designee, certain biological or chemical materials (including assays) within such Party’s or any of its Affiliates’ Control (the “Gilead Materials” or “Gritstone Materials”, as applicable, and together, the “Materials”) that are designated for transfer in the R&D Plan, which Materials will be used by the receiving Party solely to conduct the R&D Plan; provided that any transfer of such Materials by a Party to the other Party will be documented in a material transfer agreement executed by the Parties that sets forth the type, name and amount of Materials transferred, the recipient(s) and the date of the transfer. The receiving Party and any of its Affiliates or Subcontractors will have the right to use the Materials solely for conducting the R&D Plan or as otherwise specified in the applicable material transfer agreement or for such other purposes as may be agreed to by the Parties in writing and for no other purposes.

2.4. Option.

2.4.1. Option Grant. Gritstone hereby grants to Gilead the exclusive option, exercisable at Gilead’s sole discretion, to obtain the license set forth in Section 3.1.2 (such exclusive option, the “Option”). Subject to Section 2.4.3, Gilead may exercise the Option by delivering written notice of such exercise to Gritstone at any time after the Effective Date and before the earlier of (a) [**] after the earlier of (i) [**] or (ii) [**] (subject to extension under this Section 2.4.1 and Section 2.4.3(b), the “Option Term”, such notice, an “Option Exercise Notice” and the date of delivery of such notice, the “Option Exercise Date”); provided that the Option Term will be extended beyond [**] if (x) [**] or (y) [**]. In order to rely on the immediately foregoing proviso to extend the Option Term, Gilead must (1) provide Gritstone with written notice that [**], in a timely manner, [**] after [**] and (2) promptly follow-up with written notice to Gritstone specifying [**]. If Gilead does not provide an Option Exercise Notice prior to the expiration of the Option Term, then Gilead’s right to exercise the Option will terminate and Gritstone will have no further obligations to Gilead with respect to such Option and this Agreement will terminate. Unless and until the Option Effective Date occurs, Gilead shall not, and shall cause its Affiliates and its or their Sublicensees not to, [**].

2.4.2. Disclosure Schedule Update(s). In connection with Gilead’s consideration of whether to exercise the Option, Gilead will have the right to provide Gritstone written notice requesting a Disclosure Letter (such notice provided pursuant to this Section 2.4.2, the “Notice of Possible Option Exercise”); provided that [**]; provided, for clarity, that Gilead shall have the right to deliver an Option Exercise Notice without first delivering a Notice of Possible Option Exercise. [**] following Gritstone’s receipt of the Notice of Possible Option Exercise, Gritstone will deliver to Gilead a written document,

signed by a duly authorized officer of Gritstone (such letter, a “Disclosure Letter”), setting forth a schedule of exceptions to the representations and warranties in Section 15.3 as of the Disclosure Letter Date and a completed Schedule 15.3.1. From the delivery of the Disclosure Letter until Gilead’s exercise of the Option (and, as applicable, from the Option Exercise Date until the Option Effective Date), Gritstone shall have a right, but not an obligation, to further update the Disclosure Letter to reflect any further changes, supplements or amendments of which Gritstone becomes aware or as a result of an event, condition, fact or circumstance occurring during such period; provided that if Gritstone or its Affiliates receives any [**] after the Disclosure Letter Date but before Gilead’s exercise of the Option, Gritstone shall notify Gilead in writing no later than [**]. The date on which Gritstone delivers any Disclosure Letter pursuant to this Section 2.4.2, or any update to such Disclosure Letter pursuant to the immediately preceding sentence, shall be a “Disclosure Letter Date” with respect to such Disclosure Letter or update thereto, as applicable.

2.4.3. Antitrust Filings.

(a) Filings. If Gilead determines that any filings, notices, applications or other submissions under Antitrust Law are necessary in connection with Gilead’s exercise of the Option (“Antitrust Filing”), then Gilead and Gritstone will submit such Antitrust Filings within a time that Gilead determines, in its sole discretion, is prudent, and in any event, no later than [**] after the Option Exercise Date; provided that Gilead shall notify Gritstone in the Option Exercise Notice of any and all such Antitrust Filings that will or may be required. In connection with any such Antitrust Filing, the Parties will furnish promptly to the United States Federal Trade Commission (the “FTC”), the Antitrust Division of the United States Department of Justice (the “DOJ”) and any other applicable Governmental Authority any additional information requested within their authority under the HSR Act or other Antitrust Law, use commercially reasonable efforts to obtain antitrust clearance for the transactions contemplated hereunder as soon as practicable and otherwise cooperate with each other in any such governmental antitrust clearance process. Gilead will bear all fees in connection with any filings under this Section 2.4.3(a), and each Party will bear its respective attorneys’ fees and other expenses in connection therewith. Notwithstanding the foregoing, nothing in this Section 2.4.3(a) or otherwise in this Agreement will require either Party or its Affiliates to, in connection with obtaining antitrust clearance for the transaction contemplated hereunder, (i) propose, negotiate, effect or agree to, the sale, divestiture, license or other disposition of any assets or businesses of such Party or any of its Affiliates or otherwise take any action that limits its freedom of action with respect to, or its ability to retain, any of the businesses, product lines or assets of such Party or any of its Affiliates, or (ii) litigate or otherwise formally oppose any determination (whether judicial or administrative in nature) by a Governmental Authority seeking to impose any of the restrictions referenced in clause (ii) above.

(b) Effectiveness. Following the Option Exercise Notice, Gilead may not exercise the license set forth in Section 3.1.2 unless and until: (i) the applicable waiting period provided by the HSR Act has expired or terminated and all other required antitrust clearances have been obtained (solely to the extent applicable to any Antitrust Filings) or (ii) the Option Exercise Date occurs, where Gilead determines no Antitrust Filings are required, in each case ((i) and (ii)), the “Option Effective Date.” In addition, following the Option Exercise Notice, the Option Term will continue until the earlier of the Option Effective Date or the Outside Date.

(c) Outside Date. If (i) Gilead determines any Antitrust Filings are necessary or advisable in connection with Gilead’s exercise of the Option and (ii) the Option Effective Date does not occur on or before [**] after the Option Exercise Date (the “Initial Outside Date”), then Gilead may, in its sole discretion, provide written notice to Gritstone on or prior to the applicable Initial Outside Date to extend such Initial Outside Date by [**] (the Initial Outside Date, as it may be extended, if applicable, the “Outside Date”); provided, however, that the Parties may mutually agree to extend the Outside Date if such extension is necessary for Gilead to litigate, defend against, or otherwise contest any challenge, claim,

lawsuit or other cause of action in connection with the Gilead’s exercise of the Option pursuant to or under any Antitrust Law.

(d) Further Assurances. Without limiting the foregoing obligations in this Section 2.4.3, each Party will promptly notify the other of the receipt and content of any inquiries or requests for additional information made by any Governmental Authority in connection with Gilead’s exercise of the Option and keep the other apprised on a prompt basis of the status of any such inquiry or request. To the extent permitted under Applicable Law and subject to a joint defense agreement between the Parties and their respective counsel, each Party will promptly inform the other Party of any oral communication with, and provide copies of written communications with, any Governmental Authority regarding Gilead’s exercise of the Option, and permit the other Party or its counsel to review in advance, and in good faith consider the views of the other Party or its counsel concerning, any submission, filing or communication (and documents submitted therewith) intended to be given to the applicable Governmental Authority(ies). Except as prohibited by Applicable Law, no Party will independently participate in any meeting or conference call with any Governmental Authority in respect of any such filings, investigation or other such inquiry without giving the other Party prior notice of the meeting and, to the extent permitted by such Governmental Authority, the opportunity to attend and participate.

Article III
LICENSES; EXCLUSIVITY

3.1. Licenses to Gilead.

3.1.1. Collaboration License. Subject to the terms and conditions of this Agreement, Gritstone hereby grants to Gilead and its Affiliates, during the Option Term, an exclusive (even as to Gritstone, except to the extent necessary or reasonably useful for Gritstone to perform (or have performed) the Gritstone R&D Activities under the R&D Plan in accordance with this Agreement), royalty-free, worldwide license, with the right to sublicense through multiple tiers (subject to the provisions of Section 3.1.3 and Section 3.1.4), under the Licensed Technology and Gritstone’s right, title and interest in the Joint Collaboration IP, solely for the purpose of performing (or having performed) Gilead R&D Activities in the Field of Use and for use in Regulatory Filings to enable such activities for Products in the Field of Use in the Territory; provided, however, that while such license permits Gilead to conduct Gilead R&D Activities with respect to a Product that contains, incorporates or otherwise includes one or more Other Agents in addition to the Vaccine, Gritstone does not grant to Gilead and its Affiliates hereunder any license or other rights under Licensed Technology to Exploit any Other Agent.

3.1.2. Development and Commercial License. Subject to the terms and conditions of this Agreement, Gritstone hereby grants to Gilead and its Affiliates an exclusive (even as to Gritstone), worldwide, royalty-bearing license, with the right to sublicense through multiple tiers (subject to the provisions of Section 3.1.3 and Section 3.1.4), under the Licensed Technology and Gritstone’s right, title and interest in the Joint Collaboration IP, solely (subject to Section 3.1.5) to Exploit all Products in the Field of Use in the Territory; provided, however, that, while such license permits Gilead to Exploit a Product that contains, incorporates or otherwise includes one or more Other Agents in addition to the Vaccine, Gritstone does not grant to Gilead and its Affiliates hereunder any license or other rights under Licensed Technology to Exploit any Other Agent. Gilead covenants to Gritstone that Gilead and its Affiliates and its and their Sublicensees will not exercise the rights granted to it pursuant to this Section 3.1.2 unless and until the Option Effective Date occurs.

3.1.3. Sublicensing by Gilead. Gilead and its Affiliates may grant sublicenses under Sections 3.1.1 and 3.1.2 to any Affiliate or Third Party; provided that any sublicense under Section 3.1.1 to

any Third Party will require Gritstone’s prior written consent. Any sublicense under Sections 3.1.1 and 3.1.2 will be consistent with the terms of this Agreement and will include confidentiality, non-disclosure, and non-use provisions at least as restrictive or protective of the Parties as those set forth in Article XII of this Agreement. Gilead will deliver to Gritstone notice of, and, upon Gritstone’s written request, a copy of, any executed sublicense agreement granted by Gilead to a Third Party under any of the rights and licenses granted to it under Section 3.1.1 or Section 3.1.2 (which may be redacted to protect confidential information that is not necessary to confirm the scope of the sublicensed rights and compliance with this Agreement) no later than [**] following the execution thereof; provided, however, that unless required pursuant to a Gritstone In-License Agreement under which a sublicense is granted by Gilead, Gilead shall not have such obligation to deliver notice and a copy of a sublicense agreement entered into with a Subcontractor solely for the purposes of the subcontracted activities. In no event will Gilead or its Affiliates have a license under, or grant any Third Party a sublicense under, the Licensed Technology or Gritstone’s interest in any Joint Collaboration IP for a purpose or activity outside the scope of the license grants set forth under Sections 3.1.1 and 3.1.2.

3.1.4. Gritstone In-License Agreements.

(a) Limitations on Sublicense Scope. With respect to any Licensed Know-How or Licensed Patents with respect to which Gilead receives a sublicense under any Gritstone In-License Agreement, the sublicenses granted under Section 3.1.1 or Section 3.1.2 are subject to (i) any limitations under the applicable Gritstone In-License Agreements with respect to such sublicensed rights, including with respect to the scope of licensed products, the permitted field of use, the licensed territory and the scope of exclusivity (if any) (provided, for clarity, that in no event shall the sublicense granted by Gritstone to Gilead be greater in scope than provided in Section 3.1.1 or Section 3.1.2), and (ii) terms governing prosecution, enforcement and defense of Licensed Know-How or Licensed Patents governed by the applicable agreements, including as further provided in Section 11.10.

(b) Existing In-License Agreements. Gritstone has provided to Gilead a true and complete copy of each Existing In-License Agreement as of the Effective Date. Gilead shall cause its Affiliates, and, subject to Section 3.1.4(g), its and their Sublicensees to, comply with all provisions of such Existing In-License Agreements to the extent applicable.

(c) Future Core In-License Agreements. Upon adoption by Gilead of a potential Future Core In-License Agreement as a Gritstone In-License Agreement pursuant to Section 9.7.2(c), [**] with respect to such Gritstone In-License Agreement. Subject to Section 3.1.4(f), Gritstone shall have the right to [**]. Gilead shall, and shall cause its Affiliates and, subject to Section 3.1.4(g), its and their Sublicensees to, comply with [**] (including with respect to sublicensees and the Exploitation of any Product in the Field of Use) and [**] with respect to applicable terms [**] governed by the applicable agreements, in each case, [**].

(d) Future Other In-License Agreements. Upon adoption by Gilead of a potential Future Other In-License Agreement as a Gritstone In-License Agreement pursuant to Section 9.7.2(c), Gilead shall, and shall cause its Affiliates and, subject to Section 3.1.4(g), its and their Sublicensees to, comply with [**] to the extent applicable (including with respect to sublicensees and the Exploitation of any Product in the Field of Use) and either: (i) [**], with respect to such agreement or (ii) included in the copy of the such agreement provided to Gilead for review [**] pursuant to Section 9.7.2(b)(iii), as applicable based on Gritstone’s election thereunder, or were consented to by Gilead in writing.

(e) Future Gritstone Product-Related Agreement Sublicense. Upon adoption by Gilead of a potential Future Gritstone Product-Related Agreement Sublicense as a Gritstone In-License Agreement pursuant to Section 9.7.2(c), Gilead shall, and shall cause its Affiliates and, subject to Section 3.1.4(g), its and their Sublicensees to, comply with [**] to the extent applicable (including with respect to sublicensees and the Exploitation of any Product in the Field of Use) and either: (i) [**], with respect to such agreement or (ii) included in the copy of the such agreement provided to Gilead for review [**] pursuant to Section 9.7.2(b)(iii), as applicable based on Gritstone’s election thereunder, or were consented to by Gilead in writing.

(f) Cooperation. If any question of interpretation arises with respect to any [**], at the request of either Party, the Parties shall confer in good faith as requested by either Party from time to time and discuss approaches [**]. In the event that Gritstone requests any amendment to [**], Gilead shall consider such requested amendment in good faith.

(g) Compliance by Gilead Sublicensees. If a Sublicensee (of Gilead or its Affiliates) fails to comply with a Gritstone In-License Agreement in accordance with the requirements in this Section 3.1.4 or Section 11.10 and either Gilead becomes aware or Gritstone provides notice of such failure to Gilead, then Gilead shall, within [**] of becoming aware of such failure, either (i) [**] or (ii) [**] and, in the event of either (i) or (ii), [**] this Agreement pursuant to [**] (except to the extent required to comply or maintain Gritstone’s rights under such Gritstone In-License Agreement); provided that Gilead shall remain responsible for the consequences of such breach. In the event that Gritstone provides notice to Gilead of an alleged failure to comply under this Section 3.1.4(g), if the Parties in good faith disagree as to whether there has been a failure to comply, then: (1) Gilead may contest the allegation by referring such matter, within [**]following its receipt of notice, for resolution in accordance with Section 17.5; (2) the relevant [**] with respect to such alleged failure to comply will be tolled from the date on which the disputing Party notifies the other Party of such Dispute and through the resolution of such Dispute in accordance with the applicable provisions of this Agreement (provided that such tolling is consistent with the applicable Gritstone In-License Agreement and Gritstone’s ability to comply with and maintain Gritstone’s rights under such Gritstone In-License Agreement); and (3) if it is ultimately determined that such failure to comply occurred, then Gilead will have the right to cure such failure to comply, after such determination, within the [**] cure period in accordance with this Section 3.1.4(g), which will commence as of the date of such determination (to the extent such a cure is consistent with the applicable Gritstone In-License Agreement and Gritstone’s ability to comply with and maintain Gritstone’s rights under such Gritstone In-License Agreement).

(h) Sublicense under [**]. Notwithstanding Section 3.1.2 or any other terms or conditions of this Agreement to the contrary, if Gilead requests a sublicense under Section 2.1(a) of the [**], then (i) Gritstone will grant such sublicense to Gilead, (ii) [**] will be considered an Existing In-License Agreement as of the effective date of such sublicense, and (iii) in addition to being subject to the provisions of Section 3.1.3 and Section 3.1.4, such sublicense shall also subject to all the obligations and requirements of [**] as they pertain to any Product for which a sublicense is granted thereunder, including Sections [**], and without limitation to the foregoing, Gilead hereby explicitly agrees to the requirements set forth in [**] of [**], as required pursuant to [**]. [**].

3.1.5. Sublicense under [**]. Notwithstanding Section 3.1.2 or any other terms or conditions of this Agreement to the contrary and subject to the provisions of Section 3.1.3 and Section 3.1.4, the sublicense granted by Gritstone under [**] is, as provided in [**] to (a) [**], or (b) [**], in each

case ((a) and (b)), in the Field of Use during the term of [**]. For purposes of this Section 3.1.5, [**] have the meanings given in [**] has the meaning given [**] has the meaning given [**].

3.2. License to Gritstone.

3.2.1. Collaboration License. Subject to the terms and conditions of this Agreement, Gilead hereby grants to Gritstone, during the Option Term, a non-exclusive, royalty-free, worldwide license, with the right to sublicense through multiple tiers (subject to the provisions of Section 3.2.3) under the Gilead Licensed Technology solely for the purpose of performing (or having performed) the Gritstone R&D Activities or Gritstone’s activities under the Supply Agreement.

3.2.2. Grantback License. Subject to the terms and conditions of this Agreement, Gilead hereby grants to Gritstone a non-exclusive, royalty-free, worldwide license, with the right to sublicense through multiple tiers (subject to the provisions of Section 3.2.3) under the Selected Collaboration IP [**]; provided, that Gilead does not [**]; provided, further, that such license does not include any [**]; provided, further, [**]. In no event will Gritstone or its Affiliates have a license under, or grant any Third Party a sublicense under, the Selected Collaboration IP for a purpose or activity outside the scope of the license grant set forth under this Section 3.2.2.

3.2.3. Sublicensing by Gritstone. Gritstone may not grant any sublicense of the rights granted to it under Section 3.2.1 without the prior written consent of Gilead. Any sublicense granted by Gritstone of the rights granted to it under Section 3.2.1 or Section 3.2.2 will be consistent with the terms of this Agreement and will include confidentiality, non-disclosure and non-use provisions at least as restrictive or protective of the Parties as those set forth in Article XII of this Agreement. Further, (a) [**], and (b) [**], provided that such sublicense shall be sufficient to satisfy the requirements of this clause (b) if [**]. Gritstone will deliver to Gilead notice of, and, upon Gilead’s written request, a copy of, any executed sublicense agreement granted by Gritstone of the rights granted to it under Section 3.2.1 (redacted as necessary to protect confidential information that is not necessary to confirm compliance with this Agreement) no later than [**] following the execution thereof.

3.3. Subcontracting. Each Party may subcontract the performance of tasks and other obligations hereunder to its Affiliates or Third Parties (provided that [**]), which subcontract may include a sublicense of rights necessary for the performance of the subcontract as reasonably required, provided that [**], any such Third Party will not be deemed to be a Sublicensee solely as a result of such sublicense to the extent granted to enable the performance by the subcontractor of the subcontracted activities. Notwithstanding any other term or condition of this Agreement, in the event that the R&D Plan provides for Gritstone to conduct or have conducted any [**] and Gritstone engages [**] to perform such [**]: (a) such performance may, at Gritstone’s election, be conducted under the [**]; (b) the terms of the [**] shall be deemed to meet all requirements for subcontracts under this Agreement and (c) Gritstone shall be deemed in compliance with all its applicable obligations under this Agreement with respect to the engagement of [**] to perform such [**] under the [**].

3.4. No Other Rights; Retained Rights. Each Party expressly reserves and retains all Patent Rights, Know-How or other intellectual property rights not expressly granted herein, and no right or license under any Patent Rights, Know-How or other intellectual property rights of either Party is granted or will be granted by implication. Without limiting the immediately preceding sentence and for clarity, Gritstone will retain the right to use one or more HIV or SIV polypeptides in connection with Research outside the Field of Use. Except as otherwise expressly provided in this Agreement, neither Party will receive any

rights under this Agreement to own, use, or access the Patent Rights, Know-How, or other intellectual property rights of the other Party.

3.5. Exclusivity.

3.5.1. Exclusivity Obligation. [**].

3.5.2. Exception for Third Party Acquisition. Notwithstanding Section 3.5.1, except in the case of a Change of Control (which is governed by Section 3.5.3), if Gritstone or its Affiliates acquires a Third Party (whether such acquisition occurs by way of a purchase of assets, merger, consolidation, change of control or otherwise) (an “Third Party Acquisition”) that is, prior to such acquisition, researching, developing, manufacturing or commercializing a product where such activities, if conducted by Gritstone or its Affiliates at such time, would constitute a breach of Section 3.5.1 (a “Competing Product”), then Gritstone will not be in breach of Section 3.5.1 as a result of such Third Party Acquisition; provided, that Gritstone provides written notice to Gilead no later than [**] following the closing of such Third Party Acquisition that such Third Party Acquisition occurred and whether it elects to either: (x) include such Competing Product as a Product within the scope of this Agreement (subject to Gilead’s prior written approval), in which case such Competing Product in the Field of Use will be deemed a Product and be subject to the terms and conditions of this Agreement; (y) divest its rights in and to such Competing Product in the Field of Use, in which case, Gritstone and the Acquired Person will [**] within [**] (the “Divestment Period”) in which event the continued Exploitation of such Competing Product during the Divestment Period while the divestment is being pursued shall not constitute a breach of Section 3.5.1; provided, that Gritstone and the Acquired Person [**], or (z) cease all research, development, manufacturing and commercialization activities with respect to such Competing Product in the Field of Use, in which case, within [**], [**] except in the case of [**]; provided that [**]. No Licensed Technology, Joint Collaboration IP or Gritstone’s Confidential Information shall be used in connection with any subsequent performance of any such activities with respect to any such Competing Products in the Field of Use following the consummation of such Third Party Acquisition. In the event that, following notice to Gilead that Gritstone (or its Affiliate) intends to pursue divestment of the applicable Competing Product pursuant to clause (y) of this Section 3.5.2, such divestment is not completed during the Divestment Period, Gritstone shall notify Gilead whether it would like to elect to include such Competing Product as a Product pursuant to clause (x) above (subject to Gilead’s consent) or cease all research, development, manufacturing and commercialization activities with respect to such Competing Product in the Field of Use pursuant to clause (z) above (provided that in such case such activities shall be required to cease within [**] except in the case of [**]; provided that [**]). In the event that, following notice to Gilead that Gritstone (or its Affiliate) would like to include such Competing Product as a Product under this Agreement but Gilead does not approve of such inclusion, Gritstone shall notify Gilead whether it elects to divest its rights to such Competing Product pursuant to clause (y) above or cease all research, development, manufacturing and commercialization activities with respect to such Competing Product in the Field of Use pursuant to clause (z) above (provided that in such case such activities shall be required to cease [**] except in the case of [**]; provided that [**]. As used herein, “divest” means, with respect to a Competing Product, [**].

3.5.3. Exception for Change of Control. Notwithstanding the foregoing, in the event of a Change of Control of Gritstone, from and after the date of such Change of Control, [**].

3.5.4. Certain Third Party Arrangements. Gilead acknowledges that (a) prior to the Effective Date, Gritstone entered into (i) [**]; (ii) [**]; and (iii) [**], pursuant to which, [**]; and (b) following the Effective Date, Gritstone may [**] pursuant to which Gritstone may [**] similar terms to

those contained in [**]; provided that for [**] to be subject to this Section 3.5.4, Gritstone shall provide Gilead with notice of, and, upon Gilead’s written request, a redacted copy of, any such [**]. The Parties agree that this Section 3.5 is not intended and shall not be construed to restrict the agreements described in this Section 3.5.4 and Gritstone’s continued performance of such obligations will not be considered a breach of Section 3.5.1. Gritstone represents, warrants and covenants [**]) would or will require Gritstone or its Affiliates to [**].

3.6. Change of Control.

3.6.1. If Gritstone undergoes a Change of Control during the Term, then Gilead shall have the right, in its sole and absolute discretion, by written notice delivered to Gritstone (or its successor) at any time following the written notice contemplated in clause (a) of Section 3.5.3, to modify the Parties rights and obligations under this Agreement in any or all of the following ways, effective as of the date Gilead delivers such notice to Gritstone: (a) Gilead will have the right to conduct any activities allocated to Gritstone under the R&D Plan (and will have final decision-making authority at the JSC with respect to any such assumed activities or the costs thereof), (b) Gilead will have the right terminate the Supply Agreement and assume responsibility for supply of Vaccine, and (c) Gilead will have the right to immediately dissolve the JSC with any decisions formerly to be made by the JSC under this Agreement to be made (i) mutually by the Parties (subject to the final decision-making authority principles as set forth in Section 4.2, as applicable) or (ii) with respect to any activities Gilead elects to conduct as described in clause (a), by Gilead.

3.6.2. Gritstone covenants that, following such Change of Control, there shall be no material change in the level or nature of efforts or resources expended by Gritstone and its Affiliates in the performance of Gritstone’s obligations under this Agreement, which material change would reasonably be expected to adversely impact (a) Gritstone’s ability to perform its obligations under this Agreement or (b) the Exploitation of any Product under this Agreement.

Article IV
GOVERNANCE

4.1. Joint Steering Committee.

4.1.1. Formation. Promptly after the Effective Date, the Parties will establish a joint steering committee (the “Joint Steering Committee” or “JSC”) to coordinate, oversee and, as applicable, approve the Parties’ activities under this Agreement during the Option Term until dissolution of the JSC pursuant to this Section 4.1.1. The JSC will dissolve upon the earlier of (a) Gilead’s exercise of the Option, (b) termination of this Agreement or (c) dissolution by Gilead pursuant to Section 3.6.1 in the event Gritstone undergoes a Change of Control; provided that if Gilead exercises the Option prior to completion of the R&D Plan, Gilead may elect for the JSC to remain intact until completion of all activities under the R&D Plan.

4.1.2. Membership. The JSC will consist of three (3) representatives from each of the Parties (or such other equal number of representatives as the JSC may determine), each with the requisite experience and seniority to enable such person to make decisions on behalf of such Party with respect to the issues falling within the jurisdiction of the JSC. From time to time, each Party may substitute one (1) or more of its representatives on the JSC upon written notice to the other Party. Gilead will designate one (1) of its JSC representatives as one (1) of the co-chairpersons of the JSC, and Gritstone will designate one (1) of its representatives as the other co-chairperson of the JSC (each, a “JSC Co-Chair”). The JSC Co-Chairs, in consultation with the Alliance Managers, will have the following roles and responsibilities: (a) to call meetings, send notice of each such meeting and designate the time, date and place of each such

meeting; (b) to convene or poll the representatives by other permitted means; and (c) to approve (including via email) the final minutes of any meeting of the JSC.

4.1.3. Meetings and Minutes. Unless otherwise agreed by the Parties, until dissolution of the JSC pursuant to Section 4.1.1, the JSC will meet quarterly to address matters within its jurisdiction. Meetings of the JSC may be held in person or by audio or video teleconference; provided, that unless otherwise agreed by the Parties, the location of any such in-person meetings will alternate between locations designated by Gilead and locations designated by Gritstone. The JSC Co-Chairs will be responsible for scheduling meetings and setting agendas based on the input of each Party. The JSC Co-Chairs will prepare and circulate for review and approval of the Parties minutes of each meeting promptly after the meeting. The Parties will agree on the minutes of each meeting promptly, but in no event later than [**] Business Days after receipt of such meeting minutes.

4.1.4. Procedural Rules. The JSC will have the right to adopt such standing rules as will be necessary for its work to the extent that such rules are not inconsistent with this Agreement. A quorum will exist whenever there is present at a meeting at least two (2) representatives appointed by each Party. The JSC will take action by consensus of the representatives present at a meeting at which a quorum exists, with each Party having a single vote irrespective of the number of representatives of such Party in attendance, or by a written resolution signed by at least two (2) representatives appointed by each Party. Employees or consultants of either Party that are not representatives of the Parties on the JSC may attend JSC meetings with prior notice and with respect to any consultants, prior consent, of the other Party; provided, however, that such attendees: (a) will not vote; (b) will not be counted when determining whether a quorum exists at any such meeting; and (c) will be bound by obligations of confidentiality and non-disclosure equivalent to those set forth in Article XII.

4.1.5. Specific Responsibilities. Until dissolution of the JSC pursuant to Section 4.1.1, the JSC’s responsibilities are as follows: (a) coordinating and serving as a forum for discussing the Parties’ activities under the R&D Plan; (b) reviewing and approving any amendments to the R&D Plan proposed by either Party; (c) reviewing and approving any amendments to the Gritstone R&D Budget proposed by either Party; (d) resolving disputes that arise in connection with the performance of the R&D Plan; (e) coordinating and serving as a forum for discussing the Parties’ activities under the Supply Agreement; (f) resolve matters presented by any ad hoc committee that are within the scope of responsibilities delegated to such ad hoc committee by the JSC; and (g) fulfilling such other responsibilities as may be allocated to the JSC under this Agreement, the Supply Agreement or by mutual written agreement of the Parties.

4.2. Dispute Resolution.

4.2.1. JSC. If after reasonable discussion and good faith consideration of each Party’s view on a particular matter before the JSC and within the scope of its authority, the representatives of the Parties on the JSC cannot reach consensus as to such matter in accordance with Section 4.1.4 within [**] after such matter was brought to the JSC for resolution, then either Party may refer such disagreement to the Senior Officers for resolution. If the Senior Officers cannot resolve such matter within [**] after such matter has been referred to them in accordance with this Section 4.2.1, then [**]. Notwithstanding the foregoing but subject to Section 3.6.1, without [**], no decision of the JSC [**] may be adopted, in each case, (a) to the extent pertaining to [**]; (b) with respect to or that may result in a material change [**]; or (c) with respect to [**], that may (i) [**]or (ii) [**].

4.2.2. Limitations on Authority. Each Party will retain the rights, powers and discretion granted to it under this Agreement, and no such rights, powers or discretion will be delegated to or vested in the JSC unless such delegation or vesting of rights, powers or discretion is expressly provided for in this

Agreement or the Parties expressly so agree in writing. The JSC will not have the power to amend, modify or waive compliance with this Agreement or the Supply Agreement, which may only be amended, modified or waived as provided in Section 17.7 or the Supply Agreement.

4.3. Alliance Managers. Promptly following the Effective Date, each Party will appoint (and notify the other Party of the identity thereof in writing) one (1) senior representative having a general understanding of therapeutic vaccine Research and Development to act as its alliance manager under this Agreement (each, an “Alliance Manager”). The Alliance Managers will serve as the contact points between the Parties and will be primarily responsible for facilitating the flow of information and otherwise promoting communication, coordination and collaboration between the Parties, including: (a) facilitating periodic communications between the Parties in connection with the Parties’ reporting requirements; (b) providing single-point communication for seeking consensus both internally within the respective Party’s organization and together regarding key global strategy and planning issues, as appropriate, including facilitating review of external corporate communications; (c) raising cross-Party or cross-functional disputes in a timely manner; and (d) consulting with the JSC Co-Chairs, in accordance with Section 4.1.2. Each Alliance Manager may be a member of the JSC and vice versa; provided, that such Alliance Manager has the requisite experience and seniority to enable such person to make decisions on behalf of such Party with respect to the issues falling within the jurisdiction of the JSC. From time to time, each Party may substitute its Alliance Manager at any time upon written notice to the other Party.

4.4. Ad-Hoc Committees. By mutual agreement, the JSC may establish and disband ad-hoc committees having such responsibilities as may be expressly delegated by the JSC; provided that the JSC may not grant any responsibilities to an ad-hoc committee that are beyond the scope of the responsibilities of the JSC as set forth herein. Each such committee will consist of the number of representatives that is mutually agreed upon by the Parties. Each Party shall be free to change its representatives on any such committee by notice to the other Party or to send substitute representatives to any meeting of any such committee (provided that any non-employee representatives must receive prior approval of the JSC to attend committee meetings). Each Party’s representatives and any substitutes for such representatives on any such committee shall be bound by obligations of confidentiality and non-disclosure equivalent to those set forth in Article XII. No such committee shall have the authority to bind the Parties hereunder. Each such committee shall make recommendations to, and any unresolved disputes shall be referred for resolution to, the JSC.

4.5. Costs of Governance. The Parties agree that the costs incurred by each Party in connection with its participation at any meetings under this Article IV will be borne solely by such Party.

Article V
TECHNOLOGY TRANSFERS

5.1. Disclosure of Know-How.

5.1.1. Initial Know-How Transfer. Gritstone will provide to Gilead copies of the Licensed Know-How (other than Licensed Know-How relating to the Manufacture of Products, any transfer of which will be performed under Section 7.4, Section 7.5 or pursuant to the Supply Agreement as provided therein) that (a) exists as of the Effective Date, (b) [**] and (c) is either (i) [**] or (ii) otherwise reasonably requested by Gilead, in each case no later than [**] in a format reasonably acceptable to both Parties.

5.1.2. Periodic Know-How Transfers.

(a) At Gilead’s request, the Parties shall meet and confer in accordance with this Section 5.1.2, through research or development colleagues that each Party may designate from time to time, regarding [**] (any such meeting, a “R&D Team Review Meeting”). Gritstone shall use [**]. Such meetings shall occur [**], and thereafter on [**] or as otherwise mutually agreed until [**].

(b) As Gilead may reasonably request [**] following each R&D Team Review Meeting, [**], Gritstone will provide to Gilead copies of [**] and that is (a) [**]; or (b) [**], and, in each case ((a) and (b)), [**]; provided that, with respect to any [**]that is Controlled by Gritstone or its Affiliates [**], Gritstone’s obligations to [**] shall be subject to the applicable [**], as applicable. Gritstone shall [**] in a format reasonably acceptable to both Parties, with respect to such Selected Licensed Data. For purposes of this Agreement, “Selected Licensed Data” means [**], provided that, [**].

(c) As Gilead may reasonably request [**] following any such R&D Team Review Meeting, [**], Gritstone will provide to Gilead copies of [**], provided that, with respect to any [**] that is Controlled by Gritstone or its Affiliates [**], Gritstone’s obligations to [**] shall be subject to the applicable [**], as applicable with respect to such [**]. Gritstone shall [**] in a format reasonably acceptable to both Parties.

5.1.3. Cooperation. Without limiting the foregoing, to the extent reasonably requested by Gilead for Gilead’s conduct of Gilead R&D Activities or Gilead’s Exploitation of any Vaccine component of a Product pursuant to this Agreement [**], Gritstone shall consider in good faith any other reasonable requests from Gilead for Gritstone to transfer Licensed Know-How not otherwise covered by Section 2.1.3 or this Section 5.1 (other than Licensed Know-How relating to the Manufacture of Products, which shall be addressed under Section 7.4, Section 7.5 or under the Supply Agreement). For clarity, safety data exchanges will occur pursuant to the Pharmacovigilance Agreement entered into pursuant to Section 6.5.

5.1.4. Limitations. Notwithstanding the foregoing or any term or condition of this Agreement, unless Gritstone otherwise agrees in writing, Gritstone shall not have an obligation to provide or license to Gilead under this Agreement (a) [**], or (b) [**], and this Agreement shall be deemed to exclude such data (under clauses (a) and (b)) from the Licensed Technology licensed to Gilead in this Agreement; provided that this Section 5.1.4 shall not modify Gritstone’s obligations pursuant to the last sentence of Section 6.3.4 or under the Pharmacovigilance Agreement.

5.2. Consultation and Assistance. In addition to providing copies of the relevant Licensed Know-How in accordance with Section 5.1, Gritstone will make its personnel reasonably available to Gilead, [**], so as to enable Gilead to practice the Licensed Technology in connection with its performance of the Gilead R&D Activities and the Exploitation of the Products (and any components thereof). To the extent reasonably requested by Gilead after Gilead’s exercise of the Option, Gritstone will provide technical assistance and support to enable Gilead to utilize Licensed Know-How with respect to the [**] for use Exploiting the Products (and any components thereof), including by coordinating with [**] to request that [**] provide reasonable ongoing technical support in connection with the foregoing [**] (it being understood that [**] is not obligated to provide such support pursuant to the [**]). If Gilead requests assistance pursuant to this Section 5.2 [**].

Article VI
DEVELOPMENT AND REGULATORY MATTERS

6.1. Development. From and after the Option Effective Date, Gilead will be solely responsible for conducting all Development activities with respect to Products in the Field of Use in the Territory, at Gilead’s sole expense.

6.2. Development Reports. From and after the Option Effective Date, Gilead will provide to Gritstone within [**] after the end of each [**] a written report, substantially in the form attached hereto as Schedule 6.2, which [**] during the prior [**] with respect to Products in the Field of Use in [**]. Each report will be the Confidential Information of Gilead.

6.3. Regulatory.

6.3.1. General Responsibility. From and after the Effective Date, subject to Section 6.3.2, as between the Parties, Gilead will have the sole right (and will solely control, at its discretion), itself or with or through its Affiliates, Sublicensees or other Third Parties, to: (a) prepare and submit to applicable Regulatory Authorities all Regulatory Materials, including INDs, for Products; (b) obtain and maintain all Regulatory Approvals for Products; and (c) conduct communications with the Regulatory Authorities for the Products.

6.3.2. Gritstone Responsibility. As between the Parties, during the Option Term, Gritstone will be responsible for [**], except that Gilead shall remain responsible for [**]. Gritstone will (a) [**] (subject to the foregoing proviso) in a timely manner to [**]; (b) [**]; (c) timely prepare [**]; and (d) provide timely support [**]. Without limiting the foregoing, Gritstone will assist Gilead as may be reasonably requested by Gilead in connection with Gilead’s preparation, submission to Regulatory Authorities and maintenance of Regulatory Materials for respective Products, including Gilead’s preparation for [**]. Notwithstanding the foregoing or any term or condition of this Agreement, including Section 5.1, this Section 6.3.2 and Section 6.3.5, in no event will Gilead have [**].

6.3.3. Ownership. All Regulatory Materials generated under this Agreement with respect to any Product, including in the course of the R&D Program, will be owned by and held in the name of Gilead or its designee. Nothing contained in this Section 6.3.3 is intended or shall be construed to convey to Gilead any ownership of any Licensed Know-How contained in any such Regulatory Materials or any Gritstone Operational Documentation.

6.3.4. Communication with Regulatory Authorities. For clarity and without limiting Section 6.3.1, Gilead will have the exclusive right to correspond or communicate with Regulatory Authorities regarding the Products and other regulatory matters in the Field of Use under this Agreement. Unless required by Applicable Law, Gritstone, its Affiliates and its Subcontractors will not correspond or communicate with Regulatory Authorities regarding any Product without first, in each case, obtaining Gilead’s prior written consent, either during or after the Option Term; provided, that, upon Gilead’s request, Gritstone or its Affiliates will attend any meeting with a Regulatory Authority regarding any Product. If Gritstone, its Affiliates or its Subcontractors receive any correspondence or other communication from a Regulatory Authority regarding a Product, Gritstone will provide Gilead with access to or copies of all such material written or electronic correspondence promptly (and in any event, within [**]) after its receipt. If any correspondence, communication or meeting with a Regulatory Authority regarding the Products or other regulatory matters in the Field of Use under this Agreement concerns a [**], Gilead will [**]. If Gritstone has any correspondence, communication or meeting with a Regulatory Authority [**].

6.3.5. Right of Reference; Access to Data. Gilead and its designees will have, and Gritstone (on behalf of itself and its Affiliates) hereby grants to Gilead and its designees, a right of reference (without any further action required on the part of Gritstone or its Affiliates, except as set forth in Section 6.3.2, whose authorization to file this consent with any Regulatory Authority is hereby granted) to the [**] and its designees to exercise its rights and perform its obligations under this Agreement with respect to the applicable Products in the Field of Use[**]. In the interim, Gilead and its designees will [**], and Gritstone will ensure that Gilead and its designees [**]; provided that [**] in a format reasonably acceptable to both Parties. During the Term, with respect to other products or programs of Gritstone or its Affiliates, upon Gilead’s reasonable request for rights of reference with respect to Regulatory Materials Controlled by Gritstone and its Affiliates with respect to other products and programs, as may be reasonably useful to Gilead with respect to the Vaccine component of any Product, [**].

6.4. Development Diligence. Beginning as of the Option Effective Date and subject to the terms and conditions of this Agreement, Gilead will itself, or with or through its Affiliates, Sublicensees or other Third Parties, use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for (a) [**] in the Field of Use; and (b) [**]. For clarity, subject to compliance with this Section 6.4 and the other applicable terms and conditions of this Agreement, the Development of Products will be in Gilead’s sole discretion.

6.5. Pharmacovigilance. Prior to [**], the Parties will agree upon and implement a procedure for the mutual exchange of adverse event reports and safety information associated with the Products. Details of the operating procedure respecting such adverse event reports and safety information exchange will be the subject of a mutually-agreed written pharmacovigilance agreement between the Parties which will be entered into within the same period (the “Pharmacovigilance Agreement”).

6.6. Compliance. Each Party agrees that in performing its obligations under this Agreement, it: (a) will comply with all Applicable Law, including applicable current international regulatory standards, such as GMP, GLP, GCP, and other rules, regulations, and requirements; and (b) will not employ or use any person that has been debarred under Sections 306(a) or 306(b) of the FDCA.

6.7. Regulatory Notices. In the event that: (a) based on the results of an audit or inspection by a Regulatory Authority of any facility of a Party (including its CRO or CMO, subject to the terms of such Party’s contract with such CRO or CMO) involved in the Research, Development or Manufacture of a Product, a Regulatory Authority notifies such Party in writing of a finding; or (b) a Regulatory Authority takes, or gives notice in writing of its intent to take, any regulatory action with respect to any activity of a Party, in each case ((a) or (b)), which finding or action would reasonably be expected to have a material adverse effect on, with respect to Gritstone, its activities under any R&D Plan or Manufacture of a Product or, with respect to Gilead, any activities under any R&D Plan or the Research, Development, Manufacture or Commercialization of a Product, such Party will promptly notify the other Party thereof and provide a copy of such notice or summary of such action taken, as applicable. Such notice, finding, action, and all information related thereto will constitute the Confidential Information of the disclosing Party. Notwithstanding the foregoing, this Section 6.7 will terminate and be of no further force or effect, on a Product-by-Product basis, following First Commercial Sale of such Product.

Article VII
MANUFACTURING

7.1. Supply Agreement. Concurrent with the Effective Date, the Parties will execute a supply agreement (“Supply Agreement”) (and a corresponding quality agreement with customary terms and conditions) pursuant to which Gritstone will Manufacture and supply (a) Research Supply Product (as

defined in the Supply Agreement) [**], [**] and (b) GMP Supply Product containing [**] to the extent necessary for approximately [**].

7.2. Manufacturing. Subject to Section 7.1, the terms of the Supply Agreement and the Parties’ rights and responsibilities in connection with the R&D Program as provided in the R&D Plan, Gilead and its Affiliates or its Sublicensees will be solely responsible, at Gilead’s expense, for the Manufacture of the Products being Developed or Commercialized under this Agreement.

7.3. Manufacturing Know-How and Assistance. In addition to its obligations under Section 7.1 and without limiting its obligations under the Supply Agreement, during the Term, Gritstone will [**] provide assistance to Gilead or its designee, [**], to enable Gilead or its designee, in an efficient and timely manner, to prepare for Manufacturing of the Product, it being understood that any Manufacturing technology transfer and support for obtaining Regulatory Approvals for Manufacturing shall be carried out pursuant to, and governed by, Section 7.4. Without limitation to any amounts due to Gritstone pursuant to the terms of the Supply Agreement, if Gilead requests assistance pursuant to this Section 7.3, [**].

7.4. Manufacturing Technology Transfer. Without limiting the other provisions of this Article VII or Gritstone’s obligations under the Supply Agreement, as soon [**] following the Option Effective Date or [**] of Gritstone (and [**] to complete no later than [**] after the Option Effective Date or such written notice), Gritstone will transfer or cause to be transferred (from Gritstone, its Affiliates, or its CMOs) to Gilead and its designees copies (in writing and in an electronic format) of Licensed Know-How Controlled by Gritstone or its Affiliates with respect to the Manufacturing process for the Product supplied by Gritstone to Gilead pursuant to the Supply Agreement, as such Licensed Know-How is further described in Schedule 7.4 [**], in order to enable Gilead and its designees to [**] (such transfer, the “Manufacturing Technology Transfer”). Such transfers will include [**] as such Licensed Know-How is further described in Schedule 7.4. Promptly upon Gilead’s initiation of the Manufacturing Technology Transfer, the Parties will meet and confer regarding the Licensed Know-How used by or on behalf of Gritstone to Manufacture Product for Gilead pursuant to the Supply Agreement and the Parties will update Schedule 7.4 to the extent reasonably requested by Gilead based on such discussions. In addition, [**] (such period, the “Transition Period”), Gritstone will [**] to Gilead and its designees [**] in order to ensure an orderly transition of the Manufacturing technology and operations to Gilead and its designees and to assist Gilead and its designees pursuant to this Section 7.4 in the Manufacture of the Products. [**].

7.5. Future Manufacturing Improvements. At the request of either Party, the Parties shall meet and confer [**] during the period following the Manufacturing Technology Transfer and prior to [**] regarding any Transferrable Manufacturing Improvements. With respect to Transferrable Manufacturing Improvements [**], Gritstone will transfer or cause to be transferred (from its Affiliates or its CMOs) to Gilead and its designees copies (in writing and in an electronic format) of such Licensed Know-How detailing identified Transferrable Manufacturing Improvements, as is [**] to enable Gilead and its designees to [**], provided that, with respect to any [**] that is Controlled by Gritstone or its Affiliates [**], Gritstone’s obligations [**] shall be subject to the applicable [**], as applicable, with respect to such [**]. [**].

7.6. Gritstone Operational Documentation. To the extent reasonably requested by Gilead during the term of the Supply Agreement, Gritstone will permit Gilead pursuant to the audit provisions of the Supply Agreement to review, during regular business hours, the Gritstone Operational Documentation at Gritstone’s facilities to the extent such documents or information is reasonably useful for Gilead to conduct Research, Development or Manufacturing activities under this Agreement.

7.7. Transfer Limitation. Notwithstanding any term or condition of this Article VII (including Schedule 7.4) or this Agreement to the contrary, in no event shall Gritstone have any obligation to transfer, cause to be transferred or provide any [**], or any [**], unless Gilead has either (i) [**]or (ii) [**], in a form reasonably satisfactory to Gritstone [**].

Article VIII
COMMERCIALIZATION

8.1. Commercialization. From and after the Option Effective Date, Gilead will be solely responsible for Commercializing Products in the Field of Use in the Territory, at Gilead’s sole expense.

8.2. Commercialization Diligence. Following Regulatory Approval of a Product in the Field of Use in [**], Gilead will itself, or with or through its Affiliates, Sublicensees or other Third Parties, use [**] to Commercialize such Product in the Field of Use in [**]. If Gilead’s sublicense under the Genevant Agreement is in effect, following Regulatory Approval of [**] (for clarity, [**]) in the Field of Use in (i) [**] and (ii) [**], Gilead will [**]. For clarity, subject to compliance with this Section 8.2 and the other applicable terms and conditions of this Agreement, the Commercialization of the Products will be in Gilead’s sole discretion.

Article IX
FINANCIAL PROVISIONS

9.1. Upfront Payment. In consideration of the licenses and rights granted to Gilead and its Affiliates hereunder, within [**] days following the Effective Date, Gilead will pay Gritstone a non-refundable, non-creditable, one-time upfront payment of Thirty Million Dollars ($30,000,000).

9.2. Equity Investment. Concurrently with the execution of this Agreement, the Parties will execute the Stock Purchase Agreement in the form attached hereto as Schedule 9.2 (the “Stock Purchase Agreement”), pursuant to which Gilead will purchase the Shares (as such term is defined in the Stock Purchase Agreement) on the terms set forth in the Stock Purchase Agreement.

9.3. Option Exercise Fee. In the event that Gilead exercises (in its sole discretion) the Option pursuant to Section 2.4, Gilead will pay Gritstone [**] within [**] days after receipt of an invoice from Gritstone for such payment (such payment, the “Option Exercise Fee”). For clarity, Gritstone will not issue an invoice for the Option Exercise Fee until on or after the [**].

9.4. Milestone Payments.

9.4.1. Development Milestones. In further consideration of the licenses and rights granted to Gilead and its Affiliates hereunder, Gilead will make one-time milestone payments to Gritstone set forth in Table 9.4.1 below upon the first achievement by Gilead or its Affiliates or Sublicensees of each of the development milestone events set forth in Table 9.4.1 below for the first Product to achieve such milestone event (the development milestone events set forth in Table 9.4.1, the “Development Milestone Events” and the development milestone payments set forth in Table 9.4.1, the “Development Milestone Payments”). For the avoidance of doubt, each Development Milestone Payment hereunder will be payable only once upon the first achievement of the applicable Development Milestone Event. If Gilead or its Affiliates or sublicensees achieve all Development Milestone Events, then the maximum amount payable by Gilead under this Section 9.4.1 is [**]. All payments to be made pursuant to this Section 9.4.1 will be made as provided in Article X.


Table 9.4.1 - Development Milestone Event	Development Milestone Payment
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]

9.4.2. Commercial Milestones. Gilead will make one-time milestone payments to Gritstone set forth in Table 9.4.2 below upon the achievement by Gilead or its Affiliates or sublicensees of each of the sales-based milestones events set forth in Table 9.4.2 below with respect [**] (for each Product, the “Per Product Annual Net Sales,” and the sales-based milestone events set forth in Table 9.4.2, the “Sales Milestone Events,” and the sales-based milestone payments set forth in Table 9.4.2, the “Sales Milestone Payments” and together with the Development Milestone Payments, the “Milestone Payments”). For purposes of this Section 9.4.2, [**]. Each of the Sales Milestone Payments set forth below will be payable only once upon the first achievement of the applicable Sales Milestone Event. If Gilead or its Affiliates or sublicensees achieve all Sales Milestone Events, then the maximum amount payable by Gilead under this Section 9.4.2 is [**]. All payments to be made pursuant to this Section 9.4.2 will be made as provided in Article X.


Table 9.4.2 - Sales Milestone Event	Sales Milestone Payment
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]
[**]	[**]

9.5. Royalty Payments.

9.5.1. Royalty Rates. In further consideration of the licenses and rights granted to Gilead and its Affiliates hereunder, subject to the provisions of Section 9.6, on a Product-by-Product basis, Gilead will pay to Gritstone royalties in the amount of the marginal royalty rates set forth in Table 9.5.1 below based on the Per Product Annual Net Sales for such Product (such payments, “Royalties”). For purposes of this Section 9.5, [**]. For clarity, the royalty tiers will be calculated [**]. All payments made pursuant to this Section 9.5.1 will be made as provided in Article X.


Table 9.5.1 - Pre Product Annual Net Sales	Royalty Rate
Portion of Per Product Annual Net Sales that is less than [**]	[**]
Portion of Per Product Annual Net Sales that is equal to or greater than [], and less than []	[**]
Portion of Per Product Annual Net Sales that is equal to or greater than [], and less than []	[**]
Portion of Per Product Annual Net Sales that is equal to or greater than [], and less than []	[**]
Portion of Per Product Annual Net Sales that is equal to or greater than [], and less than []	[**]
Portion of Per Product Annual Net Sales that is equal to or greater than [], and less than []	[**]
Portion of Per Product Annual Net Sales that is equal to or greater than [**]	[**]

9.5.2. Royalty Term. On a Product-by-Product and country-by-country basis, Gilead’s obligation to pay Royalties for a Product in a country will begin upon the First Commercial Sale of such Product in such country and will expire upon the last to occur of (a) [**]; (b) [**]; and (c) [**] (the “Royalty Term”). Upon expiration of the Royalty Term for a given Product in a given country (i) no further Royalties will be payable in respect of sales of such Product in such country, and (ii) the licenses granted to Gilead under Section 3.1.2 with respect to the Exploitation of such Product in such country will automatically become fully paid-up, perpetual, irrevocable and royalty free. For clarity, only a single Royalty will be payable as a result of one or more Valid Claims in a Licensed Patent Covering the sale of such Product during the applicable Royalty Term. On a Product-by-Product and country-by-country basis, from and after the expiration of the Royalty Term for a Product in a country, Net Sales of such Product in such country shall be excluded for purposes of calculating the Net Sales thresholds set forth in Section 9.4.2 and the Net Sales thresholds and ceilings set forth in Section 9.5.1.

9.6. Royalty Reductions.

9.6.1. No Valid Claim. On a Product-by-Product and country-by-country basis, if the sale of such Product is no longer Covered by a Valid Claim within the Licensed Patents in such country, then the royalties payable with respect to such Product during the Royalty Term pursuant to Section 9.5 in such country will be reduced by [**] during such period.

9.6.2. Loss of Market Exclusivity. On a Product-by-Product and country-by-country basis, if [**], then, thereafter, the royalties payable with respect to annual Net Sales of such Product during the Royalty Term pursuant to Section 9.5, as may be adjusted by Section 9.6.1, in such country will be reduced to [**]of the royalties otherwise payable pursuant to Section 9.5, as may be adjusted by Section 9.6.1. [**].

9.7. Third Party Obligations.

9.7.1. Product-Specific Third Party IP. [**] will [**] a license agreement or otherwise acquire rights to Patent Rights, Know-How or other intellectual property (including by way of settlement of litigation) that is [**] to Exploit a Product in the Field of Use in the Territory and [**] (any such intellectual property, “Product-Specific Third Party IP”), [**] subject to the remainder of this Section 9.7. For clarity, [**].

9.7.2. Other Third Party IP.

(a) Notice; Negotiation of Future In-License Agreements.

(i) If Gritstone reasonably determines that any Patent Rights, Know-How or other intellectual property rights owned or otherwise controlled by a Third Party are necessary in order for Gilead to practice any Qualifying Use of Gritstone Platform Technology to Exploit a Product in the Field of Use in the Territory, then Gritstone will notify Gilead of any such intellectual property.

(ii) If Gritstone reasonably determines, or Gilead notifies Gritstone, that any Patent Rights, Know-How, or other intellectual property rights owned or otherwise controlled by a Third Party are [**] to Exploit the Gritstone Platform Technologies in the Field of Use in the Territory and such intellectual property is not Product-Specific Third Party IP, then [**]. Subject to the terms of this Section 9.7.2(a)(ii), Gritstone will [**]. Without limiting the foregoing, if Gritstone is negotiating a proposed Future Core In-License Agreement that is, [**], Gritstone will [**].

(b) Disclosure of Future In-License Agreements.

(i) Except for Future Gritstone Product-Related Agreements, which are subject to Section 9.7.2(b)(ii), in the event that Gritstone enters into an agreement with a Third Party after the Effective Date pursuant to which Gritstone in-licenses, or otherwise acquires, Control of Patent Rights, Know-How or other intellectual property rights that are [**] in order to Exploit the Gritstone Platform Technologies in the Field of Use in the Territory (excluding any such intellectual property rights that would constitute Excluded Technology), then Gritstone will promptly provide Gilead with notice of such license or other agreement.

(ii) In the event that Gritstone enters into any Future Gritstone Product-Related Agreement and pursuant to such agreement Gritstone in-licenses, or otherwise acquires, Control in the Field of Use of (1) any (A) [**], or (B) [**] or (3) [**] (in each case, ((1), (2) and (3)), “Gritstone Product-Related Agreement Selected Improvement IP”), then Gritstone will [**], (x) [**], or (y) [**] (or, if later, [**]). For clarity, Gritstone’s obligation to [**] will not arise in relation to a Future Gritstone Product-Related Agreement unless and until there are [**].

(iii) If Gritstone provides Gilead with notice of a potential Gritstone In-License Agreement pursuant to Section 9.7.2(b)(i) and [**], then Gritstone will provide Gilead with a copy of the applicable license or other agreement with the Third Party (redacted as necessary to protect agreement terms and confidential information that are not necessary to confirm the scope of the sublicensed rights and compliance with this Agreement), together with a [**] under any such potential [**] applicable to sublicensees, and (a) [**] (including with respect to sublicensees under the Licensed Technology Controlled by Gritstone pursuant to such agreement) and (b) [**], as applicable to the Licensed Technology that would be subject to such sublicense agreement. If Gritstone provides Gilead with notice of a potential Gritstone In-License Agreement pursuant to Section 9.7.2(b)(i) or Section 9.7.2(b)(ii) and [**], then Gilead may [**] (x) (I) [**] and (II) [**] or (y) a copy of the applicable proposed Gritstone In-License Agreement (redacted as necessary to protect agreement terms and confidential information that are not necessary to confirm the scope of the sublicensed rights and compliance with this Agreement). For clarity, [**].

(i) Within [**] days following receipt of such notice pursuant to Section 9.7.2(b)(i), Gilead will decide, in its sole discretion, whether or not to accept the applicable Patent Rights, Know-How or other intellectual property as Licensed Technology licensed under this Agreement and will provide Gritstone written notice of such decision. If Gilead decides to accept a sublicense under such intellectual property, then (x) such Patent Rights, Know-How or other intellectual property will constitute Licensed Technology sublicensed to Gilead under this Agreement pursuant to the license grants in Section 3.1, (y) such agreement will thereafter be included within the definition of Gritstone In-License Agreements, and (z) subject to Section 9.7.2(d), Gilead shall, and shall cause its Affiliates and, subject to Section 3.1.4(g), its and their Sublicensees to, comply with all applicable terms (including with respect to sublicensees and the Exploitation of any Product in the Field of Use) pursuant to Sections 3.1.4 and 11.10.2 with respect to such Gritstone In-License Agreement.

(ii) Within [**] days following receipt of such notice pursuant to Section 9.7.2(b)(ii), Gilead will decide, in its sole discretion, whether or not to accept a sublicense under the applicable Gritstone Product-Related Agreement Selected Improvement IP that would be Licensed Technology for purposes of this Agreement if such agreement had been in effect as of the Effective Date. If Gilead decides to accept a sublicense under such intellectual property, then (x) such Gritstone Product-Related Agreement Selected Improvement IP will constitute Licensed Technology sublicensed to Gilead under this Agreement pursuant to the license grants in Section 3.1, (y) such agreement will thereafter be included within the definition of Gritstone In-License Agreements solely with respect to the applicable Gritstone Product-Related Agreement Selected Improvement IP and the terms and conditions applicable thereto (any such Gritstone In-License Agreement, a “Future Gritstone Product-Related Agreement Sublicense”), and (z) subject to Section 9.7.2(d), Gilead shall and shall cause its Affiliates and, subject to Section 3.1.4(g), its and their Sublicensees to, comply with all applicable terms (including with respect to sublicensees and the Exploitation of any Product in the Field of Use) pursuant to Sections 3.1.4 and 11.10.2 with respect to such Future Gritstone Product-Related Agreement Sublicense.

(iii) If Gilead does not accept any Third Party agreement as a Gritstone In-License Agreement pursuant to Section 9.7.2(c)(i) or (ii), as applicable (including by failing to respond within such [**]-day period), then (1) Gilead and its Affiliates will have no obligations with respect to such Third Party agreement and (2) Gritstone will have no obligation to grant any sublicense or other rights to Gilead under such Third Party agreement. Notwithstanding any other term or condition of this Agreement, the definitions of Licensed Know-How, Licensed Patents and Licensed Technology, Licensed Technology under this Agreement shall be deemed to exclude Patent Rights, Know-How or other intellectual property licensed to Gritstone or any of its Affiliates pursuant to a license or other agreement entered into by Gritstone or its Affiliates after the Effective Date unless and until such agreement becomes a Gritstone In-License Agreement pursuant to this Section 9.7.2(c).

(d) Responsibility for Payments under Gritstone In-License Agreements. Gritstone will be solely responsible for, and will satisfy, all financial obligations, including royalties, due from Gritstone to any Third Party under the Existing In-License Agreements [**] (i) [**]and (ii) [**]. With respect to any Gritstone In-License Agreement that becomes a Gritstone In-License Agreement pursuant to Section 9.7.2(c), [**] will be responsible for all payment obligations under such agreement [**], except as follows. [**]. The Parties shall coordinate in good faith to agree upon timing and mechanics for payments and any required notice of milestone achievement under each Gritstone In-License Agreement that are [**] under this Agreement with the goal of ensuring that such payments are made and notices [**] in sufficient time [**] to make corresponding payments and notices to the Third Party in a timely manner under the Gritstone In-License Agreement. All such payments that are [**] in accordance with the terms of the applicable Gritstone In-License Agreement. For purposes of this Agreement, “Qualifying Use of

Gritstone Platform Technology” means any aspect of the Gritstone Platform Technology that both (a) [**] and (b) [**] (1) [**] or (2) [**].

9.7.3. Offset for Third Party Payments. If Gilead, any of its Affiliates or any of its Sublicensees obtains a right or license under any Patent Rights, Know-How or other intellectual property right of a Third Party after the Effective Date that is [**] for the Development, Manufacturing, Commercialization or other Exploitation of [**] in the Field of Use in the Territory by or on behalf of Gilead, its Affiliates or its Sublicensees, including any rights or licenses obtained pursuant to Section 9.7.1 or Section 9.7.2, then Gilead may deduct from the Royalties that would otherwise have been due in a particular [**] an amount equal to [**] of the amount of any payments (including payments for obtaining such right or license, royalties, milestones, amounts paid in settlement and any other amounts) paid or accrued by Gilead or any of its Affiliates or Sublicensees to such Third Party for such right or license or the exercise thereof during [**]. Notwithstanding the foregoing, to the extent any amounts paid to such Third Party for such right or license are [**], Gilead may not deduct such amounts from the Royalties.

9.8. Cumulative Effect of Reductions.

9.8.1. On a country-by-country and Product-by-Product basis, in no event will Royalties payable to Gritstone in accordance with Section 9.5.1 in any country in any [**] for any Product be reduced, pursuant to Sections 9.6.1, 9.6.2, 9.7.3 or 14.3, to less than the amount provided pursuant to clause (a) or clause (b) (as applicable, the “Royalty Floor”):

(a) in the event that [**], or

(b) in the event that [**].

9.8.2. In the event that Gilead would, but for the restriction set forth in this Section 9.8, have the right to reduce the Royalties due to Gritstone for Products pursuant to Section 9.5.1 in a country in a given [**] under Section 9.6.1, 9.6.2, or 9.7.3, alone or together to an amount lower than the Royalty Floor, then such unused reduction may be carried forward and used as a credit in one or more future [**] for Products in the same country, and such unused reduction will be [**]; provided that such Royalties due in such country are not reduced by more than the Royalty Floor for each such Product in each such [**].

9.9. No Projections. Each of Gritstone and Gilead hereby acknowledges and agrees that nothing in this Agreement will be construed as representing an estimate or projection of anticipated sales of any Product, and that the Milestones and Net Sales levels set forth above or elsewhere in this Agreement or that have otherwise been discussed by the Parties are merely intended to define the Milestone Payments and royalty obligations to Gritstone in the event such Milestones or Net Sales levels are achieved. NEITHER GRITSTONE NOR GILEAD MAKES ANY REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, THAT IT WILL BE ABLE TO SUCCESSFULLY DEVELOP, OBTAIN REGULATORY APPROVAL FOR, OR COMMERCIALIZE ANY PRODUCT OR, IF COMMERCIALIZED, THAT ANY PARTICULAR NET SALES LEVEL OF SUCH PRODUCT WILL BE ACHIEVED.

9.10. Non-Refundable and Non-Creditable Payments. Notwithstanding the non-refundable or non-creditable nature of any payments hereunder, but subject to the limitations set forth in Section 16.5, nothing in this Agreement will limit either Party’s rights to assert or obtain damages for breach of this Agreement, including damages calculated based on the payments made under this Agreement.

Article X
REPORTS AND PAYMENT TERMS

10.1. Reports; Payment Terms.

10.1.1. Development Milestone Payments. Gilead will furnish to Gritstone a written notice of the achievement by Gilead, its Affiliates or its Sublicensees of a Development Milestone Event within [**] Business Days after such Development Milestone Event has been achieved. After the receipt of any such notice, Gritstone will submit an invoice to Gilead with respect to the corresponding Development Milestone Payment. Gilead will pay such Development Milestone Payment within [**] days after receipt of such invoice.

10.1.2. Royalties and Sales Milestone Payments. During the period from the First Commercial Sale of any Product until the end of the last-to-expire Royalty Term, Gilead will, within [**] following the end of each [**] for which Royalties are due: (a) furnish to Gritstone a written report, showing the (i) aggregate Net Sales of each Product sold in each country during the relevant [**] in Dollars and amounts of such Net Sales [**], (ii) Royalties and any Sales Milestone Events that have accrued hereunder in respect of Net Sales [**], and (iii) the exchange rates used in determining the amounts payable in Dollars; and (b) pay such Royalties and Sales Milestone Payments with respect to such [**] as set forth in such written report.

10.1.3. Gritstone Reimbursable Costs. Gilead shall reimburse Gritstone for Gritstone Reimbursable Costs incurred in accordance with this Agreement [**]. After each [**] during the Term, Gritstone will invoice Gilead for any Gritstone Reimbursable Costs incurred during [**]for which reimbursement is due to Gritstone under this Agreement and Gilead shall reimburse Gritstone for undisputed Gritstone Reimbursable Costs within [**] days of receipt of Gritstone’s invoice therefor. “Gritstone Reimbursable Costs” shall mean [**].

10.1.4. Payment Method. On or before the Effective Date, Gritstone will provide its current IRS Tax Form W-9 to Gilead. All payments under this Agreement will be made by deposit of Dollars in the requisite amount to the following bank account of Gritstone or such other account as Gritstone may from time to time designate by notice to Gilead. Any payment which falls due on a date which is not a Business Day may be made on the next succeeding Business Day.

[**]

10.2. Currency. All payments under this Agreement will be payable in Dollars. With respect to sales of a Product and other amounts received or to be paid to a Third Party in a currency other than Dollars, such amounts and amounts payable will be converted to Dollars using the exchange rate mechanism generally applied by Gilead in preparing its audited financial statements for the applicable [**]; provided that such mechanism is in compliance with Accounting Standards and Gilead’s normal practices used to prepare its audited financial statements.

10.3. Blocked Currency. If at any time legal restrictions in the Territory prevent the prompt remittance of any payments with respect to sales therein, Gilead will have the right and option to make such payments by depositing the amount thereof in local currency to Gritstone’s account in a bank or depository designated by Gritstone in the Territory.

10.4. Taxes; Withholding.

10.4.1. Generally. Except as set forth in this Section 10.4.1 or Section 10.4.2, the Payee will be liable for all income and other taxes (including interest) (“Taxes”) imposed upon any payments made by the Payor to Payee under this Agreement (“Agreement Payments”). The amounts set forth herein are exclusive of all applicable sales or use, goods and services, value added, consumption or other similar fees or taxes (“Transfer Taxes”) arising on the Agreement Payments, and the Payor will be responsible for and pay any such Transfer Taxes imposed on it with respect to the Agreement Payments due to the Payee hereunder.

10.4.2. Tax Withholding. If Applicable Law requires the withholding of Taxes in respect of any Agreement Payment, the Payor is authorized to deduct the amount thereof from such Agreement Payment and shall remit such withheld amount to the relevant Governmental Authority in a timely manner. Notwithstanding the foregoing, except if as a result of Gritstone assigning this Agreement or changing its domicile, additional taxes become due that would not have otherwise been due hereunder with respect to the upfront payment pursuant to Section 9.1 and the Option Exercise Fee pursuant to Section 9.3, Gilead shall pay to Gritstone the upfront payment pursuant to Section 9.1 and the Option Exercise Fee pursuant to Section 9.3 free and clear of any withholding, and without any deduction, on account of any Taxes. For the avoidance of doubt, the Payor’s remittance of Taxes withheld in accordance with this Section 10.4.2, together with payment to the Payee of the remaining Agreement Payments, will constitute the Payor’s full satisfaction of Agreement Payments under this Agreement. The Payor will promptly (as available) submit to the Payee appropriate proof of payment of the withheld Taxes as well as the official receipts within a reasonable period of time.

10.4.3. Tax Cooperation. The Parties agree to cooperate with one another and use reasonable efforts to reduce or eliminate such withholding of Taxes, Transfer Taxes, or similar obligations in respect of payments made under this Agreement, as permitted under Applicable Law, including under any applicable provision of any present or future income tax treaty.

10.5. Records and Audit Rights.

10.5.1. Records. Each Party will keep, and will cause its Affiliates and as applicable sublicensees, to keep complete, true and accurate books and records in accordance with its Accounting Standard in relation to this Agreement and Net Sales, Royalties, Development Milestone Payments, Sales Milestone Payments and any other payments and reimbursements required hereunder, as applicable. Each Party will keep such books and records for at least [**] years following the Calendar Year to which they pertain or for such longer period of time as required under any Applicable Law.

10.5.2. Audit Rights. Subject to the other terms of this Section 10.5.2, during the Term, at the request of a Party (the “Auditing Party”), which will not be made more frequently than one (1) time per [**], upon at least [**] days’ prior written notice from the Auditing Party, the other Party (the “Audited Party”) will permit an independent, nationally-recognized certified public accountant selected by the Auditing Party and reasonably acceptable to the Audited Party (the “Auditor”) to inspect, during regular business hours, the relevant records required to be maintained by the Audited Party under Section 10.5.1; provided that such audit right will not apply to records beyond [**] years from the end of the Calendar Year to which they pertain and that records for a particular period may only be audited once. Prior to its inspection, the Auditor will enter into a confidentiality agreement with both Parties having obligations of confidentiality and non-use no less restrictive than those set forth in Article XII and limiting the disclosure and use of such information by such Auditor to authorized representatives of the Parties and the purposes germane to Section 10.5.1.

10.5.3. Payment. In the event such audit leads to the discovery of a discrepancy to the Auditing Party’s detriment, the Audited Party will, within [**] days after receipt of such report from the Auditor, pay any undisputed amount of the discrepancy. The Auditing Party will pay the full cost of the audit unless the underpayment of amounts due to or overpayment of amounts payable by the Auditing Party is greater than [**] of the amount due for the entire period being examined, in which case the Audited Party will pay the reasonable cost charged by the Auditor for such review. Any undisputed overpayments by the Audited Party revealed by an examination will be paid by the Auditing Party within [**] days of the Auditing Party’s receipt of the applicable report.

10.5.4. Disputes. Any disagreement regarding the results of any audit conducted under this Section 10.5 will be subject to the dispute resolution provisions for Selected Disputes set forth in Section 17.5.4.

Article XI
INTELLECTUAL PROPERTY RIGHTS

11.1. Inventorship. Except as otherwise expressly provided herein, determination of inventorship of any Inventions (whether patentable or not) created, conceived or reduced to practice by or on behalf of a Party or any of its Affiliates, whether solely or jointly with any Third Party (or with the other Party or any of its Affiliates), in the course of activities performed under this Agreement, will be determined by application of U.S. patent law pertaining to inventorship.

11.2. Ownership.

11.2.1. Background Intellectual Property. As between the Parties, and subject to the licenses granted under this Agreement, each Party retains all rights, title and interests in and to all Patent Rights, Know-How and other intellectual property rights that such Party owns or otherwise Controls as of the Effective Date or that it develops or otherwise acquires after the Effective Date outside the performance of the activities under this Agreement. Without limiting the generality of the foregoing, as between the Parties, and subject to the licenses granted under this Agreement, Gilead retains all of its rights, title and interests in and to the Gilead Background IP, and Gritstone retains all of its rights, title and interest in and to the Gritstone Background IP.

11.2.2. Collaboration IP.

(a) Gritstone Collaboration IP. As between the Parties, Gritstone will own and retain all right, title and interest in and to all Gritstone Collaboration IP. Gilead will promptly disclose to Gritstone in writing the creation, conception or reduction to practice of any Invention within Gritstone Collaboration IP by or on behalf of Gilead or any of its Affiliates. Gilead, for itself and on behalf of any of its Affiliates, hereby assigns (and to the extent such assignment can only be made in the future hereby agrees to assign) to Gritstone all its right, title and interest in and to any Gritstone Collaboration IP.

(b) Gilead Collaboration IP. As between the Parties, Gilead will own and retain all right, title and interest in and to all Gilead Collaboration IP. Gritstone will promptly disclose to Gilead in writing the creation, conception or reduction to practice of any Invention within Gilead Collaboration IP by or on behalf of Gritstone or any of its Affiliates. Gritstone, for itself and on behalf of any of its Affiliates, hereby assigns (and to the extent such assignment can only be made in the future hereby agrees to assign) to Gilead all its right, title and interest in and to any Gilead Collaboration IP.

(c) Joint Collaboration IP. Joint Collaboration IP will be owned jointly by Gilead and Gritstone on the basis of an equal, undivided interest and will be deemed to be Controlled by each Party. Each Party, for itself and on behalf of any of its Affiliates, hereby assigns (and to the extent such assignment can only be made in the future hereby agrees to assign) to the other Party a joint, equal and undivided right, title and interest in and to any Joint Collaboration IP. Subject to the licenses granted under Section 3.1 and the exclusivity obligations under Section 3.5, each Party will have the right to use such Joint Collaboration IP, or license such Joint Collaboration IP to its Affiliates or any Third Party, or sell or otherwise transfer its interest in such Joint Collaboration IP to its Affiliates or a Third Party, in each case, without a duty to seek consent or account to the other Party, so long as such use, sale, license or transfer is consistent with this Agreement.

(d) Cooperation. Each Party will reasonably cooperate, and will cause its Affiliates to reasonably cooperate, with the other Party to effectuate and perfect the ownership rights set forth in this Section 11.2 and Section 11.10.1, including by promptly executing and recording affidavits, assignments, agreements and other documents, as applicable, consistent with such ownership.

(e) Third Party Arrangements. In addition, each Party will ensure that its arrangements with any of its Affiliates, employees, Subcontractors and successors-in-interest include provisions that allow such Party to comply with its obligations under this Section 11.2 with respect to any Collaboration IP developed, conceived or reduced to practice from the activities of any of such Party’s Affiliates, employees, and successors-in-interest with respect to any Licensed Technology and with Section 11.10, as applicable; provided that [**], without limiting Section 3.1.3 or 3.1.4, (i) each sublicense under Section 3.1.1 or 3.1.2 shall provide, and Gilead shall ensure, that each sublicensee thereunder (through multiple tiers) shall comply with Section 11.10 (to the extent applicable) and (ii) Gilead will [**] to ensure that each sublicense under Section 3.1.1 or 3.1.2 provides a present grant of rights or present assignment such that Gritstone receives a present grantback license pursuant to Section 3.2.2 to any Patent Rights or Know-How conceived, discovered, otherwise made or invented by or on behalf of such sublicensee that (x) would be [**] and (y) that would be [**].

11.3. Prosecution and Maintenance.

11.3.1. Right to File and Prosecute.

(a) Solely Owned Patents. Except as otherwise expressly provided in this Section 11.3, as between the Parties, each Party will have the sole right (but not the obligation) to Prosecute and Maintain any Patent Rights that it owns, at its sole cost and expense.

(b) Joint Collaboration Patents. [**] will have the first right (but not the obligation) to Prosecute and Maintain the Joint Collaboration Patents, at [**] sole cost and expense. If, during the Term, [**] in any country decides not to file a Joint Collaboration Patent, or intends to allow such Patent Right to lapse or become abandoned, then it will promptly provide written notice to [**] of such decision (and, in any event, no less than [**] in advance of any applicable deadline). [**] may, upon written notice to [**], assume the Prosecution and Maintenance of such Patent Right. In such event [**] will be responsible for [**] of the costs and expenses incurred thereafter for the Prosecution and Maintenance of such Patent Right.

(c) Licensed Patents. [**] will have (i) the first right (but not the obligation) to Prosecute and Maintain [**] (such Licensed Patents, the “Gritstone Product Patents”), and (ii) the sole right (but not the obligation) to Prosecute and Maintain all other Licensed Patents, each at [**] sole cost

and expense. If, during the Term, [**] in any country decides not to file a Gritstone Product Patent, or intends to allow such Gritstone Product Patent to lapse or become abandoned, then it will promptly provide written notice to [**] of such decision (and, in any event, no less than [**] in advance of any applicable deadline). [**] may, upon written notice to [**], assume the Prosecution and Maintenance of such Gritstone Product Patent at [**] sole cost and expense. In such event [**] will be responsible [**] of the costs and expenses incurred thereafter for the Prosecution and Maintenance of such Gritstone Product Patent. [**].

11.3.2. Review and Comment Rights. The Party having the right to Prosecute and Maintain a [**] under Section 11.3.1 (the “Prosecuting Party”) will keep the other Party (the “Non-Prosecuting Party”) informed as to material developments with respect to the Prosecution and Maintenance of such Patent Right, including by providing copies of all substantive office actions or any other substantive documents to or from any patent office, including notice of all interferences, reissues, reexaminations, inter partes reviews, post grant proceedings, oppositions or requests for patent term extensions. The Prosecuting Party will also provide the Non-Prosecuting Party with a reasonable opportunity to comment substantively on the Prosecution and Maintenance of such Patent Right prior to taking material actions (including the filing of initial applications), and will in good faith consider and, solely in the case of Gritstone Product Patents, incorporate, any reasonable comments timely made by and actions timely recommended by the Non-Prosecuting Party.

11.3.3. Cooperation and Coordination. Each Party will (a) upon reasonable request by a Party, obtain and deliver to the other Party any necessary documents for the other Party to exercise its rights to Prosecute and Maintain all Patent Rights pursuant to Section 11.3.1; (b) render all signatures that will be necessary in connection with all such patent filings consistent with this Article XI; and (c) assist the other Party in all other reasonable ways that are necessary for the issuance of those Patent Rights for which such other Party is responsible, as well as for the preparation, prosecution, defense and maintenance of such Patent Rights.

11.4. Enforcement.

11.4.1. Notification. During the Term, the Parties will promptly inform each other in writing if either Party becomes aware of any suspected, threatened or actual: (a) infringement by any Third Party of any Licensed Patents or Collaboration Patents; or (b) unauthorized use or misappropriation of any of the Licensed Know-How or Collaboration Know-How (such infringement or unauthorized use or misappropriation, in each case of (a) and (b), an “Infringement”) that arises as a result of the making, using, offering to sell, selling or importing of a vaccine product that would be competitive with a Product in the Field of Use in the Territory (a “Competing Infringement”). Each Party will provide any available evidence of such Infringement with such notification.

11.4.2. Infringement Actions.

(a) Solely Owned IP. Except as otherwise expressly provided in this Section 11.4, as between the Parties, each Party will have the sole right (but not the obligation) to initiate an infringement, misappropriation or other appropriate suit (an “Infringement Action”) with respect to any infringement or misappropriation of any Patent Rights or Know-How that such Party solely Controls, by counsel of its own choice, in s