RESEARCH COLLABORATION AND LICENSE AGREEMENT

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Title: RESEARCH COLLABORATION AND LICENSE AGREEMENT
Governing Law: Delaware Date: 11/3/2006

RESEARCH COLLABORATION AND LICENSE AGREEMENT

, Parties: dynavax technologies corp , astrazeneca ab

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

Exhibit 10.30

RESEARCH COLLABORATION AND LICENSE AGREEMENT

by and between

ASTRAZENECA AB

and

DYNAVAX TECHNOLOGIES CORPORATION

DATE: 1 September 2006


[ * ]	=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

(i)

TABLE OF CONTENTS


Table of Contents		Page
1.	Definitions		2

2.	Construction		17

3.	Conduct of the Joint Research Programme		17
3.1	Overview		17
3.2	Research Term		18
3.3	Joint Research Plan		18
3.4	Research Effort and Support		18
3.5	Conduct of Research		19
3.6	Materials and Information Transfer		21
3.7	Cooperation		22
3.8	Regulatory Records		22
3.9	Reports		22
3.10	Lead Candidate Development Decision		23
3.11	CD Nomination		23
3.12	Overview of Joint Research Programme		23
3.13	Selection of Compounds		23

4.	Support and Management of the Joint Research Programme		24
4.1	Overview of the Management of the Joint Research Programme		24
4.2	Responsibilities of JPT		24
4.3	Formation of JPT		25
4.4	JPT Meetings		26
4.5	JPT Decision Making : Disputes		26
4.6	JPT Minutes		26
4.7	Dissolution of JPT		27
4.8	Responsibilities of JSC		27
4.9	Formation of JSC		28
4.10	JSC Decision Making : Disputes		29
4.11	JSC Decisions Requiring Consent		29


[ * ]	=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Table of Contents		Page
4.12	JSC Meetings		29
4.13	JSC Minutes		30
4.14	Dissolution of JSC		30
4.15	Advisory Board		30
4.15	Expenses		31
4.17	Access to Information		31
4.18	Joint Research Programme Guidelines		31

5.	Reports		31
5.1	Joint Research Programme Progress Reports		31
5.2	Copyrights		32
5.3	AstraZeneca Reports		32

6.	Ownership and Grant of Rights		32
6.1	Ownership of Collaboration Technology		32
6.2	Licences to AstraZeneca		32
6.3	Licence to Dynavax		33
6.4	Third Party Licences		34
6.5	Exclusivity		35
6.6	Sublicences		37
6.7	Distributors		37
6.8.	Confirmatory Patent Licences		38

7.	Research Funding		38
7.1	Funding		38
7.2	Invoices; Reconciliation		38
7.3	Records Retention; Audit		39
7.4	Projected Cost Reports		40

8.	Development and Commercialization		40
8.1	Overview		40
8.2	Development of Product		40
8.3	Regulatory Affairs and Information Exchange		41
8.4	Commercialization of Product and Combination Product		43
8.5	Dynavax Option to Co-Promote in the United States		43
8.6	Pricing, Price Approvals and Product Distribution		44


[ * ]	=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Table of Contents		Page
8.7	Sales and Inventory		44
8.8	Advertising and Education		44
8.9	Development and Commercialization Costs		45
8.10	Diligence Obligations		45
8.11	Breach of Diligence Obligations		47
8.12	Reversion; Abandonment		47

9.	Milestone Payments		48
9.1	Total Obligation		48
9.2	Access Fee		48
9.3	Joint Research Programme Milestones		49
9.4	Development Milestones		49
9.5	Milestone Payments		49

10.	Royalty Payments and Other Payment-Related Provisions		50
10.1	Royalties		50
10.2	Combination Products		50
10.3	Sublicensees		51
10.4	Royalty Stacking		52
10.5	*[ ] Royalty and [ * ]**		52
10.6	Reduction of Royalty		53
10.7	Royalty Floor		54
10.8	Royalty Term		54
10.9	Sales Subject to Royalties		55
10.10	Royalty Payments		55
10.10	Mode of Payment		55
10.12	Currency		56
10.13	Interest		56
10.14	Records Retention; Audit		56

11.	Taxes		57
11.1	General		57
11.2	Indirect Taxes		57
11.3	Customs Duties		58

12.	Manufacture and Supply		58


[ * ]	=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Table of Contents		Page
12.1	Preclinical Supply		58
12.2	Clinical and Commercial Supply		58
12.3	Manufacturing Know-How Transfer		59

13.	Confidentiality and Non-Disclosure		59
13.1	General Obligations		59
13.2	Permitted Disclosures		60
13.3	Exclusions		62
13.4	Confidentiality of Agreement		63
13.5	Publications and Presentations		63
13.6	Use of Name/Publicity.		64

14.	Patent Prosecution, Enforcement and Defence		65
14.1	Disclosure		65
14.2	Patent Prosecution and Maintenance		65
14.3	Patent Term Restoration		67
14.4	Enforcement of Patent Rights		67
14.5	Third Party Litigation		69
14.6	Invalidity or Unenforceability Defences or Actions		70
14.7	Cooperation		71
14.8	Compliance with Third Party Licences		71
14.9	Costs and Expenses		72

15.	Adverse Event Reporting		72
15.1	Overview		72

16.	Product Recall		73
16.1	Notification and Recall		73
16.2	Recall Expenses		73

17.	Trademarks		74

18.	Representations and Warranties		74

19.	Indemnification and Insurance		79
19.1	Indemnification of Dynavax		79
19.2	Indemnification of AstraZeneca		79
19.3	*[ ]**


[ * ]	=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Table of Contents		Page
19.4	Notice of Claim		80
19.4	Indemnification Procedures		81
19.5	LIMITATION ON DAMAGES		83
19.6	Insurance		83

20.	Term and Termination		83
20.1	Term		83
20.2	Termination by AstraZeneca		84
20.3	Termination for Infringement of Third Party Rights		84
20.4	Termination by Dynavax for Lack of Diligence		85
20.5	Termination by Either Party		85
20.6	Change of Control		87
20.7	Consequences of Termination		87
20.8	Survival		91
20.9	Rights in Bankruptcy		91

21.	Force Majeure		91

22.	Assignment		93

23.	Severability		93

24.	Dispute Resolution		94
24.1	Disputes		94
24.2	Arbitration		94
24.3	Arbitrator		95
24.4	Governing Law		95
24.5	Decision		95
24.6	Award		95
24.7	Costs		96
24.8	Injunctive Relief		96
24.9	Confidentiality		97
24.10	Survivability		97
24.11	Jurisdiction		97
24.12	Patents and Trademarks		97
24.13	Provisions Unique to Arbitrations Pursuant to Section 8.10		98

25.	Notices		98


[ * ]	=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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Table of Contents		Page
25.1	Notice Requirements		98
25.2	Address for Notice		98

26.	Relationship of the Parties		99

27.	Entire Agreement		100

28.	English Language		100

29.	Amendment		100

30.	Waiver and Non-Exclusion of Remedies		100

31.	No Benefit to Third Parties		101

32.	Equitable Relief		101

33.	Further Assurance		102

34.	Expenses		102

35.	Counterparts		103


[ * ]	=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

Page 1 of 104

RESEARCH COLLABORATION AND LICENSE AGREEMENT

This Research Collaboration and License Agreement (this “ Agreement ”) is effective as of the day of September 2006 (the “ Effective Date ”), by and between

(1)		ASTRAZENECA AB , a company incorporated in Sweden under no. 556011-7482 with offices at S-151 85 Södertälje, Sweden (“ AstraZeneca ”); and

(2)		DYNAVAX TECHNOLOGIES CORPORATION , a Delaware corporation with offices at 2929 Seventh Street, Suite 100, Berkeley, CA 94710-2753, USA (“ Dynavax ”).

Recitals

(A)		WHEREAS, AstraZeneca is a global pharmaceutical company with substantial capabilities in the field of drug discovery, development and marketing of pharmaceutical products in several therapy areas including asthma and chronic obstructive pulmonary disease;

(B)		WHEREAS, Dynavax is a pharmaceutical company engaged in the discovery and development of novel oligonucleotide agonists of TLR-9 for use in a variety of diseases and disorders, including the treatment of asthma and chronic obstructive pulmonary disease;

(C)		WHEREAS, the Parties wish to engage in a collaborative research program utilising Dynavax’s knowledge, skills and proprietary technology to identify and develop novel TLR-9 agonists for therapeutic use in the fields of asthma and chronic pulmonary disease with a mutual ambition of developing and marketing any resultant products on a global basis.

Agreement

NOW, THEREFORE, in consideration of the mutual covenants contained in this Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:


[ * ]	=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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1		Definitions

		Unless otherwise specifically provided in this Agreement, the following terms have the following meanings:

1.1		“Advisory Board” means the committee established and conducted according to Section 4.15.

1.2		“ Affiliate ” means, with respect to a Person, any Person that Controls, is Controlled by or is under common Control with such first Person, in all cases, only for as long as Control actually exists. For purposes of this definition only, “ Control ” means (a) to possess, directly or indirectly, the power to direct the management or policies of a Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance, or (b) to own, directly or indirectly, more than fifty percent (50%) of the outstanding voting securities or other ownership interest of such Person.

1.3		“ Alliance Manager ” means a Party’s representative with responsibility for the activities described in Section 4.9.

1.4		“ Annual Net Sales ” means the Net Sales made during a given calendar year.

1.5		“ Applicable Law ” means the applicable laws, rules and regulations, including any rules, regulations, guidelines or other requirements of the regulatory authorities, that may be in effect from time to time.

1.6		“Asthma” means an inflammatory pulmonary disorder that is characterized by reversible obstruction of the airways.

1.7		“ AstraZeneca Information ” has the meaning set forth in Section 13.1.2.

1.8		“AstraZeneca Know-How” means all Know-How Controlled by AstraZeneca or its Affiliates prior to and/or during the Term that is *[ ]** for the research, development, manufacture, importation, use or sale of Dynavax ISS, Collaboration ISS, Reverted ISS, CDs, Product or Combination Product(s), excluding Collaboration Know-How.

1.9		“AstraZeneca Patents” means any Patents Controlled by AstraZeneca or its Affiliates prior to and/or during the Term that are *[ ]** for the research, development,


[ * ]	=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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		manufacture, importation, use or sale of Dynavax ISS, Collaboration ISS, Reverted ISS, Product or Combination Product(s), excluding Collaboration Patents.

1.10		“AstraZeneca Technology” means AstraZeneca Patents and AstraZeneca Know-How.

1.11		“Background Technology” means either the AstraZeneca Technology or the Dynavax Technology, as appropriate and Background Technologies means the AstraZeneca Technology and the Dynavax Technology.

1.12		*[ ]** .

1.13		“ Candidate Drug ” or “ CD ” means a Dynavax ISS or a Collaboration ISS that is a Lead Candidate satisfying the relevant Candidate Drug Target Profile and *[ ] as a candidate for further Development and Commercialization as the Product or a Combination Product pursuant to Section 3.10; provided, however, upon the commencement of [ * ]** , such Collaboration ISS shall be deemed a Candidate Drug regardless of whether such Collaboration ISS meets the Candidate Drug Target Profile.

1.14		“Candidate Drug Target Profile” means the target profile for a Candidate Drug as further defined under the Joint Research Plan, the criteria for which are attached hereto as Exhibit A .

1.15		“CD Nomination” means the internal process, known by *[ ] , by which [ * ]** .

1.16		“CD Nomination Date” means the date upon which a CD Nomination is made.

1.17		“ Change of Control ,” with respect to either Party, means an event in which:

	1.17.1		any other Person or group of Persons acquires beneficial ownership of securities of such Party representing more than fifty percent (50%) of the voting power of the then outstanding securities of such Party with respect to the election of directors of such Party; or

	1.17.2		such Party effects a merger, consolidation or similar transaction with another Person in which such Party is not the surviving entity in such transaction.

1.18

[ * ] .


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1.19		*[ ]** .

1.20		“Collaboration” means all activities performed by or on behalf of Dynavax or AstraZeneca in the course of carrying out the Joint Research Programme and Development Plan, as applicable, and otherwise performing their obligations set forth in this Agreement.

1.21		“Collaboration ISS” means a *[ ]** generated during the course of the Joint Research Programme. For clarity, and in accordance with Section 3.12.2, a particular ISS will cease being subject to Research under this Agreement, and will accordingly no longer be a Collaboration ISS but will thereupon become a Reverted ISS, when it is no longer prioritized or selected for further research under the Joint Research Programme.

1.22		“ Collaboration Know-How ” means all Know-How generated by the Parties during the Research Term pursuant to the Joint Research Programme or otherwise generated by either Party in connection with the Development of any Collaboration ISS or Product.

1.23		“ Collaboration Patent ” means a Patent filed after the Effective date claiming an invention generated pursuant to the Collaboration and which claims or covers Collaboration Know-How and/or Collaboration ISS.

1.24		“ Collaboration Technology ” means Collaboration Patents, Collaboration Know-How and Collaboration ISS.

1.25		“ Combination Product ” means a pharmaceutical preparation *[ ]** .

1.26		“Commence” or “Commencement” when used to describe a Phase I Trial, Phase II Trial, Phase III Trial or Phase IV Trial, means the first dosing of the first human subject for such trial.

1.27		“ Commercialization ” means the performance of making, importing, using, selling, or offering for sale, including researching, developing, registering, modifying, enhancing, improving, manufacturing, having manufactured, holding/keeping (whether for disposal or otherwise), formulating, optimising, having used, exporting, transporting, distributing, promoting, marketing or having sold or otherwise disposing


[ * ]	=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

Page 5 of 104

		or offering to dispose of, a Product following Health Registration Approval of such Product in any part of the Territory under this Agreement.

1.28		“ Commercially Reasonable Efforts ” means, with respect to the carrying out of obligations or tasks, efforts and resources commonly used by a pharmaceutical company *[ ] , for the active development or commercialisation of a pharmaceutical product of a similar nature, with a similar commercial potential and at a similar stage in the clinical development process as the Product or the applicable Combination Product, based on conditions then prevailing, including without limitation, [ * ] , including [ * ] . Commercially Reasonable Efforts shall be determined on a market-by-market basis for the Product or each Combination Product. Notwithstanding anything to the contrary herein, Commercially Reasonable Efforts requires that a Party, at a minimum, [ * ]** .

1.29		“ Confidential Information ” means, subject to Section 13.3, any information, including any regulatory, scientific or other business information and materials, of a Party and its Affiliates disclosed to the other Party pursuant to this Agreement, and before, on or after the Effective Date of this Agreement or protected under Section 13.1.2.

1.30		“ Control ” means, with respect to any item of information, Patent, Know-How, or other intellectual property, possession of the right, whether directly or indirectly, and whether by ownership, licence or otherwise, to assign, or grant a licence, sublicense or other right to or under, such information, Patent or other intellectual property as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.

1.31		“COPD” or “Chronic Obstructive Pulmonary Disease” means a group of lung diseases involving limited airflow and varying degrees of air sac enlargement, airway inflammation, and lung tissue destruction.

1.32		“ Defending Party ” has the meaning set forth in Section 14.7.

1.33		“Develop” or “Development” means the performance of preclinical, manufacturing and clinical development and regulatory activities following the acceptance of an IND for a Candidate Drug (or the functional equivalency if the first human clinical trial of such Product or Combination Product is conducted without an IND) and that are


[ * ]	=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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		reasonably required to obtain Health Registration Approval of the Product or any Combination Product in any part of the Territory under this Agreement.

1.34		“Development Cost” means expenses and costs incurred by either Party during Development of a Candidate Drug, the Product or any Combination Product until the First Commercial Sale of the Product or any Combination Product anywhere in the world.

1.35		“Development Milestone” has the meaning set forth in Section 9.4.

1.36		“ Development Plan” has the meaning set forth in Section 8.2.

1.37		“ Disclosing Party ” has the meaning set forth in Section 13.1.1.

1.38		“ Distributor ” has the meaning set forth in Section 6.7.

1.39		“DMF” means a Drug Master File.

1.40		“Dynavax Know-How” means all Know-How Controlled by Dynavax or its Affiliates prior to and/or during the Term that is *[ ]** for the research, development, manufacture, importation, use or sale of the Dynavax ISS, Collaboration ISS, Product or Combination Product(s), excluding the Collaboration Know-How.

1.41		“Dynavax ISS” means those ISS synthesised by or on behalf of Dynavax prior to the Research Term and made available for identification and selection as *[ ]** candidates pursuant to the Joint Research Plan.

1.42		“Dynavax Patents” means any Patents Controlled by Dynavax or its Affiliates as of the Effective Date or during the Term that are *[ ]** for the research, development, manufacture, importation, use or sale of the Dynavax ISS, Collaboration ISS, Product or Combination Product(s), including without limitation, the Patents listed on Exhibit B , excluding the Collaboration Patents and the AstraZeneca Patents.

1.43		“Dynavax Technology” means the Dynavax Patents, the Dynavax Know-How and Dynavax ISS.

1.44		“ Effective Date ” means the date as set forth in the preamble to this Agreement.

1.45		“ Europe ” means the European Economic Area as it may be constituted from time to time.


[ * ]	=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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1.46		“ Field ” means the use of TLR-9 agonists that *[ ]** for the treatment of human patients who have Asthma and/or COPD, including for the prevention of the progression of Asthma and/or COPD in human patients.

1.47		“ First Commercial Sale ” means the first sale for monetary value for use or consumption by the general public of the Product or a Combination Product in any country after Health Registration Approval for such Product or Combination Product has been obtained in such country. For the avoidance of doubt, sales prior to receipt of the Health Registration Approvals necessary to commence regular commercial sales in a country, such as so-called “treatment IND sales,” “named patient sales” and “compassionate use sales,” shall not be construed as a First Commercial Sale in that country.

1.48		“ First Indication ” means the first Indication in which AstraZeneca obtains the first Health Registration Approval in respect of the Product or a Combination Product.

1.49		“ Force Majeure ” has the meaning set forth in Section 21.1.

1.50		“ Force Majeure Party ” means a Party prevented or delayed in its performance under this Agreement by an event of Force Majeure.

1.51		“ FTE ” means the equivalent of one person working full time for one 12-month period in a research, development, commercialization, regulatory or other relevant capacity, approximating *[ ] hours per year. In the interests of clarity, though, a single individual who works more than [ * ]** hours in a single year shall be treated as one FTE regardless of the number of hours worked. FTE effort shall be charged by calculating the individual’s total hours dedicated to the applicable activities under this Agreement as a percentage of total hours worked multiplied by the FTE Rate. By way of example, and not in limitation of the foregoing, (a) if a full-time, salaried employee spends 100% of his or her effort hours on the applicable activities under this Agreement, the FTE charge-out rate shall be calculated as the FTE Rate multiplied by 100%, (b) if a full-time, salaried employee spends 50% of his or her effort hours on the applicable activities under this Agreement, the FTE charge-out rate shall be calculated as the FTE Rate multiplied by 50%, and (c) if a seventy-five percent (75%)-time, salaried employee spends fifty percent (50%) of his or her efforts on the applicable activities under this Agreement, the FTE charge-out rate shall be


[ * ]	=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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		calculated as the FTE Rate multiplied by thirty-seven and one-half percent (37.5%) (50% x 75% = 37.5%). No FTE credit shall be given for overtime hours. The FTE Rate shall include: *[ ]** .

1.52		“ FTE Rate ” means the amount of *[ ] and shall cover the items referred to in the last sentence of Section 1.51 provided, however, that such FTE Rate shall be increased to [ * ]** for FTE efforts provided by Dynavax in excess of those set forth in Section 3.4.

1.53		“Good Clinical Practices” or “GCP” means current Good Clinical Practices as specified in the United States Code of Federal Regulations, at the time of testing, and all FDA and ICH guidelines, including the ICH Consolidated Guidelines on Good Clinical Practices.

1.54		“Good Laboratory Practices” or “GLP” means current Good Laboratory Practices as specified in the United States Code of Federal Regulations at 21 CFR § 58 at the time of testing and all applicable ICH guidelines.

1.55		“Governmental Authority” means any court, agency, department or other instrumentality of any national, federal, state, county, city or other political subdivision.

1.56		“ Health Registration Approval ” means, with respect to a country, any and all approvals, licences, registrations or authorisations (including supplements and amendments) of any national, supra-national (e.g., European Commission or the Council of the European Union or its equivalent), regional, state or local health or regulatory authority, agency, department, bureau, commission, council or other governmental entity, necessary to commercially manufacture, distribute, sell or market the Product or a Combination Product in such country, including, where applicable, (a) pricing and reimbursement approval in such country, (b) pre- and post-approval marketing authorisations (including any prerequisite manufacturing approval or authorisation related thereto), (c) labelling approval and (d) technical, medical and scientific licences.

1.57		“ IND ” means an Investigational New Drug application with the FDA or its foreign equivalent application or filing filed with an equivalent agency or Governmental Authority outside of the United States (including any supra-national agency such as in


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		Europe) necessary to Commence human clinical trails in such jurisdiction, and consistent with all regulations at 21 CFR § 312 et. seq. and equivalent foreign regulations.

1.58		“ Indemnification Claim Notice ” has the meaning set forth in Section 19.4.

1.59		“ Indemnified Party ” means a Party seeking to recover a Loss under Section 19.1 or 19.2.

1.60		“ Indemnifying Party ” means a Party from whom recovery of a Loss is sought under Section 19.1 or 19.2

1.61		“ Indemnitee ” has the meaning set forth in Section 19.4.

1.62		“Indication” means the treatment of Asthma, COPD, or any other disease or condition that the Parties agree, by amendment to this Agreement, to include within the Field.

1.63		“ Indirect Taxes ” means value added taxes, sales taxes, consumption taxes and other similar taxes.

1.64		“Information” means all technical, scientific and other information, trade secrets, patents and other legal information or descriptions, knowledge, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including: high-throughput screening, gene expression, genomics, proteomics and other drug discovery and development technology; biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, including study designs and protocols; assays and biological methodology; manufacturing and quality control procedures and data, including test procedures; and synthesis, purification and isolation techniques, (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed.

1.65		“ Infringement Suit ” has the meaning set forth in Section 14.5.


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1.66		“ IP ” has the meaning set forth in Section 20.9.

1.67		“ ISS ” means any synthetic oligonucleotide sequence or chimeric oligonucleotide sequence that modulates an immune response and is a TLR-9 agonist, including, but not limited to, such sequences referred to by Dynavax as immunostimulatory sequences, chimeric immunomodulatory compounds and branched immunomodulatory compounds.

1.68		“ Joint Project Team ” or “ JPT ” means the joint team established by the Parties pursuant to Article 4 to manage the day-to-day work within the Joint Research Programme.

1.69		“Joint Research Plan” means the project plan that outlines the Joint Research Programme and each Party’s obligations thereunder, including the allocation of FTEs by Dynavax, as further described in Section 3.3.

1.70		“ Joint Research Programme ” means the research programme described in the Joint Research Plan.

1.71		“ Joint Research Programme Milestones ” has the meaning set forth in Section 9.3.

1.72		“ Joint Steering Committee ” or “ JSC ” means the joint committee established by the Parties pursuant to Article 4 to oversee, manage and steer the Joint Research Programme during the Collaboration Term.

1.73		“Know-How” means any non-public, proprietary Information and other data, instructions, processes, methods, formulae, materials, expert opinions and information, including without limitation, biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, clinical, safety, manufacturing and quality control data and information. Know-How does not include any rights under Patents.

1.74		“Knowledge” means the knowledge, information or belief of any officer, or of any employee with the title of Global Vice President, Senior Scientist or higher, of either Dynavax or AstraZeneca, as the case may be, after each of them has made reasonable inquiry into the relevant subject matter.


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1.75		“Lead Candidate” means a Dynavax ISS or Collaboration ISS that, in accordance with the Joint Research Plan, has been *[ ]** at the time of its Lead Candidate Development Decision for further preclinical evaluation.

1.76		“Lead Candidate Development Decision” means the internal process, known by *[ ] , by which [ * ]** .

1.77		“Lead CD” means the CD nominated by AstraZeneca for Development and Commercialisation.

1.78		“Lead Research Candidate” means a Dynavax ISS or Collaboration ISS that has been *[ ]** for further research.

1.79		“ Losses ” means any and all liabilities, claims, demands, causes of action, damages, loss and expenses, including interest, penalties, and reasonable lawyers’ fees and disbursements.

1.80		“MAA” means a Marketing Authorization Application filed with the European Medicines Agency (known as the EMEA), or any substantial equivalent of such application or entity.

1.81		“ Major Markets ” means *[ ]** .

1.82		“NDA” means a New Drug Application (or other application for initial Health Registration Approval) filed with the FDA or the equivalent application or filing filed with any equivalent Governmental Authority outside of the United States necessary for approval of a drug or biologic in such jurisdiction.

1.83		“ Net Sales ” means, with respect to the Product and/or any Combination Product (subject to Section 10.2 below), the gross invoiced amount on sales of the Product or Combination Product by AstraZeneca, its Affiliates or their permitted Sublicensees to Third Parties (including Distributors) after deduction of (a) normal and customary trade, quantity or prompt settlement discounts (including chargebacks and allowances) actually allowed; (b) amounts actually repaid or credited by reason of rejection, returns or recalls of goods, rebates or bona fide price reductions determined by AstraZeneca or its Affiliates in good faith; (c) rebates and similar payments made with respect to sales paid for by any governmental or regulatory authority such as, by way of illustration and not in limitation of the Parties’ rights hereunder, Federal or


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		state Medicaid, Medicare or similar state program in the United States or equivalent governmental program in any other country; (d) *[ ]** as an allowance for transportation costs, distribution expenses, special packaging and related insurance charges; (e) any invoiced amounts which are not collected by AstraZeneca or its Affiliates, including bad debts; (f) excise taxes, Indirect Taxes, customs duties, customs levies and import fees actually imposed on the sale, importation, use or distribution of the Product or Combination Product as applicable; and (g) any other similar and customary deductions that are consistent with generally accepted accounting principles, or in the case of non-United States sales, other applicable accounting standards. Net Sales shall be calculated using AstraZeneca’s internal audited systems used to report such sales as adjusted for any of items (a) to (g) above not taken into account in such systems. Deductions pursuant to subsection (e) above shall be taken in the calendar quarter in which such sales are no longer recorded as a receivable.

1.84		“ Parties ” means collectively AstraZeneca and Dynavax and “ Party ” means individually either of AstraZeneca or Dynavax.

1.85		“ Patents ” means (a) all issued unexpired national, regional and international patents and (including inventor’s certificate) that has not been held invalid or unenforceable by a court of competent jurisdiction from which no appeal can be taken or has been taken within the required time period; (b) all national, regional and international patent applications, including provisional patent applications, (b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from either of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals, and continued prosecution applications, (c) any and all unexpired patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents and certificates of invention, (d) any and all substitutions, extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, renewal, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications ((a), (b) and (c)), and (e) any similar rights, including so-called pipeline protection, or any importation, revalidation,


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		confirmation or introduction patent or registration patent or patent of additions to any such foregoing patent applications and patents.

1.86		“ Payments ” has the meaning set forth in Section 11.1.

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

1.88		“Phase I Trial” means a clinical trial that generally provides for the first introduction into humans of the Lead CD or any CD to be incorporated into a Combination Product with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of the relevant CD, and generally consistent with 21 CFR § 312.21(a).

1.89		“Phase II Trial” means a clinical trial of the CD or any CD to be incorporated into a Combination Product on patients, including possibly pharmacokinetic studies, the principal purpose of which is to make a preliminary determination that such CD is safe for its intended use and to obtain sufficient information about the CD’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR § 312.21(b).

1.90		“Phase III Trial” means a clinical trial that provides for a pivotal human clinical trial of the Product or a Combination Product, which trial is designed to: (a) establish that the Product or Combination Product is safe and efficacious for its intended use; (b) define warnings, precautions and adverse reactions that are associated with the Product or Combination Product in the dosage range to be prescribed; (c) support Health Registration Approval of such Product or Combination Product; and (d) generally consistent with 21 CFR § 312.21(c).

1.91		“Phase IV Trial” means a clinical trial of the Product or any Combination Product Commenced in a particular country after Health Registration Approval for such Product or Combination Product in such country in order to support Commercialization of the Product or Combination Product, as appropriate.


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1.92		“Primary ISS” means, in accordance with the Joint Research Plan, *[ ] Dynavax ISS or Collaboration ISS selected [ * ]** .

1.93		“Primary Screening Phase” means, in accordance with the Joint Research Plan, the *[ ]** .

1.94		“ Product ” means a pharmaceutical preparation *[ ]** .

1.95		“Project Leader” means a Party’s representative with responsibility for the activities set forth in Section 4.3.

1.96		“ Prosecuting Party ” has the meaning set forth in Section 14.2.2.

1.97		“ Receiving Party ” has the meaning set forth in Section 13.1.1.

1.98		“Regents” has the meaning set forth in Section 10.5.1.

1.99		“Regulatory Authority” means any Governmental Authority with responsibility for granting any licenses or approvals necessary for the marketing and sale of pharmaceutical products including, without limitation, the FDA and any drug regulatory authority of countries of Europe, and Japan, and where applicable any ethics committee or any equivalent review board.

1.100		“Regulatory Documentation” means, with respect to the Product or Combination Product, all Regulatory Filings and supporting documents created, submitted to the FDA or any equivalent agency or government authority outside of the United States (including any supra-national agency such as in Europe) relating to such Product or Combination Product, and all data contained therein, including, without limitation, any IND(s), NDA(s), MAA(s), Biological Licence Applications (BLA(s)), Investigator’s Brochures, DMF, correspondence to and from the FDA or any equivalent agency or Governmental Authority outside of the United States, minutes from teleconferences with Regulatory Authorities, registrations and licenses, regulatory drug lists, advertising and promotion documents shared with Regulatory Authorities, adverse event files, complaint files and manufacturing records.

1.101		“Regulatory Filing” means the NDA, MAA, BLA, IND, or any foreign counterparts thereof and any other filings required by regulatory authorities relating to the study, manufacture or Commercialization of the Product or any Combination Product.


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1.102		“Research” means, with respect to a particular Dynavax ISS or Collaboration ISS, Product or Combination Product, the research and preclinical development activities undertaken in the Joint Research Programme up to and including the acceptance by the appropriate Regulatory Authority of an IND covering such Dynavax ISS, Collaboration ISS, Product or Combination Product (or first human dosing if done without an IND).

1.103		“ Research Budget ” means the funding to be provided by AstraZeneca to Dynavax in relation to the Joint Research Programme as specified in Section 3.3.

1.104		“ Research Budget Variance ” means any variance to the Research Budget as set out in the Research Plan that is permitted without further agreement of the Parties, and which variance shall not exceed *[ ]** of the agreed research Budget.

1.105		“Research Term” has the meaning set forth in Section 3.2.

1.106		“Reverted ISS” means an ISS that once was a Dynavax ISS or Collaboration ISS but that was not prioritized or selected for further Research in accordance with Section 3.10, or reverted in accordance with Sections 3.12.2 or 8.12, thereby reverting to Dynavax for use outside the Field and no longer subject to the Joint Research Programme.

1.107		“Round One Optimization Candidates” means, in accordance with the Joint Research Plan, those Collaboration ISS that are *[ ] using [ * ]** .

1.108		“Round Two Optimization Candidates” means, in accordance with the Joint Research Plan, those Collaboration ISS that are *[ ] , using [ * ]** .

1.109		“ Royalty-Bearing Claim ” means, with respect to a Dynavax Patent or a Collaboration Patent: (a) *[ ] , or (b) [ * ]** .

1.110		“Royalty Term” has the meaning set forth in Section 10.8.

1.111		“ Second Indication ” means the second Indication in which AstraZeneca obtains a Health Registration Approval in respect of the Product or a Combination Product.

1.112		“Secondary Screening Phase — Stage 1” means, in accordance with the Joint Research Plan, the *[ ]** .


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1.113		“ Secondary Screening Phase — Stage 2” means, in accordance with the Joint Research Plan, the *[ ]** .

1.114		“Sequence Modify” or “Sequence Modification” means to modify an ISS by changing, adding to, or subtracting from the *[ ]** .

1.115		“ Sublicensee ” means any Person, other than an Affiliate or a Party, to which such Party has granted a sublicense under this Agreement.

1.116		“ Term ” means the period beginning on the Effective Date and continuing until the earlier of the date upon which this Agreement expires by its terms or is terminated in accordance with Article 20.

1.117		“ Territory ” means all countries in the World, except those countries in respect of which this Agreement has been terminated, pursuant to this Agreement.

1.118		“ Third Indication ” means the third Indication in which AstraZeneca obtains a Health Registration Approval in respect of the Product or a Combination Product.

1.119		“ Third Party ” means any Person not including the Parties, the Parties’ respective Affiliates or the Sublicensees.

1.120		“ Third Party Claims ” has the meaning set forth in Section 19.1.

1.121		“ TLR-9 ” means toll-like receptor 9.

1.122		“Triggering Event” has the meaning set forth in Section 6.4.2.

1.123		“ Valid Claim ” means, with respect to a particular country, either:

	1.123.1		any Royalty-Bearing Claim of a granted and unexpired Dynavax Patent and/or Collaboration Patent in such country that (a) has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal, and (b) has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise; or

	1.123.2		a Royalty-Bearing Claim of a pending Dynavax Patent and/or Collaboration Patent application, which claim was filed and is being


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prosecuted in good faith and has not been abandoned or finally disallowed without the possibility of appeal or re-filing of the application, provided that such application has not been pending for more than five (5) years.

2		Construction

		Except where the context requires otherwise, whenever used the singular includes the plural, the plural includes the singular, the use of any gender is applicable to all genders and the word “or” has the inclusive meaning represented by the phrase “and/or.” Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The headings of this Agreement are for convenience of reference only and do not define, describe, extend or limit the scope or intent of this Agreement or the scope or intent of any provision contained in this Agreement. The term “including” or “includes” as used in this Agreement means including, without limiting the generality of any description preceding such term. The wording of this Agreement shall be deemed to be the wording mutually chosen by the Parties and no rule of strict construction shall be applied against any Party.

3		Conduct of the Joint Research Programme

3.1		Overview .The objective of the Joint Research Programme shall be to identify and select for development, manufacture, and commercialization one Product and/or Combination Product(s) based on one or more Candidate Drugs. As described in greater detail in the Joint Research Plan and this Article 3, Dynavax will identify and propose to AstraZeneca a pool of *[ ] Dynavax ISS representing each of the three major classes of ISS. Thereafter, the Parties will engage in [ * ] primary and [ * ] secondary screening phases to optimize and select [ * ] Lead Candidate and [ * ] . After further characterization of the Lead Candidate, a Lead Candidate Drug shall be selected for clinical development. The Parties may agree to conduct [ * ] , will each consist of the synthesis and selection of [ * ] Dynavax ISS or Collaboration ISS, in each such optimization phase. All decisions to select molecules for advancement or development shall be [ * ] , subject to the terms of this Agreement; provided, however, that [ * ]** , or perform Research or Development on any ISS other than the Dynavax ISS or the Collaboration ISS, selected for Research and Development pursuant to this Agreement. In conducting the foregoing work, Dynavax shall have


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		no obligation to identify or present an ISS for inclusion in the Joint Research Programme if such ISS is then currently under research in a separate Dynavax programme or is then currently subject to rights of a Third Party.

3.2		Research Term . The research term (the “Research Term” ) shall commence on the Effective Date and shall continue until the earlier of (a) the *[ ] anniversary of the Effective Date or such later date as AstraZeneca may specify pursuant to this Section 3.2, and (b) the effective date of any termination of this Agreement pursuant to Article 20. The FTE funding commitments of AstraZeneca set forth in Section 3.3 and the payment obligations of AstraZeneca set forth in Section 7.1 shall remain in force until the end of the Research Term. The Research Term may be extended by [ * ] no more than [ * ] upon written agreement between the Parties at least [ * ] prior to the end of the [ * ]** year or the relevant extension period thereof.

3.3		Joint Research Plan . The Joint Research Plan has been approved by the Parties concurrent with the execution of this Agreement. The Parties acknowledge and agree that the Joint Research Plan attached hereto as Exhibit C sets forth the goals and objectives of the Joint Research Programme and the broad terms of the Parties’ respective undertakings to achieve those goals and objectives. The Joint Research Plan will be reviewed and (if required) amended by the JSC (subject to Section 4.11) annually or from time to time during the Research Term to identify and define the specific undertakings of the Parties and the associated costs and expenses required to implement the Joint Research Programme. In the event of any inconsistency or disagreement between a Joint Research Plan and this Agreement, the terms of this Agreement shall prevail.

3.4		Research Effort and Support . Dynavax shall supply *[ ] FTEs during each of the first [ * ] contract years of the Research Term and [ * ] FTEs during the [ * ] contract year of the Research Term, unless otherwise mutually agreed by the Parties. Changes in such level of effort may be at the discretion of the JSC (subject to Section 4.11), provided Dynavax receives at least [ * ] months prior notice of any change in the maximum level of FTEs provided hereunder. The JSC shall not be entitled to give notice of its intention to change the level of FTE effort within the first [ * ]** months of the Research Term. The Parties acknowledge that Dynavax may provide increasing level of technical assistance for the transfer of certain technology to AstraZeneca or


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		its designee during the *[ ] contract year of the Research Term, which may lead the number of FTEs to be provided by Dynavax in that time period to be increased by the Parties’ mutual agreement. In the event of an extension of the Research Term, the Parties shall agree at that time on the number of FTEs that Dynavax shall supply in such extension period of the Research Term. AstraZeneca shall fund such FTEs as set forth in Section 7.1. AstraZeneca understands and agrees that Dynavax retains complete discretion to alter and reallocate the individuals who compose such FTEs and to alter the frequency and time which any individual devotes to the Joint Research Programme, provided that all such FTEs are appropriately skilled to perform the Joint Research Programme. All scientific work on or directly related to the Joint Research Programme performed by such individuals shall count towards the fulfilment of Dynavax’s FTE commitment pursuant to this Section 3.4. Such work may include, but is not limited to, experimental laboratory work, recording and writing up results, reviewing literature and references, holding scientific discussions, organizing and attending scientific meetings and conferences, managing and leading scientific staff, and carrying out Joint Research Programme management duties (including service on the JPT). All JSC pre-approved external costs, if any, incurred by Dynavax in connection with its performance of its obligations under the Joint Research Programme throughout the Research Term, to the extent not included in the FTE Rate, shall be separated invoiced by Dynavax to AstraZeneca and reimbursed by AstraZeneca pursuant to Section 7.2. The Parties acknowledge that the FTE Rate does not include the costs or expenses of [ * ]** .

3.5		Conduct of Research .

3.5.1

Commercially Reasonable Efforts . The Parties shall use Commercially Reasonable Efforts to conduct their respective tasks as assigned under the Joint Research Plan, provided that Dynavax shall not be obligated to devote any resources to the Joint Research Programme in excess of the FTEs funded by AstraZeneca pursuant to Section 3.4. In addition, during the Research Term and under the direction and supervision of the JSC, each Party shall (a) perform or cause to be performed its obligations under the Joint Research Programme in good scientific manner and in compliance in all material aspects with all Applicable Law, and (b) allocate sufficient time, effort,


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			equipment and skilled personnel to complete such activities successfully and promptly.

	3.5.2		Facilities and Personnel . The Parties shall provide facilities, equipment and manpower that are reasonably necessary or useful to carry out the work to be undertaken under the Joint Research Programme. Each of the Parties may perform or cause to be performed its obligations under the Joint Research Programme at its own facilities or at those of its permitted subcontractors and Sublicensee(s), listed in Exhibit D , as applicable.

	3.5.3		Use of Animals. Insofar as the Joint Research Programme involves the use of animals, each of AstraZeneca and Dynavax shall conduct all activities pursuant to the Joint Research Programme in accordance with any local laws and regulations applicable to the facility in which such activities occur and in accordance with the AstraZeneca policy on such use applicable at the Effective Date, a copy of which has been provided to Dynavax.

	3.5.4		Subcontracting . Each Party shall be solely responsible for successfully completing its activities set forth in the Joint Research Plan. The Parties shall conduct and carry out all activities provided for under the Joint Research Programme through its employees at the site(s) identified under Section 3.5.2 unless and only to the extent the JSC approves the Party’s engaging a subcontractor to carry out a portion of such Research activities or, if applicable, approves a major outsourcing or collaboration agreement with a Third Party. Notwithstanding the foregoing, as of the Effective Date, each of Dynavax and AstraZeneca have agreed that Dynavax may engage the Persons listed on Exhibit D to perform the specified activities of Dynavax under the Joint Research Plan. Any permitted subcontractor shall be subject to the applicable terms and conditions of this Agreement, including Articles 6 and 13, and, upon a Party’s request, the other Party shall require each such subcontractor to enter into an undertaking, pursuant to which the terms and conditions of this Agreement shall apply directly between such subcontractor and AstraZeneca or Dynavax, as applicable, prior to disclosing to such subcontractor any of the other Party’s Confidential Information; provided, however, that the subcontracting Party shall remain ultimately responsible for


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the performance of its obligations under this Agreement. The costs incurred by Dynavax in subcontracting activities under the Joint Research Programme shall be borne by Dynavax, except as provided in the following two sentences. All JSC pre-approved external costs, if any, incurred by Dynavax in connection with its performance of its obligations under the Joint Research Programme throughout the Research Term, to the extent not included in the FTE Rate, shall be separately invoiced by Dynavax to AstraZeneca and reimbursed by AstraZeneca pursuant to Section 7.2. The Parties acknowledge that the FTE Rate does not include the costs or expenses of [ * ] .

3.6

Materials and Information Transfer . Each Party shall, and shall cause its Affiliates to, [ * ] , to the extent that they are legally permitted so to do, (a) provide to the other Party the materials or equipment specified from time to time in this Agreement or the Joint Research Plan, and (b) disclose and make available to the other Party, in whatever form such Party may reasonably request, all Background Technology and Collaboration Technology relating, directly or indirectly, to the Joint Research Programme, immediately after the Effective Date and thereafter immediately upon the earlier of the conception or reduction to practice, discovery, development or making of such Background Technology and Collaboration Technology. All such Background Technology and Collaboration Technology shall be used by the receiving Party only as permitted under the applicable license rights granted under Article 6 and subject to all other restrictions and obligations under this Agreement. Except as otherwise provided under this Agreement, all such Background Technology delivered to the other Party will remain the sole property of the supplying Party, will be used only in furtherance of and in accordance with this Agreement, and together with the Collaboration Technology will not be used or delivered to or for the benefit of any Third Party without the prior written consent of the supplying Party, and will be used in compliance with all Applicable Law, will be provided without any warranties, express or implied and the Party providing them shall obtain (or cause its Third Party collaborators to obtain or certify that they have obtained) all appropriate and required consents from the source of such Background Technology and Collaboration Technology. The Background Technology and Collaboration Technology supplied under this Agreement shall be used with prudence and appropriate caution in any experimental work because not all of their characteristics may be known. Without


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		prejudice to the generality of the foregoing, if visits of either Party’s representatives to the other Party’s facilities are reasonably requested for purposes of transferring the Background Technology and Collaboration Technology to such Party or for purposes of such requesting Party to acquire expertise on the practical application of the Background Technology and Collaboration Technology or assisting on issues arising during the Research, the other Party will send appropriate representatives to the requesting Party’s facilities, provided that the requesting Party shall reimburse the other Party for its reasonable and verifiable expenses of travel and accommodations for such representatives.

3.7		Cooperation . Each Party shall cooperate with any and all reasonable requests for assistance from the other Party with respect to the activities under the Joint Research Programme, including by making its employees, consultants and other scientific staff available upon reasonable notice during normal business hours at their respective places of employment to consult with such other Party on issues arising in connection with the Joint Research Programme.

3.8		Regulatory Records . Dynavax and AstraZeneca each shall maintain, or cause to be maintained, records of its respective activities under the Joint Research Programme in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective activities under the Joint Research Programme, and which shall be retained by such Party for at least *[ ]** years after the termination of this Agreement, or for such longer period as may be required by Applicable Law. Subject to bona fide confidentiality obligations to a Third Party, each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any such records to the extent necessary for such Party to conduct its Research or perform its other obligations under this Agreement, or to secure or enforce Patents licensed under this Agreement.

3.9		Reports . Each Party assigned an obligation under the Joint Research Programme shall report to the JPT no less than *[ ] , which report shall include a written progress report summarizing the work performed under the Joint Research Programme. The JPT shall define the format and the nature of the content of the [ * ]** report, which format and nature shall be adopted by both Parties.


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3.10		Lead Candidate Development Decision .

		It is the objective of the Parties that *[ ] will be able to [ * ] within [ * ] days after the prioritization of the Lead Research Candidate and [ * ] thereto, whereby [ * ] will [ * ] . Upon written notice of such selection, the Parties shall conduct further research and characterization of the Lead Candidate with the objective of determining whether the Lead Candidate satisfies the criteria as a Candidate Drug, as specified in Exhibit A , together with any necessary further research and characterization of [ * ] by AstraZeneca as may reasonably be necessary, as determined by [ * ] , to establish the relative merits of the selected Lead Candidate [ * ]** so as to enable AstraZeneca to progress one such candidate to CD Nomination. The Parties may agree to extend any particular phase of the Joint Research Plan.

3.11		CD Nomination .

		It is noted that *[ ] has the right, but not the obligation, to nominate all of the Lead Candidate [ * ]** as CD’s pursuant to this Agreement. The first CD nominated shall be designated as the Lead CD and subject to the right to replace such CD as specified in Section 8.10 below, all subsequent Development or Commercialisation by AstraZeneca pursuant to this Agreement shall be directed at such Lead CD.

3.12		Overview of Joint Research Programme

	3.12.1		The Joint Research Programme shall be conducted in accordance with the Joint Research Plan attached as Exhibit C hereto. Once a Dynavax ISS or a Collaboration ISS is designated a Candidate Drug *[ ] , no further work shall be performed upon it pursuant to the Joint Research Programme, provided, however, if AstraZeneca desires Dynavax to perform further work on such Candidate Drug [ * ] , Dynavax shall [ * ] , provided that the Parties [ * ]** .

	3.12.2		All rights to any Dynavax ISS or Collaboration ISS, other than the Candidate Drug *[ ]** , not selected for advancement in the Joint Research Programme shall revert immediately to Dynavax, and shall thereafter be Reverted ISS.

3.13

Selection of Compounds .The Parties acknowledge that [ * ] shall have the right in its sole discretion at any time during or after the Research Term, to determine which, if any, Dynavax ISS or Collaboration ISS to select for further Research and selection for


[ * ]	=	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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		CD Nomination and which CD to select for further Research, Development and Commercialization, under this Agreement. *[ ] shall without delay notify in writing [ * ]** , as applicable, of any such selections and decisions. For clarity, nothing in this Section 3.13 shall limit Dynavax’s rights to Reverted ISS. In particular, AstraZeneca shall have no rights to select a Reverted ISS for further Research, Development or Commercialization under this Agreement.

4		Support and Management of the Joint Research Programme

4.1		Overview of the Management of the Joint Research Programme . The collaboration established by this Agreement shall be overseen by a Joint Steering Committee and a Joint Project Team, each of which, shall be established by the Parties after the Effective Date. Without limiting anything set forth in this Article 4, the Joint Steering Committee shall manage and steer the overall Collaboration and the Joint Project Team shall manage the day-to-day work within the Joint Research Programme during the Research Term. Following the CD Nomination Date, the Parties shall establish an Advisory Board to advise AstraZeneca in its Development and Commercialization of the CD, Product or any Combination Product.

4.2		Responsibilities of JPT . The Parties shall establish a Joint Project Team (the “ JPT ”) within ten (10) days following the Effective Date which shall be responsible for managing the day-to-day work within the Joint Research Programme and which shall report to the JSC. In particular, the responsibilities of the JPT shall include:

	4.2.1		proposing the strategic research goals and directions for the Joint Research Programme;

	4.2.2		preparing and proposing milestones, go/no go criteria and criteria for evaluation of the Joint Research Programme;