exv10w30



 




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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	 






 




			
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(ii)


	 	 	 	 	 	 	 
	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	 






 




			
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(iii)


	 	 	 	 	 	 	 
	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	 






 




			
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(iv)


	 	 	 	 	 	 	 
	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

	 	[ * ]	 	 	 	 






 




			
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(v)


	 	 	 	 	 	 	 
	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	 






 




			
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(vi)


	 	 	 	 	 	 	 
	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	 






 




			
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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:




 




			
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Page 2 of 104



	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,







 




			
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Page 3 of 104


	 	 	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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Page 4 of 104



	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






 




			
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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






 




			
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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.






 




			
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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






 




			
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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
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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






 




			
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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;
	 
	 	4.2.3	 	proposing the Joint Research Plan, Research Budget, Research Budget Variance
and any amendments thereto;
	 
	 	4.2.4	 	monitoring the progress of the Joint Research Programme;
	 
	 	4.2.5	 	monitoring workflow and proposing the allocation of resources for carrying out
the Joint Research Programme;






 




			
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	 	4.2.6	 	proposing priorities for the Joint Research Programme and in view of the
capacities of the Parties;
	 
	 	4.2.7	 	proposing prioritisation criteria for specific components under the Joint
Research Programme, including setting proposed dates for experimental initiation and
completion of each stage of the Joint Research Programme;
	 
	 	4.2.8	 	approving the Candidate Drug Target Profile using the criteria set forth in
Exhibit A;
	 
	 	4.2.9	 	[ * ];
	 
	 	4.2.10	 	[ * ];
	 
	 	4.2.11	 	developing and proposing updates of the Joint Research Programme;
	 
	 	4.2.12	 	proposing any subcontractor or major outsourcing and/or collaboration agreements with
Third Parties as appropriate;
	 
	 	4.2.13	 	proposing a publications strategy and preparing and proposing specific items related
to the Joint Research Programme for publication; and
	 
	 	4.2.14	 	preparing and monitoring budgets for the Joint Research Programme in discussion with
the JSC.






	4.3	 	Formation of JPT . The JPT shall consist of [ * ] members who are employees of
either Dynavax or AstraZeneca or their Affiliates, as applicable, with the requisite
experience and seniority to enable them to make proposals on behalf of the Parties with
respect to the Joint Research Programme, with equal numbers appointed by each respective
Party, which shall include a Project Leader to be designated by each Party. The Project
Leaders shall each be responsible for all day-to-day Joint Research Programme activities
undertaken by the appointing Party and shall supervise and coordinate the work of all
personnel engaged by each Party in the Joint Research Programme. Notwithstanding the
foregoing, each Party shall continue to be responsible for performing the activities
undertaken by it under the Joint Research Programme. Each Party shall have the right to
replace its respective JPT representatives upon written notice to the other Party, provided
that any such substitute representative shall be an employee of such Party or its Affiliates
and shall






 




			
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	 	 	have substantially the equivalent experience and seniority as the representative
that such person replaces. Representatives of each Party other than the members of the JPT may
attend JPT meetings at the invitation of either Party with the prior approval of the other
Party, which approval shall not be unreasonably withheld.
	 
	4.4	 	JPT Meetings. The JPT shall meet at least monthly and more frequently when required.
The first JPT meeting will be held within twenty (20) days after the Effective Date and
thereafter meetings will be held alternately at the offices of Dynavax and AstraZeneca unless
the Parties agree on another location, or by teleconference or videoconference. A quorum of
the JPT shall exist whenever there is present at a meeting each of the Project Leaders or
their respective designees. The Project Leaders shall act as co-chairs for JPT meetings. In
addition, the JPT may act without a formal meeting by a written memorandum signed by the
Project Leaders. The JPT may also invite other personnel of the Parties to attend meetings of
the JPT as appropriate to the agenda for such meeting, after giving notice to the other Party.
Whenever any action by the JPT is required hereunder during a time period in which the JPT is
not scheduled to meet, either Project Leader shall have the right to call a special meeting or
the Project Leaders may cause the JPT to take the action without a meeting in the applicable
time period. Any such additional meetings shall be held at places and on dates selected by
the Project
Leaders. The JPT may by unanimous consent, amend or expand upon the foregoing procedures for
its internal operations.
	 
	4.5	 	JPT Decision Making : Disputes. All decisions of the JPT made pursuant to this
Agreement shall be made by unanimous consent of its members. If for any reason the JPT cannot
reach unanimity regarding a particular matter, then, such matter shall be resolved in a second
meeting to be held within twenty (20) Business Days from the meeting in which the disputed
matter has remained unresolved. In the event that the JPT is again unable to resolve the
matter the disputed matter shall be promptly referred to the JSC for resolution.
	 
	4.6	 	JPT Minutes. The JPT shall keep accurate minutes of its deliberations, which minutes
shall record all proposed decisions and all actions recommended or taken. Drafts of minutes
shall be delivered to the Project Leaders within twenty (20) days after the respective
meeting. The Parties, on an alternating basis, shall prepare and circulate






 




			
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	 	 	the draft minutes.
Draft minutes shall be edited by the Project Leaders and shall be issued in final form only
with the approval and agreement of the Project Leaders.
	 
	4.7	 	Dissolution of JPT. Following the termination or expiration of the Research Term the
JPT shall be dissolved.
	 
	4.8	 	Responsibilities of JSC. The Parties shall establish a Joint Steering Committee (the
“JSC”) within ten (10) days following the Effective Date, to oversee the initiation, planning
and performance of the activities under the Joint Research Programme based on the proposals
and activities of the JPT. In particular, the responsibilities of the JSC shall include:






	 	4.8.1	 	approving the strategic research goals and direction for the Joint Research
Programme;
	 
	 	4.8.2	 	approving the go/no go criteria and criteria for evaluation of the Joint
Research Programme;
	 
	 	4.8.3	 	reviewing and approving the Research Project Plan, Research Budget, Research
Budget Variance and any amendments thereto;
	 
	 	4.8.4	 	approving workflow and the allocation of resources for carrying out the Joint
Research Programme taking into account each Party’s respective specific capabilities
and expertise in order to avoid duplication and enhance efficiency and synergies;
	 
	 	4.8.5	 	approving priorities for the Joint Research Programme and capacities of the
Parties;
	 
	 	4.8.6	 	approving prioritisation criteria for specific components under the Joint
Research Programme, including setting proposed dates for experimental initiation and
completion of each stage of the Joint Research Programme;
	 
	 	4.8.7	 	monitoring and ensuring timely execution of the Joint Research Programme,
including compliance with budgets and timelines;
	 
	 	4.8.8	 	determining within [ * ] days of the completion of each stage of the Joint
Research Programme whether the completion thereof has been successful and






 




			
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	 	 	 	deciding
whether or not to continue the Joint Research Programme into the next stage (i.e.,
making “stop/go decisions”);
	 
	 	4.8.9	 	[ * ]
	 
	 	4.8.10	 	[ * ]
	 
	 	4.8.11	 	approving any significant changes to the staffing (FTE) levels or the funding of the
Joint Research Programme;
	 
	 	4.8.12	 	approving any subcontractors or major outsourcing and/or collaboration agreements
with Third Parties as appropriate;
	 
	 	4.8.13	 	ensuring timely and appropriate support in the filing of Patent applications;
	 
	 	4.8.14	 	approving the publications strategy and approving specific items for publication
(including but not limited to articles, presentations and press releases);
	 
	 	4.8.15	 	resolving any issues that could not be resolved by the JPT; and
	 
	 	4.8.16	 	taking all other significant management decisions relating to the Joint Research
Programme.






	4.9	 	Formation of JSC. The JSC shall consist of [ * ] members who are employees of
Dynavax or AstraZeneca or their Affiliates, as applicable, with the requisite experience and
seniority to enable them to make decisions on behalf of the Parties with respect to the Joint
Research Programme, with equal numbers appointed by the respective Party, which shall include
an Alliance Manager to be designated by each Party. The Alliance Managers shall each be
responsible for supervising and coordinating the activities of the JPT and JSC pursuant to the
Joint Research Programme. The Alliance Managers shall serve as the primary contacts for the
Parties on all matters related to the Joint Research Programme. Notwithstanding the
foregoing, each Party shall continue to be responsible for performing the activities
undertaken by it under the Joint Research Programme. Each Party shall have the right to
replace its respective JSC representatives upon written notice to the other Party, provided
that any such substitute representative shall be an employee of such Party or its Affiliates
and shall have substantially the equivalent experience and seniority as






 




			
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	 	 	the representative
that such person replaces. Representatives of each Party other than the members of the JSC
may attend JSC meetings at the invitation of either Party with the prior approval of the other
Party, which approval shall not be unreasonably withheld. From time to time, the JSC may
establish subcommittees or subordinate committees (that may or may not include members of the
JSC itself) to oversee particular projects or activities, and such subcommittees or
subordinate committees shall be constituted and shall operate as the JSC agrees.
	 
	4.10	 	JSC Decision Making; Disputes. All decisions of the JSC made pursuant to this
Agreement shall be made by unanimous consent of the Parties, with each Party having a single
vote, irrespective of the number of representatives actually in attendance at a meeting. If
for any reason the JSC cannot reach unanimity within [ * ] days following a JSC meeting at
which a Party formally requests resolution of such matter, then except as set forth in Section
4.11, the matter shall be referred to and resolved in good faith by the [ * ] of AstraZeneca
and the [ * ] of Dynavax. Any final decision mutually agreed to by the said senior
managements of the Parties shall be in writing and shall be conclusive and binding on the
Parties. If such resolution is unattainable by senior management within [ * ] days from the
date the matter in dispute is first brought to the attention of
the senior management of the Parties, the dispute shall be [ * ]; provided, however, that,
if [ * ], then [ * ].
	 
	4.11	 	JSC Decisions Requiring Consent . Any [ * ] shall require the unanimous consent of
the JSC. If the JSC fails to reach unanimous consent regarding any such change to the Joint
Research Programme, then [ * ]. In addition, neither Party shall have any right to make any
changes to the Joint Research Plan relating to the Research of Dynavax ISS and/or
Collaboration ISS that would change the other Party’s [ * ], without the consent of the
other Party.
	 
	4.12	 	JSC Meetings. Unless otherwise agreed, the JSC shall meet at least quarterly and
more frequently when required. The first JSC meeting will be held within ninety (90) days
after the Effective Date and thereafter meetings will be held alternately at the offices of
Dynavax and AstraZeneca unless the Parties agree on another location, or by teleconference or
videoconference. A quorum of the JSC shall exist whenever there is present at a meeting each
of the Alliance Managers or their respective designees. A JSC representative for AstraZeneca
shall chair the first JSC meeting and






 




			
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	 	 	thereafter a JSC representative of the Party which is
hosting such JSC meeting at its offices, will chair such meeting. In addition, the JSC may
act without a formal meeting by a written memorandum signed by the Alliance Managers. The JSC
may also invite other personnel of the Parties to attend meetings of the JSC as appropriate to
the agenda for such meeting, after giving notice to the other Party. Whenever any action by
the JSC is required hereunder during a time period in which the JSC is not scheduled to meet,
either Alliance Manager shall have the right to call a special meeting or the Alliance
Managers may cause the JSC to take the action without a meeting in the applicable time period.
Any such additional meetings shall be held at places and on dates selected by the Alliance
Managers. The JSC may by unanimous consent, amend or expand upon the foregoing procedures for
its internal operations.
	 
	4.13	 	JSC Minutes. The JSC shall keep accurate minutes of its deliberations, which minutes
shall record all proposed decisions and all actions recommended or taken, Joint Research
Programme progress reports provided to the JSC pursuant to Section 5.1 , Collaboration
Technology generated of interest
in the Joint Research Programme and confirmation that Joint Research Programme Milestones
have been reached. In particular, all Dynavax ISS and Collaboration ISS [ * ] selected
and/or nominated during the Research Term and any Candidate Drug selected therefrom, shall
be recorded in the minutes of the JSC. Drafts of minutes shall be delivered to the Alliance
Managers within twenty (20) days after the respective meeting. The Parties, on an
alternating basis, shall prepare and circulate the draft minutes. Draft minutes shall be
edited by the Alliance Managers and shall be issued in final form only with the approval and
agreement of the Alliance Managers of both Parties.
	 
	4.14	 	Dissolution of JSC. Following the expiration or termination of the Research Term,
the JSC shall be dissolved and Dynavax shall provide AstraZeneca with consultation services as
AstraZeneca may reasonably request for the continued Development and Commercialization of the
Dynavax ISS and/or Collaboration ISS, the costs of which shall be managed in accordance with
Section 8.9 below.
	 
	4.15	 	Advisory Board. Within thirty (30) days following the CD Nomination Date, the Parties
shall establish an Advisory Board, which shall consist of [ * ] representatives of each
Party and shall hold meetings no less frequently than every [ * ] months with the purpose of
[ * ]. The Advisory Board shall [ * ] and its advice shall not in any






 




			
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	 	 	way limit or
restrict AstraZeneca’s rights and obligations pursuant to Article 8. The Advisory Board shall
meet in person at offices of Dynavax and AstraZeneca unless the Parties agree on another
location, or by teleconference or videoconference. The Advisory Board may invite other
personnel of the Parties to attend meetings of the Advisory Board as appropriate after giving
notice to the other Party. The Advisory Board shall dissolve upon the termination or
expiration of this Agreement.
	 
	4.16	 	Expenses. Dynavax and AstraZeneca each shall bear all expenses of its JPT, JSC and
Advisory Board members related to such members’ participation and attendance at the JPT, JSC
and/or Advisory Board meetings.
	 
	4.17	 	Access to Information. Each Party shall provide the JPT and JSC and their authorized
representatives with reasonable access during regular business hours to all records and
documents of such Party that are specific to the Research or further Development of the
Product or any Combination Product and that the JPT and JSC may reasonably require in order to
perform their obligations hereunder, subject to any bona fide obligations of confidentiality
to a Third Party.
	 
	4.18	 	Joint Research Programme Guidelines.






	 	4.18.1	 	General. In all matters related to the Joint Research Programme, the Parties
shall be guided by [ * ], to further the Joint Research Programme and [ * ].
	 
	 	4.18.2	 	Independence. Subject to the terms of this Agreement, the activities and
resources of each Party shall be managed by such Party, acting independently and in its
individual capacity. The relationship between Dynavax and AstraZeneca is that of
independent contractors and neither Party shall have the power to bind or obligate the
other Party in any manner, other than as is expressly set forth in this Agreement.






	5	 	Reports
	 
	5.1	 	Joint Research Programme Progress Reports. No later than [ * ] business days prior
to each quarterly JSC meeting, the JPT shall prepare quarterly update reports for presentation
at JSC meetings. Such reports shall provide the JSC with a detailed written progress report
in English containing information on the status of the Research






 




			
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	 	 	efforts and any [ * ] and
not previously reported to the JSC. The JSC may provide further instructions on the timing
and content of these reports.
	 
	5.2	 	Copyrights. Copyrights to reports provided for hereunder shall be jointly owned by
the Parties. Neither Party shall, without the prior written approval of the other Party,
attribute to the other Party any abstract or interpretation of any such report for sales or
promotion purposes.
	 
	5.3	 	AstraZeneca Reports. Upon dissolution of the JSC pursuant to Section 4.14,
AstraZeneca shall provide the Advisory Board with [ * ] progress reports containing
information on AstraZeneca Development and Commercialization activities in accordance with
Sections 8.2 and 8.4.
	 
	6	 	Ownership and Grant of Rights
	 
	6.1	 	Ownership of Collaboration Technology. The Parties shall jointly own all
Collaboration Technology, with each Party owning an undivided half interest in such
Collaboration Technology and, subject to the exclusive licences granted herein, each having
the right to use and to license such Collaboration Technology for any purpose without a duty
of accounting or obtaining consent from the other Party. Each Party shall promptly disclose
to the other Party in writing the development, making, conception or reduction to practice of
any Collaboration Technology, and shall, and does hereby, assign, and shall cause its
Affiliates and its and their employees and agents, as applicable, to so assign, to such other
Party, without additional compensation, such right, title and interest in and to any
Collaboration Technology, as is necessary to fully effect the joint ownership provided for in
the foregoing sentence.
	 
	6.2	 	Licences to AstraZeneca. Subject to the terms of this Agreement, Dynavax hereby
grants to AstraZeneca the following:






	 	6.2.1	 	a worldwide, co-exclusive (with Dynavax), royalty-free license, without the
right to sublicense except to Affiliates, under the Dynavax Technology solely to
perform AstraZeneca’s portion of the Research obligations under this Agreement with
respect to any Dynavax ISS, Collaboration ISS, CD, Product and Combination Product in
the Field and in the Territory; and






 




			
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	 	6.2.2	 	a worldwide, royalty bearing license, with the right to sublicense as set
forth in Section 6.6, under the Dynavax Technology and Dynavax’s rights and interest in
the Collaboration Technology, to make, have made, use, offer for sale, sell and import
the Product, and/or Combination Product(s) in the Field and in the Territory. The
foregoing license shall be exclusive (even as to Dynavax)
except that AstraZeneca hereby acknowledges that Dynavax reserves the right to [ *
]. In the event that [ * ]. If Dynavax [ * ].






	 	 	Notwithstanding the above licences, it is noted that AstraZeneca shall have no right to
make, have made, use, offer for sale, sell and import the CDs or any products incorporating
such CDs, outside of the Field in the Territory.
	 
	 	 	The Parties acknowledge that, at any time after the First Commercial Sale of the Product or
a Combination Product, such Product or Combination Product may be used by end users outside
the Field. The Parties agree that such use shall not be deemed a breach by AstraZeneca of
this Agreement, provided that AstraZeneca does not at any time, without the prior written
consent of Dynavax, [ * ].
	 
	 	 	For the avoidance of doubt, the licenses granted to AstraZeneca in this Section 6.2
convey no rights with respect to any ISS Controlled by Dynavax other than the Dynavax ISS
and Collaboration ISS.
	 
	6.3	 	Licence to Dynavax. Subject to the terms of this Agreement, AstraZeneca hereby
grants to Dynavax a worldwide, fully paid, non-exclusive license, with the right to
sublicense, under the AstraZeneca Technology and AstraZeneca’s rights and interest in the
Collaboration Technology solely to perform Dynavax’s portion of the Research obligations under
this Agreement with respect to Dynavax ISS and Collaboration ISS, CDs, Product and Combination
Products in the Field and in the Territory. In addition, AstraZeneca hereby grants to
Dynavax, a worldwide, non-exclusive, royalty-free license under the AstraZeneca Technology and
AstraZeneca’s rights and interest in the Collaboration Technology to make, have made, use,
offer for sale, sell and import Reverted ISS and products comprising Reverted ISS (i) for use
outside the Field during the Term, but, in accordance with the limitation specified in Section
6.5, excluding the right to make, have made, use, offer for sale, sell and import Reverted ISS
and products comprising Reverted ISS for use in any Dynavax existing or future






 




			
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	 	 	allergic
respiratory disease programme, and (ii) for use inside and outside of the Field following the
Term if this Agreement is terminated for any reason other than by AstraZeneca pursuant to
Section 20.5 (breach by Dynavax or other similar events specified therein).
	 
	 	 	Notwithstanding the above licences, it is noted that during the Term, Dynavax shall have no
right to make, have made, use, offer for sale, sell and import the CDs or any products
incorporating such CDs, inside or outside of the Field in the Territory, unless and until
such CD becomes a Reverted ISS.
	 
	6.4	 	Third Party Licences.






	 	6.4.1	 	The Parties, through the JPT and JSC, as appropriate, shall discuss whether
licences under Third Party technology are necessary for the Research. If during the
Research Term, the JSC agrees that such a Third Party licence is necessary, then,
AstraZeneca shall have the first right, but not the obligation, through counsel of its
choosing, to negotiate and obtain a licence from such Third Party. If AstraZeneca
incurs Third Party [ * ] licence expenses as a result of [ * ], such costs relating
to [ * ] may be recovered in part pursuant to the royalty-offset provision of Article
10 at AstraZeneca’s sole discretion, and such costs relating to Third Parties [ * ]
may be recovered in part pursuant to the royalty-offset provision of Article 10,
subject to the prior written consent of Dynavax, [ * ].
	 
	 	6.4.2	 	If, in the opinion of AstraZeneca, following discussion with the Advisory
Board, the Development and/or Commercialization of the Dynavax ISS, Collaboration ISS,
CDs, Product or Combination Products by AstraZeneca, its Affiliates or any of their
Sublicensees infringes or misappropriates any Patent or any Intellectual Property Right
of a Third Party in any country, such that AstraZeneca or any of its Affiliates,
Distributors or Sublicensees cannot Develop and/or Commercialize the Dynavax ISS,
Collaboration ISS, CDs or the Product or any Combination Product(s) in such country
without infringing the Patent or intellectual property right of such Third Party (a
“Triggering Event”), then, AstraZeneca shall have the first right, but not the
obligation, through counsel of its choosing, to negotiate and obtain a licence from
such






 




			
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	 	 	 	Third Party as necessary for AstraZeneca and its Affiliates and Sublicensees to
Develop and/or Commercialize the Dynavax ISS, Collaboration ISS, CDs, Product and any
Combination Product(s) in such country. Nothing contained in this Section 6.4.2 shall
be construed to limit AstraZeneca’s right to terminate this Agreement pursuant to
Section 20.3. If AstraZeneca incurs
Third Party [ * ] licence expenses as a result of [ * ], such costs relating to
[ * ] may be recovered in part pursuant to the royalty-offset provision of Article
10 at AstraZeneca’s sole discretion and such costs relating to Third Parties [ * ]
may be recovered in part pursuant to the royalty-offset provision of Article 10,
subject to the prior written consent of Dynavax, [ * ].






	6.5	 	Exclusivity.






	 	6.5.1	 	During the Term, each Party and its respective Affiliates shall not, directly
or indirectly, by itself or with any Third Party, conduct research on, develop or
commercialize in the Field any ISS other than the selection, Research, Development and
Commercialization of Dynavax ISS and/or Collaboration ISS and/or CDs and/or Product
and/or Combination Products in the Field pursuant to this Agreement.
	 
	 	6.5.2	 	Dynavax acknowledge that as a necessary pre-requisite of AstraZeneca being
able to benefit from the licence rights granted pursuant to Section 6.2, it is
appropriate and acceptable for Dynavax and its Affiliates to refrain from conducting
research on, developing, commercialising, making, having made, using, offering for
sale, selling and importing the Reverted ISS in the treatment of human patients who
have Asthma, COPD, and/or respiratory allergies. Accordingly for such time as
AstraZeneca is Researching, Developing or Commercialising a Dynavax ISS, Collaboration
ISS, CD, Product or Combination Product pursuant to this Agreement, Dynavax and its
Affiliates shall not, by themselves or with any Third Party, utilise any of the
Reverted ISS within any existing or future Asthma, COPD, and/or respiratory allergy
research, development and commercialisation programme.
	 
	 	6.5.3	 	The Parties acknowledge that all restrictions contained in this Section 6.5
are reasonable, valid and necessary for the adequate protection of the Product or






 




			
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	 	 	 	any
Combination Product(s) and that neither AstraZeneca nor Dynavax would have entered into
this Agreement with out the protection afforded it by this Section 6.5.
	 
	 	6.5.4	 	AstraZeneca’s exclusive position granted by Section 6.2 shall expire with
respect to the Product and each separate Combination Product, on a country-
by-country basis, on the date when AstraZeneca’s obligation to pay royalties with
respect to such Product or Combination Product (as appropriate) expires. Upon
expiry of AstraZeneca’s exclusive position with respect to the Product or any
Combination Product in a country, AstraZeneca’s licence with respect to such Product
or Combination Product in such country shall become non-exclusive, fully paid-up,
perpetual and irrevocable and the Net Sales of such Product or Combination Product
in such country shall be excluded from the royalty calculations in Article 10
(including the thresholds and ceilings). AstraZeneca and its Affiliates and
Sublicensees shall be allowed to continue Developing and Commercializing such
Product or Combination Product and using all related Patents, Know-How and
Information in connection therewith on a [ * ] basis in such country with [ * ].
	 
	 	6.5.5	 	During the Term, in line with Dynavax’s representation and warranty in Section
18.1.6, Dynavax and/or any of its Affiliates covenant:






	 	(a)	 	not, anywhere in the world, to institute or prosecute (or in
any way aid any Third Party in instituting or prosecuting), at law or in
equity, any claim, demand, action or cause of action for damages, costs,
expenses or compensation, or for an enjoinment, injunction, or any other
equitable remedy, against AstraZeneca, its Affiliates, Sublicensees, suppliers,
Distributors, vendors or customers alleging the infringement by AstraZeneca in
its Development and Commercialization in accordance with this Agreement of
Dynavax ISS, Collaboration Technology, CDs, or Products or Combination
Product(s), of any Patent that claims an invention that is based on, derived
from or otherwise relates to the Collaboration Technology or the Background
Technology of a Party and is Controlled by Dynavax or its Affiliates;






 




			
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	 	(b)	 	not, anywhere in the world, to grant any rights or licences to
any Third Party which are contrary to or inconsistent with the rights and
licences granted to AstraZeneca and its Affiliates pursuant to this Agreement;
and
	 
	 	(c)	 	notwithstanding Dynavax’s representation and warranty in
Section 18.1.6, in the event of any inadvertent grant of rights or licences to
any Third Party which are, or subsequently become, contrary to or inconsistent
with the rights and licences granted to AstraZeneca and its Affiliates pursuant
to this Agreement, to [ * ], with the aim of ensuring that, [ * ], the
rights and licences accorded to AstraZeneca supersede any conflicting rights
and licences of Third Parties. Dynavax shall also offer full cooperation to
allow AstraZeneca to [ * ].






	6.6	 	Sublicences. AstraZeneca shall have the right to grant sublicences, through multiple
tiers of sublicensees, under the licences granted in Section 6.2.1 and 6.2.2, to (a) its
Affiliates and (b) to any other Person, provided, however, that AstraZeneca shall first obtain
the written consent of Dynavax before granting a sublicence under the licences granted in
Section 6.2 for the Research, Development or Commercialization of Dynavax ISS, Collaboration
ISS, CDs, the Product or any Combination Product(s) in [ * ], except for sublicences limited
to [ * ]. Where AstraZeneca grants a sublicense to a Person, which is not an Affiliate of
AstraZeneca, and such Person is not a Distributor, that Person shall be a “Sublicensee” for
purposes of this Agreement. AstraZeneca shall use Commercially Reasonable Efforts to ensure
that all Persons to which it grants sublicences comply with all terms and conditions of this
Agreement. In all countries outside of the Major Markets, AstraZeneca shall give written
notice to Dynavax promptly following each sublicence granted hereunder, identifying the
Sublicensee and the rights granted.
	 
	6.7	 	Distributors. AstraZeneca shall have the right, in its sole discretion, to appoint
its Affiliates, and AstraZeneca and its Affiliates shall have the right, in their sole
discretion, to appoint any other Persons, to distribute, market and sell the Product or any
Combination Products (with or without packaging rights) in circumstances where the Person
purchases its requirements of Product or Combination Products from






 




			
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	 	 	AstraZeneca or its
Affiliates but does not otherwise make any royalty or other payment to AstraZeneca with
respect to its intellectual property rights. In the event that AstraZeneca or its Affiliates
so appoint a Person and such Person is not an Affiliate of AstraZeneca, that Person shall be a
“Distributor” for
purposes of this Agreement. The term “packaging rights” in this Section 6.7 shall mean the
right for the Distributor to [ * ].
	 
	 	 	Except with the consent of Dynavax, [ * ], AstraZeneca, its Affiliates and Sublicensees
shall not sell Product or Combination product in unfinished form (in that it requires
further filling or finishing) in any country of the [ * ].
	 
	6.8	 	Confirmatory Patent Licences. Dynavax shall if requested to do so by AstraZeneca
immediately enter into confirmatory licence agreements in the form or substantially the form
set out in Exhibit F for purposes of recording the licences granted under this
Agreement with such Patent Offices in the Territory as AstraZeneca considers appropriate.
Until the execution of any such confirmatory licences, so far as may be legally possible,
Dynavax and AstraZeneca shall have the same rights in respect of the licensed Patents and be
under the same obligations to each other in all respects as if the said confirmatory licences
had been executed.
	 
	7	 	Research Funding
	 
	7.1	 	Funding. Each Party shall assume responsibility for its own costs and expenses for
the Joint Research Programme with the sole exception that AstraZeneca shall provide funding to
Dynavax to support Dynavax’s efforts under the Joint Research Programme. During each contract
year of the Research Term, AstraZeneca shall pay Dynavax an amount equal to the FTE Rate
multiplied by the number of FTEs set forth in Section 3.4 for such year.
	 
	7.2	 	Invoices; Reconciliation.






	 	7.2.1	 	Each funding amount set forth in Section 7.1 above shall be paid to Dynavax [
* ]. AstraZeneca shall make its first such payment within [ * ] days of the
Effective Date (subject to receipt by AstraZeneca of an invoice in respect of such
payment) and each subsequent payment on the [ * ] of each contract






 




			
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	 	 	 	quarter during the
Research Term (subject to receipt by AstraZeneca of an invoice in respect of each such
payment).
	 
	 	7.2.2	 	In addition to the advance payment set forth in Section 7.2.1, and subject to
the JSC’s approval of any subcontractor or major outsourcing agreement other
than those Persons listed on Exhibit D hereto, any external costs or
expenses incurred by Dynavax in connection with its performance of its obligations
under the Joint Research Programme and not already included within the FTE Rate,
shall be separately invoiced to AstraZeneca and reimbursed on a pass-through basis.
Dynavax shall submit such invoice within [ * ] days after the end of the relevant
quarter in which such pass-through expenses were incurred. AstraZeneca shall
reimburse such expense within [ * ] days after the date of receipt by AstraZeneca
of the invoice.
	 
	 	7.2.3	 	Within [ * ] Business Days after the end of each contract quarter during the
Research Term, Dynavax shall report to AstraZeneca Dynavax’s actual FTEs involved in
the Research during such quarter. Within [ * ] days after AstraZeneca’s receipt of
such report, the JSC shall direct the remittance between the Parties of an amount to
effectuate the difference between the advance payment made by AstraZeneca and the
actual Dynavax FTEs involved in the research during the applicable quarter. Any such
payment shall be made, in any event, within [ * ] days of the date that the JSC
directs the remittance.






	7.3	 	Records Retention; Audit.






	 	7.3.1	 	Dynavax shall keep or cause to be kept accurate records or books of account in
accordance with applicable generally accepted accounting principles that, in reasonable
detail, fairly reflect the reimbursable Joint Research Programme expenses. Such books
and records shall be maintained by Dynavax for at least [ * ] years following the end
of the calendar year to which they pertain.
	 
	 	7.3.2	 	Upon the written request of AstraZeneca, Dynavax shall permit a certified
public accountant or a person possessing similar professional status and associated
with an independent accounting firm reasonably acceptable to the Parties to inspect
during regular business hours and no more than once a year






 




			
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	 	 	 	and going back no more than
[ * ] years after receipt of the respective invoice and report pursuant to Section
7.2, all or any part of Dynavax’s records and books necessary to verify such invoices
and reports. The accounting firm shall enter into appropriate obligations with Dynavax
to treat all information it
receives during its inspection in confidence. The accounting firm shall disclose to
Dynavax and AstraZeneca only whether such invoices and reports are correct and
details concerning any discrepancies, but no other information shall be disclosed to
AstraZeneca. The charges of the accounting firm shall be paid by AstraZeneca,
except that if the reimbursable Joint Research Programme expenses have been
overstated by more than [ * ], the charges shall be paid by Dynavax. Any
overpayment of Joint Research Programme by AstraZeneca revealed by an examination
and review shall be fully-creditable against future Joint Research Programme
expenses under Section 7.2 and AstraZeneca shall submit any underpayment so
discovered within [ * ] days of receipt by AstraZeneca of an invoice in respect
of such underpayment.






	7.4	 	Projected Cost Reports. During the Research Term and within [ * ] days after the
end of each calendar quarter, Dynavax shall provide the JSC with an [ * ] projected cost
report including: FTE hours, reimbursable Joint Research Programme expenses and expected
milestone payments by quarter.
	 
	8	 	Development and Commercialization
	 
	8.1	 	Overview. Subject to Dynavax’s option to co-promote Product in accordance with
Section 8.5, AstraZeneca shall have sole responsibility for all Development and
Commercialization of CDs, Product and Combination Products, including the clinical and
commercial manufacturing and supply thereof.
	 
	8.2	 	Development of Product. AstraZeneca shall be responsible for carrying out the
Development of any CDs, the Product and any Combination Product. The Development of any CD,
the Product or Combination Product(s) shall each be governed by a development plan that
describes the proposed overall program of Development (the “Development Plan”). AstraZeneca
shall have the sole right and responsibility for preparing and maintaining the Development
Plan for the CD, Product or any Combination Product; provided, however, AstraZeneca shall
consider






 




			
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	 	 	in good faith the comments of Dynavax as
provided through the JSC and/or Advisory Board as further described
below. The Development Plan shall include general information on
AstraZeneca’s development activities in the previous twelve (12)
months and a summary of the activities planned in the next twelve
(12) months, together with a timetable of planned and actual
submissions for Health Registration Approvals. AstraZeneca shall
promptly deliver a summary copy of each Development Plan, and
updates, to the members of the JSC, and after its disbandment, to
the Advisory Board. AstraZeneca shall use Commercially Reasonable
Efforts to conduct any Development of Product or any Combination
Product in compliance in all material aspects with the requirements
under all Applicable Laws
8.3 Regulatory Affairs and Information Exchange






	 	8.3.1	 	With regard to sharing of Regulatory Documentation and Regulatory Filings,
each Party shall provide the other Party with reasonable access, and shall provide the
other Party with sufficient rights to reference and use in association with exercising
its rights and performing its obligations under this Agreement, all of its, its
Affiliates’ and their respective suppliers’ Regulatory Documents, Regulatory Filings,
and Health Registration Approvals for Product or any Combination Product.
	 
	 	8.3.2	 	Consistent with the Development Plan, but subject to the remainder of this
Section 8.3, AstraZeneca shall be responsible for developing Regulatory Documentation
and preparing and submitting Regulatory Filings, seeking Health Registration Approvals,
and maintaining Health Registration Approvals for Product or any Combination Product,
including preparing all reports necessary as part of an IND, NDA, MAA, DMF, BLA or
other necessary filing reasonably required for Health Registration Approval.
	 
	 	8.3.3	 	Dynavax, at its sole cost and expense (but subject to the reimbursement
provisions of this Section 8.3.3), will provide AstraZeneca with all reasonable
assistance required in order to transfer the Know-How to AstraZeneca in a timely manner
or assist AstraZeneca with respect to the Development and Commercialization of the
Dynavax ISS and/or Collaboration ISS and/or CD
and/or the Product and/or the Combination Product(s) (if any). AstraZeneca






 




			
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	 	 	 	shall
reimburse, pursuant to Section 7.1, all reasonable, AstraZeneca pre-approved, FTE
costs incurred by Dynavax in connection with such technical assistance, and shall
reimburse any and all external costs incurred by Dynavax in connection with such
technical assistance pursuant to Section 7.2. Without prejudice to the generality
of the foregoing, if visits of Dynavax’s representatives to AstraZeneca’s facilities
are reasonably requested by AstraZeneca for purposes of transferring the Dynavax
KnowHow to AstraZeneca or for purposes of AstraZeneca acquiring expertise on the
practical application of the Dynavax Know-How or assisting on issues arising during
such Development or Commercialization, Dynavax will send appropriate representatives
to AstraZeneca’s facilities, provided that AstraZeneca shall reimburse Dynavax, in
addition to the FTE costs of such Dynavax representatives, at the FTE Rate defined
in Section 1.52, for its reasonable and verifiable expenses of travel and
accommodations for such representatives.
	 
	 	8.3.4	 	AstraZeneca shall keep Dynavax informed on an ongoing basis regarding the
schedule and process for Regulatory Documents and Regulatory Filings. AstraZeneca
shall prepare all responses to correspondence that are received from any regulatory
agency relating to any Regulatory Documents and any Regulatory Filing. If and when a
Health Registration Approval is obtained in any country of the Territory, AstraZeneca
shall promptly inform Dynavax of such Health Registration Approval.
	 
	 	8.3.5	 	In conducting any Development activities hereunder, AstraZeneca shall use
Commercially Reasonable Efforts to ensure that its employees, agents, clinical
institutions and clinical investigators comply with all FDA statutory and regulatory
requirements with respect to the CDs, Product or any Combination Product, including
but not limited to: the Federal Food, Drug and Cosmetic Act, as amended (FFDCA), the
Public Health Service Act (PHSA), regulatory provisions regarding protection of human
subjects, financial disclosure by clinical investigators, Institutional Review Boards
(IRB), GCP, GLP, IND regulations, and any conditions imposed by a reviewing IRB or the
FDA.






 




			
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	8.4	 	Commercialization of Product and Combination Product. Subject to Dynavax’s option to
co-promote Product with AstraZeneca in the United States of America, AstraZeneca shall have
exclusive rights throughout the Territory over the Commercialization of all Product and
Combination Product(s), including the supply of Product or Combination Product for use in all
such Commercialization activities. AstraZeneca shall keep Dynavax informed about all of
AstraZeneca’s efforts to Commercialize the Product or any Combination Product, including
summaries of AstraZeneca’s, and its Sublicensees’ marketing plans, as updated, and significant
developments in the Commercialization of the Product and/or Combination Product(s).
	 
	8.5	 	Dynavax Option to Co-Promote in the United States AstraZeneca recognises that
Dynavax wishes to increase its capability for developing and commercialising pharmaceutical
products in the future. Following written notice from AstraZeneca that it has decided to [
* ], Dynavax shall have an option to negotiate with AstraZeneca terms under which Dynavax
may co-promote the Product in the United States of America. In order for Dynavax to be
eligible to co-promote Product in the United States of America, Dynavax must [ * ].
	 
	 	 	In the event that Dynavax [ * ] and wishes to commence discussions with AstraZeneca to
co-promote Product in the United States of America, Dynavax shall notify AstraZeneca in
writing. The Parties shall meet to discuss such co-promotion in the United States of
America within [ * ] days after receipt by AstraZeneca of such notification.
	 
	 	 	The Parties shall thereafter [ * ]. If the Parties agree on such terms, the Parties shall
seek to enter into a written co-promotion agreement including mechanisms for participation
and reward commensurate with the contributions of each Party. [ * ]. In no event shall
Dynavax’s promotional effort exceed [ * ] of the total estimated promotional effort in the
United States of America without AstraZeneca’s prior written agreement.
	 
	 	 	In the event that the Parties enter into a written co-promotion agreement pursuant to this
Section 8.5, Dynavax shall be legally responsible and liable for the actions, omissions and
conduct of all members of its sales force and other employees






 




			
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	 	 	providing services thereunder.
Dynavax shall ensure that all such persons comply with:






	 	8.5.1	 	all federal, state and local laws, and the rules, regulations, guidelines and
guidances of all agencies, in effect from time to time applicable to the marketing,
promotion, distribution and sale of the product in the United States of America,
including, but not limited to (a) the American Medical Association Guidelines on Gifts
to Physicians from Industry and (b) the PhRMA Code on Interactions with Healthcare
Professionals; and
	 
	 	8.5.2	 	AstraZeneca’s US business policies, as amended from time to time by
AstraZeneca.






	8.6	 	Pricing, Price Approvals and Product Distribution . AstraZeneca shall determine the
overall pricing strategy for the Product or any Combination Product in the Territory.
AstraZeneca shall obtain such Product and/or Combination Product pricing approvals as may be
required and arrange for distribution of the Product or Combination Product in each applicable
country in the Territory.
	 
	8.7	 	Sales and Inventory. AstraZeneca shall be responsible for booking sales, stocking
inventory for itself and its Sublicensees, distributing Product and Collaboration Product(s)
and collecting accounts receivable.
	 
	8.8	 	Advertising and Education.






	 	8.8.1	 	AstraZeneca shall be responsible for developing or having developed
advertising and education materials for the Product or any Combination Product(s).
AstraZeneca shall have the authority to select Trademarks for the Product and
Combination Products and shall own all Trademarks in accordance with Article 17.
	 
	 	8.8.2	 	If any written and visual promotion or educational materials for the Product
or any Combination Product refer to or identify either of the Parties, AstraZeneca
and Dynavax shall both be presented and described. Any such materials that
specifically refer to any Party shall be subject to prior review and comment by that
Party. All labelling, documentary information, promotional material and oral
presentations (where practical) regarding the detailing and promoting of






 




			
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	 	 	 	the Product
or any Combination Product shall display the names and logos of each Party.
	 
	 	8.8.3	 	Notwithstanding the foregoing, Sections 8.8.1 and 8.8.2 are subject to the
requirements of Applicable Laws of each country in which such materials are presented
or in which such the Product or any such Combination Product is Commercialized.






	8.9	 	Development and Commercialization Costs. Except as otherwise specified in Section
8.5 above, AstraZeneca shall be responsible for all costs associated with the Development and
Commercialization of any CDs, the Product or any Combination Product. If AstraZeneca requests
Dynavax’s assistance with certain tasks related to the Development or Commercialization of any
CDs, the Product or any Combination Product, and Dynavax agrees to assist, then AstraZeneca
shall reimburse Dynavax for any reasonable costs Dynavax should incur associated with such
tasks. Within [ * ] days after the end of each calendar quarter, Dynavax shall submit to
AstraZeneca an accounting of all costs Dynavax incurs pursuant to the Development or
Commercialization of any CDs, the Product or any Combination Product during that quarter.
Such summary may include an allocation of time spent by Dynavax personnel in conducting such
Development or Commercialization activities, that shall be reimbursed at the FTE Rate.
AstraZeneca shall on a quarterly basis, within [ * ] days after the end of each quarter,
prepare and submit to Dynavax a reimbursement of the costs incurred by Dynavax, subject to
receipt by AstraZeneca of an invoice in respect of such payment.
	 
	8.10	 	Diligence Obligations.






	 	8.10.1	 	AstraZeneca shall use Commercially Reasonable Efforts to Develop and Commercialise
the Lead CD or Product during the Term of this Agreement. Specifically, but not in
limitation of the foregoing, AstraZeneca shall use
Commercially Reasonable Efforts to achieve the following objectives (the “Diligence
Objectives”):






	 	(a)	 	to fulfil AstraZeneca’s Research obligations under the Joint
Research Plan for any Dynavax ISS or Collaboration ISS according to timelines
agreed upon by the JSC;






 




			
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	 	(b)	 	if at any time AstraZeneca determines that it will cease
Development of the Lead Candidate Drug or any Lead CD, then AstraZeneca shall
choose another CD, or shall make a CD Nomination from the [ * ], for
Development within [ * ] months of such determination;
	 
	 	(c)	 	to endeavour to complete the Development of the Lead CD or
Product in a way which [ * ]; and
	 
	 	(d)	 	to endeavour to [ * ];






	 	 	 	provided, however, that such obligations are expressly conditioned
upon Dynavax and its Affiliates performing their respective obligations hereunder
and such obligations of AstraZeneca shall be delayed or suspended as long as any
such condition exists. Further, Dynavax acknowledges and agrees that nothing in
this Section 8.10 is intended, or shall be construed, to require AstraZeneca to
Develop or Commercialise a specific CD as the Lead CD or Product, or a specific
Combination Product, if the Product does not proceed. In the event that AstraZeneca
decides to discontinue the Development or Commercialization of any CD as the Lead CD
or the Product in favour of another CD, or if it decides to discontinue the
Development or Commercialization of the Product in favour of a Combination Product
its obligations under this Section 8.10 shall cease with respect to such initial CD
or the Product (as appropriate) in favour of such other CD or Combination Product.
AstraZeneca shall perform its obligation under this Section 8.10 in good scientific
manner and in compliance in all material respects with all Applicable Law. Upon
satisfaction of its obligations under this Section 8.10, AstraZeneca shall be deemed
to satisfy all diligence obligations owed to Dynavax hereunder, whether
contractually or under Applicable Law, with respect to the Development or
Commercialization of the CDs, Product or a
Combination Product, and shall have no other obligation, express or implied, to
Develop or Commercialize any CD, Product or any Combination Product.
	 
	 	8.10.2	 	Dynavax shall use Commercially Reasonable Efforts to fulfil Dynavax’s Research
obligations under the Joint Research Plan for any Dynavax ISS or Collaboration ISS
according to timelines agreed upon by the JSC.






 




			
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	 	8.10.3	 	It is recognised that the process of drug development is uncertain and the [ * ].






	8.11	 	Breach of Diligence Obligations.






	 	8.11.1	 	Notification and Meeting. If at any time Dynavax has a reasonable basis to
believe that AstraZeneca is in material breach of its material obligations under
Section 8.10, then Dynavax shall so notify AstraZeneca, specifying the basis for its
belief, and the Parties shall meet within [ * ] days after such notice to discuss in
good faith Dynavax’s concerns and AstraZeneca’s Development and Commercialisation plans
with respect to any CD, the Product or any Combination Product.
	 
	 	8.11.2	 	Right of Arbitration. If, after such good faith discussions, (a) AstraZeneca
is in material breach of its material obligations under Section 8.10, and (b)
AstraZeneca does not take reasonable steps designed to rectify such breach within [ *
] days of meeting with Dynavax pursuant to Section 8.11.1 (or, if such failure cannot
be rectified within such [ * ]-day period, if AstraZeneca does not commence actions
to rectify such breach within such period and thereafter diligently pursue such
actions) the Parties agree to meet and discuss in good faith a possible resolution
thereof, which good faith efforts shall include at least one in-person meeting between
representatives of each Party having decision-making authority (subject only to Board
of Directors’ or equivalent approval, if required). All such discussions under this
Section 8.11.2 shall be confidential and shall be treated as compromise and settlement
negotiations for purposes of applicable rules of evidence. If the matter is not
resolved within [ * ] days following the request for discussions, Dynavax
may thereafter commence a special arbitration pursuant to Section 24.13 in respect
of such matter.






	8.12	 	Reversion; Abandonment.






	 	8.12.1	 	In the event that AstraZeneca abandons or puts the development of a Lead CD on hold
for a consecutive period of time exceeding [ * ] months or an aggregate period of
time exceeding [ * ] months in any [ * ]-month period, and during such period [ *
], then AstraZeneca shall notify Dynavax in






 




			
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	 	 	 	writing. Dynavax may (but is not so
obligated), within [ * ] months from receipt of such notification, provide written
notice to AstraZeneca requesting that such Lead CD become a Reverted ISS and cease to
be a Collaboration ISS or CD. Upon receipt of such notice by AstraZeneca, such CD
shall be included in the license grant under Section 6.3.
	 
	 	 	 	For the avoidance of doubt, the foregoing time periods shall not include any period
of time during which AstraZeneca is [ * ]. AstraZeneca shall have the right to
satisfy its obligations under this Section 8.12 through one or more Affiliates,
Sublicensees or subcontractors.
	 
	 	8.12.2	 	In the event that Dynavax fails to make a written request to AstraZeneca pursuant to
Section 8.12.1, within [ * ] months following the date on which Dynavax received from
AstraZeneca the written notice referred to in the first sentence of such Section
8.12.1, AstraZeneca shall be under no further obligation to grant Dynavax any license
or other rights to such CD or to make any such above said assignments and AstraZeneca
shall retain its exclusive rights and ownership to such CD pursuant to Article 6.
	 
	 	8.12.3	 	In the event of any abandonment of a CD by AstraZeneca and reversion to Dynavax
pursuant to Section 8.12.1, AstraZeneca shall, [ * ]; provided, however, that
Dynavax’s above said rights shall be subject to [ * ].






	9	 	Milestone Payments
	 
	9.1	 	Total Obligation. Unless the Parties agree in writing otherwise, the access fee,
milestone payments and royalty payments payable by AstraZeneca to Dynavax pursuant to this
Article 9 and Article 10, taken
together with the funding to be provided by AstraZeneca to Dynavax pursuant to Article 7,
represent all of AstraZeneca’s financial obligations to Dynavax hereunder and Dynavax shall
not be entitled to any additional compensation or remuneration from AstraZeneca under this
Agreement.
	 
	9.2	 	Access Fee. AstraZeneca shall pay to Dynavax within ten (10) days following the
Effective Date an access fee of ten million US Dollars ($10,000,000) subject to receipt by
AstraZeneca of an invoice in respect of such payment. Such access fee






 




			
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	 	 	shall be non-refundable
and non-creditable against future milestones and royalties payable pursuant to this Agreement.
	 
	9.3	 	Joint Research Programme Milestones. AstraZeneca shall pay to Dynavax a milestone
payment in respect of each of the following Research and Development events in the particular
amounts specified below (in each case subject to receipt of an invoice in respect of each such
payment) no later than [ * ] days following the occurrence of such milestone event as
reasonably determined by AstraZeneca or the JSC as applicable (whether such milestone event is
achieved by AstraZeneca, its Affiliate or any of their respective Distributors or
Sublicensees) (each a “Joint Research Programme Milestone”). AstraZeneca shall make the
corresponding non-refundable and non-creditable payments to Dynavax, as follows:
	 
	 	 	[ * ]
	 
	9.4	 	Development Milestones. AstraZeneca shall pay to Dynavax a milestone payment in
respect of each of the following events in the particular amounts specified below (in each
case subject to receipt of an invoice in respect of each such payment) no later than [ * ]
days following the first occurrence of such milestone event (whether such milestone event is
achieved by AstraZeneca, its Affiliate or any of their respective Sublicensees) (each a
“Development Milestone”), AstraZeneca shall make the corresponding non-refundable and
non-creditable payments to Dynavax, as follows:
	 
	 	 	[ * ]
	 
	9.5	 	Milestone Payments. Each of the payments in relation to the Joint Research Programme
Milestones set forth under
Section 9.3 and Development Milestones set forth under Section 9.4 shall be
made by AstraZeneca no more than once under this Agreement, collectively
together with the Access Fee set forth in Section 9.2, amounting to an
aggregate maximum amount of [ * ], irrespective of the number of CDs that
have achieved the milestone events set forth in Sections 9.3 and 9.4 or the
number of countries or Major Markets in which such milestone events have been
achieved. AstraZeneca shall promptly notify Dynavax in writing of the
achievement of any milestone; provided that AstraZeneca’s failure to do so
shall not be construed as the non-occurrence of any milestone event.






 




			
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	10	 	Royalty Payments and Other Payment-Related Provisions
	 
	10.1	 	Royalties. AstraZeneca shall pay Dynavax a running royalty on Net Sales where the
royalty rate is determined based on the aggregate amount of Annual Net Sales for the Product
and any Combination Product in the Territory occurring in the particular calendar year as
follows:






	 	10.1.1	 	[ * ] on the portion of Annual Net Sales not exceeding [ * ]; and
	 
	 	10.1.2	 	[ * ] on the portion of Annual Net Sales exceeding [ * ] but not exceeding [ *
]; and
	 
	 	10.1.3	 	[ * ] on the portion of Annual Net Sales exceeding [ * ] but not exceeding [ *
]; and
	 
	 	10.1.4	 	[ * ] on the portion of Annual Net Sales exceeding [ * ].






	 	 	As used herein, “Annual Net Sales” means the Net Sales made during a given calendar year.
	 
	 	 	The calculation of royalties under this Section 10.1 shall be conducted as aggregate Net
Sales for all Product and Combination Products for the applicable calendar year.
	 
	10.2	 	Combination Products. With respect to Combination Products, the Annual Net Sales
used for the calculation of the royalties under Section 10.1 shall be determined as follows:





	 	 	 	 	 
	 

	 	  A 


A + B

	 x	Net Sales of the Combination Product, where:
	 
	 	 	 	 
	 

	 	A =
	 	Standard sales price of the Product, containing the same amount of Dynavax ISS
or Collaboration ISS as the sole active ingredient as the Combination Product
in question, in the given country.
	 
	 	 	 	 
	 

	 	B =
	 	standard sales price of the readyforsale form of a product containing the
same amount of the other therapeutically active ingredient(s) that is contained
in the Combination Product in question, in the given country.






 




			
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	 	 	In the event, however, that if, in a specific country, (a) the other therapeutically active
ingredient(s) in such Combination Product are not sold separately in such country, Net Sales
shall be adjusted by multiplying actual Net Sales of such Combination Product by the
fraction A/C, where C is the standard sales price in such country of such Combination
Product, and (b) if the Product containing such Dynavax ISS or Collaboration ISS is not sold
separately, Net Sales shall be calculated by multiplying actual Net Sales of such
Combination Product by the fraction C-B/C, where B is the standard sales price in such
country of the other therapeutically active ingredient(s) in the Combination Product and C
is the standard sales price in such country of the Combination Product. The standard sales
price for the Product containing such Dynavax ISS or Collaboration ISS and for each other
active ingredient shall be for a quantity comparable to that used in such Combination
Product and of the same class, purity and potency. If, in a specific country, both a
Product containing the Dynavax ISS or or Collaboration ISS and a product containing the
other active ingredients in such Combination Product are not sold separately, a market price
for such Product and such other active ingredients shall be negotiated by the Parties in
good faith based upon the costs, overhead and profit as are then incurred for such
Combination Product and all products then being made and marketed by AstraZeneca and having
an ascertainable market price that are comparable to such Product or such other active
ingredients, as applicable. If, in a specific country, the foregoing calculations do not
fairly represent the value of the various active ingredients included in a Combination
Product, the allocation of Net Sales for such Combination Product shall be negotiated by the
Parties in good faith.
	 
	10.3	 	Sublicensees.






	 	10.3.1	 	In the event that an AstraZeneca Sublicensee sells Product or a Combination Product
to Third Parties in the [ * ], such sales shall [ * ].
	 
	 	10.3.2	 	For all sales of Product or Combination Product by a Sublicensee to Third Parties
outside of the [ * ], any fees, milestones and/or royalty income which AstraZeneca
shall receive from the Sublicensees shall [ * ].






 




			
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	 	10.3.3	 	In the event that AstraZeneca sublicenses the sale of Product or a Combination
Product to Third Parties outside of the [ * ], the sublicense shall be obliged to [
* ].






	10.4	 	Royalty Stacking.






	 	10.4.1	 	For the Product or any Combination Product(s) sold by AstraZeneca or its Affiliates
to Third Parties (including Distributors), where the sum of royalty payments (excluding
any royalty on delivery devices) owed by AstraZeneca and its Affiliates to Dynavax and
any Third Parties in any calendar year exceeds [ * ] of Net Sales for a given Product
or Combination Product for that period, the royalty rate payable to Dynavax shall be
reduced [ * ] such that the aggregate royalty rate payable by AstraZeneca on the
Product or Combination Product, [ * ], would equal [ * ] of Net Sales thereof.
	 
	 	10.4.2	 	In the case of the Product or a Combination Product which is developed or
commercialised by a Sublicensee of AstraZeneca, where AstraZeneca is legally required
to make payment to one or more Third Parties in order that such Sublicensee may develop
or commercialise such Product or Combination Product, then if the sum of royalty
payments (excluding any royalty payments on delivery devices) owed by AstraZeneca and
its Affiliates to Dynavax and any such Third Parties exceeds [ * ] of all amounts
received by AstraZeneca from such Sublicensee that are subject to the royalty
obligations of AstraZeneca under Section 10.1 the royalty rate under Section 10.1 shall
be reduced [ * ] such that the aggregate amount payable by AstraZeneca to Dynavax and
any such Third Parties with respect to such Product or Combination Product, [ * ],
would equal [ * ] of the amounts received by
AstraZeneca from such Sublicensee that are subject to the royalty obligations of
AstraZeneca under Section 10.1.






	10.5	 	[ * ] Royalty and [ * ].






	 	10.5.1	 	Subject to Section 10.3.3, Dynavax shall pay any and all royalties arising from the
sale of the Product or any Combination Product(s) owed the [ * ] under the [ * ].






 




			
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	 	10.5.2	 	(a) To the extent that royalties payable by AstraZeneca under this Article 10, taken
as a whole, [ * ], Dynavax shall [ * ] as a result of [ * ]. To the extent
payments to Third Parties in respect of matters described in the previous sentence [ *
], then AstraZeneca shall [ * ].
	 
	 	 	 	(b) In the event of a cross-license with a Third Party which includes payments
described in Section 10.5.2(a), the Party or Parties which is/are responsible for
the payment under Section 10.5.2(a) shall [ * ].
	 
	 	 	 	(c) In the event either Party makes payments to a Third Party in respect of the
matters described in paragraph (a) of this Section 10.5.2 prior to the commencement
of Net Sales, such payment obligation shall [ * ].






	10.6	 	Reduction of Royalty.






	 	10.6.1	 	Competition. In the event that, in a country in the Territory,
generic competition with respect to the Product or a Combination Product occurs
by a product or products having [ * ] (each such product, a “Competing
Product”), and such Competing Product has any sales in a Calendar Quarter in
such country, then for the purposes of calculating the royalties of such
Product or Combination Product under Section 10.1, then, subject to Section
10.7, [ * ] of the Net Sales in such country shall be disregarded. The
calculation of the royalty reduction under this Section 10.6.1 shall be
conducted separately for each Product or Combination Product.
	 
	 	 	 	If the number of units sold of a Competing Product represents [ * ] of the
aggregate number of units sold of all products in the relevant [ * ]
class to which the Product or Collaboration Product has been allocated,
including the Product and any Combination Product, in a country in the
Territory as reported by [ * ] or any comparable reporting agency in a
Calendar Year, then AstraZeneca shall have the right, but not the
obligation, to [ * ].






	 	10.6.2	 	Compulsory Licences. In the event that a court or a governmental agency of
competent jurisdiction requires AstraZeneca or an AstraZeneca Affiliate or Sublicensee
to grant a compulsory licence to a Third Party permitting such






 




			
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	 	 	 	Third Party to make and
sell the Product or any Combination Products in a country in the Territory, then for
the purposes of calculating the royalties of the Product or Combination Product under
Section 10.1, [ * ] of the Net Sales in the country in such country shall be
disregarded. The calculation of the royalty reduction under this Section 10.6.2 shall
be conducted separately for each Product or Combination Product. In any country where
the royalty reduction of Section 10.6.1 or 10.6.2 is in effect, there shall not be any
further royalty reduction pursuant to this Section 10.6.2.
	 
	 	10.6.3	 	No Valid Claim. In the event that, and in such case from and after the date
on which, a Product or Combination Product is Developed and/or Commercialized in a
country and is not covered by a Valid Claim or other governmental grant of exclusivity
(for example, but without limitation, orphan drug status, Chinese monitoring period
exclusivity, or any other governmental grant of exclusivity of equivalent effect) in
such country, then for the purposes of calculating the royalties of such Product or
Combination Product under Section 10.1, [ * ] of the Net Sales in such country shall
be disregarded.






	10.7	 	Royalty Floor. Notwithstanding anything to the contrary in this Agreement except for
Section 10.6.2, during the Royalty Term, in no event shall the net royalty rate received by
Dynavax from the sale of Products be reduced to less than [ * ] of Net Sales (as determined
before any reductions provided for in this Article 10 other than Section 10.6.2) for the
period of time when Dynavax makes royalty payments to [ * ] as set forth in Section 10.5, or
to less than [ * ] of such Net Sales thereafter. Dynavax shall promptly notify AstraZeneca
in writing when payments to [ * ] as set forth in Section 10.5 are no longer being made.
	 
	10.8	 	Royalty Term. AstraZeneca’s obligation to pay royalties shall commence, on a
country-by-country basis, with respect to each separate Product or Combination Product, on the
date of First Commercial Sale of such Product or Combination Product in such country. The
obligation shall expire, on a country-by-country basis, with respect to each separate Product
or Combination Product on the later to occur of (a) the [ * ] anniversary of the First
Commercial Sale of the first Product in such country and (b) the expiration date in such
country of the last to expire of any issued Collaboration Patent or Dynavax Patent that
includes at least one Valid Claim






 




			
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	 	 	covering the sale of such separate Product or Combination
Product in such country (such period, the “Royalty Term”).
	 
	 	 	Upon termination of the royalty obligations of AstraZeneca under this Section 10.8, with
respect to a Product or Combination Product in any country, the licence grants to
AstraZeneca in Section 6.2 shall become fully paid-up, perpetual and irrevocable with
respect to such country and the Net Sales of such Product or Combination Product in such
country shall be excluded from the royalty calculations in this Article 10 (including the
thresholds and ceilings).
	 
	10.9	 	Sales Subject to Royalties. Sales between AstraZeneca, its Affiliates and
Sublicensees shall not be subject to royalties hereunder. Royalties shall be calculated on
AstraZeneca’s and its Affiliates’ and Sublicensees’ sale of the Product or Combination
Products to a Third Party (including Distributors). Royalties shall be payable only once for
any given batch of the Product or Combination Products. For purposes of determining Net
Sales, the Product or Combination Product, as appropriate, shall be deemed to be sold when
invoiced and a “sale” shall not include, and no royalties shall be payable on, transfers by
AstraZeneca, its Affiliates or Sublicensees of free samples of Products, Combination Products
or clinical trial materials containing Dynavax ISS and/or Collaboration ISS or other transfers
or dispositions for charitable, promotional, pre-clinical, clinical, manufacturing, testing or
qualification, regulatory or governmental purposes.
	 
	10.10	 	Royalty Payments. The royalties shall be calculated quarterly as of the last day of
March, June, September and December respectively, for the calendar quarter ending on that
date. AstraZeneca
shall pay the royalties in conjunction with the delivery of a written report to Dynavax
within [ * ] days after the end of each calendar quarter that shows, with respect to each
country and the Product or Combination Product(s), the sales volume and Net Sales, by
country, of each Product or Combination Product sold during such calendar quarter.
	 
	10.11	 	Mode of Payment. All payments set forth in this Article 10 shall be remitted by
wire transfer to the following bank account of Dynavax or such other account as Dynavax may
designate in writing to AstraZeneca:
	 
	 	 	[ * ]






 




			
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	10.12	 	Currency. All payments required under this Agreement shall be made in U.S. Dollars.
For the purpose of computing the Net Sales of Product or Combination Products sold in a
currency other than U.S. Dollars, such currency shall be converted from local currency to U.S.
Dollars by AstraZeneca in accordance with the rates of exchange for the relevant month for
converting such other currency into U.S. Dollars used by AstraZeneca’s normal internal
accounting systems, which are independently audited on an annual basis.
	 
	10.13	 	Interest. Unless any payment potentially due to Dynavax under this Agreement is in
dispute, and in such circumstances from the date upon which such dispute is resolved, if
AstraZeneca fails to make any payment due to Dynavax under this Agreement, then interest shall
accrue on a daily basis at a rate equal to the thirty (30) day U.S. dollar LIBOR rate
effective for the date that payment was due, as published by The Wall Street Journal (Western
edition) plus [ * ].
	 
	10.14	 	Records Retention; Audit.






	 	10.14.1	 	AstraZeneca shall keep or cause to be kept accurate records or books of account in
accordance with applicable generally accepted accounting principles showing the
information that is necessary for the accurate determination of the royalties due
hereunder with respect to the sale of such Product or Combination Product.
	 
	 	10.14.2	 	Upon the written request of Dynavax, AstraZeneca shall permit a certified public
accountant or a person possessing similar professional status and associated with an
independent accounting firm acceptable to the Parties to inspect during regular
business hours and no more than once a year and going back no more than [ * ] years
preceding the current year, all or any part of AstraZeneca’s records and books
necessary to check the accuracy of the royalties paid. The accounting firm shall enter
into appropriate obligations with AstraZeneca to treat all information it receives
during its inspection in confidence. The accounting firm shall disclose to Dynavax and
AstraZeneca only whether the royalty reports are correct and details concerning any
discrepancies, but no other information shall be disclosed to Dynavax. The charges of
the accounting firm shall be paid by Dynavax, except that if the






 




			
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	 	 	 	royalties have been
understated by more than [ * ], the charges shall be paid by AstraZeneca.
AstraZeneca shall promptly pay to Dynavax the amount of any underpayment of royalties
revealed by an examination and review. Any overpayment of royalties by AstraZeneca
revealed by an examination and review shall be fully-creditable against future royalty
payments under Sections 10.1.






	11	 	Taxes
	 
	11.1	 	General. The royalties, milestones and other amounts payable by AstraZeneca to
Dynavax pursuant to this Agreement (“Payments”) shall not be reduced on account of any taxes
unless required by Applicable Law. Dynavax alone shall be responsible for paying any and all
taxes (other than withholding taxes required by Applicable Law to be paid by AstraZeneca)
levied on account of, or measured in whole or in part by reference to, any Payments it
receives. AstraZeneca shall deduct or withhold from the Payments any taxes that it is
required by Applicable Law to deduct or withhold. Notwithstanding the foregoing, if Dynavax
is entitled under any applicable tax treaty to a reduction of the rate of, or the elimination
of, any applicable withholding tax, it may deliver to AstraZeneca or the appropriate
governmental authority (with the assistance of AstraZeneca to the extent that this is
reasonably required and is expressly requested in writing) the prescribed forms necessary to
reduce the applicable rate of withholding or to relieve AstraZeneca
of its obligation to withhold tax, and AstraZeneca shall apply the reduced rate of
withholding, or dispense with withholding, as the case may be, provided that AstraZeneca has
received evidence, in a form satisfactory to AstraZeneca, of Dynavax’s delivery of all
applicable forms (and, if necessary, its receipt of appropriate governmental authorization)
at least [ * ] days prior to the time that the Payments are due. If, in accordance with
the foregoing, AstraZeneca withholds any amount, it shall pay to Dynavax the balance when
due, make timely payment to the proper taxing authority of the withheld amount, and send to
Dynavax proof of such payment within [ * ] days following that payment. For purposes of
this Agreement, the stated amount of the Payments payable by AstraZeneca includes any sales
tax that Dynavax may be required to collect.
	 
	11.2	 	Indirect Taxes. Notwithstanding anything contained in Section 11.1 or this Section
11.2 shall apply with respect to Indirect Taxes. All Payments are exclusive of






 




			
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	 	 	Indirect
Taxes. If any Indirect Taxes is chargeable in respect of any Payments, AstraZeneca shall pay
Indirect Taxes at the applicable rate in respect of any such Payments following the receipt of
an Indirect Taxes invoice in the appropriate form issued by Dynavax in respect of those
Payments, such Indirect Taxes to be payable on the due date of the payment of the Payments to
which such Indirect Taxes relate.
	 
	11.3	 	Customs Duties. The Parties shall co-operate in accordance with Applicable Laws to
ensure where permissible no import duties are paid on imported clinical product. Where import
duties are payable, the Parties shall co-operate to ensure that the Party responsible for
shipping as identified in the Joint Research Plan values the clinical product in accordance
with Applicable Laws and minimises where permissible any such duties and any related import
taxes that are not reclaimable from the relevant authorities.
	 
	12	 	Manufacture and Supply.
	 
	12.1	 	Preclinical Supply. Dynavax shall be responsible (at the expense of AstraZeneca),
through either internal production capabilities or Third Party manufacturers approved by the
JSC, for the manufacture [ * ] of preclinical Dynavax ISS or Collaboration ISS for use in
the Joint Research
Programme through the Primary Screening Phase and Secondary Screening Phase for any such
Dynavax ISS or Collaboration ISS. AstraZeneca shall be solely responsible for all costs and
expenses related to the manufacture and supply of preclinical Dynavax ISS or Collaboration
ISS for use in the Joint Research Programme (other than those costs set forth in Section
3.5.4 as included in the FTE Rate) and shall reimburse Dynavax any reasonable costs or
expenses it incurs therefor. AstraZeneca shall be responsible for, or shall procure the
final formulation and packaging, including any inhalation device, of the Product or any
Combination Product for preclinical use.
	 
	12.2	 	Clinical and Commercial Supply. AstraZeneca shall be responsible for, or shall
procure, the manufacture of toxicology, clinical and commercial materials, including without
limitation any Candidate Drug, Product or Combination Product in the Territory and for all
costs associated therewith. AstraZeneca shall use Commercially Reasonable Efforts to make
necessary filings to obtain, or cause a Third Party






 




			
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	 	 	manufacturer to obtain, Health
Registration Approval for the manufacture of Candidate Drugs or Product or any Combination
Product(s) in the Territory.
	 
	12.3	 	Manufacturing Know-How Transfer. Dynavax shall transfer to AstraZeneca any
manufacturing technology, material and data sufficient to enable AstraZeneca (or its nominee)
to produce and supply toxicology, clinical and commercial Candidate Drug for use in the
Product or a Combination Product. Dynavax shall provide reasonable assistance to AstraZeneca
to effect such transfers in an orderly fashion and to enable AstraZeneca to begin
manufacturing and supplying toxicology, clinical and commercial supply of Candidate Drug for
use in the Product or a Combination Product.
	 
	13	 	Confidentiality and Non-Disclosure
	 
	13.1	 	General Obligations.






	 	13.1.1	 	At all times during the term of this Agreement and for a period of [ * ] years
following termination or expiration hereof, each Party (the “Receiving Party”) shall,
and shall cause its officers, directors, employees, agents,
Affiliates, Distributors and Sublicensees to, keep confidential and not publish or
otherwise disclose and not use, directly or indirectly, for any purpose, any
Confidential Information provided to it by the other Party (the “Disclosing Party”),
except to the extent such disclosure or use is expressly permitted by the terms of
this Agreement or is reasonably necessary for the performance of this Agreement.
	 
	 	13.1.2	 	Dynavax recognises that by reason of AstraZeneca’s status as an exclusive licensee
pursuant to certain grants under Article 6, AstraZeneca has an interest in Dynavax’s
retention in confidence of certain information of Dynavax. Accordingly, until the
expiration of AstraZeneca’s exclusive position with respect to any CD, the Product or a
Combination Product under this Agreement, Dynavax shall, and shall cause its Affiliates
and their respective officers, directors, employees and agents to, keep confidential,
and not publish or otherwise disclose, and not use directly or indirectly for any
purpose that would cause such publication or disclosure, any information relating to
(a) the CD, the Product or a Combination Product, including the Dynavax ISS or






 




			
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	 	 	 	Collaboration ISS therein, or (b) the Research, Development and/or Commercialization of
such Product or Combination Product, including the Development Plans therefor
(collectively the “AstraZeneca Information”); except to the extent (a) the AstraZeneca
Information is in the public domain through no fault of Dynavax, its Affiliates or any
of their respective officers, directors, employees and agents, (b) such disclosure or
use would be permitted under Section 13.2, or (c) such disclosure or use is otherwise
expressly permitted by the terms of this Agreement or is reasonably necessary for the
performance of this Agreement. For clarification, the disclosure by Dynavax to
AstraZeneca or by AstraZeneca to Dynavax of AstraZeneca Information shall not cause
such information to cease to be subject to the confidentiality provisions of this
Section 13.1.
	 
	 	 	 	Notwithstanding the foregoing, in the event Dynavax obtains an exclusive license
under the AstraZeneca Technology in accordance with Section 20.7.3, Dynavax shall be
relieved of the foregoing obligations and AstraZeneca, instead of Dynavax, shall,
and shall cause its Affiliates and their respective
officers, directors, employees and agents to, keep confidential, and not publish or
otherwise disclose, and not use directly or indirectly for any purpose that would
cause such publication or disclosure, any information relating to the AstraZeneca
Information, except to the extent (a) the AstraZeneca Information is in the public
domain through no fault of AstraZeneca, its Affiliates or any of their respective
officers, directors, employees and agents, (b) such disclosure or use would be
permitted under Section 13.2, or (c) such disclosure or use is otherwise expressly
permitted by the terms of this Agreement or is reasonably necessary for the
performance of this Agreement.






	13.2	 	Permitted Disclosures. Each Party may disclose Confidential Information to the
extent that such disclosure is:






	 	13.2.1	 	made in response to a valid order of a court of competent jurisdiction or other
competent authority; provided, however, that the Receiving Party shall first have given
notice to the Disclosing Party (if feasible) and given the Disclosing Party a
reasonable opportunity to quash any such order or obtain a protective order requiring
that the Confidential Information and documents that are the






 




			
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	 	 	 	subject of such order be
held in confidence by such court or authority or, if disclosed, be used only for the
purpose for which the order was issued; and provided further that if such order is not
quashed or a protective order is not obtained, the Confidential Information disclosed
in response to such court or governmental order shall be limited to that information
that is legally required to be disclosed in response to such court or governmental
order;
	 
	 	13.2.2	 	made to a Regulatory Authority as may be necessary or useful in connection with any
filing, application or request for a Health Registration Approval; provided, however,
that reasonable measures shall be taken to assure confidential treatment of such
information, to the extent such protection is available;
	 
	 	13.2.3	 	made by the Receiving Party to a patent authority as may be necessary or useful for
purposes of obtaining or enforcing a Patent (consistent with the terms and conditions
of Article 14); provided, however, that reasonable
measures shall be taken to assure confidential treatment of such information, to the
extent such protection is available;
	 
	 	13.2.4	 	otherwise required by law, provided, however, that the Receiving Party shall (a)
provide the Disclosing Party with reasonable advance notice of and an opportunity to
comment on any such required disclosure, (b) if requested by the Disclosing Party, seek
confidential treatment with respect to any such disclosure to the extent available, and
(c) use good faith efforts to incorporate the comments of the Disclosing Party in any
such disclosure or request for confidential treatment; or
	 
	 	13.2.5	 	made by the Receiving Party to its Affiliates, Distributors, Sublicensees, employees,
consultants, or agents as may be necessary or useful in connection with the Research,
Development, or Commercialization of any CD, the Product or Combination Product(s) as
contemplated by this Agreement, or otherwise in the exercise of its rights with respect
to Collaboration Know-How, including subcontracting or sublicensing transactions in
connection therewith; provided prior to disclosure by the Receiving Party to each of
the






 




			
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	 	 	 	foregoing Persons must be bound by similar obligations of confidentiality and
non-use at least equivalent in scope to those set forth in this Article 13.






	 	 	Notwithstanding the foregoing, in the event that either Party is required by Applicable Law
or the requirements of a national securities exchange or another similar regulatory body to
disclose this Agreement, in whole or in part, the Parties shall reasonably agree on a
redacted version of this Agreement as necessary to protect the Confidential Information of
the Parties prior to making such disclosure.
	 
	13.3	 	Exclusions. Notwithstanding the foregoing, Confidential Information shall not
include any information that:






	 	13.3.1	 	is or hereafter becomes part of the public domain by public use, publication, general
knowledge or the like through no wrongful act, fault or negligence on the part of the
Receiving Party;
	 
	 	13.3.2	 	can be demonstrated by documentation or other competent proof to have been in the
Receiving Party’s or its Affiliates’ possession prior to disclosure by the Disclosing
Party;
	 
	 	13.3.3	 	is subsequently received by the Receiving Party or its Affiliates from a Third Party
who is lawfully in possession thereof and not bound by any obligation of
confidentiality with respect to the said information;
	 
	 	13.3.4	 	has been published by the Disclosing Party; or
	 
	 	13.3.5	 	is independently developed by or for the Receiving Party or its Affiliates without
the application or use of the Disclosing Party’s Confidential Information.






	 	 	Specific aspects or details of Confidential Information shall not be deemed to be within the
public domain or in the possession of the Receiving Party merely because the Confidential
Information is embraced by more general information in the public domain or in the
possession of the Receiving Party. Further, any combination of Confidential Information
shall not be considered in the public domain or in the possession of the Receiving Party
merely because individual elements of such Confidential Information are in the public domain
or in the possession of the






 




			
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	 	 	Receiving Party unless the combination and its principles are in
the public domain or in the possession of the Receiving Party.
	 
	13.4	 	Confidentiality of Agreement. The Parties acknowledge that the terms of this
Agreement shall be treated as Confidential Information of both Parties. Such terms may be
disclosed by a Party to individuals or entities covered by 13.2.5 above, each of whom prior to
disclosure must be bound by similar obligations of confidentiality and non-use at least
equivalent in scope to those set forth in this Article 13. Disclosure of the terms of this
Agreement (but not other Confidential Information received from the other Party) may also be
made, under binders of confidentiality and non-use at least equivalent in scope to those set
forth in this Article 13, to actual or potential bankers, lenders, investors and acquirors of
the disclosing Party.
	 
	13.5	 	Publications and Presentations. The Parties acknowledge that scientific publications
must be strictly monitored to prevent any adverse effect from premature publication of results
of the research and Development activities hereunder. Accordingly, during the Research Term
neither Party shall publish, present or otherwise disclose any material related to the Joint
Research Programme or the Development or
Commercialization of the CDs or the Product or
any Combination Product(s) without the prior
written consent of the JSC and after the
Research Term Dynavax shall not publish,
present or otherwise disclose any material
related to the Joint Research Programme or the
Development or Commercialization of the CDs or
the Product or any Combination Product(s)
without the prior written consent of
AstraZeneca. Each Party’s contribution to such
results shall be duly recognised in such
publications. For clarity, nothing in this
Section 13.5 shall limit Dynavax’s right to
publish or present, during the Research Term,
the results of any studies carried out by or on
behalf of Dynavax prior to the Effective Date.
Each Party agrees to provide the other Party
the opportunity to review any proposed
abstracts, manuscripts or presentations
(including verbal presentations) that relate to
any Dynavax ISS or Collaboration ISS or Product
or Combination Product studied under the
Agreement at least [ * ] days prior to their
intended submission for publication and agrees,
upon request, not to submit any such abstract
or manuscript for publication until the other
Party is given a reasonable period of time
(resulting in a total of no more than [ * ]
days from the provision of such abstracts,
manuscripts or presentation by one Party to the
other for review until






 




			
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	 	 	such Party’s submission
of such abstracts, manuscripts or presentation
for publication) to secure patent protection
for any material in such publication which it
believes to be patentable. Both Parties
understand that a reasonable commercial
strategy may require delay of publication of
information or filing of patent applications.
The Parties agree to review and decide whether
to delay the publication and filing of patent
applications under certain circumstances.
Neither Party shall have the right to publish
or present Confidential Information of the
other Party which is subject to Section 13.1.
With respect to any publication or presentation
made by AstraZeneca pursuant to this Section
13.5, but without limiting anything set forth
in Section 8.8.2 above, AstraZeneca shall give
meaningful mention to Dynavax’s participation
and contribution to the Collaboration and shall
specifically mention the use of Dynavax
Technology in the Dynavax ISS, Collaboration
ISS, CDs, Product and/or any Combination
Product.
	 
	13.6	 	Use of Name/Publicity.






	 	13.6.1	 	Neither Party shall mention or otherwise use the name, insignia, symbol, trademark,
trade name or logotype of the other Party or its Affiliates in any
publication, press release, promotional material or other form of publicity without
the prior written consent of the other Party in each instance (which shall not be
unreasonably withheld or delayed), except for those disclosures for which consent
has previously been obtained or which have previously been disclosed. The
restrictions imposed by this Section 13.6.1 shall not prohibit either Party from
making any disclosure identifying the other Party that is required by Applicable Law
or the requirements of a national securities exchange or another similar regulatory
body, provided that any such disclosure shall be governed by this Article 13.
Further, the restrictions imposed on each Party under this Section 13.6 are not
intended, and shall not be construed, to prohibit a Party from identifying the other
Party in its internal business communications, provided that any Confidential
Information in such communications remains subject to this Article 13.
	 
	 	13.6.2	 	AstraZeneca and its Affiliates and Sublicensees shall have the right, with Dynavax’s
prior written consent, to use the name of Dynavax and its Affiliates to the extent
necessary or useful in connection with the Development and






 




			
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	 	 	 	Commercialization of Product
or Combination Product as contemplated by this Agreement. Additionally, with respect to
any public disclosure made by AstraZeneca pursuant to this Section 13.6.2, AstraZeneca
shall give meaningful mention to Dynavax’s participation and contribution to the
Collaboration and shall specifically mention the use of Dynavax Technology in the
Dynavax ISS, Collaboration ISS, CDs, Product and/or Combination Product, the mention in
such disclosures to be approved in writing by Dynavax.
	 
	 	13.6.3	 	An initial press release pertaining to this transaction shall be issued by the
Parties and shall be materially in the form attached as Exhibit E to this
Agreement. Neither Party shall issue any other press release or make any other public
announcement or statement concerning this Agreement or the transactions covered by it
without the prior written approval of the other Party, except that each Party (after
consultation with counsel) may make such announcements and disclosures, if any, as may
be required by Applicable Law or the requirements of a national securities exchange or
another similar
regulatory body, or in connection with a public offering of securities or any filing
with the U.S. Securities and Exchange Commission or a foreign equivalent.






	14	 	Patent Prosecution, Enforcement and Defence
	 
	14.1	 	Disclosure . Each Party shall promptly disclose to the other Party any invention
discovered or reduced to practice pursuant to the Collaboration that it believes may be
patentable.
	 
	14.2	 	 Patent Prosecution and Maintenance.






	 	14.2.1	 	Dynavax shall direct the filing, prosecution (including any interferences, reissue
proceedings and re-examinations), oppositions and maintenance of all Dynavax Patents.
Dynavax shall consult with AstraZeneca in connection with the continued prosecution and
maintenance by Dynavax of the Dynavax Patents and [ * ]. Dynavax shall provide
AstraZeneca with [ * ]. Dynavax shall bear one hundred percent (100%) of the costs
and expenses of the Dynavax Patents. Dynavax shall not abandon any Dynavax Patents
without at






 




			
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	 	 	 	least [ * ] days prior notice to AstraZeneca. If Dynavax decides to
abandon any Dynavax Patents, AstraZeneca shall have the option to continue the
prosecution and maintenance of such patents and related applications at its expense.
	 
	 	14.2.2	 	AstraZeneca shall be the Party (the “Prosecuting Party”) responsible for or for
procuring, the filing, prosecution (including any interferences, reissue proceedings
and re-examinations), oppositions and maintenance of all Collaboration Patents.
AstraZeneca shall consult with Dynavax in connection with the continued prosecution and
maintenance by AstraZeneca of the Collaboration Patents and [ * ]. AstraZeneca shall
provide Dynavax with [ * ]. AstraZeneca shall bear one hundred percent (100%) of the
costs and expenses of the Collaboration Patents. AstraZeneca shall promptly reimburse
Dynavax for any costs or expenses that Dynavax incurs in connection with the
prosecution and maintenance of the Collaboration Patents. AstraZeneca shall
not abandon any such Collaboration Patents without at least [ * ] days prior
notice to Dynavax. If AstraZeneca decides to abandon any such Collaboration
Patents, Dynavax shall have the option to continue the prosecution and maintenance
of such patents and related applications at its expense.
	 
	 	14.2.3	 	Where a patent application covers two or more Dynavax ISS and/or Collaboration ISS,
at least one of which has a use in the Field and at least one of which has no use in
the Field but a use outside of the Field, the prosecuting attorney will [ * ].
	 
	 	14.2.4	 	Each Party shall cooperate with the other and take all reasonable additional actions
and execute such agreements, instruments and documents as may be reasonably required to
perfect the other’s ownership interest in accordance with the intent of this Agreement
including, without limitation, the execution of necessary and appropriate instruments
of assignment to achieve such joint ownership as set forth in Section 14.1 and the
provision, on a reasonable basis, of its employees, agents, consultants and independent
contractors to the other Party (or to the other Party’s authorized attorneys, agents or
representatives), to the extent reasonably necessary to enable the prosecuting Party to
undertake






 




			
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	 	 	 	Patent prosecution for inventions arising out of the Collaboration, as
provided in this Agreement.






	14.3	 	Patent Term Restoration. The Parties shall cooperate with each other with respect to
obtaining patent term restoration or supplemental protection certificates or their equivalents
in any country in the Territory where applicable to Dynavax Patents and Collaboration Patents
in respect of the Product or any Combination Product(s). In the event that elections with
respect to obtaining such patent term restoration are to be made, AstraZeneca shall have the
right to make the election and Dynavax agrees to abide by such election.
	 
	14.4	 	Enforcement of Patent Rights.






	 	14.4.1	 	In the event that either Party becomes aware of a suspected infringement by a Third
Party of any Dynavax Patent licensed to AstraZeneca under this Agreement, such Party
shall notify the other Party promptly, and following
such notification, the Parties shall confer. Other than in respect of any Dynavax
Patent solely covering a CD, Dynavax shall have the right, but shall not be
obligated, to bring an infringement action at its own expense, in its own name and
entirely under its own direction and control. AstraZeneca, upon request of Dynavax,
agrees to join in any such litigation at Dynavax’s expense and to cooperate with
Dynavax in connection with such litigation. Where Dynavax notifies AstraZeneca that
it does not intend to take measures to remove such infringement, Dynavax may
nevertheless be joined as a party to any infringement action that is pursued and
shall retain the right to be heard in such proceedings and to defend the validity of
the Patent asserted by AstraZeneca. With respect to any Dynavax Patent solely
covering a CD or Product, AstraZeneca shall have the right, but shall not be
obligated, to bring an infringement action at its own expense, in its own name and
entirely under its own direction and control. Dynavax, upon request of AstraZeneca,
agrees to join in any such litigation at AstraZeneca’s expense and to cooperate with
AstraZeneca in connection with such litigation. Where AstraZeneca notifies Dynavax
that it does not intend to take measures to remove such infringement, AstraZeneca
may nevertheless be joined as a party to any infringement action






 




			
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	 	 	 	that is pursued and
shall retain the right to be heard in such proceedings and to defend the validity of
the Patent asserted by Dynavax.
	 
	 	14.4.2	 	In the event that either Party becomes aware of a suspected infringement of any
Collaboration Patent, such Party shall notify the other Party promptly. Following such
notification, the Parties shall confer. Other than in respect of any Collaboration
Patent solely covering a Reverted ISS, AstraZeneca shall have the right, but shall not
be obligated, to bring an infringement action or to defend such proceedings at its own
expense, in its own name and entirely under its own direction and control. Dynavax,
upon request of AstraZeneca, agrees to join in any such litigation at AstraZeneca’s
expense and to cooperate with AstraZeneca in connection with such litigation. Where
AstraZeneca notifies Dynavax that it does not intend to take measures to remove such
infringement, AstraZeneca may nevertheless be joined as a party to any infringement
action that is pursued and shall retain the right to be heard in such proceedings and
to defend the validity of the Patent asserted by Dynavax.
With respect to any Collaboration Patent solely covering a Reverted ISS, Dynavax
shall have the right, but shall not be obligated, to bring an infringement action at
its own expense, in its own name and entirely under its own direction and control.
AstraZeneca, upon request of Dynavax, agrees to join in any such litigation at
Dynavax’s expense and to cooperate with Dynavax in connection with such litigation.
Where Dynavax notifies AstraZeneca that it does not intend to take measures to
remove such infringement, Dynavax may nevertheless be joined as a party to any
infringement action that is pursued and shall retain the right to be heard in such
proceedings and to defend the validity of the Patent asserted by AstraZeneca.
	 
	 	14.4.3	 	If the Party having the first right to prosecute any action described in Sections
14.4.1 or 14.4.2 fails to do so within (a) [ * ] days following notice of the
alleged infringement or (b) [ * ] days before the time limit, if any, set forth in
the appropriate laws and regulations for the filings of such actions, whichever comes
first, then the other Party shall have the right, but not the obligation, to






 




			
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	 	 	 	bring and
control any such litigation at its own expense, in it own name and entirely under its
own direction and control.
	 
	 	14.4.4	 	In the event either Party exercises the rights conferred in this Section 14.4 and
recovers any damages or other sums in such action, suit or proceeding or in settlement
thereof, such damages or other sums recovered shall first be applied to all
out-of-pocket costs and expenses incurred by such Party in connection therewith,
including reasonable attorneys fees. If after such reimbursement any funds shall
remain from such damages or other sums recovered, such funds shall be retained by such
Party that controlled the litigation.






	14.5	 	Third Party Litigation. In the event of any actual or threatened suit against
Dynavax, AstraZeneca or its Affiliates, Sublicensees, Distributors or customers alleging that
the Development and/or Commercialization of CDs, Product or Combination Product, or that the
Development and/or Commercialization of a Collaboration Patent or the Background
Technologies or any part thereof by or on behalf of AstraZeneca under this
Agreement, infringes the Patent or other intellectual property rights of any
Person (an “Infringement Suit”), the Party first becoming aware of such
Infringement Suit shall promptly give written notice to the other Party.
AstraZeneca shall have the first right, but not the obligation, through
counsel of its choosing, to assume direction and control of the defence of
claims arising therefrom (including the right to settle such claims at its
sole discretion, subject to the provisions of this Section 14.5). If
AstraZeneca notifies Dynavax in writing that it does not wish to assume such
direction and control, Dynavax shall have the right, but not the obligation
to, at its sole cost and expense, defend against such claims; provided,
however, that Dynavax shall obtain the written consent of AstraZeneca prior
to ceasing to defend, settling or otherwise disposing of such claims.
Dynavax shall be entitled to be joined in any proceedings that may be
brought against AstraZeneca in relation to Dynavax’s Background Technology.
If Dynavax does so elect to be joined, it shall pay its own costs and
expenses in relation to the proceedings. AstraZeneca shall not make any
admission or settle or otherwise compromise any proceedings brought against
it in relation to Dynavax’s Background Technology without first obtaining
the written consent of Dynavax, which shall not be unreasonably withheld or
delayed.






 




			
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	 	 	Notwithstanding anything in the foregoing, each Party shall have
the right to defend itself, using the counsel of its choice and at its own
expense, any claims or law suits brought against it by any Third Party, and
each Party shall have the right to settle any such claims or law suits on
its own behalf, so long as such settlement does not provide for the payment
of money by the other Party or performance obligations, or restrictions
imposed upon, the other Party.
	 
	14.6	 	Invalidity or Unenforceability Defences or Actions.






	 	14.6.1	 	In the event that a Third Party or Sublicensee asserts, as a defence or as a
counterclaim in any Infringement Suit under Section 14.5, that any AstraZeneca Patent,
Dynavax Patent or Collaboration Patent covering a Dynavax ISS or Collaboration ISS is
invalid or unenforceable, then the Party pursuing such Infringement Suit shall promptly
give written notice to the other Party. AstraZeneca shall have the first right, but
not the obligation, through
counsel of its choosing, to respond to such defence or defend against such
counterclaim (as applicable), including the right to settle or otherwise compromise
such claim with respect to the AstraZeneca Patents and Collaboration Patents (other
than in respect of any Collaboration Patent solely covering a Reverted ISS for
which Dynavax shall have the first right), and Dynavax shall have the first right to
do so with respect to Dynavax Patents (other than in respect of any Dynavax Patent
solely covering a CD or Product for which AstraZeneca shall have the first right).
If the Party having the first right notifies the other Party in writing that it does
not wish to respond to such defence or defend against such counterclaim (as
applicable), the other Party shall, at its sole cost and expense, have the right but
not the obligation to respond to such defence or defend against such counterclaim
(as applicable); provided, however, that such other Party shall obtain the written
consent of the Party having the first right prior to ceasing to defend, settling or
otherwise compromising such defence or counterclaim.
	 
	 	14.6.2	 	Similarly, if a Third Party or Sublicensee asserts, in a declaratory judgment action
or similar action or claim filed by such Third Party or Sublicensee, that any
AstraZeneca Patent, Dynavax Patent or Collaboration Patent covering the Dynavax ISS or
Collaboration ISS is invalid or unenforceable, then the Party






 




			
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	 	 	 	first becoming aware of
such action or claim shall promptly give written notice to the other Party.
AstraZeneca shall have the first right, but not the obligation, through counsel of its
choosing, to defend against such action or claim, including the right to settle or
otherwise compromise such claim with respect to AstraZeneca Patents and Collaboration
Patents (other than in respect of any Collaboration Patent solely covering a Reverted
ISS for which Dynavax shall have the first right), and Dynavax shall have the right to
do so with respect to the Dynavax Patents (other than in respect of any Dynavax Patent
solely covering a CD or Product for which AstraZeneca shall have the first right). If
the Party having the first right to defend notifies the other Party in writing that it
does not wish to respond to or defend against or settle such action or claim, the other
Party shall, at its sole cost and expense, have the right but not the obligation to
defend against such action or claim; provided, however, that such other Party shall
obtain the written consent of the Party
having the first right prior to ceasing to defend, settling or otherwise
compromising of any such action or claim.






	14.7	 	Cooperation. The Party other than the Party defending an action or claim pursuant to
this Article 14 (the “Non-Defending Party”) will provide to the other Party (the “Defending
Party”) all reasonable assistance requested by the Defending Party in connection with any
action, claim or suit under Article 14, including allowing the Defending Party reasonable
access to the Non-Defending Party’s files and documents and to the Non-Defending Party’s
personnel who may have possession of relevant information, in all cases, during normal
business hours and with reasonable prior notice. In particular the Non-Defending Party will
promptly make available to the Defending Party, at the Defending Party’s expense, all
information in its possession or control that it is aware will assist the Defending Party in
responding to any such action, claim or suit under Article 14.
	 
	14.8	 	Compliance with Third Party Licences. To the extent any provision in this Article 14
is inconsistent with the requirements in any licence agreement between a Party and any Third
Party existing as of the Effective Date (including without limitation the license agreement
between Dynavax and the Regents), including without limitation the rights and procedures for
the filing, prosecution and maintenance of any Patents,






 




			
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	 	 	the enforcement of any Patents, or the
defense of any Third Party claims, the terms and conditions in such Third Party agreement(s)
shall control.
	 
	14.9	 	Costs and Expenses. AstraZeneca shall have the right to [ * ]. Any royalties
payable by AstraZeneca with respect to the manufacture, use or sale of Products may result in
a reduction of royalties payable to Dynavax, pursuant to Section 10.4 and subject to Section
10.7. For the avoidance of doubt, where Indirect Taxes apply to milestones, royalties or
costs, the Parties shall invoice these sums according to Applicable Law. Any amounts
recovered by AstraZeneca in connection with any action, claim or suit under Article 14 shall
first be applied to all out-of-pocket costs and expenses incurred by AstraZeneca in connection
therewith, including reasonable attorneys fees and any such sums
remaining shall be retained by AstraZeneca and
shall be included in the calculation of Net
Sales.
	 
	15	 	Adverse Event Reporting
	 
	15.1	 	Overview. AstraZeneca shall maintain a record of all non-medical and medical
Product-related or Combination Product-related complaints and reports of adverse events that
it receives with respect to any Product or Combination Product as appropriate. AstraZeneca
shall be responsible for reporting to Regulatory Authorities any adverse experiences and
safety issues for each Product and Combination Product in compliance with the requirements of
the U.S. Food, Drug and Cosmetic Act, 21 U.S.C. § 321 et seq., the regulations promulgated
thereunder, and equivalent foreign laws, rules and regulations. Without limiting the
foregoing, upon AstraZeneca’s written request, Dynavax shall provide AstraZeneca with any
information reasonably necessary for AstraZeneca to comply with all Applicable Law with
respect to the Dynavax ISS, Collaboration ISS, the Product and Combination Product(s), as the
case may be.
	 
	 	 	In the event that Dynavax exercises its option to co-promote the Product or any Combination
Product(s) in the United States of America and the Parties enter into a written co-promotion
agreement pursuant to Section 8.5, Dynavax shall, at least [ * ] months prior to
commencing such co-promotion, develop appropriate adverse experience reporting procedures to
record all non-medical and medical product-related






 




			
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	 	 	complaints and reports of adverse events
that it receives with respect to any Product or Combination Product(s).
	 
	15.2	 	Complaints. AstraZeneca shall maintain a record of any and all complaints it
receives with respect to the Product and any Combination Products. Dynavax shall notify
AstraZeneca in reasonable detail of any complaint received by it within [ * ] after the
event, and in any event in sufficient time to allow AstraZeneca to comply with all Applicable
Law in any country in which the Product or any Combination Product is being developed,
marketed or sold.
	 
	16	 	Product Recall
	 
	16.1	 	Notification and Recall. In the event that any Governmental Authority issues or
requests a recall or takes similar action in connection with a CD, the Product or any
Combination Product, or in the event [ * ], AstraZeneca shall promptly advise Dynavax
thereof by telephone or facsimile. Following notification of a recall, AstraZeneca shall
decide and have control of whether to conduct a recall or market withdrawal (except in the
case of a government-mandated recall) in the Territory and the manner in which any such recall
or market withdrawal shall be conducted.
	 
	16.2	 	Recall Expenses. AstraZeneca shall bear the expenses of any recall of a CD, the
Product or any Combination Product; provided, however, that Dynavax shall bear
the expense of a recall to the extent that such recall resulted from Dynavax’s breach of its
obligations hereunder or Dynavax’s negligence or willful misconduct or intentional omission.
Such expenses of recall shall include expenses for notification, destruction and return of the
recalled Product or Combination Product and any refund to customers of amounts paid for the
recalled Product or Combination Product.






 




			
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	17	 	Trademarks.
	 
	 	 	AstraZeneca shall have the sole right to select the Trademarks for
the marketing and sale of the Product and any Combination Product(s)
in the Territory. AstraZeneca shall own such Trademarks and all
rights and goodwill with respect thereto. AstraZeneca agrees not to
adopt or use any trademarks, brand names, words, logos, symbols,
letters, designs or marks that would be confusingly similar to
Dynavax’s trademarks. Dynavax shall not, and shall not permit its
Affiliates to, use any trademark that is the same as or confusingly
similar to, misleading or deceptive with respect to or that dilutes
the Trademarks.
	 
	18	 	Representations and Warranties
	 
	18.1	 	Each Party represents and warrants to the other that:






	 	18.1.1	 	it has full legal power to extend the rights and licences granted to the other under
this Agreement and perform its obligations hereunder;
	 
	 	18.1.2	 	it has full power and authority to enter into this Agreement and has taken all
necessary action on its part required to authorise the execution and delivery of this
Agreement;
	 
	 	18.1.3	 	its employees and agents who are performing any activities under this Agreement or
who have access to Confidential Information are bound, without request for additional
compensation, to Articles 6, 13 and 14 of this Agreement;
	 
	 	18.1.4	 	neither it nor any researcher engaged by it, in any capacity, in the Joint Research
Programme has been debarred or is subject to debarment or has otherwise been
disqualified or suspended from performing scientific or clinical investigations or
otherwise subjected to any restrictions or sanctions by the FDA or any other
governmental or regulatory authority or professional body with respect to the
performance of scientific or clinical investigations;
	 
	 	18.1.5	 	to the best of its Knowledge and belief, this Agreement is legally binding upon it
and enforceable in accordance with its terms, and the execution, delivery and
performance of this Agreement by it does not conflict with any agreement,






 




			
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	 	 	 	instrument or
understanding, oral or written, to which it is a party or by which it may be bound, nor
violate any material law or regulation of any Governmental Authority having
jurisdiction over it;
	 
	 	18.1.6	 	it has not granted, and will not grant during the Term of the Agreement, any right to
any Third Party that would conflict with the rights granted to the other Party
hereunder;
	 
	 	18.1.7	 	it has (or will have at the time performance is due) maintained and will maintain and
keep in full force and effect all agreements necessary to perform its obligations
hereunder;
	 
	 	18.1.8	 	it is aware of no action, suit or inquiry or investigation instituted by any
governmental agency that questions or threatens the validity of this Agreement; and
	 
	 	18.1.9	 	to the best of its Knowledge and belief, all necessary consents, approvals and
authorizations of all governmental authorities and other Persons required to be
obtained by such Party to enter into, or perform its obligations under, this Agreement
have been obtained.






	18.2	 	Dynavax further represents and warrants that as of the Effective date:






	 	18.2.1	 	Dynavax is the sole and exclusive owner of the entire right, title and interest in
the Dynavax Patents listed on Exhibit B(1) (the “Owned Patents”) and is
entitled to grant the licences specified herein. Such rights are not subject to any
encumbrance, lien or claim of ownership by any Third Party. Dynavax is the sole and
exclusive licensee of and Controls all right, title and interest in and to the Dynavax
Patents listed in Exhibit B(2) (the “In-licensed Patents”) and is entitled to
grant the licences specified herein. Such rights are not subject to any encumbrance,
lien or claim of ownership by any Third Party, other than the Third Party from which
such rights are licensed. True, complete and correct copies of the complete file
wrapper and other documents and materials relating to the prosecution, defence,
maintenance, validity and enforceability of the Owned Patents and the In-licensed
Patents and all license and other agreements regarding the In-licensed Patents (the
“In-Licence Agreements”), as amended to the date hereof, have been provided to





 




			
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	 	 	 	AstraZeneca prior to the date first above written. The Owned Patents and the
In-licensed Patents constitute all of the licensed Dynavax Patents as of the Effective
Date. During the Term, Dynavax shall not encumber or diminish the rights granted to
AstraZeneca hereunder with respect to the licensed Dynavax Patents, including by not [
* ]. Dynavax shall promptly provide AstraZeneca with notice of any alleged,
threatened or actual breach of any In-Licence Agreement. As of the Effective Date,
none of Dynavax, its Affiliates and, to the best of their Knowledge, any Third Party is
in breach of any In-Licence Agreement;
	 
	 	18.2.2	 	All information and data provided by or on behalf of Dynavax to AstraZeneca on or
before the Effective Date in contemplation of this Agreement was and is true and
accurate in all material respects, and Dynavax has not failed to disclose, or cause to
be disclosed, any information or data that would cause the
information and data that has been disclosed to be individually, or in the
aggregate, misleading in any material respect;
	 
	 	18.2.3	 	To Dynavax’s Knowledge, the licensed Dynavax Patents are being diligently procured
from the respective Patent Offices in accordance with all applicable laws and
regulations. The licensed Dynavax Patents have been filed and maintained properly and
correctly and all applicable fees have been paid on or before the due date for payment;
	 
	 	18.2.4	 	As of the Effective Date, to the best of Dynavax’s and its Affiliates’ Knowledge,
there is no actual infringement or threatened infringement of the licensed Dynavax
Patents, licensed Dynavax Know-How or any regulatory documentation by any Person.
	 
	 	18.2.5	 	To the best of Dynavax’s and its Affiliates’ Knowledge and except as disclosed in
Schedule 18.2.5, AstraZeneca’s use Exploitation of the regulatory documentation, the
licensed Dynavax Patents or licensed Dynavax Know-How hereunder will not infringe any
Patent or other intellectual property or proprietary right of any Person;
	 
	 	18.2.6	 	The licensed Dynavax Patents and the licensed Dynavax Know-How existing as of the
Effective Date are subsisting and to the best of Dynavax’s knowledge






 




			
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	 	 	 	are not invalid or
unenforceable, in whole or in part, except to the patent properties identified in
Schedule 18.2.6, as to which no representation is made. To Dynavax’s Knowledge, the
conception, development and reduction to practice of the regulatory documentation, the
licensed Dynavax Patents and licensed Dynavax Know-How existing as of the Effective
Date have not constituted or involved the misappropriation of trade secrets or other
rights or property of any Person. There are no claims, judgments or settlements against
or amounts with respect thereto owed by Dynavax relating to the regulatory
documentation, the licensed Dynavax Patents or the licensed Dynavax Know-How. Except
as disclosed in Schedule 18.2.6, no claim or litigation has been brought or threatened
by any Person alleging, and Dynavax is not aware of any possible claim, whether or not
asserted, that (a) the licensed Dynavax Patents or the licensed Dynavax Know-How are
invalid or unenforceable or
(b) the regulatory documentation, the licensed Dynavax Patents or the licensed
Dynavax Know-How or the disclosing, copying, making, assigning, licensing or use of
the regulatory documentation, the licensed Dynavax Patents or the licensed Dynavax
Know-How, or products and services embodying the regulatory documentation, or the
Dynavax ISS, Collaboration ISS, CDs, Product or Combination Product(s) violates,
infringes or otherwise conflicts or interferes with any intellectual property or
proprietary right of any Person;
	 
	 	18.2.7	 	Dynavax has not previously entered into any agreement, whether written or oral, with
respect to, or otherwise assigned, transferred, licensed, conveyed or otherwise
encumbered its right, title or interest in or to, the licensed Dynavax Patents,
licensed Dynavax Know-How, regulatory documentation, or the Dynavax ISS and/or
Collaboration ISS (including by granting any covenant not to sue with respect thereto)
that is inconsistent with the rights and licences granted to AstraZeneca under this
Agreement;
	 
	 	18.2.8	 	In respect of the pending United States patent applications included in the licensed
Dynavax Patents, Dynavax has presented all relevant prior art of which it has Knowledge
to the relevant Patent Examiner at the United States Patent and Trademark Office;






 




			
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	 	18.2.9	 	The licensed Dynavax Patents represent all Patents within Dynavax’s Control as of the
Effective Date that are directly related to, or are necessary, for the manufacture,
use, offer for sale or sale of the Dynavax ISS and/or the Collaboration ISS;
	 
	 	18.2.10	 	Any licensed Dynavax Know-How has been kept confidential or has been disclosed to
Third Parties only under terms of confidentiality;
	 
	 	18.2.11	 	Dynavax has made (and will make) available to AstraZeneca all regulatory
documentation, licensed Dynavax Know-How and other Information in its possession or
Control directly related to any Dynavax ISS and/or Collaboration ISS and all such
regulatory documentation, licensed Dynavax Know-How and other Information are (and, if
made available after the Effective Date, will be) true, complete and correct. As of
the Effective Date, Dynavax has prepared, maintained and retained all regulatory
documentation
that is required to be maintained or reported pursuant to and in accordance with
good laboratory and clinical practice and Applicable Law and all such information is
true, complete and correct and what it purports to be;
	 
	 	18.2.12	 	Dynavax shall obtain from each of its Affiliates, Sublicensees, employees and agents,
and from the employees and agents of its Affiliates, Sublicensees and agents, who are
performing tests or studies, or are otherwise participating in the Research of the
Dynavax ISS and/or Collaboration ISS, CDs, Product or Combination Product or who
otherwise have access to any AstraZeneca Confidential Information, rights to any and
all Information that relate to the Dynavax ISS and/or Collaboration ISS, CDs, Product
and Combination Product, such that AstraZeneca shall, by virtue of this Agreement,
receive from Dynavax, without payments beyond those required by this Agreement, the
licences and other rights granted to AstraZeneca hereunder.






	18.3	 	Each Party shall comply with all laws, rules and regulations that govern the Party’s
performance under this Agreement, including all United States and multilateral export laws and
regulations.
	 
	18.4	 	Nothing in this Agreement shall be construed as a warranty or representation by either Party
of the success of the Joint Research Programme or the Joint Research Plan.






 




			
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	18.5	 	DISCLAIMER. OTHER THAN AS PROVIDED IN THIS ARTICLE 18, THE PARTIES DISCLAIM ANY AND ALL
WARRANTIES OF ANY KIND WITH REGARD TO THE COLLABORATION MATERIALS OR THE BACKGROUND
TECHNOLOGIES, WHETHER EXPRESS OR IMPLIED, INCLUDING ANY WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, ANY WARRANTIES ARISING FROM COURSE OF DEALING OR USAGE OF
TRADE.
	 
	19	 	Indemnification and Insurance
	 
	19.1	 	Indemnification of Dynavax. In addition to any other remedy available to Dynavax,
AstraZeneca shall indemnify, defend and hold harmless Dynavax, its Affiliates and its and
their respective directors, officers and employees in full and on demand, from and against any and
all Losses incurred by them to the extent resulting from or arising out or in connection
with any claims made or suits brought by a Third Party (collectively, “Third Party Claims”)
against Dynavax, its Affiliates, Sublicensees, and their respective directors, officers or
employees:






	 	19.1.1	 	that arise or result from any intentional misconduct or gross negligence on the part
of AstraZeneca, its Affiliates, Distributors, Sublicensees or agents in performing any
activity contemplated by this Agreement, or the breach of any provision of this
Agreement (including a breach of a warranty or Applicable Law) by AstraZeneca; or
	 
	 	19.1.2	 	that allege that the claimant has suffered personal injury or death as a result of
use of the Product or Combination Product(s) or of AstraZeneca’s Development,
manufacture, use, handling, storage, sale, offer for sale, importation, or other
disposition of the Product or any Combination Product(s),






	 	 	except for any Losses for which Dynavax has an obligation to indemnify AstraZeneca and its
Affiliates pursuant to Section 19.2.
	 
	19.2	 	Indemnification of AstraZeneca. In addition to any other remedy available to
AstraZeneca, Dynavax shall indemnify, defend and hold harmless AstraZeneca, its Affiliates,
Distributors, Sublicensees and its and their respective directors, officers






 




			
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	 	 	and employees in
full and on demand, from and against any and all Losses incurred by them to the extent
resulting from or arising out of or in connection with any Third Party Claims against
AstraZeneca, its Affiliates, Distributors or Sublicensees or their respective directors,
officers or employees that:






	 	19.2.1	 	arise or result from any intentional misconduct or gross negligence on the part of
Dynavax, its Affiliates, Sublicensees or agents in performing any activity contemplated
by this Agreement, or the breach of any provision of this Agreement by Dynavax;
	 
	 	19.2.2	 	allege that the claimant has suffered personal injury or death as a result of use of
any product incorporating a Reverted ISS or reverted CD or of Dynavax’s
development, manufacture, use, handling, storage, sale, offer for sale, importation,
or other disposition of such reverted ISS, product(s) or CD(s);
	 
	 	19.2.3	 	in the event that the Agreement is terminated and Dynavax continue to Develop and
Commercialize any CD, Product or Combination Product directly or through a Third Party,
allege that the claimant has suffered personal injury or death as a result of use of
any CD, Product or Combination Product or of Dynavax’s Development, manufacture, use,
handling, storage, sale, offer for sale, importation, or other disposition of such
Product or Combination Product(s), after the date of termination;






	 	 	in all cases except for any Losses for which AstraZeneca has an obligation to indemnify
Dynavax and its Affiliates pursuant to Section 19.1.
	 
	19.3	 	[ * ]
	 
	19.4	 	Notice of Claim. An Indemnified Party shall give the Indemnifying Party prompt
written notice of any Losses or discovery of fact upon which such Indemnified Party intends to
base a request for indemnification under Section 19.1, 19.2 or 19.3 (an “Indemnification Claim
Notice”). In no event shall the Indemnifying Party be liable for any Loss that results from
any delay in providing the Indemnification Claim Notice. Each Indemnification Claim Notice
shall contain a description of the claim and the nature and amount of the Loss claimed (to the
extent that the nature and amount of such Loss is known at such time). The Indemnified Party
shall furnish






 




			
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	 	 	promptly to the Indemnifying Party copies of all papers and official documents
received in respect of any such Loss. For the avoidance of doubt, all indemnification claims
in respect of a Party, its Affiliates or their respective directors, officers, employees and
agents (each, an “Indemnitee”) shall be made solely by such Party to this Agreement.
	 
	19.5	 	Indemnification Procedures. The obligations of an Indemnifying Party under this
Article 19 shall be governed by and contingent upon the following:






	 	19.5.1	 	Assumption of Defence. At its option, the Indemnifying Party may assume the
defence of any Third Party Claim by giving written notice to the
Indemnified Party within [ * ] days after the Indemnifying Party’s receipt of an
Indemnification Claim Notice. The assumption of the defence of a Third Party Claim
by the Indemnifying Party shall not be construed as an acknowledgement that the
Indemnifying Party is liable to indemnify any Indemnitee in respect of the Third
Party Claim, nor shall it constitute a waiver by the Indemnifying Party of any
defences it may assert against any Indemnified Party’s claim for indemnification.
	 
	 	19.5.2	 	Control of Defence. Upon the assumption of the defence of a Third Party
Claim by the Indemnifying Party:






	 	(e)	 	the Indemnifying Party may appoint as lead counsel in the
defence of the Third Party Claim any legal counsel selected by the Indemnifying
Party, which shall be reasonably acceptable to the Indemnified Party, and
	 
	 	(f)	 	Except as expressly provided in Section 19.5.3, the
Indemnifying Party shall not be liable to the Indemnified Party for any legal
expenses subsequently incurred by such Indemnified Party or any Indemnitee in
connection with the analysis, defence or settlement of the Third Party Claim.
In the event that it is ultimately determined that the Indemnifying Party is
not obligated to indemnify, defend or hold harmless an Indemnitee from and
against the Third Party Claim, the Indemnified Party shall reimburse the
Indemnifying Party for any and all costs and expenses (including lawyers’ fees
and costs of suit) and






 




			
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	 	 	 	any Loss incurred by the Indemnifying Party in its
defence of the Third Party Claim with respect to such Indemnified Party or
Indemnitee.






	 	19.5.3	 	Right to Participate in Defence. Without limiting Section 19.5.1 or 19.5.2,
any Indemnitee shall be entitled to participate in, but not control, the defence of a
Third Party Claim and to retain counsel of its choice for such purpose; provided,
however, that such retention shall be at the Indemnitee’s own expense unless, (a) the
Indemnifying Party has failed to assume the defence and retain counsel in accordance
with Section 19.5.1 (in which case the Indemnified Party shall control the defence), or
(b) the interests of the
Indemnitee and the Indemnifying Party with respect to such Third Party Claim are
sufficiently adverse to prohibit the representation by the same counsel of both
parties under Applicable Law, ethical rules or equitable principles.
	 
	 	19.5.4	 	Settlement. With respect to all Losses, where the Indemnifying Party has
assumed the defence of a Third Party Claim in accordance with Section 19.5.1, (i) the
Indemnifying Party shall have authority to consent to the entry of any judgement, enter
into any settlement or otherwise dispose of such Losses, provided that it obtains the
prior written consent of the Indemnified Party, which consent shall not be unreasonably
withheld or delayed, and (ii) no Indemnified Party or Indemnitee shall admit any
liability with respect to, or settle, compromise or discharge, any such Third Party
Claim without the prior written consent of the Indemnifying Party, which consent shall
not be unreasonably withheld.
	 
	 	19.5.5	 	Cooperation. If the Indemnifying Party chooses to defend or prosecute any
Third Party Claim, the Indemnified Party shall, and shall cause each other Indemnitee
to, reasonably cooperate in the defence or prosecution thereof and shall furnish such
records, information and testimony, provide such witnesses and attend such conferences,
discovery proceedings, hearings, trials and appeals as may be reasonably requested in
connection therewith. Such cooperation shall include access during normal business
hours by the Indemnifying Party to, and reasonable retention by the Indemnified Party
of, records and information that are reasonably relevant to such Third Party Claim, and
making the Indemnified Party, the Indemnitees and its and their






 




			
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	 	 	 	employees and agents
available on a mutually convenient basis to provide additional information and
explanation of any records or information provided, and the Indemnifying Party shall
reimburse the Indemnified Party for all of its related reasonable out-of-pocket
expenses.
	 
	 	19.5.6	 	Expenses. Except as expressly provided above, the reasonable and verifiable
costs and expenses, including fees and disbursements of counsel, incurred by the
Indemnified Party in connection with any claim shall be reimbursed on a quarterly basis
by the Indemnifying Party, without prejudice to the Indemnifying Party’s right to
contest the Indemnified Party’s right to
indemnification and subject to refund in the event the Indemnifying Party is
ultimately held not to be obligated to indemnify the Indemnified Party.






	19.6	 	LIMITATION ON DAMAGES. EXCEPT IN CIRCUMSTANCES OF GROSS NEGLIGENCE OR INTENTIONAL
MISCONDUCT BY A PARTY OR ITS AFFILIATES, OR WITH RESPECT TO THIRD PARTY CLAIMS UNDER SECTION
19.1 OR 19.2, NO PARTY OR ANY OF ITS AFFILIATES SHALL BE LIABLE FOR SPECIAL, INDIRECT,
INCIDENTAL OR CONSEQUENTIAL DAMAGES, OR FOR LOST PROFITS, MILESTONES OR ROYALTIES, WHETHER IN
CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF (a) THE
DEVELOPMENT, MANUFACTURE, USE OR SALE OF ANY PRODUCT OR COLLABORATION ISS DEVELOPED,
MANUFACTURED OR MARKETED HEREUNDER, OR (b) ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE
PROVISIONS OF THIS AGREEMENT.
	 
	19.7	 	Insurance. Each Party shall have and maintain such type and amounts of liability
insurance as is normal and customary in the pharmaceutical industry generally for Persons
similarly situated, and shall upon request provide the other Party with a copy of its policies
of insurance in that regard, along with any amendments and revisions thereto.
	 
	20	 	Term and Termination
	 
	20.1	 	Term. This Agreement shall become effective on the Effective Date and shall continue
in full force and effect until the earlier of (i) expiration or termination of all






 




			
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	 	 	payment
obligations to Dynavax under this Agreement, or (ii) the effective date of termination
pursuant to Sections 20.2, 20.3, 20.4, 20.5 or 20.6 or Section 21.4 below (the “Term”). The
Term shall expire on the Product, or a Combination Product by Combination Product and country
by country basis within the Territory.
	 
	20.2	 	Termination by AstraZeneca. AstraZeneca may terminate this Agreement if it
determines, in its sole discretion, that it does not wish to pursue the Joint Research
Programme or the further research,
development, launch or sale of Dynavax ISS, Collaboration ISS, Candidate
Drugs, Product or Combination Product(s) for any reason, including but not
limited to, a scientific, technical, regulatory or commercial reasons,
including [ * ]. AstraZeneca shall promptly notify Dynavax in writing of
such determination and provide Dynavax with the pertinent information with
respect thereto. Promptly following the receipt of such notice from
AstraZeneca, the Parties shall discuss in more detail the reasons for such
termination in good faith. Following such discussion, AstraZeneca may, at
its sole discretion, terminate this Agreement in its entirety or with
respect to the Product or one or more Combination Products or one or more
countries in the Territory upon [ * ] days’ prior written notice.
Further, AstraZeneca shall have the right in its sole discretion to
terminate this Agreement with respect to a country upon [ * ] days’ prior
written notice in the event that any Governmental Authority takes, fails to
take, or reasonably could be expected to take or fail to take, any action
with respect to the CD, Product or any Combination Product that could have
an adverse effect on the Development and/or Commercialization of the CD,
Product or Combination Product(s) in such country; provided, however, that
AstraZeneca shall have the right to terminate this Agreement with respect to
all of Europe if such country is in Europe and AstraZeneca shall have the
right to terminate this Agreement in its entirety if such country is or is
in a Major Market. In the event of any such termination, if such
termination occurs at a time when AstraZeneca is conducting or sponsoring a
clinical trial of a CD, the Product or any Combination Product, AstraZeneca
shall [ * ].
	 
	20.3	 	Termination for Infringement of Third Party Rights.






	 	20.3.1	 	If a Triggering Event occurs with respect to a country, AstraZeneca shall have the
right upon written notice to Dynavax to terminate this Agreement with respect to such
country if at any time (a) AstraZeneca is unable to obtain such






 




			
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	 	 	 	a licence on
commercially reasonable terms or (b) AstraZeneca in good faith believes that
negotiation with a Third Party pursuant to Section 6.4 with respect to such country is
not likely to result in a commercially reasonable agreement; provided,
however, that AstraZeneca shall have the right to terminate this Agreement with
respect to all of Europe if such country is in
Europe and AstraZeneca shall have the right to terminate this Agreement in its
entirety if such country is or is in a Major Market.
	 
	 	20.3.2	 	If a Third Party institutes an Infringement Suit with respect to a country,
AstraZeneca shall have the right upon written notice to Dynavax to terminate this
Agreement with respect to such country if [ * ]; provided, however,
that AstraZeneca shall have the right to terminate this Agreement with respect to all
of Europe if such country is in Europe and AstraZeneca shall have the right to
terminate this Agreement in its entirety if such country is or is in a Major Market.






	20.4	 	Termination by Dynavax for Lack of Diligence. In addition to the rights of
termination in the event of material breach set forth in Section 20.5.1, Dynavax may terminate
this Agreement, in its entirety or on a Dynavax ISS-by-Dynavax ISS, Collaboration
ISS-by-Collaboration ISS, CD by CD, Product or Combination Product-by-Combination Product
basis, upon [ * ] days advance written notice to AstraZeneca in the event that an arbitrator
determines pursuant to Section 24.13 that AstraZeneca has failed to fulfil its Commercially
Reasonable Efforts obligations under Section 8.10.
	 
	20.5	 	Termination by Either Party. In addition to any other provision of this Agreement
expressly providing for termination of this Agreement, this Agreement may be terminated
immediately by either Party upon notice to the other Party:






	 	20.5.1	 	if it believes that the other Party is in material breach of this Agreement, in which
case the non-breaching Party may deliver notice of such material breach to the other
Party, such notice to describe in detail the nature of such breach. The allegedly
breaching Party shall have [ * ] days from receipt of such notice to cure such breach
(or, if such default cannot be cured within such [ * ] day period, the breaching
Party must commence actions to cure such default






 




			
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	 	 	 	during such [ * ] day period and
diligently continue such actions until the cure is effected). Any such termination
shall become effective at the end of such [ * ] day period unless the breaching Party
has cured any such breach or default prior to the expiration of such [ * ] day period
(or, if such default is
capable of being cured but cannot be cured within such [ * ] day period, the
breaching Party has commenced and diligently continued actions to cure such default
provided always that, in such instance, such cure must have occurred within [ * ]
days after notice thereof was provided to the breaching Party by the non-breaching
Party to remedy such default);
	 
	 	20.5.2	 	if such other Party ceases or threatens to cease to carry on the whole or
substantially the whole of its business or that part of its business to which this
Agreement relates;
	 
	 	20.5.3	 	if such other Party shall file in any court or agency, pursuant to any statute or
regulation of any state or country, a petition in bankruptcy or insolvency or for
reorganization or for an the appointment of a receiver or trustee of such other Party
or of its assets, or if the other Party proposes a written agreement of composition or
extension of its debts, or if the other Party shall be served with an involuntary
petition against it, filed in any insolvency proceeding, or if the other Party shall
propose or be a Party to any dissolution or liquidation, or if the other Party shall
make an assignment for the benefit of its creditors;
	 
	 	20.5.4	 	if any encumbrancer takes possession of any material part of the assets of another
Party; or
	 
	 	20.5.5	 	if any distress, execution or other such process is levied or enforced upon or
against any of the material assets of the other Party.






	 	 	It is understood that termination pursuant to this Section 20.5 shall be a remedy of last
resort and may be invoked only in the case where the breach cannot be reasonably remedied by
the payment of money damages. If a Party gives notice of termination under this Section
20.5, and the other Party disputes whether such notice was proper, then the issue of whether
this Agreement has been terminated shall be resolved in accordance with Article 24. If as a
result of such dispute resolution process it is determined that the notice of termination
was proper, then such termination shall be






 




			
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	 	 	deemed to have been effective [ * ] days
following the date of receipt of the notice of termination. If as a result of such dispute
resolution process it is determined that the notice of termination was improper, then no
termination shall have occurred and this Agreement shall remain in effect.
	 
	20.6	 	Change of Control. Upon a Change of Control of Dynavax at any time during the Joint
Research Programme, AstraZeneca shall have the right to (a) terminate this Agreement in its
entirety by delivering written notice of termination to Dynavax at any time within [ * ]
months after the date of such Change of Control or (b) terminate only the Parties’
collaboration under the Joint Research Programme with immediate effect thereby ending the
Research Term. In the event AstraZeneca exercises the latter option, AstraZeneca shall be
under no obligation to provide Dynavax with any further compensation pursuant to Article 7 but
shall remain responsible for payments under Articles 9 and 10. Following such termination of
the Research Term, Dynavax shall immediately provide AstraZeneca with all Collaboration
Technology generated by it under the Joint Research Programme and not previously provided to
AstraZeneca and shall immediately return to AstraZeneca all AstraZeneca Confidential
Information, including any and all copies thereof, and those portions of any documents,
memoranda, notes, studies, analyses or other material prepared by or on behalf of Dynavax that
incorporate or are derived from such Confidential Information. For the avoidance of doubt, in
the event of such termination, Dynavax shall have no further rights to use any Collaboration
Technology, AstraZeneca Technology or AstraZeneca Confidential Information for any purpose in
the Field. [ * ]. The Agreement shall remain valid and in full force and effect in all
other respects. Upon a Change of Control of AstraZeneca at any time during the Term, the
successor in interest and/or surviving entity shall continue to perform the obligations of and
exercise the rights of AstraZeneca pursuant to this Agreement in the same manner as intended
by AstraZeneca as of the Effective Date.
	 
	20.7	 	Consequences of Termination.






	 	20.7.1	 	Payment by AstraZeneca. Upon termination of this Agreement by AstraZeneca
pursuant to Section 20.2 prior to the [ * ] anniversary of the Effective Date,
AstraZeneca shall make a lump sum payment to Dynavax to






 




			
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	 	 	 	compensate Dynavax for such
early termination in an amount equal to [ * ]; provided, however, that AstraZeneca
shall have no obligation to make such payment in the event it terminates this Agreement
pursuant to Section 20.5.1
or 20.6 or Section 21.4. For clarity, the foregoing lump sum payment shall be in
addition to any ongoing payment obligations AstraZeneca may have for existing
clinical trials pursuant to Section 20.2. In addition to the lump sum, and on
condition that Dynavax maintain the level of internal Dynavax FTE support existing
as at the date of termination to any continuing research activities previously
covered by the Joint Research Programme, AstraZeneca shall meet [ * ] of any
reasonable external FTE costs Dynavax incurs during the period of [ * ] months
following immediately after the date of the termination. AstraZeneca shall have no
obligation to make such additional external FTE contribution in the event it
terminates this Agreement pursuant to Section 20.5.1 or 20.6 or Section 21.4.
	 
	 	20.7.2	 	Cessation of Obligations; Return of Materials. Upon termination of this
Agreement, Dynavax shall promptly cease its performance of obligations under this
Agreement. The expiration or termination of this Agreement shall be without prejudice
to any rights or obligations of the Parties that may have accrued prior to such
expiration or termination and, except as otherwise expressly provided herein, shall not
limit any rights or remedies which may be available at law or otherwise. Upon the
termination or expiration of this Agreement, each Party shall, at its sole expense,
promptly return to the other Party all Confidential Information of such other Party
and, at such other Party’s option, either destroy or return to such other Party all
materials received from such other Party, except to the extent that the Receiving Party
has a continuing licence to use such materials. Notwithstanding the foregoing, the
General Counsel of each Party may retain one copy of each business document generated
by such Party in connection with this Agreement for archival purposes only, and all
such retained documents shall be subject to the confidentiality obligations of this
Agreement.
	 
	 	20.7.3	 	Licences.






 




			
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	 	(g)	 	Upon termination of this Agreement in its entirety by
AstraZeneca pursuant to Section 20.2 or 20.3 or by Dynavax pursuant to Section
20.4 or Section 20.5, all licenses to AstraZeneca under Section 6.2 shall
terminate, and (A) AstraZeneca shall, and hereby does, grant to
Dynavax an exclusive, worldwide, perpetual, irrevocable, royalty-free
license, with right to sublicense and to enforce patents, under the
AstraZeneca Technology, to make, have made, use, import, offer for sale and
sell the then current Dynavax ISS, Collaboration ISS, CD, Product and
Combination Product(s) in the Field, and (B) [ * ]. Dynavax shall have
the right to use [ * ].
	 
	 	(h)	 	Upon termination by AstraZeneca of AstraZeneca’s obligations
and/or license rights to a specific Dynavax ISS, Collaboration ISS, CD, Product
and/or Combination Product pursuant to Sections 20.2 or 20.3, the license to
AstraZeneca under Section 6.2 shall terminate solely as to such Dynavax ISS,
Collaboration ISS, CD, Product and/or Combination Product(s), and (A)
AstraZeneca shall, and hereby does, grant to Dynavax an exclusive, worldwide,
perpetual, irrevocable, royalty-free license, with right to sublicense and to
enforce patents, under the AstraZeneca Technology, to make, have made, use,
import, offer for sale and sell such Dynavax ISS, Collaboration ISS, CD,
Product and Combination Product(s) in the Field, and (B) [ * ]. Dynavax
shall have the right to use [ * ].
	 
	 	(i)	 	Upon termination by AstraZeneca of AstraZeneca’s obligations
and/or license rights to a specific Dynavax ISS, Collaboration ISS, CD, Product
and/or Combination Product in a particular country pursuant to Sections 20.2 or
20.3, the license to AstraZeneca under Section 6.2 shall terminate solely as to
such Dynavax ISS, Collaboration ISS, CD, Product and/or Combination Product(s)
in such country, and (A) AstraZeneca shall, and hereby does, grant to Dynavax
an exclusive, worldwide, perpetual, irrevocable, royalty-free license, with
right to sublicense and to enforce patents, under the AstraZeneca Technology,
to make, have made, use, import, offer for sale and sell such Dynavax






 




			
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	 	 	 	ISS, Collaboration ISS, CD, Product and Combination Product(s) in the Field in such
country only and (B) [ * ]. Dynavax shall have the right to use [ * ].
	 
	 	(j)	 	Upon termination of this Agreement by AstraZeneca pursuant to
Section 20.5.1, the licenses to AstraZeneca under Section 6.2 shall remain in
effect. In such case, AstraZeneca shall remain liable for [ * ] of the
milestone payments and [ * ] of the royalties due under Article 10 and
Section 10.7 shall cease to apply. The foregoing milestone and royalty
reduction shall not be an exclusive remedy, but any claim for money damages by
AstraZeneca shall be reduced by the economic effect of such [ * ] reduction
in milestone payments and royalty obligations.. Following termination under
Section 20.5.1 AstraZeneca shall be relieved of its remaining obligations to
Dynavax under this Agreement except for AstraZeneca’s obligations under
Articles 9, 10 (other than Section 10.7), 13, 14, and 19.
	 
	 	(k)	 	For clarity, in the event of termination of this Agreement in
its entirety or in part by AstraZeneca or Dynavax (as appropriate) pursuant to
Sections 20.2, 20.3, 20.4 or 20.5, if the Product or Combination Product at
the time of termination is being Commercialized with or has been the subject of
human clinical trials that included a delivery device, AstraZeneca shall [ *
]. In particular, if such device was a proprietary AstraZeneca device, then
for the purposes of the above sentence, AstraZeneca shall [ * ]. If such
device was a Third Party device, then AstraZeneca shall [ * ].






	 	20.7.4	 	Manufacturing. Upon termination of this Agreement in whole or in part by
AstraZeneca pursuant to Sections 20.2 or 20.3 or by Dynavax pursuant to Section 20.4,
AstraZeneca shall immediately provide to Dynavax copies of process and manufacturing
technology, material and data sufficient to enable Dynavax concurrently to produce and
supply any Product or Combination Product that was being Commercialized. AstraZeneca
shall provide reasonable assistance to Dynavax to effect such transfers in an orderly
fashion and to enable Dynavax to begin manufacturing and supplying the Product






 




			
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	 	 	 	and/or
Combination Product as soon as possible to minimize any disruption in the continuity of
supply.






	20.8	 	Survival. The following provisions shall survive the expiration or termination of
this Agreement: Articles 1, 2, 13, 19, 23 through 28, 30, 31 and 32 and Sections 3.8, 7.3,
10.14, 18.5, 20.7 and 20.8, together with any sections referenced in such surviving provisions
or necessary to give them effect. Termination of this Agreement shall not relieve the Parties
of any liability that accrued hereunder prior to the effective date of such termination.
Termination of this Agreement shall not preclude either Party from pursuing all rights and
remedies it may have hereunder or at law or in equity with respect to any breach of this
Agreement nor prejudice either Party’s right to obtain performance of any obligation.
	 
	20.9	 	Rights in Bankruptcy. All rights and licences granted under or pursuant to this
Agreement by Dynavax are, and shall otherwise be deemed to be, for purposes of Section 365(n)
of the U.S. Bankruptcy Code or analogous provisions of Applicable Law outside the United
States, licences of right to “intellectual property” as defined under Section 101 of the U.S.
Bankruptcy Code or analogous provisions of Applicable Law outside the United States
(hereinafter “IP”). The Parties agree that each of the Parties, as licensee of such rights
under this Agreement, shall retain and may fully exercise all of its rights and elections
under the U.S. Bankruptcy Code or any other provisions of Applicable Law outside the United
States that provide similar protection for IP. The Parties further agree that, in the event
of the commencement of a bankruptcy proceeding by or against Dynavax on the one hand, or
AstraZeneca on the other hand, under the U.S. Bankruptcy Code or analogous provisions of
Applicable Law outside the United States, AstraZeneca or Dynavax, as applicable, shall be
entitled to a complete duplicate of (or complete access to, as appropriate) any such IP and
all embodiments of such IP, which, if not already in such Party’s possession, shall be
promptly delivered to it upon such Party’s written request therefor.
	 
	21	 	Force Majeure
	 
	21.1	 	In this Agreement, “Force Majeure” means an event which is beyond a non-performing Party’s
reasonable control, including an act of God, act of the other Party,






 




			
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	 	 	strike, lock-out or other
industrial/labour dispute (whether involving the workforce of the Party so prevented or of any
other Person), war, riot, civil commotion, terrorist act, malicious damage, epidemic,
quarantine, fire, flood, earthquake, storm, natural
disaster or compliance with any law or governmental order, rule, regulation or direction
(including changes in the requirements of the health authorities), whether or not it is
later held to be invalid. Notwithstanding the foregoing, the payment of invoices due and
owing hereunder shall not be delayed by the payer because of a Force Majeure affecting the
payer, unless such Force Majeure specifically precludes the payment process.
	 
	21.2	 	The Force Majeure Party shall, within [ * ] days of the occurrence of a Force Majeure
event, give notice in writing to the other Party specifying the nature and extent of the event
of Force Majeure, its anticipated duration and any action being taken to avoid or minimize its
effect. Subject to providing such notice and to Section 21.1, the Force Majeure Party shall
not be liable for delay in performance or for non-performance of its obligations under this
Agreement, in whole or in part, nor shall the other Party have the right to terminate this
Agreement, except as otherwise provided in this Agreement, where non-performance or delay in
performance has resulted from an event of Force Majeure. The suspension of performance
allowed hereunder shall be of no greater scope and no longer duration than is reasonably
required.
	 
	21.3	 	The Force Majeure Party shall use reasonable endeavours, without being obligated to incur any
expenditure or cost, to bring the Force Majeure event to a close or to find a solution by
which this Agreement may be performed despite the continuation of the event of Force Majeure.
	 
	21.4	 	If the Force Majeure Party is prevented from performing its obligations due to a Force
Majeure event for a continuous period in excess of [ * ] days after the date of the
occurrence of the Force Majeure event, and such failure to perform would constitute a material
breach of this Agreement in the absence of such Force Majeure event, the Parties shall meet
and discuss in good faith any amendments to this Agreement to permit the other Party to
exercise its rights under this Agreement. If the Parties are not able to agree on such
amendments within [ * ] days of commencement of such discussions and if the suspension of
performance continues, such other Party may






 




			
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	 	 	terminate this Agreement immediately by written
notice to the Force Majeure Party, in which case neither Party shall have any liability to the
other except for those rights and liabilities that accrued prior to the date of termination.
	 
	22	 	Assignment
	 
	22.1	 	Neither Party may assign its rights or, except as provided in Sections 3.5.4, 6.6 and 6.7, delegate its obligations
under this Agreement in whole or in part
without the prior written consent of the
other Party, except that a Party shall
always have the right, without such
consent, on written notice to the other
Party, assign any or all of its rights
and delegate any or all of its
obligations hereunder to any of its
Affiliates or to any successor in
interest (whether by merger,
acquisition, asset purchase or
otherwise) to all or substantially all
of the business to which this Agreement
relates. Any permitted successor of a
Party or any permitted assignee of all
of a Party’s rights under this Agreement
that has also assumed all of such
Party’s obligations hereunder in writing
shall, upon any such succession or
assignment and assumption, be deemed to
be a party to this Agreement as though
named herein in substitution for the
assigning Party, whereupon the assigning
Party shall cease to be a party to this
Agreement and shall cease to have any
rights or obligations under this
Agreement. All validly assigned rights
of a Party shall inure to the benefit of
and be enforceable by, and all validly
delegated obligations of such Party
shall be binding on and be enforceable
against, the permitted successors and
assigns of such Party. Any attempted
assignment or delegation in violation of
this Article 22 shall be void.
	 
	23	 	Severability
	 
	 	 	To the fullest extent permitted by applicable law, the Parties waive any provision of law
that would render any provision of this Agreement invalid, illegal or unenforceable in any
respect. If any provision of this Agreement is held to be invalid, illegal or unenforceable,
in any respect, then such provision will be given no effect by the Parties and shall not
form part of this Agreement. To the fullest extent permitted by Applicable Law and if the
rights or obligations of any Party will not be materially and adversely affected all other
provisions of this Agreement shall remain in full force and effect, and the Parties shall
use their best efforts to negotiate a provision in replacement of the provision held
invalid, illegal or unenforceable that is consistent






 




			
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	 	 	with Applicable Law and achieves, as
nearly as possible, the original intention of the Parties.
	 
	24	 	Dispute Resolution.
	 
	24.1	 	Disputes. The Parties recognize that disputes as to certain matters may from time to
time arise during the Term which relate to either Party’s rights and/or obligations hereunder.
It is the objective of the Parties to establish procedures to facilitate the resolution of
disputes arising under this Agreement in an expedient manner by mutual cooperation and without
resort to litigation. To accomplish this objective, the Parties agree to follow the
procedures set forth in this Article 24 if and when a dispute arises under this Agreement. In
the event of any disputes, controversies or differences which may arise between the Parties,
out of or in relation to or in connection with this Agreement, or for the breach thereof, upon
the request of either Party, the Parties agree to meet and discuss in good faith a possible
resolution thereof, which good faith efforts shall include at least one in-person meeting
between representatives of each Party having decision-making authority (subject only to Board
of Directors’ or equivalent approval, if required). All such discussions under this Section
shall be confidential and shall be treated as compromise and settlement negotiations for
purposes of applicable rules of evidence. If the matter is not resolved within [ * ] days
following the request for discussions, either Party may then invoke the provisions of Section
24.2 below.
	 
	24.2	 	Arbitration. Any dispute, controversy or claim arising out of or relating to the
validity, construction, interpretation, enforceability, breach, performance, application or
termination of this Agreement that is not resolved pursuant to Section 24.1, except for a
dispute, claim or controversy under Section 24.13, shall be settled by binding arbitration
administered by JAMS pursuant to its Comprehensive Arbitration Rules and Procedures of JAMS
then in effect (the “JAMS Rules”), except as otherwise provided herein. The arbitration shall
be governed by the United States Federal Arbitration Act, 9 U.S.C. §§ 1-16 (the “Federal
Arbitration Act”), to the exclusion of any inconsistent state laws. The arbitration will be
conducted in Wilmington, Delaware and the Parties consent to the personal jurisdiction of the
United States federal courts, for any case arising out of or otherwise related to this
arbitration, its conduct and its enforcement. The language used in the arbitration
proceedings shall






 




			
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	 	 	be English. Any situation not expressly covered by this Agreement shall be
decided in accordance with the JAMS Rules.
	 
	24.3	 	Arbitrator.
	 
	 	 	The arbitrator shall be one (1) neutral, independent and impartial arbitrator selected
from a pool of retired federal judges to be presented to the Parties by JAMS. Failing the
agreement of the Parties as to the selection of the arbitrator within thirty (30) days, the
arbitrator shall be appointed by JAMSin accordance with the JAMS Rules.
	 
	24.4	 	Governing Law. Resolution of all disputes arising out of or related to this
Agreement or the validity, construction, interpretation, enforcement, breach, performance,
application or termination of this Agreement and any remedies relating thereto, shall be
governed by and construed under the substantive laws of the State of Delaware, excluding any
conflicts or choice of law rule or principle that might otherwise refer construction or
interpretation of this Agreement to the substantive law of another jurisdiction.
	 
	24.5	 	Decision. The power of the arbitrator to fashion procedures and remedies within the
scope of this Agreement is recognized by the Parties as essential to the success of the
arbitration process. The arbitrator shall not have the authority to fashion remedies which
would not be available to a federal judge hearing the same dispute. The arbitrator is
encouraged to operate on this premise in an effort to reach a fair and just decision. Reasons
for the arbitrator’s decisions should be complete and explicit, including all determinations
of law and fact. The written reasons should also include the basis for any damages awarded
and a statement of how the damages were calculated. Such a written decision shall be rendered
by the arbitrator following a full comprehensive hearing, no later than [ * ] months
following the selection of the arbitrator as provided for in Section 24.3.
	 
	24.6	 	Award.






	 	24.6.1	 	Any award shall be paid in U.S. dollars free of any tax, deduction or offset; and any
costs, fees or taxes incident to enforcing the award shall, to the maximum extent
permitted by law, be charged against the Party resisting enforcement.






 




			
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	 	24.6.2	 	If as to any issue the arbitrator should determine under the applicable law that the
position taken by a Party is frivolous or otherwise irresponsible or that any
wrongdoing they find is in callous disregard of law and equity or the rights of
the other Party, the arbitrator shall also award an appropriate allocation of the
adversary’s reasonable attorney fees, costs and expenses to be paid by the offending
Party, the precise sums to be determined after a bill of attorney fees, expenses and
costs consistent with such award has been presented following the award on the
merits.
	 
	 	24.6.3	 	Each Party agrees to abide by the award rendered in any arbitration conducted
pursuant to this Article 24, and agrees that, subject to the Federal Arbitration Act,
judgment may be entered upon the final award in the Federal District Court in Delaware
and that other courts may award full faith and credit to such judgment in order to
enforce such award.
	 
	 	24.6.4	 	The award shall include interest from the date of any damages incurred for breach of
the Agreement, and from the date of the award until paid in full, at a rate fixed by
the arbitrator.
	 
	 	24.6.5	 	With respect to money damages, nothing contained herein shall be construed to permit
the arbitrator or any court or any other forum to award punitive or exemplary damages.
By entering into this agreement to arbitrate, the Parties expressly waive any claim for
punitive or exemplary damages. The only damages recoverable under this Agreement are
compensatory damages (including, without limitation, consequential damages).






	24.7	 	Costs. Except as set forth in Section 24.6.2, each Party shall bear its own legal
fees. The arbitrator shall assess his or her costs, fees and expenses against the Party
losing the arbitration unless he or she believes that neither Party is the clear loser, in
which case the arbitrator shall divide his or her fees, costs and expenses according to his or
her sole discretion.
	 
	24.8	 	Injunctive Relief. Provided a Party has made a sufficient showing under the rules
and standards set forth in the Federal Rules of Civil Procedure and applicable case law, the
arbitrator shall have the freedom to invoke, and the Parties agree to abide by, injunctive
measures after either Party submits in writing for arbitration claims






 




			
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	 	 	requiring immediate
relief. Nothing in this Article 24 will preclude either Party from seeking equitable relief in
accordance with Article 32 or interim or provisional relief from a court of competent
jurisdiction,
including a temporary restraining order, preliminary injunction or other interim equitable
relief, concerning a dispute either prior to or during any arbitration if necessary to
protect the interests of such Party or to preserve the status quo pending the arbitration
proceeding.
	 
	24.9	 	Confidentiality. The arbitration proceeding shall be confidential and the arbitrator
shall issue appropriate protective orders to safeguard each Party’s Confidential Information.
Except as required by law, no Party shall make (or instruct the arbitrator to make) any public
announcement with respect to the proceedings or decision of the arbitrator without prior
written consent of the other Party. The existence of any dispute submitted to arbitration,
and the award, shall be kept in confidence by the Parties and the arbitrator, except as
required in connection with the enforcement of such award or as otherwise required by
applicable law.
	 
	24.10	 	Survivability. Any duty to arbitrate under this Agreement shall remain in effect
and be enforceable after termination of the contract for any reason.
	 
	24.11	 	Jurisdiction. For the purposes of this Article 24, the parties acknowledge their
diversity (AstraZeneca having its principal places of business in Sweden and the UK and
Dynavax having its principal place of business in California) and agree to accept the
jurisdiction of the Federal District Court in Delaware for the purposes of enforcing or
appealing any awards entered pursuant to this Article 24 and for enforcing the agreements
reflected in this Article 24 and agree not to commence any action, suit or proceeding related
thereto except in such courts.
	 
	24.12	 	Patents and Trademarks. Any dispute, controversy or claim relating to the
scope, validity, enforceability or infringement of any Patent rights covering the manufacture,
use, importation, offer for sale or sale of the Product or any Combination Product or of any
AstraZeneca trademarks, Dynavax trademarks, or trademark rights related to the Product or any
Combination Product shall be submitted to a court of competent jurisdiction in the country in
which such Patent or trademark rights were granted or arose.






 




			
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	24.13	 	Provisions Unique to Arbitrations Pursuant to Section 8.10. Notwithstanding
anything to the contrary in this Article 24, if the arbitration is commenced pursuant to
Section 8.10 in connection with a dispute regarding whether either Party has met its diligence
obligations, then such arbitration shall be conducted by the arbitrator selected pursuant to
Section 24.3 together with two experts having at least ten (10) years of experience in drug
discovery or development, either in a commercial setting or as a full time faculty member at a
university or medical institute (the “Expert”). One such Expert shall be selected by
AstraZeneca and the other Expert shall be selected by Dynavax. Such Experts shall
participate in the arbitration solely as advisors and shall not assume any of the
authority of the arbitrator.
	 
	25	 	Notices
	 
	25.1	 	Notice Requirements. Any notice, request, demand, waiver, consent, approval or other
communication permitted or required under this Agreement shall be in writing and shall be
deemed given only if delivered by hand or sent by facsimile transmission (with transmission
confirmed) or by internationally recognised overnight delivery service that maintains records
of delivery, addressed to the Parties at their respective addresses specified in Section 25.2
or to such other address as the Party to whom notice is to be given may have provided to the
other Party in accordance with this Article 25. Such notice shall be deemed to have been
given as of the date delivered by hand or transmitted by facsimile (with transmission
confirmed) or on the second business day (at the place of delivery) after deposit with an
internationally recognised overnight delivery service. Any notice delivered by facsimile
shall be confirmed by a hard copy delivered as soon as practicable thereafter. This Article
25 is not intended to govern the day-to-day business communications necessary between the
Parties in performing their obligations under the terms of this Agreement.
	 
	25.2	 	Address for Notice





	 	 	 	 	 	 	 
	 

	 	For :
	 	AstraZeneca AB	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	Address:
	 	AstraZeneca R&D Lund,
	 

	 	 	 	 	 	Schelegatan 10
	 

	 	 	 	 	 	Sweden
	 
	 	 	 	 	 	 
	 

	 	 	 	Facsimile:
	 	[ * ]






 




			
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	 	 	For the attention of: Director Discovery Alliances
	 
	 	 	 	 
	With a copy to:	 	AstraZeneca UK Limited
	 

	 	Address:
	 	Alderley House, Alderley Park, Macclesfield, Cheshire SK10 4TF
	 

	 	Facsimile:
	 	[ * ]
	 	 	For the attention of: Assistant General Counsel
	 
	 	 	 	 
	For:	 	Dynavax Pharmaceuticals, Inc.

2929 Seventh Street

Suite 100

Berkeley, CA 94710-2753

Fax: [ * ]

Attn: D. Kevin Kwok, Vice President & Chief Business Officer
	 
	 	 	 	 
	With a copy to:
	 	 	 	 
	 	 	Cooley Godward LLP

Five Palo Alto Square

3000 El Camino Real

Palo Alto, CA 94306-2155

Fax: [ * ]

Attention: Robert L. Jones, Esq.







	26	 	Relationship of the Parties
	 
	 	 	The status of a Party under this Agreement shall be that of an independent contractor.
Nothing contained in this Agreement shall be construed as creating a partnership, joint
venture or agency relationship between the Parties or, except as otherwise expressly
provided in this Agreement, as granting either Party the authority to bind or contract any
obligation in the name of or on the account of the other Party or to make any
statements, representations, warranties or commitments on behalf of the other Party. All
persons employed by a Party shall be employees of such Party and not of the other Party and
all costs and obligations incurred by reason of any such employment shall be for the account
and expense of such Party.






 




			
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	27	 	Entire Agreement
	 
	 	 	This Agreement constitutes the entire agreement between the Parties with respect to the
subject matter of this Agreement. This Agreement supersedes all prior agreements, whether
written or oral, with respect to the subject matter of this Agreement. In particular, this
Agreement supersedes the Confidentiality Agreement between the Parties, effective 12 October
2004, and all confidential information exchanged between the Parties under such
Confidentiality Agreement shall be deemed the Confidential Information of the corresponding
Party and protected under this Agreement. Each Party confirms that it is not relying on any
representations, warranties or covenants of the other Party except as specifically set out
in this Agreement. Nothing in this Agreement is intended to limit or exclude any liability
for fraud. All Schedules and Exhibits referred to in this Agreement are intended to be and
are hereby specifically incorporated into and made a part of this Agreement. In the event of
any inconsistency between any such schedules or Exhibits and this Agreement, the terms of
this Agreement shall govern.
	 
	28	 	English Language
	 
	 	 	This Agreement is written and executed in the English language. Any translation into any
other language shall not be an official version of this Agreement and in the event of any
conflict in interpretation between the English version and such translation, the English
version shall prevail.
	 
	29	 	Amendment
	 
	 	 	Any amendment or modification of this Agreement must be in writing and signed by authorised
representatives of both Parties.
	 
	30	 	Waiver and Non-Exclusion of Remedies
	 
	 	 	A Party’s failure to enforce, at any time or for any period of time, any provision of this
Agreement, or to exercise any right or remedy shall not constitute a waiver of that
provision, right or remedy or prevent such Party from enforcing any or all provisions of
this Agreement and exercising any rights or remedies. To be effective any waiver must be in
writing. The rights and remedies provided herein are cumulative and do






 




			
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	 	 	not exclude any
other right or remedy provided by law or otherwise available except as expressly set forth
herein.
	 
	31	 	No Benefit to Third Parties
	 
	 	 	The provisions of this Agreement are for the sole benefit of the Parties and their
successors and permitted assigns, and they shall not be construed as conferring any rights
in any other Persons except as otherwise expressly provided Article 22.
	 
	 	 	The Contracts (Rights of Third Parties) Act 1999 shall not apply to this Agreement. Except
as expressly provide in Article 22, no Person who is not a party to this Agreement
(including any employee, officer, agent, representative or subcontractor of either Party)
shall have the right (whether under the Contracts (Rights of Third Parties) Act 1999 or
otherwise) to enforce any term of this Agreement which expressly or by implication confers a
benefit on that Person without the express prior agreement in writing of the Parties, which
agreement must refer to this Article 31.
	 
	32	 	Equitable Relief
	 
	 	 	Each Party acknowledges and agrees that the restrictions set forth in this Agreement are
reasonable and necessary to protect the legitimate interests of the other Party and that
neither Party would have entered into this Agreement in the absence of such restrictions,
and that any breach or threatened breach of any provision of this Agreement may result in
irreparable injury to the non-breaching Party for which there will be no adequate remedy at
law. In the event of a breach or threatened breach of any provision of this Agreement, the
non-breaching Party shall be authorised and entitled to obtain from any court of competent
jurisdiction equitable relief, whether preliminary or permanent, specific performance and an
equitable accounting of all
earnings, profits and other benefits arising from such breach, which rights shall be
cumulative and in addition to any other rights or remedies to which such non-breaching Party
may be entitled in law or equity. Each of Dynavax and AstraZeneca agrees to waive any
requirement that the non-breaching Party (a) post a bond or other security as a condition
for obtaining any such relief, and (b) show irreparable harm, balancing of harms,
consideration of the public interest or inadequacy of monetary damages as a remedy. Nothing
in this Article 32 is intended, or should be construed,






 




			
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Page 102 of 104


	 	 	to limit a non-breaching Party’s
right to equitable relief or any other remedy for a breach of any other provision of this
Agreement, provided, however, that resolution of disputes between the Parties is subject to
the provisions of Article 24.
	 
	33	 	Further Assurance
	 
	33.1	 	Each Party shall perform all further acts and things and execute and deliver such further
documents as may be necessary or as the other Party may reasonably require to implement or
give effect to this Agreement.
	 
	33.2	 	The Parties recognize that each may perform some or all of its obligations and exercise any
or all of its rights under this Agreement, without the prior consent of the other Party,
through Affiliates or Sublicensees, provided, however, that each Party shall remain
responsible for the performance by its Affiliates and Sublicensees and shall cause its
Affiliates and Sublicensees to comply with the provisions of this Agreement in connection with
such performance. In particular, if any Affiliate of a Party or a Sublicensee participates in
research under this Agreement or with respect to the Product or any Combination Product(s),
(a) the restrictions of this Agreement which apply to the activities of a Party with respect
to a CD, the Product or any Combination Product(s) shall apply equally to the activities of
such Affiliate and Sublicensee, and (b) the Party affiliated with such Affiliate or
Sublicensee shall assure that any intellectual property developed by such Affiliate or
Sublicensee shall be governed by the provisions of this Agreement (and subject to the licenses
set forth in Article 6) as if such intellectual property had been developed by the Party. Any
action or omission by a Party’s Affiliate or a Sublicensee which would, if such action or
omission were conducted by the Party, constitute a breach of the Party’s obligations under
this Agreement will constitute a breach of such obligation by the
Party (unless such obligation
were otherwise satisfied by such
Party or another of its
Affiliates or Sublicensees).
	 
	34	 	Expenses
	 
	 	 	Except as otherwise expressly provided in this Agreement, each Party shall pay the fees and
expenses of its respective lawyers and all other expenses and costs incurred






 




			
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Page 103 of 104


	 	 	by such Party
incidental to the negotiation, preparation, execution and delivery of this Agreement.
	 
	35	 	Counterparts
	 
	 	 	This Agreement may be executed in any number of counterparts, each of which shall be deemed
an original and all of which taken together shall be deemed to constitute one and the same
instrument. An executed signature page of this Agreement delivered by facsimile
transmission shall be as effective as an original executed signature page.






 




			
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Page 104 of 104

THIS AGREEMENT IS EXECUTED by the authorised representatives of the Parties, in duplicate, as of
the date first written above.




	 	 	 	 	 	 	 	 	 	 	 
	SIGNED for and on behalf of	 	 	 	SIGNED for and on behalf of	 	 
	AstraZeneca AB (publ)	 	 	 	Dynavax Technologies Corporation	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	/s/ Jan M Lundberg	 	 	 	/s/ Dino Dina	 	 
	 	 	 	 	 	 	 
	Signature	 	 	 	Signature	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Name:

	 	Jan M Lundberg
	 	 	 	Name:
	 	Dino Dina, M.D.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Title:

	 	EVP, Global Discovery
	 	 	 	Title:
	 	President and CEO	 	 






 




			
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Exhibit A




Criteria for Candidate Drug Target Profile




[ * ]




 




			
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Exhibit B




Dynavax Patents




Exhibit B(1)




[ * ]




 




			
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Exhibit B(2)




[ * ]




 




			
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Exhibit C




Joint Research Plan




Description of Joint Research




[ * ]




 




			
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HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
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Exhibit D




Pre-Approved Dynavax Subcontractors




[ * ]




 




			
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Exhibit E




Press Release




	 	 	 
	 

	 	
	 

	 	2929 Seventh Street, Suite 100
	 

	 	Berkeley, CA 94710






Contact:




Dynavax Technologies Corporation




Jane M. Green, PhD




Corporate Communications

Phone (510) 665-4630




Email: jgreen@dvax.com




DYNAVAX ESTABLISHES COLLABORATION FOR




TLR-9 AGONISTS FOR ASTHMA AND COPD WITH ASTRAZENECA



Berkeley, CA — [Date] — Dynavax Technologies Corporation (NASDAQ:DVAX) has entered into an a
three-year research collaboration and a License agreement with AstraZeneca for the discovery and
development of TLR-9 agonist-based therapies for the treatment of asthma and chronic obstructive
pulmonary disease (COPD). The collaboration will utilize Dynavax’s proprietary second-generation
TLR-9 agonist immunostimulatory sequences or ISS.



Under the terms of the agreement, Dynavax and AstraZeneca will collaborate to identify lead TLR-9
agonists and conduct appropriate research phase studies. AstraZeneca will be responsible for any
development and worldwide commercialisation of products arising out of the research programme.
Dynavax may have an opportunity for partial co-promotion in the United States of products arising
from the collaboration.



Financial terms of the collaboration include an upfront fee of $10 million plus research funding
and preclinical milestones that could bring the total committed funding of up to $20 million..
Dynavax may also receive additional development milestones potentially resulting in a collaboration
value of up to approximately $129 million.. Upon commercialization, Dynavax is also eligible to
receive royalties based on product sales.



“The management of respiratory diseases such as asthma and COPD remains a major health
challenge affecting 150 million people worldwide and representing a significant financial




 




			
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24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.










 



 



burden to the global healthcare system,” said Claude Bertrand, Vice President Respiratory and
Inflammation Research at AstraZeneca. “New approaches that have the potential to reverse the course
of respiratory disease are needed. AstraZeneca believes that Dynavax’s ISS-based technology
represents an innovative, next-generation therapeutic intervention that could potentially expand
and strengthen AstraZeneca’s strong position in the respiratory disease field.”



“We believe that AstraZeneca is the ideal partner for the development of asthma and COPD ISS-based
therapies, as they have one of the most widely respected and commercially successful respiratory
product portfolios in the industry,” said Dino Dina, MD, Dynavax’s chief executive officer. “We
appreciate AstraZeneca’s recognition of the innovative, disease-modifying potential of our TLR-9
agonist based approaches and are optimistic that with our combined resources and know-how, we will
be able to create novel therapeutics that may provide benefit to patients suffering from these
diseases.”



Continued Dr. Dina: “We believe that the positive clinical experience we have previously
demonstrated provides a strong foundation for applying ISS-based agonists to treat asthma and COPD.
We are hopeful that this collaboration, the goal of which is to explore the potential of ISS alone
to treat respiratory diseases, will help to expand our existing portfolio of ISS-based products.”



[[Conference Call Today]]



Dynavax will hold a conference call to discuss [[ ]] today at [5:00] p.m. Eastern. Interested
parties may listen to the webcast live at http://www.dynavax.com by clicking on the “Events” tab
under the heading, “Investors.” The webcast is also being distributed over CCBN’s Investor
Distribution Network to both institutional and individual investors. Individual investors can
listen to the call through CCBN’s individual investor center at http://www.fulldisclosure.com or
by visiting any of the investor sites in CCBN’s Individual Investor Network. Institutional
investors can access the call via CCBN’s password-protected event management site, StreetEvents, at
http://www.streetevents.com. A telephonic replay will be available through [[date]] by dialing
888.286.8010, access code: xxxxxxxx. International callers can dial 617.801.6888, access code:
xxxxxxxx.



Forward Looking Statements



Dynavax cautions you that this press release contains forward-looking statements, including without
limitation [[ ]]. Actual results may differ materially from those set forth in this release due to
the risks and uncertainties inherent in Dynavax’s business including, without limitation, risks
relating to: [[ ]] the progress and timing of its current and anticipated clinical trials;
difficulties or delays in developing, testing and manufacturing products to support clinical
development plans; the scope and validity of patent protection for product candidates; competition
from other companies working with ISS technologies and products; the ability to obtain additional
financing to support operations; and other risks detailed in the “Risk Factors” section of
Dynavax’s Annual Report on Form 10-K and Quarterly Report on Form 10-Q. All forward-looking
statements are made as of the date hereof and Dynavax undertakes no obligation to revise or update
information provided in this press release.




 




			
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About Dynavax



Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR-9
agonist-based products to treat and prevent allergies, infectious diseases, and chronic
inflammatory diseases using versatile, proprietary approaches that alter immune system responses in
highly specific ways. Our clinical development programs are based on immunostimulatory sequences,
or ISS, which are short DNA sequences that enhance the ability of the immune system to fight
disease and control chronic inflammation. Dynavax’s pipeline includes: TOLAMBA, a ragweed allergy
immunotherapeutic, for which a major safety and efficacy trial (DARTT) is currently underway, and
that is in a supportive clinical trial in ragweed allergic children; HEPLISAV, a hepatitis B
vaccine that is currently in a Phase 3 clinical trial; SUPERVAX, a hepatitis B vaccine; a cancer
therapy currently in a Phase 2 clinical trial in non-Hodgkins lymphoma;[ * ]; and preclinical
programs in hepatitis B therapy and hepatitis C therapy.



About AstraZeneca



AstraZeneca is a major international healthcare business engaged in the research, development,
manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services.
It is one of the world’s leading pharmaceutical companies with healthcare sales of $23.95 billion
and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory,
oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index
(Global) as well as the FTSE4Good Index.




 




			
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Exhibit F




CONFIRMATORY PATENT LICENCE




Patent Licence Agreement




Date:




Parties:




(1) ‘The Licensor’:                      having its registered office at                     .




(2) ‘The Licensee’:                      having its registered office at                     .




Recitals:



By an Agreement (‘the Main Agreement’) dated                      and made between the Licensor and
the Licensee the Licensor granted for the consideration therein contained to the Licensee a licence
under [UK Patent No                     ] [European Patent (UK) No                     ] (‘the Patent’).




Operative provisions:





	1.	 	In pursuance of the Main Agreement and for the consideration referred to in the Main
Agreement the Licensor hereby confirms the grant to the Licensee of the exclusive licence from
the Effective Date for the term specified in the Main Agreement to manufacture, market, sell
and otherwise dispose of Licensed Products (as defined in the Main Agreement) for the life of
the Patent and subject to the provisions of the Main Agreement.






	2.	 	Subject as provided in the Main Agreement this Licence shall terminate without notice in the
event of the termination for any reason of the Main Agreement.






 




			
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IN WITNESS of which this Agreement has been executed as a deed and delivered the day and year first
above written.




EXECUTED as a Deed by                      acting by:




[name of director] and:




[name of director/secretary]




EXECUTED as a Deed by                      acting by:




[name of director] and:




[name of director/secretary]





 




			
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Schedule 18.2.5




[ * ]





 




			
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Schedule 18.2.6




[ * ]






 




			
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HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
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