|
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2
OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Exhibit 10.30
RESEARCH COLLABORATION AND LICENSE
AGREEMENT
by and between
ASTRAZENECA AB
and
DYNAVAX TECHNOLOGIES CORPORATION
DATE: 1 September 2006
| |
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[ * ]
|
=
|
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
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Table of Contents
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Page
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1.
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Definitions
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2
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2.
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Construction
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17
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3.
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Conduct of the Joint Research
Programme
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17
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3.1
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Overview
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17
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3.2
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Research Term
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18
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3.3
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Joint Research Plan
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18
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3.4
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Research Effort and Support
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18
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3.5
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Conduct of Research
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19
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3.6
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Materials and Information Transfer
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21
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3.7
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Cooperation
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22
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3.8
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Regulatory Records
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22
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3.9
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Reports
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22
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3.10
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Lead Candidate Development Decision
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23
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3.11
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CD Nomination
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23
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3.12
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Overview of Joint Research Programme
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23
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3.13
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Selection of Compounds
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23
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4.
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Support and Management of the Joint Research
Programme
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24
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4.1
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Overview of the Management of the Joint Research
Programme
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24
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4.2
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Responsibilities of JPT
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24
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4.3
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Formation of JPT
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25
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4.4
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JPT Meetings
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26
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4.5
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JPT Decision Making : Disputes
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26
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4.6
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JPT Minutes
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26
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4.7
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Dissolution of JPT
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27
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4.8
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Responsibilities of JSC
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27
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4.9
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Formation of JSC
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28
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4.10
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JSC Decision Making : Disputes
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29
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4.11
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JSC Decisions Requiring Consent
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29
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[ * ]
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=
|
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.
|
(ii)
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Table of Contents
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Page
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4.12
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JSC Meetings
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29
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4.13
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JSC Minutes
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30
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4.14
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Dissolution of JSC
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30
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4.15
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Advisory Board
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30
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4.15
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Expenses
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31
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4.17
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Access to Information
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31
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4.18
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Joint Research Programme Guidelines
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31
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5.
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Reports
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31
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5.1
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Joint Research Programme Progress
Reports
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31
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5.2
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Copyrights
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32
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5.3
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AstraZeneca Reports
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32
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6.
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Ownership and Grant of Rights
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32
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6.1
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Ownership of Collaboration Technology
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32
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6.2
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Licences to AstraZeneca
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32
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6.3
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Licence to Dynavax
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33
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6.4
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Third Party Licences
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34
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6.5
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Exclusivity
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35
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6.6
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Sublicences
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37
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6.7
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Distributors
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37
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6.8.
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Confirmatory Patent Licences
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38
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7.
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Research Funding
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38
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7.1
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Funding
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38
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7.2
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Invoices; Reconciliation
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38
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7.3
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Records Retention; Audit
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39
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7.4
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Projected Cost Reports
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40
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8.
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Development and
Commercialization
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40
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8.1
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Overview
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40
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8.2
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Development of Product
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40
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8.3
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Regulatory Affairs and Information
Exchange
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41
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8.4
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Commercialization of Product and Combination
Product
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43
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8.5
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Dynavax Option to Co-Promote in the United
States
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43
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8.6
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Pricing, Price Approvals and Product
Distribution
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44
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[ * ]
|
=
|
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.
|
(iii)
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Table of Contents
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Page
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8.7
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Sales and Inventory
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44
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8.8
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Advertising and Education
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44
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8.9
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Development and Commercialization
Costs
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45
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8.10
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Diligence Obligations
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45
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8.11
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Breach of Diligence Obligations
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47
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8.12
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Reversion; Abandonment
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47
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9.
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Milestone Payments
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48
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9.1
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Total Obligation
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48
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9.2
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Access Fee
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48
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9.3
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Joint Research Programme Milestones
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49
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9.4
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Development Milestones
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49
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9.5
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Milestone Payments
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49
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10.
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Royalty Payments and Other Payment-Related
Provisions
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50
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10.1
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Royalties
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50
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10.2
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Combination Products
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50
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10.3
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Sublicensees
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51
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10.4
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Royalty Stacking
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52
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10.5
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[ * ] Royalty and [ * ]
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52
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10.6
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Reduction of Royalty
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53
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10.7
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Royalty Floor
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54
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10.8
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Royalty Term
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54
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10.9
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Sales Subject to Royalties
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55
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10.10
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Royalty Payments
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55
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10.10
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Mode of Payment
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55
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10.12
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Currency
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56
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10.13
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Interest
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56
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10.14
|
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Records Retention; Audit
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56
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11.
|
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Taxes
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|
57
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11.1
|
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General
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57
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11.2
|
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Indirect Taxes
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57
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11.3
|
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Customs Duties
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58
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12.
|
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Manufacture and Supply
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58
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| |
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[ * ]
|
=
|
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.
|
(iv)
|
|
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|
Table of Contents
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Page
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12.1
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Preclinical Supply
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58
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12.2
|
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Clinical and Commercial Supply
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58
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12.3
|
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Manufacturing Know-How Transfer
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59
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13.
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Confidentiality and
Non-Disclosure
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59
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13.1
|
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General Obligations
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59
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13.2
|
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Permitted Disclosures
|
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60
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13.3
|
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Exclusions
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62
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13.4
|
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Confidentiality of Agreement
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|
63
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13.5
|
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Publications and Presentations
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63
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13.6
|
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Use of Name/Publicity.
|
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64
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14.
|
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Patent Prosecution, Enforcement and
Defence
|
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65
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14.1
|
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Disclosure
|
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65
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|
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14.2
|
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Patent Prosecution and Maintenance
|
|
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65
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|
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14.3
|
|
Patent Term Restoration
|
|
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67
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14.4
|
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Enforcement of Patent Rights
|
|
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67
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|
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14.5
|
|
Third Party Litigation
|
|
|
69
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14.6
|
|
Invalidity or Unenforceability Defences or
Actions
|
|
|
70
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14.7
|
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Cooperation
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|
|
71
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14.8
|
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Compliance with Third Party Licences
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|
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71
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14.9
|
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Costs and Expenses
|
|
|
72
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15.
|
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Adverse Event Reporting
|
|
|
72
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15.1
|
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Overview
|
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72
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16.
|
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Product Recall
|
|
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73
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16.1
|
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Notification and Recall
|
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73
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16.2
|
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Recall Expenses
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73
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17.
|
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Trademarks
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74
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18.
|
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Representations and Warranties
|
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74
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19.
|
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Indemnification and Insurance
|
|
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79
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19.1
|
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Indemnification of Dynavax
|
|
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79
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19.2
|
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Indemnification of AstraZeneca
|
|
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79
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19.3
|
|
[ * ]
|
|
|
|
|
| |
|
|
|
[ * ]
|
=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
|
(v)
|
|
|
|
|
|
|
|
|
Table of Contents
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|
Page
|
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19.4
|
|
Notice of Claim
|
|
|
80
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|
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19.4
|
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Indemnification Procedures
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|
|
81
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19.5
|
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LIMITATION ON DAMAGES
|
|
|
83
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19.6
|
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Insurance
|
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83
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20.
|
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Term and Termination
|
|
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83
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20.1
|
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Term
|
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83
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20.2
|
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Termination by AstraZeneca
|
|
|
84
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20.3
|
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Termination for Infringement of Third Party
Rights
|
|
|
84
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20.4
|
|
Termination by Dynavax for Lack of
Diligence
|
|
|
85
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20.5
|
|
Termination by Either Party
|
|
|
85
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20.6
|
|
Change of Control
|
|
|
87
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20.7
|
|
Consequences of Termination
|
|
|
87
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|
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20.8
|
|
Survival
|
|
|
91
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20.9
|
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Rights in Bankruptcy
|
|
|
91
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21.
|
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Force Majeure
|
|
|
91
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22.
|
|
Assignment
|
|
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93
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23.
|
|
Severability
|
|
|
93
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|
|
|
|
|
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|
|
24.
|
|
Dispute Resolution
|
|
|
94
|
|
|
24.1
|
|
Disputes
|
|
|
94
|
|
|
24.2
|
|
Arbitration
|
|
|
94
|
|
|
24.3
|
|
Arbitrator
|
|
|
95
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|
|
24.4
|
|
Governing Law
|
|
|
95
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|
|
24.5
|
|
Decision
|
|
|
95
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|
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24.6
|
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Award
|
|
|
95
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|
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24.7
|
|
Costs
|
|
|
96
|
|
|
24.8
|
|
Injunctive Relief
|
|
|
96
|
|
|
24.9
|
|
Confidentiality
|
|
|
97
|
|
|
24.10
|
|
Survivability
|
|
|
97
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|
24.11
|
|
Jurisdiction
|
|
|
97
|
|
|
24.12
|
|
Patents and Trademarks
|
|
|
97
|
|
|
24.13
|
|
Provisions Unique to Arbitrations Pursuant to
Section 8.10
|
|
|
98
|
|
|
|
|
|
|
|
|
|
|
25.
|
|
Notices
|
|
|
98
|
|
| |
|
|
|
[ * ]
|
=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
|
(vi)
|
|
|
|
|
|
|
|
|
Table of Contents
|
|
Page
|
|
25.1
|
|
Notice Requirements
|
|
|
98
|
|
|
25.2
|
|
Address for Notice
|
|
|
98
|
|
|
|
|
|
|
|
|
|
|
26.
|
|
Relationship of the Parties
|
|
|
99
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|
|
27.
|
|
Entire Agreement
|
|
|
100
|
|
|
|
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|
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28.
|
|
English Language
|
|
|
100
|
|
|
|
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|
|
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|
|
29.
|
|
Amendment
|
|
|
100
|
|
|
|
|
|
|
|
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|
|
30.
|
|
Waiver and Non-Exclusion of
Remedies
|
|
|
100
|
|
|
|
|
|
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|
|
|
|
31.
|
|
No Benefit to Third Parties
|
|
|
101
|
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32.
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Equitable Relief
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101
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33.
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Further Assurance
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102
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34.
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Expenses
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102
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35.
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Counterparts
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103
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[ * ]
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=
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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
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(1)
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ASTRAZENECA AB , a company incorporated
in Sweden under no. 556011-7482 with offices at S-151 85
Södertälje, Sweden (" AstraZeneca "); and
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(2)
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DYNAVAX TECHNOLOGIES CORPORATION , a
Delaware corporation with offices at 2929 Seventh Street,
Suite 100, Berkeley, CA 94710-2753, USA (" Dynavax ").
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Recitals
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(A)
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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;
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(B)
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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;
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(C)
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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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[ * ]
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=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 2 of 104
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1
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Definitions
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Unless otherwise specifically provided in this
Agreement, the following terms have the following
meanings:
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1.1
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"Advisory Board" means the committee
established and conducted according to Section 4.15.
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1.2
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" 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.
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1.3
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" Alliance Manager " means a Party’s
representative with responsibility for the activities described in
Section 4.9.
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1.4
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" Annual Net Sales " means the Net Sales
made during a given calendar year.
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1.5
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" 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.
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1.6
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"Asthma" means an inflammatory
pulmonary disorder that is characterized by reversible obstruction
of the airways.
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1.7
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" AstraZeneca Information " has the
meaning set forth in Section 13.1.2.
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1.8
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"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.
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1.9
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"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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[ * ]
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=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 3 of 104
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manufacture, importation, use or sale of Dynavax
ISS, Collaboration ISS, Reverted ISS, Product or Combination
Product(s), excluding Collaboration Patents.
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1.10
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"AstraZeneca Technology" means
AstraZeneca Patents and AstraZeneca Know-How.
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1.11
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"Background Technology" means either
the AstraZeneca Technology or the Dynavax Technology, as
appropriate and Background Technologies means the AstraZeneca
Technology and the Dynavax Technology.
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1.12
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[ * ] .
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1.13
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" 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.
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1.14
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"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 .
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1.15
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"CD Nomination" means the internal
process, known by [ * ] , by which [ * ] .
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1.16
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"CD Nomination Date" means the date
upon which a CD Nomination is made.
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1.17
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" Change of Control ," with respect to
either Party, means an event in which:
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1.17.1
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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
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1.17.2
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such Party effects a merger, consolidation or
similar transaction with another Person in which such Party is not
the surviving entity in such transaction.
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| |
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[ * ]
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=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 4 of 104
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1.19
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[ * ] .
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1.20
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"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.
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1.21
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"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.
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1.22
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" 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.
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1.23
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" 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.
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1.24
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" Collaboration Technology " means
Collaboration Patents, Collaboration Know-How and Collaboration
ISS.
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1.25
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" Combination Product " means a
pharmaceutical preparation [ * ] .
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1.26
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"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.
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1.27
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" 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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| |
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[ * ]
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=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 5 of 104
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or offering to dispose of, a Product following
Health Registration Approval of such Product in any part of the
Territory under this Agreement.
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1.28
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" 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, [ * ] .
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1.29
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" 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.
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1.30
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" 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.
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1.31
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"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.
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1.32
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|
" Defending Party " has the meaning set
forth in Section 14.7.
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1.33
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"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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| |
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[ * ]
|
=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 6 of 104
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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.
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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.
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1.35
|
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"Development Milestone" has the meaning
set forth in Section 9.4.
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1.36
|
|
" Development Plan" has the meaning set
forth in Section 8.2.
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1.37
|
|
" Disclosing Party " has the meaning set
forth in Section 13.1.1.
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1.38
|
|
" Distributor " has the meaning set forth
in Section 6.7.
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1.39
|
|
"DMF" means a Drug Master File.
|
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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.
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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.
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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.
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1.43
|
|
"Dynavax Technology" means the Dynavax
Patents, the Dynavax Know-How and Dynavax ISS.
|
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1.44
|
|
" Effective Date " means the date as set
forth in the preamble to this Agreement.
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1.45
|
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" Europe " means the European Economic
Area as it may be constituted from time to time.
|
| |
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[ * ]
|
=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
|
Page 7 of 104
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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.
|
|
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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.
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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.
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1.49
|
|
" Force Majeure " has the meaning set
forth in Section 21.1.
|
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1.50
|
|
" Force Majeure Party " means a Party
prevented or delayed in its performance under this Agreement by an
event of Force Majeure.
|
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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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| |
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[ * ]
|
=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 8 of 104
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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: [ * ] .
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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.
|
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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.
|
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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.
|
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1.55
|
|
"Governmental Authority" means any
court, agency, department or other instrumentality of any national,
federal, state, county, city or other political
subdivision.
|
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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.
|
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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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[ * ]
|
=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 9 of 104
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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.
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1.58
|
|
" Indemnification Claim Notice " has the
meaning set forth in Section 19.4.
|
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|
1.59
|
|
" Indemnified Party " means a Party
seeking to recover a Loss under Section 19.1 or
19.2.
|
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1.60
|
|
" Indemnifying Party " means a Party from
whom recovery of a Loss is sought under Section 19.1 or
19.2
|
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1.61
|
|
" Indemnitee " has the meaning set forth
in Section 19.4.
|
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|
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.
|
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|
1.63
|
|
" Indirect Taxes " means value added
taxes, sales taxes, consumption taxes and other similar
taxes.
|
|
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|
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.
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|
|
|
1.65
|
|
" Infringement Suit " has the meaning set
forth in Section 14.5.
|
| |
|
|
|
[ * ]
|
=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
|
Page 10 of 104
|
1.66
|
|
" IP " has the meaning set forth in
Section 20.9.
|
|
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|
|
|
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.
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1.68
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|
" 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.
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1.69
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|
"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.
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1.70
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|
" Joint Research Programme " means the
research programme described in the Joint Research Plan.
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1.71
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|
" Joint Research Programme Milestones "
has the meaning set forth in Section 9.3.
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1.72
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|
" 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.
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1.73
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|
"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.
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1.74
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|
"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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[ * ]
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=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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1.75
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|
"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.
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1.76
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|
"Lead Candidate Development Decision"
means the internal process, known by [ * ] , by which [ *
] .
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1.77
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|
"Lead CD" means the CD nominated by
AstraZeneca for Development and Commercialisation.
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1.78
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|
"Lead Research Candidate" means a
Dynavax ISS or Collaboration ISS that has been [ * ] for
further research.
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1.79
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|
" Losses " means any and all liabilities,
claims, demands, causes of action, damages, loss and expenses,
including interest, penalties, and reasonable lawyers’ fees
and disbursements.
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1.80
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|
"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.
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1.81
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|
" Major Markets " means [ * ]
.
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1.82
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|
"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.
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1.83
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|
" 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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[ * ]
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=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 12 of 104
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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.
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1.84
|
|
" Parties " means collectively AstraZeneca
and Dynavax and " Party " means individually either of
AstraZeneca or Dynavax.
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1.85
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|
" 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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[ * ]
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=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 13 of 104
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confirmation or introduction patent or
registration patent or patent of additions to any such foregoing
patent applications and patents.
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1.86
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|
" Payments " has the meaning set forth in
Section 11.1.
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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.
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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).
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|
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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).
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|
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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).
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1.91
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|
"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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|
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[ * ]
|
=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 14 of 104
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1.92
|
|
"Primary ISS" means, in accordance with
the Joint Research Plan, [ * ] Dynavax ISS or Collaboration ISS
selected [ * ] .
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1.93
|
|
"Primary Screening Phase" means, in
accordance with the Joint Research Plan, the [ * ] .
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1.94
|
|
" Product " means a pharmaceutical
preparation [ * ] .
|
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1.95
|
|
"Project Leader" means a Party’s
representative with responsibility for the activities set forth in
Section 4.3.
|
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|
1.96
|
|
" Prosecuting Party " has the meaning set
forth in Section 14.2.2.
|
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|
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|
1.97
|
|
" Receiving Party " has the meaning set
forth in Section 13.1.1.
|
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|
1.98
|
|
"Regents" has the meaning set forth in
Section 10.5.1.
|
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|
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|
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.
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|
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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.
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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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[ * ]
|
=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 15 of 104
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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).
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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.
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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.
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1.105
|
|
"Research Term" has the meaning set
forth in Section 3.2.
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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.
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1.107
|
|
"Round One Optimization Candidates"
means, in accordance with the Joint Research Plan, those
Collaboration ISS that are [ * ] using [ * ] .
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1.108
|
|
"Round Two Optimization Candidates"
means, in accordance with the Joint Research Plan, those
Collaboration ISS that are [ * ] , using [ * ] .
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1.109
|
|
" Royalty-Bearing Claim " means, with
respect to a Dynavax Patent or a Collaboration Patent: (a) [ *
] , or (b) [ * ] .
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1.110
|
|
"Royalty Term" has the meaning set
forth in Section 10.8.
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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.
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1.112
|
|
"Secondary Screening Phase — Stage
1" means, in accordance with the Joint Research Plan,
the [ * ] .
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[ * ]
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=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 16 of 104
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1.113
|
|
" Secondary Screening Phase — Stage
2" means, in accordance with the Joint Research Plan, the [
* ] .
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1.114
|
|
"Sequence Modify" or "Sequence
Modification" means to modify an ISS by changing, adding to, or
subtracting from the [ * ] .
|
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1.115
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|
" Sublicensee " means any Person, other
than an Affiliate or a Party, to which such Party has granted a
sublicense under this Agreement.
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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.
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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.
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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.
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1.119
|
|
" Third Party " means any Person not
including the Parties, the Parties’ respective Affiliates or
the Sublicensees.
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1.120
|
|
" Third Party Claims " has the meaning set
forth in Section 19.1.
|
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1.121
|
|
" TLR-9 " means toll-like receptor
9.
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1.122
|
|
"Triggering Event" has the meaning set
forth in Section 6.4.2.
|
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1.123
|
|
" Valid Claim " means, with respect to a
particular country, either:
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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
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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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[ * ]
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=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 17 of 104
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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.
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2
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Construction
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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.
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3
|
|
Conduct of the Joint Research
Programme
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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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[ * ]
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=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 18 of 104
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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.
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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.
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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.
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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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[ * ]
|
=
|
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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Page 19 of 104
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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 [ * ] .
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3.5
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Conduct of Research .
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3.5.1
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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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[ * ]
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=
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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equipment and skilled personnel to complete such
activities successfully and promptly.
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3.5.2
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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.
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3.5.3
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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.
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3.5.4
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Subcontracting . Each Party shall be
solely responsible for successfully completing its activities set
forth in the Joint Research Plan. The Parties shall conduct and
carry out all activities provided for under the Joint Research
Programme through its employees at the site(s) identified under
Section 3.5.2 unless and only to the extent the JSC approves
the Party’s engaging a subcontractor to carry out a portion
of such Research activities or, if applicable, approves a major
outsourcing or collaboration agreement with a Third Party.
Notwithstanding the foregoing, as of the Effective Date, each of
Dynavax and AstraZeneca have agreed that Dynavax may engage the
Persons listed on Exhibit D to perform the specified
activities of Dynavax under the Joint Research Plan. Any permitted
subcontractor shall be subject to the applicable terms and
conditions of this Agreement, including Articles 6 and 13, and,
upon a Party’s request, the other Party shall require each
such subcontractor to enter into an undertaking, pursuant to which
the terms and conditions of this Agreement shall apply directly
between such subcontractor and AstraZeneca or Dynavax, as
applicable, prior to disclosing to such subcontractor any of the
other Party’s Confidential Information; provided, however,
that the subcontracting Party shall remain ultimately responsible
for
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[ * ]
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=
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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 [ * ] .
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3.6
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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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[ * ]
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=
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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.
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3.7
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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.
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3.8
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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.
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3.9
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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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[ * ]
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=
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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3.10
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Lead Candidate Development Decision
.
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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.
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3.11
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CD Nomination .
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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.
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3.12
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Overview of Joint Research
Programme
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3.12.1
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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 [ * ]
.
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3.12.2
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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.
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3.13
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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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[ * ]
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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CD Nomination and which CD to select for further
Research, Development and Commercialization, under this Agreement.
[ * ] shall without delay notify in writing [ * ] ,
as applicable, of any such selections and decisions. For clarity,
nothing in this Section 3.13 shall limit Dynavax’s
rights to Reverted ISS. In particular, AstraZeneca shall have no
rights to select a Reverted ISS for further Research, Development
or Commercialization under this Agreement.
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4
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Support and Management of the Joint Research
Programme
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4.1
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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.
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4.2
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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:
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4.2.1
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proposing the strategic research goals and
directions for the Joint Research Programme;
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4.2.2
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preparing and proposing milestones, go/no go
criteria and criteria for evaluation of the Joint Research
Programme;
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4.2.3
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proposing the Joint Research Plan, Research
Budget, Research Budget Variance and any amendments
thereto;
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4.2.4
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monitoring the progress of the Joint Research
Programme;
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4.2.5
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monitoring workflow and proposing the allocation
of resources for carrying out the Joint Research
Programme;
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[ * ]
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=
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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4.2.6
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proposing priorities for the Joint Research
Programme and in view of the capacities of the Parties;
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4.2.7
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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;
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4.2.8
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approving the Candidate Drug Target Profile using
the criteria set forth in Exhibit A ;
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4.2.9
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[ * ] ;
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4.2.10
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[ * ] ;
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4.2.11
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developing and proposing updates of the Joint
Research Programme;
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4.2.12
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proposing any subcontractor or major outsourcing
and/or collaboration agreements with Third Parties as
appropriate;
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4.2.13
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proposing a publications strategy and preparing
and proposing specific items related to the Joint Research
Programme for publication; and
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4.2.14
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preparing and monitoring budgets for the Joint
Research Programme in discussion with the JSC.
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4.3
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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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[ * ]
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=
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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.
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4.4
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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.
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4.5
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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.
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4.6
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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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[ * ]
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=
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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.
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4.7
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Dissolution of JPT . Following the
termination or expiration of the Research Term the JPT shall be
dissolved.
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4.8
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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:
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4.8.1
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approving the strategic research goals and
direction for the Joint Research Programme;
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4.8.2
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approving the go/no go criteria and criteria for
evaluation of the Joint Research Programme;
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4.8.3
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reviewing and approving the Research Project
Plan, Research Budget, Research Budget Variance and any amendments
thereto;
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4.8.4
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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;
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4.8.5
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approving priorities for the Joint Research
Programme and capacities of the Parties;
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4.8.6
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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;
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4.8.7
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monitoring and ensuring timely execution of the
Joint Research Programme, including compliance with budgets and
timelines;
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4.8.8
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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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[ * ]
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=
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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deciding whether or not to continue the Joint
Research Programme into the next stage (i.e., making "stop/go
decisions");
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4.8.9
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[ * ]
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4.8.10
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[ * ]
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4.8.11
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approving any significant changes to the staffing
(FTE) levels or the funding of the Joint Research
Programme;
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4.8.12
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approving any subcontractors or major outsourcing
and/or collaboration agreements with Third Parties as
appropriate;
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4.8.13
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ensuring timely and appropriate support in the
filing of Patent applications;
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4.8.14
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approving the publications strategy and approving
specific items for publication (including but not limited to
articles, presentations and press releases);
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4.8.15
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resolving any issues that could not be resolved
by the JPT; and
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4.8.16
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taking all other significant management decisions
relating to the Joint Research Programme.
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4.9
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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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[ * ]
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=
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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.
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4.10
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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 [ *
] .
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4.11
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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.
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4.12
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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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[ * ]
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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.
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4.13
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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.
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4.14
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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.
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4.15
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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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[ * ]
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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.
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4.16
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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.
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4.17
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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.
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4.18
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Joint Research Programme Guidelines
.
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4.18.1
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General . In all matters related to the
Joint Research Programme, the Parties shall be guided by [ *
] , to further the Joint Research Programme and [ * ]
.
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4.18.2
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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.
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5
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Reports
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5.1
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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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[ * ]
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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efforts and any [ * ] and not previously
reported to the JSC. The JSC may provide further instructions on
the timing and content of these reports.
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5.2
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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.
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5.3
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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.
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6
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Ownership and Grant of Rights
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6.1
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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.
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6.2
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Licences to AstraZeneca . Subject to
the terms of this Agreement, Dynavax hereby grants to AstraZeneca
the following:
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6.2.1
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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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[ * ]
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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6.2.2
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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 [ * ] .
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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.
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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, [ * ] .
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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.
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6.3
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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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[ * ]
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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).
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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.
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6.4
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Third Party Licences .
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6.4.1
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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, [ * ] .
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6.4.2
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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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[ * ]
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=
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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, [ * ]
.
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6.5
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Exclusivity .
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6.5.1
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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.
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6.5.2
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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.
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6.5.3
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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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[ * ]
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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.
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6.5.4
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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 [ * ]
.
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6.5.5
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During the Term, in line with Dynavax’s
representation and warranty in Section 18.1.6, Dynavax and/or any
of its Affiliates covenant:
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(a)
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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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[ * ]
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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(b)
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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
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(c)
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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 [ * ] .
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6.6
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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.
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6.7
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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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[ * ]
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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 [ * ] .
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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 [ *
] .
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6.8
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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.
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7
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Research Funding
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7.1
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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.
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7.2
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Invoices; Reconciliation .
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7.2.1
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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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[ * ]
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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quarter during the Research Term (subject to
receipt by AstraZeneca of an invoice in respect of each such
payment).
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7.2.2
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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.
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7.2.3
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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.
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7.3
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Records Retention; Audit .
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7.3.1
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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.
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7.3.2
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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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[ * ]
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=
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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.
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7.4
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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.
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8
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Development and
Commercialization
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8.1
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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.
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8.2
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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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[ * ]
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=
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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
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8.3.1
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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.
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8.3.2
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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.
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8.3.3
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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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[ * ]
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=
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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
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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.
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8.3.4
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AstraZeneca shall keep Dynav
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