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RESEARCH COLLABORATION AND LICENSE AGREEMENT

Research and Development Agreement

RESEARCH COLLABORATION AND LICENSE AGREEMENT | Document Parties: ASTRAZENECA AB | DYNAVAX TECHNOLOGIES CORPORATION You are currently viewing:
This Research and Development Agreement involves

ASTRAZENECA AB | DYNAVAX TECHNOLOGIES CORPORATION

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Title: RESEARCH COLLABORATION AND LICENSE AGREEMENT
Governing Law: Delaware     Date: 11/3/2006
Industry: Biotechnology and Drugs     Law Firm: Cooley Godward     Sector: Healthcare

RESEARCH COLLABORATION AND LICENSE AGREEMENT, Parties: astrazeneca ab , dynavax technologies corporation
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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.

Exhibit 10.30

RESEARCH COLLABORATION AND LICENSE AGREEMENT

by and between

ASTRAZENECA AB

and

DYNAVAX TECHNOLOGIES CORPORATION

DATE: 1 September 2006

 

     

[   *   ]

=   

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

 

 

 

 (i) 

TABLE OF CONTENTS

 

 

 

 

 

 

 

 

Table of Contents

 

Page

1.

 

Definitions

 

 

2

 

 

 

 

 

 

 

 

2.

 

Construction

 

 

17

 

 

 

 

 

 

 

 

3.

 

Conduct of the Joint Research Programme

 

 

17

 

3.1

 

Overview

 

 

17

 

3.2

 

Research Term

 

 

18

 

3.3

 

Joint Research Plan

 

 

18

 

3.4

 

Research Effort and Support

 

 

18

 

3.5

 

Conduct of Research

 

 

19

 

3.6

 

Materials and Information Transfer

 

 

21

 

3.7

 

Cooperation

 

 

22

 

3.8

 

Regulatory Records

 

 

22

 

3.9

 

Reports

 

 

22

 

3.10

 

Lead Candidate Development Decision

 

 

23

 

3.11

 

CD Nomination

 

 

23

 

3.12

 

Overview of Joint Research Programme

 

 

23

 

3.13

 

Selection of Compounds

 

 

23

 

 

 

 

 

 

 

 

4.

 

Support and Management of the Joint Research Programme

 

 

24

 

4.1

 

Overview of the Management of the Joint Research Programme

 

 

24

 

4.2

 

Responsibilities of JPT

 

 

24

 

4.3

 

Formation of JPT

 

 

25

 

4.4

 

JPT Meetings

 

 

26

 

4.5

 

JPT Decision Making : Disputes

 

 

26

 

4.6

 

JPT Minutes

 

 

26

 

4.7

 

Dissolution of JPT

 

 

27

 

4.8

 

Responsibilities of JSC

 

 

27

 

4.9

 

Formation of JSC

 

 

28

 

4.10

 

JSC Decision Making : Disputes

 

 

29

 

4.11

 

JSC Decisions Requiring Consent

 

 

29

 



 

     

[   *   ]

=   

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

 

 

(ii)

 

 

 

 

 

 

 

 

Table of Contents

 

Page

4.12

 

JSC Meetings

 

 

29

 

4.13

 

JSC Minutes

 

 

30

 

4.14

 

Dissolution of JSC

 

 

30

 

4.15

 

Advisory Board

 

 

30

 

4.15

 

Expenses

 

 

31

 

4.17

 

Access to Information

 

 

31

 

4.18

 

Joint Research Programme Guidelines

 

 

31

 

 

 

 

 

 

 

 

5.

 

Reports

 

 

31

 

5.1

 

Joint Research Programme Progress Reports

 

 

31

 

5.2

 

Copyrights

 

 

32

 

5.3

 

AstraZeneca Reports

 

 

32

 

 

 

 

 

 

 

 

6.

 

Ownership and Grant of Rights

 

 

32

 

6.1

 

Ownership of Collaboration Technology

 

 

32

 

6.2

 

Licences to AstraZeneca

 

 

32

 

6.3

 

Licence to Dynavax

 

 

33

 

6.4

 

Third Party Licences

 

 

34

 

6.5

 

Exclusivity

 

 

35

 

6.6

 

Sublicences

 

 

37

 

6.7

 

Distributors

 

 

37

 

6.8.

 

Confirmatory Patent Licences

 

 

38

 

 

 

 

 

 

 

 

7.

 

Research Funding

 

 

38

 

7.1

 

Funding

 

 

38

 

7.2

 

Invoices; Reconciliation

 

 

38

 

7.3

 

Records Retention; Audit

 

 

39

 

7.4

 

Projected Cost Reports

 

 

40

 

 

 

 

 

 

 

 

8.

 

Development and Commercialization

 

 

40

 

8.1

 

Overview

 

 

40

 

8.2

 

Development of Product

 

 

40

 

8.3

 

Regulatory Affairs and Information Exchange

 

 

41

 

8.4

 

Commercialization of Product and Combination Product

 

 

43

 

8.5

 

Dynavax Option to Co-Promote in the United States

 

 

43

 

8.6

 

Pricing, Price Approvals and Product Distribution

 

 

44

 



 

     

[   *   ]

=   

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)

 

 

 

 

 

 

 

 

Table of Contents

 

Page

8.7

 

Sales and Inventory

 

 

44

 

8.8

 

Advertising and Education

 

 

44

 

8.9

 

Development and Commercialization Costs

 

 

45

 

8.10

 

Diligence Obligations

 

 

45

 

8.11

 

Breach of Diligence Obligations

 

 

47

 

8.12

 

Reversion; Abandonment

 

 

47

 

 

 

 

 

 

 

 

9.

 

Milestone Payments

 

 

48

 

9.1

 

Total Obligation

 

 

48

 

9.2

 

Access Fee

 

 

48

 

9.3

 

Joint Research Programme Milestones

 

 

49

 

9.4

 

Development Milestones

 

 

49

 

9.5

 

Milestone Payments

 

 

49

 

 

 

 

 

 

 

 

10.

 

Royalty Payments and Other Payment-Related Provisions

 

 

50

 

10.1

 

Royalties

 

 

50

 

10.2

 

Combination Products

 

 

50

 

10.3

 

Sublicensees

 

 

51

 

10.4

 

Royalty Stacking

 

 

52

 

10.5

 

[ * ] Royalty and [ * ]

 

 

52

 

10.6

 

Reduction of Royalty

 

 

53

 

10.7

 

Royalty Floor

 

 

54

 

10.8

 

Royalty Term

 

 

54

 

10.9

 

Sales Subject to Royalties

 

 

55

 

10.10

 

Royalty Payments

 

 

55

 

10.10

 

Mode of Payment

 

 

55

 

10.12

 

Currency

 

 

56

 

10.13

 

Interest

 

 

56

 

10.14

 

Records Retention; Audit

 

 

56

 

 

 

 

 

 

 

 

11.

 

Taxes

 

 

57

 

11.1

 

General

 

 

57

 

11.2

 

Indirect Taxes

 

 

57

 

11.3

 

Customs Duties

 

 

58

 

 

 

 

 

 

 

 

12.

 

Manufacture and Supply

 

 

58

 



 

     

[   *   ]

=   

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

 

 

(iv)

 

 

 

 

 

 

 

 

Table of Contents

 

Page

12.1

 

Preclinical Supply

 

 

58

 

12.2

 

Clinical and Commercial Supply

 

 

58

 

12.3

 

Manufacturing Know-How Transfer

 

 

59

 

 

 

 

 

 

 

 

13.

 

Confidentiality and Non-Disclosure

 

 

59

 

13.1

 

General Obligations

 

 

59

 

13.2

 

Permitted Disclosures

 

 

60

 

13.3

 

Exclusions

 

 

62

 

13.4

 

Confidentiality of Agreement

 

 

63

 

13.5

 

Publications and Presentations

 

 

63

 

13.6

 

Use of Name/Publicity.

 

 

64

 

 

 

 

 

 

 

 

14.

 

Patent Prosecution, Enforcement and Defence

 

 

65

 

14.1

 

Disclosure

 

 

65

 

14.2

 

Patent Prosecution and Maintenance

 

 

65

 

14.3

 

Patent Term Restoration

 

 

67

 

14.4

 

Enforcement of Patent Rights

 

 

67

 

14.5

 

Third Party Litigation

 

 

69

 

14.6

 

Invalidity or Unenforceability Defences or Actions

 

 

70

 

14.7

 

Cooperation

 

 

71

 

14.8

 

Compliance with Third Party Licences

 

 

71

 

14.9

 

Costs and Expenses

 

 

72

 

 

 

 

 

 

 

 

15.

 

Adverse Event Reporting

 

 

72

 

15.1

 

Overview

 

 

72

 

 

 

 

 

 

 

 

16.

 

Product Recall

 

 

73

 

16.1

 

Notification and Recall

 

 

73

 

16.2

 

Recall Expenses

 

 

73

 

 

 

 

 

 

 

 

17.

 

Trademarks

 

 

74

 

 

 

 

 

 

 

 

18.

 

Representations and Warranties

 

 

74

 

 

 

 

 

 

 

 

19.

 

Indemnification and Insurance

 

 

79

 

19.1

 

Indemnification of Dynavax

 

 

79

 

19.2

 

Indemnification of AstraZeneca

 

 

79

 

19.3

 

[ * ]

 

 

 

 



 

     

[   *   ]

=   

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

 

Page

19.4

 

Notice of Claim

 

 

80

 

19.4

 

Indemnification Procedures

 

 

81

 

19.5

 

LIMITATION ON DAMAGES

 

 

83

 

19.6

 

Insurance

 

 

83

 

 

 

 

 

 

 

 

20.

 

Term and Termination

 

 

83

 

20.1

 

Term

 

 

83

 

20.2

 

Termination by AstraZeneca

 

 

84

 

20.3

 

Termination for Infringement of Third Party Rights

 

 

84

 

20.4

 

Termination by Dynavax for Lack of Diligence

 

 

85

 

20.5

 

Termination by Either Party

 

 

85

 

20.6

 

Change of Control

 

 

87

 

20.7

 

Consequences of Termination

 

 

87

 

20.8

 

Survival

 

 

91

 

20.9

 

Rights in Bankruptcy

 

 

91

 

 

 

 

 

 

 

 

21.

 

Force Majeure

 

 

91

 

 

 

 

 

 

 

 

22.

 

Assignment

 

 

93

 

 

 

 

 

 

 

 

23.

 

Severability

 

 

93

 

 

 

 

 

 

 

 

24.

 

Dispute Resolution

 

 

94

 

24.1

 

Disputes

 

 

94

 

24.2

 

Arbitration

 

 

94

 

24.3

 

Arbitrator

 

 

95

 

24.4

 

Governing Law

 

 

95

 

24.5

 

Decision

 

 

95

 

24.6

 

Award

 

 

95

 

24.7

 

Costs

 

 

96

 

24.8

 

Injunctive Relief

 

 

96

 

24.9

 

Confidentiality

 

 

97

 

24.10

 

Survivability

 

 

97

 

24.11

 

Jurisdiction

 

 

97

 

24.12

 

Patents and Trademarks

 

 

97

 

24.13

 

Provisions Unique to Arbitrations Pursuant to Section 8.10

 

 

98

 

 

 

 

 

 

 

 

25.

 

Notices

 

 

98

 



 

     

[   *   ]

=   

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

 

 

(vi)

 

 

 

 

 

 

 

 

Table of Contents

 

Page

25.1

 

Notice Requirements

 

 

98

 

25.2

 

Address for Notice

 

 

98

 

 

 

 

 

 

 

 

26.

 

Relationship of the Parties

 

 

99

 

 

 

 

 

 

 

 

27.

 

Entire Agreement

 

 

100

 

 

 

 

 

 

 

 

28.

 

English Language

 

 

100

 

 

 

 

 

 

 

 

29.

 

Amendment

 

 

100

 

 

 

 

 

 

 

 

30.

 

Waiver and Non-Exclusion of Remedies

 

 

100

 

 

 

 

 

 

 

 

31.

 

No Benefit to Third Parties

 

 

101

 

 

 

 

 

 

 

 

32.

 

Equitable Relief

 

 

101

 

 

 

 

 

 

 

 

33.

 

Further Assurance

 

 

102

 

 

 

 

 

 

 

 

34.

 

Expenses

 

 

102

 

 

 

 

 

 

 

 

35.

 

Counterparts

 

 

103

 



 

     

[   *   ]

=   

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

 

 

Page 1 of 104

RESEARCH COLLABORATION AND LICENSE AGREEMENT

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

(1)

 

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

 

   

(2)

 

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

Recitals

(A)

 

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

 

   

(B)

 

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

 

   

(C)

 

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

Agreement

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

 

     

[   *   ]

=   

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

 

 

Page 2 of 104

1

 

Definitions

 

   

 

 

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

 

   

1.1

 

"Advisory Board" means the committee established and conducted according to Section 4.15.

 

   

1.2

 

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

 

   

1.3

 

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

 

   

1.4

 

" Annual Net Sales " means the Net Sales made during a given calendar year.

 

   

1.5

 

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

 

   

1.6

 

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

 

   

1.7

 

" AstraZeneca Information " has the meaning set forth in Section 13.1.2.

 

   

1.8

 

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

 

   

1.9

 

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

 

     

[   *   ]

=   

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 3 of 104

 

 

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

 

   

1.10

 

"AstraZeneca Technology" means AstraZeneca Patents and AstraZeneca Know-How.

 

   

1.11

 

"Background Technology" means either the AstraZeneca Technology or the Dynavax Technology, as appropriate and Background Technologies means the AstraZeneca Technology and the Dynavax Technology.

 

   

1.12

 

[ * ] .

 

   

1.13

 

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

 

   

1.14

 

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

 

   

1.15

 

"CD Nomination" means the internal process, known by [ * ] , by which [ * ] .

 

   

1.16

 

"CD Nomination Date" means the date upon which a CD Nomination is made.

 

   

1.17

 

" Change of Control ," with respect to either Party, means an event in which:

 

1.17.1

 

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

 

     

 

1.17.2

 

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

1.18

 

[ * ] .

 

     

[   *   ]

=   

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 4 of 104

1.19

 

[ * ] .

 

   

1.20

 

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

 

   

1.21

 

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

 

   

1.22

 

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

 

   

1.23

 

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

 

   

1.24

 

" Collaboration Technology " means Collaboration Patents, Collaboration Know-How and Collaboration ISS.

 

   

1.25

 

" Combination Product " means a pharmaceutical preparation [ * ] .

 

   

1.26

 

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

 

   

1.27

 

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

 

     

[   *   ]

=   

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

 

 

Page 5 of 104

 

 

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

 

   

1.28

 

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

 

   

1.29

 

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

 

   

1.30

 

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

 

   

1.31

 

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

 

   

1.32

 

" Defending Party " has the meaning set forth in Section 14.7.

 

   

1.33

 

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

 

     

[   *   ]

=   

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

 

 

Page 6 of 104

 

 

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

 

   

1.34

 

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

 

   

1.35

 

"Development Milestone" has the meaning set forth in Section 9.4.

 

   

1.36

 

" Development Plan" has the meaning set forth in Section 8.2.

 

   

1.37

 

" Disclosing Party " has the meaning set forth in Section 13.1.1.

 

   

1.38

 

" Distributor " has the meaning set forth in Section 6.7.

 

   

1.39

 

"DMF" means a Drug Master File.

 

   

1.40

 

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

 

   

1.41

 

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

 

   

1.42

 

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

 

   

1.43

 

"Dynavax Technology" means the Dynavax Patents, the Dynavax Know-How and Dynavax ISS.

 

   

1.44

 

" Effective Date " means the date as set forth in the preamble to this Agreement.

 

   

1.45

 

" Europe " means the European Economic Area as it may be constituted from time to time.

 

     

[   *   ]

=   

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

 

 

Page 7 of 104

1.46

 

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

 

   

1.47

 

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

 

   

1.48

 

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

 

   

1.49

 

" Force Majeure " has the meaning set forth in Section 21.1.

 

   

1.50

 

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

 

   

1.51

 

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

 

     

[   *   ]

=   

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

 

 

Page 8 of 104

 

 

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

 

   

1.52

 

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

 

   

1.53

 

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

 

   

1.54

 

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

 

   

1.55

 

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

 

   

1.56

 

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

 

   

1.57

 

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

 

     

[   *   ]

=   

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 9 of 104

 

 

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

 

   

1.58

 

" Indemnification Claim Notice " has the meaning set forth in Section 19.4.

 

   

1.59

 

" Indemnified Party " means a Party seeking to recover a Loss under Section 19.1 or 19.2.

 

   

1.60

 

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

 

   

1.61

 

" Indemnitee " has the meaning set forth in Section 19.4.

 

   

1.62

 

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

 

   

1.63

 

" Indirect Taxes " means value added taxes, sales taxes, consumption taxes and other similar taxes.

 

   

1.64

 

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

 

   

1.65

 

" Infringement Suit " has the meaning set forth in Section 14.5.

 

     

[   *   ]

=   

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.

 

   

1.67

 

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

 

   

1.68

 

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

 

   

1.69

 

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

 

   

1.70

 

" Joint Research Programme " means the research programme described in the Joint Research Plan.

 

   

1.71

 

" Joint Research Programme Milestones " has the meaning set forth in Section 9.3.

 

   

1.72

 

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

 

   

1.73

 

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

 

   

1.74

 

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

 

     

[   *   ]

=   

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 11 of 104

1.75

 

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

 

   

1.76

 

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

 

   

1.77

 

"Lead CD" means the CD nominated by AstraZeneca for Development and Commercialisation.

 

   

1.78

 

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

 

   

1.79

 

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

 

   

1.80

 

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

 

   

1.81

 

" Major Markets " means [ * ] .

 

   

1.82

 

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

 

   

1.83

 

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

 

     

[   *   ]

=   

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 12 of 104

 

 

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

 

   

1.84

 

" Parties " means collectively AstraZeneca and Dynavax and " Party " means individually either of AstraZeneca or Dynavax.

 

   

1.85

 

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

 

     

[   *   ]

=   

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 13 of 104

 

 

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

 

   

1.86

 

" Payments " has the meaning set forth in Section 11.1.

 

   

1.87

 

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

 

   

1.88

 

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

 

   

1.89

 

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

 

   

1.90

 

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

 

   

1.91

 

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

 

     

[   *   ]

=   

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 14 of 104

1.92

 

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

 

   

1.93

 

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

 

   

1.94

 

" Product " means a pharmaceutical preparation [ * ] .

 

   

1.95

 

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

 

   

1.96

 

" Prosecuting Party " has the meaning set forth in Section 14.2.2.

 

   

1.97

 

" Receiving Party " has the meaning set forth in Section 13.1.1.

 

   

1.98

 

"Regents" has the meaning set forth in Section 10.5.1.

 

   

1.99

 

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

 

   

1.100

 

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

 

   

1.101

 

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

 

     

[   *   ]

=   

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 15 of 104

1.102

 

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

 

   

1.103

 

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

 

   

1.104

 

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

 

   

1.105

 

"Research Term" has the meaning set forth in Section 3.2.

 

   

1.106

 

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

 

   

1.107

 

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

 

   

1.108

 

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

 

   

1.109

 

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

 

   

1.110

 

"Royalty Term" has the meaning set forth in Section 10.8.

 

   

1.111

 

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

 

   

1.112

 

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

 

     

[   *   ]

=   

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 16 of 104

1.113

 

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

 

   

1.114

 

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

 

   

1.115

 

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

 

   

1.116

 

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

 

   

1.117

 

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

 

   

1.118

 

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

 

   

1.119

 

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

 

   

1.120

 

" Third Party Claims " has the meaning set forth in Section 19.1.

 

   

1.121

 

" TLR-9 " means toll-like receptor 9.

 

   

1.122

 

"Triggering Event" has the meaning set forth in Section 6.4.2.

 

   

1.123

 

" Valid Claim " means, with respect to a particular country, either:

 

1.123.1

 

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

 

     

 

1.123.2

 

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

 

     

[   *   ]

=   

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 17 of 104

 

 

 

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

2

 

Construction

 

   

 

 

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

 

   

3

 

Conduct of the Joint Research Programme

 

   

3.1

 

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

 

     

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

 

   

3.2

 

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

 

   

3.3

 

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

 

   

3.4

 

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

 

     

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

 

   

3.5

 

Conduct of Research .

 

3.5.1

 

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

 

     

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

 

     

 

3.5.2

 

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

 

     

 

3.5.3

 

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

 

     

 

3.5.4

 

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

 

     

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

3.6

 

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

 

     

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

 

   

3.7

 

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

 

   

3.8

 

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

 

   

3.9

 

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

 

     

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3.10

 

Lead Candidate Development Decision .

 

   

 

 

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

 

   

3.11

 

CD Nomination .

 

   

 

 

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

 

   

3.12

 

Overview of Joint Research Programme

 

3.12.1

 

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

 

     

 

3.12.2

 

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

3.13

 

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

 

     

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

 

   

4

 

Support and Management of the Joint Research Programme

 

   

4.1

 

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

 

   

4.2

 

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

 

4.2.1

 

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

 

     

 

4.2.2

 

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

 

     

 

4.2.3

 

proposing the Joint Research Plan, Research Budget, Research Budget Variance and any amendments thereto;

 

     

 

4.2.4

 

monitoring the progress of the Joint Research Programme;

 

     

 

4.2.5

 

monitoring workflow and proposing the allocation of resources for carrying out the Joint Research Programme;

 

     

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4.2.6

 

proposing priorities for the Joint Research Programme and in view of the capacities of the Parties;

 

     

 

4.2.7

 

proposing prioritisation criteria for specific components under the Joint Research Programme, including setting proposed dates for experimental initiation and completion of each stage of the Joint Research Programme;

 

     

 

4.2.8

 

approving the Candidate Drug Target Profile using the criteria set forth in Exhibit A ;

 

     

 

4.2.9

 

[ * ] ;

 

     

 

4.2.10

 

[ * ] ;

 

     

 

4.2.11

 

developing and proposing updates of the Joint Research Programme;

 

     

 

4.2.12

 

proposing any subcontractor or major outsourcing and/or collaboration agreements with Third Parties as appropriate;

 

     

 

4.2.13

 

proposing a publications strategy and preparing and proposing specific items related to the Joint Research Programme for publication; and

 

     

 

4.2.14

 

preparing and monitoring budgets for the Joint Research Programme in discussion with the JSC.

4.3

 

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

 

     

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have substantially the equivalent experience and seniority as the representative that such person replaces. Representatives of each Party other than the members of the JPT may attend JPT meetings at the invitation of either Party with the prior approval of the other Party, which approval shall not be unreasonably withheld.

 

   

4.4

 

JPT Meetings . The JPT shall meet at least monthly and more frequently when required. The first JPT meeting will be held within twenty (20) days after the Effective Date and thereafter meetings will be held alternately at the offices of Dynavax and AstraZeneca unless the Parties agree on another location, or by teleconference or videoconference. A quorum of the JPT shall exist whenever there is present at a meeting each of the Project Leaders or their respective designees. The Project Leaders shall act as co-chairs for JPT meetings. In addition, the JPT may act without a formal meeting by a written memorandum signed by the Project Leaders. The JPT may also invite other personnel of the Parties to attend meetings of the JPT as appropriate to the agenda for such meeting, after giving notice to the other Party. Whenever any action by the JPT is required hereunder during a time period in which the JPT is not scheduled to meet, either Project Leader shall have the right to call a special meeting or the Project Leaders may cause the JPT to take the action without a meeting in the applicable time period. Any such additional meetings shall be held at places and on dates selected by the Project Leaders. The JPT may by unanimous consent, amend or expand upon the foregoing procedures for its internal operations.

 

   

4.5

 

JPT Decision Making : Disputes . All decisions of the JPT made pursuant to this Agreement shall be made by unanimous consent of its members. If for any reason the JPT cannot reach unanimity regarding a particular matter, then, such matter shall be resolved in a second meeting to be held within twenty (20) Business Days from the meeting in which the disputed matter has remained unresolved. In the event that the JPT is again unable to resolve the matter the disputed matter shall be promptly referred to the JSC for resolution.

 

   

4.6

 

JPT Minutes . The JPT shall keep accurate minutes of its deliberations, which minutes shall record all proposed decisions and all actions recommended or taken. Drafts of minutes shall be delivered to the Project Leaders within twenty (20) days after the respective meeting. The Parties, on an alternating basis, shall prepare and circulate

 

     

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the draft minutes. Draft minutes shall be edited by the Project Leaders and shall be issued in final form only with the approval and agreement of the Project Leaders.

 

   

4.7

 

Dissolution of JPT . Following the termination or expiration of the Research Term the JPT shall be dissolved.

 

   

4.8

 

Responsibilities of JSC . The Parties shall establish a Joint Steering Committee (the " JSC ") within ten (10) days following the Effective Date, to oversee the initiation, planning and performance of the activities under the Joint Research Programme based on the proposals and activities of the JPT. In particular, the responsibilities of the JSC shall include:

 

4.8.1

 

approving the strategic research goals and direction for the Joint Research Programme;

 

     

 

4.8.2

 

approving the go/no go criteria and criteria for evaluation of the Joint Research Programme;

 

     

 

4.8.3

 

reviewing and approving the Research Project Plan, Research Budget, Research Budget Variance and any amendments thereto;

 

     

 

4.8.4

 

approving workflow and the allocation of resources for carrying out the Joint Research Programme taking into account each Party’s respective specific capabilities and expertise in order to avoid duplication and enhance efficiency and synergies;

 

     

 

4.8.5

 

approving priorities for the Joint Research Programme and capacities of the Parties;

 

     

 

4.8.6

 

approving prioritisation criteria for specific components under the Joint Research Programme, including setting proposed dates for experimental initiation and completion of each stage of the Joint Research Programme;

 

     

 

4.8.7

 

monitoring and ensuring timely execution of the Joint Research Programme, including compliance with budgets and timelines;

 

     

 

4.8.8

 

determining within [ * ] days of the completion of each stage of the Joint Research Programme whether the completion thereof has been successful and

 

     

[   *   ]

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deciding whether or not to continue the Joint Research Programme into the next stage (i.e., making "stop/go decisions");

 

     

 

4.8.9

 

[ * ]

 

     

 

4.8.10

 

[ * ]

 

     

 

4.8.11

 

approving any significant changes to the staffing (FTE) levels or the funding of the Joint Research Programme;

 

     

 

4.8.12

 

approving any subcontractors or major outsourcing and/or collaboration agreements with Third Parties as appropriate;

 

     

 

4.8.13

 

ensuring timely and appropriate support in the filing of Patent applications;

 

     

 

4.8.14

 

approving the publications strategy and approving specific items for publication (including but not limited to articles, presentations and press releases);

 

     

 

4.8.15

 

resolving any issues that could not be resolved by the JPT; and

 

     

 

4.8.16

 

taking all other significant management decisions relating to the Joint Research Programme.

4.9

 

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

 

     

[   *   ]

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the representative that such person replaces. Representatives of each Party other than the members of the JSC may attend JSC meetings at the invitation of either Party with the prior approval of the other Party, which approval shall not be unreasonably withheld. From time to time, the JSC may establish subcommittees or subordinate committees (that may or may not include members of the JSC itself) to oversee particular projects or activities, and such subcommittees or subordinate committees shall be constituted and shall operate as the JSC agrees.

 

   

4.10

 

JSC Decision Making; Disputes . All decisions of the JSC made pursuant to this Agreement shall be made by unanimous consent of the Parties, with each Party having a single vote, irrespective of the number of representatives actually in attendance at a meeting. If for any reason the JSC cannot reach unanimity within [ * ] days following a JSC meeting at which a Party formally requests resolution of such matter, then except as set forth in Section 4.11, the matter shall be referred to and resolved in good faith by the [ * ] of AstraZeneca and the [ * ] of Dynavax. Any final decision mutually agreed to by the said senior managements of the Parties shall be in writing and shall be conclusive and binding on the Parties. If such resolution is unattainable by senior management within [ * ] days from the date the matter in dispute is first brought to the attention of the senior management of the Parties, the dispute shall be [ * ] ; provided, however, that, if [ * ] , then [ * ] .

 

   

4.11

 

JSC Decisions Requiring Consent . Any [ * ] shall require the unanimous consent of the JSC. If the JSC fails to reach unanimous consent regarding any such change to the Joint Research Programme, then [ * ] . In addition, neither Party shall have any right to make any changes to the Joint Research Plan relating to the Research of Dynavax ISS and/or Collaboration ISS that would change the other Party’s [ * ] , without the consent of the other Party.

 

   

4.12

 

JSC Meetings . Unless otherwise agreed, the JSC shall meet at least quarterly and more frequently when required. The first JSC meeting will be held within ninety (90) days after the Effective Date and thereafter meetings will be held alternately at the offices of Dynavax and AstraZeneca unless the Parties agree on another location, or by teleconference or videoconference. A quorum of the JSC shall exist whenever there is present at a meeting each of the Alliance Managers or their respective designees. A JSC representative for AstraZeneca shall chair the first JSC meeting and

 

     

[   *   ]

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thereafter a JSC representative of the Party which is hosting such JSC meeting at its offices, will chair such meeting. In addition, the JSC may act without a formal meeting by a written memorandum signed by the Alliance Managers. The JSC may also invite other personnel of the Parties to attend meetings of the JSC as appropriate to the agenda for such meeting, after giving notice to the other Party. Whenever any action by the JSC is required hereunder during a time period in which the JSC is not scheduled to meet, either Alliance Manager shall have the right to call a special meeting or the Alliance Managers may cause the JSC to take the action without a meeting in the applicable time period. Any such additional meetings shall be held at places and on dates selected by the Alliance Managers. The JSC may by unanimous consent, amend or expand upon the foregoing procedures for its internal operations.

 

   

4.13

 

JSC Minutes . The JSC shall keep accurate minutes of its deliberations, which minutes shall record all proposed decisions and all actions recommended or taken, Joint Research Programme progress reports provided to the JSC pursuant to Section 5.1 , Collaboration Technology generated of interest in the Joint Research Programme and confirmation that Joint Research Programme Milestones have been reached. In particular, all Dynavax ISS and Collaboration ISS [ * ] selected and/or nominated during the Research Term and any Candidate Drug selected therefrom, shall be recorded in the minutes of the JSC. Drafts of minutes shall be delivered to the Alliance Managers within twenty (20) days after the respective meeting. The Parties, on an alternating basis, shall prepare and circulate the draft minutes. Draft minutes shall be edited by the Alliance Managers and shall be issued in final form only with the approval and agreement of the Alliance Managers of both Parties.

 

   

4.14

 

Dissolution of JSC . Following the expiration or termination of the Research Term, the JSC shall be dissolved and Dynavax shall provide AstraZeneca with consultation services as AstraZeneca may reasonably request for the continued Development and Commercialization of the Dynavax ISS and/or Collaboration ISS, the costs of which shall be managed in accordance with Section 8.9 below.

 

   

4.15

 

Advisory Board . Within thirty (30) days following the CD Nomination Date, the Parties shall establish an Advisory Board, which shall consist of [ * ] representatives of each Party and shall hold meetings no less frequently than every [ * ] months with the purpose of [ * ] . The Advisory Board shall [ * ] and its advice shall not in any

 

     

[   *   ]

=   

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.

 

   

4.16

 

Expenses . Dynavax and AstraZeneca each shall bear all expenses of its JPT, JSC and Advisory Board members related to such members’ participation and attendance at the JPT, JSC and/or Advisory Board meetings.

 

   

4.17

 

Access to Information . Each Party shall provide the JPT and JSC and their authorized representatives with reasonable access during regular business hours to all records and documents of such Party that are specific to the Research or further Development of the Product or any Combination Product and that the JPT and JSC may reasonably require in order to perform their obligations hereunder, subject to any bona fide obligations of confidentiality to a Third Party.

 

   

4.18

 

Joint Research Programme Guidelines .

 

4.18.1

 

General . In all matters related to the Joint Research Programme, the Parties shall be guided by [ * ] , to further the Joint Research Programme and [ * ] .

 

     

 

4.18.2

 

Independence . Subject to the terms of this Agreement, the activities and resources of each Party shall be managed by such Party, acting independently and in its individual capacity. The relationship between Dynavax and AstraZeneca is that of independent contractors and neither Party shall have the power to bind or obligate the other Party in any manner, other than as is expressly set forth in this Agreement.

5

 

Reports

 

   

5.1

 

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

 

     

[   *   ]

=   

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.

 

   

5.2

 

Copyrights . Copyrights to reports provided for hereunder shall be jointly owned by the Parties. Neither Party shall, without the prior written approval of the other Party, attribute to the other Party any abstract or interpretation of any such report for sales or promotion purposes.

 

   

5.3

 

AstraZeneca Reports . Upon dissolution of the JSC pursuant to Section 4.14, AstraZeneca shall provide the Advisory Board with [ * ] progress reports containing information on AstraZeneca Development and Commercialization activities in accordance with Sections 8.2 and 8.4.

 

   

6

 

Ownership and Grant of Rights

 

   

6.1

 

Ownership of Collaboration Technology . The Parties shall jointly own all Collaboration Technology, with each Party owning an undivided half interest in such Collaboration Technology and, subject to the exclusive licences granted herein, each having the right to use and to license such Collaboration Technology for any purpose without a duty of accounting or obtaining consent from the other Party. Each Party shall promptly disclose to the other Party in writing the development, making, conception or reduction to practice of any Collaboration Technology, and shall, and does hereby, assign, and shall cause its Affiliates and its and their employees and agents, as applicable, to so assign, to such other Party, without additional compensation, such right, title and interest in and to any Collaboration Technology, as is necessary to fully effect the joint ownership provided for in the foregoing sentence.

 

   

6.2

 

Licences to AstraZeneca . Subject to the terms of this Agreement, Dynavax hereby grants to AstraZeneca the following:

 

6.2.1

 

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

 

     

[   *   ]

=   

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

 

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

 

 

Notwithstanding the above licences, it is noted that AstraZeneca shall have no right to make, have made, use, offer for sale, sell and import the CDs or any products incorporating such CDs, outside of the Field in the Territory.

 

   

 

 

The Parties acknowledge that, at any time after the First Commercial Sale of the Product or a Combination Product, such Product or Combination Product may be used by end users outside the Field. The Parties agree that such use shall not be deemed a breach by AstraZeneca of this Agreement, provided that AstraZeneca does not at any time, without the prior written consent of Dynavax, [ * ] .

 

   

 

 

For the avoidance of doubt, the licenses granted to AstraZeneca in this Section 6.2 convey no rights with respect to any ISS Controlled by Dynavax other than the Dynavax ISS and Collaboration ISS.

 

   

6.3

 

Licence to Dynavax . Subject to the terms of this Agreement, AstraZeneca hereby grants to Dynavax a worldwide, fully paid, non-exclusive license, with the right to sublicense, under the AstraZeneca Technology and AstraZeneca’s rights and interest in the Collaboration Technology solely to perform Dynavax’s portion of the Research obligations under this Agreement with respect to Dynavax ISS and Collaboration ISS, CDs, Product and Combination Products in the Field and in the Territory. In addition, AstraZeneca hereby grants to Dynavax, a worldwide, non-exclusive, royalty-free license under the AstraZeneca Technology and AstraZeneca’s rights and interest in the Collaboration Technology to make, have made, use, offer for sale, sell and import Reverted ISS and products comprising Reverted ISS (i) for use outside the Field during the Term, but, in accordance with the limitation specified in Section 6.5, excluding the right to make, have made, use, offer for sale, sell and import Reverted ISS and products comprising Reverted ISS for use in any Dynavax existing or future

 

     

[   *   ]

=   

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).

 

   

 

 

Notwithstanding the above licences, it is noted that during the Term, Dynavax shall have no right to make, have made, use, offer for sale, sell and import the CDs or any products incorporating such CDs, inside or outside of the Field in the Territory, unless and until such CD becomes a Reverted ISS.

 

   

6.4

 

Third Party Licences .

 

6.4.1

 

The Parties, through the JPT and JSC, as appropriate, shall discuss whether licences under Third Party technology are necessary for the Research. If during the Research Term, the JSC agrees that such a Third Party licence is necessary, then, AstraZeneca shall have the first right, but not the obligation, through counsel of its choosing, to negotiate and obtain a licence from such Third Party. If AstraZeneca incurs Third Party [ * ] licence expenses as a result of [ * ] , such costs relating to [ * ] may be recovered in part pursuant to the royalty-offset provision of Article 10 at AstraZeneca’s sole discretion, and such costs relating to Third Parties [ * ] may be recovered in part pursuant to the royalty-offset provision of Article 10, subject to the prior written consent of Dynavax, [ * ] .

 

     

 

6.4.2

 

If, in the opinion of AstraZeneca, following discussion with the Advisory Board, the Development and/or Commercialization of the Dynavax ISS, Collaboration ISS, CDs, Product or Combination Products by AstraZeneca, its Affiliates or any of their Sublicensees infringes or misappropriates any Patent or any Intellectual Property Right of a Third Party in any country, such that AstraZeneca or any of its Affiliates, Distributors or Sublicensees cannot Develop and/or Commercialize the Dynavax ISS, Collaboration ISS, CDs or the Product or any Combination Product(s) in such country without infringing the Patent or intellectual property right of such Third Party (a "Triggering Event" ), then, AstraZeneca shall have the first right, but not the obligation, through counsel of its choosing, to negotiate and obtain a licence from such

 

     

[   *   ]

=   

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, [ * ] .

6.5

 

Exclusivity .

 

6.5.1

 

During the Term, each Party and its respective Affiliates shall not, directly or indirectly, by itself or with any Third Party, conduct research on, develop or commercialize in the Field any ISS other than the selection, Research, Development and Commercialization of Dynavax ISS and/or Collaboration ISS and/or CDs and/or Product and/or Combination Products in the Field pursuant to this Agreement.

 

     

 

6.5.2

 

Dynavax acknowledge that as a necessary pre-requisite of AstraZeneca being able to benefit from the licence rights granted pursuant to Section 6.2, it is appropriate and acceptable for Dynavax and its Affiliates to refrain from conducting research on, developing, commercialising, making, having made, using, offering for sale, selling and importing the Reverted ISS in the treatment of human patients who have Asthma, COPD, and/or respiratory allergies. Accordingly for such time as AstraZeneca is Researching, Developing or Commercialising a Dynavax ISS, Collaboration ISS, CD, Product or Combination Product pursuant to this Agreement, Dynavax and its Affiliates shall not, by themselves or with any Third Party, utilise any of the Reverted ISS within any existing or future Asthma, COPD, and/or respiratory allergy research, development and commercialisation programme.

 

     

 

6.5.3

 

The Parties acknowledge that all restrictions contained in this Section 6.5 are reasonable, valid and necessary for the adequate protection of the Product or

 

     

[   *   ]

=   

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.

 

     

 

6.5.4

 

AstraZeneca’s exclusive position granted by Section 6.2 shall expire with respect to the Product and each separate Combination Product, on a country- by-country basis, on the date when AstraZeneca’s obligation to pay royalties with respect to such Product or Combination Product (as appropriate) expires. Upon expiry of AstraZeneca’s exclusive position with respect to the Product or any Combination Product in a country, AstraZeneca’s licence with respect to such Product or Combination Product in such country shall become non-exclusive, fully paid-up, perpetual and irrevocable and the Net Sales of such Product or Combination Product in such country shall be excluded from the royalty calculations in Article 10 (including the thresholds and ceilings). AstraZeneca and its Affiliates and Sublicensees shall be allowed to continue Developing and Commercializing such Product or Combination Product and using all related Patents, Know-How and Information in connection therewith on a [ * ] basis in such country with [ * ] .

 

     

 

6.5.5

 

During the Term, in line with Dynavax’s representation and warranty in Section 18.1.6, Dynavax and/or any of its Affiliates covenant:

 

(a)

 

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

 

     

[   *   ]

=   

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)

 

not, anywhere in the world, to grant any rights or licences to any Third Party which are contrary to or inconsistent with the rights and licences granted to AstraZeneca and its Affiliates pursuant to this Agreement; and

 

     

 

(c)

 

notwithstanding Dynavax’s representation and warranty in Section 18.1.6, in the event of any inadvertent grant of rights or licences to any Third Party which are, or subsequently become, contrary to or inconsistent with the rights and licences granted to AstraZeneca and its Affiliates pursuant to this Agreement, to [ * ] , with the aim of ensuring that, [ * ] , the rights and licences accorded to AstraZeneca supersede any conflicting rights and licences of Third Parties. Dynavax shall also offer full cooperation to allow AstraZeneca to [ * ] .

6.6

 

Sublicences . AstraZeneca shall have the right to grant sublicences, through multiple tiers of sublicensees, under the licences granted in Section 6.2.1 and 6.2.2, to (a) its Affiliates and (b) to any other Person, provided, however, that AstraZeneca shall first obtain the written consent of Dynavax before granting a sublicence under the licences granted in Section 6.2 for the Research, Development or Commercialization of Dynavax ISS, Collaboration ISS, CDs, the Product or any Combination Product(s) in [ * ] , except for sublicences limited to [ * ] . Where AstraZeneca grants a sublicense to a Person, which is not an Affiliate of AstraZeneca, and such Person is not a Distributor, that Person shall be a " Sublicensee " for purposes of this Agreement. AstraZeneca shall use Commercially Reasonable Efforts to ensure that all Persons to which it grants sublicences comply with all terms and conditions of this Agreement. In all countries outside of the Major Markets, AstraZeneca shall give written notice to Dynavax promptly following each sublicence granted hereunder, identifying the Sublicensee and the rights granted.

 

   

6.7

 

Distributors . AstraZeneca shall have the right, in its sole discretion, to appoint its Affiliates, and AstraZeneca and its Affiliates shall have the right, in their sole discretion, to appoint any other Persons, to distribute, market and sell the Product or any Combination Products (with or without packaging rights) in circumstances where the Person purchases its requirements of Product or Combination Products from

 

     

[   *   ]

=   

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 [ * ] .

 

   

 

 

Except with the consent of Dynavax, [ * ] , AstraZeneca, its Affiliates and Sublicensees shall not sell Product or Combination product in unfinished form (in that it requires further filling or finishing) in any country of the [ * ] .

 

   

6.8

 

Confirmatory Patent Licences . Dynavax shall if requested to do so by AstraZeneca immediately enter into confirmatory licence agreements in the form or substantially the form set out in Exhibit F for purposes of recording the licences granted under this Agreement with such Patent Offices in the Territory as AstraZeneca considers appropriate. Until the execution of any such confirmatory licences, so far as may be legally possible, Dynavax and AstraZeneca shall have the same rights in respect of the licensed Patents and be under the same obligations to each other in all respects as if the said confirmatory licences had been executed.

 

   

7

 

Research Funding

 

   

7.1

 

Funding . Each Party shall assume responsibility for its own costs and expenses for the Joint Research Programme with the sole exception that AstraZeneca shall provide funding to Dynavax to support Dynavax’s efforts under the Joint Research Programme. During each contract year of the Research Term, AstraZeneca shall pay Dynavax an amount equal to the FTE Rate multiplied by the number of FTEs set forth in Section 3.4 for such year.

 

   

7.2

 

Invoices; Reconciliation .

 

7.2.1

 

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

 

     

[   *   ]

=   

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).

 

     

 

7.2.2

 

In addition to the advance payment set forth in Section 7.2.1, and subject to the JSC’s approval of any subcontractor or major outsourcing agreement other than those Persons listed on Exhibit D hereto, any external costs or expenses incurred by Dynavax in connection with its performance of its obligations under the Joint Research Programme and not already included within the FTE Rate, shall be separately invoiced to AstraZeneca and reimbursed on a pass-through basis. Dynavax shall submit such invoice within [ * ] days after the end of the relevant quarter in which such pass-through expenses were incurred. AstraZeneca shall reimburse such expense within [ * ] days after the date of receipt by AstraZeneca of the invoice.

 

     

 

7.2.3

 

Within [ * ] Business Days after the end of each contract quarter during the Research Term, Dynavax shall report to AstraZeneca Dynavax’s actual FTEs involved in the Research during such quarter. Within [ * ] days after AstraZeneca’s receipt of such report, the JSC shall direct the remittance between the Parties of an amount to effectuate the difference between the advance payment made by AstraZeneca and the actual Dynavax FTEs involved in the research during the applicable quarter. Any such payment shall be made, in any event, within [ * ] days of the date that the JSC directs the remittance.

7.3

 

Records Retention; Audit .

 

7.3.1

 

Dynavax shall keep or cause to be kept accurate records or books of account in accordance with applicable generally accepted accounting principles that, in reasonable detail, fairly reflect the reimbursable Joint Research Programme expenses. Such books and records shall be maintained by Dynavax for at least [ * ] years following the end of the calendar year to which they pertain.

 

     

 

7.3.2

 

Upon the written request of AstraZeneca, Dynavax shall permit a certified public accountant or a person possessing similar professional status and associated with an independent accounting firm reasonably acceptable to the Parties to inspect during regular business hours and no more than once a year

 

     

[   *   ]

=   

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.

7.4

 

Projected Cost Reports . During the Research Term and within [ * ] days after the end of each calendar quarter, Dynavax shall provide the JSC with an [ * ] projected cost report including: FTE hours, reimbursable Joint Research Programme expenses and expected milestone payments by quarter.

 

   

8

 

Development and Commercialization

 

   

8.1

 

Overview. Subject to Dynavax’s option to co-promote Product in accordance with Section 8.5, AstraZeneca shall have sole responsibility for all Development and Commercialization of CDs, Product and Combination Products, including the clinical and commercial manufacturing and supply thereof.

 

   

8.2

 

Development of Product. AstraZeneca shall be responsible for carrying out the Development of any CDs, the Product and any Combination Product. The Development of any CD, the Product or Combination Product(s) shall each be governed by a development plan that describes the proposed overall program of Development (the "Development Plan" ). AstraZeneca shall have the sole right and responsibility for preparing and maintaining the Development Plan for the CD, Product or any Combination Product; provided, however, AstraZeneca shall consider

 

     

[   *   ]

=   

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

 

8.3.1

 

With regard to sharing of Regulatory Documentation and Regulatory Filings, each Party shall provide the other Party with reasonable access, and shall provide the other Party with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement, all of its, its Affiliates’ and their respective suppliers’ Regulatory Documents, Regulatory Filings, and Health Registration Approvals for Product or any Combination Product.

 

     

 

8.3.2

 

Consistent with the Development Plan, but subject to the remainder of this Section 8.3, AstraZeneca shall be responsible for developing Regulatory Documentation and preparing and submitting Regulatory Filings, seeking Health Registration Approvals, and maintaining Health Registration Approvals for Product or any Combination Product, including preparing all reports necessary as part of an IND, NDA, MAA, DMF, BLA or other necessary filing reasonably required for Health Registration Approval.

 

     

 

8.3.3

 

Dynavax, at its sole cost and expense (but subject to the reimbursement provisions of this Section 8.3.3), will provide AstraZeneca with all reasonable assistance required in order to transfer the Know-How to AstraZeneca in a timely manner or assist AstraZeneca with respect to the Development and Commercialization of the Dynavax ISS and/or Collaboration ISS and/or CD and/or the Product and/or the Combination Product(s) (if any). AstraZeneca

 

     

[   *   ]

=   

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.

 

     

 

8.3.4

 

AstraZeneca shall keep Dynav


 
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