Exhibit 10.30

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

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.

--------------------------------------------------------------------------------

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      22    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    4.12    JSC Meetings      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.

 

(i)

 

--------------------------------------------------------------------------------

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      31    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
     42    8.5    Dynavax Option to Co-Promote in the United States      43   
8.6    Pricing, Price Approvals and Product Distribution      44    8.7    Sales
and Inventory      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.

 

(ii)

 

--------------------------------------------------------------------------------

8.8    Advertising and Education      44    8.9    Development and
Commercialization Costs      44    8.10    Diligence Obligations      45    8.11
   Breach of Diligence Obligations      46    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      49    10.1   
Royalties      49    10.2    Combination Products      50    10.3   
Sublicensees      51    10.4    Royalty Stacking      51    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      54    10.10    Royalty Payments      55    10.10    Mode of
Payment      55    10.12    Currency      55    10.13    Interest      55   
10.14    Records Retention; Audit      56    11.    Taxes      56    11.1   
General      56    11.2    Indirect Taxes      57    11.3    Customs Duties     
57    12.    Manufacture and Supply      58    12.1    Preclinical 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.

 

(iii)

 

--------------------------------------------------------------------------------

12.2    Clinical and Commercial Supply      58    12.3    Manufacturing Know-How
Transfer      58    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      62    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      66    14.4    Enforcement of Patent Rights     
67    14.5    Third Party Litigation      68    14.6    Invalidity or
Unenforceability Defences or Actions      69    14.7    Cooperation      71   
14.8    Compliance with Third Party Licences      71    14.9    Costs and
Expenses      71    15.    Adverse Event Reporting      72    15.1    Overview
     72    16.    Product Recall      72    16.1    Notification and Recall     
72    16.2    Recall Expenses      73    17.    Trademarks      73    18.   
Representations and Warranties      73    19.    Indemnification and Insurance
     78    19.1    Indemnification of Dynavax      78    19.2    Indemnification
of AstraZeneca      79    19.3    [ * ]    19.4    Notice of Claim      80   
19.5    Indemnification Procedures      80   

 

[ * ] = 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)

 

--------------------------------------------------------------------------------

19.6    LIMITATION ON DAMAGES      82    19.7    Insurance      83    20.   
Term and Termination      83    20.1    Term      83    20.2    Termination by
AstraZeneca      83    20.3    Termination for Infringement of Third Party
Rights      84    20.4    Termination by Dynavax for Lack of Diligence      84
   20.5    Termination by Either Party      85    20.6    Change of Control     
86    20.7    Consequences of Termination      87    20.8    Survival      90   
20.9    Rights in Bankruptcy      90    21.    Force Majeure      91    22.   
Assignment      92    23.    Severability      93    24.    Dispute Resolution
     93    24.1    Disputes      93    24.2    Arbitration      93    24.3   
Arbitrator      94    24.4    Governing Law      94    24.5    Decision      94
   24.6    Award      95    24.7    Costs      96    24.8    Injunctive Relief
     96    24.9    Confidentiality      96    24.10    Survivability      96   
24.11    Jurisdiction      96    24.12    Patents and Trademarks      97   
24.13    Provisions Unique to Arbitrations Pursuant to Section 8.10      97   
25.    Notices      97    25.1    Notice Requirements.      97    25.2   
Address for Notice      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.

 

(v)

 

--------------------------------------------------------------------------------

26.    Relationship of the Parties      98    27.    Entire Agreement      99   
28.    English Language      99    29.    Amendment      99    30.    Waiver and
Non-Exclusion of Remedies      100    31.    No Benefit to Third Parties     
100    32.    Equitable Relief      100    33.    Further Assurance      101   
34.    Expenses      102    35.    Counterparts      102   

 

[ * ] = 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)

 

--------------------------------------------------------------------------------

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 1 of 103

 

--------------------------------------------------------------------------------

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

 

[ * ] = 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 103

 

--------------------------------------------------------------------------------

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 3 of 103

 

--------------------------------------------------------------------------------

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

 

[ * ] = 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 103

 

--------------------------------------------------------------------------------

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

 

[ * ] = 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 103

 

--------------------------------------------------------------------------------

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 6 of 103

 

--------------------------------------------------------------------------------

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 7 of 103

 

--------------------------------------------------------------------------------

  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 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.

 

[ * ] = 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 103

 

--------------------------------------------------------------------------------

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.

 

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

 

[ * ] = 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 103

 

--------------------------------------------------------------------------------

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.

 

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.

 

[ * ] = 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 103

 

--------------------------------------------------------------------------------

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 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

 

[ * ] = 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 103

 

--------------------------------------------------------------------------------

  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, 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.

 

[ * ] = 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 103

 

--------------------------------------------------------------------------------

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.

 

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 [ * ].

 

[ * ] = 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 103

 

--------------------------------------------------------------------------------

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.

 

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).

 

[ * ] = 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 103

 

--------------------------------------------------------------------------------

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 [ * ].

 

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 [ * ].

 

[ * ] = 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 103

 

--------------------------------------------------------------------------------

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 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.

 

[ * ] = 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 103

 

--------------------------------------------------------------------------------

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 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.

 

[ * ] = 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 103

 

--------------------------------------------------------------------------------

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 third 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 third 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 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

 

[ * ] = 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 18 of 103

 

--------------------------------------------------------------------------------

  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, 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

 

[ * ] = 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 19 of 103

 

--------------------------------------------------------------------------------

  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 the performance of
its obligations under this Agreement. The costs incurred by Dynavax in
subcontracting activities under the Joint 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.

 

Page 20 of 103

 

--------------------------------------------------------------------------------

  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 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

 

[ * ] = 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 21 of 103

 

--------------------------------------------------------------------------------

  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.

 

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

 

[ * ] = 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 22 of 103

 

--------------------------------------------------------------------------------

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 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.

 

[ * ] = 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 23 of 103

 

--------------------------------------------------------------------------------

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;

 

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

 

[ * ] = 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 24 of 103

 

--------------------------------------------------------------------------------

  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 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.

 

[ * ] = 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 25 of 103

 

--------------------------------------------------------------------------------

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 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.

 

[ * ] = 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 26 of 103

 

--------------------------------------------------------------------------------

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

 

  4.8.9 [ * ]

 

[ * ] = 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 27 of 103

 

--------------------------------------------------------------------------------

  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 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

 

[ * ] = 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 28 of 103

 

--------------------------------------------------------------------------------

  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 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

 

[ * ] = 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 29 of 103

 

--------------------------------------------------------------------------------

  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 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.

 

[ * ] = 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 30 of 103

 

--------------------------------------------------------------------------------

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 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.

 

[ * ] = 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 31 of 103

 

--------------------------------------------------------------------------------

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

 

  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 [ * ].

 

[ * ] = 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 32 of 103

 

--------------------------------------------------------------------------------

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 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).

 

[ * ] = 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 33 of 103

 

--------------------------------------------------------------------------------

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
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

 

[ * ] = 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 34 of 103

 

--------------------------------------------------------------------------------

  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 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-

 

[ * ] = 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 35 of 103

 

--------------------------------------------------------------------------------

  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;

 

  (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

 

[ * ] = 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 36 of 103

 

--------------------------------------------------------------------------------

  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 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 [ * ].

 

[ * ] = 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 37 of 103

 

--------------------------------------------------------------------------------

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 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-

 

[ * ] = 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 38 of 103

 

--------------------------------------------------------------------------------

  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
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

 

[ * ] = 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 39 of 103

 

--------------------------------------------------------------------------------

  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 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

 

[ * ] = 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 40 of 103

 

--------------------------------------------------------------------------------

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 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

 

[ * ] = 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 41 of 103

 

--------------------------------------------------------------------------------

  during such Development or Commercialization, Dynavax will send appropriate
representatives to AstraZeneca’s facilities, provided that AstraZeneca shall
reimburse Dynavax, in addition to the FTE costs of such Dynavax representatives,
at the FTE Rate defined in Section 1.52, for its reasonable and verifiable
expenses of travel and accommodations for such representatives.

 

  8.3.4 AstraZeneca shall keep Dynavax informed on an ongoing basis regarding
the schedule and process for Regulatory Documents and Regulatory Filings.
AstraZeneca shall prepare all responses to correspondence that are received from
any regulatory agency relating to any Regulatory Documents and any Regulatory
Filing. If and when a Health Registration Approval is obtained in any country of
the Territory, AstraZeneca shall promptly inform Dynavax of such Health
Registration Approval.

 

  8.3.5 In conducting any Development activities hereunder, AstraZeneca shall
use Commercially Reasonable Efforts to ensure that its employees, agents,
clinical institutions and clinical investigators comply with all FDA statutory
and regulatory requirements with respect to the CDs, Product or any Combination
Product, including but not limited to: the Federal Food, Drug and Cosmetic Act,
as amended (FFDCA), the Public Health Service Act (PHSA), regulatory provisions
regarding protection of human subjects, financial disclosure by clinical
investigators, Institutional Review Boards (IRB), GCP, GLP, IND regulations, and
any conditions imposed by a reviewing IRB or the FDA.

 

8.4 Commercialization of Product and Combination Product. Subject to Dynavax’s
option to co-promote Product with AstraZeneca in the United States of America,
AstraZeneca shall have exclusive rights throughout the Territory over the
Commercialization of all Product and Combination Product(s), including the
supply of Product or Combination Product for use in all such Commercialization
activities. AstraZeneca shall keep Dynavax informed about all of AstraZeneca’s
efforts to Commercialize the Product or any Combination Product, including
summaries of AstraZeneca’s, and its Sublicensees’ marketing plans, as updated,
and significant developments in the Commercialization of the Product and/or
Combination Product(s).

 

[ * ] = 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 42 of 103

 

--------------------------------------------------------------------------------

8.5 Dynavax Option to Co-Promote in the United States AstraZeneca recognises
that Dynavax wishes to increase its capability for developing and
commercialising pharmaceutical products in the future. Following written notice
from AstraZeneca that it has decided to [ * ], Dynavax shall have an option to
negotiate with AstraZeneca terms under which Dynavax may co-promote the Product
in the United States of America. In order for Dynavax to be eligible to
co-promote Product in the United States of America, Dynavax must [ * ].

In the event that Dynavax [ * ] and wishes to commence discussions with
AstraZeneca to co-promote Product in the United States of America, Dynavax shall
notify AstraZeneca in writing. The Parties shall meet to discuss such
co-promotion in the United States of America within [ * ] days after receipt by
AstraZeneca of such notification.

The Parties shall thereafter [ * ]. If the Parties agree on such terms, the
Parties shall seek to enter into a written co-promotion agreement including
mechanisms for participation and reward commensurate with the contributions of
each Party. [ * ]. In no event shall Dynavax’s promotional effort exceed [ * ]
of the total estimated promotional effort in the United States of America
without AstraZeneca’s prior written agreement.

In the event that the Parties enter into a written co-promotion agreement
pursuant to this Section 8.5, Dynavax shall be legally responsible and liable
for the actions, omissions and conduct of all members of its sales force and
other employees providing services thereunder. Dynavax shall ensure that all
such persons comply with:

 

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

 

  8.5.2 AstraZeneca’s US business policies, as amended from time to time by
AstraZeneca.

 

[ * ] = 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 43 of 103

 

--------------------------------------------------------------------------------

8.6 Pricing, Price Approvals and Product Distribution. AstraZeneca shall
determine the overall pricing strategy for the Product or any Combination
Product in the Territory. AstraZeneca shall obtain such Product and/or
Combination Product pricing approvals as may be required and arrange for
distribution of the Product or Combination Product in each applicable country in
the Territory.

 

8.7 Sales and Inventory. AstraZeneca shall be responsible for booking sales,
stocking inventory for itself and its Sublicensees, distributing Product and
Collaboration Product(s) and collecting accounts receivable.

 

8.8 Advertising and Education.

 

  8.8.1 AstraZeneca shall be responsible for developing or having developed
advertising and education materials for the Product or any Combination
Product(s). AstraZeneca shall have the authority to select Trademarks for the
Product and Combination Products and shall own all Trademarks in accordance with
Article 17.

 

  8.8.2 If any written and visual promotion or educational materials for the
Product or any Combination Product refer to or identify either of the Parties,
AstraZeneca and Dynavax shall both be presented and described. Any such
materials that specifically refer to any Party shall be subject to prior review
and comment by that Party. All labelling, documentary information, promotional
material and oral presentations (where practical) regarding the detailing and
promoting of the Product or any Combination Product shall display the names and
logos of each Party.

 

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

 

8.9 Development and Commercialization Costs. Except as otherwise specified in
Section 8.5 above, AstraZeneca shall be responsible for all costs associated
with the Development and Commercialization of any CDs, the Product or any
Combination Product. If AstraZeneca requests Dynavax’s assistance with certain
tasks related to the Development or Commercialization of any CDs, the Product or
any Combination

 

[ * ] = 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 44 of 103

 

--------------------------------------------------------------------------------

  Product, and Dynavax agrees to assist, then AstraZeneca shall reimburse
Dynavax for any reasonable costs Dynavax should incur associated with such
tasks. Within [ * ] days after the end of each calendar quarter, Dynavax shall
submit to AstraZeneca an accounting of all costs Dynavax incurs pursuant to the
Development or Commercialization of any CDs, the Product or any Combination
Product during that quarter. Such summary may include an allocation of time
spent by Dynavax personnel in conducting such Development or Commercialization
activities, that shall be reimbursed at the FTE Rate. AstraZeneca shall on a
quarterly basis, within [ * ] days after the end of each quarter, prepare and
submit to Dynavax a reimbursement of the costs incurred by Dynavax, subject to
receipt by AstraZeneca of an invoice in respect of such payment.

 

8.10 Diligence Obligations.

 

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

 

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

 

  (b) if at any time AstraZeneca determines that it will cease Development of
the Lead Candidate Drug or any Lead CD, then AstraZeneca shall choose another
CD, or shall make a CD Nomination from the [ * ], for Development within [ * ]
months of such determination;

 

  (c) to endeavour to complete the Development of the Lead CD or Product in a
way which [ * ]; and

 

  (d) to endeavour to [ * ];

provided, however, that such obligations are expressly conditioned upon Dynavax
and its Affiliates performing their respective obligations hereunder and such
obligations of AstraZeneca shall be delayed or suspended as long as

 

[ * ] = 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 45 of 103

 

--------------------------------------------------------------------------------

any such condition exists. Further, Dynavax acknowledges and agrees that nothing
in this Section 8.10 is intended, or shall be construed, to require AstraZeneca
to Develop or Commercialise a specific CD as the Lead CD or Product, or a
specific Combination Product, if the Product does not proceed. In the event that
AstraZeneca decides to discontinue the Development or Commercialization of any
CD as the Lead CD or the Product in favour of another CD, or if it decides to
discontinue the Development or Commercialization of the Product in favour of a
Combination Product its obligations under this Section 8.10 shall cease with
respect to such initial CD or the Product (as appropriate) in favour of such
other CD or Combination Product. AstraZeneca shall perform its obligation under
this Section 8.10 in good scientific manner and in compliance in all material
respects with all Applicable Law. Upon satisfaction of its obligations under
this Section 8.10, AstraZeneca shall be deemed to satisfy all diligence
obligations owed to Dynavax hereunder, whether contractually or under Applicable
Law, with respect to the Development or Commercialization of the CDs, Product or
a Combination Product, and shall have no other obligation, express or implied,
to Develop or Commercialize any CD, Product or any Combination Product.

 

  8.10.2 Dynavax shall use Commercially Reasonable Efforts to fulfil Dynavax’s
Research obligations under the Joint Research Plan for any Dynavax ISS or
Collaboration ISS according to timelines agreed upon by the JSC.

 

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

 

8.11 Breach of Diligence Obligations.

 

  8.11.1 Notification and Meeting. If at any time Dynavax has a reasonable basis
to believe that AstraZeneca is in material breach of its material obligations
under Section 8.10, then Dynavax shall so notify AstraZeneca, specifying the
basis for its belief, and the Parties shall meet within [ * ] days after such
notice to discuss in good faith Dynavax’s concerns and AstraZeneca’s Development
and Commercialisation plans with respect to any CD, the Product or any
Combination Product.

 

[ * ] = 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 46 of 103

 

--------------------------------------------------------------------------------

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

 

8.12 Reversion; Abandonment.

 

  8.12.1 In the event that AstraZeneca abandons or puts the development of a
Lead CD on hold for a consecutive period of time exceeding [ * ] months or an
aggregate period of time exceeding [ * ] months in any [ * ]-month period, and
during such period [ * ], then AstraZeneca shall notify Dynavax in writing.
Dynavax may (but is not so obligated), within [ * ] months from receipt of such
notification, provide written notice to AstraZeneca requesting that such Lead CD
become a Reverted ISS and cease to be a Collaboration ISS or CD. Upon receipt of
such notice by AstraZeneca, such CD shall be included in the license grant under
Section 6.3.

For the avoidance of doubt, the foregoing time periods shall not include any
period of time during which AstraZeneca is [ * ]. AstraZeneca shall have the
right to satisfy its obligations under this Section 8.12 through one or more
Affiliates, Sublicensees or subcontractors.

 

  8.12.2 In the event that Dynavax fails to make a written request to
AstraZeneca pursuant to Section 8.12.1, within [ * ] months following the date
on which

 

[ * ] = 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 47 of 103

 

--------------------------------------------------------------------------------

  Dynavax received from AstraZeneca the written notice referred to in the first
sentence of such Section 8.12.1, AstraZeneca shall be under no further
obligation to grant Dynavax any license or other rights to such CD or to make
any such above said assignments and AstraZeneca shall retain its exclusive
rights and ownership to such CD pursuant to Article 6.

 

  8.12.3 In the event of any abandonment of a CD by AstraZeneca and reversion to
Dynavax pursuant to Section 8.12.1, AstraZeneca shall, [ * ]; provided, however,
that Dynavax’s above said rights shall be subject to [ * ].

 

9 Milestone Payments

 

9.1 Total Obligation. Unless the Parties agree in writing otherwise, the access
fee, milestone payments and royalty payments payable by AstraZeneca to Dynavax
pursuant to this Article 9 and Article 10, taken together with the funding to be
provided by AstraZeneca to Dynavax pursuant to Article 7, represent all of
AstraZeneca’s financial obligations to Dynavax hereunder and Dynavax shall not
be entitled to any additional compensation or remuneration from AstraZeneca
under this Agreement.

 

9.2 Access Fee. AstraZeneca shall pay to Dynavax within ten (10) days following
the Effective Date an access fee of ten million US Dollars ($10,000,000) subject
to receipt by AstraZeneca of an invoice in respect of such payment. Such access
fee shall be non-refundable and non-creditable against future milestones and
royalties payable pursuant to this Agreement.

 

[ * ] = 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 48 of 103

 

--------------------------------------------------------------------------------

9.3 Joint Research Programme Milestones. AstraZeneca shall pay to Dynavax a
milestone payment in respect of each of the following Research and Development
events in the particular amounts specified below (in each case subject to
receipt of an invoice in respect of each such payment) no later than [ * ] days
following the occurrence of such milestone event as reasonably determined by
AstraZeneca or the JSC as applicable (whether such milestone event is achieved
by AstraZeneca, its Affiliate or any of their respective Distributors or
Sublicensees) (each a “Joint Research Programme Milestone”). AstraZeneca shall
make the corresponding non-refundable and non-creditable payments to Dynavax, as
follows:

 

  9.3.1 four million five hundred thousand US Dollars ($4,500,000) within [ * ]
days following the first CD Nomination Date;

 

     [ * ]

 

9.4 Development Milestones. AstraZeneca shall pay to Dynavax a milestone payment
in respect of each of the following events in the particular amounts specified
below (in each case subject to receipt of an invoice in respect of each such
payment) no later than [ * ] days following the first occurrence of such
milestone event (whether such milestone event is achieved by AstraZeneca, its
Affiliate or any of their respective Sublicensees) (each a “Development
Milestone”), AstraZeneca shall make the corresponding non-refundable and
non-creditable payments to Dynavax, as follows:

 

     [ * ]

 

9.5 Milestone Payments. Each of the payments in relation to the Joint Research
Programme Milestones set forth under Section 9.3 and Development Milestones set
forth under Section 9.4 shall be made by AstraZeneca no more than once under
this Agreement, collectively together with the Access Fee set forth in
Section 9.2, amounting to an aggregate maximum amount of [ * ], irrespective of
the number of CDs that have achieved the milestone events set forth in
Sections 9.3 and 9.4 or the number of countries or Major Markets in which such
milestone events have been achieved. AstraZeneca shall promptly notify Dynavax
in writing of the achievement of any milestone; provided that AstraZeneca’s
failure to do so shall not be construed as the non-occurrence of any milestone
event.

 

10 Royalty Payments and Other Payment-Related Provisions

 

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

 

  10.1.1 [ * ] on the portion of Annual Net Sales not exceeding [ * ]; and

 

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

 

[ * ] = 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 49 of 103

 

--------------------------------------------------------------------------------

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

 

  10.1.4 [ * ] on the portion of Annual Net Sales exceeding [ * ].

 

     As used herein, “Annual Net Sales” means the Net Sales made during a given
calendar year.

 

     The calculation of royalties under this Section 10.1 shall be conducted as
aggregate Net Sales for all Product and Combination Products for the applicable
calendar year.

 

10.2 Combination Products. With respect to Combination Products, the Annual Net
Sales used for the calculation of the royalties under Section 10.1 shall be
determined as follows:

 

         A      

x

   Net Sales of the Combination Product, where: A  -  B      A  =      Standard
sales price of the Product, containing the same amount of Dynavax ISS or
Collaboration ISS as the sole active ingredient as the Combination Product in
question, in the given country. B  =      standard sales price of the
ready­for­sale form of a product containing the same amount of the other
therapeutically active ingredient(s) that is contained in the Combination
Product in question, in the given country.

In the event, however, that if, in a specific country, (a) the other
therapeutically active ingredient(s) in such Combination Product are not sold
separately in such country, Net Sales shall be adjusted by multiplying actual
Net Sales of such Combination Product by the fraction A/C, where C is the
standard sales price in such country of such Combination Product, and (b) if the
Product containing such Dynavax ISS or Collaboration ISS is not sold separately,
Net Sales shall be calculated by multiplying actual Net Sales of such
Combination Product by the fraction C-B/C, where B is the standard sales price
in such country of the other therapeutically active ingredient(s) in the
Combination Product and C is the standard sales price in such country of the
Combination Product. The standard sales price for the Product containing such
Dynavax ISS or Collaboration ISS and for each other active ingredient shall be
for a

 

[ * ] = 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 50 of 103

 

--------------------------------------------------------------------------------

quantity comparable to that used in such Combination Product and of the same
class, purity and potency. If, in a specific country, both a Product containing
the Dynavax ISS or or Collaboration ISS and a product containing the other
active ingredients in such Combination Product are not sold separately, a market
price for such Product and such other active ingredients shall be negotiated by
the Parties in good faith based upon the costs, overhead and profit as are then
incurred for such Combination Product and all products then being made and
marketed by AstraZeneca and having an ascertainable market price that are
comparable to such Product or such other active ingredients, as applicable. If,
in a specific country, the foregoing calculations do not fairly represent the
value of the various active ingredients included in a Combination Product, the
allocation of Net Sales for such Combination Product shall be negotiated by the
Parties in good faith.

 

10.3 Sublicensees.

 

  10.3.1 In the event that an AstraZeneca Sublicensee sells Product or a
Combination Product to Third Parties in the [ * ], such sales shall [ * ].

 

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

 

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

 

10.4 Royalty Stacking.

 

  10.4.1 For the Product or any Combination Product(s) sold by AstraZeneca or
its Affiliates to Third Parties (including Distributors), where the sum of
royalty payments (excluding any royalty on delivery devices) owed by AstraZeneca
and its Affiliates to Dynavax and any Third Parties in any calendar year exceeds
[ * ] of Net Sales for a given Product or Combination Product for that period,
the royalty rate payable to Dynavax shall be reduced [ * ] such that the
aggregate royalty rate payable by AstraZeneca on the Product or Combination
Product, [ * ], would equal [ * ] of Net Sales thereof.

 

[ * ] = 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 51 of 103

 

--------------------------------------------------------------------------------

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

 

10.5 [ * ] Royalty and [ * ].

 

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

 

  10.5.2 (a) To the extent that royalties payable by AstraZeneca under this
Article 10, taken as a whole, [ * ], Dynavax shall [ * ] as a result of [ * ].
To the extent payments to Third Parties in respect of matters described in the
previous sentence [ * ], then AstraZeneca shall [ * ].

 

       (b) In the event of a cross-license with a Third Party which includes
payments described in Section 10.5.2(a), the Party or Parties which is/are
responsible for the payment under Section 10.5.2(a) shall [ * ].

 

       (c) In the event either Party makes payments to a Third Party in respect
of the matters described in paragraph (a) of this Section 10.5.2 prior to the
commencement of Net Sales, such payment obligation shall [ * ].

 

[ * ] = 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 52 of 103

 

--------------------------------------------------------------------------------

10.6 Reduction of Royalty .

 

  10.6.1 Competition. In the event that, in a country in the Territory, generic
competition with respect to the Product or a Combination Product occurs by a
product or products having [ * ] (each such product, a “Competing Product”), and
such Competing Product has any sales in a Calendar Quarter in such country, then
for the purposes of calculating the royalties of such Product or Combination
Product under Section 10.1, then, subject to Section 10.7, [ * ] of the Net
Sales in such country shall be disregarded. The calculation of the royalty
reduction under this Section 10.6.1 shall be conducted separately for each
Product or Combination Product.

If the number of units sold of a Competing Product represents [ * ] of the
aggregate number of units sold of all products in the relevant [ * ] class to
which the Product or Collaboration Product has been allocated, including the
Product and any Combination Product, in a country in the Territory as reported
by [ * ] or any comparable reporting agency in a Calendar Year, then AstraZeneca
shall have the right, but not the obligation, to [ * ].

 

  10.6.2 Compulsory Licences. In the event that a court or a governmental agency
of competent jurisdiction requires AstraZeneca or an AstraZeneca Affiliate or
Sublicensee to grant a compulsory licence to a Third Party permitting such Third
Party to make and sell the Product or any Combination Products in a country in
the Territory, then for the purposes of calculating the royalties of the Product
or Combination Product under Section 10.1, [ * ] of the Net Sales in the country
in such country shall be disregarded. The calculation of the royalty reduction
under this Section 10.6.2 shall be conducted separately for each Product or
Combination Product. In any country where the royalty reduction of
Section 10.6.1 or 10.6.2 is in effect, there shall not be any further royalty
reduction pursuant to this Section 10.6.2.

 

  10.6.3 No Valid Claim. In the event that, and in such case from and after the
date on which, a Product or Combination Product is Developed and/or
Commercialized in a country and is not covered by a Valid Claim or other
governmental grant of exclusivity (for example, but without limitation, orphan

 

[ * ] = 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 53 of 103

 

--------------------------------------------------------------------------------

  drug status, Chinese monitoring period exclusivity, or any other governmental
grant of exclusivity of equivalent effect) in such country, then for the
purposes of calculating the royalties of such Product or Combination Product
under Section 10.1, [ * ] of the Net Sales in such country shall be disregarded.

 

10.7 Royalty Floor. Notwithstanding anything to the contrary in this Agreement
except for Section 10.6.2, during the Royalty Term, in no event shall the net
royalty rate received by Dynavax from the sale of Products be reduced to less
than [ * ] of Net Sales (as determined before any reductions provided for in
this Article 10 other than Section 10.6.2) for the period of time when Dynavax
makes royalty payments to [ * ] as set forth in Section 10.5, or to less than [
* ] of such Net Sales thereafter. Dynavax shall promptly notify AstraZeneca in
writing when payments to [ * ] as set forth in Section 10.5 are no longer being
made.

 

10.8 Royalty Term. AstraZeneca’s obligation to pay royalties shall commence, on
a country-by-country basis, with respect to each separate Product or Combination
Product, on the date of First Commercial Sale of such Product or Combination
Product in such country. The obligation shall expire, on a country-by-country
basis, with respect to each separate Product or Combination Product on the later
to occur of (a) the [ * ] anniversary of the First Commercial Sale of the first
Product in such country and (b) the expiration date in such country of the last
to expire of any issued Collaboration Patent or Dynavax Patent that includes at
least one Valid Claim covering the sale of such separate Product or Combination
Product in such country (such period, the “Royalty Term”).

Upon termination of the royalty obligations of AstraZeneca under this
Section 10.8, with respect to a Product or Combination Product in any country,
the licence grants to AstraZeneca in Section 6.2 shall become fully paid-up,
perpetual and irrevocable with respect to such country and the Net Sales of such
Product or Combination Product in such country shall be excluded from the
royalty calculations in this Article 10 (including the thresholds and ceilings).

 

10.9 Sales Subject to Royalties. Sales between AstraZeneca, its Affiliates and
Sublicensees shall not be subject to royalties hereunder. Royalties shall be
calculated on AstraZeneca’s and its Affiliates’ and Sublicensees’ sale of the
Product or Combination Products to a Third Party (including Distributors).
Royalties shall be

 

[ * ] = 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 54 of 103

 

--------------------------------------------------------------------------------

  payable only once for any given batch of the Product or Combination Products.
For purposes of determining Net Sales, the Product or Combination Product, as
appropriate, shall be deemed to be sold when invoiced and a “sale” shall not
include, and no royalties shall be payable on, transfers by AstraZeneca, its
Affiliates or Sublicensees of free samples of Products, Combination Products or
clinical trial materials containing Dynavax ISS and/or Collaboration ISS or
other transfers or dispositions for charitable, promotional, pre-clinical,
clinical, manufacturing, testing or qualification, regulatory or governmental
purposes.

 

10.10 Royalty Payments. The royalties shall be calculated quarterly as of the
last day of March, June, September and December respectively, for the calendar
quarter ending on that date. AstraZeneca shall pay the royalties in conjunction
with the delivery of a written report to Dynavax within [ * ] days after the end
of each calendar quarter that shows, with respect to each country and the
Product or Combination Product(s), the sales volume and Net Sales, by country,
of each Product or Combination Product sold during such calendar quarter.

 

10.11 Mode of Payment. All payments set forth in this Article 10 shall be
remitted by wire transfer to the following bank account of Dynavax or such other
account as Dynavax may designate in writing to AstraZeneca:

 

     [ * ]

 

10.12 Currency. All payments required under this Agreement shall be made in U.S.
Dollars. For the purpose of computing the Net Sales of Product or Combination
Products sold in a currency other than U.S. Dollars, such currency shall be
converted from local currency to U.S. Dollars by AstraZeneca in accordance with
the rates of exchange for the relevant month for converting such other currency
into U.S. Dollars used by AstraZeneca’s normal internal accounting systems,
which are independently audited on an annual basis.

 

10.13 Interest. Unless any payment potentially due to Dynavax under this
Agreement is in dispute, and in such circumstances from the date upon which such
dispute is resolved, if AstraZeneca fails to make any payment due to Dynavax
under this Agreement, then interest shall accrue on a daily basis at a rate
equal to the thirty (30) day U.S. dollar LIBOR rate effective for the date that
payment was due, as published by The Wall Street Journal (Western edition) plus
[ * ].

 

[ * ] = 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 55 of 103

 

--------------------------------------------------------------------------------

10.14 Records Retention; Audit.

 

  10.14.1 AstraZeneca shall keep or cause to be kept accurate records or books
of account in accordance with applicable generally accepted accounting
principles showing the information that is necessary for the accurate
determination of the royalties due hereunder with respect to the sale of such
Product or Combination Product.

 

  10.14.2 Upon the written request of Dynavax, AstraZeneca shall permit a
certified public accountant or a person possessing similar professional status
and associated with an independent accounting firm acceptable to the Parties to
inspect during regular business hours and no more than once a year and going
back no more than [ * ] years preceding the current year, all or any part of
AstraZeneca’s records and books necessary to check the accuracy of the royalties
paid. The accounting firm shall enter into appropriate obligations with
AstraZeneca to treat all information it receives during its inspection in
confidence. The accounting firm shall disclose to Dynavax and AstraZeneca only
whether the royalty reports are correct and details concerning any
discrepancies, but no other information shall be disclosed to Dynavax. The
charges of the accounting firm shall be paid by Dynavax, except that if the
royalties have been understated by more than [ * ], the charges shall be paid by
AstraZeneca. AstraZeneca shall promptly pay to Dynavax the amount of any
underpayment of royalties revealed by an examination and review. Any overpayment
of royalties by AstraZeneca revealed by an examination and review shall be
fully-creditable against future royalty payments under Sections 10.1.

 

11 Taxes

 

11.1 General. The royalties, milestones and other amounts payable by AstraZeneca
to Dynavax pursuant to this Agreement (“Payments”) shall not be reduced on
account of any taxes unless required by Applicable Law. Dynavax alone shall be
responsible for paying any and all taxes (other than withholding taxes required
by Applicable Law

 

[ * ] = 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 56 of 103

 

--------------------------------------------------------------------------------

  to be paid by AstraZeneca) levied on account of, or measured in whole or in
part by reference to, any Payments it receives. AstraZeneca shall deduct or
withhold from the Payments any taxes that it is required by Applicable Law to
deduct or withhold. Notwithstanding the foregoing, if Dynavax is entitled under
any applicable tax treaty to a reduction of the rate of, or the elimination of,
any applicable withholding tax, it may deliver to AstraZeneca or the appropriate
governmental authority (with the assistance of AstraZeneca to the extent that
this is reasonably required and is expressly requested in writing) the
prescribed forms necessary to reduce the applicable rate of withholding or to
relieve AstraZeneca of its obligation to withhold tax, and AstraZeneca shall
apply the reduced rate of withholding, or dispense with withholding, as the case
may be, provided that AstraZeneca has received evidence, in a form satisfactory
to AstraZeneca, of Dynavax’s delivery of all applicable forms (and, if
necessary, its receipt of appropriate governmental authorization) at least [ * ]
days prior to the time that the Payments are due. If, in accordance with the
foregoing, AstraZeneca withholds any amount, it shall pay to Dynavax the balance
when due, make timely payment to the proper taxing authority of the withheld
amount, and send to Dynavax proof of such payment within [ * ] days following
that payment. For purposes of this Agreement, the stated amount of the Payments
payable by AstraZeneca includes any sales tax that Dynavax may be required to
collect.

 

11.2 Indirect Taxes. Notwithstanding anything contained in Section 11.1 or this
Section 11.2 shall apply with respect to Indirect Taxes. All Payments are
exclusive of Indirect Taxes. If any Indirect Taxes is chargeable in respect of
any Payments, AstraZeneca shall pay Indirect Taxes at the applicable rate in
respect of any such Payments following the receipt of an Indirect Taxes invoice
in the appropriate form issued by Dynavax in respect of those Payments, such
Indirect Taxes to be payable on the due date of the payment of the Payments to
which such Indirect Taxes relate.

 

11.3 Customs Duties. The Parties shall co-operate in accordance with Applicable
Laws to ensure where permissible no import duties are paid on imported clinical
product. Where import duties are payable, the Parties shall co-operate to ensure
that the Party responsible for shipping as identified in the Joint Research Plan
values the clinical product in accordance with Applicable Laws and minimises
where permissible any such duties and any related import taxes that are not
reclaimable from the relevant authorities.

 

[ * ] = 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 57 of 103

 

--------------------------------------------------------------------------------

12 Manufacture and Supply.

 

12.1 Preclinical Supply. Dynavax shall be responsible (at the expense of
AstraZeneca), through either internal production capabilities or Third Party
manufacturers approved by the JSC, for the manufacture [ * ] of preclinical
Dynavax ISS or Collaboration ISS for use in the Joint Research Programme through
the Primary Screening Phase and Secondary Screening Phase for any such Dynavax
ISS or Collaboration ISS. AstraZeneca shall be solely responsible for all costs
and expenses related to the manufacture and supply of preclinical Dynavax ISS or
Collaboration ISS for use in the Joint Research Programme (other than those
costs set forth in Section 3.5.4 as included in the FTE Rate) and shall
reimburse Dynavax any reasonable costs or expenses it incurs therefor.
AstraZeneca shall be responsible for, or shall procure the final formulation and
packaging, including any inhalation device, of the Product or any Combination
Product for preclinical use.

 

12.2 Clinical and Commercial Supply. AstraZeneca shall be responsible for, or
shall procure, the manufacture of toxicology, clinical and commercial materials,
including without limitation any Candidate Drug, Product or Combination Product
in the Territory and for all costs associated therewith. AstraZeneca shall use
Commercially Reasonable Efforts to make necessary filings to obtain, or cause a
Third Party manufacturer to obtain, Health Registration Approval for the
manufacture of Candidate Drugs or Product or any Combination Product(s) in the
Territory.

 

12.3 Manufacturing Know-How Transfer. Dynavax shall transfer to AstraZeneca any
manufacturing technology, material and data sufficient to enable AstraZeneca (or
its nominee) to produce and supply toxicology, clinical and commercial Candidate
Drug for use in the Product or a Combination Product. Dynavax shall provide
reasonable assistance to AstraZeneca to effect such transfers in an orderly
fashion and to enable AstraZeneca to begin manufacturing and supplying
toxicology, clinical and commercial supply of Candidate Drug for use in the
Product or a Combination Product.

 

[ * ] = 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 58 of 103

 

--------------------------------------------------------------------------------

13 Confidentiality and Non-Disclosure

 

13.1 General Obligations.

 

  13.1.1 At all times during the term of this Agreement and for a period of [ *
] years following termination or expiration hereof, each Party (the “Receiving
Party”) shall, and shall cause its officers, directors, employees, agents,
Affiliates, Distributors and Sublicensees to, keep confidential and not publish
or otherwise disclose and not use, directly or indirectly, for any purpose, any
Confidential Information provided to it by the other Party (the “Disclosing
Party”), except to the extent such disclosure or use is expressly permitted by
the terms of this Agreement or is reasonably necessary for the performance of
this Agreement.

 

  13.1.2 Dynavax recognises that by reason of AstraZeneca’s status as an
exclusive licensee pursuant to certain grants under Article 6, AstraZeneca has
an interest in Dynavax’s retention in confidence of certain information of
Dynavax. Accordingly, until the expiration of AstraZeneca’s exclusive position
with respect to any CD, the Product or a Combination Product under this
Agreement, Dynavax shall, and shall cause its Affiliates and their respective
officers, directors, employees and agents to, keep confidential, and not publish
or otherwise disclose, and not use directly or indirectly for any purpose that
would cause such publication or disclosure, any information relating to (a) the
CD, the Product or a Combination Product, including the Dynavax ISS or
Collaboration ISS therein, or (b) the Research, Development and/or
Commercialization of such Product or Combination Product, including the
Development Plans therefor (collectively the “AstraZeneca Information”); except
to the extent (a) the AstraZeneca Information is in the public domain through no
fault of Dynavax, its Affiliates or any of their respective officers, directors,
employees and agents, (b) such disclosure or use would be permitted under
Section 13.2, or (c) such disclosure or use is otherwise expressly permitted by
the terms of this Agreement or is reasonably necessary for the performance of
this Agreement. For clarification, the disclosure by Dynavax to AstraZeneca or
by AstraZeneca to Dynavax of AstraZeneca Information shall not cause such
information to cease to be subject to the confidentiality provisions of this
Section 13.1.

 

[ * ] = 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 59 of 103

 

--------------------------------------------------------------------------------

       Notwithstanding the foregoing, in the event Dynavax obtains an exclusive
license under the AstraZeneca Technology in accordance with Section 20.7.3,
Dynavax shall be relieved of the foregoing obligations and AstraZeneca, instead
of Dynavax, shall, and shall cause its Affiliates and their respective officers,
directors, employees and agents to, keep confidential, and not publish or
otherwise disclose, and not use directly or indirectly for any purpose that
would cause such publication or disclosure, any information relating to the
AstraZeneca Information, except to the extent (a) the AstraZeneca Information is
in the public domain through no fault of AstraZeneca, its Affiliates or any of
their respective officers, directors, employees and agents, (b) such disclosure
or use would be permitted under Section 13.2, or (c) such disclosure or use is
otherwise expressly permitted by the terms of this Agreement or is reasonably
necessary for the performance of this Agreement.

 

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

 

  13.2.1 made in response to a valid order of a court of competent jurisdiction
or other competent authority; provided, however, that the Receiving Party shall
first have given notice to the Disclosing Party (if feasible) and given the
Disclosing Party a reasonable opportunity to quash any such order or obtain a
protective order requiring that the Confidential Information and documents that
are the subject of such order be held in confidence by such court or authority
or, if disclosed, be used only for the purpose for which the order was issued;
and provided further that if such order is not quashed or a protective order is
not obtained, the Confidential Information disclosed in response to such court
or governmental order shall be limited to that information that is legally
required to be disclosed in response to such court or governmental order;

 

  13.2.2 made to a Regulatory Authority as may be necessary or useful in
connection with any filing, application or request for a Health Registration
Approval; provided, however, that reasonable measures shall be taken to assure
confidential treatment of such information, to the extent such protection is
available;

 

[ * ] = 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 60 of 103

 

--------------------------------------------------------------------------------

  13.2.3 made by the Receiving Party to a patent authority as may be necessary
or useful for purposes of obtaining or enforcing a Patent (consistent with the
terms and conditions of Article 14); provided, however, that reasonable measures
shall be taken to assure confidential treatment of such information, to the
extent such protection is available;

 

  13.2.4 otherwise required by law, provided, however, that the Receiving Party
shall (a) provide the Disclosing Party with reasonable advance notice of and an
opportunity to comment on any such required disclosure, (b) if requested by the
Disclosing Party, seek confidential treatment with respect to any such
disclosure to the extent available, and (c) use good faith efforts to
incorporate the comments of the Disclosing Party in any such disclosure or
request for confidential treatment; or

 

  13.2.5 made by the Receiving Party to its Affiliates, Distributors,
Sublicensees, employees, consultants, or agents as may be necessary or useful in
connection with the Research, Development, or Commercialization of any CD, the
Product or Combination Product(s) as contemplated by this Agreement, or
otherwise in the exercise of its rights with respect to Collaboration Know-How,
including subcontracting or sublicensing transactions in connection therewith;
provided prior to disclosure by the Receiving Party to each of the foregoing
Persons must be bound by similar obligations of confidentiality and non-use at
least equivalent in scope to those set forth in this Article 13.

 

     Notwithstanding the foregoing, in the event that either Party is required
by Applicable Law or the requirements of a national securities exchange or
another similar regulatory body to disclose this Agreement, in whole or in part,
the Parties shall reasonably agree on a redacted version of this Agreement as
necessary to protect the Confidential Information of the Parties prior to making
such disclosure.

 

[ * ] = 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 61 of 103

 

--------------------------------------------------------------------------------

13.3 Exclusions. Notwithstanding the foregoing, Confidential Information shall
not include any information that:

 

  13.3.1 is or hereafter becomes part of the public domain by public use,
publication, general knowledge or the like through no wrongful act, fault or
negligence on the part of the Receiving Party;

 

  13.3.2 can be demonstrated by documentation or other competent proof to have
been in the Receiving Party’s or its Affiliates’ possession prior to disclosure
by the Disclosing Party;

 

  13.3.3 is subsequently received by the Receiving Party or its Affiliates from
a Third Party who is lawfully in possession thereof and not bound by any
obligation of confidentiality with respect to the said information;

 

  13.3.4 has been published by the Disclosing Party; or

 

  13.3.5 is independently developed by or for the Receiving Party or its
Affiliates without the application or use of the Disclosing Party’s Confidential
Information.

 

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

 

13.4 Confidentiality of Agreement. The Parties acknowledge that the terms of
this Agreement shall be treated as Confidential Information of both Parties.
Such terms may be disclosed by a Party to individuals or entities covered by
13.2.5 above, each of whom prior to disclosure must be bound by similar
obligations of confidentiality and non-use at least equivalent in scope to those
set forth in this Article 13. Disclosure of the terms of this Agreement (but not
other Confidential Information received from the other Party) may also be made,
under binders of confidentiality and non-use at least equivalent in scope to
those set forth in this Article 13, to actual or potential bankers, lenders,
investors and acquirors of the disclosing Party.

 

[ * ] = 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 62 of 103

 

--------------------------------------------------------------------------------

13.5 Publications and Presentations. The Parties acknowledge that scientific
publications must be strictly monitored to prevent any adverse effect from
premature publication of results of the research and Development activities
hereunder. Accordingly, during the Research Term neither Party shall publish,
present or otherwise disclose any material related to the Joint Research
Programme or the Development or Commercialization of the CDs or the Product or
any Combination Product(s) without the prior written consent of the JSC and
after the Research Term Dynavax shall not publish, present or otherwise disclose
any material related to the Joint Research Programme or the Development or
Commercialization of the CDs or the Product or any Combination Product(s)
without the prior written consent of AstraZeneca. Each Party’s contribution to
such results shall be duly recognised in such publications. For clarity, nothing
in this Section 13.5 shall limit Dynavax’s right to publish or present, during
the Research Term, the results of any studies carried out by or on behalf of
Dynavax prior to the Effective Date. Each Party agrees to provide the other
Party the opportunity to review any proposed abstracts, manuscripts or
presentations (including verbal presentations) that relate to any Dynavax ISS or
Collaboration ISS or Product or Combination Product studied under the Agreement
at least [ * ] days prior to their intended submission for publication and
agrees, upon request, not to submit any such abstract or manuscript for
publication until the other Party is given a reasonable period of time
(resulting in a total of no more than [ * ] days from the provision of such
abstracts, manuscripts or presentation by one Party to the other for review
until such Party’s submission of such abstracts, manuscripts or presentation for
publication) to secure patent protection for any material in such publication
which it believes to be patentable. Both Parties understand that a reasonable
commercial strategy may require delay of publication of information or filing of
patent applications. The Parties agree to review and decide whether to delay the
publication and filing of patent applications under certain circumstances.
Neither Party shall have the right to publish or present Confidential
Information of the other Party which is subject to Section 13.1. With respect to
any publication or presentation made by AstraZeneca pursuant to this
Section 13.5, but without limiting anything set forth in Section 8.8.2 above,
AstraZeneca shall give meaningful mention to Dynavax’s participation and
contribution to the Collaboration and shall specifically mention the use of
Dynavax Technology in the Dynavax ISS, Collaboration ISS, CDs, Product and/or
any Combination Product.

 

[ * ] = 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 63 of 103

 

--------------------------------------------------------------------------------

13.6 Use of Name/Publicity.

 

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

 

  13.6.2 AstraZeneca and its Affiliates and Sublicensees shall have the right,
with Dynavax’s prior written consent, to use the name of Dynavax and its
Affiliates to the extent necessary or useful in connection with the Development
and Commercialization of Product or Combination Product as contemplated by this
Agreement. Additionally, with respect to any public disclosure made by
AstraZeneca pursuant to this Section 13.6.2, AstraZeneca shall give meaningful
mention to Dynavax’s participation and contribution to the Collaboration and
shall specifically mention the use of Dynavax Technology in the Dynavax ISS,
Collaboration ISS, CDs, Product and/or Combination Product, the mention in such
disclosures to be approved in writing by Dynavax.

 

  13.6.3 An initial press release pertaining to this transaction shall be issued
by the Parties and shall be materially in the form attached as Exhibit E to this
Agreement. Neither Party shall issue any other press release or make any

 

[ * ] = 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 64 of 103

 

--------------------------------------------------------------------------------

  other public announcement or statement concerning this Agreement or the
transactions covered by it without the prior written approval of the other
Party, except that each Party (after consultation with counsel) may make such
announcements and disclosures, if any, as may be required by Applicable Law or
the requirements of a national securities exchange or another similar regulatory
body, or in connection with a public offering of securities or any filing with
the U.S. Securities and Exchange Commission or a foreign equivalent.

 

14 Patent Prosecution, Enforcement and Defence

 

14.1 Disclosure . Each Party shall promptly disclose to the other Party any
invention discovered or reduced to practice pursuant to the Collaboration that
it believes may be patentable.

 

14.2 Patent Prosecution and Maintenance.

 

  14.2.1 Dynavax shall direct the filing, prosecution (including any
interferences, reissue proceedings and re-examinations), oppositions and
maintenance of all Dynavax Patents. Dynavax shall consult with AstraZeneca in
connection with the continued prosecution and maintenance by Dynavax of the
Dynavax Patents and [ * ]. Dynavax shall provide AstraZeneca with [ * ]. Dynavax
shall bear one hundred percent (100%) of the costs and expenses of the Dynavax
Patents. Dynavax shall not abandon any Dynavax Patents without at least [ * ]
days prior notice to AstraZeneca. If Dynavax decides to abandon any Dynavax
Patents, AstraZeneca shall have the option to continue the prosecution and
maintenance of such patents and related applications at its expense.

 

  14.2.2 AstraZeneca shall be the Party (the “Prosecuting Party”) responsible
for or for procuring, the filing, prosecution (including any interferences,
reissue proceedings and re-examinations), oppositions and maintenance of all
Collaboration Patents. AstraZeneca shall consult with Dynavax in connection with
the continued prosecution and maintenance by AstraZeneca of the Collaboration
Patents and [ * ]. AstraZeneca shall provide Dynavax with [ * ]. AstraZeneca
shall bear one hundred percent (100%) of the costs and

 

[ * ] = 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 65 of 103

 

--------------------------------------------------------------------------------

  expenses of the Collaboration Patents. AstraZeneca shall promptly reimburse
Dynavax for any costs or expenses that Dynavax incurs in connection with the
prosecution and maintenance of the Collaboration Patents. AstraZeneca shall not
abandon any such Collaboration Patents without at least [ * ] days prior notice
to Dynavax. If AstraZeneca decides to abandon any such Collaboration Patents,
Dynavax shall have the option to continue the prosecution and maintenance of
such patents and related applications at its expense.

 

  14.2.3 Where a patent application covers two or more Dynavax ISS and/or
Collaboration ISS, at least one of which has a use in the Field and at least one
of which has no use in the Field but a use outside of the Field, the prosecuting
attorney will [ * ].

 

  14.2.4 Each Party shall cooperate with the other and take all reasonable
additional actions and execute such agreements, instruments and documents as may
be reasonably required to perfect the other’s ownership interest in accordance
with the intent of this Agreement including, without limitation, the execution
of necessary and appropriate instruments of assignment to achieve such joint
ownership as set forth in Section 14.1 and the provision, on a reasonable basis,
of its employees, agents, consultants and independent contractors to the other
Party (or to the other Party’s authorized attorneys, agents or representatives),
to the extent reasonably necessary to enable the prosecuting Party to undertake
Patent prosecution for inventions arising out of the Collaboration, as provided
in this Agreement.

 

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

 

[ * ] = 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 66 of 103

 

--------------------------------------------------------------------------------

14.4 Enforcement of Patent Rights.

 

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

 

  14.4.2 In the event that either Party becomes aware of a suspected
infringement of any Collaboration Patent, such Party shall notify the other
Party promptly. Following such notification, the Parties shall confer. Other
than in respect of any Collaboration Patent solely covering a Reverted ISS,
AstraZeneca shall have the right, but shall not be obligated, to bring an
infringement action or to defend such proceedings at its own expense, in its own
name and entirely under its own direction and control. Dynavax, upon request of
AstraZeneca, agrees to join in any such litigation at AstraZeneca’s expense and
to cooperate with AstraZeneca in connection with such litigation. Where
AstraZeneca notifies Dynavax that it does not intend to take measures to remove
such

 

[ * ] = 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 67 of 103

 

--------------------------------------------------------------------------------

  infringement, AstraZeneca may nevertheless be joined as a party to any
infringement action that is pursued and shall retain the right to be heard in
such proceedings and to defend the validity of the Patent asserted by Dynavax.
With respect to any Collaboration Patent solely covering a Reverted ISS, Dynavax
shall have the right, but shall not be obligated, to bring an infringement
action at its own expense, in its own name and entirely under its own direction
and control. AstraZeneca, upon request of Dynavax, agrees to join in any such
litigation at Dynavax’s expense and to cooperate with Dynavax in connection with
such litigation. Where Dynavax notifies AstraZeneca that it does not intend to
take measures to remove such infringement, Dynavax may nevertheless be joined as
a party to any infringement action that is pursued and shall retain the right to
be heard in such proceedings and to defend the validity of the Patent asserted
by AstraZeneca.

 

  14.4.3 If the Party having the first right to prosecute any action described
in Sections 14.4.1 or 14.4.2 fails to do so within (a) [ * ] days following
notice of the alleged infringement or (b) [ * ] days before the time limit, if
any, set forth in the appropriate laws and regulations for the filings of such
actions, whichever comes first, then the other Party shall have the right, but
not the obligation, to bring and control any such litigation at its own expense,
in it own name and entirely under its own direction and control.

 

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

 

14.5 Third Party Litigation. In the event of any actual or threatened suit
against Dynavax, AstraZeneca or its Affiliates, Sublicensees, Distributors or
customers alleging that the Development and/or Commercialization of CDs, Product
or Combination Product, or

 

[ * ] = 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 68 of 103

 

--------------------------------------------------------------------------------

  that the Development and/or Commercialization of a Collaboration Patent or the
Background Technologies or any part thereof by or on behalf of AstraZeneca under
this Agreement, infringes the Patent or other intellectual property rights of
any Person (an “Infringement Suit”), the Party first becoming aware of such
Infringement Suit shall promptly give written notice to the other Party.
AstraZeneca shall have the first right, but not the obligation, through counsel
of its choosing, to assume direction and control of the defence of claims
arising therefrom (including the right to settle such claims at its sole
discretion, subject to the provisions of this Section 14.5). If AstraZeneca
notifies Dynavax in writing that it does not wish to assume such direction and
control, Dynavax shall have the right, but not the obligation to, at its sole
cost and expense, defend against such claims; provided, however, that Dynavax
shall obtain the written consent of AstraZeneca prior to ceasing to defend,
settling or otherwise disposing of such claims. Dynavax shall be entitled to be
joined in any proceedings that may be brought against AstraZeneca in relation to
Dynavax’s Background Technology. If Dynavax does so elect to be joined, it shall
pay its own costs and expenses in relation to the proceedings. AstraZeneca shall
not make any admission or settle or otherwise compromise any proceedings brought
against it in relation to Dynavax’s Background Technology without first
obtaining the written consent of Dynavax, which shall not be unreasonably
withheld or delayed. Notwithstanding anything in the foregoing, each Party shall
have the right to defend itself, using the counsel of its choice and at its own
expense, any claims or law suits brought against it by any Third Party, and each
Party shall have the right to settle any such claims or law suits on its own
behalf, so long as such settlement does not provide for the payment of money by
the other Party or performance obligations, or restrictions imposed upon, the
other Party.

 

14.6 Invalidity or Unenforceability Defences or Actions.

 

  14.6.1 In the event that a Third Party or Sublicensee asserts, as a defence or
as a counterclaim in any Infringement Suit under Section 14.5, that any
AstraZeneca Patent, Dynavax Patent or Collaboration Patent covering a Dynavax
ISS or Collaboration ISS is invalid or unenforceable, then the Party pursuing
such Infringement Suit shall promptly give written notice to the other Party.
AstraZeneca shall have the first right, but not the obligation, through counsel
of its choosing, to respond to such defence or defend against such

 

[ * ] = 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 69 of 103

 

--------------------------------------------------------------------------------

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

 

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

 

[ * ] = 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 70 of 103

 

--------------------------------------------------------------------------------

14.7 Cooperation. The Party other than the Party defending an action or claim
pursuant to this Article 14 (the “Non-Defending Party”) will provide to the
other Party (the “Defending Party”) all reasonable assistance requested by the
Defending Party in connection with any action, claim or suit under Article 14,
including allowing the Defending Party reasonable access to the Non-Defending
Party’s files and documents and to the Non-Defending Party’s personnel who may
have possession of relevant information, in all cases, during normal business
hours and with reasonable prior notice. In particular the Non-Defending Party
will promptly make available to the Defending Party, at the Defending Party’s
expense, all information in its possession or control that it is aware will
assist the Defending Party in responding to any such action, claim or suit under
Article 14.

 

14.8 Compliance with Third Party Licences. To the extent any provision in this
Article 14 is inconsistent with the requirements in any licence agreement
between a Party and any Third Party existing as of the Effective Date (including
without limitation the license agreement between Dynavax and the Regents),
including without limitation the rights and procedures for the filing,
prosecution and maintenance of any Patents, the enforcement of any Patents, or
the defense of any Third Party claims, the terms and conditions in such Third
Party agreement(s) shall control.

 

14.9 Costs and Expenses. AstraZeneca shall have the right to [ * ]. Any
royalties payable by AstraZeneca with respect to the manufacture, use or sale of
Products may result in a reduction of royalties payable to Dynavax, pursuant to
Section 10.4 and subject to Section 10.7. For the avoidance of doubt, where
Indirect Taxes apply to milestones, royalties or costs, the Parties shall
invoice these sums according to Applicable Law. Any amounts recovered by
AstraZeneca in connection with any action, claim or suit under Article 14 shall
first be applied to all out-of-pocket costs and expenses incurred by AstraZeneca
in connection therewith, including reasonable attorneys fees and any such sums
remaining shall be retained by AstraZeneca and shall be included in the
calculation of Net Sales.

 

[ * ] = 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 71 of 103

 

--------------------------------------------------------------------------------

15 Adverse Event Reporting

 

15.1 Overview. AstraZeneca shall maintain a record of all non-medical and
medical Product-related or Combination Product-related complaints and reports of
adverse events that it receives with respect to any Product or Combination
Product as appropriate. AstraZeneca shall be responsible for reporting to
Regulatory Authorities any adverse experiences and safety issues for each
Product and Combination Product in compliance with the requirements of the U.S.
Food, Drug and Cosmetic Act, 21 U.S.C. § 321 et seq., the regulations
promulgated thereunder, and equivalent foreign laws, rules and regulations.
Without limiting the foregoing, upon AstraZeneca’s written request, Dynavax
shall provide AstraZeneca with any information reasonably necessary for
AstraZeneca to comply with all Applicable Law with respect to the Dynavax ISS,
Collaboration ISS, the Product and Combination Product(s), as the case may be.

 

     In the event that Dynavax exercises its option to co-promote the Product or
any Combination Product(s) in the United States of America and the Parties enter
into a written co-promotion agreement pursuant to Section 8.5, Dynavax shall, at
least [ * ] months prior to commencing such co-promotion, develop appropriate
adverse experience reporting procedures to record all non-medical and medical
product-related complaints and reports of adverse events that it receives with
respect to any Product or Combination Product(s).

 

15.2 Complaints. AstraZeneca shall maintain a record of any and all complaints
it receives with respect to the Product and any Combination Products. Dynavax
shall notify AstraZeneca in reasonable detail of any complaint received by it
within [ * ] after the event, and in any event in sufficient time to allow
AstraZeneca to comply with all Applicable Law in any country in which the
Product or any Combination Product is being developed, marketed or sold.

 

16 Product Recall

 

16.1 Notification and Recall. In the event that any Governmental Authority
issues or requests a recall or takes similar action in connection with a CD, the
Product or any Combination Product, or in the event [ * ], AstraZeneca shall
promptly advise Dynavax thereof by telephone or facsimile. Following
notification of a recall,

 

[ * ] = 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 72 of 103

 

--------------------------------------------------------------------------------

  AstraZeneca shall decide and have control of whether to conduct a recall or
market withdrawal (except in the case of a government-mandated recall) in the
Territory and the manner in which any such recall or market withdrawal shall be
conducted.

 

16.2 Recall Expenses. AstraZeneca shall bear the expenses of any recall of a CD,
the Product or any Combination Product; provided, however, that Dynavax shall
bear the expense of a recall to the extent that such recall resulted from
Dynavax’s breach of its obligations hereunder or Dynavax’s negligence or willful
misconduct or intentional omission. Such expenses of recall shall include
expenses for notification, destruction and return of the recalled Product or
Combination Product and any refund to customers of amounts paid for the recalled
Product or Combination Product.

 

17 Trademarks.

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

 

18 Representations and Warranties

 

18.1 Each Party represents and warrants to the other that:

 

  18.1.1 it has full legal power to extend the rights and licences granted to
the other under this Agreement and perform its obligations hereunder;

 

  18.1.2 it has full power and authority to enter into this Agreement and has
taken all necessary action on its part required to authorise the execution and
delivery of this Agreement;

 

  18.1.3 its employees and agents who are performing any activities under this
Agreement or who have access to Confidential Information are bound, without
request for additional compensation, to Articles 6, 13 and 14 of this Agreement;

 

[ * ] = 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 73 of 103

 

--------------------------------------------------------------------------------

  18.1.4 neither it nor any researcher engaged by it, in any capacity, in the
Joint Research Programme has been debarred or is subject to debarment or has
otherwise been disqualified or suspended from performing scientific or clinical
investigations or otherwise subjected to any restrictions or sanctions by the
FDA or any other governmental or regulatory authority or professional body with
respect to the performance of scientific or clinical investigations;

 

  18.1.5 to the best of its Knowledge and belief, this Agreement is legally
binding upon it and enforceable in accordance with its terms, and the execution,
delivery and performance of this Agreement by it does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party
or by which it may be bound, nor violate any material law or regulation of any
Governmental Authority having jurisdiction over it;

 

  18.1.6 it has not granted, and will not grant during the Term of the
Agreement, any right to any Third Party that would conflict with the rights
granted to the other Party hereunder;

 

  18.1.7 it has (or will have at the time performance is due) maintained and
will maintain and keep in full force and effect all agreements necessary to
perform its obligations hereunder;

 

  18.1.8 it is aware of no action, suit or inquiry or investigation instituted
by any governmental agency that questions or threatens the validity of this
Agreement; and

 

  18.1.9 to the best of its Knowledge and belief, all necessary consents,
approvals and authorizations of all governmental authorities and other Persons
required to be obtained by such Party to enter into, or perform its obligations
under, this Agreement have been obtained.

 

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

 

  18.2.1 Dynavax is the sole and exclusive owner of the entire right, title and
interest in the Dynavax Patents listed on Exhibit B(1) (the “Owned Patents”) and
is

 

[ * ] = 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 74 of 103

 

--------------------------------------------------------------------------------

  entitled to grant the licences specified herein. Such rights are not subject
to any encumbrance, lien or claim of ownership by any Third Party. Dynavax is
the sole and exclusive licensee of and Controls all right, title and interest in
and to the Dynavax Patents listed in Exhibit B(2) (the “In-licensed Patents”)
and is entitled to grant the licences specified herein. Such rights are not
subject to any encumbrance, lien or claim of ownership by any Third Party, other
than the Third Party from which such rights are licensed. True, complete and
correct copies of the complete file wrapper and other documents and materials
relating to the prosecution, defence, maintenance, validity and enforceability
of the Owned Patents and the In-licensed Patents and all license and other
agreements regarding the In-licensed Patents (the “In-Licence Agreements”), as
amended to the date hereof, have been provided to AstraZeneca prior to the date
first above written. The Owned Patents and the In-licensed Patents constitute
all of the licensed Dynavax Patents as of the Effective Date. During the Term,
Dynavax shall not encumber or diminish the rights granted to AstraZeneca
hereunder with respect to the licensed Dynavax Patents, including by not [ * ].
Dynavax shall promptly provide AstraZeneca with notice of any alleged,
threatened or actual breach of any In-Licence Agreement. As of the Effective
Date, none of Dynavax, its Affiliates and, to the best of their Knowledge, any
Third Party is in breach of any In-Licence Agreement;

 

  18.2.2 All information and data provided by or on behalf of Dynavax to
AstraZeneca on or before the Effective Date in contemplation of this Agreement
was and is true and accurate in all material respects, and Dynavax has not
failed to disclose, or cause to be disclosed, any information or data that would
cause the information and data that has been disclosed to be individually, or in
the aggregate, misleading in any material respect;

 

  18.2.3 To Dynavax’s Knowledge, the licensed Dynavax Patents are being
diligently procured from the respective Patent Offices in accordance with all
applicable laws and regulations. The licensed Dynavax Patents have been filed
and maintained properly and correctly and all applicable fees have been paid on
or before the due date for payment;

 

[ * ] = 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 75 of 103

 

--------------------------------------------------------------------------------

  18.2.4 As of the Effective Date, to the best of Dynavax’s and its Affiliates’
Knowledge, there is no actual infringement or threatened infringement of the
licensed Dynavax Patents, licensed Dynavax Know-How or any regulatory
documentation by any Person.

 

  18.2.5 To the best of Dynavax’s and its Affiliates’ Knowledge and except as
disclosed in Schedule 18.2.5, AstraZeneca’s use Exploitation of the regulatory
documentation, the licensed Dynavax Patents or licensed Dynavax Know-How
hereunder will not infringe any Patent or other intellectual property or
proprietary right of any Person;

 

  18.2.6 The licensed Dynavax Patents and the licensed Dynavax Know-How existing
as of the Effective Date are subsisting and to the best of Dynavax’s knowledge
are not invalid or unenforceable, in whole or in part, except to the patent
properties identified in Schedule 18.2.6, as to which no representation is made.
To Dynavax’s Knowledge, the conception, development and reduction to practice of
the regulatory documentation, the licensed Dynavax Patents and licensed Dynavax
Know-How existing as of the Effective Date have not constituted or involved the
misappropriation of trade secrets or other rights or property of any Person.
There are no claims, judgments or settlements against or amounts with respect
thereto owed by Dynavax relating to the regulatory documentation, the licensed
Dynavax Patents or the licensed Dynavax Know-How. Except as disclosed in
Schedule 18.2.6, no claim or litigation has been brought or threatened by any
Person alleging, and Dynavax is not aware of any possible claim, whether or not
asserted, that (a) the licensed Dynavax Patents or the licensed Dynavax Know-How
are invalid or unenforceable or (b) the regulatory documentation, the licensed
Dynavax Patents or the licensed Dynavax Know-How or the disclosing, copying,
making, assigning, licensing or use of the regulatory documentation, the
licensed Dynavax Patents or the licensed Dynavax Know-How, or products and
services embodying the regulatory documentation, or the Dynavax ISS,
Collaboration ISS, CDs, Product or Combination Product(s) violates, infringes or
otherwise conflicts or interferes with any intellectual property or proprietary
right of any Person;

 

[ * ] = 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 76 of 103

 

--------------------------------------------------------------------------------

  18.2.7 Dynavax has not previously entered into any agreement, whether written
or oral, with respect to, or otherwise assigned, transferred, licensed, conveyed
or otherwise encumbered its right, title or interest in or to, the licensed
Dynavax Patents, licensed Dynavax Know-How, regulatory documentation, or the
Dynavax ISS and/or Collaboration ISS (including by granting any covenant not to
sue with respect thereto) that is inconsistent with the rights and licences
granted to AstraZeneca under this Agreement;

 

  18.2.8 In respect of the pending United States patent applications included in
the licensed Dynavax Patents, Dynavax has presented all relevant prior art of
which it has Knowledge to the relevant Patent Examiner at the United States
Patent and Trademark Office;

 

  18.2.9 The licensed Dynavax Patents represent all Patents within Dynavax’s
Control as of the Effective Date that are directly related to, or are necessary,
for the manufacture, use, offer for sale or sale of the Dynavax ISS and/or the
Collaboration ISS;

 

  18.2.10 Any licensed Dynavax Know-How has been kept confidential or has been
disclosed to Third Parties only under terms of confidentiality;

 

  18.2.11 Dynavax has made (and will make) available to AstraZeneca all
regulatory documentation, licensed Dynavax Know-How and other Information in its
possession or Control directly related to any Dynavax ISS and/or Collaboration
ISS and all such regulatory documentation, licensed Dynavax Know-How and other
Information are (and, if made available after the Effective Date, will be) true,
complete and correct. As of the Effective Date, Dynavax has prepared, maintained
and retained all regulatory documentation that is required to be maintained or
reported pursuant to and in accordance with good laboratory and clinical
practice and Applicable Law and all such information is true, complete and
correct and what it purports to be;

 

  18.2.12 Dynavax shall obtain from each of its Affiliates, Sublicensees,
employees and agents, and from the employees and agents of its Affiliates,
Sublicensees and agents, who are performing tests or studies, or are otherwise
participating in the Research of the Dynavax ISS and/or Collaboration ISS, CDs,
Product or

 

[ * ] = 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 77 of 103

 

--------------------------------------------------------------------------------

  Combination Product or who otherwise have access to any AstraZeneca
Confidential Information, rights to any and all Information that relate to the
Dynavax ISS and/or Collaboration ISS, CDs, Product and Combination Product, such
that AstraZeneca shall, by virtue of this Agreement, receive from Dynavax,
without payments beyond those required by this Agreement, the licences and other
rights granted to AstraZeneca hereunder.

 

18.3 Each Party shall comply with all laws, rules and regulations that govern
the Party’s performance under this Agreement, including all United States and
multilateral export laws and regulations.

 

18.4 Nothing in this Agreement shall be construed as a warranty or
representation by either Party of the success of the Joint Research Programme or
the Joint Research Plan.

 

18.5 DISCLAIMER. OTHER THAN AS PROVIDED IN THIS ARTICLE 18, THE PARTIES DISCLAIM
ANY AND ALL WARRANTIES OF ANY KIND WITH REGARD TO THE COLLABORATION MATERIALS OR
THE BACKGROUND TECHNOLOGIES, WHETHER EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ANY
WARRANTIES ARISING FROM COURSE OF DEALING OR USAGE OF TRADE.

 

19 Indemnification and Insurance

 

19.1 Indemnification of Dynavax. In addition to any other remedy available to
Dynavax, AstraZeneca shall indemnify, defend and hold harmless Dynavax, its
Affiliates and its and their respective directors, officers and employees in
full and on demand, from and against any and all Losses incurred by them to the
extent resulting from or arising out or in connection with any claims made or
suits brought by a Third Party (collectively, “Third Party Claims”) against
Dynavax, its Affiliates, Sublicensees, and their respective directors, officers
or employees:

 

  19.1.1 that arise or result from any intentional misconduct or gross
negligence on the part of AstraZeneca, its Affiliates, Distributors,
Sublicensees or agents in performing any activity contemplated by this
Agreement, or the breach of any provision of this Agreement (including a breach
of a warranty or Applicable Law) by AstraZeneca; or

 

[ * ] = 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 78 of 103

 

--------------------------------------------------------------------------------

  19.1.2 that allege that the claimant has suffered personal injury or death as
a result of use of the Product or Combination Product(s) or of AstraZeneca’s
Development, manufacture, use, handling, storage, sale, offer for sale,
importation, or other disposition of the Product or any Combination Product(s),

except for any Losses for which Dynavax has an obligation to indemnify
AstraZeneca and its Affiliates pursuant to Section 19.2.

 

19.2 Indemnification of AstraZeneca. In addition to any other remedy available
to AstraZeneca, Dynavax shall indemnify, defend and hold harmless AstraZeneca,
its Affiliates, Distributors, Sublicensees and its and their respective
directors, officers and employees in full and on demand, from and against any
and all Losses incurred by them to the extent resulting from or arising out of
or in connection with any Third Party Claims against AstraZeneca, its
Affiliates, Distributors or Sublicensees or their respective directors, officers
or employees that:

 

  19.2.1 arise or result from any intentional misconduct or gross negligence on
the part of Dynavax, its Affiliates, Sublicensees or agents in performing any
activity contemplated by this Agreement, or the breach of any provision of this
Agreement by Dynavax;

 

  19.2.2 allege that the claimant has suffered personal injury or death as a
result of use of any product incorporating a Reverted ISS or reverted CD or of
Dynavax’s development, manufacture, use, handling, storage, sale, offer for
sale, importation, or other disposition of such reverted ISS, product(s) or
CD(s);

 

  19.2.3 in the event that the Agreement is terminated and Dynavax continue to
Develop and Commercialize any CD, Product or Combination Product directly or
through a Third Party, allege that the claimant has suffered personal injury or
death as a result of use of any CD, Product or Combination Product or of
Dynavax’s Development, manufacture, use, handling, storage, sale, offer for
sale, importation, or other disposition of such Product or Combination
Product(s), after the date of termination;

in all cases except for any Losses for which AstraZeneca has an obligation to
indemnify Dynavax and its Affiliates pursuant to Section 19.1.

 

[ * ] = 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 79 of 103

 

--------------------------------------------------------------------------------

19.3 [ * ]

 

19.4 Notice of Claim . An Indemnified Party shall give the Indemnifying Party
prompt written notice of any Losses or discovery of fact upon which such
Indemnified Party intends to base a request for indemnification under
Section 19.1, 19.2 or 19.3 (an “Indemnification Claim Notice”). In no event
shall the Indemnifying Party be liable for any Loss that results from any delay
in providing the Indemnification Claim Notice. Each Indemnification Claim Notice
shall contain a description of the claim and the nature and amount of the Loss
claimed (to the extent that the nature and amount of such Loss is known at such
time). The Indemnified Party shall furnish promptly to the Indemnifying Party
copies of all papers and official documents received in respect of any such
Loss. For the avoidance of doubt, all indemnification claims in respect of a
Party, its Affiliates or their respective directors, officers, employees and
agents (each, an “Indemnitee”) shall be made solely by such Party to this
Agreement.

 

19.5 Indemnification Procedures. The obligations of an Indemnifying Party under
this Article 19 shall be governed by and contingent upon the following:

 

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

 

  19.5.2 Control of Defence. Upon the assumption of the defence of a Third Party
Claim by the Indemnifying Party:

 

  (e) the Indemnifying Party may appoint as lead counsel in the defence of the
Third Party Claim any legal counsel selected by the Indemnifying Party, which
shall be reasonably acceptable to the Indemnified Party, and

 

[ * ] = 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 80 of 103

 

--------------------------------------------------------------------------------

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

 

  19.5.3 Right to Participate in Defence. Without limiting Section 19.5.1 or
19.5.2, any Indemnitee shall be entitled to participate in, but not control, the
defence of a Third Party Claim and to retain counsel of its choice for such
purpose; provided, however, that such retention shall be at the Indemnitee’s own
expense unless, (a) the Indemnifying Party has failed to assume the defence and
retain counsel in accordance with Section 19.5.1 (in which case the Indemnified
Party shall control the defence), or (b) the interests of the Indemnitee and the
Indemnifying Party with respect to such Third Party Claim are sufficiently
adverse to prohibit the representation by the same counsel of both parties under
Applicable Law, ethical rules or equitable principles.

 

  19.5.4 Settlement. With respect to all Losses, where the Indemnifying Party
has assumed the defence of a Third Party Claim in accordance with
Section 19.5.1, (i) the Indemnifying Party shall have authority to consent to
the entry of any judgement, enter into any settlement or otherwise dispose of
such Losses, provided that it obtains the prior written consent of the
Indemnified Party, which consent shall not be unreasonably withheld or delayed,
and (ii) no Indemnified Party or Indemnitee shall admit any liability with
respect to, or settle, compromise or discharge, any such Third Party Claim
without the prior written consent of the Indemnifying Party, which consent shall
not be unreasonably withheld.

 

[ * ] = 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 81 of 103

 

--------------------------------------------------------------------------------

  19.5.5 Cooperation. If the Indemnifying Party chooses to defend or prosecute
any Third Party Claim, the Indemnified Party shall, and shall cause each other
Indemnitee to, reasonably cooperate in the defence or prosecution thereof and
shall furnish such records, information and testimony, provide such witnesses
and attend such conferences, discovery proceedings, hearings, trials and appeals
as may be reasonably requested in connection therewith. Such cooperation shall
include access during normal business hours by the Indemnifying Party to, and
reasonable retention by the Indemnified Party of, records and information that
are reasonably relevant to such Third Party Claim, and making the Indemnified
Party, the Indemnitees and its and their employees and agents available on a
mutually convenient basis to provide additional information and explanation of
any records or information provided, and the Indemnifying Party shall reimburse
the Indemnified Party for all of its related reasonable out-of-pocket expenses.

 

  19.5.6 Expenses. Except as expressly provided above, the reasonable and
verifiable costs and expenses, including fees and disbursements of counsel,
incurred by the Indemnified Party in connection with any claim shall be
reimbursed on a quarterly basis by the Indemnifying Party, without prejudice to
the Indemnifying Party’s right to contest the Indemnified Party’s right to
indemnification and subject to refund in the event the Indemnifying Party is
ultimately held not to be obligated to indemnify the Indemnified Party.

 

19.6 LIMITATION ON DAMAGES. EXCEPT IN CIRCUMSTANCES OF GROSS NEGLIGENCE OR
INTENTIONAL MISCONDUCT BY A PARTY OR ITS AFFILIATES, OR WITH RESPECT TO THIRD
PARTY CLAIMS UNDER SECTION 19.1 OR 19.2, NO PARTY OR ANY OF ITS AFFILIATES SHALL
BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, OR FOR
LOST PROFITS, MILESTONES OR ROYALTIES, WHETHER IN CONTRACT, WARRANTY,
NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF (a) THE
DEVELOPMENT, MANUFACTURE, USE OR SALE OF ANY PRODUCT OR COLLABORATION ISS
DEVELOPED, MANUFACTURED OR MARKETED HEREUNDER, OR (b) ANY BREACH OF OR FAILURE
TO PERFORM ANY OF THE PROVISIONS OF THIS AGREEMENT.

 

[ * ] = 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 82 of 103

 

--------------------------------------------------------------------------------

19.7 Insurance . Each Party shall have and maintain such type and amounts of
liability insurance as is normal and customary in the pharmaceutical industry
generally for Persons similarly situated, and shall upon request provide the
other Party with a copy of its policies of insurance in that regard, along with
any amendments and revisions thereto.

 

20 Term and Termination

 

20.1 Term . This Agreement shall become effective on the Effective Date and
shall continue in full force and effect until the earlier of (i) expiration or
termination of all payment obligations to Dynavax under this Agreement, or
(ii) the effective date of termination pursuant to Sections 20.2, 20.3, 20.4,
20.5 or 20.6 or Section 21.4 below (the “Term”). The Term shall expire on the
Product, or a Combination Product by Combination Product and country by country
basis within the Territory.

 

20.2 Termination by AstraZeneca. AstraZeneca may terminate this Agreement if it
determines, in its sole discretion, that it does not wish to pursue the Joint
Research Programme or the further research, development, launch or sale of
Dynavax ISS, Collaboration ISS, Candidate Drugs, Product or Combination
Product(s) for any reason, including but not limited to, a scientific,
technical, regulatory or commercial reasons, including [ * ]. AstraZeneca shall
promptly notify Dynavax in writing of such determination and provide Dynavax
with the pertinent information with respect thereto. Promptly following the
receipt of such notice from AstraZeneca, the Parties shall discuss in more
detail the reasons for such termination in good faith. Following such
discussion, AstraZeneca may, at its sole discretion, terminate this Agreement in
its entirety or with respect to the Product or one or more Combination Products
or one or more countries in the Territory upon [ * ] days’ prior written notice.
Further, AstraZeneca shall have the right in its sole discretion to terminate
this Agreement with respect to a country upon [ * ] days’ prior written notice
in the event that any Governmental Authority takes, fails to take, or reasonably
could be expected to take or fail to take, any action with respect to the CD,
Product or any Combination Product that could have an adverse effect on the
Development and/or Commercialization of the CD, Product or Combination
Product(s) in such country; provided, however, that AstraZeneca shall have the
right to terminate this Agreement with respect to all of Europe if such country
is in Europe and AstraZeneca shall have the right to terminate

 

[ * ] = 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 83 of 103

 

--------------------------------------------------------------------------------

  this Agreement in its entirety if such country is or is in a Major Market. In
the event of any such termination, if such termination occurs at a time when
AstraZeneca is conducting or sponsoring a clinical trial of a CD, the Product or
any Combination Product, AstraZeneca shall [ * ].

 

20.3 Termination for Infringement of Third Party Rights.

 

  20.3.1 If a Triggering Event occurs with respect to a country, AstraZeneca
shall have the right upon written notice to Dynavax to terminate this Agreement
with respect to such country if at any time (a) AstraZeneca is unable to obtain
such a licence on commercially reasonable terms or (b) AstraZeneca in good faith
believes that negotiation with a Third Party pursuant to Section 6.4 with
respect to such country is not likely to result in a commercially reasonable
agreement; provided, however, that AstraZeneca shall have the right to terminate
this Agreement with respect to all of Europe if such country is in Europe and
AstraZeneca shall have the right to terminate this Agreement in its entirety if
such country is or is in a Major Market.

 

  20.3.2 If a Third Party institutes an Infringement Suit with respect to a
country, AstraZeneca shall have the right upon written notice to Dynavax to
terminate this Agreement with respect to such country if [ * ]; provided,
however, that AstraZeneca shall have the right to terminate this Agreement with
respect to all of Europe if such country is in Europe and AstraZeneca shall have
the right to terminate this Agreement in its entirety if such country is or is
in a Major Market.

 

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

 

[ * ] = 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 84 of 103

 

--------------------------------------------------------------------------------

20.5 Termination by Either Party. In addition to any other provision of this
Agreement expressly providing for termination of this Agreement, this Agreement
may be terminated immediately by either Party upon notice to the other Party:

 

  20.5.1 if it believes that the other Party is in material breach of this
Agreement, in which case the non-breaching Party may deliver notice of such
material breach to the other Party, such notice to describe in detail the nature
of such breach. The allegedly breaching Party shall have [ * ] days from receipt
of such notice to cure such breach (or, if such default cannot be cured within
such [ * ] day period, the breaching Party must commence actions to cure such
default during such [ * ] day period and diligently continue such actions until
the cure is effected). Any such termination shall become effective at the end of
such [ * ] day period unless the breaching Party has cured any such breach or
default prior to the expiration of such [ * ] day period (or, if such default is
capable of being cured but cannot be cured within such [ * ] day period, the
breaching Party has commenced and diligently continued actions to cure such
default provided always that, in such instance, such cure must have occurred
within [ * ] days after notice thereof was provided to the breaching Party by
the non-breaching Party to remedy such default);

 

  20.5.2 if such other Party ceases or threatens to cease to carry on the whole
or substantially the whole of its business or that part of its business to which
this Agreement relates;

 

  20.5.3 if such other Party shall file in any court or agency, pursuant to any
statute or regulation of any state or country, a petition in bankruptcy or
insolvency or for reorganization or for an the appointment of a receiver or
trustee of such other Party or of its assets, or if the other Party proposes a
written agreement of composition or extension of its debts, or if the other
Party shall be served with an involuntary petition against it, filed in any
insolvency proceeding, or if the other Party shall propose or be a Party to any
dissolution or liquidation, or if the other Party shall make an assignment for
the benefit of its creditors;

 

  20.5.4 if any encumbrancer takes possession of any material part of the assets
of another Party; or

 

[ * ] = 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 85 of 103

 

--------------------------------------------------------------------------------

  20.5.5 if any distress, execution or other such process is levied or enforced
upon or against any of the material assets of the other Party.

It is understood that termination pursuant to this Section 20.5 shall be a
remedy of last resort and may be invoked only in the case where the breach
cannot be reasonably remedied by the payment of money damages. If a Party gives
notice of termination under this Section 20.5, and the other Party disputes
whether such notice was proper, then the issue of whether this Agreement has
been terminated shall be resolved in accordance with Article 24. If as a result
of such dispute resolution process it is determined that the notice of
termination was proper, then such termination shall be deemed to have been
effective [ * ] days following the date of receipt of the notice of termination.
If as a result of such dispute resolution process it is determined that the
notice of termination was improper, then no termination shall have occurred and
this Agreement shall remain in effect.

 

20.6 Change of Control. Upon a Change of Control of Dynavax at any time during
the Joint Research Programme, AstraZeneca shall have the right to (a) terminate
this Agreement in its entirety by delivering written notice of termination to
Dynavax at any time within [ * ] months after the date of such Change of Control
or (b) terminate only the Parties’ collaboration under the Joint Research
Programme with immediate effect thereby ending the Research Term. In the event
AstraZeneca exercises the latter option, AstraZeneca shall be under no
obligation to provide Dynavax with any further compensation pursuant to
Article 7 but shall remain responsible for payments under Articles 9 and 10.
Following such termination of the Research Term, Dynavax shall immediately
provide AstraZeneca with all Collaboration Technology generated by it under the
Joint Research Programme and not previously provided to AstraZeneca and shall
immediately return to AstraZeneca all AstraZeneca Confidential Information,
including any and all copies thereof, and those portions of any documents,
memoranda, notes, studies, analyses or other material prepared by or on behalf
of Dynavax that incorporate or are derived from such Confidential Information.
For the avoidance of doubt, in the event of such termination, Dynavax shall have
no further rights to use any Collaboration Technology, AstraZeneca Technology or
AstraZeneca Confidential Information for any purpose in the Field. [ * ]. The
Agreement shall remain valid and in full force and effect in all other respects.
Upon a Change of Control of AstraZeneca at any time

 

[ * ] = 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 86 of 103

 

--------------------------------------------------------------------------------

  during the Term, the successor in interest and/or surviving entity shall
continue to perform the obligations of and exercise the rights of AstraZeneca
pursuant to this Agreement in the same manner as intended by AstraZeneca as of
the Effective Date.

 

20.7 Consequences of Termination.

 

  20.7.1 Payment by AstraZeneca. Upon termination of this Agreement by
AstraZeneca pursuant to Section 20.2 prior to the [ * ] anniversary of the
Effective Date, AstraZeneca shall make a lump sum payment to Dynavax to
compensate Dynavax for such early termination in an amount equal to [ * ];
provided, however, that AstraZeneca shall have no obligation to make such
payment in the event it terminates this Agreement pursuant to Section 20.5.1 or
20.6 or Section 21.4. For clarity, the foregoing lump sum payment shall be in
addition to any ongoing payment obligations AstraZeneca may have for existing
clinical trials pursuant to Section 20.2. In addition to the lump sum, and on
condition that Dynavax maintain the level of internal Dynavax FTE support
existing as at the date of termination to any continuing research activities
previously covered by the Joint Research Programme, AstraZeneca shall meet [ * ]
of any reasonable external FTE costs Dynavax incurs during the period of [ * ]
months following immediately after the date of the termination. AstraZeneca
shall have no obligation to make such additional external FTE contribution in
the event it terminates this Agreement pursuant to Section 20.5.1 or 20.6 or
Section 21.4.

 

  20.7.2 Cessation of Obligations; Return of Materials. Upon termination of this
Agreement, Dynavax shall promptly cease its performance of obligations under
this Agreement. The expiration or termination of this Agreement shall be without
prejudice to any rights or obligations of the Parties that may have accrued
prior to such expiration or termination and, except as otherwise expressly
provided herein, shall not limit any rights or remedies which may be available
at law or otherwise. Upon the termination or expiration of this Agreement, each
Party shall, at its sole expense, promptly return to the other Party all
Confidential Information of such other Party and, at such other Party’s option,
either destroy or return to such other Party all materials

 

[ * ] = 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 87 of 103

 

--------------------------------------------------------------------------------

  received from such other Party, except to the extent that the Receiving Party
has a continuing licence to use such materials. Notwithstanding the foregoing,
the General Counsel of each Party may retain one copy of each business document
generated by such Party in connection with this Agreement for archival purposes
only, and all such retained documents shall be subject to the confidentiality
obligations of this Agreement.

 

  20.7.3 Licences.

 

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

 

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

 

  (i) Upon termination by AstraZeneca of AstraZeneca’s obligations and/or
license rights to a specific Dynavax ISS, Collaboration ISS, CD, Product and/or
Combination Product in a particular country pursuant to

 

[ * ] = 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 88 of 103

 

--------------------------------------------------------------------------------

  Sections 20.2 or 20.3, the license to AstraZeneca under Section 6.2 shall
terminate solely as to such Dynavax ISS, Collaboration ISS, CD, Product and/or
Combination Product(s) in such country, and (A) AstraZeneca shall, and hereby
does, grant to Dynavax an exclusive, worldwide, perpetual, irrevocable,
royalty-free license, with right to sublicense and to enforce patents, under the
AstraZeneca Technology, to make, have made, use, import, offer for sale and sell
such Dynavax ISS, Collaboration ISS, CD, Product and Combination Product(s) in
the Field in such country only and (B) [ * ]. Dynavax shall have the right to
use [ * ].

 

  (j) Upon termination of this Agreement by AstraZeneca pursuant to
Section 20.5.1, the licenses to AstraZeneca under Section 6.2 shall remain in
effect. In such case, AstraZeneca shall remain liable for [ * ] of the milestone
payments and [ * ] of the royalties due under Article 10 and Section 10.7 shall
cease to apply. The foregoing milestone and royalty reduction shall not be an
exclusive remedy, but any claim for money damages by AstraZeneca shall be
reduced by the economic effect of such [ * ] reduction in milestone payments and
royalty obligations. Following termination under Section 20.5.1 AstraZeneca
shall be relieved of its remaining obligations to Dynavax under this Agreement
except for AstraZeneca’s obligations under Articles 9, 10 (other than
Section 10.7), 13, 14, and 19.

 

  (k) For clarity, in the event of termination of this Agreement in its entirety
or in part by AstraZeneca or Dynavax (as appropriate) pursuant to Sections 20.2,
20.3, 20.4 or 20.5, if the Product or Combination Product at the time of
termination is being Commercialized with or has been the subject of human
clinical trials that included a delivery device, AstraZeneca shall [ * ]. In
particular, if such device was a proprietary AstraZeneca device, then for the
purposes of the above sentence, AstraZeneca shall [ * ]. If such device was a
Third Party device, then AstraZeneca shall [ * ].

 

[ * ] = 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 89 of 103

 

--------------------------------------------------------------------------------

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

 

20.8 Survival. The following provisions shall survive the expiration or
termination of this Agreement: Articles 1, 2, 13, 19, 23 through 28, 30, 31 and
32 and Sections 3.8, 7.3, 10.14, 18.5, 20.7 and 20.8, together with any sections
referenced in such surviving provisions or necessary to give them effect.
Termination of this Agreement shall not relieve the Parties of any liability
that accrued hereunder prior to the effective date of such termination.
Termination of this Agreement shall not preclude either Party from pursuing all
rights and remedies it may have hereunder or at law or in equity with respect to
any breach of this Agreement nor prejudice either Party’s right to obtain
performance of any obligation.

 

20.9 Rights in Bankruptcy. All rights and licences granted under or pursuant to
this Agreement by Dynavax are, and shall otherwise be deemed to be, for purposes
of Section 365(n) of the U.S. Bankruptcy Code or analogous provisions of
Applicable Law outside the United States, licences of right to “intellectual
property” as defined under Section 101 of the U.S. Bankruptcy Code or analogous
provisions of Applicable Law outside the United States (hereinafter “IP”). The
Parties agree that each of the Parties, as licensee of such rights under this
Agreement, shall retain and may fully exercise all of its rights and elections
under the U.S. Bankruptcy Code or any other provisions of Applicable Law outside
the United States that provide similar protection for IP. The Parties further
agree that, in the event of the commencement of a bankruptcy proceeding by or
against Dynavax on the one hand, or AstraZeneca on the other hand, under the
U.S. Bankruptcy Code or analogous provisions of Applicable Law outside the
United States, AstraZeneca or Dynavax, as applicable, shall be entitled to a
complete duplicate of (or complete access to, as appropriate) any

 

[ * ] = 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 90 of 103

 

--------------------------------------------------------------------------------

  such IP and all embodiments of such IP, which, if not already in such Party’s
possession, shall be promptly delivered to it upon such Party’s written request
therefor.

 

21 Force Majeure

 

21.1 In this Agreement, “Force Majeure” means an event which is beyond a
non-performing Party’s reasonable control, including an act of God, act of the
other Party, strike, lock-out or other industrial/labour dispute (whether
involving the workforce of the Party so prevented or of any other Person), war,
riot, civil commotion, terrorist act, malicious damage, epidemic, quarantine,
fire, flood, earthquake, storm, natural disaster or compliance with any law or
governmental order, rule, regulation or direction (including changes in the
requirements of the health authorities), whether or not it is later held to be
invalid. Notwithstanding the foregoing, the payment of invoices due and owing
hereunder shall not be delayed by the payer because of a Force Majeure affecting
the payer, unless such Force Majeure specifically precludes the payment process.

 

21.2 The Force Majeure Party shall, within [ * ] days of the occurrence of a
Force Majeure event, give notice in writing to the other Party specifying the
nature and extent of the event of Force Majeure, its anticipated duration and
any action being taken to avoid or minimize its effect. Subject to providing
such notice and to Section 21.1, the Force Majeure Party shall not be liable for
delay in performance or for non-performance of its obligations under this
Agreement, in whole or in part, nor shall the other Party have the right to
terminate this Agreement, except as otherwise provided in this Agreement, where
non-performance or delay in performance has resulted from an event of Force
Majeure. The suspension of performance allowed hereunder shall be of no greater
scope and no longer duration than is reasonably required.

 

21.3 The Force Majeure Party shall use reasonable endeavours, without being
obligated to incur any expenditure or cost, to bring the Force Majeure event to
a close or to find a solution by which this Agreement may be performed despite
the continuation of the event of Force Majeure.

 

[ * ] = 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 91 of 103

 

--------------------------------------------------------------------------------

21.4 If the Force Majeure Party is prevented from performing its obligations due
to a Force Majeure event for a continuous period in excess of [ * ] days after
the date of the occurrence of the Force Majeure event, and such failure to
perform would constitute a material breach of this Agreement in the absence of
such Force Majeure event, the Parties shall meet and discuss in good faith any
amendments to this Agreement to permit the other Party to exercise its rights
under this Agreement. If the Parties are not able to agree on such amendments
within [ * ] days of commencement of such discussions and if the suspension of
performance continues, such other Party may terminate this Agreement immediately
by written notice to the Force Majeure Party, in which case neither Party shall
have any liability to the other except for those rights and liabilities that
accrued prior to the date of termination.

 

22 Assignment

 

22.1 Neither Party may assign its rights or, except as provided in
Sections 3.5.4 , 6.6 and 6.7, delegate its obligations under this Agreement in
whole or in part without the prior written consent of the other Party, except
that a Party shall always have the right, without such consent, on written
notice to the other Party, assign any or all of its rights and delegate any or
all of its obligations hereunder to any of its Affiliates or to any successor in
interest (whether by merger, acquisition, asset purchase or otherwise) to all or
substantially all of the business to which this Agreement relates. Any permitted
successor of a Party or any permitted assignee of all of a Party’s rights under
this Agreement that has also assumed all of such Party’s obligations hereunder
in writing shall, upon any such succession or assignment and assumption, be
deemed to be a party to this Agreement as though named herein in substitution
for the assigning Party, whereupon the assigning Party shall cease to be a party
to this Agreement and shall cease to have any rights or obligations under this
Agreement. All validly assigned rights of a Party shall inure to the benefit of
and be enforceable by, and all validly delegated obligations of such Party shall
be binding on and be enforceable against, the permitted successors and assigns
of such Party. Any attempted assignment or delegation in violation of this
Article 22 shall be void.

 

[ * ] = 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 92 of 103

 

--------------------------------------------------------------------------------

23 Severability

To the fullest extent permitted by applicable law, the Parties waive any
provision of law that would render any provision of this Agreement invalid,
illegal or unenforceable in any respect. If any provision of this Agreement is
held to be invalid, illegal or unenforceable, in any respect, then such
provision will be given no effect by the Parties and shall not form part of this
Agreement. To the fullest extent permitted by Applicable Law and if the rights
or obligations of any Party will not be materially and adversely affected all
other provisions of this Agreement shall remain in full force and effect, and
the Parties shall use their best efforts to negotiate a provision in replacement
of the provision held invalid, illegal or unenforceable that is consistent with
Applicable Law and achieves, as nearly as possible, the original intention of
the Parties.

 

24 Dispute Resolution.

 

24.1 Disputes. The Parties recognize that disputes as to certain matters may
from time to time arise during the Term which relate to either Party’s rights
and/or obligations hereunder. It is the objective of the Parties to establish
procedures to facilitate the resolution of disputes arising under this Agreement
in an expedient manner by mutual cooperation and without resort to litigation.
To accomplish this objective, the Parties agree to follow the procedures set
forth in this Article 24 if and when a dispute arises under this Agreement. In
the event of any disputes, controversies or differences which may arise between
the Parties, out of or in relation to or in connection with this Agreement, or
for the breach thereof, upon the request of either Party, the Parties agree to
meet and discuss in good faith a possible resolution thereof, which good faith
efforts shall include at least one in-person meeting between representatives of
each Party having decision-making authority (subject only to Board of Directors’
or equivalent approval, if required). All such discussions under this Section
shall be confidential and shall be treated as compromise and settlement
negotiations for purposes of applicable rules of evidence. If the matter is not
resolved within [ * ] days following the request for discussions, either Party
may then invoke the provisions of Section 24.2 below.

 

24.2 Arbitration. Any dispute, controversy or claim arising out of or relating
to the validity, construction, interpretation, enforceability, breach,
performance, application

 

[ * ] = 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 93 of 103

 

--------------------------------------------------------------------------------

  or termination of this Agreement that is not resolved pursuant to
Section 24.1, except for a dispute, claim or controversy under Section 24.13,
shall be settled by binding arbitration administered by JAMS pursuant to its
Comprehensive Arbitration Rules and Procedures of JAMS then in effect (the “JAMS
Rules”), except as otherwise provided herein. The arbitration shall be governed
by the United States Federal Arbitration Act, 9 U.S.C. §§ 1-16 (the “Federal
Arbitration Act”), to the exclusion of any inconsistent state laws. The
arbitration will be conducted in Wilmington, Delaware and the Parties consent to
the personal jurisdiction of the United States federal courts, for any case
arising out of or otherwise related to this arbitration, its conduct and its
enforcement. The language used in the arbitration proceedings shall be English.
Any situation not expressly covered by this Agreement shall be decided in
accordance with the JAMS Rules.

 

24.3 Arbitrator.

The arbitrator shall be one (1) neutral, independent and impartial arbitrator
selected from a pool of retired federal judges to be presented to the Parties by
JAMS. Failing the agreement of the Parties as to the selection of the arbitrator
within thirty (30) days, the arbitrator shall be appointed by JAMSin accordance
with the JAMS Rules.

 

24.4 Governing Law. Resolution of all disputes arising out of or related to this
Agreement or the validity, construction, interpretation, enforcement, breach,
performance, application or termination of this Agreement and any remedies
relating thereto, shall be governed by and construed under the substantive laws
of the State of Delaware, excluding any conflicts or choice of law rule or
principle that might otherwise refer construction or interpretation of this
Agreement to the substantive law of another jurisdiction.

 

24.5 Decision. The power of the arbitrator to fashion procedures and remedies
within the scope of this Agreement is recognized by the Parties as essential to
the success of the arbitration process. The arbitrator shall not have the
authority to fashion remedies which would not be available to a federal judge
hearing the same dispute. The arbitrator is encouraged to operate on this
premise in an effort to reach a fair and just decision. Reasons for the
arbitrator’s decisions should be complete and explicit, including all
determinations of law and fact. The written reasons should also include the
basis for any damages awarded and a statement of how the damages were

 

[ * ] = 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 94 of 103

 

--------------------------------------------------------------------------------

  calculated. Such a written decision shall be rendered by the arbitrator
following a full comprehensive hearing, no later than [ * ] months following the
selection of the arbitrator as provided for in Section 24.3.

 

24.6 Award.

 

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

 

  24.6.2 If as to any issue the arbitrator should determine under the applicable
law that the position taken by a Party is frivolous or otherwise irresponsible
or that any wrongdoing they find is in callous disregard of law and equity or
the rights of the other Party, the arbitrator shall also award an appropriate
allocation of the adversary’s reasonable attorney fees, costs and expenses to be
paid by the offending Party, the precise sums to be determined after a bill of
attorney fees, expenses and costs consistent with such award has been presented
following the award on the merits.

 

  24.6.3 Each Party agrees to abide by the award rendered in any arbitration
conducted pursuant to this Article 24, and agrees that, subject to the Federal
Arbitration Act, judgment may be entered upon the final award in the Federal
District Court in Delaware and that other courts may award full faith and credit
to such judgment in order to enforce such award.

 

  24.6.4 The award shall include interest from the date of any damages incurred
for breach of the Agreement, and from the date of the award until paid in full,
at a rate fixed by the arbitrator.

 

  24.6.5 With respect to money damages, nothing contained herein shall be
construed to permit the arbitrator or any court or any other forum to award
punitive or exemplary damages. By entering into this agreement to arbitrate, the
Parties expressly waive any claim for punitive or exemplary damages. The only
damages recoverable under this Agreement are compensatory damages (including,
without limitation, consequential damages).

 

[ * ] = 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 95 of 103

 

--------------------------------------------------------------------------------

24.7 Costs. Except as set forth in Section 24.6.2, each Party shall bear its own
legal fees. The arbitrator shall assess his or her costs, fees and expenses
against the Party losing the arbitration unless he or she believes that neither
Party is the clear loser, in which case the arbitrator shall divide his or her
fees, costs and expenses according to his or her sole discretion.

 

24.8 Injunctive Relief. Provided a Party has made a sufficient showing under the
rules and standards set forth in the Federal Rules of Civil Procedure and
applicable case law, the arbitrator shall have the freedom to invoke, and the
Parties agree to abide by, injunctive measures after either Party submits in
writing for arbitration claims requiring immediate relief. Nothing in this
Article 24 will preclude either Party from seeking equitable relief in
accordance with Article 32 or interim or provisional relief from a court of
competent jurisdiction, including a temporary restraining order, preliminary
injunction or other interim equitable relief, concerning a dispute either prior
to or during any arbitration if necessary to protect the interests of such Party
or to preserve the status quo pending the arbitration proceeding.

 

24.9 Confidentiality. The arbitration proceeding shall be confidential and the
arbitrator shall issue appropriate protective orders to safeguard each Party’s
Confidential Information. Except as required by law, no Party shall make (or
instruct the arbitrator to make) any public announcement with respect to the
proceedings or decision of the arbitrator without prior written consent of the
other Party. The existence of any dispute submitted to arbitration, and the
award, shall be kept in confidence by the Parties and the arbitrator, except as
required in connection with the enforcement of such award or as otherwise
required by applicable law.

 

24.10 Survivability. Any duty to arbitrate under this Agreement shall remain in
effect and be enforceable after termination of the contract for any reason.

 

24.11 Jurisdiction. For the purposes of this Article 24, the parties acknowledge
their diversity (AstraZeneca having its principal places of business in Sweden
and the UK and Dynavax having its principal place of business in California) and
agree to accept the jurisdiction of the Federal District Court in Delaware for
the purposes of enforcing or appealing any awards entered pursuant to this
Article 24 and for enforcing the agreements reflected in this Article 24 and
agree not to commence any action, suit or proceeding related thereto except in
such courts.

 

[ * ] = 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 96 of 103

 

--------------------------------------------------------------------------------

24.12 Patents and Trademarks. Any dispute, controversy or claim relating to the
scope, validity, enforceability or infringement of any Patent rights covering
the manufacture, use, importation, offer for sale or sale of the Product or any
Combination Product or of any AstraZeneca trademarks, Dynavax trademarks, or
trademark rights related to the Product or any Combination Product shall be
submitted to a court of competent jurisdiction in the country in which such
Patent or trademark rights were granted or arose.

 

24.13 Provisions Unique to Arbitrations Pursuant to Section 8.10.
Notwithstanding anything to the contrary in this Article 24, if the arbitration
is commenced pursuant to Section 8.10 in connection with a dispute regarding
whether either Party has met its diligence obligations, then such arbitration
shall be conducted by the arbitrator selected pursuant to Section 24.3 together
with two experts having at least ten (10) years of experience in drug discovery
or development, either in a commercial setting or as a full time faculty member
at a university or medical institute (the “Expert”). One such Expert shall be
selected by AstraZeneca and the other Expert shall be selected by Dynavax. Such
Experts shall participate in the arbitration solely as advisors and shall not
assume any of the authority of the arbitrator.

 

25 Notices

 

25.1 Notice Requirements. Any notice, request, demand, waiver, consent, approval
or other communication permitted or required under this Agreement shall be in
writing and shall be deemed given only if delivered by hand or sent by facsimile
transmission (with transmission confirmed) or by internationally recognised
overnight delivery service that maintains records of delivery, addressed to the
Parties at their respective addresses specified in Section 25.2 or to such other
address as the Party to whom notice is to be given may have provided to the
other Party in accordance with this Article 25. Such notice shall be deemed to
have been given as of the date delivered by hand or transmitted by facsimile
(with transmission confirmed) or on the second business day (at the place of
delivery) after deposit with an internationally recognised overnight delivery
service. Any notice delivered by facsimile shall be confirmed by a hard copy
delivered as soon as practicable thereafter. This Article 25 is not intended to
govern the day-to-day business communications necessary between the Parties in
performing their obligations under the terms of this Agreement.

 

[ * ] = 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 97 of 103

 

--------------------------------------------------------------------------------

25.2 Address for Notice

 

                  For:                         AstraZeneca AB       Address:   

AstraZeneca R&D Lund,

Schelegatan 10

Sweden

   Facsimile:    [ * ]    For the attention of: Director Discovery Alliances

                  With a copy  to:

   AstraZeneca UK Limited    Address:    Alderley House, Alderley Park,
Macclesfield, Cheshire SK10 4TF    Facsimile:    [ * ]    For the attention of:
Assistant General Counsel For:                        Dynavax Pharmaceuticals,
Inc.    2929 Seventh Street    Suite 100    Berkeley, CA 94710-2753    Fax: [ *
]    Attn: D. Kevin Kwok, Vice President & Chief Business Officer

Witha copy to:

      Cooley Godward LLP    Five Palo Alto Square    3000 El Camino Real    Palo
Alto, CA 94306-2155    Fax: [ * ]    Attention: Robert L. Jones, Esq.

 

26 Relationship of the Parties

The status of a Party under this Agreement shall be that of an independent
contractor. Nothing contained in this Agreement shall be construed as creating a
partnership, joint

 

[ * ] = 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 98 of 103

 

--------------------------------------------------------------------------------

venture or agency relationship between the Parties or, except as otherwise
expressly provided in this Agreement, as granting either Party the authority to
bind or contract any obligation in the name of or on the account of the other
Party or to make any statements, representations, warranties or commitments on
behalf of the other Party. All persons employed by a Party shall be employees of
such Party and not of the other Party and all costs and obligations incurred by
reason of any such employment shall be for the account and expense of such
Party.

 

27 Entire Agreement

This Agreement constitutes the entire agreement between the Parties with respect
to the subject matter of this Agreement. This Agreement supersedes all prior
agreements, whether written or oral, with respect to the subject matter of this
Agreement. In particular, this Agreement supersedes the Confidentiality
Agreement between the Parties, effective 12 October 2004, and all confidential
information exchanged between the Parties under such Confidentiality Agreement
shall be deemed the Confidential Information of the corresponding Party and
protected under this Agreement. Each Party confirms that it is not relying on
any representations, warranties or covenants of the other Party except as
specifically set out in this Agreement. Nothing in this Agreement is intended to
limit or exclude any liability for fraud. All Schedules and Exhibits referred to
in this Agreement are intended to be and are hereby specifically incorporated
into and made a part of this Agreement. In the event of any inconsistency
between any such schedules or Exhibits and this Agreement, the terms of this
Agreement shall govern.

 

28 English Language

This Agreement is written and executed in the English language. Any translation
into any other language shall not be an official version of this Agreement and
in the event of any conflict in interpretation between the English version and
such translation, the English version shall prevail.

 

29 Amendment

Any amendment or modification of this Agreement must be in writing and signed by
authorised representatives of both Parties.

 

[ * ] = 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 99 of 103

 

--------------------------------------------------------------------------------

30 Waiver and Non-Exclusion of Remedies

A Party’s failure to enforce, at any time or for any period of time, any
provision of this Agreement, or to exercise any right or remedy shall not
constitute a waiver of that provision, right or remedy or prevent such Party
from enforcing any or all provisions of this Agreement and exercising any rights
or remedies. To be effective any waiver must be in writing. The rights and
remedies provided herein are cumulative and do not exclude any other right or
remedy provided by law or otherwise available except as expressly set forth
herein.

 

31 No Benefit to Third Parties

The provisions of this Agreement are for the sole benefit of the Parties and
their successors and permitted assigns, and they shall not be construed as
conferring any rights in any other Persons except as otherwise expressly
provided Article 22.

The Contracts (Rights of Third Parties) Act 1999 shall not apply to this
Agreement. Except as expressly provide in Article 22, no Person who is not a
party to this Agreement (including any employee, officer, agent, representative
or subcontractor of either Party) shall have the right (whether under the
Contracts (Rights of Third Parties) Act 1999 or otherwise) to enforce any term
of this Agreement which expressly or by implication confers a benefit on that
Person without the express prior agreement in writing of the Parties, which
agreement must refer to this Article 31.

 

32 Equitable Relief

Each Party acknowledges and agrees that the restrictions set forth in this
Agreement are reasonable and necessary to protect the legitimate interests of
the other Party and that neither Party would have entered into this Agreement in
the absence of such restrictions, and that any breach or threatened breach of
any provision of this Agreement may result in irreparable injury to the
non-breaching Party for which there will be no adequate remedy at law. In the
event of a breach or threatened breach of any provision of this Agreement, the
non-breaching Party shall be authorised and entitled to obtain from any court of
competent jurisdiction equitable relief, whether preliminary or permanent,
specific performance and an equitable accounting of all earnings, profits and
other benefits arising from such breach, which rights shall be

 

[ * ] = 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 100 of 103

 

--------------------------------------------------------------------------------

cumulative and in addition to any other rights or remedies to which such
non-breaching Party may be entitled in law or equity. Each of Dynavax and
AstraZeneca agrees to waive any requirement that the non-breaching Party
(a) post a bond or other security as a condition for obtaining any such relief,
and (b) show irreparable harm, balancing of harms, consideration of the public
interest or inadequacy of monetary damages as a remedy. Nothing in this
Article 32 is intended, or should be construed, to limit a non-breaching Party’s
right to equitable relief or any other remedy for a breach of any other
provision of this Agreement, provided, however, that resolution of disputes
between the Parties is subject to the provisions of Article 24.

 

33 Further Assurance

 

33.1 Each Party shall perform all further acts and things and execute and
deliver such further documents as may be necessary or as the other Party may
reasonably require to implement or give effect to this Agreement.

 

33.2 The Parties recognize that each may perform some or all of its obligations
and exercise any or all of its rights under this Agreement, without the prior
consent of the other Party, through Affiliates or Sublicensees, provided,
however, that each Party shall remain responsible for the performance by its
Affiliates and Sublicensees and shall cause its Affiliates and Sublicensees to
comply with the provisions of this Agreement in connection with such
performance. In particular, if any Affiliate of a Party or a Sublicensee
participates in research under this Agreement or with respect to the Product or
any Combination Product(s), (a) the restrictions of this Agreement which apply
to the activities of a Party with respect to a CD, the Product or any
Combination Product(s) shall apply equally to the activities of such Affiliate
and Sublicensee, and (b) the Party affiliated with such Affiliate or Sublicensee
shall assure that any intellectual property developed by such Affiliate or
Sublicensee shall be governed by the provisions of this Agreement (and subject
to the licenses set forth in Article 6) as if such intellectual property had
been developed by the Party. Any action or omission by a Party’s Affiliate or a
Sublicensee which would, if such action or omission were conducted by the Party,
constitute a breach of the Party’s obligations under this Agreement will
constitute a breach of such obligation by the Party (unless such obligation were
otherwise satisfied by such Party or another of its Affiliates or Sublicensees).

 

[ * ] = 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 101 of 103

 

--------------------------------------------------------------------------------

34 Expenses

Except as otherwise expressly provided in this Agreement, each Party shall pay
the fees and expenses of its respective lawyers and all other expenses and costs
incurred by such Party incidental to the negotiation, preparation, execution and
delivery of this Agreement.

 

35 Counterparts

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

 

[ * ] = 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 102 of 103

 

--------------------------------------------------------------------------------

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

 

SIGNED for and on behalf of   SIGNED for and on behalf of AstraZeneca AB (publ)
  Dynavax Technologies Corporation

/s/ Jan M Lundberg

 

/s/ Dino Dina

Signature   Signature Name:  

Jan M Lundberg

  Name:  

Dino Dina, M.D.

Title:  

EVP, Global Discovery

  Title:  

President and CEO

 

[ * ] = 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 103 of 103

 

--------------------------------------------------------------------------------

EXHIBIT A

CRITERIA FOR CANDIDATE DRUG TARGET PROFILE

[ * ]

 

[ * ] = 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 B

DYNAVAX PATENTS

EXHIBIT B(1)

[ * ]

 

[ * ] = 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 B(2)

[ * ]

 

[ * ] = 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 C

JOINT RESEARCH PLAN

Description of Joint 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.

--------------------------------------------------------------------------------

EXHIBIT D

PRE-APPROVED DYNAVAX SUBCONTRACTORS

[ * ]

 

[ * ] = 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 E

PRESS RELEASE

LOGO [g235127image-001.jpg]

2929 Seventh Street, Suite 100

Berkeley, CA 94710

Contact:

Dynavax Technologies Corporation

Jane M. Green, PhD

Corporate Communications

Phone (510) 665-4630

Email: jgreen@dvax.com

DYNAVAX ESTABLISHES COLLABORATION FOR

TLR-9 AGONISTS FOR ASTHMA AND COPD WITH ASTRAZENECA

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

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

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

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

 

[ * ] = 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.

--------------------------------------------------------------------------------

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

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

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

[[Conference Call Today]]

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

Forward Looking Statements

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

 

[ * ] = 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.

--------------------------------------------------------------------------------

About Dynavax

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

About AstraZeneca

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

 

[ * ] = 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 F

CONFIRMATORY PATENT LICENCE

Patent Licence Agreement

Date:

Parties:

 

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

 

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

Recitals:

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

Operative provisions:

 

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

 

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

 

[ * ] = 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.

--------------------------------------------------------------------------------

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

 

EXECUTED as a Deed by                      acting by:

[name of director] and:

[name of director/secretary]

EXECUTED as a Deed by                     acting by:

[name of director] and:

[name of director/secretary]

 

[ * ] = 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.

--------------------------------------------------------------------------------

Schedule 18.2.5

[ * ]

 

[ * ] = 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.

--------------------------------------------------------------------------------

Schedule 18.2.6

[ * ]

 

[ * ] = 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.