exv10w35



 




[ * ] = Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange Commission pursuant
to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.




Exhibit 10.35




Execution Copy




MANUFACTURING AGREEMENT




between




DYNAVAX TECHNOLOGIES CORPORATION




and




MERCK & CO., INC.




 









 





Execution Copy




     This Manufacturing Agreement (the “Agreement”) dated as of October 31, 2007 (“Effective Date”)
is made by and between Dynavax Technologies Corporation (“Dynavax”), a corporation organized under
the laws of Delaware, and Merck & Co., Inc. (“Merck”), a corporation organized under the laws of
New Jersey. Each of Dynavax and Merck is sometimes referred to individually herein as a “Party”
and collectively as the “Parties”.



W I T N E S S E T H:




     Whereas, Dynavax and Merck have entered into that certain Exclusive License and
Development Collaboration Agreement (the “License Agreement”), dated as of the Effective Date under
which Dynavax has provided an exclusive license to Merck for its hepatitis B surface antigen
(“Hepatitis B Surface Antigen”) combined with the 1018 ISS (as defined in the License Agreement) in
the Hep B Field (as defined in the License Agreement); and



     Whereas, Merck desires to use the Hepatitis B Surface Antigen, along with the 1018
ISS together with Merck’s fill and finish capabilities to sell Licensed Vaccines or Product (as
defined herein); and



     Whereas, until such time that the process and formulation technology transfer from
Dynavax to Merck is completed, Dynavax shall supply Merck and Merck shall purchase, its
requirements for Licensed Vaccines or Products (solely for use in Clinical Trials (as defined in
the License Agreement)), [ * ]; and



     Whereas, Merck wishes to engage Dynavax to Manufacture (as defined herein) on Merck’s
behalf its requirements of Hepatitis B Surface Antigen in accordance with the terms and conditions
set forth in this Agreement and the License Agreement.



     Now Therefore, in consideration of the foregoing premises and mutual covenants herein
contained, Dynavax and Merck hereby 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.




1









 





1. DEFINITIONS




     As used herein, the following capitalized terms shall have the respective meanings set forth
below unless otherwise specifically provided herein and where the context requires otherwise,
whenever used the singular includes the plural, the plural includes the singular. Capitalized
terms used but not defined herein shall have the meanings ascribed to them in the License
Agreement:



     1.1 “Act” shall have the meaning given such term in Section 5.1(a).



     1.2 “Affiliate” shall have the meaning given such term in the License Agreement.



     1.3 “Agreement” shall have the meaning given such term in the preamble to this Agreement.



     1.4 “Authorization” shall mean all approvals or permits granted by a Regulatory Authority
necessary to market and sell a Product, including without limitation all applicable pricing and
reimbursement approvals, required to sell such Product in a country within the Territory.



     1.5 “BLA” shall mean the Biologics License Application prepared in accordance with applicable
FDA regulations for filings with the FDA for marketing authorization of Product, or its equivalent
in other countries within the Territory in conformance with the requirements of the applicable
Regulatory Authority.



     1.6 “Calendar Year” shall mean each successive period of twelve (12) months commencing from
January 1 and ending on December 31.



     1.7 “cGMPs” shall mean all laws and regulations relating to the manufacture of Hepatitis B
Surface Antigen, Licensed Vaccine or Product, as the case may be, in the USA and European Union,
including but not limited to the current Good Manufacturing Practices as specified in the United
States Code of Federal Regulations and/or in the European Commission Guide to Good Manufacturing
Practice for Medicinal Products (also known as EudraLex Volume 4), Q7A Good Manufacturing Practice
Guidance for Active Pharmaceutical Ingredients



[ * ] = 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.




 









 




(also known as EudraLex Volume 4 part 2), in each case, as are in effect on the Effective Date
and as may be modified or supplemented during the term of this Agreement.




     1.8 “Complete Invoice” shall have the meaning set forth in Section 8.3.



     1.9 “Delivery” shall have the meaning set forth in Article 7.



     1.10 “Dose”; “Doses” shall mean the target fill quantity of formulated Hepatitis B Surface
Antigen required to fill a vial of Licensed Vaccine or Product for clinical use or commercial sale
as more fully described and calculated on Exhibit B attached hereto.



     1.11 “Effective Date” shall have the meaning given such term in the preamble to this
Agreement.



     1.12 “Facility” shall mean Dynavax’s new Manufacturing facility currently expected to be
located at [ * ] at which Hepatitis B Surface Antigen is Manufactured.



     1.13 “FDA” shall mean the United States Food and Drug Administration and any successor
governmental authority having substantially the same function.



     1.14 “Firm Order” shall mean a binding commitment on the part of Merck or its Related Party to
purchase, and on the part of Dynavax to supply, certain quantity of Hepatitis B Surface Antigen.



     1.15 “Hepatitis B Surface Antigen” shall have the meaning given such term in the preamble to
this Agreement.



     1.16 “Initial Pricing” shall have the meaning given such term in Section 8.1.



     1.17 “Initial Pricing Period” shall have the meaning given such term in Section 8.1.



     1.18 “Know-How” shall mean, any non-public, documented or otherwise recorded or memorialized
knowledge, experience, know-how, technology, information, and data, including formulas and
formulations, processes, techniques, unpatented inventions, discoveries, ideas, 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.




 









 




developments, test procedures, and results, together will all documents and files embodying
the foregoing.




     1.19 “Launch” shall mean, on a country-by-country basis, after receipt of Authorization for
Product in any country the first day on which Merck or a Related Party ships Product to a
wholesaler or Third Party in such country, excluding however, any sale or other distribution for
use in a Clinical Trial in such country.



     1.20 “License Agreement” shall have the meaning given such term in the preamble to this
Agreement.



     1.21 “Licensed Vaccine” shall have the meaning given such term in the License Agreement.



     1.22 “Live Agent” shall have the meaning given such term in Section 6.9.



     1.23 “Long Range Forecast” shall have the meaning set forth in Section 3.1.



     1.24 “Major Market Launch” shall have the meaning set forth in Section 3.1.



     1.25 “Manufacture” shall mean all operations of Dynavax involved in (i) the receipt, incoming
inspections, storage and handling of Materials and (ii) the manufacturing, warehousing, quality
control testing (including in-process, release and stability testing), releasing, and shipping of
bulk Hepatitis B Surface Antigen.



     1.26 “Manufacturing Fee” shall have the meaning set forth in Section 8.1.



     1.27 “Manufacturing Technology” shall mean all inventions, discoveries, improvements, methods,
processes, formulas, Materials, Know-How, trade secrets, technology, data or information Controlled
by Dynavax whether patentable or not which are related to the manufacturing process of Hepatitis B
Surface Antigen, in the Control of Dynavax or its Affiliates as of the effective date of the
License Agreement, or which thereafter become Controlled by Dynavax or its Affiliates and subject
to the grant of a license under Section 3.2 of the License 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.




 









 





     1.28 “Master Cell Bank(s)” shall have the meaning given such term in Section 9.1.



     1.29 “Materials” shall mean all raw materials necessary for the Manufacture of Hepatitis B
Surface Antigen, including without limitation, intermediates, components, containers, labels and
packaging materials.



     1.30 “MST” shall have the meaning given such term in Section 4.3.



     1.31 “Party/Parties” shall have the meaning given such term in the preamble to this Agreement.



     1.32 “Pilot Facility” shall have the meaning given such term in Section 9.2.



     1.33 “Product” shall have the meaning given such term in the License Agreement.



     1.34 “Quality Agreement” shall have the meaning set forth in Section 6.11.



     1.35 “Regulatory Authority” shall mean any applicable governmental organization, agency or
administrative body subject to state supervision which has the authority to grant approvals and
regulate pharmaceutical/biological manufacturing, marketing, reimbursement and/or pricing of the
Product within the Territory, as applicable.



     1.36 “Related Party” shall mean Affiliates of Merck, and any sublicensee of Merck, in whole or
in part, of the licenses granted by Dynavax to Merck under the License Agreement (which term does
not include distributors), as applicable.



     1.37 “Rolling Forecast” shall have the meaning set forth in Section 3.2.



     1.38 “Specifications” shall mean manufactured in accordance with cGMPs and those
specifications for Hepatitis B Surface Antigen Product as set forth on Exhibit A attached hereto,
which can only be changed or modified with the prior written agreement of both Parties.



     1.39 “Steady State Pricing” shall have the meaning given such term in Section 8.1.



     1.40 “Supply Failure” shall mean [ * ].



[ * ] = 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.




 









 





     1.41 “Supply Failure Technology Transfer Notice” shall have the meaning given such term in
Section 9.1.



     1.42 “Term” shall have the meaning set forth in Section 12.1.



     1.43 “Territory” shall mean any and all countries in the world, and their territories and
possessions.



     1.44 “Third Party” shall mean any or all persons or entities other than Merck and its Related
Parties, and Dynavax and its Affiliates.



     1.45 “Working Cell Bank” shall have the meaning given such term in Section 13.1.




			
	2.	 	[ * ]; HEPATITIS B SURFACE ANTIGEN SUPPLY; LICENSED VACCINE OR PRODUCT SUPPLY





     2.1 Merck hereby [ * ] Dynavax to act for and on the behalf of Merck and Related Parties to
Manufacture and supply the Hepatitis B Surface Antigen for use with Licensed Vaccine and Product,
and Dynavax accepts [ * ] to Manufacture Hepatitis B Surface Antigen for use with Licensed Vaccine
or Product. The Parties acknowledge that the use of any Merck Know-How is solely for the
performance of [ * ] hereunder and the retained rights of Dynavax with respect to Dynavax Know-How
remain subject to Section 3.1.3 of the License Agreement. As part of its obligations, Dynavax shall
supply all Materials necessary to satisfy the production requirements of Merck for Hepatitis B
Surface Antigen in accordance with this Agreement. Materials shall remain the property of Dynavax
and shall be used by Dynavax for satisfying its exclusive Manufacturing and supply rights to the
Hepatitis B Surface Antigen.



     2.2 Except as set forth in Sections 3.3, 4.2 and 9.2 below, Dynavax shall supply Merck and
Related Parties, and Merck and Related Parties shall purchase from Dynavax, Merck’s total
requirements of Hepatitis B Surface Antigen for the manufacture of Licensed Vaccine and Product for
commercial sale by Merck and its Related Parties in the Field in the Territory; provided, however,
that the Parties acknowledge and agree Dynavax’s ability to Manufacture Hepatitis B Surface Antigen
is subject to [ * ]. For the purposes of this Agreement, the reference to the requirement of Merck
shall include those of its Related 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.




 









 





     2.3 Dynavax shall supply Merck, and Merck shall purchase from Dynavax, Merck’s and its Related
Party’s total requirements of Licensed Vaccine or Product, as the case may be, for use in Clinical
Trials, until [ * ] (a) [ * ] and (b) [ * ] and in any event subject to (i) the terms and
conditions of the Development Program (as defined in the License Agreement); and (ii) the capacity
constraints of the Pilot Facility and Facility as described in Section 2.2 above. For the
avoidance of doubt, the Development Program shall provide order mechanism and Delivery schedule for
any Delivery of the Licensed Vaccine or Product ordered in connection with Clinical Trials.




			
	3.	 	FORECASTING AND ORDERING FOR COMMERCIAL SUPPLY OF HEPATITIS B SURFACE ANTIGEN





     3.1 Long Range Forecast: At least [ * ] prior to the expected first Delivery date of Product
for the first Launch in the United States or European Market (as defined in the License Agreement)
(the “Major Market Launch”), the Parties shall discuss the projected annual quantity requirements
for the Hepatitis B Surface Antigen for [ * ]. Thereafter, by December 1st of each Calendar Year,
Merck shall provide Dynavax with an updated forecast of its annual requirements for the Hepatitis B
Surface Antigen for [ * ], along with the projected annual quantity requirements for Launch in the
Territory, other than the Major Market Launch (the “Long Range Forecast”). Merck shall use
commercially reasonable efforts to make its long range forecast as accurate as possible. In the
event the requirements for Hepatitis B Surface Antigen as set forth in the most recently updated
long range forecast are significantly different from those set forth in the Rolling Forecast for
the same period, Merck shall, at Dynavax’s request, provide to Dynavax an explanation for such
difference. The Parties shall discuss in good faith any adjustments to potential capacity and
availability of supply based on significant adjustments to the Long Range Forecast, provided that
in any event Merck and Dynavax shall only be bound by the Rolling Forecast. For the avoidance of
doubt, Dynavax shall not be obligated to supply, and Merck shall not be obligated to purchase, the
quantities of Hepatitis B Surface Antigen set forth in the Long Range Forecast.



     3.2 Rolling Forecast: At least [ * ] prior to the expected first Delivery date of Product for
the first Major Market Launch, and thereafter, on or before the dates agreed upon by



[ * ] = 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.




 









 




the MST, and in any event at least [ * ], Merck shall provide Dynavax with a good faith
forecast of monthly quantity requirements for the Hepatitis B Surface Antigen for [ * ] (the
“Rolling Forecast”).




     3.3 Firm Order: The first [ * ] of each monthly Rolling Forecast shall be deemed as a Firm
Order. Merck shall designate a Delivery date or Delivery date(s) for the Firm Orders. The Parties
agree that (i) prior to the [ * ] of the first Major Market Launch, the [ * ] of each Firm Order
shall not vary by more than [ * ] of the estimated quantity of the [ * ] of the previous Rolling
Forecast; and (ii) following the [ * ] of the first Major Market Launch, the [ * ] of each Firm
Order shall not vary by more than [ * ] of the estimated quantity of the [ * ] of the previous
Rolling Forecast. If Merck places a Firm Order in excess of the maximum amount allowed pursuant to
the foregoing sentence, Dynavax shall use its commercially reasonable efforts to meet Merck’s
request; provided that Dynavax’s failure to supply the excess quantities shall not constitute a
breach of this Agreement. Notwithstanding the foregoing, the Parties agree that all Rolling
Forecasts and Firm Orders shall be subject to the capacity constraints for the Manufacture of
Hepatitis B Surface Antigen as described in Section 2.2 above.



     3.4 Form of Firm Order: Each Firm Order will be in such form as Merck may specify from time
to time in writing; provided that, (a) the terms and conditions of this Agreement shall be
controlling over any terms and conditions included in any Firm Order and (b) any term or condition
of such Firm Order that is different from or contrary to the terms and conditions of this Agreement
shall be null and void and of no force or effect.



     3.5 [ * ]: Merck may [ * ], provided that (a) a notice is received by Dynavax [ * ]; and (b)
such [ * ]; and provided further that in any event [ * ]. Merck acknowledges and agrees that in no
event [ * ].



     3.6 Delivery Timing: Dynavax shall satisfy each Firm Order on or before the date specified in
such Firm Order by Merck unless otherwise agreed to by Merck. No Deliveries of Hepatitis B Surface
Antigen shall be made more than [ * ] in advance of the date specified for Delivery in a Firm Order
without Merck’s written approval. Site of Manufacture shall be indicated on documents accompanying
each shipment of Hepatitis B Surface Antigen.



[ * ] = 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.




 









 





     3.7 Pre-Major Market Launch Production: Subject to the capacity restraints set forth in
Section 2.2 above, the Parties acknowledge and agree that in order for Dynavax to supply Merck’s
requirements for Hepatitis B Surface Antigen, Dynavax shall commence Manufacture of the Hepatitis B
Surface Antigen prior to the submission of the BLA with the Regulatory Authority. Upon execution
of this Agreement, through the JDC, the Parties shall mutually agree upon a commencement date for
the Manufacture of the Hepatitis B Surface Antigen and the amount to be produced to support the
first Major Market Launch. Merck will issue a Firm Order for such Hepatitis B Surface Antigen to
support the first Major Market Launch at least [ * ] prior to the expected first Major Market
Launch. [ * ]. For the avoidance of doubt, the Parties agree that any Hepatitis B Surface Antigen
Delivered under this Section 3.7 shall meet the warranties set forth in Section 5.1(a) in order for
[ * ].



4. ALLOCATION; MANUFACTURING AND SUPPLY TEAM




     4.1 Notice: In the event that Hepatitis B Surface Antigen is or is anticipated by Dynavax to
be in short supply due to a shortage of Hepatitis B Surface Antigen, Materials, resources or
existing capacity, Dynavax shall notify Merck in writing of such circumstances as soon as possible,
including the underlying reasons for such anticipated shortage, proposed remedial measures and the
date such shortage is expected to end.



     4.2 Allocation: In the event of a shortage contemplated in Section 4.1, Dynavax shall
allocate to Merck an amount of Hepatitis B Surface Antigen proportionate to the (x) [ * ], divided
by (y) [ * ]. For clarity, [ * ]. In making any allocation under this Section 4.2, Dynavax shall
[ * ].



     4.3 Manufacturing and Supply Team: No less than [ * ], the Parties shall establish a
manufacturing and supply team (the “MST”) of a minimum of [ * ] members, [ * ] of whom shall be
designated by Dynavax and [ * ] of whom shall be designated by Merck and its Affiliates. The MST
shall be a deemed to be a sub-team of the JDC (as defined in the License Agreement) and shall
substantially follow the procedures of the JDC with respect to meetings and decisions as set forth
in Section 2.4 of the License Agreement; provided, however, that the Parties acknowledge and agree
that the MST (and related procedures) shall (a) not have 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.




 









 




authority to bind a Party with respect to manufacturing and ordering except as provided in
this Agreement, and (b) in any event survive past either the dissolution of the JDC or the change
in function of the JDC pursuant to Section 2.4.4 of the License Agreement. Each Party shall
appoint its representatives to the MST by written notice to the other Party and may substitute,
from time to time, one or more of its MST representatives, at its sole discretion, effective upon
notice to the other Party. The MST representatives of each Party shall have appropriate
manufacturing, quality, regulatory and/or technical background, experience and knowledge. The MST
shall serve as forum for discussion and resolution of manufacturing, quality, and regulatory issues
contained in the BLA and supply chain issues, including, but not limited to scheduling production
runs, Delivery forecasts, other production planning, capacity review and metrics. Dynavax shall
provide the MST, from time to time, an update of the status, timing, and critical/key issues
related to the completion of the Facility and overview of the capacity at the Facility and Pilot
Facility compared to the utilization rate of each Facility or Pilot Facility, as the case may be,
in order for the MST to identify any potential supply issues of the Hepatitis Surface B Antigen
prior to their occurrence. Merck shall provide the MST, from time to time, an update of the
status, timing, and critical/key issues in connection with the formulation, filling and packaging
processes in connection with Manufacturing the Licensed Vaccines or Product, as the case may be.




5. REPRESENTATIONS, WARRANTIES AND COVENANTS




     5.1 Representations and Warranties:



          (a) Dynavax represents, warrants and covenants that (i) the Hepatitis B Surface Antigen,
Licensed Vaccine or Product, as the case may be, shall, at the time of arrival at the facility
designated by Merck, from time to time (A) meet the Specifications; and (B) have been Manufactured
in accordance with cGMPs; and (ii) no Hepatitis B Surface Antigen, Licensed Vaccine or Product
shall, at the time of Delivery, (A) be adulterated or misbranded within the meaning of the U.S.
Federal Food, Drug and Cosmetic Act (the “Act”) or (B) have been Manufactured at a Facility that
employs any debarred persons pursuant to sections 306(a) and (b) of the Act.




[ * ] = 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.




 









 





          (b) Dynavax represents, warrants and covenants that, as of the Effective Date: (i) to its
knowledge, the Manufacture of Hepatitis B Surface Antigen does not infringe the intellectual
property rights of any Third Party in the United States, other than those set forth on Schedule
5.1(b) hereto, or the European Market, as applicable; and (ii) Dynavax has not received written
notice from any Third Party of or has no knowledge of (A) any actual or threatened claim or
assertion that the Manufacture of Hepatitis B Surface Antigen infringes the intellectual property
rights of such Third Party; or (B) any actual or threatened claim or assertion that the use of the
Dynavax Manufacturing Technology as contemplated by this Agreement infringes any intellectual
property rights of such Third Party in the United States or the European Market, as applicable.




     5.2 Expiry Dating: Dynavax represents that [ * ] for Hepatitis B Surface Antigen. Dynavax
shall use its best efforts to extend such dating, such that, subject to Section 3.5, all Hepatitis
B Surface Antigen; Licensed Vaccine or Product, as the case may be, supplied by Dynavax under this
Agreement will have no less than [ * ] remaining when Delivered under Section 7.



     5.3 Warranty Claims:



          (a) Merck shall, within [ * ] after arrival at the facility designated by Merck, notify
Dynavax in writing of any Hepatitis B Surface Antigen, Licensed Vaccine or Product that fails to
meet the warranties set forth in Section 5.1(a)(i), and shall notify Dynavax in writing of all
other defects within [ * ] after its discovery of the defect.




          (b) Merck shall have the right to perform analytical testing of Hepatitis B Surface Antigen,
Licensed Vaccine or Product Delivered, including, without limitation, identification testing. In
the event that the tests performed by Merck indicate that a shipment of such Hepatitis B Surface
Antigen, Licensed Vaccine or Product does not meet the Specifications, Merck shall promptly notify
Dynavax and Dynavax shall, within [ * ] after its receipt of Merck’s notice, use its best efforts
to start re-test of such Hepatitis B Surface Antigen, Licensed Vaccine or Product, as the case may
be, and shall expeditiously complete such testing so that any additional testing by the testing
organization that may be required as provided herein-below may




[ * ] = 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.




 









 




be completed within [ * ] of Merck’s notice. If the test performed by Merck and the re-test
performed by Dynavax reach inconsistent results, the Parties shall, within [ * ] after the
completion of re-test by Dynavax, have Hepatitis B Surface Antigen, Licensed Vaccine or Product, as
the case may be, sample(s) mutually agreed upon by the Parties tested by a reputable Third Party
testing organization selected jointly by the Parties. The Parties agree that such dispute shall
not be submitted to arbitration in accordance with Section 12.6.1 of the License Agreement, and the
results of such laboratory testing shall be final and binding on the Parties. If the Hepatitis B
Surface Antigen, Licensed Vaccine or Product, as the case may be is determined to meet the
Specifications by such testing organization, then Merck shall bear the cost of the Third Party
testing and pay for such Hepatitis B Surface Antigen, Licensed Vaccine or Product, as the case may
be, to the extent the Manufacturing Price for such Hepatitis B Surface Antigen has not been paid,
or the price agreed to by the Parties in the case of the Licensed Vaccine or Product. If the
Hepatitis B Surface Antigen, Licensed Vaccine or Product, as the case may be, is determined not to
have met the Specifications, then Dynavax shall bear the cost of Third Party testing, and Dynavax
shall, within [ * ], (a) replace the quantity of the Hepatitis B Surface Antigen, Licensed Vaccine
or Product, as the case may be affected at no additional cost to Merck, or (b) in the event Dynavax
cannot replace the quantity of the Hepatitis B Surface Antigen within such [ * ] period, then at
Merck’s election either (i) be granted an additional period of time to be agreed to by the Parties
to replace the quantity of the Hepatitis B Surface Antigen or (ii) refund the Manufacturing Price
paid by Merck for such Hepatitis B Surface Antigen, or the price agreed to by the Parties in the
case of the Licensed Vaccine or Product, and shall in either case, reimburse Merck for any freight,
insurance, customs duties and other charges incurred by Merck in connection with Hepatitis B
Surface Antigen, Licensed Vaccine or Product, as the case may be, that is determined not to meet
the Specifications.




          (c) Notwithstanding the foregoing provisions of Section 5.3(b), in the event the testing
results of the independent Third Party testing organization are not available within [ * ]
after Dynavax’s receipt of Merck’s notice that the Hepatitis B Surface Antigen, Licensed Vaccine or
Product, as the case may be, failed to meet the Specifications, Dynavax shall, at Merck’s request,
Deliver additional Hepatitis B Surface Antigen Licensed, Vaccine or Product, as the case may be, to
Merck corresponding to the amount of Hepatitis B Surface Antigen,




[ * ] = 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.




 









 




Licensed Vaccine or Product, as the case may be, in dispute. Any Hepatitis B Surface Antigen,
Licensed Vaccine or Product, as the case may be, which is determined by the independent testing
organization to have failed to meet the Specifications shall be destroyed or returned to Dynavax,
at Dynavax’s cost. If the independent testing organization determines that Hepatitis B Surface
Antigen, Licensed Vaccine or Product, as the case may be, meets the Specifications, Merck shall pay
for the additional Hepatitis B Surface Antigen, Licensed Vaccine or Product, as the case may be, to
the extent the Manufacturing Price for such Hepatitis B Surface Antigen has not been paid, or the
price agreed to by the Parties in the case of the Licensed Vaccine or Product.




          (d) The Parties agree that the sole remedy for Merck for failure of the warranty under this
Section 5.3 shall be to either (i) be provided a refund of amounts previously paid, or (b) for
Dynavax promptly to manufacture and Deliver a replacement quantity that meets the Specifications.




     5.4 Disclaimers: The Parties intend and agree that no warranties exist beyond these stated in
this Agreement. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES
ANY REPRESENTATIONS AND GRANTS NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF
LAW, BY STATUTE OR OTHERWISE, AND SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER WRITTEN OR
ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A
PARTICULAR USE OR PURPOSE. FURTHERMORE, EXCEPT FOR BREACH OF ITS OBLIGATIONS TO THE OTHER PARTY
UNDER SECTION 4.1 OF THE LICENSE AGREEMENT, IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER
PARTY, ITS AFFILIATES, LICENSEES OR SUBLICENSEES, OFFICERS, DIRECTORS, AGENTS, REPRESENTATIVES OR
EMPLOYEES FOR ANY LOST PROFITS, LOSS OF BUSINESS, LOSS OF CONTRACTS, DIMINISHED GOODWILL,
DIMINISHED REPUTATION, OR CONSEQUENTIAL, INDIRECT, INCIDENTAL, PUNITIVE, EXEMPLARY OR SPECIAL
DAMAGES OF THE OTHER PARTY ARISING FROM OR IN CONNECTION WITH THIS AGREEMENT, PROVIDED, HOWEVER,
THAT THIS SECTION 5.4 SHALL NOT LIMIT EITHER PARTY’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.




 









 




INDEMNIFICATION OBLIGATIONS UNDER ARTICLE 11 OF THE LICENSE AGREEMENT.




6. QUALITY CONTROL




     6.1 Compliance with Specifications, cGMP, etc: Dynavax shall Manufacture Hepatitis B Surface
Antigen in accordance with the Specifications. Hepatitis B Surface Antigen supplied hereunder
shall be labelled in compliance with the drug listing, and Dynavax shall notify Merck and the FDA
of any change to the labelling that would affect the drug listing.



     6.2 Change Control: Dynavax shall provide Merck with prior written notice of, and obtain
Merck’s prior written consent to, any proposed changes in Specifications, subcontractors,
facilities (including the Facility or Pilot Facility), equipment, Materials (including source
thereof) and Manufacturing processes in accordance with the Quality Agreement, and shall bear all
costs and expenses associated with such changes, including without limitation, direct costs and
expenses incurred by Merck as a result of such changes. All direct costs and expenses for changes
requested by Merck shall be borne by Merck. In addition, Dynavax shall at its expense, (a) provide
Merck with all information required by Merck to amend the Authorizations due to the changes
implemented by Dynavax, and (b) continue to supply Merck with Hepatitis B Surface Antigen approved
under the existing Authorizations until such time as the changes are permitted under the applicable
Authorizations.



     6.3 Quality Control Testing: Dynavax shall perform quality control testing of all the batches
of Hepatitis B Surface Antigen manufactured by Dynavax under this Agreement and shall Deliver only
the batches which passed the quality control testing. Dynavax shall furnish Merck with signed
original certificates of quality control testing for each such batch of Hepatitis B Surface
Antigen. Dynavax shall complete and maintain intermediate bulk Hepatitis B Surface Antigen hold
time stability to support defined hold times for bulk Hepatitis B Surface Antigen and the resulting
Licensed Vaccine or Product. Dynavax shall release Hepatitis B Surface Antigen in accordance with
EU Qualified Person Guidelines.



[ * ] = 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.




 









 





     6.4 Facilities, Audit and Inspection: Dynavax shall Manufacture Hepatitis B Surface Antigen
at the Pilot Facility or Facility (once qualified), which may not be relocated without Merck’s
prior written consent. Merck shall be entitled, [ * ] with reasonable notice, to audit Dynavax’s
manufacturing documents and to inspect the Pilot Facility and/or Facility or both, and Dynavax
shall, at its sole cost and expense, implement corrective actions mutually agreed upon by the
Parties if Merck identifies and documents to Dynavax any noncompliance with cGMP in Dynavax’s
manufacturing process. Notwithstanding the foregoing, Merck shall have the right to conduct
additional audits to the extent necessary to address specific quality problems relating to the
Manufacture or in response to Regulatory Authority requirements. Dynavax shall also cause its
subcontractors and suppliers to permit Merck, at reasonable intervals with appropriate notice, to
audit such subcontractors and suppliers in the event Merck elects to do so, and shall cause such
subcontractors and suppliers to implement corrective actions mutually agreed upon by the Parties if
Merck identifies and documents any noncompliance with the cGMP with respect to the performance of
Dynavax’s subcontractors or suppliers. Dynavax shall advise Merck promptly of any Regulatory
Authority inspections and their outcomes, or any written or oral inquiries by such Regulatory
Authority. Dynavax shall provide Merck promptly with a summary of the inspection results and a
copy of any responses to such inspection results.



     6.5 Equipment Validation: Dynavax shall be responsible for operating and maintaining the
Facility, the Pilot Facility and equipment, validating the equipment (including without limitation
conducting installation, operational and performance qualification), production, cleaning,
packaging, process and any other appropriate steps performed at the Facility or Pilot Facility in
accordance with (a) cGMPs and (b) Dynavax’s standard operating procedures.



     6.6 Certificates of Analysis: Dynavax shall provide Merck with certificates of analysis
related to Hepatitis B Surface Antigen for each batch released for Delivery hereunder. These
certificates will document that each batch received by Merck conforms to the Specifications at the
time such Hepatitis B Surface Antigen is Delivered from the Facility or Pilot Facility, as the case
may be. These certificates shall include results of tests performed to meet the Specifications,
the date of Manufacture, expiry date for Hepatitis B Surface Antigen 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.




 









 




appropriate, and any other information to support final release of Licensed Vaccine or
Product. A copy of each certificate shall be included with each batch Delivered to Merck, and one
copy shall be delivered by electronic media contemporaneously to the Merck representative specified
in the applicable Firm Order.




     6.7 Test Methods: Dynavax shall supply Merck and any Regulatory Authority that conducts
testing with analytical test methods and other testing know-how, including method validation,
required to perform local testing as may be required by the Regulatory Authority in the Territory,
upon request, with appropriate quantities of reference standards relating to Hepatitis B Surface
Antigen, ISS 1018, and Licensed Vaccine (to the extent controlled by Dynavax) free of charge, in
order to facilitate Merck’s testing.



     6.8 Final Release: Merck shall be responsible for the final release of Product for sale in
the Territory in accordance with Merck’s standard practices and the BLA. Dynavax shall provide
Merck with copies of all relevant records as requested by Merck, including, but not limited to any
significant Manufacturing deviations or any out-of-Specification test result, significant changes
to manufacturing or testing, and copies of each batch record controlled by Dynavax with respect to
Manufacturing hereunder and necessary in order for Merck to comply with its responsibilities for
final release of Licensed Vaccine and/or Product. A complete listing of documents required for
final release will be listed in the Quality Agreement (as defined below).



     6.9 Avoidance of Cross-Contamination: Dynavax hereby confirms, as of the Effective Date, that
Dynavax is not producing, packaging, labelling, warehousing, quality control testing (including
in-process, release and stability testing), releasing or shipping any chemical entity classified as
penicillins or other beta-lactam antibiotics such as cephalosporins or carbapenems, steroids,
hormones, alkaloids, controlled substances, Live Agents, cytotoxic drug substances, pesticides,
herbicides, fungicides, or other toxic non-drug substances in the Facilities. The term “Live
Agent” means a product containing a living organism that causes infectious disease, including, but
not limited to, viruses, bacteria, rickettsia, fungi, and protozoa. In the event that Dynavax
intends, during the Term, to produce, package, label, warehouse, quality



[ * ] = 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.




 









 




control test (including in-process, release but excluding stability testing), release or ship
any chemical entity belonging to the classes of products listed above in the Facility or Pilot
Facility, Dynavax shall promptly notify Merck in writing of its intention to do so in order to
allow Merck to consider any potential questions of cross-contamination or regulatory requirements.
In the event Merck reasonably identifies a potential problem which may result in
cross-contamination with Product or Regulatory Authority requirements that would prohibit the
activity, Merck shall provide Dynavax with written notice and the Parties shall meet to seek to
resolve the problem in good faith; provided that, in no event shall Hepatitis B Surface Antigen
Manufactured at the Pilot Facility or Facility identified in Merck’s notice be Delivered to Merck
after the date of the notice until such problem has been resolved to the reasonable satisfaction of
both Parties.




     6.10 Annual Reviews: Dynavax shall implement and perform an annual review program for the
Manufacture of bulk Hepatitis B Surface Antigen mutually agreed by the Parties including, but not
limited to, a review of production-related and quality control testing, as more fully described in
the Quality Agreement.



     6.11 Quality Agreement: No later than [ * ] after the Effective Date, the Parties shall
negotiate in good faith and execute a quality agreement (the “Quality Agreement”) which shall (a)
supplement the terms of this Article 6, and (b) set forth in detail the quality assurance
arrangements and procedures with respect to Hepatitis B Surface Antigen and the cGMPs
responsibilities between the Parties.



7. DELIVERY




     7.1 Dynavax shall Deliver, or arrange for Delivery of, the Hepatitis B Surface Antigen
purchased by Merck hereunder in accordance with the Firm Order [ * ] (as the case may be, “Deliver”
or a “Delivery”). Merck shall [ * ] for (a) [ * ], and (b) [ * ].



8. MANUFACTURING PRICE; PAYMENT PROCEDURE




     8.1 Manufacturing Price: The manufacturing price of the Hepatitis B Surface Antigen shall be
[ * ] (the “Initial Pricing”); and [ * ] (the “Steady State Pricing”, together with



[ * ] = 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.




 









 




the Initial Pricing, the “Manufacturing Fee”). On an ongoing basis but not less than once per
year, the Parties agree to hold good faith discussions to review ways in which [ * ].




     8.2 Adjustment to Steady State Pricing: The Steady State Pricing shall be subject to an
adjustment commencing [ * ] of the Major Market Launch equal to the increase in the [ * ];
provided, however, that in no event shall the annual increase be greater than [ * ] when compared
to the previous years Steady State Price; provided further that if the increase in such index for
the immediately preceding anniversary exceeds [ * ].



     8.3 Invoice and Payment: Dynavax shall invoice Merck for each shipment of Hepatitis B Surface
Antigen upon Delivery in accordance with this Section 8.3. Each Complete Invoice shall be sent via
facsimile or similar electronic means, followed by an original copy forwarded via first class mail.
Merck shall pay in full for each Complete Invoice within [ * ] from the date of Merck’s receipt of
the Complete Invoice.



     A “Complete Invoice” is an invoice that contains the following information and any other
information specifically requested by Merck prior to Delivery: (a) name of Dynavax and “Remit to”
wire account and address, (b) Merck’s purchase order number, (c) invoice number, (d) invoice date,
(e) description of goods and services, (f) total invoice amount with miscellaneous charges listed
separately and (g) payment terms consistent with the terms of this Agreement.



     8.4 Taxes: To the extent that Hepatitis B Surface Antigen supplied hereunder is subject to
any sales, use, value added or any other taxes, payment of said taxes, if any, is Merck’s sole
responsibility; provided that Dynavax shall be liable for any and all taxes on any and all income
it receives from Merck under this Agreement.



9. SECURITY OF SUPPLY




     The Parties shall undertake the following arrangements to ensure continued supply of Hepatitis
B Surface Antigen.



     9.1 Master Cell Banks. Dynavax shall [ * ] (each, a “Master Cell Bank”, together the “Master
Cell Banks”) [ * ].



[ * ] = 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.




 









 





     9.2 Backup Source. Following [ * ], in order to [ * ], Dynavax agrees to maintain [ * ]
(the “Pilot Facility”) [ * ].



10. TECHNOLOGY TRANSFER




     10.1 Supply Failure Technology Transfer: Dynavax shall promptly notify Merck in writing of
the reasons for a Supply Failure, any proposed remedial measures with regard thereto and the date
such Supply Failure is expected to end. If such Supply Failure will end [ * ], the Parties shall
continue the supply relationship. If Merck believes that the Supply Failure will not end in such
period, the Parties shall submit the matter for dispute resolution pursuant to Section 12.6 of the
License Agreement; provided, however, [ * ].



     10.2 Process Technology Transfer: As soon as practicable following the Effective Date, but no
later than [ * ] from the Effective Date, [ * ].



11. CUSTOMER COMPLAINTS AND RECALL




     11.1 Customer Complaints: Merck shall be responsible for and take control over responding to
any complaint or claim relating to the Product which is distributed and sold by Merck or its
Related Parties in the Territory; provided however that when any such complaint or claim is
reasonably suspected to be due to Dynavax’s Manufacturing of Hepatitis B Surface Antigen, Merck
shall so notify Dynavax and Dynavax shall promptly investigate its Manufacturing and report to
Merck the result of such investigation, including the rectifying steps to be taken if any defect is
found in the Manufacturing or the quality control, and shall implement such rectifying steps at
Dynavax’s sole cost and expense. In any event, Merck shall keep Dynavax informed of any complaints
or claims relating to the Product that might reasonably be related to the Manufacture of the
Hepatitis B Surface Antigen.



     11.2 Recalls: Merck shall have the right to make decisions to recall Product in the Territory
and shall promptly notify Dynavax after Merck makes such decision. In the event that a recall is
caused by (a) breach of any of the representations, warranties and covenants set forth in Sections
5.1 and 5.2 of this Agreement, or (b) Dynavax’s negligence or willful misconduct, Dynavax shall
reimburse Merck for (i) the Manufacturing Price paid by Merck for Hepatitis B



[ * ] = 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.




 









 




Surface Antigen incorporated in the recalled Product, (ii) all costs associated with shipping
and distributing the recalled Product, and (iii) all expenses reasonably incurred in connection
with such recall.




12. TERM AND TERMINATION




     12.1 Term: This Agreement shall become effective on the Effective Date and shall continue in
full force and effect for [ * ], unless otherwise terminated in accordance with this Agreement or
the License Agreement (the “Term”).



     12.2 Termination by Either Party for Uncured Material Breach: This Agreement may be
terminated by written notice given by either Party for material breach by the other Party,
effective upon notice following the expiry of the cure periods described in the License Agreement,
as set forth in Section 10.3.1 of the License Agreement, or if the BLA relating to the Licensed
Vaccine or Product is deactivated or withdrawn by any Regulatory Authority in the US or European
Market, provided that such termination shall only be effective if the deactivation or withdrawal
remains in effect [ * ] of such notice.



     12.3 Termination by Merck: This Agreement may be terminated by written notice given by Merck
to Dynavax, effective upon notice following the expiry of the cure periods described below, as
follows:



          (a) if the License Agreement terminates for other than a breach by Merck; or




          (b) if any required license (including the commercial manufacturing license issued in
Germany), permit or certificate of Dynavax to Manufacture Hepatitis B Surface Antigen is not
approved or not issued or is deactivated or withdrawn by any Regulatory Authority in the US or
European Market and such non-approval, non-issue, deactivation or withdrawal would inevitably cause
Dynavax to be unable to meet its supply obligations hereunder; provided, that such termination
shall only be effective if remaining uncured [ * ] after receipt of such notice.




[ * ] = 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.




 









 





     12.4 Consequences of Certain Terminations by Merck: In the event that this Agreement is
terminated by Merck in accordance with Sections 12.2 or 12.3 above, Merck shall, at its option,
either (a) have the right (but not the obligation) within [ * ] of termination to purchase all
Hepatitis B Surface Antigen already Manufactured by Dynavax pursuant to Firm Orders at the
Manufacturing Price and (i) to sell the resulting Product in the Territory, and (ii)receive a
technology transfer for the Hepatitis B Surface Antigen pursuant to Section 10.1; [ * ]; or (b)
require Dynavax to purchase at the Manufacturing Price all Hepatitis B Surface Antigen inventory in
Merck’s possession, along with the cost of Materials reasonably incurred by Merck to further
process the Hepatitis B Surface Antigen into Product. In such event, all Firm Orders shall be
cancelled and Merck and Dynavax shall have no further liability with respect thereto.



     12.5 Consequences of Certain Terminations by Dynavax and by Merck for Convenience: In the
event that this Agreement is terminated by Dynavax in accordance with Section 12.2 above or by
Merck in accordance with Section 10.2.1 of the License Agreement, Dynavax shall have the right to
(a) sell to Merck (and Merck shall have the obligation to purchase) (i) all Hepatitis B Surface
Antigen already Manufactured by Dynavax pursuant to Firm Orders at the Manufacturing Price and (ii)
to the extent that Dynavax shall not exercise it rights pursuant to Section 10.4.3 of the License
Agreement, all Materials and work-in-process then owned by Dynavax or for which Dyanvax has
non-cancellable commitments which cannot be diverted to Dynavax’s other uses; and (b) (i) either
cancel all Firm Orders or require Merck to purchase all Hepatitis B Surface Antigen to be
Manufactured pursuant to Firm Orders and (ii) to the extent that Dynavax shall not exercise its
rights pursuant to Section 10.4.3 of the License Agreement, all Materials and work-in-process then
owned by Dynavax or for which Dyanvax has non-cancellable commitments which cannot be diverted to
Dynavax’s other uses.



     12.6 Consequences of Natural Expiration: Upon the expiration of the Term, other than for
termination under Sections 12.2 or 12.3, Dynavax shall grant Merck a technology transfer for the
Hepatitis B Surface Antigen pursuant to Section 10.1; [ * ]. [ * ] prior to the expiration of this
Agreement, Dynavax shall provide copies of all existing Manufacturing



[ * ] = 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.




 









 




Technology to Merck in order to allow Merck to commence the process of performing the
technology transfer outlined in Section 10.1.




     12.7 Accrued Rights: Unless otherwise agreed in this Agreement, termination of this Agreement
shall not relieve the Parties of any liability or obligation which accrued under this Agreement
prior to the termination. Upon the termination under Section 12.2, outstanding debts due to the
other Party shall become due and payable immediately irrespective of any payment terms previously
agreed upon by the Parties.



     12.8 Other Remedies: Termination of this Agreement shall not preclude either Party from
pursuing all rights and remedies it may have under this Agreement or at law or in equity with
respect to any breach of this Agreement.



13. MANUFACTURING RECORDS




     13.1 All Manufacturing records (other than the Master Cell Bank and Working Cell Bank records,
which shall be retained indefinitely) shall be retained by Dynavax for a period of [ * ];
provided that all Manufacturing records associated with validation batches shall be retained by
Dynavax throughout the term of this Agreement. Dynavax shall provide Merck with complete and
accurate copies of the appropriate documents for each production batch, upon Merck’s request.
Dynavax shall notify Merck of any intention to destroy Manufacturing records after the applicable
retention period set forth above and shall afford Merck the opportunity to obtain such records.
For purposes of this Section 13.1, “Working Cell Bank” shall mean a cell bank prepared from
aliquots of a homogeneous suspension of cells obtained from culturing the Master Cell Bank.



14. INSURANCE




     14.1 Dynavax shall procure and maintain, at it sole cost and expense, with a carrier rated
“A-” or higher by A.M. Best, (a) comprehensive general liability and/or umbrella insurance, with
coverage limits of not less than [ * ], and (b) property/casualty insurance on all material
property owned, leased or in the possession of Dynavax, including, but not limited to the Facility
and Pilot Facility, with coverage limits of not less than replacement cost. In addition



[ * ] = 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.




 









 




to the foregoing, Dynavax shall maintain product liability insurance against claims arising
from the Manufacture, distribution and use of Hepatitis B Surface Antigen, Licensed Vaccine or
Product (to the extent provided by Dynavax to Merck herein), with coverage limits of not less than
[ * ]. Dynavax shall maintain such policies at all times during the Term (and any extension
thereof), and shall provide such coverage for no less than [ * ]. All Dynavax insurance required
under this Section 14.1 shall name Merck as an additional insured. Dynavax shall provide Merck
with certificates of insurance with respect to this Section 14.1 promptly following the Effective
Date. Dynavax shall immediately notify Merck or any changes in the status of the insurance
specified in this Article 14, and shall from time to time thereafter, at Merck’s reasonable
request, provide to Merck with a certificate of insurance attesting that such insurance remains in
full force and effect. Maintenance by Dynavax of the insurance required by this Section 14.1 shall
not relieve Dynavax of any responsibility for liability in excess of insurance limits or otherwise.




     14.2 Merck shall procure and maintain or otherwise self-insure at the levels corresponding to
those provided for Dynavax in Section 14.1, and shall provide coverage, if under a policy of
insurance, for no less than [ * ]. Maintenance by Merck of the insurance or self-insurance
required by this Section 14.2 shall not relieve Merck of any responsibility for liability in excess
of insurance limits or otherwise.



15. INTEGRATION; SURVIVAL




     15.1 All the following provisions of the License Agreement are hereby incorporated by
reference for all purposes herein: Articles 4, 11 and 12.



     15.2 The following provisions shall survive any expiration or termination of this Agreement:
Articles 1, 4, 5, 6, 7, 8, 9, 10, 12, 13, 14 and 15; and Sections 2.1, 2.2, 11.4, 11.5, 11.6, 11.7,
and 11.8 of this Agreement; and Articles 11 and 12 of the License Agreement. Any and all such
provisions shall remain in full force and effect in accordance with their terms.



     15.3 In the event of any conflicts between the terms of this Agreement and the License
Agreement, the terms of this Agreement shall prevail; provided that in no event shall any term of



[ * ] = 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.




 









 




this Agreement be deemed to amend or modify Article 2, Article 3, Article 5 and Article 9 of
the License Agreement.




16. U.N. CONVENTION ON INTERNATIONAL SALE OF GOODS




     16.1 Notwithstanding any provision contained herein to the contrary, the Parties hereby
expressly agree that the U.N. Convention on International Sale of Goods shall not apply.



17. COUNTERPARTS




     17.1 This Agreement may be executed in identical duplicate copies exchanged by telefacsimile
transmission or by electronic mail in .pdf format with acknowledgment of receipt (other than by
automated response) by the receiving Party. The Parties agree to execute two (2) identical
original copies of this Agreement after exchanging signed telefacsimile/electronic versions. Each
identical counterpart shall be deemed an original, but all of which together shall constitute one
and the same instrument.



     In Witness Whereof, the Parties hereto have caused this Agreement to be executed by
their duly authorized representatives as of the Effective Date.



Merck & Co., Inc.




By: /s/ Richard T. Clark                                        

Name: Richard T. Clark

Title: Chairman, President and Chief Executive Officer




Dynavax Technologies Corporation




By: /s/ Dino Dina                                                  

Name: Dino Dina, M.D.

Title: President and Chief Executive Officer




[ * ] = 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 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.




 









 





Exhibit B




Price




[ * ]




[ * ]

[ * ]




[ * ].

[ * ]

[ * ].

[ * ]




[ * ]




	 	 	 	 	 	 	 	 	 
	 

	 	[ * ]
	 	[ * ]
	 	[ * ]	 	 
	[ * ]

	 	[ * ]
	 	 	 	[ * ]
	 	[ * ] [ * ]






[ * ]




	 	 	 	 	 	 	 	 	 
	 

	 	[ * ]
	 	[ * ]
	 	[ * ]	 	 
	[ * ]

	 	[ * ]
	 	 	 	[ * ]
	 	[ * ] [ * ]






[ * ].




[ * ] = 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 5.1(b)




[ * ]




[ * ] = 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.