[ * ] = 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 10.33

 

COMMERCIAL MANUFACTURING AND SUPPLY AGREEMENT

This Commercial Manufacturing and Supply Agreement (this “Agreement”) is made
effective as of the 22nd day of November, 2013 (the “Effective Date”) by and
between Baxter Pharmaceutical Solutions LLC, a Delaware limited liability
company having a place of business at 927 South Curry Pike, Bloomington, Indiana
47403 (“Baxter”), and Dynavax Technologies Corporation, a Delaware corporation
having a principal place of business at 2929 Seventh Street, Suite 100,
Berkeley. California 94710 (“Dynavax”).

Recitals

1.Dynavax is engaged in the development, bulk production, formulation, sale and
distribution of pharmaceutical products;

2.Baxter is, among other pharmaceutical activities, engaged in the formulation,
filling, inspection, labeling and packaging of pharmaceutical products for
various biotech and pharmaceutical companies, including competitors of Dynavax
and Baxter;

3.Dynavax and Baxter desire to have Baxter purchase certain Components (as
defined below) on behalf of Dynavax, formulate, fill, inspect, package, label,
and test Product for Dynavax for commercial use.

Now, Therefore, in consideration of the mutual covenants and agreements
contained herein, Dynavax and Baxter, hereinafter referred to as “Party” or
“Parties”, agree as follows:

Article 1

DEFINITIONS

As used in this Agreement, the following words and phrases shall have the
following meanings:

“Affiliate” shall mean any corporation or other business entity directly or
indirectly controlled by, controlling, or under common control with a Party or
its parent corporation. The term “control” (including, with correlative meaning,
the terms “controlled by,” “controlling” and “under common control with”) means
the possession, directly or indirectly, of the power to direct or cause the
direction of the management and policies of such Party, whether through the
ownership of voting securities, by contract or otherwise, or such other
relationship as, in fact, constitutes actual control.

“Agreement” shall be defined in the introductory paragraph.

“Annual Obligation” shall be defined in Section 4.3.

“Batch” shall mean a specific quantity of a Product comprising a number of Units
mutually agreed upon between Dynavax and Baxter, and that (a) is intended to
have uniform character and quality within specified limits, and (b) is Produced
according to a single manufacturing order during the same cycle of Production.

1.

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“Baxter” shall be defined in the introductory paragraph.

“Baxter Property” shall be defined in Section 13.3.

“Baxter SOPs” shall mean Baxter’s standard operating procedures.

“Bill of Materials” or “BOM” shall mean the listing of Components, part numbers,
and relative quantities to be used in the Production of Product.

“BLA” shall mean the FDA-required Biologics License Application.

“Bulk Drug Substance” or “BDS” shall mean the bulk form of the active
pharmaceutical ingredient used as the raw material in the Production of Product.

“Claims” shall be defined in Section 14.1.

“Components” shall mean all components used by Baxter in the Production of
Product under this Agreement. Components are listed in the Bill of Materials,
such components are identified as the components supplied by Dynavax and
components procured by Baxter on behalf of Dynavax (collectively the “Dynavax
Supplied Components”) and the components supplied by Baxter (the “Baxter
Supplied Components”).

“Component Specifications” shall mean the specifications and testing to be
performed for the Components, as set forth in the QCMD.

“Confidential Information” shall be defined in Section 18.2.

“Confidentiality Agreement” shall be defined in Section 18.2.

“Contract Requirements” shall mean at least ninety percent (90%) of Dynavax’s
worldwide demand for Product.

“Contract Year” shall mean the twelve (12) month period commencing on the date
the first Regulatory Approval is obtained by Dynavax and each subsequent twelve
(12) month period during the Initial Term and as applicable any renewal term.

“Current Good Manufacturing Practices” or “cGMP” shall mean (a) the good
manufacturing practices required by the FDA and set forth in the FD&C Act or FDA
regulations (including without limitation 21 CFR 210 and 211), in effect at any
time during the Term of this Agreement, for the Production and testing of
pharmaceutical materials as applied solely to Products, and (b) the
corresponding requirements of each applicable Regulatory Authority.

“Delivery Date” shall mean the date that Product is made available by Baxter for
pick-up at Baxter’s facility by a common carrier designated by Dynavax.

“Development Plan” shall be defined in Section 2.1.

“Disposition Date” shall mean Baxter’s disposition of the Executed Batch Record.

“DMF” shall be defined in Section 9.6.

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.

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“Dynavax” shall be defined in the introductory paragraph. “Dynavax Insurance”
shall be defined in Section 15.1. “Dynavax Property” shall be defined in Section
13.3.

“Dynavax’s Intellectual Property” shall be defined in Section 17.1.

“Effective Date” shall be defined in the introductory paragraph.

“Executed Batch Record” shall mean the completed batch record (dispositioned by
Baxter as released, rejected or aborted) and associated exception reports, and
if applicable, a QCMD for each Batch of Product.

“Expected Yield” shall be defined in Section 4.5.

“FDA” shall mean the United States Food and Drug Administration or any successor
entity thereto.

“FD&C Act” shall mean the United States Federal Food, Drug and Cosmetic Act, as
may be amended from time to time.

“Firm Purchase Order” shall be defined in Section 4.2.

“FPPI” shall be defined in Section 6.2.

“Imported Goods” shall be defined in Section 3.7. “Importer of Record” shall be
defined in Section 3.7. “Indemnified Parties” shall be defined in Section 14.1.
“Indemnifying Party” shall be defined in Section 14.3.

“Initial Long Range Forecast” shall be defined in Section 4.1.

“Initial Term” shall be defined in Section 8.1. “Inspection Period” shall be
defined in Section 7.1. “Invention” shall be defined in Section 17.2.

“Launch Material” shall mean any Product Produced within ninety (90) calendar
days of approval of the process validation summary. In addition, Launch Material
shall include (a) any Product Produced through formulation and/or filling which
will not be immediately inspected, labeled and packaged; such delay may be due
to changes to Product, including, but not limited to, a new part number,
packaging configuration, country introduction, expiration date change, or change
in the filled Unit form, fit or function, and (b) any Product Produced through
formulation and/or filling which cannot be immediately released by Baxter due to
a failure of Dynavax to provide Baxter with the BDS manufacturer audit report(s)
or certificates of completion, license submission or other documentation.

“Long Range Forecast” shall be defined in Section 4.1.

“Losses” shall be defined in Section 14.1.

“Master Batch Record” or “MBR” shall mean, with respect to each Presentation of
Product to be Produced hereunder, a formal set of instructions for the
Production of each Presentation of such Product. The MBR shall be developed and
maintained in Baxter’s standard format by Baxter, using Dynavax’s master formula
and technical support.

“Monetary Cap” shall be defined in Section 13.2.

3.

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

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“Party” or “Parties” shall be defined in the Recitals.

“Permitted Recipients” shall be defined in Section 18.3.

“Presentation” shall mean the specific formula and Components for a Product.

“Produce” or “Production” shall mean the formulation, filling, packaging,
inspecting, labeling, and testing of Product by Baxter as specified in the
applicable Master Batch Record or finishing specification sheet.

“Product” shall mean formulated Bulk Drug Substance in syringes in final
packaged and labeled forms as specified in the Product Addendum and Produced
after the first Regulatory Approval therefore.

“Product Addendum” shall mean an addendum to this Agreement for each Product
and/or Presentation of Product Produced hereunder.

“Production Price” shall be defined in Section 5.1.

“Product Requirements” shall mean the Product Specifications, Master Batch
Record and Baxter SOPs.

“Product Specifications” shall mean, with respect to each Product, the
specifications and testing to be performed for the BDS, the Product, and/or the
stability program that are set forth in Baxter SOPs and the Master Batch
Records. The Product Specifications include all tests that Baxter is required to
conduct or cause to be conducted as specified in the QCMD. The Product
Specifications may be modified from time to time only by a written agreement of
Dynavax and Baxter.

“Project Plan” shall mean the document(s) containing the parameters for the
Production of each Presentation of Product which shall be developed by Baxter
and agreed to in writing by Dynavax for each Presentation of Product under this
Agreement as set forth in Section 2.2. In addition, the Project Plan may
include, without limitation, the Product, Components, Regulatory Authorities,
the countries where such Product will be sold, Presentations, Rescheduling Fees
and pricing for such Product Produced under this Agreement as set forth in
Section 5.1.

“Purchase Order” shall mean written orders from Dynavax to Baxter which shall
specify (a) the quantity of Product ordered, (b) shipping instructions, (c)
requested delivery dates, and (d) delivery destinations.

“Quality Agreement” shall have the meaning set forth in Section 2.5.

“Quality Control Master Document “ or “QCMD” shall mean a listing of the
analytical testing and corresponding Specifications, to be performed on the Bulk
Drug Substance, raw materials and Product. A “Lot QC Data Packet,” which
includes a Product certificate of analysis containing the same information as
the QCMD and other supporting Production documentation, may be provided in lieu
of a finished Product QCMD.

“Regulatory Approval” shall mean all authorizations by the appropriate
Regulatory Authority necessary for commercial sale in a jurisdiction, including
without limitation, approval of labeling, price, reimbursement and Production.

4.

[ * ] = 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.

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

 

“Regulatory Authority” shall mean those agencies or authorities responsible for
regulation of the Products in the United States and such other Regulatory
Authorities expressly agreed upon by the Parties in the Quality Agreement.
Baxter will have no obligation to Produce Product in compliance with the
requirements of a Regulatory Authority not specified in the applicable Quality
Agreement.

“Regulatory Plan” shall mean the document(s) containing regulatory services and
support for the development and maintenance of regulatory submissions and
supporting documentation as set forth in Section 2.4.

“Released Executed Batch Record” shall mean the completed batch record and
associated exception reports, and QCMD created for each Batch of Product.

“Reservation Fees” shall be the fees payable by Dynavax for modification of a
Firm Purchase Order as set forth in the Project Plan.

“Response Period” shall be defined in Section 7.1.

“SEC” shall be defined in Section 18.5.

“Storage Period” shall be defined in Section 3.8.1.

“Supply Plan” shall be defined in Section 4.1.

“Term” shall be defined in Section 8.1.

“Testing Standards and Procedures” shall mean, with respect to each Product
Produced hereunder, the written standards and procedures for evaluating
compliance with the applicable Product Specifications, as mutually agreed upon
in writing by Dynavax and Baxter, and incorporated in the applicable QCMD.

“Trademarks of Dynavax” shall mean the trademark(s) owned by Dynavax to be
affixed on packaging of Product as stated in a Project Plan.

“Twelve Month Rolling Forecast” shall be defined in Section 4.1.

“Unit” shall mean an individually packaged dose of a Product (prefilled syringe)
as specified in the applicable Project Plan.

“Yield Rate” shall be defined in Section 4.5.

Article 2

DEVELOPMENT PLAN, PRO JECT PLANS AND REGULATORYPLANS

2.1Development Plan. If requested by Dynavax, the Parties shall undertake a
manufacturing process development project for one or more of the Products to be
Produced by Baxter hereunder, consisting of the specific research and
development activities agreed upon by the Parties and detailed in a “Development
Plan”. In no event shall Baxter be required to schedule any development
activities with respect to any Product until a Development Plan for such Product
has been executed by both Baxter and Dynavax.

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.

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2.2Project Plan. For each Presentation of Product to be Produced hereunder, the
Parties shall agree in writing upon a Project Plan. Baxter shall deliver two (2)
copies of each Project Plan to Dynavax prior to the date of initial Production
of the applicable Presentation of Product. Dynavax shall either sign such
Project Plan and return one (1) copy to Baxter or shall return an amended
Project Plan acceptable to Dynavax, in each case within five (5) business days
of receipt of such Project Plan from Baxter. If such amended Project Plan is not
acceptable to Baxter, then Baxter shall so notify Dynavax within five (5)
business days of Baxter’s receipt of such amended Project Plan, and the Parties
shall promptly meet in order to resolve in good faith any outstanding
disagreements with respect to such amended Project Plan. In no event shall
Baxter be required to schedule or commence the Production of the Presentation of
the applicable Product until a Project Plan for such Presentation of Product has
been approved in writing by both Baxter and Dynavax.

2.3Product Addendum. For each Product and/or Presentation of Product to be
Produced by Baxter hereunder, the Parties shall agree in writing upon a Product
Addendum. In no event shall Baxter be required to schedule or commence
Production of the Presentation of the applicable Product until a Product
Addendum for such Presentation of Product has been approved in writing by both
Baxter and Dynavax.

2.4Regulatory Plan. If requested by Dynavax, Baxter shall provide regulatory
services in connection with obtaining Regulatory Approval for a Product. Baxter
shall deliver to Dynavax two (2) copies of the Regulatory Plan for each Product
requested by Dynavax after such Dynavax request and prior to the date that
Baxter is to initiate Production of the registration Batches of the applicable
Product. Dynavax shall either sign such Regulatory Plan and return one ( 1) copy
to Baxter or shall return an amended Regulatory Plan acceptable to Dynavax, in
each case within five (5) business days of receipt of such Regulatory Plan from
Baxter. If such amended Regulatory Plan is not acceptable to Baxter, then Baxter
shall so notify Dynavax within five (5) business days of Baxter’s receipt of
such amended Regulatory Plan, and the Parties shall promptly meet in order to
resolve in good faith any outstanding disagreements with respect to such amended
Regulatory Plan. Baxter shall have no obligation to conduct regulatory services
for a Product until the Regulatory Plan for such Product has been agreed upon by
the Parties.

2.5Quality Agreement. The Quality Agreement shall mean that certain Quality
Agreement executed by the Parties on October 31, 2013. The Quality Agreement
shall allocate the pharmaceutical responsibilities. In no event shall Baxter be
required to schedule any Production until a Quality Agreement has been duly
signed by both Baxter and Dynavax. Upon execution of the Quality Agreement, the
Quality Agreement shall be incorporated by reference as though fully set forth
herein.

2.6Amendment. Each Development Plan, Project Plan, Product Addendum, Regulatory
Plan and Quality Agreement may be amended from time to time, as the Parties
experience with the development, Production, testing and use of the applicable
Product warrants, only upon mutual written agreement of Dynavax and Baxter. In
the event that the terms of any Development Plan, Project Plan, Regulatory Plan
or Purchase Order are inconsistent with the terms of this Agreement, this
Agreement shall control, unless otherwise explicitly agreed to in writing by the
Parties. No Development Plan, Project Plan, Regulatory Plan or Purchase Order
shall be deemed to amend this Agreement. Upon execution of any Development Plan,
Project Plan, or Regulatory Plan, such plan shall be deemed to be incorporated
herein by reference and made a part of this Agreement. In the event of a
conflict between this Agreement and the Quality Agreement, the Quality Agreement
will prevail for matters of quality and this Agreement will control for all
business, legal, and financial issues.

2.7Effect of Failure to Execute Plans or Addendum. Failure to execute a
Development Plan, Project Plan, or Regulatory Plan with respect to a Product
will not relieve either Party of any obligation

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.

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accruing with respect to such Product prior to such failure to execute. Dynavax
shall reimburse Baxter for all non-cancelable costs incurred by Baxter for work
performed and Components ordered with respect to such Product.

Article 3

PURCHASE AND SUPPLY OF PRODUCT

3.1Agreement to Purchase and Supply. Pursuant to the terms and conditions of
this Agreement, Dynavax shall purchase from Baxter the Contract Requirements of
the Product and Baxter shall use good faith efforts to Produce and deliver to
Dynavax the Contract Requirements of Product in accordance with Article 4 of
this Agreement.

3.2Reprocessing, Rework or Reproduction. If reprocessing, rework or reproduction
is allowed pursuant to Dynavax’s regulatory submissions or approved by Dynavax,
it shall be performed in accordance with the Quality Agreement and Dynavax shall
be responsible for and promptly reimburse Baxter for all costs and expenses
incurred in connection with such reprocessing, rework or reproduction.

3.3Bulk Drug Substance and Component Delivery. Dynavax, at its expense (
including without limitation shipping costs), shall supply to Baxter in a timely
manner, (a) all Bulk Drug Substances required to satisfy the terms of this
Agreement and an applicable certificate of analysis therefore, and (b) all other
Dynavax Supplied Components, all to be delivered to Baxter as set forth in the
applicable Project Plan for Production of such Product. Except as may
specifically be set forth in the Project Plan or QCMD, on receipt of the BDS and
Dynavax Supplied Components as set forth above, Baxter’s obligations with
respect to evaluation of the BDS and Dynavax Supplied Components shall be ( i)
to review the accompanying certificate of analysis to confirm that the BDS and
Dynavax Supplied Components (if applicable) conform with the specifications and
(ii) to perform ID testing to confirm the identity of the receiving materials.

3.4Bulk Drug Substance and Component Delivery Delays. Timely delivery of Dynavax
Supplied Components shall mean that the respective Component and the required
documents reach Baxter prior to the scheduled manufacturing date of such Product
per the timing set forth in the Project Plan. Any delay in delivery of BDS or
the Components by the vendor shall not be considered to be a delay by Baxter.
Baxter shall have no responsibility for delays in delivery of Product caused by
delays in receipt of BDS or Components. Notwithstanding anything in this
Agreement to the contrary, in the event that Baxter receives the BDS or Dynavax
Supplied Components and associated cGMP documents for Production of Product from
Dynavax with less time than requested in the applicable Project Plan, Baxter
shall reschedule Production of such Product and may charge Dynavax the
applicable Reservation Fee, as specified in Section 4.2.3.

3.5Purchase of Materials. Baxter shall purchase, at Baxter’s expense, all
packaging materials listed in the Bill of Materials as Baxter supplied
materials, primary container Components and secondary packaging materials
specified in the BOM as Baxter supplied and required to Produce the Product.
Baxter shall control packaging materials listed in the BOM and shall assist
Dynavax with evaluation and purchase of modified materials in the event that
Dynavax requests a change in Presentation. Baxter shall not initiate any changes
to materials without written approval from Dynavax.

3.6Baxter Supplied Components. Baxter will purchase the Baxter Supplied
Components in quantities sufficient to meet Dynavax’s Purchase Orders for
Product consistent with Article 4. Baxter will

7.

[ * ] = 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.

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

 

invoice Dynavax for the primary packaging Components as specified in Section 5.4
and Exhibit C upon receipt of such Components. Dynavax will reimburse Baxter for
these primary packaging Components within thirty (30) calendar days after
delivery of an invoice therefore to Dynavax.

3.7Importer of Record. In the event any material or equipment to be supplied by
Dynavax, including without limitation Dynavax Supplied Components and BDS, is
imported into the United States for delivery to Baxter (the “Imported Goods”),
such Imported Goods shall be imported DDP Bloomington, IN (Incoterms, 2010).
Dynavax or its Affiliate shall be the “Importer of Record” of such Imported
Goods. As the Importer of Record, Dynavax shall be responsible for all aspects
of the Imported Goods including, without limitation (a) customs and other
regulatory clearance of Imported Goods, (b) payment of all tariffs, duties,
customs, fees, expenses and charges payable in connection with the importation
and delivery of the Imported Goods, and (c) keeping all records, documents,
correspondence and tracking information required by applicable laws, rules and
regulations arising out of or in connection with the importation or delivery of
the Imported Goods.

3.8Storage.

3.8.1Product Storage. Baxter will store Product free of charge for [ * ] after
the Disposition Date (“Storage Period”). Baxter will not be required to store
Product longer than such Storage Period without Baxter’s prior written consent
and Dynavax’s agreement to reimburse Baxter for all costs incurred in connection
with such storage. The storage fees are set forth in the Project Plan. Baxter
shall be permitted to store Product, BDS and Materials in third party storage
facilities upon the prior approval of Dynavax.

3.8.2BDS and Component Storage. In no event shall Baxter be required to store
quantities of BDS and Components more than required to Produce a [ * ] supply of
Product as calculated using the Twelve Month Rolling Forecast without the prior
written consent of Baxter and Dynavax’s agreement to reimburse Baxter for all
costs incurred in connection with such storage.

Article 4

FORECASTS, ORDERS, and CAPACITY

4.1Forecasts, Order Limits, and Supply Plan.

4.1.1Long Range Forecast. Within thirty (30) days from the Effective Date of
this Agreement and prior to June 1 of each year thereafter, Dynavax will provide
to Baxter in writing an annual forecast for the next five (5) calendar years
during the Term of Dynavax’s estimated Contract Requirements for Product (the
“Long Range Forecast”). The initial Long Range Forecast shall be included in the
Product Addendum (pursuant to Exhibit D) and shall be considered the “Initial
Long Range Forecast”. Baxter specifically agrees that such Long Range Forecasts
submitted by Dynavax will be for general planning purposes only, and shall not
be binding on Dynavax or Baxter.

4.1.2Twelve Month Rolling Forecast. Commencing one month after the date of the
first Regulatory Approval of Product, and on each December 1st, March 1st, June
1st and September 1st thereafter during the Term, Dynavax will provide to Baxter
in writing a “Twelve Month Rolling Forecast” for the following twelve month
period (i.e. the Twelve Month Rolling Forecast submitted December 1st will be
for the twelve month period beginning January 1st the Twelve Month Rolling
Forecast submitted March 1st will be for the twelve month period beginning April
1st, and so on). The total quantity of Batches of the

8.

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

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first [ * ] of the Twelve Month Rolling Forecast shall be considered 100%
binding. The total quantity of Batches of the [ * ] of the Twelve Month Rolling
Forecast shall be considered [ * ] binding. Should the quantity forecasted in
the [ * ] be an odd number of Batches, then the binding forecast shall be [ * ]
of the number of Batches forecasted. The quantity of the remaining [ * ] of the
Twelve Month Rolling Forecast shall be for general planning purposes only, and
shall not be binding on Dynavax or Baxter.

4.1.3Supply Plan. Baxter will confirm each Twelve Month Rolling Forecast within
twenty-one (21) days of receipt of the Twelve Month Rolling Forecast and supply
Dynavax with a corresponding supply plan (the “Supply Plan”) for such twelve
month period. In the case that a supply plan cannot be agreed between the two
Parties, Dynavax and Baxter shall use good faith efforts to come to an agreed
plan. During this time, Baxter agrees to supply, at a minimum, the quantities
agreed in the most recently agreed Supply Plan.

4.1.4Failure to Submit Rolling Forecast. In addition to any and all other
remedies available to Baxter under this Agreement, in the event that Dynavax
fails to provide a suitable Twelve Month Rolling Forecast prior to the tenth
(10th) day of the month in which such Forecast is due as provided in Section
4.1.2, Baxter may, in its discretion, rely on the most recent forecast
previously submitted by Dynavax in lieu of such late and/or deficient forecast.
Any previous forecast(s) so relied upon by Baxter under this Section 4.1.4 shall
be deemed binding upon Dynavax to the full extent provided under this Article 4.

4.2Purchase Orders.

4.2.1General Terms. Dynavax shall submit Purchase Orders to Baxter covering
Dynavax’s purchases of Product pursuant to this Agreement and specifying project
code, Units and delivery date. For the avoidance of doubt, supply of Product
under this Agreement shall not be subject to the terms and conditions contained
on any Purchase Order and/or acceptance thereof except insofar as any such
Purchase Order and/or acceptance establishes the quantity and requested delivery
dates for such Product.

4.2.2Order Lead Time. Dynavax shall not, without the written consent of Baxter,
designate a Delivery Date in a Purchase Order earlier than [ * ] from the date
Dynavax submits the Purchase Order. Baxter shall provide a confirmation of
receipt of each Purchase Order setting forth the Delivery Date that Baxter will
meet. Upon sending the confirmation, such Purchase Order shall become a “Firm
Purchase Order”. If Baxter is unable to meet the delivery date specified by
Dynavax, except when caused by Dynavax’s delay in delivery of BDS and/or Dynavax
Supplied Components, Baxter shall so notify Dynavax and Baxter will use
commercially reasonable efforts to provide to Dynavax an alternative Delivery
Date which shall not be more than [ * ] later than the initial delivery date
designated by Dynavax in its Purchase Order.

4.2.3Purchase Order Cancellation. In the event that Dynavax cancels a Batch(es)
of Product in a Firm Purchase Order or otherwise modifies a Firm Purchase Order
less than [ * ] prior to the Delivery Date, and as a result thereof Baxter, if
after using best efforts to substitute a production run for another Baxter
client or for a Baxter Affiliate, is left with an open production slot, Dynavax
shall pay, as liquidated damages and not as a penalty, the Reservation Fee set
forth in the table below unless expressly

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.

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

 

agreed to otherwise in the Project Plan. To the extent of any conflict between
Purchase Orders submitted by Dynavax and this Agreement, this Agreement shall
control.

Timing

Reservation Fee per Cancelled or Modified Batch

Cancellation or modification of a Firm Purchase Order [ * ] days or more from
the Delivery Date

0

Cancellation or modification of a Firm Purchase Order [ * ] days but not less
than [ * ] days from the Delivery Date

[ * ]% of the Production Price of Product

Cancellation or modification of a Firm Purchase Order [ * ] days but not less
than [ * ] days from the Delivery Date

[ * ]% of the Production Price of Product

Cancellation or modification of a Firm Purchase Order [ * ] days or less from
the Delivery Date

[ * ]% of the Production Price of Product

 

4.3Annual Obligation. Subject to Section 4.4, Dynavax shall be obligated to
purchase from Baxter Dynavax’s Contract Requirements of Product in each calendar
year during the Term of this Agreement as specified in the Product Addendum (the
“Annual Obligation”), which Annual Obligation shall be prorated for any partial
calendar year. Within thirty (30) calendar days after the end of each calendar
year, Dynavax will provide Baxter with a signed affidavit, along with supporting
documentation, that Dynavax met or exceeded its Annual Obligation in the
previous calendar year. In the event Baxter disputes the data provided by
Dynavax, Baxter will provide supporting data to Dynavax and the Parties will in
good faith work together to reach agreement on the volume of Product
representing Dynavax’s Contract Requirements during the applicable calendar
year. In the event Dynavax does not meet or exceed its Annual Obligation in any
calendar year, Dynavax shall pay to Baxter the difference between the aggregate
Production Price of Product actually purchased pursuant to Sections 4.1 and 4.2
by Dynavax and the aggregate Production Price of the Annual Obligation of
Product, with such payment due within thirty (30) days of such determination.

4.4Order Maximum. Notwithstanding anything in this Article 4 to the contrary, in
any calendar year during the Term of this Agreement, in no event shall Baxter be
obligated to Produce more Product than specified in the Product Addendum. If
changes (increases or decreases) in the annual order volume require changes in
equipment and/or process, Dynavax will cover the costs for such changes.

4.5Yield

4.5.1Yield Rate Calculation. There shall be no minimum yield requirement on the
first [ * ] Batches of commercial Product Produced hereunder. The yield from
these first [ * ] Batches will be used to calculate the Expected Yield (as
defined below) for Product. From the data collected, the Parties will calculate
the yield rate which will equal the mean of the yield of the first twenty
Batches of conforming Product Produced after the completion of the process
validation Batches, including without limitation, Product samples such as
release samples, stability samples, etc. (the “Yield Rate).

4.5.2Expected Yield Requirement and Reconciliation. Upon calculation of the
Yield Rate, the aggregate average yield of Batches of Product supplied to
Dynavax by Baxter during each calendar year shall have a quantity equal to or
greater than [ * ] of the Yield Rate calculated above (“Expected Yield”). Within
sixty (60) days after the end of each calendar year, the Parties will calculate
the actual aggregate average yield of Product Produced during the previous
calendar year. If the actual aggregate average yield of Product in any calendar
year is less than the Expected Yield, Baxter shall reimburse

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.

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Dynavax the difference of the cost of the Dynavax Supplied Components between
the Expected Yield and the actual quantity supplied, such reimbursement not to
exceed the Production Price of a Unit for each Unit short of the Expected Yield.

Article 5

PRICE

5.1Product Production Price. The price to be paid by Dynavax for the Production
of Product (the “Production Price”) shall be set forth in the Product Addendum.

5.2Regulatory Services Price. The price to be paid by Dynavax for regulatory
services s hall be set forth in the Regulatory Plan.

5.3Production Price Adjustment. Upon the first anniversary of the Effective Date
of this Agreement and on each anniversary thereafter, Baxter may increase the
Production Price of such Product by a percentage which may not exceed the
percentage change in the U.S. PPI Commodity Data (Producer Price Index Commodity
Data) for the previous twelve (12) months.

5.4Components. Based upon the Twelve Month Rolling Forecast, Baxter and Dynavax
shall develop a joint strategy for the purchase of primary packaging Components
(syringe, stopper and plunger rod). Baxter shall not be liable for delays in
receipt of such Components. Upon receipt of the primary packaging Components,
Baxter will invoice Dynavax for such Components. Such invoice will include a one
percent (1%) handling fee. Dynavax shall pay for such Components within thirty
(30) calendar days of the invoice date. Title to Dynavax Supplied Components,
including those primary packaging Components procured by Baxter on behalf of
Dynavax, shall at all times belong to and remain in Dynavax; provided, however,
that Baxter shall retain a security interest in such primary packaging
Components until receipt of payment from Dynavax. Baxter will provide Dynavax
with inventory reports for Dynavax Supplied Components and Product on hand at
Baxter in a format and on timing that is agreeable to both Parties.

Article 6

SHIPMENT AND INVOICING

6.1Delivery Terms. Product shall be delivered to Dynavax, or to a location
designated by Dynavax in the Purchase Order, EXW (Incoterms, 2010) Baxter’s
facility in Bloomington, Indiana, freight collect, by a common carrier
designated by Dynavax in the Purchase Order, at Dynavax’s expense; provided,
however, Baxter shall be responsible for the loading of the Product on departure
and shall bear all costs of such loading.

6.2Subsequent Export. Dynavax agrees and represents that Dynavax is the owner of
the goods that are consigned to Baxter for contract manufacturing services and
warrants that Dynavax is responsible for any subsequent export or re-export and
will comply with all applicable U.S. laws and regulations relating to the export
or re-export, including the prohibition against unlawful transshipments.
Further, where such goods are destined for export or re-export, Dynavax agrees
and accepts that it is the Foreign Principal Party in Interest (“FPPI”) and
warrants that as the FPPI, it will duly authorize and retain a U.S. agent who
will act on its behalf, assuming all attendant responsibilities associated with
the export or re-export, including obtaining any necessary export licenses,
pursuant to 15 C.F.R. §758.3. The Dynavax’s responsibilities as FPPI include,
but are not limited to, cooperating with its U.S. agent in providing the U.S.

11.

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

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government with a detailed description and accurate valuation and classification
of the goods, bills of lading, and all other required documentation. Dynavax
further agrees to defend Baxter against any action, civil or criminal, private
or public, in connection with the subsequent export or re-export by Dynavax of
the goods.

6.3Payment Terms. The following invoicing and payment terms apply:

Status

Invoice Date

Payment Due

Process Validation Batches

•[ * ]% of manufacturing price at Baxter’s disposition of the manufacturing
(filling portion) batch record

•[ * ]% of finishing price at Baxter’s disposition of the finishing (labeling
and packaging portion) batch record

Invoice date + [ * ] days*

Launch Material

•[ * ]% of manufacturing price at Baxter’s disposition of the manufacturing
(filling portion) batch record

•[ * ]% of finishing price at Baxter’s disposition of the finishing (labeling
and packaging portion) batch record

Invoice date + [ * ] days*

On-going Commercial

Baxter’s Disposition Date

Invoice date + [ * ] days*

Regulatory Services

Monthly

Invoice date + [ * ] days*

Development Services

As set forth in Development Plan

Invoice date + [ * ] days*

* All days specified above are calendar days.

Notwithstanding the foregoing, in the event Baxter begins Production of a Batch
of Product and is unable to release such Batch due to delays by Dynavax, Baxter
may invoice Dynavax for one hundred percent (100%) of the manufacturing portion
of the Production Price thirty (30) calendar days from the date of Baxter’s
disposition of the manufacturing (filling portion) batch record of such Batch of
Product. For purposes of example only, delays by Dynavax may include, but are
not limited to, failure to provide approval for artwork, failure to approve
bills of materials or finishing records, and failure to designate a packaging
configuration. The finishing portion of the Production Price will be invoiced
and reconciled at the time of disposition of the finishing operations and
provision of the Executed Batch Record to Dynavax.

12.

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

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Payments shall be made in U.S. dollars. Each invoice shall be payable by Dynavax
in accordance with the terms noted above. Any payment due under this Agreement
not received within the times noted above shall incur finance charges at the
lesser of (a) the maximum rate permitted by law, or (b) one and a half percent
(1.5%) per month on the outstanding balance.

6.4Default in Payment Obligations. In addition to all other remedies available
to Baxter in the event of a Dynavax default, if Dynavax fails to make payments
as required hereunder and such failure continues for thirty (30) days, Baxter
may refuse all further Purchase Orders, refuse to Produce any Product until
Dynavax’s account is paid in full, modify the foregoing terms of payment, place
the account on a letter of credit basis, require full or partial payment in
advance, suspend deliveries of Product until Dynavax provides assurance of
performance reasonably satisfactory to Baxter, and/or take other reasonable
means as Baxter may determine.

Article 7

ACCEPTANCE OF PRODUCT

7.1Product Conformity. Within [ * ] from the date of shipment of samples of
Product or the release of the Released Executed Batch Record to Dynavax,
whichever is later (the “Inspection Period”), Dynavax will determine whether
such Batch of Product was Produced in accordance with the Product Requirements
and accept or reject such Batch of Product for non-conformance to the Product
Requirements; provided, however, that Dynavax shall have the right to revoke
acceptance if, within [ * ] of receipt of the Batch, Dynavax discovers a defect
not reasonably discoverable at the time of delivery. If Dynavax fails to notify
Baxter within the applicable time periods that the Batch of Product does not
conform to the Product Requirements, Dynavax shall be deemed to have accepted
the Product and waived its right to revoke acceptance. If Dynavax believes a
Batch does not conform to the Product Requirements, it shall notify Baxter as
set forth in Section 7.1.1.

7.1.1If Baxter released a Batch of Product and Dynavax believes such Batch does
not conform to the Product Requirements, it will provide to Baxter a detailed
written explanation of the non-conformity within the Inspection Period. Upon
receipt of such notice, Baxter will investigate such alleged non-conformity and,
(a) if Baxter agrees such Batch of Product is non-conforming, deliver to Dynavax
a corrective action plan within thirty (30) calendar days after receipt of
Dynavax’s written notice of non-conformity, or such additional time as is
reasonably required if such investigation or plan requires data from sources
other than Dynavax or Baxter (the “Response Period”), or (b) if Baxter disagrees
that such Batch of Product is non-conforming, Baxter will so notify Dynavax in
writing within the Response Period.

7.1.2If the Parties dispute whether the Batch of Product is non-conforming, the
dispute will be handled in accordance with Section 9.1.1 of the Quality
Agreement. The costs of the laboratory or consultant referred to in the Quality
Agreement are to be borne by the Party whose determination was incorrect.

7.1.3In the event Baxter does not release a Batch of Product due to a
non­conformity, it shall so notify Dynavax in accordance with the Quality
Agreement.

7.2Remedies for Non-Conforming Product. If a Batch of Product is non-conforming
as a result of Baxter’s negligence or willful misconduct, then Baxter will, to
the extent of its negligence or willful misconduct, (a) reimburse Dynavax for
its actual cost of the Bulk Drug Substance and Dynavax Supplied Components
needed for its replacement Product, which reimbursement shall not exceed [ * ]
of

13.

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

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such non­conforming Batch and, [ * ], (b) if Dynavax has paid for such
non-conforming Batch, either [ * ] or [ * ] or (c) if Dynavax has not paid for
the nonconforming Batch, Baxter will not invoice for the nonconforming Batch.

7.3Remedies for Non-Conforming Stability/Process Validation Batches.
Notwithstanding the foregoing Section 7.2, if a stability Batch or process
validation Batch is non­conforming as a result of Baxter’s negligence or willful
misconduct, then Baxter will, to the extent of its negligence or willful
misconduct,(a) reimburse Dynavax for its actual cost of the Bulk Drug Substance
and Dynavax Supplied Components needed for its replacement Product, which
reimbursement will not exceed [ * ] of such non-conforming stability Batch or
process validation Batch [ * ], (b) if Dynavax has paid for such non-conforming
Batch, [ * ] or [ * ] or (c) if Dynavax has not paid for the non-conforming
Batch, Baxter will not invoice for the nonconforming Batch.

7.4Escalation Process. In the event Baxter and Dynavax disagree as to whether a
Batch of Product is non-conforming as a result of Baxter’s negligence or willful
misconduct (“Disagreement” ), and such Disagreement is not resolved by the
Parties for a period of sixty (60) days of the Parties first consideration, the
Disagreement will escalate to the Parties’ executive management for resolution
(for Baxter that shall mean the Global Franchise Head or his/ her designee and
for Dynavax that shall mean SVP Operations or his / her designee). If the
executive management cannot resolve such Disagreement within thirty (30) days of
their first consideration, then, at any time after such thirty (30) day period,
either Party may pursue any other available legal or equitable remedy.

7.5Non-conforming Bulk Drug Substance. If a Batch of Product is not released by
Baxter or is rejected by Dynavax, and such non-conformity is the result of
non-conforming Bulk Drug Substance or Dynavax Supplied Components, then Baxter
will have no liability for such non­conforming Batch, except as set forth in
Sections 7.2 or 7.3.

Article 8

TERM AND TERMINATION

8.1Initial Term. This Agreement shall commence on the Effective Date and shall
continue until the last day of the sixth (6th) Contract Year (the “Initial
Term”), unless earlier terminated in accordance with Sections 8.2 or 8.3 of this
Agreement. This Agreement may be renewed for [ * ] renewal term(s), if agreed in
writing by both Dynavax and Baxter at least [ * ] prior to the expiration of the
Initial Term or a renewal term, as the case may be. The Initial Term as may be
extended is referred to herein as the “Term”.

8.2Termination for Breach. Either Party may terminate this Agreement upon the
material breach of any provision of this Agreement by the other Party if such
breach is not cured by the breaching Party within ten (10) calendar days for
monetary defaults, and forty-five(45) calendar days for non-monetary defaults
(or such additional time as is reasonably necessary to cure such non­monetary
default after receipt by the breaching Party of written notice of default). At
the option of the non-breaching Party, such termination may be with respect to
the entire Agreement, or only with respect to the Product which is subject to
the breach.

8.3Termination for Financial Matters. Either Party may terminate this Agreement
immediately by giving the other Party written notice thereof in the event such
other Party shall become insolvent or unable to pay its debts when due, or in
the event that proceedings are commenced against, or voluntarily by, such Party
relating to its bankruptcy or insolvency.

14.

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

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8.4Additional Rights and Remedies. Subject to Section 1.3.1, termination under
this Article 8 shall be in addition to the other rights and remedies of the
terminating Party as specified herein.

8.5Non-cancelable Costs and Expenses. In the event of the termination or
expiration of this Agreement, except by Dynavax as a result of a breach by
Baxter under Section 8.2, Dynavax will (a) reimburse Baxter for all materials,
Components, and equipment ordered prior to termination and not cancelable at no
cost to Baxter, and (b) pay Baxter for any outstanding Firm Purchase Orders. In
addition, in the event of termination or expiration for any reason, Dynavax will
pay [ * ] for (a) all work-in-process commenced by Baxter and (b) all finished
Product Produced prior to expiration or termination. Baxter will ship such
materials to Dynavax pursuant to Section 6.1 at Dynavax’s cost and per Dynavax’s
instructions. Dynavax will make payments for all expenses described in this
Section 8.5, no later than thirty (30) calendar days from the invoice date.

8.6Survival. Termination, expiration, cancellation or abandonment of this
Agreement through any means or for any reason shall be without prejudice to the
rights and remedies of either Party with respect to any antecedent breach of any
of the provisions of this Agreement, subject to Article 13. The provisions of
Articles 8, 9.3, 12, 13, 14, 15, 16, 17 and 18 hereof shall survive expiration
or termination of this Agreement. Termination of this Agreement for any reason
shall not relieve any Party of any obligations accruing prior to such
termination.

Article 9

PRODUCTION OF PRODUCT

9.1Audits.

9.1.1Quality Audits. Dynavax, upon prior written notice and on dates and times
agreed by the Parties, shall have the right to inspect, [ * ], Baxter batch
records and the portions of Baxter’s facilities used for Production of Product.
In addition, Dynavax shall audit Baxter SOPs. If Dynavax chooses to audit more
than one (1) time in a calendar year, unless such additional audit is for cause,
Dynavax will reimburse Baxter for its reasonable expenses incurred in hosting
the audit. As used herein, an audit shall be “for cause” if Product has
repeatedly failed to conform to the Product Requirements, a Regulatory Authority
has found that Baxter failed to comply with applicable laws in the Production of
Product, or a recall of Product has occurred. All audited data will be treated
as Confidential Information of the Party that owns such information.

9.1.2Other Audits. Except as provided in Section 9.1.1, any audit shall be at
the expense of Dynavax and the prior written consent of Baxter, which consent
will not be unreasonably withheld.

9.2Testing. Baxter shall test, or cause to be tested by third party testing
facilities audited by Baxter, in accordance with the Product Specifications,
each Batch of Product before delivery to Dynavax. A certificate of analysis for
each Batch of Product delivered to Dynavax shall be contained in the Quality
Control Master Document and shall set forth the items tested by Baxter,
specifications, and test results. Dynavax cannot release a Batch of Product that
Baxter rejects. As required by the FDA, Dynavax shall assume full responsibility
for final release of each Batch of the Product.

9.3Stability Testing. At Dynavax’s expense, Dynavax or a party selected by
Dynavax shall perform all stability testing required to be performed on
clinical, development, and/or Production Batches

15.

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

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of Product. If performed by Baxter, such testing shall be performed in
accordance with the procedures set out in the Product-specific Baxter SOPs for
the stability protocol and the Project Plan. If Baxter is not performing
stability testing, then Baxter requires at a minimum that Baxter perform the
sterility testing as part of the stability program. Such stability protocol
shall contain a listing of the analytical testing and corresponding Product
Specifications, to be performed on the Product in connection with the stability
testing program under 21 CFR § 166.

9.4Permits and Licenses. Dynavax shall have sole responsibility, at its expense,
for obtaining, maintaining, updating and remaining in compliance with all
permits, licenses and other authorizations during the Term of this Agreement,
which are necessary or required under federal, state, and local law, rules and
regulations and which are applicable to the Production, use, and sale of
Product. Baxter shall be responsible, at its expense, to obtain and maintain all
generally required permits and licenses applicable to production of
pharmaceutical products generally which are required for Baxter to carry out its
development, regulatory and Production obligations hereunder.

9.5Regulatory Requirements. Each Party promptly shall notify the other of new
regulatory requirements of which it becomes aware which are relevant to the
Production of a Product under this Agreement and which are required by the FDA,
any other applicable Regulatory Authority or other applicable laws or
governmental regulations, and shall confer with each other with respect to the
best means to comply with such requirements. Baxter shall have no obligation to
Produce Product in compliance with the requirements of a Regulatory Authority
not explicitly specified in the Quality Agreement. Dynavax shall supply to
Baxter a copy of its license submission prior to Baxter’s Production of Product.

9.6Drug Master File. Baxter shall file and maintain the appropriate Drug Master
File (the “DMF”) and related reference applications (e.g. Site Master File) for
its Production of each Product hereunder in accordance with 21 CFR 314.420, as
may be amended from time to time, at Baxter’s expense.

9.7Annual Quality Review. Annual Quality Review will be conducted in accordance
with the Quality Agreement. If Dynavax requests Baxter to perform such quality
review, such review will be conducted at Dynavax’s cost and expense.

9.8Customer Complaints and Adverse Events. All customer complaints will be
managed in accordance with the Quality Agreement.

9.9Changes in Manufacturing.

9.9.1Changes to Master Batch Records and Product Specifications. Baxter agrees
to inform Dynavax within fifteen (15) calendar days of the result of any
regulatory development or changes to Product-specific Baxter SOPs that
materially affect the Production of the Product. Baxter shall notify Dynavax of
and require written approval from Dynavax for material changes to
Product-specific Master Batch Records and Product Specifications prior to the
Production of subsequent Batches of Product.

9.9.2Product-Specific Changes. If facility, equipment, process or system changes
are required of Baxter as a result of requirements set forth by the FDA or any
other Regulatory Authority, and such regulatory changes apply solely to the
Production and supply of one or more Products, then Dynavax

16.

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

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and Baxter will review such requirements and agree in writing to such regulatory
changes, and Dynavax shall bear [ * ] of the reasonable costs thereof.

9.9.3General Changes. If such regulatory changes apply generally to one or more
Products as well as to other products produced by Baxter for itself or for third
parties, Baxter will cover the cost of such general regulatory changes;
provided, however, such costs do not exceed [ * ]. In the event the cost of any
such regulatory change exceeds [ * ], Baxter will notify Dynavax so the Parties
can further discuss, and if Baxter determines, in its sole discretion, not to
proceed with the regulatory change, either Party may terminate this Agreement
upon one hundred eighty (180) days written notice to the other Party.

9.10Equipment Expenses. If Baxter is required to obtain specialized equipment in
order to Produce Product for Dynavax, the price of such equipment shall be paid
by Dynavax. Baxter shall advise Dynavax of the specialized equipment required
and the estimated price associated with the purchase and installation of such
equipment. Dynavax shall be invoiced for all approved costs as specified in the
Project Plan.

9.11Ownership of Equipment. Upon termination or expiration of this Agreement,
Dynavax shall either (i) take possession of the specialized equipment paid for
by Dynavax at Dynavax’s expense, or (ii) offer Baxter the option to purchase
such equipment at a price to be negotiated at the time of sale.

Article 10

REGULATORY

10.1Regulatory Approvals. Dynavax will diligently pursue Regulatory Approval of
marketing licenses for each Product Produced by Baxter hereunder. Dynavax will
advise Baxter of document requirements in support of BLA and similar
applications required of foreign governments and agencies including amendments,
license applications, supplements and maintenance of such. Baxter will provide
documents and assist Dynavax in preparation of submissions to Regulatory
Authorities (both U.S and foreign) designated by Dynavax in support of Dynavax’s
BLA and similar applications required of foreign governments and licenses. All
regulatory submission preparation and maintenance performed by Baxter for
Dynavax shall be specified in the Regulatory Plan. Prior to submission to the
Regulatory Authority, Dynavax will, at Dynavax’s option, provide Baxter with a
copy of the relevant portions of the CMC section for review and comment. A final
copy of the relevant CMC section will be provided by Dynavax to Baxter upon
submission to the Regulatory Authority. Upon Regulatory Approval, Dynavax will
notify Baxter within two (2) calendar days of such approval and the anticipated
date of Product launch to the market.

Article 11

TRADEMARKS

11.1Dynavax grants to Baxter a non-exclusive, royalty free license to use
Trademarks of Dynavax for the sole purpose of allowing Baxter to fulfill its
responsibilities under this Agreement. Such license shall not be transferable in
whole or in part.

11.2Dynavax shall be solely responsible for selecting, registering and enforcing
Trademarks of Dynavax used to identify the Product; and, except as set forth in
Section 11.1, shall have sole and exclusive rights in such Trademarks of
Dynavax.

17.

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

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Article 12

REPRESENTATIONS AND WARRANTIES

12.1Mutual Representations. Each Party hereby represents and warrants to the
other Party that (a) the person executing this Agreement is authorized to
execute this Agreement; (b) this Agreement is legal and valid and the
obligations binding upon such Party are enforceable by their terms; and (c) the
execution, delivery and performance of this Agreement does not conflict with any
agreement, instrument or understanding, oral or written, to which such Party may
be bound, nor violate any law or regulation of any court, governmental body or
administrative or other agency having jurisdiction over it.

12.2Baxter Warranty. Baxter represents and warrants that Product shall be
Produced in accordance with applicable cGMPs. Baxter shall have no obligation to
obtain Permits relating to the sale, marketing, distribution or use of BDS or
Product or with respect to the labeling of Product. Baxter makes no
representation or warranty with respect to the sale, marketing, distribution or
use of the BDS, Product or to printed materials specified by Dynavax or its
consignee.

12.3Disclaimer of Warranties. Except for those warranties set forth in Sections
12.1 and 12.2 of this Agreement, Baxter makes no warranties, written, oral,
express or implied, with respect to Product or the Production of Product. ALL
OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND
NONINFRINGEMENT HEREBY ARE DISCLAIMED BY BAXTER. NO WARRANTIES OF BAXTER MAY BE
CHANGED EXCEPT BY A DULY AUTHORIZED REPRESENTATIVE OF BAXTER. Dynavax accepts
Product subject to the terms hereof.

12.4Dynavax Warranties. Dynavax warrants that (a) it has the right to give
Baxter any information provided by Dynavax hereunder, and that Baxter has the
right to use such information for the Production of Product, (b) Dynavax has no
knowledge of any (i) patents or other intellectual property rights that would be
infringed by Baxter’s Production of Product under this Agreement, or (ii)
proprietary rights of third parties which would be violated by Baxter’s
performance hereunder, and (c) it shall comply with all applicable laws, rules
and regulations. Dynavax warrants that the BDS provided to Baxter hereunder will
(1) conform to the BDS specifications and (2) not be adulterated or misbranded
within the meaning of the FD&C Act.

Article 13

EXCLUSIVE REMEDIES, LIMITATION OF LIABILITY AND RISK OF LOSS

13.1Exclusive Remedies. Dynavax’s right to recover damages, losses or expenses
from Baxter, and Baxter’s liability under this Agreement, is limited to the
amounts set forth in the applicable sections of this Agreement. All claims by
Dynavax under this Agreement (except claims seeking indemnity) shall be brought
no later than two (2) years after the occurrence of the event giving rise to
such claim; otherwise, such claim shall be deemed waived.

13.2Limitation of Liability. Except to the extent recoverable under Article 14,
under no circumstances shall either Party be liable for incidental, special,
consequential, punitive, exemplary or indirect damages, including but not
limited to, lost profits, or except as specifically set forth in this Agreement,
loss, damage or destruction of the BDS or Dynavax Supplied Components, the cost
of cover or recall costs, whether such claims are founded in tort or contract,
and even if the other Party asserts or

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.

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establishes a failure of the essential purpose of any limited remedy provided in
this Agreement. To the extent permitted under applicable laws, under no
circumstances shall Baxter’s aggregate liability under this Agreement, including
but not limited to third party claims, exceed the aggregate amount paid to
Baxter under this Agreement (the “Monetary Cap”).

13.3Risk of Loss. All Baxter Supplied Components and equipment used by Baxter in
the Production of Product (collectively, the “Baxter Property”) shall at all
times remain the property of Baxter and Baxter assumes risk of loss for the
Baxter Supplied Components until delivery of Product to a common carrier as
specified under Section 6.1. Dynavax assumes risk of loss for Dynavax Supplied
Components, Dynavax equipment, all BDS supplied by Dynavax, and all Product
(collectively, “Dynavax Property”), except in the case of Baxter’s negligence or
willful misconduct; in which case, Baxter will, to the extent of its negligence
or willful misconduct, reimburse Dynavax for the actual cost of such loss not to
exceed one hundred percent (100%) of the Production Price of the Product
affected by such loss (which, in the case of loss of BDS or Dynavax Supplied
Components shall be calculated based on the quantity of Product that could have
been Produced using such BDS or Dynavax Supplied Components). Notwithstanding
anything herein to the contrary, Baxter shall have no liability for, and Dynavax
releases all claims against Baxter arising out of, any damage or loss to
Product, BDS or Components arising out of, or in connection with, the storage of
Product, BDS or Components after the Storage Period.

Article 14

INDEMNIFICATION

14.1Dynavax Indemnification. Dynavax shall indemnify, defend and hold harmless
Baxter and its Affiliates and any of their respective directors, officers,
employees, subcontractors and agents (collectively, the “Indemnified Parties”)
from and against any and all liabilities, obligations, penalties, claims,
judgment s, demands, actions, disbursements of any kind and nature, suits,
losses, damages, costs and expenses (including, without limitation, reasonable
attorney’s fees) (“Losses”) to, and claims, demands, actions, suits by a third
party (collectively, “Claims”), including claims of property damage, death or
personal injury for which the Indemnified Parties otherwise would be strictly
liable, in connection with pending or threatened litigation or other
proceedings, which arise out of or relate to any one of the following:

(a)Dynavax’s storage, promotion, labeling, marketing, distribution, use or sale
of Product;

(b)Baxter’s use of the BDS;

(c)Dynavax’s negligence or willful misconduct;

(d)Components;

(e)Dynavax’s breach of any covenant, representation or warranty contained in
this Agreement; or

(f)the use, sale, Production, marketing or distribution of BDS or Product by
Baxter or Dynavax violates the patent, trademark, copyright or other proprietary
rights of any third party.

19.

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

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14.2Baxter Indemnification. Baxter shall indemnify, defend and hold harmless
Dynavax and its Affiliates and any of their respective directors, officers,
employees, subcontractors and agents from and against any and all Losses to, and
Claims by a third party, in connection with pending or threatened litigation or
other proceedings, to the extent resulting from Baxter’s negligence or willful
misconduct. Baxter’s liability under this Section 14.2 shall be subject to the
Monetary Cap.

14.3Indemnitee Obligations. Any Party seeking indemnification hereunder (a)
shall give prompt written notice to the other Party (the “Indemnifying Party”)
of any claim for which indemnification is sought (b) shall permit the
indemnifying Party to assume full responsibility to investigate. prepare for and
defend against the Claim, (c) shall reasonably assist the Indemnifying Party, at
the Indemnifying Party’s reasonable expense in the investigation of, preparation
for the defense of such Claim, and (d) shall not compromise or settle such Claim
without the Indemnifying Party’s prior written consent.

Article 15

INSURANCE

15.1Dynavax Insurance. Dynavax shall procure and maintain, during the Term of
this Agreement and for a period one (1) year beyond the expiration date of
Product Produced under this Agreement, appropriate insurance coverage for the
type of liability that may occur under this Agreement; provided, however,
Dynavax shall procure and maintain no less than [ * ] in Product Liability
coverage prior to U.S. Regulatory Approval of Product and no less than [ * ] in
Product Liability coverage upon U.S. Regulatory Approval of Product. All such
coverage shall be with an insurance carrier with an A.M. Best rating of A-VII or
better. Dynavax promptly shall deliver a certificate of Dynavax Insurance to
Baxter evidencing such coverage. If Dynavax fails to furnish such certificates,
or if at any time during the Term of this Agreement Baxter is notified of the
cancellation or lapse of the Dynavax Insurance, and Dynavax fails to rectify the
same within ten (10) calendar days after notice from Baxter, in addition to all
other remedies available to Baxter hereunder, Baxter may terminate this
Agreement. Any deductible and/or self-insurance retention shall be the sole
responsibility of Dynavax.

15.2Baxter Insurance. Baxter is, and will during the Term of this Agreement
remain, self-insured for the type of liability that could arise under this
Agreement.

15.3No Limitation. The liability of either Party will not be limited to that
which is recoverable by insurance.

Article 16

RECALL OF PRODUCT

16.1Dynavax will be responsible for coordinating any recall of Product pursuant
to the Quality Agreement. Baxter shall cooperate with Dynavax in connection with
any recall, at Dynavax’s expense. Dynavax will be responsible for all of the
costs and expenses of all Product recalls (including but not limited to costs
associated with receiving and administering the recalled Product and
notification of the recall to those persons whom Dynavax deems appropriate).

20.

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

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Article 17

INTELLECTUAL PROPERTY

17.1Existing Intellectual Property. Except as the Parties may otherwise
expressly agree in writing, each Party shall continue to own its existing
patents, trademarks, copyrights, trade secrets and other intellectual property,
without conferring any interests therein on the other Party. Without limiting
the generality of the preceding sentence, Dynavax shall retain all right, title
and interest arising under the United States Patent Act, the United States
Trademark Act, the United States Copyright Act and all other applicable laws,
rules and regulations in and to all Products, BDS, Labeling and trademarks
associated therewith (collectively, the “Dynavax’s Intellectual Property”).
Neither Baxter nor any third party shall acquire any right, title or interest in
Dynavax’s Intellectual Property by virtue of this Agreement or otherwise, except
to the extent expressly provided herein.

17.2Individually Owned Inventions. Except as the Parties may otherwise agree in
writing, all Inventions (as defined herein) which are conceived, reduced to
practice, or created by a Party in the course of performing its obligations
under this Agreement shall be solely owned and subject to use and exploitation
by the inventing Party without a duty to account to the other Party. For
purposes of this Agreement, “Invention” shall mean information relating to any
innovation, improvement development, discovery, computer program, device, trade
secret, method, know-how, process, technique or the like, whether or not written
or otherwise fixed in any form or medium, regardless of the media on which
contained and whether or not patentable or copyrightable.

17.3Jointly Owned Inventions. All Inventions which are conceived, reduced to
practice, or created jointly by the Parties and/or their respective agents
(i.e., employees or agents who would be or are properly named as co-inventors
under the laws of the United States on any patent application claiming such
inventions) in the course of the performance of this Agreement shall be owned
jointly by the Parties. Each Party shall have full rights to exploit such
Inventions for its own commercial purposes without any obligation to the other.
The Parties shall share equally in the cost of mutually agreed patent filings
with respect to all such jointly owned Inventions. The decision to file for
patent coverage on jointly owned Inventions shall be mutually agreed upon, and
the Parties shall select a mutually acceptable patent counsel to file and
prosecute patent applications based on such joint Inventions.

17.4Disclaimer. Except as otherwise expressly provided herein, nothing contained
in this Agreement shall be construed or interpreted, either expressly or by
implication, estoppel or otherwise, as: (i) a grant, transfer or other
conveyance by either Party to the other of any right, title, license or other
interest of any kind in any of its Inventions or other intellectual property,
(ii) creating an obligation on the part of either Party to make any such grant,
transfer or other conveyance or (iii) requiring either Party to participate with
the other Party in any cooperative development program or project of any kind or
to continue with any such program or project.

17.5Rights in Intellectual Property. The Party owning any intellectual property
shall have the worldwide right to control the drafting, filing, prosecution and
maintenance of patents covering the Inventions relating to such intellectual
property, including decisions about the countries in which to file patent
applications. Patent costs associated with the patent activities described in
this Section shall be borne by the sole owner. Each Party will cooperate with
the other Party in the filing and prosecution of patent applications. Such
cooperation will include, but not be limited to, furnishing supporting data and
affidavits

21.

[ * ] = 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.

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

 

for the prosecution of patent applications and completing and signing forms
needed for the prosecution, assignment and maintenance of patent applications.

17.6Confidentiality of Intellectual Property. Intellectual property shall be
deemed to be the Confidential Information of the Party owning such intellectual
property. The protection of each Party’s Confidential Information is described
in Article 18. Any disclosure of information by one Party to the other under the
provisions of this Article 17 shall be treated as the disclosing Party’s
Confidential Information under this Agreement. It shall be the responsibility of
the Party preparing a patent application to obtain the written permission of the
other Party to use or disclose the other Party’s Confidential Information in the
patent application before the application is filed and for other disclosures
made during the prosecution of the patent application.

Article 18

CONFIDENTIAL INFORMATION, NONDISCLOSURE AND PUBLICITY

18.1Confidentiality. It is contemplated that in the course of the performance of
this Agreement each Party may, from time to time, disclose Confidential
Information to the other. Each Party agrees to take all reasonable steps to
prevent disclosure of Confidential Information to third parties. No provision of
this Agreement shall be construed so as to preclude disclosure of Confidential
Information as may be reasonably necessary to secure from any governmental
agency necessary approvals or licenses or to obtain patents with respect to the
Product.

18.2Prior Confidentiality Agreement. This Agreement, by reference, incorporates
the Confidentiality Agreement signed by Dynavax and Baxter on February 8, 2012
(the “Confidentiality Agreement”), and is made a part hereof as though fully set
forth herein and all terms and conditions set forth in the Confidentiality
Agreement shall continue to govern any disclosure made under the Confidentiality
Agreement and shall govern any disclosure made as of the Effective Date of this
Agreement. “Confidential Information”, as used in this Agreement, shall have the
meaning defined in the Confidentiality Agreement.

18.3Third Party Disclosure. Baxter shall be permitted to disclose Product
information to third party developmental and analytical services providers in
connection with performance of its obligations hereunder provided such providers
shall be subject to confidentiality agreements. Either Party may disclose
Confidential Information of the disclosing Party to those Affiliates, agents,
contractors and consultants who need to know such information to accomplish the
purposes of this Agreement (collectively, the “Permitted Recipients”); provided
that such Permitted Recipients are bound to maintain such Confidential
Information in confidence.

18.4Litigation and Governmental Disclosure. Each Party may disclose Confidential
Information hereunder to the extent such disclosure is reasonably necessary for
complying with applicable governmental regulations, provided that if a Party is
required by law or regulation to make any such disclosure of the other Party’s
Confidential Information it will, except where impractical for necessary
disclosures, for example in the event of a medical emergency, give reasonable
advance notice to the other Party of such disclosure requirement and will use
good faith efforts to assist such other Party to secure a protective order or
confidential treatment of such Confidential Information required to be
disclosed.

18.5Limitation of Disclosure. The Parties agree that, except as otherwise may be
required by applicable laws, regulations, rules or orders, including without
limitation the rules and regulations

22.

[ * ] = 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.

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

 

promulgated by the United States Securities and Exchange Commission (the “SEC”),
and except as may be authorized in Section 18.4 and unless otherwise agreed in
this Agreement, no information concerning this Agreement and the transactions
contemplated herein shall be made public by either Party without the prior
written consent of the other.

18.6Publicity and SEC Filings. The Parties agree that the public announcement of
the execution of this Agreement shall only be by one or more press releases
mutually agreed to by the Parties. The failure of a Party to return a draft of a
press release with its proposed amendments or modifications to such press
release to the other Party within five (5) business days of the Party’s receipt
of such press release shall be deemed as approval of such press release as
received by it. Unless the prior written consent of the other Party is obtained,
no Party shall, except as may be required by law or regulations (including
without limitation any United States Securities and Exchange Commission filings
required) in any manner disclose or advertise or publish or release for
publication any statement mentioning the other Party or information contained in
or acquired pursuant to this Agreement, or the fact that any Party has furnished
or contracted to furnish the other Party the items required by this Agreement,
or quote the opinion of any employee of the other Party. In the event Dynavax is
required by law or regulation to disclose such information, each Party agrees
that it shall cooperate fully and in a timely manner with the other with respect
to all disclosures to the Securities and Exchange Commission and any other
governmental or regulatory agencies, including providing written notice to
Baxter and sufficient time to review and request confidential treatment of
Confidential Information of either Party included in any such disclosure. Baxter
may communicate information to its investors to the extent made public by
Dynavax.

18.7Duration of Confidentiality. All obligations of confidentiality and non-use
imposed upon the Parties under this Agreement, including without limitation the
period of confidentiality and non-use as set forth in the Confidentiality
Agreement which is hereby amended by this Section 18.7, shall expire ten (10)
years after the expiration or earlier termination of this Agreement.

18.8Production of similar products for other Clients. It is understood that
Baxter may have present or future initiatives, including initiatives with third
parties, involving products or processes that compete or are similar / identical
with the Product Produced under this Agreement. Accordingly, Dynavax
acknowledges that nothing in this Agreement shall be construed as a
representation or inference by either Party that it will not develop for itself,
or produce for others products or implement processes that compete with the
Product or are similar / identical, provided that Confidential Information is
not used in breach of this Agreement.

18.9Reference List. Baxter shall be entitled to put Dynavax’s name on a
reference list if Dynavax does not explicitly object to such procedure.

Article 19

FORCE MAJEURE

19.1Any delay in the performance of any of the duties or obligations of either
Party hereto (except the payment of money) caused by an event outside the
affected Party’s reasonable control shall not be considered a breach of this
Agreement, and unless provided to the contrary herein, the time required for
performance shall be extended for a period equal to the period of such delay.
Such events shall include without limitation, acts of God; acts of public
enemies; insurrections; riots; terrorist actions; injunctions; embargoes; labor
disputes, including strikes, lockouts, job actions, or boycotts; fires;
explosions; floods; shortages of material, components or energy; delays in the
delivery of materials, Components or energy;

23.

[ * ] = 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.

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

 

acts or orders of any government or agency thereof or other unforeseeable causes
beyond the reasonable control and without the fault or negligence of the Party
so affected. The Party so affected shall give prompt notice to the other Party
of such cause and a good faith estimate of the continuing effect of the force
majeure condition and duration of the affected Party’s nonperformance, and shall
take whatever reasonable steps are appropriate to relieve the effect of such
causes as rapidly as possible. If the period of nonperformance by Baxter because
of Baxter force majeure conditions exceeds ninety (90) calendar days, Dynavax
may terminate this Agreement by written notice to Baxter. If the period of
nonperformance by Dynavax because of Dynavax force majeure conditions exceeds
ninety (90) calendar days, Baxter may terminate this Agreement by written notice
to Dynavax.

Article 20

NOTICES

20.1All notices hereunder shall be delivered by facsimile or electronic mail,
confirmed by overnight delivery with a reputable overnight delivery service, to
the following address of the respective Parties:

If to Baxter:

 

BAXTER PHARMACEUTICAL SOLUTIONS LLC

 

 

927 South Curry Pike

 

 

Bloomington, Indiana 47403

 

 

Attn: Contract Management

 

 

 

 

 

Telefax No.

(812) 332-3079

 

 

Telephone No.

(812) 333-0887

 

With a copy to:

 

BAXTER HEALTHCARE CORPORATION

 

 

One Baxter Parkway

 

 

Deerfield, Illinois 60015-4633

 

 

Attn: General Counsel

 

 

 

 

 

Telefax No.

(224) 948-2450

 

 

Telephone No.

(224) 948-3440

 

If to Dynavax:

 

DYNAVAX TECHNOLOGIES

 

 

2929 Seventh Street, Suite 100

 

 

Berkeley, California 94710

 

 

Attn: General Counsel

 

 

 

 

 

Email

mostrach@dynavax.com

 

 

Telefax No.

(510) 848-1327

 

 

Telephone No.

(510) 848-5100

 

Notices shall be effective on the day following the date of transmission by
facsimile or electronic mail. A Party may change its contact details listed
above by notice to the other Party given in accordance with this Section.

24.

[ * ] = 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.

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

 

Article 21

APPLICABLE LAW

21.1In any action brought regarding the validity, construction and enforcement
of this Agreement, it shall be governed in all respects by the laws of the State
of Delaware, without regard to the principles of conflicts of laws. The courts
of the State of Delaware shall have personal jurisdiction over the Parties
hereto in all matters arising hereunder.

Article 22

ASSIGNMENT

22.1Neither Party shall assign this Agreement or any part hereof or any interest
herein to any third party (or use any subcontractor) without the prior written
approval of the other Party. No consent shall be required in the case of an
assignment to a Party’s Affiliate or in case of a transfer to a wholly-owned
subsidiary or transaction involving the merger, consolidation, or sale of all or
substantially all of the assets of the Party seeking such assignment or transfer
and such transaction relates to the business covered by this Agreement and the
resulting entity assumes all of the obligations under this Agreement. No
assignment shall be valid unless the permitted assignee(s) assumes all
obligations of its assignor under this Agreement. No assignment shall relieve
any Party of responsibility for the performance of its obligations hereunder.

Article 23

ALLIANCES

23.1Notwithstanding anything to the contrary herein, Baxter agrees that Dynavax
shall have the right to enter into alliances with third parties who may engage
in joint (with Dynavax) or unilateral marketing and promoting of the Product or
any combination of products that includes the Product.

Article 24

TAXES

24.1Dynavax shall pay all national, state, municipal or other sales, use,
excise, import, property, value added, or other similar taxes, assessments or
tariffs assessed upon or levied against the sale of Product to Dynavax pursuant
to this Agreement or the sale or distribution of Product by Dynavax (or at
Dynavax’s sole expense, defend against the imposition of such taxes and
expenses). Baxter shall notify Dynavax of any such taxes that any governmental
authority is seeking to collect from Baxter, and Dynavax may assume the defense
thereof in Baxter’s name, if necessary, and Baxter agrees to fully cooperate in
such defense to the extent of the capacity of Baxter, at Dynavax’s expense.
Baxter shall pay all national, state, municipal or other taxes on the income
resulting from sale of Baxter of the services provided to Dynavax under this
Agreement, including but not limited to, gross income, adjusted gross income,
supplemental net income, gross receipts, excess profit taxes, or other similar
taxes.

25.

[ * ] = 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.

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

 

Article 25

SUCCESSORS AND ASSIGNS

25.1This Agreement shall be binding upon and shall inure to the benefit of the
Parties hereto, their successors and permitted assigns.

Article 26

ENTIRE AGREEMENT

26.1This Agreement and all addendums and attachments hereto (including, inter
alia, the Quality Agreement), together with the Confidentiality Agreement of
February 8, 2012 collectively constitutes the entire agreement between the
Parties concerning the subject matter hereof and supersedes all written or oral
prior agreements or understandings with respect thereto.

Article 27

SEVERABILITY

27.1If any term or provision of this Agreement shall for any reason be held
invalid, illegal or unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other term or provision hereof, and this
Agreement shall be interpreted and construed as if such term or provision, to
the extent the same shall have been held to be invalid, illegal or
unenforceable, had never been contained herein.

Article 28

WAIVER AND MODIFICATION OF AGREEMENT

28.1No waiver or modification of any of the terms of this Agreement shall be
valid unless in writing and signed by authorized representatives of both Parties
hereto. Failure by either Party to enforce any rights under this Agreement shall
not be construed as a waiver of such rights nor shall a waiver by either Party
in one or more instances be construed as constituting a continuing waiver or as
a waiver in other instances.

Article 29

INDEPENDENT CONTRACTOR

29.1Both Parties shall act as an independent contractor for the other Party in
providing the services required hereunder and shall not be considered an agent
of, or joint venturer with, the other Party.

Article 30

COUNTERPARTS

30.1For convenience, this Agreement may be executed in counterparts with the
same force and effect as if each of the signatories had executed the same
Agreement.

26.

[ * ] = 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 WHEREOF, the Parties have caused this Commercial Supply Agreement to
be signed by their duly authorized representatives as of the Effective Date
written above.

“BAXTER”

Baxter Pharmaceutical Solutions LLC

By:  /s/ Robert Felicelli

Name:  Robert Felicelli

Title:  Global Franchise Head

 

“DYNAVAX”

Dynavax Technologies Corporation

By:  /s/ Eddie Gray

Name:  Eddie Gray

Title:  CEO

 

 

 

27.

[ * ] = 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.

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

 

PRODUCT ADDENDUM

For

HEPLISAVTM HEPATITIS B VACCINE

This Product Addendum is an addendum to that certain Commercial Supply Agreement
of November 22, 2013 by and between Baxter Pharmaceutical Solutions LLC
(“Baxter”), a Delaware limited liability company having a place of business at
927 South Curry Pike, Bloomington, Indiana 47403, and Dynavax Technologies
Corporation (“Dynavax”), a Delaware corporation having a principal place of
business at 2929 Seventh Street, Suite 100, Berkeley, California 94710 (the
“Commercial Supply Agreement”).

This Product Addendum may be executed in one or more counterparts, each of which
shall be deemed an original and all of which shall constitute the same
instrument. Upon its execution, this Product Addendum shall become effective and
shall be incorporated by reference into the previously executed Commercial
Supply Agreement.

“BAXTER”

Baxter Pharmaceutical Solutions LLC

By:  /s/ Robert Felicelli

Name:  Robert Felicelli

Title:  Global Franchise Head

 

“DYNAVAX”

Dynavax Technologies Corporation

By:  /s/ Eddie Gray

Name:  Eddie Gray

Title:  CEO

 

 

28.

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

 

EXHIBIT A

to Product Addendum for HEPLISAV™ HEPATITIS B VACCINE

Product and Presentation

Product

Presentation

HEPLISAVTM HEPATITIS B VACCINE

[ * ] standard syringe, with secondary package

 

29.

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

 

Exhibit A

to Product Addendum for HEPLISAV™ HEPATITIS B VACCINE

Annual Obligation

Dynavax’s Annual Obligation each year shall be the Contract Requirements of
Product. During each calendar year of this Agreement, Dynavax shall purchase the
Contract Requirements and meets its Annual Obligation as specified in Article 4.

30.

[ * ] = 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

to Product Addendum for HEPLISAVTM HEPATITIS B VACCINE

Annual Order Maximum

In any calendar year during the Term of this Agreement, in no event shall Baxter
be obligated to Produce more than a total maximum of [ * ] Units of Product;
provided, however, Baxter will use good faith efforts to meet such increased
demand.

31.

[ * ] = 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

to Product Addendum for HEPLISAV™ HEPATITIS B VACCINE

Pricing

Batch

Price*

GMP Stability Batch (~[ * ] Units or ~[ * ])

[ * ] per Batch

Process Validation Batch (~[ * ] Units or ~[ * ])

[ * ] per Batch

Process Validation Batch (~[ * ] Units or ~[ * ])

[ * ] per Batch

 

Volume**

Manufacturing Price + Finishing Price***

Up to [ * ] Units per year

[ * ] per Unit

[ * ] to [ * ] Units per year

[ * ] per Unit

[ * ] to [ * ] Units per year

[ * ] per Unit

[ * ] to [ * ] Units per year

[ * ] per Unit

*

The Batch pricing does not include the cost for finishing and does not include
the cost of the primary packaging Components (syringes, stoppers and plunger
rods) which will be invoiced by Baxter separately.

**

For the avoidance of doubt, the volume pricing shown above is incremental or
step pricing and not based on total volume which is “ trued up” at the end of
each calendar year (i.e. the first [ * ] Units of commercial Product purchased
by Dynavax in any calendar year will be charged by Baxter at [ * ] per Unit (as
adjusted) and the second [ * ] will be charged at [ * ] per Unit (as adjusted)
and so on even if Dynavax purchases over [ * ] Units of commercial Product in a
calendar year).

***

The cost of the primary packaging Components (syringes, stoppers and plunger
rods) is not included in the Manufacturing Price + Finishing Price shown above
and shall be invoiced by Baxter separately.

Note: All pricing assumes automated inspection. In the event manual inspection
is required, the pricing referenced above may change. The Unit pricing shown in
the table above assumes that the secondary packaging materials used for Product
will include cartons, [ * ] blisterpacks with tyvek lids, unit labels and back
stops. Such Unit pricing is subject to change based on the final selection of
secondary packaging materials to be used for Product.

 

32.

[ * ] = 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

to Product Addendum for HEPLISAV HEPATITIS B VACCINE

Initial Long Range Forecast

Year

Forecast

2013

Units

2014

Units

2015

Units

2016

Units

2017

Units

2018

Units

Within thirty (30) days from the Effective date of this Agreement, the Parties
agree to amend this Exhibit D to incorporate the Initial Long Range Forecast
(the “First Amendment”). Upon the effective date of the First Amendment, this
Exhibit D shall be amended to incorporate the Initial Long Range Forecast as
though fully set forth herein.

33.

[ * ] = 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.