Exhibit 10.39
[ * ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS
FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
R ESEARCH AND D EVELOPMENT C OLLABORATION AND L ICENSE A GREEMENT
B ETWEEN
G LAXO G ROUP L IMITED
AND
D YNAVAX T ECHNOLOGIES C ORPORATION
RESEARCH AND DEVELOPMENT
COLLABORATION
AND LICENSE
AGREEMENT
This RESEARCH AND DEVELOPMENT
COLLABORATION AND LICENSE AGREEMENT (the “
Agreement ”) is entered into and made effective as of
the 15th day of December, 2008 (the “ Effective Date
”) by and between Dynavax Technologies Corporation, a
Delaware corporation having its principal place of business at 2929
Seventh Street, Suite 100, Berkeley, CA 94710 (“
Dynavax ”), and Glaxo Group Limited, a company
existing under the laws of England and Wales, having its registered
office at Glaxo Wellcome House, Berkeley Avenue, Greenford,
Middlesex, UB6 0NN, England (“ GSK ”). Dynavax
and GSK are each referred to herein by name or as a “
Party ” or, collectively, as “ Parties.
”
RECITALS
W HEREAS , Dynavax possesses proprietary technology and
know-how related to the discovery, identification, synthesis and
development of oligonucleotides as drug candidates;
W HEREAS , GSK
possesses expertise in the research, development, manufacturing and
commercialization of human pharmaceuticals, and GSK is interested
in developing such oligonucleotides as drug products;
W HEREAS , GSK
desires to engage in a collaborative effort with Dynavax pursuant
to which Dynavax will carry out up to three (3) different
research and development programs to discover and develop
oligonucleotides as inhibitors of certain toll-like receptors (or
combinations thereof), and pursuant to which GSK will have certain
options, exercisable at GSK’s sole discretion, to further
develop and commercialize such oligonucleotides for any and all
uses in the Territory (as defined below), all on the terms and
conditions set forth herein.
N OW , THEREFORE , in
consideration of the premises and mutual covenants herein
contained, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the
Parties hereto agree as follows:
ARTICLE 1
DEFINITIONS
As used in this Agreement, the
following terms will have the meanings set forth in this Article 1
unless context dictates otherwise:
1.1
“Acceptance” means with respect to an NDA or MAA filed for a
Product, (a) in the United States, the receipt by GSK or its
Affiliate or Sublicensee of written notice from the FDA in
accordance with 21 CFR 314.101(a)(2) that such NDA is officially
“filed”, (b) in the European Union, receipt by GSK
or its Affiliate or Sublicensee of written notice of acceptance by
the EMEA of such MAA for filing under the centralized European
procedure in accordance with any feedback received from European
Regulatory Authorities; provided, that if the
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
centralized filing procedure is not used, then
Acceptance shall be determined upon the acceptance of such MAA by
the applicable Regulatory Authority in the third Major Country in
the EU, and (c) in Japan, receipt by GSK or its Affiliate or
Sublicensee of written notice of acceptance of filing of such MAA
from the MHLW.
1.2
“Affiliate” means any Person, whether de jure or
de facto , which, directly or indirectly through one
(1) or more intermediaries, controls, is controlled by or is
under common control with a Party to this Agreement, regardless of
whether such Affiliate is or becomes an Affiliate on or after the
Effective Date. A Person shall be deemed to “control”
another Person if it (a) owns, directly or indirectly,
beneficially or legally, at least fifty percent (50%) of the
outstanding voting securities or capital stock (or such lesser
percentage which is the maximum allowed to be owned by a Person in
a particular jurisdiction) of such other Person, or has other
comparable ownership interest with respect to any Person other than
a corporation; or (b) has the power, whether pursuant to
contract, ownership of securities or otherwise, to direct the
management and policies of the Person.
1.3 “Alliance
Manager” has the
meaning assigned to such term in Section 3.2.
1.4 “Annual Net
Sales” means total
Net Sales in the Territory in a particular Calendar
Year.
1.5 “Arbitration
Request” has the
meaning assigned to such term in Section 13.2.
1.6 [ * ] means that certain [ * ] ,
as amended from time to time.
1.7 “Back-up
Compound” means,
with respect to a lead Compound in a Dynavax Program, a Compound in
such Dynavax Program that (i) may or may not be a [ * ]
to such lead Compound, (ii) has been or is expected to be
advanced to the [ * ] stage by Dynavax, (iii) is
expected to reasonably address [ * ] associated with such
lead Compound, and (iv) is not a [ * ] .
1.8 “Breaching
Party” has the
meaning assigned to such term in Section 12.2.1.
1.9 “Business
Day” means a day on
which banking institutions in New York, New York, United States,
and London, England are open for business, excluding any Saturday
or Sunday.
1.10 “Calendar
Day” means any day,
including a Saturday, Sunday, Business Day or public or company
holiday.
1.11 “Calendar
Quarter” means a
period of three (3) consecutive months ending on the last day
of March, June, September, or December, respectively.
1.12 “Calendar
Year” means a
period of twelve (12) consecutive months beginning on
January 1 and ending on December 31.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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1.13 “ cGMP ” means all applicable
standards relating to manufacturing practicves for fine chemicals,
intermediates, bulk products or Products, including (i) the
principles detailed in the U.S. Current Good Manufacturing
Practices, 21 CFR Parts 210 and 211 and The Rules Governing
Medicinal Products in the European Community, Volume IV, Good
Manufacturing Practice for Medicinal Products, as each may be
amended from time to time or (ii) standards promulgated by any
governmental body having jurisdiction over the manufacture of a
Compound, in the form of laws or regulations.
1.14
“Chairperson” has the meaning assigned to such term in
Section 3.1.1.
1.15 “Change of Control
Event” has the
meaning assigned to such term in Section 13.4.
1.16
“Claims” has
the meaning assigned to such term in Section 11.1.
1.17 “Clinical
Trial” means a
Phase 1 Clinical Trial, Phase 2 Clinical Trial, Phase 3 Clinical
Trial, [ * ] or Proof of Concept Study.
1.18 “Co-Development
Costs” means, with
respect to a GSK Product, the sum of the following costs to the
extent incurred after the exercise by GSK of an Option with respect
to the GSK Development Program containing such GSK
Product:
1.18.1 All direct internal and external Research and
Development costs incurred by or on behalf of GSK or its Affiliates
or Sublicensees or Dynavax and/or their respective Affiliates
during such period in the conduct of the GSK Development Program
(including but not limited to both Clinical Trials and any
non-clinical activities or studies) that are required by a
Regulatory Authority to support and obtain Regulatory Approval for
such GSK Product in the U.S. (collectively, the
“Co-Development Studies” ), and for product
material, comparator drug and placebo used in the Co-Development
Studies.
1.18.2 Allocable overhead as included [ * ] ,
for [ * ] costs described in Section 1.18.1, to the
extent [ * ] described in Section 1.18.1, where
allocable overhead shall mean costs incurred by GSK or its
Affiliates or Sublicensees or Dynavax or its Affiliates that are
attributable to the costs of [ * ] or such other generally
accepted methods, in all cases as applied by the Party in
accordance with its accounting standards on a consistent basis.
Without limitation, allocable overhead shall not include the costs
of [ * ] , including, by way of example, [ * ]
.
Such costs as described in
Section 1.18.1 and 1.18.2 shall be determined in accordance
with applicable Generally Accepted Accounting Principles (GAAP) and
in accordance with the Party’s accounting standards applied
on a consistent basis.
1.19 “Co-Development
Option” has the
meaning assigned to such term in Section 5.5.1(a).
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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1.20 “Collaboration
IP” means the
Collaboration Know-How and the Collaboration Patents.
1.21 “Collaboration
Know-How” means any
Information pertaining to a Compound that is discovered, developed,
invented or created solely by a Party or jointly by both Parties,
or their respective agents, contractors, or Affiliates, during the
Research Term and pursuant to a Dynavax Program, but prior to the
earlier of GSK’s exercise of the Option or expiration of the
Option with respect to such Dynavax Program.
1.22 “Collaboration
Patent” means any
Patent that claims or covers Collaboration Know-How that is not
specifically disclosed, included, claimed or covered in the Dynavax
Compound IP or the GSK Development IP.
1.23 “ Commercially Reasonable Efforts
” means the following: (a) with respect to Dynavax, such
efforts that are consistent with the efforts and resources normally
used by [ * ] in the exercise of its reasonable business
discretion relating to the research, development and commercial
progression of a potential pharmaceutical product owned by it or to
which it has exclusive rights, with similar product characteristics
as the relevant Compound or Product, which is of similar market
potential at a similar stage in its development or product life as
the relevant Compound or Product, taking into account issues of
patent coverage, safety and efficacy, product profile,
competitiveness of the marketplace, proprietary position, [ *
] , and profitability (including pricing and reimbursement
status achieved or likely to be achieved); and (b) with
respect to GSK, such efforts that are consistent with the efforts
and resources normally used by [ * ] in the exercise of its
reasonable business discretion relating to the development and
commercialization of a prescription pharmaceutical product or
over-the-counter product as appropriate owned by it or to which it
has exclusive rights, with similar product characteristics as the
relevant Compound or Product, which is of similar market potential
at a similar stage in its development or product life as the
relevant Compound or Product, taking into account issues of patent
coverage, safety and efficacy, product profile, the competitiveness
of the marketplace, the proprietary position, [ * ] and
profitability (including pricing and reimbursement status achieved
or likely to be achieved).
1.24 “Competitive
Infringement” has
the meaning assigned to such term in Section 8.5.1.
1.25 “ Compound ” means each
compound comprising an oligonucleotide-based immunoregulatory
sequence (“IRS”) that inhibits ( [ * ] unless
otherwise mutually agreed by the JSC without escalation pursuant to
Section 3.1.4) in a [ * ] (such [ * ] to be
mutually agreed by the Parties through the JSC) for [ * ] or
[ * ] , as applicable for that Program, and all derivatives
and improvements of such compound, (a) that are existing as of
the Effective Date or (b) that are Researched and/or Developed
by Dynavax under a Dynavax Program or (c) as identified,
further modified, optimized or otherwise Researched or Developed by
GSK under a GSK Development Program. In particular, for the TLR 7/9
directed compounds, the oligonucleotide-based IRS must have [ *
] unless otherwise mutually agreed by the JSC without
escalation pursuant to
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Section 3.1.4. For those Programs involving
[ * ] , the JSC may establish criteria by mutual agreement
for [ * ] of a Compound with respect to [ * ] TLR in
such Program. For clarity, nothing in this Section 1.25 or
elsewhere in this Agreement shall require Dynavax to measure the
[ * ] .
1.26 “Confidential
Information” has
the meaning assigned to such term in Section 9.1.
1.27 “Control,”
“Controls,” “Controlled” or
“Controlling” means, with respect to any intellectual
property, possession of the ability to grant the licenses or
sublicenses as provided herein without violating the terms of any
agreement or other arrangement with any Third Party. A Party shall
be deemed to Control Collaboration IP to the extent of its
individual or joint interest therein, as applicable.
1.28 “Co-Promotion
Agreement” has the
meaning assigned to such term in Section 5.5.2(a).
1.29
“Develop” or
“Development” means pre-clinical and clinical
drug development activities relating to the development of
Compounds, Products and/or processes and submission of information
to a Regulatory Authority for the purpose of obtaining Regulatory
Approval of a product, and activities to develop manufacturing
capabilities for products. Development includes, but is not limited
to, pre-clinical activities, pharmacology studies, toxicology
studies, formulation, manufacturing process development and
scale-up (including bulk compound production), manufacturing
Compound or Product for Clinical Trials, quality assurance and
quality control, technical support, pharmacokinetic studies,
clinical studies and regulatory affairs activities.
1.30 “Development
Plan” has the
meaning assigned to such term in Section 2.2.
1.31 “Disclosing
Party” has the
meaning assigned to such term in Section 9.1.
1.32
“Dollars” or
“$” means the legal tender of the
U.S.
1.33 “Dynavax Compound
IP” means
Dynavax’s and its Affiliates’ interest in any:
(a) Patents in the Territory that claim or cover the
composition of matter or any method of making, use or sale of a
Compound in the Field; and (b) Information that [ * ]
for the making, use or sale of a Compound in the Field, in each
case to the extent such Patents or Information are Controlled by
Dynavax or its Affiliates (i) on the [ * ] , or
(ii) thereafter [ * ] for any Patents which claim
priority to any Patent filed during the Research Term. The Dynavax
Compound IP excludes the Collaboration IP.
1.34 “Dynavax Compound
Patents” means
Patents in the Dynavax Compound IP.
1.35 “Dynavax Development
Program” means a
Dynavax Program for which GSK fails to exercise its Option before
expiration or GSK declines its Option, a Dynavax Program that is
terminated by the JSC or GSK, or a terminated GSK Development
Program containing Compounds and Products that Dynavax elects to
further Develop and commercialize.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
-5-
1.36 “Dynavax
Product” means a
Product Developed and commercialized by Dynavax under a Dynavax
Development Program.
1.37 “Dynavax
Program” means
Dynavax’s Research and Development of Compounds through to
either the [ * ] or completion of a [ * ] or Proof of
Concept Study, as applicable. For clarity, there will be a maximum
of [ * ] potential Dynavax Programs under this Agreement,
which shall be the TLR 7/9 Program [ * ] , each of which is
subject to the relevant diligence provisions and milestones as if
separate programs hereunder) and up to two (2) additional
Dynavax Programs as identified pursuant to
Section 2.5.
1.38
“EMEA” means
the European Medicines Evaluation Agency, and any successor entity
thereto.
1.39 “ European Commission ” means
the executive body of the European Union that has legal authority
to grant marketing authorization approvals for pharmaceutical
products in the European Union following scientific evaluation and
recommendation from the EMEA or other applicable Regulatory
Authorities.
1.40 “European
Union” or
“EU” means all countries that are officially
recognized as member states of the European Union at any particular
time during the Term.
1.41 “Exclusively Licensed
IP” means, with
respect to each Compound in a Dynavax Program for which GSK
exercises the Option and receives rights upon exercise pursuant to
Section 4.1, (a) Information in the Dynavax Compound IP
and Dynavax’s and its Affiliates’ interest in the
Collaboration Know-How, in each case that [ * ] for the
making, use or sale of such Compound [ * ] , and
(b) Dynavax Compound Patents and Dynavax’s and its
Affiliates’ interest in the Collaboration Patents, in each
case that claims or covers the [ * ] of such
Compound.
1.42 “Executive
Officers” has the
meaning assigned to such term in Section 3.1.4.
1.43 “FDA”
means the U.S. Food and Drug
Administration, and any successor entity thereto.
1.44
“Field” means
[ * ] the treatment, palliation, prevention and/or diagnosis
of [ * ] .
1.45 “First Commercial
Sale” means, with
respect to each Product, the first sale for which revenue has been
recognized by GSK or Dynavax or their respective Affiliate or
Sublicensees for use or consumption by the general public of such
Product in any country in the Territory after all required
Regulatory Approvals (including, where applicable, pricing and
reimbursement approval which is acceptable to GSK or Dynavax, as
applicable depending upon which Party is going to be selling
Product) have been granted, or such sale is otherwise
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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permitted, by the Regulatory Authority in such
country, provided, that, the following shall not constitute a First
Commercial Sale: (a) any sale to an Affiliate or Sublicensee
unless the Affiliate or Sublicensee is the last entity in the
distribution chain of the Product, (b) any use of such Product
in Clinical Trials, preclinical activities or other Research or
Development activities, or disposal or transfer of Products for a
bona fide charitable purpose, (c) compassionate use,
(d) so called “treatment IND sales” and
“named patient sales,” and (e) use under the ATU
system in France or other equivalent systems.
1.46 “[ *
]” means a Compound
in Development in the [ * ] that (a) is or is
reasonably expected to be [ * ] and (b) has [ *
] .
1.47 “[ *
]” means the
Research and Development, within the [ * ] , of [ * ]
to Compounds in the [ * ] .
1.48 “FTC”
has the meaning assigned to such
term in Section 4.1.5.
1.49 “FTE”
means a full-time individual’s
work time dedicated by Dynavax to the Dynavax Programs or by GSK to
the GSK Development Programs, or in the case of less than a
full-time dedicated individual, a full-time equivalent person year,
based upon a total of [ * ] hours per year of Research,
Development, manufacturing and commercialization work on or
directly related to the Dynavax Programs or GSK Development
Programs.
1.50 “Generic
Product” has the
meaning assigned to such term in Section 6.4.2(b).
1.51 “ GSK Development Compound ”
means any Compound, including Back-up Compounds, within a Dynavax
Program that has become a GSK Development Program upon GSK’s
exercise of the Option.
1.52 “GSK Development
IP” means any
(a) Patents that claim or cover the composition of matter of a
GSK Development Compound or GSK Product or the making, use, sale,
[ * ] of a GSK Development Compound or GSK Product; and
(b) any Information that [ * ] of a GSK Development
Compound or GSK Product [ * ] , in each case to the extent
such Patents or Information are Controlled by GSK or its
Affiliates, but excluding any Collaboration IP and any Dynavax
Compound IP or Exclusively Licensed IP.
1.53 “GSK Development
Patent” has the
meaning assigned to such term in Section 8.2.2.
1.54 “GSK Development Plan
and Budget” has the
meaning assigned to such term in Section 5.5.1(a).
1.55 “ GSK Development Program ”
means a Dynavax Program for which GSK exercises its Option and that
has not been terminated by GSK.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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1.56 “GSK
Product” means a
Product Developed and commercialized by GSK or its Affiliate or
Sublicensee under a GSK Development Program.
1.57 “HSR”
has the meaning assigned to such
term in Section 4.1.5.
1.58 “IND”
means an investigational new drug
application filed with the FDA pursuant to Part 312 of Title 21 of
the U.S. Code of Federal Regulations, including any amendments
thereto. References herein to IND shall include, to the extent
applicable, any comparable filing(s) outside the U.S. (such as a
clinical trial application in the European Union).
1.59
“Indemnitee” has the meaning assigned to such term in
Section 11.3.
1.60
“Information” means all tangible and intangible
(a) information, techniques, technology, practices, trade
secrets, inventions (whether patentable or not), methods,
knowledge, know-how, skill, experience, data, results (including
pharmacological, toxicological and clinical test data and results,
and Research or Development data, reports and batch records),
analytical and quality control data, analytical methods (including
applicable reference standards), full batch documentation,
packaging records, release, stability, storage and shelf-life data,
and manufacturing process information, results or descriptions,
software and algorithms and (b) compositions of matter, cells,
cell lines, assays, animal models and physical, biological or
chemical material. As used in this Section 1.60, “
clinical test data ” shall be deemed to include all
information related to the clinical or pre-clinical testing of a
Compound or Product, including without limitation patient report
forms, investigators’ reports, biostatistical,
pharmaco-economic and other related analyses, regulatory filings
and communications, and the like.
1.61 “Joint Steering
Committee” or
“JSC” has the meaning assigned to such term in
Section 3.1.
1.62 “Know-How
Royalty” has the
meaning assigned to such term in Section 6.4.2(a).
1.63 “[ *
]” means the
research and development of [ * ] , as of the Effective
Date, in the TLR 7/9 Program and its Back-up Compounds.
1.64
“Losses” has
the meaning assigned to such term in Section 11.1.
1.65 “Major EU
Country” means any
of the [ * ] .
1.66 “MAA”
means a regulatory application filed
with the EMEA or MHLW seeking Regulatory Approval of a Product, and
all amendments and supplements thereto filed with the EMEA or
MHLW.
1.67
“Materials” has the meaning assigned to such term in
Section 2.10.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
-8-
1.68
“MHLW” means
the Ministry of Health, Labour and Welfare of Japan, or the
Pharmaceuticals and Medical Devices Agency (the “PMDA,”
formerly known as IYAKUHIN SOGO KIKO), or any successor to either
of them, as the case may be.
1.69 “NDA”
means a New Drug Application (as
more fully defined in 21 C.F.R. 314.5 et seq. or its
successor regulation) and all amendments and supplements thereto
filed with the FDA.
1.70 “Net
Sales” means, with
respect to any Product, the gross invoiced sales price of such
Product sold by GSK or Dynavax or their respective Affiliates or
Sublicensees (the “ Selling Party ”) in finished
product form, packaged and labeled for sale, under this Agreement
in arm’s length sales to Third Parties, less deductions
allowed to the Third Party customer by the Selling Party and
actually incurred, allowed, paid, accrued or specifically allocated
as reported by the Selling Party in its financial statements in
accordance with the International Financial Reporting Standards
(“IFRS”) for GSK (or any other Selling Party which
accounts in accordance with IFRS) or US (as appropriate) Generally
Accepted Accounting Principles for Dynavax (or any other Selling
Party which accounts in accordance with US or UK (as appropriate)
Generally Accepted Accounting Principles), applied on a consistent
basis, for:
1.70.1 customary and reasonable trade, quantity, and
cash discounts and wholesaler allowances; provided that, in the
case of pharmacy incentive research programs, hospital performance
incentive research program chargebacks, disease management research
programs, similar research programs or discounts and wholesaler
allowances on “bundles” of products, all discounts,
wholesaler allowances and the like shall be [ * ]
;
1.70.2 customary and reasonable credits, rebates and
chargebacks (including those to managed-care entities and
government agencies), and allowances or credits to customers on
account of rejection or returns (including, but not limited to,
wholesaler and retailer returns) or on account of retroactive price
reductions affecting such Product;
1.70.3 freight, postage and duties, and transportation
charges relating to such Product, including handling and insurance
thereto;
1.70.4 sales (such as VAT or its equivalent) and excise
taxes, other consumption taxes, customs duties and compulsory
payments to governmental authorities and any other governmental
charges imposed upon the importation, use or sale of such Product
to Third Parties (excluding any taxes paid on the income from such
sales) to the extent the Selling Party is not otherwise entitled to
a credit or a refund for such taxes, duties or payments
made;
1.70.5 [ * ]
; and
1.70.6 other items actually deducted from gross sales
in relation to changes in accounting guidelines as per IFRS and to
the extent that such deductions are consistently applied across the
relevant Party’s business.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
-9-
Sales between GSK and its Affiliates
or Sublicensees, or Dynavax and its Affiliates or Sublicensees, as
applicable, shall be excluded from the computation of Net Sales,
and no payments will be payable on such sales except where such
Affiliate or Sublicensee is the last entity in the distribution
chain for the Product and is purchasing it for its own commercial
use, in which case such sales shall be deemed to be at [ * ]
. In addition, Product provided to patients for compassionate use
will not be included in Net Sales. [ * ] .
For purposes of determining
Royalties and sales milestones payable on Combination Products, Net
Sales will be calculated as follows, in each calendar
quarter:
In the event that Compound is sold
as part of a Combination Product (as defined below), the Net Sales
from the Combination Product will be determined by multiplying the
Net Sales (as determined without reference to this paragraph) of
the Combination Product by the fraction [ * ] , where [ *
] is the [ * ] of the Compound [ * ] when sold
separately in finished form and [ * ] is the [ * ] of
the other therapeutically active pharmaceutical compound(s)
included in the Combination Product when sold separately in
finished [ * ] , each during the applicable royalty period
or, if sales of all compounds did not occur in such period, then
[ * ] . In the event that such [ * ] cannot be
determined for both the Compound and all other therapeutically
active pharmaceutical compounds included in the Combination Product
[ * ] , Net Sales for the purposes of determining royalty
payments will be calculated as above, but the [ * ] in the
above equation will be replaced by [ * ] of the compound(s)
for which no such price exists. As used above, the term
“Combination Product” shall mean any
pharmaceutical product which contains a Compound together with at
least one other therapeutically active pharmaceutical compound
(whether or not co-formulated or co-packaged with the Compound in
such Product) which is not a Compound. To be a Combination Product,
products must be invoiced as one product. Notwithstanding the
foregoing, drug delivery vehicles, adjuvants and excipients shall
not be deemed to be active pharmaceutical compounds and their
presence shall not be deemed to create a Combination Product. [
* ] .
To the extent the Net Sales is used
herein with respect to Dynavax Products, Net Sales shall have the
meaning set forth above, with all references to “GSK”
replaced by “Dynavax.”
1.71 “Non-breaching
Party” has the
meaning assigned to such term in Section 12.2.1.
1.72 “[ *
]” has the meaning
assigned to such term in Section 2.8.
1.73
“Option” has
the meaning assigned to such term in Section 4.1.1.
1.74 “Option Deadline
Extension Period” has the meaning assigned to such term in
Section 4.1.5.
1.75 “Option Deadline
Period” has the
meaning assigned to such term in Section 4.1.5.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
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SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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1.76 “Option Period
Start” has the
meaning assigned to such term in Section 4.1.2.
1.77 “Party” or
“Parties” has the meaning assigned to such term in the
Preamble.
1.78
“Patent” means (a) all patents and patent
applications in any country or supranational jurisdiction in the
Territory, (b) any substitutions, divisions, continuations,
continuations-in-part, provisional applications, reissues,
renewals, registrations, confirmations, re-examinations,
extensions, supplementary protection certificates and the like of
any such patents or patent applications, and (c) foreign
counterparts of any of the foregoing.
1.79 “Patent
Costs” means the
reasonable fees and expenses paid to outside legal counsel, and
filing, maintenance and other out-of-pocket expenses paid to Third
Parties, incurred in connection with the Prosecution and
Maintenance of Patents.
1.80 “Patent
Royalty” has the
meaning assigned to such term in Section 6.4.1.
1.81
“Payee” has
the meaning assigned to such term in Section 6.9.
1.82
“Payor” has
the meaning assigned to such term in Section 6.9.
1.83
“Person” means any individual, partnership, joint
venture, limited liability company, corporation, firm, trust,
association, unincorporated organization, governmental authority or
agency, or any other entity not specifically listed
herein.
1.84 “Phase 1 Clinical
Trial” means a
human clinical trial of a product, the principal purpose of which
is a preliminary determination of safety in healthy individuals or
patients, as described in 21 C.F.R. 312.21(a), or a similar
clinical study prescribed by the relevant Regulatory Authorities in
a country other than the United States.
1.85 “Phase 2 Clinical
Trial” means a
human clinical trial of a product in any country that would satisfy
the requirements of 21 C.F.R. 312.21(b) and is intended to explore
a variety of doses, dose response, and duration of effect, and to
generate initial evidence of clinical safety and activity in a
target patient population, or a similar clinical study prescribed
by the relevant Regulatory Authorities in a country other than the
United States.
1.86 “Phase 3 Clinical
Trial” means a
human clinical trial of a product in any country that would satisfy
the requirements of 21 C.F.R. 312.21(c) and is intended to
(a) establish that the product is safe and efficacious for its
intended use, (b) define warnings, precautions and adverse
reactions that are associated with the product in the dosage range
to be prescribed, and (c) support Regulatory Approval for such
product.
1.87 “Phase I Ready
Compound” means a
Compound (including all Back-up Compounds if progressed to this
stage) from a Dynavax Program that has met the applicable Phase I
Ready Criteria, or is [ * ] such criteria.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
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1.88 “Phase I Ready
Criteria” means the
clinical and/or non-clinical criteria (a) set forth in
Exhibit C and as modified by the JSC [ * ] for the
[ * ] TLR 7/9 Program and (b) established and as
modified by the JSC pursuant to Section 2.6.2 for the other
Dynavax Programs (including the [ * ] ), for advancement of
a Pre-Candidate Selection Compound from a Dynavax Program into
clinical Development. In general, Phase I Ready Criteria for a
particular Compound will be reasonable and appropriate for [ *
] and generally may include: [ * ] .
1.89 “Phase I Ready
Report” has the
meaning assigned to such term in Section 2.7.2.
1.90 “Pre-Candidate
Selection Criteria” means the criteria established by the JSC
pursuant to Section 2.6.1 for [ * ] in the [ * ]
TLR 7/9 Program and for Compounds in the [ * ] and the other
Dynavax Programs, for advancement of a Compound from a Dynavax
Program into IND-enabling studies. In general, the Pre-Candidate
Selection Criteria for a particular Compound will be reasonable and
appropriate for [ * ] and may include [ * ]
.
1.91 “Pre-Candidate
Selection Report” has the meaning assigned to such term in
Section 2.7.1.
1.92
“Product” means any product that includes a Compound,
whether or not as the sole active ingredient and in any dosage form
or formulation.
1.93 “Product Marketing
Plan” has the
meaning assigned to such term in Section 5.5.2.
1.94
“Program” means a Dynavax Program, Dynavax Development
Program, or GSK Development Program, as applicable.
1.95 “Proof of
Concept” or
“PoC” means the stage of Development at which a
Phase I Ready Compound has successfully satisfied the Proof of
Concept Criteria, as such criteria are determined by
GSK.
1.96 “Proof of Concept
Criteria” means the
clinical and/or non-clinical criteria established [ * ] ,
pursuant to Section 2.6.5 and in accordance with the
guidelines attached hereto as Exhibit D , to determine
whether a Phase I Ready Compound demonstrates [ * ] . This
shall include [ * ] and any other reasonable parameters. The
Proof of Concept Criteria shall include, without limitation, [ *
] . The criteria may be different for each Dynavax
Program.
1.97 “Proof of Concept
Study” means a
human clinical trial for a particular Phase I Ready Compound that
meets the requirements of 21 C.F.R. Section 312.21(b) and is
intended to explore [ * ] .
1.98 “Proof of Concept
Study Design” or
“PoC Study Design” means the design, content and
endpoints for a Proof of Concept Study.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
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1.99 “Proof of Concept
Study Report” or
“PoC Study Report” has the meaning assigned to
such term in Section 2.7.4.
1.100 “[ * ]” or
“[ * ]” means the stage of Development at which a Phase
I Ready Compound has successfully satisfied the [ * ]
Criteria, as such criteria are determined by [ * ]
.
1.101 “[ * ]
Criteria” means the
criteria established by [ * ] pursuant to Section 2.6.3
and in accordance with the guidelines attached hereto as Exhibit
E .
1.102 “[ * ]” or
“[ * ] Study” means a study performed in humans in order to
[ * ] of a particular Phase I Ready Compound in humans and
to guide [ * ] .
1.103 “[ * ]
Design” or
“[ * ] Study Design” means the design, content
and endpoints for a [ * ] .
1.104 “[ * ]
Report” or
“[ * ] Study Report” has the meaning assigned to
such term in Section 2.7.3.
1.105 “Prosecuting
Party” has the
meaning assigned to such term in Section 8.2.3.
1.106 “Prosecution and
Maintenance” or
“Prosecute and Maintain” means, with regard to a
Patent, the preparing, filing, prosecuting and maintenance of such
Patent, as well as re-examinations, reissues, and requests for
patent term adjustments and patent term extensions with respect to
such Patent, together with the initiation or defense of
interferences, the initiation or defense of oppositions and other
similar proceedings with respect to the particular Patent, and any
appeals therefrom. For clarification, “Prosecution and
Maintenance” or “Prosecute and Maintain” shall
not include any other enforcement actions taken with respect to a
Patent.
1.107 “Receiving
Party” has the
meaning assigned to such term in Section 9.1.
1.108 “Regulatory
Approval” means any
and all approvals, licenses, registrations, or authorizations of
any country, federal, supranational, state or local regulatory
agency, department, bureau or other government entity that are
necessary for the manufacture, use, storage, import, transport
and/or sale of a particular Product in the applicable
jurisdiction.
1.109 “Regulatory
Authority” means
the FDA in the U.S. or any health regulatory authority in another
country in the Territory that is a counterpart to the FDA and holds
responsibility for granting regulatory marketing approval for a
Product in such country, including the European Commission and the
MHLW, and any successor(s) thereto.
1.110
“Research” means the discovery, identification, research,
characterization, modification, derivatization, optimization, and
pre-clinical testing of pharmaceutical compounds.
1.111 “Research
Term” has the
meaning assigned to such term in Section 2.3.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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1.112 “Senior Executive
Officers” has the
meaning assigned to such term in Section 5.1.2.
1.113
“Subcommittee” has the meaning assigned to such term in
Section 3.1.7.
1.114
“Sublicensee” means, with respect to a particular Product, a
Third Party to whom GSK or Dynavax, as applicable, has granted a
sublicense or license under any Dynavax Compound IP and/or
Collaboration IP and/or Exclusively Licensed IP and/or GSK
Development IP licensed to such Party pursuant to this Agreement,
but excluding any Third Party acting solely as a
distributor.
1.115 “[ *
]” means [ *
] .
1.116 “[ *
]” means that
certain [ * ] , as amended from time to time, to the extent
pertaining to [ * ] of TLRs.
1.117
“Term” has
the meaning assigned to such term in Section 12.1.
1.118
“Territory” means the entire world.
1.119 “Third
Party” means any
entity other than Dynavax or GSK or an Affiliate of Dynavax or
GSK.
1.120
“TLR” means
any of the human toll-like receptors [ * ] , [ * ] ,
[ * ] and [ * ] .
1.121 “TLR 7/9
Program” means,
collectively, the Dynavax Program directed toward the discovery,
Research and Development of Compounds that inhibit both TLR 7 and
TLR 9, [ * ] .
1.122 “United States”
or “U.S.” means the United States of America and all of
its territories and possessions.
1.123 “Valid
Claim” means any
claim within a pending ( [ * ] ), allowed or issued U.S.
patent application or patent, or pending, accepted or issued patent
application or patent in a jurisdiction outside the U.S., that has
not expired, lapsed, been cancelled or abandoned, or been dedicated
to the public, disclaimed, or held unenforceable, invalid, or
cancelled by a court or administrative agency of competent
jurisdiction in an order or decision from which no appeal has been
or can be taken, including without limitation through opposition,
reexamination, reissue or disclaimer.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED 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 2
RESEARCH AND
DEVELOPMENT
2.1 Overview.
Pursuant to this Agreement and as
further provided in this Article 2, Dynavax will undertake the TLR
7/9 Program and, if identified and agreed pursuant to
Section 2.5, one (1) or two (2) additional Dynavax
Programs under the supervision of the JSC during the Research Term.
The objective of the Dynavax Programs is the identification,
optimization, Research and Development of Compounds, which
Compounds GSK shall have Options to exclusively license on a
worldwide basis, as provided in Article 4.
2.2 Development Plans.
Each Dynavax Program will be carried
out by Dynavax pursuant to a development plan (each, a
“Development Plan” ) that will outline
anticipated Research and Development activities to be conducted by
Dynavax and [ * ] . Any estimates regarding [ * ]
shall be intended as a general guide only, and Dynavax shall
continue to progress each Dynavax Program with Commercially
Reasonable Efforts, even if Commercially Reasonable Efforts would
require a [ * ] set forth in the Development Plan. The
initial Development Plan for the [ * ] TLR 7/9 Program has
been agreed to by the Parties and is attached hereto as Exhibit
A . Development Plans for the other Dynavax Programs will be
prepared in accordance with Section 2.5. The Development Plan
for the [ * ] will be prepared within [ * ] after the
Effective Date, unless otherwise agreed by the JSC. From time to
time during the Research Term [ * ] , Dynavax shall update
each Development Plan (or applicable portion thereof) and shall
submit such updated Development Plan to the JSC for review and
comment. Dynavax shall consider all such comments in good faith
before preparing an updated Development Plan, however each such
Development Plan will be designed with the objective of enabling a
determination upon completion of the Development Plan as to whether
all of the criteria (either Pre-Candidate Selection Criteria, Phase
I Ready Criteria, [ * ] Criteria or PoC Criteria) have been
met. Each updated Development Plan shall replace the Development
Plan previously in effect. Each Development Plan will be reviewed
as necessary at each meeting of the JSC, and at any other time upon
the request of either Party, and the JSC may suggest modifications,
as appropriate, to reflect material scientific or commercial
developments. In the event of any inconsistency between any
Development Plan and this Agreement, the terms of this Agreement
shall prevail and any such inconsistent portion of a Development
Plan is hereby expressly rejected.
2.3 Research Term.
The Research term shall commence on
the Effective Date and shall expire [ * ] thereafter (the
“ Initial Research Term ”), subject to extension
(a) for up to [ * ] of the Parties, or (b) [ *
] no later than [ * ] prior to expiration of the Initial
Research Term, if [ * ] , as applicable, before the
expiration of the Initial Research Term (as may be extended, the
“ Research Term ”), and in such case, the
Research Term shall be extended [ * ] .
2.4 Dynavax
Programs.
2.4.1 Dynavax Responsibility. Prior to GSK’s exercise of an Option with
respect to a Dynavax Program, Dynavax shall have primary
responsibility for the Research and Development of each Compound
(including, but not limited to, clinical trials and submissions to
regulatory agencies) under such Dynavax Program in accordance with
the applicable Development Plan. Subject to Sections 2.6.4 and
2.6.6, Dynavax shall be solely responsible for
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all internal and external expenses in connection
with the Dynavax Programs. Subject to Section 5.2,
Dynavax’s obligation to conduct each Dynavax Program shall
terminate at the earlier of (a) GSK’s exercise of the
Option with respect to such Dynavax Program, (b) expiration of
the Research Term, as may be extended pursuant to Section 2.3,
or (c) [ * ] decision to terminate such Dynavax
Program.
2.4.2 Diligence. The objective of each Dynavax Program is to
discover and Develop [ * ] and, if applicable under [ *
] , Compounds satisfying the Proof of Concept Criteria or [
* ] Criteria, as applicable. During the Research Term, Dynavax
shall use Commercially Reasonable Efforts to conduct each Dynavax
Program and related Research and Development activities for such
Dynavax Program in accordance with the applicable Development Plan.
In particular and without limiting the generality of the foregoing,
and subject to Sections 2.6.4 and 2.6.6, for each Dynavax Program,
Dynavax shall use Commercially Reasonable Efforts to conduct
Research and Development activities to identify [ * ] that
satisfy the [ * ] for each Dynavax Program and, if
determined pursuant to [ * ] , progress [ * ] through
to either (i) completion of a [ * ] Study in an effort
to achieve the [ * ] Criteria, or (ii) completion of a
Proof of Concept Study in an effort to achieve the Proof of Concept
Criteria, as determined pursuant to Section 2.6.5.
2.4.3 TLR 7/9 Program . The TLR 7/9 Program shall include efforts to
discover, Research and Develop Compounds for [ * ] dual
inhibitors of TLR 7 and TLR 9.
2.4.4 GSK Research Activities . GSK shall, upon Dynavax’s request,
consult with Dynavax regarding the Research and Development of
Compounds under each Dynavax Program. On a Dynavax
Program-by-Dynavax Program basis, the Parties shall discuss and
consider in good faith [ * ] , prior to GSK’s exercise
of an Option with respect to such Dynavax Program in order to [
* ] . Dynavax shall [ * ] .
2.5 Identification of Additional
Programs. [ * ]
may propose to the JSC up to two (2) additional Dynavax
Programs to be conducted by Dynavax during the [ * ] . Upon
GSK’s request during the [ * ] of the [ * ] ,
GSK and Dynavax will identify and agree upon, through the JSC, such
additional two (2) Dynavax Programs to include under this
Agreement, which during the [ * ] of the [ * ] ,
would involve Research and Development of inhibitors of [ *
] , and during the [ * ] of the [ * ] , would
involve Research and Development of inhibitors of [ * ] . If
the JSC cannot reach consensus on the selection of one or both of
such additional Dynavax Programs, then [ * ] in accordance
with Section 3.1.4(c). Promptly after each such Dynavax
Program is selected, Dynavax shall prepare a Development Plan for
such Program for submission to the JSC for review and comment.
Dynavax shall consider all such comments in good faith before
finalizing such Development Plan, after which Dynavax shall
promptly commence and conduct such Program with its Commercially
Reasonable Efforts.
2.6 Compound Criteria; [ * ] and
Proof of Concept Study Designs.
2.6.1 Pre-Candidate Selection Criteria
. The JSC shall establish the
Pre-Candidate Selection Criteria for each Dynavax Program within
(a) [ * ] of the Effective Date for
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Back-up Compounds in the [ * ] TLR 7/9
Program and for the [ * ] , or (b) [ * ] of the
identification of each other Dynavax Program under
Section 2.5. Such Pre-Candidate Selection Criteria shall be
consistent with the generic criteria attached in Exhibit B ,
modified as necessary by mutual agreement of the JSC [ * ]
.
2.6.2 Phase I Ready Criteria . As of the Effective Date, the Parties have
agreed upon the Phase I Ready Criteria for the [ * ] TLR 7/9
Program, which criteria may be modified by mutual agreement of the
JSC [ * ] . The JSC shall establish the Phase I Ready
Criteria for the [ * ] within [ * ] TLR 7/9 Program.
Within [ * ] after the identification of a Dynavax Program
under Section 2.5, the JSC shall establish Phase I Ready
Criteria for such Dynavax Program, which shall be substantially
similar to the example of Phase I Ready Criteria set forth in
Exhibit C .
2.6.3 [ * ]
Criteria . Prior to the determination by the JSC of a
Phase 1 Ready Compound for a given Dynavax Program, GSK or Dynavax
may propose that Dynavax [ * ] for such Program, by
submitting to the JSC proposed [ * ] Criteria and [ *
] Study Design that are reasonably consistent with the
guidelines attached hereto as Exhibit E . The JSC shall
consider such proposal and determine, [ * ] , whether such
Dynavax Program will include a [ * ] . Promptly following a
decision by the JSC to conduct a [ * ] Study, but in no
event later than [ * ] over the [ * ]
Criteria.
2.6.4 [ * ]
Design. The JSC shall be responsible for establishing
the [ * ] Design for each Dynavax Program for which a [ *
] Study will be conducted. Notwithstanding [ * ] with
respect to the [ * ] Study Design, as set forth in
Section 3.1.4(c), in no event shall Dynavax be obligated to
[ * ] for any single [ * ] Study and all Development
activities required specifically for such [ * ] Study. In
the event that the [ * ] Study conducted in accordance with
the applicable [ * ] Study Design and Development Plan, and
all Development activities required specifically for such [ *
] Study, [ * ] , then [ * ] , except to the
extent due to [ * ] . In the event that Dynavax [ * ]
for a PoC Study and all Development activities required
specifically for such PoC Study, [ * ] , as such PoC Study
and all Development activities required specifically for such [
* ] at the time of a JSC decision [ * ] for any single
[ * ] Study and all Development activities required
specifically for such [ * ] Study, [ * ] for such
[ * ] Study and all Development activities required
specifically for such [ * ] Study against [ * ] for
such Dynavax Program after the completion of such [ * ]
Study. In the event that Dynavax [ * ] of [ * ] for
any single [ * ] Study and all Development activities
required specifically for such [ * ] Study, [ * ]
Calendar Days after [ * ] provided by Dynavax setting forth
[ * ] for such [ * ] Study in the preceding Calendar
Quarter. [ * ] of such [ * ] against [ * ] of
each milestone set forth in Sections [ * ] , up to a [ *
] of [ * ] . In any event, Dynavax shall be obligated to
complete any [ * ] Study [ * ] pursuant to this
Section 2.6.4.
2.6.5 Proof of Concept Criteria.
Prior to the initiation of the first
applicable [ * ] for a Program, [ * ] shall establish
the provisional clinical trial design, including planned [ *
] , for the Proof of Concept Study, and shall [ * ] ,
collectively, as the Proof of Concept Criteria, prior to initiation
of the PoC Study. All such Proof of Concept Criteria shall be
established reasonably in accordance with the guidelines and
examples attached hereto as Exhibit D .
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2.6.6 PoC Study Design . The JSC shall be responsible for [ * ]
for each Dynavax Program. Notwithstanding [ * ] with respect
to the PoC Study Design, as set forth in Section 3.1.4(c), in
no event shall Dynavax be obligated to [ * ] of [ * ]
for any single Proof of Concept Study and all Development
activities required specifically for such Proof of Concept Study.
In the event that the [ * ] for any Proof of Concept Study
conducted in accordance with the applicable PoC Study Design and
Development Plan, and all Development activities required
specifically for such Proof of Concept Study, [ * ] , then
[ * ] , except to the extent due to [ * ] within [
* ] after [ * ] provided by Dynavax setting forth the
[ * ] for such Proof of Concept Study in the preceding
Calendar Quarter. [ * ] of such [ * ] against [ *
] of each milestone set forth in Sections 6.2.1 and 6.2.2, up
to a [ * ] of [ * ] . In any event, Dynavax shall be
obligated to complete any PoC Study funded by GSK pursuant to this
Section 2.6.6.
2.7 Evaluation of Pre-Candidate
Selection Criteria, Phase I Ready Criteria, [ * ] Criteria and
Proof of Concept Criteria.
2.7.1 Pre-Candidate Selection Criteria
. In the event that a Compound
achieves [ * ] of the Pre-Candidate Selection Criteria after
Dynavax has completed the activities required to make such an
assessment, it being understood by the Parties that drug discovery
is an iterative problem-solving process and that multiple Compounds
may be expected to be progressed in order to identify a Compound
that merits advancement into IND-enabling studies, Dynavax shall
promptly notify GSK in writing of such event and shall provide to
the JSC a completed data package containing the complete set of the
analyses, results and raw data from the Dynavax Program for such
Compound (the “ Pre-Candidate Selection Report
”). Unless otherwise agreed to by the Parties, the JSC will
schedule an ad hoc meeting not more than [ * ] after receipt
by GSK’s JSC representatives of such complete Pre-Candidate
Selection Report to review such Pre-Candidate Selection Report and
to confirm whether or not such Compound meets [ * ] of the
Pre-Candidate Selection Criteria. In the event that the JSC agrees
that all or substantially all of the Pre-Candidate Selection
Criteria have been met, [ * ] , and Dynavax shall use its
Commercially Reasonable Efforts to continue to progress the Dynavax
Program through to completion of the PoC Study or [ * ]
Study, as applicable, subject to Section 2.7.2 below. If the
JSC fails to agree that [ * ] of the Pre-Candidate Selection
Criteria have been met, then the matter shall be resolved by [ *
] determines that all or substantially all of the Pre-Candidate
Selection Criteria have been met, then the [ * ] , and
Dynavax shall use its Commercially Reasonable Efforts to continue
to progress the Dynavax Program through to completion of the PoC
Study or [ * ] Study, as applicable under the relevant
provisions of Articles 2 and 3. [ * ] of the Pre-Candidate
Selection Criteria have been met, then Dynavax shall complete any
additional studies as are [ * ] Pre-Candidate Selection
Criteria and progress such Compound through completion of the PoC
study or [ * ] Study, as applicable under the relevant
provisions of Articles 2 and 3. If the achievement of such criteria
is [ * ] , Dynavax shall instead progress a Backup Compound
in place of the Compound that failed to meet the criteria, and
Dynavax shall use its Commercially Reasonable Efforts to progress
such Backup Compound through to completion of the PoC Study or [
* ] Study, as applicable under the relevant provisions of
Articles 2 and 3.
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2.7.2 Phase I Ready Criteria . In the event that a Compound achieves [ *
] of the Phase I Ready Criteria after Dynavax has completed the
activities required to make such an assessment, it being understood
by the Parties that drug discovery is an iterative problem-solving
process, and that multiple Compounds may be expected to be
progressed in order to identify a Compound that merits advancement
into clinical Development, Dynavax shall promptly notify GSK in
writing of such event and shall provide to the JSC a complete data
package containing all analyses, results and raw data from the
Dynavax Program for such Compound (the “ Phase I Ready
Report ”). Unless otherwise agreed to by the Parties, the
JSC will schedule an ad hoc meeting not more than [ * ]
after receipt by GSK’s JSC representatives of any such
complete Phase I Ready Report to review such Phase I Ready Report
and to confirm whether or not such Compound meets [ * ] of
the Phase I Ready Criteria.
(a) If the JSC agrees that such Compound has
achieved [ * ] of the Phase I Ready Criteria, then if such
Compound is [ * ] , the Parties shall determine whether GSK
shall [ * ] as to such Dynavax Program pursuant to [ *
] .
(b) If the JSC fails to agree that the Compound has
satisfied [ * ] of the Phase I Ready Criteria, then the
matter shall be resolved by [ * ] of the Phase I Ready
Criteria have been met, then Dynavax shall complete any additional
studies as are necessary [ * ] the Phase I Ready Criteria
and progress such Compound through completion of the PoC study or
[ * ] Study, as applicable under the relevant provisions of
Articles 2 and 3. If the achievement of such criteria is not [ *
] , Dynavax shall instead progress a Backup Compound in place
of the Compound that failed to meet the criteria, and Dynavax shall
use its Commercially Reasonable Efforts to progress such Backup
Compound through to completion of the PoC Study or [ * ]
Study, as applicable under the relevant provisions of Articles 2
and 3.
(c) If either (i) the JSC agrees that such
Compound has [ * ] of the Phase I Ready Criteria, and GSK
either [ * ] in accordance with the applicable provisions of
this Agreement, or (ii) [ * ] of the Phase I Ready
Criteria, and GSK either [ * ] in accordance with the
applicable provisions of this Agreement, then Dynavax shall
progress such Compound into a Phase 1 Clinical Trial [ * ] .
A Compound that either the JSC, [ * ] of the Phase I Ready
Criteria shall be considered to be at the “Phase I
Ready” stage.
2.7.3 [ * ]
Criteria . Upon the completion of any [ * ] Study,
Dynavax shall promptly notify GSK in writing of such event and
shall provide to the JSC a complete data package containing all
analyses, results and raw data from the completion of the [ *
] Study for such Phase I Ready Compound, and any related
correspondence and information received from or sent to any
Regulatory Authority relating to such Phase I Ready Compound (the
“ [ * ] Study Report ”). GSK shall [ * ]
upon the completion of the [ * ] Study pursuant to [ *
] . Unless otherwise agreed by the Parties, if requested by
GSK, the JSC will schedule an ad hoc meeting not more than [ *
] after receipt of any such [ * ] Study Report to review
such [ * ] Study Report
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and confirm whether or not such Phase I Ready
Compound satisfies the [ * ] Criteria. If the JSC (or the
Executive Officers or GSK pursuant to Section 3.1.4(c))
decides that the Phase I Ready Compound did not satisfy the [ *
] Criteria, then, except as provided in Section 5.3, [
* ] with respect to such Dynavax Program and GSK [ * ]
with respect to such Dynavax Program at [ * ] . In the event
that the Compound fails to satisfy the [ * ] Criteria after
completion of the [ * ] Study, but GSK [ * ] to such
Dynavax Program, and GSK determines to [ * ] Study, in such
case [ * ] for such GSK Development Program shall all be
[ * ] from the [ * ] otherwise applicable, and the
applicable [ * ] . If at any time after [ * ] the
Compound that [ * ] Study [ * ] , as applicable, then
GSK shall [ * ] .
2.7.4 Proof of Concept Criteria
. Upon the completion of any Proof
of Concept Study, Dynavax shall promptly notify GSK in writing of
such event and shall provide to the JSC a complete data package
containing all analyses, results and raw data from the completion
of the Proof of Concept Study for such Phase I Ready Compound, and
any related correspondence and information received from or sent to
any Regulatory Authority relating to such Phase I Ready Compound
(the “ PoC Study Report ”). GSK shall have the
right to exercise its Option to such Dynavax Program upon the
completion of the Proof of Concept Study pursuant to
Section 4.1 (whether or not such criteria have been
satisfied). Unless otherwise agreed by the Parties, if requested by
GSK, the JSC will schedule an ad hoc meeting not more than [ *
] Calendar Days after receipt of any such PoC Study Report to
review such PoC Study Report and confirm whether or not such Phase
I Ready Compound satisfies the Proof of Concept Criteria. If the
JSC [ * ] decides that the Phase I Ready Compound did not
satisfy the Proof of Concept Criteria, then, except as provided in
Section 5.3, Dynavax will [ * ] with respect to such
Dynavax Program, and GSK may, [ * ] . In the event that the
Compound fails to satisfy the Proof of Concept Criteria after
completion of the Proof of Concept Study, [ * ] which
completed the PoC Study, in such case the [ * ] and all
other [ * ] for such GSK Development Program shall all be
[ * ] from the [ * ] otherwise applicable, and the
applicable [ * ] . If at any time after Option exercise the
Compound that completed the PoC Study [ * ] , as applicable,
then GSK shall [ * ] .
2.8 [ * ].
During the [ * ] , the JSC
will review the progress of each Dynavax Program and [ * ] .
The JSC may, [ * ] decide to [ * ] Dynavax Program(s)
[ * ] Dynavax Program(s) that [ * ] Dynavax Programs,
[ * ] . For clarity, if prior to the exercise by GSK of an
Option with respect to a given Dynavax Program, the JSC is not in
agreement, [ * ] . All such decisions shall be based on [
* ] . Notwithstanding the above, after GSK exercises an Option
with respect to a Dynavax Program, GSK may, [ * ] , GSK
shall be obligated to [ * ] . For the purposes of
determining whether there is [ * ] , the TLR 7/9 Program
shall [ * ] (for example, if a Compound in the [ * ]
is being progressed, then the [ * ] may be rendered [ *
] , either prior to or after Option exercise by
GSK).
2.9 Reports.
Dynavax shall provide written
progress reports on the status of each Dynavax Program, including
without limitation summaries of data associated with
Dynavax’s Research and Development activities and a timetable
for completion of the respective Dynavax Program. Dynavax shall
provide such written report to JSC members at least [ * ]
Business Days in advance of the applicable JSC meeting.
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2.10 Material
Transfer. To facilitate
the conduct of the Programs, either Party may provide to the other
Party certain biological materials or chemical compounds, such as
cell-based assays or specific Compounds, owned by or licensed to
the supplying Party for use by the other Party in furtherance of
the Development Plans (such materials or compounds provided
hereunder are referred to, collectively, as “
Materials ”). Except as otherwise provided under this
Agreement, all such Materials delivered to the other Party shall
remain the sole property of the supplying Party, shall be used only
in furtherance of the Programs and solely under the control of the
other Party (or its Affiliates), shall not be used or delivered to
or for the benefit of any Third Party without the prior written
consent of the supplying Party, and shall not be used in Research
or testing involving human subjects, unless expressly agreed. The
Materials supplied under this Section 2.9 are supplied
“as is” and must be used with prudence and appropriate
caution in any experimental work, since not all of their
characteristics may be known. For the avoidance of doubt, this
Section 2.10 shall not apply to any materials and/or Compounds
supplied to GSK by Dynavax in accordance with Section 4.3
pursuant to the exercise by GSK of its Option for a Dynavax
Program.
2.11 Regulatory Matters;
Compliance.
2.11.1 Compliance . Dynavax shall conduct all pre-clinical
activities and Clinical Trials under this Agreement in good
scientific manner and in compliance in all material respects with
applicable laws, rules and regulations and all other applicable
requirements of cGMP, good laboratory practice and current good
clinical practice.
2.11.2 Data Integrity .
(a) Dynavax acknowledges the importance to GSK of
ensuring that the Dynavax Programs are undertaken in accordance
with the following good data management practices:
(i) data are being generated using sound scientific
techniques and processes;
(ii) data are being accurately and reasonably
contemporaneously recorded in accordance with good scientific
practices by Persons conducting Research hereunder;
(iii) data are being analyzed appropriately without
bias in accordance with good scientific practices; and
(iv) data and results are being stored securely and
can be easily retrieved.
(b) Dynavax agrees that it shall use Commercially
Reasonable Efforts to carry out the Dynavax Programs so as to
collect and record any data generated therefrom in a manner
consistent with the above requirements as set forth in subsection
(a) above.
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2.11.3 Ownership . [ * ] all regulatory filings for
Compounds [ * ] . Upon [ * ] with respect to a
Dynavax Program, Dynavax shall [ * ] as soon as reasonably
practicable of all regulatory filings for the resulting GSK
Development Compounds (including Back-up Compounds), including all
relevant INDs, and provide GSK with copies of such INDs and other
regulatory filings and all pre-clinical and clinical data and
results (including pharmacology, toxicology, formulation, and
stability studies). Thereafter, [ * ] and maintain all
regulatory filings and Regulatory Approvals for GSK Development
Compounds.
2.11.4 Adverse Event Reporting . Beginning on the Effective Date and continuing
until such time, if any, that GSK exercises its Option with respect
to a Dynavax Program, Dynavax shall be responsible for reporting
all adverse drug reaction experiences related to Compounds in such
Dynavax Program in connection with the activities of Dynavax under
this Agreement to the appropriate Regulatory Authorities in the
countries in the Territory in which such Compounds are being
Developed, in accordance with the appropriate laws and regulations
of the relevant countries and Regulatory Authorities. Dynavax shall
provide GSK notice of such event within five (5) days and
provide copies of all reports to GSK as soon as possible, including
using Commercially Reasonable Efforts to provide such copies.
Through the JSC, GSK shall have the right to review from time to
time Dynavax’s pharmacovigilance policies and procedures. GSK
and Dynavax agree to cooperate and use good faith efforts to ensure
that Dynavax’s adverse event database is organized in a
format that is compatible with GSK’s adverse event
databases.
2.12 Dynavax Program
Costs. Except as set
forth in this Article 2, [ * ] shall [ * ] in connection with
performing activities under a Dynavax Program.
2.13 Subcontracting.
Subject to the terms of this
Agreement, each Party shall have the right to engage Affiliates or
Third Party subcontractors to perform certain of its obligations
under this Agreement. Any Affiliate or subcontractor to be engaged
by a Party to perform a Party’s obligations set forth in the
Agreement shall meet the qualifications typically required by such
Party for the performance of work similar in scope and complexity
to the subcontracted activity. Notwithstanding the preceding, any
Party engaging an Affiliate or subcontractor hereunder shall remain
principally responsible and obligated for such activities. In
addition, each Party engaging a subcontractor with respect to its
obligations under a Dynavax Program shall in all cases retain or
obtain exclusive Control of any and all intellectual property
created by or used with the relevant Party’s permission by
such subcontractor directly related to such subcontracted activity
under the Dynavax Program. The Party engaging a subcontractor under
a Dynavax Program shall be solely responsible for all costs
associated with obtaining such exclusive Control and rights to such
intellectual property. For example and not by limitation, Dynavax
shall ensure that it retains or obtains exclusive Control of any
intellectual property created by or used with the relevant
Party’s permission by any academic or any contract research,
manufacturing or development organization appointed by Dynavax to
fulfill any of its obligations under this Agreement. However, it is
understood that, in some cases, it may not be commercially
reasonable for such Party [ * ] . To the extent that such
[ * ] from any such subcontractor under a Dynavax Program,
prior to entering into such arrangement with such
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subcontractor, such Party shall bring such
matter to the JSC for the prior approval of the JSC to enter into
such arrangement and for approval by the JSC of the licensing terms
and conditions with respect to such arrangement.
ARTICLE 3
MANAGEMENT OF THE
COLLABORATION
3.1 Joint Steering
Committee. Promptly and
in any event within [ * ] days after the Effective Date, the
Parties shall establish a committee (the “ Joint Steering
Committee ” or “JSC” ) as more fully
described in this Section 3.1. The JSC shall have review,
oversight and decision-making responsibilities for all Research and
Development activities performed under this Agreement, as more
specifically provided herein. Each Party agrees to keep the JSC
informed of its progress and activities under the
Programs.
3.1.1 Membership . The JSC shall be comprised of three
(3) representatives (or such other number of representatives
as the Parties may agree) from each of GSK and Dynavax. Each Party
shall provide the other with a list of its initial members of the
JSC no later than thirty (30) days prior to the first
scheduled meeting of the JSC, which shall be no later than ninety
(90) days after the Effective Date. Each Party may replace any
or all of its representatives on the JSC at any time upon written
notice to the other Party in accordance with Section 13.7 of
this Agreement. Each representative of a Party shall have relevant
expertise (either individually or collectively) in pharmaceutical
drug discovery and development. Any member of the JSC may designate
a substitute to attend and perform the functions of that member at
any meeting of the JSC. Each Party may, in its reasonable
discretion, invite non-member representatives of such Party to
attend meetings of the JSC as non-voting participants, subject to
the confidentiality obligations of Article 9. The Parties shall
designate a chairperson (each, a “ Chairperson
”) to oversee the operation of the JSC and prepare minutes as
set forth in Section 3.1.3, each such Chairperson to serve a
twelve (12) month term. The right to name the Chairperson
shall alternate between the Parties, with [ * ] designating
the first such Chairperson.
3.1.2 Meetings . During the Research Term, the JSC shall meet
in person or otherwise at least once each Calendar Quarter, and
more or less frequently as the Parties mutually deem appropriate,
on such dates and at such places and times as provided herein or as
the Parties shall agree. Subject to Section 5.5, upon
conclusion of the Research Term, the JSC shall meet, in person or
otherwise, at least once every Calendar Year to provide Dynavax an
update regarding GSK’s efforts to Develop and commercialize
Compounds and GSK Products in the GSK Development Programs,
including without limitation, material changes in the clinical
development plans for GSK Products, status of regulatory filings,
anticipated indications, anticipated launch dates, manufacturing
issues, and the like. Meetings of the JSC that are held in person
shall alternate between the offices of the Parties, or such other
place as the Parties may agree. The members of the JSC also may
convene or be polled or consulted from time to time by
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means of telecommunications, video conferences,
electronic mail or correspondence, as deemed necessary or
appropriate. Each Party will bear all expenses it incurs in regard
to participating in all meetings of the JSC, including all travel
and living expenses.
3.1.3 Minutes . The Alliance Manager from the Party other than
the Party of the Chairman, shall be responsible for preparing and
circulating minutes of each meeting of the JSC, setting forth,
inter alia , an overview of the discussions at the meeting
and a list of any actions, decisions or determinations approved by
the JSC and a list of any issues to be resolved by the Executive
Officers pursuant to Section 3.1.4. Such minutes shall be
effective only after approved by both Parties. With the sole
exception of specific items of the meeting minutes to which the
members cannot agree and that are escalated to the Executive
Officers as provided in Section 3.1.4 below, definitive
minutes of all JSC meetings shall be finalized no later than thirty
(30) days after the meeting to which the minutes pertain. If
at any time during the preparation and finalization of the JSC
minutes, the Parties do not agree on any issue with respect to the
minutes, such issue shall be resolved by the escalation process as
provided in Section 3.1.4. The decision resulting from the
escalation process shall be recorded by the Alliance Manager in
amended finalized minutes for such meeting.
3.1.4 Decisions . Except as otherwise provided herein, with
respect to a given Program, all decisions of the JSC prior to
Option exercise by GSK shall be made by [ * ] , with each
Party having [ * ] . In the event that the JSC [ * ]
on a matter regarding a Dynavax Program within [ * ]
Calendar Days after it has met and attempted to reach such
decision, then, except for matters expressly identified in this
Agreement as not subject to escalation to the Executive Officers
pursuant to this Section 3.1.4, either Party may, by written
notice to the other, have such issue referred to [ * ] from
time to time [ * ] , for resolution. [ * ] , which
shall in no case be more than [ * ] after the matter was
referred to [ * ] , the issue shall be finally resolved as
follows:
(a) [ * ] shall have final decision-making authority with
respect to any disputes concerning [ * ] .
(b) If the dispute concerns whether [ * ] ,
the disputed issue shall be [ * ] .
(c) GSK shall have final decision-making authority
with respect to any disputes concerning [ * ] .
3.1.5 Responsibilities . The JSC shall perform the following functions,
subject to the final decision-making authority of the respective
Parties as set forth in Section 3.1.4(a), (b) and (c),
some or all of which may be addressed directly at any given meeting
of the JSC:
(a) review and comment on the Development Plan for
each Dynavax Program and monitor progress of activities under such
Development Plan;
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(b) oversee and guide the progress of each Dynavax
Program in accordance with the applicable Pre-Candidate Selection
Criteria, Phase I Ready Criteria, [ * ] Criteria and Proof
of Concept Criteria;
(c) [ * ] ;
(d) prepare, review, modify, update and approve each
Proof of Concept Study Design and [ * ] Study
Design;
(e) identify the Dynavax Programs to be conducted by
Dynavax under this Agreement;
(f) assess the Proof of Concept Criteria and, if
applicable, the [ * ] Criteria, for each Dynavax
Program;
(g) [ * ] that a Compound has satisfied the Pre-Candidate
Selection Criteria, Phase I Ready Criteria, Proof of Concept
Criteria, or [ * ] Criteria;
(h) [ * ] all Dynavax Programs and decide whether to [
* ] a Dynavax Program;
(i) except as otherwise provided in
Section 3.1.8 below, discuss and attempt to resolve any
deadlock issues submitted to it by any Subcommittee (as defined in
Section 3.1.7), in accordance with the procedures established
in Section 3.1.4;
(j) serve as an information transfer vehicle, from
time to time, to facilitate the discussion of Development and
commercialization of GSK Products under GSK Development
Programs;
(k) periodically review the Development and
commercialization of any GSK Product and GSK Development Plan and
[ * ] ; and
(l) such other responsibilities as may be assigned
to the JSC pursuant to this Agreement or as may be mutually agreed
upon by the Parties from time to time.
For clarity, the JSC shall not have
any authority beyond the specific matters set forth above in this
Section 3.1.5, and in particular shall not have any power to
amend or modify the terms or provisions of this Agreement. In
addition, GSK (and not Dynavax or the JSC) shall have the sole
right to make decisions with respect to (i) the exercise of an
Option; or (ii) subject to Section 5.5 and GSK’s
diligence obligations in Section 5.1.3, the Research,
Development, progression, manufacture, and commercialization of
Compounds or Products in GSK Development Programs.
3.1.6 Dynavax’s Right to Withdraw
. Dynavax will have the right to
withdraw from participation on and thereby terminate any of its
rights and obligations to participate in the JSC at any time after
the [ * ] anniversary of the Effective Date upon written
notice to GSK.
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Upon withdrawal by Dynavax from participation in
the JSC, GSK will have the sole decision-making authority with
respect to any matters that would otherwise have been subject to
Sections 3.1.4(a) or 3.1.4(b) and GSK shall have the right in such
event, in its sole discretion, to immediately terminate all of
Dynavax’s Co-Development and Co-Promotion rights, whether
previously exercised or not, under this Agreement.
3.1.7 Subcommittee(s). From time to time, the JSC may establish
subcommittees to oversee particular projects or activities, as it
deems necessary or advisable (each, a “ Subcommittee
”). Each Subcommittee shall consist of such number of members
as the JSC determines is appropriate from time to time. Such
members shall be individuals with expertise and responsibilities in
the areas of pre-clinical development, clinical development,
patents, process sciences, manufacturing, regulatory affairs,
product development and/or product commercialization, as applicable
to the stage of development of the project or activity.
3.1.8 Joint Patent Subcommittee
. Within two (2) months after
the Effective Date, the JSC shall establish a Subcommittee (the
“Joint Patent Subcommittee” or
“JPS” ) to be responsible for the coordination
of the Parties’ efforts in accordance with Article 8 of this
Agreement, including the review and filing of patent applications
and assessments of inventorship of inventions created during the
Research Term under the Dynavax Programs. The JPS shall be
comprised of an equal number of representatives from each of GSK
and Dynavax and shall meet on such dates and at such places and
times agreed to by the Parties. All decisions of the JPS on matters
for which it has responsibility shall be made by consensus, with
each Party having collectively one (1) vote in all decisions.
In the event that the JPS is unable to reach a consensus decision
within fifteen (15) Calendar Days after it has met and
attempted to reach such decision, then either Party may, by written
notice to the other, have such issue submitted to the chief patent
counsel of GSK and of Dynavax (together, the “Chief Patent
Counsel” ), or such other person holding a similar
position designated by GSK or Dynavax from time to time, for
resolution. The Chief Patent Counsel shall meet promptly to discuss
the matter submitted and to determine a resolution. Prior to
exercise of an Option for a Dynavax Program, if the Chief Patent
Counsel are unable to determine a resolution in a timely manner:
(a) with respect to [ * ] related to such Program, then
the decision of the chief patent counsel [ * ] shall be
binding upon the Parties without further review, and (b) with
respect to [ * ] related to such Program, then the decision
of the chief patent counsel of [ * ] shall be binding upon
the Parties without further review. Each Party will bear all
expenses it incurs in regard to participating in all meetings of
the JPS, including all travel and living expenses. After exercise
of an Option hereunder for a Dynavax Program, if the Chief Patent
Counsel are unable to determine a resolution in a timely manner
with respect to any Patents related to such Program, [ * ]
.
3.2 Alliance Managers.
Promptly after the Effective Date,
each Party shall appoint an individual (who may not be an existing
member of the JSC) to act as alliance manager for such Party (each,
an “ Alliance Manager ”). Each Alliance Manager
shall thereafter be permitted to attend meetings of the JSC as a
nonvoting observer, subject to the confidentiality provisions of
Article 9. The Alliance Managers shall be the primary point of
contact for the Parties regarding the activities contemplated by
this Agreement and shall facilitate all such activities
hereunder
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including, but not limited to, the exchange of
Information described in Section 2.9. The Alliance Managers
shall also be responsible for assisting the JSC in performing its
oversight responsibilities. The name and contact information for
each Party’s Alliance Manager, as well as any replacement(s)
chosen by Dynavax or GSK, in their sole discretion, from time to
time, shall be promptly provided to the other Party in accordance
with Section 13.7 of this Agreement.
ARTICLE 4
GRANT OF RIGHTS
4.1 Options.
4.1.1 Grant . Dynavax hereby grants to GSK the exclusive
option, exercisable on a Dynavax Program-by-Dynavax Program basis
at GSK’s sole discretion, to obtain the exclusive license set
forth in Section 4.2.1 (each, an “ Option
”), subject to the terms and conditions described in Sections
4.1.2—4.1.6 below. GSK shall be limited to exercising one
Option per Dynavax Program, and on exercise of an Option and
payment of the applicable Option exercise fee, GSK shall have
rights to such Dynavax Program consisting of all Compounds under a
given Dynavax Program. For the purposes of this Section 4.1,
the [ * ] and the [ * ] shall be considered distinct
Dynavax Programs, each subject to a separate Option.
4.1.2 [ * ]
Period . For the two (2) Dynavax Programs other
than [ * ] , the Parties will determine whether GSK may
exercise the Option [ * ] after a Phase I Ready Compound has
completed the [ * ] Proof of Concept Study, as applicable,
as follows. Within [ * ] after the JSC determines that a
Compound has reached the Phase I Ready stage pursuant to
Section 2.7.2(a), the Parties shall [ * ] or Dynavax
shall [ * ] , as applicable. If the Parties do not agree
within such [ * ] period, or if the Parties do agree that
[ * ] , as applicable, then Dynavax shall continue to
progress the Dynavax Program, and the Option for such Dynavax
Program may be exercised only following completion of [ * ]
the Proof of Concept Study, as applicable; provided ,
however, that if in GSK’s reasonable judgment as specified in
a reasonably detailed written notice to Dynavax delivered within
[ * ] after attainment of the Phase I Ready stage, Dynavax
does not [ * ] , as applicable, then GSK [ * ] . For
clarity, GSK may exercise the Option with respect to the TLR 7/9
Program under any of the following circumstances, at the sole
discretion of GSK, but in any event [ * ] : (i) after
completion of the [ * ] or Proof of Concept Study, as
determined pursuant to Section 2.6.3, or (ii) pursuant to
Section 4.1.3(b) or 4.1.3(c).
4.1.3 Exercise .
(a) The “Option Period Start”
with respect to a Dynavax Program will commence upon the receipt by
GSK of written notice from Dynavax of the complete PoC Study
Report, complete [ * ] Study Report, or [ * ] , as
the case may be, as well as access to GSK to the Dynavax data room
containing the complete set of material or relevant clinical
and
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preclinical information related to the
applicable Dynavax Program. GSK shall decide whether or not to
exercise the Option and may exercise the Option with respect to a
Dynavax Program by written notice to Dynavax at any time within
[ * ] after the Option Period Start, unless extended
pursuant to Section 4.1.5 or otherwise extended by the mutual
written agreement of the Parties. Upon GSK’s exercise of an
Option and receipt by Dynavax of the applicable Option exercise fee
set forth in Section 6.2.1(a) or 6.2.2(a) pursuant to the
procedure set forth in Section 6.7, the Dynavax Program will
become a GSK Development Program. Subject to Section 5.3.2,
any Option exercise shall be irrevocable. GSK shall have the right,
at any time after exercising the Option with respect to a Dynavax
Program and at its sole discretion, to [ * ] from the same
Dynavax Program.
(b) In addition, in the event that either (i) a
[ * ] , or (ii) a [ * ] occurs (as defined
below), GSK shall have the right to exercise its Options to any and
all Dynavax Programs, and to terminate Dynavax’s [ * ]
rights to participate in the JSC and related Subcommittees, at
GSK’s sole discretion, by providing written notice to Dynavax
within [ * ] of (A) the event described in
(i) above; or (B) the event described in (ii) above,
provided that within [ * ] Business Days after Dynavax
notifies GSK pursuant to Section 10.2.9, Dynavax shall provide
to GSK a written plan for [ * ] and the Parties shall meet
to discuss such plan, and if such plan is not reasonably acceptable
to GSK (as reasonably detailed in written notice to Dynavax) then a
[ * ] shall have occurred. Upon the exercise by GSK of its
Option to a Dynavax Program pursuant to this Section 4.1.3(b),
the Option exercise fee and the applicable milestone payments and
royalty payments due under Article 6 shall all be [ * ] as
follows on a Program-by-Program basis for each Program with respect
to which GSK exercises its Option:
(1) if Option exercise occurs for a Dynavax Program
with a lead Compound (other than the [ * ] ) that has not
yet satisfied the Pre-Candidate Selection Criteria, then the Option
exercise fee and the milestone and royalty payments shall be [ *
] ;
(2) if Option exercise occurs for a Dynavax Program
with a lead Compound that has satisfied the Pre-Candidate Selection
Criteria but is prior to the Phase I Ready stage, then the Option
exercise fee and the milestone payments and the royalty payments
either (i) shall be [ * ] , for a Program other than
[ * ] , or (ii) shall be [ * ] .
(3) if Option exercise occurs for a Dynavax Program
with a lead Compound at the Phase I Ready stage, but prior to
initiation of a Phase 2 Clinical Trial, then the Option exercise
fee and the milestone payments and royalty payments shall all be
[ * ] from the payments that would have been payable under
Article 6 had GSK exercised its Option after completion of the
Proof of Concept Study;
(4) if Option exercise occurs for a Dynavax Program
after the initiation of a Phase 2 Clinical Trial for such Program,
then the Option exercise fee and the milestone payments and royalty
payments shall be [ * ] that would have been payable under
Article 6 had GSK exercised its Option after the Proof of Concept
Study; and
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CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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(5) if Option exercise occurs for a Dynavax Program
pursuant to Section 4.1.3(b)(ii) wherein Dynavax has [ *
] (i) within [ * ] of the Effective Date of this
Agreement, then, [ * ] above of this Section 4.1.3(b),
in the total amount of [ * ] , and, if such Option exercise
occurs (ii) more than [ * ] after the Effective Date
but prior to [ * ] after the Effective Date of this
Agreement, then, [ * ] above of this Section 4.1.3(b),
in the total amount of [ * ] .
The respective obligations of the
Parties with respect to exclusivity under Article 7 shall remain
unchanged.
(c) In the event that a [ * ] , then within
[ * ] after the [ * ] , and quarterly thereafter, the
Parties and the acquiror shall meet to discuss, in good faith and
in as much detail and specifics as is practicable at the time, [
* ] under this Agreement. If at any time in the [ * ]
following the [ * ] , GSK has a reasonable, good faith basis
to believe, based on the plans, documents, actions or inactions of
Dynavax [ * ] that Dynavax [ * ] has not or will not,
with respect to any Program, employ diligent efforts or human and
material resources that are at least equivalent to the diligent
efforts and human and material resources that were employed by
Dynavax for the Program prior to (and without any allowance for)
any delay, disruption or de-prioritization of such Program as a
result of or in contemplation of such [ * ] , then GSK shall
provide written notice to Dynavax [ * ] , such notice to
allege the specific basis for GSK’s view that the diligent
efforts or human and material resources being applied or to be
applied to the Program in question are or are expected to be less
than those that were applied to the Program by Dynavax [ * ]
. Dynavax [ * ] shall notify GSK whether or not it plans to
cure such deficiency, and if it so elects to cure, shall have a
[ * ] to cure any such deficiencies in efforts or resources
so alleged by GSK. In the event that Dynavax [ * ] notifies
GSK that it does not intend to cure such deficiencies or GSK
reasonably believes that such deficiency has not been corrected or
cured within such [ * ] , GSK shall have the right to
exercise its Options to any and all Dynavax Programs, and to
terminate Dynavax’s [ * ] rights to participate in the
JSC and related Subcommittees, at GSK’s sole discretion, by
providing written notice to Dynavax within thirty (30) days
after such [ * ] or such notice from Dynavax [ * ] .
Upon the exercise by GSK of its Option to a Dynavax Program
pursuant to this Section 4.1.3(c), the Option exercise fee and
the applicable milestone payments and royalty payments due under
Article 6 shall all be [ * ] as set forth in
Section 4.1.3(b)(1)-(5) as applicable, on a
Program-by-Program basis for each Program with respect to which GSK
exercises its Option.
4.1.4 Expiration or Termination of Option
. If GSK does not exercise the
Option with respect to a particular Dynavax Program within the
applicable [ * ] or GSK elects not to exercise the Option,
then, subject to Section 4.1.5, the Option shall terminate
with respect to such Dynavax Program, which shall become a Dynavax
Development Program, and Dynavax will thereafter have all rights,
itself or with or through an Affiliate or Third Party, (a) to
Develop and commercialize all Compounds within the Dynavax Program,
subject to any applicable royalty payments set forth in
Section 6.5, and (b) to use any data, regulatory filings
and know-how generated or used in the course of the Dynavax
Program, to the extent such [ * ] that are included in the
Dynavax Development Program.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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4.1.5 HSR and Equivalent Foreign Laws.
If GSK reasonably determines in good
faith prior to the expiration of the applicable period for exercise
of an Option for a particular Dynavax Program (the “
Option Deadline Period ”) that the exercise of such
Option is required to be filed with the Federal Trade Commission
(the “ FTC ”) under the Hart-Scott-Rodino
Antitrust Improvements Act of 1976 (15 U.S.C. §18a) (“
HSR ”) or with equivalent foreign governmental
authorities under any similar foreign law, GSK shall provide
written notice of exercise of the Option to Dynavax prior to the
end of the Option Deadline Period, which notice shall include
GSK’s binding commitment to complete the exercise of the
Option, subject only to HSR or other governmental clearance by the
FTC or other governmental authority, and the Option Deadline Period
automatically shall be extended for [ * ] (the “
Option Deadline Extension Period ”). If the exercise
of the Option does not comply with the requirements of
Section 4.1 and this Section 4.1.5, including, for
example, because it includes other conditions to the completion of
the exercise of the Option other than the grant of HSR or other
governmental clearance, then the Parties shall negotiate in good
faith to determine an appropriate way to proceed. If HSR or other
governmental clearance is not granted within the Option Deadline
Extension Period, or if GSK receives a “Second Request”
from the FTC or similar request for additional information from a
governmental authority in connection with such filing, the Option
Deadline Extension Period shall be extended for an additional
period of time (not to exceed an additional [ * ] ) to
permit GSK to obtain FTC or other governmental clearance or to
respond to the Second Request or provide additional information to
the governmental authority. If GSK elects not to respond to the
Second Request or to withdraw its request for HSR or other
governmental clearance or HSR, the Option shall terminate, and
Dynavax shall have the same rights as are set forth in
Section 4.1.4 in respect of the Compounds resulting from the
applicable Dynavax Program. If HSR or other governmental clearance
has not been granted by the end of the extended Option Deadline
Extension Period, Dynavax and GSK shall promptly meet to discuss in
good faith whether an additional extension of the Option Deadline
Extension Period is reasonable under the circumstances, and to
discuss and consider in good faith, where appropriate, the [ *
] , with the objective of placing each Party [ * ] if
the Program in question had not been included in the Agreement from
the beginning as of the Effective Date. Notwithstanding the
foregoing, nothing in this paragraph or the Agreement shall require
either Party to divest any assets or to take action (beyond
cooperation with the other Party) to respond to any Second
Request.
4.1.6 Tolling of Payment Obligations
. If the exercise by GSK of any
Option under Section 4.1 requires the making of filings under
HSR, or under any similar premerger notification provision in the
European Union or any other jurisdiction, then all rights and
obligations related to the exercise of such Option (including
payment of any Option exercise fee or other milestone) shall be
tolled until the applicable waiting period has expired or been
terminated or until approval or clearance from the reviewing
authority has been received, and each Party agrees to cooperate at
the request of the Party which decides in its sole discretion to
respond to any such request for information to expedite review of
such transaction. In the event that HSR clearance is not reasonably
achievable within [ * ] days from notification, the Parties
shall discuss in good faith potential alternatives, including,
without limitation, termination of the relevant Program or the
Agreement, as may be mutually agreed between the Parties in good
faith, and, where appropriate, to discuss and consider in good
faith the renegotiation of their financial and other obligations
under the Agreement with respect to the affected
Program.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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4.2 License
Grants.
4.2.1 License to GSK . Subject to the terms and conditions of this
Agreement and upon GSK’s exercise of the relevant Option in
accordance with Section 4.1 and Dynavax’s receipt of the
applicable Option exercise fee, Dynavax and its Affiliates shall be
hereby deemed to have granted and hereby grant to GSK the exclusive
right and license (even as to Dynavax and its Affiliates, except
for the limited purpose of conducting Research and Development
activities with respect to Back-up Compounds or formulations as
expressly contemplated under Section 5.2) in the Territory,
with the right to grant sublicenses, under all of Dynavax’s
and its Affiliates’ right, title and interest in and to the
Exclusively Licensed IP to make, have made, use, sell, offer for
sale and import Compounds under such Dynavax Program as and into
GSK Products in the Field during the Term.
4.2.2 No Grant of Rights to Third Parties
. Until such time as the Option
Deadline Period, including any Option Deadline Extension Period (as
may be extended), for an Option granted to GSK pursuant to
Section 4.1 with respect to a given Dynavax Program has
expired or terminated (including, for example, because [ * ]
terminated a Dynavax Program), Dynavax and its Affiliates shall not
grant to any Third Party rights to any Exclusively Licensed IP that
are inconsistent with or that would interfere with the grant of the
licenses that may result from the exercise of such Option by GSK
hereunder. For the avoidance of doubt, the Parties understand and
agree that for so long as an Option is in effect, such Option shall
be exclusive as to the Compounds that are the subject of the
relevant Dynavax Program, and Dynavax and its Affiliates shall have
no right to offer or negotiate with any Third Party with respect to
the grant to such Third Party of any right or license, or with
respect to any settlement, consent judgment or other disposition of
any action or proceeding under Article 8, or with respect to any
other encumbrance of any kind, in or to any of such Compounds or
any Exclusively Licensed IP that would interfere with the grant of
the licenses resulting from the exercise of such Option to GSK
hereunder. The grant of the Options by Dynavax hereunder is
irrevocable except as provided under Article 12. GSK acknowledges
that certain of the Exclusively Licensed IP to the extent that it
pertains to compounds which are not Compounds or Products hereunder
is subject to the terms and conditions of the [ * ] and that
such grant of rights, so long as such grant is consistent with and
does not interfere with the grant of exclusive licenses in the
Field and in the Territory from the exercise of an affected Option
hereunder, shall not be deemed a breach of this
Agreement.
4.3 Technology Transfer after
Option Exercise. As soon
as reasonably practicable after GSK exercises its Option for a
Dynavax Program pursuant to Section 4.1 [ * ] , Dynavax
shall deliver to GSK, at no cost to GSK, all Information and
material in its possession and Control relating to the Compounds in
such GSK Development Program, including those documents and
materials set out in Exhibit G, and any other such Information as
may be in Dynavax’s Control and in the possession of any
subcontractors (including third party
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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manufacturers) appointed by Dynavax under
Section 2.13, in each case in a format to be agreed between
the Parties but which is in an electronically editable format
suitable for eCTD submission. Dynavax shall provide such technology
transfer services as may be reasonably necessary to [ * ] the
Compound manufacturing processes at GSK’s or GSK’s
Third Party manufacturer’s site; provided that GSK shall be
responsible for [ * ] to provide those services reasonably
necessary to [ * ] of the Compound manufacturing processes by GSK,
and [ * ] from Dynavax therefor. [ * ]. Dynavax shall use
Commercially Reasonable Efforts with respect to those activities
for which it is responsible to ensure orderly transition and
uninterrupted Development of the GSK Development
Program.
4.4 Third Party
Licenses.
4.4.1 During the Term, [ * ] (a) required
for the exploitation of Dynavax’s proprietary platform
technology or any other technology used by Dynavax in conducting a
Dynavax Program or Dynavax Development Program, (b) obtained
by Dynavax prior to the Effective Date, or (c) to the extent
related to the composition of matter or method of use of a Compound
as contemplated under a Dynavax Program.
4.4.2 With respect to any Third Party license
necessary for the manufacture, formulation or commercialization of
a GSK Product in a GSK Development Program (other than any license
described in Section 4.4.1), after GSK exercises the Option
with respect to such GSK Development Program, [ * ]
obligation to pay any amounts for Third Party licenses as set forth
above shall terminate immediately if GSK or Dynavax (in the case of
an uncured material breach by GSK) [ * ] .
ARTICLE 5
POST-EXERCISE
ACTIVITIES
5.1 GSK Development and
Commercialization.
5.1.1 Following exercise of an Option with respect to
a Dynavax Program, subject to Sections 5.2 and 5.5, GSK, either
itself and/or by and through its Affiliates, Sublicensees or
contractors, shall be responsible for all Research, Development,
regulatory, manufacturing, marketing, advertising, promotional,
launch and sales activities in connection with GSK Products
containing Compounds from such Program. Except as set forth in
Section [ * ] .
5.1.2 Subject to Section 5.5.1(c), GSK shall have
sole decision-making authority with respect to the Research,
Development, progression, regulatory activities, manufacturing and
commercialization of any Compound within a GSK Development Program,
without submitting such matter to the JSC or Senior Executive
Officers. In the event that the [ * ] for resolution. [ *
] determine a resolution. [ * ] in a timely manner,
which shall in no case be [ * ] .
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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5.1.3 GSK Diligence.
(a) Following GSK’s exercise of an Option with
respect to a Dynavax Program, GSK shall use its Commercially
Reasonable Efforts to Develop and commercialize [ * ] in
such GSK Development Program in [ * ] , subject to the
provisions of Section 2.8. [ * ] provided, however,
that the Parties acknowledge and agree that, for the purposes
solely of this Section 5.1.3(a), [ * ] , it is
appropriate for [ * ] . In the event that, as a result of
any such [ * ] Country, such right of Dynavax shall be
exercised in a manner [ * ] (collectively, the “
Coordination Conditions ”); provided that if the
Coordination Conditions apply, if such Product is commercialized by
Dynavax or any Affiliate or sublicensee thereof in such country
[ * ] , and GSK [ * ] , then Dynavax or any Affiliate
or licensee thereof shall, to the extent permitted under applicable
law, [ * ] , as the case may be, or shall [ * ] under
this Section 5.1.3 in [ * ] . For clarity, and without
limiting any other provision of this Agreement, any dispute
regarding the application or enforcement of this Section 5.1.3
shall be [ * ] .
(b) Notwithstanding the foregoing
Section 5.1.3(a) and for the avoidance of doubt, Dynavax
acknowledges and agrees that in the event it (or its Affiliates or
sublicensee) commercializes a Product [ * ] then, subject to
applicable law, Dynavax shall not, and shall ensure that its
Affiliates or any sublicensee shall not, [ * ] unless
mutually agreed in writing by the Parties, provided that [ *
] . With respect to [ * ] . If Dynavax (or its Affiliate
or licensee) becomes aware that [ * ] , Dynavax shall, or
shall cause its Affiliates and licensees to, to the extent
permitted under applicable law, [ * ] .
5.2 Dynavax Post-Exercise
Activities.
5.2.1 Back-up Compounds . If, upon exercise of the Option with respect
to a Dynavax Program, there are not [ * ] Back-up Compounds
in such Dynavax Program that [ * ] , then Dynavax shall
continue, until [ * ] after GSK exercises such Option, to
Develop [ * ] Back-up Compounds that [ * ] for such
Dynavax Program, at Dynavax’s sole cost and responsibility.
Such Back-up Compounds shall be subject to GSK’s Option and
included within the applicable GSK Development Program. For
clarity, efforts undertaken pursuant to this Section 5.2.1
following expiration of the Research Term shall not be deemed to
extend the Research Term, but shall be subject to Dynavax’s
obligation to use Commercially Reasonable Efforts.
5.2.2 [ * ]
Development
. If, after completion of a Proof of
Concept Study for a Phase I Ready Compound from a Dynavax Program
or GSK Development Program, Dynavax has not [ * ] for such
Compound for [ * ] in the applicable Development Plan, then
Dynavax shall continue to develop such [ * ] , at its sole
cost and expense, notwithstanding GSK’s exercise of the
Option for the Dynavax Program; provided , however, that an
[ * ] of a Compound that is [ * ] shall be considered
a [ * ] , provided that it meets GSK’s then current
requirements for [ * ] .
[ * ] = CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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