EXHIBIT 10.5
LICENSE AGREEMENT
BETWEEN
DYNAVAX TECHNOLOGIES CORPORATION
AND
TRIANGLE PHARMACEUTICALS, INC.
TABLE OF CONTENTS
***Certain confidential portions of this Exhibit were omitted by means of
blackout of the text (the "Xxxx"). This Exhibit has been filed separately with
the Secretary of the Commission without the Xxxx pursuant to the Company's
application Requesting Confidential Treatment under Rule 24b-2 under the 1934
Act.
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ARTICLE 1. DEFINITIONS............................................. 2
ARTICLE 2. LICENSES................................................ 13
ARTICLE 3. STOCK PURCHASE, ROYALTIES, AND
MILESTONE PAYMENTS...................................... 19
ARTICLE 4. REPORTS AND ACCOUNTING.................................. 26
ARTICLE 5. PAYMENTS................................................ 29
ARTICLE 6. RESEARCH PROGRAM........................................ 31
ARTICLE 7. DEVELOPMENT PROGRAM..................................... 34
ARTICLE 8. JOINT PROJECT COMMITTEE................................. 36
ARTICLE 9. SUPPLY AND MANUFACTURE.................................. 39
ARTICLE 10. PATENT PROSECUTION...................................... 44
ARTICLE 11. INFRINGEMENT............................................ 48
ARTICLE 12. TRANSFER OF KNOW-HOW; TECHNICAL ASSISTANCE.............. 52
ARTICLE 13. WARRANTIES AND REPRESENTATIONS; LIMITATION OF
LIABILITY; DISCLAIMERS; AND COVENANTS................... 55
ARTICLE 14. INDEMNIFICATION......................................... 60
ARTICLE 15. CONFIDENTIALITY......................................... 62
ARTICLE 16. CONDITIONS PRECEDENT.................................... 64
ARTICLE 17. TERM AND TERMINATION.................................... 65
ARTICLE 18. ASSIGNMENT.............................................. 69
TABLE OF CONTENTS (continued)
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ARTICLE 19. REGISTRATION OF LICENSE................................. 69
ARTICLE 20. NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE
COMPETITION AND PATENT TERM RESTORATION ACT............. 70
ARTICLE 21. DISPUTE RESOLUTION AND ARBITRATION...................... 71
ARTICLE 22. GENERAL PROVISIONS...................................... 75
THIS LICENSE AGREEMENT is made and entered into as of this 31st day of
March, 2000, by and between DYNAVAX TECHNOLOGIES CORPORATION, with its principal
offices located at 000 Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx, Xxxxxxxxxx 00000
(hereinafter referred to as "Dynavax") and TRIANGLE PHARMACEUTICALS, INC., with
its principal offices located at 0 Xxxxxxxxxx Xxxxx, 0000 Xxxxxxxxxx Xxxxx,
Xxxxxx, Xxxxx Xxxxxxxx 00000 (hereinafter referred to as "Triangle").
WITNESSETH:
WHEREAS, Dynavax has developed know-how and is obtaining or has obtained
patent rights relating to immunostimulatory oligonucleotides containing
immunostimulatory nucleic acid sequences ("ISS") which activate or stimulate an
immune response;
WHEREAS, ISS is covered by patents and patent applications filed in
various countries throughout the world;
WHEREAS, Dynavax has entered into an Exclusive License Agreement for
Administration of Naked Nucleotides which Express Biologically Active Peptides
and Immunostimulatory Oligonucleotide Conjugates, effective ***, as amended on
*** (the "Primary License Agreement") with The Regents of the University of
California (the "Primary Licensor"), pursuant to which Dynavax has obtained an
exclusive worldwide license under the Primary Licensor's patents and patent
applications relating to ISS and has acquired the right to grant licenses under
such patents and patent applications;
WHEREAS, Dynavax possesses certain technology, know-how and patent rights
relating to ISS and has the right to grant licenses in respect of such
technology, know-how and patent rights; and
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Confidential Treatment and filed separately with the Commission.
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WHEREAS, Triangle desires to obtain an exclusive license under such
technology, know-how and patent rights;
NOW, THEREFORE, in consideration of the premises and the covenants herein
contained, the parties agree as follows:
ARTICLE 1. DEFINITIONS
The following terms as used herein, when written with an initial capital
letter, shall have the meanings ascribed to them below:
1.1 "Acquisition Cost" shall mean the actual invoiced price paid by a
party to any non-Affiliate third party for acquiring any item (e.g., ISS,
Conjugated ISS or another active ingredient), including but not limited to,
shipping and handling costs and customs duties incurred and paid by such party
in connection with the acquisition of such item.
1.2 "Affiliate" shall mean any corporation or non-corporate business
entity which controls, is controlled by, or is under common control with a party
to this Agreement. A corporation or non-corporate business entity shall be
regarded as in control of another corporation if it owns, or directly or
indirectly controls, at least fifty (50%) percent of the voting stock of the
other corporation, or (a) in the absence of the ownership of at least fifty
(50%) percent of the voting stock of a corporation or (b) in the case of a
non-corporate business entity, or non-profit corporation, if (x) it possesses,
directly or indirectly, the power to direct or cause the direction of the
management and policies of such corporation or non-corporate business entity, as
applicable or (y) for financial accounting and reporting purposes, a party
consolidates the financial results of such corporation or non-corporate business
entity with the financial results of such party.
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1.3 "Agreement" or "License Agreement" shall mean this Agreement,
including all Exhibits attached to this Agreement.
1.4 "Antigen" shall mean any substance which, when injected or otherwise
introduced into a mammal (including humans), stimulates the production of an
antibody.
1.5 "BLA" shall mean a Biological License Application or its U.S. or
foreign equivalent.
1.6 "Conjugated ISS" shall mean any ISS which is *** corresponding to
either hepatitis B virus or hepatitis C virus which modulates the activity of
the ISS.
1.7 "Development Program" shall mean the development program described in
Article 7 of this Agreement.
1.8 "Disease Indication" shall mean: (a) the treatment of HBV; (b) the
prophylaxis of HBV; (c) the treatment of HCV; (d) the prophylaxis of HCV; or (e)
the treatment of HIV.
1.9 "Disease Target" shall mean: (a) HBV; (b) HCV; or (c) HIV.
1.10 "Dollars" shall mean United States dollars.
1.11 "Drug Master File" shall mean information comprised in a submission
to the Food and Drug Administration or comparable foreign regulatory agency
providing information on the manufacturing facilities and manufacturing
processes including but not limited to all activities relating to manufacturing
processing, formulating, packaging and storage, which information may be used to
support Registration of a Licensed Product.
1.12 "Dynavax Know-How" shall mean all inventions, discoveries, trade
secrets, information, experience, data, formulas, procedures and results which
are rightfully held by
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Dynavax as of the Effective Date (including, but not limited to, any of the
foregoing items licensed to Dynavax under the Primary License Agreement), or
which are not Joint Know-How or Joint Inventions and are developed or acquired
by Dynavax during the period beginning on the Effective Date and ending upon
termination or expiration of this Agreement pursuant to Article 17 including,
but not limited to, all manufacturing and synthesis know-how; provided that, for
purposes of this Section 1.12, Dynavax Know-How shall include only such
inventions, discoveries, trade secrets, information, experience, data, formulas,
procedures and results reasonably necessary to practice the rights and licenses
granted by Dynavax to Triangle under the Dynavax Patents pursuant to Section 2.1
of this Agreement. In addition, notwithstanding the foregoing, Dynavax Know-How
shall not be deemed to include any of the foregoing to the extent, and only for
as long as, Dynavax is prohibited from disclosing the same to third parties
pursuant to binding, noncancellable contractual nondisclosure obligations
applicable to Dynavax.
1.13 "Dynavax Patents" shall mean all patents and patent applications in
the Territory owned or controlled by Dynavax or under which Dynavax has a right
to practice with the right to extend such right to practice to Triangle
(including, but not limited to, all patents and patent applications licensed to
Dynavax under the Primary License Agreement) which contain claims the rights to
which are reasonably necessary for the development, registration, manufacturing,
using or selling of ISS, Conjugated ISS or the Licensed Products which are filed
as of the Effective Date or during the term of this Agreement provided, that
such claims cover inventions or discoveries reduced to practice, actually or
constructively, prior to the first anniversary of the expiration of the Research
Program, including any addition, continuation, continuation-in-part or division
thereof or any substitute application
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thereof; any patent issued with respect to such patent application, any reissue,
extension or patent term extension of any such patent, and any confirmation
patent or registration patent or patent of addition based on any such patent;
and any other United States and foreign patent or inventor's certificate with
regard thereto. Dynavax Patents shall include but not be limited to those listed
in Exhibit A attached hereto.
1.14 "Effective Date" shall mean the later of (a) the date first written
above and (b) the date, if any, that the condition set forth in Article 16 shall
have been satisfied or, if applicable, waived.
1.15 "Effective Date of IND" shall mean the date on which Triangle, its
Affiliates or sublicensees are authorized to commence clinical trials in a given
Major Market Country pursuant to an IND filed in such Major Market Country.
1.16 "FDA" shall mean the United States Food and Drug Administration or
any successor entity.
1.17 "Field" shall mean: (a) the prophylaxis and/or treatment of HBV; (b)
the prophylaxis and/or treatment of HCV; or (c) the treatment of HIV. "Fields"
shall mean (a), (b) and (c).
1.18 "Finished Drug Substance" shall mean ISS or Conjugated ISS in
formulated and finished form suitable for preclinical or clinical use.
1.19 "Forms of Administration" shall mean: (a) in respect of ISS,
injectable and oral forms; and (b) in respect of Conjugated ISS, injectable,
oral, topical and pulmonary inhalation forms of administration.
1.20 "Future Dynavax Patents" shall mean all patents and patent
applications in the Territory owned or controlled by Dynavax or under which
Dynavax has a right to practice
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with the right to extend such right to practice to Triangle which contain claims
covering inventions or discoveries reduced to practice, actually or
constructively, on or after the first anniversary of the expiration of the
Research Program the rights to which are reasonably necessary for the
development, registration, manufacturing, using or selling of ISS, Conjugated
ISS or the Licensed Products, including any addition, continuation,
continuation-in-part or division thereof or any substitute application thereof;
any patent issued with respect to such patent application, any reissue,
extension or patent term extension of any such patent, and any confirmation
patent or registration patent or patent of addition based on any such patent;
and any other United States and foreign patent or inventor's certificate with
regard thereto.
1.21 "HBV" shall mean hepatitis B virus.
1.22 "HCV" shall mean hepatitis C virus.
1.23 "HIV" shall mean human immunodeficiency virus, including Acquired
Immune Deficiency Syndrome.
1.24 "IND" shall mean an Investigational New Drug Application or its U.S.
or foreign equivalent.
1.25 "Indemnitees" shall mean (a) in the case of the indemnity set forth
in Section 14.1, Dynavax, its Affiliates, the Primary Licensor and the trustees,
directors, officers and employees of any of the foregoing; (b) in the case of
the indemnity set forth in Section 14.2, Triangle, its Affiliates and
sublicensees, and their directors, officers and employees; and (c) in the case
of the Indemnitees referenced in Section 14.3, the parties identified in
Subsections 1.25(a) and 1.25(b) above, as applicable.
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1.26 "ISS" shall mean any immunostimulatory oligonucleotide containing a
nucleic acid sequence which can activate or stimulate a Th1 immune response
alone or in combination with other immune responses in vitro or in vivo and
wherein the nucleosides in the nucleic acid sequence can be naturally occurring
or not naturally occurring and such nucleosides can be connected through any
form of naturally occurring or not naturally occurring linkage.
1.27 "Joint Inventions" shall mean any inventions related to ISS,
Conjugated ISS or the Licensed Products, whether patented or not, which are
jointly made during the period beginning on the Effective Date and ending ***
after termination or expiration of this Agreement pursuant to Article 17 by at
least one (1) Dynavax employee or person contractually required to assign or
license patent rights covering such inventions to Dynavax and at least one (1)
Triangle employee or person contractually required to assign or license patent
rights covering such inventions to Triangle.
1.28 "Joint Know-How" shall mean all inventions, discoveries, trade
secrets, information, data, formulas, procedures and results which are
reasonably necessary for the development, registration, manufacturing, using or
selling of the ISS, Conjugated ISS or the Licensed Products which are developed
jointly by at least one (1) Dynavax employee or person contractually required to
assign or license such data and know-how to Dynavax and at least one (1)
Triangle employee or person contractually required to assign or license such
data or know-how to Triangle, during the period beginning on the Effective Date
and ending *** after termination or expiration of this Agreement pursuant to
Article 17. All Joint Know-How shall be owned jointly by the parties hereto.
Triangle shall have the exclusive right to use such Joint Know-How in the
Territory in the Fields, unless the license granted pursuant to Section 2.1 is
terminated in a given country or countries of the Territory by Dynavax pursuant
to Section 7.3 or 17.2 or by Triangle pursuant to Section 17.3, in which case,
Dynavax shall have a non-exclusive right to
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use the Joint Know-How in such country or countries in the Fields. Dynavax and
Triangle shall each have a non-exclusive right to use the Joint Know-How outside
the Fields.
1.29 "Joint Project Committee" shall mean the committee described in
Article 8 hereof.
1.30 "Licensed Product(s)" shall mean any ISS or Conjugated ISS or any
pharmaceutical product containing one or more ISS or Conjugated ISS as an active
ingredient, alone or in combination with other active ingredients, for
administration in accordance with the Forms of Administration; provided,
however, that, subject to Section 2.7, in respect of HIV, Conjugated ISS shall
not be Licensed Products for purposes of this Agreement.
1.31 "Major Market Country" shall mean ***except that, in the case of
Subsection 3.2(a)(i), *** shall also be deemed to be a Major Market Country.
1.32 "Manufacturing Cost," in respect of a particular item (e.g., ISS,
Conjugated ISS or another active ingredient), shall mean the costs of direct
labor (including allocable employee benefits and employment taxes), direct
material, direct energy, direct utilities and other charges incurred directly by
a party in the manufacture by it of such item and, without duplication, normal
production overhead (i.e., indirect labor, utilities, maintenance, depreciation
of the manufacturing equipment and facilities and other allocable overhead of
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the manufacturing facility), all determined in accordance with U.S. GAAP.
1.33 "NDA" shall mean a New Drug Application or its U.S. or foreign
equivalent.
1.34 "Net Sales" of Licensed Products which contain as their active
ingredients only one or more ISS or Conjugated ISS shall mean the gross sales
price of such Licensed Products billed by Triangle, its Affiliates or
sublicensees to independent customers, less (a) normal and customary trade,
quantity and cash discounts, all rebates (including those paid to third party
payors), sales, use, or other similar taxes, and all transportation, insurance
and handling charges; and (b) all credits and allowances granted to such
independent customers on account of returns or retroactive price reductions in
lieu of returns, whether during the specific royalty period or prior to the
specific royalty period, all determined in accordance with U.S. GAAP. In the
event that Triangle or its Affiliates or sublicensees distribute any Licensed
Products to a third party for non-monetary consideration (e.g., barter or
exchange), such distribution shall be considered a sale for accounting and
royalty purposes. Net Sales for any such distributions shall be determined on a
country-by-country basis and shall be the average price of "arm's length" sales
by Triangle or its Affiliates or sublicensees in such country in the Territory
during the royalty period in which such sale occurs or, if no such "arm's
length" sales occurred in such country in the Territory during such royalty
period, during the last royalty period in which such "arm's length" sales
occurred. If no "arm's length" sales have occurred in a particular country in
the Territory, Net Sales for any such distributions in such country in the
Territory, shall be the average price of "arm's length" sales in all countries
in the Territory during such royalty period.
1.35 "Net Sales" of Licensed Products which contain as their active
ingredients both or one or more ISS or Conjugated ISS and other active
ingredients (a "Combination
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Product") shall mean the gross sales price of such Combination Product billed by
Triangle, its Affiliates or sublicensees to independent customers, less all the
allowances, adjustments, reductions, discounts, taxes, duties, rebates and other
items referred to in Section 1.34 multiplied by a fraction, the numerator of
which shall be the billing party's Acquisition Cost or Manufacturing Cost, as
applicable, for all ISS or Conjugated ISS included in such Licensed Product and
the denominator of which shall be the billing party's Acquisition Cost or
Manufacturing Cost, as applicable, for all active ingredients contained in such
Licensed Product (including all ISS or Conjugated ISS), all determined in
accordance with U.S. GAAP. In the event that Triangle or its Affiliates or
sublicensees distribute any Licensed Products to a third party for non-monetary
consideration (e.g., barter or exchange), such distribution shall be considered
a sale for accounting and royalty purposes. Net Sales for any such distributions
shall be determined on a country-by-country basis and shall be the average price
of "arm's length" sales by Triangle or its Affiliates or sublicensees in such
country in the Territory during the royalty period in which such sale occurs or,
if no such "arm's length" sales occurred in such country in the Territory during
such royalty period, during the last royalty period in which such "arm's length"
sales occurred. If no "arm's length" sales have occurred in a particular country
in the Territory, Net Sales for any such distributions in such country in the
Territory, shall be the average price of "arm's length" sales in all countries
in the Territory during such royalty period.
1.36 "Patent Filing Countries" shall mean the ***.
1.37 "Phase II Completion Date" shall mean sixty (60) days after the
completion of statistical analyses of the final results of those Phase II
clinical studies which Triangle
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considers reasonably necessary for purposes of inclusion in an NDA or BLA, as
applicable, for a Licensed Product. As used in the preceding sentence, "Phase II
clinical trials" shall mean those well-controlled clinical trials sponsored by
Triangle, the primary objective of which (as reasonably determined by Triangle)
is to ascertain additional data regarding the safety and tolerance of a Licensed
Product and preliminary data regarding such Licensed Product's antiviral
effects.
1.38 "Registration" shall mean, in relation to any Licensed Product, such
approvals by the regulatory authorities in a given country (including pricing
approvals, if any) as may be legally required before such Licensed Product may
be commercialized or sold in such country.
1.39 "Research Program" shall mean the research program described in
Article 6 of this Agreement.
1.40 "Stock Purchase Agreement" shall mean the Series T Preferred Stock
Purchase Agreement between Dynavax and Triangle, dated as of even date herewith.
1.41 "Territory" shall mean the entire world.
1.42 "Triangle Know-How" shall mean all inventions, discoveries, trade
secrets, information, experience, data, formulas, procedures and results arising
solely out of the Development Program or the manufacture, use or sale of the
Licensed Products which are rightfully held by Triangle as of the Effective
Date, or which are not Joint Know-How or Joint Inventions and are developed or
acquired by Triangle during the period beginning on the Effective Date and
ending upon termination or expiration of this Agreement pursuant to Article 17;
provided that, for purposes of this Section 1.42, Triangle Know-How shall
include only such inventions, discoveries, trade secrets, information,
experience, data,
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formulas, procedures and results reasonably necessary to practice the rights and
licenses granted by Triangle to Dynavax under the Triangle Patents pursuant to
Section 2.4 of this Agreement. In addition, notwithstanding the foregoing,
Triangle Know-How shall not be deemed to include any of the foregoing to the
extent, and only for as long as, Triangle is prohibited from disclosing the same
to third parties pursuant to binding, non-cancellable contractual nondisclosure
obligations applicable to Triangle.
1.43 "Triangle Patents" shall mean all patents and patent applications
owned or controlled by Triangle or under which Triangle has a right to practice
with the right to extend such right to practice to Dynavax which contain claims
the rights to which are reasonably necessary for the development, registration,
manufacturing, using or selling of ISS, Conjugated ISS or the Licensed Products,
including any addition, continuation, continuation-in-part or division thereof
or any substitute application thereof; any patent issued with respect to such
patent application, any reissue, extension or patent term extension of any such
patent, and any confirmation patent or registration patent or patent of addition
based on any such patent; and any other United States and foreign patent or
inventor's certificate with regard thereto.
1.44 "U.S. GAAP" shall mean generally accepted accounting principles in
the United States, consistently applied.
1.45 "Valid Claim" shall mean an issued claim of any issued and unexpired
patent included among the Dynavax Patents, which has not been held
unenforceable, unpatentable or invalid by a decision of a court or governmental
body of competent jurisdiction, which is unappealable or unappealed within the
time allowed for appeal, which has not been rendered unenforceable through
disclaimer or otherwise or which has not been lost through an
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interference or opposition proceeding.
ARTICLE 2. LICENSES
2.1 License Under Dynavax Patents and Dynavax Know-How. Except to the
extent expressly reserved or otherwise specified in Sections 2.5, 2.8 and 2.9
below, Dynavax hereby grants Triangle the exclusive right and license to
practice the Dynavax Patents and the Dynavax Know-How in the Territory: (a) to
use, offer for sale, sell and have sold Licensed Products within the Fields
during the pre-clinical and clinical development of such Licensed Products; and
(b) in preparation of, and upon commercialization of any Licensed Product, to
make, have made, import, offer for sale, sell and have sold such Licensed
Product within the Fields during the remaining term of this Agreement.
2.2 Extension to Affiliates. Triangle shall have the right to extend its
rights under the license granted in Section 2.1 to one or more of its
Affiliates, provided, that Triangle (a) gives Dynavax at least thirty (30) days'
prior written notice of such extension and (b) shall remain responsible for such
Affiliate's compliance with all obligations under this Agreement which apply to
such Affiliate.
2.3 Sublicenses. Prior to the Phase II Completion Date for the initial
Licensed Product, Triangle may grant sublicenses to non-Affiliate third parties
only with Dynavax' prior written consent, which consent shall not be
unreasonably withheld or delayed. Subsequent to the Phase II Completion Date for
the initial Licensed Product, Triangle may grant sublicenses to non-Affiliate
third parties without Dynavax' consent. The provisions of Section 3.9 shall
apply to certain sublicenses granted pursuant to this Section 2.3. No sublicense
granted by Triangle shall relieve it of any of its obligations hereunder. With
respect to any sublicense for which Dynavax' consent is not required pursuant to
this Section
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2.3, Triangle shall provide Dynavax with notice of its grant of a sublicense
within thirty (30) days after entering into the applicable sublicense agreement.
Upon written request, Triangle shall promptly provide Dynavax with a copy of any
executed sublicense agreement.
2.4 License Under Triangle Patents and Triangle Know-How. In the event
Triangle's license granted under Section 2.1 is terminated in a given country of
the Territory (other than by expiration or by Triangle pursuant to Section 17.2
of this Agreement), Triangle hereby grants Dynavax a non-exclusive right and
license to practice the Triangle Patents and Triangle Know-How to make, have
made, use, import, offer for sale, sell and have sold Licensed Products in the
Fields, with a right to sublicense in such country from and after the date of
termination only to the extent such license has been terminated. The license
granted pursuant to this Section 2.4 shall be subject to the payment of
royalties and other amounts by Dynavax to Triangle. Such royalties and other
amounts shall: (a) correspond to the royalties and other amounts set forth in
Sections 3.2 and 3.3 of this Agreement; (b) be paid in the same manner as
prescribed in Articles 4 and 5 hereof; and (c) be subject to the same
adjustments, extensions and other conditions prescribed in Articles 3, 7 and 11
of this Agreement, mutatis mutandis.
2.5 Rights Reserved by Dynavax. Dynavax hereby reserves the right and
license to make, have made, use and import Licensed Products in the Fields in
the Territory to the extent and only to the extent necessary to fulfill its
obligations under Articles 6 and 9 of this Agreement.
2.6 Covenant Not to Xxx. Each party granting a license agrees that during
the term of this Agreement, neither it nor any of its Affiliates, sublicensees,
as applicable, will assert against the other party (a "licensed party") or its
Affiliates or sublicensees any Future
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Dynavax Patents or Triangle Patents, as applicable, that is or might be
infringed by reason of such licensed party's or its Affiliates' or sublicensees'
exercise of the license granted to it hereunder.
2.7 Rights of First Discussion.
(a) If, at any time during the term hereof, Dynavax re-acquires
rights in respect of Conjugated ISS for the prophylaxis or treatment of HIV (a
"Non-Field Use") it shall give prompt notice thereof to Triangle. Such notice
shall include a description of the rights which Dynavax has reacquired, together
with all data and information in Dynavax' possession relating to the Non-Field
Use. Thereafter, Triangle shall have sixty (60) days to notify Dynavax whether
Triangle is interested in commencing negotiations to obtain a license to such
rights (the "Non-Field License"). If Triangle does not give such notice within
such sixty (60) day period, Dynavax shall be entitled to commence negotiations
with a third party in respect of the Non-Field License and Triangle shall have
no further right in respect of the Non-Field Use. If Triangle gives such notice
within such sixty (60) days, the parties shall commence good faith negotiations
in an effort to reach agreement on the terms of the Non-Field License. If such
negotiations do not result in the execution of the Non-Field License, Dynavax
agrees that, for a period of twenty-four (24) months after cessation of such
negotiations, it will not offer the Non-Field License to a third party
containing financial terms more favorable than those last offered to Triangle
during such negotiations without first offering the Non-Field License to
Triangle on the same terms. In such event, Triangle shall have sixty (60) days
to accept the Non-Field License containing such more favorable financial terms
and if it fails to do so, it shall have no further rights to such Non-Field Use.
(b) If, at any time during the term hereof, Dynavax elects to grant
a
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license with respect to any ISS or any pharmaceutical product containing one or
more ISS as an active ingredient, alone or in combination with other active
ingredients, administered by any means other than the Forms of Administration
for use in the Fields, it shall give prompt notice thereof to Triangle.
Thereafter, Triangle shall have sixty (60) days to notify Dynavax whether
Triangle is interested in commencing negotiations to obtain such a license. If
Triangle does not give such notice within such sixty (60) day period, Dynavax
shall be entitled to commence negotiations with a third party in respect of such
a license and Triangle shall have no other rights in respect of a license to
administration by such means. If Triangle gives such notice within such sixty
(60) days, the parties shall commence good faith negotiations in an effort to
reach agreement on the terms of such a license. If such negotiations do not
result in the execution of a license with respect to the administration of ISS
or pharmaceutical products containing ISS by means other than the Forms of
Administration for use in the Fields, Dynavax agrees that, for a period of
twenty-four (24) months after cessation of such negotiations, it will not offer
a license substantial similar to the license offered to Triangle at the end of
such negotiations to a third party containing financial terms more favorable
than those last offered to Triangle during such negotiations without first
offering such license to Triangle on the same terms. In such event, Triangle
shall have sixty (60) days to accept the license containing such more favorable
financial terms and, if it fails to do so, it shall have no further rights to
the subject matter of such license.
(c) If, at any time during the term hereof, Dynavax elects to grant
a license with respect to any Future Dynavax Patents in the Fields, it shall
give prompt notice thereof to Triangle. Thereafter, Triangle shall have sixty
(60) days to notify Dynavax
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whether Triangle is interested in commencing negotiations to obtain such a
license. If Triangle does not give such notice within such sixty (60) day
period, Dynavax shall be entitled to commence negotiations with a third party in
respect of such a license and Triangle shall have no other rights in respect of
a license to Future Dynavax Patents in the Fields. If Triangle gives such notice
within such sixty (60) days, the parties shall commence good faith negotiations
in an effort to reach agreement on the terms of such a license. If such
negotiations do not result in the execution of a license with respect to the
Future Dynavax Patents in the Fields, Dynavax agrees that, for a period of
twenty-four (24) months after cessation of such negotiations, it will not offer
a license substantial similar to the license offered to Triangle at the end of
such negotiations to a third party containing financial terms more favorable
than those last offered to Triangle during such negotiations without first
offering such license to Triangle on the same terms. In such event, Triangle
shall have sixty (60) days to accept the license containing such more favorable
financial terms and, if it fails to do so, it shall have no further rights to
the subject matter of such license.
2.8 Retained License by Primary Licensor. Triangle acknowledges that,
pursuant to Paragraph 2.4 of the Primary License Agreement, the Primary Licensor
has retained on its behalf a royalty-free right and license to use the Invention
(as defined in the Primary License Agreement) and associated technology for its
own non-commercial, educational and research purposes.
2.9 United States Government Rights. Triangle acknowledges that the
portion of the Dynavax Patents and Dynavax Know-How licensed to Dynavax under
the Primary License Agreement were developed with financial or other assistance
through grants or contracts funded by the United States government. Triangle
acknowledges that its license
17
rights to such portion of the Dynavax Patents and Dynavax Know-How are subject
to the rights of the U.S. Government pursuant to 35 U.S.C. xx.xx. 200-212 and
applicable regulations promulgated thereunder.
2.10 No Implied License. The license and rights granted in this Agreement:
(a) to Triangle shall not be construed to confer any rights upon Triangle by
implication, estoppel or otherwise as to any technology, know-how or any other
intellectual property not specifically identified as Dynavax Patents or Dynavax
Know-How; and (b) to Dynavax shall not be construed to confer any rights upon
Dynavax by implication, estoppel or otherwise as to any technology, know-how or
any other intellectual property not specifically identified as Triangle Patents
or Triangle Know-How.
2.11 Uses Outside of Fields. Triangle shall use its reasonable efforts to
avoid the promotion and sale of Licensed Products by it, its sublicensors,
Affiliates and distributors for indications outside the Fields. In addition,
Triangle acknowledges and agrees that Licensed Products are for administration
only by the Forms of Administration and that Triangle will use reasonable
efforts to avoid development, promotion and sale of any ISS, Conjugated ISS or
any pharmaceutical product containing one or more ISS or Conjugated ISS as an
active ingredient, alone or in combination with other active ingredients, by it,
its sublicensees, Affiliates and distributors for administration by any means
other than the Forms of Administration for use in the Fields. Dynavax shall use
its reasonable efforts to avoid, and to cause any of its other licensees of ISS,
Conjugated ISS or any pharmaceutical product containing one or more ISS or
Conjugated ISS as an active ingredient, alone or in combination with other
active ingredients outside the Fields to avoid the development, promotion and
sales of any ISS or Conjugated ISS (or any products containing either of the
18
foregoing) for indications in the Fields.
2.12 Disease Target Specific Forms of Administration. Triangle shall use
reasonable efforts to develop Forms of Administration of the Licensed Products
which can reasonably be administered only for the Disease Targets. Dynavax shall
use reasonable efforts, and shall cause its other licensees of ISS, Conjugated
ISS or any pharmaceutical product containing one or more ISS or Conjugated ISS
as an active ingredient, alone or in combination with other active ingredients,
to develop Forms of Administration which can reasonably be administered only for
diseases other than the Disease Targets.
ARTICLE 3. STOCK PURCHASE, ROYALTIES,
AND MILESTONE PAYMENTS
3.1 Stock Purchase. Triangle is contemporaneously entering into the Stock
Purchase Agreements with Dynavax, pursuant to which it will purchase 400,000
shares of Dynavax Series T Preferred Shares for the total price of $2,000,000.
3.2 Milestone Payments.
(a) Triangle shall pay Dynavax a milestone payment ("Milestone
Payment") in the amount specified below no later than *** days after the
occurrence of the corresponding event designated below, unless Triangle has
given Dynavax notice of termination of this Agreement in the entire Territory
for the given Licensed Product prior to such due date.
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Aggregate
Milestone Payment/ Milestone
Event Disease Indication Payments
---------------------------------------------------------------------
(i) ***
(ii) ***
(iii) ***
Total Milestone Payments *** ***
(b) With respect to any Milestone Payment payable pursuant to
Subsection 3.2(a)(iii) above based on Registration in a Major Market Country
which requires pricing approval, *** percent (***%) of such Milestone Payment
will be payable upon receipt of ***, as applicable, and *** percent (***%) of
such Milestone Payment will be payable upon receipt of ***.
3.3 Earned Royalties; Duration and Reduction.
(a) Triangle shall pay Dynavax a royalty equal to *** percent (***%)
of the Net Sales of Licensed Products sold in the Territory by Triangle and its
Affiliates and sublicensees for the periods and subject to the reductions set
forth in this Agreement.
(b) Royalties shall be paid in respect of a given Licensed Product
in a given country for a period of *** years after the initial commercial
introduction of such Licensed Product in such country and, thereafter, only so
long as the manufacture, use, offer for sale, sale or importation of such
Licensed Product in such country would, in the absence of this license, infringe
a Valid Claim.
(c) If at any time during the period set forth in Subsection 3.3(b)
above, (i)
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20
a third party or third parties commence selling a product in a country of the
Territory in which no Valid Claims exist and (ii) such product contains any ISS
or Conjugated ISS ("unlicensed unit sales") and (iii) such unlicensed unit sales
for any royalty period exceed the percentage threshold of Triangle's unit sales
of such Licensed Product in such country during such royalty period as set forth
below, determined in accordance with Subsection 3.3(d) below, then Triangle's
royalty obligation in such country with respect to such Licensed Product shall
be reduced by the applicable percentage of the royalty otherwise payable, as set
forth below, commencing with the royalty period next succeeding the royalty
period in which such percentage threshold was initially exceeded and shall be
restored with the royalty period next succeeding the first royalty period in
which neither percentage threshold is exceeded.
Percent Royalty Reduction (Aggregate)
Unlicensed Unit Sales as a If Unlicensed Unit Sale
Percent of Triangle Unit Sales Percentage Threshold is Exceeded
-------------------------------------------------------------------------
***% ***%
***% ***%
By way of example only, if, during a given royalty period ("Royalty Period 1"),
unlicensed unit sales in a given country were *** percent (***%) of Triangle's
unit sales of a given Licensed Product in such country and Triangle were paying
royalties on such Licensed Product at a rate of ***percent (***%), then in the
next succeeding royalty period ("Royalty Period 2"), Triangle's royalty rate
with respect to Net Sales of such Licensed Product in such country would be
reduced by *** percent (***%) to *** percent (***%). If in Royalty Period 2,
such unlicensed unit sales were *** percent (***%) of Triangle's unit sales of
such Licensed Product in such country during Royalty Period 2, then in the next
succeeding royalty period
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("Royalty Period 3"), Triangle's royalty rate on Net Sales of Licensed Products
in such country would be only subject to a *** percent (***%) reduction and
Triangle would pay royalties at a rate of *** percent (***%) during Royalty
Period 3.
(d) For purposes of this Section 3.3, (i) "unlicensed unit sales"
and "Triangle unit sales" shall be deemed to mean the *** selected by Triangle
or its Affiliates or sublicensees and reasonably acceptable to Dynavax. The ***
of the third party product and the Licensed Product shall be appropriately
adjusted to account for any differences in potency based on the approved
labeling of such third party product and the Licensed Product. If Triangle is
entitled to a royalty reduction based on unlicensed unit sales pursuant to
Subsection 3.3(c) for any royalty period, it or its Affiliates or sublicensees
shall submit the ***, as applicable, for the relevant royalty period to Dynavax,
together with Triangle's or its Affiliates' or sublicensees' sales report for
the relevant royalty period. Such sales reports for each royalty period in which
Triangle is entitled to such royalty reduction shall be submitted with the
royalty report for such royalty period submitted pursuant to Section 4.1.
3.4 Annual Minimum Royalties. In the event that, during the third full
calendar year following the year during which the U.S. Registration for the HIV
Disease Indication or for any HCV Disease Indication is granted for a Licensed
Product or any calendar year thereafter for as long as royalty obligations exist
in the U.S. for such Licensed Product, Triangle's total annual royalty payments
to Dynavax pursuant to Section 3.3 above are less than the annual minimum amount
set forth opposite such year below (the "Annual Minimum"), Triangle shall make a
payment to Dynavax together with the royalty report for the fourth quarter of
such year required in Section 4.1 of this Agreement equal to the
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difference between such Annual Minimum and the royalties paid to Dynavax for
such year pursuant to Section 3.3 above:
Calendar Year Annual Minimum
------------- --------------
***
3.5 Accrual of Royalties. No royalty shall be payable on a Licensed
Product made, sold, or used for tests or development purposes, or distributed as
samples. No royalties shall be payable on sales among Triangle, its Affiliates
and sublicensees, but royalties shall be payable on subsequent sales by
Triangle, its Affiliates or sublicensees to a third party. Notwithstanding the
immediately preceding sentence, royalties shall be payable on sales among
Triangle, its Affiliates and sublicensees where the purchasing party does not
resell the Licensed Product and uses the Licensed Product for tests or
developmental purposes or distributes them as samples. No multiple royalty shall
be payable because the manufacture, use, offer for sale, sale or import of a
Licensed Product is covered by more than one Valid Claim or by at least one
Valid Claim and the Dynavax Know-How.
3.6 Third Party Royalties. If Triangle, its Affiliates or sublicensees
determine, after consultation with Dynavax, but at Triangle's sole discretion,
that it or they may be required to pay royalties and other amounts
(collectively, the "Third Party Royalties") to any third party because the
manufacture, use, offer for sale, sale or importation of a Licensed Product
infringes or may infringe any patent or patent which may issue from a patent
application of such third party in one or more countries (a "Third Party
License"), Triangle, its Affiliates or sublicensees may deduct the Third Party
Royalties it or they pay to such third party from royalties thereafter payable
to Dynavax. If such license relates to ISS per se,
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Conjugated ISS per se or the use of ISS or Conjugated ISS, Triangle may credit
*** percent (***%) of any Third Party Royalties up to *** percent (***%) of Net
Sales of Licensed Products and *** percent (***%) of the amount of any Third
Party Royalties in excess of *** percent (***%) of Net Sales of Licensed
Products. For all other Third Party Licenses, Triangle may credit *** percent
(***%) of all Third Party Royalties against royalties thereafter payable to
Dynavax. In no event shall the royalties due on Net Sales of Licensed Products
in any royalty period be thereby reduced on account of any reduction pursuant to
this Section 3.6 by more than *** percent (***%) of the amount which would have
been otherwise payable. In the event Triangle enters into a Third Party License
pursuant to this Section 3.6, Dynavax will use its best efforts to settle or
otherwise resolve any inter partes patent proceeding which may be pending
between Dynavax and the relevant third party relating to such Third Party
License without any claim to any Third Party Royalties and will not, thereafter
commence or take any action which might provoke the commencement of any inter
partes proceeding in respect of any patent rights licensed under such Third
Party License.
3.7 Compulsory Licenses. Should a compulsory license be granted to any
third party in any country of the Territory to make, have made, use, import,
offer for sale or sell Licensed Products, the royalty rate payable hereunder for
sales of the Licensed Products by Triangle in such country shall be adjusted to
match any lower royalty rate granted to the third party for such country.
3.8 Reduction in Royalty Due to Invalid Claims. In the event that
applicable claims of all patents or patent applications included within the
Dynavax Patents under which Triangle is selling or actively developing a
Licensed Product shall be held invalid or not
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24
infringed by the Licensed Products Triangle is selling or actively developing by
a court of competent jurisdiction in a given country of the Territory, whether
or not there is a conflicting decision by another court of competent
jurisdiction in such country, Triangle may reduce all royalty payments on its,
its Affiliates' or its sublicensees' sales of such Licensed Product covered by
such claims by *** percent (***%) until such judgment is finally reversed by an
unappealed or unappealable decision of a court of competent jurisdiction of
higher dignity in such country or is otherwise unappealable or is unappealed
within the time allowed therefor. If such judgment is finally reversed by an
unappealable decree of a court of competent jurisdiction of higher dignity in
such country, or is deemed reversed as provided herein, the former royalty rates
shall be restored and the royalty payments not theretofore made and interest
earned thereon shall become due and payable to Dynavax. If such judgment is not
reversed, deemed reversed, is unappealed or becomes unappealable, as aforesaid,
Triangle shall be entitled to all of the royalty reductions pursuant to this
Section 3.8.
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3.9 Sublicense Sharing Provision. With respect to any sublicense which may
be granted by Triangle to a non-Affiliate third party within ***, Triangle shall
pay Dynavax *** and (ii) all expenses incurred by Triangle in connection with
the development of the Licensed Products. No amounts received by Triangle as
reimbursement or prepayment for development expenses actually incurred shall be
subject to this Section 3.9. This Section 3.9 shall apply only to sublicenses
granted by Triangle on or before the first anniversary of the Effective Date.
3.10 Royalty Rate Floor. Any provision of this Agreement to the contrary
notwithstanding, the royalty rate on Net Sales of Licensed Products as set forth
in Subsection 3.3(a) shall not be reduced to less than *** percent (***%) as a
result of the applicability of the royalty rate reduction provisions set forth
herein.
ARTICLE 4. REPORTS AND ACCOUNTING
4.1 Royalty Reports and Records.
(a) During the term of this Agreement commencing with the commercial
introduction of the first Licensed Product, Triangle shall furnish, or cause to
be furnished to Dynavax, written reports governing each of Triangle's fiscal
quarters showing:
(i) the gross sales of all Licensed Products on a Licensed Product
by Licensed Product basis sold by Triangle, its Affiliates and sublicensees
during the reporting period, together with the calculations of Net Sales in
accordance with Sections 1.34 and 1.35; and
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(ii) the royalties payable in Dollars, which shall have accrued
hereunder in respect of such Net Sales; and
(iii) the exchange rates used, if any, in determining the amount of
Dollars; and
(iv) any withholding taxes (other than income taxes) required to be
made from such royalties.
(b) With respect to sales of the Licensed Product invoiced in
Dollars, the gross sales, Net Sales, and royalties payable shall be expressed in
Dollars. With respect to sales of the Licensed Product invoiced in a currency
other than Dollars, the gross sales, Net Sales, and royalties payable shall be
expressed in the domestic currency of the party making the sale together with
the Dollar equivalent of the royalty payable, calculated using the simple
average of the exchange rates published in the Wall Street Journal on the last
day of each month during the reporting period. If any Triangle Affiliate or
sublicensee makes any sales invoiced in a currency other than its domestic
currency, the gross sales and Net Sales shall be converted to its domestic
currency in accordance with the Affiliate's or sublicensee's normal accounting
practices. If the event a Triangle Affiliate or sublicensee uses its normal
accounting practices, a complete description of such normal accounting practices
shall be provided to Dynavax together with the royalty report furnished pursuant
to Article 4. Triangle or its Affiliate or sublicensee making any royalty
payment shall furnish to Dynavax appropriate evidence of payment of any tax or
other amount deducted from any royalty payment.
(c) Reports shall be made on a quarterly basis. Quarterly reports
shall be due within sixty (60) days of the close of every Triangle fiscal
quarter and shall be prepared
27
in accordance with U.S. GAAP. Triangle shall keep accurate records in sufficient
detail to enable royalties and other payments payable hereunder to be
determined. Triangle shall be responsible for all royalties and late payments
that are due to Dynavax that have not been paid by Triangle's Affiliates and
sublicensees. Triangle's Affiliates and sublicensees shall have, and shall be
notified by Triangle that they have, the option of making any royalty payment
directly to Dynavax.
4.2 Right to Audit. Dynavax shall have the right, upon prior notice to
Triangle, not more than once in each Triangle fiscal year nor more than once in
respect of any fiscal year, through an independent certified public accountant
selected by Dynavax and acceptable to Triangle, which acceptance shall not be
unreasonably refused, to have access during normal business hours to those
records of Triangle, its Affiliates and sublicensees as may be reasonably
necessary to verify the accuracy of the royalty reports required to be furnished
by Triangle pursuant to Section 4.1 of the Agreement. Such accountant may report
only the accuracy or inaccuracy of the royalty reports furnished by Triangle
and, in the event they are determined to be inaccurate, the corrections in the
amounts which need to be made to such reports. Triangle shall include in any
sublicenses granted pursuant to this Agreement a provision requiring the
sublicensee to keep and maintain records of sales made pursuant to such
sublicense in accordance with U.S. GAAP and to grant access to such records by
Dynavax' independent certified public accountant, as applicable, under the same
terms that Dynavax has access to Triangle's records. If such independent
certified public accountant's report shows any underpayment of royalties by
Triangle its Affiliates or sublicensees, within thirty (30) days after
Triangle's receipt of such report, Triangle shall remit or shall cause its
sublicensees to remit to Dynavax:
28
(a) the amount of such underpayment; and
(b) if such underpayment exceeds *** (***%) percent of the total
royalties owed for the fiscal year then being reviewed, the reasonably necessary
fees and expenses of such independent certified public accountant performing the
audit. Otherwise, Dynavax' accountant's fees and expenses shall be borne by
Dynavax. Any overpayment of royalties shall be fully creditable against future
royalties payable in any subsequent royalty periods or if this Agreement
terminates or expires before such overpayment in fully credited, Dynavax agrees
to refund the uncredited portion of such overpayment within thirty (30) days
after receipt of the final royalty payment hereunder. Upon the expiration of ***
(***) months following the end of any fiscal year, the calculation of royalties
payable with respect to such fiscal year shall be binding and conclusive on
Dynavax and Triangle, unless an audit for such fiscal year is initiated before
expiration of such *** months. Triangle shall retain, and shall cause its
Affiliates and sublicensees to retain, those records required to be maintained
pursuant to this Section 4.2 in respect of each fiscal year for a period of ***
months after the end of such fiscal year.
4.3 Confidentiality of Records. All information subject to review under
this Article 4 shall be confidential. Except where otherwise required by law,
Dynavax and its accountant shall retain all such information in confidence.
ARTICLE 5. PAYMENTS
5.1 Payments and Due Dates.
(a) Except as otherwise provided herein, royalties and other amounts
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payable to Dynavax as a result of activities occurring during the period covered
by each royalty report provided for under Article 4 of this Agreement shall be
due and payable on the date such royalty report is due. Payments of royalties
and other amounts in whole or in part may be made in advance of such due date.
(b) All payments to Dynavax shall be made by wire transfer to an
account of Dynavax designated by Dynavax from time to time; provided, however,
that in the event that Dynavax fails to designate such account, Triangle or its
Affiliates and sublicensees may remit payment to Dynavax to the address
applicable for the receipt of notices hereunder; provided, further, that any
notice by Dynavax of such account or change in such account, shall not be
effective until *** (***) days after receipt thereof by Triangle.
5.2 Currency Restrictions. Except as hereinafter provided in this Section
5.2, all royalties and other amounts shall be paid in Dollars. If, at any time,
legal restrictions prevent the prompt remittance of part of or all royalties
with respect to any country in the Territory where Licensed Products are sold,
Triangle or its sublicensee shall have the right and option to make such
payments by depositing the amount thereof in local currency to Dynavax' accounts
in a bank or depository in such country.
5.3 Overdue Payments. In the event any payment due hereunder is not made
when due, the payment shall accrue interest (beginning on the date such payment
is due) calculated at the rate of *** percent (***%) per month and such payment
when made shall be accompanied by all interest so accrued. The remittance of
such interest shall not foreclose Dynavax from exercising any other rights it
may have pursuant to this Agreement because such payment is late.
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ARTICLE 6. RESEARCH PROGRAM
6.1 Research Obligations; Funding.
(a) In addition to the payments set forth in Article 3 hereof,
Triangle also agrees to sponsor certain research work to be performed by Dynavax
to assist in the development of the Licensed Products, pursuant to the
provisions set forth in this Article 6 (the "Research Program"). Dynavax agrees
to have the Research Program conducted under the supervision of qualified,
full-time employees.
(b) The general area of focus of the Research Program is further
described in Exhibit B, attached hereto and made a part hereof. The specific
areas of focus or work to be conducted by Dynavax under the Research Program
will be determined by Dynavax and Triangle within thirty (30) days after the
Effective Date; provided, however, that in the event the parties fail to agree
on the specific areas of focus or work to be conducted by Dynavax under the
Research Program, the commencement of Triangle's funding obligations pursuant to
Subsection 6.1(e) shall be deferred until such agreement is reached. Dynavax
agrees that all work under the Research Program will be conducted on its
premises or at such other locations, if any, approved in writing by Triangle,
which approval will not be unreasonably withheld or delayed.
(c) Dynavax agrees to provide Triangle with a written quarterly
report within thirty (30) days after the end of each quarter summarizing in
reasonable detail the results of the Research Program for the immediately
preceding quarter.
(d) Unless this Agreement or Triangle's funding obligation is sooner
terminated pursuant to the terms hereof, (i) the initial term of the Research
Program shall
31
commence on the Effective Date and shall continue for a period of *** (***)
months (the "Initial Term"); and (ii) thereafter, if the Research Program is
extended pursuant to Section 6.3, the extended term shall continue for a period
of *** (***) months after the expiration of the initial term (the "Extended
Term").
(e) In full consideration of Dynavax' timely performance of its
obligations under the Research Program, Triangle agrees to pay Dynavax $*** for
each quarter during the Initial Term of the Research Program and $*** during
each quarter of the Extended Term of the Research Program. The initial quarterly
installment shall be payable within ten (10) days after the parties agree on the
specific areas of focus or work to be performed by Dynavax during the initial
term pursuant to Subsection 6.1(b) and each successive installment shall be
payable within *** (***) days after commencement of the second and each
succeeding *** (***) month period during the term of the Research Program.
Dynavax agrees that it will not use funds received from third parties directly
to support any work performed under the Research Program or enter into any other
contractual or funding arrangement with a third party pursuant to which such
third party would acquire any rights in the Results (as hereinafter defined) or
the Research Inventions (as hereinafter defined). Dynavax agrees to use the
amounts paid by Triangle under the Subsection 6.1(e) in a manner reasonably
calculated to accomplish the objectives of the Research Program.
6.2 Results; Research Program Inventions.
(a) All materials, information and data generated by Dynavax in the
performance of work under the Research Program (collectively the "Research
Program Results") shall be the property of Dynavax, except to the extent they
represent Joint
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Inventions. All Results which are reduced to writing shall be recorded in bound
(as opposed to loose-leaf) laboratory notebooks in such a manner so as to be
identifiable as Results. All entries in laboratory notebooks shall be made and
signed daily in indelible ink and corroborated at least weekly by a witness who
would not be considered an inventor or co-inventor. Copies of such notebooks
shall be available for inspection by Triangle or an authorized agent designated
by Triangle and copies of all or a portion of such notebooks shall be provided
to Triangle by Dynavax promptly upon request.
(b) Dynavax agrees promptly to disclose to Triangle any inventions
conceived solely or jointly by Dynavax employees during the Research Program
("Research Inventions"). All intellectual property covering Research Inventions
shall be Dynavax Patents or Dynavax Know-How and shall be included in the
license granted to Dynavax to Triangle pursuant to Section 2.1. Dynavax
represents that each employee (and any consultants or agents of Dynavax) who
participate in the performance of work on the Research Program will be required
to enter into a contract which provides for the assignment of Dynavax of all
inventions and discoveries made by such person during the course of his or her
work performed under the Research Program.
6.3 Extension of Research Program. Upon the effective date of the initial
IND for a Licensed Product, the Research Program will be automatically extended
for a period of *** months (irrespective of whether the Initial Term of the
Research Program expires prior to such effective date). The parties shall
attempt to reach an agreement on the specific areas of focus or work to be
performed by Dynavax under the Extended Term within thirty (30) days after the
commencement thereof; provided, however, that the commencement of Triangle's
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funding obligation for the Extended Term shall be deferred until such agreement
is reached.
6.4 Inspection. In addition to Triangle's inspection rights set forth in
Subsection 6.2(a), authorized representatives of Triangle shall have the right
to inspect progress of the Research Program on Dynavax' premises at any time
during normal business hours upon reasonable notice during the term of this
Agreement. Dynavax shall promptly notify Triangle of any findings that occur at
any time during the Research Program which Dynavax considers significant.
ARTICLE 7. DEVELOPMENT PROGRAM
7.1 Development Program. Subject to Dynavax' timely performance of its
obligations hereunder, including those set forth in Articles 6 and 9, and in
complete fulfillment of Triangle's diligence obligations hereunder, as
sublicensee under the Primary License Agreement and any such obligations implied
by law, Triangle will undertake, or, if applicable, will cause its Affiliates
and sublicensees to undertake, the development activities described in this
Article 7. Triangle shall, at its expense, use its best efforts (a) to conduct a
development program (the "Development Program") relating to the use of at least
one Licensed Product for each Disease Target and (b) if the results of the
Development Program so justify, to seek Registration for such Licensed Product
in the United States. For purposes of this Article 7, "best efforts" shall mean
that Triangle shall use reasonable efforts consistent with those used by it in
its development projects for other compounds in its development portfolio deemed
by it to have comparable commercial potential.
7.2 Fulfillment.
(a) Triangle's best efforts obligations set forth in this Article 7
shall be deemed to have been satisfied if Triangle:
34
(i) files what it reasonably believes to be a complete NDA or BLA,
as applicable, for at least one Licensed Product in a Major Market Country
within *** (***) months after the Effective Date;
(ii) commences clinical trials for at least one Licensed Product for
the second and third Disease Targets within *** (***) months after the effective
date of the initial IND for the first Disease Target; and
(iii) files what it reasonably believes to be a complete NDA or BLA
in a Major Market Country for a Licensed Product for the second and third
Disease Targets within *** (***) months after the commencement of clinical
trials for such Licensed Product. The time periods set forth in clauses (i),
(ii) and (iii) above shall each be subject to up to four (4) extensions of ***
(***) months each, at Triangle's election, by payment to Dynavax of $*** for
each of the first two (2) extensions of a given time period and $*** for each of
the second two (2) extensions for a given time period.
(b) Triangle agrees to use its best efforts to give Dynavax at least
ten (10) days' notice prior to the exercise of any extension pursuant to
Subsection 7.2 (a). Extension payments under Subsection 7.2(a) shall be made
within the first ten (10) days of each such extension period. Notwithstanding
any provision of Subsection 7.2(a) to the contrary, the time periods set forth
in Subsection 7.2(a) shall be adjusted appropriately (i) to account for any
material delay by Dynavax in the initial transfer of Dynavax Know-How beyond the
period specified in Section 12.1 and (ii) in the event the FDA or corresponding
regulatory agency in any other Major Market Country places a clinical hold on
one or more clinical
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studies relating to the applicable Licensed Product.
7.3 Dynavax Remedies.
(a) In the event Triangle fails to meet any diligence requirements
set forth in Subsection 7.2(a) with respect to a given Disease Target, and does
not demonstrate to Dynavax' reasonable satisfaction that, despite Triangle's
best efforts, the failure to meet the diligence requirement was delayed due to
reasons beyond Triangle's reasonable control, Dynavax shall have the option, as
its sole and exclusive remedy, to terminate the Agreement in the entire
Territory with respect only to that Disease Target (for either or both Disease
Indications). The remedy set forth in this Section 7.3 shall be Dynavax' sole
and exclusive remedy.
(b) Prior to exercising any rights under this Section 7.3, Dynavax
shall give Triangle *** (***) days' notice and shall meet with Triangle, at
Triangle's request, during such *** (***) day period, to discuss any
disagreements about whether Triangle has complied with the applicable diligence
requirements of this Article 7. Upon expiration of such *** (***) day period,
Dynavax shall have the right in its sole discretion to proceed with the exercise
of all rights and remedies provided for herein unless the applicable diligence
requirement is fulfilled during such *** (***) day period.
ARTICLE 8. JOINT PROJECT COMMITTEE
8.1 Appointment of Coordinators. As soon as practicable after the
Effective Date, Dynavax and Triangle shall each appoint an authorized
representative (a "Coordinator"). Each such party shall provide notice to the
other as to the identity of the individual so
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36
appointed. Each Coordinator shall be responsible for communications, other than
legal notices, between the parties with respect to the subject matter of this
Agreement. Each party may replace its Coordinator at any time for any or no
reason by providing written notice to the other party.
8.2 Joint Project Committee. The Coordinators shall establish the Joint
Project Committee consisting of representatives of Triangle and Dynavax. The
Joint Project Committee will consist of at least three (3) persons from each of
Triangle and Dynavax, such persons having significant responsibility for the
development and/or marketing of the Licensed Products. The Joint Project
Committee will meet from time to time at mutually agreeable times via
teleconference or in-person, but no less than semi-annually during the term of
the Agreement. The Coordinators shall set the agenda for each meeting, and each
Coordinator shall determine which regular members of Joint Project Committee and
other representatives of such Coordinator's party shall attend in light of the
agenda. Each party shall bear its own costs incurred in connection with
participation in the Joint Project Committee.
8.3 Objective of the Joint Project Committee. The primary objective of the
Joint Project Committee will be to facilitate the expeditious development and
Registration of Licensed Products by, inter alia:
(a) facilitating the exchange of data and study results between the
parties;
(b) providing a forum for protocol and development plan review;
(c) coordinating the developmental efforts of the parties so as to
avoid duplication and inconsistency of such efforts;
(d) coordinating the manufacturing of, and controls relating to, all
37
Licensed Products during the Development Program; and
(e) reviewing the regulatory plans and timelines relating to the
Licensed Products.
Each party agrees to give due consideration to any input received from the
other party at such Joint Project Committee meetings; provided, however, that
all final decisions relating to the development of Licensed Products in the
Territory will be made by Triangle.
8.4 Exchange of Study Results. Each party shall submit a report detailing
the results of each study or test which it performs to the other party within
forty-five (45) days after completion of the final statistical analyses of the
results of such study. In addition, each party will provide the other party with
semi-annual progress reports summarizing its activities in respect of the
development of Licensed Products during the relevant semi-annual period. Such
reports shall cover the semi-annual periods ending each June 30 and December 31
and shall be due on or before July 15 and January 15 of each year, respectively.
8.5 Publications. Each party reserves the right to publish or publicly
present the results of its own development activities in respect of the Licensed
Products (all such results, including the Research Program Results, being
collectively referred to as the "Results"). The party proposing to publish or
publicly present the Results (the "publishing party") will, however, submit a
draft of any proposed manuscript, abstract, speech, transparencies, presentation
materials and press releases to the other party (the "non-publishing party") for
comments at least: (a) fifteen (15) days prior to submission for publication or
oral presentation in the case of full manuscripts; (b) three (3) days prior to
submission for publication or oral presentation in the case of abstracts; and
(c) one (1) day prior to publication in the case of press releases, except, in
the case of press releases, where
38
applicable law, in the reasonable opinion of the publishing party, requires such
press release to be issued within time constraints which would make such review
impractical. The non-publishing party shall notify the publishing party in
writing within the applicable time period set forth above after receipt of such
draft whether such draft contains Information (as hereinafter defined) of the
non-publishing party which it considers to be confidential under the provisions
of Article 15 hereof, or information that if published would have an adverse
effect on a patent application for which the non-publishing party has initial
patent prosecution responsibility pursuant to Article 10 of this Agreement. In
the latter case, the non-publishing party shall have the right to request a
delay and the publishing party shall delay such publication for a period not
exceeding sixty (60) days. In any such notification, the non-publishing party
shall indicate with specificity its suggestions regarding the manner and degree
to which the publishing party may disclose such information. The publishing
party shall have the final authority to determine the scope and content of any
publication, provided that such authority shall be exercised with reasonable
regard for the interests of the non-publishing party, except that no publication
will contain any Information disclosed by the non-publishing party to the
publishing party without the non-publishing party's prior written permission.
Each party shall cause its Affiliates, licensees or sublicensees, as the case
may be, to comply with the requirements of this Section 8.5 with respect to any
of their proposed publications.
ARTICLE 9. SUPPLY AND MANUFACTURE
9.1 Supply of Finished Drug Substance.
(a) Dynavax agrees to supply Triangle, and Triangle agrees to
purchase from Dynavax, Triangle's requirements of Finished Drug Substance
necessary for Triangle to
39
perform the Development Program at Dynavax' Acquisition Cost or Manufacturer
Cost therefor, as applicable. Triangle acknowledges that Dynavax may subcontract
its obligations hereunder to a third party which is reasonably acceptable to
Triangle. Dynavax shall not change any subcontractor without Triangle's prior
written consent which shall not be unreasonably withheld or delayed. Such
obligation shall include all preclinical studies, Phase I and Phase II clinical
trials and, at Triangle's option all Phase III clinical trials and expanded
access trials under the Development Program.
(b) The delivery schedule for all Finished Drug Substance shall be
determined from time to time by mutual agreement of the parties, but Dynavax
shall use its best efforts to comply with Triangle's requested delivery dates.
No Finished Drug Substance shall be supplied except pursuant to firm written
purchase orders submitted to Triangle by Dynavax. All Finished Drug Substance
supplied pursuant to this Section 9.1 shall (i) be manufactured in accordance
with Current Good Manufacturing Practices as promulgated by the FDA, and (ii)
meet specifications, determined in accordance with applicable analytical
methodology, to be mutually agreed upon in good faith by the parties hereto as
promptly as practicable after the Effective Date.
(c) During the Development Program, Dynavax shall use its best
efforts to provide Triangle, free of charge, with those quantities of (i)
analytical reference materials and (ii) all impurities and degradation products
which are measured when performing the analytical methodology for the Finished
Drug Substance and which are required by Triangle to conduct the analytical work
necessary to obtain Registration of the Licensed Products in each country of the
Territory.
(d) Within thirty (30) days after the Effective Date with respect to
the
00
Xxxxxx Xxxxxx and within thirty (30) days after Triangle's request with respect
to other countries of the Territory, Dynavax shall use its best efforts to
establish, or shall use its best efforts to cause its subcontractors to
establish, a DMF (or its counterpart in other countries of the Territory) with
the FDA, and applicable government authorities for all other countries of the
Territory requested by Triangle, relating to the manufacture of the Finished
Drug Substance, and covering facilities from which all Finished Drug Substance
to be supplied to Triangle pursuant to Subsection 9.1(a) above will be supplied.
Dynavax shall provide, or shall cause its subcontractors to provide, Triangle
and its sublicensees with (i) access to the data and information of Dynavax and
its subcontractor's DMF's, and (ii) letters of authorization to the FDA and
other applicable government authorities in other countries of the Territory and
take such other actions as Triangle may reasonably request to allow Triangle or
its sublicensees to refer to Dynavax' and its subcontractor's DMF's or their
counterparts in connection with any submissions or filings which Triangle or its
sublicensees make with respect to the Licensed Product.
(e) Dynavax shall allow, and shall cause its subcontractors to
allow, Triangle employees and/or consultants and FDA and other regulatory
personnel to perform any quality assurance audits of Dynavax' and its
subcontractors' manufacturing facilities that may be required of Triangle by any
governmental authority or reasonably requested by Triangle.
(f) From time to time, Triangle shall have the right, at its own
expense, to have Triangle employees and its subcontractors participate in and
observe the development of the manufacturing, scale-up processes and analytical
testing of Dynavax and its subcontractors relating to Finished Drug Substance.
The parties agree that the intent of such
41
participation/observation shall include, but not be limited to, assistance for
Triangle in subsequently implementing the same manufacturing in its facilities
of its subcontractors in the event Dynavax ceases to supply Finished Drug
Substance, and Dynavax shall take all reasonable steps to ensure that such
Triangle employees are provided with information, materials and training
necessary to facilitate such purposes.
(g) Dynavax shall reasonably assist, and shall cause its
subcontractors to reasonably assist, Triangle employees and/or consultants and
FDA and other regulatory personnel in the development of analytical methodology
and specifications so that the respective assay methods and specifications for
the Licensed Products and the Finished Drug Substance are consistent.
(h) Dynavax shall use its best efforts to generate, and shall use
its best efforts to cause its subcontractors to generate, all documentation
necessary to support registration of the Finished Drug Substance with the FDA
and other foreign regulatory authorities. Dynavax further agrees to prepare its
facilities, and to cause its subcontractors to prepare their facilities, for
pre-approval inspections by the FDA and foreign regulatory authorities, with the
reasonable assistance of Triangle employees and/or consultants. As soon as
practicable after the Effective Date, the parties will initiate discussions to
agree on a list of necessary documentation and validation studies required to be
performed prior to NDA filing and time frames for completion.
(i) Dynavax hereby certifies that it has not been debarred under the
provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. ss.335a (a)
and (b). In the event that during the term of this Agreement, Dynavax becomes
debarred or receives notice of an action or threat of an action with respect to
its debarment, Dynavax shall notify
42
Triangle immediately. Dynavax hereby certifies that it has not and will not use
in any capacity the services of any individual, corporation, partnership or
association which has been debarred under 21 U.S.C. ss.335a (a) or (b) in
connection with the performance of services hereunder. In the event that Dynavax
becomes aware of the debarment or threatened debarment of any individual,
corporation, partnership or association (the "Debarred Entity") providing
services to Dynavax which directly or indirectly relate to activities under this
Agreement, Dynavax shall notify Triangle immediately. Upon Triangle's request,
Dynavax agrees to cease using the services of the Debarred Entity.
(j) Upon request by Triangle, Dynavax agrees to submit promptly
documentation which reasonably substantiates Dynavax' Acquisition Cost or
Manufacturing Cost for the Licensed Products, as applicable. Triangle shall have
audit rights in respect of the Acquisition Costs or Manufacturing Costs for the
Licensed Products similar to those of Dynavax as set forth in Section 4.2,
mutatis mutandis. Dynavax shall use its best efforts to negotiate a commercially
reasonable Acquisition Cost for Finished Drug Substance.
9.2 Commercial Supply of Finished Drug Substance. Triangle shall be
responsible for the commercial supply of all Finished Drug Substance and the
transition to the commercial supplier shall commence at the Phase III clinical
trial stage for each Licensed Product, unless Triangle and Dynavax agree that
Dynavax will supply Phase III clinical trial material. Dynavax shall reasonable
cooperate, and shall cause its subcontractors to reasonably cooperate, with
Triangle and its contractor in connection with the transaction of manufacture
and supply responsibilities.
9.3 Regulatory and Quality Assurance.
(a) Dynavax acknowledges that, except for any of its subcontractor's
43
DMF's, Triangle shall be solely responsible for (i) filing all regulatory
documents with the FDA and foreign regulatory agencies in connection with the
Development Program and Registration of all Licensed Products and (ii) quality
assurance oversight in respect of the Licensed Products. Dynavax will reasonably
assist Triangle by providing with such data as area available to Dynavax which
are necessary for Triangle to fulfill all FDA and foreign regulatory reporting
requirements in respect of the Licensed Products supplied hereunder. Dynavax
will use its best efforts to cause any subcontractor which it uses in connection
with the manufacture of the Licensed Products to fully disclose all data
relating to such subcontractor's manufacturing activities to Triangle.
(b) Dynavax shall use its best efforts to cause any subcontractors
it uses in connection with the supply and manufacture of the Licensed Products
to enter into such contractual arrangements with Triangle as are reasonably
necessary to comply with applicable FDA laws and regulations, relating to the
manufacturing, control, testing and release of the Licensed Products, including
the draft guidance entitled "Cooperative, Manufacturing Arrangements for
Licensed Products".
ARTICLE 10. PATENT PROSECUTION
10.1 Title to Inventions. Each party shall have and retain sole title in
inventions, whether or not patentable, made by it or on its behalf (as by its
employees or agents) in the course of work performed under this Agreement.
10.2 Dynavax Inventions. Dynavax shall, in consultation with Triangle,
file and prosecute such patent applications regarding any of Dynavax' sole
inventions which are reasonably necessary for the development, registration,
manufacture, use or sale of ISS, Conjugated ISS and the Licensed Products in the
Territory, and thereafter shall diligently and
44
in the exercise of its discretion in a manner reasonably consistent with the
goals and expectations of the parties, giving due and reasonable consideration
to Triangle's position, prosecute and maintain in force the resulting Dynavax
Patents all at the expense of Dynavax. Dynavax shall enable Triangle or its
counsel to directly contact and confer with Dynavax' patent attorney with
respect to the prosecution of any patent applications constituting part of the
Dynavax Patents and shall use its reasonable efforts to amend, correct or refile
any patent or patent application included in the Dynavax Patents to include
claims reasonably requested by Triangle. The territorial scope of such filings
shall be the subject of specific discussion between the parties, but shall
include all Patent Filing Countries and all other countries reasonably requested
by Triangle to the extent not already applied for as of the Effective Date. If
for any reason Dynavax declines to file a patent application or, having filed,
declines to prosecute or maintain any of the Dynavax Patents within the
Territory, Triangle may so file, prosecute or maintain in Dynavax' name and at
Triangle's expense in such country, in which event, Dynavax shall at Triangle's
request and expense, provide all reasonable assistance; provided, however, that
Triangle shall be entitled to credit the out-of-pocket expenses so incurred
against royalties and Milestone Payments due hereunder with respect to Licensed
Products sold in such country.
10.3 Triangle Inventions. Triangle shall, in consultation with Dynavax,
file and prosecute such patent applications regarding any of the Triangle
Patents owned or controlled by Triangle, and thereafter shall diligently and in
the exercise of its discretion in a manner reasonably consistent with the goals
and expectations of the parties hereunder, giving due and reasonable
consideration to Dynavax' position, prosecute and maintain in force the
resulting Triangle Patents, all at Triangle's expense. Triangle shall enable
Dynavax or its
45
counsel to directly contact and confer with Triangle's patent counsel, at
Dynavax' expense, with respect to the prosecution of any patent applications
constituting part of the Triangle Patents and shall use its reasonable efforts
to amend, correct or refile any patent or patent application included in the
Triangle Patents to include claims reasonably requested by Dynavax. The
territorial scope of such filings shall be the subject of specific discussion
between the parties. If for any reason Triangle declines to file a patent
application or, having filed, declines to prosecute or maintain any of the
Triangle Patents in any country, Dynavax may so file, prosecute or maintain in
Triangle's name and at Dynavax' expense in such country, in which event,
Triangle shall, at Dynavax' request and expense, provide all reasonable
assistance.
10.4 Joint Inventions. With respect to Joint Inventions: (a) all patent
applications and patents with respect thereto shall be jointly owned by Dynavax
and Triangle; (b) Triangle and its sublicensees and assignees shall be free to
use such patent applications and patents in the Territory and Dynavax and its
licensees and assignees shall be free to use such patent applications and
patents in any country of the Territory in which the license granted pursuant to
Section 2.1 is terminated only to the extent so terminated, in each event,
without payment of royalty or accounting therefor; (c) each party agrees to
consult with the other party and to give due and reasonable consideration to the
other party's position in determining the territorial scope of patent filings
within the Territory (in the case of Triangle) and outside the Territory (in the
case of Dynavax), and the prosecution and maintenance of resulting patent rights
based on Joint Inventions; and (d) Triangle shall have the sole right and
discretion to file any patent application and prosecute and maintain any
resulting patent rights on Joint Inventions, in which event, Dynavax shall, at
Triangle's
46
request, provide all reasonable assistance and shall promptly reimburse Triangle
with *** percent (***%) of the out-of-pocket expenses so incurred by Triangle.
10.5 Further Obligations.
(a) Except as otherwise provided in Articles 11 and 20, each party's
responsibilities for patent prosecution activities pursuant to this Article 10
shall also include all ex parte and inter partes activities defending such
party's relevant patent applications and patents, including all interference,
opposition defense and observation defense proceedings before any patent offices
and litigation to determine the validity, enforceability, allowability or
subsistence of such patent applications and patents. Each party agrees to give
due consideration to the other party's position with respect to any such patent
prosecution activities (which term, as used herein, shall include without
limitation, any inter partes activities of the type described in the first
sentence of this Subsection 10.5 (a)). In the event a party fails to initiate or
pursue any patent prosecution activities for which it is responsible, or having
commenced such patent prosecution activities, declines to pursue such patent
prosecution activities, the other party may initiate, pursue or assume such
patent prosecution activities, at its sole expense.
(b) In conducting its patent prosecution activities under this
Agreement, each party may use patent attorneys selected by it and reasonably
acceptable to the other party. In addition to the other obligations set forth in
this Article 10, each party undertakes to keep the other party throughout the
term of this Agreement regularly informed of the status and progress of the
patent prosecution activities it undertakes under this Agreement including, but
not limited to, supplying the other, upon reasonable request and at reasonable
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intervals, with all correspondence with the patent offices in the Patent Filing
Countries. To the extent that a party has not previously done so, or promptly
upon request by the other party in order to assist such other party in
connection with any of its activities or the exercise of any of its rights
pursuant to Articles 10 and 11, such party shall provide the other party with
such additional relevant documentation which such other party may reasonably
request relating to such patent applications and patents in the Dynavax Patents,
Triangle Patents or those relating to Joint Inventions, as applicable, including
but not limited to, copies thereof and access to laboratory notebooks, other
supporting data and relevant employees. If a party decides to abandon or allow
to lapse any patent application or patent or not to initiate or any other patent
prosecution activity for which it has patent prosecution responsibility pursuant
to this Article 10, it shall give the other party notice thereof in a
sufficiently timely manner so as to enable such other party to determine whether
to assume patent prosecution activity in connection therewith. Each party shall
use its best efforts to give such notice at least *** (***) days before any
abandonment, lapse or any other relevant deadline.
(c) Each party shall have the independent right to challenge third
party patents or patent applications which may, in such party's sole discretion,
affect the ability to commercialize Licensed Products. The party choosing to
challenge such third party patents or patent applications shall advise the other
party of the challenge in writing at least thirty (30) days prior to initiating
the challenge.
ARTICLE 11. INFRINGEMENT
11.1 Third Party Infringement. If Triangle or Dynavax becomes aware of any
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activity that it believes represents a substantial infringement of a Valid Claim
or patents relating to Joint Inventions, the party obtaining such knowledge
shall promptly advise the other of all relevant facts and circumstances
pertaining to the potential infringement. Dynavax shall have the right, but not
the obligation, to enforce any rights within the Dynavax Patents against such
infringement, at its own expense. Triangle shall have the right to enforce any
rights within the Triangle Patents and patents relating to Joint Inventions, at
its expense.
11.2 Dynavax Infringement Suits.
(a) Dynavax will give Triangle prompt written notice of any proposed
settlement, consent judgment or voluntary disposition of any suit or legal
action relating to an infringement of the Dynavax Patents, and will consider any
and all comments and suggestions relating thereto provided by Triangle prior to
any such settlement, judgment or disposition; provided that Triangle delivers
all such comments and suggestions in a timely manner; and provided further that,
notwithstanding the above, Dynavax, in Dynavax' sole discretion, exercised in
good faith, may enter into any settlement, consent judgment or voluntary final
disposition of any suit or legal action on behalf of Dynavax and Triangle so
long as such settlement, judgment or disposition does not adversely affect
Triangle's rights under the license agreement nor impose any obligations on
Triangle other than as explicitly set forth in the license agreement.
(b) In the event that Dynavax recovers any settlement amount or any
damages for past infringement as a result of such suit or legal action, such
amount or damages shall be applied first to reimburse Dynavax for any
unreimbursed expenses and legal fees relating to such suit or legal action,
second to reimburse, on a pro rata basis,
49
Triangle or its sublicensees and other licensees of Dynavax having an interest
in such infringement action, if any, for any unreimbursed expenses and legal
fees relating to such suit or legal action, and third, after such
reimbursements, to the extent that the remaining amount of such settlement
amount or damages, in whole or in part, can be reasonably attributed to losses
actually incurred as a result of such infringement by Triangle and such other
licensees of Dynavax, if any, such remaining amount will be shared such that ***
percent (***%) will be retained by Dynavax and ***% will be distributed on a pro
rata basis among Triangle and such other licensees, if any, in accordance with
each party's reasonably attributed losses or damages. In the event Triangle and
Dynavax cannot reach agreement on what constitutes a pro rata distribution, the
matter shall be referred to an independent certified public accountant (not
regularly employed by either party) for a final determination of such pro rata
distribution.
11.3 Triangle Infringement Suits.
(a) If Dynavax shall fail, within *** (***) days after receiving
notice from Triangle of a potential infringement of the Dynavax Patents or after
giving Triangle notice of such infringement, either (a) to terminate such
infringement or (b) to institute an action to prevent continuation thereof and,
thereafter, to prosecute such action diligently, or if Dynavax notifies Triangle
that it does not plan to terminate the infringement of the Dynavax Patents or
institute such action, then Triangle shall have the right to do so. Dynavax
shall cooperate with Triangle in such effort, including being joined as a party
to such action if necessary. In the event Triangle institutes any action
relating to infringement of the Dynavax Patents, Triangle may deposit up to ***
percent (***%) of any royalties which are otherwise
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payable to Dynavax during the pendency of any such infringement action in an
interest-bearing escrow account (bearing interest at rates comparable to other
Triangle deposits of immediately available funds). Triangle shall, upon the
final resolution or settlement of such infringement action, provide Dynavax with
an accounting of the total royalty payments escrowed (and interest thereon) and
Triangle's expenses incurred in such infringement action. Triangle shall be
entitled to offset any expenses which Triangle fails to recoup from any damage
award or settlement payments arising from such infringement action against such
escrowed royalties. Any escrowed payments (and interest thereon) in excess of
Triangle's unrecouped expenses shall be immediately paid to Dynavax.
(b) Any damage award or settlement payments made to Triangle for
infringement of the Dynavax Patents in excess of Triangle's expenses in
connection with any infringement action it initiates relating to the Dynavax
Patents shall next be used to reimburse Dynavax for any legal fees and expenses
it incurs in connection with such infringement action and any remaining amount
shall then be divided as follows: *** percent (***%) to Dynavax and *** percent
(***%) to Triangle. Any damage award or settlement payments made to Triangle in
connection with any action relating to infringement of the patents relating to
Joint Inventions, after first reimbursing Triangle for its expenses, shall be
equally divided by the parties. Any damage award or settlement payments made to
Triangle in connection with any action relating to infringement of the Triangle
Patents shall be retained by Triangle. Notwithstanding the above, Triangle may
not and shall have no authority to settle any such suit or legal action, or
reach an agreement with any third party, relating to the Dynavax Patents without
the prior written consent of Dynavax, which consent
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will not be unreasonably withheld or delayed.
11.4 Alleged Infringement of Third Party Patents. In the event that a
third party commences an action against Triangle alleging that Triangle's, its
Affiliates' or sublicensees' making, having made, using, importing, offering for
sale or selling a Licensed Product in one or more countries in the Territory
infringes or will infringe such third party's patent rights, Triangle may elect
to defend such suit at its sole expense and discretion. Triangle may, subsequent
to the commencement of such action, reduce all royalty payments on its, its
Affiliates' and sublicensees' sales of Licensed Products allegedly infringing
such third party's patent rights by *** percent (***%). If a court of competent
jurisdiction issues a decision which is unappealable or unappealed within the
time allowed therefor that such third party's patent rights are not being
infringed by Triangle, its Affiliates or sublicensees or that such third party's
patent rights are not valid or are unenforceable, the former royalty rates shall
be restored and the royalty payments not theretofore made and interest earned
therein, after first reimbursing Triangle for the legal fees relating to such
action, shall become due and payable to Dynavax.
ARTICLE 12. TRANSFER OF KNOW-HOW; TECHNICAL ASSISTANCE
12.1 Transfer by Dynavax. Within forty five (45) days following the
Effective Date and as far as it has not previously done so, Dynavax shall supply
Triangle with all Dynavax Know-How. With respect to any Dynavax Know-How
developed by Dynavax during the term of this Agreement, such disclosure will be
made at least on a quarterly basis or sooner, if practicable.
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12.2 Technical Assistance.
(a) Dynavax shall, upon request by Triangle, provide Triangle with
reasonable cooperation and assistance, consistent with the other provisions
hereof, in connection with the transfer of Dynavax Know-How. Such assistance may
include, but is not limited to, development of the formulations of the Licensed
Products; procurement of supplies and raw materials; initial developmental and
production batch manufacturing runs; process, specification and analytical
methodology design and improvement; and, in general, such other assistance as
may contribute to the efficient application by Triangle of the Dynavax Know-How.
In this regard, Dynavax agrees to make appropriate employees of Dynavax
reasonably available to assist Triangle, and Dynavax agrees to provide
reasonable numbers of appropriate Triangle personnel with access during normal
business hours to the appropriate personnel and operations of Dynavax for such
periods of time as may be reasonable in order to familiarize Triangle personnel
with the Dynavax Know-How as applied by Dynavax. At Triangle's reasonable
request, such assistance shall be furnished at Triangle's or its subcontractors'
or sublicensees' facilities in the Territory, subject to a mutually agreed upon
schedule. Such technical assistance shall include but not be limited to the
following:
(i) Dynavax shall: (A) provide Triangle with access to any and all
DMF's or counterparts thereof in any countries of the Territory of Dynavax
relating to the manufacture of Finished Drug Substance existing as of the
Effective Date; (B) provide Triangle with letters of authorization to the FDA
and other applicable government authorities in other countries of the Territory
to refer to Dynavax' DMF's; and (C) reasonably cooperate with Triangle in
obtaining access to and letters of authorization to refer to the DMF's of
53
Dynavax' subcontractors which are, or will be, supplying any Finished Drug
Substance; and
(ii) Within forty five (45) days after the Effective Date, Dynavax
shall provide Triangle with copies of all documentation in Dynavax' possession,
including all correspondence between Dynavax and its subcontractors, regarding
the manufacture of the Finished Drug Substance which would be necessary or
useful to assist Triangle in the commercial production of Finished Drug
Substance or to support Registration of the Licensed Products.
(b) During the period prior to the fifth anniversary of the
Effective Date, (i) Dynavax shall provide up to *** (***) man-days of such
technical assistance during each year of such period at Dynavax' sole expense
and (ii) subsequent to such *** (***) man-days of technical assistance, Dynavax
shall provide such additional technical assistance as may be reasonably
requested by Triangle, provided, that all reasonable out-of-pocket travel costs
and expenses incurred by Dynavax in rendering technical assistance pursuant to
this Section 12.2 in excess of such *** (***) man-days per year shall be
reimbursed to Dynavax by Triangle and, in addition, Triangle will pay Dynavax a
consultancy fee in an amount to be negotiated by the parties hereto in good
faith (but not to exceed the consultancy fee, if any, then being charged by
Dynavax to third parties) for each consultancy day in excess of *** (***)
man-days spent by personnel of Dynavax in rendering technical assistance to
Triangle. Technical assistance furnished pursuant to this Section 12.2 shall
continue only until the fifth anniversary of the Effective Date of this
Agreement.
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12.3 Transfer by Triangle. With respect to any Triangle Know-How developed
by Triangle during the term of this Agreement, Triangle shall supply Dynavax
with such Triangle Know-How on at least a quarterly basis or sooner, if
practicable.
12.4 Language of Disclosures. All disclosures pursuant to this Agreement
will be in English.
ARTICLE 13. WARRANTIES AND REPRESENTATIONS; LIMITATION OF LIABILITY;
DISCLAIMERS; AND COVENANTS
13.1 Warranties and Representations of Dynavax. Dynavax warrants and
represents, except as otherwise specifically disclosed in a disclosure letter
(referencing the appropriate schedule or section number) supplied by Dynavax to
Triangle and dated as of the date hereof, as of the date hereof and as of the
Effective Date, the following:
(a) It possesses the necessary right, power and authority to enter
into this License Agreement;
(b) the copy of the Primary License Agreement delivered to Triangle
on or about February 14, 2000 is a true, complete and accurate copy of the
Primary License Agreement;
(c) Exhibit A is a complete list of all patents and patent
applications included in the Dynavax Patents;
(d) it is not aware of any material facts which it has not disclosed
to Triangle regarding the manufacture, use or sale of any Licensed Products or
the practice of any inventions included in the Dynavax Patents or the use of the
Dynavax Know-How by Triangle (except, potentially, details regarding the Dynavax
Know-How to be provided under Article 12), including without limitation any
material facts regarding the possibility that such manufacture, use, sale or
practice might infringe any third party's know-how, patent rights or
55
other intellectual property in the Territory;
(e) it is aware of no third party using or infringing all or any of
the Dynavax Patents in derogation of the rights granted pursuant to this
Agreement;
(f) it is aware of no third party claim to any rights in the Dynavax
Patents or the Dynavax Know-How;
(g) it is aware of no pending interference or opposition proceeding
or litigation or any communication which threatens an interference or opposition
proceeding or litigation before any patent and trademark office, court, or any
other governmental entity or court in any jurisdiction in regard to the Dynavax
Patents; and
(h) with respect to the Primary License Agreement (i) Dynavax and,
to Dynavax' knowledge, the Primary Licensor has performed all the material
obligations required to be performed by each to date, and are not in default or
breach under the Primary License Agreement; (ii) the Primary License Agreement
has been duly authorized, executed and delivered by Dynavax and constitutes the
legal, valid and binding obligation of Dynavax, enforceable in accordance with
its terms, except as such enforcement may be limited by applicable bankruptcy,
insolvency, moratorium or similar rights affecting the enforcement of creditors'
rights generally and the application of general principles of equity; (iii)
Dynavax has no knowledge that the Primary License Agreement has not been duly
authorized, executed or delivered by the Primary Licensor, or does not
constitute the legal, valid and binding obligation of the other party thereto,
enforceable in accordance with its terms, except as such enforcement may be
limited by applicable bankruptcy, insolvency, moratorium or similar rights
affecting the enforcement of creditors' rights generally and the application of
general principles of equity; (iv) the rights under this Agreement may be
granted in full
56
without any consent of the Primary Licensor that has not been obtained; and (v)
the execution of this Agreement and the performance of the transactions
contemplated hereby will not change in any respect, or result in the termination
of, any terms or provisions of the Primary License Agreement.
13.2 Warranties and Representations of Each Party. Each party hereto
warrants and represents to: (a) the other that it is free to enter into this
Agreement (including the receipt of all corporate authorizations) and to carry
out all of the provisions hereof, including, its grant to the other of the
licenses described in Article 2; (b) to its knowledge, there is no failure to
comply with, no violation of or any default under, any law, permit or court
order applicable to it which might have a material adverse effect on its ability
to execute, deliver and perform this Agreement or on its ability to consummate
the transactions contemplated hereby; and (c) it shall comply with laws and
regulations relating to the performance of its obligations or the exercise of
its rights hereunder including, in the case of Triangle, those relating to the
manufacture, processing, producing, use, sale, or distribution of Licensed
Products; and that it shall not take any action which would cause it or the
other party to violate such laws and regulations.
13.3 Disclaimer of Warranties. EXCEPT AS OTHERWISE SET FORTH IN SECTION
13.1 ABOVE, DYNAVAX MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT
TO THE DYNAVAX PATENTS OR DYNAVAX KNOW-HOW AND EXPRESSLY DISCLAIMS ANY
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR
NONINFRINGEMENT AND ANY OTHER IMPLIED WARRANTIES WITH RESPECT TO THE
CAPABILITIES, SAFETY, UTILITY, OR COMMERCIAL APPLICATION OF
57
DYNAVAX PATENTS OR DYNAVAX KNOW-HOW.
13.4 Limitation of Liability.
(a) Neither party shall be liable to the other party or its
Affiliates, sublicensees or any of its or their customers for any special,
incidental or consequential damages resulting from defects in the testing,
labeling, manufacture or other application of the Licensed Products
manufactured, tested or sold pursuant to this Agreement.
(b) Any provision of this Agreement to the contrary notwithstanding,
Dynavax shall not be liable to Triangle, its Affiliates or sublicensees for any
damage that any party may suffer as a result of any third party actions for
patent infringement or for any other claims against Triangle, its Affiliates or
sublicensees in connection with their use of Dynavax Patents or Dynavax
Know-How; provided, however, that the foregoing limitation shall in no way
affect or otherwise limit any remedies which Triangle or its Affiliates or
sublicensees may have against Dynavax as a result of Dynavax' breach of any of
its warranties and representations set forth in Article 13 hereof.
13.5 Insurance. Without limiting Triangle's indemnity obligations under
Article 14, Triangle shall maintain throughout the term of this Agreement a
commercial, general liability insurance policy, written by a reputable insurance
company authorized to do business in the United States, which:
(a) insures Indemnitees for all claims, damages, and actions
mentioned in Section 14.1 of this Agreement;
(b) includes a contractual endorsement providing coverage for all
liability arising out of bodily injury and property damage; and
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(c) provides the Indemnitees with product liability coverage in an
amount no less than *** Dollars ($***) per occurrence for bodily injury and ***
Dollars ($***) per occurrence for property damage, subject to a reasonable
aggregate amount not to exceed *** Dollars ($***). Upon request, Triangle shall
provide Dynavax with certificates of insurance evidencing the above insurance
coverage.
13.6 Special Dynavax Covenants.
(a) Dynavax agrees that it shall (i) maintain the Primary License
Agreement in full force and effect during the term of this Agreement; (ii) take
no action that would constitute a breach or default of the Primary License
Agreement; (iii) keep Triangle informed with respect to all material
developments affecting the Agreement, including, without limitation, by promptly
forwarding to Triangle a copy of any notice provided to Dynavax by the Primary
Licensor pursuant to the Primary License Agreement; (iv) in addition, to the
extent Triangle in accordance with this Agreement pays money or provides
information or materials to Dynavax, Dynavax shall promptly forward the same to
the Primary Licensor in a manner and in such time so as not to cause a breach or
default under the Primary License Agreement; and (v) will not amend the Primary
License Agreement in a manner which adversely affects Triangle's rights and
obligations hereunder. Dynavax further agrees that Triangle shall have the right
to pay any amounts due and payable by Dynavax to the Primary Licensor pursuant
to the Primary License Agreement in the event Dynavax does not pay such amounts
in a timely manner. In such event, Triangle may totally offset such amounts paid
to the Primary Licensor against any amounts payable to Dynavax hereunder and
such offset shall not be taken into account when calculating any limitation on
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royalty reductions prescribed in Article 3 hereof.
(b) Within thirty (30) days after the Effective Date, Dynavax agrees
that it will deliver to the Primary Licensor a copy of the amendment to the
Primary License Agreement in form and substance attached hereto as Exhibit C and
request that the Primary Licensor execute such amendment. Dynavax agrees to
execute such amendment and will inform Triangle of the Primary Licensor's
response to the foregoing request.
(c) Dynavax agrees to use its best efforts to prepare and file all
patent applications relating to the Dynavax Patents as promptly as reasonably
possible.
ARTICLE 14. INDEMNIFICATION
14.1 Triangle's Indemnification. Subject to compliance by the Indemnitees
with the provisions set forth in Section 14.3, Triangle shall defend, indemnify,
and hold harmless the Indemnitees, from and against any and all claims, demands,
losses, liabilities, expenses, and damages including investigative costs, court
costs and reasonable attorneys' fees (collectively, the "Liabilities") which
Indemnitees may suffer, pay, or incur as a result of or in connection with: (a)
any and all personal injury (including death) and property damage caused or
contributed to, in whole or in part, by manufacture, testing, design, use, sale,
or labeling of any Licensed Products or the practice of the Dynavax Patents or
Dynavax Know-How by Triangle or Triangle's Affiliates or sublicensees, excluding
any Liabilities arising as a result of Dynavax' or, if applicable, its
subcontractor's negligence, intentional misconduct or breach of contract in
supplying Finished Drug Substance or Dynavax' breach of its representations and
warranties and covenants under this Agreement; and (b) any breach by Triangle of
its representations, warranties and covenants contained in this Agreement.
Triangle's obligations under this Article shall survive the expiration or
termination of this
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Agreement for any reason.
14.2 Dynavax' Indemnification. Subject to compliance by the Indemnitees
with the provisions set forth in Section 14.3, Dynavax shall indemnify and hold
the Indemnitees harmless from and against any and all Liabilities which
Indemnitees may suffer, pay or incur as a result of or in connection with: (a)
any breach by Dynavax of any of its representations, warranties and covenants
set forth in this Agreement; (b) any claims or suits asserted or commenced by
the Primary Licensor regarding any default or alleged default by Dynavax under
the Primary License Agreement. Dynavax' obligations under this Article shall
survive expiration or termination of this Agreement for any reason; and (c)
Dynavax' or, if applicable, its subcontractor's negligence, intentional
misconduct or breach of contract in supplying Finished Drug Substance.
14.3 Indemnification Procedures. Any Indemnitee which intends to claim
indemnification under this Article shall, promptly after becoming aware thereof,
notify the party from whom it is seeking indemnification (the "Indemnitor") in
writing of any matter in respect of which the Indemnitee or any of its employees
intend to claim such indemnification. The Indemnitee shall permit, and shall
cause its employees to permit, the Indemnitor, at its discretion, to settle any
such matter and agrees to the complete control of such defense or settlement by
the Indemnitor; provided, however, that such settlement does not adversely
affect the Indemnitee's rights hereunder or impose any obligations on the
Indemnitee in addition to those set forth herein in order for it to exercise
such rights. No such matter shall be settled by such Indemnitee without the
prior written consent of the Indemnitor and neither the Indemnitor nor the
Indemnitee shall be responsible for any legal fees or other costs incurred other
than as provided herein. The Indemnitee and its employees
61
shall cooperate fully with the Indemnitor and its legal representatives in the
investigation and defense of any matter covered by the applicable
indemnification. The Indemnitee shall have the right, but not the obligation, to
be represented by counsel of its own selection and expense.
ARTICLE 15. CONFIDENTIALITY
15.1 Treatment of Confidential Information. Except as otherwise provided
hereunder, during the term of this Agreement and for a period of (***) *** years
thereafter:
(a) Triangle and its Affiliates and sublicensees shall retain in
confidence and use only for purposes of this Agreement, any written information
and data supplied by or on behalf of Dynavax under this Agreement and the
Non-Disclosure Agreement, dated April 9, 1999, between Dynavax and Triangle (the
"Confidentiality Agreement"); and
(b) Dynavax shall retain in confidence and use only for purposes of
this Agreement any written information and data supplied by or on behalf of
Triangle to Dynavax under this Agreement.
For purposes of this Agreement, all such information and data which a
party is obligated to retain in confidence shall be called "Information."
15.2 Right to Disclose. To the extent that it is reasonably necessary to
fulfill its obligations or exercise its rights under this Agreement, or any
rights which survive termination or expiration hereof, each party may disclose
Information to its Affiliates, sublicensees (actual or prospective),
consultants, outside contractors, actual or prospective investors, and clinical
investigators on condition that such entities or persons agree in
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writing:
(a) to keep the Information confidential for a period of at least
*** (***) years from the date of disclosure by such party to the same extent as
such party is required to keep the Information confidential; and
(b) to use the Information only for those purposes for which the
disclosing party is authorized to use the Information.
Each party or its Affiliates or sublicensees, as applicable, may disclose
Information to the government or other regulatory authorities to the extent that
such disclosure (i) is necessary for the prosecution and enforcement of patents,
or authorizations to conduct preclinical or clinical trials to commercially
market Licensed Products, provided such party is then otherwise entitled to
engage in such activities in accordance with the provisions of this Agreement,
or (ii) is legally required.
15.3 Release from Restrictions. The obligation not to disclose or use
Information shall not apply to any part of such Information that:
(a) is or becomes patented (but the existence of a patent shall only
permit disclosure and not, unless otherwise provided hereunder, use), published
or otherwise part of the public domain, other than by unauthorized acts of the
party obligated not to disclose such Information (for purposes of this Article
15 the "receiving party") or its Affiliates or sublicensees in contravention of
this Agreement; or
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(b) is disclosed to the receiving party or its Affiliates or
sublicensees by a third party provided that such Information was not obtained by
such third party directly or indirectly from the other party to this Agreement;
or
(c) prior to disclosure under the Confidentiality Agreement or this
Agreement, as the case may be, was already in the possession of the receiving
party, its Affiliates or sublicensees, provided that such Information was not
obtained directly or indirectly from the other party to this Agreement; or
(d) results from research and development by the receiving party or
its Affiliates or sublicensees, independent of disclosures from the other party
to this Agreement, provided that the persons developing such information have
not had exposure to the information received from the other party to this
Agreement; or
(e) is required by law to be disclosed by the receiving party,
provided that in the case of disclosure in connection with any litigation, the
receiving party uses reasonable efforts to notify the other party immediately
upon learning of such requirement in order to give the other party reasonable
opportunity to oppose such requirement; or
(f) Triangle and Dynavax agree in writing may be disclosed.
ARTICLE 16. CONDITIONS PRECEDENT
This Agreement will not become effective until Dynavax and Triangle
have executed and delivered the Stock Purchase Agreement and the Closing (as
defined in the Stock Purchase Agreement) shall have occurred. In the event the
condition set forth in this Article 16 has not been satisfied within thirty (30)
days from the date set forth at the beginning of this Agreement, Triangle may
terminate this Agreement by giving Dynavax ten (10) days' prior notice.
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ARTICLE 17. TERM AND TERMINATION
17.1 Term. Unless sooner terminated as otherwise provided in this
Agreement, the term of this Agreement shall commence on the Effective Date and
shall continue in full force and effect until the expiration of Triangle's
obligations to pay royalties hereunder.
17.2 Termination by Default.
(a) If either party defaults in the performance of, or fails to be
in compliance with, any material agreement, condition or covenant of this
Agreement, the non-defaulting party may terminate this Agreement with respect to
the defaulting party if such default or noncompliance shall not have been
remedied, or, in the event the default or non-compliance cannot be remedied
within such period, reasonable steps shall not have been initiated to remedy the
same, within sixty (60) days after receipt by the defaulting party of a written
notice thereof from the non- defaulting party. If the defaulting party's default
relates solely to its obligations under the Research Program, the non-defaulting
party may elect to terminate only the Research Program pursuant to the Section
17.2(a) without affecting the remainder of the Agreement.
(b) In the event that: (i) any proceeding is commenced by or against
a party seeking relief under any bankruptcy, insolvency or similar law and if
such proceeding is involuntary, it remains undismissed for sixty (60) days; or a
party, by action or answer, approves of, consents to or acquiesces in such
proceeding or admits the material allegations of or defaults in answering a
petition filed in such proceeding; or (ii) a receiver, liquidator, assignee,
custodian or trustee (or similar official) is appointed for a party in respect
of any substantial part of its assets or for purposes of the winding-up or
liquidation of its business and such appointment remains unstayed and in effect
for a period of sixty (60) days; or (iii) a
65
party makes an assignment for the benefit of creditors; then, in any such event,
such party shall be deemed in default for purposes of this Section 17.2.
17.3 Termination by Triangle. Triangle shall have the right to terminate
this Agreement by giving Dynavax sixty (60) days' prior written notice thereof.
Such termination may be made with respect to one or more (a) countries of the
Territory; (b) Disease Indications; or (c) form of Licensed Product in respect
of an indication, without affecting this Agreement in respect of other
countries, Disease Indications or forms of Licensed Products.
17.4 Obligations Upon Termination. If this Agreement is terminated as a
result of Triangle's breach pursuant to Section 17.2, or is terminated in whole
or in part by Dynavax in accordance with Section 7.3 or by Triangle in
accordance with Section 17.3, then in the case of termination in the entire
Territory, Triangle shall use, and shall cause its Affiliates and sublicensees
to use, its and their best efforts to return, or at Dynavax' direction, destroy
all data, writings and other documents and tangible materials supplied to
Triangle by Dynavax properly organized; and (b) with respect to those countries
with respect to which termination occurs, provided the parties reach agreement
on the terms of the license described in Section 2.4, Triangle shall provide
Dynavax with full and complete copies of all toxicity, efficacy, and other data
generated by Triangle or Triangle's Affiliates, and sublicensees, in the course
of Triangle's efforts to develop Licensed Products or to obtain governmental
approval for the sale of Licensed Products, including but not limited to any
regulatory filings with any government agency in such countries. Dynavax shall
be authorized to cross-reference any such regulatory filings made by Triangle,
its Affiliates and sublicensees in the countries in which termination occurs
where permitted by law. Dynavax
66
shall be entitled to provide information pertaining to the Triangle Patents,
Triangle Know-How and Joint Know-How to any third party with a bona fide
interest in licensing such technology in the countries in which termination
occurs. Such data shall be provided on a confidential basis; provided, however,
that if such third party concludes a license with Dynavax, such third party
shall be free to use such data for all purposes, including to obtain government
approvals to sell any product containing any Compound in such countries, subject
to Dynavax' obligation to Triangle in respect thereof.
17.5 Effect of Termination. In the event of any expiration or termination
pursuant to this Article 17, neither party shall have any remaining rights or
obligations under this Agreement other than as provided below:
(a) Dynavax will have the right to receive all payments accrued
prior to the effective date of termination;
(b) termination or expiration of this Agreement for any reason shall
have no effect on the parties' obligations under Articles 11, 14 and 15 or their
respective rights in Joint Know-How set forth in Section 1.28;
(c) upon expiration of Triangle's royalty obligations under this
Agreement in a given country, Triangle shall have a perpetual, fully paid-up,
non-exclusive license to use the Dynavax Know-How in such country;
(d) termination of this Agreement by Dynavax pursuant to Section 7.3
or 17.2 or by Triangle pursuant to Section 17.3, shall have no effect on the
rights and obligations of the parties under Section 17.4; and
(e) the parties' shall retain any other remedies for breach of this
Agreement they may otherwise have.
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17.6 Bankruptcy. All rights and licenses granted under or pursuant to this
Agreement by Dynavax to Triangle are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to
"intellectual property" as defined under Section 101(56) of the Bankruptcy Code.
The parties agree Triangle, as a licensee of such rights and licenses, shall
retain and may fully exercise all of its rights and elections under the
Bankruptcy Code. The parties further agree that, in the event that any
proceeding shall be instituted by or against Dynavax seeking to adjudicate it a
bankrupt or insolvent, or seeking liquidation, winding up, reorganization,
arrangement, adjustment, protection, relief of composition of it or its debts
under any law relating to bankruptcy, insolvency or reorganization or relief of
debtors, or seeking an entry of an order for relief or the appointment of a
receiver, trustee or other similar official for it or any substantial part of
its property or it shall take any action to authorize any of the foregoing
actions (each a "Proceeding"), Triangle shall have the right to retain and
enforce its rights under this Agreement, including but not limited to the
following rights:
(a) the right to continue to use the Dynavax Patents and Dynavax
Know-How and all versions and derivatives thereof, and all documentation and
other supporting material related thereto, in accordance with the terms and
conditions of this Agreement; and
(b) the right to a complete duplicate of (or complete access to, as
appropriate) all Dynavax Patents and Dynavax Know-How and all embodiments of
such, and the same, if not already in Triangle's possession, shall be promptly
delivered to Triangle (i) upon any such commencement of a Proceeding upon
written request therefor by Triangle, unless Dynavax elects to continue to
perform all of its obligations under this Agreement; or (ii) if not delivered
under (i) above, upon the rejection of this Agreement by or on behalf of
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Dynavax upon written request therefor by Triangle; and
(c) the right to obtain from Dynavax all documentation and other
supporting materials related to the Dynavax Patents and Dynavax Know-How and all
versions and derivatives thereof.
ARTICLE 18. ASSIGNMENT
Neither party shall assign this Agreement or any part thereof without the
prior written consent of the other party, which consent shall not be
unreasonably withheld or delayed. Each party may, however, without such consent,
assign or sell its rights under this Agreement (a) in connection with the sale
or transfer of all or substantially all of its pharmaceutical business to a
third party; (b) in the event of a merger or consolidation with a third party;
or (c) to an Affiliate. No assignment shall relieve any party of responsibility
for the performance of any accrued obligation which such party has under this
Agreement. Any assignment shall be contingent upon the assignee assuming in
writing all of the obligations of its assignor under this Agreement.
ARTICLE 19. REGISTRATION OF LICENSE
Triangle, at its expense, may register the license granted under this
Agreement in any country of the Territory where the use, sale or manufacture of
a Licensed Product in such country would be covered by a Valid Claim. Upon
request by Triangle, Dynavax agrees promptly to execute any "short form"
licenses consistent with the terms and conditions of this Agreement submitted to
it by Triangle reasonably necessary in order to effect the foregoing
registration in such country.
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ARTICLE 20. NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE COMPETITION AND
PATENT TERM RESTORATION ACT
20.1 Notices Relating to the Act. Dynavax shall notify, and shall use its
best efforts to cause the Primary Licensor to notify, Triangle of (a) the
issuance of each U.S. patent included among the Dynavax Patents, giving the date
of issue and patent number for each such patent; and (b) each notice pertaining
to any patent included among the Dynavax Patents which the Primary Licensor
receive as patent owners pursuant to the Drug Price Competition and Patent Term
Restoration Act of 1984 (hereinafter the "Act"), including but not necessarily
limited to notices pursuant to ss.ss.101 and 103 of the Act from persons who
have filed an abbreviated NDA ("ANDA") or a "paper" NDA. Such notices shall be
given promptly, but in any event within ten (10) days of notice of each such
patent's date of issue or receipt of each such notice pursuant to the Act,
whichever is applicable.
20.2 Authorization Relating to Patent Term Extension. Dynavax hereby
authorizes Triangle and will use its best efforts to obtain the Primary
Licensor's authorization for Triangle (a) to include in any NDA for a Licensed
Product, as Triangle may deem appropriate under the Act, a list of patents
included among the Dynavax Patents that relate to such Licensed Product and such
other information as Triangle in its reasonable discretion believes is
appropriate to be filed pursuant to the Act; (b) to commence suit for any
infringement of the Dynavax Patents under ss. 271(e) (2) of Title 35 of the
United States Code occasioned by the submission by a third party of an IND or a
paper NDA for a Licensed Product pursuant to ss.ss.101 or 103 of the Act; and
(c) in consultation with Dynavax and the Primary Licensor, to exercise any
rights that may be exercisable by Dynavax or the Primary Licensor, as
applicable, as patent owners under the Act to apply for an extension of the term
of any patent included among the Dynavax Patents. In the event that applicable
law in any
70
other country of the Territory hereafter provides for the extension of the term
of any patent included among the Dynavax Patents in such country, upon request
by Triangle, Dynavax shall authorize Triangle and shall use its best efforts to
obtain the Primary Licensor's authorization for Triangle or, if requested by
Triangle, its sublicensees, to apply for such extension, in consultation with
Dynavax and the Primary Licensor. Dynavax agrees to cooperate and shall use its
best efforts to cause the Primary Licensor to cooperate with Triangle or its
sublicensees, as applicable, in the exercise of the authorizations granted
herein or which may be granted pursuant to this Section 20.2 and will execute
such documents and take such additional action and use its best efforts to cause
the Primary Licensor to execute such documents and to take such additional
actions as Triangle may reasonably request in connection therewith, including,
if necessary, permitting itself and using its best efforts to permit the Primary
Licensor to permit themselves to be joined as proper parties in any suit for
infringement brought by Triangle under subsection (b) above. Triangle shall bear
the costs and expenses, including but not limited to attorneys' fees, of any
suit for infringement brought by Triangle under subsection (b) above.
ARTICLE 21. DISPUTE RESOLUTION AND ARBITRATION
21.1 Initial Resolution. In the case of any disputes between the parties
arising from this Agreement (including, but not limited to, disputes regarding
alleged defaults), and in case this Agreement does not specifically provide for
how to resolve such disputes or prescribe that one party has final
decision-making authority with respect to such dispute, the parties shall
discuss and negotiate in good faith a solution acceptable to both parties and in
the spirit of this Agreement. If after negotiating in good faith pursuant to the
foregoing sentence, the parties fail to reach agreement within thirty (30) days,
then the President and
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Chief Executive Officer of Dynavax and the Chief Executive Officer of Triangle
shall discuss in good faith an appropriate resolution to the dispute. If these
executives fail, after good faith discussions not to exceed thirty (30) days, to
reach an amicable agreement either party may demand binding arbitration pursuant
to Section 21.2 ("Arbitration"). The date of submission of the matter to
substrate shall be the "Dispute Date".
21.2 Arbitration. The following provisions shall govern any arbitration
pursuant to this Agreement.
(a) Arbitration shall be conducted in accordance with the Rules of
the American Arbitration Association. In the event of any conflict between the
Rules and this Section, the provisions of this Section shall govern. The
Arbitration shall be conducted in *** if arbitration is demanded by Dynavax or
*** if arbitration is demanded by Triangle.
(b) The Arbitration shall be heard by a panel of three arbitrators
(each an "Arbitrator"). Triangle and Dynavax shall each select one Arbitrator.
Such Arbitrators shall be attorneys, licensed to practice law in the state in
which the Arbitration is being held, actively engaged in the full-time practice
of law for a period of no less than seven (7) years. Such Arbitrators shall not
be affiliated, directly or indirectly, with the parties or the attorneys
representing the parties in the Arbitration and shall not have any prior
involvement in the matter. In the event that either party fails within fifteen
(15) days after the Dispute Date (i) to select an Arbitrator who, to its
knowledge, meets the requirements set forth in this subsection (b) and (ii) to
notify the other party of the selection, the other party will then have the
right to select such Arbitrator. The third Arbitrator shall be selected by
mutual agreement of the parties from a list of neutral arbitrators compiled by
the American Arbitration Association for
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the parties. The third Arbitrator shall not have any prior or current
relationship, direct or indirect, with any party to this Agreement. If the
parties to the Arbitration are unable to agree upon the third Arbitrator within
fifteen (15) days from the Dispute Date, the appointment of the third Arbitrator
shall be made as expeditiously as possible and in compliance with this Section
21.2 by the two Arbitrators selected by the parties. If those Arbitrators cannot
agree on the third Arbitrator within ten (10) days, then the third Arbitrator
shall be designated by the American Arbitration Association or the appropriate
designated representative thereof upon the written request of any party with
simultaneous notice of such request to the other party to the Arbitration. The
third Arbitrator shall preside over the panel of Arbitrators and the
Arbitration.
(c) The Arbitrators shall apply the substantive laws of the *** to
the validity, construction and interpretation of this Agreement as is applicable
to contracts made wholly performable within the state.
(d) The Arbitration shall be resolved no later than sixty (60) days
from the date of acceptance by the third Arbitrator of his or her appointment
unless otherwise agreed to by the parties to the Arbitration.
(e) Each party shall bear the expenses and costs of the Arbitrator
selected by the party. The third Arbitrator shall be compensated for services
rendered at the prevailing hourly rate of compensation and reimbursed for any
expenses incurred in connection with rendering such services. The non-prevailing
party shall bear the costs and expenses of compensation and reimbursement for
the third Arbitrator.
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(f) The decision of the Arbitrators shall be rendered in writing
and shall be final and binding and may be enforced at the request of either
party to the Arbitration in any United States District Court in the state where
the Arbitration takes place or any state court of such state having competent
jurisdiction. Such decision may not be appealed except upon a claim of bad faith
or fraud by the Arbitrators.
(g) This Article 21 shall not apply to issues relating to the
validity, construction or effect of the Dynavax Patents. In the event that, in
any Arbitration, any issue arises concerning the validity, construction or
effect of any of the Dynavax Patents, the Arbitrators shall assume the validity
of all claims as set forth in such Dynavax Patents. Matters, controversies or
disputes concerning the Dynavax Patents shall be resolved in any court having
jurisdiction thereof or in any other manner mutually agreed to by the parties.
74
ARTICLE 22. GENERAL PROVISIONS
22.1 Export Controls. Dynavax acknowledges that Triangle is subject to
United States laws and regulations controlling the export of technical data,
biological materials, chemical compositions and other commodities and that
Triangle's obligations under this Agreement are contingent upon compliance with
applicable United States export laws and regulations. The transfer of technical
data, biological materials, chemical compositions and commodities may require a
license from the cognizant agency of the United States government or written
assurances by Dynavax that Dynavax shall not export data or commodities to
certain foreign countries without the prior approval of certain United States
agencies, or as otherwise prescribed by applicable law or regulation. Triangle
neither represents that an export license shall not be required nor that, if
required, such export license shall issue.
22.2 Independent Contractors. It is understood and agreed that the
parties hereto are independent contractors and are engaged in the operation of
their own respective businesses, and neither party hereto is to be considered
the agent of the other party for any purpose whatsoever, and neither party shall
have any authority to enter into any contracts or assume any obligations for the
other party nor make any warranties or representations on behalf of that other
party.
22.3 Patent Marking. Triangle shall xxxx Licensed Products sold in the
United States with United States patent numbers. Licensed Products manufactured
or sold in other countries shall be marked in compliance with the intellectual
property laws in force in such countries. The foregoing obligations shall be
subject to size and space limitations. If Dynavax believes that a Licensed
Product should be marked with the number of a Dynavax
75
Patent, Dynavax shall provide written notice to Triangle which identifies the
patent number and the Licensed Product on which it should appear. It shall also
be Dynavax' responsibility to inform Triangle in writing when marking with a
Dynavax Patent number should be discontinued. To the extent that Triangle
complies with Dynavax' instructions, Dynavax shall indemnify and hold Triangle
harmless for any liability, claim or action for false patent marking or
non-marking.
22.4 Publicity. The parties agree to issue mutual press releases
concerning their entry into this Agreement, with the content of such releases to
be approved (which consent shall not be unreasonably withheld or delayed) in
advance by the parties. In all other respects, except as required by law,
neither party shall use the name of the other party in any publicity release
without the prior written permission of such other party, which shall not be
unreasonably withheld. The other party shall have a reasonable opportunity to
review and comment on any such proposed publicity release. Except as required by
law, neither party shall publicly disclose the terms of this Agreement or issue
any publicity release with regard thereto unless expressly authorized to do so
by the other party which authorization shall be agreed upon.
22.5 Governing Law. This Agreement and all amendments, modifications,
alterations, or supplements hereto, and the rights of the parties hereunder,
shall be construed under and governed by the laws of the ***, exclusive of its
conflicts of laws principles.
22.6 Entire Agreement. This Agreement, together with the Exhibits
attached hereto, constitutes the entire agreement between Dynavax and Triangle
with respect to the subject matter hereof and shall not be modified, amended or
terminated, except as herein
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76
provided or except by another agreement in writing executed by the parties
hereto. Upon the Effective Date, the Confidentiality Agreement shall terminate.
22.7 Waiver. No provision of this Agreement may be waived except by a
writing signed by the party entitled to the benefit thereof, and no such waiver
of any provision hereof in one instance shall constitute a waiver of any other
provision or of such provision in any other instance. No omission, delay or
failure on the part of any party hereto in exercising any rights hereunder will
constitute a waiver of such rights or of any other rights hereunder.
22.8 Severability. All rights and restrictions contained herein may be
exercised and shall be applicable and binding only to the extent that they do
not violate any applicable laws and are intended to be limited to the extent
necessary so that they will not render this Agreement illegal, invalid or
unenforceable. If any provision or portion of any provision of this Agreement,
not essential to the commercial purpose of this Agreement, shall be held to be
illegal, invalid or unenforceable by a court of competent jurisdiction, it is
the intention of the parties that the remaining provisions or portions thereof
shall constitute their agreement with respect to the subject matter hereof, and
all such remaining provisions, or portions thereof, shall remain in full force
and effect. To the extent legally permissible, any illegal, invalid or
unenforceable provision of this Agreement shall be replaced by a valid provision
which shall implement the commercial purpose of the illegal, invalid, or
unenforceable provision. In the event that any provision essential to the
commercial purpose of this Agreement is held to be illegal, invalid or
unenforceable and cannot be replaced by a valid provision which will implement
the commercial purpose of this Agreement, this Agreement and the rights granted
herein shall terminate.
77
22.9 Force Majeure.
(a) Any delays in, or failure of performance of, any party to this
Agreement, shall not constitute a default hereunder, or give rise to any claim
for damages, if and to the extent caused by occurrences beyond the control of
the party affected, including, but not limited to, acts of God, strikes or other
concerted acts of workmen, civil disturbances, fires, floods, explosions, riots,
war, rebellion, sabotage, acts of governmental authority or failure of
governmental authority to issue licenses or approvals which may be required
("Force Majeure"), provided that any such delay shall not extend for more than
twelve (12) months.
(b) The party asserting the Force Majeure shall promptly notify the
other party of the event constituting Force Majeure and of all relevant details
of the occurrence and where appropriate an estimate of how long such Force
Majeure event shall continue.
(c) If such Force Majeure event continues thereafter and in any
event, the parties shall consult with each other in order to find a fair
solution and shall use all reasonable endeavors to minimize the consequences of
such Force Majeure.
22.10 Counterparts. This Agreement may be executed in one or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
22.11 Notices. All notices, statements, and reports required to be given
under this Agreement shall be in writing and shall be deemed to have been given
upon delivery in person or, when deposited (a) in the mail in the country of
residence of the party giving the notice, registered or certified postage
prepaid or (b) with a professional courier service (e.g., FedEx or UPS), and
addressed as follows:
78
To Dynavax: Dynavax Technologies Corporation
Attention: President and Chief Executive Officer
000 Xxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxx, Xxxxxxxxxx 00000
Facsimile: (000) 000-0000
To Triangle: Triangle Pharmaceuticals, Inc.
Attention: Xxxxx X. Xxxxxx, Executive Vice President
Business Development, General Counsel
(By Express Courier): 0 Xxxxxxxxxx Xxxxx, 0000 Xxxxxxxxxx Xxxxx
Xxxxxx, XX 00000
(By Mail): X.X. Xxx 00000
Xxxxxx, XX 00000-0000
Facsimile: (000) 000-0000
Any party hereto may change the address to which notices to such party are to be
sent by giving notice to the other party at the address and in the manner
provided above. Any notice may be given, in addition to the manner set forth
above, by telex, facsimile or cable, provided that the party giving such notice
obtains acknowledgment by telex, facsimile or cable that such notice has been
received by the party to be notified. Notices made in this manner shall be
deemed to have been given when such acknowledgment has been transmitted.
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79
IN WITNESS WHEREOF, Dynavax and Triangle have caused this Agreement to be
signed by their duly authorized representatives, under seal, as of the day and
year indicated above.
DYNAVAX TECHNOLOGIES CORPORATION
By: /s/ Dino Dina
------------------------------------------
Title:
----------------------------------------
TRIANGLE PHARMACEUTICALS, INC.
By: /s/ Xxxxx X. Xxxxxx
------------------------------------------
Title: President and COO
----------------------------------------
[SIGNATURE PAGE FOR DYNAVAX/TRIANGLE LICENSE AGREEMENT]
80
EXHIBIT A
DYNAVAX PATENTS
Note: Only pending US cases are listed. None of the following have issued as
patents.
------------------------------------------------------------------------------
Docket No. Country Serial No. Filing Date
------------------------------------------------------------------------------
***
------------------------------------------------------------------------------
20024.41 Australia 18418/97 January 28, 1997
------------------------------------------------------------------------------
00000.00 Xxxxx 09-527752 January 28, 1997
------------------------------------------------------------------------------
20024.43 Canada 2,244,946 January 28, 1997
------------------------------------------------------------------------------
20024.44 Europe 97903998.9 January 28, 1997
------------------------------------------------------------------------------
------------------------------------------------------------------------------
***
------------------------------------------------------------------------------
20025.41 Australia 49921/97 October 9, 1997
------------------------------------------------------------------------------
00000.00 Xxxxx 10-518649 October 9, 1997
------------------------------------------------------------------------------
20025.43 Canada 2,268,825 October 9, 1997
------------------------------------------------------------------------------
20025.44 Europe 97912831 October 9, 1997
------------------------------------------------------------------------------
------------------------------------------------------------------------------
***
------------------------------------------------------------------------------
20027.40 PCT PCT/US98/18382 September 4, 1998
------------------------------------------------------------------------------
20027.41 Europe 98945877.3 September 4, 1998
------------------------------------------------------------------------------
20027.42 Australia Unassigned(1) September 4, 1998
------------------------------------------------------------------------------
20027.43 Canada Unassigned(1) September 4, 1998
------------------------------------------------------------------------------
20027.44 Japan Unassigned(1) September 4, 1998
------------------------------------------------------------------------------
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(1) based on PCT/US98/18382
A-1
------------------------------------------------------------------------------
Docket No. Country Serial No. Filing Date
------------------------------------------------------------------------------
***
------------------------------------------------------------------------------
20004.41 Australia 78178/98 June 5, 1998
------------------------------------------------------------------------------
20004.42 Canada 2,291,483 June 5, 1998
------------------------------------------------------------------------------
20004.43 Europe 98926311.6 June 5, 1998
------------------------------------------------------------------------------
20004.44 Japan Unassigned(2) June 5, 1998
------------------------------------------------------------------------------
------------------------------------------------------------------------------
***
------------------------------------------------------------------------------
20002.40 PCT PCT/US99/12538 June 4, 1999
------------------------------------------------------------------------------
------------------------------------------------------------------------------
***
------------------------------------------------------------------------------
20007.40 PCT PCT/US99/23677 October 9, 1999
------------------------------------------------------------------------------
------------------------------------------------------------------------------
***
------------------------------------------------------------------------------
------------------------------------------------------------------------------
***
------------------------------------------------------------------------------
------------------------------------------------------------------------------
------------------------------------------------------------------------------
------------------------------------------------------------------------------
------------------------------------------------------------------------------
------------------------------------------------------------------------------
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(2) based on PCT/US98/11578
A-2
EXHIBIT B
SCOPE OF WORK UNDER RESEARCH PROGRAM
Dynavax-Triangle HBV/ISS Research Program
Months ***
***
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Confidential Treatment and filed separately with the Commission.
B-1
Months ***
***
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B-2
EXHIBIT C
AMENDMENT NUMBER 4
to
EXCLUSIVE LICENSE AGREEMENT
between
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
and
DYNAVAX TECHNOLOGIES CORPORATION
This AMENDMENT NUMBER 4, dated as of ________________, 2000, and effective
in accordance with Paragraph 6 hereof, by and between the THE REGENTS OF THE
UNIVERSITY OF CALIFORNIA, a California corporation having its statewide
administrative offices 0000 Xxxxxxxx Xxxxxx, 00xx Xxxxx, Xxxxxxx, Xxxxxxxxxx
00000-0000 ("THE REGENTS") and DYNAVAX TECHNOLOGIES CORPORATION, with offices
located at 000 Xxxxxx Xxxxxx, Xxxxx 000, Xxxxxxxx, Xxxxxxxxxx 00000
("LICENSEE").
WITNESSETH:
WHEREAS,THE REGENTS and LICENSEE have entered into an Exclusive License
Agreement for Administration of Naked Nucleotides which Express Biologically
Active Peptides and Immunostimulatory Oligonucleotide Conjugates, effective ***
(the "Primary License Agreement"); and
WHEREAS, LICENSEE and TRIANGLE PHARMACEUTICALS, INC., a Delaware
corporation with offices located at 4 University Place, 4611 University Drive,
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C-1
Xxxxxx, Xxxxx Xxxxxxxx 00000 ("TRIANGLE") have entered into a license agreement,
dated as of even date herewith (the "Triangle Sublicense Agreement"), pursuant
to which LICENSEE has granted TRIANGLE an exclusive sublicense to the Dynavax
Patents and Dynavax Know-How within the Fields (each as defined in the Triangle
Sublicense Agreement), in the entire world; and
WHEREAS, TRIANGLE has requested that LICENSEE and THE REGENTS execute this
Amendment Number 4 in order, inter alia, to reconcile certain inconsistencies
between this Primary License Agreement and the Triangle Sublicense Agreement and
LICENSEE and THE REGENTS are willing to do so;
NOW, THEREFORE, THE REGENTS and LICENSEE agree as follows:
1. All capitalized terms used in this Amendment Number 4 and not defined in
this Amendment Number 4 shall have the meanings given them in the Primary
License Agreement, except as otherwise explicitly set forth herein.
2. THE REGENTS confirm that the Primary License Agreement is in full force
and effect and THE REGENTS are not aware of any breach thereof by any
party thereto.
3. As of the date hereof, LICENSEE has complied with its diligence
obligations set forth in Article 9 of the Primary License Agreement.
4. The following *** is added to the Primary License Agreement:
***
5. THE REGENTS and LICENSEE agree not to amend the Primary License Agreement
in any manner which would adversely affect TRIANGLE's rights and
obligations under the Triangle Sublicense Agreement. Any such purported
amendment, without TRIANGLE's prior written consent (which Triangle may
withhold at its sole
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C-2
discretion), shall be void. THE REGENTS and LICENSEE agree to give
TRIANGLE at least thirty (30) days' notice of any other proposed amendment
to the Primary License Agreement (including a true and correct copy
thereof) and will not enter into such an amendment if prior to such thirty
(30) days' TRIANGLE identifies any provisions contained in such proposed
amendment which would adversely affect the rights and obligations of
TRIANGLE under the Triangle Sublicense Agreement. If TRIANGLE gives such
notice in a timely fashion, the parties will meet in an attempt to
mutually agree on acceptable terms of such amendment or, in lieu thereof,
THE REGENTS and LICENSEE may enter into such amendment deleting the
adverse provisions identified in TRIANGLE's notice.
6. This Amendment Number 4 shall become effective upon the Effective Date of
the Triangle Sublicense Agreement (as defined therein) provided, however,
that in the event the Triangle Sublicense Agreement terminates in one or
more countries, this Amendment Number 4 shall terminate automatically in
respect of such countries.
7. Except as otherwise expressly amended hereby, the Primary License
Agreement remains in full force and effect.
8. This Amendment Number 4 may be executed in one or more counterparts, each
of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
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C-3
IN WITNESS WHEREOF, the parties have caused this Amendment to be executed
by their duly authorized representatives, under seal, as of the date set forth
above.
LICENSOR: LICENSEE:
THE REGENTS OF THE DYNAVAX TECHNOLOGIES
UNIVERSITY OF CALIFORNIA CORPORATION
By: By:
------------------------------ ------------------------------
Name: Name:
Title: Title:
[Corporate Seal] [Corporate Seal]
[SIGNATURE PAGE TO AMENDMENT NO. 4]
C-4
