EXHIBIT 10.1
AMENDED AND RESTATED
LICENSE AGREEMENT
BETWEEN
DYNAVAX TECHNOLOGIES CORPORATION
AND
TRIANGLE PHARMACEUTICALS, INC.
TABLE OF CONTENTS
ARTICLE 1. DEFINITIONS......................................................................................2
ARTICLE 2. LICENSES........................................................................................10
ARTICLE 3. ROYALTIES AND MILESTONE PAYMENTS................................................................14
ARTICLE 4. REPORTS AND ACCOUNTING..........................................................................19
ARTICLE 5. PAYMENTS........................................................................................21
ARTICLE 6. RESEARCH PROGRAM................................................................................22
ARTICLE 7. DEVELOPMENT MILESTONES..........................................................................25
ARTICLE 8. JOINT PROJECT COMMITTEE.........................................................................26
ARTICLE 9. SUPPLY AND MANUFACTURE..........................................................................28
ARTICLE 10. PATENT PROSECUTION.............................................................................32
ARTICLE 11. INFRINGEMENT...................................................................................35
ARTICLE 12. TRANSFER OF KNOW-HOW; TECHNICAL ASSISTANCE.....................................................38
ARTICLE 13. WARRANTIES AND REPRESENTATIONS; LIMITATION OF LIABILITY; DISCLAIMERS; AND COVENANTS............39
ARTICLE 14. INDEMNIFICATION................................................................................43
ARTICLE 15. CONFIDENTIALITY................................................................................44
ARTICLE 16. TERM AND TERMINATION...........................................................................46
ARTICLE 17. ASSIGNMENT.....................................................................................50
ARTICLE 18. REGISTRATION OF LICENSE........................................................................50
ARTICLE 19. NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT....50
ARTICLE 20. DISPUTE RESOLUTION AND ARBITRATION.............................................................52
ARTICLE 21. GENERAL PROVISIONS.............................................................................53
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THIS AMENDED AND RESTATED
LICENSE AGREEMENT originally was made and
entered into as of the 31st day of March, 2000 and is amended and restated as of
the 25th day of September, 2002, 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
WHEREAS, Dynavax and Triangle entered into a
License Agreement dated as
of March 31, 2000 (the "Original
License Agreement") concerning a collaboration
to develop immunostimulatory oligonucleotide-based vaccines and therapies, as
described therein, which they now desire to amend and restate as set forth
herein, including without limitation to restrict substantially the scope of the
licenses granted by Dynavax to Triangle hereunder primarily to the treatment of
HBV (as defined below) by eliminating several other disease indications included
in the Original
License Agreement (with the corresponding rights reverting back
to
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Dynavax); and, in consideration thereof, to substantially increase Dynavax'
obligations under the Research Program (as defined below), including by adding
*** worth of services to be performed by Dynavax, all as set forth
below;
NOW, THEREFORE, in consideration of the premises and the covenants herein
contained, the parties hereby amend and restate the Original
License Agreement
in its entirety and 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., Compound
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.
1.3 "Agreement" or "
License Agreement" shall mean this Agreement,
including all Exhibits attached to this Agreement, which are hereby incorporated
by reference, in each case as amended by the parties from time to time in
accordance with this Agreement.
1.4 "Antigen" shall mean a Hepatitis B viral antigen which, when
injected or otherwise
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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 "Compound ISS" shall mean any ISS which is *** . For the
avoidance of doubt, this specifically includes instances where *** .
Notwithstanding the foregoing, in the case of prophylaxis of HBV, Compound ISS
does not include instances where *** .
1.7 "Development Program" shall mean Triangle's development program
through the milestones described in Article 7 of this Agreement.
1.8 "Dollars" shall mean United States dollars.
1.9 "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.
1.10 "Dynavax Know-How" shall mean all inventions, discoveries, trade
secrets, information, experience, data, formulas, procedures and results which
are rightfully held by 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 16 including, but not limited to, all manufacturing and synthesis
know-how; provided that, for purposes of this Section 1.10, Dynavax Know-How
shall include only such inventions, discoveries, trade secrets, information,
experience, data, formulas, procedures and results which are reasonably useful
for the development, registration, manufacturing, using or selling of Compound
ISS or the Licensed Products. 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 as of the Effective Date.
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1.11 "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 useful for the development, registration, manufacturing,
using or selling of Compound 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 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. Dynavax
shall notify Triangle in writing of additions or changes to the Dynavax patents
and any proceedings or interference related thereto. It is the parties'
intention that Exhibit A identify all Dynavax Patents; however, the omission of
a particular patent or patent application from Exhibit A shall not affect the
scope of the definition of "Dynavax Patents".
1.12 "Effective Date" shall mean March 31, 2000.
1.13 "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.
1.14 "FDA" shall mean the United States Food and Drug Administration or
any successor entity.
1.15 "Field" shall mean the treatment and prophylaxis of HBV .
1.16 "Finished Drug Substance" shall mean Compound ISS in formulated
and finished form suitable for preclinical or clinical use, including such other
active and inactive ingredients as are specified by Triangle.
1.17 "Forms of Administration" shall mean injectable, oral, topical and
pulmonary inhalation forms of administration.
1.18 "Future Dynavax Patents" shall mean all patents and patent
applications in the Territory
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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 which contain claims
covering inventions or discoveries reduced to practice, actually or
constructively, on or after the *** anniversary of the expiration of the
Research Program the rights to which are reasonably useful for the development,
registration, manufacturing, using or selling of Compound 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.
1.19 "HBV" shall mean hepatitis B virus.
1.20 "IND" shall mean an Investigational New Drug Application or its
U.S. or foreign equivalent.
1.21 "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 1.21(a) and 1.21(b) above, as applicable.
1.22 "ISS" shall mean any immunostimulatory oligonucleotide (without
limitation as to structure or length) containing a nucleic acid sequence which
can activate or stimulate an 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.
1.23 "Joint Inventions" shall mean any inventions related to Compound
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 16 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
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license patent rights covering such inventions to Triangle.
1.24 "Joint Know-How" shall mean all inventions, discoveries, trade
secrets, information, data, formulas, procedures and results which are
reasonably useful for the development, registration, manufacturing, using or
selling of the Compound 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 16. 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 Field (except for the prophylaxis of HBV using *** ,
unless the license granted pursuant to Section 2.1 is terminated in a given
country or countries of the Territory, in which case, Dynavax shall have a
non-exclusive right to use the Joint Know-How in such country or countries in
the Field. Dynavax and Triangle shall each have a non-exclusive right to use the
Joint Know-How outside the Field and for the prophylaxis of HBV using *** .
1.25 "Joint Project Committee" shall mean the committee described in
Article 8 hereof.
1.26 "Licensed Product(s)" shall mean any Compound ISS or any
pharmaceutical product containing one or more Compound ISS as an active
ingredient, alone or in combination with other active ingredients (including
ISS) or inactive ingredients, for administration in accordance with the Forms of
Administration. For the avoidance of doubt, Licensed Products may include (a)
ISS together with Compound ISS and (b) any pharmaceutical product containing one
or more ISS together with Compound ISS, but shall not include (x) ISS in the
absence of Compound ISS or (y) any pharmaceutical product containing one or more
ISS in the absence of Compound ISS.
1.27 "Major Market Country" shall mean *** except that, in the
case of Subsection 3.1(a)(i), *** shall also be deemed to be a Major
Market Country.
1.28 "Manufacturing Cost," in respect of a particular item (e.g.,
Compound ISS or another active ingredient), shall mean the costs of direct labor
(including allocable employee benefits and employment taxes),
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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 the manufacturing facility), all determined in
accordance with U.S. GAAP.
1.29 "NDA" shall mean a New Drug Application or its U.S. or foreign
equivalent.
1.30 "Net Sales" of Licensed Products which contain as their active
ingredients only one or more Compound 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.
1.31 "Net Sales" of Licensed Products which contain as their active
ingredients both one or more Compound ISS and other active ingredients (it being
understood, for the avoidance of doubt, that any Antigens or ISS shall not
constitute "other active ingredients" and shall be included with the Compound
ISS for calculations under this Section 1.31) (a "Combination 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 1.30
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multiplied by a fraction, the numerator of which shall be the *** and the
denominator of which shall be *** , 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, multiplied by a fraction as contemplated above. 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, multiplied by a fraction as contemplated above.
1.32 "Patent Filing Countries" shall mean the *** .
1.33 "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 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.
1.34 "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.
1.35 "Research Program" shall mean the research program described in
Article 6 of this Agreement.
1.36 "Restatement Date" shall mean September 25, 2002.
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1.37 "Territory" shall mean the entire world.
1.38 "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 16;
provided that, for purposes of this Section 1.38, Triangle Know-How shall
include only such inventions, discoveries, trade secrets, information,
experience, data, formulas, procedures and results reasonably useful 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, noncancellable
contractual nondisclosure obligations applicable to Triangle as of the Effective
Date.
1.39 "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 useful for the development, registration,
manufacturing, using or selling of Compound 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.
1.40 "U.S. GAAP" shall mean generally accepted accounting principles in
the United States, consistently applied.
1.41 "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 interference or
opposition proceeding.
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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 Field
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 Field 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 *** 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 *** for the initial Licensed Product,
Triangle may grant sublicenses to non-Affiliate third parties without Dynavax'
consent. 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 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 16.2
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
Field, with a right to sublicense in such country from and after the
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date of termination only to the extent such license granted under Section 2.1
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 Field in the
Territory to the extent and only to the extent necessary to fulfill its
obligations under Articles 6 and 9 of this Agreement. Furthermore, Dynavax
reserves and retains all rights not expressly granted under 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,
licensees, or sublicensees, as applicable, will assert against the other party
(a "licensed party") or its Affiliates or sublicensees any Future 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 and Approval.
(a) If, at any time during the term hereof, Dynavax
elects to grant a license with respect to any Compound ISS or any pharmaceutical
product containing one or more Compound ISS as an active ingredient, alone or in
combination with other active ingredients, for use in the Field and administered
by any means other than the Forms of Administration, it shall give prompt notice
thereof to Triangle. Thereafter, Triangle shall have *** to notify
Dynavax whether Triangle is interested in commencing negotiations to obtain such
a license. If Triangle does not give such notice within such *** 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 *** , 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
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respect to the administration of Compound ISS or pharmaceutical products
containing Compound ISS for use in the Field by means other than the Forms of
Administration, Dynavax agrees that, for a period of *** after cessation of
such negotiations, it will not offer a license with respect to the
administration of Compound ISS or pharmaceutical products containing Compound
ISS for use in the Field by means other than the Forms of Administration
substantially similar to the license offered to Triangle at the end of such
negotiations to a third party containing financial terms more favorable to the
licensee 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 *** 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.
(b) If, at any time during the term hereof, Dynavax
elects to grant a license with respect to any Future Dynavax Patents in the
Field (other than solely for prophylaxis of HBV), it shall give prompt notice
thereof to Triangle. Thereafter, Triangle shall have *** to notify
Dynavax whether Triangle is interested in commencing negotiations to obtain such
a license. If Triangle does not give such notice within such *** 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 such Future Dynavax Patents in the Field. If Triangle gives such
notice within such *** , 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 Field, Dynavax agrees that, for a period of
*** after cessation of such negotiations, it will not offer a license
to Future Dynavax Patents in the Field substantially similar to the license
offered to Triangle at the end of such negotiations to a third party containing
financial terms more favorable to the licensee 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 *** 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, Triangle
desires to develop a Licensed Product for *** , Triangle shall give prompt
notice thereof to Dynavax. Thereafter,
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Dynavax shall have *** to grant or deny approval for Triangle's proposed
development. Dynavax will not withhold approval of Triangle's development
proposal unreasonably, and Dynavax' failure to deny Triangle's proposal in
writing within such *** will be deemed to constitute approval thereof.
Triangle shall not develop a *** without Dynavax' approval pursuant to
this Section.
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 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. Sections 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 Field. 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 Field. 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 Compound ISS or any
pharmaceutical product containing one or more Compound ISS as an active
ingredient,
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alone or in combination with other active ingredients or inactive ingredients,
by it, its sublicensees, Affiliates and distributors for administration by any
means other than the Forms of Administration for use in the Field. Dynavax shall
use its reasonable efforts to avoid the development, promotion and sales of any
Dynavax Products (as defined below) by it, its other licensees, Affiliates and
distributors for indications in the Field *** . As used above, "Dynavax
Products" means any pharmaceutical product containing one or more ISS or
Compound ISS as an active ingredient, alone or in combination with other active
ingredients or inactive ingredients.
ARTICLE 3. ROYALTIES
AND MILESTONE PAYMENTS
3.1 Milestone Payments.
(a) Triangle shall pay Dynavax a milestone payment ("Milestone
Payment") in the amount specified below no later than *** 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.
Milestone
Event Payment
*** ***
Total Milestone Payments ***
(b) With respect to any Milestone Payment payable pursuant to
Subsection 3.1(a)(iii) above based on *** which requires ***, *** of
such Milestone Payment will be payable upon *** , and *** of such
Milestone Payment will be payable upon ***.
3.2 Earned Royalties; Duration and Reduction.
(a) Triangle shall pay Dynavax a royalty equal to *** of
the Net Sales of Licensed Products sold in the Territory by Triangle and its
Affiliates and sublicensees for the periods and
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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 *** 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
3.2(b) above, (i) 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 Compound 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 3.2(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 *** 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 *** , 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 *** to
***. If in Royalty Period 2, such unlicensed unit sales were *** of
Triangle's unit sales of such Licensed Product in such country during Royalty
Period 2, then in the next succeeding royalty period ("Royalty Period 3"),
Triangle's royalty rate on Net Sales of
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Licensed Products in such country would be only subject to a *** reduction
and Triangle would pay royalties at a rate of *** during Royalty Period 3.
(d) For purposes of this Section 3.2, (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 3.2(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.
3.3 Annual Minimum Royalties. In the event that, during the ***
full calendar year following the year during which the U.S. Registration for the
treatment of HBV 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 3.2 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 difference between such Annual
Minimum and the royalties paid to Dynavax for such year pursuant to Section 3.2
above:
Calendar Year Annual Minimum
*** ***
3.4 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
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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, no 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.
3.5 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 as follows. If such license relates to Compound ISS per se or the use
of Compound ISS (other than solely due to the Antigen or the use thereof),
Triangle may credit *** of any Third Party Royalties up to *** of Net
Sales of Licensed Products and *** of the amount of any Third Party
Royalties in excess of *** of Net Sales of Licensed Products. For all
other Third Party Licenses, Triangle may credit *** 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 3.5 by more than
*** of the amount which would have been otherwise payable. In the event
Triangle enters into a Third Party License pursuant to this Section 3.5, 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.
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3.6 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.
3.7 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 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 *** 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 3.7.
3.8 Royalty Rate Floor. Any provision of this Agreement to the
contrary other than Sections 11.4 and 13.6 notwithstanding, the royalty rate on
Net Sales of Licensed Products as set forth in Subsection 3.2(a) shall not be
reduced to less than *** as a result of the applicability of the royalty
rate reduction provisions set forth herein.
3.9 *** . To the extent that the actual Acquisition Cost for
*** (including any royalty or other cost specific to the acquisition of the
***) for a Licensed Product exceeds the sum of (y) ***, plus (z) ***,
Triangle may credit *** of such excess, if any, against royalties payable to
Dynavax under this Agreement. This credit shall be in addition to any other
credits against royalties
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provided under this Agreement.
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 covering 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 1.30 and 1.31; and
(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. In 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 in accordance with U.S.
19
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 calendar 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 this 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:
(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
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final royalty payment hereunder. Upon the expiration of *** 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 *** .
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 *** 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 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 fifteen (15) 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
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payment shall accrue interest (beginning on the date such payment is due)
calculated at the rate of *** 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.
ARTICLE 6. RESEARCH PROGRAM
6.1 Research Obligations; Funding.
(a) In addition to the payments set forth in Article 3 hereof,
Triangle and Dynavax agree 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"). Specifically
(but without limitation), Triangle will provide *** in funding and Dynavax
will provide *** worth of services under the Research Program. Dynavax
agrees to have the Research Program conducted under the supervision of
qualified, full-time employees of Dynavax.
(b) The Research Program and specific work to be conducted by
Dynavax thereunder shall be mutually agreed upon in good faith by the parties
hereto as promptly as practicable after the Restatement Date, but in no event
later than *** and, upon such agreement, the Research Program shall be
incorporated into Exhibit B, as attached hereto and made a part hereof. If at
any time during the period from the Restatement Date through *** ,
Triangle in its sole discretion determines that an acceptable Research Program
cannot be agreed to with Dynavax, Triangle has the right to immediately
terminate this Agreement which termination shall become effective upon written
notice to Dynavax. If, despite the reasonable best efforts of both Triangle and
Dynavax, they are not able to agree upon a Research Program by ***, either
party may, prior to agreement on a Research Plan, thereafter terminate this
Agreement immediately upon written notice to the other.
(c) Dynavax will conduct the Research Program on the schedule
and other terms set forth therein. 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
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or delayed. Dynavax agrees to provide Triangle with a written quarterly report
within ten (10) days after the end of each quarter summarizing the results of
the Research Program for the immediately preceding quarter. Each quarterly and
other report provided by Dynavax in connection with the Research Program shall
conform to the guidelines contained in Exhibit B attached hereto and made a part
hereof.
(d) Unless this Agreement or Triangle's funding obligation is
sooner terminated pursuant to the terms hereof, the term of the Research Program
shall commence on the first day of the month following the parties' agreement on
the Research Program as provided in Section 6.1(b) above and continue for ***
from that date.
(e) In full consideration of Dynavax' timely performance of its
obligations under the Research Program, Triangle has paid Dynavax *** for
each of the first six (6) quarters under this Agreement and *** during each
quarter therefrom to the Restatement Date for services rendered, and, unless
sooner terminated, will pay Dynavax *** in respect of the term of the
to-be-agreed Research Program on the schedule specified in subsection (f) below,
provided Triangle shall not be obligated to make any such payments unless and
until the parties have agreed upon a corresponding Research Program as required
in subsection (b) above. If Dynavax fails to conduct the Research Program as
specified therein, Triangle, without limiting any other available remedy, may
(x) withhold any subsequent payment(s) required under this Section until Dynavax
brings the Research Program fully current to such payment(s), and/or (y)
terminate this Agreement pursuant to Section 16.2(a).
(f) Triangle will pay its Research Program funding (referred to
above) in the manner specified in this subsection. Triangle will make a
quarterly research payment of *** to Dynavax on the first day of the
month following the date Triangle and Dynavax agree on and incorporate the
Research Program into this Agreement. Thereafter, after completion of each of
the next *** subsequent three-month periods during the Research Program,
Triangle will pay Dynavax a quarterly research payment of *** . These
payments will be due ten days following the later of 1) the end of the previous
three month period or 2) receipt by Triangle of the quarterly report from
Dynavax as described in Section 6.1(c) for
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the previous period. In the event of expiration or termination of the Research
Program or this Agreement prior to completion of the Research Program, the
provisions of Section 16.5 shall apply.
(g) Dynavax will use the amounts paid by Triangle under Section
6.1(e) solely for purposes of conducting 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,
or otherwise conduct the Research Program in a manner which would entitle any
third party to, 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.
(h) Any work proposed to be conducted by Dynavax in excess of
that in the Research Program shall be subject to a separate written agreement
between the parties.
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 "Results")
shall be the property of Dynavax, except to the extent they represent Joint
Inventions and/or Joint Know-How (which are owned jointly by both parties). 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, as applicable, and
shall be included in the license granted by 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
24
inventions and discoveries made by such person during the course of his or her
work performed under the Research Program.
6.3 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 MILESTONES
7.1 Development Milestones. Subject to Dynavax' timely performance of
its obligations hereunder, including those set forth in Articles 6 and 9, in the
event Triangle fails to meet the milestones set forth in Subsection 7.2(a),
Dynavax shall have the option to exercise the remedy set forth in Subsection
7.3.
7.2 Milestones.
(a) Subject to Subsection 7.1, Dynavax' remedy under Subsection
7.3 relates to achievement of the following milestones by Triangle:
(i) *** ; provided, however, that this milestone date
shall be subject to up to *** extensions of *** each, at Triangle's
election, by payment to Dynavax of *** for each such extension; and
(ii) *** ; provided, however, that this milestone date
shall be subject to up to *** extensions of *** each, at Triangle's
election, by payment to Dynavax of *** for each of such *** extensions
and *** for each of such *** extensions.
(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
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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 studies relating to the applicable
Licensed Product.
7.3 Dynavax Remedies.
(a) In the event Triangle fails to meet any milestone set forth
in Subsection 7.2(a) and does not demonstrate to Dynavax' reasonable
satisfaction that, despite Triangle's best efforts, the failure to meet the
milestone 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. 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 thirty (30) days' notice and shall meet with
Triangle, at Triangle's request, during such thirty (30) day period, to discuss
any disagreements about whether Triangle has complied with the applicable
milestones set forth of this Article 7. Upon expiration of such thirty (30) 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
milestone is fulfilled during such thirty (30) 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 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
26
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 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,
27
transparencies, presentation materials and press releases to the other party
(the "non-publishing party") for comments at least: (a) *** prior to
submission for publication or oral presentation in the case of full manuscripts;
(b) *** prior to submission for publication or oral presentation in the case
of abstracts; and (c) *** prior to publication in the case of press
releases, except, in the case of press releases, where 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 *** . 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 perform the Development Program at Dynavax' ***
therefor, as applicable. Triangle acknowledges that Dynavax may
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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, *** , 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 United States 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
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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 participation/observation
shall include, but not be limited to, assistance for Triangle in subsequently
implementing the same manufacturing in its facilities or those 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.
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(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.
Section 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 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. Section 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 Finished Drug Substance, as applicable. Triangle
shall have audit rights in respect of the Acquisition Costs or Manufacturing
Costs for the Finished Drug Substance 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 reasonably
cooperate, and shall cause its subcontractors to reasonably cooperate, with
Triangle and its contractor in connection with the transition of manufacture and
supply responsibilities.
9.3 Regulatory and Quality Assurance.
(a) Dynavax acknowledges that, except for its or any of its
subcontractor's 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 such data as are available to
Dynavax which are necessary for Triangle to fulfill all FDA and foreign
regulatory reporting requirements in respect of the Finished Drug Substance
supplied hereunder. Dynavax will use its best
31
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 solely 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 useful for the development, registration,
manufacture, use or sale of Compound ISS and the Licensed Products in the
Territory, and thereafter shall diligently and 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.
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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 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 have the
exclusive right to use such patent applications and patents in the Field in the
Territory *** (and Dynavax and its licensees and assignees shall be free
to use such patent applications and patents on a non-exclusive basis in the
Field 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), and each party shall be free
to use such patent applications and patents outside the Field and *** ,
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 request, provide all
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reasonable assistance and shall promptly reimburse Triangle with *** 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
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
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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 *** 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 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 this Agreement nor impose any
obligations on
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Triangle other than as explicitly set forth in this 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, 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 *** will be retained by Dynavax and *** 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 *** 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
*** of any royalties which are otherwise 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
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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: *** to Dynavax and *** 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 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 (except to the extent such action is based on
infringement due to matters other than Triangle's exercise of the licenses
granted under this Agreement), such as, for example, based on infringement due
to Triangle's manufacture, use or sale of Antigen contained within the Licensed
Product, reduce all royalty payments on its, its Affiliates' and sublicensees'
sales of Licensed Products allegedly infringing such third party's patent rights
by *** . 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
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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. Dynavax shall supply Triangle all Dynavax
Know-How developed by Dynavax during the term of this Agreement, with such
disclosure to be made at least on a quarterly basis or sooner, if practicable.
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; (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 Dynavax' subcontractors which are, or
will be, supplying any Finished Drug Substance; and
38
(ii) 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 *** anniversary of the
Effective Date, (i) Dynavax shall provide up to *** of such technical
assistance during each year of such period at Dynavax' sole expense and (ii)
subsequent to such *** 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 *** 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 *** 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 *** anniversary
of the Effective Date of this Agreement.
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 disclosure letters
(referencing the appropriate schedule or section number) supplied by Dynavax to
Triangle on or about the Effective Date (as to disclosures as of the Effective
Date) and on or about the Restatement Date (as to disclosures as of the
Restatement Date), that as of the Effective Date and as of the Restatement Date,
the following:
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(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 was a true, complete and accurate copy of
the Primary License Agreement as of the Effective Date, and the copy delivered
to Triangle on or about September 3, 2002 is true, complete and accurate as of
the Restatement Date;
(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, 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 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
40
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 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 the other that: (a) 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, nor any 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 DYNAVAX PATENTS OR
DYNAVAX KNOW-HOW.
13.4 Limitation of Liability.
41
(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
(c) provides the Indemnitees with product liability coverage in
an amount no less than *** per occurrence for bodily injury and ***
per occurrence for property damage, subject to a reasonable aggregate amount
not to exceed *** . Upon request, Triangle shall provide Dynavax with
certificates of insurance evidencing the above insurance coverage.
13.6 Special Dynavax Covenants. 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
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42
developments affecting this 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
royalty reductions prescribed in Article 3 hereof.
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 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
43
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; and (c) Dynavax' or, if
applicable, its subcontractor's negligence, intentional misconduct or breach of
contract in supplying Finished Drug Substance. Dynavax' obligations under this
Article shall survive expiration or termination of this Agreement for any
reason.
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 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
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44
"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 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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45
(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. TERM AND TERMINATION
16.1 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.
16.2 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
46
pursuant to the Section 16.2(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 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 16.2.
(c) Dynavax may terminate this Agreement as specified in
Section 7.3.
16.3 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; or (b) form of Licensed Product in respect of the treatment of
HBV, without affecting this Agreement in respect of other countries or forms of
Licensed Products.
16.4 Obligations Upon Termination.
(a) If this Agreement is terminated as a result of Triangle's
breach pursuant to Section 16.2, or is terminated by Dynavax in accordance with
Section 7.3 or in whole or in part by Triangle in accordance with Section 16.3,
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 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
47
permitted by law.
(b) If this Agreement is terminated by Triangle pursuant to
Section 6.1(b), Dynavax shall within ten (10) business days thereafter issue to
Triangle *** shares of Dynavax Preferred Stock (having rights, preferences
and privileges no less favorable than those granted to investors in Dynavax's
most recent round of financing) priced at *** per share (subject to
adjustments for any intervening stock splits or similar events) and cause
Triangle to be added as a party to Dynavax's current Investor Rights Agreement
(or equivalent) and any and all other instruments and agreements necessary to
give Triangle the full benefit of all rights granted to other purchasers of
Dynavax's Preferred Stock. In connection with such issuance, Triangle shall
execute such documents as may be necessary to add Triangle as a party and give
Triangle all such rights (subject to all corresponding obligations) referred to
above, and any related documents necessary to comply with applicable securities
laws.
(c) Dynavax 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.
16.5 Effect of Termination. In the event of any expiration or
termination pursuant to this Article 16, neither party shall have any remaining
rights or obligations under this Agreement other than as provided below or
elsewhere in this Agreement:
(a) Dynavax will have the right to receive all payments due
prior to the effective date of termination; provided, however, that no payments
under the Research Program shall accrue after the date notice of termination is
sent by either party to the other (i.e., no further obligation by Triangle to
provide further funding under the Research Program shall arise under the
Research Program during the period, if any, between the date notice of
termination is sent and the date such termination becomes effective);
(b) termination or expiration of this Agreement for any reason
shall have no effect on
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48
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 16.2 or by Triangle pursuant to Section 16.3, shall have no
effect on the rights and obligations of the parties under Section 16.4; and
(e) the parties' shall retain any other remedies for breach of
this Agreement they may otherwise have.
16.6 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
49
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 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 17. 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 18. 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.
ARTICLE 19. NOTIFICATION AND AUTHORIZATION UNDER DRUG PRICE COMPETITION
AND PATENT TERM RESTORATION ACT
19.1 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
50
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 Sections 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.
19.2 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 Section 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 Sections 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 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
19.2 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.
51
ARTICLE 20. DISPUTE RESOLUTION AND ARBITRATION
20.1 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 *** , then
the President and 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
*** , to reach an amicable agreement either party may demand binding
arbitration pursuant to Section 20.2 ("Arbitration"). The date of submission of
the matter to substrate shall be the "Dispute Date".
20.2 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 Durham, North Carolina if arbitration is
demanded by Dynavax or Berkeley, California 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 the parties. The third Arbitrator shall
not have any prior or current relationship, direct
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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 20.2 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
State of
New York 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.
(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 20 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.
ARTICLE 21. GENERAL PROVISIONS
21.1 Export Controls. Dynavax acknowledges that Triangle is subject to
United States laws and
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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.
21.2 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.
21.3 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 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.
21.4 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
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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.
21.5 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 State of
New York,
exclusive of its conflicts of laws principles.
21.6 Entire Agreement. This Agreement, together with the Exhibits
attached hereto, amends, restates and supersedes the Original License Agreement,
and as so amended and restated, 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 provided or except by another
agreement in writing executed by the parties hereto. Upon the Effective Date,
the Confidentiality Agreement shall terminate.
21.7 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.
21.8 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.
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21.9 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.
21.10 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.
21.11 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:
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: R. Xxxxxx Xxxxxx, 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
56
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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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: CEO
------------------------
TRIANGLE PHARMACEUTICALS, INC.
By: /s/ R. Xxxxxx Xxxxxx
------------------------
Title: Executive Vice President
------------------------
[SIGNATURE PAGE FOR DYNAVAX/TRIANGLE LICENSE AGREEMENT]
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