*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4),
200.83 AND 240.24B-2
Exhibit 10.94
AGREEMENT
Between
EPIMMUNE
And
BAVARIAN NORDIC
THIS AGREEMENT (the "Agreement"), effective as of November 28, 2001, by
and between BAVARIAN NORDIC A/S, a corporation organized under the laws of the
Kingdom of Denmark and having its principal place of business at Vesterbrogade
000, XX-0000 Xxxxxxxxxx X, Xxxxxxx, ("BAVARIAN NORDIC") and EPIMMUNE INC., a
corporation organized under the laws of the State of Delaware, U.S.A. and having
its principal place of business at 0000 Xxxxx Xxxxx Xxxxx, Xxx Xxxxx, Xxxxxxxxxx
00000, X.X.X. ("EPIMMUNE"). Each of EPIMMUNE and BAVARIAN NORDIC are a "Party;"
together they are the "Parties."
WITNESSETH:
WHEREAS, BAVARIAN NORDIC is a company which develops novel
pharmaceutical products utilizing its proprietary MVA-BN (as defined herein)
technology to design vaccines;
WHEREAS, EPIMMUNE, is a company which uses gene maps of
cancer-associated proteins and infectious agents to design vaccines that induce
cellular immunity;
WHEREAS, BAVARIAN NORDIC and EPIMMUNE are interested in working and
co-operating with each other to conduct a joint program for the discovery and
development of a vaccine for the treatment or prevention of HIV-infection in
humans upon the terms and conditions hereinafter set forth; and
WHEREAS, BAVARIAN NORDIC will retain rights to manufacture Program
Vaccines and the Program Vaccine portion of any BN-Combined Vaccine(s) or
EPI-Combined Vaccine(s) (each as defined herein), subject to the terms herein.
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NOW, THEREFORE, in consideration of the foregoing premises and in
consideration of the performance of the mutual covenants and promises herein
contained, BAVARIAN NORDIC and EPIMMUNE have agreed as follows:
ARTICLE 1
DEFINITIONS
As used in the Agreement each term listed below shall have the meaning,
which is given after it.
1.1 Affiliate. "Affiliate" shall mean any company, corporation or other
business entity controlling, controlled by, or under common control with
BAVARIAN NORDIC or EPIMMUNE, as the case may be, at any time during the term of
the Agreement. For purposes of this definition, the term "control" shall mean
the possession of the power to direct or cause the direction of the management
and policies of an entity, whether through the ownership of voting stock, by
contract or otherwise. In the case of a corporation, "control" shall mean the
direct or indirect ownership of more than fifty percent (50%) of the outstanding
voting stock.
1.2 Annual Budget. "Annual Budget" shall mean a budget setting forth all
Authorized R&D Expenses for a given time period.
1.3 Authorized R&D Expenses. "Authorized R&D Expenses" shall mean the
costs and expenses, including full-time equivalent costs, actually incurred by a
Party in connection with the Research and Development Program pursuant to this
Agreement, provided, such costs and expenses were approved pursuant to an Annual
Budget for the period of time in which such work was performed.
1.4 BAVARIAN NORDIC Background Technology. "BAVARIAN NORDIC Background
Technology" shall mean all inventions, improvements and/or discoveries, and all
intellectual property rights, including, without limitation, patents and patent
applications
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(including any foreign equivalents, additions, divisions, continuations,
continuations-in-part, substitutions, extensions, renewals or reissues thereof)
that cover such inventions, improvements and/or discoveries, that are owned or
licensed (with the right to further license or sublicense) by BAVARIAN NORDIC as
of the date of this Agreement or during the Research Term and are necessary or
useful to the Research and Development Program, whether or not patentable or
protectable through trade secret, including without limitation know-how, trade
secrets, research plans, technology, techniques and ideas and any biological
material, but excluding any Program Vaccines, BAVARIAN NORDIC Patent Rights,
Joint Patent Rights and BAVARIAN NORDIC Manufacturing Technology.
1.5 BAVARIAN NORDIC Manufacturing Technology. "BAVARIAN NORDIC
Manufacturing Technology" shall mean any inventions, improvements and/or
discoveries and all other intellectual property rights, including, without
limitation, patent and patent applications (including any foreign equivalents,
additions, divisions, continuations, continuations-in-part, substitutions,
extensions, renewals or reissues thereof) that cover such inventions,
improvements and /or discoveries, that are necessary or useful for the
manufacture of Program Vaccine(s) or the Program Vaccine portion of Combined
Vaccine(s), and are owned or licensed by BAVARIAN NORDIC (with the right to
further license or sublicense) as of the date of this Agreement or during the
Research Term.
1.6 BAVARIAN NORDIC Option. "BAVARIAN NORDIC Option" shall mean the
right of BAVARIAN NORDIC to commercialise Program Vaccine(s) under those
circumstances set forth in Section 6.5.
1.7 BAVARIAN NORDIC Patent Rights. The "BAVARIAN NORDIC Patent Rights"
shall mean all applications for patents covering any of the BAVARIAN NORDIC Sole
Inventions that are filed anywhere in the world, as well as any foreign
equivalents, additions, divisions, continuations, continuations-in-part,
substitutions, extensions or renewals therefor or reissues
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thereof and patents issuing thereon, but excluding all BAVARIAN NORDIC
Manufacturing Technology.
1.8 BN-Combination Option. "BN-Combination Option" shall mean the right
of BAVARIAN NORDIC to commercialise BN-Combined Vaccine(s) within the Field as
set forth in Section 6.5.
1.9 BN-Combined Vaccine(s). "BN-Combined Vaccine(s)" shall mean a
vaccine product for use within the Field comprised of a combination of
[...***...] and any other component(s) (as further set forth in Section 6.5),
provided however, that the other component(s) shall be vaccine product(s) based
on [...***...]
1.10 Combined Vaccine(s). "Combined Vaccine(s)" shall mean the
BN-Combined Vaccine(s) and/or the EPI-Combined Vaccine(s).
1.11 EPI-Combination Option. "EPI-Combination Option" shall mean the
right of EPIMMUNE to commercialise EPI-Combined Vaccine(s) within the Field as
set forth in Section 6.4.
1.12 EPI-Combined Vaccine(s). "EPI-Combined Vaccine(s)" shall mean a
vaccine product for use within the Field comprised of a combination of Program
Vaccine(s) and any other component(s) (as set forth in Section 6.4), provided
however, that the other component(s) shall be vaccine product(s) which
[...***...]
1.13 EPIMMUNE Background Technology. "EPIMMUNE Background Technology"
shall mean all inventions, improvements and/or discoveries, and all intellectual
property rights, including, without limitation, patents and patent applications
(including any foreign equivalents, additions, divisions, continuations,
continuations-in-part, substitutions, extensions, renewals or reissues thereof),
that cover such inventions, improvements and/or discoveries, that are owned or
licensed (with the right to further license or sublicense) by EPIMMUNE as of the
date of this Agreement or during the Research Term and are necessary or useful
to the Research and
*CONFIDENTIAL TREATMENT REQUESTED
4
Development Program, whether or not patentable or protectable through trade
secret, including without limitation know-how, trade secrets, research plans,
technology, techniques and ideas and any biological material, but excluding any
Program Vaccines, EPIMMUNE Patent Rights and Joint Patent Rights.
1.14 EPIMMUNE Epitope. "EPIMMUNE Epitope" shall mean any T-cell epitope
claimed or disclosed in EPIMMUNE Background Technology.
1.15 EPIMMUNE Option. "EPIMMUNE Option" shall mean the right of EPIMMUNE
to commercialise Program Vaccine(s) under those circumstances set forth in
Section 6.4.
1.16 EPIMMUNE Patent Rights. The "EPIMMUNE Patent Rights" shall mean all
applications for patents covering any of the EPIMMUNE Sole Inventions that are
filed anywhere in the world, as well as any foreign equivalents, additions,
divisions, continuations, continuations-in-part, substitutions, extensions or
renewals therefor or reissues thereof and patents issuing thereon.
1.17 FDA. "FDA" shall mean the United States Food and Drug
Administration.
1.18 Field. "Field" shall mean any use of a vaccine product for the
treatment or prevention of HIV in humans.
1.19 Invention. "Invention" shall mean any invention, improvements,
data, results and/or discoveries whether or not patentable or protectable
through trade secret, including without limitation know-how, technology,
techniques and ideas and all biological/technical materials, resulting from and
made during and as a part of the Research and Development Program.
1.20 Joint Invention. "Joint Invention" shall mean any Invention, which
is jointly conceived and reduced to practice during, and as a result of the
Research and Development Program by employees of both of the Parties.
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1.21 Joint Patent Rights. The "Joint Patent Rights" shall mean all
applications for patent covering any of the Joint Inventions that are filed
anywhere in the world, as well as any foreign equivalents, additions, divisions,
continuations, continuations-in-part, substitutions, extensions or renewals
therefor or reissues thereof and patents issuing thereon.
1.22 MVA-BN. "MVA-BN" shall mean BAVARIAN NORDIC's Modified Vaccinia
Ankara technology, which is included in the BAVARIAN NORDIC Background
Technology.
1.23 Net Sales.
(a) "Net Sales" shall mean the invoiced sales of all Program
Vaccine(s) billed to independent customers by either Party or its Affiliates,
less the following items as applicable to such Program Vaccine(s): (a) credits
or allowances granted upon returns, rejections or recalls; (b) freight, shipping
and insurance costs; (c) quantity and other trade discounts, credits or
allowances actually allowed and taken; (d) customs duties, taxes and surcharges
and other governmental charges incurred in connection with exportation or
importation; and (e) government mandated rebates. The transfer of any Program
Vaccine by any Party or one of its Affiliates to another Affiliate of that Party
shall not be considered a sale; in such cases, Net Sales shall be determined
based on the invoiced sales price by the Affiliate to its customer, less the
deductions allowed under this Section 1.21.
(b) In the event either Party transfers any Program Vaccine for
consideration, in whole or in part, other than cash, the Net Sales price for
such Program Vaccine shall be deemed to be the weighted average Net Sales cash
price then being invoiced by the seller in arms-length transactions with similar
customers. In no event shall Net Sales be deemed to occur in the case of
transfers of reasonable quantities of samples or clinical research supplies.
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(c) In the event that any Program Vaccine is sold as part of any
Combined Vaccine the Net Sales of such Program Vaccine, for the purposes of
determining royalty payments, will be determined by [...***...]
(d) In the event that the weighted average sale price of the
Program Vaccine can be determined but the weighted average sale price of the
other vaccine product(s) included in the Combined Vaccine cannot be determined,
Net Sales for purposes of determining royalty payments will be calculated by
[...***...]
(e) In the event that the weighted average sale price of the
other vaccine product(s) included in the Combined Vaccine can be determined but
the weighted average sale price of the Program Vaccine cannot be determined, Net
Sales for purposes of determining royalty payments will be calculated by
[...***...]
(f) In the event that the weighted average sale price of both the
Program Vaccine and the other vaccine product(s) included in the Combined
Vaccine cannot be determined, the Net Sales for purposes of determining royalty
payments will be [...***...]
(g) The weighted average sale price for a Program Vaccine, a
Combined Vaccine or any other vaccine product(s) included in the Combined
Vaccine shall be calculated [...***...]
1.24 [...***...]
1.25 [...***...]
1.26 Program Liaison. "Program Liaison" shall have the meaning set forth
in Section 2.2.
1.27 Program Patent Rights. The "Program Patent Rights" shall mean and
consist of the BAVARIAN NORDIC Patent Rights, the EPIMMUNE Patent Rights and
Joint Patent Rights.
1.28 Program Vaccine(s). The "Program Vaccine(s)" shall mean any vaccine
developed in the course of the Research and Development Program and comprising
both MVA-
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BN and EPIMMUNE Epitope(s), and which does not use or incorporate any
other technology or biological material. A Program Vaccine may be a stand alone
vaccine (which is subject to Section 6.3) or a component included in an
Epi-Combined Vaccine or BN-Combined Vaccine (which is subject to Sections 6.4
and 6.5, respectively).
1.29 Progress Report. A "Progress Report" shall have the meaning set
forth in Section 2.11.
1.30 Research and Development Program. The "Research and Development
Program" shall mean the basic research and development program to be conducted
jointly by BAVARIAN NORDIC and EPIMMUNE for the construction, design, selection,
evaluation and testing of Program Vaccine(s) for use in the Field. An initial
description of the Research and Development Program is provided in Appendix I,
which is incorporated herein by reference and made part of this Agreement.
1.31 Research Term. The "Research Term" shall have the meaning set forth
in Section 2.12.
1.32 Revenues. "Revenues" shall mean all (a) Net Sales, (b) license
fees, sublicense fees and milestone payments paid by a third party to obtain
rights to Program Vaccine(s) or Combined Vaccine(s), as applicable, (c) premiums
over fair market value of any equity of a Party issued to a third party in a
transaction or series of transactions in which such third party obtains rights
to Program Vaccine(s) or Combined Vaccine(s), as applicable, and (d) royalties
paid by a third party to obtain rights to Program Vaccine(s) or Combined
Vaccine(s), as applicable, but excluding any such amounts received (1) as
payment for the fair market value of any equity issued, (2) as payments for the
supply of goods equal to the cost of goods sold, (3) as research and development
funding and (4) as payment from EPIMMUNE or a third party partner of EPIMMUNE
for obtaining rights to the BAVARIAN NORDIC Manufacturing Technology.
8
1.33 Sole Invention. "Sole Invention" shall mean any Invention, which is
conceived and reduced to practice by employee(s) of only one of the Parties but
not employees of both of the Parties. For purposes of this Section, Parties
include their respective Affiliates.
ARTICLE 2
THE RESEARCH AND DEVELOPMENT PROGRAM
2.1 Research and Development Program. BAVARIAN NORDIC and EPIMMUNE shall
work and fully co-operate with each other in conducting the Research and
Development Program according to the terms of this Article 2. The Research and
Development Program will involve the systematic design and development of the
Program Vaccine(s) for use in the Field. The scope and goals of the Research and
Development Program are subject to modification as provided herein.
2.2 Research Committee. Promptly following the execution of this
Agreement, BAVARIAN NORDIC and EPIMMUNE shall establish a committee (the
"Research Committee") to guide, plan, monitor and manage the activities of the
Research and Development Program. The principal functions of the Research
Committee shall be to (i) determine and revise the specific goals for the
Research and Development Program, (ii) discuss the Research and Development
Program and set priorities thereunder, (iii) manage the ongoing research and
preclinical investigations conducted under the Research and Development Program,
(iv) monitor the progress and results of such investigations, (v) consider and
make any necessary or desirable amendments to the Research and Development
Program, (vi) determine the appropriate actions to be taken with respect to
Joint Patents, including filing, prosecution and defence thereof, and (vii) if
applicable, approve Annual Budgets and any modifications thereto. Each Party
shall appoint three representatives to be members of the Research Committee.
Either Party may permit additional employees and consultants to attend and
participate (on a non-voting basis) in the Research Committee meetings, subject
to the
9
confidentiality provisions of Article 8. All decisions made or actions taken by
the Research Committee will be made unanimously, with the EPIMMUNE members
cumulatively having one vote and the BAVARIAN NORDIC members cumulatively having
one vote. BAVARIAN NORDIC and EPIMMUNE shall each select one of its
representatives on the Research Committee (each a "Program Liaison") to be the
individual who will receive the Progress Reports, and other information and
correspondence from the other concerning the activities of the Research and
Development Program. Each Party may replace its members of the Research
Committee, including its Program Liaison, upon written notice to the other
Party.
2.3 Research Committee Meetings. Meetings of the Research Committee
shall be held at intervals of three months, on an alternating basis, at BAVARIAN
NORDIC's facilities in Copenhagen, Denmark and at EPIMMUNE's facilities in San
Diego, California or at such other times and locations as determined by the
Research Committee; provided that such meetings may be held by videoconference
or teleconference as mutually agreed by the Parties. The initial meeting shall
be held at BAVARIAN NORDIC's facilities as promptly as possible following the
date hereof. Minutes of each meeting shall be prepared in duplicate and approved
by the Research Committee and the approved minutes shall be signed and retained
by each Program Liaison. At subsequent meetings, the members, among other
things, shall report on the Research and Development Program activities
undertaken since the prior meeting, exchange ideas and data regarding the
Program Vaccine(s), exchange information about the patent status of the Program
Vaccine(s), update the Research and Development Program as may be appropriate
and discuss and resolve all other matters relevant to the activities of the
Research and Development Program. BAVARIAN NORDIC and EPIMMUNE shall bear their
respective expenses in attending the meetings of the Research Committee.
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2.4 Information and Results. Except as otherwise provided, the Parties
will make available and disclose the Progress Reports prior to and in
preparation for Research Committee meetings, in the form and format to be
designated by the Research Committee.
2.5 General Disagreements. All disagreements within the Research
Committee shall be subject to the following:
(a) The Program Liaisons will negotiate in good faith for a
period of not more than [...***...] days to attempt to resolve the dispute;
(b) If the Program Liaisons are unable to resolve the dispute in
accordance with subsection (a) above, then they shall promptly present the
disagreement to the Chief Executive Officers of the Parties and the provisions
of Article 12 shall govern.
2.6 Effort. Both BAVARIAN NORDIC and EPIMMUNE shall use commercially
reasonable efforts to conduct work on the Research and Development Program so as
to endeavor to achieve goals agreed to by the Research Committee. Each Party
represents and agrees that all employees or others acting on its behalf in
performing its obligations under this Agreement shall be obligated under a
binding written agreement to assign to such Party, or as such Party shall
direct, all Inventions conceived and reduced to practice by such employee or
other person, or in the case of non-employees working for other companies or
institutions on behalf of BAVARIAN NORDIC or EPIMMUNE.
2.7 Responsibilities of BAVARIAN NORDIC. During the Research Term,
BAVARIAN NORDIC shall:
(a) participate actively in overall project management, planning
and follow-up work of the Research Committee and/or the Research and Development
Program;
(b) attend all meetings of the Research Committee through its
appointed representatives;
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(c) keep records according to Section 2.10 hereof, and submit
Progress Reports to EPIMMUNE according to Section 2.11 hereof, or provide
information to EPIMMUNE as agreed upon otherwise;
(d) promptly (and in any event within thirty (30) days) following
the day on which an Invention is conceived and documented by employee(s) of
BAVARIAN NORDIC, provide EPIMMUNE, by telefax, with a copy of a document signed
and dated on each page by the BAVARIAN NORDIC employee(s) who conceived the
Invention on which the data and the other particulars needed to establish a
valid conception under U.S. patent laws are recited;
(e) where required to comply with FDA requirements, perform
research and development activities according to current good laboratory
practice (GLP) and current good manufacturing practice (GMP); and
(f) perform such other activities or responsibilities that may be
assigned to it by the Research Committee.
2.8 Responsibilities of EPIMMUNE. During the Research Term, EPIMMUNE
shall:
(a) make the payments which, as set forth in Article 3 hereof,
are scheduled to be paid to BAVARIAN NORDIC during the Research Term;
(b) participate actively in overall project management, planning
and follow-up work of the Research Committee and/or the Research and Development
Program; attend all meetings of the Research Committee through its appointed
representatives;
(c) keep records according to Section 2.10 hereof and submit
Progress Reports to BAVARIAN NORDIC according to Section 2.11 hereof, or provide
information to BAVARIAN NORDIC as agreed upon otherwise;
(d) promptly (and in any event within thirty (30) days) following
the day on which an Invention is conceived and documented by employee(s) of
EPIMMUNE, provide BAVARIAN NORDIC, by telefax, with a copy of a document signed
and dated on each page by
12
the EPIMMUNE employee(s) who conceived the Invention on which the data and the
other particulars needed to establish a valid conception under U.S. patent laws
are recited;
(e) where required to comply with FDA requirements, perform
research and development activities according to current good laboratory
practice (GLP) and current good manufacturing practice (GMP); and
(f) perform such other activities or responsibilities that may be
assigned to it by the Research Committee.
2.9 Subcontracts. Subject to the provisions of Article 8 hereof and
following review and approval by the Research Committee [...***...], each of
EPIMMUNE and BAVARIAN NORDIC may subcontract portions of the Research and
Development Program to be performed by it in the normal course of its business
to third parties; provided, however, that the Party that subcontracts shall
require such third parties to enter into a confidentiality agreement appropriate
to protect all Inventions, the BAVARIAN NORDIC Background Technology, BAVARIAN
NORDIC Manufacturing Technology and the EPIMMUNE Background Technology, and such
subcontracting Party shall be responsible for all work on the Research and
Development Program performed by such subcontractor. In no event shall any
Party's subcontractor(s) be granted any rights, licenses, or sublicense to or
under any of the Inventions, BAVARIAN NORDIC Background Technology, BAVARIAN
NORDIC Manufacturing Technology or EPIMMUNE Background Technology except as
required to enable the subcontractor to perform work on the Research and
Development Program under such subcontract.
2.10 Records. Each Party hereto shall keep complete and accurate records
of all its work, tests and/or activities carried out in furtherance of the
Research and Development Program. Such records shall include books, records,
reports, research notes, charts, graphs, comments, computations, analyses,
recordings, photographs, computer programs and
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documentation thereof, computer information storage means, samples of materials
and other graphic or written data generated in connection with the Research and
Development Program. Such records shall be kept in accordance with each Party's
respective notebook policy and appropriate patent practice (including all data
in the form required to be maintained under any applicable government
regulation). Upon written request and not more than [...***...], such records
shall be made available to representatives of the other Party during regular
business hours at the location where such records are maintained or by sending
copies thereof to the requesting Party's Program Liaison. Each Party agrees that
such records shall be made fully available to the other Party for the purposes
of preparing and prosecuting patent applications and enforcing any patents
issued thereon.
2.11 Progress Reports. At three (3)-month intervals during the Research
Term, and in advance of each Research Committee meeting, each Party hereto shall
prepare and transmit to the other, a summary report of the details and results
of all work, tests and/or activities carried out by it and any Program
Vaccine(s) conceived by it in furtherance of the Research and Development
Program ("Progress Report"). Within three months following the completion of the
Research and Development Program, each Party shall prepare a complete,
comprehensive and final Progress Report and submit the same to the other Party.
2.12 Research Term. The term of the Research and Development Program
shall be the [...***...] that begins on the date hereof unless: (i) extended by
mutual written agreement of the Parties, (ii) [...***...] or (iii) terminated in
accordance with Section 9.2(a) or 9.2(b) (the "Research Term").
ARTICLE 3
FUNDING
3.1 [...***...]
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3.2 Funding by the Parties. [...***...] An Annual Budget shall be agreed
upon by the Research Committee for each subsequent year during the Research Term
at least [...***...] days in advance of the beginning of any such year. The
Parties shall share equally all Authorized R&D Expenses incurred by or on behalf
of the Parties in connection with their activities performed in accordance with
this Agreement, subject to any adjustments approved by the Research Committee to
take into account contributions made by each Party. Authorized R&D Expenses may
not exceed the amounts allocated to them in the applicable Annual Budget by more
than [...***...] without the prior approval of the Research Committee; subject
to the foregoing, any costs or expenses that are not Authorized R&D Expenses
shall be borne by the Party incurring such costs or expenses. Within [...***...]
days after the end of each calendar quarter following the approval of the Annual
Budget and during the Research Term, each Party shall furnish to the Research
Committee a written statement detailing the Authorized R&D Expenses incurred by
such Party during such calendar quarter. On a quarterly basis, within
[...***...] days following receipt of the statements of both Parties, and in any
event within [...***...] days following the end of the applicable quarter, the
Research Committee shall reconcile the statements of the Parties and determine
whether a payment should be made by one Party to the other Party so that each
Party bears fifty percent (50%) of the total Authorized R&D Expenses for such
quarter. The Parties will make any applicable payments to each other within
[...***...] days of such reconciliation.
ARTICLE 4
INTELLECTUAL PROPERTY
4.1 EPIMMUNE Background Technology. EPIMMUNE Background Technology shall
continue to be owned or controlled by EPIMMUNE, subject to the licenses granted
to BAVARIAN NORDIC pursuant to Article 7.
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4.2 BAVARIAN NORDIC Background Technology and BAVARIAN NORDIC
Manufacturing Technology. BAVARIAN NORDIC Background Technology and BAVARIAN
NORDIC Manufacturing Technology shall continue to be owned or controlled by
BAVARIAN NORDIC, subject to the licenses granted to EPIMMUNE pursuant to Article
7.
4.3 Sole or Joint Inventions. Inventorship of Inventions will be
determined in accordance with the patent laws of the U.S.A. The Party that
conceives and reduces to practice such Invention (or both Parties if the Parties
conceived and reduced to practice such Invention jointly) shall own such
Invention and any intellectual property rights related thereto. The Parties
shall attempt to resolve any dispute related to inventorship upon the advice of
a patent counsel mutually selected by EPIMMUNE and BAVARIAN NORDIC.
ARTICLE 5
PATENT PROSECUTION AND INFRINGEMENT
5.1 BAVARIAN NORDIC. BAVARIAN NORDIC shall have the right, but not the
obligation, at its expense and through patent attorneys or agents of its choice,
to file and prosecute applications for patents and to maintain patents included
in the BAVARIAN NORDIC Background Technology and BAVARIAN NORDIC Manufacturing
Technology. After notice to EPIMMUNE, BAVARIAN NORDIC, at its expense and
through patent attorneys or agents of its choice, shall file and prosecute
applications for patent in the countries identified by the Research Committee
covering any Inventions that constitute Sole Inventions of BAVARIAN NORDIC.
BAVARIAN NORDIC shall not abandon any such application for patent covering any
Sole Invention of BAVARIAN NORDIC or permit any patent issuing therefrom to
lapse (other than any such patent application or patent covering Sole Inventions
pertaining only to MVA-BN or included in the BAVARIAN NORDIC Manufacturing
Technology) without first notifying EPIMMUNE and permitting EPIMMUNE to continue
the prosecution of such applications or pay any required fees, at EPIMMUNE's
expense and through patent attorneys or agents of
16
EPIMMUNE's choice. If BAVARIAN NORDIC decides not to pursue patent rights to a
Sole Invention of BAVARIAN NORDIC (other than Sole Inventions pertaining only to
MVA-BN or included in the BAVARIAN NORDIC Manufacturing Technology) in one or
more countries, in response to written inquiry from EPIMMUNE regarding the
pursuit of such patent rights in such country or countries, BAVARIAN NORDIC
shall provide written notice to EPIMMUNE and shall permit EPIMMUNE to file and
prosecute applications for patent in such countries covering such Sole
Inventions. EPIMMUNE shall not become an assignee of or acquire any license to
any application for patent to a Sole Invention of BAVARIAN NORDIC or patent as a
result of its filing or prosecuting applications for patent to a Sole Invention
of BAVARIAN NORDIC or paying any fees according to this Section 5.1.
5.2 EPIMMUNE. EPIMMUNE shall have the right, but not the obligation, at
its expense and through patent attorneys or agents of its choice, to file and
prosecute applications for patent and to maintain patents included in the
EPIMMUNE Background Technology. After notice to BAVARIAN NORDIC, EPIMMUNE, at
its expense and through patent attorneys or agents of its choice, shall file and
prosecute applications for patent in countries identified by the Research
Committee covering any Inventions that constitute Sole Inventions of EPIMMUNE.
EPIMMUNE shall not abandon any such application for patent covering any Sole
Invention of EPIMMUNE or permit any patent resulting therefrom to lapse (other
than any such patent application or patent covering Sole Inventions pertaining
only to EPIMMUNE Epitopes) without first notifying BAVARIAN NORDIC and
permitting BAVARIAN NORDIC to continue the prosecution of such applications or
pay any required fees, at BAVARIAN NORDIC's expense and through patent attorneys
or agents of BAVARIAN NORDIC's choice. If EPIMMUNE decides not to pursue patent
rights to a Sole Invention of EPIMMUNE (other than Sole Inventions pertaining
only to EPIMMUNE Epitopes) in one or more countries, in response to written
inquiry from BAVARAIN NORDIC regarding the pursuit of such patent rights in such
17
country or countries, EPIMMUNE shall provide written notice to BAVARIAN NORDIC
and shall permit BAVARIAN NORDIC to file and prosecute applications for patent
in such countries covering such Sole Inventions. BAVARIAN NORDIC shall not
become an assignee of or acquire any license to any application for patent to a
Sole Invention of EPIMMUNE or patent as a result of its filing or prosecuting
applications for patent to a Sole Invention of EPIMMUNE or paying any fees
according to this Section 5.2.
5.3 The Joint Patent Rights. The Parties, through patent attorneys or
agents mutually selected, shall file and prosecute applications for patent in
countries identified by the Research Committee covering any Joint Inventions.
The Research Committee shall agree which Party is responsible for filing and
prosecuting patents in which territories worldwide; provided, however, that
BAVARIAN NORDIC shall have the right, but not the obligation, to file and
prosecute applications for patent in the member countries of the European Patent
Organization (EPO), Norway, Hungary, Poland and Czech Republic, and EPIMMUNE
shall have the right, but not the obligation, to file and prosecute applications
for patent in the United States, Canada, Japan, Australia, New Zealand, South
Korea, Republic of South Africa and Israel, and any other territory not
otherwise specified herein. The costs of filing, prosecution and maintenance of
such Joint Inventions shall be shared equally. Neither Party shall abandon any
such application for patent or permit any patent resulting therefrom to lapse
without first notifying the other and permitting the other Party to continue the
prosecution of such applications or pay any required fees, at its sole expense
and through patent attorneys or agents of its choice. If a Party fails to share
in such expenses for a patent on a country by country basis, such Party shall
lose the rights to such patent granted on a country by country basis, and shall
be obligated to assign its rights of ownership to such patent to the other
Party.
5.4 Informing the Other Party. Each Party shall keep the other Party
currently informed of all steps to be taken in the preparation and prosecution
of all applications filed by it
18
according to this Article 5 and shall furnish the other with copies of such
applications for patent, amendments thereto and other related correspondence to
and from patent offices and permit the other Party to offer its comments thereon
before a Party makes a submission to a patent office which could materially
affect the scope or validity of the patent coverage that may result. Each Party
shall offer its comments promptly.
5.5 Infringement. BAVARIAN NORDIC and EPIMMUNE shall promptly notify
each other in writing of infringement of the Program Patent Rights and/or
unauthorized use of the BAVARIAN NORDIC Background Technology or BAVARIAN NORDIC
Manufacturing Technology and/or the EPIMMUNE Background Technology, in each case
as it relates to the Field, which may come to their attention and provide any
available evidence thereof.
5.6 Defence of Solely Owned Patent by Patent Owner. During the Term, the
patent owner shall have the right, but shall not be obligated, to prosecute at
its own expense any infringement of its BAVARIAN NORDIC Patent Rights, or
EPIMMUNE Patent Rights, respectively, and its own background technology and
manufacturing technology, and in furtherance of such right, the patent owner
agrees that the other Party may join as a Party plaintiff in any such suit, at
its own expense. The total cost of such infringement action commenced or
defended by the patent owner shall be borne by the patent owner, except such
expenses as are incurred by the other Party as a result of its joining as a
Party plaintiff. Each Party shall be entitled to full reimbursement for all
costs and expenses, including, but not limited to reasonable attorneys' fees,
incurred by each Party in such infringement action from any recovery or damages
derived therefrom. The patent owner shall be entitled to any additional amounts
recovered.
5.7 Defence of Solely Owned Patent by Non-Owner. If within [...***...]
after having been notified by the other Party hereto of any alleged infringement
of solely owned Program Patent Right, the patent owner has been unsuccessful in
persuading the alleged infringer to
*CONFIDENTIAL TREATMENT REQUESTED
19
desist and has not brought and/or has not diligently prosecuted an infringement
action, or if the patent owner notifies the other Party at any time prior
thereto, of its intention not to bring suit against any alleged infringer, then
the other Party shall have the right, but is not obligated, to prosecute at its
own expense any infringement of such Program Patent Rights that relate to the
Field, and the non-owner of the patent may, for such purposes, use the name of
the patent owner as Party plaintiff; provided, however, that such right to bring
an infringement action shall remain in effect only during the Term. No
settlement, consent, judgment or other voluntary final disposition of this suit
may be entered into without the consent of the patent owner, which consent shall
not unreasonably be withheld. The patent owner shall indemnify the other Party
against any order for judgments, costs or expenses that may be made against the
patent owner in such proceedings.
5.8 Royalty Offset. In the event that, pursuant to Section 5.7, the
non-owner of a patent shall undertake the enforcement and/or defence of Program
Patent Rights that relate to the Field, by litigation, such non-owner may
withhold its actual expenses incurred in connection therewith in an amount up to
[...***...] of the royalties otherwise thereafter due to patent owner hereunder
based on such patent and apply the same toward reimbursement of such expenses,
including reasonable attorneys' fees, in connection therewith. Any recovery of
damages by such non-owner for any suit brought pursuant to Section 5.7 shall be
applied first in satisfaction of any unreimbursed expenses and legal fees of
such non-owner relating to the suit and next toward reimbursement of patent
owner for any royalties past due or withheld and shall be applied pursuant to
Article 6. The non-owner shall be entitled to the balance remaining from any
such recovery.
5.9 Infringement of Joint Patents. If either Party becomes aware that a
third party is infringing any rights in any Joint Patent, such Party shall give
written notice to the other Party describing in detail the nature of such
infringement. The Parties shall then determine which
*CONFIDENTIAL TREATMENT REQUESTED
20
Party is better suited to enforce such Joint Patent against such infringement.
The Party not chosen to enforce such Joint Patent shall in each case provide the
enforcing Party all reasonable assistance, at the enforcing Party's expense, in
such enforcement. In the event that the enforcing Party fails to institute an
infringement suit or take other reasonable action in response to such
infringement within [...***...] days after notice of infringement of such Joint
Patent, the other Party shall have the right, but not the obligation, to
institute such suit or take other appropriate action in its own name to enforce
such Joint Patent. Any damages or other recovery, whether by settlement or
otherwise, from an action hereunder to enforce any Joint Patent shall first be
applied pro rata to each Party to pay the costs and expenses of litigation in
such action, and any remaining amount shall be divided equally between the
Parties.
5.10 Third Party Infringement Claims. In the event that a third party
files an action against a Party hereto alleging that such Party's activities
under this Agreement infringe such third party's patent rights, such Party shall
give written notice to the other Party, and the Parties will consult and
cooperate on the best course of action. The Party that was sued shall have the
right to defend itself against such action, and the other Party shall provide
all reasonable assistance in such defence. Each Party shall pay all of its own
fees and expenses (including attorneys' fees) incurred under this Section 5.10.
5.11 BAVARIAN NORDIC Patent Extension. BAVARIAN NORDIC hereby appoints
EPIMMUNE or its designee as BAVARIAN NORDIC's agent for the sole purpose of
submitting an application to extend the term of any patent within the BAVARIAN
NORDIC Patent Rights for any country in which EPIMMUNE or its designee secured
governmental approval to market a Program Vaccine covered by such patent.
BAVARIAN NORDIC shall co-operate with EPIMMUNE or its designee in connection
with any such application.
5.12 EPIMMUNE Patent Extension. EPIMMUNE hereby appoints BAVARIAN NORDIC
or its designee as EPIMMUNE's agent for the sole purpose of submitting an
*CONFIDENTIAL TREATMENT REQUESTED
21
application to extend the term of any patent within the EPIMMUNE Patent Rights
for any country in which BAVARIAN NORDIC or its designee secured governmental
approval to market a Program Vaccine covered by such patent. EPIMMUNE shall
cooperate with BAVARIAN NORDIC or its designee in connection with any such
application.
ARTICLE 6
COMMERCIAL DEVELOPMENT
6.1 Commercialisation Within the Field. Except as set forth in Sections
6.3, 6.4 and 6.5, neither Party shall, within the Field, be entitled to
commercialise any Inventions, including but not limited to Inventions claimed or
disclosed in the BAVARIAN NORDIC Patent Rights, the EPIMMUNE Patent Rights or
the Joint Patent Rights, but excluding any Inventions claimed or disclosed in
the BAVARIAN NORDIC Manufacturing Technology, without the prior written consent
of the other Party. This Section 6.1 shall not limit in any way the right of (i)
BAVARIAN NORDIC to commercialise, within the Field, a vaccine product which does
not contain EPIMMUNE Epitopes or (ii) EPIMMUNE to commercialise, within the
Field, a vaccine product which does not contain MVA-BN.
6.2 Commercialisation Outside the Field. Outside the Field, each of the
Parties may exploit any Sole Invention(s) belonging to that Party and any Joint
Inventions without the consent of the other Party.
6.3 Joint Commercialisation. The Parties shall [...***...] all Revenues
received by the Parties from any Program Vaccine(s) derived from joint
commercialisation as described in this Section 6.3. EPIMMUNE will take the lead
in negotiating joint commercialisation of any Program Vaccine(s) with any third
party; provided, however, BAVARIAN NORDIC shall be notified in advance of the
negotiations and may attend such negotiations as a non-participating observer.
To the extent BAVARIAN NORDIC decides not to attend such negotiations, BAVARIAN
NORDIC shall be informed with respect to such negotiations and shall be
consulted
*CONFIDENTIAL TREATMENT REQUESTED
22
with respect thereto. [...***...] Notwithstanding anything to the contrary set
forth herein, (a) if MVA-BN or any derivative thereof is not used in a vaccine
developed pursuant to this Agreement, then such vaccine shall not constitute a
Program Vaccine and BAVARIAN NORDIC will not be eligible for any Revenues
sharing from such vaccine and (b) if EPIMMUNE Epitope(s) or any derivative
thereof are not used in a vaccine developed pursuant to this Agreement, then
such vaccine shall not constitute a Program Vaccine and EPIMMUNE will not be
eligible for any Revenues sharing from such vaccine.
6.4 Commercialisation by EPIMMUNE.
(a) If, during the Term, the Research Committee agrees, following
reasonable good faith consideration of clinical data obtained as a result of the
Research and Development Program, that it is required to combine the Program
Vaccine(s) with another vaccine product in order to create an acceptable vaccine
product for use in the Field, then EPIMMUNE shall have the option (the
"EPI-Combination Option") to create EPI-Combined Vaccine(s) and to exclusively
commercialise any such EPI-Combined Vaccine(s). If EPIMMUNE exercises the
EPI-Combination Option, EPIMMUNE may commercialise Program Vaccine(s) in
combination with EPI-Combined Vaccine(s), which will be subject to the payment
provisions of Section 6.4(c).
(b) If BAVARIAN NORDIC terminates the Research and Development
Program pursuant to clause (ii) of Section 2.12, then EPIMMUNE shall have the
option, exercisable for a period of [...***...] days following EPIMMUNE's
receipt of notice of such termination, (i) to exclusively commercialise any
Program Vaccine(s) (the "EPIMMUNE Option"), and/or (ii) to exercise the
EPI-Combination Option.
(c) The provisions of Section 6.3 shall not apply to any
commercialisation pursuant to Section 6.4(a) or (b). EPIMMUNE will pay BAVARIAN
NORDIC a royalty of [...***...] of all Revenues received by EPIMMUNE for each
EPI-Combined Vaccine
*CONFIDENTIAL TREATMENT REQUESTED
23
commercialised pursuant to its exercise of the EPI-Combination Option, and each
Program Vaccine commercialised pursuant to its exercise of the EPIMMUNE Option.
(d) Following the exercise of the EPI-Combination Option or the
EPIMMUNE Option and continuing during the Term, EPIMMUNE shall keep or cause to
be kept accurate records for a period of [...***...] from the date thereof, and
shall furnish to BAVARIAN NORDIC a written [...***...] royalty report showing on
a country by country basis: (i) the gross sales of all EPI-Combined Vaccine(s)
and Program Vaccine(s) sold by EPIMMUNE and its Affiliates pursuant to Section
6.4 during the reporting period and the calculation of Net Sales from such gross
sales; (ii) the royalties which shall have accrued hereunder in respect of such
sales; (iii) withholding taxes, if any, required by law to be deducted in
respect of such sales, as applicable; (iv) the dates of the first commercial
sales of any such EPI-Combined Vaccine(s) and Program Vaccine(s) sold pursuant
to Section 6.4 in any country by EPIMMUNE and its Affiliates during the
reporting period; and (v) the exchange rates used in determining the applicable
amount of royalties in United States dollars. All amounts payable will first be
calculated in the currency of sale and then converted into United States dollars
using as a rate of exchange the average exchange rate reported in the Wall
Street Journal during the [...***...] to which the payment relates. The report
will also show all other components of Revenues received by EPIMMUNE during the
applicable [...***...]. Reports, together with the royalty payable for the
period to which the reports relate, shall be due on the [...***...] day
following the close of each [...***...]. If no royalty is due for any royalty
period hereunder, EPIMMUNE shall so report. The records maintained pursuant to
this Section shall be complete and accurate records and in sufficient detail to
properly reflect all Revenues and to enable the royalties payable hereunder to
be determined. During the Term and the [...***...] period after the termination
or expiration of this Agreement, upon the request of BAVARIAN NORDIC (but not
more frequently than [...***...] in each calendar year), BAVARIAN NORDIC may
designate an
*CONFIDENTIAL TREATMENT REQUESTED
24
independent public accountant acceptable to EPIMMUNE to review records
pertaining to any payments requested under this Agreement to verify the accuracy
of the payments made or payable hereunder during the preceding calendar year.
6.5 Commercialisation by BAVARIAN NORDIC.
(a) If, during the Term, the Research Committee agrees following
reasonable good faith consideration of clinical data obtained as a result of the
Research and Development Program that it is required to combine the Program
Vaccine with another vaccine product in order to create an acceptable vaccine
product for use in the Field, then BAVARIAN NORDIC shall have the option (the
"BN-Combination Option") to create BN-Combined Vaccine(s). If BAVARIAN NORDIC
exercises the BN-Combination Option, BAVARIAN NORDIC may commercialise Program
Vaccine(s) in combination with BN-Combined Vaccine(s), which shall be subject to
the payment provisions of Section 6.5(c).
(b) If EPIMMUNE terminates the Research and Development Program
pursuant to clause (ii) of Section 2.12, then BAVARIAN NORDIC shall have the
option, exercisable for a period of [...***...] days following BAVARIAN NORDIC`S
receipt of notice of such termination, (i) to exclusively commercialise any
Program Vaccine(s) (the "BAVARIAN NORDIC Option"), and/or (ii) to exercise the
BN-Combination Option.
(c) The provisions of Section 6.3 shall not apply to any
commercialisation pursuant to Section 6.5(a) or (b). BAVARIAN NORDIC will pay
EPIMMUNE [...***...] of all Revenues received by BAVARIAN NORDIC for each
BN-Combined Vaccine commercialised pursuant to its exercise of the
BN-Combination Option, and each Program Vaccine commercialised pursuant to its
exercise of the BAVARIAN NORDIC Option.
(d) Following the exercise of the BN-Combination Option or the
BAVARIAN NORDIC Option and continuing during the Term, BAVARIAN NORDIC shall
keep or cause to be kept accurate records for a period of [...***...] from the
date thereof, and shall furnish to
*CONFIDENTIAL TREATMENT REQUESTED
25
EPIMMUNE a written [...***...] royalty report showing on a country by country
basis: (i) the gross sales of all BN-Combined Vaccine(s) and Program Vaccine(s)
sold by BAVARIAN NORDIC and its Affiliates pursuant to Section 6.5 during the
reporting period and the calculation of Net Sales from such gross sales; (ii)
the royalties which shall have accrued hereunder in respect of such sales; (iii)
withholding taxes, if any, required by law to be deducted in respect of such
sales, as applicable; (iv) the dates of the first commercial sales of any such
BN-Combined Vaccine(s) and Program Vaccine(s) sold pursuant to Section 6.5 in
any country by BAVARIAN NORDIC and its Affiliates during the reporting period;
and (v) the exchange rates used in determining the applicable amount of
royalties in United States dollars. All amounts payable will first be calculated
in the currency or sale and then converted into United States dollars using as a
rate of exchange the average exchange rate reported in the Wall Street Journal
during the calendar [...***...] to which the payment relates. The report will
also show all other components of Revenues received by BAVARIAN NORDIC during
the applicable [...***...]. Reports, together with the royalty payable for the
periods to which the reports relate, shall be due on the [...***...] day
following the close of each [...***...]. If no royalty is due for any royalty
period hereunder, BAVARIAN NORDIC shall so report. The records maintained
pursuant to this Section shall be complete and accurate records and in
sufficient detail to properly reflect all Revenues and to enable the royalties
payable hereunder to be determined. During the Term and the [...***...] period
after the termination or expiration of this Agreement, upon the request of
EPIMMUNE (but not more frequently than [...***...] in each calendar year),
EPIMMUNE may designate an independent public accountant acceptable to BAVARIAN
NORDIC to review records pertaining to any payments requested under this
Agreement to verify the accuracy of the payments made or payable hereunder
during the preceding calendar year.
*CONFIDENTIAL TREATMENT REQUESTED
26
6.6 Royalty Payment Terms. Royalties shown to have accrued by each
royalty report provided for under this Agreement shall be due and payable on the
date such royalty report is due. Payment of royalties in whole or in part may be
made in advance of such due date. Royalties determined to be owing, and any
overpayments to be credited, with respect to any prior quarter shall be added,
or credited, as the case may be, together with interest thereon accruing under
this Agreement from the date of the report for the [...***...] for which such
amounts are owing, to the next [...***...] payment hereunder.
6.7 Exchange Controls. Except as hereinafter provided in this Section
6.7, all payments to be made pursuant to this Article 6 shall be paid in United
States dollars. If at any time legal restrictions prevent the prompt remittance
of part or all royalties with respect to any country where the Program
Vaccine(s) and/or Combined Vaccine(s) are sold, payment shall be made through
such lawful means or methods as the Parties may determine. When in any country
the law or regulations prohibit both the transmittal and deposit of royalties on
sales in such a country, royalty payments shall be suspended for as long as such
prohibition is in effect, and as soon as such prohibition ceases to be in
effect, all royalties that the Parties or their sublicensees would have been
obligated to transmit or deposit, for the prohibition, shall forthwith be
deposited or transmitted promptly to the extent allowable, as the case may be.
If the royalty rate specified in this Agreement should exceed the permissible
rate established in any country, the royalty rate for sales in such country
shall be adjusted to the highest legally permissible or government-approved
rate.
6.8 Interest on Late Payments. Any payments by the Parties that are not
paid on or before the date such payments are due under this Agreement shall bear
interest, to the extent permitted by applicable law, at [...***...] calculated
on the number of days payment is delinquent. [...***...]
6.9 Manufacturing Rights.
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27
(a) In anticipation of commencement of Phase III clinical trials
of any Program Vaccine(s) or Combined Vaccine(s), the Parties agree to review
commercially reasonable proposals for the manufacture of such Program Vaccine(s)
or the Program Vaccine portion of a Combined Vaccine(s), including but not
limited to a proposal from BAVARIAN NORDIC. If BAVARIAN NORDIC's proposal for
the manufacture of such Program Vaccine is competitive with the other proposals
obtained, taking into account, among other things, pricing and quality, then the
provisions of Section 6.9(b) shall apply.
(b) Subject to Sections 6.9(a) and (c), BAVARIAN NORDIC has the
exclusive right to manufacture any Program Vaccine(s) and the Program Vaccine
portion of any Combined Vaccine(s). [...***...]
(c) If EPIMMUNE provides BAVARIAN NORDIC with written
documentation that (i) BAVARIAN NORDIC cannot meet the most competitive price
for the manufacture of Program Vaccine(s) or the Program Vaccine portion of any
Combined Vaccine(s), as applicable, of comparable quantity at matching
specifications; (ii) the manufacture of Program Vaccine(s) or the Program
Vaccine portion of any Combined Vaccine(s), as applicable, by a third party
partner of EPIMMUNE is required by such partner for commercialisation of such
Program Vaccine or Combined Vaccine; (iii) BAVARIAN NORDIC cannot meet the
quantitative demand for Program Vaccine(s) or the Program Vaccine portion of any
Combined Vaccine(s), as applicable, and BAVARIAN NORDIC is not able to upscale
production within [...***...] or (iv) BAVARIAN NORDIC cannot meet material
quality requirements governing the manufacture of Program Vaccine(s) or the
Program Vaccine portion of any Combined Vaccine(s), as applicable, and is not
able to fulfill such quality requirements within a commercially reasonable
period [...***...], then, in any such case BAVARIAN NORDIC hereby grants to
EPIMMUNE (or shall grant to the applicable third party partner of EPIMMUNE) a
worldwide, non-exclusive, nontransferable (except as permitted by Section 14.9)
license, with rights to sublicense, under
*CONFIDENTIAL TREATMENT REQUESTED
28
the BAVARIAN NORDIC Manufacturing Technology, to make, have made, use, sell,
offer for sale and import Program Vaccine(s) and the Program Vaccine portion of
any Combined Vaccine(s) and to make and have made Program Vaccine(s) and the
Program Vaccine portion of any Combined Vaccine(s), such license to be upon
commercially reasonable terms to be agreed upon by the Parties or BAVARIAN
NORDIC and such third party partner of EPIMMUNE, as applicable. EPIMMUNE or its
third party partner may initiate negotiations with BAVARIAN NORDIC regarding the
terms of such license at any time that it reasonably believes the provisions of
Section 6.9(c) will apply and has documentation to support such belief. BAVARIAN
NORDIC and EPIMMUNE or its third party partner, if applicable, will use
commercially reasonable efforts to complete negotiations for and finalize the
terms surrounding such license within [...***...] days following initiation of
such negotiations by EPIMMUNE or its third party partner, as applicable.
(d) With respect to any manufacturing services performed by
BAVARIAN NORDIC in connection with this Agreement, BAVARIAN NORDIC agrees to
offer and provide such manufacturing services [...***...] by BAVARIAN NORDIC for
services of similar type, quantity and quality. BAVARIAN NORDIC will notify
EPIMMUNE in writing of any [...***...] required pursuant to this Section 6.9(d)
and automatically apply such prices. The [...***...] will apply to the balance
of all manufacturing services provided in connection with this Agreement or
until a subsequent change pursuant to this Section 6.9(d).
6.10 Additional Agreements. To the extent necessary the Parties will, in
good faith, negotiate additional agreements necessary to give effect to the
foregoing provisions related to manufacturing set forth in Section 6.9.
6.11 Commencement of Marketing. In each country for which all the
necessary governmental approvals to market any Program Vaccine or Combined
Vaccine have been obtained, EPIMMUNE, BAVARIAN NORDIC, or their respective
Affiliates or sublicensees as the
*CONFIDENTIAL TREATMENT REQUESTED
29
case may be, operating pursuant to Section 6.3, 6.4 or 6.5, as applicable, shall
commence commercialising such Program Vaccine or Combined Vaccine as promptly as
possible (and in any event within [...***...] following the date on which such
approvals were obtained). EPIMMUNE or BAVARIAN NORDIC as the case may be shall
promptly notify each other when the approvals were obtained and marketing
commenced.
6.12 Marketing Efforts. EPIMMUNE, BAVARIAN NORDIC, or their respective
Affiliates or sublicensees as the case may be, shall devote commercially
reasonable efforts to promote and to expand the demand for each of the Program
Vaccine(s) and Combined Vaccine(s) in all countries where marketed under
Sections 6.3, 6.4 or 6.5, as applicable. In the event of a dispute regarding the
adequacy of the efforts taken by EPIMMUNE, its Affiliates or sublicensees or
BAVARIAN NORDIC, its Affiliates or sublicensees as the case may be in marketing
any Program Vaccine(s) or Combined Vaccine(s), damages recoverable by the other
Party shall be limited to the amount of lost Revenue and, in no event, would a
Party hereto be required to relinquish any of its commercialisation rights
hereunder.
ARTICLE 7
LICENSES
7.1 Research and Development Program Licenses.
(a) EPIMMUNE hereby grants to BAVARIAN NORDIC a worldwide,
non-exclusive, royalty-free, non sublicensable and nontransferable (except as
permitted by Section 14.9) license during the Research Term to practice the
EPIMMUNE Background Technology, the EPIMMUNE Patent Rights and the Joint Patent
Rights, solely in connection with activities to be performed by BAVARIAN NORDIC
under the Research and Development Program.
(b) BAVARIAN NORDIC hereby grants to EPIMMUNE a worldwide,
non-exclusive, royalty-free, nonsublicensable and nontransferable (except as
permitted by
*CONFIDENTIAL TREATMENT REQUESTED
30
Section 14.9) license during the Research Term to practice the BAVARIAN NORDIC
Background Technology, the BAVARIAN NORDIC Patent Rights and the Joint Patent
Rights, solely in connection with activities to be performed by EPIMMUNE under
the Research and Development Program.
7.2 Additional License to EPIMMUNE. Subject to the exercise by EPIMMUNE
of the EPI-Combination Option or EPIMMUNE Option, BAVARIAN NORDIC hereby grants
to EPIMMUNE a worldwide, non-exclusive, royalty-bearing and non-transferable
(except as permitted by Section 14.9) license, with rights to sublicense, under
the BAVARIAN NORDIC Background Technology, the BAVARIAN NORDIC Patent Rights and
the Joint Patent Rights, to use, sell, offer for sale and import EPI-Combined
Vaccine(s) (if the EPI-Combination Option is exercised) or the Program
Vaccine(s) (if the EPIMMUNE Option is exercised) during the Term. Royalties
payable in connection with such license shall be as set forth in Section 6.4.
7.3 Additional License to BAVARIAN NORDIC. Subject to the exercise by
BAVARIAN NORDIC of the BN-Combination Option or BAVARIAN NORDIC Option, EPIMMUNE
hereby grants to BAVARIAN NORDIC a worldwide, non-exclusive, royalty-bearing and
nontransferable (except as permitted by Section 14.9) license, with rights to
sublicense, under the EPIMMUNE Background Technology, the EPIMMUNE Patent Rights
and the Joint Patent Rights, to make, have made, use, sell, offer for sale and
import BN-Combined Vaccine(s) (if the BN-Combination Option is exercised) or the
Program Vaccine(s) (if the BAVARIAN NORDIC Option is exercised). Royalties
payable in connection with such license shall be as set forth in Section 6.5.
7.4 Status of Licenses. BAVARIAN NORDIC and EPIMMUNE hereby acknowledge
that this Agreement is an executory contract for the licensing of intellectual
property as defined in Section 365(n) of the United States Bankruptcy Code
(codified at 11 U.S.C. Section 365(n) et. seq.). If either Party, as debtor in
possession, or if a trustee in bankruptcy in a case under the
31
Bankruptcy Code rejects this Agreement, then the other Party shall have the
right to elect to retain its rights under this Agreement, as provided in Section
365(n) of the Bankruptcy Code.
ARTICLE 8
CONFIDENTIALITY
8.1 Obligation of Confidentiality. During the Term and for [...***...]
thereafter, each Party shall hold in confidence all information disclosed to
such Party by the other Party in connection with this Agreement, including
without limitation, information related to background technology belonging to
the other Party, as well as Sole Invention(s) of the other Party and Joint
Invention(s) ("Confidential Information"), and not disclose any of same to any
third party except such of its employees and consultants who have a need to know
in order to effectuate the work of the Research and Development Program or the
development and marketing of the Program Vaccine(s) or Combined Vaccine(s) and
who are bound by the obligations of confidentiality contained herein; provided,
however, that such undertaking shall not apply to information received by a
Party hereunder which such receiving Party can prove:
(a) as of the date of receipt is in the public domain or
subsequently enters the public domain through no breach of the Agreement by the
receiving Party;
(b) is received at any time in good faith from a third party
lawfully in possession of the same and having the right to disclose the same;
(c) was known to the receiving Party prior to its receipt from
the disclosing Party as can be demonstrated by the receiving Party through
written evidence; or
(d) is entirely independently developed without reference to, the
aid, application or use of any of the information to which the obligation of
confidentiality applies. For the purposes of this Section each Party includes
their respective Affiliates and permitted sublicensees.
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32
8.2 Permitted Disclosures. Nothing contained herein shall prevent either
Party from disclosing information for the purpose of obtaining patents according
to Article 5 hereof or EPIMMUNE or BAVARIAN NORDIC from disclosing any Invention
to the FDA or any other relevant authority for the purpose of obtaining approval
to distribute and market Program Vaccine(s) and/or Combined Vaccine(s);
provided, however, that all reasonable steps are taken to require the FDA or any
other relevant authority to treat the information as confidential and
proprietary information. In addition, either Party may make to Affiliates and
sublicensees and potential sublicensees who in each case agree to be bound by
similar terms of confidentiality and non-use at least equivalent in scope to
those set forth in this Article 8, disclosures concerning the Program Vaccine(s)
or Combined Vaccine(s).
8.3 Terms of the Agreement. The Parties agree that the material terms of
this Agreement will be considered Confidential Information of both Parties.
Notwithstanding the foregoing, each Party shall have the right to disclose the
material terms of this Agreement in confidence to any bona fide potential
investor, investment banker, acquirer, merger partner or other potential
financial partner, and where reasonably practicable, shall obtain an adequate
agreement of confidentiality consistent with the terms of this Agreement.
Further, the Parties agree to consult with one another on the provisions of this
Agreement containing Confidential Information which are to be redacted in any
filings made by a Party with the United States Securities and Exchange
Commission, any other recognized security exchange, or as otherwise required by
law.
8.4 Publications. While it is understood that members of BAVARIAN NORDIC
and EPIMMUNE at some point shall be free to publish the results of their studies
carried out under this Agreement, each Party agrees to provide the other Party
the opportunity to review and approve or alter any proposed manuscripts, oral
presentations or abstracts at least [...***...] days prior to their intended
submission for publication. The publishing Party shall comply with
*CONFIDENTIAL TREATMENT REQUESTED
33
the other Party's reasonable requests to delete references to such other Party's
Confidential Information. In addition, if approved, each Party agrees to delay
such submission for a period sufficient to permit adequate steps to be taken to
secure patent protection for any patentable subject matter or to maintain trade
secrets referred to therein.
8.5 Press Release. Except as required by stock exchange rules or other
mandatory law, the Parties must agree on the wording and timing of any press
releases related to this Agreement and/or the Research and Development Program
prior to its release.
ARTICLE 9
TERM OF AGREEMENT
9.1 Term. Unless sooner terminated as provided herein, this Agreement
shall commence as of the date first above written and shall expire, on a
product-by-product and country-by-country basis, upon later to occur of
[...***...] EPIMMUNE, its Affiliates and sublicensees or BAVARIAN NORDIC, its
Affiliates and sublicensees may make, use and/or sell Program Vaccine(s) or
Combined Vaccine(s) in those countries where the relevant patents within the
Program Patent Rights, BAVARIAN NORDIC Background Technology and EPIMMUNE
Background Technology claiming such Program Vaccine(s) or Combined Vaccine(s) or
their manufacture or use have expired with [...***...] to the other Party.
9.2 Termination. This Agreement may be terminated by either Party:
(a) in the event of a material breach of this Agreement by the
other Party, upon [...***...] days' prior written notice to the breaching Party,
the notice to become effective at the end of the [...***...] day period unless
the breach is sooner cured by the breaching Party;
(b) upon bankruptcy, insolvency or placing of the business of the
other Party in the hands of a receiver; or
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34
(c) if the Research Term is terminated prior to expiration
pursuant to Section 2.12 and none of the EPI-Combination Option, EPIMMUNE
Option, BN-Combination Option and BAVARIAN NORDIC Option, as applicable, is
exercised.
9.3 Continuing Rights. Termination of the Agreement for any reason shall
be without prejudice to:
(a) BAVARIAN NORDIC's and EPIMMUNE's respective right to receive
all Revenues and royalties accrued and unpaid on the effective date of
termination;
(b) any other remedies which either Party may then or thereafter
have hereunder or otherwise.
9.4 Effect of Termination. Upon any termination or expiration of this
Agreement, (a) the licenses granted by EPIMMUNE to BAVARIAN NORDIC and by
BAVARIAN NORDIC to EPIMMUNE under Article 7 will terminate; (b) EPIMMUNE shall,
within [...***...] days of such termination or expiration, return to BAVARIAN
NORDIC all BAVARIAN NORDIC's Confidential Information and materials; (c)
BAVARIAN NORDIC shall, within [...***...] days of such termination or
expiration, return to EPIMMUNE all EPIMMUNE's Confidential Information and
materials; and (d) each Party will transmit to the other Party all reports and
data, including preclinical data and reports, obtained by such Party pursuant to
this Agreement within [...***...] days of such termination or expiration.
Sections 5.3, 5.9, 6.4, 6.5, 6.6, 6.7, 6.8, 9.3, 9.4, 9.5 and 14.4 and Articles
1, 4, 8 and 11 shall survive the expiration or termination of this Agreement. In
addition, if (i) BAVARIAN NORDIC does not grant a license under the BAVARIAN
NORDIC Manufacturing Technology to EPIMMUNE or the applicable third party
partner of EPIMMUNE under the circumstances set forth in Section 6.9(c), (ii)
BAVARIAN NORDIC does not comply with Section 6.9(d), or (iii) BAVARIAN NORDIC
materially breaches any agreement for the supply of Program Vaccine(s) or the
Program Vaccine portion of any Combined Vaccine(s) between BAVARIAN NORDIC and
EPIMMUNE or any third party that
*CONFIDENTIAL TREATMENT REQUESTED
35
commercialises Program Vaccine(s) or Combined Vaccine(s) (each of the
circumstances set forth in the foregoing subsections (i) through (iii) referred
to herein as a "Suspension Event"), then EPIMMUNE may suspend BAVARIAN NORDIC's
right under Section 6.5 and the license granted under Section 7.3 until such
time as the Suspension Event has been resolved to the mutual satisfaction of the
Parties.
9.5 Waiver. Failure to terminate this Agreement following a breach or
failure to comply with terms and conditions of the Agreement shall not be deemed
a waiver of the non-breaching Party's defenses, rights or causes of action
arising from such or any future breach or non-compliance.
ARTICLE 10
MUTUAL REPRESENTATION AND WARRANTIES
10.1 Mutual Representations and Warranties. Each Party hereby represents
and warrants to the other Party that:
(a) it has full corporate power and authority under the laws of
the state or country of its incorporation to enter into this Agreement and to
carry out the provisions hereunder;
(b) to the knowledge of such Party as of the Effective Date, the
performance by either Party of the activities under this Agreement will not
infringe, nor cause such Party to unlawfully or wrongly use, any existing
patent, trademark, trade secret, confidential or proprietary right or other
rights owned or claimed by a third party;
(c) this Agreement is a legal and valid obligation binding upon
it and is enforceable in accordance with its terms;
(d) the execution, delivery and performance of this Agreement by
it does not materially conflict with any agreement, oral or written, to which it
is a Party or by which it may be
36
bound, nor violate any law or regulation of any court, governmental body or
administrative or other agency having authority over it;
(e) to the knowledge of such Party as of the Effective Date, (i)
none of the patents licensed by such Party to the other Party hereunder are the
subject of any claim or demand by any third party of infringement or
misappropriation; (ii) such Party has not received any notice of such claim of
or demand related to such infringement or misappropriation; and (iii) all such
patents are either owned by such Party or may be licensed or provided hereunder
by such Party without violating such Party's contractual obligations to a third
party; and
(f) to the knowledge of such Party as of the Effective Date,
there is no claim, action, suit, proceeding or investigation pending or
threatened against or affecting (i) its patents licensed to the other Party
hereunder, or (ii) the transaction contemplated hereby.
10.2 Disclaimer of Warranties. EXCEPT AS PROVIDED IN SECTION 10.1 ABOVE,
THE TECHNOLOGY PROVIDED OR LICENSED HEREUNDER IS PROVIDED OR LICENSED "AS IS,"
AND EACH PARTY EXPRESSLY DISCLAIMS ANY AND ALL OTHER WARRANTIES OF ANY KIND,
EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF DESIGN,
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OF THE
INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES. Without limiting the generality
of the foregoing, each Party expressly disclaims any warranty of the success of
any study or test commenced pursuant to the Research and Development Program.
ARTICLE 11
INDEMNIFICATION
11.1 Indemnification by EPIMMUNE. EPIMMUNE hereby agrees to indemnify,
hold harmless and defend BAVARIAN NORDIC and its officers, directors and
employees against any and all liability, damages, judgments, awards or costs of
defence (including without
37
limitation reasonable attorneys' fees, expenses to defend and amounts paid in
settlement of any action) resulting from any claim or claims by third parties
against any of the foregoing solely to the extent that such claim or claims: (a)
are based on the material breach of any representation or warranty by EPIMMUNE
set forth in Section 10.1, (b) are based on the gross negligence or willful
misconduct of EPIMMUNE, its Affiliates or sublicensees, or any of their
respective employees or agents; or (c) arise out of the possession, storage,
transport, manufacture, use, administration, sale, distribution or other
disposition of Program Vaccine(s) and/or Combined Vaccine(s) by or on behalf of
EPIMMUNE or its Affiliates or licensees (other than BAVARIAN NORDIC), provided
that such indemnification shall not apply to the extent that any such claim
would require indemnification by BAVARIAN NORDIC under Section 11.2.
11.2 Indemnification by BAVARIAN NORDIC. BAVARIAN NORDIC hereby agrees
to indemnify, hold harmless and defend EPIMMUNE and its officers, directors and
employees against any and all liability, damages, judgments, awards or costs of
defence (including without limitation reasonable attorneys' fees, expenses to
defend and amounts paid in settlement of any action) resulting from any claim or
claims against any of the foregoing solely to the extent that such claim or
claims: (a) are based on the material breach of any representation or warranty
by BAVARIAN NORDIC set forth in Section 10.1 hereof, (b) are based on the gross
negligence or willful misconduct of BAVARIAN NORDIC, its Affiliates or
sublicensees, or any of their respective employees or agents; (c) arise out of
the manufacture of any Program Vaccine(s) or Program Vaccine portion of any
Combined Vaccine(s) by or on behalf of BAVARIAN NORDIC for commercialisation by
EPIMMUNE or its Affiliates or licensees; or (d) arise out of the possession,
storage, transport, manufacture, use, administration, sale, distribution or
other disposition of Program Vaccine(s) by or on behalf of BAVARIAN NORDIC or
its Affiliates or licensees (other than EPIMMUNE), provided that such
indemnification shall
38
not apply to the extent that any such claim would require indemnification by
EPIMMUNE under Section 11.1.
11.3 Notice and Procedures. In all cases where one Party seeks
indemnification by the other under this Article 11, the Party seeking
indemnification shall promptly notify the indemnifying Party of receipt of any
claim or lawsuit covered by such indemnification obligation and shall cooperate
fully with the indemnifying Party in connection with the investigation and
defence of such claim or lawsuit. The indemnifying Party shall have the right to
control the defence, with counsel of its choice, provided that the
non-indemnifying Party shall have the right to be represented by advisory
counsel at its own expense. The indemnifying Party shall not settle or dispose
of the matter in any manner which could negatively and materially affect the
rights or liability of the non-indemnifying Party without the non-indemnifying
Party's prior written consent, which shall not be unreasonably withheld or
delayed.
ARTICLE 12
ARBITRATION
BAVARIAN NORDIC and EPIMMUNE shall devote all reasonable efforts to
amicably resolve any disputes between them concerning their respective rights
and obligations under the Agreement. However, if the Chief Executive Officers of
the Parties are unable to resolve a dispute within [...***...] days following
the day on which either Party provides written notice of the dispute to the
other Party's Chief Executive Officer, the dispute will be resolved or settled
at the request of either Party by arbitration to be conducted in [...***...] in
accordance with the rules of the [...***...] by [...***...] selected by the
Parties in conformity with those rules. In addition to dealing with the merits
of the case, the arbitration award shall fix the costs of the arbitration and
decide which of the Parties shall bear such costs or in which proportion such
costs shall be borne by the Parties. The decision of the [...***...] shall be
final and binding upon the Parties and their respective Affiliates and the
Parties hereby waive their respective rights to
*CONFIDENTIAL TREATMENT REQUESTED
39
any form of appeal therefrom. Notwithstanding anything contained above to the
contrary, issues involving the validity of patents will be decided by the courts
or patent offices of the country which issued the patents in question. Both
Parties shall continue their respective obligations under the Agreement during
any such arbitration proceedings; provided, however, that either Party shall
have the right to seek and obtain from the appropriate court in any relevant
jurisdiction provisional remedies such as attachment, preliminary injunction,
and replevin to avoid irreparable harm, maintain the status quo or preserve the
subject matter of the arbitration.
ARTICLE 13
FORCE MAJEURE
No failure or omission by the Parties in the performance of any
obligation according to the Agreement shall be deemed a breach of the Agreement
or create any liability if the same shall arise from any cause or causes beyond
the control of the Party, including, but not limited to acts of God; acts or
omissions of any government; any rule, regulation or order issued by any
governmental authority or by any officer, department, agency or instrumentality
thereof; fire; storm; flood; natural phenomena; power outage; earthquake;
accident; war; rebellion; insurrection; riot; invasion; strike; lockout, or
other kind of force majeure.
ARTICLE 14
MISCELLANEOUS
14.1 Wire Transfer of Funds. Unless otherwise specified in writing, all
payments required according to this Agreement shall be made by wire transfer:
If made by BAVARIAN NORDIC to EPIMMUNE:
[...***...]
[...***...]
[...***...]
[...***...]
[...***...]
If made by EPIMMUNE to BAVARIAN NORDIC:
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40
[...***...]
[...***...]
[...***...]
[...***...]
[...***...]
[...***...]
14.2 Notices. Any notice or report required or permitted to be given or
made under this Agreement by one of the Parties to the other shall be in writing
and delivered to the other Party at its address indicated below or to such other
address as the addressee shall have theretofore furnished in writing to the
addressor by hand, courier or by registered or certified airmail (postage
prepaid) or by telefax, provided all telefax notices shall be promptly
confirmed, in writing, by registered or certified airmail (postage prepaid): If
to BAVARIAN NORDIC:
BAVARIAN NORDIC A/S
Xxxxxxxxxxxxx 000,
XX-0000 Xxxxxxxxxx X
Xxxxxxx
Telefax # 453326 8380
Attention: President
If to EPIMMUNE:
EPIMMUNE Inc.
5820 Xxxxx Xxxxx Xxxxx,
Xxx Xxxxx,
Xxxxxxxxxx 00000,
X.X.X.
Telefax # 0 000-000-0000
Attention: President
All notices shall be effective as of the date received by the addressee.
14.3 Independent Efforts. It is recognized that BAVARIAN NORDIC and
EPIMMUNE have carried out and plan to carry out their own independent research
activities and programs for the discovery and development of novel vaccines for
the treatment of HIV and for other purposes during the Research and Development
Program and the remainder of the term of the Agreement. Nothing contained herein
shall prevent either Party from conducting any
*CONFIDENTIAL TREATMENT REQUESTED
41
independent activities and programs within the Field that do not involve the use
of Background Technology belonging to the other Party and/or Invention(s).
Nothing contained herein shall prevent either Party from conducting any
activities and programs outside the Field that do not involve the use of
Background Technology belonging to the other Party and/or Sole Invention(s) of
the other Party.
14.4 Governing Law. This Agreement shall be construed and the respective
rights of the Parties hereto determined according to the substantive laws of New
York, other than those provisions governing conflict of laws and provided that
issues regarding patents shall be construed according to laws of the country,
which issued the patent, involved. The Parties expressly intend that the UN
Convention for the International Sale of Goods shall not, in whole or in part,
apply to this Agreement.
14.5 Insurance. Each Party shall maintain product liability insurance
with respect to development, manufacture and sales of Program Vaccine(s) and
Combined Vaccine(s) (as the case may be) in such amount as such Party
customarily maintains with respect to sales of its other products. Each Party
shall maintain such insurance for so long as it continues to manufacture or sell
any Program Vaccine(s) or Combined Vaccine (as the case may be) and thereafter
for so long as such Party maintains insurance for itself covering such
manufacture or sales.
14.6 Non-Waiver. Any waiver must be explicitly in writing. The waiver by
either of the Parties of any breach of any provision hereof by the other Party
shall not be construed to be a waiver of any succeeding breach of such provision
or a waiver of the provision itself.
14.7 Severability. Should any section, or portion thereof, of this
Agreement be held invalid by reason of any law, statute or regulation existing
now or in the future in any jurisdiction by any court of competent jurisdiction
or by a legally enforceable directive of any governmental body, such section or
portion thereof shall be validly reformed so as to approximate the intent of
42
the Parties as nearly as possible and, if unreformable, shall be divisible and
deleted in such jurisdiction; this Agreement shall not otherwise be affected.
14.8 Independent Contractors. The relationship of the Parties under the
Agreement is that of independent contractors. Nothing in this Agreement shall be
construed as creating any partnership, employment, agency or other similar
relationship between the Parties. Neither Party is authorized to take any action
binding upon the other.
14.9 Assignment. Either Party may assign this Agreement in whole or in
part to any Affiliate or Affiliates that shall be substituted directly in whole
or in part for it hereunder; provided, however, that the assignor shall
guarantee the performance of its Affiliate assignee hereunder. The Agreement
shall not otherwise be assignable by either Party without the prior written
consent of the other Party, except by a Party to the successor or assignee of
all or substantially all of its business related to this Agreement, whether by
merger, sale of stock, sale of assets or otherwise. In the event of such
transaction, however, intellectual property rights of the acquiring party to
such transaction (if other than one of the Parties to this Agreement) shall not
be included in the technology licensed hereunder.
14.10 Counterparts and Headings. The Agreement may be executed in
counterparts, each of which shall be deemed to be an original and both together
shall be deemed to be one and the same agreement. All headings and the cover
page are inserted for convenience of reference only and shall not affect its
meaning or interpretation.
14.11 Government Rights. The Parties understand that the Inventions, if
any, may be developed in part with funds furnished by the federal government of
the United States of America and that the federal government of the United
States of America has certain rights relative thereto. This Agreement and the
rights hereunder are explicitly made subject to the federal government's rights
under any applicable law or regulation. To the extent that there is a
43
conflict between any such applicable law or regulation and this Agreement, the
terms of such applicable law or regulation shall prevail.
14.12 Entire Agreement. The terms and provisions contained in this
Agreement constitute the entire agreement between the Parties and shall
supersede all previous communications, representations, agreements or
understandings, either oral or written, between the Parties with respect to the
subject matter hereof, and no agreement or understanding varying or extending
this Agreement shall be binding upon either Party hereto, unless in writing
which specifically refers to this Agreement, signed by duly authorized officers
or representatives of the respective Parties and the provisions of this
Agreement not specifically amended thereby shall remain in full force and
effect.
14.13 English Language. This Agreement has been written and executed in
the English language. Any translation into any other language shall not be an
official version thereof, and in the event of any conflict in interpretation
between the English version and such translation, the English version shall
control.
IN WITNESS WHEREOF, BAVARIAN NORDIC and EPIMMUNE have executed this
Agreement in duplicate as of the day and year first above written.
BAVARIAN NORDIC A/S EPIMMUNE INC.
By: /s/ Xxxxx Xxxxx By: /s/ Xxxxx Xxxxx
-------------------------------------- --------------------------------
Print Name: Xxxxx Xxxxx Printed Name: Xxxxx Xxxxx
------------------------------ -----------------------
Title: CEO Title: President & CEO
----------------------------------- ---------------------------------
44
APPENDIX I
RESEARCH AND DEVELOPMENT PROGRAM
APPENDIX II
[...***...]
*CONFIDENTIAL TREATMENT REQUESTED
