EXHIBIT 10.9
COLLABORATION AGREEMENT
This COLLABORATION AGREEMENT (the "Agreement"), effective as of September
26, 1997 (the "Effective Date"), is made by and between Fuso Pharmaceutical
Industries, Ltd., a corporation organized under the laws of Japan, with a
principal place of business at 3-11, 2-Chome, Xxxxxxxxxx, Xxxx-xx Xxxxx 000
Xxxxx and its registered head office at 7-10, 1-Chome, Xxxxxxxxxx, Xxxx-xx,
Xxxxx 000 Xxxxx ("Fuso"), and GenVec, Inc., a Delaware corporation, with a
principal place of business at 00000 Xxxxxxxx Xxxxx, Xxxxxxxxx, Xxxxxxxx 00000
("GenVec").
BACKGROUND
A. GenVec has expertise in the field of gene therapy and is developing
novel, proprietary materials and methods for use in the treatment of human
cancer.
B. Fuso is in the business of developing, manufacturing, and
commercializing pharmaceuticals in Japan.
C. GenVec and Fuso desire to establish a collaborative relationship to
conduct research and develop certain gene therapy products for the treatment of
human cancer.
D. GenVec and Fuso have entered into a Stock Purchase Agreement of even
date herewith, pursuant to which GenVec shall sell to Fuso, and Fuso shall
purchase 444,445 shares of GenVec Series E Convertible Preferred Stock. This
Collaboration Agreement shall only be effective if the purchase of such stock is
timely completed as set forth in the Stock Purchase Agreement.
NOW THEREFORE, for and in consideration of the covenants, conditions, and
undertakings hereinafter set forth, it is agreed by and between the parties as
follows:
1. DEFINITIONS
1.1 "Affiliate" shall mean any corporation or other entity which is
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directly or indirectly controlling, controlled by or under the common control of
a party hereto. For the purpose of this Agreement, "control" shall mean the
direct or indirect ownership of at least fifty percent (50%) of the outstanding
shares or other voting rights of the subject entity to elect directors, or if
not meeting the preceding, any entity owned or controlled by or owning or
controlling at the maximum control or ownership right permitted in the country
where such entity exists.
1.2 "Commercialization Agreement" shall mean that certain
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Commercialization Agreement entered by Fuso and GenVec of even date herewith.
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
1.3 "Collaboration Product" shall mean a Product Configuration developed
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in the Research Program intended for use in the Field which the Steering
Committee has designated as such pursuant to Section 2.4.
1.4 "Confidential Information" shall mean (i) any proprietary or
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confidential information or material in tangible form disclosed hereunder that
is marked as "Confidential" at the time it is delivered to the receiving party,
or (ii) proprietary or confidential information disclosed orally hereunder which
is identified as confidential or proprietary when disclosed and such disclosure
of confidential information is confirmed in writing within thirty (30) days by
the disclosing party.
1.5 "Development Plan" shall mean the written plan for development of a
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particular Collaboration Product prepared pursuant to Section 2.4.2.
[*]
1.7 "Fuso Technology" shall mean Fuso Patent Rights and Fuso Know-How:
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1.7.1 "Fuso Patent Rights" shall mean (i) all patents and patent
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applications conceived and reduced to practice by Fuso alone, or Fuso and/or its
agents (including researchers at [*] University), in connection with the
Research Program during the Research Program Term, and (ii) any divisions,
continuations, continuations-in-part, reissues, reexaminations, extensions or
other governmental actions which extend any of the subject matter of the patent
applications or patents in (i) above, and any substitutions, confirmations,
registrations or revalidations of any of the foregoing, in each case, which is
owned or controlled, in whole or part, by license, assignment or otherwise by
Fuso, to the extent Fuso has the right to license or sublicense, and subject to
any limitations of such license or sublicense. For the avoidance of doubt, the
Fuso Patent Rights shall not include Fuso Know-How or any [*].
1.7.2 "Fuso Know-How" shall mean confidential information and
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materials, including, but not limited to, pharmaceutical, chemical, biological
and biochemical products, technical and non-technical data, and information
relating to the results of tests, assays, methods and processes, and drawings,
plans, diagrams, specifications and/or other documents containing said
information and data, discovered, developed or acquired by Fuso alone, or Fuso
and/or its agents (including researchers at [*] University), in connection
with the Research Program during the Research Program Term which Fuso has the
right to license or sublicense, and subject to any limitations of such license
or sublicense. For the avoidance of doubt, Fuso Know-How shall not include any
Fuso Patent Rights or any [*].
1.8 "Field" shall mean Gene Therapy for the treatment of human cancer,
[*] or, in each case, any portion or derivative thereof.
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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1.9 "Gene Therapy" shall mean the introduction of a gene into a person for
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therapeutic purposes (i) by in vivo introduction for incorporation into cells of
such person, or (ii) by ex vivo introduction into cells for transfer into a
person.
1.10 [*] shall have the meaning set forth in Section 7.1.2 below.
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1.11 "GenVec Technology" shall mean GenVec Patent Rights, GenVec Know-How
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and [*].
1.11.1 "GenVec Patent Rights" shall mean (i) all patents and patent
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applications listed on Exhibit A hereto, or conceived and reduced to practice by
GenVec alone, or GenVec and/or its agents (including researchers at [*]), in
connection with the Research Program during the Research Program Term, and (ii)
any divisions, continuations, continuations-in-part, reissues, reexaminations,
extensions or other governmental actions which extend any of the subject matter
of the patent applications or patents in (i) above, and any substitutions,
confirmations, registrations or revalidations of any of the foregoing, in each
case, which is owned or controlled, in whole or part, by license, assignment or
otherwise by GenVec, to the extent GenVec has the right to license or
sublicense, and subject to any limitations of such license or sublicense. For
the avoidance of doubt, the GenVec Patent Rights shall not include GenVec Know-
How.
1.11.2 "GenVec Know-How" shall mean confidential information and
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materials, including, but not limited to, pharmaceutical, chemical, biological
and biochemical products, technical and non-technical data, and information
relating to the results of tests, assays, methods and processes, and drawings,
plans, diagrams, specifications and/or other documents containing said
information and data, discovered, developed or acquired by GenVec alone, or
GenVec and/or its agents (including researchers at [*]), in connection with the
Research Program during the Research Program Term, which GenVec has the right to
license or sublicense, and subject to any limitations of such license or
sublicense. For the avoidance of doubt, GenVec Know-How shall not include any
GenVec Patent Rights
1.12 "Joint Technology" shall mean the Joint Patent Rights and Joint Know-
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How.
1.12.1 "Joint Patent Rights" shall mean (i) all patents and patent
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applications conceived and reduced to practice jointly by Fuso (or its agents,
including researchers at [*] University) and GenVec (or its agents, including
researchers at [*]), in connection with the Research Program during the
Research Program Term and (ii) any divisions, continuations, continuations-in-
part, reissues, reexaminations, extensions or other governmental actions which
extend any of the subject matter of the patent applications or patents in (i)
above, and any substitutions, confirmations, registrations or revalidations of
any of the foregoing. For the avoidance of doubt, the Joint Patent Rights shall
not include the Joint Know-How or any [*].
1.12.2 "Joint Know-How" shall mean confidential information and
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materials, including, but not limited to, pharmaceutical, chemical, biological
and biochemical products, technical and non-technical data, and information
relating to the results of tests, assays, methods and processes, and drawings,
plans,
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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diagrams, specifications and/or other documents containing said information and
data, discovered, developed or acquired jointly by Fuso (or its agents,
including researchers at [*] University), and GenVec (or its agents, including
researchers at [*]), in connection with the Research Program during the
Research Program Term. For the avoidance of doubt, the Joint Know-How shall not
include the Joint Patent Rights or any [*].
1.13 "MHW" shall mean the Japanese Ministry of Health and Welfare, or any
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corresponding foreign registration or foreign regulatory authority in the
Territory.
1.14 "Phase I", "Phase II", and "Phase III" shall mean Phase I (or Phase
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I/II), Phase II (or Phase II/III), and Phase III clinical trials, respectively,
in each case as prescribed by the Japanese equivalent of applicable FDA IND
regulations, or any corresponding foreign statutes, rules or regulations in the
Territory.
1.15 "Pivotal Trial" shall mean a clinical trial that is designed to
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provide data establishing the safety and efficacy of a Collaboration Product in
support of obtaining marketing approval from the MHW.
1.16 "Product Configuration" shall mean any potential product for use in
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the Field containing a combination of one or more genes (or fragments thereof
and other elements (e.g., a gene delivery vehicle and/or a gene expression
cassette)).
1.17 "Product License Application" or "PLA" shall mean the Japanese
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equivalent of a Product License Application, as defined in the U.S. Food, Drug
and Cosmetic Act and the regulations promulgated thereunder, and any
corresponding foreign application, registration or certification in the
Territory.
1.18 "Research Plan" shall have the meaning set forth in Section 2.1.2
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below.
1.19 "Research Program" shall have the meaning set forth in Section 2.1
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below. For the avoidance of doubt, the Research Program shall include
activities conducted pursuant to the Research Plan and activities conducted
pursuant to any Development Plan which the parties agree are to be included
under the Research Program.
1.20 "Research Program Term" shall be that period of time described in
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Section 2.6.1 below.
1.21 "Steering Committee" shall have the meaning set forth in Section
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2.2.1 below.
1.22 "Territory" shall mean [*].
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[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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2. RESEARCH PROGRAM
2.1 Research Program.
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2.1.1 Collaborative Effort. Subject to the terms and conditions set
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forth herein Fuso and GenVec will diligently conduct mutually agreed
collaborative research in the Field pursuant to a Research Plan with the primary
objective of identifying and commencing the development of at least [*] (the
"Research Program"). The activities conducted in connection with the Research
Program will be overseen and administered by the Steering Committee pursuant to
Section 2.2 below. Fuso and GenVec shall each use reasonable efforts to conduct
the Research Program in accordance with the Research Plan within the time
schedules contemplated therein.
2.1.2 Research Plan. Annually, the Steering Committee will prepare
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and agree upon a written plan (the "Research Plan") that will (i) include a
general overview and timetable for each party's research activities and
appropriate resources and budgets for such research during the next year, and
(ii) set specific objectives for each year, which objectives will be updated or
amended, as appropriate, by the Steering Committee as research progresses. The
initial Research Plan shall be agreed in writing by the parties within [*] of
the Effective Date. The Steering Committee shall review the Research Plan on an
ongoing basis and may make changes to the Research Plan then in effect.
2.1.3 Development Plan Activities. The Research Program shall
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include those activities, within the scope of a Development Plan agreed to by
the parties pursuant to Section 2.4.2, that the parties have agreed to conduct
in connection with the Research Program.
2.1.4 Sponsored Academic Research.
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(a) GenVec. In connection with the Research Program, GenVec
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intends to sponsor certain research and development at DFCI, subject to the
terms of a written sponsored research agreement, to be negotiated and entered
into by GenVec and [*].
(b) Fuso. In connection with the Research Program, Fuso
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intends to sponsor certain research and development at the laboratory of [*]
at the [*] University School of Medicine, subject to the terms of
a written sponsored research agreement, to be negotiated and entered into by
Fuso and [*] University.
(c) Consistency. It is understood and agreed that the parties
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shall endeavor to negotiate and include in their respective academic sponsored
research agreements relating to the Research Program, provisions fully
consistent with those in this Agreement, including without limitation, policies
related to confidentiality and the filing of patent applications and enforcement
of patents. To the extent the provisions of any agreement negotiated between
GenVec and [*] or Fuso and [*] University in connection with any aspect of
the Research Program are inconsistent with the terms and conditions of this
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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Agreement, the party wishing to enter such agreement shall notify the Steering
Committee prior to the execution of such agreement, and provide an explanation
of the reason for such inconsistency. The Steering Committee shall have the
authority to approve or disapprove such agreement, and the parties hereto shall
not enter into such agreement without the prior written consent of the Steering
Committee.
2.2 Steering Committee.
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2.2.1 Responsibilities. Fuso and GenVec will establish a committee
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to oversee, review and coordinate the Research Program (the "Steering
Committee"). The Steering Committee shall be responsible for (i) establishing
the Research Plan, (ii) designating Collaboration Products for commercial
development; (iii) monitoring and reporting research progress and ensuring open
and frequent exchange between the parties with respect to Research Program
activities, (iv) determining whether to acquire licenses from third parties with
respect to intellectual property necessary or useful for the conduct of the
Research Program, and (v) discussing patent matters relating to Collaboration
Products.
2.2.2 Membership. The Steering Committee shall be comprised of six
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(6) representatives. Two (2) members shall be appointed by Fuso, two (2) members
shall be appointed by GenVec, and [*] and [*] will each serve as members of the
Steering Committee. Fuso and GenVec may each replace its Steering Committee
representatives at any time, with written notice to the other party. In the
event that [*] or [*] becomes unavailable to serve on the Steering Committee,
Fuso and GenVec shall agree on an appropriate replacement. From time to time,
the Steering Committee may establish subcommittees to oversee particular
projects or activities, such as decisions regarding patent matters.
2.2.3 Meetings. The Steering Committee will meet at least two (2)
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times per year at locations and times to be determined by the Steering
Committee. Members of the Steering Committee may participate in and vote at
meetings, in person by telephone or by video conference and may vote at meetings
by proxy. The Steering Committee shall prepare written minutes of each meeting
and a written record of all Steering Committee decisions, whether made at an
Steering Committee meeting or otherwise.
2.2.4 Decision Making. All decisions of the Steering Committee will
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be made by majority approval; provided, the designation of each Collaboration
Product as described in Section 2.4.1, and the Development Plan for each
Collaboration Product as described in Section 2.4.2, shall require unanimous
approval of the Steering Committee, and, if there is not unanimity with respect
to such a decision, such matter shall not be subject to arbitration. In the
event that a majority is not achieved within the Steering Committee for any
decision which does not require a unanimous vote, the dispute will be referred
to Fuso's President and GenVec's President, who shall meet promptly in person or
by telephone and endeavor to reach agreement. If such persons are unable to
resolve any disputes the parties shall settle such dispute as set forth in
Article 12 below.
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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2.3 Research Program Funding.
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2.3.1 Research Program Funding. During the Research Program Term,
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Fuso agrees to spend an aggregate of one million dollars ($1,000,000) per year
on funding for the Research Program.
(a) Two hundred fifty thousand dollars ($250,000) of such total
shall be expended by Fuso each year on research conducted in Japan with regard
to the Research Program, all or a portion of which will be used to sponsor
research in the laboratory of [*] pursuant to Section 2.1.4(b) above, and a
portion of which may be used by Fuso to conduct research at its facility.
(b) Fuso shall pay to GenVec the remaining seven hundred fifty
thousand dollars ($750,000) per year for the Research Program. Such amounts
shall be used by GenVec for its direct and indirect costs incurred in connection
with Research Program activities approved by the Steering Committee, including,
without limitation, research and development activities by GenVec, sponsored
research at [*], the supply by GenVec (subject to Section 6.2 below) of [*]
pursuant to the applicable Development Plan, the preparation and transfer of
documents in support of [*], patent prosecution by GenVec, travel and management
expenses related to the Research Program, and general support of technology
development by GenVec.
(c) The parties anticipate that the amount of the funding
provided in Sections 2.3.1(a) and (b) above will support the activities to be
conducted in connection with the Research Program with the goal of identifying
and commencing the development of [*] and filing an application for
authorization for [*]. It is understood and agreed that GenVec shall have no
obligation to expend any amount on the Research Program in excess of the amounts
paid by Fuso to GenVec for the conduct of the Research Program. GenVec shall use
reasonable efforts to conduct the Research Program activities approved by the
Steering Committee in a cost efficient manner consistent with the Research
Program budget and GenVec's customary practices.
2.3.2 Third Party Technology.
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(a) In the event that GenVec acquires any rights to
intellectual property or technology for its general corporate research and
development activities which are useful for the Research Program, GenVec shall
pay any costs attributable to the general use of the same; provided, GenVec
shall have no obligation to acquire with respect to any such intellectual
property or technology (i) the right to sublicense to Fuso any such intellectual
property or technology, or (ii) any rights relating to the commercialization of
Collaboration Products or any other products.
(b) In the event that it is necessary for GenVec to acquire a
license or GenVec has acquired a license from a third party specifically for
intellectual property or technology necessary or useful for the conduct of the
Research Program and/or the commercialization of Collaboration Products,
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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GenVec and Fuso shall negotiate and agree on the amounts that each party will be
responsible for paying to such third party with regard to such a license, and
for the expenses of negotiating and preparing any such license. In the event
that the parties are unable to agree on such amounts, GenVec shall have no
obligation to acquire such license and shall have no liability under this
Agreement for not acquiring such a license. It is understood and agreed that
GenVec shall have the principal responsibility for negotiating such agreements
unless otherwise agreed by the parties. In negotiating such agreements, GenVec
shall use reasonable efforts to reach an agreement which is as favorable as
possible to both GenVec and Fuso. GenVec shall report to Fuso on the progress of
such negotiations on a timely basis.
2.4 Collaboration Products.
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2.4.1 Designation. During the Research Program Term, either party
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shall have the right to nominate for further development as a Collaboration
Product any Product Configuration previously studied or currently under study in
the Research Program. Concurrently, such party shall provide a proposed
Development Plan (as described below) for such proposed Collaboration Product.
At the next Steering Committee meeting, or such later time as the parties may
agree, the Steering Committee shall vote whether or not to designate such
Product Configuration as a Collaboration Product. Any Product Configuration
which is unanimously approved as a Collaboration Product shall be a
Collaboration Product for all purposes of this Agreement. Product
Configurations which are not designated as Collaboration Products as set forth
above shall not be Collaboration Products.
2.4.2 Development Plan. Concurrent with the designation of any
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Product Configuration as a Collaboration Product, the Steering Committee shall
unanimously agree on a comprehensive written development plan for the Territory
for such Collaboration Product through the completion of clinical trials in
Japan (the "Development Plan"), which shall include specific activities, tasks
and timelines for each of Fuso and GenVec reasonable to accomplish the
foregoing, and reasonable budgets for such activities sufficient to accomplish
the foregoing, an assessment of relevant business considerations (including,
without limitation, competitive activities of third parties, any patent rights
of third parties and the likelihood that commercially valuable patent rights
could be obtained for such a Collaboration Product), and principles regarding
the coordination of such activities with the development of Collaboration
Products outside the Territory. All or some of such activities may be conducted
in connection with the Research Program, as agreed by the Steering Committee.
For any Development Plan activities which are to be conducted in connection with
the Research Program or which otherwise involve GenVec, subject to Section 5.1,
the Steering Committee shall agree on the financial obligations of each party
with respect to costs incurred in implementing such Development Plan activities.
2.4.3 No Agreement. In the event that the Steering Committee fails
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to agree to designate as a Collaboration Product a particular Product
Configuration that Fuso (i) nominated, (ii) prepared a Development Plan for
meeting the criteria in Section 2.4.2 above, and (iii) supported as a
Collaboration Product by voting for the applicable Development Plan, then GenVec
may not independently develop or commercialize such Product Configuration in the
Territory for the Field until after the Research Program Term, unless GenVec
has, subject to Section 2.4.4, previously commenced or established its intent to
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commence research (as shown by written records) with respect to such a Product
Configuration, alone or with a third party, prior to the date Fuso proposed to
the Steering Committee that such Product Configuration be designated as a
Collaboration Product.
2.4.4 Independent Development. Subject to Section 2.4.5, Fuso and
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GenVec shall each have the right to conduct research relating to the Field
independently or with third parties; provided, however, if either party wishes
to conduct such activities with a commercial third party with regard to a [*]
for a particular indication in the Field during the Research Program Term, and
has no contractual obligations to a third party that would restrict it from
offering rights for such product to the other party hereto, it shall provide the
other party hereto notice and a description of such proposed product and
indication. Within thirty (30) days of a party's receipt of such notice and
description, the party receiving such notice shall notify the other party
whether it wishes to discuss a potential collaboration for the development of
such a product for such indication, and in such event, the parties shall discuss
potential terms of a further collaboration in good faith. If the parties are
unable to reach an agreement within [*] or such longer period as the parties may
agree, the proposing party may develop such [*] product alone or may enter into
a collaboration agreement with a third party for the development of such
product, and the other party hereto shall have no further rights with respect to
such product.
2.4.5 Non-Compete. During the term of the Research Program and for
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[*] thereafter, neither GenVec nor Fuso, directly or indirectly, shall enter
into any collaboration agreement or other agreement with any commercial third
party for the development or commercialization in the Field within the Territory
of [*]. As used herein, "substantially similar" shall mean a product which
contains a gene studied by the parties in the Research program [*].
Notwithstanding the above, if both Fuso and GenVec have agreed in writing to
discontinue the development or commercialization of a particular Product
Configuration, either may develop or commercialize [*].
2.5 Records; Reports of Information.
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2.5.1 Records. The parties shall maintain (i) financial records in
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sufficient detail to establish how Research Program funds are expended, and (ii)
scientific records that will properly reflect all work done and results achieved
in the performance of the Research Program (including all data in the form
required under any applicable governmental regulations) in a manner sufficient
to establish the dates of first conception and reduction to practice of any
inventions. Upon request, the parties shall provide each other access to such
records relating to any Collaboration Product during ordinary business hours
during the Research Program Term and [*].
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THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
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2.5.2 Reports. The Steering Committee shall periodically and not
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less often than semiannually during the term of the Research Program, request
and the parties shall have the obligation to prepare and provide to the Steering
Committee written reports summarizing the progress of the research performed by
or sponsored by the parties pursuant to the Research Plan during the preceding
half-year. In addition, during the Research Program Term, each party shall
provide the other party with a quarterly accounting report regarding Research
Program expenditures by such party in the preceding quarter.
2.6 Term and Termination of Research Program.
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2.6.1 Research Program Term. The term of the Research Program shall
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commence on the Effective Date and, unless terminated earlier pursuant to
Section 2.6.2 or Article 11, shall continue until the fifth anniversary of the
Effective Date (the "Research Program Term").
2.6.2 Termination. After the second anniversary of the Effective
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Date Fuso may with ninety (90) days prior written notice to GenVec, terminate
its support for research by GenVec in connection with the Research Program. In
such an event, the Research Program shall terminate and GenVec may continue, at
its own expense, any such research initiated in connection with the Research
Program. In any such event, subsequent activities undertaken by GenVec shall
not be included in or be part of the Research Program, and notwithstanding any
other provision of this Agreement, any intellectual property developed in
connection with such independent GenVec activities shall not be included in the
GenVec Technology or the Joint Technology.
2.6.3 Lack of Diligence. If GenVec is not diligent and Fuso
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terminates the Research Program, GenVec shall return to Fuso (i) any amounts
unexpended on the Research Program by GenVec due to GenVec's lack of diligence,
and (ii) any amounts which an arbitrator, in an arbitration proceeding conducted
pursuant to Article 12, deems were expended by GenVec in the Research Program
without acting in a diligent manner ("Non-Diligent Research"). Notwithstanding
the above, any amounts that GenVec has provided to a third party [*]) with the
approval of the Steering Committee to sponsor research related to the Research
Program which an arbitrator deems Non-Diligent Research shall be returned to
Fuso by GenVec only to the extent that GenVec is able to obtain a refund from
such third party.
2.7 Publication.
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2.7.1 Review. As soon as is practicable prior to the oral public
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disclosure and prior to the submission to any outside person for publication of
a manuscript describing the scientific data resulting from any stage of the
Research Program, the authors of such disclosure shall disclose to the Steering
Committee the disclosure or manuscript to be made or submitted, and shall allow
the Steering Committee at least thirty (30) days to determine whether such
disclosure or manuscript contains subject matter for which patent protection
should be sought prior to publication or which the other believes should be
modified or deleted to avoid regulatory or commercial difficulties. With
respect to publications by investigators or other third parties, such
publications shall be subject to majority review by the Steering Committee under
this Section 2.7 to the extent that Fuso or GenVec (as the case may be) has the
right to do so.
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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2.7.2 Delay of Publication. Prior to the expiration of the thirty
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(30) day period specified in Section 2.7.1, the Steering Committee may notify
the submitting party of its determination that such oral presentation or
manuscript contains objectionable material or material that consists of
patentable subject matter for which patent protection should be sought. The
notified party shall withhold its proposed public disclosure and confer with the
Steering Committee to determine the best course of action to take in order to
modify the disclosure or to obtain patent protection. After resolution of the
regulatory or commercial issues, or the filing of a patent application, the
submitting party shall be free to submit the manuscript and/or make its public
oral disclosure.
2.7.3 Publication Rights. After the expiration of thirty (30) days
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from the date of mailing such disclosure or manuscript, unless Fuso or GenVec
has received from the other or the Steering Committee the written notice
specified above, the authoring party shall be free to submit such manuscript for
publication or to publish the disclosed research results. Any such publication
shall include an acknowledgment of the contributions of each party, subject to
customary scientific norms.
[*]
3. LICENSE GRANTS
3.1 Research Licenses.
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3.1.1 Licenses to Fuso. Subject to the terms and conditions of this
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Agreement, GenVec hereby grants to Fuso: [*] in the Territory; and (ii) a
non-exclusive, non-transferable, royalty-free license under the GenVec
Technology solely to conduct the Research Program and clinical trials as
described in Article 5 in the Field in the Territory.
3.1.2 License to GenVec. Subject to the terms and conditions of this
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Agreement, Fuso hereby grants to GenVec a non-exclusive, non-transferable,
royalty-free license under the Fuso Technology solely to conduct research
activities as contemplated herein within the Field (including, but not limited
to, the Research Program and clinical trials as described in Article 5).
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
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3.1.3 Sublicenses. GenVec and Fuso may sublicense the rights granted
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in Sections 3.1.1 and 3.1.2 to [*] only to the extent that such sublicenses are
reasonably necessary for GenVec and Fuso to conduct research activities in
connection with the Research Program and clinical trials as described in Article
5.
3.2 Retained Rights. It is understood and agreed that GenVec shall retain
---------------
the exclusive right to (i) make, have made, use, sell and otherwise
commercialize the Collaboration Products for all uses within the Field outside
the Territory; (ii) subject to Section 2.4.5, to make, have made, use, sell and
otherwise commercialize the Collaboration Products for use outside the Field,
both in and outside the Territory; (iii) to make, have made, use and sell
Collaboration Products to Fuso in connection with the activities conducted by
GenVec pursuant to this Agreement, unless and until Fuso assumes manufacture of
the Collaboration Products, and (iv) to practice any method, process or
procedure within, and otherwise develop, exploit and/or commercialize the [*].
3.3 No Implied Licenses. No rights or licenses with respect to the GenVec
-------------------
Technology or the Fuso Technology or other intellectual property owned by GenVec
or Fuso are granted or shall be deemed granted hereunder or in connection
herewith, other than those rights expressly granted in this Agreement.
3.4 Fuso Independent Technology. If during the Research Program Term Fuso
---------------------------
owns or controls intellectual property or materials not within the Fuso
Technology (as defined in Section 1.7) which may be useful for the conduct of
the Research Program or the development or commercialization of Collaboration
Products, Fuso may notify the Steering Committee identifying such intellectual
property and materials, and in such event the parties shall negotiate in good
faith the terms on which Fuso would make available such intellectual property
and materials for the Research Program and/or the development or
commercialization of Collaboration Products. Such terms shall include the terms
relating to the ownership of such Fuso independent technology and improvements
thereto, and shall govern in the event of any conflict between such terms and
the terms of this Agreement. If the parties do not enter into a further written
agreement, Fuso shall have no obligation to make such intellectual property or
materials available to GenVec for any purpose.
4. PAYMENTS
4.1 Research Program Funding. Fuso shall pay to GenVec funding for the
------------------------
Research Program of seven hundred fifty thousand dollars ($750,000) each year
during the Research Program Term. Such amounts shall be paid to GenVec in equal
quarterly installments of one hundred eighty-seven thousand five hundred dollars
($187,500), in advance. The initial payment shall be paid within [*] from the
Effective Date and subsequent payments shall be made on or before the [*] of the
Effective Date. Such payments shall be made without withholding for taxes or any
other charge and, subject to Section 2.6.3, shall be non-refundable.
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
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4.2 Milestone Cost Reimbursement. Within thirty (30) days following the
----------------------------
first occurrence in [*] of each of the events specified below with respect to
each Collaboration Product, Fuso shall pay to GenVec the following amounts:
*
Fuso shall promptly notify GenVec upon the achievement of each of the
foregoing milestones with respect to each Collaboration Product. It is
understood that such payments shall be made to share the costs incurred by
GenVec in connection with any research, [*] and/or clinical trials in the United
States for such Collaboration Product in consideration for the right to receive
data relating to such research, [*] from GenVec pursuant to Section 5.1.1.
4.3 Withholding Taxes. All payments required to be made to GenVec
-----------------
pursuant to Article 4 shall be without deduction or withholding for or on
account of any taxes or similar governmental charge.
4.4 Taxes. Any transfer taxes, import duties and other taxes or
-----
governmental charges required to be paid in connection with the transfer to Fuso
of any Collaboration Products manufactured by GenVec hereunder shall be the sole
responsibility of Fuso. In the event that GenVec is required to pay any such
amounts. Fuso shall promptly remit payment to GenVec of such amounts.
50 CLINICAL TRIALS
5.1 Collaboration Product Development by Fuso.
-----------------------------------------
5.1.1 Collaboration Products Developed by GenVec. It is understood
------------------------------------------
by the parties that the data to be obtained as the result of clinical trials
conducted by GenVec in the [*] that the Steering Committee agrees [*], and to
provide Fuso with the data [*] in a timely manner.
5.1.2 Collaboration Product Development by Fuso. Except as expressly
-----------------------------------------
provided otherwise in this Agreement, Fuso shall be responsible for all costs of
conducting development of Collaboration Product(s) in the Territory in
accordance with the applicable Development Plan(s), including, without
limitation expenses incurred [*] During the term of this Agreement, Fuso shall
keep GenVec fully informed of its activities subject to this Agreement,
including without limitation the achievement of the milestones set forth in
Section 4.2 and, in
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RESPECT TO THE OMITTED PORTIONS.
-13-
addition, on or before January 31 of each year, Fuso shall provide GenVec with a
written report detailing such events and activities.
5.2 Due Diligence.
-------------
5.2.1 Reasonable Efforts. Fuso shall use all reasonable efforts to:
------------------
(i) promptly develop the Collaboration Products following designation of such
Collaboration Product, and (ii) achieve the milestones set forth in Section
5.2.2(a).
5.2.2 Milestones.
----------
(a) Achievement Based. Subject to Sections 5.2.2(b) and 5.2.3
-----------------
below, if each of the following milestones are not timely met by Fuso or its
Sublicensees in Japan with respect to any Collaboration Product with respect to
the dates below (unless other dates are agreed by the Steering Committee and
specified in the applicable Development Plan) the license granted to Fuso with
respect to such Collaboration Product shall terminate in the Territory, and all
rights granted to Fuso relating to such Collaboration Product will revert to
GenVec.
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
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[*]
5.2.3 Lack of Diligence. In the event that Fuso fails to meet the
-----------------
achievement-based or the expenditure-based diligence milestones with respect to
a particular Collaboration Product, GenVec may terminate this Agreement with
respect to such Collaboration Product pursuant to the provision of Section 11.2,
unless Fuso establishes that it has acted reasonably, diligently and in good
faith to meet the milestones but failed due to events outside Fuso's control,
which may include, but not limited to, [*]. In such event, GenVec shall
thereafter have the exclusive rights to commercialize such Collaboration
Products in the Territory, alone or with third parties.
5.3 Regulatory Filings.
------------------
5.3.1 Research Program-Based Each party and its Affiliates, and,
----------------------
subject to such party's obligations to third parties, its sublicensees, shall
have the right, without charge, to refer to, access, cross reference, and use
documents relating to each Collaboration Product filed by a party or its
Affiliates or Sublicensees with regulatory entities with respect to activities
conducted in connection with the Research Program, [*], and any written
communications to and with the [*].
5.3.2 Outside the Research Program. Subject to its obligations to
----------------------------
third parties, each party and its Affiliates and sublicensees, may in exchange
for reasonable consideration to be agreed by the parties, obtain the right to
refer to, access, cross reference, and [*] relating to each Collaboration
Product, filed by a party or its Affiliates or Sublicensees in agreed
jurisdictions, with respect to activities conducted outside the Research
Program, including clinical studies and other supporting information, and any
[*].
6. MANUFACTURING RIGHTS
6.1 [*]
---
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
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6.1.1 [*]. GenVec shall have the first right, but not the [*].
---
6.1.2 Clinical Trials in the Territory. Fuso shall have the first
--------------------------------
right, but not the obligation [*].
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
-16-
[*]
7. INTELLECTUAL PROPERTY
7.1 Ownership of Inventions.
-----------------------
7.1.1 Research Program Technology. Subject to Section 7.1.2 below,
---------------------------
(i) title to all inventions and intellectual property made solely by GenVec
employees or its agents (including researchers at [*]) in connection with the
Research Program without inventive contribution by Fuso employees or its agents
shall be owned by GenVec; (ii) title to all inventions and intellectual property
made solely by Fuso employees or its agents (including researchers at [*]
University) in connection with the Research Program without inventive
contribution by GenVec employees or its agents shall be owned by Fuso; and (iii)
title to all inventions and intellectual property made jointly by employees or
the agents of Fuso and GenVec in connection with the Research Program, shall be
jointly owned by GenVec and Fuso.
7.1.2 [*]. Notwithstanding Section 7.1.1 above,
---
title to all inventions and intellectual property which relates to [*] made
solely by GenVec employees or its agents (including researchers at [*]) or
jointly by employees or the agents of Fuso and GenVec in connection with the
Research Program (in each case, [*]) shall be owned by GenVec. Fuso hereby
assigns to GenVec all its right, title and interest it may otherwise hold in or
to such [*] and any patent applications or patents relating thereto. Fuso shall,
at the request of GenVec, execute, and deliver or cause to be delivered, all
such consents, documents or further instruments of assignment or transfer, and
take or cause to be taken all such actions GenVec reasonably deems necessary or
desirable in order for GenVec to obtain the full benefits of the assignment
herein.
7.1.3 Inventorship. Inventorship and rights of ownership of
------------
inventions and other intellectual property rights conceived and/or reduced to
practice in connection with the Research Program shall be determined in
accordance with the patent and other intellectual property laws of the United
States or the State of Maryland, as applicable, as long as the laws of the
Territory permit application of such laws. Subject to the licenses granted in
Article 3, except as expressly provided in this Agreement, it is understood that
neither party shall have any obligation to account to the other for profits, or
to obtain any approval of
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
-17-
the other party to license or exploit a joint invention for applications outside
of the Field by reason of joint ownership of any such intellectual property.
7.2 Patent Prosecution
------------------
7.2.1 Sole Inventions. Fuso or GenVec, as the case may be, shall, be
---------------
responsible for preparing, filing, prosecuting and maintaining of the patent
applications and patents, solely owned by it, worldwide in such countries as it
deems appropriate, and conducting any interferences, reexaminations, reissues,
oppositions or requests for patent term extensions relating to the Fuso
Technology or GenVec Technology (respectively), using counsel of its choice, at
its expense; provided, such expenses may be included in the Research Program
funding described in Section 2.3.
7.2.2 Joint Patent Rights.
-------------------
(i) The parties will cooperate to file, prosecute and maintain
patent applications covering the Joint Invention(s) in the United States,
European Union (in Europe through a European Patent Convention application) and
Japan (collectively, the "Core Countries") and other countries agreed by the
parties. The parties shall agree which party shall be responsible for conducting
such activities with respect to a particular Joint Invention. The party
conducting such activities shall keep the other party fully informed as to the
status of such patent matters, including, without limitation, by providing the
other party the opportunity, at the other party's expense, to review and comment
on any documents relating to the Joint Invention which will be filed in any
patent office at least thirty (30) days before such filing, and promptly
providing the other party copies of any documents relating to Joint Invention
which the party conducting such activities receives from such patent offices,
including notice of all interferences, reissues, reexaminations, oppositions or
requests for patent term extensions. The parties will share equally all expenses
and fees associated with the filing, prosecution, issuance and maintenance of
any patent application and resulting patent for a Joint Invention in the Core
Countries and other agreed countries and such amounts shall be included within
the Research Program funding described in Section 2.3.
(ii) In the event that either party wishes to seek patent
protection with respect to any Joint Invention outside the Core Countries, it
shall notify the other party hereto. If both parties wish to seek patent
protection with respect to such Joint Invention in such country or countries,
activities shall be subject to Section 7.2.2(a) above. If only one party wishes
to seek patent protection with respect to such Joint Invention in such country
or countries, it may file, prosecute and maintain patent applications and
patents with respect thereto, at its own expense. In any such case, the party
declining to participate in such activities shall not grant any third party a
license under its interest in the applicable Joint Invention in the applicable
country or countries without the prior written consent of the other party.
-18-
7.3 Enforcement.
-----------
7.3.1 Solely Owned Technology. Subject to 7.3.2 below, in the event
-----------------------
that any GenVec Technology or Fuso Technology (in this Section, both referred to
as "Technology") necessary for use of a Collaboration Product is infringed or
misappropriated by a third party in any country in the Territory, or is subject
to a declaratory judgment action arising from such infringement in such country,
Fuso or GenVec, as the case may be, shall promptly notify the other party
hereto. The party which owns or controls such Technology (the "Owner") shall
have the initial right (but not the obligation) to enforce such Technology, or
defend any declaratory judgment action with respect thereto, at its expense. In
the event that the Owner fails to initiate a suit to enforce such Technology
against a commercially significant infringement in the Field by a third party in
any jurisdiction in the Territory within [*] of a request by the other party
(the "Licensee") to do so, Licensee may, subject to the Owner's agreements with
third parties, initiate such suit in the name of the Owner of such Technology
against such infringement, at the expense of such Licensee. The party involved
in any such claim, suit or proceeding, shall keep the other party hereto
reasonably informed of the progress of any such claim, suit or proceeding. Any
recovery by such party received as a result of any such claim, suit or
proceeding shall be used first to reimburse such party for all expenses
(including attorneys and professional fees) incurred in connection with such
claim, suit or proceeding and if the party initiating the suit was the owner of
the subject Technology, all of the remainder shall be retained by such owner,
and if the party initiating the suit is the Licensee, [*] of the remainder shall
be paid to the owner of the subject Technology and [*] retained by the Licensee.
7.3.2 Jointly Owned Technology. Notwithstanding 7.3.1 above, in the
------------------------
event that any technology that is jointly owned by GenVec and Fuso under Section
7.1 of this Agreement is infringed or misappropriated by a third party, Fuso and
GenVec shall discuss whether, and, if so, how, to enforce such Joint Technology
or defend such Joint Technology in an infringement action, declaratory judgment
or other proceeding. In the event only one party wishes to participate in such
proceeding, it shall have the right to proceed alone, at its expense, and may
retain any recovery; provided, at the request and expense of the participating
party, the other party agrees to cooperate and join in any proceedings in the
event that a third party asserts that the co-owner of such Joint Invention is
necessary or indispensable to such proceedings.
7.4 Infringement Claims. If the use of any Collaboration Product in
-------------------
clinical trials in the Territory pursuant to this Agreement results in any
claim, suit or proceeding alleging patent infringement against GenVec or Fuso,
such party shall promptly notify the other party hereto. If Fuso is not named
as a party in such a claim, suit or proceeding, Fuso may, at its own expense and
through counsel of its own choice, seek leave to intervene in such claim, suit
or proceeding. GenVec agrees not to oppose such intervention. If Fuso, and not
GenVec, is named as a party to such claim, suit or proceeding, Fuso shall have
the right to control the defense and settlement of such claim, suit or
proceeding, at its own expense, using counsel of its own choice, however GenVec,
at its own expense and through counsel of its own choice, may seek to intervene
if the claim, suit or proceeding relates to the commercialization of the
Collaboration Product in the Field, and in such event, Fuso agrees not to oppose
such intervention. If Fuso is named as a party and GenVec shall, at any time,
tender its defense to Fuso, then Fuso shall defend GenVec in such claim, suit or
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
-19-
proceeding, at Fuso' s own expense and through counsel of its own choice, and
Fuso shall control the defense and settlement of any such claim, suit or
proceeding; provided, Fuso shall not enter into any agreement which makes any
admission regarding (i) wrongdoing on the part GenVec, or (ii) the invalidity,
unenforceability or absence of infringement of any GenVec Patent Rights or
patent claiming a Joint Invention, without the prior written consent of GenVec,
which consent shall not be unreasonably withheld. The parties shall cooperate
with each other in connection with any such claim, suit or proceeding and shall
keep each other reasonably informed of all material developments in connection
with any such claim, suit or proceeding.
8. REPRESENTATIONS AND WARRANTIES
8.1 Warranties.
----------
8.1.1 GenVec. GenVec warrants and represents to Fuso that (i) it has
------
the full right and authority to enter into this Agreement and grant the rights
and licenses granted herein; (ii) as of the Effective Date, there are no
existing or threatened actions, suits or claims pending against it with respect
to the GenVec Technology or its right to enter into and perform its obligations
under this Agreement; (iii) it has not previously granted, and will not grant
during the term of this Agreement, any right, license or interest in or to
GenVec Technology or Joint Technology, or any portion thereof, which are in
conflict with the rights or licenses granted under this Agreement; and (iv) as
of the Effective Date, GenVec believes that the patent applications and patents
listed on Exhibit A hereto is a complete list of patent applications and patents
owned or controlled by GenVec necessary or useful for the conduct of the
Research Program, provided, however, the foregoing does not apply to [*] or the
use thereof.
8.1.2 Fuso. Fuso warrants and represents to GenVec that (i) it has
----
the full right and authority to enter into this Agreement, and (ii) it has not
previously granted, and will not grant during the term of this Agreement, any
right, license or interest in or to Fuso Technology or Joint Technology, or any
portion thereof, which are in conflict with the rights or licenses granted under
this Agreement.
8.2 Effect of Representations and Warranties. It is understood that if
----------------------------------------
the representations and warranties under this Article 8 are not true and
accurate and GenVec or Fuso incurs liabilities, costs or other expenses as a
result of such falsity, GenVec or Fuso, as the case may be, shall indemnify,
defend and hold the other party harmless from and against any such liabilities,
costs or expenses incurred, provided that the indemnifying party receives prompt
notice of any claim against GenVec or Fuso, as the case maybe, resulting from or
related to such falsity, the cooperation of the indemnified party, as requested
in connection with any such claim, and the sole right to control the defense or
settlement thereof.
8.3 Disclaimer of Warranties. GenVec and Fuso each specifically disclaim
------------------------
that the Research Program will be successful, in whole or part. GENVEC AND FUSO
EXPRESSLY DISCLAIM ANY WARRANTIES OR CONDITIONS, EXPRESS, IMPLIED, STATUTORY OR
OTHERWISE, WITH RESPECT TO THE CONFIDENTIAL INFORMATION, OR FUSO TECHNOLOGY OR
GENVEC
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
-20-
TECHNOLOGY, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY,
NONINFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF FUSO
TECHNOLOGY OR GENVEC TECHNOLOGY, PATENTED OR UNPATENTED, OR NON-INFRINGEMENT OF
THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
9. CONFIDENTIALITY
9.1 Confidential Information. Except as expressly provided herein, the
------------------------
parties agree that, for the term of this Agreement and for [*]
thereafter, the receiving party shall keep completely confidential and shall not
publish or otherwise disclose and shall not use for any purpose except for the
purposes contemplated by this Agreement any Confidential Information furnished
to it by the disclosing party hereto pursuant to this Agreement, except that to
the extent that it can be established by the receiving party by competent proof
that such Confidential Information:
(i) was already known to the receiving party, other than under an
obligation of confidentiality, at the time of disclosure;
(ii) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving party;
(iii) became generally available to the public or otherwise part of
the public domain after its disclosure and other than through any act or
omission of the receiving party in breach of this Agreement;
(iv) was independently developed by the receiving party without
reference to any information or materials disclosed by the disclosing party; or
(v) was subsequently disclosed to the receiving party by a person
other than a party without breach of any legal obligation to the disclosing
party.
9.2 Permitted Disclosures. Each party hereto may disclose another's
---------------------
Confidential Information to the extent such disclosure is reasonably necessary
in connection with the conduct of the Research Program activities to be
conducted at [*] (or any other academic institution approved by the Steering
Committee), in filing or prosecuting patent applications, prosecuting or
defending litigation, complying with applicable governmental regulations or
otherwise submitting information to tax or other governmental authorities, [*],
or making a permitted sublicense or otherwise exercising its rights hereunder,
provided that if a party is required to make any such disclosure of another
party's confidential information, other than pursuant to a confidentiality
agreement, it will give reasonable advance notice to the latter party of such
disclosure and, save to the extent inappropriate in the case of patent
applications, will use its best efforts to secure confidential treatment of such
information prior to its disclosure (whether through protective orders or
otherwise).
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
-21-
9.3 Non-Disclosure. Each of the parties hereto agrees not to disclose to
--------------
any third party the financial terms of this Agreement without the prior written
consent of each other party hereto, except to advisors, investors and others on
a need to know basis under circumstances that reasonably ensure the
confidentiality thereof, or to the extent required by law. Without limitation
upon any provision of this Agreement, each of the parties hereto shall be
responsible for the observance by its employees of the foregoing confidentiality
obligations. Notwithstanding the foregoing, the parties shall agree upon a
press release to announce the execution of this Agreement, together with a
corresponding Q&A outline for use in responding to inquiries about the
Agreement; thereafter, GenVec and Fuso may each disclose to third parties the
information contained in such press release and Q&A without the need for further
approval by the other.
10. INDEMNIFICATION
10.1 Indemnification of Fuso. GenVec shall indemnify and hold Fuso and
-----------------------
its Affiliates, and their respective directors, officers, employees, agents and
counsel, and the successors and assigns of the foregoing (the "Fuso
Indemnitees"), harmless from and against any and all liabilities, damages,
losses, costs or expenses (including reasonable attorneys' and professional fees
and other expenses of litigation and/or arbitration) resulting from a claim,
suit or proceeding brought by a third party against a Fuso Indemnitee, arising
from or occurring as a result of': (i) GenVec's conduct of the Research
Program, (ii) the research, development, use or clinical testing of any Product
Configuration and/or Collaboration Product by GenVec or its Affiliates or
licensees (including without limitation, product liability claims), or (iii) the
failure of Collaboration Products manufactured by GenVec to meet the relevant
specifications, except, in each case, to the extent caused by the negligence or
willful misconduct of Fuso.
10.2 Indemnification of GenVec. Fuso shall indemnify and hold GenVec and
-------------------------
its Affiliates and their respective directors, officers, employees, agents and
counsel and the successors and assigns of the foregoing (the "GenVec
Indemnitees"), harmless from and against any and all liabilities, damages,
losses, costs or expenses (including reasonable attorneys' and professional fees
and other expenses of litigation and/or arbitration) resulting from a claim,
suit or proceeding brought by a third party against a GenVec Indemnitee, arising
from or occurring as a result of; (i) Fuso's conduct of the Research Program, or
(ii) the research, development, use or clinical testing of any Product
Configuration and/or Collaboration Product by Fuso or its Affiliates or
Sublicensees (including without limitation, product liability claims), except,
in each case, to the extent caused by the negligence or willful misconduct of
GenVec.
10.3 Procedure. A party (the "Indemnitee") that intends to claim
---------
indemnification under this Article 10 shall promptly notify the other party (the
"Indemnitor") in writing of any loss, claim, damage, liability or action in
respect of which the Indemnitee or any of its Affiliates, Sublicensees or their
directors, officers, employees, agents or counsel intend to claim such
indemnification, and the Indemnitor shall have the right to participate in, and,
to the extent the Indemnitor so desires, to assume the defense thereof with
counsel mutually satisfactory to the parties. The indemnity agreement in this
Article 10 shall not apply to amounts paid in settlement of any loss, claim,
damage, liability or action if such settlement is made without the consent of
the Indemnitor, which consent shall not be withheld unreasonably. The failure
to deliver
-22-
written notice to the Indemnitor within a reasonable time after the commencement
of any such action, if prejudicial to its ability to defend such action, shall
relieve such Indemnitor of any liability to the Indemnitee under this Article
10. At the Indemnitor's request, the Indemnitee under this Article 10, and its
employees and agents, shall cooperate fully with the Indemnitor and its legal
representatives in the investigation and defense of any action, claim or
liability covered by this indemnification and provide full information with
respect thereto.
11. TERM AND TERMINATION
11.1 Term. This Agreement shall be effective as of the Effective Date
----
and, unless otherwise terminated earlier pursuant to the other provisions of
this Article 11, shall continue in full force and effect until the expiration or
termination of the Research Program; provided, that the license granted to Fuso
under Section 3.1 and the obligations set forth in Sections 5.1 and 5.2 and
Article 6 shall remain in effect with respect to any Product Configuration which
prior to the effective date of such expiration or termination was designated by
the Steering Committee as a Collaboration Product on a Collaboration Product-by-
Collaboration Product basis, until the earlier of (i) [*].
11.2 Termination for Cause. Either party may terminate this Agreement in
---------------------
the event the other party has materially breached or defaulted in the
performance of any of its obligations hereunder, and such default has continued
for [*] after written notice thereof was provided to the breaching party by the
nonbreaching party. Any termination shall become effective at the end of such
[*] period unless the breaching party has cured any such breach or default prior
to the expiration of the [*] period. Notwithstanding the above, in the case of a
failure to pay any amount due hereunder the period for cure of any such default
following notice thereof shall be [*] and, unless payment is made within such
period, the termination shall become effective at the end of such period.
11.3 Termination for Insolvency. If voluntary or involuntary proceedings
--------------------------
by or against a party are instituted in bankruptcy under any insolvency law, or
a receiver or custodian is appointed for such party, or proceedings are
instituted by or against such party for corporate reorganization or the
dissolution of such party, which proceedings, if involuntary, shall not have
been dismissed within [*] after the date of filing, or if such party makes an
assignment for the benefit of creditors, or substantially all of the assets of
such party are seized or attached and not released within [*] thereafter, the
other party may immediately terminate this Agreement effective upon notice of
such termination.
11.4 Permissive Termination. After the second anniversary of the Research
----------------------
Program, Fuso may, at its sole discretion, terminate this Agreement at any time
with [*] prior notice pursuant to Section 2.6.2.
[*]
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WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT
TO THE OMITTED PORTIONS.
-23-
[*]
11.6 Termination of Commercialization Agreement. If the Commercialization
------------------------------------------
Agreement terminates, this Agreement shall terminate concurrently.
11.7 Effect of Breach or Termination.
-------------------------------
11.7.1 Accrued Obligations. Termination of this Agreement for any
-------------------
reason shall not release any party hereto from any liability which, at the time
of such termination, has already accrued to the other party or which is
attributable to a period prior to such termination, nor preclude either party
from pursuing any rights and remedies it may have hereunder or at law or in
equity which accrued or are based upon any event occurring prior to such
termination.
11.7.2 Return of Materials. Upon the discontinuance of the research
-------------------
and development activities with respect to a particular Product Configuration,
whether due to termination of this Agreement or otherwise, if a corresponding
Collaboration Product is not being commercialized pursuant to the
Commercialization Agreement, Fuso and GenVec shall promptly return to the other
party all materials and Confidential Information received from the other party
relating specifically to such Product Configuration (except one copy of which
may be retained by legal counsel for archival purposes).
11.7.3 Licenses.
--------
(a) The licenses granted Fuso herein shall terminate in the
event of a termination pursuant to Section 11.2, 11.3, 11.4 (subject to Section
11.1), 11.5 or 11.6.
(b) The licenses granted to GenVec in Section 3.1.2 shall
terminate only in the event of a termination by Fuso pursuant to Section 11.2 or
11.3 or 11.6.
11.8 Survival. Sections 2.5.1, 2.7, 3.2, 3.3, 5.3, 11.1, 11.7 and 11.8
--------
and Articles 4, 7, 8, 9, 10, 12 and 13 shall survive the expiration or
termination of this Agreement for any reason.
12. DISPUTE RESOLUTION
12.1 Mediation. If a dispute arises out of or relates to this Agreement,
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or the breach thereof, and if said dispute cannot be settled through
negotiation, the parties agree first to try in good faith to settle the dispute
by mediation under the Commercial Mediation Rules of the American Arbitration
Association before resorting to arbitration.
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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12.2 Arbitration. Any dispute under this Agreement (except any dispute
-----------
relating to the validity or enforceability of any patent) which is not settled
by mutual consent shall be finally settled by binding arbitration. Such
arbitration shall be conducted in accordance with the International Arbitration
Rules of the Asia/Pacific Center by three (3) arbitrators appointed in
accordance with said rules and shall be held in San Francisco, California. At
least one of the arbitrators shall be an independent expert in pharmaceutical
product development (including clinical development and regulatory affairs).
The arbitrators shall determine what discovery will be permitted, consistent
with the goal of limiting the cost and time which the parties must expend for
discovery; provided the arbitrators shall permit such discovery as they deem
necessary to permit an equitable resolution of the dispute. Any written
evidence originally in a language other than English shall be submitted in
English translation accompanied by the original or a true copy thereof. The
costs of the arbitration including administrative and arbitrators' fees, shall
be shared equally by the parties and each party shall bear its own costs and
attorneys' and witness' fees incurred in connection with the arbitration. A
disputed performance or suspended performances pending the resolution of the
arbitration must be completed within thirty (30) days following the final
decision of the arbitrators or such other reasonable period as the arbitrators
determine in a written opinion. Any arbitration subject to this Article shall
be completed within one (1) year from the filing of notice of a request for such
arbitration. No punitive damages may be granted by the arbitrators. The
arbitration proceedings and the decision shall not be made public without the
joint consent of the parties and each party shall maintain the confidentiality
of such proceedings and decision unless otherwise permitted by the other party.
The parties agree that the decision shall be the sole, exclusive and binding
remedy between them regarding any and all disputes, controversies, claims and
counterclaims presented to the arbitrators. Any award may be entered in a court
of competent jurisdiction for a judicial recognition of the decision and an
order of enforcement.
13. MISCELLANEOUS
13.1 Governing Law. This Agreement and any dispute arising from the
-------------
performance or breach hereof shall be governed by and construed in accordance
with the laws of the State of California, without reference to conflicts of laws
principles.
13.2 Waiver. Neither party may waive or release any of its rights or
------
interests in this Agreement except in writing. The failure of either party to
assert a right hereunder or to insist upon compliance with any term or condition
of this Agreement shall not constitute a waiver of that right or excuse a
similar subsequent failure to perform any such term or condition.
13.3 Assignment. [*]
----------
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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13.4 Notices. Any notices, requests and other communications hereunder
-------
shall be in writing and shall be personally delivered or sent by international
express delivery service, registered or certified mail, return receipt
requested, postage prepaid, in each case to the respective address specified
below, or such other address as may be specified in writing to the other parties
hereto:
FUSO: Fuso Pharmaceutical Industries, Ltd
3-11, 2-Chome, Xxxxxxxxxx, Xxxx-xx
Xxxxx 000, Xxxxx
Attn: President
With a copy to: Director, Research and Development Center
GENVEC: GenVec, Inc.
00000 Xxxxxxxx Xxxxx,
Xxxxxxxxx, Xxxxxxxx 00000
Attn: President
With a copy to: Vice President, Corporate Development
13.5 Performance Warranty. Fuso and GenVec hereby respectively warrant
--------------------
and guarantee the performance of any and all rights and obligations of this
Agreement by their Affiliate(s) and sublicensees.
13.6 Force Majeure. Neither party shall be liable to the other for
-------------
failure or delay in the performance of any of its obligations under this
Agreement for the time and to the extent such failure or delay is caused by
earthquake, riot, civil commotion, war, hostilities between nations,
governmental law, order or regulation, embargo, action by the government or any
agency thereof, act of God, storm, fire, accident, labor dispute or strike,
sabotage, explosion or other similar or different contingencies, in each case,
beyond the reasonable control of the respective party. The party affected by
Force Majeure shall provide the other party with full particulars thereof as
soon as it becomes aware of the same (including its best estimate of the likely
extent and duration of the interference with its activities), and will use its
best endeavors to overcome the difficulties created thereby and to resume
performance of its obligations as soon as practicable. If the performance of
any obligation under this Agreement is delayed owing to a force majeure for any
continuous period of more than six (6) months, the parties hereto shall consult
with respect to an equitable solution including the possible termination of this
Agreement.
13.7 Independent Contractors. Nothing contained in this Agreement is
-----------------------
intended implicitly, or is to be construed, to constitute Fuso or GenVec as
partners in the legal sense. No party hereto shall have any express or implied
right or authority to assume or create any obligations on behalf of or in the
name of any other party or to bind any other party to any contract, agreement or
undertaking with any third party.
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13.8 Advice of Counsel. GenVec and Fuso have each consulted counsel of
-----------------
their choice regarding this Agreement, and each acknowledges and agrees that
this Agreement shall not be deemed to have been drafted by one party or another
and will be construed accordingly.
13.9 Other Obligations. Except as expressly provided in this Agreement or
-----------------
as separately agreed upon in writing between GenVec and Fuso, each party shall
bear its own costs incurred in connection with the implementation of the
obligations under this Agreement.
13.10 Independent Research. Except as expressly provided herein, each
--------------------
party acknowledges and agrees that Fuso and GenVec shall have the right to
engage in their own research and development activities outside the Research
Program. Neither party shall, by virtue of this Agreement, have any right,
title or interest in or to such independent activities or to the income or
profits derived therefrom.
13.11 Severability. In the event that any provisions of this Agreement
------------
are determined to be invalid or unenforceable by a court of competent
jurisdiction, the remainder of the Agreement shall remain in full force and
effect without said provision. The parties shall in good faith negotiate a
substitute clause for any provision declared invalid or unenforceable, which
shall most nearly approximate the intent of the parties in entering this
Agreement; provided, if the parties are unable to agree on such a substitute
clause and the deletion of the provision held invalid or unenforceable would
produce material adverse financial consequences for one party, such party shall
have the right to terminate the Agreement with [*] notice.
13.12 Further Assurances. At any time or from time to time on and after
------------------
the date of this Agreement, either party shall at the request of the other party
(i) deliver to the requesting party such records, data or other documents
consistent with the provisions of this Agreement, (ii) execute, and deliver or
cause to be delivered, all such consents, documents or further instruments of
assignment, transfer or license, and (iii) take or cause to be taken all such
actions, as the requesting party may reasonably deem necessary or desirable in
order for the requesting party to obtain the full benefits of this Agreement and
the transactions contemplated hereby.
13.13 Foreign Corrupt Practices Act. In conformity with the United States
-----------------------------
Foreign Corrupt Practices Act, Fuso and its employees and agents shall not
directly or indirectly make any offer, payment, promise to pay, or authorize
payment, or offer a gift, promise to give, or authorize the giving of anything
of value for the purpose of influencing an act or decision of an official of any
government within the Territory or the United States Government (including a
decision not to act) or inducing such official to use his influence to affect
any such governmental act or decision in order to obtain, retain, or direct any
such business.
13.14 Export Laws. Notwithstanding anything to the contrary contained
-----------
herein, all obligations of GenVec and Fuso are subject to prior compliance with
United States export regulations and such other United States or Japanese laws
and regulations as may be applicable, and to obtaining all necessary approvals
required by the applicable agencies of the government of the United States or
Japan. GenVec
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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and Fuso, respectively, shall each use its best efforts to obtain such approvals
from its own government. Each party shall cooperate with the other party and
shall provide assistance to the other party as reasonably necessary to obtain
any required approvals.
13.15 Approvals. Each party shall be responsible, at its expense, for
---------
obtaining any approvals from its own government which may be required under
applicable law, and shall use its best efforts to obtain all necessary approvals
as soon as possible after the execution of this Agreement.
13.16 Entire Agreement. This Agreement together with the attached
----------------
Exhibit, and the Commercialization Agreement, and Stock Purchase Agreement
entered by the parties of even date herewith, constitute the entire agreement,
both written or oral, with respect to the subject matter hereof, and supersede
all prior or contemporaneous understandings or agreements, whether written or
oral, between Fuso and GenVec with respect to such subject matter.
13.17 Headings. The captions to the several Sections and Articles hereof
--------
are not a part of this Agreement, but are included merely for convenience of
reference only and shall not affect its meaning or interpretation.
13.18 Counterparts. This Agreement may be executed in two counterparts,
------------
each of which shall be deemed an original and which together shall constitute
one instrument.
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
duly executed by their authorized representatives as of the Effective Date.
FUSO PHARMACEUTICAL GENVEC, INC.
INDUSTRIES, LTD.
By:_____________________________ By:________________________
Name:___________________________ Name:______________________
Title:__________________________ Title:_____________________
[*]
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
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