EXHIBIT 10.9
COMMERCIALIZATION AGREEMENT
This COMMERCIALIZATION 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, which Fuso shall have the right to commercialize in the Territory
(as defined below) and GenVec shall have the right to commercialize outside the
Territory.
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
Commercialization 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 INCORPORATION BY REFERENCE. For purposes of this Agreement, the
capitalized terms used in this Agreement which are not defined herein shall have
the meanings set forth in the Collaboration Agreement.
[*]=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. OMITTED TEXT IS INDICATED BY A "*".
1.2 "AFFILIATE" shall mean any corporation or other entity which is
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.
1.3 "COLLABORATION AGREEMENT" shall mean that certain Collaboration
Agreement between the parties effective on even date herewith.
1.4 "COLLABORATION PRODUCT" shall mean a Product Configuration developed
in the Research Program intended for use in the Field which the Steering
Committee has designated as such pursuant to Section 2.4 of the Collaboration
Agreement.
1.5 "CONFIDENTIAL INFORMATION" shall mean (i) any proprietary or
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.
1.6 "DEVELOPMENT PLAN" shall mean the written plan for development of a
particular Collaboration Product prepared pursuant to Section 2.4.2 of the
Collaboration Agreement.
1.7 "DFCI" shall mean the Xxxx Xxxxxx Cancer Institute, Inc.
1.8 "FUSO TECHNOLOGY" shall mean Fuso Patent Rights and Fuso Know-How:
1.8.1 "FUSO PATENT RIGHTS" shall mean (i) all patents and patent
applications conceived and reduced to practice by Fuso alone, or Fuso and/or
its agents (including researchers at Jikei University), in connection with
the Research Program during the Research Program Term (as defined in Section
1.19 of the Collaboration Agreement), 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 Gene
Therapy Technology.
1.8.2 "FUSO KNOW-HOW" shall mean confidential information and
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
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information and data, discovered, developed or acquired by Fuso alone, or Fuso
and/or its agents (including researchers at Jikei 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 Gene Therapy Technology.
1.9 "FIELD" shall mean Gene Therapy for the treatment of human cancer *
or, in each case, any portion or derivative thereof.
1.10 "GENE THERAPY" shall mean the introduction of a gene into a person for
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.
1.11 "GENE THERAPY TECHNOLOGY" shall have the meaning set forth in
Section 7.1.2 below.
1.12 "GENVEC TECHNOLOGY" shall mean GenVec Patent Rights, GenVec Know-How
and Gene Therapy Technology.
1.12.1 "GENVEC PATENT RIGHTS" shall mean (i) all patents and patent
applications listed on Exhibit A hereto, or conceived and reduced to practice by
GenVec alone, or GenVec and/or its agents (including researchers at DFCI) 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.
1.12.2 "GENVEC KNOW-HOW" shall mean confidential information and
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 DFCI), 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.
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1.13 "JOINT TECHNOLOGY" shall mean the Joint Patent Rights and Joint Know-
How.
1.13.1 "JOINT PATENT RIGHTS" shall mean (i) all patents and patent
applications conceived and reduced to practice jointly by Fuso (or its agents,
including researchers at Jikei University) and GenVec (or its agents, including
researchers at DFCI) 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 Gene Therapy Technology.
1.13.2 "JOINT KNOW-HOW" shall mean confidential information and
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 jointly by Fuso (or its
agents, including researchers at Jikei University), and GenVec (or its agents,
including researchers at DFCI 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 Gene Therapy Technology.
1.14 "MHW" shall mean the Japanese Ministry of Health and Welfare, or any
corresponding foreign registration or foreign regulatory authority in the
Territory.
1.15 "NET SALES" shall mean the gross revenue accrued by Fuso or its
Affiliates or Sublicensees for all Collaboration Products sold by Fuso and its
Affiliates and Sublicenses in arm's length sales to bona fide independent third
parties, and for any and all services related to the Collaboration Products
performed by or on behalf of Fuso or its Affiliates and Sublicensees, less to
the extent included in the invoice price: (1) ordinary and customary trade
discounts actually allowed; (2) credits, rebates and returns (including, but not
limited to, wholesaler and retailer returns); (3) freight, postage and duties
paid for and separately identified on the invoice or other documentation
maintained in the ordinary course of business, and (4) excise taxes, other
consumption taxes, customs duties and compulsory payments to governmental
authorities actually paid and separately identified on the invoice or other
documentation maintained in the ordinary course of business. Net Sales shall
also include the fair market value of all other consideration received by Fuso
or its Affiliates or permitted Sublicensees in respect of any grant of rights to
make, use, sell or otherwise distribute Collaboration Products, whether such
consideration is in cash payment in kind, exchange or another form.
In the case of discounts on "bundles" of products or services which include
Collaboration Products, Fuso may with notice to GenVec discount the bona fide
list price of a Collaboration Product by the average percentage discount of all
products of Fuso and/or its Affiliates or Sublicensees in a particular "bundle",
calculated as follows:
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[eszett] Average percentage A
[eszett] discount on a = (1- --- ) x 100
[eszett] particular "bundle" B
where A equals the total discounted price of a particular "bundle" of
products, and B equals the sum of the undiscounted bona fide list prices of
each unit of every product in such "bundle". Fuso shall provide GenVec
documentation, reasonably acceptable to GenVec, establishing such average
discount with respect to each "bundle". If Fuso cannot so establish the
average discount of a "bundle", Net Sales shall be based on the undiscounted
list price of the Collaboration Product in the "bundle". If a Collaboration
Product in a "bundle" is not sold separately and no bona fide list price
exists for such Collaboration Product, the parties shall negotiate in good
faith an imputed list price for such Collaboration Product and Net Sales with
respect thereto shall be based on such imputed list price.
1.16 "PRODUCT CONFIGURATION" shall mean any potential product for use in
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
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 "STEERING COMMITTEE" shall have the meaning set forth in Section 2.2
in the Collaboration Agreement.
1.19 "SUBLICENSEE" shall mean a third party to whom Fuso has granted a
license or sublicense under the GenVec Technology or Joint Technology to make,
use and/or sell a Collaboration Product subject to Section 2.2 below. As used in
this Agreement, Sublicensee shall also include a third party to whom Fuso has
granted the right to distribute the Collaboration Product, provided that such
third party has the responsibility for marketing and/or promotion of the
Collaboration Product within the territory for which such distribution rights
are granted. For the avoidance of doubt, wholesellers or retailers who do not
take such responsibility shall not be deemed as Sublicensees. Further, Contract
Manufacturers set forth in Section 2.2.2 shall not be included in Sublicensees.
1.20 "TERRITORY" shall mean Japan, and, where the option set forth in
Section 5.2.1 is exercised by Fuso, Korea and/or Taiwan, as the case may be.
"Retained Territory" shall mean, on a Collaboration Product-by-Collaboration
Product basis, Japan, Korea and Taiwan until the earlier of (i) Fuso exercises
its option with respect to a particular Collaboration Product, or (ii) the
applicable option period expires, and thereafter shall have the same meaning as
Territory with regard to such Collaboration Product.
1.21 "VALID CLAIM" shall mean a claim of a pending patent application or a
claim of an issued and unexpired patent within the GenVec Technology or Joint
Patent Rights which has not
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been held unpatentable, invalid or unenforceable by a court or other government
agency of competent jurisdiction in an unappealed or unappealable decision and
has not been admitted to be invalid or unenforceable through reissue,
re-examination, disclaimer or otherwise; provided, however, that if the holding
of such court or agency is later reversed by a court or agency with appropriate
authority, the claim shall be reinstated as a Valid Claim with respect to Net
Sales accruing after the date of such reversal.
2. LICENSE GRANTS
2.1 COMMERCIALIZATION LICENSES TO FUSO. Subject to the terms and
conditions of this Agreement, GenVec hereby grants to Fuso an exclusive,
royalty-bearing license under the GenVec Technology and GenVec's interest in the
Joint Technology, to make (subject to Article 6), have made (subject to Section
2.2.2) use, sell and otherwise commercialize Collaboration Products for all uses
in the Field in the Territory.
2.2 SUBLICENSES AND CONTRACT MANUFACTURING.
2.2.1 SUBLICENSEES. Fuso may sublicense the rights to make, use and/or
sell granted in Section 2.1 to third parties, with the prior written consent of
GenVec, which consent shall not be unreasonably withheld. Fuso may sublicense
the rights granted in Section 2.1 to make Collaboration Products to Affiliates
of Fuso without the consent of GenVec, and such sublicense shall remain in
effect so long as such party remains an Affiliate of Fuso. Each sublicense
granted by Fuso shall be consistent with all the terms and conditions of this
Agreement. Fuso shall remain responsible to GenVec for all of each such
Sublicensee's applicable financial and other obligations under this Agreement.
2.2.2 CONTRACT MANUFACTURING. Subject to Article 6, Fuso may have
Collaboration Products made by a third party contract manufacturer ("Contract
Manufacturer") that will sell the Collaboration Products produced by it only to
Fuso, its Affiliates or permitted Sublicensees; provided that (i) such Contract
Manufacturers agree in writing to be bound by the confidentiality obligations
set forth in Article 9 hereof as if they were a party to this Agreement, (ii)
Fuso shall notify the name and financial strength of each Contract Manufacturer
to GenVec prior to the commencement of the contract manufacturing, and (iii)
Fuso shall remain responsible to GenVec for any failure by Contract
Manufacturers to conform to such obligation.
2.3 OTHER LICENSES.
2.3.1 GENE THERAPY TECHNOLOGY. In the event that Fuso desires to
acquire a license under Gene Therapy Technology for commercial applications in
the Territory, Fuso shall notify GenVec, and the parties agree to negotiate in
good faith for a period of ninety (90) days, or such longer period as the
parties may agree, the terms and conditions on which GenVec would grant such a
license to Fuso; provided, however, in no event shall GenVec be obligated to
negotiate or grant a license for any commercial application(s) which might
compete with the business interests of GenVec or its Affiliates.
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2.3.2 FUSO TECHNOLOGY. Subject to the provisions of Section 7.1.2
below, Fuso hereby grants to GenVec the following licenses under the Fuso
Technology and Fuso's interest in the Joint Technology:
(a) a non-exclusive, royalty-free license to make, have made,
use, sell and otherwise commercialize Collaboration Products, in the Field,
outside the applicable Retained Territory; and
(b) an exclusive, royalty-free license, subject to Section 5.5.2
below, to make, have made, use, sell and otherwise commercialize Collaboration
Products outside the Field, in and outside the applicable Retained Territory;
and
(c) an exclusive, royalty-bearing license to make, have made,
use, sell and otherwise commercialize products other than Collaboration Products
both in and outside the Field and the applicable Retained Territory. The
financial obligations due Fuso with respect to such license shall be negotiated
in good faith by the parties; provided, in the event the parties are unable to
agree, such terms shall be established pursuant to Article 12.
2.3.3 GenVec may sublicense the rights granted in Section 2.3.2 to
third parties, with the prior written consent of Fuso, which consent shall not
be unreasonably withheld. GenVec may sublicense the right granted in Section
2.3.2 to make Collaboration Products to Affiliates of GenVec without such
consent of GenVec. Each sublicense granted by GenVec shall be consistent with
all the terms and conditions of this Agreement and no Sublicensee may grant
further sublicenses without the prior written consent of GenVec. GenVec shall
remain responsible to Fuso for all of each such sublicensee's applicable
financial and other obligations under this Agreement.
2.4 COVENANT NOT TO XXX. In partial consideration for the grant of rights
hereunder, Fuso agrees not to enforce against GenVec or its Affiliates any
patent right owned or controlled by Fuso or its Affiliates during the term of
this Agreement that GenVec or its Affiliates may infringe in practicing the
inventions claimed in the GenVec Patent Rights.
2.5 RETAINED RIGHTS. It is understood and agreed that GenVec shall retain
the exclusive right (i) to make, have made, use, sell and otherwise
commercialize the Collaboration Products for all uses within the Field outside
the applicable Retained Territory; (ii) subject to Sections 2.4.3, 2.4.4, and
2.4.5 of the Collaboration Agreement to make, have made, use, sell and otherwise
commercialize the Collaboration Products for use outside the Field, both in and
outside the applicable Retained 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 pursuant to Article 6, and (iv) to practice any
method, process or procedure within, and otherwise develop, exploit and/or
commercialize the Gene Therapy Technology.
2.6 NO IMPLIED LICENSES. Fuso acknowledges that the licenses granted by
GenVec in Section 2.1 are limited to the Field and the applicable Retained
Territory. No rights or licenses with
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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 or the Collaboration Agreement.
3. PAYMENTS
3.1 ROYALTIES.
3.1.1 ROYALTIES ON NET SALES. In partial consideration of the rights
granted hereunder, Fuso shall pay running royalties to GenVec equal to * of Net
Sales of Collaboration Products by Fuso and its Affiliates or Sublicensees.
3.1.2 SINGLE ROYALTY; NON-ROYALTY SALES. No royalty shall be payable
under Section 3.1 above with respect to sales of the Collaboration Product among
Fuso, its Affiliates and Sublicensees for resale. In no event shall more than
one such royalty be due GenVec hereunder with respect to any Collaboration
Product.
3.1.3 ROYALTY TERM. The obligation of Fuso to pay royalties under this
Article 3 shall continue for each Collaboration Product on a Collaboration
Product-by-Collaboration Product and country-by-country basis, until the later
of (i) such time as there are no Valid Claims covering the manufacture, sale or
use of such Collaboration Product in such country, or (ii) ten (10) years from
the first commercial sale of such Collaboration Product in such country.
3.1.4 MINIMUM ROYALTY. It is understood and agreed that regardless
of any offsets to which Fuso is entitled, the royalty payments made to GenVec
under Section 3.1 in any quarter shall not be less than * of Net Sales of
Collaboration Products by Fuso and its Affiliates and Sublicensees in the
applicable quarter.
3.1.5 THIRD PARTY ROYALTIES. Except as provided in Section 2.3.2 of
the Collaboration Agreement, Fuso shall be responsible for the payment of any
royalties, license fees and milestone and other payments due to third parties
under licenses or similar agreements necessary for the manufacture, use or sale
of Collaboration Products in the Territory. * of any such royalty payments due
third parties in any quarter against *
3.2 INITIAL PAYMENTS. Within thirty (30) days following the first
occurrence in * with respect to each Collaboration Product, Fuso shall pay
to * Fuso shall promptly notify GenVec upon the achievement of the foregoing
milestone with respect to each Collaboration Product.
4. PAYMENTS; BOOKS AND RECORDS
4.1 ROYALTY REPORTS AND PAYMENTS. After the first commercial sale by Fuso
or its Affiliates or Sublicensees of a Collaboration Product for which royalties
are payable under Article 3, Fuso shall make quarterly written reports to GenVec
within thirty (30) days after the end of each calendar quarter, stating in each
such report, by country, the number, description and aggregate Net
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Sales of such Collaboration Product sold during the calendar quarter.
Simultaneously with the delivery of each such report, Fuso shall pay to GenVec
the total royalties, if any, due to GenVec for the period of such report. If no
royalties are due, Fuso shall so report.
4.2 PAYMENT METHOD; LATE PAYMENTS. All amounts due GenVec hereunder shall
be paid in U.S. dollars by wire transfer in immediately available funds to an
account designated by GenVec. Any payments or portions thereof due hereunder
which are not paid on the date such payments are due under this Agreement shall
bear interest at a rate equal to the lesser of prime rate as reported by the
Chase Manhattan Bank, New York, plus * per year, or the maximum rate permitted
by law, calculated on the number of days such payment is delinquent, compounded
monthly.
4.3 CURRENCY CONVERSION. If any other currency conversion shall be
required in connection with the calculation of royalties hereunder, such
conversion shall be made using the exchange rate for conversion of the foreign
currency into U.S. Dollars, quoted for current transactions for buying U.S.
dollars, as reported in The Wall Street Journal for the last business day of the
calendar quarter to which such payment pertains.
4.4 RECORDS; INSPECTION. Fuso and its Affiliates shall keep (and cause
its Sublicensees to keep) complete, true and accurate books of account and
records for the purpose of determining the royalty amounts payable under Article
3. Such books and records shall be kept reasonably accessible for at least three
(3) years following the end of the calendar quarter to which they pertain. Such
records will be open for inspection during such three (3) year period by a
representative or agent of GenVec for the purpose of verifying the royalty
statements. Such inspections may be made no more than once each calendar year,
at reasonable times mutually agreed by Fuso and GenVec. GenVec's representative
or agent will be obliged to execute a reasonable confidentiality agreement prior
to commencing any such inspection. GenVec shall bear the costs and expenses of
inspections conducted under this Section 4.4 unless a variation or error
producing an underpayment in royalties payable exceeding * of the amount payable
for any quarter is established in the course of any such inspection, whereupon
all costs relating to the inspection and any unpaid amounts that are discovered
will be paid by Fuso, together with interest on such unpaid amounts at the rate
specified in Section 4.2 above.
4.5 WITHHOLDING TAXES.
4.5.1 ROYALTIES. Any payments due GenVec by pursuant to Section 3.1
above shall be made after deduction for any withholding taxes or similar
governmental charge ("Withholding Tax") due thereon. Fuso shall provide GenVec a
certificate evidencing payment of any such Withholding Taxes. Notwithstanding
the foregoing, if such payments by GenVec would reduce the royalty received by
GenVec on any Net Sales below * (after such withholding or other governmental
charge), then Fuso shall pay to GenVec any such additional amounts as may be
necessary to provide GenVec a royalty of no less than * on such Net Sales (after
such withholding or other governmental charge). In such event, if GenVec
receives a tax credit from the U.S. Government for any such
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additional payments, then GenVec shall promptly notify Fuso and reimburse Fuso
for such amount. GenVec agrees to use reasonable efforts to obtain any available
tax credit.
4.5.2 MILESTONES. All payments required to be made to GenVec pursuant
to Section 3.2 shall be made after deduction for any withholding taxes or
similar governmental charge required by applicable law. Fuso shall promptly
inform GenVec of the amount and basis of any such deduction, and provide GenVec
a certificate evidencing payment of any such Withholding Taxes.
4.6 SALES TAXES. Any sales taxes (such as consumption tax or value added
tax), use taxes, transfer taxes, duties or similar 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.
5. COMMERCIALIZATION
5.1 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 in conducting clinical trials (e.g., clinical
trials in the Territory, and clinical trials conducted outside the Territory
which provide data for regulatory approvals in the Territory). In addition, Fuso
shall be responsible, at its sole expense, for all commercialization of such
Collaboration Product(s) in the Field in the Territory so long as Fuso retains
rights thereto under this Agreement. During the term of this Agreement, Fuso
shall keep GenVec fully informed of its activities subject to this Agreement
and, in addition, on or before January 31 of each year, Fuso shall provide
GenVec with a written report detailing such events and activities. When a
registration package requesting approval for commercial sale of any
Collaboration Product is first filed in any country within the Territory, and
when approval is received therefore, Fuso will immediately notify GenVec in
writing.
5.2 DUE DILIGENCE.
5.2.1 OPTION. Fuso shall have the option to add both or either of
Korea and Taiwan to the Territory by notice to GenVec identifying the pertinent
country(ies) and Collaboration Product. Such option must be exercised with
respect to a particular Collaboration Product no later than the first
anniversary of the initiation of the first Phase II clinical trials of such
Collaboration Product in Japan. If Fuso fails to exercise such option with
respect to a particular Collaboration Product within the applicable period, or
Fuso's rights terminate in Japan with respect to a particular Collaboration
Product prior to the date that Fuso exercises its option for such Collaboration
Product, then Fuso shall lose its option with respect to such Collaboration
Product in Korea and Taiwan.
5.2 REASONABLE EFFORTS. Fuso shall use all reasonable efforts to:
(i) obtain regulatory approvals to market Collaboration Product(s) in each
country the Territory, and (ii) after obtaining regulatory approvals for such
Collaboration Product(s), launch such Collaboration
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Product(s) in each country in the Territory. Upon the launching of such
Collaboration Product(s), Fuso shall use reasonable efforts to promote and meet
the market demand therefor in the respective country(ies). In connection
therewith, Fuso shall use efforts not less than those efforts Fuso makes with
respect to its own pharmaceutical products of comparable commercial potential,
stage of development and patent protection.
5.2.3 LACK OF DILIGENCE. In the event that Fuso fails to use
reasonable efforts to exercise its diligence obligations under Section 5.2.2
with respect to a particular Collaboration Product as to a particular country of
the Territory, GenVec may terminate this Agreement with respect to such
Collaboration Product as to such country in accordance with Section 11.2. In
such event, GenVec shall thereafter have the exclusive rights to commercialize
such Collaboration Product in the said country, alone or with third parties.
5.2.4 LICENSES. In the event that any of Fuso's rights terminate with
respect to a particular Collaboration Product pursuant to Section 5.2.3 above,
at GenVec's request, Fuso shall grant to GenVec an exclusive (even as to Fuso),
fully-paid, royalty-free license, with the right to sublicense, under Fuso's
interest in any Joint Technology and Fuso Technology necessary or useful to
make, have made, import, use, offer for sale, sell and otherwise commercialize
such Collaboration Products in the Field in the said country.
5.3 REGULATORY FILINGS.
5.3.1 USE OF DOCUMENTS. Each party and its Affiliates, and, subject to
such party's obligations to third parties, its sublicensees, shall have the
right free of charge to refer to, access, cross reference, and use documents
relating to each Collaboration Product filed by a party or its Affiliates, its
licensees or Sublicensees with regulatory entities with respect to activities
conducted in connection with the Research Program, * and other supporting
information, and any written communications *
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 use documents filed with regulatory
entities 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, *
5.4 NO OTHER GENE THERAPY PRODUCTS. Except as specifically provided in
this Agreement or otherwise agreed in writing, neither Fuso nor its
Affiliates or Sublicensees shall commercialize any gene therapy product
studied in the Research Program, except as a Collaboration Product in
accordance with this Agreement, which is identical or substantially similar
to a Product Configuration studied in the Research Program. As used herein,
"substantially similar" shall mean a *
5.5 GENVEC COMMERCIALIZATION.
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5.5.1 GENVEC RESPONSIBILITIES. Subject to Sections 2.3.1(b) and 2.4.2
of the Collaboration Agreement, GenVec shall be responsible, at its sole
expense, for conducting all development of any Collaboration Product outside the
Field, both in and outside the Territory (including, without limitation,
clinical trials), and all commercialization of such Collaboration Product
outside the Field, both in and outside the Territory.
5.5.2 COMPETING PRODUCTS. During the term of this Agreement,
GenVec agrees that it shall not directly or indirectly develop or
commercialize in the Retained Territory any Gene Therapy product identical or
substantially similar to a Product Configuration studied by the parties in
the Research Program which GenVec knows or reasonably should know would
compete with or be a substitute for a Collaboration Product being
commercialized by Fuso or its Affiliates or Sublicensees. As used herein,
"substantially similar" shall mean a product which *
5.6 LIMITS ON COMPETING PRODUCTS. During the term of this Agreement,
Fuso shall not directly or indirectly develop, manufacture, market, sell, or
otherwise distribute any Gene Therapy products or components within the Field
in the applicable Retained Territory, which could compete with the
Collaboration Products or appoint or license any third party to develop,
market, sell, or otherwise distribute any such gene therapy products or
components which could compete with Collaboration Products during the term of
this Agreement. Fuso further agrees that, during the term of this Agreement,
it shall not, directly or indirectly, develop, manufacture or commercialize
in and/or outside the Territory (except as a Collaboration Product pursuant
to this Agreement) any Gene Therapy product identical or substantially
similar to a Product Configuration studied by the parties in the Research
Program. As used herein, "substantially similar" shall mean *
5.7 ACKNOWLEDGMENT. It is understood and agreed that the provisions of
Sections 2.4.3, 2.4.4 and 2.4.5 of the Collaboration Agreement establish certain
limits on the development and commercialization activities of the parties with
respect to certain Product Configurations and Gene Therapy products.
5.8 INOS PRODUCTS. Notwithstanding any other provision of this Agreement
or the Collaboration Agreement, GenVec may develop and commercialize Gene
Therapy products containing the iNOS gene (or a fragment or derivative thereof)
for the treatment of cardiovascular disease or other non-cancer indications,
itself or with third parties. If GenVec or such third party reasonably believes
that the commercialization of a Collaboration Product containing the iNOS gene
(or a fragment or derivative thereof) or use in the Field may compete with or
adversely affect the sales of such a product, Fuso may not develop or
commercialize such a Collaboration Product without the prior written consent of
GenVec or a licensee of GenVec with rights to such product, which consent shall
not be unreasonably withheld.
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6. MANUFACTURING RIGHTS
6.1 MANUFACTURE BY FUSO.
6.1.1 CLINICAL TRIALS IN THE TERRITORY. Fuso shall have the first
right, but not the obligation to manufacture Collaboration Products for use in
clinical trials and commercials sales in the Territory, on a Collaboration
Product-by-Collaboration Product basis, subject to GenVec's approval not to be
unreasonably withheld. GenVec's decision to approve or disapprove manufacturing
by Fuso shall be based on Fuso's ability to manufacture the applicable
Collaboration Product and/or the period Fuso may require to establish an
approved manufacturing facility. If Fuso elects not to manufacture such
Collaboration Products, or GenVec does not approve of manufacture of such
Collaboration Product by Fuso, GenVec shall have the first right, but not the
obligation to manufacture Collaboration Products for use in clinical trials and
commercial sales in the Territory, on a Collaboration Product-by-Collaboration
Product basis, subject to Fuso's approval, not to be unreasonably withheld.
Fuso's decision to approve or disapprove manufacturing by GenVec shall be based
on GenVec's ability to cost effectively manufacture the applicable Collaboration
Product. In the event that GenVec declines to manufacture a particular
Collaboration Product, or Fuso does not approve of the manufacture of such
Collaboration Product by GenVec, then, subject to Section 6.1.2, Fuso may select
a third party contract manufacturer ("Contract Manufacturer"), reasonably
acceptable to GenVec, to manufacture such Collaboration Product.
6.1.2 CONTRACT MANUFACTURING. If Fuso has Collaboration Products
manufactured by a Contract Manufacturer pursuant to Section 6.1.1 above, it will
require that such Contract Manufacturer sell the Collaboration Products produced
by it only to Fuso, its Affiliates or permitted Sublicensees. In addition (i)
such Contract Manufacturers shall agree in writing to be bound by the
confidentiality obligations set forth in Article 9 hereof as if they were a
party to this Agreement, (ii) Fuso shall notify the name and financial strength
of each Contract Manufacturer to GenVec prior to the commencement of the
contract manufacturing, and (iii) Fuso shall remain responsible to GenVec for
any failure by Contract Manufacturers to conform to such obligation.
6.1.3 TRANSFER OF MANUFACTURING KNOW-HOW. If Fuso manufactures
Collaboration Products pursuant to Section 6.1.1 above, the parties shall
negotiate in good faith the compensation to be paid to GenVec for the transfer
of process development and manufacturing know-how, and shall cooperate with each
other in order that Fuso may initiate manufacture of the Collaboration Product
as soon as practicable; provided, GenVec shall not be obligated to transfer any
manufacturing knowhow which is subject to a contractual obligation with a third
party.
6.1.4 SUPPLY AGREEMENT. If Fuso purchases Collaboration Products from
GenVec pursuant to Section 6.1.1, the parties shall promptly negotiate in good
faith the terms of a Supply Agreement which shall set forth the terms and
conditions of such supply. In the event the parties fail to enter into a written
Supply Agreement within six (6) months from the date that Fuso provides GenVec
notice of its wish to enter into such a Supply Agreement, or such longer period
as the parties may agree, then GenVec shall have no obligation to manufacture
the Collaboration Products for commercialization.
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6.1.5 SUPPLY TO GENVEC. At GenVec's request, Fuso shall, at its
option, supply Collaboration Products to GenVec for use outside the Field and/or
outside the Territory, on terms to be agreed in good faith by the parties.
6.1.6 OTHER GENVEC COLLABORATION PRODUCTS. At GenVec's request, the
parties agree to conduct good faith negotiations regarding the appointment of
Fuso by GenVec as a contract manufacturer of other agreed GenVec products;
provided, however that GenVec shall be under no obligation to appoint Fuso as
its contract manufacturer, and Fuso shall be under no obligation to accept such
appointment, unless the parties mutually agree on terms and conditions governing
such appointment.
6.2 FUSO RESPONSIBILITIES. If Fuso undertakes to manufacture the
Collaboration Product, Fuso shall be responsible for all costs and liabilities
associated therewith. All Collaboration Products manufactured by or on behalf of
Fuso will conform with all MHW regulations and all applicable foreign laws and
regulations. Fuso shall keep GenVec fully informed of the Collaboration Product
manufacturing procedures and developments relating thereto and GenVec shall have
the right on reasonable prior notice to visit the manufacturing facility during
ordinary business hours and review any relevant records relating to
Collaboration Product manufacture (excluding records relating to the
manufacturer's own proprietary manufacturing processes).
6.3 POST TERMINATION MANUFACTURING. Following the termination of this
Agreement due to the expiration of Fuso's royalty obligations in all countries
in the Territory pursuant to Section 11.1 due to completion of the full payment
term, Fuso shall have the right to make and have made Collaboration Products.
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 DFCI) 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 Jikei
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 GENE THERAPY TECHNOLOGY. Notwithstanding Section 7.1.1
above, Title to all inventions and intellectual property which relates to
Gene Therapy made solely by GenVec employees or its agents (including
researchers at DFCI) or jointly by employees or the agents of Fuso and GenVec
in connection with the Research Program (in each case, "Gene Therapy
Technology") shall be owned by GenVec. Fuso hereby assigns to GenVec all its
right, title and interest it may otherwise hold in or to such Gene Therapy
Technology and any patent applications or
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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 Maryland, as
applicable, as long as the laws of the Territory permit application of such
laws. Subject to the licenses granted in Article 2, 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 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 of the Collaboration Agreement.
7.2.2 JOINT PATENT RIGHTS.
(a) 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 of the Collaboration
Agreement.
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(b) 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.
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 manufacture, use and sale 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 manufacture, sale or use of any
Collaboration Product in the Territory pursuant to this Agreement results in any
claim, suit or proceeding alleging patent
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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 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 and (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.
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
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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 EXPRESSLY DISCLAIM ANY
WARRANTIES OR CONDITIONS, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT
TO THE CONFIDENTIAL INFORMATION, OR FUSO TECHNOLOGY OR GENVEC 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 * years 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:
(a) was already known to the receiving party, other than under an
obligation of confidentiality, at the time of disclosure;
(b) was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving party;
(c) 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;
(d) was independently developed by the receiving party without
reference to any information or materials disclosed by the disclosing party; or
(e) 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 the other'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 DFCI or Jikei University (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
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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).
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 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 development, manufacture, marketing and/or commercialization of any
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 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 development, manufacture, marketing and/or commercialization of any
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,
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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 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 on a Collaboration Product-
by-Collaboration Product and country-by-country basis until the date Fuso and
its Affiliates and Sublicensees has no remaining royalty obligations in such
country. Following the expiration of royalty obligations in any country, Fuso
shall have a non-exclusive, non-transferable, fully paid license under the
GenVec Know-How solely to commercialize the Collaboration Product in the Field
in such country.
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 sixty (60) days after written notice thereof was provided to the breaching
party by the nonbreaching party. Any termination shall become effective at the
end of such sixty (60) day period unless the breaching party has cured any such
breach or default prior to the expiration of the sixty (60) day 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 ten (10) days 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 sixty (60) days 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 sixty (60)
days thereafter, the other party may immediately terminate this Agreement
effective upon notice of such termination.
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11.4 PERMISSIVE TERMINATION. After the second anniversary of the Effective
Date, Fuso may, at its sole discretion, terminate this Agreement at any time
with ninety (90) days prior notice.
11.5 TERMINATION RELATING TO SALES OF COMPETING COLLABORATION PRODUCTS.
GenVec may, at its sole discretion, terminate this Agreement with ninety (90)
days notice in the event of any breach by Fuso of Section 5.6.
11.6 EFFECT OF BREACH OR TERMINATION.
11.6.1 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.
11.6.2 RETURN OF MATERIALS. Upon any termination of this Agreement,
Fuso and GenVec shall promptly return to the other party all materials and
Confidential Information (except as provided in 11.1 above) received from the
other party (except one copy of which may be retained by legal counsel for
archival purposes).
11.6.3 STOCK ON HAND. In the event this Agreement is terminated for
any reason, Fuso and its Affiliates and Sublicensees shall have the right to
sell or otherwise dispose of the stock of any Collaboration Products then on
hand subject to Articles 3 and 4 and the other applicable terms of this
Agreement.
11.6.4 LICENSES.
(a) The licenses granted Fuso herein shall terminate in the
event of a termination pursuant to Section 11.2 or 11.3, or any termination of
the Research Program by Fuso prior to the second anniversary of the Effective
Date. In the event of a termination of the Research Program by Fuso after the
second anniversary of the Effective Date, the licenses granted Fuso shall remain
in effect, subject to the terms and conditions herein, with respect to all
Collaboration Products designated by the Steering Committee prior to the
effective date of such termination.
(b) The licenses granted to GenVec in Section 2.3 shall
terminate only in the event of a termination by Fuso pursuant to Section 11.2 or
11.3.
(c) If more than one Collaboration Product is being
commercially developed or exploited by Fuso or its Affiliates and Sublicensees
hereunder and GenVec terminates this Agreement pursuant to Section 11.2 due to a
breach relating only to a single Collaboration Product, or pursuant to Section
11.5 due to a particular competing product, then GenVec shall be entitled to
terminate this Agreement only with respect to the applicable Collaboration
Product.
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11.7 SURVIVAL. Sections 2.4, 2.5, 2.6, 5.2.3, 5.3, 5.4, 6.4, 7.1, 7.2.2,
7.3.2, 11.6 and 11.7 and Articles 4, 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,
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.
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 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
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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. This Agreement shall not be assignable by either party to
any third party hereto without the written consent of the other party hereto;
except either party may assign this Agreement, without such consent, to (i) an
Affiliate of such party; or (ii) an entity that acquires all or substantially
all of the business or assets of such party to which this Agreement pertains,
whether by merger, reorganization, acquisition, sale, or otherwise and that
agrees in writing to be strictly bound by the terms and conditions of this
Agreement. The terms and conditions of this Agreement shall be binding on and
inure to the benefit of the permitted successors and assigns of the parties.
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), Sublicensees, 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
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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.
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 for herein or in
the Collaboration Agreement, 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 one hundred eighty (180) days notice.
13.12 PATENT MARKING. Fuso agrees to xxxx and have its Affiliates and
Sublicensees xxxx all Collaboration Products they sell or distribute pursuant to
this Agreement in accordance with the applicable statute or regulations in the
country or countries of manufacture and sale thereof.
13.13 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
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reasonably deem necessary or desirable in order for the requesting party to
obtain the full benefits of this Agreement and the transactions contemplated
hereby.
13.14 TRADEMARKS. Fuso and its Affiliates shall have the right to market
the Collaboration Product under their own labels and trademark(s). All
Collaboration Product packages shall carry the notice "Licensed from GenVec,
Inc." or a similar slogan, in a typeface and size agreed by the parties.
13.15 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.
13.16 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 and 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 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.
13.17 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.
13.18 ENTIRE AGREEMENT. This Agreement together with the attached Exhibit,
and the Collaboration Agreement and the 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.
13.19 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.
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13.20 COUNTERPARTS. This Agreement may be executed in two counterparts,
each of which shall be deemed an original and which together shall constitute
one instrument.
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 INDUSTRIES, LTD. GENVEC, INC.
By: By:
--------------------------------- --------------------------------
Name: Name:
------------------------------- ------------------------------
Title: Title:
------------------------------ -----------------------------
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EXHIBIT A
GENVEC JAPANESE PATENT RIGHTS
*
