EXHIBIT 10.12
AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT
THIS AGREEMENT (the "Restated Agreement"), effective as of the 1st day of
April, 1993, (the "Effective Date") by and between the CORNELL RESEARCH
FOUNDATION, INC., having offices at Cornell Business & Technology Park, 00
Xxxxxxxxx Xxxxx, Xxxxx 000, Xxxxxx, Xxx Xxxx 00000 (hereinafter referred to as
"FOUNDATION") and GENVEC, INC., having offices at 00000 Xxxxxxxx Xxxxx,
Xxxxxxxxx, Xxxxxxxx 00000 (hereinafter referred to as "LICENSEE").
W I T N E S S E T H T H A T:
WHEREAS, FOUNDATION is a wholly owned subsidiary corporation of Cornell
University and holds the ownership interests of patents issued on inventions
made by Cornell University's staff and administers licenses in a manner
consistent with the patent policy of Cornell University;
WHEREAS, FOUNDATION represents that it is assignee of the patents and/or
patent applications included within the Sponsored Research Intellectual Property
(as defined below) and any patents issuing thereon and has the right to grant
licenses under said patents and/or patent applications and patents issuing
thereon;
WHEREAS, LICENSEE and FOUNDATION previously entered into that certain
Sponsored Research Agreement effective as of May 18, 1993 (the "Prior Crystal
Sponsored Research Agreement"), pursuant to which LICENSEE agreed to fund
certain research conducted under the supervision of Dr. Crystal at the Cornell
University Medical College ("CUMC").
WHEREAS, LICENSEE and FOUNDATION previously entered into that certain
Sponsored Research Agreement effective as of July 10, 1995 (the "Prior Xxxxx-
Xxxxxxxx Sponsored Research Agreement"), pursuant to which LICENSEE agreed to
fund certain research conducted under the supervision of Xx. Xxxxx-Xxxxxxxx at
the Cornell University Medical College.
WHEREAS, LICENSEE and FOUNDATION intend to supersede the Prior Crystal
Sponsored Research Agreement with a further Sponsored Research Agreement
pursuant to which LICENSEE expects to fund certain research conducted under the
supervision of Dr. Crystal at the Cornell University Medical College, and
LICENSEE and FOUNDATION may enter into other agreements pursuant to which
LICENSEE may support the conduct of research at Cornell University Medical
College and its affiliated clinical entities.
WHEREAS, FOUNDATION has previously granted to LICENSEE an exclusive license
under (i) FOUNDATION's rights included in the Sponsored Research Intellectual
Property (as defined in the Prior Crystal Sponsored Research Agreement)
including the Designated Inventions,
[*]=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.
Biological Material and Technical Information and related intellectual property
rights subject to that certain License Agreement entered April 1, 1993, and (ii)
under FOUNDATION's rights in the Subject Inventions (as defined in the Prior
Xxxxx-Xxxxxxxx Sponsored Research Agreement) including the Designated
Inventions, Biological Material and Technical Information and related
intellectual property rights subject to that certain License Agreement entered
July 10, 1995;
WHEREAS, FOUNDATION and LICENSEE wish to amend and restate the License
Agreements and to include under this Restated Agreement exclusive, worldwide
licenses under the discoveries and inventions embodied in the Sponsored Research
Intellectual Property Rights (as defined below);
WHEREAS, as a benefit of funding such research, FOUNDATION is willing to
grant to LICENSEE an exclusive license under FOUNDATION's rights in such
Sponsored Research Intellectual Property Rights upon the terms and conditions
hereinafter set forth;
WHEREAS, the work leading to the Sponsored Research Intellectual Property
was supported in part by an agency of the U.S. Government, FOUNDATION is
obligated to comply with the U.S. Office of Management & Budgets Circular No. A-
124, or 37 CFR Part 401; and
WHEREAS, such FOUNDATION and LICENSEE have entered into a Warrant Agreement
on even date herewith, pursuant to which LICENSEE shall provide to FOUNDATION
warrants to purchase shares of GenVec stock, in accordance with the terms and
conditions therein.
NOW, THEREFORE, in consideration of the covenants and obligations
hereinafter set forth, the parties hereto hereby agree as follows:
I
DEFINITIONS
The following definitions will apply throughout this Restated Agreement:
1.1 "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 Restated 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 rights permitted in
the country where such entity exists.
1.2 "BIOLOGICAL RESEARCH MATERIALS" shall mean any protein, gene, gene
vector, plasmid or other construct, cell line, hybridoma, antibody or other
biological material or derivative or analogs thereof, created by one or more
employees of Cornell University and arising out of the Sponsored Research
conducted pursuant to any of the Sponsored Research Agreements (except to the
extent such biological material is subject to the Material Transfer Agreement).
It is understood and agreed
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that the Biological Research Materials shall include, without limitation, the
Biological Materials (as defined in the Prior Sponsored Research Agreements
and/or License Agreements).
1.3 "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.
1.4 "LICENSEE" shall mean GenVec, Inc. and its Affiliates.
1.5 "LICENSE YEAR" shall mean each twelve (12) month period beginning on
the effective date of this Restated Agreement first written above and thereafter
on the anniversary date thereof.
1.6 "LICENSED APPLICATION" shall mean any U.S. patent application within
the Sponsored Research Intellectual Property Rights and any continuation,
continuation-in-part, or divisional applications thereof, as well as foreign
counterparts thereof.
1.7 "LICENSED PATENT" shall mean any U.S. Patent issuing from a Licensed
Application, and all extensions, reissues and re-examinations thereof, as well
as foreign counterparts thereof.
1.8 "LICENSED PRODUCT" shall mean any product, composition or material,
within the scope of a Valid Claim, or which incorporates, in material part,
Biological Research Materials.
1.9 "MATERIAL TRANSFER AGREEMENT" shall mean that certain Material
Transfer Agreement entered by LICENSEE and Cornell University Medical College
effective as of December 19, 1996.
1.10 "NET SALES PRICE" shall mean the gross amount received by LICENSEE or
its sublicensees in arm's length sales to third parties of Licensed Products,
after deduction of the following items to the extent such items are incurred and
do not exceed reasonable and customary amounts for each such item in the market
in which such sale occurred:
1.10.1 trade, cash and quantity discounts or rebates, actually allowed
or taken;
1.10.2 credits or allowances given or made for rejection or return of,
and for uncollectible amounts on, previously sold Licensed Products or for
retroactive price reductions;
1.10.3 any separately invoiced tax, duty or other government charge
(other than an income tax) levied on the sale, transportation or delivery of a
Licensed Product and borne by the seller thereof; and
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1.10.4 any separately invoiced charges for freight, packaging and
insurance.
Net Sales Price shall not include sales or transfers between LICENSEE and its
subsidiaries, Affiliates or sublicensees, except that where such subsidiary,
Affiliate or sublicensee utilizes the Licensed Products for the performance of
commercial services for third party customers, Net Sales Price shall be based on
subsequent final sales of such Licensed Products to third parties by such
Affiliates or sublicensees, unless the intermediate sales price to a sublicensee
is higher than the subsequent final Sales Price, in which case the intermediate
Sales Price shall control.
1.11 "SPONSORED RESEARCH AGREEMENTS" shall mean the Prior Sponsored
Research Agreements and the Other Sponsored Research Agreements.
1.11.1 "PRIOR SPONSORED RESEARCH AGREEMENTS" shall mean each of the
Prior Crystal Sponsored Research Agreement and the Prior Xxxxx-Xxxxxxxx
Sponsored Research Agreement.
1.11.2 "OTHER SPONSORED RESEARCH AGREEMENTS" shall mean any Sponsored
Research Agreement entered by LICENSEE and FOUNDATION (or its affiliated
clinical entities) after December 31, 1997.
1.12 "SPONSORED RESEARCH INTELLECTUAL PROPERTY RIGHTS" shall mean
individually and collectively, all patent applications, patents, and patentable
discoveries and inventions arising, in whole or in part, out of the Sponsored
Research conducted pursuant to any of the Sponsored Research Agreements that are
first conceived or discovered and/or reduced to practice (i) by one or more
employees of the University, or (ii) jointly by one or more employees of the
University and by one or more employees of the Sponsor, or (iii) by one or more
inventors not employed in Dr. Crystal's laboratory (if funds from Sponsor
Payments have been directly utilized to make such invention), and all Biological
Research Materials and Technical Information. The parties expect that due to the
level of Sponsor Payments provided by the Sponsor will include, but not be
limited to, all Gene Therapy inventions first conceived or discovered and/or
reduced to practice in Dr. Crystal's laboratory will fall with the definition of
"Sponsored Research Intellectual Property Rights." For the avoidance of doubt,
it is understood and agreed that the Sponsored Research Intellectual Property
Rights shall include, without limitation, the Sponsored Research Intellectual
Property (as defined in the Prior Crystal Sponsored Research Agreement) and
Subject Inventions (as defined in the Prior Xxxxx-Xxxxxxxx Sponsored Research
Agreement). Neither this definition, nor any other provision of this Restated
License Agreement or any Sponsored Research Agreement, shall give the Sponsor
any rights in any patent application, patent, patentable discovery or invention
first conceived or discovered and/or reduced to practice except as described
above, or directly or indirectly related to or arising out of Dr. Crystal's
duties and responsibilities for Medical College programs outside Dr. Crystal's
laboratory including the CUMC gene therapy core (provided no Sponsor Payments
are used in connection with such activities); provided, however, that the
foregoing shall not affect the Sponsor's right to have an opportunity to
negotiate with a third-party joint inventor without prior obligations to
Sponsor.
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1.13 "TECHNICAL INFORMATION" shall mean and include all technical
information, developments, discoveries and know-how, methods, techniques,
formulae, processes, and other information conceived and/or discovered and/or
reduced to practice in connection with research conducted pursuant to any of the
Sponsored Research Agreements. "Technical Information" shall exclude any of the
foregoing that are included within a claim of a Licensed Patent or a Licensed
Application or which are Biological Research Materials.
1.14 "VALID CLAIM" shall mean a claim of an issued and unexpired patent or
a claim of a pending patent application which has not been held unpatentable,
invalid or unenforceable by a court or other government agency of competent
jurisdiction and has not been admitted to be invalid or unenforceable through
reissue, re-examination, disclaimer or otherwise; provided, however, that if any
holding of invalidity, unenforceability or unpatentability is later reversed by
a court or agency with overriding authority, the relevant claim shall be
reinstated as a Valid Claim hereunder with respect to sales made after the date
of such reversal. Notwithstanding the foregoing provisions of this Section 1.14,
if a claim of a pending patent application has not issued as a claim of an
issued patent, within * after the date from which such claim takes priority,
such pending claim shall not be a Valid Claim for purposes of this Agreement
unless and until a patent issues including such claim.
II
GRANT
2.1 Subject only to the prevailing rights of and obligations to the U.S.
Government with respect to ownership of intellectual property derived in the
course of federally sponsored research, including, without limitation, any such
rights and obligations set forth in 37 CFR Part 401, should they exist,
FOUNDATION hereby grants to LICENSEE for the term set forth below and under the
royalty basis set forth below, an exclusive license under the Sponsored Research
Intellectual Property Rights (and related Licensed Applications and Licensed
Patents) to make, have made, use, lease, import, have imported, offer for sale,
sell and otherwise exploit Licensed Products in the United States and throughout
the world, with the right to grant sublicenses, as set forth in Article XII
INFRA; or a semi-exclusive license in the case of an invention within the
Sponsored Research Intellectual Property Rights invented jointly with a third
party, since while FOUNDATION is obligated to license "exclusively" to LICENSEE
the rights obtained by FOUNDATION through the inventive activity of Dr. Crystal,
and/or employees of Cornell University in the course of Sponsored Research,
FOUNDATION is not obligated to license to LICENSEE rights obtained by a
third-party inventor, thus creating a semi-exclusive license situation, unless
LICENSEE in a separate agreement acquires the exclusive rights of the third
party inventor, so as to create a bundle of rights which together comprise an
"exclusive license". The term "exclusive license" as used hereinabove shall mean
that FOUNDATION shall not issue a license to another, nor will FOUNDATION make,
use or sell Licensed Products, within the period of exclusivity set forth
hereinafter or any agreed upon extension thereof and FOUNDATION shall not
knowingly take, and shall make reasonable efforts to cause CUMC and all
personnel engaged by the University not to take, any actions inconsistent with
the grant of such an exclusive license;
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2.2 FOUNDATION shall retain the nontransferable right to practice the
Sponsored Research Intellectual Property Rights for its internal, academic, non-
commercial research.
2.3 Promptly following execution of this Agreement, FOUNDATION shall
transfer to LICENSEE a sufficient quantity of the Biological Research Materials
existing as of the Effective Date, and thereafter as Biological Research
Materials are developed, in each case, as are reasonable and necessary for
LICENSEE to establish a viable culture of such Biological Research Materials.
LICENSEE shall reimburse FOUNDATION for the reasonable out-of-pocket costs
incurred by FOUNDATION in transferring the Biological Research Materials to
LICENSEE.
III
TO HAVE MADE
3.1 The right of LICENSEE and its sublicensees to make Licensed Products
includes the right to have made Licensed Products by contract with third
parties. Such contractual arrangements with third parties shall be subject to
and conditioned upon appropriate supervision and quality assurance and control
of the third party by LICENSEE and the third party shall be bound in writing to
respect all rights of FOUNDATION and to supply any production of Licensed
Products made by such third party exclusively to LICENSEE or a sublicensee of
LICENSEE.
IV
FOREIGN PATENTS AND PAYMENT OF COSTS
4.1 As the opportunity to file foreign counterpart applications of Licensed
Applications exists, LICENSEE may designate foreign countries where counterpart
applications shall be filed and FOUNDATION shall ensure that such patent
applications are timely filed in such designated countries. FOUNDATION will use
counsel reasonably acceptable to LICENSEE in connection with the preparation and
filing of such Licensed Applications. FOUNDATION shall direct such counsel to
provide LICENSEE an opportunity to review and comment on all papers to be filed
with any patent office at least fifteen (15) business days before such filing,
and to include in such paper any arguments and claims as LICENSEE may request,
and to promptly provide to LICENSEE copies of any documents received from any
patent office relating to the Licensed Applications.
4.2 LICENSEE agrees to pay for all reasonable and customary expenses
incurred in the preparation, filing, prosecution, renewal and continuation of
Licensed Patents and Licensed Applications in said designated countries
including all taxes, official fees and attorney's fees. Notwithstanding the
foregoing, LICENSEE may elect in writing to be released from its license any
such Licensed Patents and/or Licensed Applications at any time, in which event
it shall thereafter have no obligation to reimburse FOUNDATION for any future
expenses relating to such patent or patent application.
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V
PAYMENT OF U.S. FEES
AND CONTINUING PROSECUTION COSTS
5.1 Where renewal fees are due on a licensed United States patent within
the Sponsored Research Intellectual Property Rights and LICENSEE remains
exclusively licensed, LICENSEE agrees to reimburse FOUNDATION for the costs of
said renewal within thirty (30) days of notice thereof to LICENSEE by
FOUNDATION.
5.2 Where Licensed Applications are pending in the United States, LICENSEE
agrees to pay all reasonable prosecution costs for such applications at least
through an appeal to the U.S. Patents & Trademark Office Board of Appeals, if
the parties agree such an appeal is appropriate.
5.3 LICENSEE agrees to pay for all reasonable and customary expenses
incurred in the preparation, filing, prosecution, renewal and continuation of
Licensed Patents and Licensed Applications in the United States including all
taxes, official fees and attorney's fees. Notwithstanding the foregoing,
LICENSEE may elect in writing to be released from its license any such Licensed
Patents and/or Licensed Applications at any time, in which event it shall
thereafter have no obligation to reimburse FOUNDATION for any future expenses
relating to such patent or patent application.
5.4 FOUNDATION shall direct counsel prosecuting the Licensed Applications
to provide LICENSEE an opportunity to review and comment on all papers to be
filed with any patent office at least fifteen (15) business days before such
filing, and to include in such papers any arguments and claims as LICENSEE may
request, and to promptly provide to LICENSEE copies of any documents received
from any patent office relating to the Licensed Applications.
VI
ROYALTIES AND MINIMUM ROYALTIES TO BE
PAID DURING THE LICENSE AGREEMENT
6.1 Beginning on March 1, 1998, and continuing for a three (3) year period
thereafter, LICENSEE shall pay FOUNDATION a Thirty Thousand Dollar ($30,000.00)
maintenance fee for that License Year, and following such three (3) year period,
LICENSEE shall pay FOUNDATION a Fifty Thousand Dollar ($50,000.00) maintenance
fee for each License Year during the term of this Restated Agreement. Such
monies will be considered as a credit for any royalties due for that License
Year under this Restated Agreement and the royalty reports may reflect the use
of such credit. Such provision is to be construed as an annual maintenance fee
payment requirement and none of the maintenance fee payments are refundable or
applicable to succeeding License Years.
6.2 LICENSEE will pay to the FOUNDATION a royalty of * of the Net Sales
Price of Licensed Products within the scope of an issued Valid Claim in the
country of manufacture or sale.
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6.3 If a Licensed Product is covered in the country of manufacture or sale
only by a Valid Claim of a Licensed Patent owned jointly by the FOUNDATION and
LICENSEE, the royalty rate * .
6.4 If a Licensed Product is covered in the country of manufacture or sale
only by a Valid Claim of a Licensed Application, * of the Net Sales Price.
6.5 In the event that a Licensed Product is sold in combination as a single
product with another product or component whose sale and use are not covered by
a claim within the Sponsored Research Intellectual Property Rights in the
country for which the combination product is sold, Net Sales Price from such
sales for purposes of calculating the amounts due under this Article VI above
shall be calculated by multiplying the Net Sales Price of that combination by
the fraction A/(A+B), where A is the selling price of the Licensed Product and B
is the selling price of the other product or component sold separately. In the
event that no such separate sales are made, the Net Sales Price for royalty
determination shall be as reasonably allocated by LICENSEE between such Licensed
Product and such other product or component, based upon their relative
importance and proprietary protection.
6.6 If LICENSEE or its sublicensee is required to pay a third party with
respect to a license for intellectual property rights or other technologies
which LICENSEE, or its sublicensee, in its reasonable judgment, determines are
necessary to practice the Sponsored Research Intellectual Property Rights,
LICENSEE may offset such amounts against royalties due to FOUNDATION for such
Licensed Product. Notwithstanding the foregoing provisions of this Section 6.6
in no event shall the royalties due to FOUNDATION hereunder be reduced * of the
amount that would otherwise be due FOUNDATION pursuant to this Restated
Agreement.
6.7 If LICENSEE or its sublicensee is required to pay a third party with
respect to a license for intellectual property rights or other technologies
which LICENSEE, or its sublicensee, in its reasonable judgment, determines are
necessary or useful to make, use or sell a Licensed Product, but are not
required to practice the Sponsored Research Intellectual Property Rights,
LICENSEE may offset such amounts owing to such third parties against royalties
due to FOUNDATION for such Licensed Product. Notwithstanding the foregoing
provisions of this Section 6.7 in no event shall the royalties due to FOUNDATION
hereunder be so * of the amount that would otherwise be due FOUNDATION pursuant
to this Restated Agreement.
6.8 It is understood and agreed that regardless of any credits or offsets
to which LICENSEE or its sublicensees are entitled under the terms of this
Restated Agreement, the royalty payments due FOUNDATION under this Article 6 *
Net Sales Price of any Licensed Product.
6.9 In the event that more than one Valid Claim within the Licensed Patents
is applicable to any Licensed Product, then only one royalty shall be paid to
FOUNDATION in respect of such Licensed Product. It is understood that royalties
shall only be payable under this Article VI with respect to Licensed Products
whose sale would infringe a Valid Claim in the country for which such Licensed
Product is sold. In no event shall more than one royalty be due hereunder with
respect to
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any Licensed Product unit, nor shall a royalty be payable under this Article VI
with respect to sales of Licensed Products for use in research and/or
development, in clinical trials or as samples.
6.10 With respect to the possible renegotiation of royalty rates with
regard to any Sponsored Research Intellectual Property Rights subject to this
Agreement, FOUNDATION shall promptly notify LICENSEE if it believes that any
such a renegotiation is required under the Tax Reform Act of 1986 specifically
identifying the applicable intellectual property, and in such event the
following shall apply:
6.10.1 FAIR CONSIDERATION. FOUNDATION and LICENSEE have determined
that the consideration payable to the FOUNDATION pursuant to this Agreement is
fair and competitive with respect to all reasonably conceivable inventions and
other intellectual property which might be developed by FOUNDATION under any of
the Sponsored Research Agreements at the time each Sponsored Research Agreement
was executed.
6.10.2 LIMITED RENEGOTIATION EVENTS. If, notwithstanding the above,
inventions or other discoveries are developed during the term of this Agreement
which were not reasonably conceivable as arising out of or resulting from the
research conducted under the Sponsored Research Agreements (each an "Invention")
and with respect to which the consideration payable to FOUNDATION under this
Agreement is not reasonably believed by FOUNDATION to be competitive, FOUNDATION
shall notify LICENSEE in writing of such determination; provided, however, that
any such renegotiation right of FOUNDATION shall cease and be of no further
force or effect with respect to any Invention from and after 180 days after the
time at which the first Licensed Application on such Invention is filed or other
intellectual property protection is first sought (or, in the case of a
Biological Material, after the time such Biological Material is first indicated
as a possible Invention by LICENSEE). In the event that LICENSEE disputes such
determination of FOUNDATION and the request for renegotiation, LICENSEE shall
have a right, but not the obligation, to submit the issue to arbitration
pursuant to Article XIV hereunder. The arbitration result shall be final and
binding. The arbitrator or Panel shall determine whether (i) it was reasonably
conceivable as of the date the applicable Sponsored Research Agreement was
entered that the subject Invention might have been made or otherwise developed
in connection with the Sponsored Research Agreement and, if not, (ii) whether
the compensation payable under the Agreement is reasonably competitive with
regard to such Invention, based on all relevant circumstances, including without
limitation, the Warrant Agreement provided in partial consideration for the
grant of rights in this Agreement (the "Issues"). The expenses of the
arbitration shall be borne by LICENSEE, except that the Arbitrator may assign
the expenses to FOUNDATION if, in the Arbitrator's opinion, the decision by
FOUNDATION to request arbitration was clearly unreasonable. If either of the
Issues is resolved in favor of LICENSEE, there shall be no renegotiation of
consideration payable with respect to the Inventions or Licensed Products. If
both Issues are resolved in favor of FOUNDATION, the parties shall proceed as
set forth in subparagraph (iii) hereunder.
6.10.3 RENEGOTIATION PROCESS. If either LICENSEE agrees to renegotiate
the consideration payable without arbitration or if the Arbitrator determines
the Issues in favor of
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FOUNDATION, LICENSEE shall have an exclusive right for 90 days to negotiate with
FOUNDATION a royalty arrangement reasonably acceptable to FOUNDATION, which
shall use reasonable efforts to reach satisfactory agreement with LICENSEE.
6.10.4 Right of First Refusal. In the event that FOUNDATION and
LICENSEE are unable to reach agreement within such 90 day period, FOUNDATION
shall then have the right to negotiate with third parties other than LICENSEE
with respect to the exclusive licensing of the particular Invention in question;
provided, however, that if FOUNDATION proposes to enter into any agreement for
the licensing of such Invention to any third party, FOUNDATION shall notify
LICENSEE in writing of the proposed terms and LICENSEE shall have a right of
first refusal exercisable within 30 days of receipt of such notice to enter into
an exclusive license with FOUNDATION on substantially similar terms.
6.11 Royalties due under this Article VI shall be payable on a country-by-
country and Licensed Product-by Licensed Product basis until the expiration of
the last-to-expire issued Valid Claim covering such Licensed Product in such
country. It is understood that LICENSEE'S obligation to pay royalties with
respect to a particular Licensed Product shall cease:
(i) if the applicable claims in the Licensed Patent in any particular
country are held invalid by an unappealed or unappealable decision of a court of
competent jurisdiction, in that particular country, or
(ii) upon expiration of the last to expire Licensed Patent covering
such Licensed Product in a country;
(iv) if FOUNDATION abandons its patent solicitation efforts for all
Licensed Applications, and no issued Licensed Patent is in force.
VII
ACCOUNTING AND PAYMENT SCHEDULE
7.1 Payment, reporting and financial accounting shall be on a quarterly
basis and LICENSEE will deliver to the FOUNDATION within sixty (60) days after
the end of each quarter of the License Year a report in writing setting forth
sales of Licensed Products (including a negative report if appropriate) and will
accompany such report with an appropriate payment of royalty or maintenance fee
due for such period. LICENSEE will keep accurate records, certified by it,
showing the information by which LICENSEE arrived at a royalty determination and
upon FOUNDATION's written request, but not more frequently than once per
calendar year, will permit a person appointed by the FOUNDATION and acceptable
to LICENSEE after entering into a confidentiality agreement with LICENSEE, at
FOUNDATION's expense, to make such inspection of said records at agreed times
during LICENSEE's regular business hours for the sole purpose of and to the
extent necessary to verify royalty reports made by LICENSEE with respect to Net
Sales Price received not more than three (3) years prior to the date of
FOUNDATION's request. The report for the first quarter of the
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first License Year will include any sales of Licensed Products by LICENSEE prior
to the date of this Restated Agreement and will be accompanied by appropriate
payment of royalty therefor in the U.S. dollars. To the extent that LICENSEE
does not have the right to grant to FOUNDATION the right to audit its
sublicensees' books and records hereunder, LICENSEE shall endeavor to obtain for
itself such right and at the request and expense of FOUNDATION, LICENSEE shall
exercise such audit right with respect to sublicensees, and to the extent its
contractual obligations to the sublicensee permit, provide the results of such
audit for inspection by FOUNDATION pursuant to this Section 7.1.
7.2 Conversion from foreign currencies, if any, shall be based upon the
conversion 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.
7.3 Payments which are delayed beyond the sixty (60) days after the end of
the quarter in which they become due shall bear interest at a rate equal to the
prime rate as reported by Chase Manhattan Bank, New York, calculated on the
number of days such payment is delinquent.
VIII
TERM
8.1 The aforesaid exclusive license shall commence on April 1, 1993 and
unless terminated earlier pursuant to Article XIII, continue in full force and
effect on country-by-country and Licensed Product-by-Licensed Product basis
until the expiration, revocation or invalidation date of the last Licensed
Patent or of the abandonment of the last Licensed Application in such country,
whichever is later. LICENSEE's license with respect to Biological Research
Materials and Technical Information in each country shall survive the expiration
of this Restated Agreement and shall be deemed fully-paid as of such date.
IX
DUTY OF DILIGENCE
9.1 LICENSEE shall use its reasonable efforts to effect the introduction of
Licensed Product(s) into the commercial market as soon as practicable consistent
with sound and reasonable business practices. Upon and after such introduction
and consistent with sound and reasonable business practices, LICENSEE agrees to
continue to use its reasonable efforts to maximize commercial sales of Licensed
Products for the duration of the term of this Agreement. LICENSEE further agrees
to use reasonable best efforts to maintain quality control over Licensed
Products and generally attend to proper, safe, fair and lawful development and
exploitation of the market for Licensed Products. The foregoing diligence
requirements may be satisfied by LICENSEE or its sublicensees.
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X
INFRINGEMENT OF LICENSED PATENT RIGHTS BY THIRD PARTIES
10.1 In the event that any infringement of a patent within the Sponsored
Research Intellectual Property Rights shall come to the attention of the
FOUNDATION or LICENSEE, then FOUNDATION and LICENSEE shall duly inform each
other. LICENSEE shall have the first right (itself or through others), at its
sole option, to bring suit to enforce the Sponsored Research Intellectual
Property Rights, and/or defend any declaratory judgment action with respect
thereto, in each case with respect to the manufacture, sale or use of a Licensed
Product; provided, however, that LICENSEE shall keep FOUNDATION reasonably
informed as to the defense and/or settlement of such action. FOUNDATION shall
have the right to participate in any such action with counsel of its own choice
at its own expense. If LICENSEE fails to initiate a patent infringement action
to enforce the Sponsored Research Intellectual Property Rights against a
commercially significant infringement by a third party, within * of a request by
FOUNDATION to do so, (or within such shorter period which may be required to
preserve the legal rights of FOUNDATION under the laws of the relevant
government), FOUNDATION may initiate such action at its own expense; provided,
prior to initiating any such action it shall notify LICENSEE of its intent to do
so and shall discuss with LICENSEE and reasonably take into consideration
LICENSEE's views as to whether such an action should then be pursued. LICENSEE
shall have the right to participate in any such action with counsel of its own
choice and its own expense.
10.2 LICENSEE may credit any expenses (including, without limitation,
attorneys and expert fees) incurred in connection with any infringement or
declaratory judgment against up to * of any royalties payable by LICENSEE. Out
of any damages or awards recovered by LICENSEE in such action such amounts shall
be first applied to reimburse LICENSEE's and then FOUNDATION's unreimbursed
expenses, including without limitation, reasonable attorneys' and expert fees
and court costs. Any amount remaining belongs to *
10.3 In any action brought by LICENSEE, LICENSEE undertakes to indemnify
for and hold FOUNDATION harmless from any damages, costs or expenses incurred by
reason of such litigation. LICENSEE shall not settle any claim based on the
infringement of a patent within the Sponsored Research Intellectual Property
Rights without the consent of FOUNDATION, which consent shall not be
unreasonably withheld.
XI
ASSIGNMENT
11.1 The rights and obligations of the LICENSEE are not assignable without
the prior written consent of FOUNDATION, which consent shall not be unreasonably
withheld, except that LICENSEE may assign those rights and obligations without
such consent (i) to an Affiliate of LICENSEE, or (ii) to a successor in
connection with a sale of all or substantially all of LICENSEE's business or
assets relating to this Restated Agreement, whether by merger, operation of law
or
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otherwise; provided that such assignee or transferee is not bankrupt and
promptly agrees in writing to be bound by the terms and conditions of this
Restated Agreement.
XII
SUBLICENSING
12.1 LICENSEE may sublicense provided that: (i) FOUNDATION finds the
sublicensee generally acceptable, which such acceptance shall not be
unreasonably withheld, (ii) that all sublicensees shall be obligated to all the
terms and conditions of this Restated Agreement beneficial to or protective of
FOUNDATION, and (iii) that LICENSEE shall have the sublicensee guarantee
compliance on all such provisions. FOUNDATION hereby agrees that any Major
Pharmaceutical Company shall be an acceptable sublicensee of LICENSEE. As used
herein, "Major Pharmaceutical Company" shall be any of the top fifty (50)
pharmaceutical companies, ranked in order of worldwide pharmaceutical sales, as
published by Scrip in its most recent ranking prior to the grant of the
sublicense.
12.2 Any sublicense granted by LICENSEE (including, without limitation, any
non-exclusive sublicense) shall remain in effect in the event of any termination
of this Restated Agreement and shall provide for the assignment of such
sublicenses to FOUNDATION or its designee, in the event that the Restated
Agreement is terminated; provided, the financial obligations of each sublicensee
to FOUNDATION shall be limited to the amounts LICENSEE shall be obligated to pay
to FOUNDATION for the activities of such sublicensee pursuant to this Restated
Agreement.
XIII
TERMINATION
13.1 Either party may terminate this Restated Agreement for noncompliance
with a material term of this Restated Agreement by the other party by written
notice to the breaching party of its intentions to do so, if such breach is not
cured within ninety (90) days after such written notice is given. However, if
the party alleged to be in breach of this Restated Agreement disputes such
breach within such ninety (90) day period, the nonbreaching party shall not have
the right to terminate this Restated Agreement unless it has been determined by
an independent arbitrator that this Restated Agreement was materially breached,
and the breaching party fails to comply with its obligations hereunder within
ninety (90) days after such determination.
13.2 LICENSEE may terminate this License Agreement, in its entirety or as
to any Licensed Patent or Licensed Application, or as to any particular Licensed
Product, or as to any country, at any time by giving FOUNDATION at least sixty
(60) days prior written notice.
13.3 (a) Termination of this Restated 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
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pursuing all rights and remedies it may have hereunder or at law or in equity
with respect to any breach of this Restated Agreement.
(b) Upon termination of this Restated Agreement for any reason, each
party shall promptly return to the other party all Confidential Information
received from the other party (except one copy of which may be retained for
archival purposes).
(c) In the event this Restated Agreement is terminated for any reason,
LICENSEE and its sublicensees shall have the right to sell or otherwise dispose
of the stock of any Licensed Product subject to Articles VI and VII hereof.
(d) Articles I, VIII, X, XIV, XV and XVI and Sections 12.2 and 13.3
shall survive the expiration and any termination of this Restated Agreement.
Except as otherwise provided in this Article XIII, all rights and obligations of
the parties under this Restated Agreement shall terminate upon the expiration or
termination of this Restated Agreement.
XIV
ARBITRATION AND JURISDICTION
14.1 If a dispute arises out of or relates to this Restated 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.
14.2 Subject to Section 14.3, any dispute under this Restated 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. Any such arbitration proceeding shall be conducted in accordance
with the Commercial Arbitration Rules of the American Arbitration Association
and shall be held in New York, New York, unless otherwise agreed by the parties.
The arbitration shall be conducted by an Arbitration Panel comprising three
neutral, independent arbitrators. One arbitrator shall be appointed by
FOUNDATION, one arbitrator shall be appointed by LICENSEE, and a Chairman of the
Arbitration Panel shall be appointed by the first two arbitrators. The members
of the Arbitration Panel shall have sufficient and appropriate education and
experience to competently address the matter submitted to the Arbitration Panel
for resolution. Judgment upon the arbitration award may be entered in any court
of competent jurisdiction. 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. 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.
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Any award may be entered in a court of competent jurisdiction for a judicial
recognition of the decision and an order of enforcement.
14.3 The FOUNDATION reserves the right and power to proceed with direct
judicial remedies against LICENSEE without conciliation, mediation or
arbitration for breach of the royalty payment and sales reporting provisions of
this Restated Agreement after giving written notice of such breach to LICENSEE
followed by an opportunity period of * in which to cure such breach. In
collecting overdue royalty payments and securing compliance with reporting
obligations, FOUNDATION may use all judicial remedies available.
XV
CONFIDENTIALITY
15.1 Except as expressly provided herein or as required by law, the parties
agree that, for the term of this Restated 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 Restated Agreement any Confidential Information furnished
to it by the disclosing party hereto pursuant to this Restated Agreement, except
that to the extent that it can be established by the receiving party by
competent proof that such Confidential Information:
15.1.1 was already known to the receiving party, other than under an
obligation of confidentiality, at the time of disclosure;
15.1.2 was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving party;
15.1.3 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 Restated Agreement;
15.1.4 was independently developed by the receiving party as
demonstrated by documented evidence prepared contemporaneously with such
independent development; or
15.1.5 was subsequently lawfully disclosed to the receiving party by a
person other than a party hereto.
15.2 Each party hereto may use or disclose information disclosed to it by
the other party to the extent such use or disclosure is reasonably necessary 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, conducting clinical
trials, 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
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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).
15.3 Except as expressly provided herein, each party agrees not to disclose
any terms of this Restated Agreement to any third party without the consent of
the other party; provided, reasonable disclosures may be made as required by
securities or other applicable laws or other federal or national agency
requirements, or to actual or prospective investors or corporate partners, or to
a party's accountants, attorneys and other professional advisors. Once a
disclosure has been approved, LICENSEE may make disclosures which do not
materially differ therefrom without obtaining approvals from FOUNDATION.
XVI
OTHER
16.1 LICENSEE acknowledges that title to all Biological Research Materials
remains in FOUNDATION and that LICENSEE's possession of Biological Research
Materials under this Agreement is by way of bailment and not conditional or
unconditional sale. Upon termination for cause by FOUNDATION or termination by
LICENSEE under Article XIII, LICENSEE agrees to destroy or return all Biological
Research Materials to FOUNDATION and FOUNDATION shall destroy or return to
LICENSEE all "Sponsor Materials" (as defined in the Sponsored Research
Agreements) and any other materials provided by LICENSEE and its sublicensees
unless provided otherwise in any prevailing biological materials agreements
between the parties. At the natural termination of this Agreement (Article
VIII), LICENSEE shall have the right to continue to possess and use the
Biological Research Materials for any and all purposes without additional
payment.
16.2 LICENSEE agrees that it will not use the indicia or names of
FOUNDATION or any of its personnel in advertising, promotion, or labeling of
Licensed Products without prior written approval of the FOUNDATION, which
approval shall not be unreasonably withheld.
16.3 FOUNDATION represents and warrants that (i) FOUNDATION is and shall
remain the exclusive owner of the entire right, title, and interest in and to
Licensed Patents and Licensed Applications (and co-owner with LICENSEE of all
right, title and interest in and to the Joint Inventions and related Licensed
Patents and Licensed Applications) and Sponsored Research Intellectual Property
Rights; (ii) FOUNDATION has the sole right and authority to enter into this
Restated Agreement and grant the rights and licenses hereunder; (iii) FOUNDATION
has not previously granted and will not grant any rights in the Licensed
Patents, Licensed Applications and Sponsored Research Intellectual Property
Rights that are inconsistent with the rights and licenses granted to LICENSEE
herein; (iv) there are no pending or threatened actions, suits, investigations,
claims or proceedings in any way related to the Licensed Patents, Licensed
Applications and Sponsored Research Intellectual Property Rights; (v) the
Licensed Patents, Licensed Applications and Sponsored Research Intellectual
Property Rights are free and clear of any lien, encumbrance, security interest
and restriction on transfer and license; and (vi) FOUNDATION has and shall
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comply fully with 35 U.S.C. (S)(S)200 ET SEQ. and all implementing regulations
necessary to perfect its ownership interest in the Licensed Patents, Licensed
Applications and Sponsored Research Intellectual Property Rights.
16.4 EXCEPT AS PROVIDED IN SECTION 16.3 AND THE WHEREAS CLAUSES, NEITHER
PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES (EXPRESS, IMPLIED, STATUTORY OR
OTHERWISE) WITH RESPECT TO THE SUBJECT MATTER HEREOF, AND FOUNDATION MAKES NO
EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE.
16.5 FOUNDATION by this Restated Agreement makes no representation as to
the patentability and/or breadth of the inventions and/or discoveries involved
in the Licensed Patents, Licensed Applications and Sponsored Research
Intellectual Property Rights.
16.6 LICENSEE agrees to defend, indemnify and hold FOUNDATION harmless from
and against all liability, damages, expenses or losses for death, personal
injury, illness or property damage (including reasonable attorney's fees)
resulting from a claim, suit or proceeding brought by a third party against
FOUNDATION and arising (a) out of use by LICENSEE or its sublicensees of
inventions licensed or information furnished under this Restated Agreement, or
(b) out of any use, sale or other disposition by LICENSEE or its sublicensees of
Licensed Products made by use of such inventions or information; provided that
any indemnitee that intends to claim indemnification under this Article XVI
shall: (i) promptly notify LICENSEE in writing of any claim with respect to
which the indemnitee intends to claim such indemnification, (ii) give LICENSEE
sole control of the defense and settlement thereof, and (iii) provide LICENSEE,
at LICENSEE's expense, with reasonable assistance and full information with
respect to such claim. LICENSEE shall have no obligation for any claim if the
indemnitee seeking indemnification makes any admission, settlement, or other
communication regarding such claim without the prior consent of LICENSEE, which
consent will not be unreasonably withheld. As used in this clause, FOUNDATION
includes its trustees, officers, agents and employees, and those of Cornell
University (including CUMC) and affiliated hospitals, clinics, or other
institutions affiliated with CUMC, and "LICENSEE" includes its Affiliates,
contractors and sub-contractors. In discharge of the above, LICENSEE will
maintain general liability insurance in the amount of at least one million
($1,000,000) per occurrence with a deductible of more than $10,000 per
occurrence against damage to or destruction of property and injury to or death
of individuals and against such other risks as FOUNDATION may reasonably request
arising out of or in connection with any of the Licensed Products, FOUNDATION,
LICENSEE and their respective officers, trustees, members of their governing
boards, and employees will be named insureds under all such insurance. Such
insurance will also provide that FOUNDATION will be given notice of any material
modification thereof which would reduce insurance coverage of LICENSEE, and at
least thirty (30) days prior written notice of cancellation or termination and
reason therefore. LICENSEE will furnish FOUNDATION upon request, and in any
event on execution of this Restated Agreement and on each anniversary of the
Effective Date of this Restated Agreement, written confirmation issued by the
insurer or an independent insurance agent confirming that insurance is
maintained in accordance with the above requirements.
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16.7 This Restated Agreement shall be interpreted under the Laws of the
State of New York.
16.8 Any payment, report, notice or other communication required or
permitted to be given to either party hereto shall be deemed to have been
properly given and to be effective on the date of delivery if delivered in
person or telecopied (with confirmed answerback) to the number provided by the
other party, or five (5) days after mailing in the United States by certified
first-class United States mail, postage paid, return receipt requested, to the
other party's address as set forth below or to such other address as a party
shall designate by written notice to the other party.
To FOUNDATION: H. Xxxxxx Xxxxxxxxx, President
CORNELL RESEARCH FOUNDATION, INC.
Cornell Business & Technology Park
00 Xxxxxxxxx Xxxxx, Xxxxx 000
Xxxxxx, Xxx Xxxx 00000
To LICENSEE: GENVEC, INC.
00000 Xxxxxxxx Xxxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attn: President
with a copy to: Vice President, Corporate Development
16.9 LICENSEE's sole obligation to exploit the Licensed Patents, Licensed
Applications and Sponsored Research Intellectual Property Rights is as set forth
in Article IX. Nothing in this Restated Agreement will impair LICENSEE's right
to independently acquire, license, develop for itself, or have others develop
for it, similar technology performing similar functions as the Licensed
Technology or to market and distribute products based on such other technology.
16.10 The relationship of FOUNDATION and LICENSEE established by this
Restated Agreement is that of independent contractors. Nothing in this Restated
Agreement shall be construed to create any other relationship between FOUNDATION
and LICENSEE. Neither party shall have any right, power or authority to assume,
create or incur any expense, liability or obligation, express or implied, on
behalf of the other.
16.11 Any delays in or failures of performance by either party under this
Restated Agreement shall not be considered a breach of this Restated Agreement
if and to the extent caused by occurrences beyond the reasonable control of the
party affected, including but not limited to: acts of God, acts, regulations or
laws of any government, strikes or other concerted acts of workers, fires,
earthquakes, floods, explosions, riots, wars, rebellion, and sabotage. Any time
period for performance imposed hereunder shall be extended by the actual time of
delay caused by any such occurrence.
16.12 A waiver, express or implied, by either FOUNDATION or LICENSEE of any
right under this Restated Agreement or of any failure to perform or breach
hereof by the other party hereto
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shall not constitute or be deemed to be a waiver of any other right hereunder or
of any other failure to perform or breach hereof by such other party, whether of
a similar or dissimilar nature thereto.
16.13 SUBJECT TO SECTION 16.6, NEITHER PARTY SHALL BE LIABLE TO THE OTHER
PARTY OR ANY THIRD PARTY FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL OR EXEMPLARY
DAMAGES (INCLUDING LOST OR ANTICIPATED REVENUES OR PROFITS RELATING TO THE
SAME), ARISING FROM ANY CLAIM RELATING TO THIS RESTATED AGREEMENT, WHETHER SUCH
CLAIM IS BASED ON CONTRACT, TORT OR ANY THEORY OF LIABILITY.
16.14 Headings included herein are for convenience only, do not form a part
of this Restated Agreement and shall not be used in any way to construe or
interpret this Restated Agreement.
16.15 If any provision of this Restated Agreement shall be found by a court
to be void, invalid or unenforceable, the same shall be reformed to comply with
applicable law, or stricken if not so conformable, so as not to affect the
validity or enforceability of the remainder of this Restated Agreement.
16.16 This Restated Agreement shall be binding upon and inure to the
benefit of and be enforceable by the parties hereto and their respective
successors and permitted assigns.
16.17 At any time or from time to time on and after the date of this
Restated Agreement, either party shall at the request of the other party (i)
deliver to the other party such records, data or other documents consistent with
the provisions of this Restated Agreement, (ii) execute, and deliver or cause to
be delivered, all such consents, documents or further instruments of transfer or
license, and (iii) take or cause to be taken all such actions, as the other
party may reasonably deem necessary or desirable in order for the other party to
obtain the full benefits of this Restated Agreement and the transactions
contemplated hereby.
16.18 LICENSEE and LICENSOR have each consulted counsel of their choice
regarding this Restated Agreement, and each acknowledges and agrees that this
Restated Agreement shall not be deemed to have been drafted by one Party or
another and will be construed accordingly.
16.19 This Restated Agreement, together with the Sponsored Research
Agreements and Material Transfer Agreement, constitute the entire understanding
and agreement between the parties with respect to the subject matter hereof and
supersedes any and all prior negotiations, representations, agreements, and
understandings, written or oral, that the parties may have reached with respect
to the subject matter hereof. No agreements altering or supplementing the terms
hereof may be made except by means of a written document signed by the duly
authorized representatives of each of the parties hereto. It is understood that
the Sponsored Research Agreements and Material Transfer Agreement are separate
and independent from this Restated Agreement and termination of any of such
agreements shall not operate to terminate or otherwise affect the rights and
obligations of the parties under the other agreements.
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16.20 This Restated Agreement may be executed in counterparts, each of
which shall be deemed an original, but both of which together shall constitute
one and the same instrument.
IN WITNESS WHEREOF, the parties have caused this instrument to be executed
in duplicate as of the day and year first above written.
ATTEST: CORNELL RESEARCH FOUNDATION, INC.
By
-------------------------------- -------------------------------------
H. Xxxxxx Xxxxxxxxx
Title President
Date
-----------------------------------
ATTEST: GENVEC, INC.
By
-------------------------------- -------------------------------------
Title
----------------------------------
Date
-----------------------------------
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