EXHIBIT 10.16.1
LICENSE AGREEMENT
This AGREEMENT made this twentieth (20th) day of December, 2000 (the
"Effective Date"), by and between Northwestern University, an Illinois
corporation having a principal office at 633 Clark Street, Evanston, Illinois
60208 (hereinafter referred to as "Northwestern") and GenVec, Inc., a Delaware
corporation having a principal office at 65 West Watkins Mill Road,
Gaithersburg, Maryland 20878-4021 (hereinafter referred to as "Licensee") (each
a "Party" and collectively the "Parties").
WITNESSETH
WHEREAS, Northwestern is the owner of certain patent rights relating to
* and has the right to grant licenses hereunder, subject to a royalty-free,
nonexclusive license heretofore granted to the United States Government;
WHEREAS, Northwestern desires to have the patent rights developed and
commercialized to benefit the public and is willing to grant a license
hereunder;
WHEREAS, Licensee has represented to Northwestern that Licensee will
commit itself to a thorough, vigorous and diligent program to develop and
subsequently manufacture, market, offer for sale and sell products utilizing the
patent rights;
WHEREAS, Licensee desires to obtain a license under the patent rights
upon the terms and conditions hereafter set forth;
NOW THEREFORE, in consideration of the premises and mutual covenants
contained herein, the Parties hereto agree as follows:
ARTICLE 1 - DEFINITIONS
1.1 "AFFILIATE" shall mean any corporation, firm, partnership or other
entity, which controls, is controlled by or is under common control with a
Party. For the purposes of this definition, "control" shall mean any right or
collection of rights that together allow direction on any vote with respect to
any action by an entity or the direction of management and operations of that
entity. Such right or collection of rights includes without limitation (a) the
authority to act as sole member or shareholder or partner with a majority
interest in an entity; (b) a majority interest in an entity; and (c) the
authority to appoint, elect, or approve at least a majority of the governing
board of that entity.
1.2 "FDA" shall mean the United States Food & Drug Administration and
any successor agency thereto.
1.3 "FIELD" shall mean Gene Therapy for ocular diseases only,
including but not limited to, macular degeneration, cancer of the eye, diabetic
retinopathy, ocular histoplasmosis syndrome, and retinopathy associated with
neovascularization in neonatals. All other uses or applications unless provided
for herein are excluded.
[*] = CERTAIN INFORMATION CONTAINED 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 "*".
1.4 "IND" shall mean Investigational New Drug Application suitable for
obtaining approval to ship a Licensed Product for the purpose of safety and
effectiveness testing of such Licensed Product.
1.5 "LICENSED PRODUCT" shall mean tangible materials which, in the
course of manufacture, use, offer to sell, sale, or importation by or on behalf
of Licensee would, in the absence of the License, infringe one or more claims of
the Patent Rights that have not been held invalid or unenforceable by an
unappealed or unappealable judgment of a court or competent jurisdiction or is
otherwise expired.
1.6 "COMBINATION PRODUCT(S)" shall mean a Licensed Product(s) that is
sold in combination with one or more other products, active therapeutic
agent(s), or agents of administration of Licensed Product which are not Licensed
Product(s).
1.7 "NDA" shall mean an application suitable for obtaining Regulatory
Approval, the approval of which is necessary to market Licensed Products in the
United States, whether such application is pending or approved or has been filed
with respect to the Licensed Products, submitted to the FDA under applicable
United States Law.
1.8 "NET SALES" shall mean the total gross amounts received by Licensee
and sublicensees or Affiliates for Licensed Products sold in the First
Commercial Sale and subsequent commercial sales, less the following amounts
directly chargeable to such Licensed Products: (a) customary trade, quantity or
cash discounts and rebates, actually allowed and taken; (b) amounts repaid or
credited to customers on account of rejections; (c) freight and other
transportation costs, including insurance charges, and duties, tariffs, sales
taxes and excise duties and other governmental charges based on sales, turnover
or delivery of such Licensed Products and actually paid or allowed by Licensee
or sublicensee; (d) amounts allowed or credited due to returns or uncollectible
amounts. In the event Licensee or sublicensee or Affiliate sells Combination
Product(s), Net Sales from such sales for the purposes of calculating the
amounts due under this Agreement shall be calculated by multiplying the Net
Sales of that combination by the fraction A/A+B, where A is the gross selling
price of the Licensed Product(s) sold separately and B is the gross selling
price of the active therapeutic agent(s), or agents of administration of the
Licensed Product sold separately.
1.9 "PATENT RIGHTS" shall mean the patents and patent applications
listed on Exhibit A attached hereto and incorporated herein by reference, and
any patents which issue from the patent applications listed on Exhibit A
attached hereto and incorporated herein by reference, and all substitutions,
additions, extensions, reissues, renewals, divisions, continuations and
continuations-in-part thereof and any foreign counterparts thereto.
1.10 "VALID CLAIM" shall mean either (a) a claim of an issued and
unexpired patent included within the Patent Rights, which has not been held
invalid by a decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed for appeal, or
(b) a claim of a pending patent application included within the Patent Rights,
which claim has not been abandoned or finally disallowed without the possibility
of appeal or refiling of such application. If a claim of a pending application
has not been issued as a claim of an issued patent, in less than seven (7) years
after the filing date of such claim, such pending claim shall not be a Valid
Claim for purposes of this Agreement unless and until the patent is issued
including such claim.
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1.11 "REGULATORY APPROVAL" shall mean the approval of either the FDA or
a foreign counterpart thereto required to commence commercial sale of a Licensed
Product in such country in the Territory.
1.12 "TERRITORY" shall mean the entire world.
1.13 "FIRST COMMERCIAL SALE" shall mean with respect to any Licensed
Product on a country-by-country basis, the first sale for use or consumption of
such Licensed Product following approval by the FDA or comparable foreign
regulatory authority. A transfer of the Licensed Product by Licensee or its
sublicensees (a) solely for research and development purposes and for the
purpose of directly enabling Licensee and its sublicensees to research and
develop Licensed Product under this Agreement and/or (b) prior to Licensee's
receipt of approval of a PLA, NDA or equivalent by the FDA (or from the
governing health authority of any other country) for use of such Licensed
Product in humans, shall not be considered a First Commercial Sale in the
applicable country.
1.14 "GENE THERAPY" shall mean the introduction of nucleic acid into a
person with the purpose of modifying the functions or behaviors of cells of the
human body, either by EX VIVO introduction of nucleic acid into cells, which
cells are later introduced into such persons' body, or by IN VIVO introduction
of nucleic acid into the person's body, to be incorporated into cells of such
person (nucleic acid being any composition of matter that includes two or more
covalently joined nucleotides and/or variants thereof).
1.15 "CONFIDENTIAL INFORMATION" shall mean any and all information
contained in written or graphic form and marked "Confidential" which is
forwarded to one by the other, or, if disclosed orally, is described by a
written summary thereof sent to Recipient within thirty (30) days of initial
oral disclosure.
1.16 "PLA" shall mean 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.
ARTICLE II - GRANT
2.1 Northwestern hereby grants to Licensee and its Affiliates a
license, with the right to sublicense, under Patent Rights to make, have made,
use, import, offer for sale and sell Licensed Products in the Territory in the
Field. Such license shall be exclusive in the Field.
2.2 The grant under Paragraph 2.1 shall be subject to the obligations
of Northwestern and of Licensee to the United States Government under any and
all applicable laws, regulations, and executive orders including those set forth
in 35 U.S.C. Section 200, et seq.
2.3 Northwestern retains the right to utilize Patent Rights for
noncommercial research purposes and to grant licenses to third parties outside
of the Field as defined herein.
2.4 Licensee may grant and authorize sublicenses within the scope of
the license granted to Licensee pursuant to this Agreement. Licensee shall
notify Northwestern in writing of grant of any such sublicense which notice
shall identify the sublicensee and the business terms of such sublicensees as
they relate to Licensed Products. The identity of all sublicensees and the
business terms shall be Confidential Information of Licensee.
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ARTICLE III - CONFIDENTIAL INFORMATION
3.1 Northwestern and Licensee each agree that all Confidential
Information shall be received in strict confidence, used only for the purposes
of this Agreement, and not disclosed by the recipient (except as required by law
or court agency or administrative order), its agents or employees to any third
party without the prior written consent of an authorized officer of the
disclosing Party, unless such Confidential Information (a) was in the public
domain at the time of disclosure, (b) later became part of the public domain
through no act or omission of the recipient, its employees, agents, successors
or assigns, (c) was lawfully disclosed to the recipient by a third party having
the right to disclose it, (d) was already known by the recipient at the time of
disclosure, (e) was independently developed, as recipient can by competent
written proof demonstrate, by persons in its employ or consultants who have had
no contact or exposure to, directly or indirectly, with Confidential Information
received hereunder, (f) is required by law, regulations, court or administrative
agency order, provided that recipient gives prior written notice of such
disclosure to the disclosing party and takes all reasonable and lawful actions
to avoid and/or minimize the extent of such disclosure, or (g) is required to be
submitted to a government agency to obtain and maintain the approvals and
clearances of Licensed Products. Subject to Paragraph 3.2, disclosure of
Confidential Information may also be made to Affiliates, distributors,
customers, and agents, to nonclinical and clinical investigators, collaborators,
contract manufacturers, and to consultants underlying such disclosure.
Northwestern and Licensee also agree that Confidential Information may be orally
disclosed by one Party to the Other Party. Such Confidential Information shall
be confirmed in writing and designated "Confidential" within thirty (30) days of
disclosure for the provisions of this Article III to apply.
3.2 Each Party's obligation of confidence hereunder shall be fulfilled
by using at least the same degree of care with the other Party's Confidential
Information as it uses to protect its own confidential information. This
obligation shall exist while this Agreement is in force and for a period of two
(2) years thereafter; provided, however, with respect to Confidential
Information pertaining to sublicenses or other party agreements the obligations
of recipient under this Agreement shall, subject to Paragraph 3.1 above, survive
any termination or expiration of this Agreement until the expiration of the
applicable confidentiality obligations of those third party agreements.
3.3 This Agreement may be distributed solely (a) to those employees,
agents, active or prospective investors or corporate partners, professional
advisors, and independent contractors of Northwestern or Licensee who have a
need to know its contents, (b) to those persons whose knowledge of its contents
will facilitate performance of the obligations of the parties under this
Agreement, (c) to those persons, if any, whose knowledge of its contents is
essential in order to permit Licensee or Northwestern to maintain or secure the
benefits under policies of insurance, or (d) as may be required by law or
regulation or by court or administrative agency order or the Securities and
Exchange Commission, provided that the recipient of Confidential Information
give prior written notice of such disclosure to the disclosing party and takes
all reasonable and lawful actions to avoid and/or minimize the extent of such
disclosure.
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ARTICLE IV - MILESTONES AND DUE DILIGENCE
4.1 Licensee shall, upon execution of this Agreement, submit to
Northwestern a preliminary development and business plan that sets forth an
outline of Licensee's intended efforts to develop and commercialize Licensed
Products. Such plan shall include a summary of personnel, expenditures and
estimated timing for the development of Licensed Products and estimates of the
market potential for Licensed Products.
4.2 Licensee shall use commercially reasonable efforts to comply with
the following milestones:
(a) completion of GMP manufacturing of Licensed Product within *
from the Effective Date;
(b) completion of toxicological studies for IND and submission
of an IND for a Licensed Product within * from the Effective
Date;
(c) completion of a safety trial in humans (Phase I clinical
trial) for a Licensed Product within * from the Effective
Date;
(d) completion of a Phase II clinical trial for a Licensed
Product within * from the Effective Date;
(e) completion of a Phase III clinical trial for a Licensed
Product within * from the Effective Date;
(f) submission to an applicable regulatory authority of an NDA
or PLA for a Licensed Product within * from the Effective
Date;
The foregoing milestones may be satisfied by Licensee and/or its
Affiliates or sublicensees. Licensee agrees to devote that level of resources to
the commercialization of a Licensed Product as other companies in the industry
customarily devote to products of similar commercial potential. Further, it is
understood by Northwestern that the foregoing milestones are believed to
represent the appropriate course of action for bringing a product to the market.
It is further understood that changes in circumstances, including but not
limited to, changes in the applicable law, changes in the progress in the
development of a product, changes in the market for ocular products or changes
in the type and nature of products pursued by Licensee, and/or delays in the
commercial or scientific progress of a product or Licensee's business, may
necessitate following a different plan for commercialization of a product. In
such instances, Licensee may request that the schedule of milestones be modified
and will so notify Northwestern in writing and submit a new schedule of
milestones subject to approval of Northwestern, such approval not to be
unreasonably withheld. Northwestern agrees that receipt of a milestone payment
pursuant to Article 5 shall be construed as due diligence toward Licensee's
compliance with such milestone.
ARTICLE V - PAYMENT
In consideration of the license granted by Northwestern to Licensee
under this Agreement, Licensee shall pay to Northwestern the following:
5.1 A non-creditable, non-refundable licensing fee of $* upon execution
of this Agreement, and within 60 days of the Effective Date.
5.2 The following non-creditable and non-refundable milestone payments
on the earlier of the dates specified or upon achievement of particular
milestones in the development of Licensed Products:
(a) $* upon submission of the first IND for a Licensed Product,
or *;
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(b) $* upon the first initiation of a Phase II clinical trial of
a Licensed Product or *;
(c) $* upon the first initiation of a Phase III clinical trial
of a Licensed Product or *;
(d) $* upon the first Regulatory Approval of a Licensed Product
in a major market country (United States, Japan, France,
Germany, United Kingdom, Italy) or *.
5.3 Beginning the first full calendar year after the Regulatory
Approval of a Licensed Product in a major market country, or the year 2009,
whichever comes first, Licensee shall pay to Northwestern minimum royalty
payments of $* per year, payable on January 30 of the year. Any such
minimum royalty payments shall be fully creditable against any payments
required under Paragraph 5.4.
5.4 A running royalty of * percent (*%) of Net Sales of Licensed
Products manufactured or sold in a country within the Territory covered by
a Valid Claim of an issued patent. In the event that Licensee enters into
other licensee agreement(s) with third party(ies) with respect to
intellectual property which in Licensee's opinion is legally required or
which is cost effective, improves the manufacture, use or sale of Licensed
Product(s), Licensee may offset amounts paid to such third party(ies)
against earned royalties due Northwestern hereunder, by reducing Licensee's
obligation to Northwestern by *% for each *% of royalties which Licensee is
obligated to pay to third parties; provided, however, the minimum earned
royalty rate due Northwestern shall not be less than * percent (*%). In the
event that there is no issued Valid Claim in the Patent Rights covering
such Licensed Product(s) in a given country, but there is pending claim
within the Licensed Patent Rights covering such Licensed Product(s) and
such claims have been pending for seven (7) years or less from the filing
date of such claims, the royalties set forth above shall be reduced by *
percent (*%) (hereinafter the "Patent Pending Reduction") until the date
when such pending claims are allowed for issuance by the appropriate
authority with such country.
5.5 In addition to the running royalties under Paragraph 5.4, *
percent (*%) of the following sublicensing royalties/fees received by
Licensee from the sublicensing of the Patent Rights: (i) execution or
up-front royalties/fees, (ii) minimum annual royalties/fees, and (iii)
benchmark or milestone royalties/fees. Such sublicensing royalties/fees do
not include royalties or fees received by Licensee for the purchase of
equity, debt financing, research and/or development funds, the license or
sublicense of intellectual property other than the Licensed Product(s) or
reimbursement for patent or other expenses.
ARTICLE VI - PAYMENT, REPORT AND RECORDS
6.1 PAYMENT DATES AND REPORTS
Upon the First Commercial Sale of Licensed Product(s) and
within sixty (60) days after the end of each calendar quarter of each year
during the term of this Agreement (including the last day of any calendar
quarter following the expiration of this Agreement), Licensee shall pay to
Northwestern, all royalties accruing during such calendar quarter. Such payments
shall be accompanied by a statement showing the Net Sales of each Licensed
Product by Licensee and its sublicensees in each country, the applicable royalty
rate and the calculation of the amount of royalty due.
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6.2 ACCOUNTING
a. PAYMENTS IN U.S. DOLLARS
All dollar sums referred to in this Agreement are
expressed in U.S. dollars and Net Sales used for calculating the royalties and
other sums payable to Northwestern by Licensee pursuant to Paragraph 6.1 shall
be computed in U.S. dollars. For purposes of determining the amount of royalties
due, the amount of Net Sales in any foreign currency shall be computed by
converting such amount into U.S. dollars at the prevailing commercial rate of
exchange for purchasing U.S. dollars with such foreign currency in question as
quoted by Citibank in New York on the last business day of the calendar quarter
for which the relevant royalty payment is to be made by Licensee.
b. BLOCKED ROYALTIES
Notwithstanding the foregoing, if by reason of any
restrictive exchange laws or regulations Licensee or any Affiliate or
sublicensee hereunder shall be unable to convert to U.S. dollars an amount
equivalent to the royalty payable by Licensee hereunder in respect of Licensed
Product sold for funds other than U.S. dollars, Licensee shall notify
Northwestern promptly with an explanation of the balance thereof due hereunder
and not paid in funds other than U.S. dollars after, and to the extent that such
restrictive exchange laws or regulations are lifted so as to permit such
conversion to United States dollars, of which lifting Licensee shall promptly
notify Northwestern. At its option, Northwestern shall meanwhile have the right
to request the payment (to it or to a nominee), and upon such request Licensee
shall pay, or cause to be paid, all such amounts (or such portions thereof as
are specified by Northwestern) in funds, other than U.S. dollars, designated by
Northwestern and legally available to Licensee under such then existing
restrictive exchange laws or regulations.
6.3 RECORDS
Licensee shall keep, and shall cause its Affiliates and sublicensees to
keep, for three (3) years from the date of payment of royalties, complete and
accurate records of sales of each Licensed Product by Licensee; its Affiliates
and its sublicensees in sufficient detail to enable the accruing royalties to be
determined accurately. Northwestern shall have the right during this period of
three (3) years after receiving any report with respect to royalties due and
payable to appoint, at its expense, an independent certified public accountant
to inspect the relevant records of Licensee, its Affiliates, and its
sublicensees to verify such report. Northwestern shall submit the name of said
accountant to Licensee for approval; said approval shall not be unreasonably
withheld. Licensee shall make its records and those of its Affiliates, and use
reasonable efforts to have its sublicensees make available its records for
inspection by such independent certified public accountant during regular
business hours at such place or places where such records are customarily kept,
upon reasonable notice from Northwestern, to the extent necessary to verify the
accuracy of the reports and payments with not more than one (1) inspection per
calendar year. Northwestern agrees to hold in strict confidence all information
concerning royalty payments and reports, and all information learned in the
course of any audit or inspection, except to the extent necessary for
Northwestern to reveal such information in order to enforce its rights under
this Agreement or as may be required by law. If royalties are understated by 10
percent (10%) or more in Licensee's favor, the Licensee shall, within ten (10)
days of receipt of the audit report, pay the balance due Northwestern plus all
reasonable costs of the audit or inspection and interest
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at the prime rate as quoted by Citibank in New York from the date at which such
balance would have otherwise been due and payable. If royalties are understated
by less than ten percent (10%), Licensee shall include such understated amount
with the next scheduled payment pursuant to Paragraph 6.1.
ARTICLE VII - PUBLICATION
Northwestern will be free to publish the results of any research
conducted at Northwestern, that may be related to Patent Rights or Licensed
Products and use any information for purposes of research, teaching, and other
educationally-related matters. Such publication rights shall not require
Licensee's approval, except only if Licensee has provided Northwestern with any
Confidential Information or proprietary information of Licensee, in which case
Northwestern agrees to submit to Licensee any proposed publication or
presentation related to Patent Rights at least thirty (30) days prior to
publication or public disclosure. Licensee, within twenty (20) days after
receipt, shall advise in writing if there is any Confidential Information or
proprietary information of Licensee or potentially patentable subject matter. At
Licensee's written request Northwestern shall remove any such Confidential
Information or proprietary information from such proposed publication or public
disclosure.
ARTICLE VIII - PATENT PROSECUTION
8.1 Northwestern shall apply for, seek prompt issuance of, and maintain
during the term of this Agreement the Patent Rights in the United States and in
the foreign countries listed in Exhibit A hereto. The filing, registration,
prosecution, and maintenance of all Patent Rights shall be the primary
responsibility of Northwestern; provided, however, Licensee shall have
reasonable opportunities to advise Northwestern and shall cooperate with
Northwestern in such prosecution, filing and maintenance.
8.2 Licensee agrees to pay for one-third (1/3) of all necessary and
reasonable out-of-pocket legal expenses incurred prior to the Effective Date by
Northwestern in obtaining and maintaining Patent Rights. Licensee shall
reimburse Northwestern for such expenses within thirty (30) days of receiving an
itemized invoice for payment thereof. For all necessary and reasonable
out-of-pocket legal expenses incurred after the Effective Date by Northwestern
in obtaining and maintaining Patent Rights, Licensee agrees to pay the lesser of
one-third (1/3) or a pro rata share of such expenses, where such pro rata share
is determined by the number of third parties with option or license to any
and/or all of the Patent Rights hereunder at the time Northwestern invoices
Licensee for such expenses ("Third Party Rights"). On a monthly basis,
Northwestern shall submit to Licensee an itemized invoice for such expenses
incurred during the prior month period, together with documentation in a form
reasonably acceptable to Licensee for applicable services with respect to such
expenses rendered by third party vendors, and the number of Third Party rights
then in effect. Licensee shall reimburse Northwestern the applicable amount of
such expenses within thirty (30) days of receiving an invoice for payment
thereof. Licensee may raise any objections to such amounts invoiced within the
thirty (30) day time period for payment.
8.3 Northwestern shall permit Licensee to provide comments and
suggestions with respect to the selection of patent counsel, preparation,
filing, prosecution, and maintenance of Patent Rights, which comments and
suggestions shall be considered by
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Northwestern, but may not be accepted. Following execution of this Agreement and
receipt of the license issue fee, Northwestern shall provide Licensee with
copies of all documents relating to patents or patent applications within the
Patent Rights as soon as is reasonably practical. Northwestern agrees to consult
Licensee on matters of all Office Actions issued by the Patent Office and agrees
to consider the incorporation into the final version of such documents any
reasonable change(s) and/or claim(s) requested by Licensee thereof. In any event
Northwestern shall not cancel any claims related to the subject matter of
Licensed Products or Licensed Processes, without the consent of Licensee.
8.4 Northwestern shall seek Patent Rights in all countries as listed in
Exhibit A. If Licensee should desire to seek patent protection in countries not
listed in Exhibit A, Licensee shall notify Northwestern in writing and shall be
responsible for any associated costs, except Licensee shall only be responsible
for its pro rata share of such associated costs, if other licensees of Patent
Rights also desire patent protection in such country, and shall reimburse
Northwestern for such costs or its pro rata share, as applicable. If
Northwestern wishes to discontinue prosecuting or maintaining an application or
patent in a given country, Licensee shall have the option of assuming
responsibility for such prosecution or maintenance in Northwestern's name,
wherein, Licensee shall be responsible for all associated costs, and shall
reimburse Northwestern for such costs, except Licensee shall only be responsible
for its pro rata share of such associated costs if other licensees of Patent
Rights also desire patent protection in such country.
ARTICLE IX - INFRINGEMENT
9.1 Licensee shall inform Northwestern promptly in writing of any
alleged infringement of the Patent Rights by a third party and of any available
evidence thereof.
9.2 During the terms of this Agreement, Northwestern shall have the
right, but shall not be obligated, to prosecute at its own expense all
infringements of the Patent Rights and, in furtherance of such right, Licensee
hereby agrees that Northwestern may include Licensee as a party plaintiff in
such suit, without expense to Licensee. Prior to commencing an infringement
action, Northwestern shall give consideration to the views of Licensee in
connection with the action, including the selection of counsel. Northwestern
shall continue to inform Licensee of all contemplated strategies, including
settlement, consent judgment or other voluntary final disposition of the suit,
and shall carefully consider Licensee's views thereon. The total cost of any
such infringement action commenced or defended solely by Northwestern shall be
borne by Northwestern and Northwestern shall keep any recovery or damages for
past infringement derived therefrom.
9.3 If within six (6) months after having been notified of any alleged
infringement, Northwestern shall not have brought and shall not be diligently
prosecuting an infringement action, or if Northwestern shall notify Licensee at
any time prior thereto of its intention not to bring suit against any alleged
infringer, then, and in those events only, Licensee shall have the right, but
shall not be obligated, to prosecute at its own expense any infringement of the
Patent Rights, and Licensee may, for such purposes, use the name of Northwestern
as party plaintiff; provided, however, that such right to bring such
infringement action shall remain in effect only for so long as the license
granted herein remains exclusive. No settlement, consent judgment or other
voluntary final
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disposition of the suit may be entered into without the consent of Northwestern,
which consent shall not unreasonably be withheld. Licensee shall indemnify
Northwestern against any order for costs that may be made against Northwestern
in such proceedings. Licensee shall keep any recovery or damages for past
infringement derived therefrom; provided, however, that such recovery, less any
and all expenses or costs incurred by Licensee, including, but not limited to,
reasonable attorneys' fees, shall be treated as Net Sales for the purpose of
calculating running royalties under Paragraph 5.4.
9.4 In the event that a declaratory judgment action alleging invalidity
or noninfringement of any of the Patent Rights shall be brought against
Licensee, Northwestern, at its option, shall have the right, within thirty (30)
days after it receives notice of the commencement of such action, to intervene
and take over the sole defense of the action at its own expense.
9.5 In any infringement suit that either Party may institute to enforce
the Patent Rights pursuant to this Agreement, the other party hereto shall, at
the request and expense of the Party initiating such suit, cooperate in all
respects and, to the extent possible, have its employees testify when requested
and make available relevant records, papers, information, samples, specimens,
and the like.
9.6 Licensee, during the term of this Agreement, shall have the sole
right in accordance with the terms and conditions herein to sublicense any
alleged infringer for future use of the Patent Rights. Any sublicensing
royalties/fees received by Licensee shall be treated pursuant to Paragraph 5.5.
ARTICLE X - PRODUCT LIABILITY
10.1 Licensee shall at all times during the term of this Agreement and
thereafter, indemnify, defend and hold Northwestern, its trustees, directors,
officers, employees and Affiliates, harmless against all claims, proceedings,
demands and liabilities or any kind whatsoever, including legal expenses and
reasonable attorneys' fees arising out of the death of or injury to any person
or persons or out of any damage to property, or resulting from the production,
manufacture, sale, use, lease, consumption or advertisement of the Licensed
Product(s) or arising from any obligation of Licensee hereunder.
10.2 Licensee shall obtain and carry in full force and effect
commercial, general liability insurance which shall protect Licensee and
Northwestern with respect to events covered by paragraph 10.1 above. Such
insurance shall be written by a reputable insurance company authorized to do
business in the State of Illinois, shall list Northwestern as an additional
named insured thereunder, shall be endorsed to include product liability
coverage and shall require thirty (30) days written notice to be given to
Northwestern prior to any cancellation or material change thereof. The limits of
such insurance shall not be less than Five Million Dollars ($5,000,000) per
occurrence with an aggregate of Five Million Dollars ($5,000,000) for personal
injury or death; provided, however, upon the approval of an IND for a Licensed
Product, Licensee shall maintain insurance of not less than an aggregate of Ten
Million Dollars ($10,000,000) for personal injury or death, and upon the First
Commercial Sale of a Licensed Product maintain insurance of not less than an
aggregate of Fifteen Million Dollars ($15,000,000) for personal injury or death.
In addition, Licensee shall maintain insurance of not less than One Million
Dollars ($1,000,000) per occurrence with an aggregate of Three Million
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Dollars ($3,000,000) for property damage. Licensee shall provide Northwestern
with Certificates of Insurance evidencing the same.
10.3 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT,
NORTHWESTERN, ITS TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES, AND AFFILIATES MAKE
NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR
IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR
A PARTICULAR PURPOSE, VALIDITY OF PATENT RIGHT OF CLAIMS, ISSUED OR PENDING AND
THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE. NOTHING IN
THIS AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION MADE OR WARRANTY GIVEN BY
NORTHWESTERN THAT THE PRACTICE BY LICENSEE OF THE LICENSE GRANTED HEREUNDER
SHALL NOT INFRINGE THE PATENT RIGHTS OF ANY THIRD PARTY. IN NO EVENT SHALL
NORTHWESTERN, ITS TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES AND AFFILIATES BE
LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC
DAMAGE OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER
NORTHWESTERN SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL
KNOW OF THE POSSIBILITY.
10.4 To Northwestern's best knowledge Northwestern represents that: (i)
Northwestern is the sole and exclusive owner of all right, title and interest in
and to the Patent Rights; (ii) Northwestern has the right to grant the rights
and licenses granted herein; (iii) the Patent Rights are free and clear of any
lien, encumbrance, security interest or restriction on license; (iv)
Northwestern has not previously granted, and will not grant during the term of
this Agreement, any right, license or interest in or to the Patent Rights, or
any portion thereof, inconsistent with the license granted to Licensee herein;
(v) there are no threatened or pending actions, suits, investigations, claims or
proceedings in any way relating to the Patent Rights, except for the routine
prosecution of pending patent applications relating to the Patent Rights.
ARTICLE XI - TERM AND TERMINATION
11.1 This Agreement shall become effective on the Effective Date.
Unless sooner terminated as provided for below, this Agreement shall continue in
effect, on a Licensed Product-by-Licensed Product and country-by-country basis,
until the expiration of the last to expire patent for so long as there is an
issued Valid Claim in such country covering such Licensed Product.
11.2 Licensee shall have a unilateral right to terminate this Agreement
and/or any licenses in any country by giving Northwestern sixty (60) days
written notice to that effect.
11.3 Northwestern shall have the right to terminate or render this
license non-exclusive at any time if Northwestern determines that Licensee; (a)
has not adhered to the milestones and/or benchmarks of the commercial
development plan submitted by Licensee, and the Licensee cannot otherwise
demonstrate to Northwestern's satisfaction that Licensee has taken, or can be
expected to take within reasonable time, effective steps to achieve such
milestones and/or benchmarks, or (b) is not keeping Licensed Products
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reasonably available to the public after commercial use commences. In making
this determination, Northwestern will take into account the normal course of
such commercial development programs conducted with sound and reasonable
business practices and judgment and annual reports submitted by Licensee. Prior
to invoking this right, Northwestern shall give written notice to Licensee
providing Licensee specific notice of, and a sixty (60) day opportunity to
respond to, Northwestern's concerns as to the previous items a) and/or b). If
Licensee has not cured such breach within sixty (60) days after receipt of such
notice from Northwestern, Northwestern will be entitled, in addition to any
other rights it may have under this Agreement, to terminate this Agreement
effective immediately; provided, however, if Licensee receives notification from
Northwestern of a material breach and if Licensee notifies Northwestern in
writing within sixty (60) days of receipt of such default notice that it
disputes the asserted default, the matter will be submitted to arbitration as
provided in Article XIII of this Agreement. For disputes involving Article IV,
Northwestern shall not have the right to terminate this Agreement until it has
been determined in such arbitration proceeding that Licensee materially breached
this Agreement, and the Licensee fails to cure such breach within ninety (90)
days after the conclusion of such arbitration proceeding.
11.4 The provisions of Article III (Confidentiality), Article VI
(Payments, Reports and Records), Article X (Product Liability), Article XII
(Assignment), Article XIII (Dispute Resolution) and Article XIV (Notices and
Payments) shall survive termination or expiration of this Agreement in
accordance with their terms.
11.5 If (1) either Party breaches any material obligation imposed by
this Agreement; (2) either Party makes any general assignment for the benefit of
its creditors; (3) a petition is filed by or against either Party, or any
proceeding is initiated against either Party as a debtor, under any bankruptcy
or insolvency law, unless the laws then in effect void the effectiveness of this
provision; or (4) a receiver, trustee, or any similar office is appointed to
take possession, custody, or control of all or any part of either Party's assets
or property, then the other Party may, at its option, send a written notice that
it intends to terminate the license granted by this Agreement.
11.6 If the Party in breach does not cure the breach, negate the
assignment, obtain a dismissal of the proceeding, or have the appointment
vacated and regaining its assets within ninety (90) days from the notice date,
then the other Party shall have the right to terminate the license granted
immediately upon the date of mailing of a written notice of termination to the
Party in breach.
11.7 Upon termination of this Agreement for any cause, nothing herein
shall be construed to release either Party of any obligation that has matured
prior to the effective date of such termination. Licensee may, after the date of
such termination, sell all Licensed Products that it may have on hand at the
date of termination, provided that it pays the earned royalty thereon as
provided in this Agreement.
11.8 In the event of termination for breach by Licensee, Licensee
agrees to no longer use any of the Patent Rights under which it has been granted
a license.
11.9 Upon termination of this Agreement for any reason, Licensee shall
assign to Northwestern any and all existing sublicense agreements of any of the
Patent Rights hereunder, provided the financial obligations of each sublicensee
to Northwestern shall be limited to the amounts Licensee shall be obligated to
pay Northwestern for the activities of such sublicensee pursuant to this
Agreement. Northwestern agrees to keep
12
such assigned sublicenses in force to the extent that Northwestern is capable of
performing as Northwestern in place of Licensee. If any sublicense agreement
cannot be assigned to Northwestern, such sublicense agreement shall terminate
immediately, and such sublicensee shall be allowed to sell all Licensed Products
that it may have on hand at the date of termination, provided that it pays the
earned royalty thereon as provided in this Agreement, and Licensee agrees that
such sublicense agreements of the Patent Rights shall provide that upon the
termination of the sublicense agreement the sublicensee's rights to the Patent
Rights shall terminate under such sublicense agreement. Furthermore,
Northwestern agrees that Licensee shall be not held liable for any infringement
of any of the Patent Rights by such sublicensee after termination of the
sublicense agreement where the alleged infringing act(s) took place after
termination of the sublicense agreement.
ARTICLE XII - ASSIGNMENT
This Agreement shall not be assignable by either Party without the
prior written consent of the other, except that any Party may assign this
Agreement to any Affiliate, to a successor in interest (including the surviving
company in any consolidation or merger), or to an assignee of substantially all
the business and assets of such Party, or with respect to Licensee, to an
assignee of all or substantially all of the business to which this Agreement
relates.
ARTICLE XIII - DISPUTE RESOLUTION
13.1 The Parties agree to effect all reasonable efforts to resolve any
and all disputes between them in connection with this Agreement in an amicable
manner.
13.2 The Parties agree that any dispute that arises in connection with
this Agreement and which cannot be amicably resolved by the parties shall be
resolved by binding Alternative Dispute Resolution (ADR) in the manner set forth
in Paragraph 13.3 though Paragraph 13.5.
13.3 If a Party intends to begin ADR to resolve a dispute, such Party
shall provide written notice to the other Party informing the other Party of
such intention and the issues to be resolved. Within ten (10) business days
after its receipt of such notice, the other Party may, by written notice to the
Party initiating ADR, add additional issues to be resolved. If the Parties
cannot agree upon the selection of a neutral person within twenty (20) business
days following receipt of the original ADR notice, a neutral person shall be
selected by the then President of the Center for Public Resources (CPR), 680
Fifth Avenue, New York, New York 10019. The neutral person shall be a single
individual having experience in the biotechnology and/or pharmaceutical industry
who shall preside in resolution of any disputes between the Parties. The neutral
person selected shall not be an employee, director or shareholder of either
Party or an Affiliate or sublicensee.
13.4 Each Party shall have ten (10) business days from the date the
neutral person is selected to object in good faith to the selection of that
person. If either Party makes such an objection, the then President of the CPR
shall, as soon as possible thereafter, select another neutral person under the
same conditions as set forth above. This second selection shall be final.
13
13.5 The ADR shall be conducted in the following manner:
(a) No later than forty-five (45) business days after selection,
the neutral person shall hold a hearing to resolve each of
the issues identified by the Parties.
(b) At least five (5) days prior to the hearing, each Party must
submit to the neutral person and serve on the other Party a
proposed ruling on each issue to be resolved. Such proposed
ruling shall contain no argument on or analysis of the facts
or issues, and shall be limited to not more than fifty (50)
pages.
(c) The neutral person shall not require or permit any discovery
by any means, including depositions, interrogatories or
production of documents.
(d) Each Party shall be entitled to no more than eight (8) hours
of hearing to present testimony or documentary evidence to
the neutral person. The testimony of both Parties shall be
presented during consecutive calendar days. Such time
limitation shall apply to any direct, cross or rebuttal
testimony, but such time limitation shall only be charged
against the Party conducting such direct, cross or rebuttal
testimony. It shall be the responsibility of the neutral
person to determine whether the parties have had the eight
(8) hours to which each is entitled.
(e) Each Party shall have the right to be represented by
counsel. The neutral person shall have the sole discretion
with regard to the admissibility of any evidence.
(f) The neutral person shall rule on each disputed issue within
thirty (30) days following the completion of the testimony
of both Parties. Such ruling shall adopt in its entirety the
proposed ruling of one of the Parties on each disputed
issue.
(g) ADR shall take place in Chicago, Illinois. All costs
incurred for a hearing room shall be shared equally between
the Parties.
(h) The neutral person shall be paid a reasonable fee plus
expenses, which fees and expenses shall be shared equally by
the Parties.
(i) The ruling shall be binding on the Parties and may be
entered as an enforceable judgment by a state or federal
court having jurisdiction of the Parties.
13.6 This section XIII shall survive any termination of this Agreement.
ARTICLE XIV - NOTICES AND PAYMENTS
Any payment, notice or other communication pursuant to this Agreement
shall be sufficiently made or given on the date of mailing if sent to such Party
by certified first class mail, postage prepaid, addressed to it at its address
below or as it shall designate by written notice given to the other Party:
In the case of Northwestern: Executive Director
Technology Transfer Program
Northwestern University
14
1880 Oak Avenue, Suite 100
Evanston, Illinois 60201
In the case of Licensee: Attn: President
GenVec, Inc.
65 West Watkins Mill Road
Gaithersburg, MD 20878-4021
With a copy to Attn: Senior Vice President, Corporate
Development
ARTICLE XV - GENERAL
15.1 FORCE MAJEURE. Neither party shall be liable to the other for its
failure to perform any of its obligations under this Agreement, except for
payment obligations, during any period in which such performance is delayed
because rendered impracticable or impossible due to circumstances beyond its
reasonable control, including without limitation earthquakes, governmental
regulation, fire, flood, labor difficulties, interruption of supply of key raw
materials, civil disorder, and acts of God, provided that the Party experiencing
the delay promptly notifies the other Party of the delay.
15.2 SEVERABILITY. In the event any provision of this Agreement is held
to be invalid or unenforceable, the valid or enforceable portion thereof and the
remaining provisions of this Agreement will remain in full force and effect.
15.3 APPLICABLE LAW. This Agreement is made in accordance with and
shall be governed and construed under the laws of the State of Illinois,
excluding its choice of law rules.
15.4 ENTIRE AGREEMENT. This Agreement and the exhibits attached hereto
constitute the entire, final, complete and exclusive agreement between the
Parties and supersede all previous agreements or representations, written or
oral, with respect to the subject matter of this Agreement. This Agreement may
not be modified or amended except in writing signed by a duly authorized
representative of each party.
15.5 HEADINGS. The headings for each article and section in this
Agreement have been inserted for convenience or reference only and are not
intended to limit or expand on the meaning of the language contained in the
particular article or section.
15.6 INDEPENDENT CONTRACTORS. The Parties are not employees or legal
representatives of the other party for any purpose. Neither Party shall have the
authority to enter into any contracts in the name of or on behalf of the other
Party.
15.7 ADVERTISING. Licensee shall not use the name of the inventors for
Patent Rights, nor the name of Northwestern in any advertising, promotional or
sales literature, without prior written consent obtained from Northwestern in
each case; provided, however, Licensee, at its discretion, may make a mutually
agreed upon press release regarding the Agreement promptly following the
Effective Date of the Agreement. Once a particular press release has been
approved for disclosure by Northwestern, Licensee may make disclosures which do
not differ materially therefrom without any need for further consent by
Northwestern.
15.8 WAIVER. Any waiver (express or implied) by either Party of any
breach of this Agreement shall not constitute a waiver of any other or
subsequent breach.
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15.9 COUNTERPARTS. This Agreement may be executed in counterparts with
the same force and effect as if each of the signatories had executed the same
instrument.
15.10 PATENT MARKING. Licensee agrees to mark the Licensed Products
sold in the United States with all applicable United States patent numbers. All
Licensed Products shipped to or sold in other countries shall be marked in such
a manner as to conform with the patent laws and practice of the country of
manufacture or sale.
IN WITNESS WHEREOF, the Parties have executed this Agreement effective
on the date first set forth above.
LICENSEE NORTHWESTERN
By:________________________ By:_________________________________
Name: Thomas E. Smart Name: Lydia Villa-Komaroff, Ph.D
Title: Sr. Vice President, Title: Vice President for Research
Corporate Development
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EXHIBIT A
*
NATIONAL PHASE FILINGS IN THE FOLLOWING COUNTRIES:
Canada
Japan
Australia
EPO countries designated as follows:
Austria
Belgium
Switzerland/Liechtenstein
Germany
Denmark
Spain
Finland
France
United Kingdom
Greece
Ireland
Italy
Luxembourg
Monaco
Netherlands
Portugal
Sweden
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