EXHIBIT 10.31
Exclusive License Agreement
Between
Thomas Jefferson University
And
Neurologix, Inc.
Effective as of June 1, 2002
Re: DUR1-DSC06, DUR1-DSC07, DUR1-DSC08,
DUR1-DSC09, DUR1-DSC010
In consideration of the mutual promises and
covenants set forth below, the parties hereto agree as
follows:
ARTICLE I
DEFINITIONS
As used in this Agreement, the following terms
shall have the following meanings:
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1.1
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ACADEMIC
RESEARCH PURPOSES: use of PATENT RIGHTS for academic research or
other not-for-profit scholarly purposes which are undertaken at a
non-profit or governmental institution that does not use the PATENT
RIGHTS in the production or manufacture of products for sale or the
performance of services for a fee.
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1.2
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AFFILIATE: any
entity which controls, is controlled by, or is under common control
with a party by ownership or control of at least fifty percent
(50%) of the voting stock or other means by which control over
management of an entity can be made. Unless otherwise specified,
the term LICENSEE includes AFFILIATES.
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1.3
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FIELD: any and
all fields of use.
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1.4
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TJU: Thomas
Jefferson University, a nonprofit Pennsylvania educational
corporation having offices at 1020 Locust Street, M60,
Philadelphia, PA 19107.
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1.5
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LICENSED
PROCESSES: the methods and processes covered by at least one VALID
PATENT CLAIM under the PATENT RIGHTS, or some portion
thereof.
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1.6
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LICENSED
PRODUCTS: products covered by at least one VALID PATENT CLAIM under
the PATENT RIGHTS, or products made or services provided in
accordance with or by means of LICENSED PROCESSES.
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1.7.1
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LICENSEE:
Neurologix, Inc., a corporation organized under the laws of the
State of Delaware, having its principal offices at 271-32E Grand
Central Parkway, Floralpark, NY 11005.
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1.8
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RELATED
TECHNOLOGY: any invention not otherwise falling within the PATENT
RIGHTS, for which a patent application has not been filed as of the
date of this Agreement, that results from research conducted at TJU
under the direction of Dr. Matthew During listed in Appendix A, and
is based upon and builds on an invention described in an
application or patent listed in Appendix A, and that is dominated
(as hereafter defined) by PATENT RIGHTS of an application or patent
listed in Appendix A.
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The term DOMINATED defines a
relationship between a subsequently filed patent application or
patent and a previously filed patent application or patent, wherein
the claim or claims of the prior patent application or patent
encompass the subject matter of at least one claim in the
subsequent patent application or patent such that the practice of
the subsequent patent application or patent (i.e., the dominated
patent) necessarily infringes one or more claims of the prior
patent application or patent (i.e., the dominating
patent).”
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1.9
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NET RESEARCH
AND DEVELOPMENT INCOME: RESEARCH AND DEVELOPMENT INCOME less
LICENSEE’s actual direct and indirect costs for research,
development and/or research development services provided pursuant
to contract with a third party.
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1.10
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NET SALES: the
amount invoiced and received for sales, leases, or other transfers
of LICENSED PRODUCTS, less:
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(a)
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customary
trade, quantity or cash discounts and non-affiliated brokers’
or agents’ commissions actually allowed and taken;
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(b)
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amounts repaid
or credited by reason of rejection or return;
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(c)
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to the extent
separately stated on purchase orders, invoices, or other documents
of sale, taxes levied on and/or other governmental charges made as
to production, sale, transportation, delivery or use and paid by or
on behalf of LICENSEE or sublicensees; and
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(d)
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reasonable
charges for delivery or transportation provided by third parties,
if separately stated.
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NET SALES also includes the fair
market value of any non-cash consideration received by LICENSEE or
sublicensees for the sale, lease, or transfer of LICENSED
PRODUCTS.
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1.11
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RESEARCH AND
DEVELOPMENT INCOME: the total financial consideration received as a
result of the utilization of LICENSED PRODUCTS or LICENSED
PROCESSES by LICENSEE in connection with a contract with a third
party for research and/or development services relating to LICENSED
PRODUCTS or LICENSED PROCESSES.
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1.12
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NON-ROYALTY
SUBLICENSE INCOME: the amount paid to LICENSEE by a third party
(other than an AFFILIATE of LICENSEE) for the granting of a
sublicense under Section 3.1 hereinafter, excluding for which
royalties are paid pursuant to Section 4.2, but including, without
limitation (i) license fees, (ii) milestone payments, (iii) the
fair market value in cash of any non-cash consideration for such
sublicense, (iv) in the event that LICENSEE receives any payment
for equity in connection with such sublicense that included a
premium over the fair market value of
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such equity, the amount of such
premium, and (v) NET RESEARCH AND DEVELOPMENT INCOME.
SUBLICENSE INCOME shall exclude NET
RESEARCH AND DEVELOPMENT INCOME.
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1.13
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PATENT RIGHTS:
The patent applications and patents listed in Appendix A of this
Agreement, or that are thereafter filed and claim an invention
priority date based on such patents or patent applications,
together with the allowed claims of all such applications, patents,
and any divisions, continuations, continuations-in-part, specific
claims of any continuations-in-part of such applications to the
extent the specific claims are directed to subject matter described
in the applications and patents listed in Appendix A in a manner
sufficient to support such specific claims under 35 U.S.C., patents
issuing thereon, reissues and extensions thereof, and any and all
foreign patents and patent applications corresponding thereto, all
to the extent owned or controlled by TJU. Upon proper exercise by
LICENSEE of its rights under Sections 3.2 and 4.4 of this
Agreement, a RELATED TECHNOLOGY shall thereafter be included within
the PATENT RIGHTS.
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1.14
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TERRITORY: the
world.
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1.15
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VALID PATENT
CLAIM: a claim of an issued, unexpired patent that has not been (a)
held invalid or unenforceable by a final decision of a court or
governmental agency of competent jurisdiction, which decision is
unappealable or was not appealed within the time allowed therefore,
or (b) admitted in writing to be invalid or unenforceable by the
holder(s) by reissue, disclaimer or otherwise.
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1.16
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The terms
“Public Law 96-517” and “Public Law 98-620”
include all amendments to those laws.
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1.17
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The terms
“sold” and “sell” include, without
limitation, leases and other transfers and similar transactions
involving consideration.
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ARTICLE II
REPRESENTATIONS
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2.1
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Except as
otherwise disclosed in Appendix A, TJU is owner by assignment from
inventors of their entire right, title and interest in and to the
United States patents and patent applications as listed in Appendix
A, the foreign patents and patent applications corresponding
thereto, and in the inventions described and claimed
therein.
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2.2
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TJU has the
authority to issue licenses under the PATENT RIGHTS, to the extent
owned by TJU.
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2.3
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TJU is
committed to the policy that ideas or creative works produced at
TJU should be used for the greatest possible public benefit, and
believes that every reasonable incentive should be provided for the
prompt introduction of such ideas into public use, all in a manner
consistent with the public interest.
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2.4
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LICENSEE is
prepared and intends to diligently develop the invention and to
bring products to market which are subject to this
Agreement.
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2.5
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LICENSEE is
desirous of obtaining an exclusive license in the TERRITORY in
order to practice the above-referenced inventions covered by the
PATENT RIGHTS in the United States and in foreign countries, and to
manufacture, use and sell in the commercial market the products
made
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in accordance therewith, and TJU is
desirous of granting such a license to LICENSEE in accordance with
the terms of this Agreement.
ARTICLE III
GRANT OF RIGHTS
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3.1
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TJU hereby
grants to LICENSEE and LICENSEE accepts, subject to the terms and
conditions hereof, in the TERRITORY and in the FIELD, an exclusive
commercial right and license under the PATENT RIGHTS to make, have
made, use, offer for sell, sell and import the LICENSED PRODUCTS,
and to practice the LICENSED PROCESSES, for the life of the PATENT
RIGHTS. Such license shall include the right to grant sublicenses.
In the event of sublicensing, LICENSEE shall promptly provide TJU a
copy of such sublicense agreement for review. In order to provide
LICENSEE with commercial exclusivity for so long as the license
under the PATENT RIGHTS remains exclusive, TJU agrees that it will
not grant licenses under the PATENT RIGHTS to others except as
required by TJU’s obligations under Section 3.3(a) or as
permitted in Section 3.3(b).
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3.2
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After the
execution date of this Agreement, if the Office of Technology
Transfer (OTT) at TJU receives an invention disclosure which is a
RELATED TECHNOLOGY, TJU shall promptly notify LICENSEE of such
technology. LICENSEE shall have the option to include such RELATED
TECHNOLOGY into this Agreement by including such in Appendix A and
by paying an additional non-refundable annual license fee of xx
thousand dollars($xx). LICENSEE shall have sixty (60) days to
exercise such option upon receiving written notice from OTT at TJU,
provided TJU is legally able to offer such option and
license.
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3.3
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The grant and
exercise of this exclusive license is subject to the following
conditions:
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(a)
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TJU’s
“Patent Policy” dated December 1, 1997, Public Law
96-517, and Public Law 98-620, and TJU’s obligations under
agreements with other not-for-profit sponsors of research. Any
right granted in this Agreement greater than that permitted under
Public Law 96-517, or Public Law 98-620, shall be subject to
modification as may be required to conform to the provisions of
those statutes.
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(b)
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TJU reserves
the right to make and use, and grant to other not-for-profit
institutions non-exclusive licenses to make and use, solely for
ACADEMIC RESEARCH PURPOSES the subject matter described and claimed
in PATENT RIGHTS.
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(c)
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LICENSEE shall
use diligent efforts to effect introduction of the LICENSED
PRODUCTS into the commercial market as soon as practicable,
consistent with sound and reasonable business practice and
judgment; thereafter, until the expiration of this Agreement,
LICENSEE shall endeavor to keep LICENSED PRODUCTS reasonably
available to the public.
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(d)
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At any time
after six (6) years from the effective date of this Agreement, TJU
may, after providing sixty (60) days advance notice to LICENSEE
with an opportunity to cure, or develop a reasonable plan that is
agreeable to TJU, terminate or render this license non-exclusive
if, in TJU’s reasonable judgment, the Progress Reports or
other information furnished by LICENSEE do not substantially
demonstrate that LICENSEE:
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(i)
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has put the
licensed subject matter into commercial use in the country or
countries hereby licensed, directly or through a sublicense, and is
keeping the licensed subject matter reasonably available to the
public; or
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(ii)
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is engaged in
research, development, manufacturing, marketing or sublicensing
activity appropriate to achieving 3.3(d)(i).
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(f)
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In all
sublicenses granted by LICENSEE hereunder, LICENSEE shall include a
requirement that the sublicensee use its commercially reasonable
efforts to bring the subject matter of the sublicense into
commercial use as quickly as is reasonably practical. LICENSEE
shall further provide in such sublicenses that such sublicenses are
subject and subordinate to the terms and conditions of this
Agreement, except that : (i) the sublicensee may not grant further
sublicenses; and (ii) the rate of royalty on NET SALES paid by the
sublicensee to the LICENSEE need not to be limited to the rate of
royalty set forth herein. Copies of all sublicense agreements shall
be provided promptly to TJU.
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(g)
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TJU understands
and acknowledges that LICENSEE will be spending considerable
resources, both human and financial on the development of the
LICENSED PRODUCTS in an effort to obtain the necessary approvals of
LICENSED PRODUCTS in the Territory. LICENSEE further acknowledges
that it is TJU’s mission to make the LICENSED PRODUCTS
available to the public.
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(h)
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During the
period of exclusivity of this license in the United States,
LICENSEE shall cause any LICENSED PRODUCT produced for sale in the
United States to be manufactured substantially in the United
States.
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3.4
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All rights
reserved to the United States Government and others under Public
Law 96-517, and Public Law 98-620, shall remain and shall in no way
be affected by this Agreement.
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ARTICLE IV
ROYALTIES
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4.1
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LICENSEE shall
pay to TJU a one-time non-refundable license fee in the sum of xxxx
dollars ($xxx) upon execution of this Agreement.
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4.2
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LICENSEE shall
pay to TJU during the term of this Agreement a royalty of x percent
(x%) of NET SALES by LICENSEE and its sublicensees. In the case of
sublicenses, LICENSEE shall pay to TJU a royalty of xx percent (x%)
of NON-ROYALTY SUBLICENSE INCOME.
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4.3
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As
consideration for the rights granted hereunder, LICENSEE shall pay
to TJU during the term of this Agreement the following cash
milestone payments within thirty (30) days of their occurrence
(time of payment is of the essence):
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(i)
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xxxx dollars
($xxx) upon the filing of a New Drug Application
(“NDA”) by LICENSEE;
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(ii)
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xxxx dollars
($xxx) upon the first approval of an NDA relating to the first
LICENSED PRODUCT by the United States Food and Drug Administration
(FDA);
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4.4
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LICENSEE shall
pay TJU an additional annual license fee in the amount of xxx
dollars ($xxx) for each RELATED TECHNOLOGY to be included in this
Agreement.
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4.5
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Notwithstanding
anything herein to the contrary, if any portion of the license
pursuant to this Agreement is converted to a non-exclusive license
and if other non-exclusive licenses in the same field and territory
are granted, the above royalties shall, if necessary, be reduced so
as not to exceed the royalty rate to be paid by any other licensees
in the same field and territory during the term of the
non-exclusive license.
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4.6
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On sales
between LICENSEE and its AFFILIATES or sublicensees for resale, the
royalty shall be paid on the NET SALES of the AFFILIATE or
sublicensee.
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4.7
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No later than
each anniversary of the effective date of this Agreement, LICENSEE
shall pay to TJU the sum of one hundred thousand dollars ($100,000)
as a non-refundable license maintenance royalty and/or advance on
royalties. Such payments may only be credited against running
royalties due for the calendar year in which they are paid, and
Royalty Reports shall reflect such a credit. Such payments shall
not be credited against milestone payments (if any) nor against
royalties due for any subsequent calendar year nor for any other
payments made pursuant to this license.
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ARTICLE V
REPORTING
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5.1
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Twelve (12)
months after signing this Agreement, LICENSEE shall provide to TJU
a written research and development plan under which LICENSEE
intends to bring the subject matter of the licenses granted
hereunder into commercial use. Such plan shall include, as
applicable, sublicensing plans, projections of sales and proposed
marketing efforts.
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5.2
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Commencing in
2003, no later than sixty (60) days after June 30 of each calendar
year, LICENSEE shall provide to TJU a detailed written annual
Progress Report describing progress on research and development,
regulatory approvals, manufacturing, sublicensing, research and
development contracts, marketing and sales during the most recent
twelve (12) month period ending June 30 and plans for the
forthcoming year. If multiple technologies are covered by the
license granted hereunder, the Progress Report shall provide the
information set forth above for each technology. If progress
differs from that anticipated in the plan required under Section
5.1, LICENSEE shall explain the reasons for the difference and
propose a modified research and development plan for TJU’s
review. LICENSEE shall also provide any reasonable additional data
TJU requires to evaluate LICENSEE’s performance.
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5.3
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LICENSEE shall
report to TJU the date of first sale of LICENSED PRODUCTS (or sales
based on performance of LICENSED PROCESSES) in each country within
thirty (30) days of occurrence.
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