Animal Study Agreement
This
CLINICAL
STUDY AGREEMENT
(the
"Agreement") between Universidade Federal de Sao Paulo, hereinafter referred
to
as "University," and Neurologix, Inc., hereinafter referred to as the "Sponsor,"
is entered into as of October 20, 2004 ("Effective Date").
WHEREAS,
the
program contemplated by this Agreement, consisting of an animal study in
accordance with the Protocol titled "Animal Research in Primates affected by
Epilepsy Using Direct Delivery of Neuropeptide Y and Galanin in the Brain"
("Protocol") (a copy of the Protocol is attached hereto as Attachment A), is
of
mutual interest and benefit to the University and to the Sponsor, and will
further the instructional and research objectives of the University in a manner
consistent with its status as a non-profit, tax-exempt, educational
institution,
NOW,
THEREFORE,
the
parties hereto agree as follows:
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1.
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THE
SCOPE OF WORK.
The University agrees to use all reasonable efforts to perform the
animal
study in accordance with the Protocol (the "Study"). The University
represents and warrants that the animals used in the study shall
be
normal, healthy animals that have never been used in any previous
study or
experiment, and have never been intentionally infected with any
disease.
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2.
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PRINCIPAL
INVESTIGATOR.
The Study will be supervised by ▇▇▇▇. ▇▇▇▇ ▇▇▇▇▇▇▇ A. M. ▇▇▇▇▇ (the
"Principal Investigator"). If, for any reason, he is unable to continue
to
serve as Principal Investigator, and a successor acceptable to both
the
University and the Sponsor is not available, this Agreement shall
be
terminated as provided in Article
5.
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3.
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PERIOD
OF PERFORMANCE. The
Study shall be conducted on sixteen (16) marmosets in accordance
with the
Protocol.
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4.
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PAYMENT/REIMBURSEMENT
OF COSTS.
The total cost of the Study shall by US $62,200.00. Payments shall
be made
to the University by the Sponsor in advance in U.S. dollars, net
of taxes
or impost of any kind, on the terms and schedule set forth in Attachment
B.
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5.
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TERMINATION.
Performance under this Agreement may be terminated by the Sponsor
upon
thirty (30) days prior written notice. Performance may be terminated
by
the University if circumstances beyond its reasonable control preclude
continuation of the Study. Upon termination, the University will
be
reimbursed as specified in Article 4 for all costs incurred in the
performance of the Study prior to the termination, and any non-cancelable
commitments incurred in the performance of the Study, such reimbursement
not to exceed the total estimated project costs specified in Article
4.
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6.
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PUBLICATIONS
AND COPYRIGHTS.
The University will be free to publish the results of the Study after
providing the Sponsor with a thirty (30) day period in which to review
each publication to identify patentable subject matter, and to identify
any inadvertent disclosure of the Sponsor's proprietary information.
University will not disclose Sponsor's confidential information without
permission. Sponsor shall not have editorial rights over manuscripts
or
presentations, but may comment on implications of publication timing
for
multiple site studies or request deletion of Sponsor's confidential
or
proprietary information. If necessary to permit the preparation and
filing
of U.S. or other country patent applications, the Principal Investigator
shall agree to an additional review period not to exceed sixty (60)
days.
Any further extension will require subsequent agreement between the
Sponsor and the University.
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The
Sponsor will be given full credit and acknowledgment for the support provided
to
the University in any publication resulting from this research. Title to, and
the right to determine the disposition of, any copyrights, or copyrightable
material, first produced or composed in the performance of this research, shall
remain with the University. The University shall grant to the Sponsor an
irrevocable, royalty-free, perpetual, unrestricted, non-exclusive right to
reproduce, translate, prepare derivative works, distribute, and use all such
research data (including any informational database into which such data is
entered) and copyrighted material for its own purposes, including, but not
limited to, submission to the United States Food and Drug
Administration.
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7.
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A.
INVENTIONS
AND PATENTS.
Should any invention be created during the course of the Study, the
University will disclose each such invention to the Sponsor within
two
months after the inventor discloses it in writing to the University
personnel responsible for patent matters. The disclosure to the Sponsor
shall be in the form of a written report and shall identify the funding
Agreement under which the invention was made and the
inventor(s).
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If,
with
respect to a University Invention (as defined below) the Sponsor requests a
license in a reported invention within 45 days of receipt of the invention
report, the University:
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(a)
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Will
use reasonable efforts to solicit US Patent
protection;
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(b)
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Will
negotiate in good faith a license with reasonable initial payments,
royalties, and minimum royalties;
and
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If
patent
rights in other countries are available, they will be pursued by the University
at the Sponsor's request in those countries designated by Sponsor, provided
that
Sponsor agrees to pay all prosecution costs associated with seeking such foreign
patent protection. In all other events, the University may pursue foreign patent
protection at its sole discretion.
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INTELLECTUAL
PROPERTY.
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2
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(a)
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Title
to Inventions Based On Sponsor Information. To the extent that Sponsor
is
providing confidential information to the University and Principal
Investigator, and to the extent that the Sponsor has authored the
Protocol
to be conducted under this Agreement, and has designed and structured
the
manner in which the work is to be conducted, all inventions and
discoveries, whether or not patentable, made in the performance of
the
Study and that incorporates Sponsor's Study therapy, drug or device,
including new uses (collectively, "Sponsor Inventions"), shall be
solely
and exclusively owned by Sponsor, and University and Principal
Investigator hereby assign all of their right, title and interest
in and
to such Sponsor Inventions to Sponsor. In instances in which the
Sponsor
desires to secure protection on such inventions, the Principal
Investigator will cooperate with the Sponsor, at Sponsor's expense,
for
the purpose of filing and prosecuting patent applications, the cooperation
to include the execution of any and all lawful papers which may be
deemed
necessary or desirable by the Sponsor for the filing and prosecution
of
applications and for assignment of the same to the Sponsor, including
all
declarations, oaths, specifications, and instruments of assignment
for
filing and recordation in the U.S. and foreign Patent
Offices.
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(b)
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Title
to Other Inventions. For inventions other than Sponsor Inventions,
title
to any invention conceived or first reduced to practice in the performance
of the Study ("University Inventions") shall remain with the University.
Sponsor shall be notified of any such invention promptly after a
disclosure is received by the University Technology Licensing Office.
The
University (1) may file a patent application at the request of the
Sponsor
and at the Sponsor's expense; or (2) may file a patent application
at its
own discretion.
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(c)
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Licensing
Options. The University hereby grants to Sponsor the exclusive right
and
option to negotiate with the University for an exclusive, worldwide,
right
and license to make, have made, use and sell commercial products
embodying
any University Invention(s), with the right to sublicense, for the
lives
of any patent issuing thereon, upon commercially reasonable terms.
The
Sponsor and the University shall exercise reasonable efforts to agree
to
terms and conditions of such a license within sixty (60) days after
Sponsor's receipt of notice and disclosure of a University Invention
from
the University. If, after the end of the sixty (60) day period (or
such
additional period if agreed by both parties), Sponsor and the University
are unable to reach agreement on the terms of such a license, the
University shall thereafter be free to engage in license discussions
and
negotiations with third parties regarding such University
Invention(s).
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(d)
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Confidentiality
of Invention Disclosures. The Sponsor shall retain all invention
disclosures submitted to Sponsor by the University in confidence
and use
all reasonable efforts to prevent their disclosure to third
parties.
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(e)
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The
Sponsor shall be relieved of this obligation when this information
becomes
publicly available through no fault of the
Sponsor.
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8.
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PROPRIETARY
DATA.
The University's acceptance and use of any proprietary data which
may be
supplied by the Sponsor in the course of this research project shall
be
subject to the following:
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(a)
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The
data must be marked or designated in writing as proprietary to the
Sponsor.
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(b)
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The
University agrees to exercise its best efforts not to publish or
otherwise
reveal the data to others outside the University without the permission
of
the Sponsor, unless the data has already been published or disclosed
publicly by third parties or is required to be disclosed by order
of a
court of law.
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(c)
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The
University shall hold proprietary information in confidence for a
period
not to exceed five (5) years from the termination date of this
Agreement.
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9.
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USE
OF NAMES. Neither
party will use the name of the other in any advertising or other
form of
publicity without the written permission of the
other.
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10.
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REPORTS.
University
shall provide Sponsor with interim informal reports on the progress
of the
Study as reasonably requested by Sponsor. A final report of the progress
of the work shall be made to the Sponsor by the Principal Investigator
within three months of completion of the
Study.
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11.
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CHANGES.
The Sponsor or the University may, at any time, in writing to each
other,
suggest and by mutual written agreement make changes within the general
scope of the work, including but not limited
to:
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(a)
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revising
or adding to the work or deleting portions
thereof,
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(b)
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revising
the period or schedule of performance,
or
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(c)
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increasing
or decreasing the total cost.
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Upon
receipt of such notice of change and their mutual written agreement thereto,
the
parties shall immediately use their best efforts to take all necessary steps
to
comply therewith.
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12.
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NOTICES.
All
communications, reports, and notices required or permitted hereunder
shall
be deemed sufficiently given if in writing and personally delivered
or
sent by registered mail, postage prepaid, return receipt requested,
addressed to the parties as follows or at such other address as a
party
shall have given notice of pursuant
hereto:
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If
to the University:
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Prof.
▇▇. ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
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Universidade
Federal de Sao ▇▇▇▇▇
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▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇
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▇▇▇▇▇-▇▇▇,
▇▇▇ ▇▇▇▇▇, ▇▇
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▇▇▇▇▇▇
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Telephone:
55 11 - ▇▇▇▇ ▇▇▇▇
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Facsimile:
55 11 - 5576 4279
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If
to the sponsor:
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Neurologix,
Inc.
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▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇
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▇▇▇▇
▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
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Attention:
▇▇. ▇▇▇▇ ▇. ▇▇▇▇▇▇▇
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Fax
Number: ▇▇▇-▇▇▇-▇▇▇▇
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With
a copy to:
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Neurologix,
Inc.
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▇▇▇-▇▇
▇. ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
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▇▇▇▇▇▇
▇▇▇▇, ▇▇ ▇▇▇▇▇
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Attention:
President
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Fax
Number: (▇▇▇) ▇▇▇-▇▇▇▇
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13.
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LAWS
AND REGULATIONS.
This Agreement shall be governed by, and construed and enforced in
accordance with, the Laws of the State of New York. The Sponsor shall
cooperate with the University in complying with any applicable Federal,
state and local laws, regulations and policies governing research.
University represents that neither University nor any person University
employs in performance of the Study is debarred under section 306
of the
United States Federal Food, Drug and Cosmetics
Act.
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14.
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ASSIGNMENT.
This
Agreement may not be assigned by either party without the prior written
consent of the other party. Notwithstanding the foregoing, the Sponsor
may
assign this Agreement without the consent of the University to a
purchaser
or successor-in-interest in the event of a merger, consolidation,
or sale
of substantially all of Sponsor's stock or assets or business and/or
pursuant to any reorganization qualifying under section 368 of the
Internal Revenue Code of 1986 as amended, as may be in effect at
such
time, provided that such successor-in-interest or purchaser agrees
to
assume all of Sponsor's obligations under this
Agreement.
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15.
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ORDER
OF PRECEDENCE.
The parties hereby agree, that in the event of a conflict between
the
terms and conditions of this Agreement, and any other document either
incorporated by reference or attached to this Agreement, the terms
and
conditions of this Agreement itself shall
prevail.
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16.
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ENTIRE
AGREEMENT.
This Agreement, including all Exhibits referenced herein, shall be
the
complete Agreement of the parties hereto and shall supersede all
prior
agreements and understandings, oral or written, between the parties
respecting the subject matter
hereof.
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The
respective parties have executed this Agreement on the dates indicated
below.
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UNIVERSIDADE
FEDERAL DE SAO PAULO
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NEUROLOGIX,
INC.
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/s/
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇
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/s/
▇▇▇▇ ▇. ▇▇▇▇▇▇▇
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▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇
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▇▇▇▇
▇. ▇▇▇▇▇▇▇
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▇▇▇▇▇▇,
Universidade Federal de Sao Paolo
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Secretary
and Treasurer
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October
20, 2004
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Oct.
27, 2004
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Date
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Date
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I
agree to act as Principal Investigator for the project described
above:
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/s/
▇▇▇▇. ▇▇▇▇ ▇▇▇▇▇▇▇ A. M. ▇▇▇▇▇
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▇▇▇▇.
▇▇▇▇ ▇▇▇▇▇▇▇ A. M. ▇▇▇▇▇
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October
20, 2004
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Date
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