EXHIBIT 10.35
Cornell University for its
Medical College
Research and Sponsored
Programs
1300 York Avenue
New York, N.Y.
10021
Clinical Study
Agreement
This CLINICAL STUDY AGREEMENT (the
“Agreement”) between Cornell University for its Medical
College, hereinafter referred to as “the Medical
College,” and Neurologix, Inc., hereinafter referred to as
the “Sponsor,” is entered into as of July 2, 2003
(“Effective Date”).
WHEREAS, the program contemplated by this Agreement,
consisting of a clinical study in accordance with the Protocol
titled “Clinical Research in Patients affected by
Parkinson’s Disease Using Direct Delivery of the GAD genes in
the Brain” (“Protocol”) (a copy of the Protocol
is attached hereto as Attachment A), is of mutual interest and
benefit to the Medical College and to the Sponsor, and will further
the instructional and research objectives of the Medical College 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 Medical College
agrees to use all reasonable efforts to perform the clinical study
in accordance with the Protocol (the
“Study”).
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2.
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PRINCIPAL
INVESTIGATOR. The Study
will be supervised by Dr. Michael G. Kaplitt (the “Principal
Investigator”). If, for any reason, s(he) is unable to
continue to serve as Principal Investigator, and a successor
acceptable to both the Medical College 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 twelve patients in accordance with the
Protocol.
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4.
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PAYMENT/REIMBURSEMENT OF COSTS.
Payments shall be made to the
Medical College 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 Medical College if
circumstances beyond its reasonable control preclude continuation
of the Study. Upon termination, the Medical College 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
Medical College 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. Medical College will not disclose
Sponsor’s confidential information without permission.
Sponsor shall not have editorial rights over manuscripts
or
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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. patent applications, the Principal Investigator may agree to
an additional review period not to exceed sixty (60) days. Any
further extension will require subsequent agreement between the
Sponsor and the Medical College.
The Sponsor will be given full
credit and acknowledgment for the support provided to the Medical
College in any publication resulting from this research. Medical
College will retain ownership of its copies of all completed case
report forms. 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
Medical College. The Medical College shall grant to the Sponsor an
irrevocable, royalty-free, perpetual, non-exclusive right to
reproduce, translate, and use all such research data (including any
informational database into which such data is entered) and
copyrighted material (excluding computer software and its
documentation and/or informational databases other than those
containing research data) 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. The Medical College will disclose each subject
invention to the Sponsor within two months after the inventor
discloses it in writing to the Medical College 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 Medical
College Invention (as defined below) the Sponsor requests a license
in a reported invention within 45 days of receipt of the invention
report, the Medical College:
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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 foreign patent rights are
available, they will be pursued and licensed at the Medical
College’s sole discretion, but shall be the subject of any
exclusive license negotiation.
B. INTELLECTUAL
PROPERTY.
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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 Medical College 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 Medical College 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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