EXHIBIT 10.36
CLINICAL STUDY
AGREEMENT
This Agreement, is made by and
between NEUROLOGIX, INC., hereinafter referred to as
“SPONSOR,” with its principal office located at 271-32
E. Grand Central Parkway, Floral Park, NY 11005, and NORTH SHORE
UNIVERSITY HOSPITAL a not-for-profit corporation organized and
existing under the laws of the State of New York, with its
principal office located at 300 Community Drive, Manhasset, NY
11030, hereinafter referred to as “INSTITUTION,” as of
this day of July, 2003
(“Effective Date”).
WHEREAS, the clinical study
contemplated by this Agreement (“the Study”) is of
mutual interest and benefit to the INSTITUTION and to the SPONSOR,
and will further the Institution’s instructional and research
objectives in a manner consistent with its status as a non-profit,
tax-exempt educational INSTITUTION;
WHEREAS, the protocol for the Study
titled “Clinical Research in Patients affected by
Parkinson’s Disease Using Direct Delivery of the GAD genes in
the Brain” (“Protocol”) that will guide the
performance of this Agreement, has been reviewed and accepted by
the INSTITUTION and the INSTITUTION warrants it is fully able to
perform the Study in a professional and competent
manner;
NOW, THEREFORE, the parties agree as
follows:
1. Scope of Research
INSTITUTION agrees to use its best efforts to
conduct and carry out the Study in accordance with the Protocol,
which is attached hereto as Appendix A and made an integral part of
this agreement. Any change in Appendix A must be agreed to and
approved in writing by SPONSOR and INSTITUTION.
2. Term of Agreement
This Agreement shall begin on the Effective Date
and shall extend until the Study is concluded as to the twelve
patients, unless the period is extended by a written modification
of the Agreement, signed by both parties.
3. Principal Investigators
INSTITUTION’S Principal Investigator is
David Eidelberg, M.D. (“INVESTIGATOR”), who will be
responsible for the direction of the Study in accordance with
applicable INSTITUTION policies, which INSTITUTION warrants and
represents are not inconsistent with the terms of this Agreement,
the Protocol, and generally accepted standards of good clinical
practice and with all applicable local, State and federal laws and
regulations governing the performance of clinical investigations.
If for any reason, either or both of the INVESTIGATOR are unwilling
or unable to continue to serve as INVESTIGATOR and a successor or
successors, acceptable to both the INSTITUTION and the SPONSOR,
is/are not available, this Agreement may be terminated as provided
in Article 6.
4. Scope of Work
INSTITUTION shall provide all the necessary
qualified personnel, materials and facilities necessary to
accomplish the research tasks required by the Protocol as set forth
in Appendix A. INSTITUTION and INVESTIGATOR agree to use their best
efforts and professional expertise to perform the study in
accordance with the Protocol; generally accepted standards of good
clinical practice; and all applicable laws, rules and regulations
relating to the conduct of the study.
5. Terms of
Payment
SPONSOR will pay INSTITUTION $28,625.00 per
satisfactorily completed patient, up to a maximum of $343,500.00
for the completion of all patients, and an up-front one time fee of
$3,000.00 to cover all expenses associated with regulatory
processing, Institutional Review Board review, and video camera and
supplies. Payments shall be made in accordance with the terms set
forth in Appendix B attached hereto.
6. Termination
Performance under this Agreement may be
terminated by the SPONSOR upon thirty (30) days prior written
notice. Performance may be terminated by the INSTITUTION if
circumstances beyond its reasonable control preclude continuation
of the Study. The INSTITUTION shall take all reasonable efforts to
minimize further costs upon such notice. In the event of
termination, INSTITUTION shall be paid amounts due, as of the
effective date of termination. SPONSOR’s sole obligation
shall be to pay INSTITUTION a pro-rated amount for actual work
performed pursuant to the study and all non-cancelable obligations
undertaken with prior approval of Sponsor.
7. Publications
INSTITUTION shall have the right, consistent
with academic standards, to publish or present the results of its
work pursuant to the Study, provided such publication does not
constitute a violation of Article 8 (Confidentiality). Where this
Study is part of a multicenter study, INSTITUTION will allow a
reasonable time for the initial major publication based on the
results obtained from all study sites. Subsequent to the
multicenter publication or twenty-four (24) months after completion
of the Study, whichever occurs first, INSTITUTION may publish the
results of the study, with due regard to Article (8). In either
case, INSTITUTION will submit a copy of the manuscript to SPONSOR
for review and comment thirty (30) days prior to its submission for
publication, to permit SPONSOR to identify patentable subject
matter, and to identify any inadvertent disclosure of the
SPONSOR’s proprietary information. INSTITUTION will not
disclose SPONSOR’s Confidential Information without
permission. SPONSOR will be given full credit and acknowledgment
for the support provided to the INSTITUTION in any publication
resulting from this Study. SPONSOR shall have an irrevocable,
royalty-free, perpetual, right to reproduce, translate, and use all
research data (including any informational database into which such
data is entered) for its own purposes, including, but not limited
to, submission to the United States Food and Drug
Administration.
8. Confidential
Information
In furtherance of the conduct of the Study, it
may be necessary or desirable for the parties hereto to disclose
proprietary, trade secret and/or other confidential information
(hereinafter “Confidential Information”) to one another
or to the INVESTIGATOR or their staff. All such Confidential
information
shall remain the property of the party
disclosing same. The INVESTIGATOR and each party hereto agrees that
any such Confidential Information disclosed to him or her, or to it
or its employees, agents and contractors, shall be used only in
connection with the legitimate purposes of this Agreement, shall be
disclosed only to those who have a need to know it and are
obligated to keep same in confidence, and shall be safeguarded with
reasonable care, provided that the disclosing party has marked the
Confidential Information as such at the time of disclosure (or, if
disclosed verbally, is reduced to writing and so marked within 30
days of disclosure).
The foregoing confidentiality Obligation shall
not apply when, after and to the extent the Confidential
lnformation disclosed
|
|
a)
|
is now, or
hereafter becomes, generally available to the public thr
|