CLINICAL STUDY AGREEMENTClinical Trial Agreement |
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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
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