Clinical Research Study Agreement - 范本

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CLINICAL RESEARCH STUDY AGREEMENT

This Agreement is entered into as of the 30th day of January, 1996, by and between Novoste Corporation, located at 4350-C INTERNATIONAL BLVD., Norcross, Georgia 30093 (hereinafter referred to as "Novoste") and Emory University at 1784 North Decatur Road, Suite 510, Atlanta, GA 30322 (hereinafter referred to as "University").

WITNESSETH THAT:

The University agrees to conduct a clinical research study (the "STUDY") entitled "Beta Energy Restenosis Trial" according to the protocol attached as Exhibit A. In this undertaking, the University agrees to devote reasonable efforts in order to perform efficiently the work required under this Agreement. The University agrees that it will comply with all applicable laws, rules and regulations relating to the conduct of such STUDY, particularly such laws, rules and regulations concerning or promulgated by the Food and Drug Administration. To the extent any portions of Exhibit A are inconsistent with this Agreement, the terms of this Agreement shall govern.

NOW THEREFORE, in consideration of the foregoing and the mutual covenants herein below set forth, the parties hereto agree as follows:

(1) PRINCIPAL INVESTIGATOR.

The STUDY performed under this Agreement will be under the direction of Spencer B. King III, M. D. (hereinafter referred to as "INVESTIGATOR"). All University employees involved in the clinical research study (hereinafter referred to as INVESTIGATORs).

(2) HUMAN SUBJECTS.

This protocol has been approved by the University's Institutional Review Board (Exhibit B) and NOVOSTE. The University shall obtain from each of the patients participating in this STUDY, advance informed consent in compliance with 21 CFR 50.1 through 50.27 and any modifications thereof as may be adopted. Novoste will reimburse the University and/or the patient for reasonable costs and expenses incurred in diagnosing and treating unanticipated adverse effects, injuries, illnesses, or reactions that result from the use or application of Novoste's investigations, drugs or devices in the course of this STUDY.

(3) INDEMNIFICATION.

An "Indemnification Agreement for Clinical STUDY" is attached as Exhibit C and is incorporated for reference.

(4) UNIVERSITY AND NOVOSTE CONTACTS.

The University's scientific contact for this Agreement will be Dr. King at (404)712-4467. The University's administrative contact for this Agreement will be Nancy Wilkinson, at (404) 727-2503. Novoste's scientific contact will be Dr. Joan Macdonald, at (770) 717-0904. Novoste's administrative contact will be Dr. Jonathan Rosenat (770) 717-0904.

(5) PERIOD OF PERFORMANCE.

The term of this Agreement shall be from the date this Agreement is mutually executed until the STUDY is either completed or terminated. It is anticipated that the STUDY will begin on or about January 22, 1996 and be completed on or about December 31, 1996.

(6) PAYMENT SCHEDULE.

(A) Payments shall be made payable to EMORY UNIVERSITY and forwarded to the following address:

Ms. Marilyn Surbey
Assistant Vice President for Finance
Office of Grants and Contracts Accounting
Emory University
1784 N. Decatur Road
Suite 530
Atlanta, GA 30322
(404) 727-4240

It is agreed that Novoste will reimburse the University on a per patient basis and for the total amount of the study not to exceed one hundred ninety-five thousand nine hundred forty-five dollars ($195,945) in accordance with the approved budget and payment schedule attached as Exhibit D. Novoste acknowledges that the University has included its indirect costs for this clinical STUDY. For purposes of identification, payments will include the title of the STUDY and the name of the INVESTIGATOR.

 

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发布于 2021-11-30 17:36:58
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