CLINICAL RESEARCH STUDY AGREEMENT
This Agreement is entered into as of the 22 day of July, 1993, by and between Emory University, located at 1462 Clifton Road, NE, Room 302, Atlanta, GA 30322 (hereinafter referred to as "UNIVERSITY"), and SpectRx, Inc., a Delaware corporation, located at 6040C Unity Drive, Norcross, GA 30071 (hereinafter referred to as "COMPANY").
The COMPANY has ongoing research in the area of using the fluorescence of lens proteins and other tissues for the non-invasive diagnosis of disease. This research has led to the issuance of U.S. Patent No. 5,203,328. The COMPANY has one other patent application on file with two others in preparation for filing.
The COMPANY wishes to obtain from the UNIVERSITY an option to obtain certain rights to inventions or discoveries that are developed solely by the UNIVERSITY during the course of research funded by the COMPANY hereunder.
The COMPANY wishes to verify its hypothesis that certain fluorescence signals are related to the glycosolation of lens proteins, advanced glycosolation end products, screening for diabetes and measurement of Glycosolated Hemogolobins. The COMPANY believes the UNIVERSITY to be capable of contributing to the verification this hypotheses by the application of these techniques to human patients according to the clinical study protocol provided by the COMPANY.
WITNESSETH THAT:
The UNIVERSITY agrees to conduct a clinical research study entitled "Clinical Evaluation of a Non-Invasive Lens Measurement System for Detecting and Monitoring Diabetes Mellitus" according to the protocol attached as Exhibit A. In this undertaking, the UNIVERSITY agrees to devote its best 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. The COMPANY will provide a prototype Lens Measurement System for the use in the study. The SpectRx Lens Measurement System is not yet approved by the U.S. Food and Drug Administration. To the extent any portions of Exhibit A are inconsistent with this Agreement, the terms of this Agreement shall govern.
1. Principal Investigator
The study performed under this Agreement will be under the direction of
Dr. Dan Gallina (hereinafter "INVESTIGATOR").
2. Human Subjects
This protocol has been approved by the UNIVERSITY's Institutional
Review Board (Exhibit B) and the COMPANY. The UNIVERSITY shall obtain
from each of the patients participating in this study, advanced
informed consent in compliance with 21 CFR 50.20 through 50.27 and any
modifications thereof as may be adopted. COMPANY will reimburse
UNIVERSITY and/or the patient for the reasonable costs and expenses
incurred in diagnosing and treating unanticipated adverse effects,
injuries, illnesses, or reactions that result from the use or
application of COMPANY's investigational drug or device in the course
of this study.
3. Indemnification
The "Indemnification Agreement for Clinical Study" is attached as
Exhibit C and is incorporated by reference.
4. UNIVERSITY and COMPANY Contacts
The UNIVERSITY's scientific contact for this Agreement will be Dr. Dan
Gallina at (404) 242-8723. The UNIVERSITY's administrative contact for
this Agreement will be Ms. Nancy Wilkerson at (404) 727-2503. The
COMPANY's scientific contact will be Mr. Jonathan Eppstein at (404)
242-8723. The COMPANY's administrative contact for the Agreement will
be Mr. Mark A. Samuels at (404) 242-8723.
5. Period of Performance
The term of this Agreement shall be from the date of this Agreement is
accepted until the study is either completed or terminated. It is
anticipated that the study will begin on July 19, 1993 and be completed
by March 1994.
6. Payment Schedule
A. Payments shall be made payable to EMORY UNIVERSITY and
forwarded to the following address:
Mr. William J. Mulcahy
Assistant Vice President for Finance
Office of Grants and Contracts Accounting
313 Administration Building
1380 South Oxford Road
Atlanta, GA 30322
(404) 727-4240
It is agreed that the COMPANY will reimburse the UNIVERSITY
for an amount not to exceed $99,960.00 in accordance with the
approved budget and payment schedule
attached as Exhibit D. COMPANY acknowledges that the
UNIVERSITY has included its indirect costs for this clinical
study. For purposes of identification, payments will include
the title of the project and the name of the INVESTIGATOR.
B. In the event of termination, the sum for professional services
and expenses payable under this Agreement shall be limited to
the pro-rated fees based on actual work performed and actual
expenses committed pursuant to the protocol. Any unexpended
funds not due under this calculation but already paid shall be
returned to the COMPANY.
7. Independent Contractor
Each party to this Agreement shall act as an independent contractor and
shall not be construed for any purpose as the agent, employee, servant
or representative of the other party, and neither party shall enter
into any contract or agreement with a third party which purports to
obligate or bind the other party.
8. Publications
The UNIVERSITY shall have publication privileges in reference to ...
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