Standard Clauses for Clinical Trial Agreements

A. PAYMENT: Checks should be made payable to: MCG Research Institute, Inc. and should be mailed to:

MCG Research Institute, Inc.
PO Box 945552
Atlanta, Georgia, 30394-5552
Attention: Protocol No. __________________

MCGRI’s federal tax identification number is 58-1418202.Sponsor acknowledges that any payments made payable or sent to any individual or entity other than MCGRI, as specified above, shall not be credited towards fulfillment of Sponsor’s obligations under this Agreement.

B. OFFICE OF HUMAN RESEARCH PROTECTION: Sponsor acknowledges and agrees that the Office of Human Research Protection at MCG shall have authority to review Study records, interview Study coordinators and otherwise audit the conduct of the research contemplated by this Agreement.

C. REPORTS, CONFERENCES AND OTHER VISITS: Sponsor agrees that it will notify MCGRI prior to or concurrent with any monitoring or other visit to MCGRI or MCG associated with the study.

D. INSTITUTIONAL REVIEW BOARD: Sponsor acknowledges and agrees that any and all approvals for the involvement of human subjects in the Study, whether required by law or regulation, shall be provided only by MCG’s institutional review board or such other IRB as may be designated in writing by MCGRI.

E. PHARMACY: Sponsor acknowledges and agrees that MCGRI requires that all investigative drugs shall be delivered to the MCG Hospital and Clinics Pharmacy (hereinafter "Pharmacy") and that MCGRI shall have authority to require that any investigational drugs be stored and dispensed by Pharmacy. Such drugs shall be sent or otherwise delivered to:

MCG Hospital and Clinics Pharmacy
1120 Fifteenth Street
BI - 2101
Augusta, Georgia 30912-5600
Attention: Clinical Research Pharmacist.

F. INDEMNIFICATION AND INSURANCE: Sponsor agrees to indemnify and hold harmless MCGRI, the Medical College of Georgia and their and its duly authorized agents, servants and employees from all claims, demands, actions, causes of action and suits of whatever kind or nature and to indemnify MCGRI, the Medical College of Georgia and their and its duly authorized agents, servant and employees from all damages, losses, judgments, costs and fees, including attorneys’ fees, which result from this Study, provided that:

(1) MCGRI, MCG and their and its agents, servants and employees have followed the Protocol described herein and were not negligent in conducting the work under Protocol;  and,

          (2) MCGRI promptly gives Sponsor notice of, and the right to
          defend against, any claim or suit as well as the unconditional
          right to settlement of such suits in the sole discretion of
          Sponsor; and

          (3) MCGRI agrees to cooperate fully with Sponsor in its
          defense of any claim or suit.

G. CONFIDENTIALITY: MCGRI shall use that care which it uses to protect its own confidential information and shall not disclose to any third party any information or data provided by Sponsor to MCGRI in connection with the Study and the Protocol, provided such information or data is marked by Sponsor as confidential or with a similar legend at the time disclosure to MCGRI is made. Such confidentiality obligation shall be observed during the performance of the Study and for a period of three (3) years following the termination or expiration of this Agreement. Confidential information shall be returned to Sponsor to the extent possible upon completion by MCGRI of its obligations under this Agreement or upon demand. The obligation to protect Sponsor’s confidential information shall not apply to information that:

           (1) is already in the possession of, or is independently
           developed by, MCGRI as evidenced by written record; or

           (2) is or becomes publicly available other than through breach
           of MCGRI’s confidentiality obligations; or

           (3) is received by MCGRI from a third party without either
           knowledge of origination in Sponsor or obligation of
           confidence; or

           (4) is released for disclosure by Sponsor with its written
            consent; or

           (5) is required to be disclosed by law, regulation or court
           order, including by not limited to the Georgia Open Record
           Act, provided MCGRI has taken all reasonable efforts to keep
            information confidential to the extent permitted consistent with
            the applicable law.

H. PUBLICATION: Sponsor recognizes that under MCGRI and MCG policies, the results of the Study must be publishable and Sponsor agrees that researchers engaged in the Study shall be permitted to present at symposia, national or regional professional meetings and to publish in journals, theses or dissertations, or otherwise of their own choosing, methods and results of the Study, provided that Sponsor shall have been furnished copies of any proposed publication or presentation at least one month in advance of the submission of such proposed publication or presentation to a journal, editor or other third party. Sponsor shall have thirty (30) days after receipt of said copies to object to such proposed presentation or publication because there is patentable subject matter which needs protection. In the event Sponsor makes such objection, said researcher(s) shall refrain from making such publication or presentation for a maximum of four (4) months from date of receipt of such objection in order for MCGRI to file patent application(s) with the United States Patent and Trademark Office and/or foreign patent office(s) directed to the patentable subject matter contained in the proposed publication or presentation.

I. COMPENSATION FOR INJURIES TO SUBJECTS: Sponsor agrees that it shall compensate Study participants for any all injuries directly related to their participation in the Study.

J. INTELLECTUAL PROPERTY: MCGRI agrees that it has no proprietary rights to or interest in ________________________ (hereinafter "Product"). MCGRI further agrees that Sponsor owns all the rights to the Product. Rights to inventions, improvements and discoveries, whether or not patentable or copyrightable, relating to the Study and made solely by the employees of Sponsor shall belong to Sponsor. Such inventions, improvements and discoveries shall not be subject to the terms of this Agreement.

All rights and title to any and all inventions, improvement and discoveries which are conceived or made by one or more employees, agents or servants of MCGRI in performance of the Study during the Agreement Period (herein "MCGRI Intellectual Property") shall belong to MCGRI, subject to the right of Sponsor to take an exclusive or non-exclusive, royalty-bearing license to MCGRI, as specified herein.

MCGRI hereby grants to Sponsor a royalty-free, non-exclusive license to use MCGRI Intellectual Property within its own organization for any non-commercial purpose. MCGRI further grants to Sponsor an option, at Sponsor’s sole election, for either a (a) non-exclusive, royalty bearing license to use MCGRI Intellectual Property for any purpose except sublicensing, or (b) an exclusive, royalty-bearing license with a right to sublicense. Terms and conditions of such licenses shall be negotiated in good faith and agreed upon by Sponsor and MCGRI.

MCGRI shall notify Sponsor promptly of any MCGRI Intellectual Property. If Sponsor directs or MCGRI determines that a patent application or other intellectual property protection should be undertaken, MCGRI shall promptly prepare, file and prosecute such action in MCGRI’s name. If Sponsor directs MCGRI to file a patent or other intellectual property action, or if Sponsor exercises its rights to license MCGRI Intellectual Property as described above, Sponsor shall bear all costs incurred in connection with such intellectual property protection. Sponsor and MCGRI shall cooperate with each other in seeking protection for MCGRI Intellectual Property. If Sponsor elects not to exercise its option as described above, or decides to discontinue the financial support of any such action, MCGRI shall be free to file or continue at MCGRI’s sole expense.

K.  EARLY TERMINATION:  In the event of early termination of this Agreement, the Sponsor shall pay all costs accrued by MCGRI and the Medical College of Georgia directly related to the conduct of the study as of the date of termination, including non-cancelable obligations, incurred up to the effective date of termination.

L.  AUDIT:  In the event of an FDA or Sponsor-initiated audit, the Sponsor agrees to pay all actual costs incurred by MCGRI and the Medical College of Georgia as a direct result of the audit.

M.  RETENTION OF RECORDS: In the event that the Sponsor requires study documents to be stored beyond 2 years after the sponsor has closed the study, the Sponsor will be responsible for all study document storage fees after that time.  Storage fees should be listed as a line item in the sponsor’s budget, subject to Facilities and Administrative fee and due at study close out.

Copyright 2007
Medical College of Georgia
All rights reserved.

July 20, 2007