SAMPLE CLINICAL STUDY AGREEMENT

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THIS AGREEMENT is made this day of , 20 , between The University of Texas Health Science Center at San Antonio, whose address is 7703 Floyd Curl Drive, San Antonio, Texas 78284 ("UTHSCSA"), a component of The University of Texas System ("SYSTEM"), and ("SPONSOR"), to conduct a clinical study and evaluation ("STUDY") described in Exhibit I. UTHSCSA and SPONSOR agree as follows:

1.1   UTHSCSA agrees to use its best efforts to conduct the STUDY in accordance with UTHSCSA policy, applicable laws and Protocol Number entitled "<insert name of project>" described in Exhibit I attached hereto and incorporated herein, provided however, that any deviation from said protocol shall receive the prior written approval of SPONSOR. The STUDY will be supervised by Dr. , at UTHSCSA, with assistance from associates and colleagues as required. 1.2   SPONSOR agrees to engage the services of UTHSCSA to conduct the STUDY and further agrees to provide at no cost to UTHSCSA the Clinical Supplies for the conduct of the STUDY.

2.1   In consideration for performance of the STUDY by UTHSCSA, SPONSOR agrees to pay UTHSCSA <insert award amount> ($) for STUDY expenses and other related costs. The amount is payable as follows:

3.1   UTHSCSA shall, to the extent authorized under the Constitution and the laws of the State of Texas, hold SPONSOR harmless from liability resulting from the negligent acts or omissions of UTHSCSA, its agents or employees pertaining to the activities to be carried out pursuant to the obligations of this Agreement; provided, however, that UTHSCSA shall not hold SPONSOR harmless from claims arising out of negligence of SPONSOR, its officers, agents or any person or entity not subject to UTHSCSA supervision or control.

3.2   SPONSOR, under the protocol described in Exhibit I, agrees to indemnify, defend and hold harmless UTHSCSA, SYSTEM, its Regents, officers, agents, and employees from any demands, claims or costs of judgments that may be made or instituted against any of them by reason of personal injury (including death) to any person, or damage to property, which is sustained as a direct result of the performance of the activities to be carried out pursuant to said protocol, including but not limited to the use by SPONSOR of the results of the STUDY.

Notwithstanding the foregoing, SPONSOR shall not have liability for loss or damage resulting from (i) a negligent failure to adhere to the terms of said protocol or any written instructions (including, without limitation, package inserts, where appropriate) relative to the use of any products used in connection with the performance of said protocol, (ii) failure to comply with any applicable FDA or other governmental requirements, or (iii) the negligence of UTHSCSA, its officers, agents or employees.

Both parties agree that upon the receipt of a notice of claim or action arising out of the activities to be carried out pursuant to said protocol, the party receiving the notice shall promptly advise the other party of same. SPONSOR agrees, at its own expense, and subject to the statutory duties of the Texas Attorney General's Office, to provide attorneys to defend against any actions brought or filed against UTHSCSA, its officers, agents and employees within the terms of the indemnity set forth above, whether such claims or actions are rightfully brought or filed, and UTHSCSA agrees to cooperate with SPONSOR in the defense of such claim or action. SPONSOR shall have the right and subject to the statutory duties of the Texas Attorney General's Office to control the defense and disposition (including without limitation, settlement, litigation or appeal) of any such claim.

4.1   This Agreement shall begin and continue in force through unless earlier terminated by either party by giving thirty (30) days advance written notice of termination.

4.2   SPONSOR shall be liable for all reasonable costs and noncancelable commitments incurred by UTHSCSA at the time of termination. SPONSOR agrees to pay UTHSCSA for such costs within thirty (30) days of receipt of an invoice for same. To the extent that amounts paid to UTHSCSA by SPONSOR exceed such reasonable costs and noncancelable commitments, UTHSCSA shall remit such overpayment of SPONSOR within thirty (30) days of the effective date of termination.

4.3   Upon termination of this Agreement, UTHSCSA agrees to return SPONSOR's materials and equipment to SPONSOR.

5.1   UTHSCSA reserves the right to publish results of the STUDY. UTHSCSA will submit the manuscript to SPONSOR for review and comment at least sixty (60) days prior to submission for publication. UTHSCSA shall have the final authority to determine the scope and content of any publications.

5.2   Except as required by applicable laws or government regulation, the parties agree not to release or distribute any materials or information containing the name of the other party or any of its employees without prior written approval by an authorized representative of the non-releasing party, said approval not to be unreasonably withheld.

5.3   Each party agrees to hold in confidence for three (3) years after the termination of this agreement any confidential information identified as proprietary or confidentially obtained from the other party during the course of this STUDY. Nothing herein, however, shall prevent UTHSCSA or any other component of SYSTEM from using any information generated hereunder for ordinary research and educational purposes of a university.

6.1   Title to all inventions and discoveries made by UTHSCSA resulting from the research performed hereunder shall reside in UTHSCSA. Notwithstanding the foregoing, UTHSCSA agrees to grant to SPONSOR an option to negotiate an exclusive, worldwide, royalty-bearing license to make, use or sell under any patent resulting from an invention or discovery conceived and reduced to practice during the term of this agreement and directly resulting form the performance of research hereunder. SPONSOR shall have three (3) months from disclosure of any invention of discovery to notify UTHSCSA of its desires to enter into such a license agreement, and a license agreement shall be negotiated in good faith within a period not to exceed six (6) months from SPONSOR's notifications to UTHSCSA of its desire to enter into a license agreement, or such period of time as the parties shall mutually agree.

6.2   In the event SPONSOR elects to exercise its option as to any invention or discovery, in accordance with the procedures detailed above, it shall be obligated to pay all patent expenses for such invention or discovery. This shall include but not be limited to the cost of any prior activities investigating patentability of said invention or discovery before exercise of the option, such as search and opinion for patentability, that may have been performed by UTHSCSA pursuant to its arrival at a judgment of commercially exploitable status. It is contemplated that, in the majority of instances, SPONSOR will be asked to determine whether it will exercise its option prior to the filing of the first patent application.

7.1   This Agreement constitutes the entire and only agreement between the parties relating to the STUDY, and all prior negotiations, representations, agreements and understandings are hereby superseded. No agreements altering or supplementing the terms hereof, including the Exhibit I, may be made except by means of a written document signed by the duly authorized representatives of each of the parties.

7.2   Any conflicts between the Protocol and this Agreement are controlled by this Agreement.

7.3   This Agreement shall be construed and enforced in accordance with the internal laws of the State of Texas.

7.4   This agreement anticipates educational training and may involve health science postgraduates and other students of the UTHSCSA.

IN WITNESS HEREOF, UTHSCSA AND SPONSOR hereby enter into this Agreement effective as of the date first hereinabove written and execute two (2) original counterparts.

<Sponsor Name>		THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO
By: ________________________		By: ________________________
Title:______________________		Jane A. Youngers Director of Grants Management I have read this agreement and understand my obligations hereunder. By: ________________________ <name> Principal Investigator