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Clincal Trials Office (CTO)

The following information may be helpful in expediting the CONTRACT approval process at Texas Tech University Health Sciences Center.

The CTO has found that the following items are common issues as they apply to TTUHSC Agreements pertaining to Confidentiality, Clinical Trials, and Industry Sponsored Research.

PARTIES TO THE AGREEMENT

The Agreement must identify the parties to the agreement as the Sponsor and Texas Tech University Health Sciences Center (TTUHSC). It is not acceptable to have the physician/PI listed as a party to the Agreement, since that person is an employee of TTUHSC.

TTUHSC will designate an employee/physician as Principal Investigator for the Research. TTUHSC, rather than the Principal Investigator, should be identified throughout the contract as the responsible party, except where the obligation lies clearly with the Principal Investigator as the TTUHSC employee carrying out those duties (e.g. Principal Investigator duties listed on FDA Form 1572).

The Principal Investigator does not have authority to sign for TTUHSC on any document that binds the TTUHSC, including Confidentiality Agreements.

The person authorized to sign Clinical Research Agreements for TTUHSC is:

Barbara C. Pence, PhD

Associate Vice-President for Research

The Principal Investigator may sign under a separate signature block entitled: "READ AND UNDERSTOOD".

The Institution requires an original of all documents, so two originals should be sent for signature if an original is required by the sponsor.

INTELLECTUAL PROPERTY

TTUHSC makes a distinction between a Clinical Trial Agreement and a Sponsored Research Agreement.

A Clinical Trial Agreement involves a protocol provided by the Sponsor that must be firmly adhered to by TTUHSC and the Principal Investigator. Under this circumstance, TTUHSC would be providing no intellectual contribution, and would not disagree with the Sponsor retaining ownership of any inventions.

Conversely, a Sponsored Research Agreement is formed when TTUHSC personnel have proposed and designed research that the Sponsor agrees to fund. When the Agreement requires independent action by the investigator, the standard sponsored research agreement intellectual property rules apply.

PUBLICATION

TTUHSC must retain a right to be involved with the publication of the study results.

For Clinical Trial Agreements, it is understood that the Sponsor would desire to control publication of multi-center trial results through the completion of the study and review of the data. TTUHSC will, however, retain the right to publish the data if the Sponsor does not do so within a reasonable time after the study ends.

For Sponsored Research Agreements, TTUHSC and the Principal Investigator retain full publication rights. Reasonable notice will be given to the Sponsor prior to the publication of study results for review of the manuscript for accuracy and to allow for any patent/filings.

CONFIDENTIALITY

As a state institution of higher education, TTUHSC is subject to the Texas Public Information Act. All confidentiality provisions will have the stipulation "except as may be required by law". Commercial information may be excepted upon a showing of substantial competitive harm. If a request for proprietary information is received, TTUHSC must provide notice to the owner.

TEXAS TORT CLAIMS ACT

TTUHSC is a State of Texas public institution of higher education and is responsible for the conduct of its employees and property as provided under the Texas Tort Claims Act, Chapter 101; $250,000 per person and $500,000 in the aggregate per occurrence.

SELF-INSURANCE

TTUHSC physicians are covered by the Texas Tech University Health Sciences Center School of Medicine Professional Medical Malpractice Self-Insurance Plan with limits of $400,000 per claim and $1,200,000 in the aggregate.

INDEMNIFICATION

For any Clinical Trial Agreement, including Phase IV trials, TTUHSC requires that the Sponsor:

Indemnify and hold harmless The Institution, the Texas Tech University regents, officers, agents and employees and IRB members from any liability, loss, damage, costs and expenses of claims and suits (including the costs and expenses of handling such claims and defending such suits) resulting from judgments or claims against them arising out of the activities to be carried out pursuant to the obligations of this Agreement, including but not limited to the use by Sponsor of the results of the Study.

If the Clinical Trial Agreement is between TTUHSC and a Clinical Research Organization, the Sponsor must provide a letter agreeing to indemnify TTUHSC per the above. This indemnification letter will be attached to the contract and will be incorporated by reference.

Texas Tech University Health Sciences Center, as an institution of the State of Texas, must be represented by the Texas Attorney General in any litigation; however, Texas Tech University Health Sciences Center shall fully cooperate, insofar as allowed by the laws and constitution of the State of Texas in the investigation and defense of any such claims.

A physician named in professional liability litigation shall be represented by the TTUHSC School of Medicine Self-Insurance Plan, who will cooperate in the investigation and defense of such claims.

Under the Texas State Constitution, TTUHSC as a state entity is prohibited from indemnifying another party. It would effectively create a debt of the state for which TTUHSC has no authority, as stated in Texas Attorney General opinions.

CHOICE OF LAW

TTUHSC, as a State Institution, cannot agree to laws or venue other than that of the State of Texas.

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