Louisiana State University Medical Center
Sponsored Projects Manual
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CLINICAL STUDIES

| Introduction | Steps for Preparation | Clinical Research Agreement |

The LSUHSC requires formal contracts/agreements between pharmaceutical and other industrial companies and the LSU Health Sciences Center. These contracts/agreements must contain the scope of work, standard clauses and a budget. They are processed via an LSUHSC Checklist in the same manner as other sponsored projects. Two originals are required!

Before negotiating with a pharmaceutical company, it is important that the PI obtain a copy of a sample contract/agreement containing clauses as required by the State of Louisiana and the LSUHSC (see page 6.3). IF THE COMPANY PLANS TO INITIATE THE CONTRACT/AGREEMENT, THE LSUHSC SAMPLE SHOULD BE SENT TO THEM IN ORDER TO INCORPORATE LSUHSC REQUIREMENTS INTO THE CONTRACT LANGUAGE.

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Steps for Preparation:

1. Institutional Review Board approval is required if the study involves human subjects. Note that IRB approval takes approximately 6 weeks and must be secured BEFORE the study is initiated. Forms and instructions are available through the IRB Office at 568-4060. An executed Clinical Research Agreement/Contract MUST be in place before enrolling any research subjects. This process is requisite. If not followed, untimely delays will result in initiating your study.
2. If the company initiates the contract/agreement, review the document to make certain LSUHSC required clauses are complete. If LSUHSC initiates the contract/agreement, use sample in this section. Complete the Agreement, including budget page. Indirect costs are assessed on all sponsored projects, so be sure to request the appropriate percentage MTDC (See Chapter 11)
3. Obtain GGP PROPOSAL CHECKLIST - available in the Office for Research or GGP (568-4802) and complete in its entirety. Obtain signatures through routing process as indicated on Checklist.
4. If the pharmaceutical company has issued the check in the interim, attach the check to the contract/agreement with the Proposal Checklist and route through the Business Manager of your Department, the Head of Department, the Office for Research and finally, to the Office for Grants and Governmental Programs located at: 433 Bolivar Street, Resource Center, Room 206, New Orleans, LA 70112.
5. After all parties sign the contract/agreement, an account will be established for your project.

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THIS SAMPLE IS PROVIDED AS A MODEL AGREEMENT AND SHOULD BE PROVIDED TO THE COMPANY.

CLINICAL RESEARCH AGREEMENT

This Clinical Research Agreement entered into this _______ day of ______________________ by and between the Board of Supervisors, Louisiana State University and A&M College, herein represented by Louisiana State University Health Sciences Center (hereinafter "University") and _______________________________ (hereinafter "Company") to conduct a study entitled:
__________________________________________________________

is subject to the following terms and conditions:

2. Funded Amount

Company will pay to conduct this study, the amount of $_________. Fifty (50%) of personnel costs shall be paid by Company to University upon execution of this Agreement plus 25% of the remaining budget. The balance of these funds will be paid in the following manner: (Complete as necessary)

It is expected that these funds will be expended in accordance with the budget attached, however, University will have the discretion to rebudget between categories to reflect actual expenditures.

3. Reporting Requirements - (Complete as necessary)

This Agreement shall begin on _________________ and shall not extend beyond the estimated completion date of _______________, unless further extended by amendment of this Agreement, which amendment shall be in writing and signed by all parties to this Agreement.

The University shall have publication privileges in reference to the subject study. Company shall have the right to review and approve such publication with respect to disclosure of confidential material prior to submission for publication. Such approval will not be unreasonably withheld, and will be provided within 30 calendar days from the date of submission to the Company. In the event Company does not respond to the submission within such time, approval will be deemed to have been given. The University shall furnish all data resulting from this study to the Company.

The parties shall retain title to any patent or other intellectual property rights and inventions made by their respective employers in the course of the study. In the event the University is an inventor, Company shall have a first right to negotiate for a exclusive world-wide royalty-bearing license to all rights in the invention. The University shall promptly notify Company of any such invention and shall assist Company in gaining patent protection for the invention. Company shall reimburse the University for all reasonable expenses incurred thereby. If Company commercializes the invention, Company shall pay University a reasonable royalty rate based on the relative contribution to the invention and the commercial value of the invention. If Company and University fail to finalize a license agreement in 180 days, the University is free to negotiate with any other entity without obligation to the Company.

Company agrees to indemnify and hold harmless the Principal Investigator, Louisiana State University Health Sciences Center, its Board of Supervisors, officers, faculty, employees and students (hereinafter "University") from any liability, loss or damage they may suffer as the result of claims, demands, costs or judgements against them arising out of activities to be carried out pursuant to this research agreement, provided, however, that any such liability, loss or damage resulting from: (1) material failure by the University to adhere to the terms of the Protocol or Company's written instructions relative to the use of the investigational drug, (2) material failure by University to comply with any applicable FDA, or other governmental requirements, or (3) acts of negligence or willful malfeasance by the Principal Investigator or University are excluded from this Agreement to indemnify, defend and hold harmless. In the event of illness or injury, which the University and/or Company reasonably determines to be an adverse reaction to administration of medication pursuant to the protocol should occur, emergency medical treatment for such adverse reaction will be provided free of charge by Company. In the event any such claim is made or lawsuit is initiated, the University shall make all reasonable attempts to notify Company within ten (10) days of receipt of notice of claim, in writing, and shall cooperate fully in the defense of such lawsuit and permit Company or its insurance carrier to defend such a claim or lawsuit. Failure by University to so notify or cooperate will not relieve Company of its obligations.

The provisions of this paragraph shall continue after the termination of this Agreement.

Company agrees to carry and keep in force, at its expense, product liability insurance at an amount acceptable to University and shall provide evidence thereof within 10 days of execution of agreement.

This document contains the entire agreement and understanding between the parties as to its subject matter. This Agreement can only be modified by written agreement duly signed by persons authorized to sign agreements on behalf of Company and the University.

The Sponsor shall not make use of the University's name or any member of its staff for publicity or advertising purposes, except with the written consent of an authorized University official.

This agreement may be terminated by either party providing the other party receives written notice thirty (30) days prior to the effective date of termination.

This Agreement shall be governed by the laws of the State of Louisiana.

IN WITNESS THEREOF, the parties have executed this agreement by their duly authorized officers on the date first herein set out:

NOTE: #11 above: If contract cannot be governed by the "State of Louisiana", then delete clause from contract.

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The statements found on this page are for informational purposes only. While every effort is made to ensure that this information is up-to-date and accurate, for official information please consult a printed University publication.

Last revised: 08/17/98