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Páginas: 29 (7005 palabras) Publicado: 18 de abril de 2011
SUBCONTRACT No. 0007448
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This Subcontract (“Subcontract”) is made and entered into as of 1 April, 2010, by and between The University of Texas Health Science Center at Houston (“UTH”), a member institution of The University of Texas System (“System”), whose address is 7000 Fannin, Suite 1006, Houston, Texas 77030 and Oaxaca Site Management Organization (“Subcontractor”), whose addressis Humboldt 302, Col Centro, Oaxaca de Juarez, Oaxaca, ZP 68000, Mexico.

RECITALS

A. UTH negotiated a Clinical Trial Agreement with INC Research, Inc. (“INC Research”) on behalf of Santarus, Inc. (“Sponsor”).

B. This Subcontract provides funds for Subcontractor participation.

C. Subcontractor possesses the facilities, personnel and/or professional proficiencyrequisite to the conduct of work of the nature contemplated by this Subcontract.

D. It is in the best interests of UTH to obtain the assistance of Subcontractor in the performance of the work required by the Subcontract.

NOW, THEREFORE, UTH and Subcontractor mutually agree as follows:

ARTICLE I
Description of Work

Subcontractor, as an independent contractor, and not as an agentor employee of the UTH, shall perform the work described in the Protocol C2009-0201 entitled “A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Rifamycin SV MMX® for the Treatment of Traveler’s Diarrhea”, (“Trial”) as described in Exhibit A and further described in Exhibit D, Principal Investigator Study Assumptions.Obligations. Subcontractor shall not subcontract with any other person or entity to perform any obligations of Subcontractor under this Agreement without UTH’s and Sponsor’s prior written consent. The Trial shall be conducted solely at the locations and by the sub-investigators listed in Exhibit E. Subcontractor will ensure that any personnel who assist in the conduct of the Trial, including withoutlimitation all approved subcontractors and their respective personnel, are informed of and agree to abide by all terms of this Subcontract applicable to the activities they perform or the obligations of Subcontractor or the Subcontractor Principal Investigator subcontracted to them. Subcontractor is responsible jointly and severally to each of UTH, INC Research and Sponsor for compliance by allTrial personnel, including the Subcontractor Principal Investigator, all subcontractors and their respective personnel, with the terms of this Subcontract.

Compliance with Institutional Policies. Each of Subcontractor and Subcontractor Principal Investigator will comply with the policies and procedures of the organization with which it is affiliated, including any applicable financialpolicies. Subcontractor represents and warrants that there is no conflict between the terms of this Subcontract and any such policy or procedure.

Protocol. Each of the Subcontractor and the Subcontractor Principal Investigator will conduct the Trial in accordance with the Protocol.

Amendments. The Protocol may be modified only by a written Amendment, signed by both Sponsor andthe UTH Principal Investigator. The parties acknowledge that Protocol Amendments are also subject to approval by the responsible Institutional Review Board (“IRB”).

Emergency Amendments. If it is necessary to change the Protocol on an emergency basis for the safety of the patients participating in the Trial (collectively “Trial Subjects”, Subcontractor will notify UTH and UTH will notifyINC Research and the responsible IRB as soon as practicable but, in any event, no later than one working day after the change is implemented. Any emergency change to the Protocol must be followed by a written Amendment.

No Additional Research. No additional research may be conducted on Trial Subjects during the conduct of the Trial, unless it is approved by Sponsor and documented as a...
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