Master Clinical Services Agreement
Category: 270 Legal Recent Posts, Pharmaceutical
MASTER CLINICAL SERVICES AGREEMENT
BETWEEN:
FORENAP PHARMA EURL, having its registered offices at 27 rue du 4ème RSM – B.P. 27, F-68250 ROUFFACH, France, represented by Rémy LUTHRINGER, Ph.D., CEO, hereinafter referred to as “FORENAP”
and
TARGACEPT, INC., having its office at 200 East First Street, Suite 300, Winston-Salem, North Carolina 27101, hereinafter referred to as “THE SPONSOR.”
FORENAP and THE SPONSOR are hereinafter collectively referred to as “the Parties.”
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5. Conduct of Studies
5.1. For each Study, FORENAP shall ensure that the Principal Investigator and all members of the Study Staff are appropriately qualified, trained, and experienced for the Services they perform. For the avoidance of doubt, FORENAP shall be solely responsible for each Study for the actions or omissions of the Principal Investigator and all members of the Study Staff. FORENAP shall not utilize or engage in any capacity in the performance of Services any person or entity debarred or disqualified from participating in the conduct or reporting of human clinical trials by the FDA or any Review Body.
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14. Confidentiality and Data Protection
14.1. With respect to each Study, FORENAP shall comply, and shall take such action as shall be necessary to ensure that THE SPONSOR is in compliance, in all respects with Directive 95/46 (the European Union Directive on Data Protection) on the protection of individuals with regard to the processing, use and transfer of personal data and on the free movement of such data and with the national legislation implementing such Directive in any country in which Services are provided by FORENAP. In particular FORENAP shall ensure that only personnel authorised by FORENAP to process such personal data have access to the personal data and that such personnel are reliable, trustworthy and trained to the highest industry standards.
Without limiting the generality of the foregoing paragraph, FORENAP shall ensure that the informed consent form obtained from each subject in each Study contains the “unambiguous consent” (within the meaning of the European Union Directive on Data Protection, or such similar language as may have been enacted in the country in which such Study is conducted) to the transfer of his or her personal data to THE SPONSOR in the United States and to United States and foreign governmental and regulatory agencies and authorities. In addition, if THE SPONSOR reasonably determines that an additional agreement between the parties is necessary to enable compliance with applicable data protection laws, FORENAP agrees to execute such an agreement. Any such agreement shall survive the termination of this Master Agreement and any Work Order.
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