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Indemnification

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					                   From of Indemnity for Clinical Trials

To:.

(“The Indemnified Party”).

From: ………………………….. Located at ………………………..

Re: Clinical Study No:
(………………………………………………………………………………
………)

   1. The Indemnified Party agrees to participate in the above sponsored
      study (“the study) involving patients of site name .to be conducted by
      Dr…………….. (“ the Investigator”) in accordance with the protocol
      annexed, as amended in writing from time to time with the agreement
      of the Sponsor and the Indemnified Party (“the Protocol”). The
      Sponsor confirms that it is a term of its agreement with the
      Investigator that the Investigator shall obtain all necessary approvals
      from the applicable Ethics Committee (“EC”) and the Indemnified
      Party, where appropriate.

   2. The Indemnified Party agrees to participate by making its EC
      available to provide review, approval and oversight of the conduct of
      the Study in accordance with the requirements of the ICMR guidelines
      on Ethical Conduct in Research Involving Humans(2006)

Indemnification: The sponsor indemnifies and hold harmless the
Institution, Principal Investigator and its employees, Agents and
members of and advisors to its EC in respect of and against all claims
and proceedings ( including any settlements or ex gratia payments made
with the consent of the parties hereto and reasonable legal and expert
costs and expenses) made or brought (whether successfully or otherwise
) by or on behalf of subjects (including their dependants) against the
Indemnified Party Institution, Principal Investigator or any of its
employee, agents or members of and advisors to its EC for personal
injury (including death) under investigation or any clinical intervention
or procedure provided for or required by the protocol to which the
subjects would not have been exposed but for the participation of the
Subjects in the Study administered in accordance with the Protocol;
provided, however that:
(a) the Indemnitees shall have complied with all applicable federal,
     state and local laws and regulations (including without limitation,
     obtaining informed consents, and IEC approvals), the Protocol and
     all recommendations furnished by Sponsor or CRO for the use and
     administration of any Study Drug(s);
(b) Sponsor is promptly notified in writing of any such claim or suit;
(c) the Indemnitees cooperate fully in the investigation and defense of
     any such claim or suit;
(d) Sponsor retains the right to defend any claim or suit in any manner
     it deems appropriate, including the right to retain counsel of its
     choice; and
(e) Sponsor shall have the sole right to settle the claim; provided,
     however, that Sponsor shall not admit fault on Indemnitees’ behalf
     without Indemnitees’ advance written permission.
Notwithstanding the foregoing, Sponsor’s obligation of indemnification
shall not extend to any loss, damage or expense to the extent arising
from the negligence, willful malfeasance or malpractice by any of the
Indemnitees, it being understood that the administration of any
substance in accordance with the Protocol shall not constitute
negligence or malpractice for purposes of this Agreement.

				
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posted:11/21/2010
language:English
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