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It also specifies requirements needed for execution readiness through review and agreement by applicable parties.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What types of claims does the sponsor indemnify the institution for?",{"text":113,"@type":109},"The sponsor agrees to indemnify institution indemnified parties for damages, liabilities, costs, and expenses arising from the proper performance of the study under the protocol, the sponsor’s use of study data/results, and sponsor-related negligence or willful misconduct. The indemnity excludes claims stemming from institution noncompliance with the study or applicable law, or institution negligence, willful misconduct, or material breach of statutory duty.",{"name":115,"@type":106,"acceptedAnswer":116},"How are study-related injuries handled under the LOI?",{"text":117,"@type":109},"The sponsor will pay reasonable and customary fees for standard-of-care diagnosis, care, and treatment of any study injury or illness. 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It is subject to change depending upon the specific needs of a study. In order for it to be considered ready for execution, it must be reviewed by the IU Office of Clinical Research and agreed upon by the applicable parties. If you have any questions, please contact the IU Office of Clinical Research at 317-278-2546 [and/or](and/or ocr@iu.edu)[ ](and/or ocr@iu.edu)[ocr@iu.edu](and/or ocr@iu.edu)  \nLETTER OF INDEMNIFICATION  \nPROTOCOL: Protocol Number   (“Protocol”)  \nSTUDY:   (“Study”)  \nThis Letter of Indemnification (“LOI”) is entered into by and between the Trustees of Indiana University, an educational institution organized under the laws of the State of Indiana, with an address Office of Clinical Research, 410 West 10th Street, Suite 1020, Indianapolis, IN 46202 (“Institution”) and INSERT SPONSOR INFORMATION (“SPONSOR”) (individually a “party”; collectively “parties”) .   , an employee of the Institution, shall serve as the principal investigator for this Study at the Institution (“Principal Investigator”) .  \nIndemnification  \nSPONSOR agrees to indemnify, defend, and hold harmless Institution, trustees, officers, employees, agents, affiliated hospitals, and directors (each a “Institution Indemnitee”, collectively “Institution Indemnitees”) from and against any suits, actions, claims, demands or judgments (“Claims”) against Institution Indemnitees for any damages, liabilities, costs, and expenses (including reasonable attorneys’ fees and costs of litigation at the trial and appellate levels) for Claims related to or arising from (i) the proper performance of the Study in accordance with the Protocol; (ii) the SPONSOR’s use of the data/results provided to it by Institution and/or Principal Investigator as part of the Study, including any products or tangible items developed or made therefrom; and/or (iii) the negligence or willful misconduct of SPONSOR, SPONSOR’s officers, employees, agents, or affiliates; (“Institution Claim”); provided that SPONSOR shall not indemnify any Institution Indemnitee for any Institution Claim to the extent the Institution Claim arose out of:  \n(i) failure by Institution Indemnitees to conduct the Study in accordance with the Study or applicable law; or  \n(ii) the negligence or willful misconduct or material breach of statutory duty of Institution Indemnitees.  \nSPONSOR’s indemnification obligation with respect to an Institution Claim is conditioned on:  \n(i) Prompt written notification to the SPONSOR of the Institution Claim;  \n(ii) Institution Indemnitees’ agreement that SPONSOR has full control over the defense or settlement of the Institution Claim and to reasonably cooperate with  \nLetter of Indemnification  \nSPONSOR in the defense or settlement of the Institution Claim; provided, that, SPONSOR will not settle any such Institution Claim without the written approval of the Institution nor admit any liability or wrongdoing by an Institution Indemnitee (such consent will not be unreasonably withheld); provided, however, that Institution shall have the right to employ separate legal counsel of its own choice and at its own expense; and  \n(iii) Institution Indemnitees’ agreement not to make any admission in respect of such  \nInstitution Claim or take any action relating to such Institution Claim prejudicial to the defense of it without the written consent of SPONSOR.  \nStudy-related Injury  \nSPONSOR will pay all reasonable and customary fees for standard-of-care diagnosis, care, and treatment of any Study injury or illness provided, however, that:  \n(i) the injury or illness was not caused by Institution Indemnitees’ deviation from the Study, other current written instructions provided by SPONSOR to Institution, applicable laws and regulations, except to protect the safety and welfare of the Study subject;  \n(ii) the injury or illness was not caused by the negligence or misconduct of Institution Indemnitees;  \n(iii) the injury ","cbCaitXzb5n2z1us","https://ap.wps.com/l/cbCaitXzb5n2z1us","pdf",168384,"English","# Indemnification Framework\n## Definitions and Parties\n## Indemnification Terms and Exclusions\n## Conditions for Indemnification\n## Study-Related Injury Payment\n## Notices and Communications\n## Signature Page","[{\"question\":\"What is the purpose of the Letter of Indemnification (LOI) template?\",\"answer\":\"The LOI template sets the indemnification framework between the sponsor and Indiana University for claims related to or arising from proper study performance, sponsor use of provided data, and certain negligence or willful misconduct. It also specifies requirements needed for execution readiness through review and agreement by applicable parties.\"},{\"question\":\"What types of claims does the sponsor indemnify the institution for?\",\"answer\":\"The sponsor agrees to indemnify institution indemnified parties for damages, liabilities, costs, and expenses arising from the proper performance of the study under the protocol, the sponsor’s use of study data/results, and sponsor-related negligence or willful misconduct. The indemnity excludes claims stemming from institution noncompliance with the study or applicable law, or institution negligence, willful misconduct, or material breach of statutory duty.\"},{\"question\":\"How are study-related injuries handled under the LOI?\",\"answer\":\"The sponsor will pay reasonable and customary fees for standard-of-care diagnosis, care, and treatment of any study injury or illness. Payment is limited to situations where the injury or illness was not caused by institution deviation or negligence/misconduct, not attributable to underlying illness unless exacerbated by the study, and where study drugs/devices and procedures were used or performed in accordance with the study.\"}]","Letter of Indemnification - Template | PDF",1789512998]