Common use of Indemnification by Sponsor Clause in Contracts

Indemnification by Sponsor. SPONSOR will indemnify, defend and hold harmless the Institution, the Facility where Institution conducts the Study, the IRB (solely with respect to its role in the approval and regulatory oversight of the Study), and their respective subsidiaries, affiliated hospitals, trustees, directors, officers, faculty, agents, employees, students, the Principal Investigator and any Sub-investigator and their respective employers (individually an “Institutional Indemnified Party” and collectively, the “Institutional Indemnified Parties”) from and against any and all third party actions, suits, claims, proceedings, investigations, demands, costs and expenses (including reasonable attorney fees incurred prior to engagement of counsel for the Institutional Indemnified Party by SPONSOR Indemnifying Party), judgments, liabilities, losses, personal injuries (including death), or other damages (collectively, “Losses”), of all types whatsoever, that have arisen from or are related to the (a) use of the applicable Study Device(s) in accordance with the applicable Protocol or procedures that the Subject would not have undergone but for participation in the Study (b) SPONSOR’s negligence or misconduct, (c) breach of this Agreement, (d) SPONSOR’s failure to comply with Applicable Law, or (e) SPONSOR’s use or commercialization of the Study Results or Intellectual Property. The SPONSOR's obligation to indemnify, defend and hold harmless an Institutional Indemnified Party will be reduced to the extent that any Losses are adjudicated to have been directly caused by: (i) a material failure by such Institutional Indemnified Party to comply with the applicable Protocol, allowing for deviations for Subject safety, and/or with state or federal statutes or regulations, including FDA regulations; or (ii) the negligence or misconduct of such Institutional Indemnified Party, provided that complying with the applicable Protocol, SPONSOR's instructions, or the terms of this Agreement or the applicable SOW shall not be considered negligence for purposes of this exception.

Appears in 4 contracts

Samples: Master Clinical Study Agreement, Master Clinical Study Agreement, Master Clinical Study Agreement

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Indemnification by Sponsor. SPONSOR will indemnify, defend and hold harmless the Institution, the Facility where Institution conducts the Study, the IRB (solely with respect to its role in the approval and regulatory oversight of the Study), and their respective subsidiaries, affiliated hospitals, trustees, directors, officers, faculty, agents, employees, students, the Principal Investigator and any Sub-investigator and their respective employers and their respective successors, heirs and assigns (individually an “Institutional Indemnified Party” and collectively, the “Institutional Indemnified Parties”) from and against any and all third party actions, suits, claims, proceedings, investigations, demands, costs and expenses (including reasonable attorney fees incurred prior to engagement of counsel for the Institutional Indemnified Party by SPONSOR Indemnifying Party), judgments, liabilities, losses, personal injuries (including death), or other damages (collectively, “Losses”), of all types whatsoever, that have arisen from or are related to the (a) use of the applicable Study Device(s) in accordance with the applicable Protocol or procedures that the Subject would not have undergone but for participation in the Study (b) SPONSOR’s negligence or misconduct, (c) breach of this Agreement, (d) SPONSOR’s failure to comply with Applicable Law, or (e) SPONSOR’s use or commercialization of the Study Results or Intellectual Property. The SPONSOR's obligation to indemnify, defend and hold harmless an Institutional Indemnified Party will be reduced to the extent that any Losses are adjudicated to have been directly caused by: (i) a material failure by such Institutional Indemnified Party to comply with the applicable Protocol, allowing for deviations for Subject safety, and/or with state or federal statutes or regulations, including FDA regulations; or (ii) the negligence or misconduct of such Institutional Indemnified Party, provided that complying with the applicable Protocol, SPONSOR's instructions, or the terms of this Agreement or the applicable SOW shall not be considered negligence for purposes of this exception.

Appears in 2 contracts

Samples: Master Clinical Study Agreement, Master Clinical Study Agreement

Indemnification by Sponsor. SPONSOR will indemnify, defend and hold harmless the Institution, the Facility where Institution conducts the StudyTrial, the IRB (solely with respect to its role in the approval and regulatory oversight of the StudyTrial), and their respective subsidiaries, affiliated hospitals, trustees, directors, officers, faculty, agents, employees, students, the Principal Investigator and any Sub-investigator and their respective employers and their respective successors, heirs and assigns (individually an “Institutional Indemnified Party” and collectively, the “Institutional Indemnified Parties”) from and against any and all third party actions, suits, claims, proceedings, investigations, demands, costs and expenses (including reasonable attorney fees incurred prior to engagement of counsel for the Institutional Indemnified Party by SPONSOR Indemnifying Party), judgments, liabilities, losses, personal injuries (including death), or other damages (collectively, “Losses”), of all types whatsoever, that have arisen from or are related to the (a) use of the applicable Study Trial Device(s) in accordance with the applicable Protocol or procedures that the Subject would not have undergone but for participation in the Study Trial (b) SPONSOR’s negligence or misconduct, (c) breach of this Agreement, (d) SPONSOR’s failure to comply with Applicable Law, or (e) SPONSOR’s use or commercialization of the Study Trial Results or Intellectual Property. The SPONSOR's obligation to indemnify, defend and hold harmless an Institutional Indemnified Party will be reduced to the extent that any Losses are adjudicated to have been directly caused by: (i) a material failure by such Institutional Indemnified Party to comply with the applicable Protocol, allowing for deviations for Subject safety, and/or with state or federal statutes or regulations, including FDA regulations; or (ii) the negligence or misconduct of such Institutional Indemnified Party, provided that complying with the applicable Protocol, SPONSOR's instructions, or the terms of this Agreement or the applicable SOW shall not be considered negligence for purposes of this exception.

Appears in 1 contract

Samples: Master Clinical Trial Agreement

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Indemnification by Sponsor. SPONSOR will Sponsor agrees to indemnify, defend and hold harmless the InstitutionInstitution and its employees, the Facility where Institution conducts the Study, the IRB (solely with respect to its role in the approval and regulatory oversight of the Study), and their respective subsidiaries, affiliated hospitals, trusteesofficers, directors, officers, faculty, consultants and agents, employees, students, including the Principal Investigator and any Sub-investigator and their respective employers (individually an “Institutional Indemnified Party” and collectively, the “Institutional Indemnified PartiesInstitution Indemnitees”) from and against any and all third party actionsloss, suits, claims, proceedings, investigations, demands, costs and expenses cost and/or expense (including reasonable attorney fees incurred prior attorneys’ fees) resulting from any claim, complaint, cause of action or demand brought against an Institution Indemnitee by or on behalf of a subject participating in the Study alleging illness, injury, death, loss of consortium or a similar claim (whether brought by or on behalf of such subject by a friend, spouse, guardian, relative or companion of such subject) (a “Claim”) to engagement of counsel for the Institutional Indemnified Party by SPONSOR Indemnifying Party), judgments, liabilities, losses, personal injuries (including death), or other damages (collectively, “Losses”), of all types whatsoever, extent that have arisen such Claim arises directly from or are related to is a direct result of the (a) use of the applicable Study Device(s) Investigational Material in accordance with the Protocol, the written instructions of Sponsor, and all applicable Protocol laws and IRB and Institution directions and policies. Notwithstanding the foregoing, with respect to any Claim, Sponsor shall not be liable for indemnification of any Institution Indemnitee to the extent that such Claim arises from or is a result of an Institution Indemnitee’s (i) failure to obtain approval from the IRB and/or any required permission from the subject making such Claim in accordance with the IRB’s approved procedures that and the Subject would not have undergone but for participation in the Study (b) SPONSOR’s negligence or misconduct, (c) breach terms of this Agreement, (dii) SPONSOR’s failure to comply with Applicable Lawfollow the Protocol or Sponsor’s written instructions in any material respect, (iii) failure otherwise to perform his, her or its material obligations hereunder, or (eiv) SPONSOR’s use negligence, malpractice, willful misconduct or commercialization of other wrongful acts or failure to act in connection with the Study Results or Intellectual PropertyStudy. The SPONSOR's obligation In addition, Sponsor shall not be obligated to indemnify, defend and hold harmless an Institutional Indemnified Party will be reduced Institution Indemnitees with respect to any Claim for which Institution Indemnitee has made any admission or has taken any action relating to such Claim prejudicial to the extent that any Losses are adjudicated defense of it without the prior written consent of Sponsor, such consent not to have been directly caused by: (i) a material failure by such Institutional Indemnified Party to comply with the applicable Protocol, allowing for deviations for Subject safety, and/or with state or federal statutes or regulations, including FDA regulations; or (ii) the negligence or misconduct of such Institutional Indemnified Partybe unreasonably withheld, provided that complying with the applicable Protocol, SPONSOR's instructions, or the terms of this Agreement or the applicable SOW condition shall not be considered negligence for purposes treated as breached by any statement required to be made by any Institution Indemnitee in connection with the operation of this exceptionthe Institution’s internal complaint procedures, accident reporting procedures or disciplinary procedures or by law.

Appears in 1 contract

Samples: Clinical Trial Agreement

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