Reimbursement of Medical Expenses. Institution will offer or will coordinate medical care to Subjects who suffer an adverse reaction, illness, or injury during a Study. For each Study, SPONSOR will reimburse Institution or other medical provider at rates that constitute fair market value for industry sponsored studies, for the reasonable and necessary, actually incurred costs of providing such medical diagnosis and treatment of any adverse reaction, illness or injury directly arising from the 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. Notwithstanding the foregoing, SPONSOR's obligation to reimburse Institution will be reduced to the extent that such adverse reaction, illness or injury is attributable to: (i) the negligence or misconduct of Institution, the applicable Principal Investigator, or their respective employees and agents; (ii) if applicable, a known risk of an FDA approved treatment or device of the type being studied; (iii) failure to adhere to the applicable Protocol (it being understood, however, that emergency medical care shall not be deemed a violation of the Protocol), other non-conflicting written instructions provided by SPONSOR, or Applicable Laws by Institution, the applicable Principal Investigator, or their respective employees and agents; or (iv) the natural progression of a pre-existing medical condition or underlying disease of the Subject. For purposes of this Section causation of adverse reactions, illness and injury, and whether the exception set forth in Section 20.3(iii) applies shall be determined in the reasonable medical judgement of the Principal Investigator after consultation with SPONSOR and good faith consideration of all data presented by SPONSOR related to causation. SPONSOR's agreement to pay Institution under this Section 20.3 is being provided as reasonable consideration for Subjects' willingness to participate in a Study, and does not constitute an admission of liability for any injury, which ultimately could be determined only through an adjudication process, or as a settlement or compromise of any potential future liability claim.
Appears in 2 contracts
Samples: Master Clinical Study Agreement, Master Clinical Study Agreement
Reimbursement of Medical Expenses. Institution will offer or will coordinate medical care to Subjects who suffer an adverse reaction, illness, or injury during a Study. For each Study, SPONSOR will reimburse Institution or other medical provider at rates that constitute fair market value for industry sponsored studies, for the reasonable and necessary, actually incurred costs of providing such medical diagnosis and treatment of any adverse reaction, illness or injury directly arising from the 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. Notwithstanding the foregoing, SPONSOR's obligation to reimburse Institution will be reduced to the extent that such adverse reaction, illness or injury is attributable to: (i) the negligence or misconduct of Institution, the applicable Principal Investigator, or their respective employees and agents; (ii) if applicable, a known risk of an FDA approved treatment or device of the type being studied; (iii) failure to adhere to the applicable Protocol (it being understood, however, that emergency medical care shall not be deemed a violation of the Protocol), other non-conflicting written instructions provided by SPONSOR, or Applicable Laws by Institution, the applicable Principal Investigator, or their respective employees and agents; or (iv) the natural progression of a pre-existing medical condition or underlying disease of the Subject. For purposes of this Section causation of adverse reactions, illness and injury, and whether the exception set forth in Section 20.3(iii) applies shall be determined in the reasonable medical judgement of the Principal Investigator after consultation with SPONSOR and good faith consideration of all data presented by SPONSOR related to causation. SPONSOR's agreement to pay Institution under this Section 20.3 is being provided as reasonable consideration for Subjects' willingness to participate in a Study, and does not constitute an admission of liability for any injury, which ultimately could be determined only through an adjudication process, or as a settlement or compromise of any potential future liability claim.Section
Appears in 2 contracts
Samples: Master Clinical Study Agreement, Master Clinical Trial Agreement
Reimbursement of Medical Expenses. Institution will offer or will coordinate medical care to Subjects who suffer an adverse reaction, illness, or injury during a Study and two (2) years after the closure of such Study. For each Study, SPONSOR will reimburse Institution or other medical provider at rates that constitute fair market value for industry sponsored studies, for the reasonable and necessary, actually incurred costs of providing such medical diagnosis and treatment of any adverse reaction, illness or injury directly arising from (i) the use of the applicable Study Device(s) in accordance with the applicable Protocol or Protocol, (ii) procedures that the Subject would not have undergone but for participation in the Study, or (iii) SPONSOR’s negligence. Notwithstanding the foregoing, SPONSOR's obligation to reimburse Institution will be reduced to the extent that such adverse reaction, illness or injury is attributable to: (i) the negligence or misconduct of Institution, the applicable Principal Investigator, or their respective employees and agents; (ii) if applicable, a known risk of an FDA approved treatment or device of the type being studied; (iii) failure to adhere to the applicable Protocol (it being understood, however, that emergency medical care shall not be deemed a violation of the Protocol), other non-conflicting written instructions provided by SPONSOR, or (iii) breach of Applicable Laws by Institution, the applicable Principal Investigator, or their respective employees and agents; or (iv) the natural progression of a pre-existing medical condition or underlying disease of the Subject. Further, the parties agree that payments made pursuant to this Section are not intended for any purpose other than for the reimbursement of actual medical expenses and shall constitute both parties best good faith estimation of fair market value of the services in question. For purposes of this Section causation of adverse reactions, illness and injury, and whether the exception set forth in Section 20.3(iii20.3(ii) applies shall be determined in the reasonable medical judgement judgment of the Principal Investigator after consultation with SPONSOR and good faith consideration of all data presented by SPONSOR related to causation. SPONSOR's agreement to pay Institution under this Section 20.3 is being provided as reasonable consideration for Subjects' willingness to participate in a Study, and does not constitute an admission of liability for any injury, which ultimately could be determined only through an adjudication process, or as a settlement or compromise of any potential future liability claim. Institution agrees that it will not submit any claims for coverage of expenses covered by SPONSOR under this Section 20.3.
Appears in 1 contract
Samples: Master Clinical Study Agreement