Subject Injury. If a Study subject suffers an adverse reaction, medical illness, or injury which was directly caused by a {CHOOSE: Study Drug or Study Device} and/or any properly performed procedures required by the Protocol, Sponsor shall reimburse for the reasonable and necessary expenses of diagnosis and treatment of any Study subject injury, including hospitalization, but only to the extent such adverse reaction, medical illness or injury are not directly caused by (i) Institution's negligence or willful misconduct; (ii) the natural progression of an underlying or pre-existing condition or events, unless exacerbated by participating in the Study; or (iii) Institution’s failure to adhere to and comply with the specifications of the Protocol and all reasonable written instructions furnished by Sponsor for the use and administration of any {CHOOSE: Study Drug or Study Device} used in the Study, provided that deviations from the Protocol and written instructions resulting from an imminent threat to the health or safety of a Study subject that do not cause the injury to the Study subject will not disqualify Institution from reimbursement under this provision.
Appears in 5 contracts
Samples: International Accelerated, Accelerated Clinical Trial Agreement, Accelerated Clinical Trial Agreement
