Common use of Study Subject Injury, indemnification, INSURANCE AND DAMAGES Clause in Contracts

Study Subject Injury, indemnification, INSURANCE AND DAMAGES. Sponsor hereby represents and warrants that it will provide clinical trial insurance in accordance with § 52, par. 3, letter f) Act on Pharmaceuticals as may be subsequently amended. The Institution shall promptly notify Quintiles and Sponsor in writing of any claim of illness or injury actually or allegedly due to an adverse reaction to the Investigational Product and cooperate with Sponsor in the handling of the adverse event. Sponsor shall reimburse Institution for costs of immediate medical treatment of a Study Subject who sustains physical illness or injury as a direct result of the treatment of such Study Subject in accordance with the terms of the Protocol and this Agreement. Sponsor shall indemnify Institution for and against any liability or loss resulting from judgements or claims against them arising out of the physical illness, injury or death of a Study Subject as a direct result of treatment of such subject in accordance with the terms of the Protocol and this Agreement except to the extent that such adverse event, illness or personal injury is caused by: failure by Institution, Investigator or any of their respective personnel to comply with this Agreement, the Protocol, any written instructions of Sponsor concerning the Study, or any applicable law, regulation or guidance, including GCPs, issued by any competent regulatory authority, or negligence or willful misconduct by Institution, Investigator or any of their respective personnel; or failure of the Study Subject to follow the reasonable instructions of the Investigator relating to the requirements of the Study. The Sponsor’s liability to reimburse the Institution under this provision shall not be limited to the amount payable under any insurance required to be carried by Sponsor but shall extend to the full amount of the Institution’s actual damages in the amount of subject’s claim or of subject's legal representative's claim successfully claimed. Institution shall not be entitled to such reimbursement according to the previous paragraph if: The injury of subject (including death) has been caused by wilful act, negligence, wrongful conduct or breach of any obligation stipulated for the Institution or the Investigator by legal guideline or by this Agreement including all its appendices; The Institution fails to notify the Sponsor in writing within twenty (20) working days of the date the Institution became aware of the claim for damages having been made. The notice shall be send by registered post to the Sponsor. Upon Sponsor’s request the Institution has not made possible for the Sponsor take a part in out of court negotiations concerning the claim which may result in a legal suit at law; The Institution has recognized the claim without prior obtaining Sponsor’s written consent to such recognition. Institution agrees to indemnify and hold harmless Quintiles, the Sponsor, and their Affiliates, officers, agents or employees from and against any liability or loss resulting from judgments or claims against them arising out of the physical illness, injury or death of a Study Subject due to (i) the failure of Institution, its officers, agents, employees or affiliated entities to adhere to the terms of the Protocol and this Agreement, or (ii) the negligence or willful misconduct of Institution, its officers, agents, employees or affiliated entities; provided however, that Institution shall have no obligation to indemnify and hold harmless with respect to judgments and claims arising out of the negligence and willful misconduct of Sponsor Quintiles, their officers, agents or employees. This Section 7 subsections “Study Subject Injury and Damages” shall survive termination or expiration of this Agreement.

Study Subject Injury, indemnification, INSURANCE AND DAMAGES. Sponsor hereby represents and warrants that it will provide clinical trial insurance in accordance with § 52, par. 3, letter f) Act on Pharmaceuticals as may be subsequently amended. A copy of the Certificate of Insurance is attached hereto as Attachment C. The Institution shall promptly notify Quintiles and Sponsor in writing of any claim of illness or injury actually or allegedly due to an adverse reaction to the Investigational Product and cooperate with Sponsor in the handling of the adverse event. Sponsor shall reimburse Institution for costs of immediate medical treatment of a Study Subject who sustains physical illness or injury as a direct result of the treatment of such Study Subject in accordance with the terms of the Protocol and this Agreement. Sponsor shall indemnify Institution for and against any liability or loss resulting from judgements or claims against them arising out of the physical illness, injury or death of a Study Subject as a direct result of treatment of such subject in accordance with the terms of the Protocol and this Agreement except to the extent that such adverse event, illness or personal injury is caused by: failure by Institution, Investigator or any of their respective personnel to comply with this Agreement, the Protocol, any written instructions of Sponsor concerning the Study, or any applicable law, regulation or guidance, including GCPs, issued by any competent regulatory authority, or negligence or willful misconduct by Institution, Investigator or any of their respective personnel; or failure of the Study Subject to follow the reasonable instructions of the Investigator relating to the requirements of the Study. The Sponsor’s liability to reimburse the Institution under this provision shall not be limited to the amount payable under any insurance required to be carried by Sponsor but shall extend to the full amount of the Institution’s actual damages in the amount of subject’s claim or of subject's legal representative's claim successfully claimedclaimed under Czech legal order. Institution shall not be entitled to such reimbursement according to the previous paragraph if: The injury of subject (including death) has been caused by wilful wllful act, negligence, wrongful conduct or breach of any obligation stipulated for the Institution or the Investigator by legal guideline or by this Agreement including all its appendices; The Institution fails to notify the Sponsor in writing within twenty (20) working days of the date the Institution became aware of the claim for damages having been made. The notice shall be send by registered post to the Sponsor. Upon Sponsor’s request the Institution has not made possible for the Sponsor take a part in out of court negotiations concerning the claim which may result in a legal suit at law; The Institution has recognized the claim without prior obtaining Sponsor’s written consent to such recognition. Institution agrees to indemnify and hold harmless Quintiles, the Sponsor, and their Affiliates, officers, agents or employees from and against any liability or loss resulting from judgments or claims against them arising out of the physical illness, injury or death of a Study Subject due to (i) the failure of Institution, its officers, agents, employees or affiliated entities to adhere to the terms of the Protocol and this Agreement, or (ii) the negligence or willful misconduct of Institution, its officers, agents, employees or affiliated entities; provided however, that Institution shall have no obligation to indemnify and hold harmless with respect to judgments and claims arising out of the negligence and willful misconduct of Sponsor QuintilesSponsor, their its officers, agents or employees. This Section 7 subsections “Study Subject Injury and Damages” shall survive termination or expiration of this Agreement.

Study Subject Injury, indemnification, INSURANCE AND DAMAGES. Sponsor hereby represents and warrants that it will provide clinical trial insurance in accordance with § 52, par. 3, letter f) Act on Pharmaceuticals as may be subsequently amended. The Institution Site shall promptly notify Quintiles and Sponsor in writing of any claim of illness or injury actually or allegedly due to an adverse reaction to the Investigational Product and cooperate with Sponsor in the handling of the adverse event. Sponsor shall reimburse Institution for costs of immediate medical treatment of a Study Subject who sustains physical illness or injury as a direct result of the treatment of such Study Subject in accordance with the terms of the Protocol and this Agreement. Sponsor shall indemnify Institution for and against any liability or loss resulting from judgements or claims against them arising out of the physical illness, injury or death of a Study Subject as a direct result of treatment of such subject in accordance with the terms of the Protocol and this Agreement Agreement, except to the extent that such adverse event, illness or personal injury is caused by: failure by Institution, Investigator or any of their respective personnel to comply with this Agreement, the Protocol, any written instructions of Sponsor concerning the Study, or any applicable law, regulation or guidance, including GCPs, issued by any competent regulatory authority, or negligence or willful misconduct by Institution, Investigator or any of their respective personnel; or failure of the Study Subject to follow the reasonable instructions of the Investigator relating to the requirements of the Study. The Sponsor’s liability to reimburse the Institution under this provision shall not be limited to the amount payable under any insurance required to be carried by Sponsor but shall extend to the full amount of the Institution’s actual damages in the amount of subject’s claim or of subject's legal representative's claim successfully claimedclaimed under Czech legal order. Institution shall not be entitled to such reimbursement according to the previous paragraph if: The injury of subject (including death) has been caused by wilful willful act, negligence, wrongful conduct or breach of any obligation stipulated for the Institution or the Investigator by legal guideline or by this Agreement including all its appendicesattachments; The Institution fails to notify the Sponsor in writing within twenty (20) working days of the date the Institution became aware of the claim for damages having been made. The notice shall be send by registered post to the Sponsor. Upon Sponsor’s request the Institution has not made possible for the Sponsor take a part in out of court negotiations concerning the claim which may result in a legal suit at law; The Institution has recognized the claim without prior obtaining Sponsor’s written consent to such recognition. Institution agrees to indemnify and hold harmless Quintiles, the Sponsor, and their Affiliates, officers, agents or employees from and against any liability or loss resulting from judgments or claims against them arising out of the physical illness, injury or death of a Study Subject due to (i) the failure of Institution, its officers, agents, employees or affiliated entities to adhere to the terms of the Protocol and this Agreement, or (ii) the negligence or willful misconduct of Institution, its officers, agents, employees or affiliated entities; provided however, that Institution shall have no obligation to indemnify and hold harmless with respect to judgments and claims arising out of the negligence and willful misconduct of Sponsor QuintilesSponsor, their its officers, agents or employees. This Section 7 subsections “Study Subject Injury and Damages” shall survive termination or expiration of this Agreement.

Study Subject Injury, indemnification, INSURANCE AND DAMAGES. Sponsor hereby represents and warrants that it will provide clinical trial insurance in accordance with § 52, par. 3, letter f) Act on Pharmaceuticals as may be subsequently amended. The Institution Site shall promptly notify Quintiles and Sponsor in writing of any claim of illness or injury actually or allegedly due to an adverse reaction to the Investigational Product and cooperate with Sponsor in the handling of the adverse event. Sponsor shall reimburse Institution Provider for costs of immediate medical treatment of a Study Subject who sustains physical illness or injury as a direct result of the treatment of such Study Subject in accordance with the terms of the Protocol and this Agreement. Sponsor shall indemnify Institution for Provider of Medical Services and against shall compensate to it expenses incurred, the Provider of Medical Services had to settle to Study Subject or any liability or loss resulting from other authorised persons on basis of judgements or claims against them arising out of the physical illness, injury or death of a Study Subject as a direct result of treatment of such subject in accordance with the terms of the Protocol and this Agreement Agreement, except to the extent that such adverse event, illness or personal injury is caused by: failure by InstitutionProvider, Investigator or any of their respective personnel to comply with this Agreement, the Protocol, any written instructions of Sponsor concerning the Study, or any applicable law, regulation or guidance, including GCPs, issued by any competent regulatory authority, or negligence or willful misconduct by InstitutionProvider, Investigator or any of their respective personnel; or failure of the Study Subject to follow the reasonable instructions of the Investigator relating to the requirements of the Study. The Sponsor’s liability to reimburse the Institution Provider under this provision shall not be limited to the amount payable under any insurance required to be carried by Sponsor but shall extend to the full amount of the InstitutionProvider’s actual damages in the amount of subject’s claim or of subject's legal representative's other entitled parties’ claim successfully claimedclaimed under Czech legal order. Institution Provider shall not be entitled to such reimbursement according to the previous paragraph if: The injury of subject (including death) has been caused by wilful willful act, negligence, wrongful conduct or breach of any obligation stipulated for the Institution Provider or the Investigator by legal guideline or by this Agreement including all its appendices; The Institution Provider fails to notify the Sponsor in writing within twenty (20) working days of the date the Institution Provider became aware of the claim for damages having been made. The notice shall be send by registered post to the Sponsor. Upon Sponsor’s request the Institution Provider has not made possible for the Sponsor take a part in out of court negotiations concerning the claim which may result in a legal suit at law; The Institution Provider has recognized the claim without prior obtaining Sponsor’s written consent to such recognition. Institution Provider agrees to indemnify and hold harmless Quintiles, the Sponsor, and their Affiliates, officers, agents or employees from and Affiliates against any liability or loss resulting from judgments or claims against them arising out of the physical illness, injury or death of a Study Subject due to (i) the failure of InstitutionProvider, its officers, agents, agents or employees or affiliated entities to adhere to the terms of the Protocol and this Agreement, or (ii) the negligence or willful misconduct of InstitutionProvider, its officers, agents, employees agents or affiliated entitiesemployees; provided however, that Institution Provider shall have no obligation to indemnify Quintiles and hold harmless Sponsor with respect to judgments and claims arising out of the negligence and willful misconduct of Sponsor QuintilesQuintiles and Sponsor, their officers, agents or employees. This Section 7 subsections “„Study Subject Injury and Damages” „ shall survive termination or expiration of this Agreement.

Study Subject Injury, indemnification, INSURANCE AND DAMAGES. Sponsor hereby represents and warrants that it will provide clinical trial insurance in accordance with § 52, par. 3, letter f) Act on Pharmaceuticals as may be subsequently amended. The Institution shall promptly notify Quintiles and Sponsor in writing of any claim of illness or injury actually or allegedly due to an adverse reaction to the Investigational Product and cooperate with Sponsor in the handling of the adverse event. Sponsor shall reimburse Institution for costs of immediate medical treatment of a Study Subject who sustains physical illness or injury as a direct result of the treatment of such Study Subject in accordance with the terms of the Protocol and this Agreement. Sponsor shall indemnify Institution for and against any liability or loss resulting from judgements or claims against them arising out of the physical illness, injury or death of a Study Subject as a direct result of treatment of such subject in accordance with the terms of the Protocol and this Agreement except to the extent that such adverse event, illness or personal injury is caused by: failure by Institution, Investigator or any of their respective personnel to comply with this Agreement, the Protocol, any written instructions of Sponsor concerning the Study, or any applicable law, regulation or guidance, including GCPs, issued by any competent regulatory authority, or negligence or willful misconduct by Institution, Investigator or any of their respective personnel; or failure of the Study Subject to follow the reasonable instructions of the Investigator relating to the requirements of the Study. The Sponsor’s liability to reimburse the Institution under this provision shall not be limited to the amount payable under any insurance required to be carried by Sponsor but shall extend to the full amount of the Institution’s actual damages in the amount of subject’s claim or of subject's legal representative's claim successfully claimedclaimed under Czech legal order. Institution shall not be entitled to such reimbursement according to the previous paragraph if: The injury of subject (including death) has been caused by wilful willful act, negligence, wrongful conduct or breach of any obligation stipulated for the Institution or the Investigator by legal guideline or by this Agreement including all its appendices; The Institution fails to notify the Sponsor in writing within twenty (20) working days of the date the Institution became aware of the claim for damages having been made. The notice shall be send by registered post to the Sponsor. Upon Sponsor’s request the Institution has not made possible for the Sponsor take a part in out of court negotiations concerning the claim which may result in a legal suit at law; The Institution has recognized the claim without prior obtaining Sponsor’s written consent to such recognition. Institution agrees to indemnify and hold harmless Quintiles, the Sponsor, and their Affiliates, officers, agents or employees from and against any liability or loss resulting from judgments or claims against them arising out of the physical illness, injury or death of a Study Subject due to (i) the failure of Institution, its officers, agents, employees or affiliated entities to adhere to the terms of the Protocol and this Agreement, or (ii) the negligence or willful misconduct of Institution, its officers, agents, employees or affiliated entities; provided however, that Institution shall have no obligation to indemnify and hold harmless with respect to judgments and claims arising out of the negligence and willful misconduct of Sponsor QuintilesSponsor, their its officers, agents or employees. This Section 7 subsections “Study Subject Injury and Damages” shall survive termination or expiration of this Agreement.