Study Subject Injury, indemnification, INSURANCE AND DAMAGES Sample Clauses

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 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 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 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 ...

Study Subject Injury, indemnification, INSURANCE AND DAMAGES. 7.1 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. 7. POŠKOZENÍ ZDRAVÍ SUBJEKTU STUDIE, NÁHRADA ŠKODY, POJIŠTĚNÍ A ODŠKODNĚNÍ 7.1 Zadavatel prohlašuje a potvrzuje, že v souladu s ust. § 52 odst. 3, písm. f) zákona č. 378/2007 Sb., o léčivech, v platném znění, zajistí pojištění klinického hodnocení. Kopie pojistného certifikátu tvoří přílohu C této Smlouvy. 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 the direct, reasonable and necessary medical expenses incurred by Institution for the treatment of any adverse event Zdravotnické zařízení je povinno neprodleně písemně vyrozumět Quintiles a Zadavatele o jakémkoli nároku vztahujícímu se k onemocnění či újmě na zdraví, k nimž skutečně či údajně došlo v souvislosti s nežádoucí reakcí na Hodnocené léčivo a zavazuje se plně spolupracovat se Zadavatelem při řešení nežádoucí události. Zadavatel uhradí Zdravotnickému zařízení přímé, přiměřené a nezbytné zdravotní 7.2 Sponsor shall defend, indemnify and hold harmless the Institution, its officers, employees and agents (“Indemnitees”) from any and all liabilities, claims, actions or suits for personal injury or death directly arising out of the treatment of the Study Subject in accordance with the Protocol; provided that: 7. 2.1 The Study is conducted in accordance with the Protocol, together with any written instruction from Sponsor and this Agreement; výdaje, které vznikly Zdravotnickému zařízení v souvislosti s léčbou jakýchkoli nežádoucích událostí, nemocí nebo újmy na zdraví Subjektu studie způsobené léčbou Subjektu studie v souladu s Protokolem, s výjimkou případů, kdy taková nežádoucí událost, nemoc nebo újma na zdraví je způsobeno: a) pochybením Zdravotnického zařízení, Zkoušejícího nebo jakéhokoliv jejich zaměstnance jednat v souladu s touto Smlouvou, Protokolem, jakoukoliv písemnou instrukcí Zadavatele týkající se Studie, nebo jakéhokoliv platného zákona nebo prováděcího předpisu nebo postupu, včetně GCP, vydaném jakoukoliv regulační autoritou, nebo b) nedbalostí nebo úmyslným nesprávným jednáním Zdravotnického ...

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. An evidence proving the existence of such insurance is enclosed hereto as Attachment F. 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: a) 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 regulatory authority, or b) negligence or willful misconduct by Institution, Investigator or any of their respective personnel.

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 Site shall promptly notify Xxxxxxxxx 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 Místo provádění klinického hodnocení je povinno neprodleně písemně vyrozumět Quintiles a Zadavatele o jakémkoli nároku vztahujícím se k onemocnění či újmě na zdraví, k xxxx skutečně či údajně došlo v souvislosti s nežádoucí reakcí na Hodnocené léčivo a zavazuje se plně spolupracovat se Zadavatelem při řešení nežádoucí události. Zadavatel uhradí Poskytovateli náklady na bezprostřední zdravotní výdaje na léčbu Subjektu studie, který onemocněl nebo jemuž 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 and Investigator for and against any liability or loss resulting from judgements or claims against them arising out of the physical illness, injury, including mental 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: a) 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 regulatory authority, or b) negligence or willful misconduct by Institution, Investigator or any of their respective personnel; or c) 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 under Czech legal order. Institution shall not be entitled...

Study Subject Injury, indemnification, INSURANCE AND DAMAGES. 7.1. 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 Site shall promptly notify 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 Provider for the direct, reasonable and necessary medical expenses incurred by Provider for the treatment of any adverse event experienced by, illness of or bodily injury to a Study Subject that caused by treatment of the Study Subject with Investigational Product in accordance with the Protocol, except to the extent that such adverse event, illness or personal injury is caused by: a) failure by Provider, 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, Tento Článek 6 “Osobní údaje” zůstane v platnosti i v případě ukončení platnosti či při vypršení platnosti této Smlouvy.

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 during the whole period of study.. transparentnost; a

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 IQVIA 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 s jakýmikoli osobními údaji na základě této Smlouvy jakožto správce dat, v takovém případě bude IQVIA správcem takových osobních údajů v rozsahu, v jakém s nimi nakládá. XXXXX je oprávněn zpracovávat „osobní údaje“, jak jsou tyto definovány příslušnými právními předpisy na úseku ochrany osobních údajů, jež byly vydány na základě shodné či ekvivalentní/obdobné národní legislativy (společně dále jen „Právní předpisy na ochranu osobních údajů“), Zkoušejícího a členů Studijního personálu pro účely související se Studií, přičemž veškerá taková zpracování budou prováděna v souladu s Právními předpisy na ochranu osobních údajů. Všechny Strany souhlasí, že v případě nakládání s osobními údaji mimo území EU, budou postupovat v přísném souladu zejména s GDPR, resp. prováděcím rozhodnutím Komise EU 2016/1250.

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 6.2 Osobní údaje Subjektu studie Zkoušející zajistí získání písemného souhlasu Subjektu studie pro účely získání a použití osobních údajů Subjektu studie pro účely související se Studií, a to včetně odhalení, převodu a zpracování osobních údajů získaných dle Protokolu, a dále v souladu s příslušnými předpisy na poli ochrany dat.

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 a použití osobních údajů Subjektu studie pro účely související se Studií, a to včetně odhalení, převodu a zpracování osobních údajů získaných dle Protokolu, a dále v souladu s příslušnými předpisy na poli ochrany dat.

Study Subject Injury, indemnification, INSURANCE AND DAMAGES. The Sponsor has ensured, that contract insurance of liability for damage for the Sponsor and Investigator within the meaning of § 52 paragraph 3 letter f) Act on Drugs No. 378/2007 Coll. will be concluded before the commencement of the Study. This policy also covers compensation of death of subject or compensation of the subject in case of injury Zkoušející tímto dává souhlas a Zdravotnické zařízení souhlasí s tím, že poskytne součinnost při získávání jakýchkoli potřebných souhlasů Studijního personálu nebo jiného příslušného člena personálu Zdravotnického zařízení s přenosem těchto údajů pro výše uvedené účely do jiných zemí než do jejich vlastní země.