{"component": "clause", "props": {"groups": [{"snippet_links": [{"key": "represents-and-warrants-that-it", "type": "clause", "offset": [15, 46]}, {"key": "will-provide", "type": "clause", "offset": [47, 59]}, {"key": "clinical-trial-insurance", "type": "clause", "offset": [60, 84]}, {"key": "in-accordance-with", "type": "definition", "offset": [85, 103]}, {"key": "the-site", "type": "clause", "offset": [183, 191]}, {"key": "promptly-notify", "type": "clause", "offset": [198, 213]}, {"key": "in-writing", "type": "clause", "offset": [236, 246]}, {"key": "illness-or-injury", "type": "definition", "offset": [263, 280]}, {"key": "adverse-reaction", "type": "definition", "offset": [313, 329]}, {"key": "investigational-product", "type": "definition", "offset": [337, 360]}, {"key": "cooperate-with", "type": "clause", "offset": [365, 379]}, {"key": "adverse-event", "type": "definition", "offset": [411, 424]}, {"key": "costs-of", "type": "clause", "offset": [466, 474]}, {"key": "treatment-of", "type": "clause", "offset": [493, 505]}, {"key": "direct-result", "type": "definition", "offset": [567, 580]}, {"key": "the-protocol", "type": "clause", "offset": [652, 664]}, {"key": "resulting-from", "type": "definition", "offset": [759, 773]}, {"key": "arising-out-of", "type": "definition", "offset": [808, 822]}, {"key": "death-of-a", "type": "clause", "offset": [855, 865]}, {"key": "except-to-the-extent", "type": "clause", "offset": [993, 1013]}, {"key": "personal-injury", "type": "definition", "offset": [1050, 1065]}, {"key": "caused-by", "type": "clause", "offset": [1069, 1078]}, {"key": "by-institution", "type": "clause", "offset": [1088, 1102]}, {"key": "comply-with", "type": "clause", "offset": [1157, 1168]}, {"key": "written-instructions", "type": "definition", "offset": [1203, 1223]}, {"key": "the-study", "type": "definition", "offset": [1246, 1255]}, {"key": "applicable-law", "type": "clause", "offset": [1264, 1278]}, {"key": "issued-by", "type": "definition", "offset": [1320, 1329]}, {"key": "regulatory-authority", "type": "definition", "offset": [1334, 1354]}, {"key": "willful-misconduct", "type": "clause", "offset": [1373, 1391]}, {"key": "failure-of-the", "type": "clause", "offset": [1462, 1476]}, {"key": "subject-to", "type": "definition", "offset": [1483, 1493]}, {"key": "the-investigator", "type": "clause", "offset": [1532, 1548]}, {"key": "relating-to", "type": "definition", "offset": [1549, 1560]}, {"key": "requirements-of-the", "type": "clause", "offset": [1565, 1584]}, {"key": "the-sponsor", "type": "clause", "offset": [1592, 1603]}, {"key": "to-reimburse", "type": "definition", "offset": [1616, 1628]}, {"key": "amount-payable", "type": "clause", "offset": [1694, 1708]}, {"key": "insurance-required", "type": "clause", "offset": [1719, 1737]}, {"key": "by-sponsor", "type": "clause", "offset": [1752, 1762]}, {"key": "actual-damages", "type": "definition", "offset": [1820, 1834]}, {"key": "legal-representative", "type": "clause", "offset": [1884, 1904]}, {"key": "legal-order", "type": "definition", "offset": [1946, 1957]}, {"key": "institution-shall", "type": "clause", "offset": [1959, 1976]}, {"key": "according-to", "type": "definition", "offset": [2015, 2027]}, {"key": "wrongful-conduct", "type": "definition", "offset": [2139, 2155]}, {"key": "breach-of-any", "type": "clause", "offset": [2159, 2172]}, {"key": "for-the-institution", "type": "definition", "offset": [2195, 2214]}, {"key": "by-this-agreement", "type": "clause", "offset": [2257, 2274]}, {"key": "notify-the", "type": "clause", "offset": [2331, 2341]}, {"key": "working-days", "type": "clause", "offset": [2380, 2392]}, {"key": "claim-for-damages", "type": "clause", "offset": [2441, 2458]}, {"key": "having-been", "type": "clause", "offset": [2459, 2470]}, {"key": "the-notice", "type": "clause", "offset": [2477, 2487]}, {"key": "registered-post", "type": "definition", "offset": [2505, 2520]}, {"key": "consent-to", "type": "clause", "offset": [2800, 2810]}, {"key": "agrees-to", "type": "clause", "offset": [2841, 2850]}, {"key": "indemnify-and-hold-harmless", "type": "clause", "offset": [2851, 2878]}, {"key": "affiliated-entities", "type": "clause", "offset": [3188, 3207]}, {"key": "adhere-to", "type": "clause", "offset": [3211, 3220]}, {"key": "provided-however", "type": "clause", "offset": [3384, 3400]}, {"key": "no-obligation-to-indemnify", "type": "clause", "offset": [3430, 3456]}, {"key": "with-respect-to", "type": "clause", "offset": [3475, 3490]}, {"key": "and-claims", "type": "clause", "offset": [3501, 3511]}, {"key": "this-section-7", "type": "clause", "offset": [3612, 3626]}, {"key": "injury-and", "type": "clause", "offset": [3654, 3664]}, {"key": "termination-or-expiration-of-this-agreement", "type": "clause", "offset": [3688, 3731]}], "snippet": "Sponsor hereby represents and warrants that it will provide clinical trial insurance in accordance with \u00a7 52, par. 3, letter f) Act on Pharmaceuticals as may be subsequently amended. The 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, 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\u2019s 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\u2019s actual damages in the amount of subject\u2019s 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 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 attachments; 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\u2019s 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\u2019s 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, its officers, agents or employees. This Section 7 subsections \u201cStudy Subject Injury and Damages\u201d shall survive termination or expiration of this Agreement.", "samples": [{"hash": "gjNYUXeM1cH", "uri": "/contracts/gjNYUXeM1cH#study-subject-injury-indemnification-insurance-and-damages", "label": "Clinical Trial Agreement", "score": 27.1417920166, "published": true}], "size": 5, "hash": "9a0d94d0bf65ade9b057025cc129dd7e", "id": 1}, {"snippet_links": [{"key": "represents-and-warrants-that-it", "type": "clause", "offset": [15, 46]}, {"key": "will-provide", "type": "clause", "offset": [47, 59]}, {"key": "clinical-trial-insurance", "type": "clause", "offset": [60, 84]}, {"key": "in-accordance-with", "type": "definition", "offset": [85, 103]}, {"key": "institution-shall", "type": "clause", "offset": [187, 204]}, {"key": "promptly-notify", "type": "clause", "offset": [205, 220]}, {"key": "in-writing", "type": "clause", "offset": [239, 249]}, {"key": "illness-or-injury", "type": "definition", "offset": [266, 283]}, {"key": "adverse-reaction", "type": "definition", "offset": [316, 332]}, {"key": "investigational-product", "type": "definition", "offset": [340, 363]}, {"key": "cooperate-with", "type": "clause", "offset": [368, 382]}, {"key": "adverse-event", "type": "definition", "offset": [414, 427]}, {"key": "costs-of", "type": "clause", "offset": [469, 477]}, {"key": "treatment-of", "type": "clause", "offset": [496, 508]}, {"key": "study-subject", "type": "clause", "offset": [511, 524]}, {"key": "direct-result", "type": "definition", "offset": [570, 583]}, {"key": "the-protocol", "type": "clause", "offset": [655, 667]}, {"key": "this-agreement", "type": "clause", "offset": [672, 686]}, {"key": "resulting-from", "type": "definition", "offset": [762, 776]}, {"key": "arising-out-of", "type": "definition", "offset": [811, 825]}, {"key": "osobn\u00ed-\u00fadaje", "type": "clause", "offset": [1040, 1052]}], "snippet": "Sponsor hereby represents and warrants that it will provide clinical trial insurance in accordance with \u00a7 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 jak\u00fdmikoli osobn\u00edmi \u00fadaji na z\u00e1klad\u011b t\u00e9to Smlouvy jako\u017eto spr\u00e1vce dat, v takov\u00e9m p\u0159\u00edpad\u011b bude IQVIA spr\u00e1vcem takov\u00fdch osobn\u00edch \u00fadaj\u016f v rozsahu, v jak\u00e9m s nimi nakl\u00e1d\u00e1. \u2587\u2587\u2587\u2587\u2587 je opr\u00e1vn\u011bn zpracov\u00e1vat \u201eosobn\u00ed \u00fadaje\u201c, jak jsou tyto definov\u00e1ny p\u0159\u00edslu\u0161n\u00fdmi pr\u00e1vn\u00edmi p\u0159edpisy na \u00faseku ochrany osobn\u00edch \u00fadaj\u016f, je\u017e byly vyd\u00e1ny na z\u00e1klad\u011b shodn\u00e9 \u010di ekvivalentn\u00ed/obdobn\u00e9 n\u00e1rodn\u00ed legislativy (spole\u010dn\u011b d\u00e1le jen \u201ePr\u00e1vn\u00ed p\u0159edpisy na ochranu osobn\u00edch \u00fadaj\u016f\u201c), Zkou\u0161ej\u00edc\u00edho a \u010dlen\u016f Studijn\u00edho person\u00e1lu pro \u00fa\u010dely souvisej\u00edc\u00ed se Studi\u00ed, p\u0159i\u010dem\u017e ve\u0161ker\u00e1 takov\u00e1 zpracov\u00e1n\u00ed budou prov\u00e1d\u011bna v souladu s Pr\u00e1vn\u00edmi p\u0159edpisy na ochranu osobn\u00edch \u00fadaj\u016f. V\u0161echny Strany souhlas\u00ed, \u017ee v p\u0159\u00edpad\u011b nakl\u00e1d\u00e1n\u00ed s osobn\u00edmi \u00fadaji mimo \u00fazem\u00ed EU, budou postupovat v p\u0159\u00edsn\u00e9m souladu zejm\u00e9na s GDPR, resp. prov\u00e1d\u011bc\u00edm rozhodnut\u00edm Komise EU 2016/1250.", "samples": [{"hash": "6o2GIrXFaWg", "uri": "/contracts/6o2GIrXFaWg#study-subject-injury-indemnification-insurance-and-damages", "label": "Clinical Trial Agreement", "score": 29.3795501488, "published": true}], "size": 2, "hash": "90e008781cde0fec06fa9aa4742bba10", "id": 2}, {"snippet_links": [{"key": "represents-and-warrants-that-it", "type": "clause", "offset": [15, 46]}, {"key": "will-provide", "type": "clause", "offset": [47, 59]}, {"key": "clinical-trial-insurance", "type": "clause", "offset": [60, 84]}, {"key": "in-accordance-with", "type": "definition", "offset": [85, 103]}, {"key": "institution-shall", "type": "clause", "offset": [187, 204]}, {"key": "promptly-notify", "type": "clause", "offset": [205, 220]}, {"key": "in-writing", "type": "clause", "offset": [243, 253]}, {"key": "illness-or-injury", "type": "definition", "offset": [270, 287]}, {"key": "adverse-reaction", "type": "definition", "offset": [320, 336]}, {"key": "investigational-product", "type": "definition", "offset": [344, 367]}, {"key": "cooperate-with", "type": "clause", "offset": [372, 386]}, {"key": "adverse-event", "type": "definition", "offset": [418, 431]}, {"key": "costs-of", "type": "clause", "offset": [473, 481]}, {"key": "treatment-of", "type": "clause", "offset": [500, 512]}, {"key": "direct-result", "type": "definition", "offset": [574, 587]}, {"key": "the-protocol", "type": "clause", "offset": [659, 671]}, {"key": "resulting-from", "type": "definition", "offset": [766, 780]}, {"key": "arising-out-of", "type": "definition", "offset": [815, 829]}, {"key": "death-of-a", "type": "clause", "offset": [862, 872]}, {"key": "except-to-the-extent", "type": "clause", "offset": [999, 1019]}, {"key": "personal-injury", "type": "definition", "offset": [1056, 1071]}, {"key": "caused-by", "type": "clause", "offset": [1075, 1084]}, {"key": "by-institution", "type": "clause", "offset": [1097, 1111]}, {"key": "comply-with", "type": "clause", "offset": [1166, 1177]}, {"key": "written-instructions", "type": "definition", "offset": [1212, 1232]}, {"key": "the-study", "type": "definition", "offset": [1255, 1264]}, {"key": "applicable-law", "type": "clause", "offset": [1273, 1287]}, {"key": "issued-by", "type": "definition", "offset": [1329, 1338]}, {"key": "regulatory-authority", "type": "definition", "offset": [1343, 1363]}, {"key": "willful-misconduct", "type": "clause", "offset": [1385, 1403]}, {"key": "failure-of-the", "type": "clause", "offset": [1477, 1491]}, {"key": "subject-to", "type": "definition", "offset": [1498, 1508]}, {"key": "the-investigator", "type": "clause", "offset": [1547, 1563]}, {"key": "relating-to", "type": "definition", "offset": [1564, 1575]}, {"key": "requirements-of-the", "type": "clause", "offset": [1580, 1599]}, {"key": "the-sponsor", "type": "clause", "offset": [1607, 1618]}, {"key": "to-reimburse", "type": "definition", "offset": [1631, 1643]}, {"key": "po\u0161kozen\u00ed-zdrav\u00ed-subjektu-studie", "type": "clause", "offset": [1697, 1729]}, {"key": "n\u00e1hrada-\u0161kody", "type": "clause", "offset": [1755, 1768]}, {"key": "poji\u0161t\u011bn\u00ed-klinick\u00e9ho-hodnocen\u00ed", "type": "clause", "offset": [1907, 1937]}, {"key": "zdravotnick\u00e9-za\u0159\u00edzen\u00ed", "type": "clause", "offset": [1939, 1960]}, {"key": "hodnocen\u00e9-l\u00e9\u010divo", "type": "clause", "offset": [2158, 2174]}, {"key": "the-claim", "type": "definition", "offset": [3652, 3661]}, {"key": "consent-to", "type": "clause", "offset": [3789, 3799]}, {"key": "agrees-to", "type": "clause", "offset": [3830, 3839]}, {"key": "indemnify-and-hold-harmless", "type": "clause", "offset": [3840, 3867]}, {"key": "affiliated-entities", "type": "clause", "offset": [4177, 4196]}, {"key": "adhere-to", "type": "clause", "offset": [4200, 4209]}, {"key": "provided-however", "type": "clause", "offset": [4373, 4389]}, {"key": "no-obligation-to-indemnify", "type": "clause", "offset": [4419, 4445]}, {"key": "with-respect-to", "type": "clause", "offset": [4464, 4479]}, {"key": "and-claims", "type": "clause", "offset": [4490, 4500]}, {"key": "this-section-7", "type": "clause", "offset": [6498, 6512]}, {"key": "injury-and", "type": "clause", "offset": [6540, 6550]}, {"key": "termination-or-expiration-of-this-agreement", "type": "clause", "offset": [6574, 6617]}, {"key": "quintiles-disclaimer", "type": "clause", "offset": [6622, 6642]}, {"key": "in-connection-with", "type": "clause", "offset": [6687, 6705]}, {"key": "liability-for", "type": "clause", "offset": [6749, 6762]}, {"key": "study-procedures", "type": "clause", "offset": [6837, 6853]}, {"key": "associated-with", "type": "definition", "offset": [6854, 6869]}, {"key": "breach-of-this-agreement", "type": "clause", "offset": [6975, 6999]}, {"key": "section-8", "type": "clause", "offset": [7019, 7028]}], "snippet": "Sponsor hereby represents and warrants that it will provide clinical trial insurance in accordance with \u00a7 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: 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\u2019s liability to reimburse the Institution under this provision shall not be 7. Po\u0161kozen\u00ed zdrav\u00ed subjektu studie, od\u0161kodn\u011bn\u00ed, poji\u0161t\u011bn\u00ed a n\u00e1hrada \u0161kody Zadavatel prohla\u0161uje a potvrzuje, \u017ee v souladu s ust. \u00a7 52 odst. 3, p\u00edsm. f) z\u00e1kona \u010d. 378/2007 Sb., o l\u00e9\u010divech, v platn\u00e9m zn\u011bn\u00ed, zajist\u00ed poji\u0161t\u011bn\u00ed klinick\u00e9ho hodnocen\u00ed. Zdravotnick\u00e9 za\u0159\u00edzen\u00ed je povinno neprodlen\u011b p\u00edsemn\u011b vyrozum\u011bt Quintiles a Zadavatele o jak\u00e9mkoli n\u00e1roku vztahuj\u00edc\u00edm se k onemocn\u011bn\u00ed \u010di \u00fajm\u011b na zdrav\u00ed, k \u2587\u2587\u2587\u2587 skute\u010dn\u011b \u010di \u00fadajn\u011b do\u0161lo v souvislosti s ne\u017e\u00e1douc\u00ed reakc\u00ed na Hodnocen\u00e9 l\u00e9\u010divo, a zavazuje se pln\u011b spolupracovat se Zadavatelem p\u0159i \u0159e\u0161en\u00ed ne\u017e\u00e1douc\u00ed ud\u00e1losti. Zadavatel uhrad\u00ed Zdravotnick\u00e9mu za\u0159\u00edzen\u00ed n\u00e1klady na bezprost\u0159edn\u00ed zdravotn\u00ed v\u00fddaje na l\u00e9\u010dbu Subjektu studie, kter\u00fd onemocn\u011bl nebo jemu\u017e byla zp\u016fsobena \u00fajma na zdrav\u00ed jako p\u0159\u00edm\u00fd n\u00e1sledek jeho l\u00e9\u010dby v souladu s ustanoven\u00edmi Protokolu a t\u00e9to Smlouvy. Zadavatel od\u0161kodn\u00ed Zdravotnick\u00e9 za\u0159\u00edzen\u00ed za ve\u0161kerou odpov\u011bdnost nebo ztr\u00e1tu vypl\u00fdvaj\u00edc\u00ed z rozsudk\u016f nebo n\u00e1rok\u016f vznikl\u00fdch z onemocn\u011bn\u00ed, \u00fajmy na zdrav\u00ed nebo \u00famrt\u00ed Subjektu studie, kter\u00e9 je p\u0159\u00edm\u00fdm n\u00e1sledkem l\u00e9\u010dby tohoto subjektu v souladu s ustanoven\u00edmi Protokolu a t\u00e9to Smlouvy, s v\u00fdjimkou p\u0159\u00edpad\u016f, kdy takov\u00e1 ne\u017e\u00e1douc\u00ed ud\u00e1lost, nemoc nebo \u00fajma na zdrav\u00ed jsou zp\u016fsobeny: a) pochyben\u00edm Zdravotnick\u00e9ho za\u0159\u00edzen\u00ed, Zkou\u0161ej\u00edc\u00edho nebo jak\u00e9hokoli jejich zam\u011bstnance jednat v souladu s touto Smlouvou, Protokolem, jakoukoli p\u00edsemnou instrukc\u00ed Zadavatele t\u00fdkaj\u00edc\u00ed se Studie nebo jak\u00fdmkoli platn\u00fdm z\u00e1konem nebo prov\u00e1d\u011bc\u00edm p\u0159edpisem nebo postupem, v\u010detn\u011b GCP, vydan\u00fdm jakoukoli regula\u010dn\u00ed autoritou nebo b) nedbalost\u00ed nebo \u00famysln\u00fdm nespr\u00e1vn\u00fdm jedn\u00e1n\u00edm Zdravotnick\u00e9ho za\u0159\u00edzen\u00ed, Zkou\u0161ej\u00edc\u00edho nebo jak\u00e9hokoli jejich z\u00e1stupce nebo c) poru\u0161en\u00edm povinnosti Studijn\u00edm Subjektem jednat v souladu s d\u016fvodn\u00fdmi pokyny Zkou\u0161ej\u00edc\u00edho t\u00fdkaj\u00edc\u00edmi se po\u017eadavk\u016f Studie. Odpov\u011bdnost Zadavatele od\u0161kodnit Zdravotnick\u00e9 za\u0159\u00edzen\u00ed i dle tohoto ustanoven\u00ed\nc) Upon Sponsor\u2019s 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; d) The Institution has recognized the claim without prior obtaining Sponsor\u2019s 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, its officers, agents or employees. nebude limitov\u00e1na \u010d\u00e1stkou splatnou dle jak\u00e9hokoli poji\u0161t\u011bn\u00ed uzav\u0159en\u00e9ho Zadavatelem, ale bude se vztahovat na celou \u010d\u00e1stku skute\u010dn\u00e9 \u0161kody Zdravotnick\u00e9ho za\u0159\u00edzen\u00ed ve v\u00fd\u0161i n\u00e1roku subjektu nebo n\u00e1roku jeho z\u00e1konn\u00e9ho z\u00e1stupce \u00fasp\u011b\u0161n\u011b uplatn\u011bn\u00e9ho dle \u010desk\u00e9ho pr\u00e1vn\u00edho \u0159\u00e1du. N\u00e1rok Zdravotnick\u00e9ho za\u0159\u00edzen\u00ed na n\u00e1hradu \u0161kody dle p\u0159edchoz\u00edho ustanoven\u00ed nevznik\u00e1, jestli\u017ee: a) po\u0161kozen\u00ed zdrav\u00ed (v\u010detn\u011b smrti) subjektu hodnocen\u00ed bylo zp\u016fsobeno \u00famysln\u011b, nedbalost\u00ed, protipr\u00e1vn\u00edm jedn\u00e1n\u00edm nebo nespln\u011bn\u00edm povinnosti stanoven\u00e9 Zdravotnick\u00e9mu za\u0159\u00edzen\u00ed \u010di Zkou\u0161ej\u00edc\u00edmu pr\u00e1vn\u00edm p\u0159edpisem nebo v t\u00e9to Smlouv\u011b, v\u010detn\u011b v\u0161ech jej\u00edch p\u0159\u00edloh; b) Zdravotnick\u00e9 za\u0159\u00edzen\u00ed do dvaceti (20) pracovn\u00edch dn\u016f ode dne, kdy se dozv\u011bd\u011blo, \u2587\u2587 \u2587\u2587\u2587 v\u016f\u010di n\u011bmu uplatn\u011bn n\u00e1rok na n\u00e1hradu \u0161kody, neozn\u00e1milo tuto skute\u010dnost p\u00edsemn\u011b Zadavateli. Ozn\u00e1men\u00ed mus\u00ed b\u00fdt odesl\u00e1no doporu\u010denou po\u0161tou Zadavateli.\nc) na \u017e\u00e1dost Zadavatele mu Zdravotnick\u00e9 za\u0159\u00edzen\u00ed neumo\u017enilo \u00fa\u010dastnit se mimosoudn\u00edho vyjedn\u00e1v\u00e1n\u00ed o vznesen\u00e9m n\u00e1roku nebo n\u00e1sledn\u00e9ho soudn\u00edho \u0159\u00edzen\u00ed; d) Zdravotnick\u00e9 za\u0159\u00edzen\u00ed uznalo vznesen\u00fd n\u00e1rok, ani\u017e by obdr\u017eelo p\u0159edchoz\u00ed p\u00edsemn\u00fd souhlas Zadavatele. Zdravotnick\u00e9 za\u0159\u00edzen\u00ed se zavazuje od\u0161kodnit a ochr\u00e1nit Quintiles, Zadavatele a jejich Sp\u0159\u00edzn\u011bn\u00e9 osoby, vedouc\u00ed pracovn\u00edky, z\u00e1stupce nebo zam\u011bstnance za ve\u0161kerou odpov\u011bdnost nebo ztr\u00e1tu vypl\u00fdvaj\u00edc\u00ed z rozsudk\u016f nebo n\u00e1rok\u016f vznikl\u00fdch z onemocn\u011bn\u00ed, \u00fajmy na zdrav\u00ed nebo \u00famrt\u00ed Subjektu studie zp\u016fsoben\u00fdch (i) nedodr\u017een\u00edm ustanoven\u00ed Protokolu a t\u00e9to Smlouvy ze strany Zdravotnick\u00e9ho za\u0159\u00edzen\u00ed, jeho vedouc\u00edch pracovn\u00edk\u016f, z\u00e1stupc\u016f, zam\u011bstnanc\u016f nebo sp\u0159\u00edzn\u011bn\u00fdch subjekt\u016f nebo (ii) nedbalost\u00ed nebo \u00famysln\u00fdm protipr\u00e1vn\u00edm jedn\u00e1n\u00edm Zdravotnick\u00e9ho za\u0159\u00edzen\u00ed, jeho vedouc\u00edch pracovn\u00edk\u016f, z\u00e1stupc\u016f, zam\u011bstnanc\u016f nebo sp\u0159\u00edzn\u011bn\u00fdch subjekt\u016f, av\u0161ak s \u2587\u2587\u2587, \u017ee Zdravotnick\u00e9 za\u0159\u00edzen\u00ed nebude povinno od\u0161kodnit a ochr\u00e1nit za rozsudky a n\u00e1roky vypl\u00fdvaj\u00edc\u00ed z nedbalosti a \u00famysln\u00e9ho protipr\u00e1vn\u00edho jedn\u00e1n\u00ed Zadavatele, jeho This Section 7 subsections \u201cStudy Subject Injury and Damages\u201d shall survive termination or expiration of this Agreement. 8. Quintiles Disclaimer Quintiles expressly disclaims any liability in connection with the Investigational Product, including any liability for any claim arising out of a condition caused by or allegedly caused by any Study procedures associated with such product except to the extent that such liability is caused by the negligence, willful misconduct or breach of this Agreement by Quintiles. This Section 8 \u201cQuintiles Disclaimer\u201d shall survive termination or expiration of this Agreement.", "samples": [{"hash": "fLu0ZduSBkr", "uri": "/contracts/fLu0ZduSBkr#study-subject-injury-indemnification-insurance-and-damages", "label": "Clinical Trial Agreement", "score": 25.2430746171, "published": true}], "size": 2, "hash": "04a8a8e81c49a1560a7fbfa1cc0bf63c", "id": 3}, {"snippet_links": [{"key": "represents-and-warrants-that-it", "type": "clause", "offset": [15, 46]}, {"key": "will-provide", "type": "clause", "offset": [47, 59]}, {"key": "clinical-trial-insurance", "type": "clause", "offset": [60, 84]}, {"key": "in-accordance-with", "type": "definition", "offset": [85, 103]}, {"key": "certificate-of-insurance", "type": "definition", "offset": [205, 229]}, {"key": "the-site", "type": "clause", "offset": [270, 278]}, {"key": "promptly-notify", "type": "clause", "offset": [285, 300]}, {"key": "in-writing", "type": "clause", "offset": [319, 329]}, {"key": "illness-or-injury", "type": "definition", "offset": [346, 363]}, {"key": "adverse-reaction", "type": "definition", "offset": [396, 412]}, {"key": "investigational-product", "type": "definition", "offset": [420, 443]}, {"key": "cooperate-with", "type": "clause", "offset": [448, 462]}, {"key": "adverse-event", "type": "definition", "offset": [494, 507]}, {"key": "costs-of", "type": "clause", "offset": [549, 557]}, {"key": "treatment-of", "type": "clause", "offset": [576, 588]}, {"key": "study-subject", "type": "clause", "offset": [591, 604]}, {"key": "direct-result", "type": "definition", "offset": [650, 663]}, {"key": "administration-of-the", "type": "clause", "offset": [671, 692]}, {"key": "the-protocol", "type": "clause", "offset": [771, 783]}, {"key": "this-agreement", "type": "clause", "offset": [788, 802]}, {"key": "immaterial-loss", "type": "definition", "offset": [883, 898]}, {"key": "resulting-from", "type": "definition", "offset": [899, 913]}, {"key": "arising-out-of", "type": "definition", "offset": [948, 962]}, {"key": "death-of-a", "type": "clause", "offset": [995, 1005]}, {"key": "except-to-the-extent", "type": "clause", "offset": [1133, 1153]}, {"key": "personal-injury", "type": "definition", "offset": [1190, 1205]}, {"key": "caused-by", "type": "clause", "offset": [1209, 1218]}, {"key": "by-institution", "type": "clause", "offset": [1231, 1245]}, {"key": "research-company", "type": "definition", "offset": [1264, 1280]}, {"key": "comply-with", "type": "clause", "offset": [1321, 1332]}, {"key": "written-instructions", "type": "definition", "offset": [1367, 1387]}, {"key": "the-study", "type": "definition", "offset": [1410, 1419]}, {"key": "applicable-law", "type": "clause", "offset": [1428, 1442]}, {"key": "issued-by", "type": "definition", "offset": [1484, 1493]}, {"key": "regulatory-authority", "type": "definition", "offset": [1498, 1518]}, {"key": "ukon\u010den\u00ed-platnosti", "type": "clause", "offset": [1545, 1563]}], "snippet": "Sponsor hereby represents and warrants that it will provide clinical trial insurance in accordance with \u00a7 52, par. 3, letter f) Act on Pharmaceuticals as may be subsequently amended, to sufficient extent. Certificate of Insurance is incorporated herein as Attachment B. The Site 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 administration of the Investigational Product to such Study Subject in accordance with the terms of the Protocol and this Agreement. Sponsor shall indemnify Institution for and against any liability, material or immaterial 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 Research Company 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 platnosti i v p\u0159\u00edpad\u011b ukon\u010den\u00ed platnosti \u010di p\u0159i vypr\u0161en\u00ed platnosti t\u00e9to Smlouvy. 7", "samples": [{"hash": "aOQ5o4cpyHL", "uri": "/contracts/aOQ5o4cpyHL#study-subject-injury-indemnification-insurance-and-damages", "label": "Clinical Trial Agreement", "score": 29.9897990173, "published": true}], "size": 2, "hash": "a87ebbd5a6096e2a838602a4a43ac42e", "id": 4}, {"snippet_links": [{"key": "represents-and-warrants-that-it", "type": "clause", "offset": [20, 51]}, {"key": "will-provide", "type": "clause", "offset": [52, 64]}, {"key": "clinical-trial-insurance", "type": "clause", "offset": [65, 89]}, {"key": "in-accordance-with", "type": "definition", "offset": [90, 108]}, {"key": "certificate-of-insurance", "type": "definition", "offset": [202, 226]}, {"key": "the-site", "type": "clause", "offset": [263, 271]}, {"key": "promptly-notify", "type": "clause", "offset": [278, 293]}, {"key": "in-writing", "type": "clause", "offset": [302, 312]}, {"key": "illness-or-injury", "type": "definition", "offset": [329, 346]}, {"key": "adverse-reaction", "type": "definition", "offset": [379, 395]}, {"key": "investigational-product", "type": "definition", "offset": [403, 426]}, {"key": "cooperate-with", "type": "clause", "offset": [431, 445]}, {"key": "adverse-event", "type": "definition", "offset": [477, 490]}, {"key": "reasonable-and-necessary", "type": "definition", "offset": [541, 565]}, {"key": "expenses-incurred", "type": "clause", "offset": [574, 591]}, {"key": "by-provider", "type": "clause", "offset": [592, 603]}, {"key": "treatment-of", "type": "clause", "offset": [612, 624]}, {"key": "illness-of", "type": "clause", "offset": [659, 669]}, {"key": "bodily-injury-to", "type": "clause", "offset": [673, 689]}, {"key": "study-subject", "type": "clause", "offset": [692, 705]}, {"key": "caused-by", "type": "clause", "offset": [711, 720]}, {"key": "the-study", "type": "definition", "offset": [734, 743]}, {"key": "the-protocol", "type": "clause", "offset": [800, 812]}, {"key": "except-to-the-extent", "type": "clause", "offset": [814, 834]}, {"key": "personal-injury", "type": "definition", "offset": [871, 886]}, {"key": "failure-by", "type": "clause", "offset": [904, 914]}, {"key": "comply-with", "type": "clause", "offset": [978, 989]}, {"key": "this-agreement", "type": "clause", "offset": [990, 1004]}, {"key": "written-instructions", "type": "definition", "offset": [1024, 1044]}, {"key": "concerning-the", "type": "clause", "offset": [1056, 1070]}, {"key": "applicable-law", "type": "clause", "offset": [1085, 1099]}, {"key": "osobn\u00ed-\u00fadaje", "type": "clause", "offset": [1157, 1169]}, {"key": "ukon\u010den\u00ed-platnosti", "type": "clause", "offset": [1203, 1221]}], "snippet": "7.1. Sponsor hereby represents and warrants that it will provide clinical trial insurance in accordance with \u00a7 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 \u010cl\u00e1nek 6 \u201cOsobn\u00ed \u00fadaje\u201d z\u016fstane v platnosti i v p\u0159\u00edpad\u011b ukon\u010den\u00ed platnosti \u010di p\u0159i vypr\u0161en\u00ed platnosti t\u00e9to Smlouvy.", "samples": [{"hash": "ctDOQJ7qGNH", "uri": "/contracts/ctDOQJ7qGNH#study-subject-injury-indemnification-insurance-and-damages", "label": "Clinical Trial Agreement", "score": 28.9657396582, "published": true}], "size": 1, "hash": "75c3cbd2b04cae5f61c366ce80e4e79d", "id": 5}, {"snippet_links": [{"key": "represents-and-warrants-that-it", "type": "clause", "offset": [15, 46]}, {"key": "will-provide", "type": "clause", "offset": [47, 59]}, {"key": "clinical-trial-insurance", "type": "clause", "offset": [60, 84]}, {"key": "in-accordance-with", "type": "definition", "offset": [85, 103]}, {"key": "period-of-study", "type": "clause", "offset": [199, 214]}], "snippet": "Sponsor hereby represents and warrants that it will provide clinical trial insurance in accordance with \u00a7 52, par. 3, letter f) Act on Pharmaceuticals as may be subsequently amended during the whole period of study.. transparentnost; a", "samples": [{"hash": "kh3vhuvTTYN", "uri": "/contracts/kh3vhuvTTYN#study-subject-injury-indemnification-insurance-and-damages", "label": "Clinical Trial Agreement", "score": 30.8298869803, "published": true}], "size": 1, "hash": "2a3faeb990058a953b20fd35bf2eadb2", "id": 6}, {"snippet_links": [{"key": "zdravotnick\u00e9-za\u0159\u00edzen\u00ed", "type": "clause", "offset": [0, 21]}], "snippet": "Zdravotnick\u00e9 za\u0159\u00edzen\u00ed sv\u00e9mu Person\u00e1lu po\u017eadovan\u00e9 informace o zpracov\u00e1n\u00ed \u00fadaj\u016f Zadavatelem, aby Zadavatel ve vztahu k Person\u00e1lu jednal v souladu s po\u017eadavky ohledn\u011b poskytnut\u00ed informac\u00ed vypl\u00fdvaj\u00edc\u00ed z P\u0159\u00edslu\u0161n\u00fdch z\u00e1kon\u016f na ochranu osobn\u00edch \u00fadaj\u016f. K tomuto \u00fa\u010delu m\u016f\u017ee Zdravotnick\u00e9 za\u0159\u00edzen\u00ed pou\u017e\u00edt \u0161ablonu v P\u0159\u00edloze B. Pro \u00fa\u010dely \u010cl\u00e1nku 6.1 (iv) vynalo\u017e\u00ed Zdravotnick\u00e9 za\u0159\u00edzen\u00ed p\u0159im\u011b\u0159en\u00e9 \u00fasil\u00ed k tomu, aby z\u00edskalo od Person\u00e1lu souhlas se zpracov\u00e1n\u00edm osobn\u00edch \u00fadaj\u016f, kter\u00e9 \u2587\u2587\u2587\u2587 b\u00fdt publikov\u00e1ny. Person\u00e1l m\u016f\u017ee poskytnout souhlas podeps\u00e1n\u00edm P\u0159\u00edlohy", "samples": [{"hash": "21MaRGBWrBM", "uri": "/contracts/21MaRGBWrBM#study-subject-injury-indemnification-insurance-and-damages", "label": "Clinical Trial Agreement", "score": 31.6191838489, "published": true}], "size": 1, "hash": "e1824f465ecb0ab25a6b7dc30e9155eb", "id": 7}, {"snippet_links": [{"key": "represents-and-warrants-that-it", "type": "clause", "offset": [15, 46]}, {"key": "will-provide", "type": "clause", "offset": [47, 59]}, {"key": "clinical-trial-insurance", "type": "clause", "offset": [60, 84]}, {"key": "in-accordance-with", "type": "definition", "offset": [85, 103]}, {"key": "institution-shall", "type": "clause", "offset": [187, 204]}, {"key": "promptly-notify", "type": "clause", "offset": [205, 220]}, {"key": "in-writing", "type": "clause", "offset": [243, 253]}, {"key": "illness-or-injury", "type": "definition", "offset": [270, 287]}, {"key": "adverse-reaction", "type": "definition", "offset": [320, 336]}, {"key": "investigational-product", "type": "definition", "offset": [344, 367]}, {"key": "cooperate-with", "type": "clause", "offset": [372, 386]}, {"key": "adverse-event", "type": "definition", "offset": [418, 431]}, {"key": "costs-of", "type": "clause", "offset": [473, 481]}, {"key": "osobn\u00ed-\u00fadaje-subjektu-studie", "type": "clause", "offset": [486, 514]}], "snippet": "Sponsor hereby represents and warrants that it will provide clinical trial insurance in accordance with \u00a7 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 Osobn\u00ed \u00fadaje Subjektu studie Zkou\u0161ej\u00edc\u00ed zajist\u00ed z\u00edsk\u00e1n\u00ed p\u00edsemn\u00e9ho souhlasu Subjektu studie pro \u00fa\u010dely z\u00edsk\u00e1n\u00ed a pou\u017eit\u00ed osobn\u00edch \u00fadaj\u016f Subjektu studie pro \u00fa\u010dely souvisej\u00edc\u00ed se Studi\u00ed, a to v\u010detn\u011b odhalen\u00ed, p\u0159evodu a zpracov\u00e1n\u00ed osobn\u00edch \u00fadaj\u016f z\u00edskan\u00fdch dle Protokolu, a d\u00e1le v souladu s p\u0159\u00edslu\u0161n\u00fdmi p\u0159edpisy na poli ochrany dat.", "samples": [{"hash": "4JfY52EdOKk", "uri": "/contracts/4JfY52EdOKk#study-subject-injury-indemnification-insurance-and-damages", "label": "Clinical Trial Agreement", "score": 33.3199291715, "published": true}], "size": 1, "hash": "45437f5f1b1972e49130774e2e0daf25", "id": 8}, {"snippet_links": [{"key": "represents-and-warrants-that-it", "type": "clause", "offset": [19, 50]}, {"key": "will-provide", "type": "clause", "offset": [51, 63]}, {"key": "clinical-trial-insurance", "type": "clause", "offset": [64, 88]}, {"key": "in-accordance-with", "type": "definition", "offset": [89, 107]}, {"key": "certificate-of-insurance", "type": "definition", "offset": [201, 225]}, {"key": "po\u0161kozen\u00ed-zdrav\u00ed-subjektu-studie", "type": "clause", "offset": [265, 297]}, {"key": "n\u00e1hrada-\u0161kody", "type": "clause", "offset": [299, 312]}, {"key": "poji\u0161t\u011bn\u00ed-a-od\u0161kodn\u011bn\u00ed", "type": "clause", "offset": [314, 336]}, {"key": "poji\u0161t\u011bn\u00ed-klinick\u00e9ho-hodnocen\u00ed", "type": "clause", "offset": [479, 509]}, {"key": "institution-shall", "type": "clause", "offset": [574, 591]}, {"key": "promptly-notify", "type": "clause", "offset": [592, 607]}, {"key": "in-writing", "type": "clause", "offset": [630, 640]}, {"key": "illness-or-injury", "type": "definition", "offset": [657, 674]}, {"key": "adverse-reaction", "type": "definition", "offset": [707, 723]}, {"key": "investigational-product", "type": "definition", "offset": [731, 754]}, {"key": "cooperate-with", "type": "clause", "offset": [759, 773]}, {"key": "adverse-event", "type": "definition", "offset": [805, 818]}, {"key": "reasonable-and-necessary", "type": "definition", "offset": [872, 896]}, {"key": "expenses-incurred", "type": "clause", "offset": [905, 922]}, {"key": "by-institution", "type": "clause", "offset": [923, 937]}, {"key": "treatment-of", "type": "clause", "offset": [946, 958]}, {"key": "zdravotnick\u00e9-za\u0159\u00edzen\u00ed", "type": "clause", "offset": [977, 998]}, {"key": "hodnocen\u00e9-l\u00e9\u010divo", "type": "clause", "offset": [1197, 1213]}, {"key": "indemnify-and-hold-harmless", "type": "clause", "offset": [1398, 1425]}, {"key": "employees-and-agents", "type": "definition", "offset": [1457, 1477]}, {"key": "actions-or-suits", "type": "clause", "offset": [1532, 1548]}, {"key": "personal-injury-or-death", "type": "clause", "offset": [1553, 1577]}, {"key": "arising-out-of", "type": "definition", "offset": [1587, 1601]}, {"key": "study-subject", "type": "clause", "offset": [1623, 1636]}, {"key": "the-protocol", "type": "clause", "offset": [1656, 1668]}, {"key": "provided-that", "type": "clause", "offset": [1670, 1683]}, {"key": "written-instruction", "type": "clause", "offset": [1766, 1785]}, {"key": "this-agreement", "type": "clause", "offset": [1803, 1817]}, {"key": "klinick\u00e9-hodnocen\u00ed", "type": "clause", "offset": [3394, 3412]}], "snippet": "7.1 Sponsor hereby represents and warrants that it will provide clinical trial insurance in accordance with \u00a7 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. PO\u0160KOZEN\u00cd ZDRAV\u00cd SUBJEKTU STUDIE, N\u00c1HRADA \u0160KODY, POJI\u0160T\u011aN\u00cd A OD\u0160KODN\u011aN\u00cd 7.1 Zadavatel prohla\u0161uje a potvrzuje, \u017ee v souladu s ust. \u00a7 52 odst. 3, p\u00edsm. f) z\u00e1kona \u010d. 378/2007 Sb., o l\u00e9\u010divech, v platn\u00e9m zn\u011bn\u00ed, zajist\u00ed poji\u0161t\u011bn\u00ed klinick\u00e9ho hodnocen\u00ed. Kopie pojistn\u00e9ho certifik\u00e1tu tvo\u0159\u00ed p\u0159\u00edlohu C t\u00e9to 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 Zdravotnick\u00e9 za\u0159\u00edzen\u00ed je povinno neprodlen\u011b p\u00edsemn\u011b vyrozum\u011bt Quintiles a Zadavatele o jak\u00e9mkoli n\u00e1roku vztahuj\u00edc\u00edmu se k onemocn\u011bn\u00ed \u010di \u00fajm\u011b na zdrav\u00ed, k nim\u017e skute\u010dn\u011b \u010di \u00fadajn\u011b do\u0161lo v souvislosti s ne\u017e\u00e1douc\u00ed reakc\u00ed na Hodnocen\u00e9 l\u00e9\u010divo a zavazuje se pln\u011b spolupracovat se Zadavatelem p\u0159i \u0159e\u0161en\u00ed ne\u017e\u00e1douc\u00ed ud\u00e1losti. Zadavatel uhrad\u00ed Zdravotnick\u00e9mu za\u0159\u00edzen\u00ed p\u0159\u00edm\u00e9, p\u0159im\u011b\u0159en\u00e9 a nezbytn\u00e9 zdravotn\u00ed\n7.2 Sponsor shall defend, indemnify and hold harmless the Institution, its officers, employees and agents (\u201cIndemnitees\u201d) 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.\n2.1 The Study is conducted in accordance with the Protocol, together with any written instruction from Sponsor and this Agreement; v\u00fddaje, kter\u00e9 vznikly Zdravotnick\u00e9mu za\u0159\u00edzen\u00ed v souvislosti s l\u00e9\u010dbou jak\u00fdchkoli ne\u017e\u00e1douc\u00edch ud\u00e1lost\u00ed, nemoc\u00ed nebo \u00fajmy na zdrav\u00ed Subjektu studie zp\u016fsoben\u00e9 l\u00e9\u010dbou Subjektu studie v souladu s Protokolem, s v\u00fdjimkou p\u0159\u00edpad\u016f, kdy takov\u00e1 ne\u017e\u00e1douc\u00ed ud\u00e1lost, nemoc nebo \u00fajma na zdrav\u00ed je zp\u016fsobeno: a) pochyben\u00edm Zdravotnick\u00e9ho za\u0159\u00edzen\u00ed, Zkou\u0161ej\u00edc\u00edho nebo jak\u00e9hokoliv jejich zam\u011bstnance jednat v souladu s touto Smlouvou, Protokolem, jakoukoliv p\u00edsemnou instrukc\u00ed Zadavatele t\u00fdkaj\u00edc\u00ed se Studie, nebo jak\u00e9hokoliv platn\u00e9ho z\u00e1kona nebo prov\u00e1d\u011bc\u00edho p\u0159edpisu nebo postupu, v\u010detn\u011b GCP, vydan\u00e9m jakoukoliv regula\u010dn\u00ed autoritou, nebo b) nedbalost\u00ed nebo \u00famysln\u00fdm nespr\u00e1vn\u00fdm jedn\u00e1n\u00edm Zdravotnick\u00e9ho za\u0159\u00edzen\u00ed, Zkou\u0161ej\u00edc\u00edm nebo jak\u00fdmkoliv jejich z\u00e1stupcem nebo c) poru\u0161en\u00edm povinnosti Studijn\u00edm Subjektem jednat v souladu s d\u016fvodn\u00fdmi pokyny Zkou\u0161ej\u00edc\u00edho t\u00fdkaj\u00edc\u00edch se po\u017eadavk\u016f Studie. Odpov\u011bdnost Zadavatele od\u0161kodnit Zdravotnick\u00e9 za\u0159\u00edzen\u00ed i dle tohoto ustanoven\u00ed nebude limitov\u00e1na \u010d\u00e1stkou splatnou dle jak\u00e9hokoliv poji\u0161t\u011bn\u00ed uzav\u0159en\u00e9ho Zadavatelem, ale bude se vztahovat na celou \u010d\u00e1stku skute\u010dn\u00e9 \u0161kody Zdravotnick\u00e9ho za\u0159\u00edzen\u00ed ve v\u00fd\u0161i n\u00e1roku subjektu nebo n\u00e1roku jeho z\u00e1konn\u00e9ho z\u00e1stupce \u00fasp\u011b\u0161n\u011b uplatn\u011bn\u00e9ho dle \u010desk\u00e9ho pr\u00e1vn\u00edho \u0159\u00e1du.\n7.2 Zadavatel nahrad\u00ed Zdravotnick\u00e9mu za\u0159\u00edzen\u00ed a jeho zam\u011bstnanc\u016fm a z\u00e1stupc\u016fm (d\u00e1le jen \u201eOpr\u00e1vn\u011bn\u00ed p\u0159\u00edjemci n\u00e1hrady \u0161kody\u201c) vzniklou \u0161kodu, bude je h\u00e1jit a chr\u00e1nit p\u0159ed ve\u0161kerou odpov\u011bdnost\u00ed, n\u00e1roky, \u017ealobami a soudn\u00edmi spory t\u00fdkaj\u00edc\u00edmi se \u00fajmy na zdrav\u00ed nebo smrti vznikl\u00fdmi p\u0159\u00edmo z l\u00e9\u010dby Subjektu Studie v souladu s Protokolem, a to za p\u0159edpokladu, \u017ee: 7.2.1 Klinick\u00e9 hodnocen\u00ed bude prov\u00e1d\u011bno v souladu s Protokolem a p\u0159\u00edpadn\u00fdmi dal\u0161\u00edmi p\u00edsemn\u00fdmi pokyny Zadavatele a v souladu", "samples": [{"hash": "6vhYtt66k3j", "uri": "/contracts/6vhYtt66k3j#study-subject-injury-indemnification-insurance-and-damages", "label": "Clinical Trial Agreement", "score": 31.1442066019, "published": true}], "size": 1, "hash": "bf9a94ad0320010aeff0d648150a6e23", "id": 9}, {"snippet_links": [{"key": "the-sponsor", "type": "clause", "offset": [0, 11]}, {"key": "contract-insurance", "type": "clause", "offset": [30, 48]}, {"key": "liability-for-damage", "type": "clause", "offset": [52, 72]}, {"key": "meaning-of", "type": "clause", "offset": [117, 127]}, {"key": "paragraph-3", "type": "definition", "offset": [133, 144]}, {"key": "the-study", "type": "definition", "offset": [232, 241]}, {"key": "this-policy", "type": "definition", "offset": [243, 254]}, {"key": "death-of", "type": "definition", "offset": [283, 291]}, {"key": "the-subject", "type": "clause", "offset": [319, 330]}, {"key": "in-case-of-injury", "type": "clause", "offset": [331, 348]}, {"key": "zdravotnick\u00e9-za\u0159\u00edzen\u00ed", "type": "clause", "offset": [381, 402]}], "snippet": "The Sponsor has ensured, that contract insurance of liability for damage for the Sponsor and Investigator within the meaning of \u00a7 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 Zkou\u0161ej\u00edc\u00ed t\u00edmto d\u00e1v\u00e1 souhlas a Zdravotnick\u00e9 za\u0159\u00edzen\u00ed souhlas\u00ed s t\u00edm, \u017ee poskytne sou\u010dinnost p\u0159i z\u00edsk\u00e1v\u00e1n\u00ed jak\u00fdchkoli pot\u0159ebn\u00fdch souhlas\u016f Studijn\u00edho person\u00e1lu nebo jin\u00e9ho p\u0159\u00edslu\u0161n\u00e9ho \u010dlena person\u00e1lu Zdravotnick\u00e9ho za\u0159\u00edzen\u00ed s p\u0159enosem t\u011bchto \u00fadaj\u016f pro v\u00fd\u0161e uveden\u00e9 \u00fa\u010dely do jin\u00fdch zem\u00ed ne\u017e do jejich vlastn\u00ed zem\u011b.", "samples": [{"hash": "2uBcPNyUxfN", "uri": "/contracts/2uBcPNyUxfN#study-subject-injury-indemnification-insurance-and-damages", "label": "Clinical Trial Agreement", "score": 27.752224987, "published": true}], "size": 1, "hash": "a66999860fb2abe1114937a85d7240dc", "id": 10}], "next_curs": "CoMBEn1qFXN-bGF3aW5zaWRlcmNvbnRyYWN0c3JfCxIWQ2xhdXNlU25pcHBldEdyb3VwX3Y1NiJDc3R1ZHktc3ViamVjdC1pbmp1cnktaW5kZW1uaWZpY2F0aW9uLWluc3VyYW5jZS1hbmQtZGFtYWdlcyMwMDAwMDAwYQyiAQJlbhgAIAA=", "clause": {"title": "Study Subject Injury, indemnification, INSURANCE AND DAMAGES", "children": [["", ""], ["p\u0159etrv\u00e1vaj\u00edc\u00ed", "P\u0159etrv\u00e1vaj\u00edc\u00ed"], ["term", "Term"], ["assignment-of-the-agreement", "Assignment of the Agreement"], ["platnost", "Platnost"]], "size": 19, "parents": [], "id": "study-subject-injury-indemnification-insurance-and-damages", "related": [["indemnification-insurance", "Indemnification; Insurance", "Indemnification; Insurance"], ["insurance-and-indemnification", "Insurance and Indemnification", "Insurance and Indemnification"], ["indemnification-and-liability-insurance", "Indemnification and Liability Insurance", "Indemnification and Liability Insurance"], ["liability-indemnification", "Liability Indemnification", "Liability Indemnification"], ["limits-of-liability-indemnification", "Limits of Liability; Indemnification", "Limits of Liability; Indemnification"]], "related_snippets": [], "updated": "2025-07-07T12:37:53+00:00"}, "json": true, "cursor": ""}}