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No modifications will be made to the Protocol unless agreed in writing by the Sponsor and the Provider. No study subject treatments will be initiated prior to receipt of EC / S\u00daKL approval and any other compliance with Applicable Law and approvals required to conduct the Clinical Trial. poskytnutou Zadavatelem v souvislosti s akceptac\u00ed nov\u00fdch povinnost\u00ed vypl\u00fdvaj\u00edc\u00edch z role Hlavn\u00edho Zkou\u0161ej\u00edc\u00edho.", "size": 1, "samples": [{"hash": "glP0oU5tMAA", "uri": "/contracts/glP0oU5tMAA#ec-approval", "label": "Clinical Trial Agreement", "score": 22.4483230664, "published": true}], "snippet_links": [{"key": "the-sponsor-will", "type": "clause", "offset": [0, 16]}, {"key": "approval-of", "type": "clause", "offset": [24, 35]}, {"key": "the-applicable", "type": "clause", "offset": [36, 50]}, {"key": "ethics-committee", "type": "clause", "offset": [75, 91]}, {"key": "other-applicable", "type": "clause", "offset": [134, 150]}, {"key": "data-safety", "type": "clause", "offset": [163, 174]}, {"key": "clinical-trial-subject", "type": "clause", "offset": [182, 204]}, {"key": "monitoring-board", "type": "definition", "offset": [205, 221]}, {"key": "or-equivalent", "type": "definition", "offset": [222, 235]}, {"key": "by-the-provider", "type": "clause", "offset": [291, 306]}, {"key": "in-particular", "type": "clause", "offset": [342, 355]}, {"key": "the-approval", "type": "clause", "offset": [356, 368]}, {"key": "state-institute-for-drug-control", "type": "definition", "offset": [372, 404]}, {"key": "no-modifications", "type": "clause", "offset": [446, 462]}, {"key": "the-protocol", "type": "clause", "offset": [479, 491]}, {"key": "in-writing", "type": "clause", "offset": [506, 516]}, {"key": "study-subject", "type": "clause", "offset": [553, 566]}, {"key": "prior-to", "type": "definition", "offset": [596, 604]}, {"key": "receipt-of", "type": "clause", "offset": [605, 615]}, {"key": "compliance-with-applicable-law", "type": "clause", "offset": [649, 679]}, {"key": "role-hlavn\u00edho-zkou\u0161ej\u00edc\u00edho", "type": "clause", "offset": [818, 844]}], "hash": "9addd6942a70bb4068f5111c8f688767", "id": 3}, {"snippet": "The Company will obtain approval of the applicable Protocol from the Local Ethics Committee and Multicentric Ethics Committee and any other applicable independent data safety and/or clinical trial subject monitoring board or equivalent entity (\u201cEC\u201d), as Instituce. Instituce poskytne ve\u0161ker\u00fd person\u00e1l, a to zejm\u00e9na v\u010detn\u011b odborn\u00fdch pracovn\u00edk\u016f na \u00faseku laborato\u0159e, l\u00e9k\u00e1rny a klinick\u00e9 podpory a \u2587\u2587\u2587\u2587 l\u00e9ka\u0159e v m\u00ed\u0159e dostate\u010dn\u00e9 pro \u00fa\u010dely v\u010dasn\u00e9ho a \u0159\u00e1dn\u00e9ho dokon\u010den\u00ed ka\u017ed\u00e9ho Klinick\u00e9ho hodnocen\u00ed. Slu\u017eby Hlavn\u00edho Zkou\u0161ej\u00edc\u00edho jsou nezbytn\u00e9 k prov\u00e1d\u011bn\u00ed Klinick\u00e9ho hodnocen\u00ed. Pokud ukon\u010d\u00ed Hlavn\u00ed Zkou\u0161ej\u00edc\u00ed jeho/jej\u00ed vztah s Instituc\u00ed, nebo pokud z n\u011bjak\u00e9ho jin\u00e9ho d\u016fvodu nen\u00ed Hlavn\u00ed Zkou\u0161ej\u00edc\u00ed k dispozici nebo nen\u00ed-\u2587\u2587 \u2587\u2587\u2587\u2587\u2587\u2587\u2587 zajistit v\u00fdkon Klinick\u00e9ho hodnocen\u00ed, Instituce okam\u017eit\u011b ozn\u00e1m\u00ed Zadavateli tuto skute\u010dnost. Instituce ozn\u00e1m\u00ed v p\u00edsemn\u00e9 podob\u011b Spole\u010dnosti, pokud Hlavn\u00ed Zkou\u0161ej\u00edc\u00ed pl\u00e1nuje ukon\u010dit pracovn\u00ed pom\u011br v Instituci a Instituce poskytne (a) nov\u00e9 kontaktn\u00ed \u00fadaje t\u00fdkaj\u00edc\u00ed se navrhovan\u00e9ho n\u00e1stupce za Hlavn\u00edho Zkou\u0161ej\u00edc\u00edho, a (b) zajist\u00ed, \u017ee Hlavn\u00ed Zkou\u0161ej\u00edc\u00ed poskytne rozumnou podporu p\u0159i p\u0159echodu povinnost\u00ed Hlavn\u00edho Zkou\u0161ej\u00edc\u00edho na nov\u00e9ho n\u00e1stupce. Nelze-li nal\u00e9zt n\u00e1hradu p\u0159ijatelnou pro Spole\u010dnost, m\u016f\u017ee Spole\u010dnost od t\u00e9to Smlouvy odstoupit zp\u016fsobem v t\u00e9to Smlouv\u011b stanoven\u00fdm v \u010dl\u00e1nku 14.3. 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The Sponsor will apply for the Clinical Trial Authorization, in which case the Sponsor shall keep the Healthcare Provider fully apprised of the progress of ethics committee submissions and shall upon request provide the Healthcare Provider with all correspondence relating to such submissions. The Sponsor shall provide the Healthcare Provider with written confirmation of the EC\u2019s approval prior to the enrollment of any Study subjects in the Study. If the EC withdraws approval of the Study at any time, the Sponsor shall immediately notify Healthcare Provider in writing and concurrently provide a written explanation of the circumstances leading to such withdrawal. In such event Sponsor may terminate this Agreement by written notice to the Healthcare Provider effective immediately upon delivery.", "size": 1, "samples": [{"hash": "diVKTknxq2M", "uri": "/contracts/diVKTknxq2M#ec-approval", "label": "Clinical Trial Agreement", "score": 25.045123318, "published": true}], "snippet_links": [{"key": "responsible-for", "type": "clause", "offset": [21, 36]}, {"key": "clinical-trial-authorization", "type": "definition", "offset": [63, 91]}, {"key": "ethics-committee", "type": "clause", "offset": [101, 117]}, {"key": "competent-authorities", "type": "clause", "offset": [129, 150]}, {"key": "conduct-of-the", "type": "clause", "offset": [159, 173]}, {"key": "amendments-to-the-protocol", "type": "clause", "offset": [205, 231]}, {"key": "the-sponsor-will", "type": "clause", "offset": [233, 249]}, {"key": "healthcare-provider", "type": "definition", "offset": [335, 354]}, {"key": "upon-request", "type": "definition", "offset": [428, 440]}, {"key": "provide-the", "type": "clause", "offset": [441, 452]}, {"key": "relating-to", "type": "definition", "offset": [497, 508]}, {"key": "confirmation-of", "type": "clause", "offset": [590, 605]}, {"key": "prior-to-the", "type": "clause", "offset": [624, 636]}, {"key": "study-subjects", "type": "definition", "offset": [655, 669]}, {"key": "in-the-study", "type": "clause", "offset": [670, 682]}, {"key": "approval-of-the-study", "type": "clause", "offset": [704, 725]}, {"key": "at-any-time", "type": "clause", "offset": [726, 737]}, {"key": "in-writing", "type": "clause", "offset": [796, 806]}, {"key": "provide-a", "type": "definition", "offset": [824, 833]}, {"key": "written-explanation", "type": "clause", "offset": [834, 853]}, {"key": "event-sponsor", "type": "definition", "offset": [911, 924]}, {"key": "terminate-this-agreement", "type": "clause", "offset": [929, 953]}, {"key": "notice-to-the", "type": "clause", "offset": [965, 978]}, {"key": "upon-delivery", "type": "clause", "offset": [1021, 1034]}], "hash": "1400dfed80a2d433455f14234e819e22", "id": 7}, {"snippet": "The Study shall not commence until the Sponsor has obtained in writing EC approval of the terms and conditions of the Study, including the Informed Consent and related instructions for use; the Protocol; and the participation of Institution and any Research Personnel in the Study and this approval will not be submitted to the Institution. All modifications to the Protocol shall be made by the Sponsor and shall not be implemented by any Investigator until Sponsor provide them any necessary FDA or EC approvals. Modifications to the Informed Consent shall be agreed upon by the Sponsor and the Principal Investigator, and shall not be implemented by any Investigator until receipt of EC written approval. The Parties agrees that any conditions of approval imposed by the EC shall be adhered to. The Sponsor is responsible for fulfilling the legal obligations required of a Sponsor in a clinical trial in relation to S\u00daKL and the EC or to other regulatory authorities, including, , notification of the commencement and termination of the clinical trial, submission of the reports and reporting of adverse events, notification of new facts and taken measures , and other information obligations, as well as approval of the Informed Consent and its amendments, the approval of Protocol amendments.", "size": 1, "samples": [{"hash": "jErkZkMq69", "uri": "/contracts/jErkZkMq69#ec-approval", "label": "Clinical Trial Research Agreement", "score": 22.6913073238, "published": true}], "snippet_links": [{"key": "the-sponsor", "type": "clause", "offset": [35, 46]}, {"key": "in-writing", "type": "clause", "offset": [60, 70]}, {"key": "approval-of", "type": "clause", "offset": [74, 85]}, {"key": "terms-and-conditions-of-the", "type": "clause", "offset": [90, 117]}, {"key": "informed-consent", "type": "definition", "offset": [139, 155]}, {"key": "instructions-for-use", "type": "clause", "offset": [168, 188]}, {"key": "the-protocol", "type": "clause", "offset": [190, 202]}, {"key": "the-participation", "type": "clause", "offset": [208, 225]}, {"key": "research-personnel", "type": "definition", "offset": [249, 267]}, {"key": "in-the-study", "type": "clause", "offset": [268, 280]}, {"key": "the-institution", "type": "clause", "offset": [324, 339]}, {"key": "modifications-to-the", "type": "clause", "offset": [345, 365]}, {"key": "the-principal-investigator", "type": "clause", "offset": [593, 619]}, {"key": "receipt-of", "type": "clause", "offset": [676, 686]}, {"key": "written-approval", "type": "clause", "offset": [690, 706]}, {"key": "the-parties", "type": "definition", "offset": [708, 719]}, {"key": "conditions-of-approval", "type": "clause", "offset": [736, 758]}, {"key": "responsible-for", "type": "clause", "offset": [813, 828]}, {"key": "legal-obligations", "type": "definition", "offset": [844, 861]}, {"key": "clinical-trial", "type": "clause", "offset": [889, 903]}, {"key": "in-relation-to", "type": "clause", "offset": [904, 918]}, {"key": "regulatory-authorities", "type": "definition", "offset": [947, 969]}, {"key": "notification-of", "type": "definition", "offset": [984, 999]}, {"key": "termination-of-the", "type": "clause", "offset": [1021, 1039]}, {"key": "reporting-of-adverse-events", "type": "clause", "offset": [1086, 1113]}, {"key": "new-facts", "type": "definition", "offset": [1131, 1140]}, {"key": "other-information-obligations", "type": "clause", "offset": [1166, 1195]}, {"key": "the-approval", "type": "clause", "offset": [1261, 1273]}, {"key": "protocol-amendments", "type": "clause", "offset": [1277, 1296]}], "hash": "5fd6a86cb56bf7863f1138e178be3822", "id": 8}, {"snippet": "The Company will obtain approval of the applicable Protocol from the Local Ethics Committee and Multicentric Ethics Committee and any other applicable independent data safety and/or clinical trial subject monitoring board or equivalent entity (\u201cEC\u201d), as well as any other approvals required by the Institution and Applicable Law (defined below) in particular the approval of State Institute for Drug Control (\u201cS\u00daKL\u201d), to perform the Clinical Trial. No modifications will be made to the Protocol unless agreed in writing by the Company and the Institution. No study subject treatments will be initiated prior to receipt of EC / S\u00daKL approval and any other compliance with Applicable Law and approvals required to conduct the Clinical Trial. navrhovan\u00e9ho n\u00e1stupce za Hlavn\u00edho Zkou\u0161ej\u00edc\u00edho, a (b) zajist\u00ed, \u017ee Hlavn\u00ed Zkou\u0161ej\u00edc\u00ed poskytne rozumnou podporu p\u0161i p\u0161echodu povinnost\u00ed Hlavn\u00edho Zkou\u0161ej\u00edc\u00edho na nov\u00e9ho n\u00e1stupce. Nelze- li nal\u00e9zt n\u00e1hradu p\u0161ijatelnou pro Spole\u010dnost, mn\u017ee Spole\u010dnost od t\u00e9to Smlouvy odstoupit zpnsobem v t\u00e9to Smlouve stanoven\u00fdm v \u010dl\u00e1nku 14.3. Pokud je n\u00e1hrada nalezena, nov\u00fd n\u00e1stupce Zkou\u0161ej\u00edc\u00edho by \u2587\u2587\u2587 podepsat dokumentaci poskytnutou Spole\u010dnost\u00ed v souvislosti s akceptac\u00ed nov\u00fdch povinnost\u00ed vypl\u00fdvaj\u00edc\u00edch z role Hlavn\u00edho Zkou\u0161ej\u00edc\u00edho.", "size": 1, "samples": [{"hash": "iAk4PCfgFaj", "uri": "/contracts/iAk4PCfgFaj#ec-approval", "label": "Clinical Trial Agreement", "score": 25.8516310531, "published": true}], "snippet_links": [{"key": "the-company-will", "type": "clause", "offset": [0, 16]}, {"key": "approval-of", "type": "clause", "offset": [24, 35]}, {"key": "the-applicable", "type": "clause", "offset": [36, 50]}, {"key": "ethics-committee", "type": "clause", "offset": [75, 91]}, {"key": "other-applicable", "type": "clause", "offset": [134, 150]}, {"key": "data-safety", "type": "clause", "offset": [163, 174]}, {"key": "clinical-trial-subject", "type": "clause", "offset": [182, 204]}, {"key": "monitoring-board", "type": 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