{"component": "clause", "props": {"groups": [{"snippet_links": [{"key": "the-term", "type": "clause", "offset": [0, 8]}, {"key": "phase-i-study", "type": "clause", "offset": [39, 52]}, {"key": "phase-ii-study", "type": "definition", "offset": [54, 68]}, {"key": "phase-iii-study", "type": "clause", "offset": [70, 85]}], "snippet": "The term \u201cClinical Study\u201d shall mean a Phase I Study, Phase II Study, Phase III Study, as applicable.", "size": 4, "samples": [{"hash": "5YduHGoMT7d", "uri": "/contracts/5YduHGoMT7d#clinical-study", "label": "Collaboration and License Agreement (C4 Therapeutics, Inc.)", "score": 31.6913073238, "published": true}, {"hash": "gxmQcM8SeQm", "uri": "/contracts/gxmQcM8SeQm#clinical-study", "label": "Collaboration and License Agreement (C4 Therapeutics, Inc.)", "score": 31.5954825462, "published": true}], "hash": "79720cdb2542e88f63a60a7773debabc", "id": 2}, {"snippet_links": [{"key": "days-after", "type": "definition", "offset": [46, 56]}, {"key": "date-of", "type": "clause", "offset": [61, 68]}, {"key": "execution-of-this-agreement", "type": "clause", "offset": [90, 117]}, {"key": "an-additional", "type": "clause", "offset": [187, 200]}, {"key": "completion-of-a", "type": "clause", "offset": [317, 332]}, {"key": "working-with", "type": "definition", "offset": [499, 511]}, {"key": "this-article", "type": "definition", "offset": [658, 670]}, {"key": "responsible-for", "type": "clause", "offset": [740, 755]}, {"key": "additional-costs", "type": "definition", "offset": [760, 776]}, {"key": "with-respect-to", "type": "clause", "offset": [777, 792]}, {"key": "costs-of", "type": "clause", "offset": [866, 874]}, {"key": "pay-to", "type": "definition", "offset": [1022, 1028]}, {"key": "payment-of", "type": "definition", "offset": [1083, 1093]}, {"key": "five-thousand", "type": "clause", "offset": [1101, 1114]}, {"key": "in-the-event", "type": "clause", "offset": [1133, 1145]}, {"key": "within-thirty", "type": "clause", "offset": [1219, 1232]}, {"key": "after-notification", "type": "clause", "offset": [1243, 1261]}, {"key": "for-example", "type": "definition", "offset": [1322, 1333]}, {"key": "study-costs", "type": "clause", "offset": [1348, 1359]}, {"key": "pursuant-to-paragraph", "type": "clause", "offset": [1479, 1500]}], "snippet": "A. Within five (5) days and within sixty (60) days after the date of the December 3, 2004 execution of this Agreement, Life Medical shall give one hundred thousand ($100,000) dollars and an additional one hundred thousand ($100,000) dollars, respectively, to Scantek, which funds shall be utilized by Scantek for the completion of a clinical study consisting of at least two hundred (200) patients (the \"Clinical Study\") by Dr. Virgilio Sacchini (\"Dr. Sacchi\u2587\u2587\") \u2587\u2587 \u2587\u2587 \u2587\u2587\u2587 \u2587\u2587\u2587\u2587\u2587\u2587\u2587 or \u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587st working with Dr. Sacchini, if Dr. Sacchini is not \u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587 \u2587or an\u2587 \u2587\u2587\u2587\u2587\u2587\u2587.\nB. After the two hundred thousand ($200,000) dollars set forth in Paragraph \"A\" of this Article \"3\" of this Agreement has been utilized by Scantek, Scantek shall be responsible for all additional costs with respect to the Clinical Study; provided, however, that if Scantek incurs additional costs of the Clinical Study beyond the two hundred thousand ($200,000) set forth in Paragraph \"A\" of this Article \"3\" of this Agreement, Life Medical shall pay to Scantek 50% of such additional costs, up to a maximum payment of twenty-five thousand ($25,000) dollars in the event that Scantek pays at least fifty thousand ($50,000) in additional costs, within thirty (30) days after notification by Scantek that Scantek has paid said additional costs. If, for example, the Clinical Study costs an additional forty thousand ($40,000) dollars beyond the two hundred thousand ($200,000) dollars paid by Life Medical pursuant to Paragraph \"A\" of this Article \"3\" of this Agreement, Life Medical shall pay $20,000 to Scantek.\nC. Life Medical shall not be responsible for any costs with respect to the Clinical Study in excess of the aggregate of two hundred twenty five thousand ($225,000) dollars set forth in Paragraphs \"A\" and \"B\" of this Article \"3\" of this Agreement.", "size": 1, "samples": [{"hash": "58NBITGkUQN", "uri": "/contracts/58NBITGkUQN#clinical-study", "label": "Distribution Agreement (Scantek Medical Inc)", "score": 18.0, "published": true}], "hash": "632ba53ce38f43cb7108ba1592e80728", "id": 5}, {"snippet_links": [{"key": "the-term", "type": "clause", "offset": [0, 8]}], "snippet": "The term \u201c", "size": 30, "samples": [{"hash": "f0gfXfivcnd", "uri": "/contracts/f0gfXfivcnd#clinical-study", "label": "License and Collaboration Agreement", "score": 35.7160069321, "published": true}, {"hash": "83YABg8UMmc", "uri": "/contracts/83YABg8UMmc#clinical-study", "label": "License Agreement (Kiniksa Pharmaceuticals, Ltd.)", "score": 33.8377823409, "published": true}, {"hash": "7uWGVx1DHQa", "uri": "/contracts/7uWGVx1DHQa#clinical-study", "label": "Research Collaboration and License Agreement (HOOKIPA Pharma Inc.)", "score": 33.7994524298, "published": true}], "hash": "e6abc5b81feb3c0a954d10eb23e67d9b", "id": 1}, {"snippet_links": [{"key": "agree-to", "type": "clause", "offset": [26, 34]}, {"key": "best-efforts", "type": "clause", "offset": [45, 57]}, {"key": "professional-expertise", "type": "clause", "offset": [62, 84]}, {"key": "according-to", "type": "definition", "offset": [115, 127]}, {"key": "the-protocol", "type": "clause", "offset": [128, 140]}, {"key": "to-provide", "type": "definition", "offset": [184, 194]}, {"key": "qualified-personnel", "type": "definition", "offset": [200, 219]}, {"key": "materials-to-be", "type": "clause", "offset": [250, 265]}, {"key": "by-sponsor", "type": "clause", "offset": [275, 285]}, {"key": "comply-with", "type": "clause", "offset": [410, 421]}, {"key": "all-applicable-laws-and-regulations", "type": "definition", "offset": [422, 457]}, {"key": "relating-to", "type": "definition", "offset": [458, 469]}, {"key": "materials-and-facilities", "type": "clause", "offset": [497, 521]}, {"key": "employment-of", "type": "clause", "offset": [533, 546]}], "snippet": "Hospital and Investigator agree to use their best efforts and professional expertise to perform the Clinical Study according to the Protocol as set forth in Exhibit A. Hospital agrees to provide such qualified personnel, equipment, materials (except materials to be provided by Sponsor as hereinafter set forth) and facilities as are necessary to perform the Clinical Study. Hospital and Investigator agree to comply with all applicable laws and regulations relating to the use of such equipment, materials and facilities and to the employment of such personnel.", "size": 3, "samples": [{"hash": "jQTHESgAEzn", "uri": "/contracts/jQTHESgAEzn#clinical-study", "label": "Clinical Investigation Agreement (HeartWare LTD)", "score": 16.0, "published": true}, {"hash": "6MYcV4XwdBj", "uri": "/contracts/6MYcV4XwdBj#clinical-study", "label": "Clinical Investigation Agreement (HeartWare LTD)", "score": 16.0, "published": true}], "hash": "a4e3869af3c42ff201c0eec37930c077", "id": 3}, {"snippet_links": [{"key": "research-study", "type": "definition", "offset": [2, 16]}, {"key": "effect-of", "type": "definition", "offset": [89, 98]}, {"key": "types-of", "type": "clause", "offset": [172, 180]}, {"key": "clinical-studies", "type": "clause", "offset": [181, 197]}, {"key": "clinical-trials", "type": "definition", "offset": [229, 244]}, {"key": "uses-and-disclosures", "type": "clause", "offset": [294, 314]}, {"key": "organizational-requirements", "type": "clause", "offset": [316, 343]}, {"key": "restricted-data", "type": "clause", "offset": [517, 532]}, {"key": "executive-order", "type": "clause", "offset": [626, 641]}, {"key": "classified-national-security-information", "type": "definition", "offset": [713, 753]}, {"key": "atomic-energy-act-of-1954", "type": "definition", "offset": [897, 922]}, {"key": "office-of-the-general-counsel", "type": "clause", "offset": [1006, 1035]}, {"key": "nuclear-regulatory-commission", "type": "clause", "offset": [1042, 1071]}, {"key": "federal-register", "type": "definition", "offset": [1213, 1229]}, {"key": "by-the-executive", "type": "clause", "offset": [1230, 1246]}, {"key": "the-federal-government", "type": "clause", "offset": [1275, 1297]}, {"key": "in-the-united-states", "type": "clause", "offset": [1298, 1318]}, {"key": "protection-of-human-subjects", "type": "clause", "offset": [1337, 1365]}, {"key": "financial-disclosure", "type": "definition", "offset": [1385, 1405]}, {"key": "institutional-review", "type": "definition", "offset": [1451, 1471]}, {"key": "investigational-new-drug", "type": "definition", "offset": [1499, 1523]}, {"key": "part-314", "type": "clause", "offset": [1547, 1555]}, {"key": "applications-for", "type": "clause", "offset": [1556, 1572]}, {"key": "fda-approval", "type": "definition", "offset": [1573, 1585]}, {"key": "cfr-part-46", "type": "clause", "offset": [1700, 1711]}, {"key": "data-classification", "type": "clause", "offset": [1761, 1780]}, {"key": "federal-rule", "type": "definition", "offset": [1785, 1797]}, {"key": "funded-research", "type": "definition", "offset": [1826, 1841]}, {"key": "to-ensure", "type": "clause", "offset": [1886, 1895]}, {"key": "rights-of", "type": "definition", "offset": [1905, 1914]}, {"key": "research-project", "type": "clause", "offset": [1967, 1983]}, {"key": "protection-from", "type": "clause", "offset": [2010, 2025]}, {"key": "regulatory-authorities", "type": "definition", "offset": [2092, 2114]}, {"key": "referring-to", "type": "definition", "offset": [2120, 2132]}, {"key": "study-participant", "type": "definition", "offset": [2135, 2152]}, {"key": "the-issue", "type": "clause", "offset": [2163, 2172]}, {"key": "personal-data", "type": "clause", "offset": [2180, 2193]}, {"key": "approved-person", "type": "definition", "offset": [2227, 2242]}, {"key": "the-organization", "type": "definition", "offset": [2267, 2283]}, {"key": "the-data", "type": "clause", "offset": [2299, 2307]}, {"key": "further-uses", "type": "clause", "offset": [2333, 2345]}, {"key": "the-individual", "type": "clause", "offset": [2398, 2412]}, {"key": "data-use-agreements", "type": "clause", "offset": [2483, 2502]}, {"key": "protected-health-information", "type": "definition", "offset": [2512, 2540]}, {"key": "limiting-access", "type": "clause", "offset": [2598, 2613]}, {"key": "party-of-the", "type": "clause", "offset": [2642, 2654]}, {"key": "confidentiality-of-data", "type": "clause", "offset": [2689, 2712]}, {"key": "relating-to", "type": "definition", "offset": [2713, 2724]}, {"key": "to-establish", "type": "clause", "offset": [2772, 2784]}, {"key": "disclosure-agreement", "type": "definition", "offset": [2839, 2859]}], "snippet": "A research study using human subjects or data from living human subjects to evaluate the effect of interventions or exposures on biomedical or health-related outcomes. Two types of clinical studies are interventional studies (or clinical trials) and observational studies. 6 45 CFR 164.504(e): Uses and disclosures: Organizational requirements: \u2587\u2587\u2587\u2587://\u2587\u2587\u2587.\u2587\u2587\u2587\u2587.\u2587\u2587\u2587/cgi-bin/text- idx?SID=938e08839465e82e2c30c3bd4a359ce2&node=pt45.1.164&rgn=div5%23se45.1.164_1402#se4 5.1.164_1504 8 10 CFR 1045.21 Privately Generated Restricted Data: \u2587\u2587\u2587\u2587\u2587://\u2587\u2587\u2587.\u2587\u2587\u2587.\u2587\u2587\u2587/fdsys/granule/CFR-1999-title10- vol4/CFR-1999-title10-vol4-sec1045-21 9 Executive Order 12958: 32 CFR 701.23 \u2587\u2587\u2587\u2587\u2587://\u2587\u2587\u2587.\u2587\u2587\u2587.\u2587\u2587\u2587\u2587\u2587\u2587\u2587.\u2587\u2587\u2587/cfr/text/32/701.23 10 Classified National Security Information, April 17, 1995: Executive Order 13526 \u2587\u2587\u2587\u2587\u2587://\u2587\u2587\u2587.\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587.\u2587\u2587\u2587/the-press-office/executive-order-classified-national-security-information 11 Atomic Energy Act of 1954: Nuclear Regulatory Legislation, 109th Congress: Session NUREG-0980 Vol. 1, Mo. 7. Office of the General Counsel, U.S. Nuclear Regulatory Commission: \u2587\u2587\u2587\u2587://\u2587\u2587\u2587\u2587\u2587\u2587\u2587.\u2587\u2587\u2587\u2587\u2587\u2587.\u2587\u2587\u2587/~/media/bes/pdf/nureg_0980_v1_no7_june2005.pdf A codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government in the United States. \u2022 21 CFR Part 50 Protection of Human Subjects12 \u2022 21 CFR Part 54 Financial Disclosure by Clinical Investigators13 \u2022 21 CFR Part 56 Institutional Review Boards14 \u2022 21 CFR Part 312 Investigational New Drug Application15 \u2022 21 CFR Part 314 Applications for FDA Approval to Market an New Drug or an Antibiotic16 \u2022 21 CFR Part 320 Bioavailability and Bioequivalence Requirements17 \u2022 45 CFR Part 46 Protection of Human Subjects (Common Rule)18 See Data Classification The federal rule that governs most federally funded research conducted on living human subjects and aims to ensure that the rights of human subjects are protected during the course of a research project, historically focusing on protection from physical and mental harm by stressing autonomy and consent.19 See Regulatory Authorities When referring to a study participant addresses the issue of how personal data that have been collected for one approved person may be held and used by the organization that collected the data, what other secondary or further uses may be made of the data, and when the permission of the individual is required for such uses.20 This term in this context is specific to data use agreements covering protected health information. This term may also be used in the more general sense of limiting access, for instance the providing party of the data use might want to stress the confidentiality of data relating to a pending patent request. Care should be taken to establish the appropriate context when using this term. See Non-Disclosure Agreement", "size": 1, "samples": [{"hash": "eeXeA6B49AJ", "uri": "/contracts/eeXeA6B49AJ#clinical-study", "label": "Data Transfer and Use Agreement", "score": 22.7275838467, "published": true}], "hash": "92da25f1ce3c2fe9f5755ac67362c784", "id": 4}, {"snippet_links": [{"key": "the-manufacturer", "type": "definition", "offset": [3, 19]}, {"key": "being-conducted", "type": "definition", "offset": [125, 140]}, {"key": "working-with", "type": "definition", "offset": [217, 229]}, {"key": "pursuant-to", "type": "definition", "offset": [244, 255]}, {"key": "the-definitive-agreement", "type": "clause", "offset": [297, 321]}, {"key": "five-thousand", "type": "clause", "offset": [425, 438]}, {"key": "by-the-distributor", "type": "clause", "offset": [472, 490]}, {"key": "completion-of-the", "type": "clause", "offset": [503, 520]}], "snippet": "A. The Manufacturer is involved in a clinical study consisting of at least two hundred (200) patients (the \"Clinical Study\") being conducted by Dr. Virgilio Sacchini (\"Dr. Sacchin\u2587\"), \u2587\u2587 \u2587\u2587\u2587 \u2587\u2587\u2587\u2587\u2587\u2587\u2587 or \u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587st working with Dr. Sacchini. Pursuant to Paragr\u2587\u2587\u2587\u2587 \"\u2587\" \u2587\u2587\u2587 \"B\" of Article \"3\" of the Definitive Agreement, an aggregate of at least two hundred thousand ($200,000) dollars and not more than two hundred twenty five thousand ($225,000) dollars shall be paid by the Distributor towards the completion of the Clinical Study.", "size": 1, "samples": [{"hash": "58NBITGkUQN", "uri": "/contracts/58NBITGkUQN#clinical-study", "label": "Distribution Agreement (Scantek Medical Inc)", "score": 18.0, "published": true}], "hash": "b8f4b2815919f0c6debede26a06638c9", "id": 6}, {"snippet_links": [{"key": "study-staff", "type": "clause", "offset": [23, 34]}, {"key": "the-site", "type": "clause", "offset": [36, 44]}, {"key": "agreed-period", "type": "definition", "offset": [115, 128]}, {"key": "for-performance", "type": "clause", "offset": [129, 144]}, {"key": "this-agreement", "type": "clause", "offset": [171, 185]}, {"key": "the-protocol", "type": "clause", "offset": [187, 199]}, {"key": "the-budget", "type": "definition", "offset": [238, 248]}, {"key": "exhibit-a", "type": "clause", "offset": [261, 270]}, {"key": "performed-by", "type": "clause", "offset": [347, 359]}, {"key": "in-accordance-with", "type": "definition", "offset": [363, 381]}, {"key": "consent-of", "type": "clause", "offset": [452, 462]}], "snippet": "Through the use of the Study Staff, the Site shall undertake and complete in a timely fashion the Study within the agreed period for performance in strict accordance with this Agreement, the Protocol (including all amendments hereto) and the budget outlined in Exhibit A hereto (the \u201cBudget\u201d). Site shall not subcontract any of the services to be performed by it in accordance with the Study, the Protocol, or this Agreement, without the prior written consent of CRO.", "size": 1, "samples": [{"hash": "e8GnYIQIo31", "uri": "/contracts/e8GnYIQIo31#clinical-study", "label": "Clinical Trial Agreement", "score": 25.1957563313, "published": true}], "hash": "f79aaa5c4672cd28646432c612caaa86", "id": 7}, {"snippet_links": [{"key": "the-pre", "type": "clause", "offset": [7, 14]}, {"key": "closing-period", "type": "definition", "offset": [15, 29]}, {"key": "the-company-shall", "type": "clause", "offset": [31, 48]}, {"key": "clinical-trial", "type": "clause", "offset": [90, 104]}, {"key": "in-the-ordinary-course-of-business", "type": "definition", "offset": [105, 139]}, {"key": "consistent-with-past-practices", "type": "definition", "offset": [140, 170]}, {"key": "reasonable-best-efforts", "type": "definition", "offset": [195, 218]}, {"key": "the-company-will", "type": "clause", "offset": [298, 314]}, {"key": "status-of-the", "type": "clause", "offset": [354, 367]}, {"key": "promptly-notify", "type": "clause", "offset": [405, 420]}, {"key": "new-data", "type": "definition", "offset": [439, 447]}, {"key": "safety-reports", "type": "clause", "offset": [479, 493]}, {"key": "from-the-company", "type": "clause", "offset": [534, 550]}, {"key": "development-plan", "type": "definition", "offset": [562, 578]}, {"key": "other-material-changes", "type": "clause", "offset": [592, 614]}, {"key": "changes-to-the", "type": "definition", "offset": [630, 644]}, {"key": "conduct-of-the-study", "type": "clause", "offset": [645, 665]}, {"key": "serious-adverse-events", "type": "clause", "offset": [698, 720]}, {"key": "each-case", "type": "definition", "offset": [754, 763]}, {"key": "with-respect-to", "type": "clause", "offset": [765, 780]}, {"key": "following-the", "type": "definition", "offset": [845, 858]}, {"key": "meeting-minutes", "type": "clause", "offset": [904, 919]}, {"key": "review-meetings", "type": "clause", "offset": [953, 968]}, {"key": "by-the-company", "type": "clause", "offset": [1024, 1038]}, {"key": "provided-that", "type": "clause", "offset": [1092, 1105]}, {"key": "comply-with", "type": "clause", "offset": [1156, 1167]}, {"key": "contractual-arrangements", "type": "definition", "offset": [1168, 1192]}, {"key": "legal-privilege", "type": "clause", "offset": [1204, 1219]}, {"key": "outside-counsel-only", "type": "definition", "offset": [1242, 1262]}, {"key": "the-information", "type": "clause", "offset": [1285, 1300]}, {"key": "outside-consultants", "type": "clause", "offset": [1385, 1404]}, {"key": "in-the-case", "type": "clause", "offset": [1429, 1440]}, {"key": "efforts-to-obtain", "type": "clause", "offset": [1504, 1521]}, {"key": "required-consents", "type": "clause", "offset": [1526, 1543]}, {"key": "other-action", "type": "clause", "offset": [1557, 1569]}, {"key": "joint-defense", "type": "clause", "offset": [1596, 1609]}, {"key": "agreement-or", "type": "definition", "offset": [1629, 1641]}, {"key": "other-arrangement", "type": "definition", "offset": [1642, 1659]}, {"key": "loss-of", "type": "definition", "offset": [1669, 1676]}, {"key": "client-privilege", "type": "clause", "offset": [1686, 1702]}, {"key": "material-actions", "type": "definition", "offset": [1772, 1788]}, {"key": "consent-not-to-be-unreasonably-withheld", "type": "clause", "offset": [1902, 1941]}], "snippet": "During the Pre-Closing Period, the Company shall continue to conduct its Ongoing IMPT-314 Clinical Trial in the Ordinary Course of Business consistent with past practices, including by using its reasonable best efforts [*] for the Ongoing IMPT-314 Clinical Trial as soon as reasonably practicable. The Company will keep Parent reasonably informed of the status of the Ongoing IMPT-314 Clinical Trial, and promptly notify Parent of (i) any new data or findings, including any new safety reports or imaging results, (ii) any deviations from the Company\u2019s existing development plan or (iii) any other material changes, including any changes to the conduct of the study, events (including any reported Serious Adverse Events) circumstances or conditions, in each case, with respect to the Ongoing IMPT-314 Clinical Trial. The Company shall promptly following the availability thereof provide Parent with all meeting minutes, including minutes of any safety review meetings, regarding any with respect to actions or changes made by the Company with respect to the Ongoing IMPT-314 Clinical Trial; provided that such material may be (A) redacted as necessary to comply with contractual arrangements or address legal privilege or (B) designated as \u201coutside counsel only,\u201d which materials and the information contained therein shall be given only to outside counsel and previously agreed upon outside consultants; provided further that, in the case of clause (A) above, the Company shall use its reasonable best efforts to obtain any required consents or take such other action (such as the entry into a joint defense or common interest agreement or other arrangement to avoid loss of attorney client privilege) to permit such access or disclosure. The Company shall not take any material actions or make material changes with respect to the Ongoing IMPT-314 Clinical Trial without Parent\u2019s consent (with such consent not to be unreasonably withheld, conditioned or delayed). The Company shall also use its reasonable best efforts with respect to the entry and cleaning of data for the anticipated presentation at [*].", "size": 1, "samples": [{"hash": "1xsXyIY4X8V", "uri": "/contracts/1xsXyIY4X8V#clinical-study", "label": "Merger Agreement (Lyell Immunopharma, Inc.)", "score": 35.8117727584, "published": true}], "hash": "2fca0bab0f5d4847574420f6e868b66b", "id": 8}, {"snippet_links": [{"key": "section-6", "type": "definition", "offset": [0, 9]}, {"key": "the-co", "type": "clause", "offset": [13, 19]}, {"key": "participation-agreement", "type": "definition", "offset": [20, 43]}], "snippet": "Section 6 of the Co-Participation Agreement is hereby amended to add Section", "size": 1, "samples": [{"hash": "2oVYITNr8Vm", "uri": "/contracts/2oVYITNr8Vm#clinical-study", "label": "Co Participation Agreement (Salix Pharmaceuticals LTD)", "score": 18.0, "published": true}], "hash": "9a824b39404ea977246da777fd0d7e9e", "id": 9}, {"snippet_links": [{"key": "the-principal-investigator", "type": "clause", "offset": [19, 45]}, {"key": "study-staff", "type": "clause", "offset": [54, 65]}, {"key": "institution-shall", "type": "clause", "offset": [71, 88]}, {"key": "the-study", "type": "definition", "offset": [132, 141]}, {"key": "agreed-period", "type": "definition", "offset": [153, 166]}, {"key": "for-performance", "type": "clause", "offset": [167, 182]}, {"key": "this-agreement", "type": "clause", "offset": [209, 223]}, {"key": "the-protocol", "type": "clause", "offset": [225, 237]}, {"key": "the-budget", "type": "definition", "offset": [276, 286]}, {"key": "exhibit-a", "type": "clause", "offset": [299, 308]}, {"key": "performed-by", "type": "clause", "offset": [392, 404]}, {"key": "in-accordance-with", "type": "definition", "offset": [408, 426]}, {"key": "consent-of", "type": "clause", "offset": [497, 507]}], "snippet": "Through the use of the Principal Investigator and its Study Staff, the Institution shall undertake and complete in a timely fashion the Study within the agreed period for performance in strict accordance with this Agreement, the Protocol (including all amendments hereto) and the budget outlined in Exhibit A hereto (the \u201cBudget\u201d). Institution shall not subcontract any of the services to be performed by it in accordance with the Study, the Protocol, or this Agreement, without the prior written consent of CRO.", "size": 1, "samples": [{"hash": "4AkcV4gWCEQ", "uri": "/contracts/4AkcV4gWCEQ#clinical-study", "label": "Clinical Trial Agreement", "score": 27.195678535, "published": true}], "hash": "4364116a109c4ee6fab1f1a5f682846d", "id": 10}], "next_curs": "ClcSUWoVc35sYXdpbnNpZGVyY29udHJhY3RzcjMLEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IhdjbGluaWNhbC1zdHVkeSMwMDAwMDAwYQyiAQJlbhgAIAA=", "clause": {"size": 45, "title": "Clinical Study", "parents": [["definitions", "Definitions"], ["scope-of-work-term", "Scope of Work Term"], ["regulatory", "Regulatory"], ["miscellaneous", "Miscellaneous"], ["severability", "Severability"]], "children": [["klinick\u00e1-studie", "Klinick\u00e1 studie"], ["handling-and-use", "Handling and Use"], ["study-supplies", "Study Supplies"], ["periodic-reports", "Periodic Reports"], ["financial-reporting", "Financial Reporting"]], "id": "clinical-study", "related": [["clinical-studies", "Clinical Studies", "Clinical Studies"], ["clinical-trials", "Clinical Trials", "Clinical Trials"], ["clinical", "Clinical", "Clinical"], ["study", "Study", "Study"], ["tests-and-preclinical-and-clinical-trials", "Tests and Preclinical and Clinical Trials", "Tests and Preclinical and Clinical Trials"]], "related_snippets": [], "updated": "2025-07-07T12:37:53+00:00", "also_ask": ["What are the essential elements to include in a Clinical Study clause to protect both parties?", "How can the clause be negotiated to allocate liability for adverse events or data breaches?", "What are the most common legal pitfalls or ambiguities in Clinical Study clauses?", "How do Clinical Study clauses differ across jurisdictions or regulatory frameworks?", "What factors determine the enforceability of Clinical Study obligations in court?"], "drafting_tip": "Specify study objectives and protocols to ensure clarity; define data ownership to prevent disputes; outline reporting obligations to guarantee regulatory compliance.", "explanation": "A clinical-study clause defines the terms and conditions under which clinical research or trials are conducted as part of an agreement. It typically outlines the responsibilities of the parties involved, the scope of the study, data collection and reporting requirements, and compliance with regulatory standards. For example, it may specify how patient data is handled, who owns the study results, and what protocols must be followed. The core function of this clause is to ensure that all parties understand their obligations and that the clinical study is conducted ethically, legally, and in accordance with industry standards."}, "json": true, "cursor": ""}}