{"component": "definition", "props": {"groups": [{"size": 80, "snippet_links": [{"key": "investigation-to-be-conducted", "type": "clause", "offset": [10, 39]}, {"key": "in-accordance-with", "type": "definition", "offset": [40, 58]}, {"key": "the-protocol", "type": "clause", "offset": [59, 71]}], "snippet": "means the investigation to be conducted in accordance with the Protocol.", "samples": [{"hash": "iJi6vZPZ6Ok", "uri": "/contracts/iJi6vZPZ6Ok#study", "label": "Clinical Trial Research Agreement", "score": 33.7807693481, "published": true}, {"hash": "jhjV1v9BBfk", "uri": "/contracts/jhjV1v9BBfk#study", "label": "Clinical Trial Research Agreement (Incannex Healthcare LTD)", "score": 33.0657081604, "published": true}, {"hash": "dYPuFvV1tvG", "uri": "/contracts/dYPuFvV1tvG#study", "label": "Clinical Trial Research Agreement (Incannex Healthcare LTD)", "score": 33.0657081604, "published": true}], "hash": "cd56618512da2c78ac021cdbc63a0444", "id": 1}, {"size": 55, "snippet_links": [{"key": "clinical-trial", "type": "clause", "offset": [4, 18]}, {"key": "in-accordance-with", "type": "definition", "offset": [43, 61]}, {"key": "this-agreement", "type": "clause", "offset": [62, 76]}, {"key": "the-protocol", "type": "clause", "offset": [81, 93]}, {"key": "for-purposes-of", "type": "clause", "offset": [94, 109]}, {"key": "gathering-information", "type": "clause", "offset": [110, 131]}, {"key": "medical-device", "type": "clause", "offset": [151, 165]}, {"key": "klinick\u00e9-hodnocen\u00ed", "type": "clause", "offset": [202, 220]}], "snippet": "the clinical trial that is to be performed in accordance with this Agreement and the Protocol for purposes of gathering information about the compound/medical device identified in the Protocol. Studie: klinick\u00e9 hodnocen\u00ed, kter\u00e9 bude provedeno v souladu s touto Smlouvou a Protokolem pro \u00fa\u010dely z\u00edsk\u00e1n\u00ed a shrom\u00e1\u017ed\u011bn\u00ed informac\u00ed o slo\u017ece/zdravotnick\u00e9m prost\u0159edku popsan\u00e9m v Protokolu.", "samples": [{"hash": "3ZhYw6ZivJj", "uri": "/contracts/3ZhYw6ZivJj#study", "label": "Clinical Trial Agreement", "score": 35.9516448975, "published": true}, {"hash": "7ABMCKlhZ3D", "uri": "/contracts/7ABMCKlhZ3D#study", "label": "Clinical Trial Agreement", "score": 34.7262115479, "published": true}, {"hash": "f93MATlivt8", "uri": "/contracts/f93MATlivt8#study", "label": "Clinical Trial Agreement", "score": 34.6015892029, "published": true}], "hash": "612e674b34145f10df7a0901de72e136", "id": 2}, {"size": 43, "snippet_links": [{"key": "the-consideration", "type": "clause", "offset": [207, 224]}, {"key": "the-issue", "type": "clause", "offset": [228, 237]}, {"key": "preliminary-stage", "type": "clause", "offset": [259, 276]}, {"key": "prior-to-completion", "type": "clause", "offset": [332, 351]}], "snippet": "means any written, recorded, transcribed, taped, filmed, or graphic matter, however produced or reproduced, either formally or informally, a particular issue or situation, in whatever detail, whether or not the consideration of the issue or situation is in a preliminary stage, and whether or not the consideration was discontinued prior to completion.", "samples": [{"hash": "arf53AawpJi", "uri": "https://psc.ky.gov/pscecf/2024-00310/byron@kyrc.org/02062025094816/2025-02-03-JI-DR3.pdf", "label": "psc.ky.gov", "score": 20.0152320862, "published": false}, {"hash": "3mTaqfz9S8k", "uri": "https://psc.ky.gov/pscecf/2023-00310/byron@kyrc.org/01262024094014/2024-01-26-2023-00310-JI-DR2-PUBLIC.pdf", "label": "psc.ky.gov", "score": 19.6328697205, "published": false}, {"hash": "jGWpL8AhYrJ", "uri": "https://psc.ky.gov/pscecf/2024-00310/byron@kyrc.org/10282024101930/2024-10-28-2024-00310-JI-DR1.pdf", "label": "psc.ky.gov", "score": 19.5362625122, "published": false}], "hash": "e0daba28130fad192e3474ac2a6d0313", "id": 3}, {"size": 33, "snippet_links": [{"key": "clinical-trial", "type": "clause", "offset": [10, 24]}, {"key": "in-accordance-with", "type": "definition", "offset": [54, 72]}, {"key": "the-protocol", "type": "clause", "offset": [73, 85]}, {"key": "study-drug", "type": "clause", "offset": [98, 108]}], "snippet": "means the clinical trial conducted or to be conducted in accordance with the Protocol to test the Study Drug;", "samples": [{"hash": "awETZcOKw8v", "uri": "/contracts/awETZcOKw8v#study", "label": "Clinical Trial Agreement", "score": 35.7947883606, "published": true}, {"hash": "kM2BJts0kNO", "uri": "/contracts/kM2BJts0kNO#study", "label": "Clinical Trial Agreement", "score": 35.216053009, "published": true}, {"hash": "7y6Pny2MSde", "uri": "/contracts/7y6Pny2MSde#study", "label": "Draft Agreement for Clinical Trials", "score": 34.8455047607, "published": true}], "hash": "a680f84292e23229b573126236b2ee1d", "id": 4}, {"size": 33, "snippet_links": [{"key": "scientific-research", "type": "clause", "offset": [10, 29]}, {"key": "the-protocol", "type": "clause", "offset": [44, 56]}, {"key": "klinick\u00e9-hodnocen\u00ed", "type": "clause", "offset": [59, 77]}], "snippet": "means the scientific research as defined in the Protocol. \"Klinick\u00e9 hodnocen\u00ed\" je v\u011bdeck\u00fd v\u00fdzkum ve smyslu definovan\u00e9m v protokolu.", "samples": [{"hash": "4B7R5uwYFQQ", "uri": "/contracts/4B7R5uwYFQQ#study", "label": "Collaboration Agreement", "score": 30.0351886749, "published": true}, {"hash": "jeKuQy5vNIG", "uri": "/contracts/jeKuQy5vNIG#study", "label": "Clinical Site Agreement", "score": 28.9562416077, "published": true}, {"hash": "7R7Q3KwAX8s", "uri": "/contracts/7R7Q3KwAX8s#study", "label": "Clinical Research Agreement", "score": 28.6618919373, "published": true}], "hash": "e27978d2749fa3ac4ca42477726efc76", "id": 5}, {"size": 30, "snippet_links": [{"key": "investigation-to-be-conducted", "type": "clause", "offset": [10, 39]}, {"key": "in-accordance-with", "type": "definition", "offset": [40, 58]}], "snippet": "means the investigation to be conducted in accordance with the Clinical Investigation Plan.", "samples": [{"hash": "4x1RfIAbBpt", "uri": "/contracts/4x1RfIAbBpt#study", "label": "Clinical Investigation Research Agreement", "score": 36.4757080078, "published": true}, {"hash": "1i5JUmaXqFb", "uri": "/contracts/1i5JUmaXqFb#study", "label": "Clinical Investigation Research Agreement", "score": 34.7751998901, "published": true}, {"hash": "5xPfGFmrcw3", "uri": "/contracts/5xPfGFmrcw3#study", "label": "Clinical Investigation Research Agreement", "score": 33.7889823914, "published": true}], "hash": "272a630363a9db0af51830333a331cea", "id": 6}, {"size": 21, "snippet_links": [{"key": "attachment-b", "type": "clause", "offset": [52, 64]}, {"key": "facility-owned-by-seller", "type": "clause", "offset": [66, 90]}, {"key": "to-this-agreement", "type": "clause", "offset": [92, 109]}], "snippet": "Shall have the meaning set forth in Section 4(e) of Attachment B (Facility Owned by Seller) to this Agreement.", "samples": [{"hash": "csO9WbF9et0", "uri": "/contracts/csO9WbF9et0#study", "label": "Power Purchase Agreement", "score": 35.9222602844, "published": true}, {"hash": "8BSpezmdl6A", "uri": "/contracts/8BSpezmdl6A#study", "label": "Power Purchase Agreement", "score": 26.6536617279, "published": true}, {"hash": "dUsbI2s9Iy1", "uri": "/contracts/dUsbI2s9Iy1#study", "label": "Power Purchase Agreement", "score": 26.5455169678, "published": true}], "hash": "8da8347c93278d3025c97723125283d2", "id": 7}, {"size": 19, "snippet_links": [{"key": "section-63", "type": "clause", "offset": [29, 40]}], "snippet": "has the meaning specified in Section 6.3.", "samples": [{"hash": "9Bb8FvoZQxI", "uri": "/contracts/9Bb8FvoZQxI#study", "label": "Commercial License Agreement (Sage Therapeutics, Inc.)", "score": 34.5961685181, "published": true}, {"hash": "1KJ60zJQnKG", "uri": "/contracts/1KJ60zJQnKG#study", "label": "License and Supply Agreement (Melinta Therapeutics, Inc. /New/)", "score": 29.4325809479, "published": true}, {"hash": "3YIw2xEBFaN", "uri": "/contracts/3YIw2xEBFaN#study", "label": "License Agreement (Marinus Pharmaceuticals Inc)", "score": 28.2607803345, "published": true}], "hash": "ad1cc6bfe5dad36b22748d84d351f6ce", "id": 8}, {"size": 17, "snippet_links": [{"key": "report-in", "type": "clause", "offset": [8, 17]}, {"key": "electronic-form", "type": "clause", "offset": [29, 44]}, {"key": "vertebrate-animals", "type": "clause", "offset": [97, 115]}, {"key": "relate-to", "type": "definition", "offset": [124, 133]}, {"key": "exposure-assessment", "type": "clause", "offset": [175, 194]}, {"key": "risk-characterization", "type": "clause", "offset": [199, 220]}, {"key": "safety-report", "type": "definition", "offset": [237, 250]}, {"key": "pursuant-to", "type": "definition", "offset": [298, 309]}], "snippet": "means a report in written or electronic form on tests, or other examinations (including tests on vertebrate animals), which relate to intrinsic Substance properties or to the exposure assessment and risk characterization in the chemical safety report and as such, are of relevance for registration pursuant to REACH; this also includes study summaries and robust study summaries of the report(s);", "samples": [{"hash": "gzvNXq21rfI", "uri": "/contracts/gzvNXq21rfI#study", "label": "Letter of Access Agreement", "score": 32.2314186096, "published": true}, {"hash": "gfwJSP5GsjO", "uri": "/contracts/gfwJSP5GsjO#study", "label": "Letter of Access Agreement", "score": 27.0273780823, "published": true}, {"hash": "2Yc6dH6vPq1", "uri": "/contracts/2Yc6dH6vPq1#study", "label": "Only Representative Agreement", "score": 27.0273780823, "published": true}], "hash": "c43e9a84c4702f04b68544ea03727437", "id": 9}, {"size": 12, "snippet_links": [{"key": "investigation-to-be-conducted", "type": "clause", "offset": [10, 39]}, {"key": "in-accordance-with", "type": "definition", "offset": [40, 58]}, {"key": "the-protocol", "type": "clause", "offset": [59, 71]}, {"key": "study-completion", "type": "definition", "offset": [73, 89]}, {"key": "the-database", "type": "definition", "offset": [96, 108]}, {"key": "essential-documents", "type": "clause", "offset": [133, 152]}, {"key": "the-organisation", "type": "clause", "offset": [175, 191]}, {"key": "a-copy-of-the", "type": "clause", "offset": [203, 216]}, {"key": "responsible-hrec", "type": "definition", "offset": [233, 249]}, {"key": "of-the-final-report", "type": "clause", "offset": [272, 291]}, {"key": "closure-letter", "type": "definition", "offset": [299, 313]}, {"key": "the-principal-investigator", "type": "clause", "offset": [319, 345]}], "snippet": "means the investigation to be conducted in accordance with the Protocol. Study Completion means the database has been locked and all Essential Documents have been provided to the Organisation, including a copy of the letter from the Responsible HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.", "samples": [{"hash": "dkU5K29lZLu", "uri": "/contracts/dkU5K29lZLu#study", "label": "Clinical Trial Research Agreement", "score": 27.3682403564, "published": true}, {"hash": "bdN1oYJmSaM", "uri": "/contracts/bdN1oYJmSaM#study", "label": "Clinical Trial Research Agreement", "score": 27.0304203033, "published": true}, {"hash": "6YyS8wZIzOH", "uri": "/contracts/6YyS8wZIzOH#study", "label": "Clinical Trial Research Agreement", "score": 26.7768650055, "published": true}], "hash": "79bededae89ab44dca9994dc0259a780", "id": 10}], "next_curs": "ClISTGoVc35sYXdpbnNpZGVyY29udHJhY3Rzci4LEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiIOc3R1ZHkjMDAwMDAwMGEMogECZW4YACAA", "definition": {"size": 1105, "title": "Study", "snippet": "means the investigation to be conducted in accordance with the Protocol.", "id": "study", "examples": ["Collaborator shall provide to MSD all Collaborator Clinical Trial information and documentation reasonably requested by MSD to enable MSD to: (i) comply with any of its legal, regulatory or contractual obligations, or any request by any Regulatory Authority related to the MSD Compound; and (ii) determine whether the MSD Compound <strong>Study</strong> has been performed in accordance with this Agreement.", "For clarity, Eikon shall have the right to utilize the data and results generated by Impact, including from Impact\u2019s performance of the first-in-human Clinical <strong>Study</strong> or the global Clinical Studies in the Impact Territory, for its Drug Approval Applications in Eikon Territory.", "Each Party shall use commercially reasonable efforts to supply its Compound hereunder with an adequate remaining shelf life at the time of Delivery to meet the MSD Compound <strong>Study</strong> requirements.", "The results of the MSD Compound <strong>Study</strong> will be published in accordance with the Protocol.", "Promptly after the Effective Date, Impact shall deliver to Eikon or Eikon\u2019s designee Licensed Product or Licensed Compound to enable Eikon\u2019s commencement of a first Eikon Clinical <strong>Study</strong> of the first Licensed Product, including, without limitation, certificates and other documentation regarding the properties of such Licensed Product or Licensed Compound.", "Collaborator shall register the MSD Compound <strong>Study</strong> and Collaborator Clinical Trial with the clinical trials registry located at \u2587\u2587\u2587.\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587\u2587.\u2587\u2587\u2587 (or any non-U.S. equivalent clinical trial registry), shall list MSD as a collaborator with respect to the Collaborator Clinical Trial, and shall timely publish the results following completion of the MSD Compound <strong>Study</strong>, after taking appropriate action to secure any intellectual property rights arising from the MSD Compound <strong>Study</strong>.", "If Parties agree in writing that Eikon will not Develop the Licensed Compound or Licensed Product with respect to an indication under a Global Clinical <strong>Study</strong>, then, subject to JSC approval, Impact shall have the right to Develop the Licensed Compound or Licensed Product with respect to such indication in the Impact Territory under the Impact Development Plan approved by the JSC.", "For the avoidance of doubt, except for the Impact [***] IND submission work outlined in 4.1.1(i)(C), all clinical development of [***] and [***] shall be treated the same as provided for a Global Clinical <strong>Study</strong> with respect to roles and responsibilities of the parties and the bearing of costs and expenses.", "Parties will discuss in good faith the subsequent supply arrangement during the Term, and with respect to any global Clinical <strong>Study</strong>, the Parties shall use the same Licensed Compound or Licensed Product Manufactured by on behalf of the same Party unless otherwise agreed by the JSC; provided that in the event that Impact uses alternatively-Manufactured Licensed Compound or Licensed Product, Impact is responsible for performing any and all applicable equivalence studies at Impact\u2019s sole cost and expense.", "The Parties desire to have Eikon fully enabled to supply the clinical materials (including Licensed Product and Licensed Compound) for the first Pivotal <strong>Study</strong> of the first Licensed Product conducted by Eikon; provided, however, that in the event that supply of such clinical materials by Impact is necessary for Eikon\u2019s performance of such Pivotal <strong>Study</strong>, Impact will use commercially reasonable efforts to supply such clinical materials to Eikon."], "related": [["clinical", "Clinical", "Clinical"], ["clinical-study", "Clinical Study", "Clinical <strong>Study</strong>"], ["clinical-trial", "Clinical Trial", "Clinical Trial"], ["phase-i-study", "Phase I Study", "Phase I <strong>Study</strong>"], ["studies", "Studies", "Studies"]], "related_snippets": [], "updated": "2026-03-20T05:48:33+00:00"}, "json": true, "cursor": ""}}