{"component": "definition", "props": {"groups": [{"size": 45, "snippet": "means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).", "samples": [{"hash": "25tl54bJL63", "uri": "/contracts/25tl54bJL63#phase-i-clinical-study", "label": "Master Collaboration and License Agreement", "score": 32.8346099854, "published": true}, {"hash": "5RZPiYInoI7", "uri": "/contracts/5RZPiYInoI7#phase-i-clinical-study", "label": "Master Collaboration and License Agreement (Moderna, Inc.)", "score": 29.8542098999, "published": true}, {"hash": "8SXfpMngZh8", "uri": "/contracts/8SXfpMngZh8#phase-i-clinical-study", "label": "Master Collaboration and License Agreement (Moderna, Inc.)", "score": 29.8295688629, "published": true}], "snippet_links": [{"key": "clinical-study", "type": "clause", "offset": [14, 28]}, {"key": "purpose-of", "type": "clause", "offset": [57, 67]}, {"key": "determination-of", "type": "clause", "offset": [91, 107]}], "hash": "52babca0966a364543799becd77e7ad9", "id": 1}, {"size": 15, "snippet": "means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of preliminarily assessing the Licensed Product\u2019s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.", "samples": [{"hash": "8uOJzHOzHTg", "uri": "/contracts/8uOJzHOzHTg#phase-i-clinical-study", "label": "Multi Target Agreement (Immunogen Inc)", "score": 29.3504447937, "published": true}, {"hash": "jQ42BsHSUjC", "uri": "/contracts/jQ42BsHSUjC#phase-i-clinical-study", "label": "Multi Target Agreement (Immunogen Inc)", "score": 26.6290206909, "published": true}, {"hash": "lx8WD6CW45F", "uri": "/contracts/lx8WD6CW45F#phase-i-clinical-study", "label": "Multi Target Agreement (Immunogen Inc)", "score": 23.773443222, "published": true}], "snippet_links": [{"key": "licensed-product", "type": "definition", "offset": [26, 42]}, {"key": "clinical-study", "type": "clause", "offset": [55, 69]}, {"key": "purpose-of", "type": "clause", "offset": [89, 99]}], "hash": "1b87dd09777a9cd7269845cb40b90e68", "id": 2}, {"size": 14, "snippet": "means, as to a specific Licensed Product, a study of such product in humans designed to satisfy the requirements of 21 C.F.R. \u00a7 312.21(a), as amended from time to time, or the corresponding regulation in jurisdictions other than the United States.", "samples": [{"hash": "lk46uYToBKr", "uri": "/contracts/lk46uYToBKr#phase-i-clinical-study", "label": "License Agreement (BioNTech SE)", "score": 31.5516777039, "published": true}, {"hash": "gEfF0q72SP2", "uri": "/contracts/gEfF0q72SP2#phase-i-clinical-study", "label": "License Agreement", "score": 31.3408622742, "published": true}, {"hash": "8lRrZYFYGZv", "uri": "/contracts/8lRrZYFYGZv#phase-i-clinical-study", "label": "License Agreement (Neon Therapeutics, Inc.)", "score": 29.4106769562, "published": true}], "snippet_links": [{"key": "licensed-product", "type": "definition", "offset": [24, 40]}, {"key": "the-requirements", "type": "clause", "offset": [96, 112]}, {"key": "as-amended", "type": "definition", "offset": [139, 149]}, {"key": "from-time-to-time", "type": "clause", "offset": [150, 167]}, {"key": "the-united-states", "type": "definition", "offset": [229, 246]}], "hash": "dc6143bc065fc5e28e06853dad2cb15c", "id": 3}, {"size": 8, "snippet": "means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product\u2019s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.", "samples": [{"hash": "1dOF1noIYvX", "uri": "/contracts/1dOF1noIYvX#phase-i-clinical-study", "label": "Multi Target Agreement (Immunogen Inc)", "score": 26.6290206909, "published": true}, {"hash": "6oGNdK1nVTp", "uri": "/contracts/6oGNdK1nVTp#phase-i-clinical-study", "label": "Multi Target Agreement (Immunogen Inc)", "score": 24.3429164886, "published": true}, {"hash": "51tsk10G1Ob", "uri": "/contracts/51tsk10G1Ob#phase-i-clinical-study", "label": "Multi Target Agreement (Immunogen Inc)", "score": 23.773443222, "published": true}], "snippet_links": [{"key": "licensed-product", "type": "definition", "offset": [26, 42]}, {"key": "clinical-study", "type": "clause", "offset": [55, 69]}, {"key": "purpose-of", "type": "clause", "offset": [89, 99]}], "hash": "eb07e38f2924250d2e37988a8e4ac9ab", "id": 4}, {"size": 6, "snippet": "means a clinical study conducted in accordance with good clinical practice (\"GCP\") in a small number of healthy volunteers or patients designed or intended to establish an initial safety profile, pharmacodynamics or pharmacokinetics of Product.", "samples": [{"hash": "e0USbEW8iDf", "uri": "/contracts/e0USbEW8iDf#phase-i-clinical-study", "label": "Exclusive License Agreement (Sepracor Inc /De/)", "score": 18.0, "published": true}, {"hash": "9UxObVLyOXy", "uri": "/contracts/9UxObVLyOXy#phase-i-clinical-study", "label": "Exclusive License Agreement (Sepracor Inc /De/)", "score": 18.0, "published": true}], "snippet_links": [{"key": "clinical-study", "type": "clause", "offset": [8, 22]}, {"key": "in-accordance-with", "type": "definition", "offset": [33, 51]}, {"key": "good-clinical-practice", "type": "definition", "offset": [52, 74]}, {"key": "number-of", "type": "definition", "offset": [94, 103]}, {"key": "to-establish", "type": "definition", "offset": [156, 168]}], "hash": "d008402a1904c8cbfe972702b72ba35b", "id": 5}, {"size": 5, "snippet": "means a study of a Licensed Product in human subjects with the endpoint of determining initial tolerance, safety or pharmacokinetic information in single dose, single ascending dose, multiple dose and/or multiple ascending dose regimens.", "samples": [{"hash": "kxyVT9TCfw9", "uri": "/contracts/kxyVT9TCfw9#phase-i-clinical-study", "label": "Collaboration and License Agreement (Aptevo Therapeutics Inc.)", "score": 31.6173858643, "published": true}, {"hash": "iH6tgVVhJtu", "uri": "/contracts/iH6tgVVhJtu#phase-i-clinical-study", "label": "Collaboration and License Agreement (Trubion Pharmaceuticals, Inc)", "score": 18.0, "published": true}, {"hash": "hlHc2DPcEBf", "uri": "/contracts/hlHc2DPcEBf#phase-i-clinical-study", "label": "Collaboration and License Agreement (Trubion Pharmaceuticals, Inc)", "score": 18.0, "published": true}], "snippet_links": [{"key": "licensed-product", "type": "definition", "offset": [19, 35]}, {"key": "in-human-subjects", "type": "clause", "offset": [36, 53]}, {"key": "single-dose", "type": "definition", "offset": [147, 158]}], "hash": "5dca1b3f0ca9a4950949d8bd480a7613", "id": 6}, {"size": 5, "snippet": "means a human clinical trial in any country that would satisfy the requirements of 21 CFR 312.21(a).", "samples": [{"hash": "aeeFDr6sD3n", "uri": "/contracts/aeeFDr6sD3n#phase-i-clinical-study", "label": "Mrna Cancer Vaccine Collaboration and License Agreement (Moderna, Inc.)", "score": 29.8542098999, "published": true}, {"hash": "h8TvRT5YTfq", "uri": "/contracts/h8TvRT5YTfq#phase-i-clinical-study", "label": "Mrna Cancer Vaccine Collaboration and License Agreement (Moderna, Inc.)", "score": 29.659822464, "published": true}, {"hash": "g6a2xi8JHhf", "uri": "/contracts/g6a2xi8JHhf#phase-i-clinical-study", "label": "Mrna Cancer Vaccine Collaboration and License Agreement", "score": 26.226556778, "published": true}], "snippet_links": [{"key": "human-clinical-trial", "type": "definition", "offset": [8, 28]}, {"key": "the-requirements", "type": "clause", "offset": [63, 79]}], "hash": "0b565d3991436793919976cc69f436ed", "id": 7}, {"size": 4, "snippet": "means that portion of the Development program that generally provides for the first introduction into humans of the Compound with the primary purpose of determining safety, metabolism and pharmacokinetic properties and clinical pharmacology of the CTM Product in healthy patients, and generally consistent with 21 CFR \u00a7312.21(a), or its foreign equivalent in non-U.S. countries of the Territory. A Phase I Clinical Study can comprise a Phase Ia clinical study and a Phase Ib clinical study. A Phase Ia clinical study is a study performed in healthy humans. A Phase Ib clinical study is a study performed in human patients.", "samples": [{"hash": "eBrPTQpFg8M", "uri": "/contracts/eBrPTQpFg8M#phase-i-clinical-study", "label": "Option and License Agreement (Furiex Pharmaceuticals, Inc.)", "score": 21.3942508698, "published": true}, {"hash": "jFZUTcPFKEw", "uri": "/contracts/jFZUTcPFKEw#phase-i-clinical-study", "label": "Option and License Agreement (Furiex Pharmaceuticals, Inc.)", "score": 21.3641338348, "published": true}, {"hash": "3re0f4a7KDY", "uri": "/contracts/3re0f4a7KDY#phase-i-clinical-study", "label": "Option and License Agreement (Furiex Pharmaceuticals, Inc.)", "score": 21.1478443146, "published": true}], "snippet_links": [{"key": "the-development-program", "type": "clause", "offset": [22, 45]}, {"key": "purpose-of", "type": "clause", "offset": [142, 152]}, {"key": "clinical-pharmacology", "type": "clause", "offset": [219, 240]}, {"key": "ctm-product", "type": "definition", "offset": [248, 259]}, {"key": "consistent-with", "type": "definition", "offset": [295, 310]}, {"key": "foreign-equivalent", "type": "definition", "offset": [337, 355]}, {"key": "the-territory", "type": "clause", "offset": [381, 394]}, {"key": "a-phase", "type": "definition", "offset": [396, 403]}, {"key": "phase-ia", "type": "definition", "offset": [436, 444]}, {"key": "phase-ib-clinical-study", "type": "definition", "offset": [466, 489]}], "hash": "e5d720d14ad8f37cfce61ac2a16f2562", "id": 8}, {"size": 4, "snippet": "means (a) in connection with obtaining Marketing Authorization Approval in the United States, the first Clinical Study conducted in human volunteers or patients to obtain preliminary information on a Licensed Product\u2019s safety, tolerability, pharmacodynamic activity, pharmacokinetics, drug metabolism and mechanism of action, as well as early evidence of effectiveness if possible, as more fully defined in 21 C.F.R. \u00a7 312.21(a), as may be amended or (b) in connection with obtaining Marketing Authorization Approval in any other jurisdiction, the equivalent of any such Clinical Study in such other country or jurisdiction.", "samples": [{"hash": "kuZnn9GLKKn", "uri": "https://www.sec.gov/Archives/edgar/data/1401914/000119312518143344/d575362dex101.htm", "label": "License and Collaboration Agreement (Dare Bioscience, Inc.)", "score": 17.3258037567, "published": false}, {"hash": "1D04xn4mEaD", "uri": "https://www.sec.gov/Archives/edgar/data/1401914/000156459018006989/dare-ex101_432.htm", "label": "License and Collaboration Agreement (Dare Bioscience, Inc.)", "score": 17.2354545593, "published": false}, {"hash": "5AMKjiJDgP6", "uri": "https://ir.darebioscience.com/static-files/a5d63b7a-37c6-4966-a39b-71df6a54eb4d", "label": "ir.darebioscience.com", "score": 9.8309373856, "published": false}], "snippet_links": [{"key": "in-connection-with", "type": "clause", "offset": [10, 28]}, {"key": "marketing-authorization-approval", "type": "definition", "offset": [39, 71]}, {"key": "in-the-united-states", "type": "clause", "offset": [72, 92]}, {"key": "clinical-study", "type": "clause", "offset": [104, 118]}, {"key": "information-on", "type": "clause", "offset": [183, 197]}, {"key": "licensed-product", "type": "definition", "offset": [200, 216]}, {"key": "mechanism-of-action", "type": "definition", "offset": [305, 324]}, {"key": "evidence-of-effectiveness", "type": "clause", "offset": [343, 368]}, {"key": "other-jurisdiction", "type": "clause", "offset": [524, 542]}, {"key": "the-equivalent-of", "type": "definition", "offset": [544, 561]}], "hash": "a65b6da7297a5fc073f417f752e836d5", "id": 9}, {"size": 4, "snippet": "means a study, conducted in accordance with a protocol approved by the JSC, of a Development Candidate in human volunteers or patients with the endpoint of determining initial tolerance, safety and/or pharmacokinetic information in single dose, single ascending dose, multiple dose and/or multiple ascending dose regimens.", "samples": [{"hash": "iM9xiHb4dzq", "uri": "/contracts/iM9xiHb4dzq#phase-i-clinical-study", "label": "Collaboration and License Agreement (Viropharma Inc)", "score": 18.0, "published": true}, {"hash": "2I08g3szznK", "uri": "/contracts/2I08g3szznK#phase-i-clinical-study", "label": "Collaboration and License Agreement (Viropharma Inc)", "score": 18.0, "published": true}], "snippet_links": [{"key": "in-accordance-with", "type": "definition", "offset": [25, 43]}, {"key": "approved-by", "type": "clause", "offset": [55, 66]}, {"key": "development-candidate", "type": "definition", "offset": [81, 102]}, {"key": "single-dose", "type": "definition", "offset": [232, 243]}], "hash": "61791e72de1c3551c071bb0903a9977b", "id": 10}], "next_curs": "CmMSXWoVc35sYXdpbnNpZGVyY29udHJhY3Rzcj8LEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiIfcGhhc2UtaS1jbGluaWNhbC1zdHVkeSMwMDAwMDAwYQyiAQJlbhgAIAA=", "definition": {"size": 169, "snippet": "means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).", "title": "Phase I Clinical Study", "id": "phase-i-clinical-study", "examples": ["June 30, 2017 \u00b7 Initiate Neon-sponsored <strong>Phase I Clinical Study</strong> for the Licensed NeoVax Product.", "Initiation of the respective phase of the clinical study shall be deemed to be achieved after the dosing of the first patient (or, in the event of a <strong>Phase I Clinical Study</strong>, of the first healthy person) in such clinical study.", "For each Initial Indication, the Parties shall, in accordance with Section 4.3(d), conduct one or more Indication Survey Studies to assess the merit of treating such particular Indication with the Targeted AIM approach using Development Candidates for which an IND has been filed and a <strong>Phase I Clinical Study</strong> has been completed.", "December 31, 2017 \u00b7 Continue to execute and evaluate patient data for Neon-sponsored <strong>Phase I Clinical Study</strong>.", "Initial Research ends with respect to a Compound, Compound by Compound, upon such time as the Joint Project Team selects such Compound for <strong>Phase I Clinical Study</strong>.", "The Foundation therefore agrees that prior to the completion of a <strong>Phase I Clinical Study</strong> in respect of a Phase I Product (a \u201cPre-Phase I Product\u201d) the Company may decide, at its reasonable discretion, acting in good faith and following good faith consultations with the Foundation, that upon review of the available pre-clinical and clinical data that to administer said Pre-Phase I Product to a human subject would place such subject at unacceptable risk of harm (a \u201cSafety Decision\u201d).", "Licensee agrees to expend a minimum of Five Hundred Thousand United States Dollars ($500,000 USD) during this 18 month period to complete the regulatory requirements for chemistry, manufacturing &amp; control (CMC), toxicology, and a <strong>Phase I Clinical Study</strong> necessary to initiate the Phase Il Clinical Study.", "The Licensee will provide 100% of the funding to support the clinical development and commercialization of Licensed Compounds, alone and in combination therapy, in the Territory, including, without limitation, funding of the <strong>Phase I Clinical Study</strong>, the Phase Il Clinical Study and the Phase Ill Clinical Study for the treatment of prostate cancer, which will be conducted in compliance with ICH guidelines.", "As used herein, \u201cPre-Clinical Compound\u201d means a Targeted AIM controlled or owned by Licensor or any of its Affiliates which has not at the time of license grant or sale to a Third Party been the subject of any <strong>Phase I Clinical Study</strong>.", "June 30, 2017 \u2022 Initiate Neon-sponsored <strong>Phase I Clinical Study</strong> for the Licensed NeoVax Product."], "related": [["phase-ii-clinical-study", "Phase II Clinical Study", "Phase II Clinical Study"], ["phase-i-clinical-trial", "Phase I Clinical Trial", "Phase I Clinical Trial"], ["phase-iii-clinical-study", "Phase III Clinical Study", "Phase III Clinical Study"], ["phase-ii-clinical-trial", "Phase II Clinical Trial", "Phase II Clinical Trial"], ["phase-2-clinical-trial", "Phase 2 Clinical Trial", "Phase 2 Clinical Trial"]], "related_snippets": [], "updated": "2025-12-20T05:53:03+00:00"}, "json": true, "cursor": ""}}