{"component": "definition", "props": {"groups": [{"snippet_links": [{"key": "united-states-federal", "type": "definition", "offset": [10, 31]}, {"key": "as-amended", "type": "definition", "offset": [87, 97]}, {"key": "from-time-to-time", "type": "clause", "offset": [98, 115]}, {"key": "regulations-and-requirements", "type": "clause", "offset": [142, 170]}], "samples": [{"hash": "dv0e3RguMCe", "uri": "/contracts/dv0e3RguMCe#ffdca", "label": "License Agreement (LeonaBio, Inc.)", "score": 37.2436687201, "published": true}, {"hash": "2JTO8pApSQJ", "uri": "/contracts/2JTO8pApSQJ#ffdca", "label": "Purchase and Sale Agreement (Ligand Pharmaceuticals Inc)", "score": 36.3511276245, "published": true}, {"hash": "3mwjWhrF5UJ", "uri": "/contracts/3mwjWhrF5UJ#ffdca", "label": "Asset Purchase Agreement (Acadia Pharmaceuticals Inc)", "score": 36.1567420959, "published": true}], "snippet": "means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. \u00a7 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).", "size": 345, "hash": "8e41de0df5ef0953b48085923c221aab", "id": 1}, {"snippet_links": [{"key": "united-states-federal", "type": "definition", "offset": [10, 31]}, {"key": "as-amended", "type": "definition", "offset": [62, 72]}, {"key": "from-time-to-time", "type": "clause", "offset": [73, 90]}, {"key": "regulations-and-requirements", "type": "clause", "offset": [117, 145]}, {"key": "extensions-and-modifications", "type": "clause", "offset": [208, 236]}], "samples": [{"hash": "komvCthxGS7", "uri": "/contracts/komvCthxGS7#ffdca", "label": "Exclusive Collaboration Agreement (Eikon Therapeutics, Inc.)", "score": 37.0219039917, "published": true}, {"hash": "2DaoFn5XB5E", "uri": "/contracts/2DaoFn5XB5E#ffdca", "label": "Exclusive License and Development Agreement (Eikon Therapeutics, Inc.)", "score": 37.0219039917, "published": true}, {"hash": "luKL30jWn9J", "uri": "/contracts/luKL30jWn9J#ffdca", "label": "License Agreement (Black Titan Corp)", "score": 36.4168395996, "published": true}], "snippet": "means the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).", "size": 92, "hash": "b81aedec6c9016ffb707a960439c6dea", "id": 2}, {"snippet_links": [{"key": "united-states-federal", "type": "definition", "offset": [10, 31]}, {"key": "as-amended", "type": "definition", "offset": [62, 72]}, {"key": "from-time-to-time", "type": "clause", "offset": [73, 90]}], "samples": [{"hash": "c496cTBMO6K", "uri": "/contracts/c496cTBMO6K#ffdca", "label": "License Agreement (Erasca, Inc.)", "score": 35.611907959, "published": true}, {"hash": "1M1qMYpf5WG", "uri": "/contracts/1M1qMYpf5WG#ffdca", "label": "License Agreement (Erasca, Inc.)", "score": 35.611907959, "published": true}, {"hash": "7yNXIL4Ouj4", "uri": "/contracts/7yNXIL4Ouj4#ffdca", "label": "License Agreement (Global Blood Therapeutics, Inc.)", "score": 32.3401794434, "published": true}], "snippet": "means the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time.", "size": 81, "hash": "02a9edc4e7b179ff01dd42382d438624", "id": 3}, {"snippet_links": [], "samples": [{"hash": "e0JQ8Ff8SSe", "uri": "/contracts/e0JQ8Ff8SSe#ffdca", "label": "Purchase and Sale Agreement (Amarin Corp Plc\\uk)", "score": 33.1615333557, "published": true}, {"hash": "eawdYbmZv5E", "uri": "/contracts/eawdYbmZv5E#ffdca", "label": "Revenue Participation Agreement", "score": 31.3408622742, "published": true}, {"hash": "2BlVTipMYym", "uri": "/contracts/2BlVTipMYym#ffdca", "label": "Asset Purchase Agreement (Provention Bio, Inc.)", "score": 29.4654350281, "published": true}], "snippet": "means the Federal Food, Drug, and Cosmetic Act.", "size": 42, "hash": "64f3057aa54b67b049f4cdc57c5ddce5", "id": 4}, {"snippet_links": [{"key": "united-states-code", "type": "definition", "offset": [52, 70]}, {"key": "as-amended", "type": "definition", "offset": [82, 92]}], "samples": [{"hash": "9sITGhh3TPl", "uri": "/contracts/9sITGhh3TPl#ffdca", "label": "License Agreement (HilleVax, Inc.)", "score": 33.2600975037, "published": true}, {"hash": "noyxPfUyp6", "uri": "/contracts/noyxPfUyp6#ffdca", "label": "License Agreement (Harrow Health, Inc.)", "score": 32.8548927307, "published": true}, {"hash": "jmlZ7QKPtRS", "uri": "/contracts/jmlZ7QKPtRS#ffdca", "label": "License Agreement (HilleVax, Inc.)", "score": 32.7973976135, "published": true}], "snippet": "means the Federal Food, Drug and Cosmetic Act under United States Code, Title 21, as amended.", "size": 37, "hash": "06a7d2753de6036168c6e6e38e546095", "id": 5}, {"snippet_links": [{"key": "as-amended", "type": "definition", "offset": [73, 83]}, {"key": "from-time-to-time", "type": "clause", "offset": [84, 101]}, {"key": "regulations-and-requirements", "type": "clause", "offset": [128, 156]}], "samples": [{"hash": "6LyItI8XB0Q", "uri": "/contracts/6LyItI8XB0Q#ffdca", "label": "License and Option Agreement (ImmunoGen, Inc.)", "score": 34.319644928, "published": true}, {"hash": "fUYBGJx8GcD", "uri": "/contracts/fUYBGJx8GcD#ffdca", "label": "License Agreement (Coya Therapeutics, Inc.)", "score": 33.9253921509, "published": true}, {"hash": "aM5Ikwy4mnt", "uri": "/contracts/aM5Ikwy4mnt#ffdca", "label": "License Agreement (Coya Therapeutics, Inc.)", "score": 33.8788490295, "published": true}], "snippet": "means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. \u00a7 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).", "size": 11, "hash": "fc014952768e49b7a25f1152cb82ed93", "id": 6}, {"snippet_links": [{"key": "united-states-federal", "type": "definition", "offset": [10, 31]}], "samples": [{"hash": "jorPkXYW0NG", "uri": "/contracts/jorPkXYW0NG#ffdca", "label": "Products Purchase Agreement (Rockwell Medical, Inc.)", "score": 34.8672142029, "published": true}, {"hash": "kIw51Jdi282", "uri": "/contracts/kIw51Jdi282#ffdca", "label": "Products Purchase Agreement (Rockwell Medical, Inc.)", "score": 30.861738205, "published": true}, {"hash": "21NResPOJU5", "uri": "/contracts/21NResPOJU5#ffdca", "label": "Products Purchase Agreement (Rockwell Medical, Inc.)", "score": 22.5811080933, "published": true}], "snippet": "means the United States Federal Food, Drug and Cosmetic Act of 1938 and all regulations promulgated thereunder.", "size": 10, "hash": "1aef10ba297f5666ae6d91d9646291ec", "id": 7}, {"snippet_links": [{"key": "united-states-federal", "type": "definition", "offset": [10, 31]}, {"key": "from-time-to-time", "type": "clause", "offset": [107, 124]}, {"key": "the-rules", "type": "clause", "offset": [130, 139]}], "samples": [{"hash": "6E1O6QTFSzG", "uri": "/contracts/6E1O6QTFSzG#ffdca", "label": "Transaction Agreement", "score": 31.3408622742, "published": true}, {"hash": "eOX2fafHhW5", "uri": "/contracts/eOX2fafHhW5#ffdca", "label": "Supply Agreement (Arena Pharmaceuticals Inc)", "score": 28.340177536, "published": true}, {"hash": "eyNjNvvhHOf", "uri": "/contracts/eyNjNvvhHOf#ffdca", "label": "Transaction Agreement (Arena Pharmaceuticals Inc)", "score": 28.200548172, "published": true}], "snippet": "means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301, et seq., as it may be amended from time to time, and the rules, regulations, guidances, guidelines, and requirements promulgated or issued thereunder.", "size": 10, "hash": "1447e84c843d1be15372f70951958141", "id": 8}, {"snippet_links": [{"key": "the-us", "type": "clause", "offset": [6, 13]}, {"key": "as-amended", "type": "definition", "offset": [45, 55]}], "samples": [{"hash": "h9KI1RJodzL", "uri": "/contracts/h9KI1RJodzL#ffdca", "label": "Stock Purchase Agreement (Eagle Pharmaceuticals, Inc.)", "score": 27.8692684174, "published": true}, {"hash": "jzJo1ZquxZZ", "uri": "/contracts/jzJo1ZquxZZ#ffdca", "label": "Research, Option and License Agreement (BIND Therapeutics, Inc)", "score": 24.6550312042, "published": true}, {"hash": "eXGxipcOdYH", "uri": "/contracts/eXGxipcOdYH#ffdca", "label": "License Agreement (BIND Therapeutics, Inc)", "score": 24.6550312042, "published": true}], "snippet": "means the U.S. Food, Drug, and Cosmetic Act, as amended or replaced.", "size": 9, "hash": "6fac92fd1e8394635cbb3726ff7422fc", "id": 9}, {"snippet_links": [{"key": "as-amended", "type": "definition", "offset": [56, 66]}], "samples": [{"hash": "7h2usY1FGFn", "uri": "/contracts/7h2usY1FGFn#ffdca", "label": "Asset Purchase Agreement (DR Reddys Laboratories LTD)", "score": 28.4633808136, "published": true}, {"hash": "1La8cPmeusp", "uri": "/contracts/1La8cPmeusp#ffdca", "label": "Asset Purchase Agreement (DR Reddys Laboratories LTD)", "score": 28.4633808136, "published": true}, {"hash": "jP9GJmTO533", "uri": "/contracts/jP9GJmTO533#ffdca", "label": "Asset Purchase Agreement (Cell Therapeutics Inc)", "score": 21.0, "published": true}], "snippet": "means the Federal Food, Drug, and Cosmetic Act of 1938, as amended.", "size": 9, "hash": "fca254be3e5ebfcd310e038a178607f3", "id": 10}], "next_curs": "ClISTGoVc35sYXdpbnNpZGVyY29udHJhY3Rzci4LEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiIOZmZkY2EjMDAwMDAwMGEMogECZW4YACAA", "definition": {"snippet": "means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. \u00a7 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).", "title": "FFDCA", "size": 782, "id": "ffdca", "examples": ["The Company has not received any notice or other communication alleging a possible material violation by the Company of the <strong>FFDCA</strong> or any comparable foreign Law.", "The Company is not subject to any pending or asserted material fine, action, penalty or liability as a result of a failure to comply with any provisions of the <strong>FFDCA</strong> or any comparable foreign Law.", "The Company is not in material breach of, or material default under, and has not been in material breach of, or material default under, the <strong>FFDCA</strong> or any comparable foreign Law."], "related": [["fdca", "FDCA", "FDCA"], ["fdc-act", "FD&C Act", "FD&amp;C Act"], ["new-drug-application", "New Drug Application", "New Drug Application"], ["fda", "FDA", "FDA"], ["340b-drug", "340B drug", "340B drug"]], "related_snippets": [], "updated": "2026-04-02T05:49:26+00:00"}, "json": true, "cursor": ""}}