{"component": "definition", "props": {"groups": [{"snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [6, 21]}, {"key": "approval-by", "type": "clause", "offset": [48, 59]}, {"key": "the-fda", "type": "clause", "offset": [60, 67]}, {"key": "use-of-the-product", "type": "clause", "offset": [87, 105]}, {"key": "in-the-united-states", "type": "clause", "offset": [106, 126]}], "samples": [{"hash": "70R25cfvO4O", "uri": "/contracts/70R25cfvO4O#fda-approval", "label": "License Agreement (Braeburn Pharmaceuticals, Inc.)", "score": 27.9952087402, "published": true}, {"hash": "2kT9xlxZgC3", "uri": "/contracts/2kT9xlxZgC3#fda-approval", "label": "License Agreement (Braeburn Pharmaceuticals, Inc.)", "score": 27.937713623, "published": true}, {"hash": "hMialDa2nLM", "uri": "/contracts/hMialDa2nLM#fda-approval", "label": "License Agreement (Titan Pharmaceuticals Inc)", "score": 24.1594791412, "published": true}], "size": 41, "snippet": "means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.", "hash": "45b4b566a07ca7f8f0cd8ab74885a0c4", "id": 1}, {"snippet_links": [{"key": "approval-of", "type": "definition", "offset": [27, 38]}, {"key": "the-fda", "type": "clause", "offset": [39, 46]}, {"key": "commercial-marketing", "type": "clause", "offset": [68, 88]}], "samples": [{"hash": "lwXjx1tkRtA", "uri": "/contracts/lwXjx1tkRtA#fda-approval", "label": "Technology License Agreement (Dura Pharmaceuticals Inc/Ca)", "score": 18.0, "published": true}, {"hash": "kkh2Y0HFzC5", "uri": "/contracts/kkh2Y0HFzC5#fda-approval", "label": "Technology License Agreement (Spiros Development Corp Ii Inc)", "score": 18.0, "published": true}, {"hash": "jpSGxMwnWLM", "uri": "/contracts/jpSGxMwnWLM#fda-approval", "label": "Technology License Agreement (Dura Pharmaceuticals Inc/Ca)", "score": 18.0, "published": true}], "size": 17, "snippet": "means the final regulatory approval of the FDA required to commence commercial marketing of a health product.", "hash": "f02877ede277613c9f54d3ca4b3365df", "id": 2}, {"snippet_links": [{"key": "approval-of", "type": "definition", "offset": [10, 21]}, {"key": "new-drug-application", "type": "definition", "offset": [26, 46]}, {"key": "finished-product", "type": "definition", "offset": [61, 77]}, {"key": "food-and-drug-administration", "type": "definition", "offset": [85, 113]}, {"key": "the-united-states-of-america", "type": "clause", "offset": [117, 145]}], "samples": [{"hash": "7hFNxYUrowM", "uri": "/contracts/7hFNxYUrowM#fda-approval", "label": "Supply, Development & Exclusive Licensing Agreement (Insys Therapeutics, Inc.)", "score": 27.1601638794, "published": true}, {"hash": "2jLTLarOnOO", "uri": "http://pdf.secdatabase.com/130/0001193125-11-158711.pdf", "label": "pdf.secdatabase.com", "score": 20.4470329285, "published": false}, {"hash": "iLS2phbjzX9", "uri": "https://insysrx.gcs-web.com/static-files/fc89a1b3-ca39-4d1f-9332-fdde68e6da56", "label": "Amendment", "score": 13.9637231827, "published": false}], "size": 10, "snippet": "means the approval of the new drug application (NDA) for the Finished Product by the Food and Drug Administration in the United States of America (FDA).", "hash": "92cff11e5c73f36401ffb6ed65c43ab4", "id": 3}, {"snippet_links": [{"key": "approval-of", "type": "definition", "offset": [10, 21]}, {"key": "food-and-drug-administration", "type": "definition", "offset": [40, 68]}, {"key": "necessary-for", "type": "definition", "offset": [69, 82]}, {"key": "interstate-commerce", "type": "clause", "offset": [114, 133]}, {"key": "sale-of-the", "type": "clause", "offset": [138, 149]}, {"key": "initial-product", "type": "definition", "offset": [150, 165]}, {"key": "collaboration-and-license-agreement", "type": "definition", "offset": [185, 220]}, {"key": "in-the-united-states", "type": "clause", "offset": [222, 242]}], "samples": [{"hash": "h8Wuam5Vowg", "uri": "/contracts/h8Wuam5Vowg#fda-approval", "label": "Common Stock Purchase Agreement (G42 Investments AI Holdings RSC Ltd.)", "score": 33.4380569458, "published": true}, {"hash": "fzHPiFUIpLx", "uri": "/contracts/fzHPiFUIpLx#fda-approval", "label": "Common Stock Purchase Agreement (vTv Therapeutics Inc.)", "score": 33.4134140015, "published": true}, {"hash": "ksXvJaeT4I4", "uri": "http://pdf.secdatabase.com/1241/0001104659-22-070134.pdf", "label": "pdf.secdatabase.com", "score": 9.9486656189, "published": false}], "size": 9, "snippet": "means the approval of the United States Food and Drug Administration necessary for the marketing, distribution in interstate commerce and sale of the Initial Product (as defined in the Collaboration and License Agreement) in the United States.", "hash": "205fd6c66550048f679945b4641afea4", "id": 4}, {"snippet_links": [{"key": "the-fda", "type": "clause", "offset": [33, 40]}, {"key": "the-act", "type": "clause", "offset": [65, 72]}, {"key": "subpart-e", "type": "definition", "offset": [117, 126]}, {"key": "premarket-approval", "type": "definition", "offset": [135, 153]}, {"key": "in-accordance-with", "type": "definition", "offset": [162, 180]}], "samples": [{"hash": "fiiseeoaYVP", "uri": "/contracts/fiiseeoaYVP#fda-approval", "label": "Co Marketing Agreement", "score": 31.3408622742, "published": true}, {"hash": "g9BpBiPiZiF", "uri": "/contracts/g9BpBiPiZiF#fda-approval", "label": "Development, Supply and Distribution Agreement (Cambridge Heart Inc)", "score": 21.1423683167, "published": true}, {"hash": "iqlrOPMiM8h", "uri": "/contracts/iqlrOPMiM8h#fda-approval", "label": "Development, Supply and Distribution Agreement (Cambridge Heart Inc)", "score": 21.0, "published": true}], "size": 7, "snippet": "means clearance for marketing by the FDA under Section 510(k) of the Act, 21 U.S.C. \u00a7360(k), and 21 C.F.R. Part 807, Subpart E, or FDA premarket approval granted in accordance with 21 U.S.C. \u00a7 360e and 21 C.F.R. Part 814.", "hash": "23a9d2702a085b9da6bbf99e0dbde26f", "id": 5}, {"snippet_links": [{"key": "the-fda", "type": "clause", "offset": [27, 34]}, {"key": "in-the-united-states", "type": "clause", "offset": [71, 91]}, {"key": "approved-label", "type": "definition", "offset": [100, 114]}, {"key": "opioid-overdose-indication", "type": "definition", "offset": [147, 173]}], "samples": [{"hash": "h7Pa1ZUewrI", "uri": "/contracts/h7Pa1ZUewrI#fda-approval", "label": "Contingent Value Rights Agreement (Indivior PLC)", "score": 34.388092041, "published": true}, {"hash": "a8e0FLF38ge", "uri": "/contracts/a8e0FLF38ge#fda-approval", "label": "Merger Agreement (Indivior PLC)", "score": 34.388092041, "published": true}, {"hash": "8KHUOou0GyZ", "uri": "/contracts/8KHUOou0GyZ#fda-approval", "label": "Contingent Value Rights Agreement (Indivior PLC)", "score": 34.1854896545, "published": true}], "size": 5, "snippet": "means written receipt from the FDA of approval for marketing a Product in the United States with an approved label including an indication for the Opioid Overdose Indication.", "hash": "6ab636c14983aef0aba883c03398b0cb", "id": 6}, {"snippet_links": [{"key": "the-fda", "type": "clause", "offset": [6, 13]}, {"key": "biologics-license-application", "type": "definition", "offset": [53, 82]}, {"key": "interstate-commerce", "type": "clause", "offset": [168, 187]}, {"key": "in-the-united-states", "type": "clause", "offset": [197, 217]}, {"key": "by-the-issuer", "type": "clause", "offset": [218, 231]}, {"key": "member-of-the-group", "type": "definition", "offset": [253, 272]}, {"key": "granted-to", "type": "definition", "offset": [275, 285]}, {"key": "for-the-avoidance-of-doubt", "type": "clause", "offset": [372, 398]}, {"key": "accelerated-approval", "type": "definition", "offset": [441, 461]}, {"key": "subpart-e", "type": "definition", "offset": [519, 528]}], "samples": [{"hash": "mc1TUuClmv", "uri": "https://www.sec.gov/Archives/edgar/data/1898416/000119312522287821/d408752dex999.htm", "label": "Alvotech", "score": 18.8761119843, "published": false}, {"hash": "BTWeyfJugy", "uri": "https://www.sec.gov/Archives/edgar/data/1898416/000119312523056506/d454484dex29.htm", "label": "Alvotech", "score": 16.1608486176, "published": false}, {"hash": "27qUx2mWALs", "uri": "https://www.sec.gov/Archives/edgar/data/1898416/000119312523056506/d454484dex210.htm", "label": "Alvotech", "score": 16.1608486176, "published": false}], "size": 5, "snippet": "means the FDA approval under 42 U.S.C. \u00a7 262(k) of a biologics license application (BLA) authorizing the manufacture and introduction or delivery for introduction into interstate commerce of AVT02 in the United States by the Issuer (or as relevant, any member of the Group), granted to the Issuer (or as relevant, any member of the Group) by FDA of the United States; and for the avoidance of doubt, such an FDA Approval does not include an accelerated approval permitted under 21 U.S.C. 356(c) and 21 C.F.R. part 601, subpart E;", "hash": "f5c33f76d43efb2fcc1ae052490d6468", "id": 7}, {"snippet_links": [{"key": "by-medtronic", "type": "clause", "offset": [18, 30]}, {"key": "all-approvals", "type": "clause", "offset": [34, 47]}, {"key": "the-fda", "type": "clause", "offset": [51, 58]}, {"key": "united-states-of", "type": "definition", "offset": [114, 130]}, {"key": "royalty-product", "type": "definition", "offset": [133, 148]}], "samples": [{"hash": "iyW3YnizCa8", "uri": "/contracts/iyW3YnizCa8#fda-approval", "label": "License and Development Agreement (Avi Biopharma Inc)", "score": 21.0, "published": true}, {"hash": "1SteMeVCGTE", "uri": "/contracts/1SteMeVCGTE#fda-approval", "label": "License and Development Agreement (Avi Biopharma Inc)", "score": 21.0, "published": true}, {"hash": "gmtg4KbCETU", "uri": "https://investorrelations.sarepta.com/static-files/1ce0c2f5-1351-45e9-b381-164d4a95d670", "label": "Amendment", "score": 13.965092659, "published": false}], "size": 5, "snippet": "means the receipt by Medtronic of all approvals by the FDA necessary or required for the commercialization in the United States of a Royalty Product.", "hash": "958a459571f8425dc292d12bf1e46e4a", "id": 8}, {"snippet_links": [{"key": "approval-by", "type": "clause", "offset": [6, 17]}, {"key": "the-fda", "type": "clause", "offset": [18, 25]}], "samples": [{"hash": "ilBHCpY6lOB", "uri": "/contracts/ilBHCpY6lOB#fda-approval", "label": "License Agreement (ProUroCare Medical Inc.)", "score": 21.0, "published": true}, {"hash": "c8Td4ilgwaE", "uri": "/contracts/c8Td4ilgwaE#fda-approval", "label": "Development and Commercialization Agreement (ProUroCare Medical Inc.)", "score": 21.0, "published": true}], "size": 5, "snippet": "means approval by the FDA of a 510K or PMA to commercially sell a Product.", "hash": "30aeaaecca2f1826ae69d9cc94e01735", "id": 9}, {"snippet_links": [{"key": "approval-by", "type": "clause", "offset": [10, 21]}, {"key": "the-fda", "type": "clause", "offset": [22, 29]}, {"key": "new-drug-application", "type": "definition", "offset": [36, 56]}, {"key": "in-respect-of", "type": "clause", "offset": [62, 75]}], "samples": [{"hash": "htB3prs8blo", "uri": "/contracts/htB3prs8blo#fda-approval", "label": "Licence Agreement (Acadia Pharmaceuticals Inc)", "score": 35.1567420959, "published": true}, {"hash": "hZBvknQKiJ2", "uri": "/contracts/hZBvknQKiJ2#fda-approval", "label": "Licence Agreement (Acadia Pharmaceuticals Inc)", "score": 27.1553726196, "published": true}], "size": 5, "snippet": "means the approval by the FDA for a New Drug Application made in respect of any Product.", "hash": "6754de2ed5a7cfdc0e6e5bc1997015a2", "id": 10}], "next_curs": "ClkSU2oVc35sYXdpbnNpZGVyY29udHJhY3RzcjULEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiIVZmRhLWFwcHJvdmFsIzAwMDAwMDBhDKIBAmVuGAAgAA==", "definition": {"size": 341, "snippet": "means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.", "title": "FDA Approval", "id": "fda-approval", "examples": ["Subject to the satisfaction (or waiver by the party so entitled to waive) of the conditions set forth in ARTICLE 8, the Closing shall take place remotely via the exchange of documents and signatures within [***] Days following the <strong>FDA Approval</strong> (the \u201cClosing Date\u201d)."], "related": [["nda-approval", "NDA Approval", "NDA Approval"], ["regulatory-approval", "Regulatory Approval", "Regulatory Approval"], ["maa-approval", "MAA Approval", "MAA Approval"], ["regulatory-approval-application", "Regulatory Approval Application", "Regulatory Approval Application"], ["marketing-approval", "Marketing Approval", "Marketing Approval"]], "related_snippets": [], "updated": "2026-05-20T04:25:14+00:00"}, "json": true, "cursor": ""}}