{"component": "definition", "props": {"groups": [{"samples": [{"hash": "dmIsujFHWdC", "uri": "/contracts/dmIsujFHWdC#cmc-section", "label": "License Agreement (Acorda Therapeutics Inc)", "score": 22.5468856947, "published": true}, {"hash": "3FrrobTWrHr", "uri": "/contracts/3FrrobTWrHr#cmc-section", "label": "License Agreement (Acorda Therapeutics Inc)", "score": 22.3497604381, "published": true}, {"hash": "hULdvjFgoVg", "uri": "/contracts/hULdvjFgoVg#cmc-section", "label": "License Agreement (Acorda Therapeutics Inc)", "score": 21.0, "published": true}], "size": 13, "snippet_links": [{"key": "registration-applications", "type": "definition", "offset": [135, 160]}], "snippet": "means the chemistry, manufacturing, and controls section of an NDA as defined in 21 CFR Section 314.50 (1) and its equivalent in other registration applications.", "hash": "dc1468ac599126dc55e26d8374d08331", "id": 1}, {"samples": [{"hash": "gCnV8JQj68N", "uri": "/contracts/gCnV8JQj68N#cmc-section", "label": "License Agreement (Zogenix, Inc.)", "score": 20.6707734428, "published": true}, {"hash": "gI4eCsfehiO", "uri": "/contracts/gI4eCsfehiO#cmc-section", "label": "License Agreement (Zogenix Inc)", "score": 20.0, "published": true}, {"hash": "aagGZYq9MAU", "uri": "/contracts/aagGZYq9MAU#cmc-section", "label": "License Agreement (Zogenix Inc)", "score": 20.0, "published": true}], "size": 7, "snippet_links": [{"key": "regulatory-application", "type": "clause", "offset": [64, 86]}, {"key": "in-the-territory", "type": "clause", "offset": [87, 103]}, {"key": "from-time-to-time", "type": "clause", "offset": [166, 183]}], "snippet": "means the chemistry, manufacturing, and controls section of the Regulatory Application in the Territory as defined in 21 C.F.R. Section 314.50 (1), as may be amended from time to time.", "hash": "3b9428cdfb31d450d830b04ffef0b233", "id": 2}, {"samples": [{"hash": "l1FujjBxi2z", "uri": "/contracts/l1FujjBxi2z#cmc-section", "label": "Development, License and Supply Agreement", "score": 31.340862423, "published": true}, {"hash": "7y07qlO2LKT", "uri": "/contracts/7y07qlO2LKT#cmc-section", "label": "Development, License and Supply Agreement (Endo Pharmaceuticals Holdings Inc)", "score": 23.3299110198, "published": true}], "size": 4, "snippet_links": [{"key": "application-for-regulatory-approval", "type": "definition", "offset": [61, 96]}], "snippet": "means the chemistry, manufacturing and control section of an Application for Regulatory Approval.", "hash": "3b13792aecdddd56e0f4f7deeb8ba494", "id": 3}, {"samples": [{"hash": "1267xTOcSwX", "uri": "/contracts/1267xTOcSwX#cmc-section", "label": "Option and License Agreement (Warner Chilcott CORP)", "score": 21.0, "published": true}], "size": 4, "snippet_links": [{"key": "regulatory-submission", "type": "clause", "offset": [61, 82]}], "snippet": "means the Chemistry, Manufacturing and Controls Section of a regulatory submission document included in an ANDA as set forth in 21 C.F.R. \u00a7314.94(a)(9).", "hash": "fd91f189b5c677388f18c1d19e837070", "id": 4}, {"samples": [{"hash": "vaDRt6wtWL", "uri": "/contracts/vaDRt6wtWL#cmc-section", "label": "License and Supply Agreement", "score": 31.340862423, "published": true}, {"hash": "lLLThYmj5nH", "uri": "/contracts/lLLThYmj5nH#cmc-section", "label": "Licence and Supply Agreement (Recro Pharma, Inc.)", "score": 26.6153319644, "published": true}], "size": 3, "snippet_links": [{"key": "from-time-to-time", "type": "clause", "offset": [124, 141]}, {"key": "other-regulatory-filings", "type": "clause", "offset": [168, 192]}], "snippet": "means the chemistry, manufacturing, and controls section of the Regulatory Filing, as defined in the CFR, as may be amended from time to time, and/or its equivalent in other Regulatory Filings.", "hash": "c2eaa5dc4f049f7fc8d9c3f559a0b2cd", "id": 5}, {"samples": [{"hash": "18lM6jeZobY", "uri": "/contracts/18lM6jeZobY#cmc-section", "label": "Development and License Agreement (Pfenex Inc.)", "score": 29.5995893224, "published": true}, {"hash": "9LhfywTskk1", "uri": "http://pdf.secdatabase.com/530/0001193125-18-242749.pdf", "label": "pdf.secdatabase.com", "score": 20.2358554545, "published": false}], "size": 2, "snippet_links": [{"key": "other-jurisdiction", "type": "clause", "offset": [112, 130]}, {"key": "with-respect-to", "type": "clause", "offset": [132, 147]}], "snippet": "means the \u201cChemistry, Manufacturing and Controls\u201d section of a NDA, or the comparable section of an MAA for any other jurisdiction, with respect to Product.", "hash": "1bb60b21dcc70b07a1e984c544d77383", "id": 6}, {"samples": [{"hash": "8JxpW7pf3d9", "uri": "/contracts/8JxpW7pf3d9#cmc-section", "label": "Supply Agreement", "score": 31.340862423, "published": true}, {"hash": "57K2zrhRUvU", "uri": "/contracts/57K2zrhRUvU#cmc-section", "label": "Supply Agreement (Neos Therapeutics, Inc.)", "score": 26.4811772758, "published": true}], "size": 2, "snippet_links": [{"key": "anda-filing", "type": "definition", "offset": [75, 86]}], "snippet": "means the chemistry, manufacturing and controls section(s) and data in the ANDA Filing.", "hash": "404d2f8332a712c3d5e8e9a5e91865c7", "id": 7}, {"samples": [{"hash": "hTxYgoCzZpL", "uri": "/contracts/hTxYgoCzZpL#cmc-section", "label": "Commercial Supply Agreement (Supernus Pharmaceuticals Inc)", "score": 24.1019849418, "published": true}], "size": 1, "snippet_links": [{"key": "approval-by", "type": "clause", "offset": [120, 131]}, {"key": "fda-and-other-regulatory-authorities", "type": "clause", "offset": [132, 168]}, {"key": "regulatory-filings", "type": "definition", "offset": [225, 243]}], "snippet": "means a dossier containing all Chemistry, Manufacturing and Controls documents in a form acceptable for filing with and approval by FDA and other Regulatory Authorities for inclusion by Supernus or its sub-licensees in their regulatory filings.", "hash": "b74cd078dbd691acf0f2890c171ec94f", "id": 8}, {"samples": [{"hash": "3Juh9k0ABof", "uri": "/contracts/3Juh9k0ABof#cmc-section", "label": "License and Supply Agreement (Light Sciences Oncology Inc)", "score": 18.0, "published": true}], "size": 1, "snippet_links": [{"key": "foreign-equivalent", "type": "definition", "offset": [133, 151]}, {"key": "by-or-on-behalf-of", "type": "definition", "offset": [175, 193]}, {"key": "the-fda", "type": "clause", "offset": [215, 222]}, {"key": "with-respect-to", "type": "clause", "offset": [257, 272]}, {"key": "the-product", "type": "clause", "offset": [285, 296]}], "snippet": "means the Section on chemistry, manufacture and control defined in 21 C.F.R. 312.23 (a) (7) or any successor to such provision, or a foreign equivalent thereof, and submitted by or on behalf of Meiji or Licensee to the FDA, or a foreign equivalent thereof, with respect to the Bulk or the Product, as applicable.", "hash": "1cffdac393f68d692a0891a6207ee4fc", "id": 9}, {"samples": [{"hash": "8euoSQOQPIu", "uri": "https://investors.neostx.com/static-files/e4923e73-03ac-4abf-b1fc-9f443c7ba8a0", "label": "Amendment", "score": 11.9637234771, "published": false}], "size": 1, "snippet_links": [{"key": "anda-filing", "type": "definition", "offset": [75, 86]}, {"key": "successors-and-affiliates", "type": "clause", "offset": [137, 162]}], "snippet": "means the chemistry, manufacturing and controls section(s) and data in the ANDA Filing. \u201cCompetitor\u201d means: (a) Tris Pharma, Inc. or its successors and Affiliates, or (b) UCB or its successors and Affiliates.", "hash": "7e99d24bbafe8c196f7fcdd86499bb54", "id": 10}], "next_curs": "ClgSUmoVc35sYXdpbnNpZGVyY29udHJhY3RzcjQLEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiIUY21jLXNlY3Rpb24jMDAwMDAwMGEMogECZW4YACAA", "definition": {"size": 42, "title": "CMC Section", "snippet": "means the chemistry, manufacturing, and controls section of an NDA as defined in 21 CFR Section 314.50 (1) and its equivalent in other registration applications.", "id": "cmc-section", "examples": ["In the event that there is a deficiency in the <strong>CMC Section</strong> attributable to negligence by Elan in the activities conducted by Elan, then Elan shall be responsible for correcting such deficiency, at Elan\u2019s expense, and shall use reasonable efforts to do so as soon as practicable.", "Acorda shall provide Elan as soon as practicable with a copy of any comments received by Acorda from the FDA or any other regulatory authority relating to the <strong>CMC Section</strong> and Elan shall provide or, at Acorda\u2019s request, cooperate with Acorda to provide, a response to such comments as soon as practicable.", "In circumstances where the third party is entitled to, or is likely to be able to obtain, access to the <strong>CMC Section</strong>, the prior written consent of Elan shall be obtained to any sub-licence or other agreement permitted by this Article 2.", "Elan shall manufacture or procure the manufacture the Product under this Agreement in conformity with the Specifications, the relevant portions of the <strong>CMC Section</strong> and, if applicable, the DMF and in a manner which fully complies with all United States of America and foreign statutes, ordinances, regulations and practices.", "Elan shall indemnify and hold harmless Acorda, its agents and employees from and against all claims, damages, losses, liabilities and expenses to which Acorda, its agents, and employees may become subject related to or arising out of Elan\u2019s bad faith, gross negligence or intentional misconduct in connection with the preparation of the <strong>CMC Section</strong>.", "Elan shall be responsible, at Elan\u2019s expense, for filing for and maintaining all license and permits pertinent to Elan\u2019s Facility, as distinct from the Regulatory Approvals specific to the Product, without prejudice to Elan\u2019s responsibilities under the Licence Agreement in respect of preparation and delivery to Acorda for incorporation into the NDA or any NDA Equivalent, of the <strong>CMC Section</strong>.", "To the extent required, Bayer shall either: (i) be responsible for the preparation and delivery to Licensee of the Summary <strong>CMC Section</strong> in electronic and hard copy form and the latter in format suitable for inclusion in an NDA or NDA Equivalent in accordance with Applicable Laws and as the Parties may mutually agree; or (ii) provide Licensee with all data and information (including, without limitation, all Information) required to complete the Summary <strong>CMC Section</strong> in accordance with Applicable Laws.", "In the event that there is a deficiency in the Summary <strong>CMC Section</strong> attributable to Bayer (including as a result of any deficiency in or changes required to be made to the DMF), then Bayer shall be responsible for correcting such deficiency, at Bayer\u2019s expense, and shall use Commercially Reasonable Efforts to do so as soon as practicable.", "Leave under the provisions of this Article shall be limited to four (4) months (nine [9] pay periods [720 hours]) during a twelve (12) month period, regardless of the number of incidents.", "The <strong>CMC Section</strong> of any regulatory filing, to the extent it relates to the System, may be maintained by ALZA, in one or more of ALZA&#x27;s Drug Master Files to the extent permissible under applicable laws and regulations, for which Durect shall have the right of reference for each Product hereunder."], "related": [["tomographic-section", "Tomographic section", "Tomographic section"], ["line-section", "Line section", "Line section"], ["description-section", "Description Section", "Description Section"], ["permitted-section-5d-communication", "Permitted Section 5(d) Communication", "Permitted Section 5(d) Communication"], ["nominal-tomographic-section-thickness", "Nominal tomographic section thickness", "Nominal tomographic section thickness"]], "related_snippets": [], "updated": "2025-07-06T21:58:41+00:00"}, "json": true, "cursor": ""}}