{"component": "clause", "props": {"groups": [{"size": 3, "snippet": "Company will maintain original batch documentation for each Batch as set forth in the Quality Agreement.", "samples": [{"hash": "ftwskT2nUrW", "uri": "/contracts/ftwskT2nUrW#batch-documentation", "label": "Manufacture and Supply Agreement", "score": 31.3408622742, "published": true}, {"hash": "eyqA2keMMuO", "uri": "/contracts/eyqA2keMMuO#batch-documentation", "label": "Manufacture and Supply Agreement (Codexis Inc)", "score": 22.8206710815, "published": true}, {"hash": "hNbwFd9bCts", "uri": "/contracts/hNbwFd9bCts#batch-documentation", "label": "Manufacture and Supply Agreement (Codexis Inc)", "score": 22.5852165222, "published": true}], "snippet_links": [{"key": "company-will", "type": "clause", "offset": [0, 12]}, {"key": "quality-agreement", "type": "clause", "offset": [86, 103]}], "hash": "4adb6876535dea8f8394ee465f8d439f", "id": 1}, {"size": 3, "snippet": "With respect to each Batch, Provider will provide Senti with a copy of each document in the Batch Documentation for such Batch on a rolling basis as Provider reasonably determines such document is ready to be shared. Following completion of each Batch, Provider will provide Senti with a copy of all applicable Batch Documentation not previously shared. All Batch Documentation will be in Provider\u2019s standard formats unless otherwise mutually agreed in writing by the Parties. Any Senti requests for documents or other work product related to Batch Documentation that are not specified or contemplated in the applicable Statement of Work or the Quality Agreement and are not produced by Provider in the ordinary course of business must be agreed upon in writing in the form of a Change Order or a separate agreement for such additional services, and Provider will not be obligated with respect thereto unless and until so agreed.", "samples": [{"hash": "94LdbyESuNJ", "uri": "/contracts/94LdbyESuNJ#batch-documentation", "label": "Development and Manufacturing Services Agreement (Senti Biosciences, Inc.)", "score": 36.2142372131, "published": true}, {"hash": "3VHSFTsFQ6N", "uri": "/contracts/3VHSFTsFQ6N#batch-documentation", "label": "Framework Agreement (Senti Biosciences, Inc.)", "score": 36.2142372131, "published": true}, {"hash": "aqvhxnlpk8Y", "uri": "/contracts/aqvhxnlpk8Y#batch-documentation", "label": "Development and Manufacturing Services Agreement (Senti Biosciences, Inc.)", "score": 34.8672142029, "published": true}], "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [0, 15]}, {"key": "will-provide", "type": "clause", "offset": [37, 49]}, {"key": "a-copy-of", "type": "clause", "offset": [61, 70]}, {"key": "rolling-basis", "type": "definition", "offset": [132, 145]}, {"key": "ready-to", "type": "clause", "offset": [197, 205]}, {"key": "completion-of", "type": "clause", "offset": [227, 240]}, {"key": "mutually-agreed", "type": "definition", "offset": [434, 449]}, {"key": "in-writing", "type": "clause", "offset": [450, 460]}, {"key": "by-the-parties", "type": "clause", "offset": [461, 475]}, {"key": "requests-for-documents", "type": "clause", "offset": [487, 509]}, {"key": "to-batch", "type": "definition", "offset": [540, 548]}, {"key": "not-specified", "type": "definition", "offset": [572, 585]}, {"key": "the-applicable", "type": "clause", "offset": [605, 619]}, {"key": "statement-of-work", "type": "definition", "offset": [620, 637]}, {"key": "quality-agreement", "type": "clause", "offset": [645, 662]}, {"key": "by-provider", "type": "clause", "offset": [684, 695]}, {"key": "in-the-ordinary-course-of-business", "type": "definition", "offset": [696, 730]}, {"key": "form-of", "type": "definition", "offset": [769, 776]}, {"key": "a-change-order", "type": "clause", "offset": [777, 791]}, {"key": "agreement-for", "type": "clause", "offset": [806, 819]}, {"key": "additional-services", "type": "definition", "offset": [825, 844]}], "hash": "bd149892d17c441b5b2046bb45818c46", "id": 2}, {"size": 3, "snippet": "4.1 Originals of all batch documentation and associated retain samples will be retained by Patheon for a period of one year past the expiry date of the Product at which time the Client will be contacted concerning the future storage or destruction of the documentation. Client to have option of taking ownership of completed batch records, copies of analytical data, and product retains at the end of the storage period.\n4.2 At the request of the Client, Patheon agrees to provide a copy of any of the executed batch documents relating to Products to the Client by facsimile or courier within two Business Days.", "samples": [{"hash": "e8WquaYBul", "uri": "/contracts/e8WquaYBul#batch-documentation", "label": "Manufacturing Services Agreement (Critical Therapeutics Inc)", "score": 18.0, "published": true}, {"hash": "9fyqFIWR25E", "uri": "/contracts/9fyqFIWR25E#batch-documentation", "label": "Manufacturing Services Agreement (Critical Therapeutics Inc)", "score": 18.0, "published": true}], "snippet_links": [{"key": "retain-samples", "type": "clause", "offset": [56, 70]}, {"key": "period-of", "type": "clause", "offset": [105, 114]}, {"key": "one-year", "type": "definition", "offset": [115, 123]}, {"key": "date-of", "type": "clause", "offset": [140, 147]}, {"key": "the-product", "type": "clause", "offset": [148, 159]}, {"key": "the-client-will", "type": "clause", "offset": [174, 189]}, {"key": "the-future", "type": "clause", "offset": [214, 224]}, {"key": "ownership-of", "type": "clause", "offset": [302, 314]}, {"key": "batch-records", "type": "definition", "offset": [325, 338]}, {"key": "copies-of", "type": "definition", "offset": [340, 349]}, {"key": "analytical-data", "type": "clause", "offset": [350, 365]}, {"key": "at-the-end-of-the", "type": "clause", "offset": [387, 404]}, {"key": "storage-period", "type": "definition", "offset": [405, 419]}, {"key": "the-request", "type": "clause", "offset": [428, 439]}, {"key": "a-copy-of", "type": "clause", "offset": [481, 490]}, {"key": "relating-to", "type": "definition", "offset": [527, 538]}, {"key": "to-the-client", "type": "clause", "offset": [548, 561]}, {"key": "business-days", "type": "definition", "offset": [597, 610]}], "hash": "b6df3b6bb3b5136d5ac0045d971cda63", "id": 3}, {"size": 3, "snippet": "4.1 Originals of all batch documents will be retained by the Contractor according to regulatory and Contractor requirements; these records will be maintained for a period of one (1) year following the Product lot\u2019s expiration date.", "samples": [{"hash": "gssyw5b7L7o", "uri": "/contracts/gssyw5b7L7o#batch-documentation", "label": "Distribution Agreement (Lantheus MI Intermediate, Inc.)", "score": 19.9911022186, "published": true}, {"hash": "dbPmNlURURf", "uri": "/contracts/dbPmNlURURf#batch-documentation", "label": "Distribution Agreement (Lantheus MI Intermediate, Inc.)", "score": 19.9746742249, "published": true}], "snippet_links": [{"key": "by-the-contractor", "type": "clause", "offset": [54, 71]}, {"key": "according-to", "type": "definition", "offset": [72, 84]}, {"key": "contractor-requirements", "type": "clause", "offset": [100, 123]}, {"key": "period-of", "type": "clause", "offset": [164, 173]}, {"key": "product-lot", "type": "definition", "offset": [201, 212]}, {"key": "expiration-date", "type": "clause", "offset": [215, 230]}], "hash": "3aa1d5061457e1bfee5db7d444595706", "id": 4}, {"size": 3, "snippet": "SCHERING will document the conduct of all the procedural steps stipulated in the Manufacturing Description as well as all in-process controls in Batch-specific records as customarily kept by SCHERING. SCHERING will provide INDEVUS with timely notification of all significant deviations, notes to file, and other deficiencies that may reasonably be expected to impact the quality of the Finished Product, as well as all FDA correspondence regarding testing, Manufacture, Final Packaging, or Packing of the Finished Product. SCHERING will provide INDEVUS with a complete copy of - 44 - the Executed Batch Records of the first [*] Batches of Finished Product. An English version of the Master Batch Record for Finished Product will be provided to INDEVUS. Such records will be provided to INDEVUS prior to shipment of such Batches in accordance with the provisions of Section 5.6 of the MSA. The records must be accompanied by a Certificate of Compliance (COC) and a Certificate of Analysis (COA) for the Substance used in Finished Product and the Finished Product. Deviation and Out of Specification (OOS) reports will be included if applicable, which detail in writing any problems and deviations within the Manufacturing process and analytical testing. The accompanying COC, COA, and deviation and OOS reports will be provided in English. All additional Batches will be accompanied by some pages of the Executed Batch Record mutually agreed between the Parties, the COA and the COC for Substance used in Finished Product and for Finished Product, and, if applicable, deviation and OOS reports. SCHERING will retain the complete Batch documentation for at least [*] after the expiration date of the respective Batch as required by cGMP regulations, especially US federal regulation 21CFR211.180. SCHERING will provide these records to INDEVUS on reasonable request. SCHERING will present Manufacturing and testing documentation to Regulatory Authorities upon request as appropriate and in the manner required by cGMP regulations, especially US federal regulation 21CFR211.180(c) and (d). To the extent not covered by this Section 5.2, the provisions of Section 6.2 of the MSA shall also govern any records and Documentation.", "samples": [{"hash": "gSp9f6xsPNv", "uri": "/contracts/gSp9f6xsPNv#batch-documentation", "label": "Manufacturing & Supply Agreement", "score": 31.3408622742, "published": true}], "snippet_links": [{"key": "conduct-of", "type": "clause", "offset": [27, 37]}, {"key": "procedural-steps", "type": "clause", "offset": [46, 62]}, {"key": "process-controls", "type": "clause", "offset": [125, 141]}, {"key": "specific-records", "type": "clause", "offset": [151, 167]}, {"key": "kept-by", "type": "definition", "offset": [183, 190]}, {"key": "will-provide", "type": "clause", "offset": [210, 222]}, {"key": "timely-notification-of", "type": "clause", "offset": [236, 258]}, {"key": "to-file", "type": "definition", "offset": [293, 300]}, {"key": "other-deficiencies", "type": "clause", "offset": [306, 324]}, {"key": "quality-of-the", "type": "clause", "offset": [371, 385]}, {"key": "finished-product", "type": "definition", "offset": [386, 402]}, {"key": "fda-correspondence", "type": "clause", "offset": [419, 437]}, {"key": "final-packaging", "type": "definition", "offset": [470, 485]}, {"key": "complete-copy", "type": "definition", "offset": [560, 573]}, {"key": "executed-batch-records", "type": "clause", "offset": [588, 610]}, {"key": "english-version", "type": "definition", "offset": [660, 675]}, {"key": "master-batch-record", "type": "clause", "offset": [683, 702]}, {"key": "prior-to", "type": "definition", "offset": [794, 802]}, {"key": "in-accordance-with", "type": "definition", "offset": [828, 846]}, {"key": "section-56", "type": "clause", "offset": [865, 876]}, {"key": "the-msa", "type": "definition", "offset": [880, 887]}, {"key": "the-records", "type": "clause", "offset": [889, 900]}, {"key": "certificate-of-compliance", "type": "definition", "offset": [926, 951]}, {"key": "certificate-of-analysis", "type": "definition", "offset": [964, 987]}, {"key": "out-of-specification", "type": "definition", "offset": [1077, 1097]}, {"key": "if-applicable", "type": "definition", "offset": [1129, 1142]}, {"key": "in-writing", "type": "clause", "offset": [1157, 1167]}, {"key": "manufacturing-process", "type": "clause", "offset": [1207, 1228]}, {"key": "analytical-testing", "type": "clause", "offset": [1233, 1251]}, {"key": "in-english", "type": "definition", "offset": [1327, 1337]}, {"key": "agreed-between-the-parties", "type": "clause", "offset": [1434, 1460]}, {"key": "date-of", "type": "clause", "offset": [1686, 1693]}, {"key": "as-required-by", "type": "clause", "offset": [1715, 1729]}, {"key": "federal-regulation", "type": "clause", "offset": [1762, 1780]}, {"key": "reasonable-request", "type": "definition", "offset": [1845, 1863]}, {"key": "testing-documentation", "type": "clause", "offset": [1905, 1926]}, {"key": "regulatory-authorities", "type": "definition", "offset": [1930, 1952]}, {"key": "upon-request", "type": "clause", "offset": [1953, 1965]}, {"key": "to-the-extent", "type": "clause", "offset": [2087, 2100]}, {"key": "covered-by", "type": "definition", "offset": [2105, 2115]}, {"key": "section-52", "type": "clause", "offset": [2121, 2132]}, {"key": "section-62", "type": "clause", "offset": [2152, 2163]}, {"key": "records-and-documentation", "type": "clause", "offset": [2197, 2222]}], "hash": "c9b432b00aa52766052395784a507551", "id": 5}, {"size": 2, "snippet": "4.1 GTC shall prepare or have prepared relevant written Source Material Collection, clarification, purification, and quality control documents according to its internal procedures and standards. These documents shall be approved by GTC, and made reasonably available to MERRIMACK upon written request. MERRIMACK shall at its option review and approve all MERRIMACK specific batch documentation and release testing documentation.\n4.2 GTC shall provide to MERRIMACK copies of documents for the following:", "samples": [{"hash": "1RKj3KLo4sB", "uri": "/contracts/1RKj3KLo4sB#batch-documentation", "label": "Manufacturing Agreement", "score": 31.3408622742, "published": true}, {"hash": "kJsN2ZF8XiZ", "uri": "/contracts/kJsN2ZF8XiZ#batch-documentation", "label": "Manufacturing Service Agreement (GTC Biotherapeutics Inc)", "score": 20.0, "published": true}], "snippet_links": [{"key": "source-material", "type": "clause", "offset": [56, 71]}, {"key": "control-documents", "type": "definition", "offset": [125, 142]}, {"key": "according-to", "type": "definition", "offset": [143, 155]}, {"key": "procedures-and-standards", "type": "clause", "offset": [169, 193]}, {"key": "approved-by", "type": "clause", "offset": [220, 231]}, {"key": "available-to", "type": "definition", "offset": [257, 269]}, {"key": "written-request", "type": "definition", "offset": [285, 300]}, {"key": "review-and-approve", "type": "clause", "offset": [332, 350]}, {"key": "testing-documentation", "type": "clause", "offset": [406, 427]}, {"key": "provide-to", "type": "clause", "offset": [443, 453]}, {"key": "copies-of-documents", "type": "clause", "offset": [464, 483]}], "hash": "df26eec89a37a2a0fcea18c04ad27abc", "id": 6}, {"size": 2, "snippet": "6.1. ELAN will retain batch records and related documents in accordance with regulatory and corporate retention requirements.\n6.2. ELAN will, by issuing a certificate of analysis to the COMPANY, confirm that each batch of PRODUCT supplied to COMPANY complies with the relevant analytical specifications and that it has been manufactured in accordance with cGMP.", "samples": [{"hash": "lshbGWFnO0S", "uri": "/contracts/lshbGWFnO0S#batch-documentation", "label": "License Agreement (Jazz Pharmaceuticals Inc)", "score": 19.0, "published": true}, {"hash": "ac8SaBggESO", "uri": "/contracts/ac8SaBggESO#batch-documentation", "label": "License Agreement (Jazz Pharmaceuticals Inc)", "score": 19.0, "published": true}], "snippet_links": [{"key": "batch-records", "type": "definition", "offset": [22, 35]}, {"key": "related-documents", "type": "definition", "offset": [40, 57]}, {"key": "in-accordance-with", "type": "definition", "offset": [58, 76]}, {"key": "retention-requirements", "type": "definition", "offset": [102, 124]}, {"key": "certificate-of-analysis", "type": "definition", "offset": [155, 178]}, {"key": "to-the-company", "type": "clause", "offset": [179, 193]}, {"key": "to-company", "type": "definition", "offset": [239, 249]}, {"key": "the-relevant", "type": "clause", "offset": [264, 276]}], "hash": "1b5932ec8cb80f3284e0942099b31ef9", "id": 7}, {"size": 2, "snippet": "8.1 The Contractor will deliver to the Customer a Certificate of Analysis with all the release records signed and approved by the Contractor for each batch of Products, certifying that the Contractor has the Batch Documentation and supportive test results with respect to each batch of Products manufactured and delivered to the Customer pursuant to this Agreement, demonstrating that the product release specifications, as defined in the quality agreement, have been met. The Contractor represents and warrants that the Certificate of Analysis, the Batch Documentation and other documentation supplied to the Customer under this Agreement will be accurate and complete. If the Customer requires supplemental documents from the Contractor, including and without limitation in order to obtain or in connection with any Regulatory Authority approvals for the Product, or in connection with any Product recall, the Contractor agrees to cooperate with the Customer and to make available to the Customer such additional or supplemental documentation as may reasonably be requested by the Customer. The Customer shall bear all pre-approved costs and expenses related to obtaining the above mentioned supplemental documents. The Contractor will retain originals of all Batch Documentation, any and all other documentation generated by it in connection with the processing and testing of the Products under the terms of this Agreement, and all records which may be reasonably necessary to assist the Customer in the event of a product recall or otherwise, for not less than five (5) years after the date of expiration of date of the Batch of Product to which they pertain and, if longer, such period as is required by local regulations in force in the Territory.", "samples": [{"hash": "4hxcidsbKJf", "uri": "/contracts/4hxcidsbKJf#batch-documentation", "label": "Manufacturing Agreement (Macrocure Ltd.)", "score": 25.4736480713, "published": true}, {"hash": "iKwoL9qQ3vH", "uri": "/contracts/iKwoL9qQ3vH#batch-documentation", "label": "Manufacturing Agreement (Macrocure Ltd.)", "score": 25.4599590302, "published": true}], "snippet_links": [{"key": "the-contractor-will", "type": "clause", "offset": [4, 23]}, {"key": "deliver-to", "type": "definition", "offset": [24, 34]}, {"key": "customer-a", "type": "definition", "offset": [39, 49]}, {"key": "certificate-of-analysis", "type": "definition", "offset": [50, 73]}, {"key": "the-release", "type": "clause", "offset": [83, 94]}, {"key": "by-the-contractor", "type": "clause", "offset": [123, 140]}, {"key": "test-results", "type": "definition", "offset": [243, 255]}, {"key": "with-respect-to", "type": "clause", "offset": [256, 271]}, {"key": "pursuant-to-this-agreement", "type": "clause", "offset": [338, 364]}, {"key": "release-specifications", "type": "definition", "offset": [397, 419]}, {"key": "quality-agreement", "type": "clause", "offset": [439, 456]}, {"key": "contractor-represents", "type": "clause", "offset": [477, 498]}, {"key": "the-certificate", "type": "clause", "offset": [517, 532]}, {"key": "other-documentation", "type": "definition", "offset": [574, 593]}, {"key": "accurate-and-complete", "type": "clause", "offset": [648, 669]}, {"key": "if-the-customer", "type": "clause", "offset": [671, 686]}, {"key": "supplemental-documents", "type": "clause", "offset": [696, 718]}, {"key": "without-limitation", "type": "clause", "offset": [754, 772]}, {"key": "in-order-to", "type": "clause", "offset": [773, 784]}, {"key": "in-connection-with", "type": "clause", "offset": [795, 813]}, {"key": "authority-approvals", "type": "clause", "offset": [829, 848]}, {"key": "product-recall", "type": "clause", "offset": [892, 906]}, {"key": "contractor-agrees-to", "type": "clause", "offset": [912, 932]}, {"key": "cooperate-with", "type": "clause", "offset": [933, 947]}, {"key": "available-to", "type": "definition", "offset": [973, 985]}, {"key": "supplemental-documentation", "type": "definition", "offset": [1018, 1044]}, {"key": "by-the-customer", "type": "clause", "offset": [1076, 1091]}, {"key": "the-customer-shall", "type": "clause", "offset": [1093, 1111]}, {"key": "costs-and-expenses", "type": "definition", "offset": [1134, 1152]}, {"key": "related-to", "type": "clause", "offset": [1153, 1163]}, {"key": "the-processing", "type": "clause", "offset": [1350, 1364]}, {"key": "the-products", "type": "clause", "offset": [1380, 1392]}, {"key": "terms-of-this-agreement", "type": "clause", "offset": [1403, 1426]}, {"key": "all-records", "type": "clause", "offset": [1432, 1443]}, {"key": "reasonably-necessary", "type": "clause", "offset": [1457, 1477]}, {"key": "assist-the", "type": "clause", "offset": [1481, 1491]}, {"key": "in-the-event-of-a", "type": "clause", "offset": [1501, 1518]}, {"key": "expiration-of", "type": "clause", "offset": [1599, 1612]}, {"key": "required-by", "type": "definition", "offset": [1698, 1709]}, {"key": "regulations-in-force", "type": "clause", "offset": [1716, 1736]}, {"key": "in-the-territory", "type": "clause", "offset": [1737, 1753]}], "hash": "1134d4f982a77c014bea750560db8dfa", "id": 8}, {"size": 2, "snippet": "Company shall provide to University the following documents that Company receives from the supplier of the Study Drug (the \u201cSupplier\u201d): (a) records that document the Supplier\u2019s steps and processes utilized in the manufacture of the Study Drug; (b) the documents that are required under the applicable quality technical agreement; (c) the certificate of analysis for the Study Drug; and (d) the certificate of compliance for the Study Drug. Upon reasonable written request by University, Company shall request, and make reasonable efforts to obtain, additional records and documents from the Supplier to provide further assurance of conformance with CGMP; provided, however, Company shall not be obligated to provide additional records and documents unless such records and documents are received from the Supplier.", "samples": [{"hash": "iSMb7kbcFV7", "uri": "/contracts/iSMb7kbcFV7#batch-documentation", "label": "Investigator Initiated Clinical Trial Agreement (GT Biopharma, Inc.)", "score": 33.8884315491, "published": true}], "snippet_links": [{"key": "to-university", "type": "clause", "offset": [22, 35]}, {"key": "the-supplier", "type": "definition", "offset": [87, 99]}, {"key": "study-drug", "type": "clause", "offset": [107, 117]}, {"key": "the-documents", "type": "clause", "offset": [248, 261]}, {"key": "the-applicable", "type": "clause", "offset": [286, 300]}, {"key": "quality-technical-agreement", "type": "definition", "offset": [301, 328]}, {"key": "certificate-of-analysis", "type": "definition", "offset": [338, 361]}, {"key": "certificate-of-compliance", "type": "definition", "offset": [394, 419]}, {"key": "upon-reasonable", "type": "clause", "offset": [440, 455]}, {"key": "written-request", "type": "definition", "offset": [456, 471]}, {"key": "by-university", "type": "clause", "offset": [472, 485]}, {"key": "efforts-to-obtain", "type": "clause", "offset": [530, 547]}, {"key": "records-and-documents", "type": "clause", "offset": [560, 581]}, {"key": "supplier-to-provide", "type": "clause", "offset": [591, 610]}, {"key": "further-assurance", "type": "clause", "offset": [611, 628]}], "hash": "0f5dba6d7d970bbc9b0ddc7a37022096", "id": 9}, {"size": 2, "snippet": "Sanofi shall ensure that KaloBios is provided with copies of all of the batch release documentation (as defined in Section 6.3) for Bulk Substance Manufactured by Sanofi or its subcontractor at the time of delivery to KaloBios of the Bulk Substance, except when KaloBios has agreed to have Bulk Substance shipped to it under quarantine; in which case Sanofi shall provide all outstanding documentation to KaloBios as soon as it is available.", "samples": [{"hash": "2PxUZcNiwzP", "uri": "/contracts/2PxUZcNiwzP#batch-documentation", "label": "Supply Agreement (Kalobios Pharmaceuticals Inc)", "score": 23.7597541809, "published": true}], "snippet_links": [{"key": "copies-of-all", "type": "clause", "offset": [51, 64]}, {"key": "release-documentation", "type": "clause", "offset": [78, 99]}, {"key": "section-63", "type": "clause", "offset": [115, 126]}, {"key": "bulk-substance", "type": "definition", "offset": [132, 146]}, {"key": "by-sanofi", "type": "clause", "offset": [160, 169]}, {"key": "the-time-of-delivery", "type": "clause", "offset": [194, 214]}, {"key": "agreed-to", "type": "definition", "offset": [275, 284]}], "hash": "47b072c7dfa35636e19966e5a42e8bd2", "id": 10}], "next_curs": "ClwSVmoVc35sYXdpbnNpZGVyY29udHJhY3RzcjgLEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IhxiYXRjaC1kb2N1bWVudGF0aW9uIzAwMDAwMDBhDKIBAmVuGAAgAA==", "clause": {"title": "Batch Documentation", "size": 46, "children": [], "parents": [["miscellaneous", "Miscellaneous"], ["counterparts", "Counterparts"], ["gmp-manufacture-packaging-and-delivery", "GMP Manufacture Packaging and Delivery"], ["enzyme-supply", "Enzyme Supply"], ["general-provisions", "General Provisions"]], "id": "batch-documentation", "related": [["licensed-documentation", "Licensed Documentation", "Licensed Documentation"], ["product-documentation", "Product Documentation", "Product Documentation"], ["technical-documentation", "Technical Documentation", "Technical Documentation"], ["project-documentation", "Project Documentation", "Project Documentation"], ["medical-documentation", "Medical Documentation", "Medical Documentation"]], "related_snippets": [], "updated": "2026-04-09T05:26:19+00:00", "also_ask": ["What essential elements must be included in a batch documentation clause to ensure legal sufficiency?", "How can parties strategically negotiate batch documentation obligations to allocate risk and responsibility?", "What are the most common pitfalls or ambiguities in batch documentation clauses that could undermine enforceability?", "How do batch documentation requirements differ across key jurisdictions or industry standards?", "What evidence is typically required in court to prove compliance or breach of a batch documentation clause?"], "drafting_tip": "Specify required documents, set submission timelines, and outline approval procedures to ensure traceability, timely compliance, and regulatory adherence.", "explanation": "The Batch Documentation clause defines the requirements and procedures for recording and maintaining information related to specific batches of goods or products. Typically, this clause outlines what details must be included in the documentation, such as batch numbers, production dates, and quality control results, and may specify the format and retention period for these records. By establishing clear documentation standards, the clause ensures traceability, facilitates quality assurance, and helps resolve disputes or recalls by providing a reliable record of each batch's history."}, "json": true, "cursor": ""}}