{"component": "clause", "props": {"groups": [{"snippet_links": [{"key": "relating-to", "type": "definition", "offset": [37, 48]}, {"key": "generic-product", "type": "definition", "offset": [92, 107]}, {"key": "be-prepared", "type": "clause", "offset": [133, 144]}, {"key": "in-accordance-with", "type": "definition", "offset": [145, 163]}, {"key": "other-records", "type": "definition", "offset": [192, 205]}, {"key": "by-salix", "type": "clause", "offset": [260, 268]}, {"key": "period-of-time", "type": "clause", "offset": [278, 292]}, {"key": "applicable-rules-and-regulations", "type": "clause", "offset": [314, 346]}, {"key": "the-fda", "type": "clause", "offset": [350, 357]}, {"key": "in-the-event", "type": "clause", "offset": [359, 371]}, {"key": "regulatory-letter", "type": "definition", "offset": [393, 410]}, {"key": "federal-agency", "type": "definition", "offset": [432, 446]}, {"key": "in-connection-with", "type": "clause", "offset": [447, 465]}, {"key": "action-by", "type": "clause", "offset": [584, 593]}, {"key": "third-party-manufacturer", "type": "definition", "offset": [608, 632]}, {"key": "not-limited", "type": "clause", "offset": [649, 660]}, {"key": "receipt-of", "type": "clause", "offset": [665, 675]}, {"key": "form-483", "type": "clause", "offset": [678, 686]}, {"key": "warning-letter", "type": "clause", "offset": [721, 735]}, {"key": "pursuant-to-this-agreement", "type": "clause", "offset": [795, 821]}, {"key": "subject-of", "type": "clause", "offset": [829, 839]}, {"key": "recall-or-market-withdrawal", "type": "clause", "offset": [842, 869]}, {"key": "for-cause", "type": "clause", "offset": [895, 904]}, {"key": "promptly-following", "type": "clause", "offset": [917, 935]}, {"key": "written-request", "type": "definition", "offset": [951, 966]}, {"key": "available-to", "type": "definition", "offset": [994, 1006]}, {"key": "during-business-hours", "type": "clause", "offset": [1035, 1056]}, {"key": "complete-copy", "type": "definition", "offset": [1060, 1073]}, {"key": "executed-batch-record", "type": "definition", "offset": [1080, 1101]}, {"key": "associated-with", "type": "definition", "offset": [1134, 1149]}, {"key": "section-48", "type": "clause", "offset": [1267, 1278]}, {"key": "to-the-extent", "type": "clause", "offset": [1284, 1297]}, {"key": "for-review", "type": "clause", "offset": [1325, 1335]}, {"key": "validation-report", "type": "clause", "offset": [1402, 1419]}, {"key": "equipment-cleaning-validation", "type": "clause", "offset": [1424, 1453]}, {"key": "at-all-times", "type": "definition", "offset": [1554, 1566]}, {"key": "all-records", "type": "clause", "offset": [1591, 1602]}, {"key": "made-available", "type": "clause", "offset": [1603, 1617]}, {"key": "highly-confidential-materials", "type": "definition", "offset": [1658, 1687]}, {"key": "any-person", "type": "definition", "offset": [1734, 1744]}, {"key": "for-purposes-of", "type": "clause", "offset": [1781, 1796]}, {"key": "ensuring-compliance", "type": "clause", "offset": [1797, 1816]}], "samples": [{"hash": "fobIWI7pEsh", "uri": "/contracts/fobIWI7pEsh#batch-records", "label": "Supply and Distribution Agreement", "score": 31.340862423, "published": true}, {"hash": "lUSf9KNQT4s", "uri": "/contracts/lUSf9KNQT4s#batch-records", "label": "Supply and Distribution Agreement (Salix Pharmaceuticals LTD)", "score": 19.0, "published": true}, {"hash": "lBFWMHyDcrl", "uri": "/contracts/lBFWMHyDcrl#batch-records", "label": "Supply and Distribution Agreement (Salix Pharmaceuticals LTD)", "score": 19.0, "published": true}], "snippet": "Batch records, including information relating to the Manufacturing for each lot of finished Generic Product produced hereunder, will be prepared in accordance with cGMP. Batch records and all other records relating to Manufacturing hereunder shall be retained by Salix for such period of time as is required under applicable rules and regulations of the FDA. In the event (i) Salix receives a regulatory letter or comments from any federal agency in connection with its Manufacture of Generic Product or the facility(ies) where Generic Product is Manufactured requiring a response or action by Salix, or the Third Party manufacturer, including, but not limited to, receipt of a Form 483 (Inspectional Observations) or a \u201cWarning Letter,\u201d or (ii) any batch of Generic Product purchased by \u2587\u2587\u2587\u2587\u2587\u2587 pursuant to this Agreement is the subject of a recall or market withdrawal (each of (i) and (ii) a \u201cFor Cause Incident\u201d), promptly following \u2587\u2587\u2587\u2587\u2587\u2587\u2019\u2587 prior written request therefor, Salix shall make available to \u2587\u2587\u2587\u2587\u2587\u2587, at Salix\u2019s premises during business hours, a complete copy of an executed batch record for each SKU of Generic Product associated with such For Cause Incident. Additionally, Salix shall, upon \u2587\u2587\u2587\u2587\u2587\u2587\u2019\u2587 written request in connection with any audit under Section 4.8, and to the extent applicable, make available for review by \u2587\u2587\u2587\u2587\u2587\u2587 during the course of such audit, updates to the process validation report and equipment cleaning validation for Generic Product. Any representative of \u2587\u2587\u2587\u2587\u2587\u2587 shall be accompanied by a representative of Salix at all times during any such review. All records made available to \u2587\u2587\u2587\u2587\u2587\u2587 hereunder shall be considered highly confidential materials of Salix, shall not be disclosed by \u2587\u2587\u2587\u2587\u2587\u2587 to any person, and shall be used by \u2587\u2587\u2587\u2587\u2587\u2587 solely for purposes of ensuring compliance by Salix with its obligations hereunder.", "size": 4, "hash": "0004746eb20938024a38cccd889a3122", "id": 1}, {"snippet_links": [{"key": "relating-to", "type": "definition", "offset": [37, 48]}, {"key": "testing-and-analysis", "type": "clause", "offset": [109, 129]}, {"key": "finished-product", "type": "definition", "offset": [146, 162]}, {"key": "be-prepared", "type": "clause", "offset": [188, 199]}, {"key": "with-applicable-laws", "type": "clause", "offset": [255, 275]}, {"key": "standard-operating-procedures", "type": "clause", "offset": [298, 327]}, {"key": "other-records", "type": "definition", "offset": [351, 364]}, {"key": "by-bms", "type": "clause", "offset": [416, 422]}, {"key": "the-period", "type": "clause", "offset": [427, 437]}, {"key": "required-by", "type": "definition", "offset": [438, 449]}, {"key": "the-product", "type": "clause", "offset": [496, 507]}, {"key": "made-available", "type": "clause", "offset": [579, 593]}, {"key": "upon-request-of-the-company", "type": "clause", "offset": [611, 638]}, {"key": "calendar-quarter", "type": "clause", "offset": [664, 680]}, {"key": "to-the-company", "type": "clause", "offset": [708, 722]}], "samples": [{"hash": "j72zb4Cf5vz", "uri": "/contracts/j72zb4Cf5vz#batch-records", "label": "Supply Agreement (Skinmedica Inc)", "score": 21.0, "published": true}, {"hash": "3bOb9JHrbZq", "uri": "/contracts/3bOb9JHrbZq#batch-records", "label": "Supply Agreement (Skinmedica Inc)", "score": 21.0, "published": true}], "snippet": "Batch records, including information relating to the manufacturing, packaging, labeling, and quality control testing and analysis for each lot of finished Product produced hereunder, will be prepared as and when BMS performs any such tasks, in accordance with applicable Laws and BMS\u2019 then current standard operating procedures. Batch records and all other records relating to production hereunder shall be retained by BMS for the period required by applicable Laws. Batch records for any SKU of the Product, as well as updates to the validation package for the Product, will be made available during an Audit. Upon request of the Company not more than once every calendar quarter, BMS will copy and provide to the Company batch records for each SKU of the Product.", "size": 3, "hash": "99aece3a70161e1db1179ad7a4c69c38", "id": 4}, {"snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [45, 60]}, {"key": "production-lot", "type": "definition", "offset": [66, 80]}, {"key": "relating-to", "type": "definition", "offset": [115, 126]}, {"key": "testing-and-analysis", "type": "clause", "offset": [162, 182]}, {"key": "with-applicable-laws", "type": "clause", "offset": [197, 217]}, {"key": "other-records", "type": "definition", "offset": [246, 259]}, {"key": "technical-agreement", "type": "clause", "offset": [341, 360]}, {"key": "in-addition", "type": "clause", "offset": [362, 373]}, {"key": "make-available", "type": "definition", "offset": [385, 399]}, {"key": "site-visit", "type": "definition", "offset": [505, 515]}, {"key": "section-62", "type": "clause", "offset": [535, 546]}], "samples": [{"hash": "jcnba8rClHA", "uri": "/contracts/jcnba8rClHA#batch-records", "label": "Clinical Drug Substance Supply Agreement (Facet Biotech Corp)", "score": 21.0, "published": true}, {"hash": "jMYv9YR8H2w", "uri": "/contracts/jMYv9YR8H2w#batch-records", "label": "Asset Purchase Agreement (PDL Biopharma, Inc.)", "score": 21.0, "published": true}, {"hash": "bR3laXGhKOZ", "uri": "/contracts/bR3laXGhKOZ#batch-records", "label": "Clinical Drug Substance Supply Agreement (Facet Biotech Corp)", "score": 21.0, "published": true}], "snippet": "GMN shall prepare and maintain Batch Records with respect to each production lot of Product, including information relating to the manufacturing, quality control testing and analysis in accordance with applicable Laws. Such Batch Records and all other records relating to production hereunder shall be retained by GMN in accordance with the Technical Agreement. In addition, GMN shall make available such Batch Records, as well as updates to the validation package for Product, to PDL during any audit or site visit in accordance with Section 6.2.", "size": 3, "hash": "483e7ebec0901ecc5bf1af9c130a33f3", "id": 3}, {"snippet_links": [{"key": "the-information", "type": "clause", "offset": [22, 37]}, {"key": "relating-to", "type": "definition", "offset": [38, 49]}, {"key": "packaging-and", "type": "clause", "offset": [69, 82]}, {"key": "by-supplier", "type": "clause", "offset": [143, 154]}, {"key": "time-at-which", "type": "clause", "offset": [175, 188]}, {"key": "the-records", "type": "clause", "offset": [212, 223]}, {"key": "not-limited", "type": "clause", "offset": [247, 258]}, {"key": "raw-materials-and-components", "type": "clause", "offset": [307, 335]}, {"key": "packaging-component", "type": "definition", "offset": [383, 402]}, {"key": "testing-results", "type": "clause", "offset": [519, 534]}, {"key": "final-product", "type": "clause", "offset": [551, 564]}, {"key": "inspection-results", "type": "clause", "offset": [574, 592]}, {"key": "finished-product", "type": "definition", "offset": [628, 644]}, {"key": "approved-procedure", "type": "definition", "offset": [695, 713]}, {"key": "the-supplier", "type": "clause", "offset": [726, 738]}, {"key": "corrective-actions", "type": "definition", "offset": [757, 775]}, {"key": "processing-and-packaging", "type": "clause", "offset": [797, 821]}, {"key": "the-lot", "type": "definition", "offset": [825, 832]}, {"key": "original-documents", "type": "definition", "offset": [857, 875]}, {"key": "manufacturing-site", "type": "definition", "offset": [922, 940]}, {"key": "supplier-shall", "type": "clause", "offset": [956, 970]}, {"key": "according-to", "type": "definition", "offset": [994, 1006]}, {"key": "date-of", "type": "clause", "offset": [1045, 1052]}, {"key": "product-lot", "type": "definition", "offset": [1058, 1069]}], "samples": [{"hash": "8uVDQswjHvP", "uri": "/contracts/8uVDQswjHvP#batch-records", "label": "Agreement for the Supply of Argatroban and Topotecan (Eagle Pharmaceuticals, Inc.)", "score": 21.9671457906, "published": true}, {"hash": "bJG6WyocGCz", "uri": "/contracts/bJG6WyocGCz#batch-records", "label": "Agreement for the Supply of Argatroban and Topotecan (Eagle Pharmaceuticals, Inc.)", "score": 21.9589322382, "published": true}, {"hash": "iEW6JOkVqZk", "uri": "/contracts/iEW6JOkVqZk#batch-records", "label": "Agreement for the Supply of Argatroban and Topotecan (Eagle Pharmaceuticals, Inc.)", "score": 21.8986995209, "published": true}], "snippet": "Records which include the information relating to the manufacturing, packaging and quality operation for each lot of Product shall be prepared by Supplier for each lot at the time at which such operations occur. The records shall include, but are not limited to, the following documentation: manufacturing, raw materials and components charge-in-records; mixing and filling records; packaging component charge-in records; packaging records; container and component traceability records; in-process and final laboratory testing results; in-process and final product physical inspection results; yield reconciliation for bulk and finished product; label samples; deviations and/or excursions from approved procedure (as well as the Supplier investigation and corrective actions) incurred during the processing and packaging of the lot. Company may review the original documents for each lot at its request when auditing the manufacturing site of Product(s). Supplier shall keep all batch records according to this section [*] after the expiration date of each Product lot.", "size": 3, "hash": "3c7cc7f739c70e7ec8f61c5ab4150d6c", "id": 2}, {"snippet_links": [{"key": "the-information", "type": "clause", "offset": [22, 37]}, {"key": "relating-to", "type": "definition", "offset": [38, 49]}, {"key": "packaging-and", "type": "clause", "offset": [69, 82]}, {"key": "prepared-by", "type": "definition", "offset": [133, 144]}, {"key": "at-the-time", "type": "clause", "offset": [160, 171]}, {"key": "in-accordance-with", "type": "definition", "offset": [236, 254]}, {"key": "the-specifications", "type": "definition", "offset": [263, 281]}, {"key": "technical-quality-agreement", "type": "definition", "offset": [290, 317]}], "samples": [{"hash": "cm1lP2aeDbg", "uri": "/contracts/cm1lP2aeDbg#batch-records", "label": "Note Purchase Agreement (Acusphere Inc)", "score": 21.0, "published": true}, {"hash": "5dj32CjQBzX", "uri": "/contracts/5dj32CjQBzX#batch-records", "label": "Note Purchase Agreement (Acusphere Inc)", "score": 21.0, "published": true}], "snippet": "Records which include the information relating to the manufacturing, packaging and quality operation for each lot of Product will be prepared by [MANUFACTURER] at the time such operations occur. [MANUFACTURER] will prepare such records in accordance with cGMP\u2019s, the Specifications and the Technical Quality Agreement.", "size": 3, "hash": "4595b5736b0301f35aa9622f31a1b363", "id": 5}, {"snippet_links": [{"key": "to-the-extent", "type": "clause", "offset": [0, 13]}, {"key": "related-to", "type": "clause", "offset": [32, 42]}, {"key": "to-be-reviewed", "type": "clause", "offset": [105, 119]}, {"key": "clinical-trials", "type": "definition", "offset": [157, 172]}, {"key": "available-to", "type": "definition", "offset": [210, 222]}, {"key": "employees-of", "type": "clause", "offset": [223, 235]}, {"key": "a-separate", "type": "definition", "offset": [279, 289]}, {"key": "disclosure-agreement", "type": "definition", "offset": [294, 314]}, {"key": "relating-to", "type": "definition", "offset": [315, 326]}, {"key": "employees-will", "type": "clause", "offset": [373, 387]}, {"key": "agree-to", "type": "clause", "offset": [388, 396]}, {"key": "the-relevant", "type": "clause", "offset": [458, 470]}, {"key": "to-maintain", "type": "clause", "offset": [505, 516]}, {"key": "strict-confidence", "type": "clause", "offset": [538, 555]}, {"key": "development-of", "type": "clause", "offset": [609, 623]}, {"key": "decision-making", "type": "definition", "offset": [781, 796]}], "samples": [{"hash": "jrcmIAbNSkL", "uri": "/contracts/jrcmIAbNSkL#batch-records", "label": "License and Co Development Agreement (BioNTech SE)", "score": 30.6865160849, "published": true}, {"hash": "6ThlFuZqEbS", "uri": "/contracts/6ThlFuZqEbS#batch-records", "label": "License and Co Development Agreement (BioNTech SE)", "score": 30.5906913073, "published": true}], "snippet": "To the extent any batch records related to the manufacture of BioNTech Products by Genevant are required to be reviewed in order for BioNTech to conduct any clinical trials, such batch records may only be made available to employees of BioNTech or its Affiliates who have signed a separate non-disclosure agreement relating to the use of the batch records under which such employees will agree to only use such batch records for quality purposes relating to the relevant batches Manufactured by Genevant, to maintain the batch records in strict confidence and not to use the batch records in the research and development of any products or technology including or relating to LNP (other than BioNTech Products). Such employees will not be involved in or have any responsibility or decision making authority for the research and development of any products or technology including or relating to LNP (other than BioNTech Products).", "size": 2, "hash": "855121c2a098dda956ccc7ea23948923", "id": 6}, {"snippet_links": [{"key": "development-products", "type": "clause", "offset": [34, 54]}, {"key": "in-compliance-with", "type": "definition", "offset": [55, 73]}, {"key": "preparation-and", "type": "clause", "offset": [93, 108]}, {"key": "available-to", "type": "definition", "offset": [348, 360]}, {"key": "other-party", "type": "definition", "offset": [365, 376]}], "samples": [{"hash": "6CsEluZYDwu", "uri": "/contracts/6CsEluZYDwu#batch-records", "label": "Manufacturing and Distribution Agreement", "score": 31.340862423, "published": true}, {"hash": "gbsH6S4YHOm", "uri": "/contracts/gbsH6S4YHOm#batch-records", "label": "Manufacturing and Distribution Agreement (Nanogen Inc)", "score": 21.0, "published": true}], "snippet": "PBM shall develop and manufacture Development Products in compliance with all cGMP including preparation and maintaining of all Batch History Records. NANOGEN shall develop and manufacture NANOGEN Reagents in compliance with all cGMP including preparation and maintaining of all Batch History Records. Both PBM and NANOGEN shall make these Records available to the other party during their Audits.", "size": 2, "hash": "039ea48f61a7e90495d973f9f6dc18ac", "id": 7}, {"snippet_links": [{"key": "upon-request", "type": "definition", "offset": [0, 12]}, {"key": "by-licensee", "type": "clause", "offset": [13, 24]}, {"key": "make-available", "type": "definition", "offset": [44, 58]}, {"key": "the-individual", "type": "clause", "offset": [80, 94]}, {"key": "master-batch-records", "type": "definition", "offset": [99, 119]}, {"key": "step-in", "type": "definition", "offset": [166, 173]}, {"key": "manufacture-of-licensed-product", "type": "clause", "offset": [178, 209]}, {"key": "licensee-may", "type": "clause", "offset": [231, 243]}, {"key": "the-information", "type": "clause", "offset": [248, 263]}, {"key": "the-license-agreement", "type": "clause", "offset": [301, 322]}, {"key": "regulatory-submissions", "type": "clause", "offset": [337, 359]}, {"key": "in-order-to", "type": "clause", "offset": [360, 371]}, {"key": "regulatory-approvals", "type": "clause", "offset": [389, 409]}], "samples": [{"hash": "vxw7nqAd7Y", "uri": "/contracts/vxw7nqAd7Y#batch-records", "label": "Supply Agreement (Pharmion Corp)", "score": 21.0, "published": true}, {"hash": "bpgQjxNy2VM", "uri": "/contracts/bpgQjxNy2VM#batch-records", "label": "Supply Agreement (GPC Biotech Ag)", "score": 21.0, "published": true}], "snippet": "Upon request by Licensee, GPC Biotech shall make available for review copies of the individual and master batch records received from Subcontractors and used for any step in the Manufacture of Licensed Product delivered hereunder. Licensee may use the information in such batch records as provided in the License Agreement, including in regulatory submissions in order to gain or maintain regulatory approvals.", "size": 2, "hash": "9b939074f82928e7d782f120fcdcbe9c", "id": 8}, {"snippet_links": [{"key": "written-report", "type": "definition", "offset": [39, 53]}, {"key": "production-batch", "type": "definition", "offset": [63, 79]}, {"key": "for-the-purpose-of", "type": "definition", "offset": [112, 130]}, {"key": "complying-with", "type": "clause", "offset": [131, 145]}, {"key": "the-registration", "type": "clause", "offset": [146, 162]}, {"key": "documentation-requirements", "type": "clause", "offset": [171, 197]}, {"key": "applicable-regulations", "type": "clause", "offset": [201, 223]}, {"key": "including-without-limitation", "type": "clause", "offset": [225, 253]}, {"key": "gmp-guidelines", "type": "clause", "offset": [258, 272]}, {"key": "article-9", "type": "definition", "offset": [300, 309]}, {"key": "from-time-to-time", "type": "clause", "offset": [334, 351]}], "samples": [{"hash": "3Y06tfDSLwb", "uri": "/contracts/3Y06tfDSLwb#batch-records", "label": "European Product Sales Agreement (Talecris Biotherapeutics Holdings Corp.)", "score": 21.0, "published": true}, {"hash": "k9iqaCa7gWI", "uri": "/contracts/k9iqaCa7gWI#batch-records", "label": "European Product Sales Agreement (Talecris Biotherapeutics Holdings Corp.)", "score": 19.0, "published": true}], "snippet": "Talecris GmbH shall provide to \u2587\u2587\u2587\u2587\u2587 a written report for each production batch (each a \u201cManufacturing Record\u201d) for the purpose of complying with the registration and the documentation requirements of applicable Regulations, including without limitation, ED GMP Guidelines and of ED directive 91/356 article 9, as each may be amended from time to time, and any successors thereto.", "size": 2, "hash": "ea35ac0f049d40de83f69c1f9dd897a8", "id": 9}, {"snippet_links": [{"key": "pilot-batch", "type": "definition", "offset": [74, 85]}, {"key": "control-records", "type": "definition", "offset": [117, 132]}, {"key": "the-information", "type": "clause", "offset": [156, 171]}, {"key": "relating-to", "type": "definition", "offset": [172, 183]}, {"key": "packaging-and", "type": "clause", "offset": [203, 216]}, {"key": "prepared-by", "type": "definition", "offset": [267, 278]}, {"key": "at-the-time", "type": "clause", "offset": [285, 296]}, {"key": "the-records", "type": "clause", "offset": [320, 331]}, {"key": "without-limitation", "type": "clause", "offset": [346, 364]}, {"key": "equipment-usage", "type": "clause", "offset": [440, 455]}, {"key": "testing-results", "type": "clause", "offset": [497, 512]}, {"key": "final-product", "type": "clause", "offset": [529, 542]}, {"key": "inspection-results", "type": "clause", "offset": [552, 570]}, {"key": "finished-product", "type": "definition", "offset": [606, 622]}, {"key": "labeling-and-packaging", "type": "clause", "offset": [624, 646]}, {"key": "approved-procedure", "type": "definition", "offset": [696, 714]}, {"key": "corrective-actions", "type": "definition", "offset": [753, 771]}, {"key": "copies-of", "type": "definition", "offset": [773, 782]}, {"key": "prior-to", "type": "definition", "offset": [827, 835]}, {"key": "product-lot", "type": "definition", "offset": [867, 878]}], "samples": [{"hash": "cb4tKW1fbNv", "uri": "/contracts/cb4tKW1fbNv#batch-records", "label": "Toll Manufacturing and Packaging Agreement (Cephalon Inc)", "score": 18.0, "published": true}, {"hash": "59ivk526WSy", "uri": "/contracts/59ivk526WSy#batch-records", "label": "Toll Manufacturing and Packaging Agreement (Cephalon Inc)", "score": 18.0, "published": true}], "snippet": "CIRCA will supply for each batch of Product, including ------------- each pilot batch, complete batch production and control records. Records which include the information relating to the manufacturing, packaging and quality operation for each lot of Product will be prepared by CIRCA at the time such operations occur. The records will include, without limitation, mixing and filling records; container and component traceability records; equipment usage records; in-process and final laboratory testing results; in-process and final Product physical inspection results; yield reconciliation for bulk and finished Product; labeling and packaging records; and records relating to deviations from approved procedure, as well as CIRCA's investigation and corrective actions. Copies of batch records will be forwarded to CEPHALON prior to or along with shipment of each Product lot.", "size": 2, "hash": "e178f263dfafba73acf9460ac7245d5f", "id": 10}], "next_curs": "ClYSUGoVc35sYXdpbnNpZGVyY29udHJhY3RzcjILEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IhZiYXRjaC1yZWNvcmRzIzAwMDAwMDBhDKIBAmVuGAAgAA==", "clause": {"title": "Batch Records", "size": 88, "children": [["", ""], ["authority", "Authority"], ["non-infringement", "Non-Infringement"], ["consequential-damages", "Consequential Damages"], ["independent-contractors", "Independent Contractors"]], "parents": [["regulatory-matters", "Regulatory Matters"], ["miscellaneous", "Miscellaneous"], ["control-records-and-inspections", "Control Records and Inspections"], ["supply-of-product", "Supply of Product"], ["definitions", "Definitions"]], "id": "batch-records", "related": [["project-records", "Project Records", "Project Records"], ["api", "API", "API"], ["certificate-of-analysis", "Certificate of Analysis", "Certificate of Analysis"], ["quality-agreement", "Quality Agreement", "Quality Agreement"], ["development-records", "Development Records", "Development Records"]], "related_snippets": [], "updated": "2025-07-07T12:37:48+00:00", "also_ask": ["What minimum information must be included in batch records to ensure regulatory compliance?", "How can batch record clauses be negotiated to allocate liability for incomplete or inaccurate records?", "What are the most common legal pitfalls in batch record drafting that could undermine enforceability?", "How do batch record requirements differ across key jurisdictions or regulatory regimes?", "What evidentiary standards do courts apply when assessing the sufficiency of batch records in disputes?"], "drafting_tip": "Specify required batch record contents to ensure regulatory compliance, mandate retention periods to facilitate audits, and define access rights to protect confidential information.", "explanation": "The Batch Records clause requires the documentation and maintenance of detailed records for each production batch in a manufacturing process. These records typically include information such as raw materials used, processing steps, equipment utilized, and quality control results, ensuring traceability and accountability for every batch produced. By mandating comprehensive batch records, this clause helps ensure product quality, regulatory compliance, and facilitates the investigation of any issues or deviations that may arise during production."}, "json": true, "cursor": ""}}