{"component": "clause", "props": {"groups": [{"snippet": "(MBR) shall mean the formal set of instructions for the production of the Drug Product. The MBR shall be developed and maintained in \u2587\u2587\u2587\u2587'\u2587 standard format by \u2587\u2587\u2587\u2587, using CLIENT's master formula and technical support.", "snippet_links": [{"key": "the-formal", "type": "clause", "offset": [17, 27]}, {"key": "the-production", "type": "clause", "offset": [52, 66]}, {"key": "drug-product", "type": "definition", "offset": [74, 86]}, {"key": "in-\u2587", "type": "clause", "offset": [130, 134]}, {"key": "master-formula", "type": "definition", "offset": [180, 194]}, {"key": "technical-support", "type": "clause", "offset": [199, 216]}], "size": 5, "samples": [{"hash": "jYXdIR4LhM5", "uri": "/contracts/jYXdIR4LhM5#master-batch-record", "label": "Product Development and Clinical Supply Agreement (Biomira CORP)", "score": 21.0, "published": true}], "hash": "34597dc98b88cc25056d9b69a08485b8", "id": 1}, {"snippet": "The Master Batch Record shall be reviewed and approved in writing by Patheon and by Client prior to commencement of Manufacturing Services. Any material change to an approved Master Batch Record shall be reviewed and approved in writing by Patheon and by Client prior to said change being implemented. Each batch of Product shall be manufactured by using a copy of the Master Batch Record. Each copy of the Master Batch Record for such batch of Product shall be assigned a unique batch number. Any deviation from the manufacturing process specified in the Master Batch Record must be documented in the batch record for that batch.", "snippet_links": [{"key": "in-writing", "type": "clause", "offset": [55, 65]}, {"key": "by-client", "type": "clause", "offset": [81, 90]}, {"key": "commencement-of", "type": "clause", "offset": [100, 115]}, {"key": "manufacturing-services", "type": "clause", "offset": [116, 138]}, {"key": "change-to", "type": "definition", "offset": [153, 162]}, {"key": "a-copy-of-the", "type": "clause", "offset": [355, 368]}, {"key": "batch-number", "type": "definition", "offset": [480, 492]}, {"key": "manufacturing-process", "type": "definition", "offset": [517, 538]}], "size": 2, "samples": [{"hash": "9mrJxs7N2QX", "uri": "/contracts/9mrJxs7N2QX#master-batch-record", "label": "Master Manufacturing Services Agreement (La Jolla Pharmaceutical Co)", "score": 32.1813812256, "published": true}, {"hash": "bp0ODUSnFOR", "uri": "/contracts/bp0ODUSnFOR#master-batch-record", "label": "Master Manufacturing Services Agreement (Tetraphase Pharmaceuticals Inc)", "score": 28.5838470459, "published": true}], "hash": "3f42727e53076c2ab6664bea45c25049", "id": 4}, {"snippet": "The Client will provide the Specifications to Patheon and Patheon will manufacture Product in accordance with the Specifications. Patheon is responsible for preparing the master batch records for the Product, however, the Client is responsible to review and approve the master batch records prior to the manufacture of the Product unless otherwise agreed to in writing. Patheon will not make changes to master batch records except through the established Patheon change control system, and all master document revisions will be approved by the Client\u2019s quality unit unless otherwise agreed to in writing. Any changes made to issued batch records (prior to master revisions) must be reviewed and approved by the Client\u2019s quality unit prior to implementation unless otherwise agreed to in writing. Patheon will maintain a batch numbering system designed to assure traceability of the product and associated documentation.", "snippet_links": [{"key": "the-specifications", "type": "definition", "offset": [24, 42]}, {"key": "in-accordance-with", "type": "definition", "offset": [91, 109]}, {"key": "responsible-for", "type": "clause", "offset": [141, 156]}, {"key": "master-batch-records", "type": "clause", "offset": [171, 191]}, {"key": "responsible-to", "type": "clause", "offset": [232, 246]}, {"key": "review-and-approve", "type": "clause", "offset": [247, 265]}, {"key": "prior-to-the", "type": "clause", "offset": [291, 303]}, {"key": "manufacture-of-the-product", "type": "clause", "offset": [304, 330]}, {"key": "agreed-to", "type": "definition", "offset": [348, 357]}, {"key": "in-writing", "type": "clause", "offset": [358, 368]}, {"key": "changes-to", "type": "clause", "offset": [392, 402]}, {"key": "change-control-system", "type": "clause", "offset": [463, 484]}, {"key": "document-revisions", "type": "clause", "offset": [501, 519]}, {"key": "by-the-client", "type": "clause", "offset": [537, 550]}, {"key": "numbering-system", "type": "clause", "offset": [826, 842]}, {"key": "associated-documentation", "type": "clause", "offset": [894, 918]}], "size": 3, "samples": [{"hash": "9mrJxs7N2QX", "uri": "/contracts/9mrJxs7N2QX#master-batch-record", "label": "Master Manufacturing Services Agreement (La Jolla Pharmaceutical Co)", "score": 32.1813812256, "published": true}, {"hash": "bp0ODUSnFOR", "uri": "/contracts/bp0ODUSnFOR#master-batch-record", "label": "Master Manufacturing Services Agreement (Tetraphase Pharmaceuticals Inc)", "score": 28.5838470459, "published": true}], "hash": "b8d1ca46e8fe48a8543f0dd03154b8d5", "id": 2}, {"snippet": "Based on the information provided by Senti and including process changes developed by or on behalf of Provider pursuant to an applicable Statement of Work (if any), Provider will prepare the Master Batch Record for the Manufacturing Process for each Product, which shall be subject to Senti\u2019s written approval pursuant to Section 9.1.4 (Senti Approval). Senti will inform Provider of any specific requirements Senti may have relating to the Master Batch Record, including any information or procedures Senti wishes to have incorporated therein in accordance with Section 9.1.3 (Senti Assistance).", "snippet_links": [{"key": "based-on", "type": "clause", "offset": [0, 8]}, {"key": "information-provided-by", "type": "clause", "offset": [13, 36]}, {"key": "process-changes", "type": "clause", "offset": [57, 72]}, {"key": "by-or-on-behalf-of", "type": "definition", "offset": [83, 101]}, {"key": "statement-of-work", "type": "clause", "offset": [137, 154]}, {"key": "manufacturing-process", "type": "definition", "offset": [219, 240]}, {"key": "subject-to", "type": "definition", "offset": [274, 284]}, {"key": "written-approval", "type": "definition", "offset": [293, 309]}, {"key": "section-914", "type": "clause", "offset": [322, 335]}, {"key": "specific-requirements", "type": "clause", "offset": [388, 409]}, {"key": "relating-to", "type": "definition", "offset": [425, 436]}, {"key": "in-accordance-with", "type": "definition", "offset": [544, 562]}], "size": 3, "samples": [{"hash": "94LdbyESuNJ", "uri": "/contracts/94LdbyESuNJ#master-batch-record", "label": "Development and Manufacturing Services Agreement (Senti Biosciences, Inc.)", "score": 36.2142372131, "published": true}, {"hash": "3VHSFTsFQ6N", "uri": "/contracts/3VHSFTsFQ6N#master-batch-record", "label": "Framework Agreement (Senti Biosciences, Inc.)", "score": 36.2142372131, "published": true}], "hash": "51a0163c6d66110ee78319ba20f82909", "id": 3}, {"snippet": "Prior to DMF Approval, CPI will manufacture and bulk package the Drug Resin Complex in accordance with the ANDA and applicable Laws. Following DMF Approval, CPI will manufacture and bulk package the Drug Resin Complex in accordance with the DMF and applicable Laws. CPI is responsible for preparing the master batch records for manufacture and bulk packaging of the Drug Resin Complex. Prior to DMF Approval, the Regulatory Consultant, is responsible to review and approve the master batch records for the manufacture and bulk packaging of Drug Resin Complex. Following DMF Approval, CPI will follow their approved SOP\u2019s to fully investigate any \u201cfor cause\u201d circumstances and provide Neos a written summary of those findings CPI will not make changes to master batch records except through an established change control system. CPI shall provide Neos with written notification of significant changes made to the Drug Resin Complex batch records that may directly impact Neos\u2019s manufacture of Generic Tussionex.", "snippet_links": [{"key": "prior-to", "type": "clause", "offset": [0, 8]}, {"key": "in-accordance-with", "type": "definition", "offset": [84, 102]}, {"key": "the-anda", "type": "clause", "offset": [103, 111]}, {"key": "applicable-laws", "type": "definition", "offset": [116, 131]}, {"key": "responsible-for", "type": "clause", "offset": [273, 288]}, {"key": "master-batch-records", "type": "clause", "offset": [303, 323]}, {"key": "responsible-to", "type": "clause", "offset": [439, 453]}, {"key": "review-and-approve", "type": "clause", "offset": [454, 472]}, {"key": "for-cause", "type": "clause", "offset": [647, 656]}, {"key": "written-summary", "type": "clause", "offset": [691, 706]}, {"key": "changes-to", "type": "clause", "offset": [743, 753]}, {"key": "change-control-system", "type": "clause", "offset": [805, 826]}, {"key": "notification-of", "type": "definition", "offset": [864, 879]}, {"key": "significant-changes", "type": "definition", "offset": [880, 899]}, {"key": "directly-impact", "type": "definition", "offset": [954, 969]}], "size": 2, "samples": [{"hash": "8JxpW7pf3d9", "uri": "/contracts/8JxpW7pf3d9#master-batch-record", "label": "Supply Agreement", "score": 31.3408622742, "published": true}, {"hash": "57K2zrhRUvU", "uri": "/contracts/57K2zrhRUvU#master-batch-record", "label": "Supply Agreement (Neos Therapeutics, Inc.)", "score": 26.4811763763, "published": true}], "hash": "bc1493d617e2172bc4fd7580acf2103d", "id": 5}, {"snippet": "Cangene will provide the Specifications to Patheon and Patheon will manufacture Product in accordance with the Specifications. Patheon is responsible for preparing the master batch records for the Product, however, Cangene is responsible to review and approve such master batch records prior to the manufacture of the Product. Patheon will not make changes to master batch records except through the established Patheon change control system, and all master document revisions will be approved by Cangene\u2019s quality unit. Any changes made to issued batch records (prior to master revisions) must be reviewed and approved by Cangene\u2019s quality unit prior to implementation unless otherwise agreed to in writing. Quality QG01-05-T001-01 Agreement", "snippet_links": [{"key": "the-specifications", "type": "definition", "offset": [21, 39]}, {"key": "in-accordance-with", "type": "definition", "offset": [88, 106]}, {"key": "responsible-for", "type": "clause", "offset": [138, 153]}, {"key": "master-batch-records", "type": "clause", "offset": [168, 188]}, {"key": "responsible-to", "type": "clause", "offset": [226, 240]}, {"key": "review-and-approve", "type": "clause", "offset": [241, 259]}, {"key": "prior-to-the", "type": "clause", "offset": [286, 298]}, {"key": "manufacture-of-the-product", "type": "clause", "offset": [299, 325]}, {"key": "changes-to", "type": "clause", "offset": [349, 359]}, {"key": "change-control-system", "type": "clause", "offset": [420, 441]}, {"key": "document-revisions", "type": "clause", "offset": [458, 476]}, {"key": "approved-by", "type": "definition", "offset": [485, 496]}, {"key": "agreed-to", "type": "definition", "offset": [687, 696]}, {"key": "in-writing", "type": "clause", "offset": [697, 707]}], "size": 2, "samples": [{"hash": "jNdrXbKu5Y3", "uri": "/contracts/jNdrXbKu5Y3#master-batch-record", "label": "Manufacturing Services Agreement", "score": 31.3408622742, "published": true}, {"hash": "cmILwbEsTyO", "uri": "/contracts/cmILwbEsTyO#master-batch-record", "label": "Manufacturing Services Agreement (Aptevo Therapeutics Inc.)", "score": 27.4120464325, "published": true}], "hash": "22110c8232b53f9e6ca8ae8c3a947571", "id": 8}, {"snippet": "The Client will provide the early development reports and CTM Specifications to Patheon and Patheon will manufacture the CTM in accordance with the Specifications. Patheon is responsible for preparing the master batch records for the CTM, however, the Client is responsible to review and approve such master batch records prior to the manufacture of the CTM. Patheon will not make changes to master batch records except through the established Patheon change control system, and all master document revisions will be approved by the Client\u2019s quality unit. Any changes made to issued batch records (prior to master revisions) must be reviewed and approved by the Client\u2019s quality unit prior to implementation unless otherwise agreed to in writing.", "snippet_links": [{"key": "provide-the", "type": "clause", "offset": [16, 27]}, {"key": "development-reports", "type": "definition", "offset": [34, 53]}, {"key": "in-accordance-with", "type": "definition", "offset": [125, 143]}, {"key": "the-specifications", "type": "definition", "offset": [144, 162]}, {"key": "responsible-for", "type": "clause", "offset": [175, 190]}, {"key": "master-batch-records", "type": "clause", "offset": [205, 225]}, {"key": "responsible-to", "type": "clause", "offset": [262, 276]}, {"key": "review-and-approve", "type": "clause", "offset": [277, 295]}, {"key": "prior-to-the", "type": "clause", "offset": [322, 334]}, {"key": "changes-to", "type": "clause", "offset": [381, 391]}, {"key": "change-control-system", "type": "clause", "offset": [452, 473]}, {"key": "document-revisions", "type": "clause", "offset": [490, 508]}, {"key": "by-the-client", "type": "clause", "offset": [526, 539]}, {"key": "agreed-to", "type": "definition", "offset": [725, 734]}, {"key": "in-writing", "type": "clause", "offset": [735, 745]}], "size": 2, "samples": [{"hash": "6adK5pTGV72", "uri": "/contracts/6adK5pTGV72#master-batch-record", "label": "Supply Agreement (Relypsa Inc)", "score": 26.1663246155, "published": true}, {"hash": "7t8HDp0CbjH", "uri": "/contracts/7t8HDp0CbjH#master-batch-record", "label": "Supply Agreement (Relypsa Inc)", "score": 25.8569469452, "published": true}], "hash": "39bd566581f0aa34cc8e1ed3336daf7b", "id": 6}, {"snippet": "(MBR) shall mean the formal set of instructions for Production of Company Plasmid DNA. The MBR shall be developed and maintained in ALTHEA\u2019s standard format by A\u2587\u2587\u2587\u2587\u2587, using CLIENT\u2019s master formula and technical support.", "snippet_links": [{"key": "the-formal", "type": "clause", "offset": [17, 27]}, {"key": "master-formula", "type": "definition", "offset": [183, 197]}, {"key": "technical-support", "type": "clause", "offset": [202, 219]}], "size": 2, "samples": [{"hash": "8ZDYDlZv8r9", "uri": "/contracts/8ZDYDlZv8r9#master-batch-record", "label": "Company Plasmid Dna Production Agreement (Biocancell Therapeutics Inc.)", "score": 21.0, "published": true}, {"hash": "g1un5VwuzRG", "uri": "/contracts/g1un5VwuzRG#master-batch-record", "label": "Company Plasmid Dna Production Agreement (Biocancell Therapeutics Inc.)", "score": 19.0, "published": true}], "hash": "cd1835e0615b461809490123bcaeff65", "id": 7}, {"snippet": "(MBR) shall mean the formal set of instructions setting forth the procedure to be followed for the Production of Drug Product, including but not limited to the history of a Batch from the raw material stage up through and until completion of the Batch, a complete list of all active and inactive ingredients, components, weights and measures, descriptions of Drug Product containers, closures, packaging materials, and labeling and complete specifications for each.", "snippet_links": [{"key": "the-formal", "type": "clause", "offset": [17, 27]}, {"key": "procedure-to-be-followed", "type": "clause", "offset": [66, 90]}, {"key": "the-production", "type": "clause", "offset": [95, 109]}, {"key": "drug-product", "type": "definition", "offset": [113, 125]}, {"key": "not-limited", "type": "clause", "offset": [141, 152]}, {"key": "raw-material", "type": "definition", "offset": [188, 200]}, {"key": "completion-of-the", "type": "clause", "offset": [228, 245]}, {"key": "complete-list", "type": "clause", "offset": [255, 268]}, {"key": "inactive-ingredients", "type": "definition", "offset": [287, 307]}, {"key": "weights-and-measures", "type": "clause", "offset": [321, 341]}, {"key": "packaging-materials", "type": "definition", "offset": [394, 413]}], "size": 2, "samples": [{"hash": "3bGqwlQBp8s", "uri": "/contracts/3bGqwlQBp8s#master-batch-record", "label": "Drug Product Development and Clinical Supply Agreement", "score": 31.3408622742, "published": true}, {"hash": "8SZejNZNJV0", "uri": "/contracts/8SZejNZNJV0#master-batch-record", "label": "Drug Product Development and Clinical Supply Agreement (Nuvelo Inc)", "score": 21.0, "published": true}], "hash": "257d5dc1dda3c83a577f8b9c9b1021fc", "id": 9}, {"snippet": "The original, approved template used for the execution of each Manufacturing Batch Record.", "snippet_links": [{"key": "the-original", "type": "definition", "offset": [0, 12]}, {"key": "the-execution", "type": "clause", "offset": [41, 54]}, {"key": "manufacturing-batch-record", "type": "definition", "offset": [63, 89]}], "size": 2, "samples": [{"hash": "c8yHlO88DKz", "uri": "/contracts/c8yHlO88DKz#master-batch-record", "label": "Quality Agreement (Gensight Biologics)", "score": 26.5112934113, "published": true}, {"hash": "gjwTHE7g7En", "uri": "/contracts/gjwTHE7g7En#master-batch-record", "label": "Quality Agreement (Gensight Biologics)", "score": 26.459274292, "published": true}], "hash": "d4897d872f8cb70377d591b66c716cfe", "id": 10}], "next_curs": "ClwSVmoVc35sYXdpbnNpZGVyY29udHJhY3RzcjgLEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IhxtYXN0ZXItYmF0Y2gtcmVjb3JkIzAwMDAwMDBhDKIBAmVuGAAgAA==", "clause": {"title": "Master Batch Record", "size": 48, "children": [], "parents": [["production-controls", "Production Controls"], ["definitions", "DEFINITIONS"], ["governing-law", "Governing Law"], ["counterparts", "Counterparts"], ["tech-transfer-engineering-batches", "Tech Transfer Engineering Batches"]], "id": "master-batch-record", "related": [["certificate-of-analysis", "Certificate of Analysis", "Certificate of Analysis"], ["quality-agreement", "Quality Agreement", "Quality Agreement"], ["api", "API", "API"], ["random-drug-testing", "Random Drug Testing", "Random Drug Testing"], ["quality-management-system", "Quality Management System", "Quality Management System"]], "related_snippets": [], "updated": "2025-11-12T05:19:44+00:00", "also_ask": ["What key elements must a Master Batch Record include to ensure regulatory compliance and enforceability?", "How can parties negotiate control over updates or changes to the Master Batch Record?", "What are the most common legal pitfalls or ambiguities in Master Batch Record clauses?", "How do Master Batch Record requirements differ across major jurisdictions or regulatory regimes?", "What evidence is needed to prove breach or non-compliance with Master Batch Record obligations in court?"], "drafting_tip": "Specify required contents and approval process to ensure regulatory compliance; define update procedures to maintain accuracy; clarify retention period to support audit readiness.", "explanation": "The Master Batch Record clause defines the requirements and standards for the creation, approval, and maintenance of a comprehensive document that outlines the manufacturing process for a specific product batch. This record typically includes detailed instructions, materials specifications, equipment settings, and quality control measures necessary to ensure consistent production. By establishing a clear and standardized reference for each batch, the clause helps ensure product quality, regulatory compliance, and traceability throughout the manufacturing process."}, "json": true, "cursor": ""}}