{"component": "clause", "props": {"groups": [{"samples": [{"hash": "9soaFvs8EwS", "uri": "/contracts/9soaFvs8EwS#batch-failure", "label": "Api Supply Agreement", "score": 31.3408622742, "published": true}, {"hash": "l4VY8r0ZMNM", "uri": "/contracts/l4VY8r0ZMNM#batch-failure", "label": "Api Supply Agreement (Baudax Bio, Inc.)", "score": 30.8042430878, "published": true}, {"hash": "fd2t8X34yYw", "uri": "/contracts/fd2t8X34yYw#batch-failure", "label": "Api Supply Agreement (Recro Pharma, Inc.)", "score": 24.9096508026, "published": true}], "snippet": "Supplier agrees to notify Customer as soon as reasonably possible, but in any event within five (5) business days of discovery of any batch failure that could result in Supplier\u2019s inability to meet Customer\u2019s requested delivery dates, or of learning of any failure of any batch of API manufactured for delivery to Customer to meet standards set forth in the Specifications or warranties herein.", "snippet_links": [{"key": "agrees-to", "type": "clause", "offset": [9, 18]}, {"key": "business-days-of", "type": "clause", "offset": [100, 116]}, {"key": "discovery-of", "type": "clause", "offset": [117, 129]}, {"key": "inability-to", "type": "clause", "offset": [180, 192]}, {"key": "delivery-dates", "type": "clause", "offset": [219, 233]}, {"key": "delivery-to-customer", "type": "clause", "offset": [302, 322]}, {"key": "the-specifications", "type": "definition", "offset": [354, 372]}], "size": 3, "hash": "f8c1d09bea74f22d9cfae44fd0766a28", "id": 2}, {"samples": [{"hash": "dzB8rNfCHV1", "uri": "/contracts/dzB8rNfCHV1#batch-failure", "label": "Master Manufacturing and Supply Services Agreement (Legend Biotech Corp)", "score": 37.1861738535, "published": true}, {"hash": "4TVhipsAnSF", "uri": "/contracts/4TVhipsAnSF#batch-failure", "label": "Master Manufacturing and Supply Services Agreement (Legend Biotech Corp)", "score": 36.1895942688, "published": true}, {"hash": "4TuOikyd5Ro", "uri": "/contracts/4TuOikyd5Ro#batch-failure", "label": "Master Technology Transfer, Manufacturing and Clinical Supply Services Agreement (Legend Biotech Corp)", "score": 34.2813148499, "published": true}], "snippet": "If a Batch fails to conform to [***] (\u201cNon-Conforming Product\u201d) then Provider shall notify Collaboration Partners as soon as reasonably practicable after such Non-Conforming Product is identified, and in any event, within the time set forth in the Quality Agreement, in which case Provider and Company shall comply with their respective obligations under Section 6.6 (Root Cause Analysis).", "snippet_links": [{"key": "conforming-product", "type": "clause", "offset": [43, 61]}, {"key": "provider-shall", "type": "clause", "offset": [69, 83]}, {"key": "collaboration-partners", "type": "clause", "offset": [91, 113]}, {"key": "quality-agreement", "type": "clause", "offset": [248, 265]}, {"key": "and-company", "type": "clause", "offset": [290, 301]}, {"key": "comply-with", "type": "clause", "offset": [308, 319]}, {"key": "respective-obligations", "type": "clause", "offset": [326, 348]}, {"key": "section-66", "type": "clause", "offset": [355, 366]}, {"key": "root-cause-analysis", "type": "definition", "offset": [368, 387]}], "size": 3, "hash": "574a4e6543da5d14e5415ecf95563ea8", "id": 1}, {"samples": [{"hash": "iPAyJbHP6HE", "uri": "/contracts/iPAyJbHP6HE#batch-failure", "label": "Licensing, Contract Manufacturing & Supply Agreement (Impax Laboratories Inc)", "score": 18.0, "published": true}, {"hash": "5YJejSkphSW", "uri": "/contracts/5YJejSkphSW#batch-failure", "label": "Licensing, Contract Manufacturing & Supply Agreement (Impax Laboratories Inc)", "score": 18.0, "published": true}], "snippet": "Impax agrees to notify Schering within thirty-six (36) hours of discovery after any batch failure which could result in Impax's inability to meet Schering's requested delivery dates, or of learning of any failure of any batch of Product to meet standards set forth in the Impax Know-How. Impax shall notify Schering within thirty-six (36) hours after any failure of a released batch during stability testing. Impax shall complete out-of-specification investigations within thirty (30) calendar days from date of discovery.", "snippet_links": [{"key": "agrees-to", "type": "clause", "offset": [6, 15]}, {"key": "within-thirty", "type": "clause", "offset": [32, 45]}, {"key": "hours-of", "type": "clause", "offset": [55, 63]}, {"key": "inability-to", "type": "clause", "offset": [128, 140]}, {"key": "delivery-dates", "type": "clause", "offset": [167, 181]}, {"key": "failure-of-a", "type": "clause", "offset": [355, 367]}, {"key": "stability-testing", "type": "definition", "offset": [390, 407]}, {"key": "calendar-days", "type": "clause", "offset": [485, 498]}, {"key": "date-of-discovery", "type": "definition", "offset": [504, 521]}], "size": 3, "hash": "8563718fc4971f50c2d9e2f5da74c80b", "id": 3}, {"samples": [{"hash": "hdvhkXUxA7s", "uri": "/contracts/hdvhkXUxA7s#batch-failure", "label": "Master Manufacturing Services and Supply Agreement", "score": 30.3408622742, "published": true}, {"hash": "cIhd8n0VoFN", "uri": "/contracts/cIhd8n0VoFN#batch-failure", "label": "Master Manufacturing Services and Supply Agreement (Keryx Biopharmaceuticals Inc)", "score": 29.1396312714, "published": true}], "snippet": "Vendor agrees to notify Keryx promptly (but in no event more than [***]) of discovery after any Batch failure which could result in Vendor\u2019s inability to meet Keryx\u2019s requested delivery dates, or of learning of any failure of any Batch of Product to meet Specifications or the manufacturing requirements or if Vendor has any other safety or efficacy concerns with respect to a Batch of Product. Vendor agrees not to reprocess or rework any Batch of Product, or any intermediate in the manufacture of Product, without the prior written approval of Keryx in writing (in its sole discretion). Vendor shall notify Keryx promptly (but in no event more than [***]) after any failure of a released Batch during stability testing.", "snippet_links": [{"key": "agrees-to", "type": "clause", "offset": [7, 16]}, {"key": "in-no-event", "type": "clause", "offset": [44, 55]}, {"key": "inability-to", "type": "clause", "offset": [141, 153]}, {"key": "delivery-dates", "type": "clause", "offset": [177, 191]}, {"key": "manufacturing-requirements", "type": "definition", "offset": [277, 303]}, {"key": "if-vendor", "type": "clause", "offset": [307, 316]}, {"key": "with-respect-to", "type": "clause", "offset": [359, 374]}, {"key": "manufacture-of-product", "type": "clause", "offset": [485, 507]}, {"key": "approval-of", "type": "definition", "offset": [535, 546]}, {"key": "in-writing", "type": "clause", "offset": [553, 563]}, {"key": "sole-discretion", "type": "definition", "offset": [572, 587]}, {"key": "vendor-shall", "type": "clause", "offset": [590, 602]}, {"key": "failure-of-a", "type": "clause", "offset": [669, 681]}, {"key": "stability-testing", "type": "definition", "offset": [704, 721]}], "size": 2, "hash": "cea927a6e642ca623f0c155378bfb2ab", "id": 4}, {"samples": [{"hash": "k0sdhUE1UCf", "uri": "/contracts/k0sdhUE1UCf#batch-failure", "label": "Development and Commercial License Agreement (Precision Biosciences Inc)", "score": 30.1937026978, "published": true}, {"hash": "4naiH06NA7C", "uri": "/contracts/4naiH06NA7C#batch-failure", "label": "Development and Commercial License Agreement (Precision Biosciences Inc)", "score": 29.988363266, "published": true}], "snippet": "If Precision is unable to achieve Phase II Ready Batch Success within [***] after the date of the Commercial Option Exercise Notice with respect to a Licensed Product Candidate, then the JSC shall meet to consider (a) whether Phase II Ready Batch Success can be achieved, (b) whether it is commercially reasonable to continue to seek to achieve Phase II Ready Batch Success and, (c) upon positive determination of (a) and (b), to develop a plan for such achievement (the \u201cBatch Success Achievement Plan\u201d). Following receipt of the Batch Success Achievement Plan from the JSC, Precision will use Commercially Reasonable Efforts to perform the activities set forth in such plan as promptly as practicable. If, subsequent to the performance of the activities set forth in the Batch Success Achievement Plan, Phase II Ready Batch Success has not been achieved, the JSC shall meet to discuss the considerations set forth in clauses (a) through (c) above, and any further obligations of Precision in relation to manufacturing and quality testing of the Phase II Ready Batch shall be subject to the JSC\u2019s approval of an additional Batch Success Achievement Plan.", "snippet_links": [{"key": "phase-ii", "type": "definition", "offset": [34, 42]}, {"key": "date-of", "type": "clause", "offset": [86, 93]}, {"key": "option-exercise-notice", "type": "definition", "offset": [109, 131]}, {"key": "with-respect-to", "type": "clause", "offset": [132, 147]}, {"key": "licensed-product-candidate", "type": "definition", "offset": [150, 176]}, {"key": "determination-of", "type": "clause", "offset": [397, 413]}, {"key": "to-develop", "type": "definition", "offset": [427, 437]}, {"key": "receipt-of", "type": "clause", "offset": [516, 526]}, {"key": "efforts-to-perform", "type": "clause", "offset": [619, 637]}, {"key": "the-activities", "type": "clause", "offset": [638, 652]}, {"key": "the-performance", "type": "clause", "offset": [722, 737]}, {"key": "meet-to-discuss", "type": "clause", "offset": [871, 886]}, {"key": "in-clauses", "type": "clause", "offset": [916, 926]}, {"key": "obligations-of", "type": "clause", "offset": [966, 980]}, {"key": "in-relation-to", "type": "clause", "offset": [991, 1005]}, {"key": "quality-testing", "type": "clause", "offset": [1024, 1039]}, {"key": "the-phase", "type": "clause", "offset": [1043, 1052]}, {"key": "subject-to-the", "type": "definition", "offset": [1077, 1091]}, {"key": "approval-of", "type": "definition", "offset": [1098, 1109]}, {"key": "an-additional", "type": "clause", "offset": [1110, 1123]}], "size": 2, "hash": "3c43b998f52a50d010478fa08c0c70e4", "id": 5}, {"samples": [{"hash": "gy0kpgXtUQo", "uri": "/contracts/gy0kpgXtUQo#batch-failure", "label": "Supply Agreement (Anthra Pharmaceuticals Inc)", "score": 18.0, "published": true}, {"hash": "b46BIpUrlHc", "uri": "/contracts/b46BIpUrlHc#batch-failure", "label": "Supply Agreement (Anthra Pharmaceuticals Inc)", "score": 18.0, "published": true}], "snippet": "14 7.8 Notification of Inspections................................. 15 7.9", "snippet_links": [{"key": "notification-of-inspections", "type": "clause", "offset": [7, 34]}], "size": 2, "hash": "32e902342f4fdcd2bf2a8777be0774a2", "id": 6}, {"samples": [{"hash": "94LdbyESuNJ", "uri": "/contracts/94LdbyESuNJ#batch-failure", "label": "Development and Manufacturing Services Agreement (Senti Biosciences, Inc.)", "score": 36.2142372131, "published": true}, {"hash": "3VHSFTsFQ6N", "uri": "/contracts/3VHSFTsFQ6N#batch-failure", "label": "Framework Agreement (Senti Biosciences, Inc.)", "score": 36.2142372131, "published": true}], "snippet": "In the event any Batch is terminated or unable to be released by Provider to Senti hereunder (each, a \u201cFailed Batch\u201d), Provider will conduct an appropriate investigation to determine the cause of such failure (which investigation shall include an impact assessment on products that Provider or Senti reasonably believes may be an Impacted Product at the relevant time), provide Senti with the opportunity to participate in such investigation (to the extent Provider\u2019s obligations with respect thereto are provided in the Quality Agreement, in accordance with the Quality Agreement), disclose to Senti the results of such investigation, and notify Senti in writing of Provider\u2019s good faith conclusions regarding the cause of the nonconformity. If Provider determines that the cause of the nonconformity is Provider\u2019s or its subcontractor\u2019s negligence or willful misconduct or failure to follow the Manufacturing Process as documented in the Master Batch Record, standard operating procedures, or GMP requirements, or equipment failure not caused by Senti or by an event of Force Majeure (any such cause of the nonconformity, a \u201cProvider Processing Default\u201d) or if an independent investigation or analysis conducted pursuant to Section 10.7 (Disputes as to Failed Batches or Product Conformity) determines that the cause of the nonconformity is a Provider Processing Default, then, in each case, Senti will have the remedies set forth in Section 10.6 (Remedies).", "snippet_links": [{"key": "in-the-event", "type": "clause", "offset": [0, 12]}, {"key": "by-provider", "type": "clause", "offset": [62, 73]}, {"key": "an-appropriate", "type": "clause", "offset": [141, 155]}, {"key": "determine-the", "type": "clause", "offset": [173, 186]}, {"key": "impact-assessment", "type": "clause", "offset": [247, 264]}, {"key": "reasonably-believes", "type": "definition", "offset": [300, 319]}, {"key": "impacted-product", "type": "definition", "offset": [330, 346]}, {"key": "relevant-time", "type": "clause", "offset": [354, 367]}, {"key": "participate-in", "type": "definition", "offset": [408, 422]}, {"key": "to-the-extent", "type": "clause", "offset": [443, 456]}, {"key": "quality-agreement", "type": "clause", "offset": [521, 538]}, {"key": "in-accordance-with", "type": "clause", "offset": [540, 558]}, {"key": "in-writing", "type": "clause", "offset": [653, 663]}, {"key": "good-faith", "type": "clause", "offset": [678, 688]}, {"key": "willful-misconduct", "type": "clause", "offset": [853, 871]}, {"key": "failure-to", "type": "clause", "offset": [875, 885]}, {"key": "manufacturing-process", "type": "clause", "offset": [897, 918]}, {"key": "master-batch-record", "type": "definition", "offset": [940, 959]}, {"key": "standard-operating-procedures", "type": "clause", "offset": [961, 990]}, {"key": "gmp-requirements", "type": "definition", "offset": [995, 1011]}, {"key": "equipment-failure", "type": "definition", "offset": [1016, 1033]}, {"key": "caused-by", "type": "clause", "offset": [1038, 1047]}, {"key": "an-event-of-force-majeure", "type": "clause", "offset": [1060, 1085]}, {"key": "independent-investigation", "type": "definition", "offset": [1166, 1191]}, {"key": "pursuant-to-section", "type": "definition", "offset": [1214, 1233]}, {"key": "failed-batches", "type": "clause", "offset": [1255, 1269]}, {"key": "product-conformity", "type": "clause", "offset": [1273, 1291]}, {"key": "each-case", "type": "definition", "offset": [1383, 1392]}], "size": 2, "hash": "def8cefd4b3361c0a7eca7a7bb53a6dd", "id": 7}, {"samples": [{"hash": "gy0kpgXtUQo", "uri": "/contracts/gy0kpgXtUQo#batch-failure", "label": "Supply Agreement (Anthra Pharmaceuticals Inc)", "score": 18.0, "published": true}, {"hash": "b46BIpUrlHc", "uri": "/contracts/b46BIpUrlHc#batch-failure", "label": "Supply Agreement (Anthra Pharmaceuticals Inc)", "score": 18.0, "published": true}], "snippet": "Genchem Pharma agrees to cause Sicor to notify Anthra within two (2) working days of discovery of any batch failure which could result in Sicor's inability to meet Anthra's requested delivery dates, or of learning of any failure of any batch of AD32 manufactured by Sicor for delivery to Anthra to meet standards set forth in the Manufacturing Know-how or the Specifications.", "snippet_links": [{"key": "agrees-to", "type": "clause", "offset": [15, 24]}, {"key": "working-days", "type": "clause", "offset": [69, 81]}, {"key": "discovery-of", "type": "clause", "offset": [85, 97]}, {"key": "inability-to", "type": "clause", "offset": [146, 158]}, {"key": "delivery-dates", "type": "clause", "offset": [183, 197]}, {"key": "the-specifications", "type": "definition", "offset": [356, 374]}], "size": 2, "hash": "6d21e143577d462ef13a701ee85e5159", "id": 8}, {"samples": [{"hash": "i2Us1hPWfOc", "uri": "/contracts/i2Us1hPWfOc#batch-failure", "label": "Product Manufacture and Supply and Facility Construction Agreement (Akebia Therapeutics, Inc.)", "score": 31.6940460205, "published": true}], "snippet": "BioVectra agrees to notify Keryx within [**] of discovery after any Batch failure which could result in BioVectra\u2019s inability to meet the agreed upon delivery dates, or of learning of any failure of any Batch of Product to meet Specifications or the Manufacturing Requirements, or if BioVectra has any other safety or efficacy concerns with respect to a Batch of Product. BioVectra agrees not to Reprocess any Batch of Product, or any intermediate in the Manufacture of Product, without the prior written approval of Keryx in writing (in Keryx\u2019s sole discretion). Should Keryx provide such approval, BioVectra will Reprocess the affected Batch(es) or intermediate(s) in the Manufacture of Product at its own cost. BioVectra will schedule any Reprocess as soon as practicable.", "snippet_links": [{"key": "agrees-to", "type": "clause", "offset": [10, 19]}, {"key": "inability-to", "type": "clause", "offset": [116, 128]}, {"key": "delivery-dates", "type": "clause", "offset": [150, 164]}, {"key": "manufacturing-requirements", "type": "definition", "offset": [250, 276]}, {"key": "with-respect-to", "type": "clause", "offset": [336, 351]}, {"key": "manufacture-of-product", "type": "clause", "offset": [455, 477]}, {"key": "approval-of", "type": "definition", "offset": [505, 516]}, {"key": "in-writing", "type": "clause", "offset": [523, 533]}, {"key": "sole-discretion", "type": "definition", "offset": [546, 561]}, {"key": "own-cost", "type": "clause", "offset": [704, 712]}, {"key": "as-soon-as-practicable", "type": "definition", "offset": [752, 774]}], "size": 2, "hash": "a6b4d4066b3ad366129ab36128a58b9b", "id": 9}, {"samples": [{"hash": "5k0KzokBjkp", "uri": "/contracts/5k0KzokBjkp#batch-failure", "label": "Research, Development and License Agreement (Ionis Pharmaceuticals Inc)", "score": 27.4394245148, "published": true}], "snippet": "If Isis encounters any unforeseen difficulties or hazards during the manufacturing of the ISIS-TTRRX API that prevent Isis from successfully manufacturing such batch of ISIS-TTRRX API in accordance with this Amendment No. 6 (including but not limited to the failure of such ISIS-TTRRX API to conform to the warranty set forth in Section 12 of this Schedule 3 of Amendment No. 6), Isis will use its commercially reasonable efforts to manufacture a replacement batch of ISIS-TTRRX API, such that GSK receives such ISIS-TTRRX API as close to the originally-scheduled delivery date as possible.", "snippet_links": [{"key": "unforeseen-difficulties", "type": "clause", "offset": [23, 46]}, {"key": "in-accordance-with", "type": "clause", "offset": [184, 202]}, {"key": "this-amendment-no", "type": "clause", "offset": [203, 220]}, {"key": "not-limited", "type": "clause", "offset": [239, 250]}, {"key": "the-warranty", "type": "clause", "offset": [303, 315]}, {"key": "section-12", "type": "clause", "offset": [329, 339]}, {"key": "schedule-3", "type": "definition", "offset": [348, 358]}, {"key": "commercially-reasonable-efforts", "type": "definition", "offset": [398, 429]}, {"key": "to-manufacture", "type": "definition", "offset": [430, 444]}, {"key": "replacement-batch", "type": "definition", "offset": [447, 464]}, {"key": "close-to", "type": "definition", "offset": [530, 538]}, {"key": "scheduled-delivery-date", "type": "clause", "offset": [554, 577]}], "size": 1, "hash": "2d6855d2320531bff18d6c8920720a07", "id": 10}], "next_curs": "ClYSUGoVc35sYXdpbnNpZGVyY29udHJhY3RzcjILEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IhZiYXRjaC1mYWlsdXJlIzAwMDAwMDBhDKIBAmVuGAAgAA==", "clause": {"children": [["batch-failure-when-cause-is-outside-of-coriums-control-or-indeterminable", "Batch Failure When Cause is Outside of Corium\u2019s Control or Indeterminable"], ["batch-failure-caused-by-corium", "Batch Failure Caused By Corium"], ["confidentiality-and-publicity", "CONFIDENTIALITY AND PUBLICITY"], ["no-implied-license", "NO IMPLIED LICENSE"], ["authorized-disclosure", "AUTHORIZED DISCLOSURE"]], "parents": [["technology-transfer-manufacturing-and-supply-services", "Technology Transfer, Manufacturing, and Supply Services"], ["gmp-manufacture-packaging-and-delivery", "GMP Manufacture Packaging and Delivery"], ["control", "Control"], ["product-quality-disposition", "Product Quality, Disposition"], ["limitations-on-jsc-responsibility-after-the-commercial-option-exercise-date-annual-reports", "Limitations on JSC Responsibility after the Commercial Option Exercise Date; Annual Reports"]], "size": 35, "title": "Batch Failure", "id": "batch-failure", "related": [["payment-failure", "Payment Failure", "Payment Failure"], ["equipment-failures", "Equipment Failures", "Equipment Failures"], ["epidemic-failure-warranty", "Epidemic Failure Warranty", "Epidemic Failure Warranty"], ["power-failure", "Power Failure", "Power Failure"], ["lenders-failure-to-perform", "Lenders\u2019 Failure to Perform", "Lenders\u2019 Failure to Perform"]], "related_snippets": [], "updated": "2026-03-14T06:33:37+00:00", "also_ask": ["What are the minimum criteria for defining a 'batch failure' to avoid ambiguity?", "How can the clause allocate risk and remedies for batch failure most effectively?", "What negotiation levers exist regarding batch size, testing methods, and retesting rights?", "How does this clause compare to industry standards or regulatory requirements for batch failures?", "What are the main enforceability challenges courts have faced with batch failure clauses?"], "drafting_tip": "Specify criteria for batch failure, outline notification procedures, and detail remedies to ensure clarity, prompt response, and effective risk allocation.", "explanation": "The Batch Failure clause defines the consequences and procedures that apply when a group (or batch) of goods or services fails to meet agreed-upon standards or specifications. Typically, this clause outlines what constitutes a batch failure, such as a certain percentage of defective items within a shipment, and details the remedies available, which may include replacement, repair, or rejection of the entire batch. Its core practical function is to allocate risk and responsibility between parties in the event of widespread defects, ensuring clarity and efficiency in resolving quality issues affecting multiple items at once."}, "json": true, "cursor": ""}}