{"component": "clause", "props": {"groups": [{"size": 3, "snippet_links": [{"key": "finished-product", "type": "clause", "offset": [30, 46]}, {"key": "manufacturing-agreement", "type": "definition", "offset": [111, 134]}], "samples": [{"hash": "bAdI2iILPlW", "uri": "/contracts/bAdI2iILPlW#product-release", "label": "Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)", "score": 21.0, "published": true}, {"hash": "izOmX8EqZdr", "uri": "/contracts/izOmX8EqZdr#product-release", "label": "Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)", "score": 19.0, "published": true}, {"hash": "dDcKxlkSEIV", "uri": "/contracts/dDcKxlkSEIV#product-release", "label": "Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)", "score": 19.0, "published": true}], "snippet": "6.1 Reliant shall only accept finished product that complies with the NDA or approved Supplement, and with the Manufacturing Agreement", "hash": "c917bf37aabe71ff73a64f62a0f86329", "id": 4}, {"size": 6, "snippet_links": [{"key": "the-client-will", "type": "clause", "offset": [0, 15]}, {"key": "responsibility-for", "type": "clause", "offset": [26, 44]}, {"key": "release-of", "type": "clause", "offset": [45, 55]}, {"key": "the-product", "type": "definition", "offset": [56, 67]}, {"key": "the-market", "type": "definition", "offset": [71, 81]}, {"key": "qualified-person", "type": "definition", "offset": [96, 112]}, {"key": "for-distribution", "type": "clause", "offset": [178, 194]}, {"key": "on-behalf-of", "type": "clause", "offset": [195, 207]}], "samples": [{"hash": "kgvbecs0MXO", "uri": "/contracts/kgvbecs0MXO#product-release", "label": "Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co)", "score": 32.1485290527, "published": true}, {"hash": "elyDqPRPLDb", "uri": "/contracts/elyDqPRPLDb#product-release", "label": "Manufacturing Services Agreement (Horizon Pharma PLC)", "score": 28.3976726532, "published": true}, {"hash": "6ELKZooBdbF", "uri": "/contracts/6ELKZooBdbF#product-release", "label": "Master Manufacturing Services Agreement (Horizon Pharma, Inc.)", "score": 25.3887748718, "published": true}], "snippet": "The Client will have sole responsibility for release of the Product to the market. When Patheon qualified person (\u201cQP\u201d) services are employed, Patheon QP may release the Product for distribution on behalf of the Client.", "hash": "88ff534242c26d7ced7425a5d03801b3", "id": 1}, {"size": 3, "snippet_links": [{"key": "review-and-approve", "type": "clause", "offset": [48, 66]}, {"key": "batch-production-records", "type": "definition", "offset": [80, 104]}, {"key": "batch-release", "type": "definition", "offset": [114, 127]}, {"key": "by-supplier", "type": "clause", "offset": [198, 209]}, {"key": "for-client", "type": "definition", "offset": [210, 220]}, {"key": "to-client", "type": "definition", "offset": [234, 243]}, {"key": "the-client", "type": "clause", "offset": [248, 258]}, {"key": "for-review", "type": "clause", "offset": [331, 341]}, {"key": "batch-disposition", "type": "clause", "offset": [351, 368]}, {"key": "supplier-will", "type": "clause", "offset": [370, 383]}, {"key": "by-client", "type": "clause", "offset": [464, 473]}, {"key": "prior-written-approval", "type": "clause", "offset": [560, 582]}, {"key": "responsible-for", "type": "clause", "offset": [670, 685]}, {"key": "the-issuance", "type": "clause", "offset": [686, 698]}, {"key": "certificate-of-analysis", "type": "clause", "offset": [751, 774]}, {"key": "certificate-of-conformance", "type": "clause", "offset": [779, 805]}, {"key": "section-16", "type": "definition", "offset": [816, 826]}], "samples": [{"hash": "cJqIZhUDlPw", "uri": "/contracts/cJqIZhUDlPw#product-release", "label": "Development and Manufacturing Services Agreement (Radius Health, Inc.)", "score": 26.1854896545, "published": true}, {"hash": "isdyzHXMEmm", "uri": "/contracts/isdyzHXMEmm#product-release", "label": "Development and Manufacturing Services Agreement (Radius Health, Inc.)", "score": 22.8097190857, "published": true}, {"hash": "fteTObpwZ9H", "uri": "/contracts/fteTObpwZ9H#product-release", "label": "Development and Manufacturing Services Agreement (Radius Health, Inc.)", "score": 22.7440109253, "published": true}], "snippet": "Supplier quality unit has the responsibility to review and approve the executed batch production records prior to batch release. Supplier has the responsibility to release any products manufactured by Supplier for Client for shipment to Client. At the Client\u2019s request, the executed batch production records will be sent to Client for review prior to batch disposition. Supplier will not ship any products manufactured for Client to any destination, as identified by Client, until the product(s) manufactured for Client is or are released for shipment, unless prior written approval has been received from Client to perform such a shipment under quarantine. Supplier is responsible for the issuance for each batch of product manufactured for Client a Certificate of Analysis and Certificate of Conformance (see also section 16).", "hash": "6c40b4e3b09e3cf2371bb688edd202f6", "id": 6}, {"size": 3, "snippet_links": [{"key": "certify-that", "type": "clause", "offset": [27, 39]}, {"key": "in-accordance-with", "type": "definition", "offset": [66, 84]}, {"key": "production-standards", "type": "definition", "offset": [89, 109]}, {"key": "prior-to", "type": "clause", "offset": [165, 173]}, {"key": "release-of", "type": "clause", "offset": [174, 184]}, {"key": "the-products", "type": "clause", "offset": [210, 222]}, {"key": "responsibility-of", "type": "clause", "offset": [332, 349]}, {"key": "quality-department", "type": "definition", "offset": [364, 382]}, {"key": "acceptance-or-rejection", "type": "clause", "offset": [384, 407]}, {"key": "released-product", "type": "definition", "offset": [411, 427]}, {"key": "based-on", "type": "definition", 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"right-to-review", "type": "clause", "offset": [2492, 2507]}, {"key": "the-protocol", "type": "clause", "offset": [2508, 2520]}, {"key": "on-request", "type": "definition", "offset": [2532, 2542]}, {"key": "requests-for", "type": "clause", "offset": [2544, 2556]}, {"key": "full-documentation", "type": "definition", "offset": [2557, 2575]}, {"key": "business-days", "type": "definition", "offset": [2665, 2678]}, {"key": "requested-by", "type": "clause", "offset": [2682, 2694]}, {"key": "product-quality", "type": "definition", "offset": [2711, 2726]}, {"key": "batch-recall", "type": "clause", "offset": [2767, 2779]}, {"key": "audit-report", "type": "clause", "offset": [2799, 2811]}, {"key": "documentation-package", "type": "definition", "offset": [2975, 2996]}, {"key": "article-9", "type": "definition", "offset": [3016, 3025]}, {"key": "see-appendix", "type": "definition", "offset": [3067, 3079]}, {"key": "claims-of", "type": "clause", "offset": [3135, 3144]}, {"key": "hidden-defects", "type": "clause", "offset": [3145, 3159]}, {"key": "immediate-response", "type": "clause", "offset": [3451, 3469]}, {"key": "period-of", "type": "definition", "offset": [3500, 3509]}], "samples": [{"hash": "7BXhRc8uhD1", "uri": "/contracts/7BXhRc8uhD1#product-release", "label": "Development and Supply Agreement (TransMedics Group, Inc.)", "score": 30.2566738129, "published": true}, {"hash": "dhd8UjGHT3t", "uri": "/contracts/dhd8UjGHT3t#product-release", "label": "Development and Supply Agreement (TransMedics Group, Inc.)", "score": 29.9445590973, "published": true}, {"hash": "bLMi0d3O7Nb", "uri": "/contracts/bLMi0d3O7Nb#product-release", "label": "Development and Supply Agreement (TransMedics Group, Inc.)", "score": 29.7967147827, "published": true}], "snippet": "Fresenius shall ensure and certify that the PRODUCT has been made in accordance with the Production Standards by reviewing all manufacturing and control information prior to release of the PRODUCT. Shipment of the PRODUCTS to TransMedics, once dispositioned as \u201creleased\u201d by Fresenius and delivered to TransMedics\u2019s carrier, is the responsibility of TransMedics\u2019s quality department. Acceptance or rejection of released PRODUCT will be undertaken by TransMedics, based on TransMedics\u2019s internal procedures (as set forth below), and the full document package provided by Fresenius, and completion of any release testing required by TransMedics Quality Assurance. Product Release Procedure\n1. Fresenius will provide the following items to TransMedics Quality Assurance: \u2013 A Certificate of Analysis (COA), executed by Fresenius, confirming that the PRODUCT has been tested, and meets the registered specifications. Test specifications and test results must be included for each test. The COA shall also contain the information set forth in Appendix III; \u2013 A Certificate of Compliance (COC) (Not required if statement of cGMP compliance is on COA) executed by Fresenius stating the PRODUCT has been manufactured in accordance with the approved Batch record and listing all deviations and investigations related to the Batch and confirming that all deviations and investigations related to the Batch were completed in compliance with applicable SOP\u2019s, and the Quality Requirements. The COC shall also contain the information set forth in Appendix III. \u2013 Any Quality-Analytical Investigation Report or any other significant deviation investigations related to the batch.\n2. Upon receipt of finished product at its indicated distribution center, TransMedics QA will perform an appropriate statistical sampling of received product. The inspection will include verification of visual properties and label integrity.\n3. Upon review of Fresenius documents, the TransMedics QA will either (i) reject the PRODUCT for non-conformance or (ii) accept the PRODUCT subject to its rights under the DEVELOPMENT AND SUPPLY AGREEMENT and issue authorization for distribution. Batch Record Review Procedure Validation batches: Fresenius is responsible for providing TransMedics with a validation package that includes: (1) the validation protocol, (2) full batch document packages, (3) all validation data and (4) validation report for all validation batches of the PRODUCT manufactured. TransMedics shall have the right to review the protocol and report on request. Requests for full documentation. Fresenius commits to providing TransMedics with a full document package within ten (10) business days if requested by TransMedics for PRODUCT quality concerns, any regulatory reasons (e.g., Batch Recall) or unsatisfactory audit report. Any problem discovered by TransMedics likely to cause rejection of the PRODUCTS will be communicated to Fresenius within 15 days from receipt of the full release documentation package in accordance with Article 9 of the DEVELOPMENT AND SUPPLY AGREEMENT (see Appendix III). TransMedics is responsible for investigating any claims of Hidden Defects and shall report Hidden Defects discovered by or reported to it in accordance with Section 12.2.4 of the DEVELOPMENT AND SUPPLY AGREEMENT and will notify Fresenius of any complaint it receives which may impact the PRODUCT quality and may result from manufacturing. Fresenius will provide an immediate response and a report within a maximum period of two (2) weeks from the notification.", "hash": "3d99e6305c97110e2f9003b47f984a10", "id": 3}, {"size": 2, "snippet_links": [{"key": "certificate-of-analysis", "type": "clause", "offset": [50, 73]}, {"key": "the-product", "type": "definition", "offset": [155, 166]}, {"key": "required-by", "type": "definition", "offset": [173, 184]}, {"key": "the-specifications", "type": "definition", "offset": [185, 203]}, {"key": "for-clarity", "type": "clause", "offset": [215, 226]}, {"key": "be-responsible", "type": "clause", "offset": [249, 263]}, {"key": "own-cost", "type": "clause", "offset": [272, 280]}, {"key": "annual-stability-testing", "type": "clause", "offset": [294, 318]}, {"key": "stability-studies", "type": "clause", "offset": [324, 341]}, {"key": "per-year", "type": "definition", "offset": [364, 372]}, {"key": "site-procedures", "type": "clause", "offset": [395, 410]}, {"key": "by-horizon", "type": "clause", "offset": [478, 488]}, {"key": "expenses-incurred", "type": "definition", "offset": [508, 525]}, {"key": "by-sanofi", "type": "clause", "offset": [526, 535]}, {"key": "for-non", "type": "clause", "offset": [544, 551]}, {"key": "at-the-time", "type": "clause", "offset": [609, 620]}, {"key": "prior-to", "type": "clause", "offset": [621, 629]}, {"key": "agreed-by", "type": "definition", "offset": [656, 665]}, {"key": "based-on", "type": "definition", "offset": [693, 701]}, {"key": "the-study", "type": "definition", "offset": [731, 740]}], "samples": [{"hash": "hVs9OI5G3F6", "uri": "/contracts/hVs9OI5G3F6#product-release", "label": "Manufacturing Agreement", "score": 31.3408622742, "published": true}, {"hash": "hMIW6NUztUg", "uri": "/contracts/hMIW6NUztUg#product-release", "label": "Manufacturing and Supply Agreement (Horizon Pharma, Inc.)", "score": 22.4291572571, "published": true}], "snippet": "No Product shall be released to Horizon without a Certificate of Analysis and Certificate of GMP Compliance. Sanofi-aventis shall conduct such testing for the Product as is required by the Specifications and cGMPs. For clarity, sanofi-aventis shall be responsible, at its own cost, for routine annual stability testing. Any stability studies in excess of the once per year stability testing per site procedures will be considered non-routine. Sanofi-aventis shall be reimbursed by Horizon for all reasonable expenses incurred by sanofi-aventis for non-routine stability testing, which expenses will be quoted at the time prior to initiation of testing and agreed by sanofi-aventis and Horizon based on the extent and complexity of the study in question.", "hash": "b63e818a1322b13d1577f4c780384ff4", "id": 10}, {"size": 3, "snippet_links": [{"key": "responsible-for", "type": "clause", "offset": [15, 30]}, {"key": "product-disposition", "type": "clause", "offset": [47, 66]}, {"key": "provide-a", "type": "definition", "offset": [95, 104]}, {"key": "product-yield", "type": "clause", "offset": [117, 130]}], "samples": [{"hash": "dbgXawI7Ihc", "uri": "/contracts/dbgXawI7Ihc#product-release", "label": "Manufacturing Agreement (Reliant Pharmaceuticals, Inc.)", "score": 21.0, "published": true}, {"hash": "9vQC35ep8V7", "uri": "/contracts/9vQC35ep8V7#product-release", "label": "Manufacturing Agreement (Reliant Pharmaceuticals, Inc.)", "score": 21.0, "published": true}, {"hash": "7jS4zmvKC1t", "uri": "/contracts/7jS4zmvKC1t#product-release", "label": "Manufacturing Agreement (Reliant Pharmaceuticals, Inc.)", "score": 21.0, "published": true}], "snippet": "7.1 Reliant is responsible for assessing final product disposition and release. Cardinal shall provide a COA/COC and product yield page for each lot manufactured.", "hash": "5d4ec0c77c3d65771edf9edcc022b0e1", "id": 5}, {"size": 3, "snippet_links": [{"key": "complaints-and", "type": "clause", "offset": [15, 29]}], "samples": [{"hash": "jmYod2Qi0g7", "uri": "/contracts/jmYod2Qi0g7#product-release", "label": "Toll Manufacturing and Packaging Agreement (Cephalon Inc)", "score": 18.0, "published": true}, {"hash": "8Uzl0Qwh9kD", "uri": "/contracts/8Uzl0Qwh9kD#product-release", "label": "Toll Manufacturing and Packaging Agreement (Cephalon Inc)", "score": 18.0, "published": true}], "snippet": "10 7.4 Product Complaints and Recall......................... 10 7.5", "hash": "dd2b5624c3e8c646f1f4a65363e08f66", "id": 7}, {"size": 4, "snippet_links": [{"key": "product-testing", "type": "definition", "offset": [4, 19]}, {"key": "performed-by", "type": "clause", "offset": [46, 58]}, {"key": "final-approval", "type": "clause", "offset": [100, 114]}, {"key": "the-material", "type": "definition", "offset": [128, 140]}, {"key": "further-processing", "type": "clause", "offset": [145, 163]}, {"key": "certificate-of-conformance", "type": "clause", "offset": [213, 239]}, {"key": "reviewed-by", "type": "definition", "offset": [344, 355]}, {"key": "qualified-and-authorized", "type": "definition", "offset": [383, 407]}, {"key": "responsibility-for", "type": "clause", "offset": [441, 459]}, {"key": "processing-activities", "type": "definition", "offset": [464, 485]}, {"key": "release-of", "type": "clause", "offset": [532, 542]}, {"key": "the-product", "type": "definition", "offset": [543, 554]}, {"key": "designated-locations", "type": "definition", "offset": [586, 606]}, {"key": "certificate-will", "type": "definition", "offset": [612, 628]}, {"key": "work-order", "type": "definition", "offset": [681, 691]}, {"key": "purchase-order-numbers", "type": "clause", "offset": [692, 714]}, {"key": "part-number", "type": "definition", "offset": [735, 746]}, {"key": "lot-number", "type": "definition", "offset": [782, 792]}, {"key": "manufacture-date", "type": "definition", "offset": [817, 833]}, {"key": "in-compliance-with", "type": "definition", "offset": [901, 919]}, {"key": "quality-system", "type": "definition", "offset": [932, 946]}, {"key": "certain-confidential-information", "type": "clause", "offset": [1031, 1063]}, {"key": "contained-in", "type": "definition", "offset": [1064, 1076]}, {"key": "omitted-and-filed-separately-with-the-securities-and-exchange-commission", "type": "clause", "offset": [1121, 1193]}, {"key": "pursuant-to-rule", "type": "clause", "offset": [1194, 1210]}, {"key": "securities-exchange-act-of-1934", "type": "definition", "offset": [1224, 1255]}, {"key": "as-amended", "type": "definition", "offset": [1257, 1267]}, {"key": "test-method", "type": "definition", "offset": [1342, 1353]}, {"key": "signature-and-date", "type": "clause", "offset": [1406, 1424]}], "samples": [{"hash": "eawdYbmZv5E", "uri": "/contracts/eawdYbmZv5E#product-release", "label": "Revenue Participation Agreement", "score": 31.3408622742, "published": true}, {"hash": "3I23JpkGSUR", "uri": "/contracts/3I23JpkGSUR#product-release", "label": "Revenue Participation Agreement (Sunesis Pharmaceuticals Inc)", "score": 23.3682403564, "published": true}], "snippet": "5.1 Product testing arid disposition shall be performed by AAIPS; however, Sunesis shall assign the final approval before using the material for further processing and/or before releasing for any shipments.\n5.2 A Certificate of Conformance shall be generated for each lot produced. All data generated as part of the process and testing will be reviewed by AAIPS QA (or a technically qualified and authorized AAIPS employee not having direct responsibility for the processing activities). AAIPS QA shall be the signer of the COC and release of the product for shipment to Sunesis and/or designated locations. The certificate will cover at a minimum the following information:\n5.2.1 Work Order/Purchase Order numbers, Description, AAIPS part number or part name, Sunesis part number, lot number, quantity manufactured, manufacture date.\n5.2.2 Conformance statement such as \u201cThe product was manufactured in compliance with GMPs, AAIPS quality system, current procedures and specifications. 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