{"component": "clause", "props": {"groups": [{"snippet": "If applicable, Patheon will conduct stability testing on the Products in accordance with the protocols set out in the Specifications for the separate fees and during the time periods set out in Schedule C to a Product Agreement. Patheon will not make any changes to these testing protocols without prior written approval from Client. If a confirmed stability test failure occurs, Patheon will notify Client within one Business Day, after which Patheon and Client will jointly, reasonably and in good faith, determine the proceedings and methods to be undertaken to investigate the cause of the failure, including which party will bear the cost of the investigation. Patheon will not be liable for these costs unless it has failed to perform the Manufacturing Services in accordance withthe Specifications and cGMP. 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Patheon shall not make any changes to these testing protocols without prior written approval from the Client. In the event that any batch of Products fails stability testing, Patheon and the Client shall jointly determine the proceedings and methods to be undertaken to investigate the causes of such failure, including which party shall bear the cost of such investigation, provided that Patheon shall not be liable for any such costs unless there has been a failure by it to provide the Manufacturing Services in accordance with the Specifications and cGMPs. 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If SBS confirms a stability failure with respect to the Product, SBS shall notify Voyager thereof within twenty-four (24) hours and the parties shall discuss in good faith appropriate corrective action. 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COMPANY shall receive a copy of DPT\u2019s Annual Product Review for each Product as long as DPT is continuing to produce such Product for COMPANY and for as long as COMPANY\u2019s account is current. If COMPANY elects to perform its own stability testing on Product, COMPANY agrees to provide DPT with a copy of the results from such testing on an annual basis.", "size": 8, "snippet_links": [{"key": "test-program", "type": "definition", "offset": [41, 53]}, {"key": "agreed-to", "type": "definition", "offset": [97, 106]}, {"key": "in-accordance-with", "type": "clause", "offset": [107, 125]}, {"key": "the-products", "type": "clause", "offset": [144, 156]}, {"key": "annual-product-review", "type": "clause", "offset": [213, 234]}, {"key": "for-company", "type": "clause", "offset": [305, 316]}, {"key": "to-provide", "type": "definition", "offset": [448, 458]}, {"key": "a-copy-of-the", "type": "clause", "offset": [468, 481]}, {"key": "annual-basis", "type": "clause", "offset": [514, 526]}], "samples": [{"hash": "9OS522QnrLt", "uri": "/contracts/9OS522QnrLt#stability-testing", "label": "Manufacturing Agreement (Insys Therapeutics, Inc.)", "score": 24.1567420959, "published": true}, {"hash": "ly75EkwbKmN", "uri": "/contracts/ly75EkwbKmN#stability-testing", "label": "Manufacturing Agreement (Insys Therapeutics, Inc.)", "score": 22.5331954956, "published": true}, {"hash": "kVVa2D4KdlM", "uri": "/contracts/kVVa2D4KdlM#stability-testing", "label": "Manufacturing Agreement (Insys Therapeutics, Inc.)", "score": 22.4866523743, "published": true}], "hash": "7ecddbca6cb3a7f36acb23327b5ff544", "id": 3}, {"snippet": "Supplier shall perform stability testing of API according to the ICH Guidelines and as required by the Regulatory Requirements.", "size": 3, "snippet_links": [{"key": "supplier-shall", "type": "clause", "offset": [0, 14]}, {"key": "testing-of-api", "type": "clause", "offset": [33, 47]}, {"key": "according-to", "type": "definition", "offset": [48, 60]}, {"key": "ich-guidelines", "type": "definition", "offset": [65, 79]}, {"key": "as-required-by", "type": "clause", "offset": [84, 98]}, {"key": "regulatory-requirements", "type": "definition", "offset": [103, 126]}], "samples": [{"hash": "9soaFvs8EwS", "uri": "/contracts/9soaFvs8EwS#stability-testing", "label": "Api Supply Agreement", "score": 31.3408622742, "published": true}, {"hash": "l4VY8r0ZMNM", "uri": "/contracts/l4VY8r0ZMNM#stability-testing", "label": "Api Supply Agreement (Baudax Bio, Inc.)", "score": 30.8042430878, "published": true}, {"hash": "fd2t8X34yYw", "uri": "/contracts/fd2t8X34yYw#stability-testing", "label": "Api Supply Agreement (Recro Pharma, Inc.)", "score": 24.9096508026, "published": true}], "hash": "5500eed8a1b0572d91e3690b249d7ab8", "id": 10}, {"snippet": "At Client\u2019s request and expense, B\u2587\u2587\u2587\u2587\u2587 shall perform all stability testing required to be performed on development, conformance and/or production batches of Product. 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From time to time, Aptevo may reasonably request that Emergent revise its stability testing program for the Products, in which case the Parties shall negotiate in good faith with according adjustments to the pricing for such services outlined on Schedule A. Any such changes shall be agreed by both Parties in writing before becoming effective.", "size": 4, "snippet_links": [{"key": "ongoing-stability", "type": "clause", "offset": [23, 40]}, {"key": "program-services", "type": "clause", "offset": [49, 65]}, {"key": "the-products", "type": "clause", "offset": [90, 102]}, {"key": "section-36", "type": "clause", "offset": [120, 131]}, {"key": "quality-agreement", "type": "definition", "offset": [139, 156]}, {"key": "subject-to", "type": "clause", "offset": [158, 168]}, {"key": "applicable-fees", "type": "definition", "offset": [200, 215]}, {"key": "on-schedule", "type": "definition", "offset": [243, 254]}, {"key": "from-time-to-time", "type": "clause", "offset": [258, 275]}, {"key": "reasonably-request", "type": "definition", "offset": [288, 306]}, {"key": "the-parties-shall", "type": "clause", "offset": [390, 407]}, {"key": "negotiate-in-good-faith", "type": "definition", "offset": [408, 431]}, {"key": "adjustments-to", "type": "clause", "offset": [447, 461]}, {"key": "by-both-parties", "type": "clause", "offset": [549, 564]}, {"key": "in-writing", "type": "definition", "offset": [565, 575]}], "samples": [{"hash": "hbUDaRjl1XX", "uri": "/contracts/hbUDaRjl1XX#stability-testing", "label": "Manufacturing Services Agreement (Kamada LTD)", "score": 34.1991767883, "published": true}, {"hash": "eHbzNbEuufR", "uri": "/contracts/eHbzNbEuufR#stability-testing", "label": "Manufacturing Services Agreement (Aptevo Therapeutics Inc.)", "score": 29.1943874359, "published": true}, {"hash": "e0wH5DhT4qS", "uri": "/contracts/e0wH5DhT4qS#stability-testing", "label": "Manufacturing Services Agreement (Aptevo Therapeutics Inc.)", "score": 27.5845317841, "published": true}], "hash": "7f7adfdf461f5c6815bc86153231e34e", "id": 7}, {"snippet": "Seller shall maintain a stability testing program for the Product and provide Purchaser with an annual product review thereon. At least one batch per year of Product shall be included in the stability program.", "size": 8, "snippet_links": [{"key": "seller-shall", "type": "clause", "offset": [0, 12]}, {"key": "testing-program", "type": "clause", "offset": [34, 49]}, {"key": "the-product", "type": "definition", "offset": [54, 65]}, {"key": "annual-product-review", "type": "clause", "offset": [96, 117]}, {"key": "per-year", "type": "definition", "offset": [146, 154]}, {"key": "stability-program", "type": "clause", "offset": [191, 208]}], "samples": [{"hash": "e9TTP8piNbX", "uri": "/contracts/e9TTP8piNbX#stability-testing", "label": "Distribution Agreement (Amphastar Pharmaceuticals, Inc.)", "score": 25.3805618286, "published": true}, {"hash": "223ma3dJc2i", "uri": "/contracts/223ma3dJc2i#stability-testing", "label": "Distribution Agreement (Amphastar Pharmaceuticals, Inc.)", "score": 25.1013011932, "published": true}, {"hash": "jcKXdXZcFrx", "uri": "/contracts/jcKXdXZcFrx#stability-testing", "label": "Distribution Agreement (Andrx Corp /De/)", "score": 21.0, "published": true}], "hash": "9091dd63afaf355d3198c562d3f54f85", "id": 2}, {"snippet": "At Celator\u2019s expense, Baxter shall perform all stability testing in compliance with the International Conference on Harmonization for Registration of Pharmaceuticals for Human Use (ICH) requirements performed on clinical, development, conformance and/or commercial Production Batches of Product. Such testing shall be performed in accordance with the procedures set out in the Product specific \u2587\u2587\u2587\u2587\u2587\u2587 SOPs for the stability protocol and Product Master Plan. Prior to any stability testing, Celator shall have the right to review and approve the stability testing protocol and Celator shall receive a summary report of the data generated from the stability tests. 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