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Quality Agreement QG01-05-T001-01 Page14of18 The Client will give Patheon the Active Material Specifications including a CoA. The Client will give Patheon the test methods for Active Material (if non -compendial). The Client is responsible for validating non-compendial testing methods. 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Agilent will follow written quality system procedures for the identification, quarantine, handling, sampling, testing and approval or rejection of materials. Agilent will perform testing per established methods/procedures and review results against the Specifications. Changes to these methods and procedures will be consistent with the Change Management section of this Agreement. Deviations to the test methods and procedures and OOS results will be handled in a manner consistent with the Deviation and OOS sections of this agreement.\n4.6.2.2. Critical Raw Materials \u2014 Agilent will make recommendations for any change in Critical Raw Material Specifications and test methods as necessary to assure quality and compliance. The establishment of formal Critical Raw Material Specifications and test methods will occur per Agilent\u2019s internal procedures.\n4.6.2.3. In-Process \u2014 Ophthotech and Agilent will agree on in-process Specifications and test methods used during development. 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The Client will provide to Patheon the API Specifications for furnished API, including a certificate of analysis for each batch. The Client will supply any required reference standards that are not readily available through a commonly recognized source. These reference standards must be accompanied by a Certificate of Analysis listing the expiration date and any correction factors that need to be applied.", "samples": [{"hash": "9mrJxs7N2QX", "uri": "/contracts/9mrJxs7N2QX#specifications-and-test-methods", "label": "Master Manufacturing Services Agreement (La Jolla Pharmaceutical Co)", "score": 32.1813826146, "published": true}, {"hash": "bp0ODUSnFOR", "uri": "/contracts/bp0ODUSnFOR#specifications-and-test-methods", "label": "Master Manufacturing Services Agreement (Tetraphase Pharmaceuticals Inc)", "score": 28.5838466804, "published": true}], "size": 2, "hash": "df36feab83fc97075edd173327ab1a93", "id": 3}, {"snippet_links": [{"key": "starting-materials", "type": "definition", "offset": [26, 44]}, {"key": "in-accordance-with", "type": "definition", "offset": [84, 102]}, {"key": "the-specifications", "type": "definition", "offset": [103, 121]}], "snippet": "CPI will test and approve starting materials, intermediates, and Drug Resin Complex in accordance with the Specifications, cGMP and the SOPs.", "samples": [{"hash": "8JxpW7pf3d9", "uri": "/contracts/8JxpW7pf3d9#specifications-and-test-methods", "label": "Supply Agreement", "score": 31.340862423, "published": true}, {"hash": "57K2zrhRUvU", "uri": "/contracts/57K2zrhRUvU#specifications-and-test-methods", "label": "Supply Agreement (Neos Therapeutics, Inc.)", "score": 26.4811772758, "published": true}], "size": 2, "hash": "5433abd4a3775857d9a9b59f348e5c9f", "id": 4}, {"snippet_links": [{"key": "starting-material", "type": "definition", "offset": [30, 47]}, {"key": "finished-product", "type": "definition", "offset": [71, 87]}, {"key": "in-accordance-with", "type": "definition", "offset": [88, 106]}, {"key": "approved-specifications", "type": "definition", "offset": [111, 134]}, {"key": "analytical-methods", "type": "definition", "offset": [136, 154]}, {"key": "upon-receipt", "type": "clause", "offset": [177, 189]}, {"key": "the-materials", "type": "definition", "offset": [191, 204]}, {"key": "after-approval", "type": "clause", "offset": [273, 287]}, {"key": "will-provide", "type": "clause", "offset": [310, 322]}, {"key": "material-specifications", "type": "definition", "offset": [345, 368]}, {"key": "test-methods", "type": "definition", "offset": [402, 414]}, {"key": "responsible-for", "type": "clause", "offset": [483, 498]}, {"key": "testing-methods", "type": "definition", "offset": [525, 540]}], "snippet": "Patheon will test and approve starting material, intermediate, and the finished Product in accordance with the approved Specifications, analytical methods, and Patheon\u2019s SOP\u2019s. Upon receipt, the materials are generally fully tested. Nevertheless, these may be reduced only after approval from Cangene. Cangene will provide to Patheon the Active Material Specifications. Cangene will provide to Patheon test methods for Active Material and excipient\u2019s (if non-compendial). Cangene is responsible for validating non-compendial testing methods. 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The Client will provide to Patheon the Active Material Specifications including a certificate of analysis. The Client will provide to Patheon test methods for Active Material and excipient\u2019s (if non-compendial). The Client is responsible for validating non-compendial testing methods. If these methods are not validated by the Client, then Patheon may assist in validation development with [***].", "samples": [{"hash": "7t8HDp0CbjH", "uri": "/contracts/7t8HDp0CbjH#specifications-and-test-methods", "label": "Supply Agreement (Relypsa Inc)", "score": 25.8569472964, "published": true}], "size": 2, "hash": "9ef57ca3561dfcad3029abd7e61d1dcd", "id": 6}, {"snippet_links": [{"key": "supplier-will", "type": "clause", "offset": [0, 13]}, {"key": "control-testing", "type": "clause", "offset": [76, 91]}, {"key": "in-accordance-with", "type": "definition", "offset": [92, 110]}, {"key": "approved-specifications", "type": "definition", "offset": [115, 138]}, {"key": "analytical-methods", "type": "definition", "offset": [166, 184]}], "snippet": "SUPPLIER will test and disposition raw material(s); will perform in-process control testing in accordance with the approved specifications, validated and/or verified analytical methods, and SUPPLIER\u2019s SOPs.", "samples": [{"hash": "hTxYgoCzZpL", "uri": "/contracts/hTxYgoCzZpL#specifications-and-test-methods", "label": "Commercial Supply Agreement (Supernus Pharmaceuticals Inc)", "score": 24.1019849418, "published": true}], "size": 1, "hash": "f56938fe4c5595f8378e6fcd53e76c91", "id": 7}, {"snippet_links": [{"key": "starting-material", "type": "definition", "offset": [30, 47]}, {"key": "finished-product", "type": "definition", "offset": [71, 87]}, {"key": "in-accordance-with", "type": "definition", "offset": [88, 106]}, {"key": "approved-specifications", "type": "definition", "offset": [111, 134]}, {"key": "analytical-methods", "type": "definition", "offset": [136, 154]}, {"key": "this-exhibit", "type": "definition", "offset": [196, 208]}, {"key": "pursuant-to-a", "type": "definition", "offset": [227, 240]}, {"key": "confidential-treatment-request", "type": "clause", "offset": [241, 271]}, {"key": "the-commission", "type": "clause", "offset": [342, 356]}, {"key": "upon-receipt", "type": "clause", "offset": [358, 370]}, {"key": "the-materials", "type": "definition", "offset": [372, 385]}, {"key": "after-approval", "type": "clause", "offset": [454, 468]}, {"key": "will-provide", "type": "clause", "offset": [493, 505]}, {"key": "certificate-of-analysis", "type": "definition", "offset": [552, 575]}, {"key": "test-methods", "type": "definition", "offset": [610, 622]}, {"key": "responsible-for", "type": "clause", "offset": [649, 664]}, {"key": "testing-methods", "type": "definition", "offset": [691, 706]}, {"key": "subject-to", "type": "definition", "offset": [846, 856]}, {"key": "prior-written-approval", "type": "definition", "offset": [868, 890]}], "snippet": "Patheon will test and approve starting material, intermediate, and the finished Product in accordance with the approved Specifications, analytical methods, and Patheon\u2019s SOP\u2019s. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. Upon receipt, the materials are generally fully tested. Nevertheless, these may be reduced only after approval from Synageva. Synageva will provide to Patheon the BDS Specifications including a certificate of analysis. Synageva will provide to Patheon test methods for BDS [**]. Synageva is responsible for validating non-compendial testing methods. If these methods are not validated by Synageva, then Patheon may assist in validation development with the costs being borne by Synageva, subject to Synageva\u2019s prior written approval.", "samples": [{"hash": "cDPuJ3eyGaJ", "uri": "/contracts/cDPuJ3eyGaJ#specifications-and-test-methods", "label": "Manufacturing Services Agreement (Synageva Biopharma Corp)", "score": 26.325119781, "published": true}], "size": 1, "hash": "2f45798929bae3253d9a65ea0c1a6fd7", "id": 8}, {"snippet_links": [{"key": "finished-product", "type": "definition", "offset": [34, 50]}, {"key": "in-accordance-with", "type": "definition", "offset": [51, 69]}, {"key": "approved-specifications", "type": "definition", "offset": [74, 97]}, {"key": "analytical-methods", "type": "definition", "offset": [105, 123]}], "snippet": "Patheon will test and approve the finished Product in accordance with the approved Specifications, cGMP, analytical methods, and Patheon\u2019s SOP\u2019s.", "samples": [{"hash": "alDHUK1Q6xh", "uri": "/contracts/alDHUK1Q6xh#specifications-and-test-methods", "label": "Manufacturing Services Agreement (Penwest Pharmaceuticals Co)", "score": 21.5941136208, "published": true}], "size": 1, "hash": "26ce8fbb6563411f5fcdac0d3df71cae", "id": 9}, {"snippet_links": [{"key": "starting-material", "type": "definition", "offset": [30, 47]}, {"key": "the-product", "type": "clause", "offset": [75, 86]}, {"key": "in-accordance-with", "type": "definition", "offset": [87, 105]}, {"key": "approved-specifications", "type": "definition", "offset": [110, 133]}, {"key": "analytical-methods", "type": "definition", "offset": [135, 153]}, {"key": "will-provide", "type": "clause", "offset": [181, 193]}, {"key": "api-specifications", "type": "definition", "offset": [211, 229]}, {"key": "the-manufacturer", "type": "definition", "offset": [240, 256]}, {"key": "certificate-of-analysis", "type": "definition", "offset": [259, 282]}, {"key": "responsible-for", "type": "clause", "offset": [300, 315]}, {"key": "test-methods", "type": "definition", "offset": [399, 411]}, {"key": "for-api", "type": "clause", "offset": [412, 419]}, {"key": "testing-methods", "type": "definition", "offset": [509, 524]}], "snippet": "Patheon will test and approve starting material, in-process materials, and the Product in accordance with the approved Specifications, analytical methods, and Patheon\u2019s SOP\u2019s. MDCO will provide Patheon with the API Specifications including the manufacturer\u2019s Certificate of Analysis. Patheon will be responsible for performing only an assay and ID testing on the API. MDCO will provide Patheon with test methods for API and excipients (if non-compendial). Patheon is responsible for validating non-compendial testing methods.\n4.5.5 Out of Specifications (OOS)", "samples": [{"hash": "hxkLZHLPYL9", "uri": "/contracts/hxkLZHLPYL9#specifications-and-test-methods", "label": "Manufacturing Services Agreement (Medicines Co /De)", "score": 22.8535249829, "published": true}], "size": 1, "hash": "cfdb22f20b9fab0ce7a6177658b7d285", "id": 10}], "next_curs": "CmgSYmoVc35sYXdpbnNpZGVyY29udHJhY3RzckQLEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IihzcGVjaWZpY2F0aW9ucy1hbmQtdGVzdC1tZXRob2RzIzAwMDAwMDBhDKIBAmVuGAAgAA==", "clause": {"children": [], "title": "Specifications and Test Methods", "parents": [["laboratory-controls", "Laboratory Controls"], ["miscellaneous", "Miscellaneous"], ["governing-law", "Governing Law"], ["procedure", "Procedure"], ["description-of-responsibilities", "Description of Responsibilities"]], "size": 20, "id": "specifications-and-test-methods", "related": [["technical-specifications-and-drawings", "Technical Specifications and Drawings", "Technical Specifications and Drawings"], ["specifications-and-standards", "Specifications and Standards", "Specifications and Standards"], ["certain-calculations-and-tests", "Certain Calculations and Tests", "Certain Calculations and Tests"], ["technical-specifications", "Technical Specifications", "Technical Specifications"], ["oduf-packing-specifications", "ODUF Packing Specifications", "ODUF Packing Specifications"]], "related_snippets": [], "updated": "2025-07-07T12:37:53+00:00", "also_ask": [], "drafting_tip": "Specify detailed product requirements and reference recognized test standards to ensure clarity and facilitate objective compliance assessment.", "explanation": "The \"Specifications and Test Methods\" clause defines the technical standards, criteria, and procedures that products or services must meet and the methods by which their compliance will be verified. Typically, this clause outlines the precise requirements for materials, performance, or quality, and details the testing protocols or industry standards to be used for evaluation. By clearly establishing both the expectations and the means of assessment, this clause ensures that all parties have a shared understanding of what constitutes acceptable performance, thereby reducing disputes and ensuring consistent quality."}, "json": true, "cursor": ""}}