{"component": "clause", "props": {"groups": [{"samples": [{"hash": "coWgqBWpMF9", "uri": "/contracts/coWgqBWpMF9#quality-technical-agreement", "label": "License Agreement", "score": 32.0589650238, "published": true}, {"hash": "fqHf3zy7ZdY", "uri": "/contracts/fqHf3zy7ZdY#quality-technical-agreement", "label": "License Agreement (Correvio Pharma Corp.)", "score": 29.5256673511, "published": true}, {"hash": "71HILX05N79", "uri": "/contracts/71HILX05N79#quality-technical-agreement", "label": "License Agreement (Cardiome Pharma Corp)", "score": 27.3737166324, "published": true}], "snippet_links": [{"key": "in-addition", "type": "clause", "offset": [0, 11]}, {"key": "the-parties-shall", "type": "clause", "offset": [13, 30]}, {"key": "technical-agreement", "type": "clause", "offset": [63, 82]}, {"key": "the-supply-agreement", "type": "clause", "offset": [124, 144]}], "snippet": "In addition, the Parties shall negotiate and execute a Quality/Technical Agreement as further detailed in Section 5.1(b) of the Supply Agreement.", "size": 3, "hash": "986db0b8cf694cc7e12c5c732dc6f559", "id": 1}, {"samples": [{"hash": "jk4mEqBlMyN", "uri": "/contracts/jk4mEqBlMyN#quality-technical-agreement", "label": "License and Collaboration Agreement (Lexicon Pharmaceuticals, Inc.)", "score": 25.9746748802, "published": true}, {"hash": "dgZyBIVphrc", "uri": "/contracts/dgZyBIVphrc#quality-technical-agreement", "label": "License and Collaboration Agreement (Lexicon Pharmaceuticals, Inc./De)", "score": 25.8459958932, "published": true}], "snippet_links": [{"key": "diligent-efforts", "type": "definition", "offset": [18, 34]}, {"key": "to-manufacture", "type": "definition", "offset": [35, 49]}, {"key": "have-manufactured", "type": "definition", "offset": [53, 70]}, {"key": "in-accordance-with", "type": "definition", "offset": [92, 110]}, {"key": "product-specifications", "type": "definition", "offset": [115, 137]}, {"key": "quality-agreement", "type": "definition", "offset": [188, 205]}, {"key": "entered-into", "type": "clause", "offset": [222, 234]}, {"key": "between-the-parties", "type": "clause", "offset": [235, 254]}, {"key": "the-effective-date", "type": "clause", "offset": [270, 288]}, {"key": "set-out", "type": "definition", "offset": [317, 324]}, {"key": "the-responsibility-of-the-parties", "type": "clause", "offset": [325, 358]}, {"key": "in-connection-with", "type": "clause", "offset": [359, 377]}, {"key": "licensed-products", "type": "clause", "offset": [382, 399]}, {"key": "related-to", "type": "clause", "offset": [403, 413]}, {"key": "quality-control", "type": "clause", "offset": [414, 429]}, {"key": "quality-assurance", "type": "definition", "offset": [431, 448]}, {"key": "change-control", "type": "definition", "offset": [453, 467]}], "snippet": "Lexicon shall use Diligent Efforts to manufacture or have manufactured the Licensed Product in accordance with the product specifications and in accordance with cGMP and as set forth in a quality agreement, which shall be entered into between the Parties within [**] of the Effective Date. The quality agreement will set out the responsibility of the Parties in connection with the Licensed Products as related to quality control, quality assurance and change control (\u201cQuality Technical Agreement\u201d).", "size": 2, "hash": "e9a3cf982b4038d50548ac6545422b03", "id": 2}, {"samples": [{"hash": "cm1lP2aeDbg", "uri": "/contracts/cm1lP2aeDbg#quality-technical-agreement", "label": "Note Purchase Agreement (Acusphere Inc)", "score": 21.0, "published": true}, {"hash": "5dj32CjQBzX", "uri": "/contracts/5dj32CjQBzX#quality-technical-agreement", "label": "Note Purchase Agreement (Acusphere Inc)", "score": 21.0, "published": true}], "snippet_links": [{"key": "days-after", "type": "definition", "offset": [18, 28]}, {"key": "date-of-this-agreement", "type": "definition", "offset": [33, 55]}, {"key": "representatives-of-the-parties", "type": "definition", "offset": [57, 87]}, {"key": "quality-assurance", "type": "definition", "offset": [89, 106]}, {"key": "to-develop", "type": "definition", "offset": [130, 140]}, {"key": "key-contacts", "type": "clause", "offset": [221, 233]}, {"key": "quality-and-compliance", "type": "clause", "offset": [238, 260]}, {"key": "related-issues", "type": "clause", "offset": [261, 275]}, {"key": "will-provide", "type": "clause", "offset": [292, 304]}, {"key": "for-review", "type": "clause", "offset": [363, 373]}, {"key": "prior-to", "type": "definition", "offset": [374, 382]}, {"key": "as-specified", "type": "clause", "offset": [391, 403]}, {"key": "without-limitation", "type": "clause", "offset": [491, 509]}, {"key": "annual-product-reviews", "type": "clause", "offset": [511, 533]}, {"key": "returned-goods", "type": "clause", "offset": [535, 549]}, {"key": "regulatory-audits", "type": "clause", "offset": [551, 568]}, {"key": "compliance-with", "type": "definition", "offset": [570, 585]}], "snippet": "Within sixty (60) days after the date of this Agreement, representatives of the parties\u2019 Quality Assurance departments shall meet to develop, agree and approve a Quality Technical Agreement outlining responsibilities and key contacts for quality and compliance related issues. [MANUFACTURER] will provide PURCHASER with certain production and control information for review prior to release as specified in the Quality Technical Agreement. The Quality Technical Agreement will also address, without limitation, annual product reviews, returned goods, regulatory audits, compliance with FDA cGMPs, and such other quality related concerns deemed appropriate.", "size": 2, "hash": "6890b81e92bf6b4b6f361a2b09a35908", "id": 3}, {"samples": [{"hash": "d5nk6KXbJyQ", "uri": "/contracts/d5nk6KXbJyQ#quality-technical-agreement", "label": "Development and Supply Agreement (Trevena Inc)", "score": 29.4490075291, "published": true}], "snippet_links": [{"key": "the-parties-will", "type": "clause", "offset": [0, 16]}, {"key": "all-commercially-reasonable-efforts", "type": "clause", "offset": [21, 56]}, {"key": "to-negotiate", "type": "definition", "offset": [57, 69]}, {"key": "technical-agreement", "type": "clause", "offset": [95, 114]}, {"key": "after-the-effective-date", "type": "clause", "offset": [184, 208]}, {"key": "prior-to", "type": "definition", "offset": [226, 234]}, {"key": "manufacture-of-the-product", "type": "clause", "offset": [244, 270]}, {"key": "certain-confidential-information", "type": "clause", "offset": [278, 310]}, {"key": "contained-in", "type": "definition", "offset": [311, 323]}, {"key": "omitted-and-filed-separately-with-the-securities-and-exchange-commission", "type": "clause", "offset": [368, 440]}, {"key": "pursuant-to-rule", "type": "clause", "offset": [441, 457]}, {"key": "securities-exchange-act-of-1934", "type": "clause", "offset": [471, 502]}, {"key": "as-amended", "type": "definition", "offset": [504, 514]}], "snippet": "The Parties will use all commercially reasonable efforts to negotiate and conclude a Quality & Technical Agreement which will be attached hereto as Schedule 7.2 no later than [*] days after the Effective Date, but in any case prior to any cGMP manufacture of the Product. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.", "size": 2, "hash": "4138109bbe9db0e437f2704761c214ee", "id": 5}, {"samples": [{"hash": "5wqrdkV1BCk", "uri": "/contracts/5wqrdkV1BCk#quality-technical-agreement", "label": "Exclusive Supply and Distribution Agreement (CytoDyn Inc.)", "score": 32.575633128, "published": true}], "snippet_links": [{"key": "as-soon-as-practicable", "type": "definition", "offset": [0, 22]}, {"key": "after-the-effective-date", "type": "clause", "offset": [23, 47]}, {"key": "the-parties", "type": "definition", "offset": [49, 60]}, {"key": "negotiate-in-good-faith", "type": "definition", "offset": [77, 100]}, {"key": "the-execution", "type": "clause", "offset": [101, 114]}, {"key": "technical-agreement", "type": "clause", "offset": [128, 147]}, {"key": "agreed-to", "type": "clause", "offset": [200, 209]}, {"key": "in-writing", "type": "clause", "offset": [210, 220]}, {"key": "prior-to", "type": "definition", "offset": [221, 229]}, {"key": "placement-of", "type": "definition", "offset": [230, 242]}, {"key": "purchase-order", "type": "definition", "offset": [247, 261]}, {"key": "the-product", "type": "clause", "offset": [266, 277]}], "snippet": "As soon as practicable after the Effective Date, the Parties hereby agree to negotiate in good faith the execution of a Quality/Technical Agreement. Such Quality/Technical Agreement shall be mutually agreed to in writing prior to placement of any Purchase Order for the Product.", "size": 1, "hash": "d411e28a9bf8c1377e4458120d4a8dd0", "id": 6}, {"samples": [{"hash": "98cif3BZgGw", "uri": "/contracts/98cif3BZgGw#quality-technical-agreement", "label": "Api Supply Agreement", "score": 31.340862423, "published": true}, {"hash": "c1altgMQRDh", "uri": "/contracts/c1altgMQRDh#quality-technical-agreement", "label": "Api Supply Agreement (Indevus Pharmaceuticals Inc)", "score": 21.0, "published": true}], "snippet_links": [{"key": "after-the-effective-date", "type": "clause", "offset": [23, 47]}, {"key": "the-parties-shall", "type": "clause", "offset": [49, 66]}, {"key": "key-contacts", "type": "clause", "offset": [139, 151]}, {"key": "for-api", "type": "clause", "offset": [152, 159]}, {"key": "quality-and-compliance", "type": "clause", "offset": [160, 182]}, {"key": "related-issues", "type": "clause", "offset": [183, 197]}, {"key": "will-provide", "type": "clause", "offset": [207, 219]}, {"key": "for-review", "type": "clause", "offset": [276, 286]}, {"key": "prior-to", "type": "definition", "offset": [287, 295]}, {"key": "as-specified", "type": "clause", "offset": [304, 316]}, {"key": "without-limitation", "type": "clause", "offset": [404, 422]}, {"key": "annual-product-reviews", "type": "clause", "offset": [424, 446]}, {"key": "returned-goods", "type": "clause", "offset": [448, 462]}, {"key": "regulatory-audits", "type": "clause", "offset": [464, 481]}, {"key": "compliance-with", "type": "definition", "offset": [483, 498]}, {"key": "current-good-manufacturing-practices", "type": "clause", "offset": [499, 535]}, {"key": "the-final", "type": "clause", "offset": [597, 606]}, {"key": "agreed-quality", "type": "definition", "offset": [607, 621]}, {"key": "to-this-agreement", "type": "clause", "offset": [659, 676]}, {"key": "in-the-event", "type": "clause", "offset": [730, 742]}, {"key": "material-provisions", "type": "definition", "offset": [789, 808]}, {"key": "regulatory-standards", "type": "clause", "offset": [862, 882]}], "snippet": "Within sixty (60) days after the Effective Date, the Parties shall enter into a Quality Technical Agreement outlining responsibilities and key contacts for API quality and compliance related issues. Helsinn will provide Indevus with certain production and control information for review prior to release as specified in the Quality Technical Agreement. The Quality Technical Agreement will also address, without limitation, annual product reviews, returned goods, regulatory audits, compliance with Current Good Manufacturing Practices, and such other quality related concerns deemed appropriate. The final agreed Quality Technical Agreement will be attached to this Agreement as Exhibit 1.22 and deemed a part of this Agreement. In the event that the Quality Technical Agreement contains material provisions that substantially differ from applicable comparable Regulatory Standards, the Regulatory Standards shall control.", "size": 2, "hash": "b69488c5189114c2838cc84788abc6b6", "id": 4}, {"samples": [{"hash": "6VgVYLgZ2E5", "uri": "/contracts/6VgVYLgZ2E5#quality-technical-agreement", "label": "Manufacturing Services Agreement (Alnylam Pharmaceuticals, Inc.)", "score": 29.3367556468, "published": true}], "snippet_links": [{"key": "as-required-by", "type": "clause", "offset": [0, 14]}, {"key": "applicable-law", "type": "clause", "offset": [15, 29]}, {"key": "the-parties-will", "type": "clause", "offset": [31, 47]}, {"key": "provisions-for", "type": "clause", "offset": [123, 137]}, {"key": "manufacture-of-product", "type": "clause", "offset": [142, 164]}], "snippet": "As required by Applicable Law, the parties will also agree upon a Quality Technical Agreement containing quality assurance provisions for the Manufacture of Product (\u201cQuality Technical Agreement\u201d).", "size": 1, "hash": "159b5db736d8bc273f07676105c410a1", "id": 9}, {"samples": [{"hash": "5QyLI64o0yU", "uri": "/contracts/5QyLI64o0yU#quality-technical-agreement", "label": "Api Supply Agreement (Nabriva Therapeutics PLC)", "score": 30.1909650924, "published": true}], "snippet_links": [{"key": "the-effective-date", "type": "clause", "offset": [15, 33]}, {"key": "representatives-of-the-parties", "type": "definition", "offset": [35, 65]}, {"key": "the-terms", "type": "definition", "offset": [189, 198]}, {"key": "contained-in", "type": "definition", "offset": [199, 211]}, {"key": "terms-of-this-agreement", "type": "clause", "offset": [275, 298]}, {"key": "to-the-extent", "type": "clause", "offset": [347, 360]}, {"key": "in-the-event-of-a", "type": "clause", "offset": [371, 388]}, {"key": "terms-of-the", "type": "clause", "offset": [410, 422]}, {"key": "with-respect-to", "type": "clause", "offset": [526, 541]}, {"key": "legal-matters", "type": "clause", "offset": [566, 579]}, {"key": "quality-control-and-quality-assurance", "type": "clause", "offset": [660, 697]}, {"key": "related-to", "type": "clause", "offset": [706, 716]}, {"key": "without-limitation", "type": "clause", "offset": [737, 755]}, {"key": "change-management", "type": "definition", "offset": [799, 816]}, {"key": "validation-activities", "type": "clause", "offset": [821, 842]}, {"key": "inclusion-of-a", "type": "clause", "offset": [873, 887]}, {"key": "level-of-detail", "type": "clause", "offset": [907, 922]}, {"key": "conflict-in-terms", "type": "clause", "offset": [1145, 1162]}, {"key": "the-principal", "type": "definition", "offset": [1166, 1179]}, {"key": "the-agreements", "type": "clause", "offset": [1231, 1245]}, {"key": "material-breach", "type": "clause", "offset": [1314, 1329]}, {"key": "breach-of-this-agreement", "type": "clause", "offset": [1383, 1407]}], "snippet": "Within [**] of the Effective Date, representatives of the Parties\u2019 quality assurance departments shall meet to review and revise, if necessary, and execute the Quality Technical Agreement. The terms contained in the Quality Technical Agreement are intended to complement the terms of this Agreement, and they shall be interpreted as complementary to the extent possible. In the event of a conflict between the terms of the Quality Technical Agreement and the terms of this Agreement, the terms of this Agreement shall control with respect to business, financial and legal matters, and the terms of the Quality Technical Agreement shall control with respect to quality control and quality assurance matters related to the API (including, without limitation, Manufacturing, testing, storage, release, change management and validation activities); provided, however, that the inclusion of a particular term or level of detail in the Quality Technical Agreement where such term or level of detail is absent from this Agreement shall not be deemed to constitute a conflict between the two agreements. Only where competing terms in the two agreements conflict in terms of the principal focus of an express prescription or prohibition in the agreements shall a conflict between the two agreements be deemed to exist. Any material breach of the Quality Technical Agreement shall be deemed a breach of this Agreement.", "size": 1, "hash": "d35d0997c5e923501cc03e661423230a", "id": 8}, {"samples": [{"hash": "l1kz04gCNX3", "uri": "/contracts/l1kz04gCNX3#quality-technical-agreement", "label": "Master Supply Agreement (Genzyme Corp)", "score": 21.6023271732, "published": true}], "snippet_links": [{"key": "entered-into", "type": "clause", "offset": [17, 29]}, {"key": "attached-hereto-as-exhibit", "type": "definition", "offset": [63, 89]}, {"key": "authorized-personnel", "type": "clause", "offset": [96, 116]}, {"key": "of-the-parties", "type": "clause", "offset": [117, 131]}, {"key": "this-exhibit", "type": "definition", "offset": [161, 173]}, {"key": "pursuant-to-a", "type": "definition", "offset": [192, 205]}, {"key": "confidential-treatment-request", "type": "clause", "offset": [206, 236]}, {"key": "the-commission", "type": "clause", "offset": [307, 321]}, {"key": "provisions-of-the", "type": "clause", "offset": [323, 340]}, {"key": "mutual-agreement-in-writing", "type": "clause", "offset": [372, 399]}, {"key": "amendment-to", "type": "definition", "offset": [416, 428]}, {"key": "master-agreement", "type": "clause", "offset": [434, 450]}], "snippet": "The Parties have entered into a Quality Technical Agreement as attached hereto as Exhibit 10.2. Authorized personnel of the Parties may amend [**] = 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. provisions of the Quality Technical Agreement by mutual agreement in writing, without formal amendment to this Master Agreement.", "size": 1, "hash": "86ddd85a9a6e7678eea8801626b853d1", "id": 10}, {"samples": [{"hash": "e2IhKwOfZxN", "uri": "/contracts/e2IhKwOfZxN#quality-technical-agreement", "label": "Technical Transfer and Supply Agreement (Amag Pharmaceuticals Inc.)", "score": 27.1403148528, "published": true}], "snippet_links": [{"key": "entered-into", "type": "clause", "offset": [17, 29]}, {"key": "technical-agreement", "type": "clause", "offset": [42, 61]}, {"key": "quality-assurance", "type": "definition", "offset": [154, 171]}, {"key": "manufacture-of-product", "type": "clause", "offset": [192, 214]}, {"key": "notwithstanding-the-foregoing", "type": "clause", "offset": [240, 269]}, {"key": "authorized-personnel", "type": "clause", "offset": [271, 291]}, {"key": "of-the-parties", "type": "clause", "offset": [292, 306]}, {"key": "for-purposes-of-this-agreement", "type": "definition", "offset": [384, 414]}, {"key": "work-and", "type": "clause", "offset": [436, 444]}, {"key": "incorporated-by-reference", "type": "clause", "offset": [611, 636]}], "snippet": "The parties have entered into a Quality & Technical Agreement dated June 25, 2012 and amended June 10, 2014, which agreement shall continue to govern the quality assurance aspects of Pfizer\u2019s manufacture of Product at its [\u2026***\u2026] Facility. Notwithstanding the foregoing, authorized personnel of the parties must negotiate and conclude a new Quality & Technical Agreement as necessary for purposes of this Agreement and the Statement of Work and before any cGMP manufacture of Product can take place at the Pfizer [\u2026***\u2026] Facility. Upon its execution, the new Quality & Technical Agreement shall be deemed to be incorporated by reference herein.", "size": 1, "hash": "be694ce3857c95a49522b25838c547b2", "id": 7}], "next_curs": "CmQSXmoVc35sYXdpbnNpZGVyY29udHJhY3RzckALEhZDbGF1c2VTbmlwcGV0R3JvdXBfdjU2IiRxdWFsaXR5LXRlY2huaWNhbC1hZ3JlZW1lbnQjMDAwMDAwMGEMogECZW4YACAA", "clause": {"parents": [["api-quantity-quality-and-manufacturing-processes-technical-assistance", "Api Quantity Quality and Manufacturing Processes Technical Assistance"], ["quality-assurance", "Quality Assurance"], ["manufacture-and-supply-of-finished-product", "Manufacture and Supply of Finished Product"], ["miscellaneous", "Miscellaneous"], ["specific-performance", "Specific Performance"]], "size": 21, "children": [["exceptions", "Exceptions"], ["handling-of-confidential-information", "Handling of Confidential Information"]], "title": "Quality Technical Agreement", "id": "quality-technical-agreement", "related": [["quality-agreement", "Quality Agreement", "Quality Agreement"], ["technical-specifications", "Technical Specifications", "Technical Specifications"], ["statement-of-work", "Statement of Work", "Statement of Work"], ["quality-of-work", "Quality of Work", "Quality of Work"], ["packing-specifications", "Packing Specifications", "Packing Specifications"]], "related_snippets": [], "updated": "2025-07-07T12:36:17+00:00", "also_ask": ["What are the essential quality metrics and audit rights that must be included for enforceability?", "How can liability for non-conformance be strategically allocated or limited?", "What are the most common negotiation pitfalls or leverage points in Quality Technical Agreements?", "How do courts typically interpret ambiguous quality standards in these agreements?", "How do Quality Technical Agreements differ across key jurisdictions or industries?"], "drafting_tip": "Specify quality standards, allocate responsibilities, and outline audit rights to ensure clear expectations, accountability, and enforceability.", "explanation": "A quality-technical agreement is a contractual provision that outlines the specific quality standards and technical requirements that products or services must meet between two parties, often in manufacturing or supply arrangements. This clause typically details the responsibilities of each party regarding quality control, testing procedures, documentation, and compliance with regulatory standards. By clearly defining these expectations, the clause helps prevent disputes over product quality, ensures consistent performance, and allocates responsibility for addressing any technical or quality-related issues that may arise during the course of the agreement."}, "json": true, "cursor": ""}}