{"component": "clause", "props": {"groups": [{"size": 7, "snippet": "Manufacturer will take and retain, for such period and in such quantities as may be required by cGMP (if applicable) and the applicable Quality Agreement, samples of Product from the Manufacturing Process produced under this Agreement. Further, Manufacturer will submit such samples to RADIUS, upon RADIUS\u2019 written request.", "samples": [{"hash": "cJqIZhUDlPw", "uri": "/contracts/cJqIZhUDlPw#sample-retention", "label": "Development and Manufacturing Services Agreement (Radius Health, Inc.)", "score": 26.1854896545, "published": true}, {"hash": "isdyzHXMEmm", "uri": "/contracts/isdyzHXMEmm#sample-retention", "label": "Development and Manufacturing Services Agreement (Radius Health, Inc.)", "score": 22.8097190857, "published": true}, {"hash": "fteTObpwZ9H", "uri": "/contracts/fteTObpwZ9H#sample-retention", "label": "Development and Manufacturing Services Agreement (Radius Health, Inc.)", "score": 22.7440109253, "published": true}], "snippet_links": [{"key": "required-by", "type": "definition", "offset": [84, 95]}, {"key": "if-applicable", "type": "definition", "offset": [102, 115]}, {"key": "the-applicable", "type": "clause", "offset": [121, 135]}, {"key": "quality-agreement", "type": "definition", "offset": [136, 153]}, {"key": "manufacturing-process", "type": "definition", "offset": [183, 204]}, {"key": "this-agreement", "type": "clause", "offset": [220, 234]}, {"key": "written-request", "type": "clause", "offset": [307, 322]}], "hash": "9eefdec9d4555537b1c4b3e5149b011a", "id": 1}, {"size": 6, "snippet": "Seller, on behalf of both Buyer and Seller, shall retain representative samples and associated documentation from each lot of finished Product and manufacturer\u2019s corresponding lot of key ingredients used in the Manufacture of Products for the period required by the applicable FDA regulations and the Act.", "samples": [{"hash": "j0Xs9os43FO", "uri": "/contracts/j0Xs9os43FO#sample-retention", "label": "Manufacturing Agreement", "score": 31.3408622742, "published": true}, {"hash": "gdFjTqm2v1J", "uri": "/contracts/gdFjTqm2v1J#sample-retention", "label": "Manufacturing Agreement (Reliant Pharmaceuticals, Inc.)", "score": 21.0, "published": true}, {"hash": "dKDT4yR6UW", "uri": "/contracts/dKDT4yR6UW#sample-retention", "label": "Manufacturing Agreement (Reliant Pharmaceuticals, Inc.)", "score": 21.0, "published": true}], "snippet_links": [{"key": "on-behalf-of", "type": "definition", "offset": [8, 20]}, {"key": "buyer-and-seller", "type": "clause", "offset": [26, 42]}, {"key": "representative-samples", "type": "definition", "offset": [57, 79]}, {"key": "associated-documentation", "type": "definition", "offset": [84, 108]}, {"key": "finished-product", "type": "definition", "offset": [126, 142]}, {"key": "manufacture-of-products", "type": "clause", "offset": [211, 234]}, {"key": "the-period", "type": "clause", "offset": [239, 249]}, {"key": "required-by", "type": "definition", "offset": [250, 261]}, {"key": "the-applicable", "type": "clause", "offset": [262, 276]}, {"key": "fda-regulations", "type": "definition", "offset": [277, 292]}, {"key": "the-act", "type": "clause", "offset": [297, 304]}], "hash": "dc1f258fc11ce243c16690e0912697b5", "id": 2}, {"size": 2, "snippet": "24.1 Subject to Section 24.2 and any provisions in Exhibit A, all Samples associated with the Services shall be retained, returned to the Sponsor or disposed of (including destruction) in accordance with the Work Order, Protocol/Scientific Plan or the Sponsor\u2019s reasonable written instructions and applicable Regulatory Requirements. Where no provision is made in the Work Order or Protocol/Scientific Plan, the Sponsor shall be contacted to determine whether the Samples should be destroyed, returned to the Sponsor or retained by Covance subject to agreement of the Parties on the time period and fees payable for retention.\n24.2 Regulatory samples obtained from drug substance or drug product shall be retained and disposed of in accordance with the Protocol/Scientific Plan. Samples obtained from clinical trials and HBS shall be retained and disposed of in accordance with the provisions of Section 25 of this Agreement.", "samples": [{"hash": "knJKhYnG8cR", "uri": "/contracts/knJKhYnG8cR#sample-retention", "label": "Master Services Agreement (Galectin Therapeutics Inc)", "score": 30.2067070007, "published": true}, {"hash": "dLHRKbI24bi", "uri": "/contracts/dLHRKbI24bi#sample-retention", "label": "Master Services Agreement (Immunomedics Inc)", "score": 27.8548946381, "published": true}], "snippet_links": [{"key": "section-242", "type": "clause", "offset": [16, 28]}, {"key": "exhibit-a", "type": "definition", "offset": [51, 60]}, {"key": "associated-with", "type": "definition", "offset": [74, 89]}, {"key": "the-services", "type": "clause", "offset": [90, 102]}, {"key": "the-sponsor", "type": "clause", "offset": [134, 145]}, {"key": "disposed-of", "type": "definition", "offset": [149, 160]}, {"key": "in-accordance-with", "type": "clause", "offset": [185, 203]}, {"key": "the-work-order", "type": "definition", "offset": [204, 218]}, {"key": "written-instructions", "type": "clause", "offset": [273, 293]}, {"key": "applicable-regulatory-requirements", "type": "definition", "offset": [298, 332]}, {"key": "no-provision", "type": "clause", "offset": [340, 352]}, {"key": "in-the-work", "type": "clause", "offset": [361, 372]}, {"key": "determine-whether", "type": "clause", "offset": [442, 459]}, {"key": "agreement-of-the-parties", "type": "clause", "offset": [551, 575]}, {"key": "time-period", "type": "definition", "offset": [583, 594]}, {"key": "fees-payable", "type": "definition", "offset": [599, 611]}, {"key": "drug-substance", "type": "definition", "offset": [665, 679]}, {"key": "drug-product", "type": "definition", "offset": [683, 695]}, {"key": "the-protocol", "type": "clause", "offset": [749, 761]}, {"key": "clinical-trials", "type": "definition", "offset": [801, 816]}, {"key": "section-25", "type": "clause", "offset": [896, 906]}, {"key": "this-agreement", "type": "clause", "offset": [910, 924]}], "hash": "71a130bff8af5a934b74c31c9c9c0a80", "id": 8}, {"size": 4, "snippet": "Manufacturer on behalf of both Company and Manufacturer shall retain representative samples and associated documentation from each lot of finished Product and Packaged Tablets for period required by applicable Regulatory Requirements and applicable Law.", "samples": [{"hash": "lHaVXYjfJIu", "uri": "/contracts/lHaVXYjfJIu#sample-retention", "label": "Supply & Packaging Agreement (Reliant Pharmaceuticals, Inc.)", "score": 21.0, "published": true}, {"hash": "9KhfroQSjMV", "uri": "/contracts/9KhfroQSjMV#sample-retention", "label": "Supply & Packaging Agreement (Reliant Pharmaceuticals, Inc.)", "score": 21.0, "published": true}, {"hash": "2vEc5MULpz", "uri": "/contracts/2vEc5MULpz#sample-retention", "label": "Supply & Packaging Agreement (Reliant Pharmaceuticals, Inc.)", "score": 21.0, "published": true}], "snippet_links": [{"key": "on-behalf-of", "type": "definition", "offset": [13, 25]}, {"key": "representative-samples", "type": "definition", "offset": [69, 91]}, {"key": "associated-documentation", "type": "definition", "offset": [96, 120]}, {"key": "finished-product", "type": "definition", "offset": [138, 154]}, {"key": "packaged-tablets", "type": "definition", "offset": [159, 175]}, {"key": "required-by", "type": "definition", "offset": [187, 198]}, {"key": "applicable-regulatory-requirements", "type": "definition", "offset": [199, 233]}, {"key": "applicable-law", "type": "definition", "offset": [238, 252]}], "hash": "f7c7e1418123ca546c86bada0029c9c4", "id": 4}, {"size": 3, "snippet": "Manufacturer will take and retain under suitable storage conditions, for such period and in such quantities as may be required by cGMP (if applicable) and the applicable Quality Agreement, samples of Product from the Manufacturing Process produced under this Agreement. Further, Manufacturer will submit such samples to Anterios, upon Anterios\u2019 written request. In any event, Manufacturer will retain samples for at least [*] following completion of Services under a Work Order, with the exception of bioanalytical samples which will be retained for at least [*] following analysis.", "samples": [{"hash": "gfCeEYAmxVo", "uri": "/contracts/gfCeEYAmxVo#sample-retention", "label": "Development and Manufacturing Services Agreement (Anterios Inc)", "score": 26.3169059753, "published": true}, {"hash": "9Y9YYQ3oh3Z", "uri": "/contracts/9Y9YYQ3oh3Z#sample-retention", "label": "Development and Manufacturing Services Agreement (Anterios Inc)", "score": 26.2429847717, "published": true}, {"hash": "99lLLut51zl", "uri": "/contracts/99lLLut51zl#sample-retention", "label": "Development and Manufacturing Services Agreement (Anterios Inc)", "score": 26.1143054962, "published": true}], "snippet_links": [{"key": "storage-conditions", "type": "clause", "offset": [49, 67]}, {"key": "required-by", "type": "definition", "offset": [118, 129]}, {"key": "if-applicable", "type": "definition", "offset": [136, 149]}, {"key": "the-applicable", "type": "clause", "offset": [155, 169]}, {"key": "quality-agreement", "type": "definition", "offset": [170, 187]}, {"key": "manufacturing-process", "type": "definition", "offset": [217, 238]}, {"key": "this-agreement", "type": "clause", "offset": [254, 268]}, {"key": "written-request", "type": "clause", "offset": [345, 360]}, {"key": "retain-samples", "type": "clause", "offset": [394, 408]}, {"key": "completion-of-services", "type": "definition", "offset": [436, 458]}, {"key": "work-order", "type": "definition", "offset": [467, 477]}, {"key": "with-the-exception-of", "type": "clause", "offset": [479, 500]}], "hash": "9c17c226365ec991662f8853445e21e6", "id": 5}, {"size": 2, "snippet": "Unless the parties agree otherwise in writing, PROVIDER will maintain raw material, clinical supply and analytical samples in storage for a time period based upon sample retention policy, or such longer period of time as CUSTOMER may reasonably request or any Regulatory Authority may request or require.", "samples": [{"hash": "emxtTl5hDha", "uri": "/contracts/emxtTl5hDha#sample-retention", "label": "Tech Transfer, Manufacturing and Supply Agreement (RedHill Biopharma Ltd.)", "score": 23.9212875366, "published": true}, {"hash": "9wyiRd0Hoh3", "uri": "/contracts/9wyiRd0Hoh3#sample-retention", "label": "Tech Transfer, Manufacturing and Supply Agreement (RedHill Biopharma Ltd.)", "score": 23.8172492981, "published": true}], "snippet_links": [{"key": "the-parties-agree", "type": "clause", "offset": [7, 24]}, {"key": "in-writing", "type": "definition", "offset": [35, 45]}, {"key": "raw-material", "type": "definition", "offset": [70, 82]}, {"key": "clinical-supply", "type": "clause", "offset": [84, 99]}, {"key": "time-period", "type": "definition", "offset": [140, 151]}, {"key": "retention-policy", "type": "definition", "offset": [170, 186]}, {"key": "period-of-time", "type": "clause", "offset": [203, 217]}, {"key": "customer-may", "type": "clause", "offset": [221, 233]}, {"key": "reasonably-request", "type": "definition", "offset": [234, 252]}, {"key": "regulatory-authority", "type": "definition", "offset": [260, 280]}], "hash": "3e74f6cfe2ff570829ce90a89a3c5c8e", "id": 10}, {"size": 2, "snippet": "Manufacturer will take and retain, (i) for such period and in such quantities as may be required by cGMP (or other applicable Authority), and (ii) for such additional period and in such additional quantities as may be required by the applicable Quality Agreement, samples of Product from the Manufacturing Process produced under this Agreement. Further, upon Rhythm\u2019s written request, Manufacturer will submit such samples to Rhythm, except to the extent that Manufacturer is required by applicable cGMP to retain possession of any such samples pursuant to the preceding clause (i).", "samples": [{"hash": "jpaebLV5Qpd", "uri": "/contracts/jpaebLV5Qpd#sample-retention", "label": "Development and Manufacturing Services Agreement (Rhythm Pharmaceuticals, Inc.)", "score": 28.6769332886, "published": true}, {"hash": "7gTNbz0HOmp", "uri": "/contracts/7gTNbz0HOmp#sample-retention", "label": "Development and Manufacturing Services Agreement (Rhythm Pharmaceuticals, Inc.)", "score": 28.6413421631, "published": true}], "snippet_links": [{"key": "required-by", "type": "definition", "offset": [88, 99]}, {"key": "applicable-authority", "type": "definition", "offset": [115, 135]}, {"key": "additional-period", "type": "definition", "offset": [156, 173]}, {"key": "additional-quantities", "type": "definition", "offset": [186, 207]}, {"key": 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"/contracts/kbMPZz1uQsg#sample-retention", "label": "License and Supply Agreement", "score": 31.3408622742, "published": true}, {"hash": "jaNfwlTU7wO", "uri": "/contracts/jaNfwlTU7wO#sample-retention", "label": "License & Supply Agreement (Reliant Pharmaceuticals, Inc.)", "score": 21.0, "published": true}, {"hash": "hOnPUBhZDTA", "uri": "/contracts/hOnPUBhZDTA#sample-retention", "label": "License & Supply Agreement (Reliant Pharmaceuticals, Inc.)", "score": 21.0, "published": true}], "snippet_links": [{"key": "of-both-parties", "type": "clause", "offset": [19, 34]}, {"key": "representative-samples", "type": "definition", "offset": [49, 71]}, {"key": "associated-documentation", "type": "definition", "offset": [76, 100]}, {"key": "manufacture-of-api", "type": "clause", "offset": [199, 217]}, {"key": "the-period", "type": "clause", "offset": [222, 232]}, {"key": "required-by", "type": "definition", "offset": [233, 244]}, {"key": "the-act", "type": "clause", "offset": [274, 281]}], "hash": 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"Development and Manufacture of Product"], ["record-and-sample-retention", "Record and Sample Retention"], ["supply-of-api-for-the-product-and-additional-products", "Supply of Api for the Product and Additional Products"], ["replacement-of-nonconforming-shipment", "Replacement of Nonconforming Shipment"], ["manufacture-of-product", "Manufacture of Product"]], "children": [["taxes", "Taxes"], ["testing-by-sanofi", "Testing by Sanofi"], ["disputes", "Disputes"], ["myokardia-payment-and-sanofi-invoices", "MyoKardia Payment and Sanofi Invoices"], ["batch-documentation", "Batch Documentation"]], "id": "sample-retention", "related": [["record-and-file-retention", "Record and File Retention", "Record and File Retention"], ["retainage", "Retainage", "Retainage"], ["final-retention", "Final Retention", "Final Retention"], ["records-retention", "Records Retention", "Records Retention"], ["document-retention", "Document Retention", "Document Retention"]], "related_snippets": [], "updated": "2025-07-17T04:25:46+00:00", "also_ask": ["What are the minimum and maximum retention periods that should be negotiated for different sample types?", "How can the clause address ownership and destruction rights over retained samples?", "What are the key risks if the clause lacks clear chain-of-custody or access provisions?", "How does this clause compare to industry standards or regulatory requirements for sample retention?", "What factors most influence a court\u2019s decision to enforce or invalidate a sample retention clause?"], "drafting_tip": "Specify retention period and storage conditions to ensure compliance; define disposal procedures to prevent liability; identify responsible parties to clarify obligations.", "explanation": "The Sample Retention clause outlines the requirements for keeping physical or digital samples related to a contract, such as product specimens, test materials, or prototypes, for a specified period. Typically, it details who is responsible for storing the samples, the duration of retention, and the conditions under which the samples may be accessed, tested, or disposed of. This clause ensures that relevant samples are available for future reference, quality control, or dispute resolution, thereby providing a clear process for handling materials that may be critical to verifying compliance or resolving disagreements."}, "json": true, "cursor": ""}}