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The Manufacturing Fee does not include, without limitation, any research & development support, package engineering studies, validation support, FDA audit support, extensive reporting requirements, or additional laboratory testing performed by an outside testing laboratory or testing beyond that required in the Specifications, warehousing or distribution of Product, any materials costs or costs associated with establishing or manufacturing new materials such as art charges, die costs, plate costs, or packaging equipment change parts. 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The Manufacturing Fee is quoted in single final Product Unit increments (i.e., by the can, bottle, or tube), and will be set for each Product and for each size or formulation. . The Manufacturing Fee shall include services for incoming inspection of materials (including costs associated with establishing, testing and storing Raw Materials or Components), compounding of bulk, packaging Product, testing Product for release, making Product ready for shipment, and minimum product documentation (one copy of Certificate of Analysis, batch records).", "snippet_links": [{"key": "fee-paid", "type": "clause", "offset": [10, 18]}, {"key": "by-connetics", "type": "clause", "offset": [19, 31]}, {"key": "services-required", "type": "clause", "offset": [43, 60]}, {"key": "to-manufacture", "type": "definition", "offset": [61, 75]}, {"key": "product-unit", "type": "definition", "offset": [146, 158]}, {"key": "services-for", "type": "clause", "offset": [312, 324]}, {"key": "inspection-of-materials", "type": "clause", "offset": [334, 357]}, {"key": "associated-with", "type": "definition", "offset": [375, 390]}, {"key": "raw-materials", "type": "clause", "offset": [425, 438]}, {"key": "packaging-product", "type": "definition", "offset": [476, 493]}, {"key": "testing-product", "type": "definition", "offset": [495, 510]}, {"key": "product-documentation", "type": "definition", "offset": [571, 592]}, {"key": "certificate-of-analysis", "type": "definition", "offset": [606, 629]}, {"key": "batch-records", "type": "definition", "offset": [631, 644]}], "samples": [{"hash": "gvz9lD7MZX1", "uri": "/contracts/gvz9lD7MZX1#manufacturing-fee", "label": "Manufacturing Agreement (Connetics Corp)", "score": 18.0, "published": true}, {"hash": "5h6sLFhb133", "uri": "/contracts/5h6sLFhb133#manufacturing-fee", "label": "Manufacturing Agreement (Connetics Corp)", "score": 18.0, "published": true}], "size": 2, "hash": "3c325053524ffed001efa0b95f87c36c", "id": 8}, {"snippet": "means the manufacturing fee to be charged by Manufacturer for the Services to be provided to Customer hereunder in accordance with Section 3.1, as may be adjusted in accordance with Section 3.2.\u201d\nii. Section 1.42 (definition of \u201cPurchase Order\u201d) is revised as follows: the words \u201cand supply\u201d in the third line are deleted.\niii. 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The Manufacturing Fee is quoted in single final Product unit increments (i.e. by the bottle or tube.) The Manufacturing Fee shall include services for incoming inspection of raw material, compounding of bulk, packaging Product, testing Product for release, making Product ready for shipment, and minimum product documentation (five (5) copies of Certificate of Analysis.) The Manufacturing Fee does not include, without limitation, any Research & Development support, Package Engineering studies, Validation support, Warehousing or Distribution of Product, FDA audit support, extensive reporting requirements, or additional laboratory testing beyond that required in the Specifications. These services are in addition to the Manufacturing Fee and shall be billed by the hour at DPT\u2019s then-prevailing R&D hourly rate. In addition, the Manufacturing Fee does not include any material costs or costs associated with establishing or manufacturing new material such as art charges, die costs, plate costs, and packaging equipment change parts. These items are billed separately in accordance with paragraph 2.8 below.", "snippet_links": [{"key": "fee-paid", "type": "clause", "offset": [10, 18]}, {"key": "by-company", "type": "clause", "offset": [19, 29]}, {"key": "services-required", "type": "clause", "offset": [41, 58]}, {"key": "to-manufacture", "type": "definition", "offset": [59, 73]}, {"key": "product-unit", "type": "definition", "offset": [144, 156]}, {"key": "services-for", "type": "clause", "offset": [234, 246]}, {"key": "inspection-of", "type": "clause", "offset": [256, 269]}, {"key": "raw-material", "type": "clause", "offset": [270, 282]}, {"key": "packaging-product", "type": "definition", "offset": [305, 322]}, {"key": "testing-product", "type": "definition", "offset": [324, 339]}, {"key": "product-documentation", "type": "definition", "offset": [400, 421]}, {"key": "copies-of", "type": "definition", "offset": [432, 441]}, {"key": "certificate-of-analysis", "type": "definition", "offset": [442, 465]}, {"key": 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supplied materials will be billed to COMPANY on the respective invoice for Product, into which the DPT supplied materials was converted, as part of the Materials Fee, and in addition to the <strong>Manufacturing Fee</strong>, all in accordance with the provisions of paragraph 2.8 below.", "In addition, the <strong>Manufacturing Fee</strong> does not include warehousing or distribution of Product, any materials costs or costs associated with establishing or manufacturing new materials such as art charges, die costs, plate costs, and packaging equipment change parts.", "These services are in addition to the <strong>Manufacturing Fee</strong> and shall be billed by the hour at DPT\u2019s then-prevailing R&amp;D hourly rate in accordance with Section XI contained herein.", "In addition, a fifty percent (50%) <strong>Manufacturing Fee</strong> deposit will be required prior to DPT manufacturing any Product and the balance of the invoice must be paid in full prior to shipment.", "At the end 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price per Unit of Product equal to the <strong>Manufacturing Fee</strong> plus the Materials Fee."], "related": [["manufacturing-costs", "Manufacturing Costs", "Manufacturing Costs"], ["manufacturing-cost", "Manufacturing Cost", "Manufacturing Cost"], ["manufacturing-services", "Manufacturing Services", "Manufacturing Services"], ["manufacturing-facility", "Manufacturing Facility", "Manufacturing Facility"], ["manufacturing-site", "Manufacturing Site", "Manufacturing Site"]], "related_snippets": [], "updated": "2025-07-10T04:27:38+00:00"}, "json": true, "cursor": ""}}