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or (b) supports a filing for Regulatory Approval of the implementation of a subsequent process or equipment change with respect to the commercial manufacture of PRODUCT. [**] = 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.", "snippet_links": [{"key": "validation-protocol", "type": "definition", "offset": [82, 101]}, {"key": "as-agreed", "type": "clause", "offset": [102, 111]}, {"key": "in-writing", "type": "definition", "offset": [112, 122]}, {"key": "between-the-parties", "type": "clause", "offset": [123, 142]}, {"key": "according-to", "type": "definition", "offset": [165, 177]}, {"key": "in-accordance-with", "type": "clause", "offset": [218, 236]}, {"key": "good-manufacturing-practice", "type": "clause", "offset": [249, 276]}, {"key": "active-pharmaceutical-ingredients", "type": "definition", "offset": [290, 323]}, {"key": "without-limitation", "type": "clause", "offset": [357, 375]}, {"key": "manufacturing-process", "type": "definition", "offset": [501, 522]}, {"key": "filing-for-regulatory-approval", "type": "clause", "offset": [569, 599]}, {"key": "complete-the", "type": "clause", "offset": [633, 645]}, {"key": "stability-studies", "type": "clause", "offset": [677, 694]}, {"key": "in-connection-with", "type": "clause", "offset": [707, 725]}, {"key": "approval-of", "type": "clause", "offset": [814, 825]}, {"key": "equipment-change", "type": "definition", "offset": [872, 888]}, {"key": "with-respect-to", "type": "clause", "offset": [889, 904]}, {"key": "manufacture-of-product", "type": "clause", "offset": [920, 942]}, {"key": "this-exhibit", "type": "definition", "offset": [963, 975]}, {"key": "pursuant-to-a", "type": "clause", "offset": [994, 1007]}, {"key": "confidential-treatment-request", "type": "clause", "offset": [1008, 1038]}, {"key": "the-commission", "type": "clause", "offset": [1109, 1123]}], "size": 1, "hash": "9da02a8180d023c215d6c097f8224a8f", "id": 7}, {"samples": [{"hash": "fEoaF5Ixi5k", "uri": "/contracts/fEoaF5Ixi5k#validation-batch", "label": "Development and Manufacturing Agreement (Immucell Corp /De/)", "score": 21.6214923859, "published": true}], "snippet": "has the meaning set forth in Schedule 2, Stage 8. \u201cCommercialBatch\u201d xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx \u201cCommercial Campaign\u201d xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx", "snippet_links": [{"key": "schedule-2", "type": "clause", "offset": [29, 39]}, {"key": "stage-8", "type": "definition", "offset": [41, 48]}], "size": 1, "hash": "ae86018b19d32288474d19129a31f426", "id": 8}, {"samples": [{"hash": "k3ZvTATeGoE", "uri": "/contracts/k3ZvTATeGoE#validation-batch", "label": "Commercial Manufacturing Agreement (Viropharma Inc)", "score": 18.0, "published": true}], "snippet": "means a batch of approximately 580 kg of API, but in no event less than 450 kg of API, produced pursuant to Section 3.8 and the Validation Protocol.", "snippet_links": [{"key": "in-no-event", "type": "clause", "offset": [50, 61]}, {"key": "section-38", "type": "clause", "offset": [108, 119]}, {"key": "validation-protocol", "type": "definition", "offset": [128, 147]}], "size": 1, "hash": "fb579eb9df6b2f0bf35a384c78d32e71", "id": 9}, {"samples": [{"hash": "2QZAD1UQrHS", "uri": "/contracts/2QZAD1UQrHS#validation-batch", "label": "Supply Agreement", "score": 20.3408622742, "published": false}], "snippet": "means a batch of Product, data from which is used to demonstrate the efficacy of the manufacturing process, the reproducibility of Product quality, Product stability, and other parameters which may be required by regulatory authorities in order to grant approval of the manufacturing process and Product quality. \"Writing\" and \"Written\" mean transmission of information by means of black or blue ink applied by hand or machine to paper by the sender and signed and dated by the sender. The definition expressly excludes information sent by facsimile or electronic mail (e-mail) by means of the internet unless otherwise authorised by the Parties. \"Year\" means the period of 12 (twelve) months from the date of this Agreement and each subsequent consecutive period of 12 (twelve) months during the period of this Agreement.", "snippet_links": [{"key": "manufacturing-process", "type": "definition", "offset": [85, 106]}, {"key": "product-quality", "type": "definition", "offset": [131, 146]}, {"key": "other-parameters", "type": "clause", "offset": [171, 187]}, {"key": "by-regulatory-authorities", "type": "clause", "offset": [210, 235]}, {"key": "in-order-to", "type": "clause", "offset": [236, 247]}, {"key": "approval-of", "type": "clause", "offset": [254, 265]}, {"key": "process-and-product", "type": "clause", "offset": [284, 303]}, {"key": "transmission-of-information", "type": "clause", "offset": [342, 369]}, {"key": "by-hand", "type": "definition", "offset": [408, 415]}, 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#3, or 20 days from date requested by RADIUS Activity 9: Validation Stability Stability study to start within one month of batch purification and continue according to protocol Activity 10: DMF Filing Within 40 working days of date requested by RADIUS, but not earlier than 3.5 months after the end of the Validation Campaign.", "ACP will complete <strong>Validation Batch</strong> #1, <strong>Validation Batch</strong> #2 and <strong>Validation Batch</strong> #3 for one indication as described in Exhibit A to the Master Service Agreement entered into by parties as of January 28, 2015 as of the Effective Date.", "The foregoing remedy shall be Indivior&#x27;s sole and exclusive remedy for any failure of a <strong>Validation Batch</strong> to conform to the Manufacturing Standards.", "In the event that Anthra determines that any <strong>Validation Batch</strong> does not conform to the Specifications or the CMC, Anthra shall give Sicor notice of its rejection thereof (including a sample from the batch analyzed) within forty-five (45) days after receipt of such <strong>Validation Batch</strong>.", "For each <strong>Validation Batch</strong> and upon request for Production Batches of the Drug manufactured for ORPHAN hereunder, Supplier shall furnish to ORPHAN at the time of its delivery copies of the following records.", "Nisso shall provide to Replidyne (i) written notice of its release of the relevant <strong>Validation Batch</strong>, (ii) a certificate of analysis for such <strong>Validation Batch</strong>, (iii) the results of all relevant testing data for such <strong>Validation Batch</strong>, and (iv) samples of such <strong>Validation Batch</strong> for Replidyne\u2019s independent testing, which shall be reasonably satisfactory to Replidyne and Replidyne shall pay Nisso the reasonable shipping cost of such samples separately.", "PYRAMID will produce a <strong>Validation Batch</strong> only upon the written request of Client submitted in a Purchase Order.", "In the event that Anthra shall give Sicor such notice, then Anthra shall make payment for such <strong>Validation Batch</strong> within thirty days after receipt by Anthra of notice, if any, from the Testing Laboratory that the <strong>Validation Batch</strong> is conforming.", "Each <strong>Validation Batch</strong> shall be shipped for final formulation to a facility in the United States to be mutually agreed by Anthra and Vinchem.", "Supplier and ORPHAN will jointly review all process development and analytical test results, the Validation Protocol, and stability study results prior to manufacture of each <strong>Validation Batch</strong>."], "related": [["batch", "Batch", "Batch"], ["validation", "Validation", "Validation"], ["drug-substance", "Drug Substance", "Drug Substance"], ["open-type-traction-battery", "Open type traction battery", "Open type traction battery"], ["bulk-drug-substance", "Bulk drug substance", "Bulk drug substance"]], "related_snippets": [], "updated": 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