Changes to Master Batch Records and Product Specifications Sample Clauses

Changes to Master Batch Records and Product Specifications. ▇▇▇▇▇▇ agrees to inform CLIENT within fifteen (15) days of the result of any regulatory development or changes to Drug Product-specific SOPs that materially affect the Production of Drug Product. ▇▇▇▇▇▇ shall notify CLIENT of and receive written approval from CLIENT for changes to Master Batch Records and Drug Product Specifications prior to the Production of subsequent Batches of Drug Product.
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Changes to Master Batch Records and Product Specifications. A▇▇▇▇▇ agrees to inform CLIENT within fifteen (15) days of the result of any regulatory development or regulatory changes to Company Plasmid DNA-specific SOPs that materially affect the Production of Company Plasmid DNA. A▇▇▇▇▇ shall notify CLIENT of and require written approval from CLIENT for changes to Master Batch Records and Company Plasmid DNA Specifications prior to the Production of subsequent Batches of Company Plasmid DNA.
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Changes to Master Batch Records and Product Specifications. ▇▇▇▇▇▇ shall notify AMYLIN of and require written approval from AMYLIN for changes to Master Batch Records and Product Specifications prior to the Production of subsequent Batches of Product.
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Changes to Master Batch Records and Product Specifications. ▇▇▇▇▇▇ agrees to inform Altus within 15 days of the result of any regulatory development or changes that ▇▇▇▇▇▇ believes may materially affect the Production of Drug Product. ▇▇▇▇▇▇ shall not make any changes to the Master Batch Record or the Specifications or Product Specifications without the prior written consent of Altus.
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Changes to Master Batch Records and Product Specifications. Any regulatory development or change to any SOP that affects the Manufacture of the Product shall be discussed by the Parties, and any resulting changes to Master Batch Records or Product Specifications shall be agreed in writing by the Parties prior to such change in accordance with the terms of the Collaboration and Development Plan and the terms of the Collaboration Agreement as applicable to changes to the Collaboration and Development Plan.
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Changes to Master Batch Records and Product Specifications. Catalent agrees to inform Client promptly (but in any case not later than [***] days) of the result of any regulatory development or other required changes to Product Specifications that materially affect the Production of the Product. Catalent shall notify Client of and require [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED timely written approval from Client for changes to Master Batch Records and Product Specifications prior to the Production of subsequent Batches of Product. Provided that Catalent has provided Client with at least [***] days prior written notice, failure of Client to respond in a timely manner may result in: (i) delay in the Product Availability Date; or (ii) loss of a Production slot in Catalent’s schedule; but in either case shall not relieve Client of its obligations to pay Catalent for all activities described in the applicable Project Plan, including any lost Production slot.
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Changes to Master Batch Records and Product Specifications. ▇▇▇▇▇▇▇▇ shall inform ▇▇▇▇▇▇▇ within [****] of the result of any regulatory development or changes to any Contracted Product-specific ▇▇▇▇▇▇▇▇ SOPs that may materially affect the Manufacture of such Contracted Product. In accordance with requirements in the Quality Agreement, ▇▇▇▇▇▇▇▇ shall notify ▇▇▇▇▇▇▇ of and obtain written approval from ▇▇▇▇▇▇▇ for changes to Contracted Product-specific Master Batch Records and Product Specifications prior to the Manufacture of subsequent Batches of such Contracted Product.
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Related to Changes to Master Batch Records and Product Specifications

  • Product Specifications (a) Supplier shall manufacture all Products according to the Specifications in effect as of the date of this Agreement, with such changes or additions to the Specifications of the Products related thereto as shall be requested by Buyer in accordance with this Section or as otherwise agreed in writing by the Parties. All other Products shall be manufactured with such Specifications as the Parties shall agree in writing. (b) Buyer may request changed or additional Specifications for any Product by delivering written notice thereof to Supplier not less than one hundred twenty (120) days in advance of the first Firm Order for such Product to be supplied with such changed or additional Specifications. Notwithstanding the foregoing, if additional advance time would reasonably be required in order to implement the manufacturing processes for production of a Product with any changed or additional Specifications, and to commence manufacture and delivery thereof, Supplier shall so notify Buyer, and Supplier shall not be required to commence delivery of such Product until the passage of such additional time. (c) Supplier shall be required to accommodate any change of, or additions to, the Specifications for any Product, if and only if (i) in Supplier’s good faith judgment, such changed or additional Specifications would not require Supplier to violate good manufacturing practice, (ii) the representation and warranty of Buyer deemed made pursuant to Subsection (e) below is true and correct, and (iii) Buyer agrees to reimburse Supplier for the incremental costs and expenses incurred by Supplier in accommodating the changed or additional Specifications, including the costs of acquiring any new machinery and tooling. For the avoidance of doubt, such costs and expenses shall be payable by Buyer separately from the cost of Products at such time or times as Supplier shall request. (d) Supplier shall notify Buyer in writing within thirty (30) days of its receipt of any request for changed or additional Specifications (i) whether Supplier will honor such changed or additional Specifications, (ii) if Supplier declines to honor such changed or additional Specifications, the basis therefor and (iii) if applicable, the estimated costs and expenses that Buyer will be required to reimburse Supplier in respect of the requested changes or additions, as provided in Subsection (c) above. Buyer shall notify Supplier in writing within fifteen (15) days after receiving notice of any required reimbursement whether Buyer agrees to assume such reimbursement obligation. (e) By its request for any changed or additional Specifications for any Product, Buyer shall be deemed to represent and warrant to Supplier that the manufacture and sale of the Product incorporating Buyer’s changed or additional Specifications, as a result of such incorporation, will not and could not reasonably be expected to (i) violate or conflict with any contract, agreement, arrangement or understanding to which Buyer and/or any of its Affiliates is a party, including this Agreement and any other contract, agreement, arrangement or understanding with Supplier and/or its Affiliates, (ii) infringe on any trademark, service ▇▇▇▇, copyright, patent, trade secret or other intellectual property rights of any Person, or (iii) violate any Applicable Law. Buyer shall indemnify and hold Supplier and its Affiliates harmless (including with respect to reasonable attorneys’ fees and disbursements) from any breach of this representation and warranty.

  • Technical Specifications The purpose of the Technical Specifications (TS), is to define the technical characteristics of the Goods and Related Services required by the Procuring Entity. The Procuring Entity shall prepare the detailed TS consider that:

  • Changes to Specifications All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.

  • Packing Specifications 7.3.1 A pack will contain a minimum of one message record or a maximum of 99,999 message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of 99 packs and a minimum of one pack.

  • ODUF Packing Specifications 6.3.1 A pack will contain a minimum of one message record or a maximum of 99,999 message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of 99 packs and a minimum of one pack.