Process Validation Batches definition

Process Validation Batches. Gilead will provide Eyetech with at least 3 batches (anticipated) of Product of each strength (i.e. 0.3 mg, 1 mg or 3mg of Macugen) that Eyetech has plans to commercialize, for purposes of process validation ("Process Validation Batches"). Each Process Validation Batch will consist of approximately [**] units of Product. Each Product in a Process Validation Batch will consist of 0.3 mg, 1 mg or 3mg of Macugen as requested by Eyetech. Eyetech will pay Gilead batch charges at $[**] (i.e., $102,000.00 per single shift of aseptic filling) plus an additional filling labor charge of $[**] for each unit of Product (i.e., $[**] per single dose unit), as invoiced by Gilead. For Validation Batches packaged by Gilead, Eyetech will pay Gilead an additional packaging charge of $[**] for each unit of Product (i.e., $[**] per single dose unit), as invoiced by Gilead. Also for Validation Batches packaged by Gilead, Gilead will charge for additional support services/handling requirements/materials purchasing as it relates to all aspects (except the packaging labor charge identified above) of primary (i.e., the pouch/bag/tray directly containing the filled syringe) and of secondary (i.e., product shelf cartoning) labeling and packaging materials, on a cost plus [**]% basis. For process Validation Batches tested by Gilead, Eyetech will pay an additional testing charge of $[**] per lot. This price will be adjusted for increases due to changes to the Specifications or changes to the Product Supplement provided to Gilead after the Effective Date. Gilead will deliver entire Process Validation Batches of the Product, bulk packaged only, CPT to the finished packaging site designated by Eyetech (Incoterms 2000) and will deliver partial Process Validation Batches of the Product FCA Gilead's San Dimas facility (Incoterms 2000). Gilead will provide for storage up to 90 days following completion of production (i.e. the Batch is packaged and ready for shipment to Eyetech), with a provision for longer storage as follows: Days over 90 days: [**] [**] Room Temperature Storage per pallet/day $[**] $[**] Refrigerated Storage per pallet/day $[**] $[**]
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Process Validation Batches means vials produced for the purposes of validating the processing parameters for Production of Product produced pursuant to the Drug Product Development Agreement dated November 7, 2003. The parties agree that the Product Produced in the Process Validation Batches may be sold commercially provided regulatory approval is obtained which allows commercial sale of such Process Validation Batches and that all the terms of this Agreement, except Article 7, shall apply to the Product Produced in the Process Validation Batches.
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Process Validation Batches means the anticipated process validation batches of the Licensed Product to be completed by Forma, all of which are described on Schedule 1.98.
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Examples of Process Validation Batches in a sentence

  • Lonza shall manufacture and deliver Process Validation Batches as mutually agreed by Parties sufficient to document the operability and reproducibility of the Manufacturing Process and permit the Parties to complete and file the necessary regulatory documents.

  • All such regulatory support activities are excluded from the Price of Process Validation Batches, shall be approved by the Customer in advance, and shall be paid for by the Customer at the Price set out in the applicable Project Plan.

  • All process validation activities are excluded from the Price of Process Validation Batches shall be approved by the Customer in advance and shall be paid for by the Customer at the Price set out in the applicable Project Plan.

  • All process validation activities are excluded from the Price of Process Validation Batches shall be approved by Forty Seven in advance and shall be paid for by Forty Seven at the Price set out in the applicable Project Plan.

  • Prior to commencement of Process Validation Batches, SBL and Client shall agree to a validation plan identifying the validation requirements of the Manufacturing Process.

  • The cost of all such regulatory support activities are excluded from the Price of Process Validation Batches, shall be approved by Forty Seven in advance, and shall be paid for by Forty Seven at the Price set out in the applicable Project Plan.

  • All such regulatory support activities are excluded from the price of Process Validation Batches, shall be approved by the Client in advance, and shall be paid for by the Client at the price set out in the applicable PSA.

  • Each invoice issued by Gilead hereunder shall specify, at a minimum, the Price in respect of the Product delivered, or, for Registration Batches and Process Validation Batches, the applicable charges; and the quantity of the Product delivered.

  • Customer may request Lonza to manufacture and deliver Process Validation Batches as mutually agreed by Parties sufficient to document the operability and reproducibility of the Manufacturing Process and permit the Parties to complete and file the necessary regulatory documents.

  • Any such future Process Validation or Process Validation Batches shall be approved by the Customer in advance and shall be paid for by the Customer at a Price to be determined in a separate Project Plan.