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.

  • 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 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.

  • 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.

  • 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.

  • It is agreed that Lonza shall manufacture [*] Engineering Batches at the Visp Facility prior to the commencement of Process Validation Batches, or such fewer number as shall be agreed by the Parties.

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

  • The Parties shall separately agree, acting reasonably, to a Scope of Work for the start-up of the Facility, to cover Technology Transfer, Process Qualification, Confirmatory Batches and Process Validation Batches.

  • Pilot Batches and/or Engineering Batches and/or Process Validation Batches shall not form part of the Minimum Order, unless the Parties agree otherwise.

Related to Process Validation Batches

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Manufacturing Process means any process for—

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.

  • Process Wastewater means any water which, during manufacturing or processing, comes into direct contact with or results from the production or use of any raw material, intermediate product, finished product, by-product, or waste product.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • labelling means any words, particulars, trade marks, brand name, pictorial matter or symbol relating to a food and placed on any packaging, document, notice, label, ring or collar accompanying or referring to such food;

  • Product Specifications means those product, labeling and performance specifications for the Product filed with and approved by the relevant Regulatory Authority, including Product formulae, labeling, and materials required for the manufacture of the Product that is to be purchased and supplied under this Agreement, as such are set forth on Schedule 1.25, which specifications may be amended by the Parties from time to time in accordance with this Agreement.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Batch Record means the production record pertaining to a Batch.