cGMP Batches definition

cGMP Batches means any Batches which are required under the Project Plan to be manufactured in accordance with cGMP.
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cGMP Batches means any Batches which are required under the applicable Binding Order to be manufactured in accordance with cGMP.
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cGMP Batches means any Batches which are to be manufactured in accordance with cGMP, which is every Batch unless the Parties mutually agree otherwise.
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Examples of cGMP Batches in a sentence

  • Lonza will, in accordance with the terms of this Agreement and Quality Agreement, manufacture at the Facility and Release to Customer, cGMP Batches that comply with the Manufacturing Process, cGMP and the Specifications, together with a Certificate of Analysis; provided, however, that cGMP manufacture shall not commence until at least [***] has been manufactured in compliance with cGMP and Specifications.

  • Lonza will, in accordance with the terms of this Agreement and Quality Agreement, manufacture at the Facility and Release to Customer, cGMP Batches that comply with the Manufacturing Process, cGMP and the Specifications, together with a Certificate of Analysis; provided, however, that cGMP manufacture shall not commence until at least [***] has been manufactured in compliance with the Specifications.

  • If an Alternate Product is introduced, the number of cGMP Batches to be manufactured within the Assigned Capacity in each year may be revised as agreed in writing by the Parties.

  • NOVASEP will, on agreement of, and in accordance with, a Work Plan, reserve slots in its cGMP manufacturing suite for those cGMP Batches to be manufactured under the relevant Work Plan according to the time frame in that Work Plan.

  • The Parties will use good faith efforts to negotiate and execute the Quality Agreement for Development Services no later than * days after the Effective Date, but in any event prior to commencement of Manufacturing of any cGMP Batches, and the Quality Agreement for Manufacturing Services no later than * days after a Commercial Supply Election.

  • In addition to Clause 8.1, pricing for the Services (other than the manufacture of Batches within the Assigned Capacity, Engineering Batches and Additional cGMP Batches) provided by Lonza are set out in, and based on the assumptions and information set out in, the applicable Project Plan.

  • With respect to the cGMP Batches of Product manufactured, it is agreed that Lonza shall manufacture the cGMP Batches of Product to meet the Specification provided that there shall be no obligation (other than to use commercially reasonable efforts) to meet the Specification in respect of the first [*] cGMP Batches of Product manufactured, or in respect of the first [*] cGMP Batches of Product manufactured following any change in the process for such Product agreed to or requested by Forty Seven.

  • Lonza will, in accordance with the terms of this Agreement and Quality Agreement, manufacture at the Facility and Release to Customer, cGMP Batches that comply with the Manufacturing Process, cGMP and the Specifications, together with a Certificate of Analysis.

  • Lonza shall manufacture [*] cGMP Batches per year during the Assigned Capacity.

  • The manufacture of cGMP Batches or activities requiring the use of a cGMP Facility: CUSTOMER may delay or request the reschedule of any slot reservation for the manufacture of any cGMP Product or cGMP Batch, or any activities which require the use of a cGMP Facility (the “Rescheduled Activity” and the “Reschedule Notice”) at any time upon prior written notice to NOVASEP.


More Definitions of cGMP Batches

cGMP Batches means any Batches which are required under the Project Plan to be manufactured in accordance with cGMP. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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cGMP Batches means any Batches which are required under the Project Plan to be manufactured in accordance with cGMP. “Commencement Date” means the date of removal of the vial of cells from frozen storage for the production of a Batch. “Confidential Information” means Customer Information and/or Lonza Information, as the context requires.
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cGMP Batches means any Batches which are required under a purchase order that are to be manufactured in accordance with cGMP. “Change Order” means document mutually approved in writing by both Parties in accordance with the procedures set forth in Clause
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Related to cGMP 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.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • API means the American Petroleum Institute.

  • 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.

  • Master Batch Record means the document that defines the manufacturing methods, materials, and other procedures, directions and controls associated with the manufacture and testing of the Product, which may be amended in writing from time to time by mutual agreement of the parties.