GMP Product definition

GMP Product means the Product from or in the GMP Batch.

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GMP Product means Product that is intended for use for clinical applications as opposed to non-clinical research and development purposes.

GMP Product means [***].

Examples of GMP Product in a sentence

• If Alder requests delivery of the Non-Conforming GMP Product, and the parties agree on an equitable price for the Non-Conforming GMP Product (which shall be negotiated in good faith by the parties), then, unless prohibited by applicable Legal Requirements, Fujifilm shall deliver such Non-Conforming GMP Product in accordance with Section 12(a) and Alder shall pay to Fujifilm the agreed price.

• Fujifilm shall manufacture GMP Product in compliance with the Process Specification, cGMP and all other applicable Legal Requirements.

• The Parties agree to work in good faith to implement any changes to the manufacture of GMP Product that may be necessary to support Regulatory Approval.

• All GMP Product shall be manufactured in accordance with GMP and conform to Product Specifications on the Warranty Date.

• Lubrizol is not permitted to make any Significant Change that affects the GMP Product without notifying Braeburn, except as may be authorized in a separate Quality Agreement among the Parties.

• The Parties intend for the GMP Product to be used by Braeburn, or an IDDS Commercial Partner, as an Excipient in an IDDS Product that contains one or more other components as API, and, accordingly, that Lubrizol shall only be required to meet Regulatory Authority manufacturing requirements applicable to Excipients.

• Fujifilm warrants (as of the time of delivery), and covenants, as applicable, that each GMP Batch and all GMP Product: [***].

• During the Term, Lubrizol shall maintain commercial general insurance or a program of self-insurance adequate to cover any Claims or Losses arising in connection with the manufacture or sale of GMP Product and until the date of delivery to Braeburn in coverage amounts consistent with normal business practices of prudent companies similarly situated.

• Braeburn shall have the right, at Braeburn’s expense and upon [***] days’ notice, to audit Lubrizol’s Manufacturing Facility and any other facilities that are used to manufacture and store the GMP Product or to maintain Backup Supply or Backup Resin, including to ensure GMP compliance.

• Lubrizol agrees to manufacture GMP Product at its Manufacturing Facility according to current good manufacturing practices [***], or, if such guide is updated in a subsequent published version, the most recent version (“GMP”).

More Definitions of GMP Product

GMP Product means a Licensed Product that (a) is a eukaryotic cell or eukaryotic cell line, the genome or genetic composition of which has been modified through the use (whether directly or indirectly) of a ZFP Product in a manner that (i) facilitates or improves the ability of such cell or cell line to produce a Therapeutic Product or (ii) modifies the molecular characteristics of such Therapeutic Product and (b) is not a Plant Product.”

GMP Product means a Licensed Product that (a) is a eukaryotic cell or eukaryotic cell line, the genome or genetic composition of which has been modified through the use (whether directly or indirectly) of a ZFP Product in a manner that (i) facilitates or improves the ability of such cell or cell line to produce a Therapeutic Product or (ii) modifies the molecular characteristics of such Therapeutic Product and (b) is not a Plant Product.” 1.15 The following new Section 1.99 shall be added to read in its entirety as follows:

GMP Product. Product that is manufactured according to GMP and the Specification;