Key Quality Concern definition

Key Quality Concern means a critical or material deficiency or nonconformity which has a high probability of causing adverse consequences to the patient or consumer, significant deviations in the safety, identity, strength or purity of the Product, serious breaches of cGMP, major deficiencies cited Governmental Authorities or lead to a critical system failure. For the avoidance of doubt, this option shall apply only to the manufacture and supply of Product and not to the API Compound.
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Examples of Key Quality Concern in a sentence

  • GSK shall have the option to assume the manufacture and supply of Drug Product pursuant to Section 13.5.2 in the event that (a) GSK observes a Key Quality Concern which is disclosed in writing by GSK to Adolor as a Key Quality Concern in GSK’s audit report of Adolor, (b) Adolor agrees that a Key Quality Concern exists and (c) such Key Quality Concern is not corrected to the reasonable satisfaction of GSK within a time period mutually agreed upon by the Parties.

  • The provisions of this Section 13.5.2 in the case of insolvency of Adolor or in the event there is a Key Quality Concern shall be the sole remedy available to GSK with respect to any such event.

  • The foregoing right of GSK to assume responsibility for supply and manufacture of the Product shall apply until the later of (a) such time as Adolor is no longer insolvent or experiencing a Key Quality Concern, but no sooner than as reasonably practicable giving effect to any obligations or commitments GSK may have undertaken, or (b) such longer time as may be agreed to by the Parties.

Related to Key Quality Concern

  • iron ore concentrates means products (whether in pellet or other form) resulting from secondary processing but does not include metallised agglomerates;

  • Small Diversity business concern means a small business concern that is a least (51) percent unconditionally owned by one or more individuals who are both socially and economically diverse, or a publicly owned business that has at least (51) percent of its stock unconditionally owned by one or more socially and economically diverse individuals and that has its management and daily business controlled by one or more such individuals. This term also means a small business concern that is at least (51) percent unconditionally owned by an economically diverse Indian tribe or Native Hawaiian Organization, or a publicly owned business that has least (51) percent of its stock unconditionally owned by one of these entities, that has its management and daily business controlled by members of an economically diverse Indian tribe or Native Hawaiian Organization.

  • General air quality operating permit or "general permit" means an air quality operating permit that meets the requirements of ARM 17.8.1222, covers multiple sources in a source category, and is issued in lieu of individual permits being issued to each source.

  • High-quality waters means all state waters, except:

  • Business concern means any corporation, company, limited liability company, partnership, joint venture, trust, unincorporated association or any other form of association.