Non-Conformance definition

Non-Conformance means, with respect to a given unit of Compound: (i) an event that deviates from an approved cGMP requirement with respect to the applicable Compound, such as a procedure, Specification, or operating parameter, or that requires an investigation to assess impact to the quality of the applicable Compound; or (ii) that such Compound failed to meet the applicable representations and warranties set forth in Article 8 (Supply and Use of Compounds) or Section 13.2 (Compounds). “Non-Conforming” shall have a correlative meaning.
Non-Conformance means the situation when any Deliverable does not conform to the requirements set out in Clauses 6.1 and 6.2.
Non-Conformance means any Default by the Operating Company, including without limitation:

Examples of Non-Conformance in a sentence

  • MSD shall investigate any Non-Conformance of the MSD Compound in accordance with the Clinical Supply Quality Agreement.

  • The sole and exclusive remedies of MSD with respect to any Collaborator Compound that is found to have a Non-Conformance at the time of Delivery shall be: [***].

  • Disagreements regarding any determination of Non-Conformance by Collaborator shall be resolved in accordance with the Clinical Supply Quality Agreement or, in situations where the Clinical Supply Quality Agreement does not apply, Section 20 (GOVERNING LAW; DISPUTE RESOLUTION).

  • Collaborator shall be responsible for, and MSD shall have no obligation or liability with respect to, any Collaborator Compound that is found to have a Non-Conformance.


More Definitions of Non-Conformance

Non-Conformance means, with respect to any Product, such Product deviates from (a) the applicable specifications for such Product (including, in the case of the Regeneron Product, the Specifications) or (b) any Applicable Law, including cGMP or health, safety or environmental protections.
Non-Conformance means a failure of the Product supplied hereunder to comply with any of the Product warranties set forth in Section 20.1.5. For clarity, a Latent Defect is an instance of Non-Conformance. The adjective “Non-Conforming” shall have the correlative meaning. “Non-Conformance” does not include damage caused to Products caused by actions of or on behalf of ARIAD SWISSCO following Delivery by ARIAD US to ARIAD SWISSCO, including Manufacture, where applicable.
Non-Conformance means any deviation, discrepancy, non-conformance or failure to meet the applicable requirements of this Contract with respect to: (i) the Satellite, SCIP Software or the DSS Software; (ii) materials, workmanship or processes; or (iii) any Deliverable Data, Training or Deliverable Services.
Non-Conformance means a failure of the Developed Technology to conform materially to the Specifications or to materially perform correctly when measured against the Specifications.
Non-Conformance has the meaning set forth in Subsection 12.4 hereto.
Non-Conformance means, with respect to any Product, such Product deviates from (a) the applicable specifications for such Product for the applicable Study or (b) any Applicable Law, including cGMP or health, safety or environmental protections.
Non-Conformance is defined in Section 3.6.