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 Section 2.3. Classification of the Non-Conformance is detailed in the Clinical Quality Agreement.

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, with respect to a given unit of Compound, (a) 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 (b) that such Compound failed to meet the applicable representations and warranties set forth in Section 2.3. Classification of the Non-Conformance is detailed in the Clinical Quality Agreement.

Examples of Non-Conformance in a sentence

• Unless otherwise agreed to by the Parties in writing, the sole and exclusive remedies of Sponsor with respect to any Xxxxx Xxxxxxxx that is found to have a Non-Conformance at the time of Delivery shall be replacement of such Xxxxx Xxxxxxxx as set forth in this Section 8.4.2.

• The process for investigations of any Non-Conformance shall be handled in accordance with the Quality Agreement.

• Disagreements regarding any determination of Non-Conformance by Collaborator shall be resolved in accordance with this Clinical Quality Agreement or, in situations where the Clinical Quality Agreement does not apply, Section 21 (GOVERNING LAW; DISPUTE RESOLUTION) of this Agreement.

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

• Non-Conformance issues that may lead to a “for cause” audit include, but are not limited to, [*].

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 any Default by the Operating Company, including without limitation:

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 (a) Developed Product to conform materially to the Specifications, or to perform correctly when measured against the Specifications; or (b) Documentation to describe accurately an observable function of the Developed Product.

Non-Conformance has the meaning set forth in Subsection 12.4 hereto.

Non-Conformance. Each party agrees to share with the other party in a timely fashion any data gathered by such party or by independent third parties concerning the performance of the Co-Branded Site. e-centives shall be considered to not be in compliance with performance measurement guidelines if it fails to meet the conditions outlined above for two consecutive measurement periods or for three measurement periods in any six (6) week period.