Non-Conformance

Example Definitions of "Non-Conformance"
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. View More
Found in Advaxis, Inc. contract
Non-Conformance. Means, with 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, parameter (including shelf life as specified in Section 8.2 and the applicable Specifications), 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. Compound. Classification of the Non-Conformance is detailed in the Clinical Quality Agreement. Agreements. View More
Found in Syndax Pharmaceuticals Inc contract
Non-Conformance. Means, with 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. 2.3.1. View More
Found in Syndax Pharmaceuticals Inc contract
View Variations (2)
Non-Conformance. 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.
Found in Checkmate Pharmaceuticals, Inc. contract
Non-Conformance. With respect to any Product, such Product deviates from (a) the applicable specifications for such Product (including, in for the case of the Regeneron Product, the Specifications) applicable Study or (b) any Applicable Law, including cGMP or health, safety or environmental protections.
Found in BioAtla, Inc. contract
View Variation
Non-Conformance. With respect to a given unit of Compound, an event that deviates from (i) the approved Specifications for such Compound; (ii) the applicable Clinical Supply Quality Agreement; and (iii) all Applicable Law, including cGMP and health, safety and environmental protections.
Found in Replimune Group, Inc. contract
All Definitions