Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8.3.
Appears in 15 contracts
Samples: Trial Collaboration and Supply Agreement (Intensity Therapeutics, Inc.), Clinical Trial Collaboration and Supply Agreement (IO Biotech, Inc.), Clinical Trial Collaboration and Supply Agreement (IMMUTEP LTD)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.1Sections 8.7.1 (After Manufacturer’s Release)), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality AgreementAgreements. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8.38.8 (Resolution of Discrepancies).
Appears in 4 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (Vaccinex, Inc.), Clinical Trial Collaboration and Supply Agreement (Vaccinex, Inc.), Clinical Trial Collaboration and Supply Agreement (Syndax Pharmaceuticals Inc)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8.3.
Appears in 3 contracts
Samples: Collaboration and Supply Agreement (BioLineRx Ltd.), Collaboration and Supply Agreement (BioLineRx Ltd.), Collaboration and Supply Agreement (BioLineRx Ltd.)
Non-Conformance. (a) 9.7.2.1 In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.1Sections 8.7.1 (After Manufacturer’s Release)), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8.38.8 (Resolution of Discrepancies).
Appears in 2 contracts
Samples: Clinical Trial Collaboration and Supply Agreement (IDEAYA Biosciences, Inc.), Clinical Trial Collaboration and Supply Agreement (IDEAYA Biosciences, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8.3. Confidential material omitted and filed separately with the Commission.
Appears in 1 contract
Non-Conformance. (a) 8.7.2.1 In the event that either a Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.1Sections 8.7.1 (After Manufacturer’s Release)), such Party shall immediately notify the other Party Parties in accordance with the procedures of the Clinical Quality AgreementAgreements. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8.38.8 (Resolution of Discrepancies).
Appears in 1 contract
Samples: Trial Collaboration and Supply Agreement (Checkmate Pharmaceuticals, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound Compounds may have a Non-Conformance, despite any testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.112.7 (After Manufacturer’s Release)), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 12.10 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8.312.9 (Resolution of Discrepancies).
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (SpringWorks Therapeutics, Inc.)
Non-Conformance. (a) In the event that either Party becomes aware that any Compound may have a Non-Non- Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.18.7.1), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any such Non-Conformance in accordance with Section 8.9 8.8 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8.38.7.3.
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Shattuck Labs, Inc.)
Non-Conformance. (a) a. In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.1Sections 8.7.1 (After Manufacturer's Release)), such Party shall immediately notify the other Party in accordance with the procedures upon identification of the Clinical Quality AgreementNon-Conformance. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8.38.8 (Resolution of Discrepancies).
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (Context Therapeutics Inc.)
Non-Conformance. (a) 8.7.2.1 In the event that either Party becomes aware that any Compound may have a Non-Conformance, despite testing and quality assurance activities (including any activities conducted by the Parties under Section 8.8.1Sections 8.7.1 (After Manufacturer’s Release)), such Party shall immediately notify the other Party in accordance with the procedures of the Clinical Quality Agreement. The Parties shall investigate any Non-Conformance in accordance with Section 8.9 (Investigations) and any discrepancy between them shall be resolved in accordance with Section 8.8.38.8 (Resolution of Discrepancies).
Appears in 1 contract
Samples: Clinical Trial Collaboration and Supply Agreement (IDEAYA Biosciences, Inc.)
