Notice of Nonconformity. LONZA shall provide PROTEON’s quality assurance department with copies of completed Batch Disposition Documentation, and shall endeavor to do so within ten (10) Business Days of Quality Review and Approval. Within thirty (30) days after PROTEON’s receipt of such Batch Disposition Documentation, PROTEON shall determine by review of such Batch Disposition Documentation whether or not the given Clinical Batch conforms to the warranties set forth in Section 14.2.1; provided that LONZA provides timely answers to information requests and resolution of issues arising from PROTEON’s review of such Batch Disposition Documentation (and the thirty (30) day period shall be extended to account for LONZA’s failure to provide timely answers to information requests and resolution of such issues). If within the thirty (30) day period, PROTEON’s quality assurance department makes a determination that PROTEON believes such Batch to be nonconforming, PROTEON shall have the right to reject such Batch in its entirety and shall notify LONZA in writing within such thirty (30) day period. Such written notice shall specify the manner in which the Clinical Batch fails to conform to the warranties set forth in Section 14.2.1. If PROTEON does not submit written notice of rejection within such thirty (30) day period, such Batch will be deemed to be a Conforming Drug Substance and accepted by PROTEON; provided that such failure to notify shall not prejudice PROTEON’s right to reject or revoke acceptance of the Batch if the non-conforming condition which justifies rejection could not have been detected by PROTEON’s inspection undertaken pursuant to this Section 10.1; and provided further that the warranty provided in Section 14.2 and LONZA’s obligations under Section 15.2 shall survive acceptance of the Batch by PROTEON. In the event that PROTEON desires to accept such Batch prior to the end of the thirty (30) day period, PROTEON will fax written notice of such acceptance to LONZA’s Project Manager.
Notice of Nonconformity. Tibotec shall notify Gilead in writing of any claim that any Territory Combination Product supplied under this TDA is not in conformance with the warranties set forth herein (“Nonconforming”) [*] Tibotec shall promptly provide Gilead with a sample of such Nonconforming Territory Combination Product, if available, and all relevant reports, data, and laboratory test results indicating that such Territory Combination Product is Nonconforming. Tibotec shall [*] If Gilead and Tibotec disagree as to whether Units of Territory Combination Product are Nonconforming, Gilead and Tibotec shall designate an independent testing laboratory reasonably acceptable to both Parties to make a determination, which determination shall be binding on the Parties, absent manifest error. Gilead shall [*] 5.2 [*] Nonconforming Territory Combination Product. If the independent testing laboratory (as set forth above) determines that the Territory Combination Product was Nonconforming or the Parties agree that the Territory Combination Product was Nonconforming, then [*] 5.3
Notice of Nonconformity. In the event that Client believes that a Production Batch is Non-Conforming Product, Client may reject the same by giving written notice thereof to Paragon within fourteen (14) days after the delivery of the Batch Documentation and/or receipt of the Product pursuant to Section 5.3 (for reasons that cannot be determined from the Batch Documentation), whichever is later. Such written notice shall specify the manner in which such Production Batch fails to conform to the warranties set forth in Section 11.2.1, and shall be accompanied by any test results or reports evidencing such nonconformity.
Notice of Nonconformity. LONZA shall complete Quality Assurance Release and shall deliver to Client the necessary Batch Disposition Documentation and Clinical Batch Sample. Within forty-five (45) days following Quality Assurance Release and Client’s receipt of such Batch Disposition Documentation and Clinical Batch Sample, Client shall determine by review of such Batch Disposition Documentation and Clinical Batch Sample whether or not the given Clinical Batch conforms to the warranties set forth in Section 14.2.1; provided that LONZA provides timely answers to information requests and resolution of issues arising from Client’s review of such Batch Disposition Documentation and Clinical Batch Sample. If within the forty-five (45) day period Client’s quality assurance department makes a determination that Client believes such Clinical Batch Sample to be nonconforming, Client shall have the right to reject such Clinical Batch in its entirety and shall notify LONZA in writing within such forty-five (45) day period. Such written notice shall specify the manner in which the Clinical Batch Sample fails to conform to the warranties set forth in Section 14.2.1. If Client does not submit written notice of rejection within such forty-five (45) day period such Clinical Batch will be deemed to be a Conforming Drug Substance and accepted by Client. In the event that Client desires to accept such Clinical Batch prior to the end of the forty-five (45) day period Client will fax written notice of such acceptance to LONZA’s Project Manager.
Notice of Nonconformity. In the event that Client determines that a Production Batch is Non-Conforming Product, Client may reject the same by giving written notice thereof to Paragon within [***] after the delivery of the Batch Documentation or receipt of the Product pursuant to Section 5.3 (for reasons that cannot be determined from the Batch Documentation), whichever is later. Such written notice shall specify the manner in which such Production Batch fails to conform to the warranties set forth in Section 11.2.1 and shall be accompanied by any test results or reports evidencing such nonconformity.
