Common use of Notice of Nonconformity Clause in Contracts

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. LONZA shall provide PROTEON’s quality assurance department with copies of completed complete Quality Assurance Release and shall deliver to Client the necessary Batch Disposition Documentation, Documentation and shall endeavor to do so within ten (10) Business Days of Quality Review and ApprovalClinical Batch Sample. Within thirty forty-five (3045) days after PROTEONfollowing Quality Assurance Release and Client’s receipt of such Batch Disposition DocumentationDocumentation and Clinical Batch Sample, PROTEON 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 PROTEONClient’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)Clinical Batch Sample. If within the thirty forty-five (3045) day period, PROTEONperiod Client’s quality assurance department makes a determination that PROTEON Client believes such Clinical Batch Sample to be nonconforming, PROTEON Client shall have the right to reject such Clinical Batch in its entirety and shall notify LONZA in writing within such thirty forty-five (3045) 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 PROTEON Client does not submit written notice of rejection within such thirty forty-five (3045) day period, period such Clinical 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 PROTEONClient. In the event that PROTEON Client desires to accept such Clinical Batch prior to the end of the thirty forty-five (3045) day period, PROTEON period Client will fax written notice of such acceptance to LONZA’s Project Manager. [*] = Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Notice of Nonconformity. LONZA Xxxxxxx shall provide PROTEON’s quality assurance department notify Gilead in writing of any claim that any Territory Combination Product supplied under this JDA is not in conformance with copies of completed Batch Disposition Documentation, and shall endeavor to do so the warranties set forth in Section 11.1 (“Nonconforming”) 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 Delivery thereof (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 within thirty (30) day period shall be extended to account for LONZA’s failure to provide timely answers to information requests and resolution days after discovery of such issues). If within the thirty (30) day period, PROTEON’s quality assurance department makes a determination any Nonconformity 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 reasonably have been detected by PROTEON’s inspection undertaken pursuant on receipt at the applicable Xxxxxxx Destination). Xxxxxxx 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. Xxxxxxx shall have the option to this Section 10.1; require that Gilead use its Commercially Reasonable Efforts to replace such potentially Nonconforming Territory Combination Product as promptly as possible by placing a Firm Order therefor. Xxxxxxx shall be liable to pay for such Firm Order unless and provided further until it shall have been determined by the independent testing laboratory described below, or by agreement of the Parties, that the warranty provided Territory Combination Product in Section 14.2 question was Nonconforming. If Gilead and LONZA’s obligations under Section 15.2 Xxxxxxx disagree as to whether Units of Territory Combination Product are Nonconforming, Gilead and Xxxxxxx shall survive acceptance of designate an independent testing laboratory reasonably acceptable to both Parties to make a determination, which determination shall be binding on the Batch by PROTEONParties, absent manifest error. In Gilead shall bear the event that PROTEON desires to accept such Batch prior to the end of the thirty (30) day period, PROTEON will fax written notice costs of such acceptance laboratory testing if such Territory Combination Product is determined to LONZA’s Project Managerbe Nonconforming (other than due to non-conforming Supplied RPV), and otherwise Xxxxxxx shall bear such costs. The Parties shall attempt to resolve any Nonconformity issue within ninety (90) days after Xxxxxxx notifies Gilead that any Territory Combination Product is Nonconforming.