Non-Conformity Dispute. In the event that a dispute arises between CATALENT and INTERMUNE regarding the nonconformity of a lot of the PRODUCT, or regarding other matters, then both companies shall in good faith promptly attempt to resolve disputed issues. INTERMUNE may only dispute a lot of PRODUCT which has been Dispositioned for Release by CATALENT. Financial liability shall be determined according to the SUPPLY Agreement. INTERMUNE Quality Representatives will resolve any disputes or conflicts relating to this QUALITY AGREEMENT in a timely InterMune/Catalent - KY Quality Agreement Confidential [ * ] = Certain information on this document has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. and equitable manner, in compliance with all applicable regulatory requirements, and in accordance with CCGMPs. Such resolutions shall be in writing and will be signed by CATALENT and INTERMUNE. If any issue remains unresolved for more than [ * ] ([ * ]) business days, senior corporate representatives from each party will meet to resolve the issue.
Non-Conformity Dispute. 9.1.1 In the event that a dispute arises between C*P and CLIENT in the nonconformity of a batch of the PRODUCTS, the heads of Quality from both companies shall in good faith promptly attempt to reach an agreement. Whatever the outcome, CLIENT Quality retains the absolute right to determine product release status. Financial liability is determined in the Definitive Agreement.
Non-Conformity Dispute. 9.1.1 In the event that a dispute arises between C*P and ORPHAN in the nonconformity of a batch of the PRODUCTS, the heads of Quality from both companies shall in good faith promptly attempt to reach an agreement. Whatever the outcome, ORPHAN Quality retains the absolute right to determine product release status. Financial liability is determined in the Definitive Agreement.
Non-Conformity Dispute. 9.1.1 In the event that a dispute arises between C*P and POZEN in the nonconformity of a batch of the PRODUCTS, the heads of Quality from both companies shall in good faith promptly attempt to reach an agreement. Whatever the outcome, POZEN Quality retains the absolute right to determine product release status. Financial liability is determined in the Definitive Agreement.
Non-Conformity Dispute. In the event that a dispute arises between SkyePharma and Enzon in the nonconformity of a batch of the PRODUCTS, the heads of the Quality departments from both companies will in good faith promptly attempt to reach an agreement .Financial liability will be determined according to the Supply Agreement.
Non-Conformity Dispute. 9.1.1 In the event that a dispute arises between Xxxxxx and Halozyme in the non-conformity of a batch of the Product, the heads of Quality from both companies shall in good faith promptly attempt to reach an agreement. Whatever the outcome, Halozyme retains the absolute right to determine product release status.
Non-Conformity Dispute. In the event that a dispute arises between SCHERING and IDEC in the non-conformity of a lot of the PRODUCTS, the heads of Quality, or their delegated representatives, from both companies will in good faith promptly attempt to reach an agreement.
Non-Conformity Dispute. In the event that a dispute arises between LONZA and ORPHAN in the nonconformity of a lot of the PRODUCT, the supervisors of the Quality departments from both companies shall in good faith promptly attempt to reach an agreement. ORPHAN may only dispute a lot of PRODUCT which has been dispositioned and released by LONZA. Whatever the outcome, ORPHAN Quality retains the absolute right to determine product release status. Financial liability shall be determined according to the Supply Agreement. Quality Agreement: Page 11 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. APPENDIX H
Non-Conformity Dispute. In the event that a dispute arises between LONZA and ORPHAN in the nonconformity of a lot of the PRODUCT, the supervisors of the Quality departments from both companies shall in good faith promptly attempt to reach an agreement. ORPHAN may only dispute a lot of PRODUCT which has been dispositioned and released by LONZA. Whatever the outcome, ORPHAN Quality retains the absolute right to determine product release status. Financial liability shall be determined according to the Supply Agreement.
Non-Conformity Dispute. In the event that a dispute arises between PYRAMID and XERIS regarding the conformity of a Batch of Product, the resolution will proceed in stages. The first stage requires direct communication between the Quality units from both Parties (Appendix 2), who will in good faith promptly [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED Document No: Revision: Revision Date: Replaces: Page: QA-Xeris 00 11/10/16 NA Page 24 of 52 attempt to reach an agreement. If these actions fail to achieve resolution, the second stage will employ a qualified third party consultant to review the Batch Record Package and related documentation. This third party consultant must be agreeable to both Parties prior to use. The results from this referee consultant will be used as final authority regarding the conformity or non-conformity of the Batch of Product and the responsibility therefore if non-conforming. Financial liability is determined in the Master Services Agreement.
