Product Non-Compliance and Remedies. If a Batch of Product fails to conform to the Specifications or was not Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process, then Manufacturer will, as Rhythms’ sole and exclusive remedy and in lieu of other remedies available at law or in equity (except for any right of Rhythm to indemnification pursuant to Section 12.1 hereof in connection with third party claims), at Rhythm’s sole option:
Product Non-Compliance and Remedies. If a Batch of Product fails to conform to the Specifications or was not Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process, then Manufacturer will, at Customer’s sole option:
Product Non-Compliance and Remedies. If a Batch of Product fails to conform to the Specifications due to the fault of Manufacturer or was not Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process, then Manufacturer will, at RADIUS’ sole option:
Product Non-Compliance and Remedies. If a Batch of Product fails to conform to the Specifications due to the actions or omissions of Manufacturer, or was not Manufactured in compliance with cGMP (if applicable) or the Manufacturing Process, then Manufacturer will, at Anterios’ sole option:
Product Non-Compliance and Remedies. If [***] a Batch of Product fails to conform to the Specifications subject to Section 16.7 or was not Manufactured in compliance with GMP and the Manufacturing Process [***], then FRESENIUS will, at COMPANY’s sole option, promptly:
Product Non-Compliance and Remedies. If a lot of Product fails to conform to the specifications or was not manufactured in compliance with cGMP (if applicable) and the manufacturing process, then Supplier will, at Vericel’s sole option: (a) at Supplier’s cost and expense, replace the Product by manufacture of a new lot as soon as reasonably possible; or (b) refund in full the fees and expenses paid by Vericel for such lot. Moreover, the parties will meet to discuss, evaluate and analyze the reasons for and implications of the failure to comply with cGMP (if applicable) and/or the manufacturing process and will decide whether to proceed with the services via a change order, or to terminate such services.
Product Non-Compliance and Remedies. If the parties agree or if determined in accordance with Section 6.5 above that a Batch of Product (i) fails to conform to the Specifications, (ii) was not Manufactured in compliance with cGMP (if applicable) or (iii) was not Manufactured in compliance with the Manufacturing Process (as modified by any Planned Deviations, if any), then, then Manufacturer will, [ * ]: [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Product Non-Compliance and Remedies. If a Batch of Product fails to conform to the warranty in Section 11.1(e), then Manufacturer will, at Alnylam’s sole option:
Product Non-Compliance and Remedies. If following the receipt of a notice of rejection from Portola pursuant to Section 6.3, it is determined by agreement of the Parties (or in the absence of such agreement, by the laboratory) that a Batch of Product fails to conform to the Specifications or was not Manufactured in compliance with the Quality Agreement and the Manufacturing Process, then Manufacturer will, [*]:
Product Non-Compliance and Remedies. If [***] a Batch of Product fails to conform to the Specifications subject to Section 16.7 or was not Manufactured in compliance with GMP and the Manufacturing Process [***], then FRESENIUS will, at COMPANY’s sole option, 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 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED
