Remedies for Non-Conformance Sample Clauses

Remedies for Non-Conformance. Xxxxxxxx shall be entitled to the replacement of any Non-Conforming Products delivered to Xxxxxxxx by Durata with corresponding Product meeting their respective Specifications to be delivered within the lead time described in Section 4.1. Durata shall not be responsible for Non-Conforming Products if the Non-Conformance arose (i) after receipt of the Product by Xxxxxxxx (including, without limitation, as a result of improper storage by Xxxxxxxx of the Product) or (ii) as a result of any change in artwork, labelling, product inserts and other packaging designs for the Product requested by Xxxxxxxx and/or required a Governmental Authority in the Territory. Durata shall bear the costs of freight and insurance for return of the Non-Conforming Products which must be replaced by Durata pursuant to this Section 8.3. Xxxxxxxx shall, at Durata’s option and cost, either return to Durata at the Facility or destroy the Non-Conforming Products. Except as set forth in this Section 8.3 and Section 11.3 of the License Agreement, Durata shall have no liability for Non-Conforming Product, and Xxxxxxxx’x sole remedy shall be as set forth in this Section 8.3 and Section 11.3 of the License Agreement.

Remedies for Non-Conformance. In case of any disagreement between the parties as to whether Product conforms to the applicable specifications or cGMP (if applicable), warranties, or was manufactured in accordance with the manufacturing process, the quality assurance and/or engineering representatives of the parties will attempt in good faith to resolve any such disagreement and Vericel and Supplier will follow their respective SOPs to determine the conformity of the Product to the specifications and cGMP (if applicable) and manufacture in compliance with the manufacturing process. If the foregoing discussions do not resolve the disagreement in a reasonable time (which will not exceed thirty (30) days), a representative sample of such Product and/or relevant documentation will be submitted to an independent testing laboratory (in the case of an alleged failure to meet Specifications) and/or independent cGMP consultant (in the case of an alleged failure to comply with cGMP or the manufacturing process), as appropriate, that are mutually agreed upon by the parties for tests and final determination of whether such Product conforms with such specifications and/or cGMP (if applicable). The laboratory must meet cGMP (if applicable). The laboratory and consultant, as applicable, must be of recognized standing in the industry, and consent to the appointment of such laboratory and consultant will not be unreasonably withheld or delayed by either party. Such laboratory will use the test methods contained in the applicable specifications. The determination of conformance by such laboratory and/or cGMP consultant, as applicable, with respect to all or part of such Product will be final and binding on the parties absent manifest error. The fees and expenses of the laboratory and/or consultant, as applicable, incurred in making such determination will be paid by the party against whom the determination is made.

Remedies for Non-Conformance. In addition to all remedies provided by law or by this Agreement, Client’s remedy for breach of any standard of care or warranty shall, at Client’s option, include, without limitation, prompt re-performance by Vendor of non-conforming Services. Vendor shall bear all expenses of and associated with the re-performance of non-conforming Services. Re- performed Services shall be subject to the provisions of this Agreement to the same extent as the original Services.