Dispute Regarding Batch Sample Clauses

Dispute Regarding Batch. In case of any disagreement between the parties as to whether a Batch conforms to the relevant Work Order or cGMP (if applicable) Synthorx shall notify Provider in writing, including a detailed explanation of the non-conformity. The quality assurance representatives of the Parties will attempt in good faith to resolve any such disagreement and Synthorx and Provider will follow their respective standard operating procedures to determine the conformity of the Batch to the Work Order and cGMP (if applicable). If the foregoing discussions do not resolve the disagreement in a reasonable time (which must not exceed […***…]), a representative sample of such Batch and/or relevant documentation will be submitted to an independent testing laboratory (in the case of an alleged failure to conform to the relevant Work Order) and/or independent cGMP consultant (in the case of an alleged failure to comply with cGMP), mutually agreed upon by the parties, for tests and final determination of whether the Batch conforms with such Work Order and/or cGMP (if applicable). The laboratory and retesting of the Batch must comply with cGMP (if applicable). The laboratory or consultant, as applicable, must be of recognized standing in the industry. Neither party may unreasonably withhold consent to the appointment of such laboratory and consultant. Such laboratory will use the test methods contained in the relevant Work Order. The determination of conformance by such laboratory and/or cGMP consultant, as applicable, with respect to all or part of such Batch 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 shall be paid by the party against whom the determination is made.