Replacement Batch Sample Clauses
Replacement Batch. If Licensor is notified within ten (10) working days that the sample is not acceptable, Licensor shall, save for the situation described below, be obligated to provide and send to Licensee a replacement batch within twenty (20) days of receipt of Raw Material sufficient to produce a replacement batch. Dispute: If Licensor does not agree with Licensee's claim on batch failure, Licensor may within said time limit of thirty (30) days ask an independent testing laboratory to give an opinion and statement as to whether the pre-delivery sample sent to the Licensee meets the technical specification of the Licensed Product as defined in Appendix 2. If Licensee does not agree with Licensor's claim of batch failure and subsequent rejection of a particular shipment of Raw Material, the Licensor shall within fourteen (14) working days submit samples and other evidence substantiating his claims to an independent testing laboratory to obtain an opinion and statement as to whether the disputed batch of Raw Material meets the mutually accepted quality specification. The parties agree to accept an independent testing laboratory selected by the Clinical Laboratory Research Association of Germany which shall be approached by the parties at the time of any dispute hereunder.
Replacement Batch. COPHARMA shall notify SERAGEN promptly of a rejection of a Batch by COPHARMA QA, or any delay or irregularity encountered during manufacture which could lead to a rejection. SERAGEN and COPHARMA shall promptly and mutually agree upon new dates for the initiation and completion by COPHARMA of the manufacture of a replacement Batch of PRODUCT if required to meet any outstanding purchase order. In the event that a replacement Batch is commenced prior to a rejection and the Parties subsequently determine that the replacement Batch is not required, SERAGEN will bear the costs associated with the manufacture of the replacement Batch, up to the time of such determination. SERAGEN and COPHARMA will negotiate in good faith terms for the continuance or discontinuation of the manufacture of any such replacement Batch. Subject to prior resolution of the dispute in accordance with the procedures set forth in Section 2.15, below in the event there is a dispute between COPHARMA and SERAGEN over whether a Batch is nonconforming, COPHARMA shall replace all non-conforming shipments at its expense, refund any payments made for the nonconforming shipment, and shall reimburse SERAGEN for any reasonable charges incurred by SERAGEN for shipping or storage, if applicable, of the non-conforming shipment. Any replacement Batch of PRODUCT to be manufactured by COPHARMA shall be invoiced by COPHARMA in accordance with the purchase order placed by SERAGEN for the nonconforming shipment of PRODUCT.
Replacement Batch. In the event that it is determined in accordance with this Article 5 that all or any portion of a shipment of a Production Batch does not meet the Specifications,[****]. Manufacturer will make every effort to replace the Production Batch within one hundred twenty (120) days from the date that such determination is made that the Production Batch does not meet Specifications, such that Customer will not incur any delay in the down-stream process. Manufacturer shall use its best efforts to assist Customer in avoiding product back-order problems due to unavailability of Bulk Drug Substance, resulting from failure to meet Specifications. Manufacturer shall not reprocess a shipment or portion of a shipment of Bulk Drug Substance that failed to meet Specifications without prior written approval from Customer, which approval shall not be unreasonably withheld.