Batch Packet definition
Examples of Batch Packet in a sentence
The warranties set forth in this Section (i) survive acceptance of the Product or Manufacturing Services by Customer (including any Batch Packet acceptance); and (ii) are for the sole benefit of Customer.
Sponsor shall provide for shipping within fourteen (14) calendar days of receiving of a complete Batch Packet by Sponsor.
Copies of all analytical QC raw data (including chromatograms) and reports generated by Agilent will be provided to Ophthotech with the Batch Packet for in-process and final API analysis following manufacture.
Fujifilm shall provide Sponsor’s quality assurance department with a Batch Packet and a recommendation for such Batch to be released.
Upon disposition of a cGMP Batch determined by Fujifilm to conform to cGMP and Product Specifications, Fujifilm shall provide Sponsor’s quality assurance department with a Batch Packet and a recommendation for such Batch to be released.
Upon Customer’s request, during the Target Review Period [**] Agilent will make available for up to [**] business days the necessary personnel for in-person, on-site meetings at the Facility (or such other location as the Parties may agree) to facilitate Customer review of the Batch Packet.
Agilent shall provide Customer with the remaining Batch Packet documentation (i.e., the records and documentation identified in Sections 2.1.6.2 through 2.1.6.7 of the Quality Agreement) at least [**] business days prior to the proposed Product shipment date.
Upon receipt of a complete copy of the Batch Packet, Customer will use commercially reasonable efforts to review such Batch Packet, and advise Agilent of any deficiencies or corrections needed within [**] business days (“Target Review Period”).
Agilent will subsequently provide Customer a complete Batch Packet (in electronic PDF format).
Following Agilent’s resolution (to Customer’s satisfaction) of any issues raised by Customer’s review of the Batch Packet, Agilent shall ship the Batch of Product.