Analysis of Polymer Product Sample Clauses

Analysis of Polymer Product. Prior to the delivery of any Batch of Polymer Product, Alkermes will send to Amylin a Certificate of Analysis and Compliance for such Batch as well as, if the Parties agree, a quality control sample of such Batch (the date Alkermes sends such documents and/or materials to Amylin, the “Release Date”). Such information will be deemed to be the Confidential Information of Alkermes. Within […***…] from the date Amylin’s Quality Department receives these documents and/or materials, Amylin may review the batch records and analyze the quality control sample to determine whether the Batch meets the Specifications and will report any adverse findings to Alkermes promptly upon their discovery and in any event within such[…***…] period. Unless the Parties otherwise agree, in testing the quality control sample, Amylin will use the analytical testing methods established by Alkermes, which methods have been transferred from Alkermes to Amylin in accordance with an agreed transfer protocol. In order to reject a Batch, Amylin must give written notice to Alkermes * ***Confidential Treatment Requested Amylin Ohio LLC April 30, 2009 within this [*…***…] period specifying the deviation of such Batch from the Specifications; if no such notice of rejection is given, Amylin will be deemed to have accepted such Batch. No shipment of the Polymer Product will be made until the earlier of Amylin’s actual or deemed acceptance of the Batch. Amylin agrees to keep, true, accurate and complete records of all such sampling and analyses in accordance with its record retention policies; copies of such records will be promptly provided to Alkermes and its representatives.”
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