REJECTION BY SERAGEN Sample Clauses

REJECTION BY SERAGEN. CBSH shall provide SERAGEN's QA and Compliance department with copies of completed MRR Documentation listed in Exhibit "A", and shall endeavor to do so within ten (10) business days of CBSH QA Release of Fermentation Pellets, First Gen PDS and/or Second Gen PDS. Within thirty (30) days after SERAGEN's receipt of all MRR Documentation, SERAGEN shall determine by review of the MRR Documentation whether or not, in SERAGEN's sole opinion, the given Batch of Fermentation Pellets, First Gen PDS and/or Second Gen PDS conforms to the Manufacturing and Release Requirements, and was manufactured in accordance with cGMP; provided that CBSH provides timely answers to information requests and resolution of issues arising from SERAGEN's review of MRR Documentation. If within the thirty (30) day period, SERAGEN QA makes a determination that SERAGEN believes the Batch to be nonconforming, SERAGEN shall have the right to reject the Batch in its entirety and shall notify CBSH in writing within the thirty (30) day period. If SERAGEN does not submit written notice of rejection within such thirty (30) day period, the Batch will be deemed accepted by SERAGEN. In the event that SERAGEN desires to accept the Batch prior to the end of the thirty (30) day period, SERAGEN will fax a signed Batch acceptance form specifying the new Batch Acceptance Date(s) to CBSH's Director of QA. Any dispute between CBSH and SERAGEN as to whether or not a Batch that has been rejected by SERAGEN is nonconforming will be resolved in accordance with the procedures set forth in Section 2.14(c). Replacement of a non-conforming Batch shall be in accordance with Section 2.14(d).
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