Shipment Lot definition
Examples of Shipment Lot in a sentence
In such case, AASTROM shall provide MSP with a written notice of rejection setting forth in detail the reason for rejection and return the rejected Shipment Lot, or portion thereof, to MSP at MSP's expense for repair or replacement.
Except as set forth in Section 7.3, all claims against HCC with respect to any shipment of a Drug Substance, including claims for allegedly defective goods or shortage, will be deemed waived unless made in writing and received by HCC within sixty (60) days after Pharmacyclics receipt of such Shipment Lot.
No shipment of any Shipment Lot shall take place without the written approval of Pharmacyclics, such approval not to be unreasonably withheld.
In such case, AASTROM shall provide MOLL with a written notice of rejection setting forth in detail the ▇▇▇▇on for rejection and return the rejected Shipment Lot, or portion thereof, to MOLL at MOLL's expense for repair or replacement.
Each Drug Substance Appendix will set forth the identification testing procedures to be conducted by Pharmacyclics or its designee upon receipt of a Shipment Lot of the applicable Drug Substance (the "Identification Testing Procedures").
Copies of all documentation and test results, including batch records, a certificate of analysis appropriately signed and an HCC quality assurance release appropriately signed, as are necessary to demonstrate HCC's compliance with Section 2.4 for each Shipment Lot, shall be provided to Pharmacyclics no later than ten (10) business days prior to the expected shipment date for such Shipment Lot from the HCC Manufacture Site or the HCC Inventory Site.
Promptly thereafter, Pharmacyclics will provide written notice to HCC indicating whether it is accepting or rejecting such Shipment Lot and, if such Shipment Lot is rejected, the basis for such rejection.
Pharmacyclics will conduct, or will cause a third party to conduct, the Identification Testing Procedures for each Shipment Lot of Drug Substance, within ten (10) business days after such Shipment Lot is received.
During the Acceptance Period, AASTROM shall have the right, ----------- but not the obligation, to conduct lot testing on a statistically significant number of units from each Shipment Lot.
Upon receipt of AASTROM's notice of rejection and return of such Shipment Lot of part thereof, MSP shall (i) within ten (10) business days thereafter, provide AASTROM with a root-cause analysis and suggested corrective/preventative actions; and (ii) diligently replace the nonconforming Shipment Lot or part thereof by delivery of nondefective conforming units within a reasonable time (not to exceed thirty (30) calendar days after notification) and endeavor to resolve the issues related to the rejection.