Disposition of Certain Products. If GSK's failure to manufacture, test, package, store, label, or release any Product in accordance with the Specifications, cGMPs, Applicable Laws, Regulatory Acts, and the Quality Agreement directly results in any quantity of that Product having a Nonconformity or Product Event, then Prometheus shall, at GSK's direction and at GSK's expense as set forth in Section 6.9, either (i) return the affected Product to GSK for rework or reprocessing by GSK; (ii) return the affected Product for destruction by GSK; or (iii) have the Product disposed of by a Third Party designated by Prometheus (Prometheus or such Third Party to provide GSK with written documentation of destruction) and in accordance with Applicable Laws. In addition, Prometheus shall be entitled to the remedies set forth in Section 6.9. The remedies provided in this Section 6.8 and Section 6.9 shall be Prometheus' sole remedy with respect to any rejected quantity not distributed to Third Parties, and GSK shall have no other liability therefor. The Party undertaking destruction of the Product shall be solely responsible for compliance with all Applicable Laws in connection with the destruction.
Appears in 5 contracts
Samples: Supply Agreement (Prometheus Laboratories Inc), Supply Agreement (Prometheus Laboratories Inc), Asset Purchase and Sale Agreement (Prometheus Laboratories Inc)