Common use of Conforming Products Clause in Contracts

Conforming Products. XANODYNE shall be entitled to reject any portion or all of any shipment of PRODUCTS (or any component thereof) that, at the time of transfer from BIRI to a common carrier, (i) fails to comply with any of the SPECIFICATIONS with respect to a particular PRODUCT, (ii) is not suitable for sale due to (A) the failure to manufacture such PRODUCT in accordance with GOOD MANUFACTURING PRACTICES or (B) the failure to comply with other FDA laws and regulations, DEA laws and regulations or material requirements of other applicable laws (all such PRODUCTS, "NONCONFORMING PRODUCTS", and any of such events, a "NONCONFORMITY"); provided that XANODYNE notifies BIRI within [**] days after receipt of the shipment that XANODYNE is rejecting such shipment. If no such notice is provided by XANODYNE, then XANODYNE shall be deemed to have accepted the shipment regardless of whether XANODYNE has actually performed any testing on such PRODUCTS. Notwithstanding the foregoing, in the event XANODYNE determines after acceptance of a PRODUCT that such PRODUCT is a NONCONFORMING PRODUCT due to a NONCONFORMITY that was not, and should not reasonably have been, discovered upon reasonable diligent examination and testing by XANODYNE upon receipt or otherwise known by XANODYNE, XANODYNE may subsequently revoke its acceptance of such NONCONFORMING PRODUCTS upon confirmation of such NONCONFORMITY, provided that it has given to BIRI written notice of its discovery of the NONCONFORMITY within [**] days after XANODYNE discovers or should reasonably have discovered such NONCONFORMITY and promptly proceeded to diligently investigate such NONCONFORMITY and notify BIRI of the results thereof. Any notification by' XANODYNE to BIRI of NONCONFORMING PRODUCTS shall indicate the SPECIFICATIONS or other applicable laws or regulations claimed to be unmet and any pertinent analysis performed by XANODYNE in making this conclusion.

Appears in 2 contracts

Sources: Manufacturing Agreement (Xanodyne Pharmaceuticals Inc), Manufacturing Agreement (Xanodyne Pharmaceuticals Inc)