Stability Failures. Any confirmed Out of Specification result which arises as a result of or during any of the stability programs will be communicated in writing within [**]to Xanodyne Corporate Quality Assurance.
Appears in 2 contracts
Sources: Manufacturing Agreement (Xanodyne Pharmaceuticals Inc), Manufacturing Agreement (Xanodyne Pharmaceuticals Inc)
Stability Failures. Any confirmed Out problems or out of Specification result results which arises arise as a result of or during any of the stability programs will be communicated in writing within [**]to Xanodyne Corporate Quality AssuranceAssurance in sufficient time for Xanodyne to comply with any regulatory requirements.
Appears in 1 contract
Sources: Manufacturing Agreement (Xanodyne Pharmaceuticals Inc)