Stability Failures. Any confirmed problems that arise as a result of the stability program will be immediately communicated by C*P to CLIENT.
6.6 Out-of-Specification (OOS) Investigations
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.
Stability Failures. Patheon will notify the Client of any stability failure for Product supplied to the Client within two Business Days If a result indicates that a Product has failed to remain within stability Specifications, Patheon will notify the Client within one Business Day.
Stability Failures. Patheon will notify the Client of any stability failure for CTM supplied to the Client. If a result indicates that a CTM has failed to remain within CTM stability Specifications. Patheon will notify the Client within [***].
Stability Failures. Patheon will notify the Client of any potential OOS within [**] of the potential OOS being identified. Client will notify regulatory agencies in accordance with Section 4.17 of this Agreement.
Stability Failures. Any failures that are identified according to the stability program will be immediately communicated by DSM to Barrier.
Stability Failures. CPI will notify NEOS and the Regulatory Consultant within one (1) Business Day of any failure as measured against the Specifications for the Drug Resin Complex supplied to NEOS. NEOS will be responsible for any post market reporting to the ANDA; however, CPI shall work with the Regulatory Consultant in this regard to ensure the proprietary nature of CPI’s RC Confidential Information.
Stability Failures. Cangene will notify Patheon of any Stability Failure occurred on batches manufactured by Patheon for proper evaluation to determine existing impact deriving from Patheon activities. Patheon will notify Cangene of any stability failure for Product supplied to Cangene where employed to conduct such testing. If a result indicates that a Product has failed to remain within Stability Specifications, Patheon will notify Cangene within [**]. For OOS discovered during stability refer to 4.12.3 paragraph.
Stability Failures. Any Out-of-Specifications ("OOS") occurrences identified and confirmed according to the stability program and applicable Nastech S.O.P will be immediately communicated to LICENSEE by Nastech, in any event not later than two business days after the identification thereof.
Stability Failures. Patheon will notify Penwest of any stability failure for Product supplied to Penwest. If a result indicates that a Product has failed to remain within stability Specifications, Patheon will notify Penwest within one (1) Business Day.
