Stability. 14.01 Maintain a documented, ongoing stability program to monitor the stability of the Product using stability indicating procedures. X 14.02 Data analysis and trending reporting will be performed. X
Stability. Proof. We prove each property separately.
Stability. During the Term, Seller shall conduct the commercial stability program pursuant to Regulatory Requirements applicable as of the Effective Date at its own expense. Should additional stability studies be required, the Parties shall agree, in good faith, upon the protocol, and associated charges, based on the then current charge rates for the staff services, with invoicing for such additional services to occur when the lot is placed on stability.
Stability. 4.13.1 Sample Storage Patheon will store stability samples as required.
Stability. Stability related activities for which BTG is responsible shall be completed in accordance with Quality Agreement. All costs incurred by BTG related to such activities shall be reimbursed by Savient in the manner and at the rates set forth on Exhibit B hereto.
Stability. BTG will perform the stability testing, data interpretation, reporting and updating of stability information to regulatory documents for the Product and Bulk Product and for Product until such time as a third party laboratory has been qualified to perform such testing. Stability related activities for which BTG is responsible shall be completed in accordance with the timing specified in stability protocols and BTG procedures.
Stability. 5.1 Patheon shall perform such stability testing as described in a stability protocol agreed to by both Patheon and the Client.
Stability. While operating in parallel with the System, the Customer Generator’s generating equipment shall maintain a stable output level with no noticeable hunting exhibited. In the event a system instability condition arises due to Customer Generator-owned generation, it is the Customer Generator’s responsibility to take measures to rectify the source of instability.
Stability. For purposes of this Agreement, an effect on stability shall mean that the proposed Registry Service (1) is not compliant with applicable relevant standards that are authoritative and published by a well-established, recognized and authoritative standards body, such as relevant Standards-Track or Best Current Practice RFCs sponsored by the IETF or (2) creates a condition that adversely affects the throughput, response time, consistency or coherence of responses to Internet servers or end systems, operating in accordance with applicable relevant standards that are authoritative and published by a well-established, recognized and authoritative standards body, such as relevant Standards-Track or Best Current Practice RFCs and relying on Registry Operator’s delegation information or provisioning services.
Stability. 4.1. OCS Lung Solution stability and determination of product shelf life was demonstrated through enrollment of the OCS Lung Solution in stability studies of up to [***]. Accelerated stability conditions were applied to the Technical batch with sample withdrawals scheduled throughout a [***] period. Real-time and accelerated stability conditions were applied to a minimum of [***] Stability batches with sample withdrawals scheduled throughout the enrollment period. The shelf life of existing clinical batches may be updated periodically based on the most current aging data available. Document: [***] Purchased Component Specification, OCS Lung Solution, REF [***] [***] THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Purchased Component specification, OCSTM Lung Solution, REF 2300
