Stability. Trubion or its designee shall be responsible for conducting all necessary stability testing to comply with cGMP and other applicable regulatory guidelines. Such stability testing shall include testing to validate the lead times for shipment, the shelf life of Bulk Drug, and the Bulk Drug Specifications applicable to shipment, storage and handling of Bulk Drug. Lonza shall prepare all stability samples, and shall sublot stability samples and package and ship stability samples to Trubion, all in accordance with timelines, protocols and procedures agreed upon by Lonza and Trubion and as set forth in the Quality Agreement.
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. 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. 16.1 The economic terms and conditions which will apply to PETCO for the activities to be conducted by PETCO under this Petroleum Agreement and throughout its period of validity, have been agreed after negotiations in good faith on the basis of the legislation in force in Morocco on the date of signature.
Stability. 5.1 Patheon shall perform such stability testing as described in a stability protocol agreed to by both Patheon and the Client.
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. 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. 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.