Stability Activities. Xxxxxxxxx-Xxxxx shall provide Auxilium or its designee with samples of the Product, when required, for stability testing upon request in writing. Samples must arrive at Auxilium or its designee within 5 business days after Xxxxxxxxx-Xxxxx’x receipt of Auxilium’s written request for release and stability samples or completion of the Manufacture of the Products, whichever is later. Sample shipping shall be performed following client-specific Xxxxxxxxx-Xxxxx SOP (approved by Auxilium). For stability testing performed at Xxxxxxxxx-Xxxxx, pull dates shall be provided to Auxilium, and testing shall be initiated within five (5) business days of actual pull dates. Auxilium shall inform Xxxxxxxxx-Xxxxx of the sample quantities required for stability testing prior to production as well as an appropriate Shipping Notification for shipment of such samples. Such Shipping Notifications may be part of the initial Purchase Order.
Stability Activities. A stability protocol shall be prepared by UMAN and approved by UMAN and CLIENT. Stability testing, Product sampling, data interpretation and reporting shall be UMAN’s responsibility and CLIENT shall update stability information in the regulatory documents for the Product. CLIENT shall inform UMAN in timely manner of any change in the approved shelf life of Product.
Stability Activities. The responsibility for stability testing and reporting shall belong to BVL so long as Customer contracts such activities with BVL. Stability protocols will be prepared by BVL and jointly reviewed and approved by BVL and Customer. BVL will provide stability reports to Customer in accordance with specifications contained in stability proposals. Data interpretation and the updating of stability information to regulatory documents for the Product is the responsibility of Customer. All stability related activities under the responsibility of BVL shall be completed in accordance with BVL SOPs.
Stability Activities. The responsibility for stability testing, data interpretation, and reporting shall belong to CBSB or a mutually approved Subcontractor. CBSB or a mutually approved Subcontractor shall also supply stability reports to Tercica. The updating of stability information for Regulatory Filings for the Drug Substance is the responsibility of Tercica. All stability related activities under the responsibility of CBSB or a mutually approved Subcontractor shall be completed in a timely manner.
Stability Activities. The responsibility for stability testing and reporting shall belong to BVL so long as Customer contracts such activities with BVL. Stability protocols will be prepared by BVL and jointly reviewed and approved by BVL and Customer. BVL will provide stability reports to Customer in accordance with specifications contained in stability proposals. Data interpretation and the updating of stability information to regulatory documents for the Product is the responsibility of Customer. Unless otherwise set forth in the applicable Proposal, all stability related activities under the responsibility of BVL shall be completed in accordance with Applicable Law and BVL SOPs, which, as to the portions of such SOPs that are Product-specific, shall be acceptable to Customer, which such acceptance shall not be unreasonably withheld.
Stability Activities. The responsibility for stability testing, data interpretation, and reporting shall belong to AVID, providing HALOZYME has agreed to and signed off on the stability protocol and project authorization form. AVID shall supply stability reports to HALOZYME within four (4) weeks of the completion of all testing at each stability time point. The *** Confidential material redacted and submitted separately to the Commission updating of stability information to regulatory documents for the BDS is the responsibility of HALOZYME. All stability related activities under the responsibility of AVID shall be completed in a timely manner.
Stability Activities. Xxxxxxxxx-Xxxxx shall provide Dyax or its designee with samples of the Product for stability testing upon request in writing, when required. Samples must be shipped to Dyax at its cost or its designee within 1 week after Xxxxxxxxx-Xxxxx’x receipt of Dyax’s request for release and stability samples or completion of the Manufacture of the Products, whichever is later. Confidential materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such omission. QUALITY SYSTEMS AGREEMENT Dyax shall inform Xxxxxxxxx-Xxxxx of the sample quantities required for stability testing prior to production as well as an appropriate Shipping Notification for shipment of such samples. Such Shipping Notifications may be part of the initial purchase order.
Stability Activities. Company will have the right to set forth commercially reasonable standards and requirements for stability testing, data interpretation, reporting, and updating stability information to regulatory documents for the subject Beverages. Company is responsible for providing stability testing for hemp-derived ingredients at their cost. Supplier will provide stability testing documentation on other ingredients.
Stability Activities. The responsibility for stability testing, data interpretation and reporting shall belong to Axcan, as does the updating of stability information to regulatory documents for the Product. Axcan will provide written instruction to Paddock for the delivery of stability samples.
Stability Activities. Formosa is responsible for writing of stability protocols, stability testing, data interpretation and reporting. Stability studies will be conducted in accordance with ICH guidelines. Stability protocols will be approved by NGX prior to initiation of the stability study. Stability samples will be placed in qualified xxxxxxxx with continuous temperature monitoring. For each batch on stability, Formosa will provide NGX with an updated summary table of all stability results for all time points up to the current time point and no later than [***] after the completion of testing for each time point. [***], as part of the [***] report, Formosa will compile a report discussing and trending all available results for all batches on stability. NGX will review and approve the report. After completion of a stability study, Formosa will generate a final report for NGX review and approval. NGX is responsible for updating stability information with Regulatory Authorities and for establishing retest / expiration dates. All stability related activities under the responsibility of Formosa will be completed in a timely manner according to Formosa’s internal procedures, the agreed-upon stability protocols and applicable regulations. NGX will notify Formosa to terminate stability programs 1) at the conclusion of a [***] Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. clinical trial, 2) when a stability protocol is cancelled or 3) when the lot on stability is no longer relevant due to product or clinical program decisions made by NGX.
