Validation Activities. The Contractor’s quality program shall be examined using a series of required validation procedures. The examination shall be implemented and conducted by HCA, its agent, or an EQRO.
Validation Activities. Patheon may assist in the development and approval of the validation protocols for analytical methods and manufacturing procedures (including packaging procedures) for the Products. The fees associated with Patheon’s assistance in providing validation development assistance are set out in Schedule C to a Product Agreement.
Validation Activities. “Validation Activities” shall mean those activities to be performed by DSM prior to the First Commercial Sale including, but not limited to, process qualification of content uniformity, analytical testing, preparation of validation technical reports, cleaning validation, manufacturing and testing of Validation Lots.
Validation Activities. Supplier shall prepare the documentation, protocols, and procedures as set out in a Scope of Work. Supplier shall validate its pharmaceutical manufacturing processes, tests, and methods as well as associated facilities, equipment and systems, keep such processes, tests, methods, facilities, equipment, and systems current, and make results of validation and annual reviews of such processes, tests, methods, facilities, equipment, and systems available on site for audit or review by Zogenix in accordance with the Quality/Technical Agreement
Validation Activities. Supplier shall prepare the documentation, protocols, and procedures. Supplier shall make documents available on site for audit or review by Company in accordance with the Quality Agreement.
Validation Activities. Nisso shall undertake and complete all necessary qualification and validation activities for the Nihongi Facility to manufacture and supply commercial quantities of the Drug Substance meeting the Specifications in accordance with the then-current Drug Master File for the Drug Substance and all Regulations and Regulatory Approvals. Such activities shall be undertaken in accordance with the timeline and plan set forth in Attachment 2.3 hereto (“Timeline”). Subject to Section 2.4 (Purchase of Validation Lots of Drug Substance) hereof, all costs related to such activities shall be for the sole account of Nisso. It is acknowledged by the Parties that Nisso have already commenced a part of such activities in accordance with the Letter Agreement.
Validation Activities. Patheon may assist in the development and approval of the validation protocols for analytical methods and manufacturing procedures (including packaging procedures) for the Products. The fees associated with Patheon's assistance in providing validation development assistance are set out in Schedule C to a Product Agreement. (i) Product Rejection for Finished Product Specification Failure. Internal process specifications will be defined and agreed upon. If it is determined by a quality investigation that Patheon manufactured Product in accordance with the agreed upon process specifications, the batch production record, and Patheon's standard operating procedures for manufacturing, but a batch or portion of batch of Product does not meet a Finished Product Specification, Client will pay Patheon the applicable fee per unit for the non-conforming Product. The API in the non-conforming Product will be included in the "Quantity Converted" for purposes of calculating the "Actual Annual Yield" under Section 2.2(a).
Validation Activities. At Client’s request, Patheon will (i) assist in the development and approval of the validation protocols for analytical methods and manufacturing procedures (including packaging procedures) for the Products and (ii) validate all applicable processes, methods, equipment, utilities, facilities and computers used in the manufacture, packaging, storage, testing and release of Products in conformance with all Applicable Laws, including, but not limited to cGMPs. Upon request, Patheon will provide to Client a copy of the results of Product specific validation when such results are available. The fees associated with Patheon’s assistance in providing validation development assistance are set out in Schedule C.
Validation Activities. GXXX shall be responsible for Validating all critical systems, processes, tests and equipment necessary in connection with the Manufacture of API for SAVARA under this Agreement in a timely manner as set forth in the API Specifications. Without limiting the foregoing, SAVARA shall have the right to review and approve (a) specified individual Validation protocols with respect to any processes relating to the Manufacture of API for SAVARA, prior to the implementation of the same and (b) a written process Validation report provided by GXXX to SAVARA upon completion of the Validation activities. In addition, upon completion of such Validation activities, GXXX shall provide to SAVARA all API Manufactured as a result of such Validation activities and SAVARA shall have the right to use or dispose of such quantities of API resulting for any purpose.
Validation Activities. XenoPort acknowledges that certain validation activities have been on-going with respect to the 300mg (gabapentin enacarbil) strength Product (the “300mg Product”) to allow for commercial supply of the 300mg Product. [… * …] With respect to any API required to [… * …] (i) for such quantities as are required prior to the Inventory Transfer Date to conduct such activities, GSK shall use quantities of API from the Inventory in GSK’s possession, and (ii) for such quantities as are required after the Inventory Transfer Date to conduct such activities, GSK may place orders for such quantities of additional API in accordance with the principles set forth in Section 4.2(h) above, and any such API supplied to GSK pursuant to this Section 4.11 shall be included within the meaning of “Tolled API” (and, if applicable, subject to the terms agreed in Section 4.2(h) above). For the avoidance of doubt, in the event that XenoPort is not able to provide additional quantities of API in accordance with this Section 4.11, and in such case, GSK is prevented from fulfilling its agreed obligations in this Section 4.11 (and only to the extent it is precluded from fulfilling these obligations), [… * …] Notwithstanding anything to the contrary contained in this Termination Agreement, XenoPort acknowledges and agrees that GSK will be under no further obligation to create (or attempt to create), or assist XenoPort in creating (or attempting to create) any Improvements with respect to the Product after the Termination Effective Date, including, without limitation, Improvements to the manufacturing processes of the Product.
