Analytical Method Transfer Clause Samples
The Analytical Method Transfer clause outlines the process by which validated laboratory testing procedures are formally transferred from one party or facility to another. This typically involves the sharing of detailed protocols, training of personnel, and verification that the receiving party can reliably reproduce results using the specified methods. The clause ensures consistency and reliability in analytical testing across different sites, minimizing variability and maintaining data integrity during the transfer of analytical responsibilities.
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Analytical Method Transfer. The Parties shall cooperate to transfer any and all analytical methods for existing Product from Horizon to sanofi-aventis US or its designated Affiliate as promptly as practicable following the execution of this Agreement, but in no event later than 60 days prior to the date on which the manufacture of the validation batches is scheduled to commence. Sanofi-aventis US’ or its designated Affiliate’s costs in relation with any such transfer shall be deemed included in the expenditure set forth in Section A of Exhibit 3. Horizon shall bear its own costs in connection with said analytical transfer. For purposes of clarification, the costs outlined in Exhibit 3 are merely for transfer of any such analytical methodologies and do not include costs associated with method optimization.
Analytical Method Transfer. Upon the reasonable prior written request of Purchaser, Aventis agrees to provide Purchaser with all required documentation and support for analytical method transfer for the Product in order to enable Purchaser to analyze the Product in order to determine its suitability and stability under this Agreement and according to all applicable requirements of Regulatory Authorities (a "METHOD Transfer"). Aventis agrees to actively participate in such Method Transfer by, inter alia, providing samples and conducting parallel testing up to an aggregate commitment of Aventis personnel resources to such Method Transfer of one person for two weeks (the "RESOURCE LIMIT"). In the event that the Aventis resources required for such Method Transfer exceed the Resource Limit, Purchaser shall pay for such resources at the then-current daily rate for personnel and laboratory time, as required. Notwithstanding the foregoing, Purchaser shall pay all reasonable costs and expenses associated with the travel of Aventis personnel to the site of any Method Transfer in connection therewith. Anything herein to the contrary notwithstanding, Aventis shall only be obligated to perform one (1) Method Transfer pursuant to this Agreement.
Analytical Method Transfer. As soon as possible after the Effective Date and in any event in due time prior to launch of Products in the Territory, Kos agrees to provide Merck with all required documentation and support for analytical method transfer for the Products to one site designated by Merck, to enable Merck to analyze the Product in order to determine its suitability and stability under this Agreement and according to all applicable requirements of a Regulatory Authority or to ensure that the finished Products are in line with the Marketing Authorization and all other (local) applicable regulations. Kos agrees to actively participate in such analytical method transfer by, inter alia, providing samples and conducting parallel testing. Merck shall be solely responsible for transfers of analytical methods to additional Merck sites at its cost, and Merck shall notify Kos that it has done so. Merck may request Kos to participate in and to support any such additional analytical method transfer, and Merck shall reimburse Kos for all of Kos' reasonable costs associated with such additional analytical method transfer, to the extent Kos has notified Merck in advance of the amount of such costs. Otherwise, each Party shall bear its own costs related to such analytical method transfer.
Analytical Method Transfer. Upon the reasonable prior written request of Purchaser, VIVUS agrees to provide Purchaser or use Commercially Reasonable Efforts to cause its Third Party designee hereunder to provide Purchaser with all required documentation and support for analytical method transfer for the Product in order to enable Purchaser to analyze the Product in order to determine its suitability and stability under this Agreement and according to all applicable requirements of Regulatory Authorities or to ensure that the Products are in line with the Regulatory Approvals (a “Method Transfer”). VIVUS agrees to actively participate, or use Commercially Reasonable Efforts to cause its Third Party designee hereunder to participate, in such Method Transfer by, among other things, providing samples and conducting parallel testing. Purchaser shall pay for any out-of-pocket costs incurred by VIVUS in connection with such Method Transfer, except in connection with the first Method Transfer to establish stability testing.
Analytical Method Transfer. Analytical test methods will be developed by KBI Biopharma or transferred from the Client site using mutually agreed upon protocols. The Client will be responsible for training KBI Biopharma personnel to use product assays or product specific test methods that are transferred to KBI Biopharma. KBI Biopharma will be responsible for generating protocols to confirm method equivalency, validating or qualifying the test methods and providing a final report for method transfer to the Client. The Client and KBI Biopharma will jointly review and approve the validation or qualification protocol, final report and test methods prior to implementation of routine testing. KBI Biopharma will be responsible for any subsequent analytical method transfers to other sites identified by the Client.