Supply of Additional Materials. Sucampo shall purchase or have purchased all Additional Materials (as referred to in the relevant Regulatory Approvals) which are needed for the manufacture of the Product as per the current regulatory files, under its own liability and costs. If Sucampo wishes to change suppliers of such Additional Materials and the change will have an impact on a Regulatory Filing, such change shall be subject to Xxxxxx’x prior written approval, such approval not to be unreasonably withheld, conditioned or delayed.
Supply of Additional Materials. (a) Packager shall purchase all Additional Materials (as referred to in Exhibit 2.5(a)) which are required for the Packaging of the Product as per the then current Specifications, under its own liability and costs, from suppliers indicated in Exhibit 2.5(a) or as may be approved in advance in writing by Purchaser, such approval not to be unreasonably withheld. Packager is responsible for the testing and approval of the Additional Materials.
(b) In the event of a change of supplier of Additional Materials listed in the current regulatory files and which is approved by Purchaser, Packager shall be responsible for the audit and qualification of the new supplier, unless otherwise agreed by the Parties. If the change of suppliers of the relevant Additional Materials is requested by Purchaser or is due to the discontinuation by any of the registered suppliers as of the Effective Date, then Purchaser shall bear the costs of audit and qualification of such new supplier. If Packager requests the change of supplier for a reason other than the discontinuation of supply by the existing supplier, provided that such discontinuation was not caused by Packager, then Packager shall bear the costs of audit and qualification of such new supplier.
(c) For those Additional Materials listed on Exhibit 2.5(a), Packager shall first be obligated to purchase such Additional Materials as a beneficiary under any current supply arrangements between Purchaser, or its relevant Affiliate, and the designated Third Party suppliers (as listed in such Exhibit 2.5(a)) and Purchaser shall arrange for any necessary consent of any such Third Party suppliers to the amendment of the relevant supply arrangements.
(d) For the term of this Agreement, and subject to timely provision by Purchaser of forecasts pursuant to Section 2.2(a), Packager shall maintain sufficient inventories of Additional Materials required to Package the Products in order to ensure timely delivery of the Products.
Supply of Additional Materials. Sucampo shall purchase or have purchased all Additional Materials (as referred to in the relevant Regulatory Approvals) which are needed for the manufacture of the Product in the Field as per the current regulatory files, at Gloria’s sole cost and expense. Xxxxxx shall pay for the cost of the Additional Materials in accordance with Section 8.4.
Supply of Additional Materials. At RTU’s own expense, RTU shall purchase all Additional Materials (as referred to in the relevant Regulatory Approvals) which are needed for the manufacture of Drug Substance and/or Drug Products as per the current regulatory files, under its own liability and costs, from suppliers approved by SPA. If RTU wishes to change suppliers, this must be approved in advance in writing by SPA, such approval not to be unreasonably withheld. RTU is responsible for the testing and approval of the Additional Materials.
