Manufacturing Facilities, Equipment and Licenses. Supplier shall, at Supplier's expense, acquire or cause to be acquired all equipment and licenses, including, without limitation, all necessary plant equipment and facilities licenses, necessary to enable the manufacture and testing of the Components as required hereunder. Supplier shall obtain and maintain all necessary Regulatory Approvals. Purchaser, its Affiliates and Sublicensees shall obtain any required importation licenses or approvals for importation of Dendreon Products and Kirin Products, and the Components necessary for such Kirin Products and Dendreon Products, as applicable for sale in any given country. Supplier shall cooperate reasonably with Purchaser, at Purchaser's reasonable request and expense, to obtain such licenses or approvals. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Manufacturing Facilities, Equipment and Licenses. In manufacturing clinical supplies pursuant to Section 5.1, BPTD and BPTD's Affiliates shall:
Manufacturing Facilities, Equipment and Licenses. Lynx shall, at Lynx's expense, acquire or cause to be acquired all equipment and licenses, including, without limitation, all necessary plant equipment and facilities licenses, necessary to enable the manufacture of the Products as required hereunder. Lynx shall use its commercially reasonable efforts to keep such equipment properly maintained and to reduce risks of breakdown of critical machinery. Lynx shall obtain and maintain all necessary United States manufacturing licenses and approvals including but not limited to FDA approval for the manufacturing facilities and export approval. Xxxxxxx Pharma, its Affiliates and its Sublicensees shall obtain any required importation licenses or approvals for importation of Product for sale in the Territory. Lynx shall cooperate reasonably with Xxxxxxx Pharma to obtain such licenses or approvals, provided that Lynx shall cause the Drug Master File to progress through the approval process at its own expense.
Manufacturing Facilities, Equipment and Licenses. Aradigm shall, at Aradigm's expense, acquire or cause to be acquired all equipment and licenses, including, without limitation, all necessary plant equipment and facilities licenses, necessary to enable the manufacture and testing of the AERx DEVICES and DRUG PRODUCTS as required hereunder. Aradigm shall use commercially reasonable efforts to keep such equipment properly maintained and to reduce risks of breakdown of critical machinery. Aradigm shall obtain and maintain all necessary U.S.A. manufacturing licenses and approvals including but not limited to FDA approval for the manufacturing facilities. SB, its AFFILIATES and its sublicensees shall obtain any required export and importation licenses or approvals for importation of PRODUCTS for sale in any given country in the TERRITORY. Aradigm shall cooperate reasonably with SB to obtain such licenses or approvals. Aradigm shall maintain all records as are necessary and appropriate to demonstrate compliance with cGMPs. Aradigm shall manufacture PRODUCTS in a facility maintaining a current drug establishment registration with FDA as set forth in 21 C.F.R., Part 207 and registration as importer and/or manufacturer of controlled substances with the Drug Enforcement Agency ("DEA") as set forth in 21 C.F.R., Part 1300, if applicable.
Manufacturing Facilities, Equipment and Licenses. Supplier shall, at Supplier's expense, acquire or cause to be acquired all equipment and licenses, including, without limitation, all necessary plant equipment and facilities licenses, necessary to enable the manufacture and testing of the Components as required hereunder. Supplier shall obtain and maintain all necessary Regulatory Approvals. Purchaser, its Affiliates and Sublicensees shall obtain any required importation licenses or approvals for importation of Dendreon Products and Kirin Products, and the Components necessary for such Kirin Products and Dendreon Products, as applicable for sale in any given country. Supplier shall cooperate reasonably with Purchaser, at Purchaser's reasonable request and expense, to obtain such licenses or approvals.
