Facility Qualification. Halsxx xxxll, at no cost to Watsxx, xxke all such actions to qualify (and thereafter to maintain qualification of) the facility (or facilities) at which Halsxx xxxufactures Active Ingredient hereunder, as required under applicable law in the United States and each other country in which Watsxx xxx informed Halsxx xxxt Watsxx xxxends to sell Commercial Products incorporating the Active Ingredient, to enable Watsxx xx obtain and maintain all applicable Regulatory Dossiers for the Commercial Products.
Facility Qualification. Interpharm shall take all Commercially Reasonable actions to qualify (and thereafter to maintain qualification of) the facility (or facilities) at which Interpharm will manufacture Product hereunder, as required under applicable law.
Facility Qualification. Unless and until Wxxxxx enters into Territory Supply Agreements with Catalent and [*], Adamis shall, at its expense, use Commercially Reasonable Efforts to cause each of the Catalent and [*] Manufacturing Facility to be qualified and capable of manufacturing the Product as required under Applicable Law (including FDA requirements), in order to maintain Regulatory Approvals for the Product.
Facility Qualification. Contractor shall, at no cost to Allergan, take all such actions to qualify (and thereafter to maintain qualification of) the facility (or facilities) at which Contractor manufactures any specific Product hereunder, as required under applicable law in the United States to enable Allergan to obtain and maintain all applicable regulatory approvals for any specific Product, as applicable.
Facility Qualification. Tris shall take all Commercially Reasonable actions to qualify (and thereafter to maintain qualification of) the facility (or facilities) at which Tris will manufacture Products hereunder, as required under applicable law.
Facility Qualification. In addition to Hercon’s responsibilities set forth hereunder, Hercon shall, at no cost to CTI, take all such actions to qualify (and thereafter to maintain qualification of) the facility (or facilities) at which Hercon Processes Clinical Trial Products hereunder, as required under applicable law and regulations in the United States and each other country in the Territory, to enable CTI to obtain and maintain all applicable Regulatory Dossiers for the Clinical Trial Products, including the Product NDA, consistent with the requirements of the FDA and other applicable regulatory authorities in the Territory.
Facility Qualification. Supplier shall, at no cost to Purchaser, take, or cause, all such actions to qualify and maintain qualification of the facility (or facilities) at which Supplier manufactures the Product for supply to Purchaser hereunder, as required under Applicable Laws.
Facility Qualification. 2.5 Xicor Deliverables
Facility Qualification. Verification per ISO 9001 criteria and QS9000 qualification shall be completed prior to the beginning of Risk Production Starts.
Facility Qualification. Manufacturer shall, at no cost to Customer, take all such actions to qualify (and thereafter to maintain qualification of) the Facility (or facilities) at which Manufacturer Processes and Packages Products hereunder, as required under applicable law in the United States of America.
