Facility Validation. Except as expressly provided in this Agreement, and excluding process validation and validation of Bioverativ-owned equipment, Biogen shall perform at no additional cost to Bioverativ and on an on-going basis the necessary Facility validation activities required by cGMPs or Applicable Law in connection with the regular course of manufacturing the product.
Facility Validation. Atara will be responsible for performing all validation of any Atara Equipment, unless otherwise agreed in any Work Order. Manufacturer will be responsible for performing all validation of the Facility, Equipment and cleaning and maintenance processes employed in the Manufacturing Process in accordance with cGMP (if applicable), Manufacturer’s SOPs, the applicable Quality Agreement (if any), Applicable Law, and in accordance with any other validation procedures established by Atara and agreed to in writing by Manufacturer, and the applicable Work Order.
Facility Validation. Cognate will be responsible for performing all necessary validation of all Equipment, unless otherwise agreed in an SOW. Cognate will be responsible for performing any required validation of the Facility and cleaning and maintenance processes employed in the Manufacturing Process in accordance with cGMP (if applicable), the applicable Quality Agreement, and any other validation procedures established by the parties and agreed to in writing by Cognate.
Facility Validation. Prior to commencing the Manufacture and supply of the Material under this Agreement and throughout the Term of the Agreement, the CAMBRIDGE Facility shall be appropriately validated for commercial activities in accordance with cGMPs, the regulations of the FDA or any applicable Regulatory Authority. In the event regulatory approval is sought in countries outside the United States in accordance with Section 2.3 hereof, CAMBRIDGE shall use commercially reasonable efforts to meet and maintain any such country’s requirements for validation of the CAMBRIDGE Facility in accordance with the regulations of any applicable Regulatory Authority. Furthermore, CAMBRIDGE shall complete validation of its chemical processes, methods and equipment used in the Manufacture, packaging, storage, testing and release of the Material in conformance with all MSDSs and current FDA or any Regulatory Authority regulations as applicable to the Material, and will review such validation annually and through effective change control procedures assure that the validation is kept current throughout the Term of this Agreement. [*] = 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 24b-2 of the Securities Exchange Act of 1934, as amended.
