Manufacturing Processes. The Contractor shall maintain and control manufacturing processes to fabricate, assemble, inspect, test, and deliver VLS LCU as described in the SOW. The processes shall cover all phases from the ordering of raw materials to Government acceptance of the finished product. All hardware components shall be manufactured in accordance with the drawings and specifications referenced in the TDP and this SOW.
Manufacturing Processes. The Contractor shall maintain and control manufacturing processes to fabricate, assemble, inspect, test, and deliver VLS UCEU and associated cables as described in the SOW. The processes shall cover all phases from the ordering of raw materials to Government acceptance of the finished product. All hardware components shall be manufactured in accordance with the drawings and specifications referenced in the TDP and this SOW.
Manufacturing Processes. The Certified Product that Licensee produces and that is marked with one or more of the Xxxx(s) under this Agreement shall be substantially identical to the Certified Product that was approved and registered pursuant to the Certification Program. Further, Licensee covenants, represents, and warrants that, to the best of Licensee’s knowledge, Licensee’s Certified Product meets the applicable requirements of the XxX Certification Program Test Plan.
Manufacturing Processes. 6.1.1 Human dermal tissues from which GRAFTJACKET® is produced shall be procured in accordance with FDA regulations and AATB guidelines.
6.1.2 Dermal and epidermal cells shall be removed and the product freeze-dried by LifeCell Corporation per their patented processes.
6.1.3 GRAFTJACKET® shall be certified to conform to the appropriate WMT material specification upon receipt.
Manufacturing Processes. Circa has furnished CEPHALON with a copy of ----------------------- its production procedures and has identified to CEPHALON the equipment to be used to produce the Product, all as set forth in Schedule C hereto. CIRCA agrees that it will not modify these procedures, nor modify any method of formulation, packaging, labeling or testing the Product (including analytical procedures, components, process, Specifications, controls, storage, stability protocols), without notifying CEPHALON or obtaining CEPHALON's prior written consent as required in Schedule C hereto. Costs incurred by CIRCA as a result of any such changes or modifications requested by the FDA or by CEPHALON and relating solely to the production of the Product will be borne by CEPHALON; costs for other changes will be borne by CIRCA.
Manufacturing Processes. [MANUFACTURER] has furnished to PURCHASER a copy of its production procedures and in the Quality Technical Agreement the parties will agree upon the equipment to be used to produce the Product. Costs incurred by [MANUFACTURER] as a result of any changes or modifications requested by the FDA or by PURCHASER and relating solely to the production of the Product will be borne by PURCHASER; costs for other changes affecting [MANUFACTURER]’s cGMP compliance or affecting other products generally will be borne by [MANUFACTURER].
Manufacturing Processes. 8.1 Horizon shall use all of its contractual rights to cause the Third-Party Manufacturer at all times to operate in accordance with the criteria defined in the Technical Agreement and in compliance with the Registrations and cGMP and all other relevant regulations and legislation. Horizon shall regularly audit the Third-Party Manufacturer and endeavour to ensure that they receive regular inspections by the relevant Medicines Inspectorate to ensure that the Manufacturing processes are always in conformity with such requirements.
8.2 The parties shall enter into the Technical Agreement as soon as practicable after the Commencement Date but no later than ninety (90) days after the Commencement Date.
8.3 Any delivery of the Products to Mundipharma or its designee must be first analyzed by the Third-Party Tester or Horizon and released by the Third-Party Tester or Horizon’s Qualified Person (the “QP”), or a person acting on Horizon’s authority in the capacity of person responsible for quality assurance. This QP shall draw up a written report certifying the conformity of the delivery to the conditions specified in the Technical Agreement.
Manufacturing Processes. CATALYTICA has furnished CEPHALON with a copy of its production procedures and has identified to CEPHALON the equipment to be used to produce the Product, all as set forth in Schedule G hereto. CATALYTICA agrees that it will not modify these procedures, nor modify any method of formulating, packaging, labeling or testing the Product (including analytical procedures, components, process, Specifications, controls, storage, stability protocols), without notifying CEPHALON or obtaining CEPHALON's prior written consent as required in Schedule C hereto, which consent shall not be unreasonably withheld or delayed. Costs incurred by CATALYTICA as a result of any such changes or modifications requested by the FDA or by CEPHALON and relating primarily to the production of the Product will be borne by CEPHALON; costs for other changes affecting CATALYTICA's cGMP compliance or affecting products generally will be borne by CATALYTICA.
Manufacturing Processes. Helsinn has furnished and will continue to furnish to Indevus during the term of this Agreement a copy of its current production procedures and in the Quality Technical Agreement the Parties will agree upon the equipment to be used to produce the API. Except as otherwise set forth in this Agreement, costs incurred by Helsinn as a result of any such changes or modifications requested by the FDA or by Indevus and relating solely to the production of the API will be borne by Indevus; costs for other changes affecting Helsinn’s compliance with cGMP or affecting other products generally will be borne by Helsinn.
Manufacturing Processes. Seller will provide Exabyte documentation of all related manufacturing, maintenance, and quality control processes, including types of data available and maintained. Seller shall not make any changes to the Product or processes governed by the Quality Plan.
