Common use of MANUFACTURE AND QUALITY CONTROL Clause in Contracts

MANUFACTURE AND QUALITY CONTROL. (a) For each shipment of Product, AccuLase shall conform to the requirements set forth in ▇▇▇▇▇▇'▇ Supplier Quality Standard attached hereto as Exhibit B and any other incoming quality standards which are agreed to by the parties. (b) All Product shall meet the Specifications. All product shall be manufactured in accordance with Good Manufacturing Practices for Medical Devices established by the United States Food and Drug Administration ("FDA") as provided in 21 U.S.C. 360j (f) and as promulgated by regulations in 21 CFR 820. Product shall be subjected to quality control inspection by AccuLase in accordance with ▇▇▇▇▇▇'▇ quality control standards and the quality control system to be developed by AccuLase prior to production of any Product. AccuLase shall permit Baxter to review periodically AccuLase's production and quality control procedures and records and to visit AccuLase's facilities at reasonable times with a representative of AccuLase present in order to assure satisfaction of the requirements of this Agreement.