Common use of Product Requirements Clause in Contracts

Product Requirements. The Products and all components and ingredients thereof shall be produced in strict accordance with: (a) current Good Manufacturing Practices (as defined in regulations promulgated by the Food and Drug Administration ("FDA") under the U.S. Food, Drug and Cosmetic Act, as amended (the "Act"), and as generally understood and interpreted by the pharmaceutical industry) ("cGMPs"), and (b) quality control procedures and associated test methods for the manufacturing process as developed by JSP. Each of LCI and JSP warrant and guarantee to the other that each article shipped by them under this Agreement: (i) will not, on the date of shipment, be adulterated or misbranded (A) within the meaning of the Act, or (B) within the meaning of any applicable state law in which the definitions of "adulteration" and "misbranding" are substantially the same as those contained in the Act, as such laws are constituted and effective at the time of such shipment or delivery and (ii) will not be an article which may not under the provisions of Section 404 or 505 of the Act be introduced into interstate commerce. Products may only be shipped if the package configuration is in compliance with the cGMPs and FDA regulations.