definiens: as further defined hereinbelow ) for drug products containing active pharmaceutical ingredient ( as further defined hereinbelow ), and upon approval of such application(s ), Company w ill manufacture and market product containing such API to be exclusively supplied by JMI ( as fur ther defined hereinbelow ) in the United States of Americ a and its Territories ( the ) ; and WHEREAS, JMI is in the business of, among other things, de veloping, manufacturing and marketing raw materials, and JMI wishes to supply Company with al l of Company ’s requirements of API for Product subj ect to the terms of this Agreement ; and NOW, THEREFORE, in consideration of the mutual covenants and agre ements contained herein, the parties agree as follows : ARTICLE 1 . Definitions means the Federal Food, Drug and Cosmetic Act of 1938, including any amendments thereto and all regulations promulgated thereunder