definiens: means, with respect to TXMD, all laws, ordinances, rules and regulations of each jurisdiction in which an API or Product is produced, marketed, distributed, used or sold ; and with res pect to [COMPANY], all laws, treaties, or ordinances, rules, regulations, cGMP, guidances, interpretations, auth orizations, judgments, directives, injunctions, or orders of an y court of any international, national, regional, l ocal, or other governmental body, agency, authority, or court, or arbitrator, that has jurisdiction over the location where [COMPANY] performs services, handles or stores an API, Raw Ma terials or Product, and manufactures Product under this Agreement ( and applicable cGMP ), including, but not limited to, the Federal Food, Drug and Cosmetic Ac t and Good Laboratory Practices, in each of the foregoing cases as in effect from time - to - time