definiens: means the generic compounds Estradiol and Progest erone, as further described in the Specifications that have been released by Client an d provided to [COMPANY], along with a certificate of analysis, as provided in this Agreement . 1.5 means, with respect to Client, all laws, ordinanc es, rules and regulations of each jurisdiction in which API or Product is produced, m arketed, distributed, used or sold ; and with respec t to [COMPANY], all laws, treaties, or ordinances, rules, regulatio ns, cGMP, guidances, interpretations, authorization s, judgments, directives, injunctions, or orders of any court of any international, national, regional, local, or ot her governmental body, agency, authority, or court, or arbitrator, t hat has jurisdiction over the location where Catale nt performs services under this Agreement ( and applicable cGMP ), including, but not limited to, the Federal Food, Drug and Cosmetic Act and Good Laboratory Practices, in each of the foregoing cases as in effect from time - to - t ime