definiens: or means the laws, statutes, rules, co des, regulations, orders, judgments and/or ordinances of a Governmental Authority including, w ithout limitation, the 4 Confidential Materials omitted and filed separately with the Securities and Exchange Commission pursua nt to a request for confidential treatment under Rule 406 u nder the Securities Act of 1933, as amended . Confid ential portions are marked : [ * * * ] United States Federal Food, Drug and Cosmetic Act, European Directives 2001/83 / EC on the Community Cod e for medicinal products and 93/42 / EEC concerning med ical devices, and any implementing legislation of t he EU Member States, as any of the same may be amended fr om time to time, and directives, regulations, promu lgations, guidance and guidelines promulgated thereunder havi ng jurisdiction over or related to the Development, registration, approval, Manufacture, Commercializat ion and use of Product in the Territory, as may be in effect from time to time