definiens: shall mean all applicable laws, rules and regulations, including any applicable gui delines, or other Page 2 † DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BE EN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION requirements of Regulatory Authorities in the Terri tory and in any Agreed Additional Compliance Region s, that may be in effect from time to time and that are app licable to pharmaceutical products for human use an d the manufacturing and commercialization thereof in the Territory and in any Agreed Additional Compliance R egions, including as applicable and without limitation ( a ) the FD&C Act as amended ; ( b ) cGMP ; ( c ) guidances promulgated or adopted by the FDA ; and ( d ) ICH guid ances ; provided, however, that as used in this Agre ement the term as it appl ies to [COMPANY] shall exclusively relate to provisions o f the forgoing or any other laws, guidances, or regulatio ns referenced in this Section 1.9 as they apply to pharmaceutical Manufacturing activities . The Parties agree that if a Product Addendum specifies Europe or the Europea n Union as an Agreed Additional Compliance Region then Appl icable Pharmaceutical Law for Manufacturing pursuan t to such Product Addendum shall also include ( e ) Regula tion ( EC ) No . 726/2004, Directive 2001/83 / EC and na tional implementations thereof, each as amended from time to time, ( f ) guidances promulgated or adopted by th e European Commission and the European Medicines Agen cy, including within limitation those compiled in T he Rules Governing Medicinal Products in the European Union ; ( g ) legislation, rules and guidances compile d in The Rules Governing Medicinal Products in the European Union or otherwise adopted, promulgated or enforced by the European Medicines Agency ; and ( h ) legislation, rules and guidances promulgated, adopted or enforc ed by the relevant Regulatory Authorities in the member state s of the European Union ( as constituted from time t o time )