definiens: means all laws, ordinances, rules and regulations applicable to the Product and the Services ( including Processing of Product o r any aspect thereof ) and the obligations of Hospir a or [COMPANY], as the context requires under this Agreement, inclu ding ( a ) all applicable federal, state and local la ws and regulations, including the Act and U.S. Federal Acq uisition Regulations ( FAR ) 52.244 - 6, ( b ) all applic able FDA regulations promulgated under the Act, ( c ) Regulati on ( EC ) No . 726/2004, Directive 2001/83 / EC and national implementations thereof, including guidances promul gated or adopted by the European Commission and the European Medicines Agency, ( d ) legislation, rules a nd guidances promulgated, adopted or enforced by th e relevant Regulatory Authorities in the member states of the European Union, all as may be amended from time to time, ( e ) all applicable cGMPs, ( f ) all applicable guidances promulgated or adopted by FDA, including all applic able International Conference on Harmonization ( ) guidances, each as amended from time to time, an d ( g ) all other applicable laws and regulations within the Te rritory, including ICH guidances, that are applicab le to the Processing of Product for commercial supply