definiens: means any governmental or regulatory authority, dep artment, body or agency or any court, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or muni cipal ; means a day other than a Saturday, Sunday or a day that is a federal holiday in the United States ; means current good manufacturing practices as descr ibed in : ( i ) Parts 210 and 211 of Title 21 of the United States Code of Federal Regulations toget her with the latest FDA guidance documents pertaining to manufacturing and quality control pra ctice and ( ii ) European Community Directive 2003/94 / EC ( Principles and guidelines of good manuf acturing practice in respect of medicinal products for human use and investigational medicinal products fo r human use ) ; in each case as interpreted by the IC H Harmonized Tripartite Guideline, any U.S., European, or other applicable laws, regulations or respecti ve guidance documents subsequently established by a go vernmental or regulatory authority, and any arrangements, additions or clarifications agreed fr om time to time between the Parties