definiens: means all laws, ordinances, rules and regulations withinthe Territory applicable to the Processing of the Product or any aspect thereofand the obligations of [COMPANY] Health or Client, as the context requires, underthis Agreement, including ( A ) all applicable federal, state and local laws andregulations of each country within the Territory, ( B ) the U.S. Federal Food, Drug and Cosmetic Act and ( C ) the Good Manufacturing Practices promulgated bythe Regulatory Authorities, as amended from time to time ( ) . ApplicableLaws shall also include all laws, ordinances, rules and regulations applicablein Territories added to this < PAGE > Agreement in accordance with its terms, solely to the extent Client has providedwritten copies of such laws to [COMPANY] Health prior to the commencement ofCardinal Health 's Processing for such Territories . Copies of all laws shall bein the English language1.4 means defined quantity of formulated bulk drug that has beenProcessed in accordance with the Specifications