definiens: means the direct or indirectownership of more than fifty percent ( 50 % ) of the voting stock or other votinginterests or interest in the profits of the Party ; Agreementmeans this Agreement ; Alliance Managermeans the individual appointed by each Party as the principal point of contactfor communication between the Parties under this Agreement and inaccordance with Exhibit 4 ; Applicable Lawsmeans all applicable international, multi - national, national, regional, state, provincial and local laws, rules, regulations, ordinances, declarations, requirements, directives, guidance, policies and guidelines which are in forceduring the Term and in any jurisdiction in which any Clinical Trial or otheractivity under this Agreement is performed or in which any Product ismanufactured, sold or supplied to the extent in each case applicable to anyParty to this Agreement, including, as applicable to activities hereunder, theregulations and regulatory guidance promulgated by the FDA, the ConsolidatedGuidance E6 on Good Clinical Practice adopted by the InternationalConference on Harmonisation of Technical Requirements for Registration ofPharmaceuticals for Human Use, as ratified by the FDA and the Clinical TrialsDirective ( Directive 2001/20 / EC of 4th April 2001 ) and the respectiveimplementing legislation, the conditions and requirements imposed by therelated ethics committee and any of the foregoing which relate to ethicalbusiness conduct, the import or export of goods, technical data or other items, and data protection and privacy rules, as any of the foregoing may beamended from time to time ; [ * * * ] [ * * * ]