definiens: means the Federal Food, Drug, and Cosmetic Act, together with anyregulationpromulgated thereunder, including without limitation cGMPs, ineach case asamended from timetotime ;, or means themalerials listedonSchedule D ; means thethen current fully burdened cost ( per kilogram ) toClient ofreplacing theActive Materials assupported byreasonable documentation atthetime ofreplacement ; or willhave themeaning ascribed thereto inSection 2.2.1 ( a ) ; willmean anyside effect, injury, toxicity, sensitivity reaction, unexpectedincidence, untoward medical occurrence orother adverse event orexperience associated withtheuseoftheProducts, including, butnotIimiled to, aAffiliate " means:(a ) abusiness entity which owns, directly orindirecUy, acontrolling interest inaparty tothisAgreement, bystock ownership orotherwise ; or(b ) abusiness entity which iscontrolled byaparty tothis Agreement, either directly orindirectly, byslock ownership orotherwise ; or(c ) abusiness entity, thecontrolling interest ofwhich isdirectly orindirectly common tothemajority ownership ofaparty tothisAgreement;Forthisdefinition, means theownership ofshares carrying atleast amajority ofthevotes fortheelection ofthedirectors ofacorporation, orthepower 10direct orcause thedirectionofthemanagement and policies ofsuch corporation orother business entity whether byownership ofvoting securities, bycontract orotherwise, orsuch other relationship as, infact, constitutes control