definiens: means, with respect to either Party, any business entity controlling, controlled by, or under common control with suchParty . For the purpose of this definition only, means ( i ) the possession, directly or indirectly, of the power to direct the management orpolicies of a business entity, whether through the ownership of voting securities, by contract or otherwise, or ( ii ) the ownership, directly orindirectly, of at least fifty percent ( 50 % ) of the voting securities or other ownership interest of a business entity . Notwithstanding the above, inno event shall Sutro ( or any entity that would be an Affiliate of [COMPANY] solely because it is an Affiliate of Sutro ) be deemed an Affiliate ofSutroVax, or [COMPANY] ( or any entity that would be an Affiliate of Sutro solely because it is an Affiliate of [COMPANY] ) an Affiliate of Sutro.1.2 means all laws, ordinances, rules, rulings, directives and regulations of any Governmental Authority that apply tothe development, manufacture or supply of any Product or the other activities contemplated under this Supply Agreement, including ( i ) allapplicable federal, state and local laws, rules and regulations ; ( ii ) the U.S. Federal Food, Drug and Cosmetic Act ; ( iii ) regulations andguidelines of the FDA and other Regulatory Authorities, including cGMPs, if applicable ; and ( iv ) any applicable non - U.S