definiens: means My orlne following : an life · threatening adverse drug experience, scr!OUll adverse drug experience, unexpected adverse drug experience, " lIS lhose terms are defined al either 2 ] C.F.R. § 312.32 or 2 ] C.F.R. § 314.80, or their cquivalen15 under Laws of jurisdictions outside the United States . 1.1.5 means, l'Iith rcspecllo II Pllfly, any other Pe.-,on that directly or lIIdirecdy controls, IS contro lled by or is under common control with SlJCh Party . For purpo5CS of this definition, ( including, with correlative meanings,, ~controllingunder common control with " ) means possession, direct or iodirect, of ( a ) the power 10 direct or cau$CI direction of the management and policies of slJCh Party ( whether through ownem.ip of securities or other ownership interests ), or ( b ) greater than 50-, .. of the voting securi ties ( wbcthcrdirectly or pursuant to any option, warrant orother similar II/1"aJlgemcnt ) or other comparable equity interests . Notwithshmding that GelJClltcch and Roche Holding & ; Ltd