definiens: means [ * * * ] 1.103 . means the 12 month fiscal periods observed by [COMPANY] ( a ) commencing on January 1 withrespect to the United States and ( b ) commencing on December 1 with respect to any country in the Territoryother than the United States1.104 . means a study of a [COMPANY] Licensed Product in human subjects or patients withthe endpoint of determining initial tolerance, safety, metabolism or pharmacokinetic information and clinicalpharmacology of such product as and to the extent defined for the United States in 21 C.F.R. § 312.21(a ), or itssuccessor regulation, or the equivalent regulation in any other country . A so - called Phase I / II Clinical Trial will bedeemed to be a Phase I Clinical Trial unless such study, when completed, allows [COMPANY] to proceed directly to aPhase III Clinical Trial