definiens: shall mean : ( i ) any US and foreign patenl applications and patents, including all certificates of invention and applications of certifICates of Invention ; ( ii ) any national, regional and internatlonal patent appllcatloos filed from patent applications and patents Included In ( i ) . including eny divisional and continuation applications or supplementary protecUort certificates of the patent applications and patents included In ( I ) and any contlnuation -In - part applications to \he e)(lent dominated by patent applications and patents Included In ( I ) ; ( Ill ) any and all patents that haVe Issued Of in ! he future issue from patent applications Included In ( i ) and ( ii ) ; and ( iv ) any and al extensions or restorations by e)(isting Of future extension or reslOration mechanisms, indudiog subs ~ tutions, reexaminations, revalidations, reissues, renewals, and extensions thereof, in each case that are necessary or useful for \he Development, COfoI ~ lD£NT tAL TREATMENT RIiQUESTED -6 -manufacturing . CommerCla ~ zation or use of Substance, Product or any Improvement including bot not limited 10 methods of their Development . manufacture . or use 1.41 · Pre - cfnical Oeye!ooment " shall mean aU adivlbes relating 10 the planning and execution of non - human studies conducted IfI in vitro or in relevant in VIVO arimal models directed towards obtaining Regulatory Approval of Product in ! he Territory . This indtlcles pre - dinical testing . pharmac : olOnetics, toxicology . documeotary and medical writing directly related to Pre - dinical Oevelopmeflt activities . and related regulatory affairs