definiens: means a rell . .. l ~ tOl ) ' approvals ( i .. dllding, 001 nOllirnitcd .... IND or NDA ) required and/or granted by IIny Competeol Authorily liS a prcmjuisite to lhc development, manufacturing . rodllCl 1.28 meam, on a country - by .. :ountry and Liocnscd I'lt lod'1C1 - by - Liccn!iCd Product basi ., ttw . period _,,,,, ing on the Effwive Date and, Valid Claim " !, Iration including . for pIIrptlIIC!I hereof, the oJa.\O : uf'OII which 00 Valid Cl.ims remain .. · ith re > peetto a pani<:ulat collnlry, e.en if such date occurs pri ...... 10 patent i, .... uo(:c }, provided that, for f'Urp0se8 of ! hi . : ! definition . any Valid Claim that has not is < u~ but has been pernling more than five ( 5 ) ye ~ rs from filing ~hall be d""med expired ( and not a Valid Ctftim )