definiens: has the meaning assigned in Section 2.04(2)(b ) ; ( oo ) means those manufacturing and production standards and quality controlsas set out at Schedule, as may be amended by the Parties from time to time ; ( pp ) ( or ) has the meaning assigned in Section 2.02(4 ) ; ( qq ) has the meaning assigned in Section 4.01 ; ( rr ) has the meaning assigned in Section 2.18 ; ( ss ) in relation to a country or region, means the governmentalauthority, whether federal, state, provincial, or municipal, regulating the use, importation, manufacture, marketing, sale or distribution of pharmaceutical substances and the grant ofMarketing Authorisations in such country or region ; ( tt ) means the period of time during which Feedstock may be stored and remain suitablefor use, which will be a minimum of [ … * * * … ] and may be extended based on stability studiesdemonstrating longer shelf life ; ( uu ) means the specifications for the Feedstock, which are attached as Schedule ; ( vv ) has the meaning assigned in Section 2.02(1 ) ; ( ww ) has the meaning assigned in Section 2.02(1 ) ; ( xx ) has the meaning assigned in Section 3.01 ; ( yy ) means worldwide ; and ( zz ) has the meaning assigned in Section 2.06