definiens: means a change to any lJd.tlng ProdUd, ndudlng lhelnitial Product ' IItlIc : h /MIts ~ of the following c : riteria : ( I ) In respect of wNd'I the govlrning r.guIatory authority would r.quIre ~ PIvot . ! ClIniCal Tnal . belen granting R ~ tory ' Appmvll, and ( Ii ) wnId'I i. for a dil'fWWlllablllndlcation than such Product . and ( i ) wnId'I targets a different organ than .ud ' ! Produc : l mean . the later 01 ( I ) October 1, 19117, ot ( Kl any extensions ol.ud'I data pursuant to this Agrllment or, if earlier than Ihose datil, 1hI AccapWlel of a Cualified Gene