definiens: means all ! nermal ane eestsmary aetiYities by er sn behalf sf Agseren sr Rsehe, independently sr jSifltly, as the case m~ ' be, as generally set furth in Seetisn 5.Q2 ane BKhibit 1 ( as seeh exhibit is amefldee in the fufw : e ) whieh are neeessary fur the timely develspment sf the Csmpel::lJle ane / sr a PredHet fur eancer ineieatiens, ineleeing, bet net limitee ts : ( i ) furmelatisn ane stability stedies ; ( ii ) sther nsn elinieal stl : ldies, incll : leing te~£ieslegy steeies ( sr the applieable eE):eiYalent ), in preparatisn fur regl : llatery sebmissisns ; ( iii ) manl : lfaetere sf preclinical and clinieal materials ane sl : lpplies ; ( iY ) plar.ning, implementatisn, elialeatisn, aeministratisn and csneeet sf hWHan elinieal trials, incleding pharmacs eesnsmic, E):l : lality sf life ane sther elinieal stHdies whieh are necessary fur the pw - psses sf Registratisn, sr ts expand the labeling sf the Prsdl : lct fur cancer ifleieatisns ; ( v ) maRl : lfactl : lring prseess eeIlelepmeBt ane seale l : lP ; aBd ( vi ) preparatisB and sl : lbmissisn sf Registratisfl applicatisns . The nsrmal and el : lstsmary aetiYities neeessary fur timely develspment sf the CsmpsWld and / sr a Prsdeet fur eaneer indieatisns are, sr will be, eescribee generally in the wsrldw1ee de\'elspment plan whieh is cSBtained in B ~ ffiibit 1, as seeh e ~ ffiibit is amended in the fuMe