definiens: means the following : ( i ) altering the [ Developmen t Plan ] to provide for the Development of [ new indications ] other than the [ Initial Indication . J ; and ( ii ) [ tennill<!tillg a Phase IU Clinical Trial ] for the Product [ prior to completion ] in accordance with its protocol, as a consequence of Iclinical results ] that are likely to affect the [ approved labeling on the Product or [ adversely ] affect the [ potential market ] for such Product [ UllIside the Licen . ed Territory ], other than for purposes of [ addressing patient 18 l I = CERTAI1I > CONfIDEN'IUL INFO){l\I.\ TION C : ONTAIN[O If'\ TillS OOClJ;\IE,'iT., \IAJU .., ED BY UH,\CKETS, IS FI LEO WITH THE SECURITIES Ai'lO EXClIM - ICE COMMISSION I'URSUA NT TO RULE 406 or THE SEC ' URITIES ACT OF J 93.3 . AS AMENDE [ ) . · arety concerns ] or pursuant to a requirem ent imposed by the Regulatory Authorities in the Licensed Territory or the externall11onitoring board for such trial ; ( iii ) altering the [ Development Plan ] or otherwise proposing to conduct or conducting any Development activities in a manner that would reasonably be expected to [ adver ' ely impact ArrYl11ux 's r its Third Party Partner 's own ] ] development or commercia lization efforts for Products in the lAITym<1x Territory ], other than for purposes of [ addressing p, llient safelY concerns J or pursuant to a requirement imposed by the Regulatory Authorities in the Licensed Territory or the external monitoring board for such trial