definiens: means a therapy in the Field that, based on the data then available, ( a ) dcmonstrably appears to ofIer cithcr supcrior cfficaey or safety or significantly lower cost oftherapy, as compared with both ( i ) those therapies that arc marketed ( either by Ampliphi or others ) at such time for the indication or, as evidenced to lntrexon by Ampliphi, have been in human clinical trials for the same indication by Third Parlies, and ( ii ) those therapies that are being actively developed by AmpJiphi for such indication or known by Ampliphi to be or have been in human clinical trials for thc same indication by othcrs ; ( b ) demonstrably appears to represent a substantial improvement over such existing therapies ; and ( c ) has intellectual property protection and a rcgulatory approval pathway that, in cach case, would not present a significant barrier to commercial development 1.54 has the mean111 g set forth 111 Section 3.8(a )