definiens: means the occurrence of either of the following : ( a ) [ ... * * * ... ] of [ ... * * * ... ] from the [ ... * * * ... ] of [ ... * * * ... ] - [ ... * * * ... ] for the [ ... * * * ... ] of the Lead Compound demonstrating a [ ... * * * ... ] in at least [ ... * * * ... ] of [ ... * * * ... ] or greater at [ ... * * * ... ] ( [ ... * * * ... ] ) [ ... * * * ... ] ( or such other [ ... * * * ... ] that is accepted by the JSC ) and a [ ... * * * ... ] that is [ ... * * * ... ] to the [ ... * * * ... ] and an acceptable clinical safety profile that [ ... * * * ... ] ( [ ... * * * ... ] ) [ ... * * * ... ] as [ ... * * * ... ] ; or ( b ) a decision by the JSC to initiate the Phase 2b HCV Clinical Trial of the Lead Compound based on the Target Product Profile