definiens: shall mean : ( a ) with respect to the On - Going Phase I / II Trial, no treatment - related safety findings during the treatment periodand the six ( 6 ) month follow up period, that were considered by the Independent Safety Monitoring Board for the On - GoingPhase I / II Trial ( in accordance with and subject to the Independent Safety Monitoring Board Charter attached hereto asSchedule 1.42(a ) ) to be of sufficient concern to discontinue the On - Going Phase I / II Trial ; ( b ) with respect to the Interim Analysis of the Pivotal Clinical Trial / Phase IIb Proof of Concept, safety andefficacy data from completion of all patients at the [ * * * ] follow up demonstrates more than a [ * * * ] probability of meeting pre - specified endpoints at [ * * * ] in the Pivotal Clinical Trial, and no apparent safety signal in the treatment group for the entire cohortat all times ; ( c ) with respect to the Pivotal Clinical Trial for the Primary Indication, safety and efficacy data from completionof all patients at the [ * * * ] follow up meets the primary endpoint and demonstrates a positive benefit - to - risk ratio to enable FDAsubmission ; and ( d ) with respect to all other clinical trials of a Product, that the JDC has determined that the final results of suchclinical trial have achieved the success criteria established by the JDC with respect to such clinical trial