definiens: means, through the conduct of the POC Studies, th e determination in human clinical studies that the use of ImmTOR in conjunction with ( a ) AAV [ * * * ] or ( b ) [ * * * ] as mutually agreed by both Parties for the treatment of Methylmalonic Acidemia ( MMA ), based on Selecta ’s product candidate SEL- 302, in each case, ( a ) and ( b ), using both the Selecta Core Technology and the [COMPANY] Core Technology, serves to mitigate the formation of neutralizing anti- AAV capsid antibodies ; provided, however, that if t he FDA does not approve the conduct of the POC Studies wit h respect to the [ * * * ] or otherwise withdraws suc h approval, then POC shall also mean, through the con duct of other studies mutually agreed to by the Parties, the determination in human clinical studie s that the use of ImmTOR serves to mitigate the formation of neutralizing anti - AAV capsid antibodie s. Fo r clarification, the Parties may elect to conduct the POC Studies in territories outside of the Unite d States