definiens: means ( a ) a Phase III Clinical Trial, or ( b ) a Clin ical Trial regarding the efficacy and safety of a Product, whi ch is designed to demonstrate statistically whether such Product is effective and safe for use in a particular Indication in a manner that generates data sufficient ( by itself or together wi th other Clinical Trials ) to permit the submission of a BLA for such Product, consistent wi th regional regulatory requirement for an accelerated approval pathway . To the extent that su ch approval is associated with conditional approval in Japan for a hematology oncology indicat ion, which may be granted on the temporary basis with Phase 2 data, and that a furth er confirmatory Clinical Trial is required before the full approval can be granted in Japan, t hen 50 % of the BLA - enablin g Clinical Trial milestone will be due sixty ( 60 ) days after receipt of such conditional approval, wi th the other 50 % becoming due within sixty ( 60 ) days after the date that the database for the confi rmatory Clinical Trial has been locked