definiens: shall mean sixty ( 60 ) days after the completion of statistical analyses o f the final results of those Phase II clinical studies wh ich BUKWANG or its sublicensee considers reasonably necessary for the purpose of inclusion i n a New Drug Application,, or other such application submitted to the regulatory authorities in a given country, requesting marketing approval for Licensed Product(s ) . As used in the preceding sente nce, “ Phase II clinical trials shall mean those wel l - controlled clinical trials sponsored by BUKWANG or its sublicensee, the primary objective of which ( as reasonably determined by BUKWANG or its sublice nsee ) is to ascertain additional data regarding the safety 1 Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality . Such omi tted portions, which are marked with brackets and asteri sks [ * * * ], have been separately filed with the Comm ission