definiens: tcnt Authority(ie . ) " means COlle<:liveiy the entitie~ in each country in the Territory · responsible for ( a ) the regulation of medicinal products intended for hllman IlSC Of the establishment, maintenance and/or protection of rights related to the Patent Rights, including bllt not limited to til < ' fDA, the Ellropean Agency for Evaluation of Medicinal Products ( " EMEA ', ), and the Ministry of Health, I .. abor and Welfare in Japan, and any other applicahl e administmtive agenc ), in any conntry in tll < ' Territory having the aforementioned responsibilities, and any, uccns.or entitie, thereto, ( b ) the estahlishment, maintenanc e and10r protection of rights related to the Patent RightUSPTO " ), and ( cl any other applicable regulatory or administrative agenoy in any country in the TelTitory that is comparable to, or a counterpart of, the foregoing, 1.4 means the Company 's, its Affiliate ., ', or Sublicensees ' use of commercially reasonable effOlt, to S ~ Gur e Marketing Allthorizations for Li ~ ensed Products in the Territory