definiens: re.uooable effons " sllall mean effon s and resources commonly used In the reselrch·bls.ed phannaceutkll industry fOf I product at I similar $ lacc in i15 product lifc tiling into account the cstlblishment of the produ ct In thc markctpla ce . the compctllivcllCss of the marketplacc . the propricury position of the product . the regulalOry StruCture mvol ved . the profitability of the producllnd other relevant factors . Su ch rcsotJrc cs and effons shall be detennmed for a panicular ProdIKl and it is Inticipated that the le\cI of effon wlll chal\le over time ~f1cct i n, c han~ s tn the SUNS of the Product and the marltetplace