definiens: means ( i ) any investigational new drug applicatio n, as defined in 21 C.F.R. § 312.3(b ) ( or any successor statute or regu lation, as updated from 36 ACTIVE/104823866.3 time to time ) or any comparable application filed w ith the applicable Regulatory Authority in a given country or regulatory jurisdiction, the filing of w hich is necessary to commence or conduct clinical testing of a product in humans in such country or j urisdiction, and ( ii ) all supplements and amendment s that may be filed with respect to the foregoing . ( x ) means, without duplication, ( i ) any indebtedness for borrowed money ( including the issuance of any debt security ) to any Person, ( ii ) any obligations evidenced by notes, bonds, debentures or similar Co ntracts ( as defined below ) to any Person, ( iii ) any obligations for the deferred purchase price of prop erty, goods or services to any Person, ( iv ) any cap ital lease obligations properly categorized as such unde r GAAP to any Person, ( v ) any obligations in respec t of letters of credit and bankers ’ acceptances, or ( vi ) any guaranty of any such obligations described in clauses ( i ) through ( vi ) of any Person, in each cas e, together with all interest, fees and penalties r elating to any of the foregoing