definiens: shall mean the ( a ) United States investigational new drug application ( ! ND ) # 51,111, dated July 15, 1996 ; ( b ) United States IND # 54,597, dated November 20, 1997 ; ( c ) Spain CTA # PEI97 - 06 dated August 17, 1998 ; ( d ) Canada IND # # 044571, 056065 and 056082, approved September 25, 1996, June 16, 1998, June dcb / agreementslversicor / versicor agreement-FINAL.doc -8 - 16,1998, respectively ; ( e ) Japan IND # 10 - 2469, dated August 3,1998 ; and ( g ) equivalent filings, authorizations and applications in the countries of France, Uni ~ ed Kingdom CTX 6/350 / A # 61292 ; and Belgium, Finland ( KLN nro 130/98 ), Germany ( 4013536 ), Argentina ( 2345/98 ) and Brazil ; and ( h ) all amendments and reports related to the aforementioned documents