definiens: ( as defined in 21 CFR 314.80 or any successor provision thereto ) about which · [COMPANY] obtains information, in accordance with the following procedure : ( i ) Information concerning any Adverse Drug Experience or any clinical complaint associated with the Product shall be reported to MiddleBrook 's designated medical liaison by telefax within twenty - four ( 24 ) hours and by hard copy in writing within three ( 3 ) days after initial receipt of such information ; ( ii ) [COMPANY] 's report to MiddleBrook under Section 2.2(g)(i ) shall contain ( a ) the date the report was received by [COMPANY] ; ( b ) the name of the reporter ; ( c ) the address and telephone number of the reporter ; ( d ) how, when and where the took place ; ( e ) the names and addresses of any injured persons and witnesses ; ( f ) the nature and location of any injury or damage arising out ofthe ; and ( g ) an indication of the adverse drug expenence