AMENDMENT #1 TO CLINICAL STUDY AGREEMENTClinical Study Agreement • November 24th, 2020
Contract Type FiledNovember 24th, 2020This Amendment (the "Amendment") to the Clinical Study Agreement, dated 26 November 2019 (the “Agreement”), for the clinical study (the “Study”) sponsored by MENARINI RICERCHE S.P.A., with head office at 10, Via Tito Speri, 00071, Pomezia, Rome, Italy having its registered place of business at 10, Via Tito Speri, 00071, Pomezia, Rome, Italy (the "Sponsor"), conducted in accordance with the protocol DELA-01 “A randomized, observer- blinded, active-controlled, Phase IIIb study to compare IV / Oral delafloxacin fixed-dose monotherapy with best available treatments in a microbiologically enriched population with surgical site infections” and any amendments thereto (the “Protocol”), is made by and between: