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AMENDMENT #1 TO CLINICAL STUDY AGREEMENTStudy Agreement • September 12th, 2023
This Amendment (the "Amendment") to the Clinical Study Agreement, dated 18th May 2023 (the “Agreement”), for the clinical study (the “Study”) sponsored by Celcuity, Inc. having its registered place of business at 16305 36th Avenue North, Suite 100, Minneapolis, MN 55446, USA (the "Sponsor"), conducted in accordance with the protocol CELC-G-301 “A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1)” and any amendments thereto (the “Protocol”), is made by and between:
