Historic Agreement between U.S. and Cuba Pharmaceutical Companies
Since 2015, our firm has served as counsel to Mercurio Biotech, a start-up U.S. biotech company, throughout a lengthy negotiation process with Cuban state owned biotechnology companies.
This involved advice on complex regulatory, legal and political matters, as well as numerous meetings in Washington, D.C., with U.S. regulators and officials, and many meetings in Havana with Cuban officials to negotiate various agreements. In 2018, these negotiations resulted in agreements between the Cuban company Heber Biotec S.A. and Mercurio Biotec to bring the Cuban diabetic foot ulcer medication Heberprot-P to the United States for clinical trials and, if approved by the FDA, commercialization of Heberprot-P in the U.S. The agreements are historic within the context of U.S.-Cuba political and business relations and Kegler Brown is only the second U.S. law firm to successfully complete any such agreements with Cuba. Kegler Brown continues to provide counsel as these agreements progress into new phases.