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.
Export + International Trade Compliance Advice for University Client
In 2016, Kegler Brown represented a public university with the analysis of obligations under the U.S. Department of State, International Traffic in Arms regulations (ITAR), U.S. Department of Commerce, Export Administration Regulations, and sanctions administered by the U.S. Department of Treasury, Office of Foreign Assets Control related to the release of technology and software to certain countries outside of the United States.
Export Compliance Program Development for a Public University
Since 2013, our firm has represented a public university in the U.S. with the development and operation of an Export Compliance Program. Our role included providing strategic assistance with the creation of risk assessments, as well as advice related to the formation of an export compliance task force. During this process, we assisted with the identification and analysis of export activities throughout the university, the identification and assessment of existing compliance capabilities, and the development of the export compliance program. We continue to provide ongoing training and assistance related to the implementation and assessment of the program.
Federal Export Investigations Assistance
From 2015-2016, Kegler Brown assisted a global freight forwarding company with U.S. Department of Homeland Security, U.S. Department of State, and U.S. Department of Treasury export investigations.
Homeland Security Compliance + Communications for University Client
A public university utilized Kegler Brown’s representation in response to inquiries by the Department of Homeland Security related to restricted research access. Our involvement included the analysis of both contractual and compliance obligations and strategic advice related to communicating with applicable government authorities.
International Spin-off of Dayton Tool Company Assembly Plant
Kegler Brown attorneys recently represented a Dayton, Ohio, tool company (“ToolCo”) in the sale of its subsidiary assembly plant in Mexico City to an international supplier of parts for light-duty trucks. The subsidiary was organized under the laws of Mexico and was subject to Mexican labor law and Mexican contract law. Extensive negotiations were required with Mexican labor organization and Mexican tax authorities.