Ropes & Gray Represents uniQure in $1.6 Billion Global Licensing Agreement with CSL Behring to Commercialize Hemophilia B Gene Therapy

Ropes & Gray represented Amsterdam-based gene therapy company uniQure N.V. in a licensing agreement to provide biopharmaceutical company CSL Behring with exclusive global rights to uniQure’s investigational gene therapy for patients with hemophilia B. The transaction was announced on June 24.

The collaboration leverages CSL Behring’s global commercial infrastructure in hematology to accelerate access to uniQure’s gene therapy to hemophilia B patients worldwide.

Under the financial terms of the agreement, uniQure will receive a $450 million upfront cash payment and be eligible to receive up to $1.6 billion in payments based on regulatory and commercial milestones. uniQure will also be eligible to receive tiered double-digit royalties in a range of up to a low-twenties percentage of net product sales arising from the collaboration.

Under the development terms of the agreement, uniQure will be responsible for the completion of the pivotal study, manufacturing process validation, and the manufacturing supply of gene therapy until such time that these capabilities are transferred to CSL Behring. Clinical development and regulatory activities performed by uniQure under the agreement will be reimbursed by CSL Behring. CSL Behring will be responsible for regulatory submissions and commercialization of the gene therapy. 

The closing of the transaction is contingent on completion of review under antitrust laws in the United States, Australia and the United Kingdom.

The Ropes & Gray team included IP transactions partner David McIntosh (Boston), litigation & enforcement partners Michael McFalls (Washington, D.C.) and Ruchit Patel (London), tax partner David Saltzman (Boston) and IP transactions associate Hannah Freeman (Boston).