Lexology November 22, 2024
As briefly mentioned in our article last week on Priority Review Vouchers, the financial terms of a biopharma patent licence agreement typically include some combination of an upfront fee, royalties and/or milestone payments. Conventionally, milestone payments are triggered upon successful achievement of a regulatory or commercial event (e.g. commencement of specific clinical trial phases, obtaining a marketing authorisation (“MA”) or hitting certain sales thresholds).
However, with the push towards precision medicines and advanced therapies, more complex biotechnology products, the blurring of boundaries between clinical trial phases and myriad regulatory decisions to make, we often come across triggers in patent licences which are not appropriate for the type of product licensed. The recent announcement of the advancement of Regenxbio’s Duchenne muscular...
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