HUMA · Humacyte, Inc.

Humacyte, Inc. entered into a Third Amendment to its Distribution Agreement with Fresenius Medical Care Holdings, Inc., originally dated June 25, 2018. This amendment effectively reverts the ex-U.S. commercialization rights for the 6mm acellular tissue engineered vessel (Symvess) back to Humacyte. Consequently, Humacyte now possesses the sole right to develop, manage regulatory affairs, and commercialize the product globally. This strategic realignment allows Humacyte to directly advance commercial initiatives in regions such as the Kingdom of Saudi Arabia and Israel, and to actively pursue new corporate partnerships for international and indication-specific rights.

In consideration for the reversion of rights, Humacyte agreed to pay Fresenius low-single-digit royalties on net sales outside the United States. These royalties are subject to a 'Holiday Period'—a two-year royalty-free window following the product launch in each specific country. The existing terms regarding U.S. distribution remain unchanged; Humacyte will continue to pay Fresenius royalties on U.S. net sales at rates ranging from mid-single digits to low double digits. Additionally, Fresenius retains an obligation to adopt the product as a standard of care for hemodialysis patients where clinically supported. The amendment also grants Humacyte a non-exclusive, sublicensable license to Fresenius Technology necessary for the product's exploitation worldwide.