Novartis has reached an agreement to transfer the worldwide marketing and distribution rights of Apligraf, previously licensed to Novartis, back to Organogenesis, which developed the product and remained solely responsible for the manufacture of the product.
Apligraf is a wound care substitute approved by the FDA for treatment for venous leg and diabetic foot ulcers. Deliveries of Apligraf to Novartis have been suspended since 9 September 2002 in advance of the filing of a voluntary petition for reorganization under Chapter 11 of the US Bankruptcy Code by Organogenesis on 25 September 2002.
Under the terms of the agreement, Novartis will market and distribute Apligraf until 17 June 2003 and will transfer marketing and distribution rights back to Organogenesis at the time of consummation of Organogenesis' plan of reorganization. The agreement gives Organogenesis until 31 August 2003 for the consummation of its plan of reorganization. Novartis' ability to resume marketing and distribution of the product is contingent upon Organogenesis' compliance with applicable regulatory requirements. As a consequence of that bankruptcy filing by Organogenesis, the proposed agreement with Novartis is subject to approval by the US bankruptcy court for the District of Massachusetts.