Akebia grants Averoa exclusive license for ferric citrate in European area, U.K.

In a regulatory filing, Akebia Therapeutics disclosed that on December 22, the company, Keryx Biopharmaceuticals, a wholly-owned subsidiary of the company, and Averoa SAS entered into a license agreement, pursuant to which the company granted to Averoa an exclusive license to develop and commercialize ferric citrate in the European Economic Area, Turkey, Switzerland and the United Kingdom. Under the license agreement, the company is entitled to receive tiered, escalating royalties ranging from a mid-single digit percentage to a low double-digit percentage of Averoa’s annual net sales of the licensed product in the territory, including certain minimum royalty amounts in certain years, and subject to reduction in certain circumstances. The royalties will expire on a country-by-country basis upon the latest to occur of (a) 10 years following the date of first commercial sale of the licensed product in such country; (b) expiration of the last valid claim of company patent rights and joint patent rights in such country; and (c) the date of expiration of the data, regulatory, or marketing exclusivity period conferred by the applicable regulatory authority in such country with respect to the licensed product. The company and Averoa will establish a joint steering committee to oversee the development, manufacturing and commercialization of the licensed product in the territory. The license agreement expires on the date of expiration of all royalty obligations due thereunder with respect to the licensed product on a country-by-country basis in the territory, unless earlier terminated in accordance with the agreement. Averoa has the right to terminate the license agreement upon 30 days’ notice if the European Medicines Agency rejects Averoa’s marketing authorization application for the licensed product and the parties in good faith agree that submitting a new MAA to the EMA will not result in approval. The license agreement provides that the company and Averoa will enter into a supply agreement pursuant to which the company will supply the licensed product to Averoa for commercial use in the territory. The company will have the right to terminate the supply agreement for convenience upon 24 months’ notice, which may be provided on or after January 1, 2024.