Keryx and Patheon Manufacturing enter master manufacturing services agreement
On October 12, Keryx Biopharmaceuticals and Patheon Manufacturing Service and certain of its affiliates entered into a Master Manufacturing Services Agreement and two related Product Agreements for Patheon's manufacture of commercial supplies of Auryxia tablets at Patheon's Greenville, North Carolina and Bourgoin-Jallieu Cedex, France manufacturing sites. Under the Agreement, Keryx is responsible for supplying the active pharmaceutical ingredient for Auryxia to Patheon. Patheon is responsible for manufacturing the Auryxia tablets, conducting quality control, quality assurance, analytical testing and stability testing, packaging, and providing related services for the Auryxia tablets. Pursuant to the Agreement, Keryx has agreed to order from Patheon at least a certain percentage of its annual commercial requirements for Auryxia tablets in the United States and European Union each year for the term of the Agreement, which initial percentage is subject to reduction if Patheon fails to supply specified quantities of Auryxia tablets within specified timeframes.The Agreement has an initial term ending December 31, 2021, and will automatically renew after the initial term for successive terms of two years each, unless either party gives notice of its intention to terminate the Agreement within a specified time prior to the end of the then current term.Keryx may terminate a Product Agreement upon 30 days prior written notice if any governmental agency takes any action that prevents Keryx from researching, developing, importing, exporting, purchasing, selling or otherwise commercializing Auryxia. Further, Keryx will give at least six months' advance notice if Keryx intends to no longer order manufacturing services for Auryxia due to discontinuance of Auryxia in the market.