Biopure has manufacturing facilities in Pennsylvania for the collection and separation of blood and in Cambridge, Massachusetts, where processing is completed. In connection with Biopure’s application for marketing approval for Oxyglobin, the FDA inspected these facilities for compliance with good manufacturing practices. The Medicines Control Agency, on behalf of the European Medicines Evaluation Agency, also inspected Biopure’s facilities prior to granting marketing approval for Oxyglobin.

     Biopure manufactures separation materials in a 10,000 square foot plant in New Hampshire. The current annual lease payment for this facility is $56,000. The lease expires on March 31, 2005. Biopure has an option to extend this lease for an additional five years.

     Biopure leases two facilities for office and research space in Massachusetts. One lease covers 24,000 square feet, and its current annual lease payment is $239,000. This lease expires on December 31, 2007. Biopure has an option to extend this lease for ten five-year periods, or an additional 50 years. The other lease, of office space, covers 14,000 square feet. This lease expires on February 29, 2008, and annual lease payments are $329,000.

     Biopure leases 33,000 square feet of manufacturing space under four leases in Massachusetts. The current annual lease payments for these facilities is $283,000. The leases expire on November 30, 2005. Biopure has an option to extend these leases for four five-year periods, or an additional 20 years, with an exclusive right to negotiate for an additional 25 years. Biopure owns 18,000 square feet of manufacturing space in Pennsylvania. It also leases warehouse space in New Hampshire.

     Biopure’s current process is designed to be scalable, such that additional capacity can be obtained by adding duplicate equipment and additional raw material including power and water. Biopure is in the process of constructing a 1,700 square foot building abutting the existing research and manufacturing building. This will facilitate the addition of utilities to maximize production in Cambridge. The Cambridge facilities currently have the capacity to produce 40,000 units of Hemopure or 140,000 units of Oxyglobin per year, operating continuously. Through the installation of additional water supply and the completion of its automated filling line, Biopure can attain capacity to produce 100,000 units of Hemopure or 350,000 units of Oxyglobin per year in its current facilities operating continuously. Work on the capacity increase to produce approximately 75,000 units of Hemopure is underway. Further validation will be conducted after the biologic license application filing to achieve the 100,000-unit capacity. This capacity can be used for any combination of Oxyglobin and Hemopure units.

     Biopure has selected a site and completed engineering work sufficient to support the start of construction of a new plant with a capacity of 500,000 units of Hemopure. Construction is expected to begin in spring 2002. The plant is designated to be capable of scale-up to meet future product demand. Biopure believes that the engineering from this plant will be applicable to any future new plants.