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Swedish Orphan Biovitrum AB and Biogen Idec Update on rFVIIIFc and rFIXFc Hemophilia Programs
Swedish Orphan Biovitrum AB (Sobi) announced that the Company and Biogen Idec have agreed to disclose further details on their agreement regarding the development and commercialization of recombinant factor VIII and factor IX hemophilia programs restructured in February 2010. Under the new agreement, Biogen Idec assumed full development responsibilities and costs, as well as manufacturing rights. In addition, the cross-royalty rates were reduced and commercial rights for certain territories were changed. Subject to the exercise of an option right, Sobi will have commercial rights in Europe, Russia, Turkey and certain countries in the Middle East (the Sobi territory). Biogen Idec has commercial rights for North America (the Biogen North American territory) and for rest of the world markets outside of Europe, Russia, Turkey and certain countries in the Middle East (the Biogen Direct territory). Under the terms of the option right and following Biogen Idec's submission of a marketing authorization application to the European Medicines Agency (EMA) for each program, Sobi may opt to take over final regulatory approval, pre-launch and commercialization activities on the Sobi territory at a cost of USD 10.0 million per program. Sobi will be liable to reimburse Biogen Idec 50% of the sum of all manufacturing and development expenses incurred by Biogen Idec from October 1, 2009, as well as 100% of certain development expenses incurred exclusively for the benefit of the Sobi territory.
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