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Biogen gains recombinant factor VIII, factor IX manufacturing rights

Sobi and Biogen have announced an agreement under which Biogen assumed full development responsibilities and costs, as well as manufacturing rights of long-lasting recombinant factor VIII and factor IX.

Under the agreement, the cross-royalty rates were reduced and commercial rights for certain territories were changed.

Sobi will have commercial rights in Europe, Russia, Turkey and certain countries in the Middle East (the Sobi territory).

Biogen has commercial rights for North America and for rest of the world markets outside of Europe, Russia, Turkey and certain countries in the Middle East (the Biogen Direct territory).

Following Biogen’s submission of MAA to EMA for each program, Sobi may opt to take over final approval, pre-launch and commercialization activities in its territory at $10m per program.

To effect Sobi’s reimbursement to Biogen for each program, the cross-royalty structure for direct sales in each company’s respective territories will be adjusted until the consideration is paid in full.