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news.BioSphere Medical, a medical device company, has signed an exclusive agreement with Nippon Kayaku for the planned distribution of HepaSphere microspheres and Embosphere microspheres in Japan.
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According to the agreed-upon terms, Nippon Kayaku will be responsible for regulatory strategy and seeking to obtain requisite product registrations, including performing any clinical studies that may be required as a condition to product registration, and will bear the related cost for these activities.
Assuming either or both of the products receive market clearance and the government reimbursement rate is set, BioSphere will provide the approved product to Nippon Kayaku for distribution and sale based on a predetermined formula indexed to the final Japanese government reimbursement rate.
The agreement calls for BioSphere to receive a $1 million milestone payment in 2009. Also, Nippon Kayaku has agreed to pay up to $3 million in additional milestone payments in subsequent periods based on achievement of product registration goals and revenue targets.
Richard Faleschini, CEO of BioSphere, said: “As a well-respected chemical and pharmaceutical company in Japan with a substantial oncology franchise, we believe that Nippon Kayaku is well positioned to gain regulatory approval for our embolic products and drive market adoption with interventional oncologists in this significant market.”