The following is from Botanix announcement and should answer your questions
Botanix will assume responsibility for the future development of Sofpironium Bromide including filing for approval with FDA and any other international regulatory authority outside of Kaken’s Far East Asia licensed territory. The asset has been licensed to leading pharmaceutical company Kaken Pharmaceuticals (“Kaken”) in Japan, who has already secured approval of sofpironium bromide 5% for the treatment of primary axillary hyperhidrosis from the Japanese equivalent of the FDA, the Pharmaceuticals and Medical Devices Agency (“PMDA”). Kaken launched sofpironium bromide 5% in late 2020 and is expected to work closely with Botanix to support the approval of the product in the USA and will take the lead in filing for approvals in other Far East Asian countries. As part of the purchase price, Botanix is entitled to retain 25% of the royalties and milestone payments that Botanix receives from Kaken.
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