The agreement extends to geographical Europe, the CIS, Latin America, Australia, and New Zealand.
Under the terms of the agreement, Mithra is eligible to receive upfront payments totaling EUR 55 million, of which EUR 5 mln was paid upon signature of a binding term sheet in December 2022, as well as EUR 15 mln in additional milestone payments subject to regulatory achievements and "tiered low double-digit" royalties depending on net sales of the 20-year term contract.
Richter will be in charge of the production and supply of Donesta for all of its territories.
Mithra announced positive top-line results from Donesta phase 3 studies in menopausal women in January 2022.
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