Bayer AG agreed to acquire a license that grants the company an option to commercialize Daré Bioscience Inc.'s experimental contraceptive product Ovaprene in the U.S. after the intervaginal ring is approved.
San Diego-based Daré Bioscience will have full control of the development and regulatory processes access, while Bayer will allow the company access to its clinical and market resources.
Under the agreement, Daré will receive an up-front payment of $1 million and access to Bayer's clinical and market capabilities while retaining control over Ovaprene’s development and regulatory approval process.
If Bayer makes a payment of $20 million to Daré, which plans to apply for reimbursement of clinical study costs, then the exclusive license to commercialize Ovaprene in the U.S. will become effective.
According to a Jan. 13 press release, Daré will also be eligible to receive up to $310 million in potential milestone payments as well as double-digit tiered royalties on net sales.
Daré expects to apply in the first half of 2020 to start clinical studies for the device in the U.S. and plans to begin trials in the second half, subject to the U.S. Food and Drug Administration's approval.
Results from the clinical trials are expected to support marketing applications in the U.S., Europe and elsewhere.