Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 96

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 96
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aprene and Sildenafil Cream, have only a single source of supply and alternative supply sources may not be readily available. Global supply chain disruptions, including those related to recent and ongoing geopolitical events, may contribute to manufacturing and supply delays. See ITEM 1A. "RISK FACTORS – Risks Related to Product Research & Development and Regulatory Approval – Delays in the manufacture of our clinical supplies as well as other supply chain disruptions could postpone the initiation of or interrupt clinical studies, extend the timeframe and cost of development of our product candidates, delay potential regulatory approvals and impact the commercialization of any approved products” below.

19

Strategic Agreements for Product Commercialization 

Organon License Agreement

In March 2022, we entered into an agreement with Organon, which became fully effective in June 2022, whereby Organon licensed exclusive worldwide rights to develop, manufacture and commercialize XACIATO and other future intravaginal or urological products for human use formulated with clindamycin that rely on intellectual property we control. In 2022, we received a $10.0 million non-refundable and non-creditable payment from Organon, which was recorded as license fee revenue. In 2023, Organon paid us $1.0 million in connection with entering into an amendment to our license agreement, which was also recorded as license fee revenue, and $1.8 million in connection with the first commercial sale of a licensed product in the United States, which was recorded as milestone revenue.

Under the terms of our license agreement, as amended, Organon agreed to pay tiered double-digit royalties based on net sales and potential future milestone payments of up to $180.0 million in tiered commercial sales milestones and regulatory milestones. Royalty payments will be subject to customary reductions and offsets. The royalty period for each licensed product will continue on a country-by-country basis from the first commercial sale of the licensed product in the country until the expiration of the later of (i) the date that no valid patent claim would be infringed in the absence of the license granted under the agreement by the sale of the licensed product in the country, (ii) 10 years after the end of the month in which the first commercial sale of the licensed product in the country occurred, and (iii) the expiration of regulatory market exclusivity for the licensed product in that country.

As described below, in April 2024, we sold to XOMA our rights to all royalty and potential milestone payments