Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 41

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 41
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 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 based on net sales of XACIATO under our license agreement with Organon, net of our obligations to certain third parties, until XOMA receives a specified return on its investment, after which we will share equally in the royalty and milestone payments earned on net sales of XACIATO from Organon. Unless terminated earlier, our license agreement with Organon will expire on a product-by-product and country-by-country basis upon expiration of the applicable royalty period for each licensed product. In addition to customary termination rights for both parties, Organon may terminate the agreement in its entirety or on a country-by- country basis at any time in Organon’s sole discretion on 120 days’ advance written notice. Our license agreement with Organon includes customary representations and warranties, covenants