Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 11

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 11
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-19 pandemic. In 2022, we licensed to Organon exclusive worldwide rights to develop, manufacture and commercialize XACIATO. See "Strategic Agreements for Product Commercialization" below for further discussion of the terms of our agreement with Organon. We remained the NDA holder of XACIATO until December 2023, at which time the NDA was transferred by the FDA to Organon, and Organon assumed all manufacturing responsibilities, regulatory and compliance matters. Organon is also responsible for commercializing, promoting, determining pricing, and negotiating reimbursement matters related to XACIATO. Organon commenced U.S. marketing of XACIATO in the fourth quarter of 2023, and, in January 2024, announced that XACIATO was available nationwide. As described below, to provide funding for the development of the product candidates in our pipeline, in April 2024, we sold to XOMA our rights to all royalty and potential milestone payments based on net sales of XACIATO under our 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. See below under "Royalty Monetization Transactions" for additional details. XACIATO previously received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for the treatment of bacterial vaginosis in women. As a result of the QIDP designation, XACIATO was eligible to receive a five-year extension of the three years of data exclusivity in the U.S. available to the product based on the submission of new clinical data that were essential to its approval. The FDA granted XACIATO for the treatment of bacterial vaginosis in female patients 12 years of age and older three years of data exclusivity, which was extended by five years, such that the data exclusivity period will expire on December 7, 2029. XACIATO has also been designated as a reference listed drug by the FDA for purposes of future generic drug development. The data exclusivity period should block the FDA from approving either a subsequent abbreviated NDA or 505(b)(2) NDA that relies in whole or in part on our protected clinical data. See also "Government Regulation - U.S. Government Regulation- New Drug Marketing Exclusivity under the Hatch-Wax