Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 4

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 4
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 and Cosmetic Act, or FDCA; • The removal of sildenafil citrate or any other bulk drug substance needed to compound the compounded drugs that we seek to make available under Section 503B of the FDCA from the FDA’s list of bulk drug substances that can be compounded under Section 503B of the FDCA; • The performance of third parties on which we will rely to bring to market, or assist us in bringing to market, compounded drugs; • A change in regulatory requirements related to compounded drugs under Section 503B of the FDCA; • Our failure, or a failure of a strategic collaborator, to successfully commercialize our product candidates, if approved, or our failure to otherwise monetize our portfolio programs and assets; • Termination by a collaborator of our respective out-license agreements for commercialization of XACIATO™ (clindamycin phosphate) vaginal gel 2%, or XACIATO, and Ovaprene®, or, in the case of Ovaprene, a decision by the collaborator not to make the license grant fully effective following its review of the results of the ongoing pivotal clinical trial of Ovaprene; 1

• The timing and amount of future royalty, milestone or other payments to us, if any, under our out-license agreement for Ovaprene, and of upside-sharing milestone payments from XOMA under our traditional and synthetic royalty purchase agreements, if any; • The performance of third parties on which we rely to commercialize, or assist us in commercializing, XACIATO and any future product; • Difficulties with maintaining existing collaborations relating to the development and/or commercialization of our product candidates, or establishing new ones on a timely basis or on acceptable terms, or at all; • The terms and conditions of any future strategic collaborations relating to our product candidates; • The degree of market acceptance that XACIATO and any future product achieves; • Coverage and reimbursement levels for XACIATO and any future product by government health care programs, private health insurance companies and other third-party payors; • Our loss of, or inability to attract, key personnel; • A change in the FDA's prior determination that the Center for Devices and Radiological Health would lead the review of a premarket approval application for potential marketing approval of Ovaprene; • A change in regulatory requirements for our product candidates, including the development pathway pursuant to Section 505(b)(2) of the FDCA, or the FDA's 505(b