Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 40

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 40
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 responsible for obtaining supplies, at our expense, of all components necessary for the manufacture of XACIATO, including the API, clindamycin. In December 2023, Organon assumed our obligations under the agreement with the CMO and our product supply agreement with Organon was terminated. Under our agreement with ADVA-Tec, ADVA-Tec is responsible for providing all clinical trial and commercial supplies of Ovaprene, either directly or through a CMO, and except under limited circumstances, we may not obtain supplies of Ovaprene from any source other than ADVA-Tec or its CMO and licensor, Poly-Med, Inc. Other than our agreement with ADVA-Tec, we have no long-term arrangements for the production or supply of our product candidates or the materials required to produce them. Under the terms of our license agreement with SST, SST was responsible for providing clinical supplies of Sildenafil Cream for Phase 2 clinical studies in the U.S., and we are responsible for providing supplies of Sildenafil Cream for Phase 3 clinical development and, if approved, for marketing and sale. Currently, we plan to obtain clinical supplies of Sildenafil Cream from the same CMO that manufactured Sildenafil Cream for the Phase 2b RESPOND clinical study. We expect that our current arrangements will meet our foreseeable needs for clinical trial materials or, generally, that alternative supply sources will be readily available. However, we may experience manufacturing and supply delays and disruptions in the event we need to engage alternative supply sources, as well as in connection with our current CMOs scaling up production to meet our clinical supply requirements for later stage clinical studies. In addition, some key raw materials or components of our clinical-stage product candidates, including Ovaprene 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