Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 156

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 156
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 XACIATO from us in December 2023, commercial production and supply of XACIATO remains subject to comparable manufacturing risks as described herein, and any interruption in the commercial supply of XACIATO that directly or indirectly results in significant loss of product sales could have a material adverse effect on future payments we may receive under the traditional royalty purchase agreement we entered into with XOMA. In some cases, we may be contractually required to obtain clinical or commercial product supplies from specific third parties or there may be a limited number of third-party suppliers of raw materials and other components of our product candidates or future products, which may heighten our dependence on those third parties, increase the risk of manufacturing disruptions, and result in higher development costs or costs of goods sold. Our agreement with ADVA-Tec restricts our ability to engage a manufacturing source for Ovaprene other than ADVA-Tec during Ovaprene's development period as well as following regulatory approval, subject to limited exceptions. If ADVA-Tec fails to provide sufficient clinical supply of Ovaprene on anticipated timelines, our ability to complete clinical development and seek regulatory approval of Ovaprene could be significantly delayed. A substantial scale up in production of Ovaprene clinical supplies was necessary to support the ongoing Phase 3 clinical study of Ovaprene, which took longer and was more expensive than anticipated, and if Ovaprene receives marketing approval, further substantial manufacturing scale up will be necessary. If Ovaprene receives marketing approval, failure by ADVA-Tec to provide sufficient commercial product quantities at reasonable costs could have a significant adverse effect on our revenue and ability to become profitable. Furthermore, for some key raw materials and components of Ovaprene, there currently is only a single source of supply, and alternate sources of supply may not be readily available. 78

We rely on, and intend to continue to rely on, third parties to conduct our clinical and nonclinical studies and execute other significant aspects of our product development programs. Failure of these third parties to successfully carry out their contractual duties, comply with our clinical protocols or regulatory requirements and applicable law, or meet expected deadlines may cause significant delays in our development timelines and/or failure of our programs. Our business model relies on the outsourcing of important product development functions, tests and services to third parties. We rely on CROs, medical institutions, clinical investigators, laboratories, vendors and consultants to conduct all of our clinical trials and perform nonclinical testing. These third parties play