Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 203

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 203
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 on which we rely may not be effective. The occurrence of such an event or condition could cause significant delays in the timelines for our clinical studies, our regulatory submissions or potential marketing approvals of our product candidates, substantially increase our development costs, and delay or contribute to delays in the commercial launch of any approved product or market acceptance of the product. The longer such an event or condition persists, the greater the potential for significant adverse impacts to our business operations and those of the CROs, CMOs, commercial collaborators, and other third-party service providers and vendors on which we depend to, among other things, conduct our clinical and nonclinical studies, supply our clinical trial materials, assist with regulatory affairs necessary to advance and seek regulatory approval for our programs, and market, sell and distribute our products, if approved for commercial sale. Public health emergencies, natural or manmade disasters, acts of terrorism, war or telecommunications or electrical failures may also have the effect of heightening many of the other risks and uncertainties described in this Risk Factors section. Product liability lawsuits against us could cause us to incur substantial liabilities. We face an inherent risk of product liability exposure as a result of testing of our product candidates in human clinical trials and will face an even greater risk following commercial launch of a product we develop. If we cannot successfully defend ourselves against claims that our products or product candidates caused injuries, we will incur substantial liabilities or be required to limit commercialization of our products. Regardless of merit or eventual outcome, liability claims may result in: • decreased demand for any marketed product; • product recalls, withdrawals or labeling, marketing or promotional restrictions; • termination of product development or commercial collaborations; • loss of revenue; • withdrawal of clinical study participants and delays in commencement or completion of clinical studies; • injury to our reputation and significant negative media attention; • significant costs to defend the related litigation; • substantial monetary awards to patients or clinical study participants; • diversion of our management’s time and other resources from pursuing our business strategy; and • a decline in our stock price. We carry product liability insurance that we believe to be adequate for our clinical testing and product development programs and in connection with XACIATO. However, insurance coverage is increasingly expensive, and it may be difficult to obtain adequate product liability insurance in the future. Our inability to obtain and retain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of any of our product candidates, if approved for commercial sale. We also have indemnification obligations to our