Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 185

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 185
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 costly or damaging to us; • inability to procure or maintain state licenses in those states into which our proprietary Sildenafil Cream formulations are shipped; • third parties may not devote sufficient resources to our needs; • the operations of third parties could be disrupted by conditions unrelated to our business or operations; and • logistics carrier disruptions or increased costs that are beyond our control. Adverse developments affecting the supply of sildenafil citrate or the compounding or distribution operations of parties involved in the compounding and distribution of our proprietary Sildenafil Cream formulation may result in lot 93

failures, inventory shortages, shipment delays, product withdrawals or recalls or other interruptions in the availability of our proprietary Sildenafil Cream formulation. We may also have to undertake costly remediation efforts, or seek more costly supply, compounding and distribution alternatives. Some of these events could be the basis for FDA action, including injunction, request for recall, seizure, total or partial suspension of production, or issuance of a Form 483 or Warning Letter. Our plan to bring our proprietary Sildenafil Cream formulation to market under Section 503B will subject us to a variety of new regulations and related potential liability. We plan to enter into arrangements with one or more outsourcing facility(ies) to produce and distribute our proprietary Sildenafil Cream formulation under Section 503B. An outsourcing facility must meet certain conditions under Section 503B, including registering with the FDA, operating in compliance with the FDA’s cGMP regulations and guidance, and is subject to FDA inspection. Outsourcing facilities have been subject to increased scrutiny of their compounding activities by the FDA and state governmental agencies. Governmental inquiries or actions or litigation brought against us or any of our suppliers or outsourcing facilities relating to our proprietary Sildenafil Cream formulation, whether or not such inquiry, action or litigation ultimately results in penalties, changes to our business practices or other consequences, could have an adverse effect on our reputation, business and financial condition. We or any outsourcing facility with which we have a business relationship may also face allegations, litigation, and regulatory investigations under federal or state laws related to the promotion, advertising, fulfillment, distribution, and/or sale of our proprietary Sildenafil Cream formulation under Section 503B. Litigation and regulatory proceedings, and particularly the healthcare, pharmaceutical-related, consumer protection, data privacy and/or class action matters we could face, may be protracted and expensive, and the results are difficult to predict. Such litigation or regulatory proceedings and investigations, unexpected side effects or safety or efficacy concerns with our proprietary Sildenafil Cream formulation or related negative