Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 229

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 229
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 also “Risks Related to Our Business Operations and Industry- The pharmaceutical and medical device industries are highly regulated and subject to various fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback Statute, the U.S. federal False Claims Act and the U.S. Foreign Corrupt Practices Act” below. 

If we or our commercial collaborators, as applicable, cannot successfully manage the product promotion to ensure compliance with these legal and regulatory requirements, we could become subject to significant liability, our reputation could be damaged, and adoption of our products could be considerably impaired.

Unexpected safety, efficacy or quality concerns relating to XACIATO could develop, which could have significant negative consequences for us.

XACIATO was approved by the FDA based on prior findings of safety or effectiveness of previously approved clindamycin products and on clinical data from the Phase 3 DARE-BVFREE clinical trial, in which 307 patients were randomized and treated once. In light of its commercial launch, XACIATO will be used by larger numbers of patients, and some patients may use multiple regimens over the course of a year. New data may emerge from market surveillance or future clinical trials of XACIATO that give rise to safety, efficacy or quality concerns and result in negative consequences, including: 

•modification to the product’s prescribing information, such as the addition of boxed or other warnings, contraindications, or limitations of use;

•restrictions on the promotion or marketing of the product;  

•issuance of “Dear Doctor Letters” or similar communications to health care professionals or the public regarding safety or efficacy concerns;

•imposition of post-marketing clinical trial requirements or other post-marketing studies; 

•product distribution restrictions or other risk management measures, such as a risk evaluation and mitigation strategy, or REMS, which could include elements to assure safe use;

•warning or untitled letters;

•suspension or withdrawal of marketing approvals; 

•suspension or termination of ongoing clinical trials, if any; 

•refusal by regulators to approve pending marketing applications or supplements to approved applications that we submit;

•suspension of, or imposition of restrictions on, the operations of our commercial collaborator or any CMO producing commercial supplies of XACIATO, including costly new manufacturing requirements;

•costly and time-consuming corrective actions; 

•voluntary or mandatory product recalls or withdrawals from the market;

•significant reputational harm; and 

•product liability claims and lawsuits