Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 256

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 256
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 and information gained from the project funded by the grant (referred to as the Global Access Commitment). In connection with the Global Access Commitment, under the agreement, we also granted the foundation that awarded the grant a nonexclusive, perpetual, irrevocable, worldwide, royalty-free, fully paid up, sublicensable license to make, use, sell, offer to sell, import, distribute, copy, create derivative works, publicly perform, and display Funded Developments and essential background technology (referred to as the Humanitarian License). We are required to ensure that the Humanitarian License survives the assignment or transfer of Funded Developments and essential background technology. Our obligations under the Global Access Commitment and the Humanitarian License may limit the value to us of the Funded Developments.

Risks Related to Our Business Operations and Industry

Disruptions at the FDA, NIH, SEC and other government agencies, including due to lack of funding, changes in leadership, significant personnel turnover, or diminished staffing, could delay or disrupt clinical and preclinical development and potential marketing approval of our product candidates and hinder our ability to raise additional capital. 

Twice in the past decade, the previous appropriations legislation deadline was reached and Congress failed to pass a new appropriations bill or continuing resolution to temporarily extend funding, resulting in U.S. government shutdowns that caused federal agencies to halt non-essential operations. The federal government came close to another shutdown several times in recent years. Political polarization among lawmakers may lead to a higher frequency and longer duration of government shutdowns in the future. A federal government shutdown could prevent or delay staff at federal agencies from performing key functions that may adversely affect our business.

In addition, considerable uncertainty exists regarding how federal government policy changes and budget decisions will unfold, including the regulatory and spending priorities of the new U.S. presidential administration and Congress, and what challenges potential policy changes and budget reductions will present for us and our industry generally. Measures being implemented by the new U.S. presidential administration are expected to significantly impact federal regulatory agencies, such as by reducing funding to or restructuring such agencies. For example, in the first quarter of 2025, the new U.S. presidential administration began terminating federal government employees and federal agencies were directed to develop plans for large-scale reductions in force and reorganization. As a result, agencies throughout the federal government may experience mass layoffs, as well as a significant number of voluntary departures. The impact of these changes at federal government agencies with which we interact is uncertain at this time, however,