Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 208

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 208
---
 which may include discussing a mechanism to potentially provide for additional future payments by us in support of the Phase 3 study for the CCTN sites to complete subjects already enrolled, in the event that the currently budgeted CRADA funds are insufficient. If NICHD is unable to enter into new contracts or contract modifications with CCTN sites for a prolonged period, or terminates its contracts with CCTN sites in our study before the study follow-up visits with existing participants are completed or before the study is completed, we may determine to contract directly with those sites to enable them to restart recruitment and enrollment of new participants and/or ensure they remain active sites to continue follow-up with existing participants, which could increase the time and cost to us to complete the study. In addition, if CCTN sites are closed, some participants may drop out of the study, which could adversely affect completion or results of the study.

Though the CRADA has a five-year term ending in 2026, either party may terminate it for any reason or for no reason upon 30 days’ prior written notice to the other party. Termination of the CRADA by NICHD or by us could significantly delay the conduct and/or completion of the Phase 3 study and significantly increase the overall timeline and costs for development of Ovaprene. If the CRADA is terminated before completion of the Phase 3 study, NICHD will cooperate with us to transfer the data and the conduct of the study to us or our designee and will continue to conduct the study for so long as necessary to enable such transfer to be completed without interrupting the study. If we terminate the CRADA before the completion of any active study protocol, we generally will be responsible for providing sufficient clinical supplies of Ovaprene to NICHD in order to complete the study. NICHD may retain and use the cash payments we have made under the CRADA for up to one year after expiration or termination to cover costs associated with the conduct of activities described under the research plan in the CRADA that were initiated prior to expiration or termination. Suspension by NICHD of activities under the CRADA or termination by NICHD or by us of the CRADA could have a material adverse effect on the Phase 3 study and on our business, results of operations and financial condition, and may cause the market price of our common stock to decline.

We do not have, and we do not have plans to establish, our own manufacturing capabilities and instead rely on third-party suppliers and manufacturers for our clinical study supplies, including multiple single source suppliers and