Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 210

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 210
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 or personnel constraints, their obligations to, or their decision to prioritize the production and supply of products for, other customers, partial or full loss of their facilities, or supply chain disruptions, including as a result of geopolitical conflicts, macroeconomic events or conditions, natural or manmade disasters, or public health emergencies such as the COVID-19 pandemic. For example, our single source CMO for Ovaprene is located in an area of the U.S. that is vulnerable to tropical storms, hurricanes, flooding and tornadoes, which have potential to render its facilities inoperative for protracted periods. One or more of our CMOs may fail or be unable to perform at a time that is costly or inconvenient for us. We may not have adequate or any recourse against a CMO or supplier who does not perform or terminates its agreement with us if such non-performance or termination is excused under the applicable agreement. 

We do not have long-term supply agreements with any of our CMOs or raw materials suppliers. We generally enter into manufacturing agreements on a project-by-project basis based on our development needs, which may heighten the risk of timely availability of sufficient quantities of our product candidates at acceptable costs for clinical trials. For example, we do not have any long-term manufacturing or supply agreements with the CMO from which we plan to obtain clinical supplies for our first Phase 3 clinical study of Sildenafil Cream or with the current supplier of the API for Sildenafil Cream. Future supplies of Sildenafil Cream or the raw materials required to produce it may be more difficult and costly to obtain because we do not have long-term supply contracts, which could make us more vulnerable to significant price increases. As we advance development of our product candidates, we will need to negotiate agreements for commercial supply and we may not be able to reach agreement on a timely basis or acceptable terms, or at all. In addition, the FDA or regulatory authorities outside of the U.S. may require that we have an alternate manufacturer of a product before approving it for marketing and sale in the U.S. or other jurisdiction, and securing such alternate manufacturer before approval of a marketing application could result in considerable additional time and cost prior to product approval.

Currently, we do not have alternative CMOs or API suppliers to back up our primary vendors of clinical trial material. Identification of and discussions with other vendors may be protracted and/or unsuccessful, or new vendors may not be successful in producing the same results as our current vendors on a timely basis at the appropriate volumes, at an acceptable cost