Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 241

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 241
---
 our other operations, require significant capital expenditures and distract management and our other employees from other aspects of our business.

We will be reliant on Section 503B-registered outsourcing facilities to produce our proprietary Sildenafil Cream formulation, and their failure to adequately perform their obligations could harm our reputation, business and financial condition.

If we are able to enter into arrangements with one or more outsourcing facilities, we will be reliant on them to compound and distribute our proprietary Sildenafil Cream formulation and to comply with applicable statutory and regulatory requirements, including FDA's cGMP regulations and related FDA guidance for drugs compounded at outsourcing facilities. We will also be reliant on suppliers that supply sildenafil citrate to the outsourcing facilities. We will not control or direct the compounding or distribution process used by these parties, and we will have no control over their ability to maintain adequate quality control, quality assurance and qualified personnel. These arrangements also involve other risks, including:

•the inability of third parties to consistently meet product specifications and quality requirements;

•delay or inability to procure or expand sufficient manufacturing capacity;

•issues related to scale-up of manufacturing;

•costs and validation of new equipment and facilities required for scale-up;

•third parties may not be able to appropriately execute necessary manufacturing procedures and other logistical support requirements;

•third parties may fail to comply with cGMP requirements and other FDA or other comparable regulatory requirements;

•breach, termination or non-renewal of agreements in a manner or at a time that is 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