Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 100

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 100
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 program. Under the agreement, we received an exclusive, worldwide, royalty-bearing license to research, develop and commercialize the licensed technology. We are entitled to sublicense the rights granted to us under the agreement.

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Milestone Payments. We agreed to make potential future development and sales milestone payments of (1) up to $6.25 million in the aggregate upon achieving certain development and regulatory milestones, and (2) up to $45.0 million in the aggregate upon achieving certain commercial sales milestones for each product covered by the licenses granted under the agreement, which may be paid, in our sole discretion, in cash or shares of our common stock. 

Royalty Payments. Hennepin is eligible to receive tiered royalties in low single-digit to low double-digit percentages based on worldwide net sales of products and processes covered by the licenses granted under the agreement.

Efforts. We must use commercially reasonable efforts to develop and introduce to market at least one product.

Term.  Unless earlier terminated, the agreement expires in its entirety upon the last to expire royalty term. In addition to customary termination rights for both parties, we may elect to terminate the agreement at any time, with or without cause, on a country-by-country basis, and Hennepin may terminate the agreement if we do not undertake any development work with respect to the licensed intellectual property for five consecutive years from the date of the agreement.

Cooperative Research and Development Agreement with NICHD

In July 2021, we entered into a CRADA with the U.S. Department of Health and Human Services (HHS), as represented by NICHD, part of the NIH, for the conduct of a pivotal Phase 3 clinical study of Ovaprene.  Pursuant to the terms of the CRADA, we are responsible for providing clinical supplies of Ovaprene, coordinating interactions with the FDA, preparing and submitting supportive regulatory documentation, and providing a total of $5.5 million to NICHD to be applied toward the costs of conducting the Phase 3 study,  all of which had been paid as of September 30, 2024. NICHD is responsible for the other costs related to the conduct of the Phase 3 study and for managing the payment of expenses to other parties involved with the study. However, for recent developments relating to NICHD's performance under the CRADA, see "Our Pipeline: Clinical Stage Programs–Ovaprene–Pivotal Phase 3 Clinical Study" above. Either we or NICHD may terminate