Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 98

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 98
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 and our rights to a portion of future net sales of Ovaprene under our agreement with Bayer. 

Efforts. We will be responsible for the pivotal trial for Ovaprene and for its development and regulatory activities and we have product supply obligations. After payment of the Clinical Trial and Manufacturing Activities Fee, Bayer will be responsible for the commercialization of Ovaprene for human contraception in the U.S.

Term. The initial term of the agreement, which is subject to automatic renewal terms, continues until the later of (a) the expiration of any valid claim covering the manufacture, use, sale or import of Ovaprene in the U.S.; or (b) 15 

20

years from the first commercial sale of Ovaprene in the U.S. In addition to customary termination rights for both parties, Bayer may terminate the agreement at any time on 90 days’ notice and the agreement will automatically terminate if we do not receive the Clinical Trial and Manufacturing Activities Fee if and when due.

Strategic Agreements for Pipeline Development

The following is a summary of certain rights and obligations under our strategic agreements and describes expenses incurred during 2024 and our future payment or potential future payment obligations thereunder.

Theramex Co-Development and License Agreement

In February 2025, we entered into a co-development and licensing agreement with Theramex for  an investigational biodegradable contraceptive implant called Casea S recently acquired by Theramex. Under the agreement, we received a royalty-free, exclusive, fully paid up, sublicensable license to the U.S. patents Theramex recently acquired for Casea S. We paid a minimal fee to Theramex in connection with entering into the agreement. There are no development costs to us at this time. If we determine that the results from the ongoing Phase 1 clinical study are positive and elect to proceed with development, we would be responsible for conducting a Phase 2 study in the U.S. In accordance with our agreement, the costs of such Phase 2 study, and the costs of a future Phase 3 study in the U.S., would be shared by us and Theramex on terms to be agreed upon, taking into account the size of the opportunity for Casea S in our respective markets. If we do not elect to proceed with development after reviewing the results from the Phase 1 study, we may terminate the agreement upon notice to Theramex. 

Douglas License Agreement / The University of Manchester Stand-by Direct License Arr