Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 43

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 43
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 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 Arrangement In August 2023, we entered into a license agreement with Douglas Pharmaceuticals Limited, or Douglas, under which we acquired the exclusive rights to develop and commercialize a lopinavir and ritonavir combination soft gel vaginal insert for the treatment of CIN and other HPV-related pathologies, and an agreement with The University of Manchester, pursuant to which The University of Manchester consented to Douglas' sublicense to us of certain rights it previously granted to Douglas and agreed to grant us a direct license to such rights if its license agreement with Douglas is terminated. As a result of these agreements, we commenced our DARE-CIN program. Under our agreement with Douglas, we received an exclusive, royalty-bearing license to research, develop and commercialize the licensed intellectual property in the United States for the treatment or prevention of all indications