Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 255

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 255
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 we are subject to certain restrictions on foreign access to the intellectual property and other technology developed by or for us in or for the provision of such services, including restrictions on our sale or other transfer of such technology to a foreign firm or institution (which would include a sale of our company and a sale or licensing of such technology, but not sales of products or components) without the prior approval of the federal agency providing funding for the subaward agreement. 

The U.S. federal government retains certain rights in inventions produced with its financial assistance. Under the Bayh-Dole Act, the federal government retains a nonexclusive, nontransferable, irrevocable, paid-up license for its own benefit. The Bayh-Dole Act also provides federal agencies with “march-in” rights. March-in rights allow federal agencies, in specified circumstances, to require the recipient of federal funding (the contractor) or successors in title to the patent to grant a nonexclusive, partially exclusive or exclusive license to a third party if it determines that (i) adequate steps have not been taken to achieve practical application of the invention, (ii) government action is necessary to meet public health or safety needs, (iii) government action is necessary to meet requirements for public use under federal regulations or (iv) unless the requirement has been waived, the contractor has failed to substantially manufacture in the U.S. any product embodying the subject invention that is intended for U.S. commerce. If the contractor or its successor refuses to do so, the government may grant the license itself. The federal government also has the right to take title to these inventions if the contractor or its successor fails to disclose the invention to the government or fails to file an application to register the intellectual property within specified time limits. To date, no federal agency has ever exercised march-in rights; however, the Biden administration announced that it viewed march-in rights as a legitimate means for the government to address rising pharmaceutical costs and future use of march-in rights by the government is uncertain. Any exercise by the government of march-in rights could harm our competitive position, business, financial condition, results of operations and prospects. 

Under our grant agreements with the Foundation, we agreed to make products, services, processes, technologies, materials, software, data, other innovations, and intellectual property resulting from the respective 

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projects funded by the respective grants (referred to as Funded Developments), available and accessible at an affordable price to people most in need within developing countries, and to promptly and broadly disseminate the knowledge