Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 138

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 138
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In addition, the U.S. federal government retains
certain rights in inventions produced with its financial assistance under Patent and Trademark Law Amendments Act (the Bayh-Dole Act).
The U.S. 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 the government, in specified circumstances,
to require the contractor or successors in title to the patent to grant a “nonexclusive, partially exclusive, or exclusive license”
to a “responsible applicant or applicants.” If the patent owner refuses to do so, the government may grant the license itself.
Tvardi may at times choose to collaborate with academic institutions to accelerate its preclinical research or development. If Tvardi
engages with university partners in projects where there is a risk that federal funds may be commingled, it cannot be sure that any co-developed
intellectual property will be free from government rights pursuant to the Bayh-Dole Act. If the federal government chooses to exercise
its march-in rights with respect to any patents or technology Tvardi in-licensed and which is critical to its business that is developed
in whole or in part with federal funds subject to the Bayh-Dole Act, Tvardi’s ability to enforce or otherwise exploit patents covering
such patents or technology may be adversely affected.

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Patent terms may be inadequate to protect Tvardi’s competitive position on its products for an adequate amount of time.

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Patents have a limited lifespan. In the United States,
if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional
filing date. The patent term of a U.S. patent may be lengthened by patent term adjustment, which compensates a patentee for administrative
delays by the USPTO in granting a patent or may be shortened if a patent is terminally disclaimed over an earlier-filed patent.

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Various extensions may be available, but the life
of a patent, and the protection it affords, is limited. Given the amount of time required for the development, testing and regulatory
review of new pharmaceutical products, patents protecting such pharmaceutical products might expire before or shortly after such pharmaceutical
products are commercialized.

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In the United States, the Drug Price