Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 148

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 148
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i’s
defenses to such assertions of infringement were unsuccessful, it could be liable for a court-determined reasonable royalty on its existing
sales and further damages to the patent owner (or licensee), such as lost profits. Such royalties and damages could be significant. If
Tvardi is found to have willfully infringed the claims of a third party’s patent, the third party could be awarded treble damages
and attorney’s fees. Further, unless Tvardi obtains a license to such patent, it may be precluded from commercializing the infringing
product candidate. Any of the aforementioned could have a material adverse effect on its business, financial condition, results of operations
and prospects.

​

Tvardi cannot guarantee the completeness or thoroughness
of any of its patent searches or analyses including, but not limited to, the identification of relevant patents, the scope of patent claims
or the expiration of relevant patents, nor can it be certain that it has identified each and every patent and pending application in the
United States and abroad that is relevant to or necessary for the commercialization of any of its product candidates in any jurisdiction.
Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in
issued patents that any of Tvardi’s product candidates may be accused of infringing. In addition, third parties may obtain patents
in the future and claim that use of Tvardi’s technologies

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infringes upon these patents. Accordingly, third parties may assert
infringement claims against Tvardi based on intellectual property rights that exist now or arise in the future. The outcome of intellectual
property litigation is subject to uncertainties that cannot be adequately quantified in advance. The pharmaceutical and biotechnology
industries have produced a significant number of patents, and it may not always be clear to industry participants, including Tvardi, which
patents cover various types of products or methods of use or manufacture. The scope of protection afforded by a patent is subject to interpretation
by the courts, and the interpretation is not always uniform. If Tvardi were sued for patent infringement, it would need to demonstrate
that the relevant product or methods of using the product either do not infringe the patent claims of the relevant patent or that the
patent claims are invalid or unenforceable, and Tvardi may not be able to do this. Proving invalidity is difficult. For