Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 142

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 142
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 governing patents could change in unpredictable ways that would weaken its ability
to obtain new patents or to enforce its existing patents and patents that it might obtain in the future.

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Further, a new court system recently became operational
in the European Union. The Unified Patent Court (UPC), began accepting patent cases on June 1, 2023. The UPC is a common patent court
with jurisdiction over patent infringement and revocation proceedings effective for multiple member states of the European Union. The
broad geographic reach of the UPC could enable third parties to seek revocation of any of Tvardi’s European patents in a single
proceeding at the UPC rather than through multiple proceedings in each of the individual European Union member states in which the European
patent is validated. Under the UPC, a successful revocation proceeding for a European Patent under the UPC would result in loss of patent
protection in those European Union countries. Accordingly, a single proceeding under the UPC could result in the partial or complete loss
of patent protection in numerous European Union countries. Such a loss of patent protection could have a material adverse impact on Tvardi’s
business and its ability to commercialize its technology and product candidates and, resultantly, on its business, financial condition,
prospects and results of operations. Moreover, the controlling laws and regulations of the UPC will develop over time and Tvardi cannot
predict what the outcomes of cases tried before the UPC will be. The case law of the UPC may adversely affect Tvardi’s ability to
enforce or defend the validity of

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its European patents. Patent owners have the option to opt-out their
European Patents from the jurisdiction of the UPC, defaulting to pre-UPC enforcement mechanisms. Tvardi has decided to opt out certain
European patents and patent applications from the UPC. However, if certain formalities and requirements are not met, its European patents
and patent applications could be subject to the jurisdiction of the UPC. Tvardi cannot be certain that its European patents and patent
applications will avoid falling under the jurisdiction of the UPC, if it decides to opt out of the UPC.

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Tvardi may not be able to seek or obtain patent protection throughout the world or enforce such patent protection once obtained.

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Filing, prosecuting, enforcing and defending patents
protecting Tvardi’s product candidates in all countries throughout the world would be prohibitively expensive, and its intellectual
property rights