Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 129

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 129
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vardi’s patent portfolio, such patents may be invalid and/or unenforceable, and such applications
may never result in valid, enforceable patents. Periodic maintenance fees, renewal fees, annuity fees and various other government fees
on patents and/or applications will be due to be paid to the U.S. Patent and Trademark Office (USPTO), and various government patent agencies
outside of the United States over the lifetime of Tvardi’s owned or licensed patents and patent applications. Tvardi currently relies
on its outside counsel and BCM to pay these fees due to U.S. and non-U.S. patent agencies. The USPTO and various non-U.S. government patent
agencies require compliance with

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several procedural, documentary, fee payment and other similar provisions
during the patent application process. Any of these outcomes could impair Tvardi’s ability to prevent competition from third parties,
which may have an adverse impact on its business.

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The patent position of biotechnology and pharmaceutical
companies carries uncertainty. In addition, the determination of patent rights with respect to pharmaceutical products commonly involves
complex legal and factual questions, which are dependent upon the current legal and intellectual property context, extant legal precedent
and interpretations of the law by individuals. As a result, the issuance, scope, validity, enforceability and commercial value of Tvardi’s
patent rights are characterized by uncertainty.

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Tvardi’s competitors may seek approval to
market their own products similar to or otherwise competitive with Tvardi’s products. In these circumstances, Tvardi may need to
defend or assert its own and in-licensed patents, or both, including by filing lawsuits alleging patent infringement. In any of these
types of proceedings, a court or other agency with jurisdiction may find Tvardi’s patents invalid or unenforceable, or that Tvardi’s
competitors do not infringe its own and licensed patents. As such, even if Tvardi has valid and enforceable patents, these patents still
may not provide protection against competing products or processes sufficient to achieve its business objectives.

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Tvardi also maintains certain information as company
trade secrets. This information may relate to inventions that are not patentable or not optimally protected with patents. Tvardi uses
commercially acceptable practices to protect this information, including, for example, limiting access to the information and requiring
passwords for its computers.