Company: TVRD
Filing Date: 2025-02-14
Form Type: 424B3
Source: 0001104659-25-014310
Chunk: 501

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: 424B3
Chunk 501
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 States, patents that cover an FDA-approved drug or biologic may also be eligible for patent term extension, which permits patent term restoration as compensation for the patent term lost during FDA regulatory review process. The Hatch-Waxman Act permits a patent term extension of up to five years beyond the expiration of the patent. The length of the patent term extension is related to the length of time the drug or biologic is under regulatory review. Patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent applicable to an approved drug or biologic may be extended and only those claims covering the approved drug or biologic, a method for using it, or a method for manufacturing it may be extended. Similar provisions are available in European Member States and other foreign jurisdictions to extend the term of a patent that covers an approved drug or biologic. In the future, if Tvardi’s product candidates receive FDA approval, it expects to apply for patent term extensions where applicable on patents covering those products. Tvardi plans to seek patent term extensions to any of its issued patents in any jurisdiction where these are available, however there is no guarantee that the applicable authorities, including the U.S. Patent and Trademark Office in the United States, will agree with Tvardi’s assessment of whether these extensions should be granted, and if granted, the length of these extensions.

Tvardi’s intellectual property is critical to its business, and it strives to protect it through a variety of approaches, including by obtaining and maintaining patent protection in various countries for its product candidates and other inventions that are important to its business.

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#### Trademarks
As of September 30, 2024, Tvardi owns the trademark registrations for the company. Trademarks include “TVARDI,” which is registered in Australia, China, European Union, Japan, the United Kingdom and the United States, and pending in Canada and Korea.

#### Trade Secrets and Proprietary Information
In addition to Tvardi’s reliance on patent protection for its inventions, it also relies on trade secrets, know-how, confidentiality agreements and continuing technological innovation to develop and maintain Tvardi’s competitive position. Although Tvardi takes steps to protect its proprietary information and trade secrets, including through contractual means with its employees, advisors and consultants, these agreements may be breached, and Tvardi may not have adequate remedies for any breach. In addition, third parties may