Company: TVRD
Filing Date: 2025-02-14
Form Type: 424B3
Source: 0001104659-25-014310
Chunk: 439

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: 424B3
Chunk 439
---
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A third party may hold intellectual property, including patent rights, which are important or necessary to the development of Cara’s products. It may be necessary for Cara to use the patented or proprietary technology of third parties to commercialize its products, in which case Cara would be required to obtain a license from these third parties on commercially reasonable terms, or its business could be harmed, possibly materially. If Cara were not able to obtain a license or were not able to obtain a license on commercially reasonable terms, its business could be harmed, possibly materially.

The patent positions of biopharmaceutical companies like Cara are generally uncertain and involve complex legal, scientific and factual questions. In addition, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and the patent’s scope can be modified after issuance by later judicial decisions. Consequently, Cara does not know whether its product candidates will be adequately protectable or remain protected by enforceable patents. Cara cannot predict whether the patent applications Cara is currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient proprietary protection from competitors. Any patents that Cara holds may be challenged, circumvented or invalidated by third parties.

Because patent applications in the United States and certain other jurisdictions are maintained in secrecy for up to 18 months, and since publication of discoveries in the scientific or patent literature often lags behind actual discoveries, Cara cannot be certain of its entitlement to the inventions covered by pending patent applications. Moreover, although unlikely, Cara may have to participate in interference proceedings declared by the United States Patent and Trademark Office (USPTO), to determine priority of invention, or in post-grant challenge proceedings in the USPTO, or a foreign patent office such as oppositions, inter-partes review, post grant review, or a derivation proceeding, that challenge Cara’s entitlement to an invention

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or the patentability of one or more claims in its patent applications or issued patents. Such proceedings could result in substantial cost, even if the eventual outcome is favorable to Cara.

The patent portfolios for Cara’s most advanced programs are summarized below.

#### Difelikefalin
Cara’s synthetic peptide amide kappa opioid agonist patent portfolio is wholly owned by Cara. The portfolio includes eighteen issued U.S. patents (U.S. Patent Nos. 7,402,564; 7,713,937; 7,727,963; 7,842,