Company: TVRD
Filing Date: 2025-11-13
Form Type: 424B3
Source: 0001104659-25-111336
Chunk: 187

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 424B3
Chunk 187
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 regulations, its internal policies and procedures or its contracts governing the processing of personal information
could result in, among other things, negative publicity, government investigations and enforcement actions, claims by third parties and
damage to Tvardi’s reputation, any of which could have a material adverse effect on its business, results of operation, and financial
condition.

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In the United States, federal, state, and local
governments have enacted numerous data privacy and security laws, including data breach notification laws, data privacy laws, and other
similar laws. For example, HIPAA, as amended by HITECH (collectively, HIPAA), imposes among other things, certain requirements relating
to the privacy, security, transmission, and breach of individually identifiable health information. Tvardi may obtain health information
from third parties (including research institutions from which it obtains clinical trial data) that are subject to privacy and security
requirements under HIPAA. Depending on the facts and circumstances, Tvardi could be subject to significant penalties if it violates HIPAA.

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Certain states have also adopted comparable privacy
and security laws and regulations, which govern the privacy, processing and protection of health-related and other personal information.
Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially
complex compliance issues for Tvardi and its future customers and strategic partners. For example, the CCPA, went into effect on January
1, 2020 and applies to the personal information of consumers, business representatives, and employees who are California residents, and
increases the privacy and security obligations of covered businesses under the CCPA that handle personal information subject to the CCPA,
including among other things, requiring such businesses to provide specific disclosures in privacy notices and honor requests of California
residents to exercise certain privacy rights, including the right to opt out of certain disclosures of their information. The CCPA provides
for civil penalties as well as a private right of action with statutory damages for certain data breaches, thereby potentially increasing
the likelihood of, and risks associated with, data breach litigation. Although the law includes limited exceptions, including for certain
information collected as part of clinical trials, the CCPA may impact Tvardi’s processing of personal information and increase its
compliance costs. Additionally, the California Privacy Rights Act of 2020 (CPRA) went into effect on January 1, 2023, and significantly
expands the CCPA, such as by granting additional rights to California residents,