Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 336

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1A
Chunk 336
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 restrictions;

●requirements to conduct additional post-market clinical
trials to assess the safety of the product;

51

●fines, warning letters or holds on clinical trials;

●refusal by the FDA to approve pending applications or supplements
to approved applications filed by us or suspension or revocation of license approvals;

●product seizure or detention or refusal to permit the import
or export of our product candidates; and

●injunctions or the imposition of civil or criminal penalties.

The FDA’s, European Medicines Agency’s and other regulatory
authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory
approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future
legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing
requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any
marketing approval that we may have obtained and we may not achieve or sustain profitability.

The FDA, European Medicines Agency and other regulatory agencies
actively enforce the laws and regulations prohibiting the promotion of off-label uses.

The FDA, European Medicines Agency and other regulatory agencies strictly
regulate the post-approval marketing, labeling, advertising, and promotion of products that are placed on the market. The FDA, European
Medicines Agency and other regulatory agencies impose stringent restrictions on sponsors’ communications regarding off-label use.
Products may be promoted only for the approved indications and in accordance with the provisions of the approved label. However, companies
may share truthful and not misleading information that is not inconsistent with the labeling. The FDA, European Medicines Agency and other
agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses and a company that is found to have
improperly promoted off-label uses may be subject to significant liability. The federal government has levied large civil and criminal
fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion.
Violation of the Federal Food, Drug, and Cosmetic Act and other statutes, including the FCA, and equivalent legislation in other countries
relating to the promotion and advertising of prescription products may also lead to investigations or allegations of violations of federal
and state and other countries’ health care fraud and abuse laws and state consumer protection laws.