Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 99

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 99
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 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. Even if it is later determined
we were not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our actions and
have to divert significant management resources from other matters. If we cannot successfully manage the promotion of our product candidates,
if approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

The Affordable Care Act and the Inflation Reduction Act, as well
as other ongoing healthcare legislative and regulatory reform measures, may have a material adverse effect on our business and results
of operations.

Congress and regulatory agencies in the United States (and to
a lesser extent, state legislatures) have in recent years proposed and sometimes adopted substantial changes in laws and regulations
that affect the healthcare and pharmaceutical industry. These laws, including what is known as the Affordable Care Act (the “ACA”),
and the IRA, have substantially changed the way health care is financed by both governmental and private insurers, and significantly impacted
the