Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 97

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 97
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 may violate broadly
applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute
(“AKS”) and the federal False Claims Act (“FCA”). Those laws and regulations may constrain the business
or financial arrangements and relationships through which pharmaceutical manufactures sell, market and distribute pharmaceutical products.
In particular, the research of our product candidates, as well as the promotion, sales and marketing of healthcare items and services,
as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks,
self-dealing and other abusive practices. If we do not strictly comply with these laws and regulations, we may be found to be criminally
or civilly liable for violations under those laws and regulations, including a false or fraudulent claim, which could subject us (and,
potentially, our employees) from significant fines and penalties, including prison.

The scope and enforcement of each of these laws may be uncertain and
subject to rapid change in the current environment of healthcare reform. Ensuring business arrangements comply with applicable healthcare
laws, as well as responding to possible investigations by government authorities, can be time- and resource-consuming and can divert
a company’s attention from the business.

If we are not successful in defending ourselves or asserting our rights,
governmental or other actions could have a significant impact on our business, including the imposition of significant civil, criminal
and administrative penalties, damages, fines, disgorgement, imprisonment, reputational harm, possible exclusion from participation in
federal and state funded healthcare programs, contractual damages and the curtailment or restricting of our operations, as well as additional
reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations
of non-compliance with these laws. Any action for violation of these laws, even if successfully defended, could cause a pharmaceutical
manufacturer to incur significant legal expenses and divert management’s attention from the operation of the business. Prohibitions
or restrictions on sales or withdrawal of future marketed products could materially affect business in an adverse way.

Even if we receive regulatory approval of any product candidates,
we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense
and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product
candidates.

If any of our product candidates are approved, they will be subject
to ongoing regulatory requirements for